Humacyte — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $1.028 million, compared to $0.753 million in the same period in 2025.
• Product revenue (Symvess) was $1.023 million in Q3 2026, up from $0.703 million in Q3 2025 and $0.4 million in Q2 2026.
• Contract revenue was minimal at $5,000 in Q3 2026, compared to $50,000 in Q3 2025.
• For the nine months ended September 30, 2026, total revenue was $1.929 million, compared to $1.571 million for the same period in 2025.
• Cost of goods sold was $1.429 million in Q3 2026, compared to $0.260 million in Q3 2025; $4.698 million for the nine months ended September 30, 2026, compared to $0.620 million in the prior-year period.
• Research and development expenses were $14.1 million in Q3 2026, down from $17.3 million in Q3 2025; $51.7 million for the nine months ended September 30, 2026, compared to $54.7 million in the prior-year period.
• General and administrative expenses were $9.0 million in Q3 2026, up from $7.6 million in Q3 2025; $25.0 million for the nine months ended September 30, 2026, compared to $23.6 million in the prior-year period.
• Other net income was $8.0 million in Q3 2026, compared to $6.9 million in Q3 2025; $9.5 million for the nine months ended September 30, 2026, compared to $61.3 million in the prior-year period.
• Net loss was $15.5 million in Q3 2026, compared to $17.5 million in Q3 2025; $70.0 million for the nine months ended September 30, 2026, compared to $16.0 million in the prior-year period.
• Cash, cash equivalents, and restricted cash totaled $64.9 million as of September 30, 2026.
• Net cash used in operating activities was $15.0 million for the three months ended September 30, 2026, compared to $23.9 million in the same period in 2025.

Guidance and Future Outlook:

• Humacyte anticipates Q4 2026 Symvess sales revenue to at least double Q3 2026 sales ($1.0 million), driven by expanded hospital adoptions and physician engagement.
• The company expects to add at least 20 new hospitals during the second half of 2026.
• A Supplemental Biologics License Application (SBLA) for the ATEV in dialysis access is on track for filing with the FDA in November 2026.
• Management believes the revamped commercial strategy positions Symvess for sustainable growth through the remainder of 2026 and beyond.

Business Segments and Product Lines:

• Symvess: Commercial sales reached $1.0 million in Q3 2026, a 151% increase over Q2 2026. Hospital orders increased by 44% during the quarter, rising from 34 to 49 hospitals. October 2026 sales totaled $0.8 million.
• ATEV (Dialysis Access): Phase 3 V012 trial results presented at ASN Kidney Week 2026 showed women implanted with ATEV achieved functional access more than three months sooner and spent significantly more time free of dialysis catheters compared to the AV fistula standard of care. V007 Phase 3 results were published in The Lancet Digital Health, demonstrating superiority over autogenous AV fistulae, particularly in female, obese, and diabetic patients.
• CTEV (CABG): The FDA accepted the IND application for a first-in-human Phase 2a study of the Coronary Tissue Engineered Vessel (CTEV) for coronary artery bypass grafting. The study initiated in November 2026 with the first clinical site activated, supported by the completion of the first large-scale manufacturing lot.
• Advisory Appointments: Robert J. Kossmann, MD, FACP, FASN, and Prabir Roy-Chaudhury, MD, PhD, FASN, were appointed as advisors to support the planned commercialization of the ATEV in dialysis access.

Market and Competitive Landscape:

• The ATEV for dialysis access is positioned as a potential first major advance in decades, offering an alternative for patients where AV fistula maturation is difficult.
• Symvess commercial adoption accelerated significantly, with sequential monthly increases in new hospital orders throughout Q3 2026.
• The company highlights unmet needs in dialysis access for specific patient populations (female, obese, diabetic) where current standard of care (AV fistula) experiences higher failure rates.

Risks and Challenges:

• Litigation Costs: General and administrative expenses included $0.6 million in net expense related to a reserve for the settlement of shareholder litigation and legal costs.
• Production Costs: Cost of goods sold in Q3 2026 included $0.8 million primarily comprised of overhead related to unused production capacity and royalties; for the nine months ended September 30, 2026, $2.3 million related to inventory reserves.
• Regulatory Status: The ATEV is investigational for dialysis access and has not been approved for sale by the FDA or any other regulatory agency. The CTEV is also investigational.
• Product Safety: Symvess carries a Boxed Warning for graft failure (rupture or anastomotic failure) which can result in life-threatening hemorrhage. Contraindications include patients unable to take long-term antiplatelet therapy.

Management Commentary and Tone:

• CEO Laura Niklason, M.D., Ph.D., stated the company is transforming the Symvess commercial program, doubling revenue over the second quarter and significantly increasing hospital orders.
• CCO Jim Mercadante noted that the execution of the revamped commercial program generated significant momentum, achieving the Q3 goal and anticipating at least doubling Q3 sales in Q4.
• Management expressed confidence that the established strategy is working and that Symvess is positioned for sustainable growth.

Other Key Points:

• Board Expansion: Scott Coward and Paul Kuznik were appointed to the Board of Directors in September 2026, bringing experience in commercialization, enterprise leadership, and global operations.
• Balance Sheet Changes: The contingent earnout liability decreased from $11.492 million at December 31, 2025, to $6.091 million at September 30, 2026. Common stock warrant liabilities decreased from $19.392 million to $9.115 million over the same period.
• Insurance Recovery: An insurance recovery asset of $9.119 million was recorded as of September 30, 2026.
• Litigation Liability: A litigation settlement liability of $9.75 million was recorded as of September 30, 2026.
• Stock Performance: Net loss per share was $(0.06) for the three months ended September 30, 2026, compared to $(0.11) in the same period in 2025.