Chimerix (CMRX) Q2 2024 earnings summary

Executive summary

• Advanced enrollment and execution of the Phase 3 ACTION study for dordaviprone, with interim overall survival data expected in Q3 2025 and potential regulatory submissions to follow positive results.

• ONC206 Phase 1 trials progressed, showing dose-proportional exposure, no dose-limiting toxicity, and favorable safety profile; enrollment completion expected by year-end 2024.

• Initiated steps for provisional registration of dordaviprone in Australia, aiming for NDA filing by year-end 2024 and potential commercial availability in early 2026.

• The company is conducting a business development review to expand its pipeline through licensing, M&A, or asset transactions.

Financial highlights

• Reported Q2 2024 net loss of $20.7 million ($0.23 per share), compared to $18.6 million ($0.21 per share) in Q2 2023.

• R&D expenses increased to $18.4 million in Q2 2024, mainly due to ACTION and ONC206 study costs; G&A expenses were $4.5 million.

• Revenue for Q2 2024 was $0.1 million, up from $26,000 in Q2 2023, mainly from a North Carolina grant.

• Maintained cash, cash equivalents, and investments of $171.5 million at quarter-end, with cash runway expected into Q4 2026.

• No outstanding debt as of June 30, 2024.

Outlook and guidance

• Interim overall survival data from the ACTION study anticipated in Q3 2025.

• ONC206 dose escalation trials expected to complete enrollment by year-end 2024, with initial response data in H1 2025.

• Modest increase in operating expenses projected as launch readiness investments ramp up through 2025.

• Existing cash and investments expected to fund operations for at least the next 12 months.

• The company is actively monitoring its Nasdaq listing compliance and considering options to regain compliance.