Chimerix(US:CMRX)2024-08-13 11:22Part I Financial Statements Chimerix, Inc.'s unaudited consolidated financial statements for H1 2024 report a $42.6 million net loss and decreased assets Consolidated Balance Sheets Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,658 | $27,661 | | Total current assets | $153,455 | $189,110 | | Total assets | $178,511 | $212,774 | | Total current liabilities | $22,102 | $18,443 | | Total liabilities | $22,929 | $19,745 | | Total stockholders' equity | $155,582 | $193,029 | Consolidated Statements of Operations and Comprehensive Loss Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $129 | $26 | $129 | $309 | | Research and development | $18,428 | $16,926 | $37,272 | $35,748 | | General and administrative | $4,533 | $4,448 | $10,079 | $10,127 | | Loss from operations | $(22,832) | $(21,348) | $(47,222) | $(45,566) | | Net loss | $(20,685) | $(18,576) | $(42,554) | $(39,948) | | Net loss per share | $(0.23) | $(0.21) | $(0.48) | $(0.45) | Consolidated Statements of Stockholders' Equity - Total stockholders' equity decreased from $193.0 million at December 31, 2023, to $155.6 million at June 30, 2024, primarily due to a net loss of $42.6 million for the six-month period, partially offset by $4.9 million in share-based compensation1012 Consolidated Statements of Cash Flows Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,201) | $(36,567) | | Net cash provided by investing activities | $23,032 | $30,656 | | Net cash provided by financing activities | $166 | $168 | | Net decrease in cash and cash equivalents | $(12,003) | $(5,743) | | Cash and cash equivalents, end of period | $15,658 | $20,099 | Notes to the Consolidated Financial Statements - Chimerix is a biopharmaceutical company focused on developing imipridones as cancer therapies, with its lead candidate dordaviprone (ONC201) in clinical development for H3 K27M-mutant diffuse glioma16 - On June 27, 2024, the company received a notice from Nasdaq for non-compliance with the minimum bid price rule ($1.00 per share) and has until December 24, 2024, to regain compliance3940 - In February 2024, Chimerix established an At-The-Market (ATM) equity offering agreement to sell up to $75 million of its common stock, with no sales made as of June 30, 202457 - The company is eligible for up to $124 million in milestone payments and tiered royalties from Emergent BioSolutions related to the 2022 sale of TEMBEXA2967 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses dordaviprone's clinical progress and reports a $42.6 million net loss for H1 2024, affirming sufficient capital for the next 12 months - The Phase 3 ACTION trial for dordaviprone is enrolling patients across 13 countries, with interim overall survival (OS) data expected in Q3 2025, and the company is also pursuing a Provisional Registration pathway in Australia7779 Results of Operations Comparison (in thousands) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Total Revenues | $129 | $309 | | Research & Development Expenses | $37,272 | $35,748 | | General & Administrative Expenses | $10,079 | $10,127 | | Net Loss | $(42,554) | $(39,948) | - As of June 30, 2024, Chimerix had approximately $171.5 million in available capital, which is believed to be sufficient to fund operations and capital requirements for at least the next 12 months113117 - Net cash used in operating activities was $35.2 million for the first six months of 2024, a slight decrease from $36.6 million in the same period of 2023119 Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate sensitivity on its short-term investment portfolio, with no material impact expected from rate changes or inflation - The company's main market risk is interest income sensitivity, affected by U.S. interest rate changes129 - Due to the short-term, low-risk nature of its investment portfolio, an immediate 10% change in interest rates is not expected to have a material effect on the company's financial condition129 - Inflation is not believed to have had a material effect on the results of operations for the reported periods130 Controls and Procedures The company's disclosure controls and procedures were deemed effective as of June 30, 2024, with no material changes to internal control over financial reporting during Q2 2024 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period, June 30, 2024131 - There were no changes in internal control over financial reporting during the second quarter of 2024 that have materially affected, or are reasonably likely to materially affect, these controls132 Part II Legal Proceedings The company reports that there were no material legal proceedings during the reporting period - The company reports "None"134 Risk Factors The company faces significant risks including historical losses, product development uncertainty, reliance on third parties, potential Nasdaq delisting, competition, and intellectual property and data privacy concerns - The company has a history of significant losses, with an accumulated deficit of approximately $838.1 million as of June 30, 2024, and anticipates incurring future losses136138 - All product candidates are in clinical development and may not obtain regulatory approval or be successfully commercialized, making the success of the lead candidate, dordaviprone, critical136156 - The company's common stock is at risk of being delisted from The Nasdaq Global Market for failing to maintain a minimum bid price of $1.00 per share, which could negatively impact its price and liquidity136251252 - The company relies on third-party manufacturers for drug supply and CROs for clinical trials, creating risks related to supply disruption, quality control, and regulatory compliance136193201 - The company is subject to stringent data privacy and security laws (e.g., GDPR, CCPA), where a failure to comply or a data breach could result in significant fines, litigation, and reputational harm272283 Unregistered Sales of Equity Securities and Use of Proceeds The company reports that there were no unregistered sales of equity securities during the period - The company reports "None"295 Defaults Upon Senior Securities The company reports that there were no defaults upon senior securities - The company reports "None"295 Mine Safety Disclosures This item is not applicable to the company's business - The company reports "Not applicable"295 Other Information The company reports no other material information for the period, including any trading arrangements by directors or officers - The company reports no trading arrangements296 Exhibits This section lists all exhibits filed with the quarterly report, including corporate governance documents, equity award agreements, and required officer certifications - The report includes exhibits such as the Chimerix, Inc. 2024 Equity Incentive Plan, forms of stock option and RSU agreements, and officer certifications required under the Securities Exchange Act of 1934298 Signatures - The report was duly signed on August 13, 2024, by Michael T. Andriole, President and Chief Executive Officer, and Michelle LaSpaluto, Chief Financial Officer302