Humacyte (HUMA) Q2 2026 earnings summary

Executive summary

• Achieved transformative progress in Q2 2026, advancing commercial launch of SYMVESS, reporting strong clinical trial results, and preparing for regulatory filings in dialysis access and coronary artery bypass grafting.

• Commercial launch of the first FDA-approved product, Symvess, began in Q1 2025 for vascular trauma; positive interim Phase 3 results in AV access for hemodialysis announced in June 2026.

• Breakthrough Phase 3 results showed ATEV outperformed AV fistula in female dialysis patients, reducing catheter use and infections, supporting a planned supplemental BLA filing in H2 2026.

• Rebuilt commercial team and strategy, leading to increased hospital adoption and utilization of SYMVESS, with new leadership, pricing incentives, and education initiatives.

• Expanded global rights for the Distribution Product through an amended agreement with Fresenius Medical Care in April 2026.

Financial highlights

• Q2 2026 commercial sales reached $0.4M, up from $0.1M in Q2 2025; six-month sales were $0.9M, up from $0.2M year-over-year.

• Cost of goods sold for Q2 2026 was $1.2M, including a $0.7M inventory reserve and overhead for unused capacity.

• R&D expenses for Q2 2026 were $8.1M, down from $22.0M in Q2 2025, due to reduced manufacturing and clinical trial costs.

• Net loss for Q2 2026 was $36.8M; six-month net loss was $54.4M, primarily due to non-cash remeasurement of contingent earnout liability.

• Cash, cash equivalents, and restricted cash totaled $80.3M as of June 30, 2026.

Outlook and guidance

• Plans to file a supplemental BLA for ATEV in dialysis access in H2 2026, targeting a potential launch by end of Q2 2027 if granted priority review.

• Initiation of Phase IIa CTEV study in CABG expected in Q3 2026, with minimal impact on commercial manufacturing.

• Focused on expanding hospital adoption and preparing for broader dialysis indication launch.

• Company expects continued operating losses and negative cash flows as commercialization and development efforts expand.

• Insufficient liquidity to fund operations beyond one year without additional capital or increased product revenue; substantial doubt exists about ability to continue as a going concern.