Chimerix Announces Q3 2024 Financial Results and Operational Update

Chimerix, a biopharmaceutical company dedicated to developing life-improving treatments for severe diseases, has shared its financial results for the third quarter ending September 30, 2024, along with an operational update.

The company is progressing with the Phase 3 ACTION study of dordaviprone (ONC201), a first-in-class treatment targeting H3 K27M-mutant diffuse glioma. This study, which enrolls patients across 145 sites in 15 countries, remains on track with its first interim overall survival data expected in the third quarter of 2025. A preplanned safety review by the Independent Data Monitoring Committee (IDMC) affirmed the continuation of the study as-is, including the more intense twice-weekly dosing schedule. Chimerix has also aligned with the Therapeutic Goods Administration (TGA) in Australia to file a New Drug Application (NDA) for Provisional Approval within the coming months. The TGA has granted orphan drug designation to dordaviprone, supporting its potential accelerated path to market.

Dordaviprone's mechanism involves crossing the blood-brain barrier to selectively bind to the mitochondrial protease ClpP and the dopamine receptor D2 (DRD2), reversing the loss of H3 K27me3, a hallmark of H3 K27M-mutant gliomas. This unique action makes it a promising candidate for treating this specific type of diffuse glioma.

Chimerix also highlighted the promotion of Dr. Josh Allen to Chief Scientific Officer. Dr. Allen, who has been pivotal in the development of the imipridone class of compounds, brings extensive experience in cancer biology to the role, promising to guide early-phase developments at Chimerix effectively.

Additionally, the second-generation imipridone ONC206 is being explored. This compound is a ClpP agonist and DRD2 antagonist that has shown significant anti-cancer activity in both central nervous system (CNS) and non-CNS tumor models. Phase 1 dose escalation studies are ongoing in collaboration with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) and the National Institutes of Health (NIH). These trials have enrolled over 80 patients, demonstrating a consistent safety profile with mostly mild to moderate adverse events. The dose escalation study is expected to complete enrollment in 2024, with the first assessments of objective responses anticipated in the first half of 2025.

On the financial side, Chimerix reported a net loss of $22.9 million for the third quarter of 2024, slightly improving from a $24.0 million net loss in the same quarter of 2023. Research and development expenses rose to $19.6 million, while general and administrative expenses decreased to $5.2 million due to a one-time non-cash expense recognized in the previous year. The company's balance sheet showed $152.4 million in capital available to fund operations, with approximately 89.9 million shares of common stock and no outstanding debt.

Chimerix continues to focus on advancing its clinical programs and maximizing the potential of its pipeline to address unmet medical needs in oncology. The company’s strategic initiatives, including the progression of dordaviprone and ONC206, reflect its commitment to developing innovative treatments for patients with life-threatening conditions.