Prime Medicine (PRME) Q4 2025 earnings summary

Executive summary

• Advanced regulatory milestones for Wilson Disease and AATD programs, with IND/CTA filings expected in 1H and mid-2026, and initial clinical data anticipated in 2027.

• Ongoing FDA engagement for PM359 in CGD, with plans to submit a BLA following final alignment.

• Breakthrough Phase 1/2 data for PM359 published in NEJM, showing rapid engraftment and durable clinical benefit without safety concerns.

• Continued R&D execution with focus on liver programs and preclinical progress in Cystic Fibrosis and CAR-T collaborations.

Financial highlights

• R&D expenses were $160.6M for 2025, up from $155.3M in 2024, mainly due to license/IP and facility costs, partially offset by workforce reduction.

• G&A expenses rose to $52.3M in 2025 from $50.2M in 2024, driven by higher professional and consultant fees.

• Net loss was $201.1M for 2025, compared to $195.9M in 2024.

• Cash, cash equivalents, investments, and restricted cash totaled $191.4M at year-end 2025, down from $204.5M at year-end 2024.

• Collaboration revenue increased to $4.6M in 2025 from $46K in 2024.

Outlook and guidance

• Cash position expected to fund operations and capital expenditures into 2027.

• IND/CTA filings for Wilson Disease and AATD programs targeted for 2026, with initial clinical data in 2027.

• Preclinical proof-of-concept data for Cystic Fibrosis program anticipated in 2026.