Chimerix(CMRX) - 2024 Q1 - Quarterly Results

Chimerix First Quarter 2024 Financial Results and Operational Update Operational Update Chimerix is advancing its lead drug candidate, dordaviprone, and second-generation drug, ONC206, alongside a Board of Directors change Dordaviprone (ONC201) The company is advancing the Phase 3 ACTION study for dordaviprone and pursuing a provisional registration pathway in Australia - The Phase 3 ACTION study is enrolling 450 patients across 135 sites in 13 countries to evaluate dordaviprone for H3 K27M-mutant glioma[20] - Key data readouts for the ACTION study are expected with interim Overall Survival (OS) data in 2025 and final OS data in 2026[3][19] - Chimerix is advancing dordaviprone in Australia's Provisional Registration process after a positive Pre-Submission Meeting with the TGA[1][21] ONC206 ONC206 is progressing in Phase 1 trials for CNS tumors, with preliminary safety and pharmacokinetic data expected in mid-2024 - ONC206 is a second-generation ClpP agonist and DRD2 antagonist being evaluated in Phase 1 dose escalation trials for CNS tumors[3][29] - To date, ONC206 has been generally well tolerated with no dose-limiting toxicities reported in ongoing Phase 1 studies[3][9] - Preliminary safety and pharmacokinetic (PK) data from the Phase 1 studies are expected to be reported starting in mid-2024[3] Corporate Updates The company appointed Marc D Kozin to its Board of Directors and announced the retirement of Patrick Machado - Marc D. Kozin was appointed to the Company's Board of Directors in March 2024[13] - Patrick Machado will retire from the Board in June 2024 after ten years of service[13] First Quarter 2024 Financial Results The company reported a Q1 2024 net loss of $21.9 million with stable operating expenses and ended the quarter with $188.2 million in capital Financial Performance Summary Chimerix reported a Q1 2024 net loss of $21.9 million, slightly increased from Q1 2023, with stable R&D and G&A expenses Q1 2024 vs Q1 2023 Financial Highlights (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $0 | $283 | | R&D Expenses | $18,844 | $18,822 | | G&A Expenses | $5,546 | $5,679 | | Loss from Operations | $(24,390) | $(24,218) | | Net Loss | $(21,869) | $(21,372) | | Net Loss per Share | $(0.25) | $(0.24) | - The company ended Q1 2024 with $188.2 million in capital available to fund operations and no outstanding debt[24] Financial Statements The balance sheet shows total assets of $194.0 million as of March 31, 2024, with the statement of operations detailing the net loss Consolidated Balance Sheet Summary (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total Assets | $194,042 | $212,774 | | Total Current Assets | $163,032 | $189,110 | | Total Liabilities | $19,940 | $19,745 | | Total Current Liabilities | $18,935 | $18,443 | | Total Stockholders' Equity | $174,102 | $193,029 | Consolidated Statement of Operations Summary (in thousands) | Account | Three Months Ended March 31, 2024 | | :--- | :--- | | Total Revenues | $0 | | Total Operating Expenses | $24,390 | | Loss from Operations | $(24,390) | | Net Loss | $(21,869) | Other Information This section provides details on the investor conference call, forward-looking statements, and a company overview Conference Call and Webcast Chimerix held a conference call and webcast to discuss Q1 2024 financial results and provide a business update - A conference call and webcast were held at 8:30 a.m. ET on May 1, 2024, to discuss Q1 2024 results and provide a business update[32] Forward-Looking Statements The press release contains forward-looking statements regarding drug development and regulatory approvals that are subject to risks - The report contains forward-looking statements concerning regulatory applications, the ACTION study, and ONC206 development, which are subject to risks[6] About Chimerix Chimerix is a biopharmaceutical company focused on developing medicines for deadly diseases like H3 K27M-mutant glioma - Chimerix is a biopharmaceutical company whose lead clinical program, ONC201, is in development for H3 K27M-mutant glioma[25]