Scholar Rock (SRRK) Q4 2025 earnings summary

Executive summary

• Apitegromab BLA resubmission and anticipated U.S. launch expected in 2026, pending FDA reinspection and approval, with commercial readiness activities underway in both the U.S. and Europe.

• EMA review of apitegromab ongoing, with a decision expected mid-2026 and European launch planned for H2 2026, starting in Germany.

• Pipeline advancement includes ongoing clinical trials for apitegromab in SMA and FSHD, development of subcutaneous formulations, and SRK-439 studies.

• New debt facility secured for up to $550 million to support commercialization and pipeline advancement.

• Cash, cash equivalents, and marketable securities totaled $368 million at year-end 2025, bolstered by $60.4 million from warrant exercises.

Financial highlights

• Ended 2025 with $368 million in cash and cash equivalents; no revenue recorded for Q4 or full year 2025 and 2024.

• Q4 2025 operating expenses were $91.9 million ($72.5 million excluding stock-based compensation); net loss for Q4 2025 was $91.0 million.

• Full-year 2025 operating expenses were $384.6 million ($309 million excluding stock-based compensation); net loss for 2025 was $377.9 million.

• Research and development expenses for 2025 were $208.4 million; general and administrative expenses were $176.2 million.

• Net loss per share was $0.88 for Q4 2025; weighted average shares outstanding for 2025: 114.7 million.

Outlook and guidance

• Reaffirmed guidance for BLA resubmission and U.S. launch of apitegromab in 2026, pending successful FDA reinspection.

• EMA decision for apitegromab anticipated mid-2026, with European launch preparations focused on Germany and broader EMEA.

• Phase 2 OPAL trial for infants and toddlers with SMA ongoing; Phase 2 FORGE trial for FSHD set to begin mid-2026.

• Topline data from SRK-439 Phase 1 study expected in H2 2026.

• Plans to file a supplemental BLA for a second fill-finish facility later in 2026.