Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Chimerix Inc (CMRX, Financial) is making meaningful progress in the Phase 3 ACTION study for dordaviprone, with the first interim overall survival readout expected in Q3 2025.
- The company has initiated the second step in the provisional registration process for dordaviprone in Australia, potentially accelerating commercial access.
- Positive safety and pharmacokinetic (PK) data for ONC206, with no dose-limiting toxicities observed thus far.
- Chimerix Inc (CMRX) has a strong cash position with over $171 million in cash and cash equivalents, expected to last into Q4 2026.
- The company is maintaining tight control on general and administrative expenses, which have remained flat year-on-year.
Negative Points
- Chimerix Inc (CMRX) reported a net loss of $20.7 million for Q2 2024, an increase from $18.6 million in Q2 2023.
- Research and development expenses increased to $18.4 million in Q2 2024, driven by spending on the ACTION study.
- The commercial opportunity for dordaviprone in Australia is relatively small compared to the US and EU.
- The company expects operating expenses to increase modestly in the coming quarters due to investments in launch readiness.
- Screen failure rates for the Phase 3 ACTION trial are consistent but highlight the challenges in enrolling patients with specific criteria.
Q & A Highlights
Q: For the higher dose cohorts for ONC206, could you potentially backfill any of those cohorts and maybe talk more about the first half of the 2025 update?
A: (Joshua Allen, Chief Technology Officer) We will be looking at treatment-naive patients, with the opportunity for some intrapatient dose escalation after naive patients have completed their DLT window. We expect safety data and PK data to follow in the months after the final dose escalation cohorts are completed by the end of the year. The initial readout of objective response is expected in the first half of 2025.
Q: Are you seeing event rates stabilized or is there anything else on clinical metrics that you can comment on that you're seeing in the study?
A: (Michael Andriole, President, Chief Executive Officer, Director) Enrollment rates are consistent, stable, and predictable. Blinded event rates are just now beginning to come in, so it's still early days. We have enough confidence to project the first interim OS assessment in Q3 of next year.
Q: Did you provide any color on the enrollment status of the Phase 3 ACTION trial? Will you be providing any baseline characteristics in a blinded fashion ahead of the data?
A: (Michael Andriole, President, Chief Executive Officer, Director) Enrollment is on track with meaningful contributions geographically around the world. We haven't provided exact guidance on enrollment but are on track for the first interim OS assessment in Q3 of next year. We do not plan to disclose early patient characteristics; this will be part of the final data readout.
Q: Would you be providing any color on screen failure rate?
A: (Allen Melemed, Chief Medical Officer) Our screen failure rate is consistent with expectations. These are hard patients to get due to the rare patient population, but the rate has been consistent throughout the study.
Q: When will the final PK and safety data for ONC206 be available?
A: (Joshua Allen, Chief Technology Officer) The safety experience requires about a month DLT window. We plan to complete the dose escalation cohorts by the end of the year, with safety and PK data to follow in the subsequent months.
Q: Can you discuss your ex-US strategy for dordaviprone, particularly in Australia?
A: (Thomas Riga, Chief Operating Officer, Chief Commercial Officer) We are working through the TGA process and studying a lean commercial model that could include distribution partners. This strategy aims to minimize expenses while providing commercial availability.
Q: What kind of investments have been made towards the launch of dordaviprone, and will these expenses impact the back half of this year?
A: (Michelle LaSpaluto, Chief Financial Officer) We have made some investments this year, including bringing Tom on board. We expect modest increases in expenses this year, with more significant investments continuing into 2025. Early investments include engaging key stakeholders, sales forecasting, and structure planning.
Q: How large do you think the commercial opportunity for dordaviprone in Australia could be relative to the US and EU?
A: (Thomas Riga, Chief Operating Officer, Chief Commercial Officer) The commercial opportunity in Australia is small relative to Europe and the US due to population size. However, gaining first regulatory approval and providing commercial access for patients in need is important.
Q: Do you think the TGA will want to see the first interim OS data from the ACTION study before they issue an approval?
A: (Michael Andriole, President, Chief Executive Officer, Director) Our discussions with TGA are based on the Phase 2 response rate data, not the interim OS data. However, the interim OS data could potentially read out within the window of our discussions.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
