DURHAM — Chimerix Inc. (CMRX) on Thursday sees progress being made with the drug company’s pipeline even though it reported a loss of $21.4 million in its first quarter.
The Durham-based company said it had a loss of 24 cents per share.
The results met Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was also for a loss of 24 cents per share.
The biopharmaceutical company posted revenue of $283,000 in the period.
CEO Mike Sherman provided an update on what’s happening with its products:
“2023 is off to a strong start and has been highlighted by multiple presentations of data in support of our imipridone platform [targeting brain tumors] during the recent American Association for Cancer Research Annual Meeting (AACR) and our sponsorship at the Canadian Neuro-Oncology Meeting (CNO) this week.
“Dr. Carl Koschmann’s ONC201 presentation at AACR marks the first known example of any therapy reversing the H3 K27 trimethyl loss (H3 K27me3-loss) seen in H3 K27M-mutant glioma patients. This shows that dordaviprone (ONC201) can reverse the epigenetic signature which is thought to be a defining characteristic of the disease. Recent literature suggests that reversing the H3 K27M mutation that increases H3 K27 trimethylation in established tumor models results in significant antitumor effects and prolongation of survival. This finding provides additional objective evidence of ONC201 biological activity in this patient population to complement the tumor response observed in the Phase 2 clinical studies.
“We have also recently completed multiple clinical pharmacology studies, the findings of which have been consistent with our expectations. These studies comprise key elements of a future new drug application (NDA) for ONC201 following positive data from the ACTION study. Our focus has been on accelerating every aspect possible of the Phase 3 ACTION study in order to expedite patient access to this potentially life-altering drug. To that end, we have now received authorization for the ACTION study from nine countries including the United States, the United Kingdom, South Korea, Israel and key markets across Western Europe, as our ramp of site activations continues.”
“In addition, we are making good progress advancing the Phase 1 dose escalation studies for our second generation compound, ONC206. As these are open-label studies, in addition to the previously announced objective response observed to ONC206 monotherapy, we hope to identify additional signals of activity this year and look forward to completing dose escalation by first half of 2024.”
