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.