Corbus Pharmaceuticals(CRBP) - 2023 Q1 - Quarterly Report

PART I - FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's analysis for the first quarter of 2023 Item 1. Condensed Consolidated Financial Statements This section presents Corbus Pharmaceuticals Holdings, Inc.'s unaudited condensed consolidated financial statements for Q1 2023, detailing a net loss of $17.7 million and decreased total assets Condensed Consolidated Balance Sheets Total assets decreased to $51.6 million from $66.3 million by March 31, 2023, primarily due to reduced cash and investments, while equity significantly declined to $16.5 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $7,324,437 | $17,002,715 | | Investments | $36,902,563 | $42,194,296 | | Total current assets | $45,864,999 | $60,181,102 | | Total assets | $51,645,273 | $66,311,940 | | Liabilities & Equity | | | | Total current liabilities | $14,358,947 | $12,639,938 | | Total liabilities | $35,186,321 | $33,321,923 | | Accumulated deficit | $(409,825,479) | $(392,080,667) | | Total stockholders' equity | $16,458,952 | $32,990,017 | Condensed Consolidated Statements of Operations and Comprehensive Loss The company reported a net loss of $17.7 million (or $4.24 per share) for Q1 2023, an increase from $9.4 million in Q1 2022, driven by higher research and development expenses Statement of Operations Highlights (Unaudited, for the three months ended March 31) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Research and development | $13,388,343 | $3,286,236 | | General and administrative | $3,908,682 | $5,230,923 | | Total operating expenses | $17,297,025 | $8,517,159 | | Operating loss | $(17,297,025) | $(8,517,159) | | Net loss | $(17,744,812) | $(9,437,242) | | Net loss per share, basic and diluted | $(4.24) | $(2.26) | Condensed Consolidated Statement of Stockholders' Equity Stockholders' equity decreased from $33.0 million to $16.5 million by March 31, 2023, primarily due to a $17.7 million net loss, partially offset by stock-based compensation - The balance of stockholders' equity fell to $16,458,952 at March 31, 2023, down from $32,990,017 at December 31, 2022[9] - Key changes during the quarter included a net loss of $17,744,812, stock-based compensation expense of $1,026,379, and proceeds from the issuance of common stock upon exercise of stock options of $129,745[9] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $15.1 million for Q1 2023, resulting in a $9.7 million net decrease in cash and equivalents, bringing the period-end balance to $8.0 million Cash Flow Highlights (Unaudited, for the three months ended March 31) | Activity | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,114,972) | $(10,615,350) | | Net cash provided by investing activities | $5,549,704 | $42,962,177 | | Net cash used in financing activities | $(113,010) | $(327,125) | | Net (decrease) increase in cash | $(9,678,278) | $32,019,702 | | Cash at end of period | $7,994,337 | $57,696,234 | Notes to Condensed Consolidated Financial Statements These notes detail the company's precision oncology business, liquidity, accounting policies including a 1-for-30 reverse stock split, and specifics on license agreements and compensation - The company is a precision oncology firm developing CRB-701 (ADC targeting Nectin-4), CRB-601 (anti-integrin monoclonal antibody), and seeking partners for CRB-913 (obesity treatment)[12] - The company expects its cash, cash equivalents, and investments of $44.2 million as of March 31, 2023, to be sufficient to fund operations for at least twelve months from the report's issuance[97] - On February 14, 2023, the company completed a 1-for-30 reverse stock split of its common stock, with all share and per-share data retroactively adjusted[98][154] - In Q1 2023, the company recorded a $7.5 million upfront license payment to CSPC and a $1.2 million development milestone under the UCSF License Agreement as research and development expenses[64] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition and Q1 2023 operational results, highlighting the precision oncology pipeline, increased R&D expenses due to licensing, and a cash runway extending through Q2 2024 Overview Corbus is a precision oncology company developing CRB-701 and CRB-601, seeking partners for CRB-913, and has an accumulated deficit of approximately $409.8 million as of March 31, 2023 - The company's precision oncology pipeline includes CRB-701 (Nectin-4 ADC) and CRB-601 (anti-αvβ8 monoclonal antibody)[186][217] - The IND for CRB-701 has been cleared by the FDA, with plans to start a U.S. clinical trial in mid-2024, and an IND submission for CRB-601 is planned for the second half of 2023[204] - The company is seeking partners to fund further development of CRB-913, a CB1 inverse agonist for obesity[187][217] Results of Operations Research and development expenses increased by $10.1 million to $13.4 million in Q1 2023 due to licensing costs, while general and administrative expenses decreased by $1.3 million - Research and development expenses increased to $13.4 million in Q1 2023 from $3.3 million in Q1 2022, driven by a $7.5 million upfront payment for the CSPC License Agreement and a $1.2 million milestone payment under the UCSF License Agreement[224] - General and administrative expenses decreased to $3.9 million in Q1 2023 from $5.2 million in Q1 2022, a reduction of $1.3 million, attributed to lower legal costs, stock-based compensation, and insurance premiums[241] Liquidity and Capital Resources The company's $44.2 million in cash and equivalents are expected to fund operations through Q2 2024, but significant additional capital will be required for future development and operations - The company's cash, cash equivalents, and marketable securities of approximately $44.2 million at March 31, 2023, are expected to fund operations through the second quarter of 2024[228] - Net cash used in operating activities for Q1 2023 was approximately $15.1 million[227] - The company will need to raise significant additional capital to continue funding operations and may be required to delay or scale back activities if funding is not secured on acceptable terms[215][244] Critical Accounting Policies and Estimates Key accounting policies requiring significant judgment include stock-based compensation, accrued research and development expenses, and lease accounting, involving complex estimates and models - Critical accounting policies involve significant estimates for stock-based compensation, accrued research and development expenses, and right-of-use assets and lease liabilities[237][247] - Stock-based compensation is valued using the Black-Scholes model, with key assumptions including expected volatility (100.13% in Q1 2023), term (6.25 years), and forfeiture rate (17.64% in Q1 2023)[180][261] - Accrued R&D expenses are estimated based on services performed by research institutions and CROs, with payments often tied to milestones, and no significant changes to prior estimates were noted[249][262][263] Item 3. Quantitative and Qualitative Disclosures about Market Risk This section is not applicable as the company qualifies as a smaller reporting company - Not Applicable[268] Item 4. Controls and Procedures Disclosure controls and procedures were deemed ineffective as of March 31, 2023, due to a material weakness in reporting accruals for licensing agreement payments - Disclosure controls and procedures were concluded to be not effective as of March 31, 2023[251] - A material weakness was identified in the control environment over internal control activities for processing and reporting accruals associated with upfront payments and fees in licensing agreements[253] PART II - OTHER INFORMATION This section provides other required information, including legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[279] Item 1A. Risk Factors No material changes or additions to the risk factors previously disclosed in the company's 2022 Annual Report on Form 10-K have occurred - There have been no material changes to the risk factors disclosed in the company's 2022 Annual Report on Form 10-K[269] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities were reported during the period - None reported for the period[281] Item 3. Defaults Upon Senior Securities This item is not applicable - Not applicable[271] Item 4. Mine Safety Disclosures This item is not applicable - Not applicable[282] Item 5. Other Information The Board ratified the issuance of 43,836 common shares from March 2023 option exercises, which were inadvertently issued on a pre-reverse stock split basis and are undergoing a ratification process - On May 7, 2023, the Board ratified the issuance of 43,836 shares of common stock (36,757 on March 8 and 7,079 on March 20) that were inadvertently issued on a pre-reverse stock split basis[272] - The issuances were deemed potentially defective corporate acts, and the company has initiated a ratification process under Section 204 of the Delaware General Corporation Law[272] Item 6. Exhibits This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including CEO and CFO certifications and XBRL data files - Lists filed exhibits, including CEO/CFO certifications (Exhibits 31.1, 31.2, 32.1, 32.2) and various Inline XBRL documents[274][275][283]