Chimerix gains on regulatory updates for cancer therapy

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Chimerix, Inc. (NASDAQ:CMRX), a biotech known for its smallpox therapy Tembexa added ~7% pre-market Thursday after its Q3 2022 results as the company updated on the regulatory path for its investigational cancer therapy ONC201.

The Durham, North Carolina-based company said that with plans to start its Phase 3 ACTION trial for ONC201 in certain patients with CNS cancer glioma, it had completed talks with the FDA on the trial design.

With the support of a safety dataset and results from a healthy volunteer study for ONC201, Chimerix (CMRX) has also scheduled a meeting with the agency regarding a potential accelerated approval submission for the treatment.

In terms of financials, the company reported $32.6M in revenue, up from $0.1M in the prior year's quarter due to global sales of Tembexa amid the monkeypox outbreak.

While R&D expenses rose ~11% YoY to $15.3M, driven by ONC20-related development costs, G&A expenses added ~8% YoY to $5.3M.

Chimerix (CMRX) reported $241.1M net income during the last quarter compared to $18.6M of net loss in Q3 2021, thanks to $229.7M gain on sale from the transition of Tembexa rights to Emergent BioSolutions (EBS).

The company’s liquidity position improved to $274.3M at the end of the quarter compared to $15.4M at the 2021-year end.

“With our lead program fully funded through potential commercial launch, we will continue to exercise financial discipline with regard to capital allocation,” Chief Financial Officer Mike Andriole remarked.

Read more about the deal between Chimerix (CMRX) and Emergent (EBS) for exclusive worldwide rights to Tembexa.