
Financial Performance - Revenue from awards and licenses for Q2 2021 was $136,558, down 52% from $286,346 in Q2 2020[15] - Total operating expenses decreased to $16,837,617 in Q2 2021, a reduction of 56% from $38,425,039 in Q2 2020[15] - The net loss for Q2 2021 was $17,138,376, compared to a net loss of $38,105,323 in Q2 2020, indicating a 55% improvement[15] - The company reported a basic and diluted net loss per share of $0.15 for Q2 2021, an improvement from $0.52 in Q2 2020[15] - The company had a total comprehensive loss of $17,115,065 for Q2 2021, compared to $38,105,323 in Q2 2020[15] - The net loss for the second quarter of 2021 was $33,203,544, a significant improvement from a net loss of $67,762,123 in the same period of 2020, representing a 51% reduction[27] - The net loss for the three months ended June 30, 2021, was $33,203,544, compared to a net loss of $17,138,376 for the same period in 2020, representing an increase of approximately 93%[73] - The net loss per share of common stock for the three months ended June 30, 2021, was $(0.28), compared to $(0.15) for the same period in 2020, reflecting a deterioration in per-share performance[73] - The company has an accumulated deficit of $337,296,882 as of June 30, 2021, highlighting ongoing financial challenges[32] - The company anticipates continued operating losses due to costs related to research funding and development of product candidates[32] Assets and Liabilities - Total current assets increased to $111,580,059 as of June 30, 2021, compared to $92,074,631 at December 31, 2020, representing a 21% increase[13] - Cash and cash equivalents decreased to $36,080,292 as of June 30, 2021, down 58% from $85,433,441 at December 31, 2020[13] - Total liabilities decreased to $43,649,938 as of June 30, 2021, down 23% from $57,020,006 at December 31, 2020[13] - The total assets increased to $120,609,139 as of June 30, 2021, compared to $102,294,931 at December 31, 2020, reflecting an 18% increase[13] - Total current liabilities were approximately $18,737,000, resulting in working capital of approximately $92,843,000 as of June 30, 2021[186] Cash Flow - Cash used in operating activities decreased to $39,338,076 in Q2 2021 from $54,208,282 in Q2 2020, indicating improved cash flow management[27] - Cash used in operating activities for the six months ended June 30, 2021 was approximately $39,338,000, which includes a net loss of approximately $33,204,000[187] - The company expects to have sufficient cash and marketable securities of approximately $106,452,000 to meet its operating and capital requirements for at least the next twelve months[32] - The company expects to have sufficient cash and equivalents of approximately $107,122,000 to meet operating and capital requirements into 2024, along with a final $2,500,000 milestone payment expected by the end of the second half of 2021[192] Research and Development - The company plans to expand its pipeline through internal efforts and business development, focusing on new medicines targeting inflammation and fibrosis[28] - Research and development expenses decreased to approximately $11,265,000 for the three months ended June 30, 2021, down from $30,686,000 in the same period of 2020, primarily due to lower clinical trial expenses[175] - The company has focused on research and development, including clinical studies for lenabasum and pre-clinical studies for other drug candidates[161] - The company expects to file INDs for CRB-601 and CRB-602 in late 2022 and early 2023, respectively[158] - Lenabasum is in Phase 2 study for systemic lupus erythematosus (SLE), with top line results expected by the end of 2021[155] Stock and Equity - The weighted average number of common shares outstanding increased to 116,364,131 in Q2 2021, compared to 73,885,548 in Q2 2020[15] - The company issued 50,000 and 838,600 shares of common stock upon the exercise of stock options during the three and six months ended June 30, 2021, respectively, generating proceeds of $50,000 and $944,800[129] - As of June 30, 2021, there were 18,476,829 stock options outstanding with a weighted average exercise price of $4.38[138] - The total fair value of options that were vested as of June 30, 2021, was $37,286,931, up from $31,198,928 in 2020[139] - The company has never paid dividends on its common stock and does not anticipate doing so in the foreseeable future[199] Debt and Financing - The company has a secured Loan and Security Agreement with K2 HealthVentures LLC for $50,000,000, with the first tranche of $20,000,000 received upon signing[92] - The interest rate on the K2 HealthVentures loan is variable, with a minimum of 8.5%, and the loan matures on August 1, 2024[92] - The total principal amount of the loan outstanding as of June 30, 2021, is $21,190,000, which includes a final payment of $1,190,000[95] - Future principal payments due under long-term debt total $21,190,000, with $3,093,344 due in 2022 and $9,835,341 due in 2023[99] - The company expects to incur significant operating losses and will need additional financing to support ongoing operations, with plans to seek funding through public or private equity or debt financings[167] License Agreements - The company has entered into a License Agreement with Jenrin Discovery, LLC, involving an upfront payment of $250,000 and potential milestone payments up to $18,400,000 for each compound developed[79][80] - Under the Milky Way License Agreement, the company paid an upfront fee of $500,000 and is obligated to pay up to $53,000,000 in milestone payments[81][82] - The UCSF License Agreement required a license issue fee of $1,500,000 and includes potential milestone payments totaling up to $153,000,000[83][84] - The company has a potential obligation to pay milestone payments totaling up to approximately $173,000,000 under the collaboration agreement with Kaken[103] Accounting and Compliance - The company is currently evaluating the potential impact of recently issued accounting standards on its consolidated financial statements and related disclosures[69] - The company recognizes stock-based compensation costs using the Black-Scholes option-pricing model, amortized over the vesting period, which is generally 48 months[199] - The company has recorded a valuation allowance equal to 100% of the deferred tax assets due to cumulative losses since inception, indicating no expectation of realizing these tax benefits[61] - The company was in compliance with financial and non-financial covenants of the Loan Agreement as of June 30, 2021[96]