Crystalline forms, crystalline salt forms, compositions containing the same, and methods of using the same

Abstract

Disclosed are crystalline forms of (S)-Compound 1 and crystalline forms of (R)-Compound 1. (1-S) (1-R) as well as pharmaceutically acceptable salts, solvates, or hydrates thereof, useful for the treatment of a disease or condition, e.g., cancer.

Description

[0001] PATENT ATTORNEY DOCKET NO.: 51246-037WO2 CRYSTALLINE FORMS, CRYSTALLINE SALT FORMS, COMPOSITIONS CONTAINING THE SAME, AND METHODS OF USING THE SAME FIELD OF THE INVENTION The invention features novel crystalline forms of compounds, or a pharmaceutically acceptable salt, solvate, or hydrate thereof, useful for the treatment of a disease or condition. BACKGROUND OF THE INVENTION DNA is continuously subjected to both endogenous insults (e.g., stalled replication forks, reactive oxygen species) and exogenous insults (UV, ionizing radiation, chemical) that can lead to DNA damage. As a result, cells have established sophisticated mechanisms to counteract these deleterious events that would otherwise compromise genomic integrity and lead to genomic instability diseases such as cancer. These mechanisms are collectively referred to as the DNA damage response (DDR). One component of the overall DDR is the activation of various checkpoint pathways that modulate specific DNA-repair mechanisms throughout the various phases of the cell cycle, which includes the G1, S, G2 and Mitosis checkpoints. A majority of cancer cells have lost their G1 checkpoint owing to one or more mutations and as such, rely on the G2 checkpoint to make the necessary DNA damage corrections prior to committing to enter mitosis and divide into 2 daughter cells. Compounds which inhibit G2 checkpoint proteins (e.g., inhibitors of membrane-associated tyrosine and threonine-specific cdc2-inhibitory kinase (Myt1)) may therefore be used in the treatment of cancer. Crystalline forms of these compounds (including crystalline salt forms), as well as solvates or hydrates thereof, are useful for the treatment of a disease or condition, e.g., cancer, could benefit properties such as the stability of the compounds. Generally, crystalline forms are easier to handle than amorphous forms. Crystallization may also help optimize the purity of a compound, or a pharmaceutically acceptable salt, solvate, or hydrate thereof. Accordingly, there is a need for identifying new crystalline forms of compounds, or a pharmaceutically acceptable salt, solvate, or hydrate thereof, useful for the treatment of a disease or condition, e.g., cancer, that exhibit improved physical properties, e.g., stability, to be suitable for use in pharmaceutical compositions. SUMMARY OF THE INVENTION The disclosure features crystalline forms of compounds useful for the treatment of a disease or condition (e.g., cancer, e.g., cancers including, expressing, or characterized by an overexpression or amplification of CCNE1, a loss of function mutation in FBXW7, a loss of function mutation in PPP2R1A, a gain-of-function mutation in KRAS, an amplification of or a gain-of-function mutation in CMYC, a loss-of- function mutation in PTEN, a gain-of-function mutation in PIK3CA, a loss-of-function mutation in CDK12, a mutation imparting resistance to CDK4 or CDK6, a loss-of-function mutation in RB1, a gain-of-function mutation in HRAS, a gain-of-function mutation in NRAS, a gain-of-function mutation in BRAF, a loss-of- function mutation in CDKN2A, a gain-of-function mutation in CDC25A, a gain of function mutation in EGFR, or a prior or current infection with HPV), in particular those diseases or conditions which may have PATENT ATTORNEY DOCKET NO.: 51246-037WO2 an increased dependence on the activity of membrane-associated tyrosine and threonine-specific cdc2-inhibitory kinase (Myt1) (e.g., due to a mutation or overexpression above). In an aspect, the disclosure provides a crystalline form of (S)-Compound 1: or a solvate thereof, wherein the crystalline form is characterized by a x-ray powder diffraction (XRPD) pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.1 °2^ ± 0.2 °2^, and 19.4 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.8 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, 16.6 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^. In some embodiments, the solvate is a hydrate. In some embodiments, the solvate is a monohydrate. In some embodiments, the monohydrate is further characterized by a unit cell with parameters a = 10.6597 Å ± 0.0003 Å, b = 10.6597 Å ± 0.0003 Å, c = 15.1615 Å ± 0.0006 Å and ^ = ^ = ^ = 90 °. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 35 °C to 43 °C by differential scanning calorimetry (DSC). In some embodiments, the crystalline form is further characterized by an endothermic event onset at 277 °C to 281 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (S)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.8 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 16.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 4.9 °2^ ± 0.2 °2^, 8.4 °2^ ± 0.2 °2^, 12.3 °2^ ± 0.2 °2^, and 19.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 187 °C to 206 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 278 °C to 285 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (S)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 13.3 °2^ ± 0.2 °2^, and 18.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 63 °C to 76 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 285 °C to 288 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (S)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 14.8 °2^ ± 0.2 °2^, 15.5 °2^ ± 0.2 °2^, and 22.7 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.5 °2^ ± 0.2 °2^, 10.9 °2^ ± 0.2 °2^, 18.5 °2^ ± 0.2 °2^, 23.5 °2^ ± 0.2 °2^, and 28.9 °2^ ± 0.2 °2^. In PATENT ATTORNEY DOCKET NO.: 51246-037WO2 some embodiments, the crystalline form is further characterized by an endothermic event onset at 136 °C to 139 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 150 °C to 156 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 280 °C to 285 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (S)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.5 °2^ ± 0.2 °2^, 14.6 °2^ ± 0.2 °2^, 17.9 °2^ ± 0.2 °2^, and 25.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^ and 22.4 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 165°C to 188 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 191°C to 197 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 271°C to 279 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (S)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.9 °2^ ± 0.2 °2^, 11.3 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.9 °2^ ± 0.2 °2^, 15.7 °2^ ± 0.2 °2^, 19.1 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 151 °C to 161 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 283 °C to 287 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (S)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.2 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.7 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, and 16.6 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 39 °C to 52 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic even onset at 138 °C to 144 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 268 °C to 275 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.1 °2^ ± 0.2 °2^, and 19.4 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.8 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, 16.6 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^. In some embodiments, the solvate is a hydrate. In some embodiments, the solvate is a monohydrate. In some embodiments, the monohydrate is further characterized by a unit cell with parameters a = 10.6597 Å ± 0.0003 Å, b = 10.6597 Å ± 0.0003 Å, c = 15.1615 Å ± 0.0006 Å and ^ = ^ = ^ = 90 °. In some embodiments, the crystalline form is further characterized by an endothermic event onset at from 34 °C to 44 °C by DSC. In PATENT ATTORNEY DOCKET NO.: 51246-037WO2 some embodiments, the crystalline form is further characterized by an endothermic event onset at 277 °C to 282 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.8 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 16.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 4.9 °2^ ± 0.2 °2^, 8.4 °2^ ± 0.2 °2^, 12.3 °2^ ± 0.2 °2^, and 19.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 187 to 206 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 278 °C to 285 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 13.3 °2^ ± 0.2 °2^, and 18.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 63 °C to 76 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 285 °C to 288 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 14.8 °2^ ± 0.2 °2^, 15.5 °2^ ± 0.2 °2^, and 22.7 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.5 °2^ ± 0.2 °2^, 10.9 °2^ ± 0.2 °2^, 18.5 °2^ ± 0.2 °2^, 23.5 °2^ ± 0.2 °2^, and 28.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 136°C to 139 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 150 °C to 156 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 280 °C to 285 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.5 °2^ ± 0.2 °2^, 14.6 °2^ ± 0.2 °2^, 17.9 °2^ ± 0.2 °2^, and 25.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^ and 22.4 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 165 °C to 188 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 191 °C to PATENT ATTORNEY DOCKET NO.: 51246-037WO2 197 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 271 °C to 279 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.9 °2^ ± 0.2 °2^, 11.3 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.9 °2^ ± 0.2 °2^, 15.7 °2^ ± 0.2 °2^, 19.1 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 151°C to 161 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 283°C to 286 °C by DSC. In a further aspect, the disclosure provides a crystalline form of (R)-Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.2 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at further characterized by having peaks at 11.7 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, and 16.6 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 39 °C to 52 °C by DSC. In some embodiments, the crystalline form is characterized by an endothermic event onset at 138 °C to 144 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 268 °C to 275 °C by DSC. In a further aspect, the disclosure provides a solvate (e.g., a crystalline containing at least one solvent molecule) of (S)-Compound 1 or a salt thereof. In some embodiments, the solvate is a hydrate. In some embodiments, the hydrate is a monohydrate. In some embodiments, the hydrate is a hemihydrate. In a further aspect, the disclosure provides a solvate (e.g., a crystalline form containing at least one solvent molecule) of 1 or a salt thereof. In some embodiments, the solvate is a hydrate. In some embodiments, the hydrate is a monohydrate. In some embodiments, the hydrate is a hemihydrate. In a further aspect, the disclosure provides a crystalline form of a hemi-maleate salt of (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.8 °2^ ± 0.2 °2^, 13.7 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^, 18.8 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 17.5 °2^ ± 0.2 °2^, 18.6 °2^ ± 0.2 °2^, 25.6 °2^ ± 0.2 °2^, and 26.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 200 °C to 209 °C by DSC. In a further aspect, the disclosure provides a crystalline form of a hemi-maleate salt of (S)- Compound 1 or a solvent thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 13.2 °2^ ± 0.2 °2^, 17.6 °2^ ± 0.2 °2^, 23.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 22.2 °2^ ± 0.2 °2^ and 22.6 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset from 115 °C to PATENT ATTORNEY DOCKET NO.: 51246-037WO2 134 °C by DSC. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 195 °C to 198 °C by DSC. In a further aspect, the disclosure provides a crystalline form of a mesylate salt of (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.0 °2^ ± 0.2 °2^, 11.8 °2^ ± 0.2 °2^, and 21.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern having peaks at 19.7 °2^ ± 0.2 °2^, 22.6 °2^ ± 0.2 °2^, and 29.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 238 °C to 243 °C by DSC. In a further aspect, the disclosure provides a crystalline form of a mesylate salt of (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.3 °2^ ± 0.2 °2^, 13.4 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern having peaks at 12.4 °2^ ± 0.2 °2^, 17.8 °2^ ± 0.2 °2^, 22.4 °2^ ± 0.2 °2^, and 29.5 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 50 °C to 75 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 140 °C to 147 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 150 °C to 159 °C. In some embodiments, the solvate is a THF solvate. In a further aspect, the disclosure provides a crystalline form of a mesylate salt of formula (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.0 °2^ ± 0.2 °2^, 14.3 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.0 °2^ ± 0.2 °2^, 17.7 °2^ ± 0.2 °2^, 18.0 °2^ ± 0.2 °2^, and 20.0 ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 135 °C to 164 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 235 °C to 239 °C. In some embodiments, the solvate is a 1,4-dioxne solvate. In a further aspect, the disclosure provides a crystalline form of a hydrochloric acid salt of (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.2 °2^ ± 0.2 °2^, 15.0 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.1 °2^ ± 0.2 °2^, 16.1 °2^ ± 0.2 °2^, and 23.4 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is characterized by an endothermic event onset at 50 °C to 105 °C. In some embodiments, the crystalline form is characterized by an endothermic event onset at 220 °C to 232 °C. In a further aspect, the disclosure provides a crystalline form of a hydrochloric acid salt of (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 15.5 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.5 °2^ ± 0.2 °2^, 23.6 °2^ ± 0.2 °2^, PATENT ATTORNEY DOCKET NO.: 51246-037WO2 24.7 °2^ ± 0.2 °2^, and 27.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is characterized by an endothermic event onset at from 100 °C to 195 °C. In a further aspect, the disclosure provides a crystalline form of a hydrochloric acid salt of (S)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 13.8 °2^ ± 0.2 °2^, and 23.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 19.0 °2^ ± 0.2 °2^, 18.9 °2^ ± 0.2 °2^ and 28.6 °2^ ± 0.2 °2^. In some embodiments, the crystalline form of claim 109 or 110, wherein the crystalline form is further characterized by an endothermic onset at 120 °C to 167 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 160 °C to 192 °C. In a further aspect, the disclosure provides a crystalline form of a hemi-maleate salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.8 °2^ ± 0.2 °2^, 13.7 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation at 15.2 °2^ ± 0.2 °2^, 25.6 °2^ ± 0.2 °2^ and 26.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 200 °C to 209 °C by DSC. In a further aspect, the disclosure provides a crystalline form of a hemi-maleate salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 13.2 °2^ ± 0.2 °2^, 17.6 °2^ ± 0.2 °2^, 23.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation at 22.1 °2^ ± 0.2 °2^ and 22.6 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 115 °C to 134 °C by DSC. In some embodiments, the crystalline form is further characterized by a endothermic event onset from 195 °C to 198 °C by DSC. In a further aspect, the disclosure provides for a crystalline form of a mesylate salt of (R)- Compound 1 or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 11.8 °2^ ± 0.2 °2^, and 21.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern having peaks at 19.7 °2^ ± 0.2 °2^, 22.6 °2^ ± 0.2 °2^, and 29.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 238 °C to 243 °C. In some embodiments, the crystalline form is a solvate. In a further aspect, the disclosure provides a crystalline form of a mesylate salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.3 °2^ ± 0.2 °2^, 13.4 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern having peaks at 12.4 °2^ ± 0.2 °2^, 17.8 °2^ ± 0.2 °2^, 22.4 °2^ ± 0.2 °2^, and 29.5 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 50 °C to 75 °C. In some embodiments, the crystalline form is further characterized by an endothermic PATENT ATTORNEY DOCKET NO.: 51246-037WO2 event onset at 140 °C to 147 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 150 °C to 159 °C. In some embodiments, the solvate is a THF solvate. In a further aspect, the disclosure provides a crystalline form of a mesylate salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.0 °2^ ± 0.2 °2^, 14.3 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.0 °2^ ± 0.2 °2^, 17.7 °2^ ± 0.2 °2^, 18.0 °2^ ± 0.2 °2^, and 20.0 ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 135 °C to 164 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 235 °C to 239 °C. In some embodiments, the solvate is a 1,4-dioxane solvate. In some embodiments, the mesylate salt is a mono-mesylate salt. In a further aspect, the disclosure provides a crystalline form of a hydrochloric acid salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.2 °2^ ± 0.2 °2^, 15.0 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.1 °2^ ± 0.2 °2^, 16.1 °2^ ± 0.2 °2^, and 23.4 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 50 °C to 105 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 220 °C to 232 °C. In a further aspect, the disclosure provides a crystalline form of a hydrochloric acid salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 15.5 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.5 °2^ ± 0.2 °2^, 23.6 °2^ ± 0.2 °2^, 24.7 °2^ ± 0.2 °2^, and 27.8 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic event onset at from 100 °C to 195 °C. In a further aspect, the disclosure provides a crystalline form of a hydrochloric acid salt of (R)- Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 13.8 °2^ ± 0.2 °2^, and 23.1 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 18.9 °2^ ± 0.2 °2^, 19.0 °2^ ± 0.2 °2^, and 28.6 °2^ ± 0.2 °2^. In some embodiments, the crystalline form is further characterized by an endothermic onset at 120 °C to 167 °C. In some embodiments, the crystalline form is further characterized by an endothermic event onset at 160 °C to 192 °C. In a further aspect, the disclosure provides a pharmaceutical composition including a crystalline form of any preceding aspect. In a still further aspect, the disclosure provides a method of inhibiting the activity of membrane associated tyrosine and threonine-specific cdc2-inhibitory kinase in a cell, the method including the administration of an effective amount of the crystalline form of a preceding aspect or the pharmaceutical composition of a preceding aspect. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 In a still further aspect, the disclosure provides a method of inducing cell death in a cancer cell, the method including contacting the cell with an effective amount of the crystalline form of a preceding aspect or the pharmaceutical composition of a preceding aspect. In some embodiments of a preceding method aspect, the cell is in a subject. In some embodiments, the subject has been identified as having a disease. In some embodiments, the disease is cancer. In some embodiments, the cancer includes a mutation in, an amplification of, or the overexpression of KRAS, NRAS, HRAS, TP53, CCNE1, CDK4, CDK6, CDK12, CDKN2A, CDC25A, EGFR, FBXW7, c-MYC, PIK3CA, PPP2R1A, PTEN, RB1, BRAF, or a prior or current infection with HPV. In some embodiments, the cancer includes a mutation in FBXW7. In some embodiments, the cancer includes an amplification or overexpression of CCNE1. In some embodiments, the cancer includes mutation in KRAS. In some embodiments, the cancer includes a mutation in HRAS. In some embodiments, the cancer includes a mutation in NRAS. In some embodiments, the cancer is uterine cancer, ovarian cancer, breast cancer, stomach cancer, esophageal cancer, lung cancer, colorectal cancer or endometrial cancer. Definitions The term “about,” as used herein, refers to a range of values equal to ± 10 % of a recited value. The term "cancer," as used herein, refers to all types of cancer, neoplasm or malignant tumors found in mammals (e.g., humans) including leukemia, carcinomas and sarcomas. Non limiting examples of cancers that may be treated with a compound or method provided herein include prostate cancer, thyroid cancer, endocrine system cancer, brain cancer, breast cancer, cervix cancer, colon cancer, head & neck cancer, liver cancer, kidney cancer, lung cancer, non-small cell lung cancer, melanoma, mesothelioma, ovarian cancer, sarcoma, stomach cancer, uterus cancer, medulloblastoma, ampullary cancer, colorectal cancer, and pancreatic cancer. Additional non-limiting examples may include, Hodgkin's disease, Non-Hodgkin's lymphoma, multiple myeloma, neuroblastoma, glioma, glioblastoma multiforme, ovarian cancer, rhabdomyosarcoma, primary thrombocytosis, primary macroglobulinemia, primary brain tumors, cancer, malignant pancreatic insulinoma, malignant carcinoid, urinary bladder cancer, premalignant skin lesions, testicular cancer, lymphoma, thyroid cancer, neuroblastoma, esophageal cancer, genitourinary tract cancer, malignant hypercalcemia, endometrial cancer, adrenal cortical cancer, neoplasms of the endocrine or exocrine pancreas, medullary thyroid cancer, medullary thyroid carcinoma, melanoma, colorectal cancer, papillary thyroid cancer, hepatocellular carcinoma, and prostate cancer. The term "carcinoma," as used herein, refers to a malignant new growth made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. Non limiting examples of carcinomas that may be treated with a compound or method provided herein include, e.g., medullary thyroid carcinoma, familial medullary thyroid carcinoma, acinar carcinoma, acinous carcinoma, adenocystic carcinoma, adenoid cystic carcinoma, carcinoma adenomatosum, carcinoma of adrenal cortex, alveolar carcinoma, alveolar cell carcinoma, basal cell carcinoma, carcinoma basocellulare, basaloid carcinoma, basosquamous cell carcinoma, bronchioalveolar carcinoma, bronchiolar carcinoma, bronchogenic carcinoma, cerebriform carcinoma, cholangiocellular carcinoma, chorionic carcinoma, PATENT ATTORNEY DOCKET NO.: 51246-037WO2 colloid carcinoma, comedo carcinoma, corpus carcinoma, cribriform carcinoma, carcinoma en cuirasse, carcinoma cutaneum, cylindrical carcinoma, cylindrical cell carcinoma, duct carcinoma, carcinoma durum, embryonal carcinoma, encephaloid carcinoma, epidermoid carcinoma, carcinoma epitheliale adenoides, exophytic carcinoma, carcinoma ex ulcere, carcinoma fibrosum, gelatiniforni carcinoma, gelatinous carcinoma, giant cell carcinoma, carcinoma gigantocellulare, glandular carcinoma, granulosa cell carcinoma, hair-matrix carcinoma, hematoid carcinoma, hepatocellular carcinoma, Hurthle cell carcinoma, hyaline carcinoma, hypernephroid carcinoma, infantile embryonal carcinoma, carcinoma in situ, intraepidermal carcinoma, intraepithelial carcinoma, Krompecher's carcinoma, Kulchitzky-cell carcinoma, large-cell carcinoma, lenticular carcinoma, carcinoma lenticulare, lipomatous carcinoma, lymphoepithelial carcinoma, carcinoma medullare, medullary carcinoma, melanotic carcinoma, carcinoma molle, mucinous carcinoma, carcinoma muciparum, carcinoma mucocellulare, mucoepidermoid carcinoma, carcinoma mucosum, mucous carcinoma, carcinoma myxomatodes, nasopharyngeal carcinoma, oat cell carcinoma, carcinoma ossificans, osteoid carcinoma, papillary carcinoma, periportal carcinoma, preinvasive carcinoma, prickle cell carcinoma, pultaceous carcinoma, renal cell carcinoma of kidney, reserve cell carcinoma, carcinoma sarcomatodes, Schneiderian carcinoma, scirrhous carcinoma, carcinoma scroti, signet ring cell carcinoma, carcinoma simplex, small-cell carcinoma, solanoid carcinoma, spheroidal cell carcinoma, spindle cell carcinoma, carcinoma spongiosum, squamous carcinoma, squamous cell carcinoma, string carcinoma, carcinoma telangiectaticum, carcinoma telangiectodes, transitional cell carcinoma, carcinoma tuberosum, tuberous carcinoma, verrucous carcinoma, and carcinoma villosum. The terms “CCNE1” and “cyclin E1,” as used interchangeably herein, refer to G1 / S specific cyclin E1 (encoded for by the CCNE1 gene). A cell overexpressing CCNE1 (alternatively referred to herein as a CCNE1-high cell) is one that exhibits a higher activity of CCNE1 than a cell normally expressing CCNE1. For example, a CCNE1-overexpressing cell is a cell that exhibits a copy number of at least 3 compared to a diploid normal cell with 2 copies. Thus, a cell exhibiting a copy number greater than 3 of CCNE1 is a cell overexpressing CCNE1. The CCNE1 overexpression may be measured by identifying the expression level of the gene product in a cell (e.g., CCNE1 mRNA transcript count or CCNE1 protein level). The term “Cdc25A” as used herein, refers to M-phase inducer phosphatase 1 (encoded for by the CDC25A gene). Cdc25A acts to prevent the inhibition of Cdk proteins by removing inhibitory phosphorylation events. A CDC25A gene with a gain-of function mutation is one which encodes for a Cdc25A protein which increased activity, e.g., one with more activity for dephosphorylating Cdk proteins. The term “Cdk” as used herein, refers to the family of cyclin-dependent kinases, e.g., cyclin- dependent kinase 4 (Cdk4; encoded for by the CDK4 gene), cyclin-dependent kinase 6 (Cdk6, encoded for by the CDK6 gene), or cyclin-dependent kinase 12 (Cdk12; encoded for by the CDK12 gene). Cdk proteins interact with a variety of regulatory proteins via phosphorylation of prescribed sites of the protein, either activating or inhibiting the protein. Though they are most commonly associated with cyclin proteins (e.g., cyclin A, cyclin B, cyclin C, cyclin D, cyclin E, cyclin F, cyclin G, cyclin H, cyclin I, cyclin J, cyclin K, cyclin L, cyclin O, cyclin P, cyclin T, and cyclin Y), Cdk proteins are known to interact with and regulate PATENT ATTORNEY DOCKET NO.: 51246-037WO2 several other cell-signaling proteins. A CDK gene with a loss-of-function mutation is one that fails to produce a functional Cdk protein or produces reduced quantities of Cdk protein in a cell. The term “CDKN2A” as used herein refers to the CDKN2A gene, which encodes for the p16 and p14arf proteins. Both p16 and P14arf are inhibitors of Cdk proteins, such as Cdk4 and Cdk6. A mutation to CDKN2A (e.g., a loss of function mutation) may result in a p16 or p14arf protein with reduced functionality. Accordingly, they may fail to inhibit the activity of Cdk proteins, increasing the relative activity of the Cdk protein. As used herein, the term “Compound 1” refers to a compound having the structure shown below. Compound 1 may also be referred to as 2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H- pyrrolo-[2,3-b]pyridine-3-carboxamide. Compound 1 has two enantiomeric forms: (S)-Compound 1 and (R)-Compound 1. The two enantiomers are shown below. Enantiomers of the same compound are known in the art to display identical physical properties (e.g., XRPD patterns, TGA thermograms, DSC thermograms,1H NMR spectra, etc.) unless certain conditions are introduced to create an enantiomer specific response. As such, it should be understood that a physical characterization provided for one enantiomer may be used to characterize the other enantiomer. For example, an XRPD spectra of a (R)-Compound 1 may be used to identify a possible crystalline form of (S)-Compound 1. As used herein, Compound 1 may refer to a mixture of both enantiomers, e.g., racemic mixture, or to refer to both enantiomers collectively. The terms "crystalline," “crystalline form,” and “Pattern” as used herein interchangeably, refer to a crystalline form of a compound (e.g., (S)-Compound 1, (R)-Compound 1, or an enantiomerically enriched mixture thereof), or pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the crystalline form is characterized by an x-ray powder diffraction pattern (XRPD). A crystalline form of a compound may be further characterized by a combination of, e.g., a thermogravimetric analysis (TGA) procedure or a differential scanning calorimetry (DSC) procedure. In some embodiments, a crystalline form is characterized by a combination of XRPD, TGA, and DSC. In some embodiments, the crystalline form may be of one enantiomer of Compound 1 (e.g., a crystalline form of (R)-Compound 1 or a PATENT ATTORNEY DOCKET NO.: 51246-037WO2 crystalline form of (S)-Compound 1). In some embodiments, the two enantiomer crystalline forms may be identified by the same XRPD pattern. In some embodiments, the two enantiomer crystalline forms may be identified by different XRPD patterns. A crystalline form of (S)-Compound 1 or (R)-Compound 1 may be a salt form, i.e., a crystalline form including a charged (e.g., protonated) form of (S)-Compound 1 or (R)- Compound 1 and a counterion (e.g., maleate, mesylate, chloride, sulfate, etc.). The term “crystalline form A,” or “Pattern A,” as used herein with regards to (S)-Compound 1, refers to a crystalline form (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.1 °2^ ± 0.2 °2^, and 19.4 °2^ ± 0.2 °2^. In some embodiments, crystalline form A of (S)-Compound 1 further characterized by an XRPD pattern having peaks at 11.8 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, 16.6 °2^ ± 0.2 °2^, and 22.22^ ± 0.2 °2^. In some embodiments, crystalline form A of (S)-Compound 1 is characterized by a unit cell with parameters a = 10.6597 Å ± 0.3 Å, b = 10.6597 Å ± 0.3 Å, c = 15.1615 Å ± 0.6 Å and ^ = ^ = ^ = 90 °. In some embodiments, crystalline form A of (S)-Compound 1 is further characterized by a differential scanning calorimetry (DSC) thermogram having an endothermic event onset at 35 °C to 42 °C by differential scanning calorimetry. In some embodiments crystalline form A of (S)-Compound 1 is further characterized by an endothermic event onset at 273 °C to 278 °C by DSC. The term “crystalline form A,” or “Pattern A,” as used herein with regards to (R)-Compound 1, refers to a crystalline form (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.1 °2^ ± 0.2 °2^, and 19.4 °2^ ± 0.2 °2^. In some embodiments, crystalline form A is further characterized by an XRPD pattern having peaks at 11.8 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, 16.6 °2^ ± 0.2 °2^, and 22.22^ ± 0.2 °2^. In some embodiments, crystalline form A of (R)-Compound 1 is characterized by a unit cell with parameters a = 10.6597 Å ± 0.3 Å, b = 10.6597 Å ± 0.3 Å, c = 15.1615 Å ± 0.6 Å and ^ = ^ = ^ = 90 °. In some embodiments, crystalline form A of (R)-Compound 1 is further characterized by an endothermic event onset at 34 °C to 44 °C by DSC. In some embodiments crystalline form A of (R)-Compound 1 is further characterized by an endothermic event onset at 277 °C to 282 °C by DSC. The term “crystalline form C,” or “Pattern C,” as used herein with regards to (S)-Compound 1, refers to a crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.8 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 16.8 °2^ ± 0.2 °2^ . In some embodiments, crystalline form C of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 4.9 °2^ ± 0.2 °2^, 8.4 °2^ ± 0.2 °2^, 12.3 °2^ ± 0.2 °2^, and 19.0 °2^ ± 0.2 °2^. In some embodiments, crystalline form C of (S)-Compound 1 is further characterized by an endothermic event onset at 187 °C to 206 °C by DSC. In some embodiments, crystalline form C of (S)-Compound 1 is further characterized by an endothermic event onset at 278 °C to 285 °C by DSC. The term “crystalline form C,” or “Pattern C,” as used herein with regards to (R)-Compound 1, refers to a crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.8 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 16.8 °2^ ± 0.2 °2^. In some embodiments, crystalline form C of (R)-Compound 1 PATENT ATTORNEY DOCKET NO.: 51246-037WO2 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 4.9 °2^ ± 0.2 °2^, 8.4 °2^ ± 0.2 °2^, 12.3 °2^ ± 0.2 °2^, and 19.0 °2^ ± 0.2 °2^. In some embodiments, crystalline form C of (R)-Compound 1 is further characterized by an endothermic event onset at 187 °C to 206 °C by DSC. In some embodiments, crystalline form C of (R)-Compound 1 is further characterized by an endothermic event onset at 278 °C to 285 °C by DSC. The term “crystalline form Q,” or “Pattern Q,” as used herein with regards to (S)-Compound 1, refers to a crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 13.3 °2^ ± 0.2 °2^, and 18.8 °2^ ± 0.2 °2^. In some embodiments, crystalline form Q of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 15.0 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^. In some embodiments, crystalline form Q of (S)-Compound 1 is further characterized by an endothermic event onset at 63 °C to 76 °C by DSC. In some embodiments, crystalline form Q of (S)-Compound 1 is further characterized by an endothermic event onset at 285 °C to 288 °C by DSC. The term “crystalline form Q,” or “Pattern Q,” as used herein with regards to (R)-Compound 1, refers to a crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 13.3 °2^ ± 0.2 °2^, and 18.8 °2^ ± 0.2 °2^. In some embodiments, crystalline form Q of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 15.0 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^. In some embodiments, crystalline form Q of (R)-Compound 1 is further characterized by an endothermic event onset at 63 °C to 76 °C by DSC. In some embodiments, crystalline form Q of (R)-Compound 1 is further characterized by an endothermic event onset at 285 °C to 288 °C by DSC. The term “crystalline form K” or “Pattern K,” as used herein with regards to (S)-Compound 1, refers to a crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 14.8 °2^ ± 0.2 °2^, 15.5 °2^ ± 0.2 °2^, and 22.7 °2^ ± 0.2 °2^. In some embodiments, crystalline form K of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 9.5 °2^ ± 0.2 °2^, 10.9 °2^ ± 0.2 °2^, 18.5 °2^ ± 0.2 °2^, 23.5 °2^ ± 0.2 °2^, and 28.9 °2^ ± 0.2 °2^. In some embodiments, crystalline form K of (S)-Compound 1 is further characterized by an endothermic event onset at 136 °C to 139 °C by DSC. In some embodiments, crystalline form K of (S)-Compound 1 is further characterized by a endothermic event onset at 150 °C to 156 °C. In some embodiments, crystalline form K of (S)-Compound 1 is further characterized by an endothermic event onset at 280 °C to 285 °C by DSC. The term “crystalline form K” or “Pattern K,” as used herein with regards to (R)-Compound 1, refers to a crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 14.8 °2^ ± 0.2 °2^, 15.5 °2^ ± 0.2 °2^, and 22.7 °2^ ± 0.2 °2^. In some embodiments, crystalline form K of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 9.5 °2^ ± 0.2 °2^, 10.9 °2^ ± 0.2 °2^, 18.5 °2^ ± 0.2 °2^, 23.5 °2^ ± 0.2 °2^, and 28.9 °2^ ± 0.2 °2^. In PATENT ATTORNEY DOCKET NO.: 51246-037WO2 some embodiments, crystalline form K of (R)-Compound 1 is further characterized by an endothermic event onset at 136°C to 139 °C by DSC. In some embodiments, crystalline form K of (R)-Compound 1 is further characterized by a endothermic event onset at 150 °C to 156 °C. In some embodiments, crystalline form K of (R)-Compound 1 is further characterized by an endothermic event onset at 280 °C to 285 °C by DSC. The term “crystalline form R” or “Pattern R,” as used herein with regards to (S)-Compound 1, refers to a crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.5 °2^ ± 0.2 °2^, 14.6 °2^ ± 0.2 °2^, 17.9 °2^ ± 0.2 °2^, and 25.0 °2^ ± 0.2 °2^. In some embodiments, crystalline form R of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 15.0 °2^ ± 0.2 °2^ and 22.4 °2^ ± 0.2 °2^. In some embodiments, crystalline form R of (S)-Compound 1 is further characterized by an endothermic event onset at 165 °C to 188 °C by DSC. In some embodiments, crystalline form R of (S)-Compound 1 is further characterized by an endothermic event onset at 191 °C to 197 °C by DSC. In some embodiments, crystalline form R of (S)- Compound 1 is further characterized by an endothermic event onset at 271 °C to 279 °C by DSC. The term “crystalline form R” or “Pattern R,” as used herein with regards to (R)-Compound 1, refers to a crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.5 °2^ ± 0.2 °2^, 14.6 °2^ ± 0.2 °2^, 17.9 °2^ ± 0.2 °2^, and 25.0 °2^ ± 0.2 °2^. In some embodiments, crystalline form R of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 15.0 °2^ ± 0.2 °2^ and 22.4 °2^ ± 0.2 °2^. In some embodiments, crystalline form R of (R)-Compound 1 is further characterized by an endothermic event onset at 165 °C to 188 °C by DSC. In some embodiments, crystalline form R of (R)-Compound 1 is further characterized by an endothermic event onset at 191 °C to 197 °C by DSC. In some embodiments, crystalline form R of (R)- Compound 1 is further characterized by an endothermic event onset at 271 °C to 279 °C by DSC. The term “crystalline form P” or “Pattern P,” as used herein with regards to (S)-Compound 1, refers to a crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.9 °2^ ± 0.2 °2^, 11.3 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, crystalline form P of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 12.9 °2^ ± 0.2 °2^, 15.7 °2^ ± 0.2 °2^, 19.1 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, crystalline form P of (S)-Compound 1 is further characterized by an endothermic event onset of 150 °C to 161 °C by DSC. In some embodiments, crystalline form P of (S)- Compound 1 is further characterized by an endothermic event onset at 283 °C to 287 °C by DSC. The term “crystalline form P” or “Pattern P,” as used herein with regards to (R)-Compound 1, refers to a crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.9 °2^ ± 0.2 °2^, 11.3 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, crystalline form P of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 12.9 °2^ ± 0.2 °2^, 15.7 °2^ ± 0.2 °2^, 19.1 °2^ ± 0.2 °2^, and 22.0 °2^ ± PATENT ATTORNEY DOCKET NO.: 51246-037WO2 0.2 °2^. In some embodiments, crystalline form P of (R)-Compound 1 is further characterized by an endothermic event onset of 151 °C to 161 °C by DSC. In some embodiments, crystalline form P of (R)- Compound 1 is further characterized by an endothermic event onset of 283 °C to 287 °C by DSC. The term “crystalline form B” or “Pattern B,” as used herein with regards to (S)-Compound 1, refers to a crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.2 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^. In some embodiments, crystalline form B of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 11.7 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, and 16.6 °2^ ± 0.2 °2^. In some embodiments, crystalline form B of (S)-Compound 1 is further characterized by an endothermic event onset at 39 °C to 52 °C by DSC. In some embodiments, crystalline form B of (S)-Compound 1 is further characterized by an endothermic event onset at 138 °C to 144 °C by DSC. In some embodiments, crystalline form B of (S)-Compound 1 is further characterized by an endothermic event onset at 268 °C to 275 °C by DSC. The term “crystalline form B” or “Pattern B,” as used herein with regards to (R)-Compound 1, refers to a crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.2 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^. In some embodiments, crystalline form B of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at having peaks at 11.7 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, and 16.6 °2^ ± 0.2 °2^. In some embodiments, crystalline form B of (R)-Compound 1 is further characterized by an endothermic event onset at 39 °C to 52 °C by DSC. In some embodiments, crystalline form B of (R)-Compound 1 is further characterized by an endothermic event onset at 138 °C to 144 °C by DSC. In some embodiments, crystalline form B of (R)-Compound 1 is further characterized by an endothermic event onset at 268 °C to 275 °C by DSC. "Disease" or "condition" refers to a state of being or health status of a patient or subject capable of being treated with the compounds or methods provided herein. The term “EGFR,” as used herein, refers to the epidermal growth factor receptor protein (encoded for by the EGFR gene). EGFR is a transmembrane glycoprotein with an extracellular domain and an intracellular domain. The extracellular domain receives signals (e.g., in the form of a signal peptide such as epidermal growth factor), resulting in a confirmational or chemical change in the intracellular domain. The intracellular domain may then interact with a variety of cell signaling pathways (e.g., the RAS / MAPK pathway). An EGFR gene with a loss-of-function mutation is one that fails to produce a functional EGFR protein or produces reduced quantities of EGFR protein in a cell. The term “FBXW7,” as used herein, refers to F-box / WD Repeat-Containing Protein 7 transcript (gene name: FBXW7). An FBXW7 gene having an inactivating mutation is one that fails to produce a functional FBXW7 protein or produces reduced quantities of FBXW7 protein in a cell. The term “hydrochloric acid salt,” as used herein, refers to a salt form of a compound includingchloride as an anion (Cl ), and a protonated form of a compound as a cation. The cation may be aprotonated form of (S)-Compound 1 or a protonated form of (R)-Compound 1. A hydrochloric acid salt form of a compound may be formed by, e.g., reacting (e.g., protonating) the compound with hydrochloric acid (HCl). PATENT ATTORNEY DOCKET NO.: 51246-037WO2 The term “HPV,” as used herein, refers to the human papillomavirus. A subject infected with HPV (e.g., a subject currently possessing a viral load of HPV) may incur long term DNA damage, which in turn may result in the development of a cancer (e.g., a cancer described herein). DNA damage sustained from HPV may remain in a subject long after the subject is cured of HPV (e.g., a subject wherein the HPV viral load is reduced, a subject wherein the HPV viral load is reduced to zero, a subject with reduced or eliminated disease symptoms from a HPV infection, etc.). A subject currently or formerly infected with HPV may be referred to as “HPV+” herein. The term “Hras” (or alternatively “H-Ras,” or “H-ras”), as used herein, refers to a protein, peptide, or polypeptide encoded for by the HRAS (or alternatively “H-RAS”) gene. “HRAS mutation,” as used herein, refers to a mutation in the HRAS gene which results in the alteration of the amino acid sequence of an Hras protein. HRAS mutations are commonly observed in thyroid cancer, bladder cancer, head and neck cancer, and kidney cancer. The terms “hydrochloric acid salt Pattern A,” “crystalline hydrochloric acid salt form A,” or “crystalline hydrochloric acid form A” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a hydrochloric acid salt of (S)-Compound 1 wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.2 °2^ ± 0.2 °2^, 15.0 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form A of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.1 °2^ ± 0.2 °2^, 16.1 °2^ ± 0.2 °2^, and 23.4 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form A of (S)-Compound 1 is further characterized by an endothermic event onset at 50 °C to 105 °C by DSC. In some embodiments, crystalline hydrochloric acid salt form A of (S)- Compound 1 is further characterized by an endothermic event onset at 220 °C to 232 °C. The terms “hydrochloric acid salt Pattern A,” “crystalline hydrochloric acid salt form A,” or “crystalline hydrochloric acid form A” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a hydrochloric acid salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.2 °2^ ± 0.2 °2^, 15.0 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form A of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.1 °2^ ± 0.2 °2^, 16.1 °2^ ± 0.2 °2^, and 23.4 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form A of (R)-Compound 1 is further characterized by an endothermic event onset at 50 °C to 105 °C by DSC. In some embodiments, crystalline hydrochloric acid salt form A of (R)-Compound 1 is further characterized by an endothermic event onset at 220 °C to 232 °C. The terms “hydrochloric acid salt Pattern B,” “crystalline hydrochloric acid salt form B,” or “crystalline hydrochloric acid form B” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a hydrochloric acid salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 15.3 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form B of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.5.1 °2^ ± 0.2 °2^, 23.6 °2^ ± 0.2 °2^, 24.7 °2^ ± 0.2 °2^, and PATENT ATTORNEY DOCKET NO.: 51246-037WO2 27.8 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form B of (S)-Compound 1 is further characterized by an endothermic event onset at 100 °C to 195 °C by DSC. The terms “hydrochloric acid salt Pattern B,” “crystalline hydrochloric acid salt form B,” or “crystalline hydrochloric acid form B” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a hydrochloric acid salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 15.3 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form B of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.5.1 °2^ ± 0.2 °2^, 23.6 °2^ ± 0.2 °2^, 24.7 °2^ ± 0.2 °2^, and 27.8 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form B of (R)-Compound 1 is further characterized by an endothermic event onset at 100 °C to 195 °C by DSC. The terms “hydrochloric acid salt Pattern C,” “crystalline hydrochloric acid salt form C,” or “crystalline hydrochloric acid form C” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a hydrochloric acid salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 13.8 °2^ ± 0.2 °2^, and 23.1 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form C of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 18.9 °2^ ± 0.2 °2^, 19.0 °2^ ± 0.2 °2^, and 28.6 °2^ ± 0.2 °2^.. In some embodiments, crystalline hydrochloric acid salt form C of (S)-Compound 1 is further characterized by an endothermic event onset at 120 °C to 167 °C by DSC. In some embodiments, crystalline hydrochloric acid salt form C of (S)-Compound 1 is further characterized by an endothermic event onset at 160 °C to 192 °C by DSC. The terms “hydrochloric acid salt Pattern C,” “crystalline hydrochloric acid salt form C,” or “crystalline hydrochloric acid form C” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a hydrochloric acid salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 13.8 °2^ ± 0.2 °2^, and 23.1 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form C of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 18.9 °2^ ± 0.2 °2^, 19.0 °2^ ± 0.2 °2^, and 28.6 °2^ ± 0.2 °2^. In some embodiments, crystalline hydrochloric acid salt form C of (R)-Compound 1 is further characterized by an endothermic event onset at 120 °C to 167 °C by DSC. In some embodiments, crystalline hydrochloric acid salt form C of (R)-Compound 1 is further characterized by an endothermic event onset at 160 °C to 192 °C by DSC. The term “Kras” (or alternatively “K-Ras,” or “K-ras”), as used herein, refers to a protein, peptide, or polypeptide encoded for by the KRAS (or alternatively “K-RAS”) gene. Two common isoforms of the Kras protein are known, isoform a (Kras4A) and isoform b (Kras4B), which arise from alternative gene splicing. Unless otherwise specified, Kras should be understood to refer to both isoforms. “KRAS mutation,” as used herein, refers to a mutation in the KRAS gene which results in the alteration of the amino acid sequence of a Kras protein. KRAS mutations are commonly observed in colorectal cancer, PATENT ATTORNEY DOCKET NO.: 51246-037WO2 lung cancer, pancreatic cancer, gynecological cancer (e.g., uterine cancer, ovarian cancer, cervical cancer, etc.) and gastro-esophageal cancer. The term "leukemia," as used herein, refers broadly to progressive, malignant diseases of the blood-forming organs and is generally characterized by a distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow. Leukemia is generally clinically classified on the basis of (1) the duration and character of the disease-acute or chronic; (2) the type of cell involved; myeloid (myelogenous), lymphoid (lymphogenous), or monocytic; and (3) the increase or non-increase in the number abnormal cells in the blood-leukemic or aleukemic (subleukemic). Exemplary leukemias that may be treated with a compound or method provided herein include, e.g., acute nonlymphocytic leukemia, chronic lymphocytic leukemia, acute granulocytic leukemia, chronic granulocytic leukemia, acute promyelocytic leukemia, adult T-cell leukemia, aleukemic leukemia, a leukocythemic leukemia, basophylic leukemia, blast cell leukemia, bovine leukemia, chronic myelocytic leukemia, leukemia cutis, embryonal leukemia, eosinophilic leukemia, Gross' leukemia, hairy-cell leukemia, hemoblastic leukemia, hemocytoblastic leukemia, histiocytic leukemia, stem cell leukemia, acute monocytic leukemia, leukopenic leukemia, lymphatic leukemia, lymphoblastic leukemia, lymphocytic leukemia, lymphogenous leukemia, lymphoid leukemia, lymphosarcoma cell leukemia, mast cell leukemia, megakaryocytic leukemia, micromyeloblastic leukemia, monocytic leukemia, myeloblastic leukemia, myelocytic leukemia, myeloid granulocytic leukemia, myelomonocytic leukemia, Naegeli leukemia, plasma cell leukemia, multiple myeloma, plasmacytic leukemia, promyelocytic leukemia, Rieder cell leukemia, Schilling's leukemia, stem cell leukemia, subleukemic leukemia, and undifferentiated cell leukemia. The term “lymphoma,” as used herein, refers to a cancer arising from cells of immune origin. Non- limiting examples of T and B cell lymphomas include non-Hodgkin lymphoma and Hodgkin disease, diffuse large B-cell lymphoma, follicular lymphoma, mucosa- associated lymphatic tissue (MALT) lymphoma, small cell lymphocytic lymphoma-chronic lymphocytic leukemia, Mantle cell lymphoma, mediastinal (thymic) large B-cell lymphoma, lymphoplasmacytic lymphoma-Waldenstrom macroglobulinemia, peripheral T-cell lymphoma (PTCL), angioimmunoblastic T-cell lymphoma (AITL) / follicular T-cell lymphoma (FTCL), anaplastic large cell lymphoma (ALCL), enteropathy-associated T-cell lymphoma (EATL), adult T- cell leukemia / lymphoma (ATLL), or extranodal NK / T-cell lymphoma, nasal type. The term “maleate salt,” as used herein, refers to a salt form of a compound including a deprotonated form of maleic acid as an anion: The cation of the salt may be a protonated form of (S)-Compound 1 or a protonated form of (R)-Compound 1. The term “hemi-maleate,” as used herein, refers to a salt form of a compound wherein the stoichiometric ratio of maleic acid to the compound of interest corresponds to fewer than 1 molecule of maleate per molecule of its counter ion (e.g., 1 equivalent of Compound 1 to 0.5 equivalents of maleate). A maleate salt form or a hemi-maleate salt form of a compound may be formed by, e.g., reacting (e.g., protonating) the compound with maleic acid: . PATENT ATTORNEY DOCKET NO.: 51246-037WO2 The terms “maleate salt Pattern A,” “crystalline maleate salt form A,” or “crystalline maleate form A” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a hemi-maleate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.8 °2^ ± 0.2 °2^, 13.7 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form A of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 17.5 °2^ ± 0.2 °2^, 25.6 °2^ ± 0.2 °2^ and 26.1 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form A of (S)- Compound 1 is further characterized by an endothermic event onset at 200 °C to 209 °C by DSC. The terms “maleate salt Pattern A,” “crystalline maleate salt form A,” or “crystalline maleate form A” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a hemi-maleate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.8 °2^ ± 0.2 °2^, 13.7 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form A of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 17.5 °2^ ± 0.2 °2^, 25.6 °2^ ± 0.2 °2^ and 26.1 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form A of (R)- Compound 1 is further characterized by an endothermic event onset at 200 °C to 209 °C by DSC. The terms “maleate salt Pattern B,” “crystalline maleate salt form B,” or “crystalline maleate form B” as used herein with regards to (S)-Compound 1, refers to crystalline form of a hemi-maleate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 13.2 °2^ ± 0.2 °2^, 17.6 °2^ ± 0.2 °2^, 23.9 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form B of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 22.2 °2^ ± 0.2 °2^ and 22.6 °2^ ± 0.2 °2^. In some embodiments, maleate salt B of (S)-Compound 1 is further characterized by an endothermic event onset at 115 °C to 134 °C by DSC. In some embodiments, crystalline maleate salt form B of (S)-Compound 1 is further characterized by an endothermic event onset at 195 °C to 198 °C by DSC. The terms “maleate salt Pattern B,” “crystalline maleate salt form B,” or “crystalline maleate form B” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a hemi-maleate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 13.2 °2^ ± 0.2 °2^, 17.6 °2^ ± 0.2 °2^, 23.9 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form B of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 22.2 °2^ ± 0.2 °2^ and 22.6 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form B of (R)-Compound 1 is further characterized by an endothermic event onset at 115 °C to 134 °C by DSC. In some embodiments, crystalline maleate salt form B of (R)-Compound 1 is further characterized by an endothermic event onset at 195 °C to 198 °C by DSC. The terms “maleate salt Pattern C,” “crystalline maleate salt form C,” or “crystalline maleate form C” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a hemi-maleate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.9 °2^ ± 0.2 °2^, 22.0 °2^ ± 0.2 °2^, 22.7 °2^ ± 0.2 °2^, PATENT ATTORNEY DOCKET NO.: 51246-037WO2 and 23.0 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form C of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 16.0 °2^ ± 0.2 °2^, 17.3 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^. The terms “maleate salt Pattern C,” “crystalline maleate salt form C,” or “crystalline maleate form C” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a hemi-maleate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.9 °2^ ± 0.2 °2^, 22.0 °2^ ± 0.2 °2^, 22.7 °2^ ± 0.2 °2^, and 23.0 °2^ ± 0.2 °2^. In some embodiments, crystalline maleate salt form C of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 16.0 °2^ ± 0.2 °2^, 17.3 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^. The term “Myc” as used herein, refers to the Myc family of cell signaling proteins. The MYC family includes c-Myc, l-Myc, and n-Myc (encoded for by the c-MYC, l-MYC, and n-MYC genes respectively; collectively referred to as MYC genes). Myc family proteins perform several regulatory processes across cellular functions, many of which are associated with cell division, cell proliferation, and DNA replication. A c-MYC gene with a gain-of-function mutation is one that produces a c-Myc protein with enhanced activity (e.g., a c-Myc protein which participates in a signal transduction pathway in the absence of a signal activating the pathway) or produces increased quantities of a c-Myc protein in a cell. A cell overexpressing c-MYC is one that exhibits a higher activity of a c-MYC gene than a cell normally expressing c-MYC. For example, a c-MYC-overexpressing cell is a cell that exhibits a copy number of at least 3 compared to a diploid normal cell with 2 copies. Thus, a cell exhibiting a copy number greater than 3 of c-MYC is a cell overexpressing c-MYC. c-MYC overexpression or c-MYC amplification may be measured by identifying the expression level of the gene product in a cell (e.g., MYC mRNA transcript count or MYC protein level). The term "melanoma," as used herein, is taken to mean a tumor arising from the melanocytic system of the skin and other organs. Melanomas that may be treated with a compound or method provided herein include, e.g., acral-lentiginous melanoma, amelanotic melanoma, benign juvenile melanoma, Cloudman's melanoma, S91 melanoma, Harding-Passey melanoma, juvenile melanoma, lentigo maligna melanoma, malignant melanoma, nodular melanoma, subungual melanoma, and superficial spreading melanoma. The term “mesylate salt,” as used herein, refers to a salt form of a compound including a deprotonated form of methane sulfonic acid as an anion: . The cation of the salt may be a protonated form of (S)-Compound 1 or a protonated form of (R)-Compound 1. A mesylate salt form of a compound may be formed by, e.g., reacting (e.g., protonating) the compound with methanesulfonic acid: . The terms “mesylate salt Pattern A,” “crystalline mesylate salt form A,” or “crystalline mesylate form A” as used herein with regards to (S)-Compound 1, refers to a crystalline form of mesylate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.0 °2^ ± 0.2 °2^, 11.8 °2^ ± 0.2 °2^, and PATENT ATTORNEY DOCKET NO.: 51246-037WO2 21.0 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form A of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 19.7 °2^ ± 0.2 °2^, 22.6 °2^ ± 0.2 °2^, and 29.8 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form A of (S)- Compound 1 is further characterized by an endothermic event onset at 238 °C to 243 °C by DSC. The terms “mesylate salt Pattern A,” “crystalline mesylate salt form A,” or “crystalline mesylate form A” as used herein with regards to (R)-Compound 1, refers to a crystalline form of q mesylate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.0 °2^ ± 0.2 °2^, 11.8 °2^ ± 0.2 °2^, and 21.0 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form A of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 19.7 °2^ ± 0.2 °2^, 22.6 °2^ ± 0.2 °2^, and 29.8 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form A of (R)- Compound 1 is further characterized by an endothermic peak at 238 °C to 243 °C by DSC. The terms “mesylate salt Pattern B,” “crystalline mesylate salt form B,” or “crystalline mesylate form B” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a mesylate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.3 °2^ ± 0.2 °2^, 13.4 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form B of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.4 °2^ ± 0.2 °2^, 17.8 °2^ ± 0.2 °2^, 22.4 °2^ ± 0.2 °2^, and 29.5 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form B of (S)-Compound 1 is further characterized by an endothermic event onset at 50 °C to 75 °C by DSC. In some embodiments, crystalline mesylate salt form B of (S)-Compound 1 is further characterized by an endothermic event onset at 140 °C to 147 °C by DSC. In some embodiments, crystalline mesylate salt form B of (S)-Compound 1 is further characterized by an endothermic event onset at 150 °C to 159 °C by DSC. The terms “mesylate salt Pattern B,” “crystalline mesylate salt form B,” or “crystalline mesylate form B” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a mesylate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.3 °2^ ± 0.2 °2^, 13.4 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form B of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.4 °2^ ± 0.2 °2^, 17.8 °2^ ± 0.2 °2^, 22.4 °2^ ± 0.2 °2^, and 29.5 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form B of (R)-Compound 1 is further characterized by an endothermic event onset at 50 °C to 75 °C by DSC. In some embodiments, crystalline mesylate salt form B of (R)-Compound 1 is further characterized by an endothermic event onset at 140 °C to 147 °C by DSC. In some embodiments, crystalline mesylate salt form B of (R)-Compound 1 is further characterized by an endothermic event onset at 150 °C to 159 °C by DSC. The terms “mesylate salt Pattern C,” “crystalline mesylate salt form C,” or “crystalline mesylate form C” as used herein with regards to (S)-Compound 1, refers to a crystalline form of a mesylate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.0 °2^ ± 0.2 °2^, 14.3 °2^ ± 0.2 °2^, and PATENT ATTORNEY DOCKET NO.: 51246-037WO2 21.9 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form C of (S)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.0 °2^ ± 0.2 °2^, 17.7 °2^ ± 0.2 °2^, 18.0 °2^ ± 0.2 °2^, and 20.0 ± 0.2 °2^. In some embodiments, crystalline mesylate salt form C of (S)-Compound 1 is further characterized by an endothermic event onset at 135 °C to 164 °C by DSC. In some embodiments, crystalline mesylate salt form C of (S)-Compound 1 is further characterized by an endothermic event onset at 235 °C to 239 °C by DSC. The terms “mesylate salt Pattern C,” “crystalline mesylate salt form C,” or “crystalline mesylate form C” as used herein with regards to (R)-Compound 1, refers to a crystalline form of a mesylate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.0 °2^ ± 0.2 °2^, 14.3 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^. In some embodiments, crystalline mesylate salt form C of (R)-Compound 1 is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.0 °2^ ± 0.2 °2^, 17.7 °2^ ± 0.2 °2^, 18.0 °2^ ± 0.2 °2^, and 20.0 ± 0.2 °2^. In some embodiments, crystalline mesylate salt form C of (R)-Compound 1 is further characterized by an endothermic event onset at 135 °C to 164 °C by DSC. In some embodiments, crystalline mesylate salt form C of (R)-Compound 1 is further characterized by an endothermic event onset at 235 °C to 239 °C by DSC. Mesylate salt C may be a mono-mesylate salt. The term “Myt1,” as used herein, refers to membrane-associated tyrosine and threonine-specific cdc2-inhibitory kinase (Myt1) (Gene name PKMYT1). The term “pharmaceutical composition,” as used herein, represents a composition containing a compound or crystalline form described herein, formulated with a pharmaceutically acceptable excipient, and manufactured or sold with the approval of a governmental regulatory agency as part of a therapeutic regimen for the treatment of disease in a mammal. Pharmaceutical compositions can be formulated, for example, for oral administration in unit dosage form (e.g., a tablet, capsule, caplet, gelcap, or syrup); for topical administration (e.g., as a cream, gel, lotion, or ointment); for intravenous administration (e.g., as a sterile solution free of particulate emboli and in a solvent system suitable for intravenous use); or in any other formulation described herein. The term “pharmaceutically acceptable excipient” or “pharmaceutically acceptable carrier,” as used interchangeably herein, refers to any ingredient other than the compounds described herein (e.g., a vehicle capable of suspending or dissolving the active compound) and having the properties of being nontoxic and non-inflammatory in a patient. Excipients may include, for example: antiadherents, antioxidants, binders, coatings, compression aids, disintegrants, dyes (colors), emollients, emulsifiers, fillers (diluents), film formers or coatings, flavors, fragrances, glidants (flow enhancers), lubricants, preservatives, printing inks, sorbents, suspending or dispersing agents, sweeteners, or waters of hydration. Exemplary excipients include, but are not limited to: butylated hydroxytoluene (BHT), calcium carbonate, calcium phosphate (dibasic), calcium stearate, croscarmellose, crosslinked polyvinyl pyrrolidone, citric acid, crospovidone, cysteine, ethylcellulose, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, maltitol, mannitol, methionine, methylcellulose, methyl paraben, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, povidone, pregelatinized starch, propyl paraben, retinyl palmitate, shellac, silicon dioxide, sodium PATENT ATTORNEY DOCKET NO.: 51246-037WO2 carboxymethyl cellulose, sodium citrate, sodium starch glycolate, sorbitol, starch (corn), stearic acid, stearic acid, sucrose, talc, titanium dioxide, vitamin A, vitamin E, vitamin C, and xylitol. The term “pharmaceutically acceptable salt,” as use herein, represents those salts which are, within the scope of sound medical judgment, suitable for use in contact with the tissues of humans and animals without undue toxicity, irritation, allergic response and the like and are commensurate with a reasonable benefit / risk ratio. Pharmaceutically acceptable salts are well known in the art. For example, pharmaceutically acceptable salts are described in: Berge et al., J. Pharmaceutical Sciences 66:1-19, 1977 and in Pharmaceutical Salts: Properties, Selection, and Use, (Eds. P.H. Stahl and C.G. Wermuth), Wiley-VCH, 2008. The salts can be prepared in situ during the final isolation and purification of the compounds described herein or separately by reacting (e.g., protonating) the free base group with a suitable organic acid. Representative acid addition salts include acetate, adipate, alginate, ascorbate, aspartate, benzenesulfonate, benzoate, bisulfate, borate, butyrate, camphorate, camphorsulfonate, citrate, cyclopentanepropionate, digluconate, dodecylsulfate, ethanesulfonate, 1,2-ethane-disulfonate, fumarate, glucoheptonate, glycerophosphate, hemisulfate, heptonate, hexanoate, hydrobromide, hydrochloride, hydroiodide, 2-hydroxy-ethanesulfonate, lactobionate, lactate, laurate, lauryl sulfate, malate, maleate, malonate, methanesulfonate (also referred to herein as mesylate), 2- naphthalenesulfonate, nicotinate, 1,5-naphthalene-disulfonatenicotinate, nitrate, oleate, oxalate, palmitate, pamoate, pectinate, persulfate, 3-phenylpropionate, phosphate, picrate, pivalate, propionate, stearate, succinate, sulfate, tartrate, thiocyanate, toluenesulfonate, undecanoate, valerate salts, and the like. Representative alkali or alkaline earth metal salts include sodium, lithium, potassium, calcium, magnesium, and the like, as well as nontoxic ammonium, quaternary ammonium, and amine cations, including, but not limited to ammonium, tetramethylammonium, tetraethylammonium, methylamine, dimethylamine, trimethylamine, triethylamine, ethylamine, and the like. The term “tautomer” refers to structural isomers that readily interconvert, often by relocation of a proton. Tautomers are distinct chemical species that can be identified by differing spectroscopic characteristics, but generally cannot be isolated individually. Non-limiting examples of tautomers include ketone - enol, enamine - imine, amide - imidic acid, nitroso - oxime, ketene – ynol, and amino acid – ammonium carboxylate. The term “pre-malignant” or “pre-cancerous,” as used herein, refers to a condition that is not malignant but is poised to become malignant. Non-limiting examples of pre-malignant conditions include myelodysplastic syndrome, polyps in the colon, actinic keratosis of the skin, dysplasia of the cervix, metaplasia of the lung, and leukoplakia. The term “Pik3ca,” as used herein, refers to phosphatidylinositol-4,5-biphosphate 3-kinase, catalytic subunit alpha (alternatively referred to as P110^; encoded for by the PIK3CA gene); the catalytic subunit of phosphatidylinositol-4,5-bisphosphate 3-kinase (Pi3k). Pi3k plays an important role in cell signaling, e.g., the Pi3k / Akt / mTor pathway. A PIKC3A gene with a gain-of-function mutation is one that produces a Pik3ca protein with enhanced activity (e.g., a Pik3ca protein which participates in a signal transduction pathway in the absence of a signal activating the pathway) or produces increased quantities of a Pik3ca protein in a cell. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 The term “Ppp2r1a,” as used herein, refers to the Serine / threonine-protein phosphatase 2A 65kDa regulatory subunit A alpha isoform (encoded by the PPP2R1A gene). Ppp2r1a is a regulatory subunit of protein phosphatase 2 (Pp2a), one of the four major Ser / Thr phosphatases. Wild type Pp2a is implicated for its role in regulating tumor production by controlling phosphorylation events in cell signaling pathways. A PPP2R1A gene with a loss-of-function mutation is one that fails to produce a functional Ppp2r1a protein or produces reduced quantities of Ppp2r1a protein in a cell. The term “Pten,” as used herein, refers to the phosphatase and tensin homolog protein (encoded for by the PTEN gene). Pten is a cell-cycle regulating phosphatase that plays a role in the regulation of several cell signaling pathways, e.g., the Akt / Pkb signaling pathway. A PTEN gene with a loss-of-function mutation is one that fails to produce a functional Pten protein or produces reduced quantities of Pten protein in a cell. The term “Raf” (or alternatively, “rapidly accelerated fibrosarcoma”), as used herein, refers to the Raf family of cell signaling proteins. The Raf family of proteins includes Araf, Braf, and Craf (encoded for by the ARAF, BRAF, and CRAF gene respectively). A BRAF gene with a gain-of-function mutation is one that produces a Braf protein with enhanced activity (e.g., a Raf protein which participates in a signal transduction pathway in the absence of a signal activating the pathway) or produces increased quantities of a BRAF protein in a cell. The term “Ras” (or alternatively “Ras GTPase”), as used herein, refers to the Ras family of cell signaling proteins. The Ras family includes Kras, Hras, and Nras (encoded for by the KRAS, HRAS, and NRAS genes; collectively referred to as RAS genes). About 25% of human cancers are observed to involve a mutation to a RAS gene. The term "sarcoma" generally refers to a tumor which is made up of a substance like the embryonic connective tissue and is generally composed of closely packed cells embedded in a fibrillar or homogeneous substance. Non-limiting examples of sarcomas that may be treated with a compound or method provided herein include, e.g., a chondrosarcoma, fibrosarcoma, lymphosarcoma, melanosarcoma, myxosarcoma, osteosarcoma, Abernethy’s sarcoma, adipose sarcoma, liposarcoma, alveolar soft part sarcoma, ameloblastic sarcoma, botryoid sarcoma, chloroma sarcoma, chorio carcinoma, embryonal sarcoma, Wilms' tumor sarcoma, endometrial sarcoma, stromal sarcoma, Ewing's sarcoma, fascial sarcoma, fibroblastic sarcoma, giant cell sarcoma, granulocytic sarcoma, Hodgkin's sarcoma, idiopathic multiple pigmented hemorrhagic sarcoma, immunoblastic sarcoma of B cells, immunoblastic sarcoma of T-cells, Jensen's sarcoma, Kaposi's sarcoma, Kupffer cell sarcoma, angiosarcoma, leukosarcoma, malignant mesenchymoma sarcoma, parosteal sarcoma, reticulocytic sarcoma, Rous sarcoma, serocystic sarcoma, synovial sarcoma, and telangiectaltic sarcoma. The term “solvate,” as used herein, refers to a solid crystalline form of (S)-Compound 1 or (R)- Compound 1 or a salt thereof, wherein the solid crystalline form includes the incorporation of one or more molecules that are not (S)-Compound 1, (R)-Compound 1 or an associated counterion. In some embodiments, the one or more molecules that are not (S)-Compound 1, (R)-Compound 1, or the associated counterion may originate in the solvent from which (S)-Compound 1 or (R)-Compound 1 were precipitated. In some embodiments, the one or more molecules that are not (S)-Compound 1 or (R)-Compound 1 may be in a stoichiometric ratio with (S)-Compound 1 or (R)-Compound 1 (e.g., 1 PATENT ATTORNEY DOCKET NO.: 51246-037WO2 molecule that is not (S)-Compound 1 or (R)-Compound 1 per 1 molecule of (S)-Compound 1 or (R)- Compound 1, 2 molecules that are not (S)-Compound 1 or (R)-Compound 1 per 1 molecule of (S)- Compound 1 or (R)-Compound 1, etc.). In some embodiments, the molecules that are not (S)- Compound 1 or (R)-Compound 1 may occupy a regular position in the crystalline form. In some embodiments, the one or more molecules that are not (S)-Compound 1 or (R)-Compound 1 may include water. In such embodiments, the solvate form is referred to as a “hydrate” (e.g., a solvate that includes at least 1 molecule of water) herein. In some embodiments, the one or more molecules that are not (S)- Compound 1 or (R)-Compound 1 may include 1,4-dioxane. In some embodiments, the one or more molecules that are not (S)-Compound 1 or (R)-Compound 1 may include THF. The term “subject,” as used herein, represents a human or non-human animal (e.g., a mammal) that is suffering from, or is at risk of, disease or condition, as determined by a qualified professional (e.g., a doctor or a nurse practitioner) with or without known in the art laboratory test(s) of sample(s) from the subject. Preferably, the subject is a human. Non-limiting examples of diseases and conditions include diseases having the symptom of cell hyperproliferation, e.g., a cancer. “Treatment” and "treating," as used herein, refer to the medical management of a subject with the intent to improve, ameliorate, stabilize, prevent or cure a disease or condition. This term includes active treatment (treatment directed to improve the disease or condition); causal treatment (treatment directed to the cause of the associated disease or condition); palliative treatment (treatment designed for the relief of symptoms of the disease or condition); preventative treatment (treatment directed to minimizing or partially or completely inhibiting the development of the associated disease or condition); and supportive treatment (treatment employed to supplement another therapy). BRIEF DESCRIPTION OF THE DRAWINGS FIG.1 is a graph showing the XRPD patterns for (R)-Compound 1 as prepared. Arrows indicate peaks associated with an inorganic impurity (sodium sulfate). FIG.2A is a microscopic image at 100X magnification of (R)-Compound 1 crystals as prepared. The scale bar represents 100 ^m. FIG.2B is a microscopic image at 100X magnification of (R)-Compound 1 crystals as prepared. The scale bar represents 100 ^m. FIG.2C is a microscopic image at 400X magnification of (R)-Compound 1 crystals as prepared. The scale bar represents 20 ^m. FIG.2D is a microscopic image at 400X magnification of (R)-Compound 1 crystals as prepared. The scale bar represents 20 ^m. FIG.3 is a graph showing the XRPD patterns for (R)-Compound 1 (1) before the adapted vial scale process described in Example 1; and (2) after the adapted vial scale process described in Example 1. The peaks indicated with an arrow in FIG.1 (peaks associated with an inorganic impurity) are noticeably decreased intensity in (2). FIG.4A is a microscopic image at 100X magnification of (R)-Compound 1 after the vial-scale process described in Example 1. The scale bar represents 100 ^m. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.4B is a microscopic image at 100X magnification of (R)-Compound 1 after the vial-scale process described in Example 1. The scale bar represents 100 ^m. FIG.4C is a microscopic image at 400X magnification of (R)-Compound 1 after the vial-scale process described in Example 1. The scale bar represents 20 ^m. FIG.4D is a microscopic image at 400X magnification of (R)-Compound 1 after the vial-scale process described in Example 1. The scale bar represents 20 ^m. FIG.5A is a microscopic image at 100X magnification of (R)-Compound 1 from the slurry produced in the EasyMax process described in Example 1. The scale bar represents 100 ^m. FIG.5B is a microscopic image at 100X magnification of (R)-Compound 1 from the slurry produced in the EasyMax process described in Example 1. The scale bar represents 100 ^m. FIG.5C is a microscopic image at 400X magnification of (R)-Compound 1 from the slurry produced in the EasyMax process described in Example 1. The scale bar represents 20 ^m. FIG.5D is a microscopic image at 400X magnification of (R)-Compound 1 from the slurry produced in the EasyMax process described in Example 1. The scale bar represents 20 ^m. FIG.6A is a microscopic image at 100X magnification of (R)-Compound 1 after cooling in the EasyMax process described in Example 1. The scale bar represents 100 ^m. FIG.6B is a microscopic image at 100X magnification of (R)-Compound 1 after cooling in the EasyMax process described in Example 1. The scale bar represents 100 ^m. FIG.6C is a microscopic image at 400X magnification of (R)-Compound 1 after cooling in the EasyMax process described in Example 1. The scale bar represents 20 ^m, FIG.6D is a microscopic image at 400X magnification of (R)-Compound 1 after cooling in the EasyMax process described in Example 1. The scale bar represents 20 ^m. FIG.7A is a microscopic image at 100X magnification of (R)-Compound 1 after stirring overnight in the EasyMax process described in Example 1. The scale bar represents 100 ^m. FIG.7B is a microscopic image at 100X magnification of (R)-Compound 1 after stirring overnight in the EasyMax process described in Example 1. The scale bar represents 100 ^m. FIG.7C is a microscopic image at 400X magnification of (R)-Compound 1 after stirring overnight in the EasyMax process described in Example 1. The scale bar represents 20 ^m. FIG.7D is a microscopic image at 400X magnification of (R)-Compound 1 after stirring overnight in the EasyMax process described in Example 1. The scale bar represents 20 ^m. FIG.8 is a graph showing the XRPD patterns for (R)-Compound 1 (1) before the vial scale process; (2) after short term slurry in ethanol at 50 °C (crystalline forms A+B); (3) after filtration in EasyMax step (wet cake, crystalline forms A+B); (4) after filtration in EasyMax step (dry, crystalline form A+B); and (5) recovered from mother liquor of EasyMax step (dry, crystalline form A+B), as described in Example 1. FIG.9 is a microscopic image at 100X magnification of (R)-Compound 1 after filtration in EasyMax step as described in Example 1. The scale bar represents 100 ^m. FIG.10 is a microscopic image at 100X magnification of (R)-Compound 1 recovered from mother liquor of EasyMax step as described in Example 1. The scale bar represents 100 ^m. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.11 is a histogram plot for particle size of (R)-Compound 1 after filtration in EasyMax step as described in Example 1. FIG.12 is a histogram plot for particle size of (R)-Compound 1 recovered from mother liquor of EasyMax step as described in Example 1. FIG.13 is a plot of the cumulative percent of particle sizes represented in (R)-Compound 1 (1) after filtration in EasyMax step and (2) recovered from the mother liquor of EasyMax step, as described in Example 1. FIG.14 is a microscopic image at 100X magnification of (S)-Compound 1 from Lot 1 as described in Example 1 (agglomerated). The scale bar represents 100 ^m. FIG.15 is a microscopic image at 100X magnification of (S)-Compound 1 from Lot 1 as described in Example 1 (dispersed). The scale bar represents 100 ^m. FIG.16 is a microscopic image at 400X magnification of (S)-Compound 1 from Lot 2 as described in Example 1. The scale bar represents 20 ^m. FIG.17 is a microscopic image at 400X magnification of (S)-Compound 1 from Lot 3 as described in Example 1. The scale bar represents 20 ^m. FIG.18A is a histogram plot for particle size of (S)-Compound 1 from Lot 1 as described in Example 1. FIG.18B is a histogram plot for particle size of (S)-Compound 1 from Lot 2 as described in Example 1. FIG.18C is a histogram plot for particle size of (S)-Compound 1 from Lot 3 as described in Example 1. FIG.19 is a graph showing the XRPD patterns for (S)-Compound 1 from (1) Lot C; (2) Lot D; (3) Lot B; (4) Lot 1; and (5) Lot A. FIG.20 is a graph showing the XRPD patterns for (S)-Compound 1 from (1) Lot C; (2) Lot C 50 °C slurry in acetone; (3) Lot D; and (4) Lot D, a 50 °C slurry in toluene. FIG.21 is a graph showing the XRPD patterns for (S)-Compound 1 from (1) Lot D; (2) Lot C; (3) Lot 1; and (4) Lot 2. FIG.22A is a graph showing the XRPD pattern for (S)-Compound 1 from Lot E. FIG.22B is a graph showing the XRPD pattern for (S)-Compound 1 from Lot F. FIG.23 is graph showing the XRPD patterns of (R)-Compound 1 with varying amounts of a sodium sulfate impurity. (1) Reference pattern of crystalline form A; (2) crystalline form A+B from short term slurry experiments in EtOH at 50 °C; (3) crystalline form A+B, obtained as the wet-cake filtered solid from EasyMax experiments; (4) crystalline form A+B, obtained as the dried filtered solid from EasyMax experiments; (5) crystalline form A+B obtained from the mother liquor of EasyMax experiments. Peaks resulting from sodium sulfate are marked with an arrow. FIG.24A is an XRPD pattern of (R)-Compound 1 with peaks resulting from sodium sulfate marked. FIG.24B is XRPD pattern of (R)-Compound 1 (ethanol slurry) overlaid with the reference pattern for Na2SO4 (phase III + V). PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.25 is a graph showing the XRPD pattern for (R)-Compound 1 (1) As prepared; (2) After a water slurry. (3) After a methanol slurry (4) After an ethanol slurry and (5) After a THF slurry. The dashed line indicates °2^ value of peaks associated with phase III + V of Na2SO4. FIG.26 is differential scanning calorimetry (DSC) thermogram of (R)-Compound 1. FIG.27 is coupled thermogravimetric analysis (TGA) / DSC thermogram of (R)-Compound 1. FIG.28 is a graph showing the XRPD patterns for (1) (R)-Compound 1; (2) reference crystalline form A; and (3) dried solids after the water slurry, crystalline form A. The hashed lines provide guides to the eye to signify the peak shifts attributed to interaction of (R)-Compound 1 with sodium sulfate. FIG.29 is a graph showing the XRPD patterns for (1) (R)-Compound 1. (2) reference crystalline form A; and (3) dried solids after the water slurry, identified as crystalline form A. FIG.30 is XRPD pattern of (R)-Compound 1, identified as crystalline form A after removal of the inorganic impurity. FIG.31 is1H NMR spectrum of (R)-Compound 1 (crystalline form A) after removal of the inorganic impurity. FIG.32 is DSC thermogram of (R)-Compound 1 (crystalline form A) after removal of the inorganic impurity. FIG.33 is coupled TGA / DSC thermogram of (R)-Compound 1, (crystalline form A) after removal of the inorganic impurity. FIG.34 is DVS isotherm of (R)-Compound 1, Sample 1 (crystalline form A) after removal of the inorganic impurity. FIG.35 is a graph showing the XRPD patterns of (R)-Compound 1 (1) before DVS measurement of a crystalline form A sample; and (2) after DVS measurement of a crystalline form A sample. FIG.36A is XRPD pattern of (S)-Compound 1 from Lot 2, identified as crystalline form A. FIG.36B is a peak list for the XRPD pattern of (S)-Compound 1 from Lot 2, identified as crystalline form A, shown in FIG.36A. FIG.37 is1H NMR spectrum of (S)-Compound 1 (crystalline form A) from Lot 2. FIG.38 is DSC thermogram of (S)-Compound 1 (crystalline form A) from Lot 2. FIG.39 is coupled DSC / TGA thermogram of (S)-Compound 1 (crystalline form A) from Lot 2. FIG.40 is DVS isotherm of (S)-Compound 1 (crystalline form A) from Lot 2. FIG.41 is a graph showing the XRPD patterns for (S)-Compound 1 (crystalline form A) from Lot 2 (1) before DVS, identified as crystalline form A; and (2) after DVS, identified as crystalline form A with two additional peaks at 7.4 °2^ and 11.7 °2^. FIG.42A is a graph showing the XRPD patterns for purified crystalline form A of (S)-Compound 1 produced from a first batch (1) and a second batch (2). FIG.42B is a graph showing DSC and TGA for purified crystalline form A of (S)-Compound 1. FIG.43A is a graph including the XRPD patterns for (S)-Compound 1 slurry in IPA (Sample 2). (1) Reference pattern B; (2) reference pattern D; (3) crystalline form B+D from slurry experiments in IPA (pattern B+D); (4) crystalline form B+D from slurry experiments in IPA after drying . PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.43B is a graph including the XRPD patterns for (S)-Compound 1 slurry in EtOAc (Sample 3). (1) Reference pattern D; (2) crystalline form D from slurry experiments in EtOAc; (3) crystalline form D from slurry experiments in EtOAc after drying. FIG.43C is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF (Sample 4). (1) Reference pattern F; (2) crystalline form F from slurry experiments in THF; (3) crystalline form F from slurry experiments in THF after drying. FIG.43D is a graph including the XRPD patterns for (S)-Compound 1 slurry in 2-MeTHF (Sample 5). (1) Reference pattern D; (2) crystalline form D from slurry experiments in 2-MeTHF; (3) crystalline form D from slurry experiments in 2-MeTHF after drying. FIG.43E is a graph including the XRPD patterns for (S)-Compound 1 slurry in toluene (Sample 6). (1) Reference pattern of crystalline form F; (2) reference pattern B; (3) reference pattern B+F from slurry experiments in toluene; (4) crystalline form B+F from slurry experiments in toluene after drying. FIG.43F is a graph including the XRPD patterns for (S)-Compound 1 slurry in MtBE (Sample 7). (1) Reference pattern of crystalline form F; (2) crystalline form F from slurry experiments in MtBE; (3) crystalline form F from slurry experiments in MtBE after drying. FIG.43G is a graph including the XRPD patterns for (S)-Compound 1 slurry in ACN (Sample 8). (1) Reference pattern of crystalline form H; (2) reference pattern of crystalline form B; (3) crystalline form B+H from slurry experiments in CAN; (4) crystalline form B+H is the result of slurry experiments in ACN after drying. FIG.43H is a graph including the XRPD patterns for (S)-Compound 1 slurry in 1,4-dioxane (Sample 9). (1) Reference pattern of crystalline form K; (2) crystalline form K from slurry experiments in 1,4-dioxane (pattern K); (3) crystalline form K from slurry experiments in 1,4-dioxane after drying. FIG.43I is a graph including the XRPD patterns for (S)-Compound 1 slurry in acetone (Sample 10). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry experiments in acetone; (3) crystalline form D from slurry experiments in acetone after drying. FIG.43J is a graph including the XRPD patterns for (S)-Compound 1 slurry in MeOH (Sample 11). (1) Reference pattern of crystalline form B; (2) crystalline form B from slurry experiments in MeOH; (3) crystalline form B from slurry experiments in MeOH after drying. FIG.43K is a graph including the XRPD patterns for (S)-Compound 1 slurry in n-PA (Sample 12). (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form E+A; (3) crystalline form E from slurry experiments in n-PA (pattern E); (4) crystalline form E from slurry experiments in n-PA after drying. FIG.43L is a graph including the XRPD patterns for (S)-Compound 1 slurry in anisole (Sample 13). (1) Reference pattern of crystalline form F; (2) crystalline form F from slurry experiments in anisole. (3) crystalline form F from slurry experiments in anisole after drying. FIG.43M is a graph including the XRPD patterns for (S)-Compound 1 slurry in MeOAc (Sample 14). (1) Reference pattern F. (2) Crystalline form F from slurry experiments in MeOAc (pattern F). (3) Crystalline form F from slurry experiments in MeOAc after drying (pattern F). PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.43N is a graph including the XRPD patterns for (S)-Compound 1 slurry in MEK (Sample 15). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry experiments in MEK; (3) crystalline form D from slurry experiments in MEK after drying. FIG.43O is a graph including the XRPD patterns for (S)-Compound 1 slurry in EtOH (Sample 17). (1) Reference pattern of crystalline form B; (2) crystalline form B from slurry experiments in EtOH; (3) crystalline form B from slurry experiments in EtOH after drying. FIG.44A is a graph including the XRPD patterns for (S)-Compound 1 slurry in EtOH:EtOAc (1:1) (Sample 18). (1) Reference pattern of crystalline form S; (2) Reference pattern of crystalline form T; (3) crystalline form S+T from slurry experiments in EtOH:EtOAc (1:1); (4) crystalline form T from slurry experiments in EtOH:EtOAc (1:1) after drying. FIG.44B is a graph including the XRPD patterns for (S)-Compound 1 slurry in EtOH:DMSO (9:1) (Sample 19). (1) Reference pattern of crystalline form R; (2) crystalline form R from slurry experiments in EtOH:DMSO (9:1); (3) crystalline form R from slurry experiments in EtOH:DMSO (9:1) after drying. FIG.44C is a graph including the XRPD patterns for (S)-Compound 1 slurry in EtOH:DMSO:Water (3:3:4) (Sample 20). (1) Reference pattern of crystalline form R; (2) reference pattern of crystalline form B; (3) crystalline form R+B from slurry experiments in EtOH:DMSO:Water (3:3:4); (4) crystalline form R+B from slurry experiments in EtOH:DMSO:Water (3:3:4) after drying (pattern R+B). FIG.44D is a graph including the XRPD patterns for (S)-Compound 1 slurry in EtOH:1,4-dioxane (1:1) (Sample 21). (1) Reference pattern of crystalline form G; (2) reference pattern of crystalline form K; (3) crystalline form G from slurry experiments in EtOH:1,4-dioxane; (4) crystalline form K from slurry experiments in EtOH:1,4-dioxane (1:1) after drying. FIG.44E is a graph including the XRPD patterns for (S)-Compound 1 slurry in MeOH:MtBE (1:1) (Sample 22). (1) Reference pattern of crystalline form F; (2) crystalline form F from is slurry experiments in MeOH:MtBE (1:1); (3) crystalline form F from slurry experiments in MeOH:MtBE (1:1) after drying. FIG.44F is a graph including the XRPD patterns for (S)-Compound 1 slurry in MeOH:DMSO:Water (2:2:6) (Sample 23). Reference pattern of crystalline form B. (2) Reference pattern of crystalline form F; (3) crystalline forms B+F from slurry experiments in MeOH:DMSO:Water (2:2:6); (4) crystalline form B from slurry experiments in MeOH:DMSO:Water (2:2:6) after drying. FIG.44G is a graph including the XRPD patterns for (S)-Compound 1 slurry in MeOH:1,4- dioxane (1:1) (Sample 24). (1) Reference pattern of crystalline form K; (2) reference pattern of crystalline form G; (3) crystalline form G from slurry experiments in MeOH:1,4-dioxane (1:1); (4) crystalline form K from slurry experiments in MeOH:1,4-dioxane (1:1) after drying. FIG.44H is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:Water (1:1) (Sample 25). (1) Reference pattern of crystalline form B; (2) reference pattern R; (3) reference pattern of crystalline form R+N; (4) crystalline forms R+N+B from slurry experiments in DMSO:Water (1:1); (5) crystalline forms B+R from slurry experiments in DMSO:Water (1:1) after drying. FIG.44I is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:2-MeTHF (1:1) (Sample 26). (1) Reference pattern of crystalline form R; (2) reference pattern of crystalline form R+N; (3) crystalline forms R+N from slurry experiments in DMSO:2-MeTHF (1:1); (4) crystalline forms R+N from slurry experiments in DMSO:2-MeTHF (1:1) after drying. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.44J is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:acetone (1:1) (Sample 27). (1) Reference pattern of crystalline form R; (2) reference pattern R+N; (3) crystalline form N from slurry experiments in DMSO:acetone (1:1); (4) crystalline form R from slurry experiments in DMSO:acetone (1:1) after drying. FIG.44K is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:IPA (1:1) (Sample 28). (1) Reference pattern of crystalline form E+A; (2) reference pattern of crystalline form A; crystalline form E from slurry experiments in THF:IPA (1:1); (4) crystalline form E from slurry experiments in THF:IPA (1:1) after drying. FIG.44L is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:acetone (1:1) (Sample 29). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry experiments in THF:acetone (1:1); (3) crystalline form D from slurry experiments in THF:acetone (1:1) after drying. FIG.44M is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:2-MeTHF (1:1) (Sample 30). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry experiments in THF:2-MeTHF (1:1); (3) crystalline form D from slurry experiments in THF:2-MeTHF (1:1) after drying. FIG.44N is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:EtOH (8:2) (Sample 31). (1) Reference pattern of crystalline form L; (2) reference pattern of crystalline form T; (3) crystalline forms L+T from slurry experiments in THF:EtOH (8:2); (4) crystalline forms L+T from slurry experiments in THF:EtOH (8:2) after drying. FIG.44O is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:EtOH (1:1) (Sample 32). (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form E+A. (3) crystalline form E from slurry experiments in THF:EtOH (1:1); (4) crystalline form E from slurry experiments in THF:EtOH (1:1) after drying. The peak in crystalline form E at 6.28 °2^ is not present in this pattern. FIG.44P is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:EtOH (2:8) (Sample 33). (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form E+A; (3) crystalline form E from slurry experiments in THF:EtOH (2:8); (4) crystalline form K from slurry experiments in THF:EtOH (2:8) after drying. The peak in crystalline form E at 6.28 °2^ is not present in this pattern. FIG.44Q is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:1,4-dioxane (1:1) (Sample 34). (1) Reference pattern of crystalline form K; (2) reference pattern of crystalline form G; (3) crystalline form G from slurry experiments in THF:1,4-dioxane (1:1); (4) crystalline form K from slurry experiments in THF:1,4-dioxane (1:1) after drying. FIG.44R is a graph including the XRPD patterns for (S)-Compound 1 slurry in 2-MeTHF:MeOH (8:2) (Sample 35). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry experiments in 2-MeTHF:MeOH (8:2); (3) crystalline form D from slurry experiments in 2-MeTHF:MeOH (8:2) after drying. FIG.44S is a graph including the XRPD patterns for (S)-Compound 1 slurry in 2-MeTHF:MeOH (1:1) (Sample 36). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry PATENT ATTORNEY DOCKET NO.: 51246-037WO2 experiments in 2-MeTHF:MeOH (1:1); (3) crystalline form D from slurry experiments in 2-MeTHF:MeOH (1:1) after drying. FIG.44T is a graph including the XRPD patterns for (S)-Compound 1 slurry in 2-MeTHF:EtOH (8:2) (Sample 37). (1) Reference pattern D; (2) crystalline form D from slurry experiments in 2- MeTHF:EtOH (8:2); (3) crystalline form D from slurry experiments in 2-MeTHF:EtOH (8:2) after drying. FIG.44U is a graph including the XRPD patterns for (S)-Compound 1 slurry in 2-MeTHF:EtOH (1:1) (Sample 38). (1) Reference pattern of crystalline form D; (2) crystalline form D from slurry experiments in 2-MeTHF:EtOH (1:1); (3) crystalline form D from slurry experiments in 2-MeTHF:EtOH (1:1) after drying. FIG.44V is a graph including the XRPD patterns for (S)-Compound 1 slurry in 2-MeTHF:1,4- dioxane (1:1) (Sample 39). (1) Reference pattern of crystalline form K; (2) reference pattern of crystalline form G. (3) crystalline form G from slurry experiments in 2-MeTHF:1,4-dioxane (1:1); (4) crystalline form K from slurry experiments in 2-MeTHF:1,4-dioxane (1:1) after drying. FIG.44W is a graph including the XRPD patterns for (S)-Compound 1 slurry in 1,4- dioxane:EtOH (8:2) (Sample 40). (1) Reference pattern of crystalline form K. The reference pattern has been scaled by a factor of 0.25; (2) reference pattern of crystalline form G; (3) crystalline form G from slurry experiments in 1,4-dioxane:EtOH (8:2); (4) crystalline form K from slurry experiments in 1,4- dioxane:EtOH (8:2) after drying. FIG.44X is a graph including the XRPD patterns for (S)-Compound 1 slurry in Toluene:MEK (1:1) (Sample 42). (1) Reference pattern of crystalline form F. The reference pattern has been scaled by a factor of 0.5; (2) crystalline form F from slurry experiments in Toluene:MEK (1:1); (3) crystalline form F from slurry experiments in Toluene:MEK (1:1) after drying. FIG.45A is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF. (1) Reference pattern of crystalline form F; (2) Wet cake of (S)-Compound 1 slurry in THF (crystalline form F; low crystallinity); (3) (S)-Compound 1 slurry in THF after drying (crystalline form F; low crystallinity). FIG.45B is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:DMSO (8:2). (1) Reference pattern of crystalline form R; (2) reference pattern of crystalline form R+N; (3) crystalline form N from slurry experiments in THF:DMSO (8:2); (4) crystalline form N from slurry experiments in THF:DMSO (8:2) after drying. (3) and (4) were low crystallinity samples. FIG.45C is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:2-MeTHF (1:1). (1) Reference pattern of crystalline form R; (2) reference pattern of crystalline form R+N; (3) crystalline form N from slurry experiments in DMSO:2-MeTHF (1:1); (4) crystalline form N of (S)- Compound 1 slurry in DMSO:2-MeTHF (1:1) after drying. (3) and (4) were low crystallinity samples. FIG.45D is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:2-MeTHF (2:8). (1) Reference pattern of crystalline form R; (2) reference pattern R+N; (3) crystalline form N from slurry experiments in DMSO:2-MeTHF (2:8); (4) crystalline form N from slurry experiments in DMSO:2- MeTHF (2:8) after drying. (4) was a low crystallinity sample. FIG.45E is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:2-MeTHF (7:3). (1) Reference pattern of crystalline form R; (2) reference pattern of crystalline form R+N; (3) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 crystalline form N from slurry experiments in DMSO:2-MeTHF (7:3); (4) crystalline form N from slurry experiments in DMSO:2-MeTHF (7:3) after drying. (4) was a low crystallinity sample. FIG.45F is a graph including the XRPD patterns for (S)-Compound 1 slurry in DMSO:2-MeTHF (9:1). (1) Reference pattern of crystalline form R; (2) reference pattern of crystalline form R+N; (3) crystalline form N from slurry experiments in DMSO:2-MeTHF (9:1); (4) crystalline form N from slurry experiments in DMSO:2-MeTHF (9:1) after drying. (3) was a low crystallinity sample. FIG.45G is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:DMSO (95:5). (1) Reference pattern of crystalline form R; (2) reference pattern R+N. (3) crystalline form N from slurry experiments in THF:DMSO (95:5); (4) crystalline form N from slurry experiments in THF:DMSO (95:5) after drying. (3) and (4) were low crystallinity samples. FIG.45H is a graph including the XRPD patterns for (S)-Compound 1 slurry in THF:DMSO (9:1). (1) Reference pattern of crystalline form R; (2) crystalline forms R+N; (3) crystalline form N from slurry experiments in THF:DMSO (9:1); (4) crystalline form N from slurry experiments in THF:DMSO (9:1) after drying. (3) and (4) were low crystallinity samples. FIG.46A is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in water and n-heptane. (1) Crystalline form A from slurry experiments in water at room temperature; (2) crystalline form A from slurry experiments in n-heptane at room temperature; (3) crystalline form A from slurry experiments in water at 50 °C; (4) crystalline form A from slurry experiments in n-heptane at 50 °C. FIG.46B is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in IPA:water (9:1 volume) and cyclohexane. (1) Crystalline form A from slurry experiments in IPA:water (9:1 volume) at room temperature; (2) crystalline form A from slurry experiments in cyclohexane at room temperature. (3) crystalline form A from slurry experiments in IPA:water (9:1 volume) at 50°C; (4) crystalline form A from slurry experiments in cyclohexane 50°C. FIG.46C is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in MeOH. (1) Reference pattern of crystalline form A; (2) crystalline forms A+B from slurry experiments in MeOH at room temperature; (3) crystalline forms A+B from slurry experiments in MeOH at 50°C; (4) crystalline forms A+B from slurry experiments in MeOH after drying. FIG.46D is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in EtOH. (1) Reference pattern of crystalline form A; (2) crystalline forms A+B from slurry experiments in EtOH at room temperature; (3) crystalline forms A+B from slurry experiments in EtOH at 50°C; (4) crystalline forms A+B from slurry experiments in EtOH after drying. FIG.46E is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in IPA. (1) Reference pattern of crystalline form A; (2) crystalline forms A+C from slurry experiments in IPA at room temperature; (3) crystalline forms A+C from slurry experiments in IPA at 50°C; (4) crystalline forms A+C from slurry experiments in EtOH at room temperature after drying. FIG.46F is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in EtOAc. (1) Reference pattern of crystalline form A; (2) crystalline form D from slurry experiments in EtOAc at room temperature; (3) crystalline form D from slurry experiments in EtOAc at 50°C; (4) crystalline forms A+C from slurry experiments in EtOAc at room temperature after drying. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.46G is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in THF. (1) reference pattern of crystalline form A; (2) crystalline forms A+D from slurry experiments in THF at room temperature; (3) crystalline form D from slurry experiments in THF at 50°C; (4) crystalline forms A+D from slurry experiments in THF at room temperature after drying. FIG.46H is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in toluene. (1) Reference pattern of crystalline form A; (2) crystalline forms A+F from slurry experiments in toluene at room temperature; (3) crystalline form F from slurry experiments in toluene at 50°C; (4) crystalline form F from slurry experiments in toluene after drying. FIG.46I is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in 1,4-dioxane. (1) Reference pattern of crystalline form A; (2) crystalline form G from slurry experiments in 1,4-dioxane at room temperature; (3) crystalline form G from slurry experiments in 1,4- dioxane at 50°C; (4) crystalline form K from slurry experiments in EtOH after drying. FIG.46J is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in MtBE. (1) Reference pattern of crystalline form A; (2) crystalline form F from slurry experiments in MtBE at room temperature; (3) crystalline form F from slurry experiments in MtBE at 50°C; (4) crystalline form F from slurry experiments in EtOH after drying. FIG.46K is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in ACN. (1) Reference pattern of crystalline form A; (2) crystalline form H from slurry experiments in ACN at room temperature; (3) crystalline form H from slurry experiments in ACN at 50°C; (4) crystalline form H from slurry experiments in ACN at room temperature after drying. FIG.46L is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in 2-MeTHF. (1) Reference pattern of crystalline form D; (2) crystalline form L from slurry experiments in 2-MeTHF at room temperature; (3) crystalline form L from slurry experiments in 2-MeTHF at 50°C; (4) crystalline form D from slurry experiments in acetone at room temperature; (5) crystalline form D from slurry experiments in acetone at 50 °C after drying. FIG.46M is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in EtOH:water (1:1 volume) and EtOH:water (8:2 volume). (1) Reference pattern of crystalline form A; (2) crystalline form A from slurry experiments in 1:1 EtOH:water at room temperature; (3) crystalline form A from slurry experiments in EtOH:water (8:2 volume) at room temperature; (4) crystalline form A from slurry experiments in EtOH:water (1:1 volume) at 50 °C; (5) crystalline form A from EtOH:water (8:2 volume) at 50 °C. FIG.47A is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in water and MeOH. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form A+B; (3) amorphous pattern from recrystallization from water; (4-5) crystalline form A+B from evaporative crystallization from MeOH. Pattern (4) and Pattern (5) are from separate evaporation experiments. FIG.47B is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in EtOH. (1) Reference pattern of crystalline form A; (2-3) crystalline forms A+E from evaporative recrystallization from EtOH. Pattern (2) and Pattern (3) are from separate evaporation experiments. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.47C is a graph showing the XRPD patterns from evaporative crystallization in IPA. (1) Reference pattern of crystalline form A; (2-3) Crystalline form C from evaporative crystallization from IPA. Pattern (2) and Pattern (3) are from separate evaporation experiments. FIG.47D is a graph showing the XPRD patterns for (R)-Compound 1 from evaporative crystallization in EtOAc. (1) Reference pattern of crystalline form C; (2) reference pattern of crystalline form F; (3-4) crystalline form C from evaporative crystallization from IPA. Pattern (3) and Pattern (4) are from separate evaporation experiments. FIG.47E is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in THF. (1) Reference pattern of crystalline form D; (2-3) Crystalline form D from evaporative crystallization from THF. Pattern (2) and Pattern (3) are from separate evaporation experiments. FIG.47F is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in toluene, n-heptane, 1,4-dioxane, and MtBE. (1) Amorphous pattern from evaporative crystallization in toluene; (2) amorphous pattern from evaporative crystallization in n-heptane; (3) amorphous pattern from evaporative crystallization in MtBE; (4) amorphous pattern from evaporative crystallization in MtBE. FIG.47G is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in ACN. (1) Reference pattern of crystalline form H; (2) crystalline form H from evaporative crystallization in ACN. FIG.47H is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in acetone. (1) Reference pattern of crystalline form F; (2) crystalline form F from evaporative crystallization in acetone. One additional unassigned peak is present at 11.72 °2^. FIG.47I is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in IPA:water (9:1 volume). (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form A+B; (3-4) crystalline form A from evaporative crystallization from IPA:water (9:1 volume). Pattern (3) and Pattern (4) are from different experiments. FIG.47J is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in 2Me-THF. Patterns (1) and (2) are from different experiments. FIG.47K is a graph showing the XRPD patterns for (R)-Compound 1 from evaporative crystallization in EtOH:water. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form A+B; (3,5) Pattern A with trace Crystalline form B from evaporative crystallization from EtOH:water (1:1 volume); (4,6) crystalline form A with trace crystalline form B from evaporative crystallization from EtOH:water (8:2 volume). FIG.48A is a graph showing XRPD patterns for (R)-Compound 1 of solids from slow cooling experiments in THF. (1) Reference pattern of crystalline form D; (2) reference pattern of crystalline form L; (3) unidentified pattern resulting from slow cooling of THF; (4) unidentified pattern resulting from slow cooling of THF, after drying. FIG.48B is a graph showing XRPD patterns for (R)-Compound 1 from slow-cooling experiments in IPA:water (9:1 volume) and EtOH:water (8:2 volume). (1) Reference pattern of crystalline form D; (2) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 crystalline form D from slow cooling experiments in IPA:water (9:1 volume); (3) crystalline form D resulting from slow-cooling experiments in EtOH:water (8:2 volume). FIG.48C is a graph showing the XRPD patterns for (R)-Compound 1 from slow cooling experiments in acetone. (1) Reference pattern of crystalline form D; (2) crystalline form B from slow cooling experiments in acetone. (3) crystalline form D from slow cooling experiments in acetone, after drying. FIG.49A is a graph showing the XRPD patterns for (R)-Compound 1 of solids from fast-cooling experiments in THF and acetone. (1) Reference pattern of crystalline form D; (2) unassigned pattern from fast-cooling experiments in THF; (3) unassigned pattern from fast-cooling experiments in acetone. FIG.49B is a graph showing the XRPD patterns for (R)-Compound 1 of solids from rapid evaporation experiments in MeOH. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form D; (3) reference pattern A+E; (4) unassigned pattern resulting from rapid evaporation experiments in MeOH. FIG.49C is a graph showing the XRPD patterns for (R)-Compound 1 of solids from rapid evaporation experiments in THF. (1) Reference pattern of crystalline form A; (2) unassigned pattern resulting from rapid evaporation experiments in THF. FIG.50A is a graph showing the XRPD patterns for (R)-Compound 1 from the direct antisolvent addition experiments which resulted in Crystalline form A. (1) Reference pattern of crystalline form A; (2) crystalline form A resulting from addition of antisolvent water into solvent water; (3) crystalline form A resulting from addition of antisolvent water into solvent EtOH. FIG.50B is a graph showing the XRPD patterns for (R)-Compound 1 from the direct antisolvent addition experiment with DMSO and water. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form R. (3) unassigned patterns from direct antisolvent addition experiments with DMSO and water; (4) unassigned patterns from direct antisolvent addition experiments with DMSO and water, after drying. FIG.50C is a graph showing the XRPD patterns for (R)-Compound 1 from the reverse antisolvent addition experiments where pattern A was observed. (1) Reference pattern of crystalline form A; (2) crystalline form A resulting from reverse antisolvent addition of DMSO with water; (3) crystalline form A resulting from reverse antisolvent addition of EtOH with water; (4) crystalline form A resulting from reverse antisolvent addition of EtOH with 2-MeTHF. FIG.50D is a graph showing the XRPD patterns for (R)-Compound 1 from the reverse antisolvent addition experiments with DMSO and 2-MeTHF. (1) Reference pattern of crystalline form A; (2) crystalline forms R+N resulting from antisolvent addition experiments with DMSO and 2-MeTHF; (3) crystalline form R resulting from antisolvent addition experiments with DMSO and 2-MeTHF, after drying. FIG.50E is a graph showing the XRPD patterns for (R)-Compound 1 from the reverse antisolvent addition experiments with DMSO and 2-MeTHF. (1) Reference pattern of crystalline form R+N; (2) reference pattern of crystalline form R; (3) crystalline forms O+N resulting from reverse antisolvent addition experiments with DMSO and EtOAc; (4) crystalline form O resulting from antisolvent addition experiments with DMSO and EtOAc, after drying. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.50F is a graph showing the XRPD patterns for (R)-Compound 1 from direct antisolvent addition experiments after 5 days. (1) Reference pattern of crystalline form D; (2) crystalline form D resulting from direct antisolvent addition of MeOH with MtBE, after standing for 5 days; (3) crystalline form D resulting from direct antisolvent addition of EtOH with EtOAc, after standing for 5 days. FIG.50G is a graph showing the XRPD patterns for (R)-Compound 1 from reverse antisolvent addition experiments after 5 days. (1) Reference pattern of crystalline form F; (2) crystalline form F resulting from reverse antisolvent addition of MeOH with MtBE, after standing for 5 days; (3) amorphous pattern resulting from reverse antisolvent addition of EtOH with 2-MeTHF, after standing for 5 days. FIG.50H is a graph showing the XRPD patterns for (R)-Compound 1 from reverse antisolvent addition experiments after 5 days in EtOH with EtOAc. (1) Reference pattern of crystalline form A+B; (2) reference pattern of crystalline form D; (3) crystalline form S resulting from reverse antisolvent addition of EtOH with EtOAc, after standing for 5 days in EtOH and EtOAc; (4) crystalline form T resulting from reverse antisolvent addition of EtOH with EtOAc, after standing for 5 days in EtOH and EtOAc, after drying. FIG.51A is a graph showing the XRPD patterns for (R)-Compound 1 from milling experiments where Crystalline form A was observed. (1) Reference pattern of crystalline form A; (2) crystalline form A resulting from milling experiments without additional solvent; (3) crystalline form B resulting from milling experiment in EtOH. (4) crystalline form A resulting from milling experiments in ACN; (5) crystalline form A resulting from milling experiments in water. FIG.51B is a graph showing the XRPD patterns for (R)-Compound 1 from milling experiments with 1,4-dioxane. (1) Reference pattern of crystalline form G; (2) reference pattern of crystalline form K; (3) reference pattern of crystalline form P; (4) crystalline forms P+G resulting from milling experiments in 1,4-dioxane; (5) crystalline forms P+K resulting from milling experiments in 1,4-dioxane after drying. Fig.51C is a graph showing the XRPD patterns for (R)-Compound 1 from the milling experiments with 2-MeTHF. (1) Reference pattern of crystalline form G; (2) reference pattern of crystalline form K; (3) crystalline forms P+G from milling experiments in 2-MeTHF; (4) crystalline forms P+K from milling experiments in 2-MeTHF after drying. FIG.52A is a graph showing the XRPD patterns for (R)-Compound 1 of the solids from the generation of crystalline form F. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form F; (3) Crystalline forms A+F from slurrying Crystalline form A in MtBE at 50 °C, filtering, and drying. FIG.52B is a graph showing the XRPD patterns for (R)-Compound 1 of the solids from the generation of crystalline form F. (1) Reference pattern of crystalline form A; (2) Reference pattern of crystalline form H; (3) crystalline forms A+H from slurrying crystalline form A in ACN, filtering, and drying. FIG.52C is a graph showing the XRPD patterns for (R)-Compound 1 of the solids from the generation of crystalline form J. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form J; (3) crystalline forms A+J from slurrying crystalline form A in acetone, filtering, and drying. FIG.52D is a graph showing the XRPD patterns for (R)-Compound 1 of the solids from the generation of crystalline forms A+B. (1) Reference pattern of crystalline form A; (2) reference pattern of PATENT ATTORNEY DOCKET NO.: 51246-037WO2 crystalline form A+B; (3) crystalline forms A+B from slurrying crystalline form A in EtOH at 50 °C, filtering, and drying. FIG.52E is a graph showing the XRPD patterns for (R)-Compound 1 of the solids from the generation of crystalline forms G+K. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form G; (3) crystalline forms G from slurrying crystalline form A in 1,4-dioxane. FIG.53A is a graph showing the XRPD patterns for (R)-Compound 1 of solids from the thermal treatment of crystalline form J. (1) Reference pattern of crystalline form A; (2) Reference pattern of crystalline form Q; (3) crystalline form Q and trace crystalline form A, resulting from thermal treatment of crystalline form J to 165 ºC; (4) crystalline form Q and crystalline form A, resulting from thermal treatment of crystalline form J to 220 ºC. FIG.53B is a graph showing the XRPD patterns for (R)-Compound 1 of solids from the thermal treatment of crystalline form K. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form K; (3) crystalline form Q+A, resulting from thermal treatment of crystalline form K to 160 ºC. FIG.53C is a graph showing the XRPD patterns of solids from the thermal treatment of crystalline form C. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form C; (3) crystalline form Q+A, resulting from thermal treatment of crystalline form C to 160 ºC. FIG.53D is a graph showing the XRPD patterns for (R)-Compound 1 of solids from the thermal treatment of crystalline form P. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form Q; (3) crystalline form Q and trace crystalline form A, resulting from thermal treatment of crystalline form P to 190 ºC FIG.53E is a graph showing the XRPD patterns for (R)-Compound 1 of solids from the thermal treatment of crystalline form F, crystalline form H, and crystalline form K. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form Q; (3) crystalline form Q+A, resulting from the thermal treatment of crystalline form F to 200 ºC; (4) crystalline form Q and trace crystalline form A, resulting from the thermal treatment of crystalline form H to 200 ºC; (5) crystalline form Q, resulting from the thermal treatment of crystalline form K to 160 ºC FIG.53F is a graph showing the XRPD patterns for (R)-Compound 1 of solids from the thermal treatment of crystalline form A. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form A+B; (3) crystalline form A before thermal treatment; (4) crystalline form A+B from the thermal treatment of crystalline form A at 200 ºC. FIG.54A is a graph showing the XRPD patterns for (R)-Compound 1 of solids from lyophilization in t-BuOH:water (8:2 volume). (1) Reference pattern of crystalline form C; (2) low crystallinity crystalline form C resulting from lyophilization in t-BuOH:water (8:2 volume); (3) low crystallinity pattern C from lyophilization in t-BuOH:water (8:2 volume). FIG.54B is a graph showing the XRPD patterns for (R)-Compound 1 of solids from lyophilization in t-BuOH:water (8:2 volume). (1) Reference pattern of crystalline form C; (2) low crystallinity crystalline form C resulting from lyophilization in t-BuOH:water (8:2 volume); (3) amorphous pattern lyophilization in t-BuOH:water (8:2 volume); (4) low crystallinity crystalline form C from lyophilization in t-BuOH:water (8:2 volume). PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.54C is a graph showing the XRPD patterns for (R)-Compound 1 of solids from lyophilization in t-BuOH:water (8:2 volume). (1) Reference pattern of crystalline form A; (2-3) unassigned patterns from lyophilization in t-BuOH:water (8:2 volume). Pattern (2) and Pattern (3) are from different experiments. FIG.55A is a graph showing the XRPD patterns for (R)-Compound 1 of solids from humidity studies. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form B (3) crystalline form A, with trace B, from storage at 10% RH; (4) crystalline form A from storage at 23% relative humidity; (5) crystalline form A, with trace B, from storage at 33% RH. FIG.55B is a graph showing a magnified view of the XRPD patterns for (R)-Compound 1 resulting from the humidity studies shown in FIG.55A. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form B (3) crystalline form A, with trace B, from storage at 10% RH; (4) crystalline form A from storage at 23% relative humidity; (5) crystalline form A, with trace B, from storage at 33% RH. Arrows indicate peaks which shift, decrease in relative intensity, or increase in relative intensity in solids stored at different relative humidities. FIG.55C is a graph showing the XRPD patterns for (R)-Compound 1 of solids from slurry experiments in EtOH at 70 ºC for 4 days. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form B; (3) unassigned pattern resulting from slurry experiments in EtOH at 70 ºC for 4 days. FIG.55D is a graph showing the XRPD patterns for (R)-Compound 1 of solids from small-scale vial experiments in EtOH:water. (1) Reference pattern of crystalline form A; (2) crystalline form A resulting from small scale vial experiments in EtOH:water. FIG.55E is a graph showing the XRPD patterns for (R)-Compound 1 of solids from small-scale vial experiments in EtOH:water. (1) Reference pattern of crystalline form A; (2) crystalline form A resulting from small scale vial experiments in EtOH:water. FIG.55F is a graph showing the XRPD patterns for (R)-Compound 1 of solids from small-scale vial experiments in EtOH:water with seeding of crystalline form B. (1) Reference pattern of crystalline form A; (2) unidentified pattern from small scale vial experiments in EtOH:water with seeding of pattern B, after being filtered at 60 ºC; (3) crystalline form A from small scale vial experiments in EtOH:water with seeding of pattern B, after being filtered at 60 ºC FIG.56 is a form map of the XRPD patterns of (R)-Compound 1. FIG.57A is a graph showing the XRPD pattern of crystalline form B of (R)-Compound 1. FIG.57B is a graph showing the XRPD pattern of crystalline form C of (R)-Compound 1. FIG.57C is a graph showing the XRPD pattern of crystalline form D of (R)-Compound 1 from short term slurry experiments in EtOAc. (1) Reference pattern of crystalline form A; (2) crystalline form D as prepared after drying; (3) Crystalline form D+A, formed after 1 week of storage under laboratory conditions. FIG.57D is a graph showing the XRPD pattern of crystalline form E of (R)-Compound 1. (1) Reference pattern of crystalline form A; (2) crystalline form E as prepared after drying. (3) Crystalline form E+A, formed after 1 week of storage under laboratory conditions. FIG.57E is a graph showing the XRPD pattern of crystalline form G of (R)-Compound 1. FIG.57F is a graph showing the XRPD pattern of crystalline form H of (R)-Compound 1. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.57G is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in acetone. (1) Reference pattern of crystalline form A; (2) crystalline form A+I from slurry experiments in acetone. FIG.57H is a graph showing the XRPD patterns for (R)-Compound 1 from the short-term slurry experiments in acetone. (1) Reference pattern of crystalline form A; (2) crystalline forms A+I from slurry experiments in acetone at room temperature; (3) crystalline forms A+I from slurry experiments in acetone at 50 °C; (4) crystalline forms A+I from slurry experiments in acetone at room temperature after drying; (5) crystalline form J from slurry experiments in acetone at 50 °C after drying. FIG.57I is a graph showing the XRPD pattern of crystalline form J of (R)-Compound 1. FIG.57J is a graph showing the XRPD pattern of crystalline form K of (R)-Compound 1. FIG.57K is a graph showing the XRPD pattern of crystalline form L of (R)-Compound 1. FIG.57L is a graph showing the XRPD pattern of crystalline form M of (R)-Compound 1. FIG.57M is a graph showing the XRPD patterns for (R)-Compound 1 observed after reverse antisolvent addition with DMSO and EtOAc. (1) XRPD pattern corresponding to crystalline forms R+N (wet cake); (2) crystalline form R, formed after drying the solids. FIG.57N is a graph showing the XRPD patterns for (R)-Compound 1 observed after reverse antisolvent addition with DMSO and EtOAc. (1) Reference XRPD pattern of crystalline form R+N (wet cake); (2) reference XRPD pattern of crystalline form R; (3) crystalline form O+N (wet cake). Arrows indicate signals crystalline form O. FIG.57O is a graph showing the XRPD pattern of crystalline form FIG.57P is a graph showing the XRPD pattern of crystalline form FIG.57Q is a graph showing the XRPD pattern of crystalline form FIG.57R is a graph showing the XRPD pattern of crystalline form FIG.57S is a graph showing the XRPD pattern of crystalline form FIG.58A is a graph showing a coupled TGA / DSC thermogram of crystalline form B of (R)- Compound 1, formed from drying crystalline form A at 65 °C under N2. FIG.58B is a graph showing a coupled TGA / DSC thermogram of crystalline form C of (R)- Compound 1, formed from slurrying crystalline form A in IPA at 50 °C IPA at 50 °C. FIG.58C is a graph showing a coupled TGA / DSC thermogram of crystalline form D of Compound 1, formed from slurrying crystalline form A in. EtOAc at 50 °C. Some crystalline form A is present in the sample. FIG.58D is a graph showing a coupled TGA / DSC thermogram of crystalline form E of (R)- Compound 1, formed from evaporative crystallization in EtOH. Some crystalline form A is present in the sample. FIG.58E is a graph showing a coupled TGA / DSC thermogram of crystalline form F of (R)- Compound 1, formed from slurrying crystalline form A in toluene. Some crystalline form A is present in the sample. FIG.58F is a graph showing a coupled TGA / DSC thermogram of crystalline form H of (R)- Compound 1. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.58G is a graph showing a coupled TGA / DSC thermogram of crystalline form J of (R)- Compound 1, formed from slurrying crystalline form A in acetone at 50 °C. Some crystalline form A is present in the sample. FIG.58H graph showing a coupled TGA / DSC thermogram of crystalline form K of (R)- Compound 1. FIG.58I graph showing a coupled TGA / DSC thermogram of crystalline form P of (R)-Compound 1. FIG.58J graph showing a DSC thermogram of crystalline form Q of (R)-Compound 1. FIG.58K graph showing a DSC thermogram of crystalline form R of (R)-Compound 1. FIG.59A shows polarized light microscopy (PLM) images of crystals with cracks perpendicular to the long dimension of large rods. FIG.59B shows PLM images of a collection of crystals with cracks perpendicular to the long dimension of large rods. The crystal indicated with the arrow was examined by x-ray single crystal diffraction. Images were taken after data collection. FIG.60 shows an ORTEP diagram of (S)-Compound 1 monohydrate: non-hydrogen atoms drawn in ellipsoids at 60% probability level and hydrogen atoms in small circles. H-bonding is shown as dotted lines (N4-H…O1120.62º, 2.402Å, 2.949Å; Ow-H…N2142.82º, 1.918Å, 2.816Å). FIG.61 shows the unit cell content of (S)-Compound 1 monohydrate: four (S)-Compound 1 monohydrate molecules and four water molecules / sites. FIG.62 is a graph showing XRPD overlay of bulk (S)-Compound 1 monohydrate (top) and simulated pattern of (S)-Compound 1 monohydrate at 223K (bottom). FIG.63 shows the hydrogen bonding interactions involved the water molecule: Ow-H…O1 (165.79º, 2.072Å, 2.860Å), Ow-H…N2 (142.82º, 1.918Å, 2.816Å), N3-H…Ow (127.89º, 2.360Å, 2.975Å), N4-H…Ow (141.78º, 2.204Å, 2.938Å). FIG.64 shows the intermolecular hydrogen bonding interactions between (S)-Compound 1 molecules: O2-H…O1 (173.79º, 1.828Å, 2.655Å) along the crystallographic a-axis (and the b-axis as well). FIGS.65A and 65B show the molecular packing in (S)-Compound 1, viewed along the crystallographic c-axis (FIG.65A) and b-axis (FIG.65B). Water molecules are in ball-stick presentation. FIG.66 is a graph showing XRPD patterns of the slurried solids that precipitated out prior to seeding. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form R; (3) 8 vol. of MeOH:DMSO (6:4 vol.) with 1 vol. of water, Crystalline form R. (4) 8 vol. of EtOH:DMSO (6:4 vol.) with 1 vol. of water crystalline form R. (5) 6 vol. of MeOH:DMSO (1:1 vol.) with 1 vol. of water crystalline form R. FIG.67 is a graph showing XRPD patterns of the slurried solids from Recrystallization 1, 400X magnification. (1) Reference pattern of crystalline form A; (2) after seeding, identified as crystalline form A; (3) after dosing 2.5 vol. of water, identified as crystalline form A; (4) after dosing 5.0 vol. of water, identified as crystalline form A; (5) after drying, identified as crystalline form A. FIG.68 is a graph showing XRPD patterns of the slurried solids from Recrystallization 4. (1) Reference pattern of crystalline form A; (2) after seeding, identified as crystalline form A; (3) after PATENT ATTORNEY DOCKET NO.: 51246-037WO2 dosing 2.5 vol. of water, identified as crystalline form A; (4) after dosing 5.0 vol. of water, crystalline form A; (5) after drying, crystalline form A. FIG.69 is a graph showing XRPD patterns of the slurried solids from Recrystallization 6. (1). Reference pattern of crystalline form A; (2) reference pattern of crystalline form R; (3) reference pattern of crystalline form O+N; (4) after seeding, identified as crystalline form A; (5) after dosing 2.5 vol. of water, identified as crystalline form A; (6) after drying, identified as crystalline forms A+R+O. FIG.70 shows microscopy images of the solid collected from Recrystallization 1, 400X magnification. (1) After seeding; (2) After dosing 2.5 vol. of antisolvent; (3) after dosing 5.0 vol. of antisolvent; (4) after dosing 7.5 vol. of antisolvent; (5) after dosing 10 vol. of antisolvent; (6) before drying. FIG.71 shows microscopy images of the solid collected from Recrystallization 4, 400X magnification. (1) After seeding; (2) after dosing 2.5 vol. of antisolvent; (3) after dosing 5.0 vol. of antisolvent; (4) after dosing 7.5 vol. of antisolvent; (5) after dosing 10 vol. of antisolvent; (6) before drying. FIG.72 shows microscopy images of the solid collected from Recrystallization 6, 400X magnification. (1) After seeding; (2) after dosing 2.5 vol. of antisolvent; (3) after dosing 7.5 vol. of antisolvent; (4) before drying. FIG.73 is a graph showing XRPD patterns of solids collected from the recrystallization in EtOH:water systems. (1) Reference pattern of crystalline form A; (2) Recrystallization 7, after seeding, identified as crystalline form A; (3) Recrystallization 7, before drying, identified as crystalline form A. (4) Recrystallization 9, after seeding, identified as crystalline form A; (5) Recrystallization 9, before drying. Identified as crystalline form A. FIG.74 is a graph showing XRPD patterns of solids collected from recrystallization in MeOH:water systems. (1) Reference pattern of crystalline form A; (2) Recrystallization 8, after dosing 8 vol. of water. Identified as crystalline form A; (3) Recrystallization 8 before drying, identified as crystalline form A; (4) Recrystallization 10, after dosing with 8 vol. of water, identified as crystalline form A; (5) Recrystallization 10, before drying, identified as crystalline form A. FIG.75 shows microscopy images of the collected solid from Recrystallization 7, 400X magnification. (1) After seeding; (2) after dosing 4 vol. of antisolvent; (3) after dosing 8 vol. of antisolvent; (4) after dosing 12 vol. of antisolvent; (5) after dosing 16 vol. of antisolvent; (6) before filtration. FIG.76 shows microscopy images of the collected solid from Recrystallization 8, 400X magnification. (1) After seeding; (2) after aging the seed for 1.5 h; (3) after dosing 2.25 vol. of antisolvent; (3) after dosing 4.50 vol. of antisolvent; (4) after dosing 7.5 vol. of antisolvent; (5) before filtration. FIG.77 shows microscopy images of the collected solid from Recrystallization 9. (1) After seeding; (2) after dosing 4 vol. of antisolvent; (3) after dosing 8 vol. of antisolvent; (4) after dosing 12 vol. of antisolvent; (5) after dosing 16 vol. of antisolvent; (6) before filtration. FIG.78 shows microscopy images of the collected solid from Recrystallization 10, 400X magnification. (1) After seeding; (2) after aging the seed for 1.5 h; (3) after dosing 2.25 vol. of antisolvent; (3) after dosing 4.50 vol. of antisolvent; (4) after dosing 7.50 vol. of antisolvent; (5) before filtration. FIG.79 is a graph showing XRPD patterns of the collected solid from Recrystallization 11 and Recrystallization 12. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form B. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 (3) dried solids from Recrystallization 11, identified as crystalline form A+B; (4) dried solids from Recrystallization 12, identified as crystalline forms A+B. FIG.80 shows microscopy images of the collected solid from Recrystallization 11, 400X magnification. (1) After seeding; (2) after dosing 2.5 vol. of antisolvent; (3) after dosing 4.5 vol. of antisolvent; (4) before filtration. FIG.81 shows microscopy images of the collected solid from Recrystallization 12, 400X magnification. (1) After seeding, vial A; (2) during dosing, vial A; (3) before filtration, vial A; (4) after seeding, vial B; (5) during dosing, vial B; (6) before filtration, vial B. FIG.82 is a graph showing XRPD patterns of the collected solid from Recrystallization 13 and Recrystallization 14. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline form B. (3) dried solids from Recrystallization 13, identified as crystalline form B; (4) dried solids from Recrystallization 14, identified as crystalline form B; (5) aged solids from Recrystallization 13, Identified as crystalline form A, (6) aged solids from Recrystallization 14, identified as crystalline form A. FIG.83 shows microscopy images of the seed crystals used in Recrystallization 13 and Recrystallization 14, 400X magnification. (1) Suspension of 20 mg of seed in 2 mL of MeOH:water (1:1 vol.), vial 1; (2) suspension of 20 mg of seed in 2 mL of MeOH:water (1:1 vol.), vial 2. FIG.84 shows microscopy images of the collected solid from Recrystallization 13. (1) After seeding, vial A, 400X magnification; (2) after the 30-min hold, 400X magnification; (3) during antisolvent addition, 1 h, 100X magnification; (4) during antisolvent addition, 2 h 40 min, 100X magnification; (5) during cooling, 100X magnification; (6) before filtration, 100X magnification. FIG.85 shows microscopy images of the collected solid from Recrystallization 14. (1) After seeding, vial A, 400X magnification; (2) during antisolvent addition, 2 h, 100X magnification; (3) during cooling,100X magnification; (4) before filtration, 100X magnification. FIG.86A is a graph showing XRPD patterns of crystalline hydrochloric acid salt form A, and a table summarizing the peaks observed. FIG.86B is a graph showing XRPD patterns of crystalline hydrochloric acid salt form B, and a table summarizing the peaks observed. FIG.86C is a graph showing XRPD patterns of crystalline hydrochloric acid salt form C, and a table summarizing the peaks observed. FIG.86D is a coupled TGA / DSC thermogram of crystalline hydrochloric acid salt form A as prepared. FIG.86E is a coupled TGA / DSC thermogram of crystalline hydrochloric acid salt form B as prepared. FIG.86F is a coupled TGA / DSC thermogram of crystalline hydrochloric acid salt form C as prepared. FIG.86G is a graph showing an XRPD pattern of crystalline sulfate salt form A as prepared. FIG.86H is a coupled TGA / DSC thermogram of crystalline sulfate salt form A as prepared. FIG.86I is a graph showing an XRPD pattern of crystalline maleate salt form A. FIG.86J is a coupled TGA / DSC thermogram of crystalline maleate salt form A as prepared. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.86K is a1H NMR spectra of crystalline maleate salt form A. The relative peak integrations indicate crystalline maleate salt form A is a hemi-maleate. FIG.86L is a graph showing XRPD patterns of fumarate salt forms. (1) Crystalline fumarate salt form A; (2) crystalline fumarate salt form B; (3) crystalline fumarate salt form C; (4) unreacted fumaric acid. FIG.86M is a coupled TGA / DSC thermogram of crystalline fumarate salt form A as prepared. FIG.86N is a coupled TGA / DSC thermogram of crystalline fumarate salt form B as prepared. FIG.86O is a coupled TGA / DSC thermogram of crystalline fumarate salt form C as prepared. FIG.86P is a graph showing XRPD patterns of 1,5-naphthalenedisulfonate salt forms. (1) Crystalline 1,5-naphthalenedisulfonate salt form A; (2) crystalline 1,5-naphthalenedisulfonate salt form B; (3) crystalline 1,5-naphthalenedisulfonate salt form D; (4) unreacted fumaric acid. FIG.86Q is a coupled TGA / DSC thermogram of crystalline 1,5-naphthalenedisulfonate salt form A as prepared. FIG.86R is a coupled TGA / DSC thermogram of crystalline 1,5-naphthalenedisulfonate salt form B as prepared. FIG.86S is a coupled TGA / DSC thermogram of crystalline 1,5-naphthalenedisulfonate salt form D as prepared. FIG.86T is a graph showing XRPD patterns of 1,2-ethanedisulfonate salt form. (1) Crystalline 1,2-ethanedisulfonate salt form A; (2) crystalline 1,2-ethanedisulfonate salt form B. FIG.86U is a coupled TGA / DSC thermogram of crystalline 1,2-ethanedisulfonate salt form A as prepared. FIG.86V is a coupled TGA / DSC thermogram of crystalline 1,2-ethanedisulfonate salt form B as prepared. FIG.86W is a graph showing XRPD patterns of crystalline mesylate salt form A, and a table summarizing the peaks observed. FIG.86X is a coupled TGA / DSC thermogram of crystalline mesylate salt form A as prepared. FIG.86Y is a graph showing XRPD patterns of crystalline besylate salt form A. FIG.86Z is a coupled TGA / DSC thermogram of crystalline besylate salt form A as prepared. FIG.87A is a graph showing XRPD patterns of crystalline maleate salt form B, and a table summarizing the peaks observed. FIG.87B is a TGA thermogram of crystalline maleate salt form B. FIG.87C is a DSC thermogram of crystalline maleate salt form B. FIG.87D is a graph showing XRPD patterns of crystalline maleate salt form B. (1) Before heating; (2) after heating to 100 °C; (3) after heating to 150 °C. FIG.87E is a1H NMR spectra of crystalline maleate salt form B. The relative peak integrations indicate crystalline maleate salt form B is a hemi-maleate. FIG.87F is a graph showing XRPD patterns after solid vapor diffusion of crystalline mesylate salt form A with DMSO. (1) Reference pattern of crystalline form R; (2) wet crystalline maleate salt form C; (3) Crystalline maleate salt form C after drying. XRPD peaks corresponding to crystalline form R are marked with a star. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.87G is a graph showing XRPD patterns of crystalline maleate salt form C, and a table summarizing the peaks observed. FIG.87H is a1H NMR spectra of crystalline maleate salt form C. The relative peak integrations indicate crystalline maleate salt form C includes 0.4 equivalents of maleic acid per molecule of (S)- Compound 1, and 2.1 equivalents of DMSO per molecule of (S)-Compound 1. FIG.87I shows an XRPD pattern of crystalline mesylate salt form B. (1) Wet cake. (2) After drying. FIG.87J is a graph showing XRPD patterns of crystalline mesylate salt form B, and a table summarizing the peaks observed. FIG.87K is a coupled TGA / DSC thermogram of crystalline mesylate salt form B as prepared. FIG.87L is a graph showing XRPD patterns of crystalline mesylate salt form B. (1) Before heating. (2) After heating to 100 °C. (3) After heating to 170 °C. FIG.87M is a coupled TGA / DSC thermogram of crystalline mesylate salt form B after heating to 100 °C. FIG.87N is a1H NMR spectra of crystalline mesylate salt form B. The relative peak integrations indicate crystalline mesylate salt form B includes about 0.5 equivalents of THF per molecule of (S)- Compound 1. FIG.87O is a graph showing XRPD patterns of crystalline mesylate salt form C. (1) Wet Cake; (2) after drying. FIG.87P is a graph showing XRPD patterns of crystalline mesylate salt form C, and a table summarizing the peaks observed. FIG.87Q is a coupled TGA / DSC thermogram of crystalline mesylate salt form C. FIG.87R is a1H NMR spectra of crystalline mesylate salt form C. The relative peak integrations indicate crystalline mesylate salt form C includes about 1.3 equivalents of 1,4-dioxane per molecule of (S)-Compound 1. FIG.87S shows an XRPD pattern of crystalline mesylate salt form D. (1) Wet cake; (2) after drying; (3) reference XRPD of crystalline mesylate salt form A FIG.87T shows an XRPD pattern of crystalline mesylate salt form E. (1) Wet cake; (2) after drying. Drying results in a near total loss of crystallinity. FIG.88A shows the kinetic solubility of crystalline form A, crystalline maleate salt form A, crystalline mesylate salt form A, and crystalline hydrochloric acid salt form C in water at 37 °C. FIG.88B shows the kinetic solubility of crystalline form A, crystalline maleate salt form A, crystalline mesylate salt form A, and crystalline hydrochloric acid salt form C in fasted state simulated intestinal fluid (FaSSIF) at 37 °C. FIG.88C shows the kinetic solubility of crystalline form A, crystalline maleate salt form A, crystalline mesylate salt form A, and crystalline hydrochloric acid salt form C in fed state simulated intestinal fluid (FeSSIF) at 37 °C. FIG.88D shows the kinetic solubility of crystalline form A, crystalline maleate salt form A, crystalline mesylate salt form A, and crystalline hydrochloric acid salt form C in simulated gastric fluid (SGF) at 37 °C. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 FIG.88E shows XRPD patterns of crystalline form A after dissolution and recovery in various media after 24 hours. (1) Reference pattern of crystalline form A; (2) SGF media; (3) FeSSIF media; (4) FaSSIF media; (5) water media. FIG.88F shows XRPD patterns of crystalline maleate salt form A after dissolution and recovery in various media after 1 hour. (1) Reference pattern of crystalline maleate salt form A; (2) reference pattern of crystalline form A; (3) SGF media; (4) FeSSIF media; (5) FaSSIF media; (6) water media. FIG.88G shows XRPD patterns of crystalline mesylate salt form A after dissolution and recovery in various media after 1 hour. (1) Reference pattern of crystalline mesylate salt form A; (2) reference pattern of crystalline form A; (3) SGF media; (4) FeSSIF media; (5) FaSSIF media; (6) water media. FIG.88H shows XRPD patterns of crystalline hydrochloric acid salt form C after dissolution and recovery in various media. (1) Reference pattern of crystalline hydrochloric acid salt form C; (2) reference pattern of crystalline form A; (3) SGF media after 24 hr; (4) SGF media after 1 hr; (5) FeSSIF media after 1 hr; (6) FaSSIF media after 1 hr; (7) water media. Stars indicate the presence of weak signals corresponding to crystalline hydrochloric acid salt form C in pattern (3) and (4). FIG.89A shows XRPD patterns of crystalline maleate salt form A under various storage conditions. (1) Reference pattern of crystalline maleate salt form A; (2) storage of crystalline maleate salt form A at 40 °C / 75% RH for 2 months; (3) storage of crystalline maleate salt form A at 40 °C / 75% RH for 1 months; (4) Storage of crystalline maleate salt form A at 25 °C / 60% RH for 2 months; (5) storage of crystalline maleate salt form A at 25 °C / 60% RH for 1 months. FIG.89B shows XRPD patterns of crystalline mesylate salt form A under various storage conditions. (1) Reference pattern of crystalline form A; (2) reference pattern of crystalline mesylate salt form A; (3) storage of crystalline mesylate salt form A at 40 °C / 75% RH for 2 months; (4) storage of crystalline mesylate salt form A at 40 °C / 75% RH for 1 months; (5) storage of crystalline mesylate salt form A at 25 °C / 60% RH for 2 months; (6) storage of crystalline mesylate salt form A at 25 °C / 60% RH for 1 months. DETAILED DESCRIPTION In general, the invention provides crystalline forms of an enantiomer of Compound 1, e.g., crystalline forms of formula (1-S) (hereafter, (S)-Compound 1) or formula (1-R) (hereafter, (R)- Compound 1) . (1-S) (1-R) The crystalline form of the enantiomers of Compound 1 (e.g., the crystalline form of (S)-Compound 1 or the crystalline form of (R)-Compound 1) may be, e.g., crystalline form A, crystalline form B, crystalline PATENT ATTORNEY DOCKET NO.: 51246-037WO2 form C, crystalline form D, crystalline form E, crystalline form F, crystalline form G, crystalline form H, crystalline form I, crystalline form J, crystalline form K, crystalline form L, crystalline form M, crystalline form N, crystalline form O, crystalline form P, crystalline form Q, crystalline form R, crystalline form S, or crystalline form T. In preferred embodiments, the crystalline form of (S)-Compound 1 is crystalline form A, crystalline form C, crystalline form Q, crystalline form K, crystalline form R, crystalline form P, or crystalline form B. In preferred embodiments, the crystalline form of (R)-Compound 1 is crystalline form A, crystalline form C, crystalline form Q, crystalline form K, crystalline form R, crystalline form P, or crystalline form B. Hereafter, the crystalline forms of (S)-Compound 1 or (R)-Compound 1 are identified by their XRPD patterns and may be interchangeably referred to by their XRPD pattern, i.e., crystalline form A may be interchangeably referred to as Pattern A. As described in the examples, several crystalline forms are identified for (S)-Compound 1 and (R)-Compound 1, such as: crystalline form A (which formed block-like crystals as shown in FIGS.2A-2D, characterized by XRPD (see, e.g., FIG.42A) and DSC (see, e.g., FIG.42B)), crystalline form B (characterized by XRPD (see, e.g., FIG.57A) and coupled TGA / DSC (see, e.g., FIG.58A)), crystalline form C (characterized by XRPD (see, e.g., FIG.57B) and coupled TGA / DSC (see, e.g., FIG.58B)), crystalline form K (characterized by XRPD (see, e.g., FIG.57J) and coupled TGA / DSC (see, e.g., FIG. 58H), crystalline form P (characterized by XRPD (see, e.g., FIG.57O) and coupled TGA / DSC (see, e.g., FIG.58I)), crystalline form Q (characterized by XRPD (see, e.g., FIG.57P) and coupled TGA / DSC (see, e.g., FIG.58J)), crystalline form R (characterized by XRPD (see, e.g., FIG.57Q) and coupled TGA / DSC (see , e.g., FIG.58K)). Additionally, several crystalline salt forms are identified for (S)-Compound 1 and (R)-Compound 1, such as: crystalline maleate salt form A (characterized by XRPD (see, e.g., FIG.86I), coupled TGA / DSC (see, e.g., FIG.86J), and1H NMR (see, e.g., FIG.86K)), crystalline maleate salt form B (characterized by XRPD (see, e.g., FIG.87A), TGA (see, e.g., FIG.87B), DCS (see, e.g., FIG.87C) and1H NMR (see, e.g., FIG.87E)), crystalline mesylate salt form A (characterized by XRPD (see, e.g., FIG. 86W) and coupled TGA / DSC (see, e.g., FIG.86X)), crystalline mesylate salt form B (characterized by XRPD (see, e.g., FIG.87G), coupled TGA / DSC (see, e.g., FIG.87H), and1H NMR (see, e.g., FIG.87N)), crystalline mesylate salt form C (characterized by XRPD (see, e.g., FIG.87P), coupled TGA / DSC (see, e.g., FIG.87Q), and1H NMR (see, e.g., FIG.87R)), crystalline hydrochloric acid salt form A (characterized by XRPD (see, e.g., FIG.86A) and coupled TGA / DSC (see, e.g., FIG.86D)), crystalline hydrochloric acid salt form B (characterized by XRPD (see, e.g., FIG.86B) and coupled TGA / DSC (see, e.g., FIG.86E)), and crystalline hydrochloric acid salt form C (characterized by XRPD (see, e.g., FIG. 86C) and coupled TGA / DSC (see, e.g., FIG.86F)). Methods of Use Methods of treating a disease or condition having the symptom of cell hyperproliferation (e.g., a cancer) and methods for treating cancers that harbor CCNE1 amplification / overexpression or FBXW7- mutated cancers, which depend on the activity of membrane-associated tyrosine and threonine-specific cdc2-inhibitory kinase (Myt1), have been described in US Patent Application Publication: US 2023 / 0151014 A1, the disclosure of which is incorporated by reference herein in its entirety. The PATENT ATTORNEY DOCKET NO.: 51246-037WO2 crystalline forms of the present disclosure may further be used in the treatment of cancers including a replication stress biomarker (e.g., a mutation or gene amplification of a gene associated with replication stress, e.g., a mutation or gene amplification of KRAS, NRAS, HRAS, TP53, CCNE1, CDK4, CDK6, CDK12, CDKN2A, CDC25A, EGFR, FBXW7, c-MYC, PIK3CA, PPP2R1A, PTEN, RB1, BRAF, a prior or current infection with HPV, or a combination thereof). The method may include contacting the cell with an effective amount of a crystalline form or a pharmaceutical composition containing the crystalline form disclosed herein. A method of treating a subject in need thereof (e.g., a subject suffering from, and is in need of a treatment for, a disease or condition having the symptom of cell hyperproliferation (e.g., a cancer (e.g., a carcinoma, sarcoma, adenocarcinoma, leukemia, or melanoma) and / or a pre-malignant condition)) may include administering to the subject an effective amount of a crystalline form or a pharmaceutical composition containing the crystalline form disclosed herein. In some embodiments, the crystalline form used in the methods described herein is a crystalline form A. In some embodiments, the crystalline form used in the methods described herein is a crystalline form C. In some embodiments, the crystalline form used in the methods described herein is a crystalline form Q. In some embodiments, the crystalline form used in the methods described herein is a crystalline form K. In some embodiments, the crystalline form used in the methods described herein is a crystalline form R. In some embodiments, the crystalline form used in the methods described herein is a crystalline form P. In some embodiments, the crystalline form used in the methods described herein is a crystalline form B. In some embodiments, the crystalline form used in the methods described herein is a crystalline maleate salt form A. In some embodiments, the crystalline form used in the methods described herein is a crystalline maleate salt form B. In some embodiments, the crystalline form used in the methods described herein is a crystalline mesylate salt form A. In some embodiments, the crystalline form used in the methods described herein is a crystalline mesylate salt form B. In some embodiments, the crystalline form used in the methods described herein is a crystalline mesylate salt form C. In some embodiments, the crystalline form used in the methods described herein is a crystalline hydrochloric acid salt form A. In some embodiments, the crystalline form used in the methods described herein is a crystalline hydrochloric acid salt form B. In some embodiments, the crystalline form used in the methods described herein is a crystalline hydrochloric acid salt form C. Non-limiting examples of carcinomas include medullary thyroid carcinoma, familial medullary thyroid carcinoma, acinar carcinoma, acinous carcinoma, adenocystic carcinoma, adenoid cystic carcinoma, carcinoma adenomatosum, carcinoma of adrenal cortex, alveolar carcinoma, alveolar cell carcinoma, basal cell carcinoma, carcinoma basocellulare, basaloid carcinoma, basosquamous cell carcinoma, bronchioalveolar carcinoma, bronchiolar carcinoma, bronchogenic carcinoma, cerebriform carcinoma, cholangiocellular carcinoma, chorionic carcinoma, colloid carcinoma, comedo carcinoma, corpus carcinoma, cribriform carcinoma, carcinoma en cuirasse, carcinoma cutaneum, cylindrical carcinoma, cylindrical cell carcinoma, duct carcinoma, carcinoma durum, embryonal carcinoma, encephaloid carcinoma, epidermoid carcinoma, carcinoma epitheliale adenoides, exophytic carcinoma, carcinoma ex ulcere, carcinoma fibrosum, gelatiniforni carcinoma, gelatinous carcinoma, giant cell carcinoma, carcinoma gigantocellulare, glandular carcinoma, granulosa cell carcinoma, hair-matrix carcinoma, hematoid carcinoma, hepatocellular carcinoma, Hurthle cell carcinoma, hyaline carcinoma, PATENT ATTORNEY DOCKET NO.: 51246-037WO2 hypernephroid carcinoma, infantile embryonal carcinoma, carcinoma in situ, intraepidermal carcinoma, intraepithelial carcinoma, Krompecher's carcinoma, Kulchitzky-cell carcinoma, large-cell carcinoma, lenticular carcinoma, carcinoma lenticulare, lipomatous carcinoma, lymphoepithelial carcinoma, carcinoma medullare, medullary carcinoma, melanotic carcinoma, carcinoma molle, mucinous carcinoma, carcinoma muciparum, carcinoma mucocellulare, mucoepidermoid carcinoma, carcinoma mucosum, mucous carcinoma, carcinoma myxomatodes, nasopharyngeal carcinoma, oat cell carcinoma, carcinoma ossificans, osteoid carcinoma, papillary carcinoma, periportal carcinoma, preinvasive carcinoma, prickle cell carcinoma, pultaceous carcinoma, renal cell carcinoma of kidney, reserve cell carcinoma, carcinoma sarcomatodes, Schneiderian carcinoma, scirrhous carcinoma, carcinoma scroti, signet ring cell carcinoma, carcinoma simplex, small-cell carcinoma, solanoid carcinoma, spheroidal cell carcinoma, spindle cell carcinoma, carcinoma spongiosum, squamous carcinoma, squamous cell carcinoma, string carcinoma, carcinoma telangiectaticum, carcinoma telangiectodes, transitional cell carcinoma, carcinoma tuberosum, tuberous carcinoma, verrucous carcinoma, and carcinoma villosum. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline form A. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline form C. In some embodiments the crystalline form used in the treatment of a carcinoma is a crystalline form Q. In some embodiments the crystalline form used in the treatment of a carcinoma is a crystalline form R. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline form K. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline form P. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline form B. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline maleate salt form A. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline maleate salt form B. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline mesylate salt form A. In some embodiments, crystalline form used in the treatment of a carcinoma is a crystalline mesylate salt form B. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline mesylate salt form C. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline hydrochloric acid salt form A. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline form identified by crystalline hydrochloric acid salt form B. In some embodiments, the crystalline form used in the treatment of a carcinoma is a crystalline hydrochloric acid salt form C. Non-limiting examples of leukemias include nonlymphocytic leukemia, chronic lymphocytic leukemia, acute granulocytic leukemia, chronic granulocytic leukemia, acute promyelocytic leukemia, adult T-cell leukemia, aleukemic leukemia, a leukocythemic leukemia, basophylic leukemia, blast cell leukemia, bovine leukemia, chronic myelocytic leukemia, leukemia cutis, embryonal leukemia, eosinophilic leukemia, Gross' leukemia, hairy-cell leukemia, hemoblastic leukemia, hemocytoblastic leukemia, histiocytic leukemia, stem cell leukemia, acute monocytic leukemia, leukopenic leukemia, lymphatic leukemia, lymphoblastic leukemia, lymphocytic leukemia, lymphogenous leukemia, lymphoid leukemia, lymphosarcoma cell leukemia, mast cell leukemia, megakaryocytic leukemia, micromyeloblastic leukemia, monocytic leukemia, myeloblastic leukemia, myelocytic leukemia, myeloid granulocytic leukemia, myelomonocytic leukemia, Naegeli leukemia, plasma cell leukemia, multiple myeloma, PATENT ATTORNEY DOCKET NO.: 51246-037WO2 plasmacytic leukemia, promyelocytic leukemia, Rieder cell leukemia, Schilling's leukemia, stem cell leukemia, subleukemic leukemia, and undifferentiated cell leukemia. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline form A. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline form C. In some embodiments the crystalline form used in the treatment of a leukemia is a crystalline form Q. In some embodiments the crystalline form used in the treatment of a leukemia is a crystalline form R. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline form K. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline form P. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline form B. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline maleate salt form A. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline maleate salt form B. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline mesylate salt form A. In some embodiments, crystalline form used in the treatment of a leukemia is a crystalline mesylate salt form B. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline mesylate salt form C. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline hydrochloric acid salt form A. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline form identified by crystalline hydrochloric acid salt form B. In some embodiments, the crystalline form used in the treatment of a leukemia is a crystalline hydrochloric acid salt form C. Non-limiting examples of melanomas include acral-lentiginous melanoma, amelanotic melanoma, benign juvenile melanoma, Cloudman's melanoma, S91 melanoma, Harding-Passey melanoma, juvenile melanoma, lentigo maligna melanoma, malignant melanoma, nodular melanoma, subungual melanoma, and superficial spreading melanoma. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline form A. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline form C. In some embodiments the crystalline form used in the treatment of a melanoma is a crystalline form Q. In some embodiments the crystalline form used in the treatment of a melanoma is a crystalline form R. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline form K. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline form P. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline form B. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline maleate salt form A. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline maleate salt form B. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline mesylate salt form A. In some embodiments, crystalline form used in the treatment of a melanoma is a crystalline mesylate salt form B. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline mesylate salt form C. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline hydrochloric acid salt form A. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline form identified by crystalline hydrochloric acid salt form B. In some embodiments, the crystalline form used in the treatment of a melanoma is a crystalline hydrochloric acid salt form C. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Non-limiting examples of cancer include prostate cancer, thyroid cancer, endocrine system cancer, brain cancer, breast cancer, cervix cancer, colon cancer, head & neck cancer, liver cancer, kidney cancer, lung cancer, non-small cell lung cancer, melanoma, mesothelioma, ovarian cancer, sarcoma, stomach cancer, uterus cancer, medulloblastoma, ampullary cancer, colorectal cancer, pancreatic cancer, Hodgkin's Disease, Non-Hodgkin's Lymphoma, multiple myeloma, neuroblastoma, glioma, glioblastoma multiforme, rhabdomyosarcoma, primary thrombocytosis, primary macroglobulinemia, primary brain tumors, cancer, malignant pancreatic insulinoma, malignant carcinoid, urinary bladder cancer, premalignant skin lesions, testicular cancer, lymphoma, esophageal cancer, genitourinary tract cancer, malignant hypercalcemia, endometrial cancer, adrenal cortical cancer, neoplasms of the endocrine or exocrine pancreas, medullary thyroid cancer, or papillary thyroid cancer. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline form A. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline form C. In some embodiments the crystalline form used in the treatment of a cancer is a crystalline form Q. In some embodiments the crystalline form used in the treatment of a cancer is a crystalline form R. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline form K. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline form P. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline form B. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline maleate salt form A. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline maleate salt form B. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline mesylate salt form A. In some embodiments, crystalline form used in the treatment of a cancer is a crystalline mesylate salt form B. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline mesylate salt form C. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline hydrochloric acid salt form A. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline form identified by crystalline hydrochloric acid salt form B. In some embodiments, the crystalline form used in the treatment of a cancer is a crystalline hydrochloric acid salt form C. Pharmaceutical Compositions A crystalline form described herein (e.g., a crystalline form of (S)-Compound 1, (R)-Compound 1, a salt form thereof, or a solvate thereof) may be formulated into a pharmaceutical composition for administration to human subjects in a biologically compatible form suitable for administration in vivo. A pharmaceutical composition typically includes an active agent as described herein and a physiologically acceptable excipient (e.g., a pharmaceutically acceptable excipient). Formulation principles for Compound 1 have been described in US Patent Application Publication: US 2023 / 0151014 A1, the disclosure of which is incorporated by reference herein in its entirety. Methods of producing enantiomerically pure (S)-Compound 1 or (R)-Compound 1 have been further described in WO 2024 / 130425 A1, the disclosure of which is incorporated by reference herein in its entirety. The crystalline forms described herein are especially beneficial for solid pharmaceutical compositions, e.g., solid dosage forms (e.g., tablets, powders, lozenges, sachets, cachets, and soft and hard gelatin capsules). PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Compound 1, (S)-Compound 1, or (R)-Compound 1 or a salt form thereof may be administered, for example, by oral, parenteral, buccal, sublingual, nasal, or rectal administration, and the pharmaceutical compositions formulated accordingly. Preferably, a crystalline form of Compound 1, (S)- Compound 1, (R)-Compound 1, or a salt form thereof is administered orally. Suitable pharmaceutical carriers, as well as pharmaceutical necessities for use in pharmaceutical formulations, are described in Remington: The Science and Practice of Pharmacy, 21stEd., Gennaro, Ed., Lippencott Williams & Wilkins (2005), a well-known reference text in this field, and in the USP / NF (United States Pharmacopeia and the National Formulary). Formulations A compound identified as capable of treating any of the conditions described herein, using any of the methods described herein, may be administered to patients or animals with a pharmaceutically- acceptable diluent, carrier, or excipient, in unit dosage form. The chemical compounds for use in such therapies may be produced and isolated by any standard technique known to those in the field of medicinal chemistry. Conventional pharmaceutical practice may be employed to provide suitable formulations or compositions to administer the identified compound to patients suffering from a disease or condition. Administration may begin before the patient is symptomatic. Exemplary routes of administration of the compounds (e.g., a compound of the invention), or pharmaceutical compositions thereof, used in the present invention include oral, sublingual, buccal, transdermal, intradermal, intramuscular, parenteral, intravenous, intra-arterial, intracranial, subcutaneous, intraorbital, intraventricular, intraspinal, intraperitoneal, intranasal, inhalation, and topical administration. The compounds desirably are administered with a pharmaceutically acceptable carrier. Pharmaceutical formulations of the compounds described herein formulated for treatment of the disorders described herein are also part of the present invention. Formulations for Oral Administration The pharmaceutical compositions contemplated by the invention include those formulated for oral administration (“oral dosage forms”). Oral dosage forms can be, for example, in the form of tablets, capsules, a liquid solution or suspension, a powder, or liquid or solid crystals, which contain the active ingredient(s) in a mixture with non-toxic pharmaceutically acceptable excipients. These excipients may be, for example, inert diluents or fillers (e.g., sucrose, sorbitol, sugar, mannitol, microcrystalline cellulose, starches including potato starch, calcium carbonate, sodium chloride, lactose, calcium phosphate, calcium sulfate, or sodium phosphate); granulating and disintegrating agents (e.g., cellulose derivatives including microcrystalline cellulose, starches including potato starch, croscarmellose sodium, alginates, or alginic acid); binding agents (e.g., sucrose, glucose, sorbitol, acacia, alginic acid, sodium alginate, gelatin, starch, pregelatinized starch, microcrystalline cellulose, magnesium aluminum silicate, carboxymethylcellulose sodium, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, polyvinylpyrrolidone, or polyethylene glycol); and lubricating agents, glidants, and antiadhesives (e.g., magnesium stearate, zinc stearate, stearic acid, silicas, hydrogenated vegetable oils, or talc). Other PATENT ATTORNEY DOCKET NO.: 51246-037WO2 pharmaceutically acceptable excipients can be colorants, flavoring agents, plasticizers, humectants, buffering agents, and the like. Formulations for oral administration may also be presented as chewable tablets, as hard gelatin capsules where the active ingredient is mixed with an inert solid diluent (e.g., potato starch, lactose, microcrystalline cellulose, calcium carbonate, calcium phosphate or kaolin), or as soft gelatin capsules where the active ingredient is mixed with water or an oil medium, for example, peanut oil, liquid paraffin, or olive oil. Powders, granulates, and pellets may be prepared using the ingredients mentioned above under tablets and capsules in a conventional manner using, e.g., a mixer, a fluid bed apparatus or a spray drying equipment. Controlled release compositions for oral use may be constructed to release the active drug by controlling the dissolution and / or the diffusion of the active drug substance. Any of a number of strategies can be pursued in order to obtain controlled release and the targeted plasma concentration versus time profile. In one example, controlled release is obtained by appropriate selection of various formulation parameters and ingredients, including, e.g., various types of controlled release compositions and coatings. Examples include single or multiple unit tablet or capsule compositions, oil solutions, suspensions, emulsions, microcapsules, microspheres, nanoparticles, patches, and liposomes. In some embodiments, compositions include biodegradable, pH, and / or temperature-sensitive polymer coatings. Dissolution or diffusion-controlled release can be achieved by appropriate coating of a tablet, capsule, pellet, or granulate formulation of compounds, or by incorporating the compound into an appropriate matrix. A controlled release coating may include one or more of the coating substances mentioned above and / or, e.g., shellac, beeswax, glycowax, castor wax, carnauba wax, stearyl alcohol, glyceryl monostearate, glyceryl distearate, glycerol palmitostearate, ethylcellulose, acrylic resins, dl- polylactic acid, cellulose acetate butyrate, polyvinyl chloride, polyvinyl acetate, vinyl pyrrolidone, polyethylene, polymethacrylate, methylmethacrylate, 2-hydroxymethacrylate, methacrylate hydrogels, 1,3 butylene glycol, ethylene glycol methacrylate, and / or polyethylene glycols. In a controlled release matrix formulation, the matrix material may also include, e.g., hydrated methylcellulose, carnauba wax and stearyl alcohol, carbopol 934, silicone, glyceryl tristearate, methyl acrylate-methyl methacrylate, polyvinyl chloride, polyethylene, and / or halogenated fluorocarbon. The liquid forms in which the compounds and compositions of the present invention can be incorporated for administration orally include aqueous solutions, suitably flavored syrups, aqueous or oil suspensions, and flavored emulsions with edible oils, e.g., cottonseed oil, sesame oil, coconut oil, or peanut oil, as well as elixirs and similar pharmaceutical vehicles. Formulations for Parenteral Administration The compounds described herein for use in the methods of the invention can be administered in a pharmaceutically acceptable parenteral (e.g., intravenous or intramuscular) formulation as described herein. The pharmaceutical formulation may also be administered parenterally (intravenous, intramuscular, subcutaneous or the like) in dosage forms or formulations containing conventional, non- toxic pharmaceutically acceptable carriers and adjuvants. In particular, formulations suitable for parenteral administration include aqueous and non-aqueous sterile injection solutions which may contain PATENT ATTORNEY DOCKET NO.: 51246-037WO2 anti-oxidants, buffers, bacteriostats and solutes which render the formulation isotonic with the blood of the intended recipient; and aqueous and non-aqueous sterile suspensions which may include suspending agents and thickening agents. For example, to prepare such a composition, the compounds of the invention may be dissolved or suspended in a parenterally acceptable liquid vehicle. Among acceptable vehicles and solvents that may be employed are water, water adjusted to a suitable pH by addition of an appropriate amount of hydrochloric acid, sodium hydroxide or a suitable buffer, 1,3-butanediol, Ringer’s solution and isotonic sodium chloride solution. The aqueous formulation may also contain one or more preservatives, for example, methyl, ethyl, or n-propyl p-hydroxybenzoate. Additional information regarding parenteral formulations can be found, for example, in the United States Pharmacopeia-National Formulary (USP-NF), herein incorporated by reference. The parenteral formulation can be any of the five general types of preparations identified by the USP-NF as suitable for parenteral administration: (1) Drug Injection: a liquid preparation that is a drug substance (e.g., a compound of the invention), or a solution thereof; (2) Drug for Injection: the drug substance (e.g., a compound of the invention) as a dry solid that will be combined with the appropriate sterile vehicle for parenteral administration as a drug injection; (3) Drug Injectable Emulsion: a liquid preparation of the drug substance (e.g., a compound of the invention) that is dissolved or dispersed in a suitable emulsion medium; (4) Drug Injectable Suspension: a liquid preparation of the drug substance (e.g., a compound of the invention) suspended in a suitable liquid medium; and (5) Drug for Injectable Suspension: the drug substance (e.g., a compound of the invention) as a dry solid that will be combined with the appropriate sterile vehicle for parenteral administration as a drug injectable suspension. Formulations for parenteral administration include solutions of the compound prepared in water suitably mixed with a surfactant, e.g., hydroxypropylcellulose. Dispersions can also be prepared in glycerol, liquid polyethylene glycols, DMSO and mixtures thereof with or without alcohol, and in oils. Under ordinary conditions of storage and use, these preparations may contain a preservative to prevent the growth of microorganisms. Conventional procedures and ingredients for the selection and preparation of suitable formulations are described, for example, in Remington: The Science and Practice of Pharmacy, 21st Ed., Gennaro, Ed., Lippincott Williams & Wilkins (2005) and in The United States Pharmacopeia: The National Formulary (USP 36 NF31), published in 2013. Formulations for parenteral administration may, for example, contain excipients, sterile water, or saline, polyalkylene glycols, e.g., polyethylene glycol, oils of vegetable origin, or hydrogenated napthalenes. Biocompatible, biodegradable lactide polymer, lactide / glycolide copolymer, or polyoxyethylene-polyoxypropylene copolymers may be used to control the release of the compounds. Other potentially useful parenteral delivery systems for compounds include ethylene-vinyl acetate copolymer particles, osmotic pumps, implantable infusion systems, and liposomes. Formulations for inhalation may contain excipients, for example, lactose, or may be aqueous solutions containing, for example, polyoxyethylene-9-lauryl ether, glycocholate and deoxycholate, or may be oily solutions for administration in the form of nasal drops, or as a gel. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 The parenteral formulation can be formulated for prompt release or for sustained / extended release of the compound. Exemplary formulations for parenteral release of the compound include: aqueous solutions, powders for reconstitution, cosolvent solutions, oil / water emulsions, suspensions, oil- based solutions, liposomes, microspheres, and polymeric gels. Exemplary methods A-C for producing enantiomerically pure (S)-2-amino-1-(3-hydroxy-2,6- dimethylphenyl)-5,6-dimethyl-1H-pyrrolo-[2,3-b]pyridine-3-carboxamide (S)-Compound 1 The following methods (“Exemplary methods A-C”) are non-limiting examples of the sysnthesis of (S)-Compound 1. Both (S)-Compound 1 and (R)-Compound 1 have been obtained via chiral salt resolution (see, e.g., WO 2024 / 130425 A1). Exemplary method A: This example describes a batch procedure for the synthesis of (S)-2-amino-1-(3-hydroxy-2,6- dimethylphenyl)-5,6-dimethyl-1H-pyrrolo-[2,3-b]pyridine-3-carboxamide ((S)-Compound 1). The synthetic route starts from 2,6-dimethyl-4-methoxyaniline (INT 2a) and 2,3-dibromo-5,6-dimethylpyridine (INT 2b) and comprises four chemical transformations (see Scheme 1). The first step involves Buchwald-Hartwig coupling of INT 2a and INT 2b to 3-bromo-N-(3- methoxy-2,6-dimethylphenyl)-5,6-dimethylpyridin-2-amine (INT 1e). This intermediate is reacted with malononitrile to racemic 2-amino-1-(3-methoxy-2,6-dimethyl-phenyl)-5,6-dimethyl-1H-pyrrolo[2,3- b]pyridine-3-carbonitrile (INT 1f). (S)-INT 1f / (R)-CSA salt can be crystallized in situ from INT 1f and (R)- CSA with around 85% chiral purity. Additional rounds of slurrying will improve this to over 95%. Intermediate salt (S)-INT 1f / (R)-CSA is converted to crude (S)-Compound 1, which is recrystallized to afford final product. Scheme 1 Raw materials: All key raw materials, reagents, solvents, and process chemicals were used as received from commercial suppliers. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Step 1: Synthesis of 3-Bromo-N-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethylpyridin-2-amine (INT 1e) A mixture of 3-methoxy-2,6-dimethylaniline (INT 2a, 95.0 g, 0.628 mol), 2,3-dibromo-5,6-dimethyl- pyridine (INT 2b, 182 g, 0.685 mol), Cs2CO3 (409 g, 1.26 mol), Xantphos (21.8 g, 37.7 mmol), Pd(OAc)2 (2.82 g, 12.6 mmol), and DME (1.9 L) is stirred at reflux for 16 h. After completion of reaction the mixture is cooled to ambient temperature and filtered through a pad of diatomite (47.5 g). The filter cake is washed with EtOAc (3x250 mL). The combined filtrate and washing liquids are stirred with activated charcoal (95.0 g) at ambient temperature for 1.5 h. The decolorized solution is filtered, and the filter cake is washed with EtOAc (240 mL). The combined filtrate and washing liquids are concentrated under vacuum to approx.700 mL, after which a solvent switch to EtOH is performed by repeated addition of EtOH (715 mL) and concentration to 700 mL. Then, more EtOH (425 mL) is added, and the resulting mixture is heated at reflux for about 30 min, cooled down to ambient temperature, stirred overnight, and filtered. The filter cake is washed with EtOH (240 mL) and dried under vacuum at 50°C to afford INT 1e as a yellowish green solid (163 g) in 77% yield.1H NMR (400 MHz, DMSO) ^ 7.57 (s, 1H), 7.26 (s, 1H), 7.03 (d, J = 8.0 Hz, 1H), 6.77 (d, J = 8.3 Hz, 1H), 3.76 (s, 3H), 2.06 (s, 3H), 2.03 (s, 6H), 1.94 (s, 3H).13C NMR (101 MHz, DMSO) ^ 156.14, 153.90, 151.45, 141.56, 139.05, 128.28, 127.24, 124.64, 121.57, 108.46, 101.20, 55.87, 22.25, 18.37, 17.59, 11.83. Step 2: Synthesis of 2-Amino-1-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]-pyridine- 3-carbonitrile (INT 1f) To a solution of malononitrile (644 g, 9.74 mol) in DME (32 L) is added portion wise NaO-t-Bu (895 g, 9.31 mol) at 0 °C. This is followed by addition of INT 1e (1.57 kg, 4.68 mol) and Pd(dppf)Cl2·CH2- Cl2 (204.1 g, 0.250 mol) at ambient temperature. The resulting mixture is heated at reflux for 18 h. After completion of reaction the reaction mass is cooled to 35°C and filtered through a pad of diatomite (1.57 kg). The filter cake is washed with DME (3x3.0 L). The combined filtrate and washing liquids are stirred with activated charcoal (1.75 kg) at 60 °C for 2 h. The decolorized solution is filtered, and the filter cake is washed with EtOAc (2x5.2 L). The decolorization procedure is repeated once. The combined filtrate and washing liquids are concentrated under vacuum to 11 L, after which a solvent switch to i-PrOH is performed by repeated addition of i-PrOH (10 L) and concentration to 11 L. The resulting mixture is heated at reflux for about 30 min, cooled down to ambient temperature, stirred overnight, and filtered. The filter cake is washed with i-PrOH (4.0 L) and dried under vacuum at 50°C to afford INT 1f as a light-yellow solid (1.13 kg) in 76% yield.1H NMR (400 MHz, DMSO) ^ 7.39 (s, 1H), 7.22 (d, J = 8.5 Hz, 1H), 7.07 (d, J = 8.5 Hz, 1H), 6.78 (s, 2H), 3.84 (s, 3H), 2.25 (d, J = 5.1 Hz, 6H), 1.79 (s, 3H), 1.70 (s, 3H).13C NMR (101 MHz, DMSO) ^ 156.53, 153.19, 147.39, 143.51, 132.59, 129.06, 128.60, 126.18, 125.25, 124.53, 119.06, 117.58, 112.00, 59.05, 56.09, 22.31, 19.20, 17.32, 11.29. Step 3: Synthesis of (S)-2-Ammonium-1-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]- pyridine-3-carbonitrile / (R)-CSA ((S)-INT 1f / (R)-CSA) A mixture of INT 1f (1.12 kg, 3.50 mol), (R)-CSA (818 g, 3.52 mol), and anisole (32 L) is heated at 85°C for 1 h and cooled to 50°C, after which crystal seeds (2.2 g, 7.0 mmol) are added. The mixture is stirred at 50°C for 14 h, cooled to 10°C over a period of 5 h, aged at this temperature for 16 h, and PATENT ATTORNEY DOCKET NO.: 51246-037WO2 filtered. The filter cake is washed with anisole (2.25 L) and dried on the centrifuge for 1 h to afford crude, wet (S)-INT 1f / (R)-CSA (1.46 kg). A suspension of crude (S)-INT 1f / (R)-CSA in anisole (16 L) is heated at 85°C for 2 h, cooled to 10°C over a period of several h, aged at this temperature for 16 The filter cake is washed with anisole (1.8 L) and dried under vacuum at 50°C to CSA with a chiral purity of 97.5% as an off-white solid (758 g) in 39% yield.1H NMR 7.55 (s, 1H), 7.25 (d, J = 8.5 Hz, 1H), 7.11 (d, J = 8.5 Hz, 1H), 3.85 (s, 3H), 2.95 (d, J 2.68 – 2.55 (m, 1H), 2.48 – 2.51 (m, 1H), 2.28 (d, J = 4.7 Hz, 6H), 2.25 – 2.18 (m, 1H), 1.96 (t, J = 4.5 Hz, 1H), 1.91 – 1.82 (m, 2H), 1.79 (s, 3H), 1.71 (s, 3H), 1.39 – 1.23 (m, 2H), 1.04 (s, 3H), 0.75 (s, 3H).13C NMR (101 MHz, DMSO) ^ 216.42, 156.61, 153.38, 146.07, 142.02, 131.90, 129.03, 128.82, 126.27, 125.98, 125.78, 119.94, 117.10, 112.37, 59.38, 58.57, 56.14, 47.60, 47.36, 42.68, 42.60, 26.84, 24.64, 21.28, 20.48, 19.97, 18.98, 17.24, 11.27. Step 4: Synthesis of (S)-2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3- b]pyridine-3-carboxamide ((S)-Compound 1) To a mixture of methanesulfonic acid (3.5 L) and water (65.6 mL, total water content 1.60% w / w) is added (S)-INT 1f / (R)-CSA (750 g, 1.36 mol) in portions at 45°C. Stirring is continued at this temperature for 4 h. After completion of reaction, the resulting mass is cooled to ambient temperature and DL-methionine (810 g, 5.43 mol) is added. The reaction mixture is stirred at 75°C for 18 h, cooled to ambient temperature, and quenched by drop wise addition to chilled water (15 L) keeping the temperature below 20°C. The quenched mixture is diluted with water (5.6 L) and stirred with activated charcoal (75.0 g) at ambient temperature for 3 h. The decolorized solution is filtered through a pad of diatomite (375 g), and the filter cake is washed with water (7.5 L). Then, 2-MeTHF (3.3 L) is added to the combined filtrate and washing liquid. The pH of the biphasic system is adjusted to 8-9 with aqueous NaOH (30% w / w, approx.6 L). The suspension that is obtained is heated at 55°C for 30 min, cooled to ambient temperature, stirred for 10h, and filtered. The filter cake is washed with water (3x2.3 L) dried under vacuum at 50°C to afford crude (S)-Compound 1 as a light-brown solid (410 g, chemical purity 98.8% area, chiral purity 97.4%) in 93% yield. Crude (S)-Compound 1 (270 g, 0.832 mol) is dissolved in methanol (3.4 L) at 65°C, the resulting mixture is cooled to 55°C and filtered (warm) to remove insoluble material. The filter cake is washed with methanol (680 mL). Water (270 mL) is added to the filtrate at 55°C, which is then cooled to 0°C. Seed crystals (16 mg as a suspension in methanol / water 1:1 v / v (270 mL)) are added, and the subsequent mixture is stirred at 0°C for 3 h. Water (3.8 L) is dosed over a period of several hours, after which stirring is continued at 0°C for 10 h. The resulting suspension is filtered. The filter cake is washed with methanol / water (1:1 v / v, 405 mL) and dried under vacuum at 50 °C to afford (S)-Compound 1 (217 g) as a light-brown solid (217 g, chemical purity 99.6% area, chiral purity 99.9%) in 80% yield from crude (S)- Compound 1.1H NMR (400 MHz, DMSO) ^ 9.48 (s, 1H), 7.83 (s, 1H), 7.05 (d, J = 8.1 Hz, 1H), 6.91 (d, J = 8.1 Hz, 1H), 6.71 (s, 2H), 6.65 (s, 2H), 2.25 (d, J = 8.1 Hz, 6H), 1.75 (s, 3H), 1.67 (s, 3H).13C NMR (101 MHz, DMSO) ^ 168.91, 154.62, 152.27, 145.59, 143.95, 133.10, 128.26, 127.52, 125.67, 124.47, 124.11, 116.59, 115.97, 83.56, 22.22, 19.34, 17.38, 11.35. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Exemplary method B: This example describes a batch procedure for the synthesis of (S)-2-amino-1-(3-hydroxy-2,6- dimethylphenyl)-5,6-dimethyl-1H-pyrrolo-[2,3-b]pyridine-3-carboxamide ((S)-Compound 1). The synthetic route starts from 2,6-dimethyl-4-methoxyaniline (INT 2a) and 2,3-dibromo-5,6- dimethylpyridine (INT 2b) and comprises four chemical transformations (see Scheme 2). The first step involves Buchwald-Hartwig coupling of INT 2a and INT 2b to 3-bromo-N-(3- methoxy-2,6-dimethylphenyl)-5,6-dimethylpyridin-2-amine (INT 1e). This intermediate is reacted with malononitrile to racemic 2-amino-1-(3-methoxy-2,6-dimethyl-phenyl)-5,6-dimethyl-1H-pyrrolo[2,3- b]pyridine-3-carbonitrile (INT 1f). (S)-INT salt can be crystallized in situ from INT 1f and (R)- CSA followed by additional rounds of slurrying with over 97% chiral purity. Intermediate salt (S)-INT 1f / (R)-CSA is converted to crude (S)-Compound 1, which is recrystallized to afford final product. Scheme 2 Raw materials: All key raw materials, reagents, solvents, and process chemicals were used as received from commercial suppliers. Step 1: Synthesis of 3-Bromo-N-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethylpyridin-2-amine (INT 1e) A mixture of 3-methoxy-2,6-dimethylaniline (INT 2a, 80.0 g, 0.529 mol) in 1,2-dimethoxyethane (DME; 1.38 L) is stirred for 5 - 10 min at 20 - 30 °C, after which 2,3-dibromo-5,6-dimethylpyridine (INT 2b, 152.8 g, 0.576 mol), Cs2CO3 (258.6 g, 0.794 mol), Xantphos (18.4 g, 31.7 mmol), and Pd(OAc)2 (2.4 g, 11 mmol) are added under nitrogen. The resulting mixture is stirred at 80 - 85 °C for 20 - 24 h, cooled to 20 - 30 °C, and filtered through a pad of diatomite (20.0 g, 0.25 rel. weights). The filter cake is washed with DME (2 x 460 mL, then 276 mL). The combined filtrate and washing liquids are concentrated under vacuum at 40 - 50 °C to 600 mL (7 - 8 rel. volumes), after which water (240 mL) is added at 60 - 75 °C. The resulting mixture is cooled to 20 - 30 °C, aged for 10 - 15 h, and filtered. The filter cake is washed with a mixture of DME (276 mL) and water (120 mL) and dried under nitrogen protection for 30 - 60 minutes at 20 - 30°C to PATENT ATTORNEY DOCKET NO.: 51246-037WO2 afford crude INT 1e as a yellow solid (164.2 g, 93% yield). A mixture of crude INT 1e (164.2 g) in ethanol (800 mL) is heated at 75 - 78 °C for 1 - 2 hours, then cooled to 20 - 30 °C, aged for 10-15 h, and filtered. The filter cake is washed with ethanol (200 mL) and dried under vacuum at 45 - 55°C to afford INT 1e as a yellow solid (145.2 g, 82% yield). Step 2: Synthesis of 2-Amino-1-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]-pyridine- 3-carbonitrile (INT 1f) A solution of malononitrile (53.2 g, 0.805 mol) in DME (4.5 L) under nitrogen is stirred for 5 - 10 min at 20 - 30 °C and then cooled to 0 - 10 °C (target 5 °C). Sodium tert-butoxide (96.8 g, 1.01 mmol) is added in 5 portions at 0 - 10 °C. The reactor mixture is warmed up to 20-30 °C and aged at that temperature for 30 - 40 min. Then, INT 1e (225.0 g, 0.671 mol), 1,1’-bis(diphenylphosphino)ferrocene (dppf; 7.44 g, 0.0134 mol) and Pd(dppf)Cl2·CH2Cl2 (10.96 g, 13.4 mmol) are added. The resulting mixture is heated at 83 - 87 °C for 18 - 24 hours, cooled to 30 - 50 °C and filtered through a pad of diatomite (112.5 g). The filter cake is washed with DME (2 x 1.3 L). The combined filtrate and washing liquid are concentrated under vacuum at 40 - 50 °C to approx. 1,700 mL (7-8 rel. volumes), after which water (675 mL) is added. The resulting suspension is heated at 60 - 75 °C for 1 - 2 hours, then cooled to 20 - 30 °C, aged for 10 - 15 h, and filtered. The filter cake is washed with a mixture of DME (620 mL) and water (270 mL) and dried under nitrogen protection for 30 - 60 minutes at 20 - 30°C to afford crude INT 1f as an off-white solid (189.5 g), which is suspended in 2-propanol (2.02 L) and heated at 80 - 83 °C for 30 - 45 min. The mixture is cooled to 18 - 28 °C, aged for 2 - 4 h, and filtered. The filter cake is washed with 2-propanol (572 mL) and dried under vacuum at 45 - 55 °C to afford INT 1f as a white solid (153.0 g, 74% yield). Step 3: Synthesis of (S)-2-Ammonium-1-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]- pyridine-3-carbonitrile / (R)-CSA ((S)-INT 1f / (R)-CSA) A mixture of INT 1f (148 g, 0.462 mol), (R)-CSA (107.3 g, 0.462 mol), and anisole (2.97 L) is heated at 85°C for 1 h and cooled to 45 -50°C, after which crystal seeds (296 mg, 0.536 mmol) are added. The mixture is stirred at 48 - 52 °C for 4-6 h, is cooled to 7 - 13 °C at a cooling rate of 5-10 °C / h and aged at this temperature for approx.16 h. The suspension is filtered and the filter cake is washed with anisole (297 mL) and dried on the filter or centrifuged for 1 h to afford wet crude (S)-INT 1f / (R)-CSA. A suspension of crude (S)-INT 1f / (R)-CSA in anisole (2.05 L) is stirred at 20 - 30 °C for 5 - 10 min, heated at 80 - 85 °C for 1 - 2 h, cooled to 7 - 13 °C, and subsequently aged at this temperature for 16 h. The suspension is filtered, and the filter cake is washed with anisole (296 g, 2.0 rel. weights) and dried under vacuum at 45 - 55 °C to afford (S)-INT 1f / (R)-CSA as an off-white solid (106.2 g, 42% yield) with a chiral purity of 97.4%. Step 4: Synthesis of (S)-2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3- b]pyridine-3-carboxamide ((S)-Compound 1) To a mixture of methanesulfonic acid (657.4 g) and water (6.11 mL, total water content 1.60% w / w) is added (S)-INT 1f / (R)-CSA (95.0 g, 0.172 mol) in 16 portions at 40 - 48 °C. Stirring is continued at this temperature for 8 h, after which the reaction mixture is cooled down to 15 - 25 °C and DL-Methionine (102.6 g, 0.688 mol) is added. The resulting mixture is heated at 70 - 78 °C for 18 -24 h, cooled to 15 - 25 °C and PATENT ATTORNEY DOCKET NO.: 51246-037WO2 then slowly added to pre-cooled (0 - 10°C) water (2.38 kg). The quenched mixture is diluted with water (475 mL,) and 2-MeTHF (334 mL). The pH is adjusted to 7-9 by addition of aqueous NaOH (approx.30% w / w). The suspension is aged at 30 - 35 °C for 20 - 60 min and at 15 - 25 °C for 10 - 15 h, and filtered. The filter cake is washed with water (3 x 475 mL) and dried under vacuum at 45 - 55°C to give a brown solid (54.2 g, 91% yield). A suspension of the above solid (53.0 g) in THF (425 mL) is heated at 65 - 70 °C for 20 - 40 min, then cooled to -3 - 3 °C, aged for 20 - 24 h, and filtered. The filter cake is washed with THF (2 x 53 mL) and dried under vacuum at 45 – 55 °C to afford crude (S)-Compound 1 as a light brown solid (57.5 g, 108 % yield) To crude (S)-Compound 1 (58.3 g, 0.180 mol) in methanol (736 mL) is added activated carbon (5.83 g). The suspension is stirred at 20 – 30 °C for 5 - 10 min and at 60 - 66 °C for 1 - 2 h, cooled down to 50 - 55 °C and filtered to remove insoluble matter. The filter cake is washed with methanol (147 mL). Water (29.2 mL) is added slowly to the combined filtrate and washing liquid at 50 - 55 °C. The resulting mixture is cooled to 3 - 7 °C, after which a suspension of crystal seeds (0.58 g, 1.8 mmol) in MeOH / water (4:5 v / v, 58 mL) is charged. Stirring is continued at 3 - 7 °C for 3 h, which is followed by the addition of water (857 mL) at 3 - 7 °C over a period of 4 - 9 h. The resulting suspension is aged at this temperature for 8 - 12 h and filtered. The filter cake is washed with a mixture of MeOH (49 mL) and water (43.7 mL) twice and dried under vacuum at 45 – 55 °C to afford (S)-Compound 1 as a yellowish to off-white solid (44.3 g, 76% yield) with a purity of >99.9% and chiral purity of 99.7%. Exemplary method C: This example describes a procedure for GMP manufacture of (S)-2-amino-1-(3-hydroxy-2,6- dimethylphenyl)-5,6-dimethyl-1H-pyrrolo-[2,3-b]pyridine-3-carboxamide ((S)-Compound 1). The GMP manufacture of (S)-2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H- pyrrolo[2,3-b]pyridine-3-carboxamide (1) starts from 2,6-dimethyl-4-methoxyaniline (2) and 2,3-dibromo- 5,6-dimethylpyridine (3) and comprises four chemical transformations (see Scheme 3). The first step involves Buchwald-Hartwig coupling of 2 and 3 to 3-bromo-N-(3-methoxy- 2,6-dimethylphenyl)-5,6-dimethylpyridin-2-amine (4). This intermediate is reacted with malononitrile to racemic 2-amino-1-(3-methoxy-2,6-dimethyl-phenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]pyridine-3-carbonitrile (INT 1f). (S)-2-ammonium-1-(3-methoxy-2,6-dimethyl-phenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]pyridine-3- carbonitrile / (R)-CSA ((S)-INT 1f / (R)-CSA) can be crystallized in situ from INT 1f and (R)-CSA with around 85% chiral purity. Additional rounds of slurrying will improve this to over 95%. Intermediate salt (S)-INT 1f / (R)-CSA is converted to crude (S)-Compound 1, which is recrystallized to afford final product. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Scheme 3 Raw materials: All key raw materials, reagents, solvents, and process chemicals were used as received from commercial suppliers. Step 1: Synthesis of 3-Bromo-N-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethylpyridin-2-amine (INT 1e) A mixture of 3-methoxy-2,6-dimethylaniline (INT 2a, 8.08 kg, 53.4 mol), 2,3-dibromo-5,6-dimethyl- pyridine (INT 2b, 15.5 kg, 58.5 mol), Cs2CO3 (35.0 kg, 107 mol), Xantphos (1.86 kg, 3.21 mol), Pd(OAc)2 (243 g, 1.08 mol), and DME (160 L) is stirred at reflux for 16 h. After completion of reaction the mixture is cooled to ambient temperature and filtered through a pad of diatomite (4.1 kg). The filter cake is washed with EtOAc (3x65 L). The combined filtrate and washing liquids are stirred with activated charcoal (8.1 kg) at ambient temperature for 2 h. The decolorized solution is filtered, and the filter cake is washed with EtOAc (61 L). The combined filtrate and washing liquids are concentrated under vacuum to approx.60 L, after which a solvent switch to EtOH is performed by repeated addition of EtOH (61 L) and concentration to 60 L. Then, more EtOH (36 L) is added, and the resulting mixture is heated at reflux for about 30 min, cooled down to ambient temperature, stirred overnight, and filtered. The filter cake is washed with EtOH (20 L) and dried under vacuum at 50°C to afford INT 1e as a light-yellow solid (13.3 kg) in 74% yield. Step 2: Synthesis of 2-Amino-1-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]-pyridine- 3-carbonitrile (INT 1f) To a solution of malononitrile (12.8 kg, 194 mol) in DME (620 L) is added portion wise NaO-t-Bu (17.6 kg, 183 mol) at 0 °C. This is followed by addition of INT 1e (30.9 kg, 92.2 mol) and Pd(dppf)Cl2·CH2-Cl2 (4.01 kg, 4.91 mol) at ambient temperature. The resulting mixture is heated at reflux for 18 h. After completion of reaction the reaction mass is cooled to 35 °C and filtered through a pad of diatomite (30.9 kg). The filter cake is washed with DME (3x180 L). The combined filtrate and washing liquids are stirred with activated charcoal (30.9 kg) at 60 °C for 1.5 h. The decolorized solution is filtered, and the filter cake is washed with DME (2x107 L). The combined filtrate and washing liquids are subjected to a second decolorization with activated charcoal (30.9 kg) at 60 °C but washing of the filter cake is this time performed with EtOAc (2x103 L). The combined filtrate and washing liquids are concentrated under PATENT ATTORNEY DOCKET NO.: 51246-037WO2 vacuum to 240 L, after which a solvent switch to i-PrOH is performed by repeated addition of i-PrOH (197 L) and concentration to 240 L. The resulting mixture is heated at reflux for about 30 min, cooled down to ambient temperature, stirred overnight, and filtered. The filter cake is washed with i-PrOH (79 L) and dried under vacuum at 50 °C to afford INT 1f as a light-yellow solid (21.3 kg) in 72% yield. Step 3: Synthesis of (S)-2-Ammonium-1-(3-methoxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]- pyridine-3-carbonitrile / (R)-CSA ((S)-INT 1f / (R)-CSA) A mixture of INT 1f (21.0 kg, 65.7 mol), (R)-CSA (15.4 kg, 66.3 mol), and anisole (612 L) is heated at 85°C for 1 h and cooled to 50 °C, after which crystal seeds (42 g, 0.13 mol) are added. The mixture is stirred at 50°C for 14 h, cooled to 10 °C over a period of 6 h, aged at this temperature for 16 h, and filtered. The filter cake is washed with anisole (53 L) and dried on the centrifuge for 1 h to afford crude, wet (S)-INT 1f / (R)-CSA (17.2 kg). A suspension of crude (S)-INT 1f / (R)-CSA in anisole (302 L) is heated at 85 °C for 2 h, cooled to 10°C over a period of 10 h, aged at this temperature for 16 h, and filtered. The filter cake is washed with anisole (43 L) and dried under vacuum at 50 °C to afford (S)-INT 1f / (R)-CSA with a chiral purity of 97.2% as an off-white solid (14.4 kg) in 40% yield. Step 4: Synthesis of (S)-2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3- b]pyridine-3-carboxamide ((S)-Compound 1) To a mixture of methanesulfonic acid (32 L) and water (0.48 L, total water content 1.60% w / w) is added (S)-INT 1f / (R)-CSA (6.76 kg, 24.6 mol) in portions at 45 °C. Stirring is continued at this temperature for 4 h. After completion of reaction, the resulting mass is cooled to ambient temperature and DL-methionine (14.8 kg, 99.2 mol) is added. The reaction mixture is stirred at 75 °C for 18 h, and cooled to ambient temperature, and quenched by drop wise addition to chilled water (141 L) keeping the temperature below 20°C. The quenched mixture is diluted with water (51 L) and stirred with activated charcoal (0.70 kg) at ambient temperature for 3 h. The decolorized solution is filtered through a pad of diatomite (3.4 kg), and the filter cake is washed with water (69 L). Then, 2-MeTHF (30 L) is added to the combined filtrate and washing liquid. The pH of the biphasic system is adjusted to 8-9 with aqueous NaOH (30% w / w, approx.50 L). The suspension that is obtained is heated at 55 °C for 30 min, cooled to ambient temperature, stirred for 10h, and filtered. The filter cake is washed with water (3x20 L), dried under vacuum at 50 °C to afford crude (S)-Compound 1 as a light-brown solid (3.75 kg, chemical purity 98.8% area, chiral purity 97.3%) in 94% yield. Crude (S)-Compound 1 (7.40 kg, 22.8 mol) is dissolved in methanol (93 L) at 65°C, the resulting mixture is cooled to 55°C and filtered (warm) to remove insoluble material. The filter cake is washed with methanol (19 L). Water (3.7 L) is added to the filtrate at 55 °C, which is then cooled to 5 °C. Seed crystals (74 g as a suspension in methanol / water 1:1 v / v (8 L)) are added and the subsequent mixture is stirred at 0 °C for 3 h. Water (109 L) is dosed over a period of several hours, after which stirring is continued at 0 °C for 10 h. The resulting suspension is filtered. The filter cake is washed with methanol / water (1:1 v / v, 6 L) and dried under vacuum at 50 °C to afford (S)-Compound 1 as a light-yellow solid (6.11 kg, chemical purity 99.6% area, chiral purity 99.8%) in 83% yield from crude (S)-Compound 1. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Examples The following examples are meant to illustrate the invention. They are not meant to limit the invention in any way. Abbreviations Explanations MeCN Acetonitrile n-BuOH 1-Butanol 2-BuOH 2-Butanol t-BuOH tert-Butanol / 2-Methylpropan-2-ol CPME Cyclopentyl methyl ether DCM Dichloromethane DMAc Dimethylacetamide DME Dimethoxyethane DMF N,N-Dimethylformamide DMSO Dimethyl sulfoxide DSC Differential Scanning Calorimetry DVS Dynamic Vapor Sorption EtOAc Ethyl Acetate EtOH Ethanol FB Free Base 1H NMR Proton Nuclear Magnetic Resonance HPLC High Performance Liquid Chromatography IPA Isopropanol / Propan-2-ol IPAc Isopropyl Acetate MEK Butanone / Methyl Ethyl Ketone MeOH Methanol 2-MeTHF 2-Methyl Tetrahydrofuran MIBK Methyl Isobutyl Ketone NMP N-Methyl-2-pyrrolidone n-PA 1-Propanol / n-Propanol PLM Polarized Light Microscopy XRPD X-Ray Powder Diffraction RH Relative Humidity RT Room Temperature (20-25^) SLS Sodium Lauryl Sulfate TG Thermogravimetry TGA Thermogravimetric Analysis THF Tetrahydrofuran PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Experimental Methods Crystalline forms and crystalline salt forms of the present example may be investigated using any characterization means known in the art. In particular, solid forms of the present application may be characterized by, e.g., x-ray diffraction (XRD); e.g., x-ray powder diffraction (XRPD) or x-ray diffraction single crystal diffraction), nuclear magnetic resonance (NMR; e.g., proton NMR,1H NMR), or thermal analysis (e.g., thermogravimetric analysis (TGA) or differential scanning calorimetry (DSC)).X-Ray Powder Diffraction (XRPD) Instrument: Bruker D2 Phaser 2nd Gen Equipped with LYNXEYE detector in reflection mode. Parameters: X-Ray tube Cu (K^1) with 1.54184 Å; Tube Voltage 40 kV; Tube current 40 mA Slit Condition: 0.6 mm div. + 2.5 °soller Scanning range: 4 to 30 °2^ Step size: 0.03 ° Dwell Time: 0.23 s / step Peak lists were generated using HighScore Plus: Parameters: Minimum significance: 2.00 Minimum tip width Gonio: 0.01 Maximum tip width Gonio: 1.00 Peak base width Gonio: 2.00 Method: Minimum 2ndderivative Peaks were evaluated visually and removed / added manually. Profile fitting with default setting was used. Nuclear Magnetic Resonance (NMR) Instrument: Nanalysis 60e NMReady 60MHz Temperature: 30.00 °C Number of Scans: 256 Relaxation Delay 1.0 s Pulse Angle 78.88 ° Pulse Width 14.45 ^s Acquisition Time 3.7 s Digital Resolution 0.04Hz Spectrometer Freq. 60 Hz Unless otherwise specified, all1H NMR experiments were performed using DMSO-d6 as a solvent. Thermogravimetric Analysis (TGA) and Differential Scanning Calorimetry (DSC) Instrument: Mettler Toledo TGA / DSC3+Sample Size: 5-10 mg Parameters: Ramp 10 °C per minute, 25 °C to 300 °C PATENT ATTORNEY DOCKET NO.: 51246-037WO2 N2 was used as a protective gas and a purge gas. N2 was flown through the instrument at a flow rate of 20 to 30 mL / min when used as a protective gas. N2was flown through the instrument at a flow rate of 20 to 30 mL / min when used as a purge gas. Dynamic Vapor Sorption Analysis (DVS) Instrument: Q5000SA Sample Size: 5-15 mg Measurement Interval: 5 s Parameters: 25 °C, 0-90-0% RH for 2 cycles Program: Equilibration at 50% RH 50% to 2% (50%, 40%, 30%, 20%, 10%, 2%) 2% to 95% (2%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%) 95% to 2% (95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 2%) 2% to 50% (2%, 10%, 20%, 30%, 40%, 50%) Sample Pan: Metallic Quartz The sample pan was suspended from a microbalance, and weight changes were measured relative to an empty pan. The sample pan was exposed to a stream of N2 gas humidified to the specified level. The humidity was maintained until the weight in the sample pan had changed by less than 0.002% or after 240 min. Differential Scanning Calorimetry (DSC) Instrument: Mettler Toledo DSC3+Sample Size: 1-5 mg Parameters: 10 °C per minute, 30 °C to 300 °C X-Ray Diffraction X-ray diffraction (XRD) is an analytical technique used to interrogate the arrangement of atoms and molecules in a solid. Each solid form of a compound may be identified by a unique collection of XRD signals at various diffraction angles (measured in °2^). Accordingly, solid forms of the present disclosure may be differentiated by an XRD experiment. In some embodiments, the x-ray diffraction experiment is a x-ray powder diffraction (XRPD) experiment. An XRPD experiment is performed on a disperse collection of crystallites of the material with random orientation. The crystallinity of a sample may be estimated from, e.g., the width of a peak in an XRPD experiment. A more crystalline sample, i.e., a sample with a more uniform ordering of its constituent atoms or molecules, will commonly result in an XRPD pattern with narrower peaks. In some embodiments, the XRD experiment may be a x-ray diffraction single crystal experiment. The crystallinity of an observed pattern may be improved (e.g., the XRPD peaks may be narrowed), e.g., using a method described herein. A single-crystal experiment allows for the determination of specific reflections relative to the orientation of the crystal. This information can then be used to determine, e.g., the unit-cell (i.e., the smallest repeatable portion the materials three-dimensional PATENT ATTORNEY DOCKET NO.: 51246-037WO2 structure, specified by three vectors (a, b, and c) and the three angles between the vectors (^, ^, and ^)) or the specific solid state arrangement of atoms in the unit cell. Thermal Analysis Thermal analysis refers to any collection of techniques used to determine how a material responds to applied heat. Thermal analysis may be used to determine, e.g., phase changes (e.g., melting) or desolvation of a material. Thermal analysis includes thermogravimetric analysis (hereafter referred to as TGA) and differential scanning calorimetry (hereafter referred to as DSC). TGA consists of measuring the weight of a sample as temperature is controllably monitored. When a phase change associated with the loss of solvent molecules occurs, the sample mass decreases. The change in sample mass can be used to quantitatively determine the percent weight of the original sample that was solvent (e.g., water). In some embodiments, TGA experiments were combined with infrared (IR) spectroscopy experiments, hereafter referred to as TGA-IR. DSC experiments consist of measuring the amount of heat required to increase or decrease the temperature of a sample. During an endothermic phase change (i.e., one in which heat is absorbed by the sample), the amount of heat required to increase the sample’s temperature is less than the amount of heat required to increase the sample’s temperature without the phase change. This increase in required energy is used as an indicator of endothermic events in a sample. An endothermic phase change may be characterized herein by the endothermic event onset (i.e., the temperature at which the increased heat required to change the sample’s temperature is observed) or the endothermic event peak (i.e., the temperature at which the maximum amount of heat is absorbed by the sample to promote a phase change rather than a temperature change). Example 1. Crystallization of (S)-Compound 1 and (R)-Compound 1 The present example describes the generation of crystalline (S)-Compound 1 and (R)- Compound 1. Baseline characterization First, baseline characterization of (S)-Compound 1 and (R)-Compound 1 was conducted. A sample of (R)-Compound 1 (a pale-yellow powder) was plated and analyzed by XRPD. The material was crystalline, and the pattern was designated as crystalline form A (FIG.1). During the crystalline form screening, it was determined that the sample of (R)-Compound 1 contained sodium sulfate. A sample was taken for microscopy. Two images with 100X magnification were captured (FIG.2A and FIG.2B), and two images with 400X magnification were also captured (FIG.2C and FIG.2D). The material appeared as fine particles and agglomerates. Recrystallization of (R)-Compound 1 (R)-Compound 1 was recrystallized in alcohol:water using both a vial-scale process and a chemical reactor process performed on the EasyMax platform. Solids resulting from both experiments were then characterized by XRPD and microscopy. Both experiments resulted in solids characterized by an XRPD pattern designated as crystalline form A. Additional peaks were also observed in some PATENT ATTORNEY DOCKET NO.: 51246-037WO2 patterns, attributed to the anhydrate or less hydrated form of crystalline form A (hereafter, referred to as crystalline form B), and an inorganic salt impurity, determined to be sodium sulfate. Vial-Scale Process: A process was performed on vial scale to test the process and identify critical parameters. First, about 100 mg of (R)-Compound 1 was weighed into a 4 mL vial and10 mm stir bar was added. To the vial, 19.5 volumes (vol.) (1.95 mL) of reagent grade ethanol (EtOH) was added. The mixture was stirred on a hot plate and was heated to 90 °C. The vial was elevated in the hot plate to provide a low temperature headspace for reflux. The mixture was boiled for 15 min, the cap was loosened to avoid pressurizing the system. A cloudy yellow slurry was observed while boiling. The temperature of the liquid was checked with a thermocouple probe and observed to be 80 °C. A substantial volume of the EtOH had boiled away, so more EtOH was added to the vial, filling it up back to the level previously observed when it was first filled with EtOH. The temperature was monitored in a separate vial of water with the thermocouple probe. When the temperature on the probe read 85 °C, the experiment vial was boiling consistently, and the temperature on the hot plate was reduced by 2 °C every 6 min until the thermocouple probe reading was 80 °C (temperature was observed after 18 min), where the temperature was held. A cloudy yellow slurry was observed. Approximately 11.5 vol. (1.15 mL) distilled water was added over 90 min, in increments of 144 ^L added every 10 min (a total of 8 increments were added). The slurry was cooled to room temperature (RT) over 1 h by reducing the temperature of the hot plate by 10 °C every 10 min. The slurry was stirred at RT for 20 min and was filtered and washed twice with 0.5 vol. (50 ^L) of distilled water. A substantial proportion of the slurry passed through the filter. The solids recovered from the filter paper were dried overnight under vacuum (-29 in. Hg) at 50 °C. The dry solid was plated for XRPD analysis. All peaks agreed with crystalline form A, however some patterns displayed additional peaks (FIG. 3). The differences in the XRPD patterns are due to the difference in the quantity of sodium sulfate before and after recrystallization. A sample of the dry solid was analyzed by microscopy (FIG.4A-4D). The material appeared as fine particles and agglomerates. EasyMax Process: The process was performed on Mettler-Toledo EasyMax Chemical Reactor Set to achieve recrystallized (R)-Compound 1 in advance of the crystalline form screening and study morphological changes during the process. The use of a chemical reactor set-up, as described below, allows for a scalable, reproducible, reaction. This then allows for rapid work-up of a compound, in particular for slurry experiments at various temperatures. First, about 1.003 g of (R)-Compound 1 was weighed into a 100 mL EasyMax vessel. To the vessel, 19.5 vol. (19.5 mL) of reagent grade EtOH was added. The slurry was stirred at 270 rpm (mixing energy of 0.23 W / kg when final volume was reached after water addition) using a 3.8 cm PTFE-coated impeller. The jacket temperature (Tj) was set to 90 °C. The vessel was elevated to lift it out of the jacket slightly and provide lower temperature headspace for reflux. A pale-yellow slurry was observed. Approximately 2 vol. (2 mL) EtOH was added to thin the slurry, but no change was observed. The slurry temperature was checked with thermocouple probe and the temperature was 73 °C, so Tj was elevated to 100 °C. The slurry was stirred for 15 min. Some minor crusting was observed and the vessel was shaken slightly to recapture the crust material into the slurry. The thermocouple probe measured 78 °C and the PATENT ATTORNEY DOCKET NO.: 51246-037WO2 slurry was stirred for 15 min more. Tj was then reduced to 90 °C; slurry temperature was 74 °C. Distilled water was added via syringe pump, 11.5 vol. (11.5 mL) over 2 h, dosing rate of 0.0958 mL / min. A sample of the slurry was taken after water was dispensed for microscopy; needles were observed at 100X magnification (FIG.5A and FIG.5B) and 400X magnification (FIG.5C and FIG.5D). The slurry was cooled to 20 °C over 2 h by setting Tj to 20 °C with a cooling rate of 0.58 °C / min. A sample was taken for microscopy after cooling was done; dendrites were observed at 100X magnification (FIG.6A and FIG.6B) and 400X magnification (FIG.6C and FIG.6D). It appeared that the needles had grown some dendritic structures. This is likely due to the presence of sodium sulfate. The vessel was held at 20 °C and the slurry was stirred overnight. A sample was taken for microscopy the following day after stirring overnight. Rod / prism-shaped particles and agglomerates were observed at 100X magnification (FIG.7A and FIG.7B) and 400X magnification (FIG.7C and FIG.7D). The slurry was filtered into a clean 250 mL filter flask through filter cloth presoaked in distilled water. The vessel, impeller, and wet cake were washed 4 times with 1 vol. (1 mL) of distilled water to capture all the residual solids. A 20 mL vial was tared for recovery. The wet solids were transferred to the vial and weighed. The weight of the wet solids was 0.8178 g. A sample of the wet solids was plated and analyzed by XRPD. The observed pattern corresponded to a mixture of crystalline form A+B (FIG.8). The vial of solids was dried under vacuum (-29 in Hg) at 50 °C for 3 h. The weight of dried solids recovered from filtration was 0.4836 g (48% yield). A sample of the dry solids were plated and analyzed by XRPD. The observed pattern corresponded to a mixture of crystalline forms B+ A (FIG.8). The mother liquor was evaporated in a tared round bottom flask by rotary evaporation. When sufficiently dried, the flask was placed under vacuum at 50 °C overnight. The weight of dried solids recovered from mother liquor was 0.3045 g (an additional 30% yield). The color of the dry solids from mother liquor were a slightly darker-yellow than the solids recovered from filtration. XRPD analysis was done on the dry solids recovered from evaporation of the mother liquor. The observed pattern corresponded to a mixture of crystalline forms A+B (FIG.8). Based on the preliminary experiment, three unique XRPD patterns were observed (summarized in FIG.8; Pattern (2), Pattern (3), and Pattern (5); with Pattern (4) being similar to Pattern (2)). All three patterns were assigned to a mixture of crystalline form A and crystalline form B. All three XRPD patterns display similar features below 19 °2^, but some peaks were slightly shifted. A more notable difference was observed above 19 °2^. The discrepancies at large °2^ were attributed to the proportional differences in the quantity of sodium sulfate from the as-received material, decreasing relative to (R)- Compound 1 in the dried filtered solid and increasing relative to (R)-Compound 1 in the dried solid recovered from mother liquor. Microscopy was done on dry solids from filtration at 100X magnification (FIG.9), and on dry solids recovered from mother liquor at 100X magnification (FIG.10). Both materials appeared as rod- shaped particles and fine particles, though the dry solid recovered from mother liquor appeared to contain smaller particles. Particle size analysis on the two dried solids was done using ImageJ software. Select particles from 100X magnification images were analyzed for particle size. Histogram plots were generated from the image data to show the particle size distribution for each dried solid; the distributions are bimodal due to the rod-like shape, as length and width values were captured. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Particle Size Analysis of (R)-Compound 1 For the dried material recovered by filtration, the length and width of 150 particles was measured. For the solids recovered from the mother liquor, the length and width of 115 particles was measured. This data confirmed that the particle size of the material recovered from the mother liquor was smaller than that of the material recovered from filtration. Solid from filtration had d50 (count basis) of 32–34 ^m (FIG. 11). Solid from the mother liquor had d50 (count basis) of 18–20 ^m (FIG.12). A plot of the cumulative percent of particle sizes represented in the images of both dried solids is shown in FIG.13. Particle Size Analysis of (S)-Compound 1 Three lots of as-prepared (S)-Compound 1 (Lot 1, Lot 2, and Lot 3) were plated and analyzed by XRPD. Each lot exhibited an XRPD pattern corresponding to crystalline form A identified above for (R)- Compound 1. Particle size analysis on the three lots of (S)-Compound 1 was done using ImageJ software. Select particles from 100X magnification images were analyzed for particle size for (S)- Compound 1. Additionally, 400X magnification images were used for (S)-Compound 1, Lot 2 and (S)- Compound 1, Lot 3 because these particles were much smaller. (S)-Compound 1, Lot 1 appeared to agglomerate more than the other lots (FIG 18). Microscopy images of Lot 1, Lot 2, and Lot 3 are shown in FIG.14, FIG.15, FIG.16, and FIG.17. Histogram plots were generated from the image data to show the particle size distribution for each dried solid. The distributions were bimodal due to the rod-like shape, as length and width values were captured. A plot of cumulative percent of particle sizes is shown in FIG. 18A-18C Lot 1 had a d50 (count basis) of 14–15 ^m (FIG.18A). Lot 2 had a d50 (count basis) of 3–4 ^m (FIG 18B). Lot 3 had a d50 (count basis) of 4 ^m (FIG.18C). Further Crystalline Form Screening Four additional lots (Lot A, Lot B, Lot C, Lot D) of as-prepared (S)-Compound 1 were then examined. Lot A and Lot B both appeared to correspond to crystalline form A. (FIG.19). Lot C appeared as a low crystalline pattern unique from crystalline form A (later assigned to be crystalline form J, matching a crystalline form observed form slurrying (R)-Compound 1 at 50 °C in acetone; see Example 3). Lot D appeared as a low crystalline pattern unique from crystalline form A (later assigned to be crystalline form F, matching a crystalline form observed during slurrying (R)-Compound 1 at 50 °C in toluene (FIG.20); see Example 3). FIG.21 shows XRPD patterns of four lots of (S)-Compound 1 for comparison: Lot D; Lot C; Lot 1; and Lot 2. Two additional lots of (S)-Compound 1 were manufactured and studied (Lot E and Lot F). XRPD patterns for these lots were found to match crystalline form A (FIG. 22A and FIG.22B). Summary of Results The data from analysis of the various lots of (S)-Compound 1 and (R)-Compound 1 is summarized below in Table 1. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Table 1. Analysis of various lots of (S)-Compound 1 and (R)-Compound 1 HPLC Chiral PSD (µm) XRPD KF Yield Compound Lot purity purity pattern (%) (%) d10 d50 d90 (%) (%ee) (S)-Compound 1 Lot 1 A *** *** *** *** 10a14-15a102a(S)-Compound 1 Lot 2 A *** *** *** *** 1a3-4a12a0.5- a 15- (S)-Compound 1 Lot 3 A *** *** *** ***a4 1.5 16a(S)-Compound 1 Lot A A *** *** *** *** *** *** *** Low *** *** *** (S)-Compound 1 Lot D crystalline *** *** *** *** FbLow *** *** *** (S)-Compound 1 Lot C crystalline *** *** *** *** Jb(S)-Compound 1 Lot B A *** *** *** *** *** *** *** (S)-Compound 1 Lot E A 98.13 99.2 0.81 79.45 2.51 10.7 37.7 (S)-Compound 1 Lot F A 97.91 99.2 1.20 77.56 3.46 12.7 59.1 (S)-Compound 1 *** (crystallized from A 98.98 *** *** *** 5.34 13.7 34.1 EtOH / water) (R)-Compound 1 *** ter EasyMax A *** *** *** 48* 17-18a80- (af 33a81astep) (R)-Compound 1 *** (recovered from A *** *** *** 30** 9.5a19a43amother liquor)aCount basis;bRefer to Table 4 for a summary of all observed crystalline forms (R)-Compound 1; *recovered from filtration; **additionally recovered from mother liquor; *** not measured From these experiments, it is concluded that there are differences in the XRPD patterns of (R)- Compound 1 as prepared. A mixture of crystalline forms A+B is observed with the solid from filtration, and crystalline form A+B is seen with the solid recovered from mother liquor. In addition to XRPD peaks corresponding to crystalline forms A and B, a series of other peaks are observed, e.g., at about 19 °2^, °22.52^, 27.5 °2^, and 28.7 °2^ (see, e.g., FIG.22A). These peaks were attributed to the presence of sodium sulfate. The amount of sodium sulfate impurity was observed to decrease with filtration and increase in the mother liquor, in proportion to (R)-Compound 1. Changes in morphology during recrystallization indicate sodium sulfate was playing a role, as dendritic structures common to sodium sulfate were observed. After recrystallization, the particle size was larger with the material recovered from filtration compared to the material from mother liquor (d50 for filtered solids PATENT ATTORNEY DOCKET NO.: 51246-037WO2 was 33 ^m and solids from mother liquor was 19 ^m). Adding filtered and recovered mother liquor solids together, the yield was 78% (w / w). A comparison of several obtained XRPD patterns with varying amounts of the sodium sulfite impurity is provided in FIG.23. Of the several lots of (S)-Compound 1 that were analyzed, all showed crystalline form A except Lot D (which was determined to be low crystallinity crystalline form F, see Example 3) and Lot C (which was determined to most be low crystallinity crystalline form J, see Example 3). Patterns matching the XRPD patterns of Lot C and Lot D were also observed during slurry experiments in the crystalline form screening of (R)-Compound 1. Particle size analysis of (S)-Compound 1 by ImageJ (count basis) showed a d50 of 14-15 ^m for Lot 1; 3-4 ^m for Lot 2; and 4 ^m for Lot 3. Example 2: Removal of Sodium Sulfate From As-Prepared Patterns and Baseline Characterization The present example is directed towards the preparation of (S)-Compound 1 and (R)- Compound 1 for baseline characterization, including the removal of an occasionally present sodium sulfate impurity. It is noted that the presence of sodium sulfate was inconsistent across samples of (S)- Compound 1 and (R)-Compound 1, and the methods provided below represent exemplary methods for the removal of sodium sulfate from (S)-Compound 1 and (R)-Compound 1. Removal of Sodium Sulfate Baseline characterization of (R)-Compound 1 following a water slurry was halted due to the presence of sodium sulfate decahydrate observed in the solids (> 7 wt%). XRPD was performed on the solids, but the observed pattern was determined to be a mixture of (R)-Compound 1 and a mixture of sodium sulfate phases (e.g., Na2SO4 phase III (metastable needles and dendrites), Na2SO4 phase V (thermodynamically stable prisms), and any Na2SO4 hydrates, collectively referred to as sodium sulfate herein; see, e.g., FIG.24A and FIG.24B). During gravimetric solubility assessment, a trend was observed in the XRPD peaks of the slurried solids. Peaks no longer present in crystalline form A, from the water slurry, were the only observed peaks or the peaks with greatest intensity in alcohols and organic solvents (ethanol (EtOH), methanol (MeOH), tetrahydrofuran (THF)) (FIG.25). The peaks of interest were in good agreement with Na2SO4 (FIG.24). The XRPD pattern showed a mixture of phase III and V while differential scanning calorimetry (DSC) revealed a water loss associated with water uptake by sodium sulfate. Sodium sulfate is polymorphic under standard laboratory conditions and with respect to the types of experiments performed during the crystalline form screening. DSC and coupled thermogravimetric analysis (TGA) / DSC were performed on the solids. The DSC thermogram revealed an initial broad endotherm below 100 °C (associated with the loss of surface water from the sample), a small endotherm (-4.43 J / g) with an onset at 122.4 °C, and a melt and decomposition event with an onset of 274.7 °C (FIG.26). The TGA / DSC thermogram resolved a mass loss of 1.45 wt% below 100 °C and a loss of 2.42 wt% associated with the thermal event with an onset of 124.5 °C. A final mass loss was observed on melt and due to decomposition of (R)-Compound 1 (FIG. 27). The mass loss of 2.42 wt% was associated with water loss from the sodium sulfate content in the sample. While the XRPD pattern agreed with the anhydrous phases of sodium sulfate (phase III + V), a minimum sample content can be estimated from the DSC / TGA mass loss. Assuming full hydration of the PATENT ATTORNEY DOCKET NO.: 51246-037WO2 sodium sulfate, water loss from Na2SO4·10H2O equates to approximately 7 wt% of the hydrated salt in the sample (assuming the loss of all ten equivalents of water, 2.42 wt%), but does not account for partial hydration under ambient conditions or any further anhydrous Na2SO4. Therefore, the sodium sulfate contained within the sample was > 7 wt%, which agreed with laboratory observations of the first round of solubility assessments. No further characterization on the solid was carried out prior to removal of the sodium sulfate. Water slurry of (R)-Compound 1was conducted to remove Na2SO4. Since the solubility of (R)- Compound 1 in water was low, the solids were slurried in water to assess the feasibility of this method for removal of the water-soluble inorganic salt prior to continuation of the crystalline form screening. (R)- Compound 1 (499.8 mg) was weighed into a 20 mL vial with a 10 mm stir bar and 10 vol. of water added. The slurry was stirred overnight at RT prior to filtration under reduced pressure. The cake was washed with 2 × 10 vol. of water and dried under reduced pressure for 20 min. The solids were then transferred to a 50 °C vacuum oven (~-29 in Hg) to dry overnight. Solids were recovered in a 60% w / w yield (292.1 mg). The XRPD of the dried solids did not resolve any peaks assigned to the inorganic component of the as- received material and the pattern was consistent with crystalline form A (FIG.28). There were some peak shifts from the original XRPD pattern of the solid, which may be attributed to interaction with the inorganic salt in the solid. These peak shifts are shown in FIG.28 with hatched lines to guide the eye. Water slurry of (R)-Compound 1 was conducted on a larger scale to remove Na2SO4. (R)- Compound 1 was weighed into a 100 mL EasyMax vessel to slurry in water using the following process. First, (R)-Compound 1 (3.5049 g) was slurried in 10 vol. of water at 25 °C in a 100 mL EasyMax vessel (Cowie white retreat PTFE 5 cm impeller; mixing energy of 0.23 W / kg). Then the mixture was held at 25 °C for 4 h. The mixture was then filtered under reduced pressure and washed with 2 × 10 vol. of water. Then the solid was dried under reduced pressure on the filter for 20 minutes before moving to the RT vacuum oven to dry under active vacuum (about -24 in Hg) for 4 h. Finally, the sample was dried at 50 °C under active vacuum (about -29 in Hg) overnight. Solids were recovered in a 62% w / w yield (2.16 g). The XRPD of the dried solids did not resolve any peaks assigned to the inorganic component of the starting material, and the pattern was consistent with crystalline form A (FIG.29). The previously observed peak shifts seen in (R)-Compound 1 were also present. Baseline Characterization of (R)-Compound 1 Crystalline form A from the water slurry of (R)-Compound 1 was characterized as the baseline material for the crystalline form screening portion of the project. The XRPD pattern of the long-scan (4 – 40 °2^) was consistent with crystalline form A and did not contain any evidence of sodium sulfate (FIG. 30).1H NMR was carried out in DMSO-d6 and found to agree with the structure and to contain 0.89 wt% residual EtOAc (FIG.31). The water content was measured by Karl Fischer (KF) titration to be 1.16 wt%. DSC and TGA / DSC were performed on the as-received solids. The DSC thermogram revealed a broad endotherm before 100 °C and a melt and decomposition event with an onset of 277.3 °C (FIG.32). The TGA / DSC thermogram resolved a mass loss of 1.67 wt% from 35 to 128 °C and a final mass loss observed during the melt and due to decomposition of (R)-Compound 1 (FIG.33). PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Dynamic Vapor Sorption isotherms of (R)-Compound 1 are shown in FIG.34. The total mass change observed between 2 and 95% RH was 4.5 wt%, and the mass change between 15 and 75% RH was 3.3 wt%. The mass change was reversible, and no hysteresis was observed. XRPD of the sample before and after DVS measurement was crystalline form A as demonstrated in FIG.35. Baseline Characterization of (S)-Compound 1 Baseline characterization of (S)-Compound 1 (Lot 2, 300 mg) was carried out on the solids. The XRPD pattern of the long-scan (4–402^°) was designated as crystalline form A (FIG.36A and FIG.36B) and did not contain any of the inorganic peaks seen in (R)-Compound 1. Proton nuclear magnetic resonance spectroscopy (1H NMR) was carried out in deuterated dimethyl sulfoxide (DMSO-d6) and found to be in agreement with the structure and to contain 0.63 wt% residual EtOAc (FIG.37). The water content measured by KF was 2.32 wt% (0.4 eq. water). DSC and TGA / DSC were performed on the solids. The DSC thermogram revealed a broad low temperature endotherm with an onset at 38.2 °C followed by the melt and decomposition with an onset of 278.4 °C (FIG.38). The TGA / DSC thermogram resolved a mass loss of 1.84 wt% from 38 to 135 °C and a final mass loss observed during the melt and due to decomposition of (S)-Compound 1 (FIG.39). Dynamic Vapor Sorption (DVS) of (S)-Compound 1 from Lot 2 (crystalline form A) was conducted. The total mass chance observed between 2% and 95% RH was 4.3 wt%, and the mass change between 15 and 75% RH was 3.1 wt.%. The mass change was reversible, and no hysteresis was observed. The DVS isotherms are shown in FIG.40. XRPD of the sample before and after DVS measurement was crystalline form A with two additional peaks at 7.4 °2^ and 11.7 °2^, as demonstrated in FIG.41. The two additional peaks post DVS were visually sharper than the peaks associated with crystalline form A. Example 3. Purity improvement of (S)-Compound 1 via slurry In this example, the purity improvement of (S)-Compound 1 through slurry was assessed. First, baseline characterization of (S)-Compound 1 was conducted. The XRPD, DSC, and TGA results can be found in FIGS.59A-59O and FIGS.60A-60X. Then initial slurries of (S)-Compound 1 in selected solvents were investigated. Finally, scale-up of slurries in selected solvents was achieved. Slurry experiments were performed as follows. (S)-Compound 1 was weighed (38–42 mg) in 2 mL vials with a 6 mm stir bar. A variety of solvents or solvent mixtures (41 in total) were used to slurry the sample for four days at RT. Approximately 8 vol. of solvent or solvent system was added to each vial. After four days the stir bars were removed, and samples were centrifuged for 10 min at 4400 rpm. The mother liquor was then removed to perform gravimetric solubility analysis to estimate expected recovery. The remaining solids were then filtered and rinsed twice with 2 vol. of solvent. A small amount of the wet cake was plated for XRPD. After XRPD was performed on the wet cake, samples were dried at 50 °C under active vacuum for 2–3 h. The remaining wet cake was placed into the oven to dry overnight. Samples were then prepared for high performance liquid chromatography (HPLC) purity analysis. The results of the slurry assessments in a variety of solvents for (S)-Compound 1 are summarized in Table 2. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Table 2. Slurry Assessment of (S)-Compound 1 Gravimetric Dimer Sample XRPD XRPD XRPD Purity Yield* Solvent solubility impurity No. Wet Dry pattern^HPLC (%) (%) (mg / mL) HPLC (%) 1 N / A B N / A FIG.42A N / A 98.20 1.46 N / A 2 IPA B+D B+D FIG.43A 6 98.05 1.68 95 D D 3 EtOAc FIG.43B 7 97.88 1.57 95 (L.C.) (L.C.) 4 THF F F FIG.43C 8 98.62 0.77 93 D D 5 2-MeTHF FIG.43D 31 98.18 1.50 75 (L.C.) (L.C.) 6 Toluene F+B F+B FIG.43E 3 97.80 1.49 97 7 MtBE F F FIG.43F 12 97.44 1.55 91 8 ACN H+B H+B FIG.43G 4 97.99 1.57 97 K K 9 1,4-dioxane FIG.43H 2 97.19 1.33 99 (L.C.) (L.C.) D D 10 Acetone FIG.43I 9 98.29 1.52 93 (L.C.) (L.C.) 11 MeOH B B FIG.43J 90 96.03 3.85 28 E E 12 n-PA FIG.43K 28 97.64 1.62 78 (L.C.) (L.C.) F F 13 Anisole FIG.43L 0 91.4 1.12 100 (L.C.) (L.C.) F F 14 MeOAc FIG.43M 15 92.47 1.49 88 (L.C.) (L.C.) D D 15 MEK FIG.43N 3 98.09 1.46 98 (L.C.) (L.C.) 16aFormic acid N / A N / A N / A 147 N / A N / A N / A 17 EtOH B B FIG.43O 40 97.69 2.27 68 EtOH:EtOAc S+T T 18 FIG.44A 23 97.61 1.60 81 (1:1) (L.C.) (L.C.) EtOH:DMSO 19 R R FIG.44B 37 97.97 1.95 71 (9:1) EtOH:DMSO: 20 B+R B+R FIG.44C 9 97.82 1.65 93 Water (3:3:4) EtOH:1,4- G K 21 FIG.44D 16 97.76 1.30 87 dioxane (1:1) (L.C.) (L.C.) MeOH:MtBE F F 22 FIG.44E 39 94.93 2.15 69 (1:1) (L.C.) (L.C.) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Gravimetric Dimer Sample XRPD XRPD XRPD Purity Yield* Solvent solubility impurity No. Wet Dry pattern^HPLC (%) (%) (mg / mL) HPLC (%) MeOH:DMSO: 23 B+F B FIG.44F 0 98.12 1.59 100 Water (2:2:6) MeOH:1,4- G K 24 FIG.44G 26 98.7 1.26 79 dioxane (1:1) (L.C.) (L.C.) DMSO:Water R+N B+R 25 FIG.44H 12 98.35 1.40 90 (1:1) +B (L.C.) DMSO: R+N R+N 26 FIG.44I 99 99.95 0.06 21 2-MeTHF (1:1) (L.C.) (L.C.) b DMSO:acetone N R 27 FIG.44J >152 N / A N / A N / A (1:1) (L.C.) (L.C.) E E 28 THF:IPA (1:1) FIG.44K 29 97.04 1.17 77 (L.C.) (L.C.) c THF:acetone D D 29 FIG.44L N / A 98.58 1.24 N / A (1:1) (L.C.) (L.C.) THF:2-MeTHF D D 30 FIG.44M 40 98.45 1.37 68 (1:1) (L.C.) (L.C.) L+T L+T 31 THF:EtOH (8:2) FIG.44N 32 98.96 0.82 74 (L.C.) (L.C.) E Ee32 THF:EtOH (1:1) FIG.44O 32 98.53 1.37 75 (L.C.) (L.C.) E Ee33 THF:EtOH (2:8) FIG.44P 39 98.05 1.71 69 (L.C.) (L.C.) THF:1,4-dioxane G K 34 FIG.44Q 17 98.64 0.98 86 (1:1) (L.C.) (L.C.) 2-MeTHF: D D 35 FIG.44R 0 98.51 1.41 100 MeOH (8:2) (L.C.) (L.C.) 2-MeTHF: D D 36 FIG.44S 69 98.17 1.78 44 MeOH (1:1) (L.C.) (L.C.) 2-MeTHF:EtOH D D 37 FIG.44T 21 98.44 1.47 83 (8:2) (L.C.) (L.C.) 2-MeTHF:EtOH D D 38 FIG.44U 67 98.39 1.53 46 (1:1) (L.C.) (L.C.) 2-MeTHF:1,4- G K 39 FIG.44V 25 98.53 1.3 80 dioxane (1:1) (L.C.) (L.C.) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Gravimetric Dimer Sample XRPD XRPD XRPD Purity Yield* Solvent solubility impurity No. Wet Dry pattern^HPLC (%) (%) (mg / mL) HPLC (%) 1,4- G K 40 dioxane:EtOH FIG.44W 34 93.27 1.48 73 (L.C.) (L.C.) (8:2) d Formic acid:water 41 N / A N / A N / A N / A N / A N / A N / A (1:1) Toluene:MEK F F 42 FIG.44X 28 93.27 1.48 78 (1:1) (L.C.) (L.C.) L.C., low crystalline; N / A, not applicable ^Gravimetric solubility (mg / mL solvent) *Yield estimated from solubility aSolution was observed, therefore no XRPD or HPLC data is available. bMinimal solids were recovered, therefore no HPLC data is available. cLimited mother liquor was available, therefore no gravimetric solubility or % yield data is available. dSolution was observed, therefore no XRPD or HPLC data is available. eCrystalline form E minus 1 peak at 6.282^ (°) THF showed some purging of the dimer impurity and XRPD indicated conversion to a solvate pattern F (FIG.43C). A mixture of 2-MeTHF with DMSO showed good purging of the impurity as well. The XRPD was indicative of a DMSO solvate pattern N (FIG.44I). A scaled up method was then performed. (S)-Compound 1 was weighed (98–102 mg) in 4 mL vials with a 10 mm stir bar. Solvent mixtures of 2-MeTHF, DMSO, and THF were used to slurry the sample for 2–3 days at RT. Samples 43-46 were slurried for 3 days while samples 47 to 50 were slurried for 2 days (Table 3). Approximately 8 vol. of each solvent system was added to the vials. After 2–3 days the stir bars were removed, and samples were centrifuged for 10 min at 4400 rpm. The mother liquor was then removed to perform gravimetric solubility analysis to estimate expected recovery. The remaining solids were then filtered and washed twice with 2 vol. of solvent and placed into pre-weighed 4 mL vial. A small amount of the wet cake was plated for XRPD. After XRPD was performed on the wet cake, samples were dried at 50 °C under active vacuum for 2–3 h. The remaining wet cake was dried in the oven over the weekend. Samples were prepared for HPLC purity analysis. From the results found in the 40 mg slurries, additional slurries were explored using various compositions of THF, DMSO, and 2-MeTHF at 100 mg scale. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Table 3. Further Slurry Experiments on (S)-Compound 1 Gravimetric Purity Dimer Yield Sample XRPD XRPD XRPD Yield** Solvent solubility HPLC impurity * No. Wet Dry pattern^(%) (mg / mL) (%) HPLC (%) (%) FIG. 43 THF F F 8 99.11 0.65 94 63 45A THF:DMSO N FIG. 44 N 70 99.12 0.05 44 30 (8:2) (L.C.) 45B DMSO: N FIG. 45 2-MeTHF N 100 99.81 0.04 20 16 (L.C.) 45C (1:1) DMSO: N FIG. 46 2-MeTHF R+N 28 99.88 0.12 78 58 (L.C.) 45D (2:8) DMSO: N FIG. 47 2-MeTHF R+N 48 99.92 0.08 62 53 (L.C.) 45E (7:3) DMSO: N FIG. 48 2-MeTHF R+N 10 99.49 0.48 92 84 (L.C.) 45F (9:1) THF:DMSO N FIG. 49 N 27 99.74 0.22 78 81 (95:5) (L.C.) 45G THF:DMSO N FIG. 50 N 36 99.80 0.17 71 68 (9:1) (L.C.) 45H L.C., low crystalline ^Gravimetric solubility (mg / mL solvent) *Yield estimated from solubility **Yield from 100 mg-scale experiment The scale-up of THF agreed with the smaller scale experiments and showed some purging of the dimer impurity and XRPD indicated conversion to a solvate (FIG.45A) with a predicted yield of 94 % based on gravimetric solubility. The measured yield was 63%. A 2-MeTHF:DMSO (9:1) composition also showed some purging of the dimer impurity. The XRPD was indicative of a DMSO solvate (FIG.45F) and had a predicted yield of 92 % based on gravimetric solubility. The measured yield was 84%. The difference between measured and predicted yield may be due to generation of fines which pass through the filter paper, or small losses due to sampling and transfer of solids. Although the other compositions showed good purging of the impurity, (S)-Compound 1 had high solubility in DMSO and the yield was low. The more DMSO present, the lower the yield and therefore further slurrying experiments were not performed. The most promising systems for purging the dimer impurity were THF (dimer impurity decreased PATENT ATTORNEY DOCKET NO.: 51246-037WO2 from 1.46 % to 0.65 %) and 2-MeTHF:DMSO (9:1 vol) (dimer impurity decreased from 1.46 to 0.48%). The predicted yields from the experiments based on solubility were 94% and 92%, respectively. The yield at 100-mg scale was lower than estimated, likely due to some solid losses during filtration, sampling, or transfer of solids. XRPD indicated conversion to solvates pattern F and N, respectively. Example 4. Crystalline form screening of (R)-Compound 1 This example provides a description of further crystalline form screening to determine the polymorphs of (S)-Compound 1 and (R)-Compound 1 amenable to further investigation. In addition to slurry experiments (e.g., those described in Example 3), evaporative crystallization, antisolvent crystallization, cooling crystallization, solvent milling, and thermal treatment experiments were performed. Viability of the observed patterns was assessed in terms of crystallinity, stability to drying, stability under ambient storage conditions, solvent content (anhydrous or solvate (e.g., hydrate)), and method of formation. Methods for producing select patterns are summarized in the form map in FIG.56. Slurry Experiments Slurry experiments were performed as described in Example 3. Briefly, slurries (~30 mg) were stirred at constant temperature in 2 mL vials with 7 mm stir bars for two days. After stirring for two days, solids were allowed to settle, and supernatant was recovered for gravimetric solubility assessment. Supernatant solutions were evaporated to dryness at 40 °C in atmosphere on the hot plate and then placed at 50 °C under vacuum for 3 h before final weighing. Short-term slurries were carried out at two temperatures in 14 solvents during the initial screening. About 20–30 mg solid was added to a 2 mL vial followed by 0.75 mL of solvent. Slurries were stirred at constant temperature for two days. If all solids dissolved, more solid was added until a slurry was formed within reason. After stirring for two days, solids were allowed to settle and were recovered by vacuum filtration for XRPD analysis. These slurry experiments resulted in the observation of several crystalline forms, summarized in Table 3, FIG.43A- 43O, FIG.44A-44X, FIG.45A-45H, and FIG.46A-46M. Evaporative Crystallization Evaporation crystallization refers to the process of obtaining a crystalline form of a material by dissolving the material in a solvent into which the material is homogeneously dispersed. The mixture is given time for the liquid solvent to evaporate. In some embodiments, evaporation occurred above room temperature, e.g., at 40 °C or at 50 °C. In some embodiments, the evaporation began at one temperature, e.g., 40 °C, before the temperature was increased to, e.g., 50 °C. Supernatant from gravimetric solubility slurries was recovered for evaporative crystallization. The solutions were evaporated to dryness at 40 °C in atmosphere over the weekend and then placed at 50 °C under vacuum for 4 h. Two cooling regimes were employed: slow cooling from 50 °C to 25 °C at 5 °C per hour and fast cooling from 50 °C to 0 °C. For all experiments, about 20 mg of solid was weighed in a 2 mL vial. Solvent was then added incrementally at 50 °C until dissolution. In all experiments, solids were completely dissolved before cooling. In cases where solids persisted, syringe filtration was employed. For slow-cooling experiments, the solutions were cooled at 5 °C per hour to 25 °C with mixing. The rate was PATENT ATTORNEY DOCKET NO.: 51246-037WO2 regulated by a chiller control program. If solids did not precipitate from solution after stirring at 25 °C overnight (^16 h), the solutions were further cooled to ^5 °C in a fridge without mixing. For fast-cooling experiments, the solutions were transferred to an ice-water bath near 0 °C without mixing. After 10 min in the ice-water bath, mixing was resumed. If precipitation was observed, slurries were filtered immediately. If solids did not precipitate from solution at 0 °C for one hour, the solutions were further cooled to -20 °C by placing in a freezer without mixing. The results from evaporative crystallization experiments are summarized in FIG.47A-47K. Cooling Crystallization Cooling crystallization refers to the process of obtaining a solid form of a material by dissolving the material in a solvent at a first temperature wherein the solid is appreciably soluble in the solvent, then cooling the mixture to a second temperature wherein the solid is less soluble or insoluble in the solvent, resulting in the precipitation of a solid form of the material. The crystal form and / or the crystallinity of the recovered solid form can be controlled by adjusting the first temperature, the second temperature, or the rate of cooling. In some embodiments, the cooling crystallization is a slow cooling crystallization (i.e., a crystallization wherein rate of change in temperature of the solution is controlled, e.g., via a chiller at a rate of 5 °C per hour). A slow cooling crystallization was typically performed using the following exemplary procedure. First, 20 mg of (R)-Compound 1 was dissolved in an appropriate volume of solvent at 50 °C. If not all solid dissolved, the solution was filtered to removed undissolved material. The solution was then cooled at a rate of 5 °C per hour to a final temperature of 25 °C with stirring. If no solid precipitation was observed after 16 hr, the solution was further cooled to 5 °C without stirring. In some embodiments, the cooling crystallization is a fast cooling crystallization (i.e., a crystallization aiming to change the temperature of the solution to a final temperature as rapidly as possible, e.g., by placing the solution in a freezer or an ice-water bath). A fast cooling crystallization was typically performed using the following exemplary procedure. First, 20 mg of (R)-Compound 1 was dissolved in an appropriate volume of solvent at 50 °C. If not all solid dissolved, the solution was filtered to remove undissolved material. The solution was then immediately transferred to an ice-water bath near 0 °C without stirring. After 10 minutes, stirring was resumed. If no solid precipitation was observed after 1 hr at 0 °C, the solution was further cooled to -20 °C without stirring. The results from slow cooling experiments are summarized in FIG.48A-48C. The results from rapid cooling experiments are summarized in FIG.49A-49C. Antisolvent Addition Antisolvent crystallization refers to a process of obtaining a crystalline form of a material by first dissolving it in a first solvent into which the material is homogeneously dispersed (i.e., is soluble in), followed by the addition of a second solvent, hereafter referred to as an antisolvent, which facilitates the dissolution or precipitation of the material from the solvent mixture. In some embodiments, Antisolvent crystallizations may proceed at room temperature, below room temperature, or above room temperature. In some embodiments, antisolvent crystallization may begin at a given temperature for some length of PATENT ATTORNEY DOCKET NO.: 51246-037WO2 time before either being heated or cooled to a different temperature to facilitate precipitation. Antisolvent crystallization was done in various solvent systems. First, about 20–30 mg solid was dissolved in solvent. In MeOH and EtOH, a thin haze persisted in the vials and the solutions were either syringe filtered or centrifuged to obtain a clear solution. Then antisolvent crystallization was done using either the direct or reverse addition method. For direct antisolvent addition, twice the volume of solvent was used for the antisolvent, and this was added in four portions dropwise over one hour. Solutions / slurries were mixed during antisolvent addition. For example, if solids dissolved in 0.5 mL solvent, then 1.0 mL antisolvent was added over 60 min. For reverse antisolvent addition, the solution was transferred all at once to twice the solvent volume of antisolvent with rapid stirring. For example, if solids dissolved in 0.5 mL solvent, then the solution was added at once to 1.0 mL antisolvent while stirring. Once the solids were formed, the slurries were filtered, and the solids were recovered for XRPD analysis. If solids did not form immediately, the solutions were monitored for solid formation and stirred overnight at RT. Solutions, which had no precipitate after 16 h, were moved to a -20 ˚C freezer. No additional solids were observed after 48 h. After 5 days, small amounts of solids were observed at the bottom of some vials and collected for XRPD analysis. The results from antisolvent addition experiments are summarized in FIG.50A-50H. Milling Solvent-assisted milling was done using a small Wig-L-Bug ball mill with ¼” stainless steel ball as milling media. About 50 mg solid L1MA74003-13-6 was weighed into vessel and one volume solvent was added. The milling was carried out in 3 × 30 s increments at 3500 rpm, scraping solids off vessel walls to minimize caking between millings. The results from milling experiments are summarized in FIG.51A-51C. Thermal Treatment Several crystalline forms from previous experiments were identified as candidates for new crystalline form generation using thermal treatment due to multiple observed endotherms in DSC characterization experiments. Crystalline forms F (tert-butyl methyl ether (MtBE) slurry, 50 ˚C), H (acetonitrile (ACN) slurry, RT and 50 ˚C), J (acetone slurry, 50 ˚C), A+B (EtOH slurry, 50 ˚C), and K (on drying G, dioxane slurry) were of interest for thermal treatment due to multiple observed endotherms. Approximately 20 mg of (R)-Compound 1 was slurried in 0.5 mL of solvent at 50 ˚C for 2 days to generate additional material for thermal treatment. Trace or no detectable crystalline form A was observed in these prepared samples. The XRPD patterns for the reprepared samples are shown in FIG 52A-52E. The selected patterns were heated from 30 ˚C to a target temperature (e.g., 160 ˚C, 170 ˚C, 180 ˚C, 190 ˚C¸ 200 ˚C, 210 ˚C, or 220 ˚C) at a rate of 10 ˚C / min, held at the target temperature for 2 min, then cooled to 30 ˚C at a rate of 20 ˚C. The solids were then collected and examined using XRPD to determine if a form change had occurred. The results from thermal treatment experiments are summarized in FIG.53A-53F. Lyophilization for Amorphous Generation Lyophilization refers to the process of removing water from a material via sublimation of ice at low pressure. Lyophilization may result in the generation of amorphous material. Lyophilization was therefore PATENT ATTORNEY DOCKET NO.: 51246-037WO2 explored as a method to generate amorphous (R)-Compound 1. An exemplary lyophilization procedure was performed as follows.20 mg of (R)-Compound 1 was dissolved in 1.5 mL of a solvent mixture including organic solvent (e.g., t-butanol) and water at an 8:2 ratio at 80 °C. Once fully dissolved, the solution was transferred to a pre-cooled scintillation vial in a liquid nitrogen bath. The frozen material was then lyophilized overnight. The results from lyophilization experiments are summarized in FIG.54A-54C. Stability Under Ambient Conditions The stability of all obtained compounds after storage under ambient conditions was then examined. Several crystalline forms were observed to convert to crystalline form A under ambient storage conditions in sealed vials. Generation of Pure Crystalline Form B Crystalline form A was not isolated under anhydrous conditions and only observed from water containing systems. Crystalline form A was found to be closely related to crystalline form B with conversion between the two patterns occurring within the range of standard laboratory temperature and humidity. Crystalline form A was observed to consistently contain between 0.2 equivalents and 0.4 equivalents of water, while crystalline form B was obtained by removal of water from crystalline form A. They reversible converted depending on the conditions (e.g., relative humidity (RH) and temperature), where crystalline form A was favored in humid conditions (greater than about 23 % RH) and crystalline form B was favored in dry conditions (less than about 23 % RH). XRPD diffractograms obtained at each relative humidity demonstrate the prevalence of crystalline form B at lower humidity and crystalline form A at higher (FIG.55A-55B). A series of experiments were performed with the goal of isolating pure crystalline form B directly. A first method was performed by slurrying (R)-Compound 1 in EtOH at 70 °C. About 50 mg of (R)-Compound 1 was weighed in a 2 mL vial and 0.75 mL of EtOH was dispensed to make a slurry. This was stirred at 70 °C for four days. The solids were then filtered and plated for XRPD, revealing crystalline form A as shown in FIG.55C. A second method was performed on a 50 mg scale. (R)-Compound 1 was added to a 4 mL vial with 19.5 vol. EtOH (0.975 mL) and a 10 mm stir bar. The slurry was heated to 80 ˚C and remained hazy after 30 min. A small amount of water (4 drops) and additional EtOH (8 drops) was added, and the solution became clear. Water (0.575 mL) was added dropwise over 1 h (0.095 mL every 10 min). By the end of antisolvent addition, a thin slurry was observed. The slurry was cooled by 5 ˚C every 10 min (precipitation observed at 65 ˚C) until RT was reached, where it was allowed to stir overnight before filtration under reduce pressure. Solids were washed with 2 × 1.5 vol. of water before drying in the vacuum (~29 inHg, active) oven overnight. The wet cake was analyzed by XRPD and identified as crystalline form A (FIG.55D). A third method was carried out by omitting the overnight hold of the second method and sampling the slurry for XRPD immediately after cooling to RT. (R)-Compound 1 was added to a 4 mL vial with 19.5 vol. EtOH (0.975 mL) and a 10 mm stir bar. The slurry was heated to 80 ˚C and remained hazy after 30 min. Water (0.575 mL) was added dropwise over 1 h (0.095 mL every 10 min). Midway through the water PATENT ATTORNEY DOCKET NO.: 51246-037WO2 addition, the solution was almost clear, but by the end of antisolvent addition, a thin slurry was observed. The slurry was cooled by 5 ˚C every 10 min (precipitation observed at 40 °C) until RT was reached, when it was sampled for XRPD. The wet cake was analyzed by XRPD and identified as crystalline form A (FIG. 55E). A fourth method was then attempted at a larger scale and seeding the slurry with crystalline form B. (R)-Compound 1 was added to a 4 mL vial with 19.5 vol. EtOH (1.95 mL) and a10 mm stir bar. The slurry was heated to 80 ˚C and remained hazy after 30 min. After the addition of 8 drops of water, the solution thinned, but was still hazy. To remove any potential seed, the solution was syringe filtered (at 70 ˚C) to obtain a clear solution prior to antisolvent addition. Water (1.15 mL) was added dropwise over 1 h 40 min (0.115 mL every 10 min). After three additions of antisolvent, the solution was seeded with crystalline form B and the seed was not retained. After five more additions of water, the seed was retained, and the slurry thickened over the course of the remaining antisolvent addition. The slurry was then cooled by 5 ˚C every 10 min until 60 ˚C was achieved, when there were sufficient solids to sample for XRPD. It was identified as crystalline form A (FIG.55F). Cooling Crystallization in THF, Seeded with Crystalline Form Q Crystalline form Q was only observed from the thermal treatment of solvate patterns. To probe the availability of crystalline form Q for crystallization processes, cooling crystallization with seeding was carried out with THF. (R)-Compound 1 was dissolved in minimum THF (~0.75 mL) at 80 ˚C in a 2 mL vial containing a 7 mm stir bar. Once full dissolution was achieved, the vial was cooled to 50 ˚C and seeded with crystalline form Q (one spatula tip, dry). The seed was partially retained so the vial was further cooled to 45 ˚C and another spatula tip of seed was added. The seed was retained, and the slurry began to thicken. The vial was further cooled to RT at a rate of 5 ˚C every 10 min. Once at RT, the slurry was sampled for XRPD analysis. Solids were identified as crystalline form D + trace Q. Generating Crystalline Forms D, C, and B for TGA-IR Analysis Crystalline form D, crystalline form C, and crystalline form B were identified as being of further interest for additional characterization. While crystalline form D and crystalline form B were not selected for scale-up, as they were both observed to convert to crystalline form A under ambient conditions, additional material was required to confirm their identity as potential solvates. The scale-up of crystalline form C was also unsuccessful, and an additional attempt to generate crystalline form C was made. (R)- Compound 1 (~25 mg), was slurried in solvent (1.5 mL) at 50 ˚C for two days prior to sampling (Table 13). Solids sampled from the 2-propanol (IPA) and EtOH slurries remained as crystalline form A. Solids isolated from EtOAc were identified as crystalline form D and collected by filtration under reduced pressure and dried at 50 ˚C under active and static vacuum (~-29 inHg) overnight. XRPD patterns of the wet cakes are shown in FIG.43F. Crystals Observed on Recovery of Solids from Screening Experiments Following screening experiments, solids of known patterns and solutions were recovered for bulk evaporation in a 20 mL scintillation vial. The vial was heated to 50 ˚C to evaporate the mixture of solvents PATENT ATTORNEY DOCKET NO.: 51246-037WO2 overnight under ambient pressure. After 12 h, large crystals clusters were observed at the bottom of the vial and recovered. XRPD of the solids revealed a previously unobserved pattern, designated, crystalline form P. Summary of Crystalline Form Screening 20 crystalline forms were observed during the form screening process. The properties of these crystalline forms are summarized below in Table 4. A form map summarizing the results is provided as FIG.56. Table 4. Summary of all Crystalline Forms Identified During Screening Crystalline Form Change After Observed From XRPD DSC Form Thermal Treatment • As-prepared • From water containing systems and stable in n-heptane and cyclohexane slurries. • From evaporative crystallization as a mixture with other crystalline forms. • From cooling crystallization from FIG. FIG. Mixture of crystalline form A A EtOH:water and IPA:water. 42A 42B and crystalline form B • From direct antisolvent addition of water in EtOH and MeOH • From reverse antisolvent addition of water with DMSO, EtOH, and MeOH • Stable in dry milling and solvent- assisted milling with water, EtOH, and ACN

[0002] PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Crystalline Form Change After Observed From XRPD DSC Form Thermal Treatment • Anhydrous pattern • Observed to form when crystalline form A is exposed to dehydration conditions (low (less than 23 % RH), vacuum drying at RT or FIG. FIG. B higher temperatures, or thermal ** 57A 58A treatment) • Converts from crystalline form A on drying and in low humidity environments (10 % and 23 % RH, RT) • From slurry of crystalline form A in IPA (50 ˚C) • From IPA slurry of crystalline form FIG. FIG. Mixture of crystalline forms C A (mixed with crystalline form A) 57B 58B A+Q • From evaporative crystallization of IPA • Observed in EtOAc and THF slurries of crystalline form A • Evaporative crystallization from FIG. FIG. D ** THF 57C 58C • Cooling crystallization from THF and acetone • As a mixture with crystalline form A FIG. FIG. E from evaporative crystallization of ** 57D 58D or in or with EtOH. • From toluene and MtBE slurries of crystalline form A (mixed with crystalline form A at room temperature) FIG. FIG. Mixture of crystalline form Q F • From evaporative crystallization 46H 58E and crystalline form A from acetone • From solvent assisted milling with 2-MeTHF (mixed with crystalline form A) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Crystalline Form Change After Observed From XRPD DSC Form Thermal Treatment • From wet cake from 1,4-dioxane slurries FIG. G * *** • From milling crystalline form A with 57E 1,4-dioxane • From ACN slurries of Pattern A FIG. FIG. Crystalline form Q with trace H • From evaporative crystallization in 57F 58F crystalline form A or with ACN • From acetone slurry of crystalline FIG. I form A (mixed with crystalline form * ** 57G A at room temperature) • From acetone slurry at 50 ˚C FIG. Crystalline form Q with trace JFIG.57I 58G crystalline form A • From drying crystalline form G FIG. Mixture of crystalline form Q KFIG.57J 58H and crystalline form A • From short term slurry experiments FIG. ** L * with 2-MeTHF (wet cake) 57K • From evaporative crystallization of FIG. ** M * 2-MeTHF 57L • From reverse antisolvent addition ** of EtOAc with DMSO (mixed with crystalline form O). FIG. N * • From reverse antisolvent addition 57M of 2-MeTHF with DMSO (mixed with crystalline form N). • From reverse antisolvent addition ** FIG. O of EtOAc with DMSO (mixed with * 57N crystalline form N) • From solvent assisted milling with 1,4-dioxane (mixed with crystalline form G; wet solids) • From solvent assisted milling with FIG. FIG. Crystalline form Q with trace P 1,4-dioxane (mixed with crystalline 57O 58I crystalline form A form K; dried solids) • Evaporation of mixed solvents at 50 ˚C during recovery of material from screening PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Crystalline Form Change After Observed From XRPD DSC Form Thermal Treatment • From thermal treatment of crystalline form P (mixed with trace crystalline form A) • From thermal treatment of crystalline form C (mixed with crystalline form A) • From thermal treatment of crystalline form F (mixed with crystalline form A) • From thermal treatment of FIG. FIG. Q crystalline form H (mixed with ** 57P 58J crystalline form A) • From thermal treatment of crystalline form J (mixed with crystalline form A) • From thermal treatment of crystalline form P (mixed with crystalline form A) • Observed as the pure form from thermal treatment of crystalline form K to 160 ˚C • As a mixture with crystalline form A from direct antisolvent addition of water with DMSO. FIG. FIG. R ** • As a mixture with crystalline form N 57Q 58K from reverse antisolvent addition of 2-MeTHF with DMSO. Dried to R. • From the reverse antisolvent FIG. S addition of EtOH and EtOAc after 5 * ** 57R days at - 20 ˚C (wet solids). • From drying S. FIG. T * ** 57S *: DSC experiment not performed; **: no form change observed after thermal treatment; ***: form change on drying precludes DSC experiments Conclusions Of the 20 observed patterns crystalline form C, crystalline form Q, crystalline form K, crystalline form A, crystalline form R, crystalline form P, and crystalline form B were identified as promising PATENT ATTORNEY DOCKET NO.: 51246-037WO2 candidates for crystalline forms of (S)-Compound 1 and / or (R)-Compound 1 suitable for pharmaceutical administration. The remaining patterns were observed to be unstable to drying, unstable under ambient storage conditions, or of low crystallinity. Example 5: Scale-Up and Characterization of Selected Patterns Based on preliminary characterization of the patterns observed from screening, crystalline form Q, crystalline form C, crystalline form K, crystalline form R, and crystalline form P were selected for scale- up and further characterization. Crystalline forms were selected based on crystallinity, stability, and apparent viability. Crystalline form B was also examined due to its close relationship with crystalline form A. Crystalline Form Q Crystalline form Q was observed from the thermal treatment of solvate patterns (crystalline form C, crystalline form K, crystalline form P, crystalline form F, crystalline form H, and crystalline form J). crystalline form Q was highly crystalline with a melt onset greater than the melt observed for crystalline form A (crystalline form B). Crystalline form Q was selected for scale up and further characterization to understand the relationship with crystalline form A and to determine the viability of the pattern. (R)- Compound 1, 101.8 mg, was placed in a 4 mL vial with a 10 mm stir bar and 1.5 mL of ACN. The slurry was stirred on a hot plate and heated to 50 ˚C for two days. The thick looking, beige-colored slurry was sampled and the solids identified as crystalline form H. The slurry was filtered under reduced pressure with 2 × 1.5 vol. wash of ACN. Solids were placed in the 50 ˚C vacuum oven (~29 inHg) overnight to dry under static vacuum. Solids were confirmed as crystalline form H by XRPD. Microscopy of the solids from the slurry, crystalline form H, gave the morphology as a mixture of fines and small irregular crystals. crystalline form H was thermally treated in two batches in 100 ^L DSC pans by heating the solids from 30 ˚C to 200 ˚C at a rate of 10 ˚C / min, holding for 5 min, and then cooling to RT at a rate of 20 ˚C / min. The thermally treated solids were confirmed as crystalline form Q + trace A. Solids were isolated at 85 % w / w yield. The water content measured by KF was 2.56 wt%.1H NMR revealed 2.58 wt% residual 1,4-dioxane (0.1 eq.1,4-dioxane) in the solids. The sample of (R)-Compound 1 used to generate crystalline form Q for the scale-up was evaporated from a solvent mixture containing 1,4-dioxane. That the solvent remained in the sample after the water reslurry and scale-up of crystalline form H from ACN indicated that 1,4-dioxane is a tightly held solvent with this API. The DSC thermogram was consistent with crystalline form Q, but contained a low energy endotherm (-6.94 J / g) with an onset of 63.4 ˚C before the melt at an onset of 282.4 ˚C. DSC / TGA-IR showed an initial mass loss of 3.97 wt% correlating to the first endotherm observed by DSC. However, the endotherm was too low energy to be resolved on TGA / DSC. TGA-IR revealed that the mass loss was related to the loss of loosely held 1,4-dioxane. Crystalline form Q was determined to be anhydrous. A comparison of physical properties of crystalline form A and crystalline form Q is provided in Table 5. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Table 5. (R)-Compound 1: Summary of Crystalline Form A and Crystalline Form Q Residual Water TGA 30 min solubility at 37 °C DSC Crystalline Purity* Solvent Purity** content mass onsets^m (%a / a)1DVS For°H NMR (% a / a) by KF loss (°C) (wt%) (wt%) (wt.%) Solubility Solution (mg / mL) Water 0.04 0.89 38.2 FaSSGF 2.09 A 95.96 95.75 1.16 1.67 4.5 (EtOAc) 278.4 FaSSIF 0.08 FeSSIF 0.09 Water 0.04 (0.63 36.2 FaSSGF 2.44 A 96.46 96.31 2.32 1.84 4.3 (EtOAc) 277.1 FaSSIF 0.10 FeSSGF 0.17 Water 0.04 2.56 (1,4- FaSSGF 2.25 Q + trace A 99.82 98.60 2.56 3.97 282.4 2.07 Dioxane) FaSSIF 0.04 FeSSGF 0.05 *before 1 week stability; **after 1 week at 40 °C, 75% RH; ^mass change 2-95% RH (wt.%) Crystalline Form C Crystalline form C was observed to be a highly crystalline pattern that was stable under ambient laboratory conditions for 1 week. While other patterns were observed to partially convert to crystalline form A after 1 week, crystalline form C remained stable by XRPD. crystalline form C was selected for scale up for further characterization. (R)-Compound 1, 110.6 mg, was placed in a 4 mL vial with a 10 mm stir bar and 1.5 mL of IPA. The slurry was stirred on a hotplate and heated to 50 ˚C for two days. The beige slurry was sampled, and the solids were identified as crystalline form A. An additional 1.5 mL of IPA was added to the slurry with ~1 mg of dry seed of crystalline form C. The slurry was stirred at 50 ˚C for an additional 2 days. After 4 days, the solids remained mostly crystalline form A with some additional peaks. Crystalline Form K Crystalline form K was only observed to be moderately crystalline. However, crystalline form K was stable by XRPD after 1 week under ambient laboratory conditions and selected for scale up for further characterization. (R)-Compound 1, 102.7 mg, was placed in a 4 mL vial with a 10 mm stir bar and 1.5 mL of 1,4-dioxane. The slurry was stirred on a hotplate and heated to 50 ˚C for two days. The thick looking, salmon-colored slurry was sampled, and the solids identified as crystalline form G. The slurry was filtered under reduced pressure with 2 × 1.5 vol. wash of 1,4-dioxane. Solids were placed in the 50 ˚C vacuum oven (~29 inHg) overnight to dry under static vacuum. Solids were confirmed as crystalline form K by XRPD (FIG.43I). Microscopy of the solids from the slurry, crystalline form G, gave the morphology as a mixture of fines and small irregular crystals. Solids were isolated at 101 % w / w yield. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 The water content measured by KF was 1.48 wt%.1H NMR revealed 11.9 wt% residual 1,4-dioxane (0.5 equivalents (eq.) 1,4-dioxane) in the solids indicating that crystalline form K is a hemi solvate. The DSC thermogram was consistent with crystalline form K with an initial endotherm with an onset of 136.8 ˚C, but also contained a second endotherm at an onset of 150.5 ˚C before the melt at an onset of 280.4. DSC / TGA-infra red (IR) revealed a gradual initial mass loss of 1.34 wt% prior to a large mass loss correlating to the two endotherms with onsets of 134.3 ˚C (12.19 wt%) and 140.8 ˚C (4.55 wt%). The mass loss observed by TGA / DSC was greater than could be attributed to 1,4-dioxane. Crystalline Form R Crystalline form R was observed to be highly crystalline with large, plate-like crystals. Slurries of crystalline form R were further observed to filter rapidly, indicating rapid processability. Further characterization and scale-up of syntheses of crystalline form R were therefore attempted. (R)- Compound 1, 107.0 mg, was placed in a 4 mL vial with a 10 mm stir bar and 5 vol. of DMSO at RT. After dissolution was complete, 200 ^L of 2-MeTHF was added prior to seeding with crystalline form R. An additional 700 µL of 2-MeTHF was added over 1 h. The white solids were filtered under reduced pressure from the yellow solution and washed with 2 x 1.5 vol. of 2 Me-THF. Solids were then dried in a 50 ˚C vacuum oven overnight. Solids were confirmed as crystalline form R by XRPD. Microscopy of the solids from the slurry, gave the morphology as large plate-like crystals. Solids were isolated at 55 % w / w yield. The water content measured by KF was 1.76 %.1H NMR was consistent with (R)-Compound 1.1H NMR further indicated the presence of residual DMSO. The precise amount could not be quantified due to residual DMSO in the solvent (d6-DMSO). The DSC thermogram was consistent with crystalline form R, with an initial low temperature endotherm with an onset of 84.2 ˚C, a second endotherm with an onset of 161.9 ˚C, and a melt onset of 284.2 ˚C. DSC / TGA- IR showed an initial mass loss of 3.44 wt% at the first endotherm, prior to a large mass loss with an onset of 167.0 ˚C (9.93 wt%), attributed to the loss of DMSO from the solid. Crystalline Form B Crystalline form B was observed as a mixture of crystalline form A from EtOH and MeOH short- term slurries as well as from evaporative crystallization from MeOH and IPA / EtOH:water systems. Storing crystalline form A with desiccant at RT for 5 days or thermally treating crystalline form A to 200 ˚C resulted in a mixture of crystalline form A+B. Crystalline form B without XRPD signals associated with crystalline form A from drying under a mix of static and active vacuum for 5 days at 50 ˚C and after 3 h drying under active vacuum at 65 ˚C with a nitrogen bleed. crystalline form B was not extensively characterized due to rapid conversion (< 30 min) to crystalline form A under ambient laboratory conditions. The XRPD long scan of crystalline form B was not obtained because crystalline form B was observed to convert to crystalline form A rapidly under ambient conditions. The DSC thermogram of crystalline form B showed a low energy endotherm with an onset of 39.6 ˚C. The final melt and decomposition had an onset of 268.4 ˚C (Figure 43P). The DSC of crystalline form A+B form resolves no additional features. PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Example 6. Analysis of Crystalline Form A of (S)-Compound 1 by X-Ray Single Crystal Diffraction The preceding examples demonstrated the viability of crystalline form A as a solid form of (S)- Compound 1 or (R)-Compound 1, e.g., for use as a medicament. The present example is directed towards a more direct exploration of the crystal structure of crystalline form A, and provides a description of the preparation and analysis of a single crystal diffraction experiment performed on crystals of a monohydrate crystalline form of (S)-Compound 1 monohydrate. Experimental Details (S)-Compound 1 (35 mg) was dissolved in MeOH (1 mL). Purified water (2 mL) was added at 15~25 °C. The mixture was filtered through a Millipore filter (0.45 µm), and the filtrate was kept in a vial open to air via a needle at 15~25 °C for 12 days. The crystals formed were filtered and collected. Bruker D8 QUEST Single-crystal X-ray Diffractometer, equipped with high brightness IµS 3.0 microfocus (50kV x 1 mA) for Cu radiation (^ = 1.54178 Å) and with PHOTON II Charge-Integrating Pixel Array Detector of superior speed, sensitivity, and accuracy, was used for screening / evaluation of crystals and for diffraction data collection. Bruker APEX3 software suite including SHELXTL was used for diffraction experiments including data collection and integration, and for solving, refining, displaying, and publishing of structural results. A Cryostream 800 PLUS low temperature device was used. Keeping a crystal in a cold nitrogen gas stream prevents possible decay, reduces thermal motion of atoms, and increases scattering power leading to better quality data / structures. A clear colorless block-like crystal, approximate dimensions 0.100 mm x 0.140 mm x 0.180 mm, was used for the X-ray crystallographic analysis. The X-ray intensity data were measured (^ = 1.54178 Å) at 223K. A total of 391 frames were collected. The frames were integrated with the Bruker SAINT software package using a narrow-frame algorithm. The integration of the data using a tetragonal unit cell yielded a total of 3494 reflections to a maximum ^ angle of 50.56° (1.00 Å resolution), of which 1635 were independent (average redundancy 2.137, completeness = 94.6%, Rint = 2.60%, Rsig = 3.49%) and 1573 (96.21%) were greater than 2^(F2). The final cell constants of a = 10.6597(3) Å, b = 10.6597(3) Å, c = 15.1615(6) Å, volume = 1722.79(12) Å3, are based upon the refinement of the XYZ-centroids of 7348 reflections above 20 ^(I) with 16.59° < 2^ < 137.0°. Data were corrected for absorption effects using the Multi-Scan method (SADABS). The ratio of minimum to maximum apparent transmission was 0.799. The calculated minimum and maximum transmission coefficients (based on crystal size) are 0.8770 and 0.9290. The structure was solved and refined using the Bruker SHELXTL Software Package, using the space group P 41, with Z = 4 for the formula unit, C18H22N4O3. The final anisotropic full-matrix least- squares refinement on F2with 238 variables converged at R1 = 3.58%, for the observed data and wR2 = 9.62% for all data. The goodness-of-fit was 1.093. The largest peak in the final difference electron density synthesis was 0.112 e- / Å3and the largest hole was -0.221 e- / Å3with an RMS deviation of 0.036 e- / Å3. On the basis of the final model, the calculated density was 1.320 g / cm3and F(000), 728 e-. Although examined crystals occasionally included very fine cracks (FIG.59A and FIG.59B), a specimen suitable for single-crystal X-ray diffraction data collection was obtained by carefully cutting the PATENT ATTORNEY DOCKET NO.: 51246-037WO2 rods. The specimen was immediately cooled in a nitrogen stream at 223K, and the crystal structure of a monohydrate of (S)-Compound 1 was solved from a dataset collected at the same temperature, from which the absolute configuration of (S)-Compound 1 was determined to be Sa(FIG.60 and FIG.61). C18H20N4O2·H2O 342.39 g / mole A simulated XRPD pattern was generated from the crystal structure solved at 223 K and compared to the bulk pattern of the starting material collected at RT (FIG.62). The two patterns essentially match, although some peak shifts were observed, especially at higher 2^ angles. Those deviations may be due to some difference in water content between the single crystal and the bulk sample. Alternatively or in addition to the water content, the deviations may be due to a change in temperature of the crystal between the single crystal experiment and PXRD experiments. The monohydrate was also confirmed with higher resolution data collected at 223K and RT. However, the data is of lower crystal quality because the crystal cracked during the experiment (FIG.59B). In the crystal, each water molecule has a 5-centered hydrogen bonding interaction with molecules of (S)-Compound 1 molecules (FIG.63), while only one unique hydrogen bond is formed between molecules of (S)-Compound 1 (FIG.64). Crystal packing of the monohydrate is shown in FIG. 65A and FIG.65B. Experimental details, atomic coordinates, torsion angles of non-hydrogen atoms, and H-bond geometry derived from 223 K data are given in Tables 6 to 11. Table 6. Sample and crystal data Chemical Formula C18H22N4O3 Formula Weight 342.39 g / mol Temperature 223(2) K Wavelength 1.54178 Å Crystal Size 0.100 x 0.140 x 0.180 mm Crystal Habit Clear Colorless Blocks Crystal System Tetragonal Space Group P 41 Unit Cell Dimensions a = 10.6597(3) Å ^ = 90 ° b = 10.6597(3) Å ^ = 90 ° PATENT ATTORNEY DOCKET NO.: 51246-037WO2 b = 15.1615(6) Å ^ = 90 ° Volume 1722.79(12) Å3Density (calculated) 1.320 g / cm3Absorption coefficient 0.751 mm-1F(000) 728 Table 7. Data collection and structure refinement Theta range for data collection 5.87 to 50.56° Index ranges -10<=h<=10, -3<=k<=7, -14<=l<=14 Reflections collected 3494 Independent reflections 1635 [R(int) = 0.0260] Coverage of independent reflections 94.6% Absorption correction Multi-Scan Max. and min. transmission 0.9290 and 0.8770 Structure solution technique direct methods Structure solution program SHELXT 2014 / 5 (Sheldrick, 2014) Refinement method Full-matrix least-squares on F2Refinement program SHELXL-2018 / 3 (Sheldrick, 2018) Function minimized ^ w(Fo2- Fc2)2Data / restraints / parameters 1635 / 3 / 238 Goodness-of-fit on F21.093 R1 = 0.0358, wR2 1573 data; I>2^(I) = 0.0939 Final R indices R1 = 0.0380, wR2 all data = 0.0962 w=1 / [^2(Fo2)+(0.0598P)2+0.3906P] Weighting scheme where P=(Fo2+2Fc2) / 3 Absolute structure parameter 0.06(14) Extinction coefficient 0.0128(19) Largest diff. peak and hole 0.112 and -0.221 eÅ-3R.M.S. deviation from mean 0.036 eÅ-3Table 8. Atomic coordinates and equivalent isotropic atomic displacement parameters (Å2) x / a y / b z / c U(eq) O1 0.6197(3) 0.2653(3) 0.4042(2) 0.0409(10) O2 0.8609(3) 0.2766(4) 0.3613(2) 0.0475(11) N1 0.2544(4) 0.3306(4) 0.5072(3) 0.0322(11) N2 0.1891(4) 0.5278(4) 0.5702(3) 0.0393(12) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 N3 0.6750(4) 0.4258(4) 0.4935(3) 0.0412(12) N4 0.3666(4) 0.1659(4) 0.4401(3) 0.0388(12) C1 0.2768(5) 0.4540(5) 0.5359(3) 0.0336(13) C2 0.2287(6) 0.6467(5) 0.5893(4) 0.0430(16) C3 0.3498(6) 0.6880(5) 0.5710(4) 0.0461(16) C4 0.4359(5) 0.6064(5) 0.5362(4) 0.0417(14) C5 0.4025(4) 0.4833(5) 0.5195(3) 0.0334(14) C6 0.4604(4) 0.3725(4) 0.4805(3) 0.0323(13) C7 0.3646(4) 0.2830(5) 0.4728(3) 0.0304(13) C8 0.1289(6) 0.7291(6) 0.6304(5) 0.064(2) C9 0.3855(7) 0.8245(6) 0.5844(6) 0.077(2) C10 0.5882(4) 0.3505(5) 0.4566(3) 0.0304(13) C11 0.1346(4) 0.2690(4) 0.5020(3) 0.0292(12) C12 0.0552(4) 0.3028(4) 0.4330(3) 0.0294(13) C13 0.9396(4) 0.2434(5) 0.4288(3) 0.0335(13) C14 0.9060(5) 0.1544(5) 0.4912(4) 0.0396(14) C15 0.9887(5) 0.1227(5) 0.5581(4) 0.0402(14) C16 0.1051(5) 0.1782(5) 0.5656(3) 0.0357(14) C17 0.0925(5) 0.3987(5) 0.3658(3) 0.0379(14) C18 0.1933(6) 0.1452(6) 0.6386(4) 0.0571(16) OW 0.9278(4) 0.5203(5) 0.5434(3) 0.0777(15) U(eq) is defined as one third of the trace of the orthogonalized Uij tensor. Table 9. Torsion Angles (º) C2-N2-C1-C5 1.4(8) C2-N2-C1-N1 -176.4(4) C7-N1-C1-N2 178.0(5) C11-N1-C1-N2 6.4(8) C7-N1-C1-C5 -0.2(5) C11-N1-C1-C5 -171.9(4) C1-N2-C2-C3 2.4(7) C1-N2-C2-C8 -178.6(4) N2-C2-C3-C4 -3.1(8) C8-C2-C3-C4 178.0(5) N2-C2-C3-C9 173.6(6) C8-C2-C3-C9 -5.4(9) C2-C3-C4-C5 0.0(8) C9-C3-C4-C5 -176.7(5) C3-C4-C5-C1 3.3(7) C3-C4-C5-C6 176.2(5) N2-C1-C5-C4 -4.3(8) N1-C1-C5-C4 173.9(4) N2-C1-C5-C6 -179.2(5) N1-C1-C5-C6 -1.1(5) C4-C5-C6-C7 -171.3(6) C1-C5-C6-C7 1.9(5) C4-C5-C6-C10 11.1(10) C1-C5-C6-C10 -175.7(5) C1-N1-C7-N4 -179.5(4) C11-N1-C7-N4 -7.6(7) C1-N1-C7-C6 1.5(5) C11-N1-C7-C6 173.3(4) PATENT ATTORNEY DOCKET NO.: 51246-037WO2 C10-C6-C7-N4 -3.3(9) C5-C6-C7-N4 179.0(5) C10-C6-C7-N1 175.7(4) C5-C6-C7-N1 -2.1(5) C7-C6-C10-O1 21.3(8) C5-C6-C10-O1 -161.5(5) C7-C6-C10-N3 -158.4(5) C5-C6-C10-N3 18.8(8) C7-N1-C11-C12 -95.1(5) C1-N1-C11-C12 75.3(6) C7-N1-C11-C16 84.2(6) C1-N1-C11-C16 -105.4(5) C16-C11-C12-C13 1.0(7) N1-C11-C12-C13 -179.6(4) C16-C11-C12-C17 -178.8(5) N1-C11-C12-C17 0.5(6) C11-C12-C13-O2 179.7(4) C17-C12-C13-O2 -0.4(7) C11-C12-C13-C14 -0.1(7) C17-C12-C13-C14 179.8(4) O2-C13-C14-C15 179.5(5) C12-C13-C14-C15 -0.7(7) C13-C14-C15-C16 0.5(7) C14-C15-C16-C11 0.4(7) C14-C15-C16-C18 179.1(5) C12-C11-C16-C15 -1.2(7) N1-C11-C16-C15 179.5(4) C12-C11-C16-C18 -179.9(5) N1-C11-C16-C18 0.8(7) Table 10. Hydrogen atomic coordinates and isotropic atomic displacement parameters (Å2) x / a y / b z / c U(eq) H2 -0.2130 0.2695 0.3777 0.071 H3A 0.7540 0.4156 0.4811 0.062 H3B 0.6521 0.4847 0.5299 0.062 H4A 0.2989 0.1205 0.4407 0.058 H4B 0.4358 0.1355 0.4184 0.058 H4 0.5177 0.6340 0.5238 0.05 H8A 0.1034 0.7928 0.5884 0.096 H8B 0.1625 0.7690 0.6828 0.096 H8C 0.0570 0.6781 0.6463 0.096 H9A 0.4725 0.8367 0.5677 0.116 H9B 0.3747 0.8467 0.6460 0.116 H9C 0.3323 0.8773 0.5482 0.116 H14 -0.1730 0.1154 0.4881 0.048 H15 -0.0352 0.0617 0.5996 0.048 H17A 0.1828 0.3971 0.3581 0.057 H17B 0.0669 0.4813 0.3858 0.057 H17C 0.0519 0.3800 0.3101 0.057 H18A 0.2636 0.0983 0.6149 0.086 H18B 0.1498 0.0945 0.6820 0.086 H18C 0.2237 0.2214 0.6662 0.086 HWA -0.120(7) 0.584(6) 0.567(6) 0.117 PATENT ATTORNEY DOCKET NO.: 51246-037WO2 HWB 0.0138(16) 0.523(8) 0.542(6) 0.117 Table 11. Hydrogen bond distances (Å) and angles (°) Donor-H Acceptor-H Donor-Acceptor Angle O2-H2...O1#1 0.83 1.83 2.655(5) 173.8 O2-H2...N3#1 0.83 2.7 3.236(5) 123.9 N3-H3A...O2#2 0.87 2.61 3.236(5) 130.2 N3-H3A...OW#2 0.87 2.36 2.974(6) 127.8 N3-H3B...O1#4 0.87 2.53 3.257(6) 141.6 N4-H4B...O1 0.87 2.41 2.949(5) 120.6 N4-H4B...OW#5 0.87 2.2 2.937(6) 141.8 OW-HWA...O1#3 0.920(15) 2.07(5) 2.859(6) 143.(7) OW-HWB...N2 0.918(16) 1.92(3) 2.817(6) 166.(9) Symmetry transformations used to generate equivalent atoms: #1 x-1, y, z #2 x+1, y, z #3 -y, x, z+1 / 4 #4 -y+1, x, z+1 / 4 #5 y, -x, z-1 / 4 Conclusions This example has demonstrated the characterization of a single crystalline form representative of crystalline form A. We describe the bond lengths of (S)-Compound 1, the interactions between (S)- Compound 1 and water molecules in the crystalline form, and the unit cell structure. Example 7. Crystallization process development of (S)-Compound 1 This example describes the development of a process for generating crystalline form A of (S)- Compound 1 in high purity and yield. During baseline process development, three potential ternary solvent systems and two binary solvent systems were considered. Vial Scale Recrystallization Experiments in Alcohol:Water:DMSO Systems Based on the solubility of (S)-Compound 1 in MeOH:DMSO and EtOH:DMSO:Water systems, three experiments were devised to examine potential methods for production of pure, crystalline (S)- Compound 1 (referred to as “Recrystallization 1”, “Recrystallization 2”, and “Recrystallization 3”, on a vial scale. The three examined systems further avenues for scale-up to a high throughput system. While DMSO can present process challenges, it is possible to develop robust processes to ensure that the residual solvents fall within acceptable medicament guidelines. These experiments are summarized in Table 12 and Table 13. The XRPD patterns of each sample prior to the procedures set forth in Table 12 PATENT ATTORNEY DOCKET NO.: 51246-037WO2 and Table 13 are provided in FIG.66. All experiments recite the solvent ratio of alcohol:DMSO (S)- Compound 1 was dissolved in, the amount of antisolvent (water) added to precipitate (S)-Compound 1, and various experimental considerations. All cooling occurred at a rate of 0.5 °C / min. Table 12. Vial Scale Recrystallization of (S)-Compound 1 in Alcohol:DMSO Solvent Systems Recrystallization 1 Recrystallization 2 Recrystallization 3 Solvent System EtOH:DMSO (6:4) MeOH:DMSO (6:4) EtOH:DMSO (6:4) Vol. Solvent 4 mL 4 mL 4 mL Vol. Antisolvent 6 mL 6 mL 6 mL Mass 0.500 g 0.500 g 0.500 g (S)-Compound 1 Temp. of Polish 65 °C 55 °C 65 °C Filtration Temp. Cooled to 55 °C 45 °C 55 °C 0.5 mL of water 0.5 mL of water 0.5 mL of water added. added. added. Seeded with 10 mg of Held at 45 °C for 1.5 Held at 45 °C for 2.5 Seeding Conditions crystalline form A h before incorrect h before incorrect suspended in 0.5 mL pattern precipitated. pattern precipitated. water. Experiment halted Experiment halted Held for 30 min. Antisolvent Addition 5 mL over 1 h Temp. Cooled to Room Temperature Under reduced pressure. 2x 0.75 mL water for Filtration Procedure the wash Filter cake was still wet after 30 min. 50 °C under active Drying Conditions and static vacuum (~29 inHg) overnight Yield 71 % w / w Maximum theoretical 94 % w / w 94 % w / w 94% w / w yield Purity 96.50 % PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Recrystallization 1 Recrystallization 2 Recrystallization 3 XRPD pattern after A drying Reference XRPD FIG.67 Figure Microscopy Images FIG.70 Residual solvent by 0.51 wt% DMSO1H NMR <0.1 wt% EtOH Only pattern A observed during sampling of the Other comments slurry. Rods and irregular crystals Table 13. Vial Scale Recrystallization of (S)-Compound 1 in Alcohol:DMSO Solvent Systems Recrystallization 4 Recrystallization 5 Recrystallization 6 Solvent System MeOH:DMSO (6:4) MeOH:DMSO (1:1) EtOH:DMSO (6:4) Vol. Solvent 4 mL 3 mL 4 mL Vol. Antisolvent 6 mL 6 mL 6 mL Mass 0.500 g 0.500 g 0.500 g (S)-Compound 1 Temp. of Polish 55 °C 55 °C 65 °C Filtration Temp. Cooled to 45 °C 45 °C 50 °C 0.5 mL of water 0.5 mL of water added. 0.5 mL of water added. added. Cooled to 50 °C and Seeded with 10 mg of seeded with 10 mg of Incorrect pattern Seeding Conditions crystalline form A crystalline form A precipitated suspended in 0.5 mL suspended in 0.5 mL immediately. water. water. Experiment halted Held for 30 min. Cooled to 35 °C at a rate of 0.5 °C / min. Antisolvent Addition 5 mL over 1 h 5 mL over 1 h Temp. Cooled to Room Temperature Room Temperature PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Recrystallization 4 Recrystallization 5 Recrystallization 6 Under reduced Under reduced pressure. pressure. 2x 0.75 mL water for 2x 0.75 mL water for Filtration Procedure the wash the wash Filter cake was still Filter cake was still wet after 30 min. wet after 30 min. 50 °C under active 50 °C under active Drying Conditions and static vacuum and static vacuum (~29 inHg) overnight (~29 inHg) overnight Yield 66 % w / w 80% w / w M...

Claims

PATENT ATTORNEY DOCKET NO.: 51246-037WO2 Claims 1. A crystalline form of (S)-Compound 1:or a solvate thereof, wherein the crystalline form is characterized by an x-ray powder diffraction (XRPD) pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.1 °2^ ± 0.2 °2^, and 19.4 °2^ ± 0.2 °2^.

2. The crystalline form of claim 1, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.8 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, 16.6 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^.

3. The crystalline form of claim 1 or 2, wherein the solvate is a hydrate.

4. The crystalline form of claim 3, wherein the solvate is a monohydrate.

5. The crystalline form of claim 4, wherein the monohydrate is further characterized by a unit cell with parameters a = 10.6597 Å ± 0.0003 Å, b = 10.6597 Å ± 0.0003 Å, c = 15.1615 Å ± 0.0006 Å and ^ = ^ = ^ = 90 °.

6. The crystalline form of any one of claims 1 to 5, wherein the crystalline form is further characterized by an endothermic event onset at 35 °C to 43 °C by differential scanning calorimetry (DSC).

7. The crystalline form of any one of claims 1 to 6, wherein the crystalline form is further characterized by an endothermic event onset at 273 °C to 278 °C by DSC.

8. A crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.8 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 16.8 °2^ ± 0.2 °2^.

9. The crystalline form of claim 8, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 4.9 °2^ ± 0.2 °2^, 8.4 °2^ ± 0.2 °2^, 12.3 °2^ ± 0.2 °2^, and 19.0 °2^ ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 10. The crystalline form of claim 8 or 9, wherein the crystalline form is further characterized by an endothermic event onset at 187 °C to 206 °C by DSC.

11. The crystalline form of any one of claims 8 to 10, wherein the crystalline form is further characterized by an endothermic event onset at 278 °C to 285 °C by DSC.

12. A crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 13.3 °2^ ± 0.2 °2^, and 18.8 °2^ ± 0.2 °2^.

13. The crystalline form of claim 12, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^.

14. The crystalline form of claim 12 or 13, wherein the crystalline form is further characterized by an endothermic event onset at 63 °C to 76 °C by DSC.

15. The crystalline form of any one of claims 12 to 14, wherein the crystalline form is further characterized by an endothermic event onset at 285 °C to 288 °C by DSC.

16. A crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 14.8 °2^ ± 0.2 °2^, 15.5 °2^ ± 0.2 °2^, and 22.7 °2^ ± 0.2 °2^.

17. The crystalline form of claim 16, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.5 °2^ ± 0.2 °2^, 10.9 °2^ ± 0.2 °2^, 18.5 °2^ ± 0.2 °2^, 23.5 °2^ ± 0.2 °2^, and 28.9 °2^ ± 0.2 °2^.

18. The crystalline form of claim 16 or 17, wherein the crystalline form is further characterized by an endothermic event onset at 136 °C to 139 °C by DSC.

19. The crystalline form of any one of claims 16 to 18, wherein the crystalline form is further characterized by an endothermic event onset at 150 °C to 156 °C by DSC.

20. The crystalline form of any one of claims 16 to 19, further characterized by an endothermic event onset at 280 °C to 285 °C by DSC.

21. A crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.5 °2^ ± 0.2 °2^, 14.6 °2^ ± 0.2 °2^, 17.9 °2^ ± 0.2 °2^, and 25.0 °2^ ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 22. The crystalline form of claim 21, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^ and 22.4 °2^ ± 0.2 °2^.

23. The crystalline form of claim 21 or 22, wherein the crystalline form is further characterized by an endothermic event onset at 165°C to 188 °C by DSC.

24. The crystalline form of any one of claims 21 to 23, wherein the crystalline form is further characterized by an endothermic event onset at 191°C to 197 °C by DSC.

25. The crystalline form of any one of claims 21 to 24, wherein the crystalline form is further characterized by an endothermic event onset at 271°C to 279 °C by DSC.

26. A crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.9 °2^ ± 0.2 °2^, 11.3 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^.

27. The crystalline form of claim 26, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.9 °2^ ± 0.2 °2^, 15.7 °2^ ± 0.2 °2^, 19.1 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^.

28. The crystalline form of claim 26 or 27, wherein the crystalline form is further characterized by an endothermic event onset at 151 °C to 161 °C by DSC.

29. The crystalline form of any one of claims 26 to 28, wherein the crystalline form is further characterized by an endothermic event onset at 283 °C to 286 °C by DSC.

30. A crystalline form of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.2 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^.

31. The crystalline form of claim 30, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.7 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, and 16.6 °2^ ± 0.2 °2^.

32. The crystalline form of claim 30 or 31, wherein the crystalline form is further characterized by an endothermic event onset at 39 °C to 52 °C by DSC.

33. The crystalline form of any one of claims 30 to 32, wherein the crystalline form is further characterized by an endothermic even onset at 138 °C to 144 °C by DSC.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 34. The crystalline form of any one of claims 30 to 33, wherein the crystalline form is further characterized by an endothermic event onset at 268 °C to 275 °C by DSC.

35. A crystalline form of (R)-Compound 1:or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.1 °2^ ± 0.2 °2^, and 19.4 °2^ ± 0.2 °2^.

36. The crystalline form of claim 35, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.8 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, 16.6 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^.

37. The crystalline form of claim 35 or 36, wherein the solvate is a hydrate.

38. The crystalline form of claim 37, wherein the solvate is a monohydrate.

39. The crystalline form of claim 38, wherein the monohydrate is further characterized by a unit cell with parameters a = 10.6597 Å ± 0.0003 Å, b = 10.6597 Å ± 0.0003 Å, c = 15.1615 Å ± 0.0006 Å and ^ = ^ = ^ = 90 °.

40. The crystalline form of any one of claims 35 to 39, wherein the crystalline form is further characterized by an endothermic event onset at from 34 °C to 44 °C by DSC.

41. The crystalline form of any one of claims 35 to 40, wherein the crystalline form is further characterized by an endothermic event onset at 277 °C to 282 °C by DSC.

42. A crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.8 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 16.8 °2^ ± 0.2 °2^.

43. The crystalline form of claim 42, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 4.9 °2^ ± 0.2 °2^, 8.4 °2^ ± 0.2 °2^, 12.3 °2^ ± 0.2 °2^, and 19.0 °2^ ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 44. The crystalline form of claim 42 or 43, wherein the crystalline form is further characterized by an endothermic event onset at 187 to 206 °C by DSC.

45. The crystalline form of any one of claims 42 to 44, wherein the crystalline form is further characterized by an endothermic event onset at 278 °C to 285 °C by DSC.

46. A crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 10.9 °2^ ± 0.2 °2^, 13.3 °2^ ± 0.2 °2^, and 18.8 °2^ ± 0.2 °2^.

47. The crystalline form of claim 46, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 22.2 °2^ ± 0.2 °2^.

48. The crystalline form of claim 46 or 47, wherein the crystalline form is further characterized by an endothermic event onset at 63 °C to 76 °C by DSC.

49. The crystalline form of any one of claims 46 to 48, wherein the crystalline form is further characterized by an endothermic event onset at 285 °C to 288 °C by DSC.

50. A crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 14.8 °2^ ± 0.2 °2^, 15.5 °2^ ± 0.2 °2^, and 22.7 °2^ ± 0.2 °2^.

51. The crystalline form of claim 50, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.5 °2^ ± 0.2 °2^, 10.9 °2^ ± 0.2 °2^, 18.5 °2^ ± 0.2 °2^, 23.5 °2^ ± 0.2 °2^, and 28.9 °2^ ± 0.2 °2^.

52. The crystalline form of claim 50 or 51, wherein the crystalline form is further characterized by an endothermic event onset at 136°C to 139 °C by DSC.

52. The crystalline form of claim 50 or 51, wherein the crystalline form is further characterized by an endothermic event onset at 150°C to 156 °C by DSC.

54. The crystalline form of any one of claims 51 to 53, wherein the crystalline form is further characterized by an endothermic event onset at 280 °C to 285 °C by DSC.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 55. A crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.5 °2^ ± 0.2 °2^, 14.6 °2^ ± 0.2 °2^, 17.9 °2^ ± 0.2 °2^, and 25.0 °2^ ± 0.2 °2^.

56. The crystalline form of claim 55, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 15.0 °2^ ± 0.2 °2^ and 22.4 °2^ ± 0.2 °2^.

57. The crystalline form of claim 55 or 56, wherein the crystalline form is further characterized by an endothermic event onset at 165 °C to 188 °C by DSC.

58. The crystalline form of any one of claims 55 to 57, wherein the crystalline form is further characterized by an endothermic event onset at 191 °C to 197 °C by DSC.

59. The crystalline form of any one of claims 55 to 58, wherein the crystalline form is further characterized by an endothermic event onset at 271 °C to 279 °C by DSC.

60. A crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 9.9 °2^ ± 0.2 °2^, 11.3 °2^ ± 0.2 °2^, 14.9 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^.

61. The crystalline form of claim 60, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.9 °2^ ± 0.2 °2^, 15.7 °2^ ± 0.2 °2^, 19.1 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^.

62. The crystalline form of claim 60 or 61, wherein the crystalline form is further characterized by an endothermic event onset at 151°C to 161 °C by DSC.

63. The crystalline form of any one of claims 60 to 62, wherein the crystalline form is further characterized by an endothermic event onset at 283°C to 286 °C by DSC.

64. A crystalline form of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.3 °2^ ± 0.2 °2^, 10.2 °2^ ± 0.2 °2^, and 19.8 °2^ ± 0.2 °2^.

65. The crystalline form of claim 64, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at further characterized by having peaks at 11.7 °2^ ± 0.2 °2^, 13.1 °2^ ± 0.2 °2^, and 16.6 °2^ ± 0.2 °2^.

66. The crystalline form of claim 64 or 65, wherein the crystal form is further characterized by an endothermic event onset at 39 °C to 52 °C by DSC.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 67. The crystalline form of any one of claims 64 to 66, wherein the crystalline form is further characterized by an endothermic event onset at 138 °C to 144 °C by DSC.

68. The crystalline form of any one of claims 64 to 67, wherein the crystalline form is further characterized by an endothermic event onset at 268 °C to 275 °C by DSC.

69. A solvate crystalline form of (S)-Compound 1, or a salt thereof.

70. The solvate of claim 69, wherein the solvate is a hydrate.

71. The hydrate of claim 70, wherein the hydrate is a monohydrate.

72. The hydrate of claim 70, wherein the hydrate is a hemihydrate.

73. A solvate crystalline form of (R)-Compound 1, or a salt thereof.

74. The solvate of claim 73, wherein the solvate is a hydrate.

75. The hydrate of claim 74, wherein the hydrate is a monohydrate.

76. The hydrate of claim 74, wherein the hydrate is a hemihydrate.

77. A crystalline form of a hemi-maleate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.8 °2^ ± 0.2 °2^, 13.7 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^.

78. The crystalline form of claim 77, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 17.5 °2^ ± 0.2 °2^, 18.6 °2^ ± 0.2 °2^ and 26.1 °2^ ± 0.2 °2^.

79. The crystalline form of claim 77 or 78, wherein the crystalline form is further characterized by an endothermic event onset at 200 °C to 209 °C by DSC.

80. A crystalline form of a hemi-maleate salt of (S)-Compound 1, or a solvent thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 13.2 °2^ ± 0.2 °2^, 17.6 °2^ ± 0.2 °2^, and 23.9 °2^ ± 0.2 °2^.

81. The crystalline form of claim 80, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 22.2 °2^ ± 0.2 °2^ and 22.6 °2^ ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 82. The crystalline form of claim 80 or 81, wherein the crystalline form is further characterized by an endothermic event onset from 115 °C to 134 °C by DSC.

83. The crystalline form of any one of claims 80 to 82, wherein the crystalline form is further characterized by an endothermic event onset from 195 °C to 198 °C by DSC.

84. A crystalline form of a mesylate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.0 °2^ ± 0.2 °2^, 11.8 °2^ ± 0.2 °2^, and 21.0 °2^ ± 0.2 °2^.

85. The crystalline form of claim 84, wherein the crystalline form is further characterized by an XRPD pattern having peaks at 19.7 °2^ ± 0.2 °2^, 22.6 °2^ ± 0.2 °2^, and 29.8 °2^ ± 0.2 °2^.

86. The crystalline form of claim 84 or 85, wherein the crystalline form is further characterized by an endothermic event onset at 238 °C to 243 °C by DSC.

87. A crystalline form of a mono-mesylate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.3 °2^ ± 0.2 °2^, 13.4 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^.

88. The crystalline form of claim 87, wherein the crystalline form is further characterized by an XRPD pattern having peaks at 12.4 °2^ ± 0.2 °2^, 17.8 °2^ ± 0.2 °2^, 22.4 °2^ ± 0.2 °2^, and 29.5 °2^ ± 0.2 °2^.

89. The crystalline form of claim 87 or 88, wherein the crystalline form is further characterized by an endothermic event onset at 50 °C to 75 °C.

90. The crystalline form of any one of claims 87 to 89, wherein the crystalline form is further characterized by an endothermic event onset at 140 °C to 147 °C.

91. The crystalline form of any one of claims 87 to 90, wherein the crystalline form is further characterized by an endothermic event onset at 150 °C to 159 °C.

92. A crystalline form of a mono-mesylate salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.0 °2^ ± 0.2 °2^, 14.3 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^.

93. The crystalline form of claim 92, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.0 °2^ ± 0.2 °2^, 17.7 °2^ ± 0.2 °2^, 18.0 °2^ ± 0.2 °2^, and 20.0 ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 94. The crystalline form of claim 92 or 93, wherein the crystalline form is further characterized by an endothermic event onset at 135 °C to 164 °C.

95. The crystalline form of any one of claims 92 to 94, wherein the crystalline form is further characterized by an endothermic event onset at 235 °C to 239 °C.

96. A crystalline form of a hydrochloric acid salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.2 °2^ ± 0.2 °2^, 15.0 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^.

97. The crystalline form of claim 96, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.1 °2^ ± 0.2 °2^, 16.1 °2^ ± 0.2 °2^, and 23.4 °2^ ± 0.2 °2^.

98. The crystalline form of claim 96 or 97, wherein the crystalline form is characterized by an endothermic event onset at 50 °C to 105 °C.

99. The crystalline form of any one of claims 96 to 98, wherein the crystalline form is further characterized by an endothermic event onset at 220 °C to 232 °C.

100. A crystalline form of a hydrochloric acid salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 15.5 °2^ ± 0.2 °2^.

101. The crystalline form of claim 100, further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.5 °2^ ± 0.2 °2^, 23.6 °2^ ± 0.2 °2^, 24.7 °2^ ± 0.2 °2^ , and 27.8 °2^ ± 0.2 °2^.

102. The crystalline form of claim 100 or 101, wherein the crystalline form is characterized by an endothermic event onset at from 100 °C to 195 °C.

103. A crystalline form of a hydrochloric acid salt of (S)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 13.8 °2^ ± 0.2 °2^, and 23.1 °2^ ± 0.2 °2^.

104. The crystalline form of claim 103, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 18.9 °2^ ± 0.2 °2^, 19.0 °2^ ± 0.2 °2^, and 28.6 °2^ ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 105. The crystalline form of claim 103 or 104, wherein the crystalline form is characterized by an endothermic event onset at 120 °C to 167 °C.

106. The crystalline form of any one of claims 103 to 105, wherein the crystalline form is characterized by an endothermic event onset at 160 °C to 192 °C.

107. A crystalline form of a hemi-maleate salt of (R)-Compound 1, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.8 °2^ ± 0.2 °2^, 13.7 °2^ ± 0.2 °2^, and 22.1 °2^ ± 0.2 °2^.

108. The crystalline form of claim 107, further characterized by an XRPD pattern obtained with CuK^ radiation at 17.5 °2^ ± 0.2 °2^, 18.6 °2^ ± 0.2 °2^, 25.6 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^.

109. The crystalline form of claim 107 or 108, wherein the crystalline form is further characterized by a endothermic event onset at 200 °C to 209 °C by DSC.

110. A crystalline form of a hemi-maleate salt of (R)-Compound 1, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.6 °2^ ± 0.2 °2^, 13.2 °2^ ± 0.2 °2^, 17.6 °2^ ± 0.2 °2^, and 23.9 °2^ ± 0.2 °2^.

111. The crystalline form of claim 110, further characterized by an XRPD pattern obtained with CuK^ radiation at 22.2 °2^ ± 0.2 °2^ and 22.6 °2^ ± 0.2 °2^.

112. The crystalline form of claim 110 or 111, wherein the crystalline form is further characterized by an endothermic event onset at 115 °C to 134 °C by DSC.

113. The crystalline form of any one of claims 110 to 112, wherein the crystalline form is further characterized by an endothermic event onset from 195 °C to 198 °C by DSC.

114. A crystalline form of a mono-mesylate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.0 °2^ ± 0.2 °2^, 11.8 °2^ ± 0.2 °2^, and 21.0 °2^ ± 0.2 °2^.

115. The crystalline form of claim 114, wherein the crystalline form is further characterized by an XRPD pattern having peaks at 19.7 °2^ ± 0.2 °2^, 22.6 °2^ ± 0.2 °2^, and 29.8 °2^ ± 0.2 °2^.

116. The crystalline form of claim 114 or 115, wherein the crystalline form is further characterized by an endothermic event onset at 238 °C to 243 °C.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 117. A crystalline form of a mono-mesylate salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.3 °2^ ± 0.2 °2^, 13.4 °2^ ± 0.2 °2^, and 22.0 °2^ ± 0.2 °2^.

118. The crystalline form of claim 117, wherein the crystalline form is further characterized by an XRPD pattern having peaks at 12.4 °2^ ± 0.2 °2^, 17.8 °2^ ± 0.2 °2^, 22.4 °2^ ± 0.2 °2^, and 29.5 °2^ ± 0.2 °2^,.

119. The crystalline form of claim 117 or 118, wherein the crystalline form is further characterized by an endothermic event onset at 50 °C to 75 °C.

120. The crystalline form of any one of claims 117 to 119, wherein the crystalline form is further characterized by an endothermic event onset at 140 °C to 147 °C.

121. The crystalline form of any one of claims 117 to 120, wherein the crystalline form is further characterized by an endothermic event onset at 150 °C to 159 °C.

122. A crystalline form of a mesylate salt of a compound of formula (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 12.0 °2^ ± 0.2 °2^, 14.3 °2^ ± 0.2 °2^, and 21.9 °2^ ± 0.2 °2^.

123. The crystalline form of claim 122, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.0 °2^ ± 0.2 °2^, 17.7 °2^ ± 0.2 °2^, 18.0 °2^ ± 0.2 °2^, and 20.0 ± 0.2 °2^.

124. The crystalline form of claim 122 or 123, wherein the crystalline form is further characterized by an endothermic event onset at 135 °C to 164 °C.

125. The crystalline form of any one of claims 122 to 124, wherein the crystalline form is further characterized by an endothermic event onset at 235 °C to 239 °C.

126. A crystalline form of a hydrochloric acid salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.2 °2^ ± 0.2 °2^, 15.0 °2^ ± 0.2 °2^, and 26.1 °2^ ± 0.2 °2^.

127. The crystalline form of claim 126, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 13.1 °2^ ± 0.2 °2^, 16.1 °2^ ± 0.2 °2^, and 23.4 °2^ ± 0.2 °2^.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 128. The crystalline form of claim 126 or 127, wherein the crystalline form is characterized by an endothermic event onset at 50 °C to 105 °C.

129. The crystalline form of any one of claims 126 to 128, wherein the crystalline form is characterized by an endothermic event onset at 220 °C to 232 °C.

130. A crystalline form of a hydrochloric acid salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 15.1 °2^ ± 0.2 °2^, and 15.5 °2^ ± 0.2 °2^.

131. The crystalline form of claim 130, further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 8.5 °2^ ± 0.2 °2^, 23.6 °2^ ± 0.2 °2^, 24.7 °2^ ± 0.2 °2^ , and 27.8 °2^ ± 0.2 °2^.

132. The crystalline form of claim 130 or 131, wherein the crystalline form is characterized by an endothermic event onset at from 100 °C to 195 °C.

133. A crystalline form of a hydrochloric acid salt of (R)-Compound 1, or a solvate thereof, wherein the crystalline form is characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 11.6 °2^ ± 0.2 °2^, 13.8 °2^ ± 0.2 °2^, and 23.1 °2^ ± 0.2 °2^.

134. The crystalline form of claim 133, wherein the crystalline form is further characterized by an XRPD pattern obtained with CuK^ radiation having peaks at 18.9 °2^ ± 0.2 °2^, 19.0 °2^ ± 0.2 °2^, and 28.6 °2^ ± 0.2 °2^.

135. The crystalline form of claim 133 or 134, wherein the crystalline form is characterized by an endothermic event onset at 120 °C to 167 °C.

136. The crystalline form of any one of claims 133 to 135, wherein the crystalline form is characterized by an endothermic event onset at 160 °C to 192 °C.

137. A pharmaceutical composition comprising the crystalline form of any one of claims 1 to 136.

138. A method of inhibiting the activity of membrane associated tyrosine and threonine-specific cdc2- inhibitory kinase in a cell, comprising the administration of an effective amount of the crystalline form of any one of claims 1 to 136 or the pharmaceutical composition of claim 137.

139. A method of inducing cell death in a cell, comprising contacting the cell with an effective amount of the crystalline form of any one of claims 1 to 136 or the pharmaceutical composition of claim 137.PATENT ATTORNEY DOCKET NO.: 51246-037WO2 140. The method of claim 138 or 139, wherein the cell is in a subject.

141. The method of claim 140, wherein the subject has been identified as having a disease.

142. The method of claim 141, wherein the disease is cancer.

143. The method of any one of claims 138 to 142, wherein the cell is a cancer cell.

144. The method of claim 143, wherein the cancer comprises a mutation in, an amplification of, or the overexpression of KRAS, NRAS, HRAS, TP53, CCNE1, CDK4, CDK6, CDK12, CDKN2A, CDC25A, EGFR, FBXW7, c-MYC, PIK3CA, PPP2R1A, PTEN, RB1, BRAF, or a prior or current infection with HPV.

145. The method of claim 144, wherein the cancer comprises a mutation in FBXW7.

146. The method of claim 144, wherein the cancer comprises an amplification or overexpression of CCNE1.

147. The method of claim 144, wherein the cancer comprises mutation in KRAS.

148. The method of claim 144, wherein the cancer comprises a mutation in HRAS.

149. The method of claim 144, wherein the cancer comprises a mutation in NRAS.

150. The method of any one of claims 142 to 149, wherein the cancer is uterine cancer, ovarian cancer, breast cancer, stomach cancer, esophageal cancer, lung cancer, colorectal cancer or endometrial cancer.

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