Chimerix Q2 2024 Financial Results and Operational Update

Chimerix, a biopharmaceutical company dedicated to developing medications for life-threatening diseases, has reported its financial results for the second quarter ending June 30, 2024. The company also provided updates on its ongoing clinical trials and operational progress.

Chimerix is advancing its Phase 3 ACTION study, with the first interim overall survival data expected in the third quarter of 2025. CEO Mike Andriole emphasized their preparations for a U.S. launch and the ongoing strength of their U.S. capabilities. Additionally, Chimerix is progressing ONC206 through Phase 1 trials, achieving therapeutic-range dosing without dose-limiting toxicities. The company aims to complete enrollment in the ONC206 dose escalation trials by the end of 2024.

In a significant development, Chimerix has filed for a Provisional Determination for dordaviprone with Australia's Therapeutic Goods Administration. This filing is part of a three-step process towards potential Provisional Approval, marking a step forward in making new treatments available to patients.

Dordaviprone, a first-in-class imipridone, is under investigation as a potential treatment for H3 K27M-mutant diffuse glioma, a form of brain cancer. This small molecule drug can cross the blood-brain barrier and specifically targets the mitochondrial protease ClpP and dopamine receptor D2. It affects key epigenetic modifications, including reversing the hallmark H3 K27me3-loss in these gliomas. The company estimates that around 2,000 patients in the U.S. and 5,000 globally could benefit from this treatment, as current standard care remains palliative post-radiotherapy.

The Phase 3 ACTION trial for dordaviprone is underway, enrolling patients at over 140 sites across 13 countries. Interim overall survival data from this trial is anticipated in the third quarter of 2025. The potential for Provisional Registration in Australia could see commercial availability by 2026, assuming the process progresses as planned.

ONC206, another imipridone, is a second-generation ClpP agonist and DRD2 antagonist, showing higher potency in laboratory settings compared to dordaviprone. It has exhibited anti-cancer activity in central nervous system tumor models and other solid tumors. Phase 1 dose escalation trials in partnership with the Pacific Pediatric Neuro-Oncology Consortium and the National Institutes of Health have enrolled over 75 patients with various central nervous system tumors. The trials have reached high dosing levels without observing dose-limiting toxicities, and the company plans to complete enrollment in 2024.

The safety profile of ONC206 has been consistent, with most adverse events being mild to moderate, such as fatigue, reduced lymphocyte counts, and vomiting. Current trials continue to assess the drug's efficacy, with objective response evaluations expected by the first half of 2025.

Chimerix reported a net loss of $20.7 million for the quarter, slightly higher than the $18.6 million loss in the same period last year. Research and development expenses increased to $18.4 million from $16.9 million, and general and administrative expenses rose slightly to $4.5 million. The company's balance sheet as of June 30, 2024, showed $171.5 million in capital, with no outstanding debt.

Chimerix plans to participate in upcoming healthcare conferences, including the Wedbush PacGrow Healthcare Conference in August and the H.C. Wainwright Global Investment Conference in September.

Chimerix remains committed to developing innovative treatments for patients with severe and life-threatening diseases, with its current focus on advancing dordaviprone and ONC206 through clinical trials and regulatory processes.

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