Chimerix (CMRX) Q3 2024 earnings summary

Executive summary

• Dordaviprone's global Phase III ACTION Study is active in 15 countries, nearing full enrollment, with interim overall survival data expected in Q3 2025 and continued positive safety reviews from the IDMC.

• ONC206 Phase I dose escalation studies are close to completion, showing positive safety and tolerability in both adult and pediatric patients, with objective response assessment planned for H1 2025.

• NDA submission for dordaviprone in Australia is anticipated in the coming months, with orphan drug designation granted and potential commercial availability by year-end 2025.

• Chimerix received a Nasdaq notice for noncompliance with the $1.00 minimum bid price, with a grace period until December 24, 2024, to regain compliance.

• Dr. Josh Allen was promoted to Chief Scientific Officer, recognized for his contributions to imipridone compound development.

Financial highlights

• Q3 2024 net loss was $22.9 million ($0.26 per share), an improvement from $24 million in Q3 2023.

• Research and development expenses increased to $19.6 million from $17.4 million year-over-year, mainly due to higher ACTION study spending.

• General and administrative expenses decreased to $5.2 million from $9.3 million, reflecting lower compensation and a one-time non-cash expense in 2023.

• Revenues were $26,000 for Q3 2024, up from $11,000 in Q3 2023, mainly from contract and grant revenue.

• Cash, cash equivalents, and investments totaled $152.4 million as of September 30, 2024, with no outstanding debt and a cash runway into Q4 2026.

Outlook and guidance

• Interim overall survival data from the ACTION Study is expected in Q3 2025.

• NDA for dordaviprone in Australia is targeted for year-end, with possible commercial availability by year-end 2025 and potential for accelerated regulatory pathways in other markets.

• ONC206 Phase I enrollment is expected to complete in 2024, with next steps to be announced as data matures.

• Existing capital is expected to fund operations for at least the next 12 months, but additional funding may be needed for future development or commercialization.

• Commercialization efforts are underway, focusing on payer engagement and infrastructure build, with a conservative, data-driven approach to spending.