Chimerix Q1 2024 Financial Results and Operational Update

DURHAM, N.C., May 01, 2024 -- Chimerix, a biopharmaceutical company dedicated to developing treatments for fatal diseases, has disclosed its financial performance for the first quarter ending March 31, 2024, along with key operational updates.

Mike Andriole, the CEO of Chimerix, highlighted the urgency for innovative therapies for conditions like H3 K27M-mutant diffuse glioma. Dordaviprone (ONC201) is seen as a promising treatment in this domain. The company's focus remains on completing the ACTION study and engaging with regulators for early patient access. They are exploring accelerated pathways in selective markets due to limited treatment options for this rare disease. A positive interaction with the Therapeutic Goods Administration (TGA) in Australia is an encouraging step towards this goal. Successful progression of the pivotal Phase 3 ACTION study is a crucial factor in global regulatory discussions about accelerated approval.

Chimerix is also advancing ONC206, a second-generation imipridone. The Phase 1 dose escalation trials for ONC206 have shown promising activity and have been well-tolerated with no dose-limiting toxicities. Preliminary safety and pharmacokinetic data are anticipated in mid-2024. The company is optimistic about ONC206's potential and plans to detail its future development by the end of the year.

Dordaviprone (ONC201) is an oral, first-in-class small molecule imipridone targeting the G-protein coupled dopamine receptor D2 (DRD2) and the mitochondrial protease ClpP. The Phase 3 ACTION trial is currently enrolling H3 K27M-mutant glioma patients across 135 sites in 13 countries. Following front-line radiation therapy, 450 patients will be randomized to receive dordaviprone at one of two dosing frequencies or a placebo. Chimerix expects interim overall survival data in 2025 and final data in 2026.

Chimerix has been evaluating dordaviprone's eligibility for Provisional Registration in Australia. The initial Pre-Submission Meeting with the TGA concluded that dordaviprone meets the criteria for the next step in the process, moving towards a Provisional Determination application. This assessment supports the view that dordaviprone could be a significant therapeutic advance in treating H3 K27M-mutant glioma. Chimerix plans to continue working with TGA as the process progresses, potentially resulting in commercial availability by 2026.

ONC206, a second-generation ClpP agonist and DRD2 antagonist, has shown anti-cancer activity in pre-clinical models for both primary CNS tumors and other solid tumors. The ongoing Phase I dose escalation trials at the National Institutes of Health (NIH) and the Pacific Pediatric Neuro-Oncology Consortium (PNOC) are dosing patients on a schedule aimed at maximizing therapeutic exposure. Initial data from these trials is expected to be released by mid-2024.

On the corporate front, Chimerix has appointed Marc D. Kozin to its Board of Directors. Kozin brings over 35 years of experience in corporate strategy and mergers and acquisitions. Additionally, Patrick Machado will retire from the board after ten years of service, effective at the 2024 Annual Meeting of Stockholders in June.

Financially, Chimerix reported a net loss of $21.9 million, or $0.25 per share, for the first quarter of 2024, compared to a net loss of $21.4 million, or $0.24 per share, during the same period in 2023. Research and development expenses remained steady at $18.8 million, while general and administrative expenses slightly decreased to $5.5 million. As of March 31, 2024, Chimerix had $188.2 million in capital to support its operations, with approximately 89.6 million outstanding shares of common stock and no outstanding debt.

Chimerix will host a conference call at 8:30 a.m. ET today to discuss the financial results and provide a business update.