Chimerix (CMRX) Q2 2024 earnings summary

Executive summary

• Advanced clinical programs for dordaviprone (ONC201) in Phase 3 for H3 K27M-mutant diffuse glioma and ONC206 in Phase 1 trials for CNS tumors, with interim overall survival data for the ACTION study expected in Q3 2025.

• ONC206 Phase 1 trials show dose-proportional exposure, favorable safety, and no dose-limiting toxicity, with enrollment completion expected by year-end 2024 and initial efficacy readout in H1 2025.

• Dordaviprone filed for Provisional Determination with the Australian Therapeutic Goods Administration, aiming for potential NDA filing by year-end 2024 and possible 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

• Net loss of $20.7 million ($0.23 per share) for Q2 2024, compared to $18.6 million ($0.21 per share) in Q2 2023; net loss for the six months ended June 30, 2024 was $42.6 million.

• Revenue for Q2 2024 was $0.1 million, mainly from a North Carolina grant for CMX521 development.

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

• Cash, cash equivalents, and investments totaled $171.5 million at June 30, 2024, expected to fund operations into Q4 2026.

• Average cash burn of $16 million per quarter over the past six months, with a modest increase expected as launch investments begin.

Outlook and guidance

• Interim overall survival readout for the ACTION study expected in Q3 2025.

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

• Modest increase in operating expenses anticipated in the back half of 2024 and into 2025 due to launch readiness activities.

• Management expects to continue incurring significant losses as clinical development progresses, with no near-term product revenue anticipated.

• The company is actively monitoring its Nasdaq listing compliance and considering options to regain compliance with the minimum bid price requirement.