Humacyte, Inc. (HUMA) Earnings

Management highlights

### Commercial Launch of CIMVEST - U.S. Q1 2026 sales grew 400% year-over-year to $0.5 million, but management acknowledges faster uptake is needed to meet the product's full potential - Restructured and expanded commercial leadership: hired industry veteran James Mercadante as Chief Commercial Officer and prominent vascular surgeon Dr. Todd Rasmussen as Chief Surgical Officer, with additional field sales hires to improve coverage of key U.S. markets and large integrated delivery networks (IDNs) - Shifted commercial strategy to prioritize surgeon education and support, in addition to ongoing hospital value analysis committee (VAC) approvals, to address missed adoption opportunities from under-supported on-shelf inventory - Advanced international expansion: submitted and secured acceptance of a Marketing Authorization Application (MAA) for CIMVEST for arterial injury repair with the Israeli Ministry of Health, which has a 180 working day review period; secured a $1.475 million purchase commitment from the Kingdom of Saudi Arabia for clinical evaluation and outreach, with ongoing joint venture and licensing negotiations for in-country commercialization - Secured dedicated U.S. Department of Defense funding for evaluation of the company's bioengineered vascular technology, with plans to collaborate with military health facilities to expand access for service members ### Workforce Restructuring - Implemented a 25% workforce reduction (45 positions eliminated) in May 2026, achieved via trimming existing staff and deferring planned hires, alongside other operating expense cuts, enabled by completion of prior technical and clinical projects - One-time severance costs are estimated at $0.8 million, mostly to be incurred in Q2 2026; estimated net annual savings for the remainder of 2026 is $14.3 million, with savings relatively evenly spread across the second half of the year - Restructuring reallocated resources to prioritize commercial activities while retaining all key personnel and initiatives to meet 2026 core corporate goals ### Development Pipeline Progress - **Dialysis Access (ATEV, VO-12 Phase III Trial):** Full enrollment of 120 female patients is complete, with top-line interim results scheduled for presentation at the June 11, 2026 Vascular Annual Meeting in Boston. If results meet pre-specified endpoints, the trial will stop early per protocol, and a supplemental Biologics License Application (BLA) for the dialysis indication will be submitted in H2 2026. The trial compares ATEV to standard-of-care AV fistulas for dialysis access, an area of high unmet need for female patients. - **Coronary Tissue Engineered Vessel (CTAV) for CABG:** An Investigational New Drug (IND) application was submitted to the FDA in late 2025; large-scale manufacturing of the 3.5mm diameter CTAV (smaller than the approved 6mm peripheral product) is nearing completion. The first-in-human Phase 1-2 trial is on track to commence in H2 2026 following manufacturing completion and FDA clearance.

Guidance

• Management does not expect to provide full-year 2026 commercial revenue guidance until the end of 2026, as it is too early to predict the adoption ramp following the commercial team restructuring. The company expects the revamped commercial strategy will accelerate revenue growth during 2026, but no specific quantitative targets were provided. • If VO-12 Phase III interim results are positive, the supplemental BLA for the dialysis indication is planned for submission in H2 2026. With accelerated review under the RMAT designation, potential FDA clearance could come as early as July 2027, though accelerated review is not guaranteed. • Restructuring is expected to deliver $14.3 million in net savings for the remainder of 2026, spread relatively evenly across the second half of the year. • The company expects the DOD procurement of CIMVEST will be completed by around September 2026.

Segment performance

Humacyte reports one core commercial product segment (CIMVEST / CIMVAS / SimVest) for arterial injury repair, plus pipeline development programs. In Q1 2026, CIMVEST generated $0.5 million in commercial sales from 29 units, a 400% increase from $0.1 million (5 units) in Q1 2025. The product accounted for 99.96% of total Q1 2026 revenue, with the remaining 0.04% coming from $2,000 in contract revenue from a research collaboration (down from $0.4 million in Q1 2025, due to completion of the current collaboration phase). Cost of goods sold for Q1 2026 was $2 million, compared to $0.1 million in Q1 2025: $0.2 million of this related to direct costs of sold units, with the remainder consisting of a $1.6 million inventory reserve for obsolete stock and overhead for unused production capacity. Research and development expenses were $19.5 million (up from $15.4 million in Q1 2025), driven by $4.3 million in material costs for CTEV manufacturing and process improvement work. General and administrative expenses were $7.9 million, consistent with $8.1 million in Q1 2025. Net other income was $11.3 million, down from $62.3 million in Q1 2025 due to lower non-cash income from contingent earn-out liability re-measurement. Net loss for Q1 2026 was $17.6 million, compared to a net income of $39.1 million in Q1 2025, primarily due to the decrease in non-cash income. As of March 31, 2026, the company held $48.9 million in cash, cash equivalents, and restricted cash.

Risks & headwinds

• Commercial adoption of CIMVEST in the U.S. has been slower than expected, with underutilization of the product even at hospitals where it is already approved and on the shelf. • Regulatory approval timelines and outcomes for the supplemental BLA for the dialysis indication are uncertain, despite existing approval of the same product for the trauma indication, due to potential FDA changes and unpredictable review processes. • U.S. government and Department of Defense procurement timelines are uncertain and difficult to predict, which may delay revenue from public sector adoption. • The company reported a net loss of $17.6 million in Q1 2026, and sustained negative cash flow from operations may impact long-term liquidity even with the current $48.9 million cash balance.

Analyst Q&A

• Q: What revenue trajectory should be expected from U.S. commercial adoption of CIMVEST outside of government contracts, and how has the commercial strategy shifted? What lessons from CIMVEST's trauma launch apply to the future dialysis launch?

  A: Management says it is too early to provide 2026 revenue guidance, but expects the new customer-focused commercial strategy to accelerate growth this year. The company has shifted from primarily pursuing hospital VAC approvals to also prioritizing direct surgeon education and support, which addresses missed adoption opportunities when the product sits unused on shelves. Lessons from trauma adoption show surgeons are satisfied with CIMVEST performance in even high-risk cases, and existing relationships with trauma surgeons (many of whom also perform dialysis access procedures) will help drive early dialysis adoption if trial results are positive, especially for the large unmet need of access in female patients.

• Q: What is the path to FDA clearance for the dialysis indication, and how de-risked is approval given the existing trauma approval?

  A: If interim results are positive, the trial will stop early per protocol, and the company will submit a supplemental BLA combining VO-12 data with positive data from the completed VO-7 trial. Since the product is identical to the already-approved trauma product, all non-clinical sections of the BLA are already reviewed and approved. The company plans to request accelerated review under the RMAT designation, which could result in clearance by July 2027, but clearance is not guaranteed, and review timelines are dependent on FDA. No recent substantive updates have been received from the FDA, but the review team for this application has remained largely intact, providing regulatory continuity.

• Q: Following the reacquisition of ex-U.S. rights from Fresenius, what is the company's international strategy, including for the European market?

  A: The company will continue advancing and expanding ongoing efforts in the Middle East, including the already announced Saudi Arabia program and Israel MAA review. The reacquisition of ex-U.S. rights now allows the company to pursue partnership discussions with prospective partners for other major ex-U.S. markets including Europe and Japan, and initial outreach to potential partners has already begun. Fresenius supported data collection for the dialysis trial at their treatment centers but is not involved in the BLA submission itself.

• Q: How do CMS's 2026 ESRD Quality Incentive Program rules impact adoption potential for the dialysis indication, especially for female patients?

  A: The new rules financially penalize dialysis clinics that maintain high long-term catheter use, creating a strong incentive to find alternatives for patients who cannot get a functional mature fistula. Per national data, nearly one in three U.S. female dialysis patients rely on catheters because their fistulas fail to mature, with no good existing alternatives. If ATEV proves effective, it will reduce catheter reliance, cut high costs of catheter-related hospitalizations and failed procedures, improve patient outcomes, and help clinics meet CMS requirements, creating strong market demand.