Humacyte, Inc. Q3 FY2025 earnings call

Commercial Launch of Symvess

• 25 hospitals/health care systems completed VAC process, 92 civilian hospitals eligible for Symvess. 45 VAC committees ongoing. Product sales rose to $703,000 in Q3 vs $100,000 in Q2. ECAT approval for DoD access, with first commercial sale to military facilities. Publications on Symvess in vascular trauma, including outcomes in hospital-acquired vascular complications, wartime injuries in Ukraine, and comparison to autologous vein.

Dialysis Access Program

• V007 Phase III trial showed ATEV superior in duration of use vs autogenous fistula in high-need subgroups. V012 Phase III trial in women ongoing, interim analysis expected Apr 2026, plan to submit supplemental BLA for dialysis access in H2 2026.

Coronary Tissue Engineered Vessel (CTEV)

• Preclinical study results published, on track for first-in-human study in CABG in 2026, IND filed with FDA.

Intellectual Property

• New U.S. patent granted for bioengineered esophagus, expanding tubular prosthesis patent family to include trachea, urinary conduits, and esophagus.

For the three months ended September 30, 2025, revenue was $0.8 million, with $0.7 million from U.S. sales of Symvess and $0.1 million from a research collaboration. For the nine months ended September 30, 2025, revenue was $1.6 million, with $0.9 million from Symvess sales and $0.6 million from the research collaboration. Cost of goods sold was $0.3 million for the three months and $0.6 million for the nine months of 2025. Research and development expenses were $17.3 million for the three months and $54.7 million for the nine months of 2025. Selling, general and administrative expenses were $7.6 million for the three months and $23.6 million for the nine months of 2025. Net loss was $17.5 million for the three months and $16.0 million for the nine months of 2025. Cash, cash equivalents, and restricted cash were $19.8 million as of September 30, 2025, and subsequent to that date, additional net proceeds from stock sales added ~$56.5 million to cash position.

Cash Runway

• Cash runway exceeds 12 months from Q3 2025 date, including proceeds from stock sales.

BLA Submission

• Plan to submit supplemental BLA for dialysis access in H2 2026, leveraging V007 and V012 trial data.

CTEV Timeline

• On track for first-in-human study in CABG in 2026, with IND already filed with FDA.

CMS Decision Impact

• CMS determined Symvess in trauma is not novel, leading to decision not to resubmit NTAP. Impact on market adoption.

Price Sensitivity

• Hospitals are price-sensitive, affecting VAC approval timelines and adoption speed.

Regulatory Delays

• Potential delays in FDA approvals for BLA submissions or clinical trial interim analyses.

Q: In Q2, you mentioned 12 of 45 hospitals had initiated the VAC process and now you said that 16 had started ordering. How many of those that have started ordering have begun the reorder process?

A: We have not disclosed that data previously, but I believe the majority have reordered.

Q: Now that you have this new data from the trial for 007, how does that change your view for the potential for Symvess in dialysis?

A: The very strong results in duration of usability in high-unmet need subgroups going out to 2 years is very strong data, and will support the supplemental BLA application for dialysis access.

Q: Out of the units that you've been purchased, I was curious what is or how many of those have been used versus what are initial stocking orders at these hospitals?

A: Initial stocking orders range from 1 to 3 units. Typically, hospitals reorder when they fall below par level based on usage.

Q: I was hoping that just -- you guys have generated some strong supportive evidence for Symvess in the vascular trauma indication. And it sounds like this question has already been answered, but how impactful has that been just in terms of getting that processes started and then moving through the process?

A: The steady drumbeat of publications has been helpful in providing assurance to surgeons. There's a post-approval registry study with FDA, expected to kick off in H1 2026 with data forthcoming.

Q: I wanted to ask about Symvess in the AV access indication. In terms of the BLA process and this interim analysis, I mean, should we be thinking that if the interim analysis for the first 80 patients in V012 kind of those results mirror the 1 and 2 results in females from V007 that the package will be robust enough for the FDA to consider approval?

A: Yes, we believe that if the interim analysis of V012 mirrors V007 results, it would provide robust support for FDA approval of the BLA for dialysis access.

Q: I'd like to just ask you a little bit about what's involved in transitioning the sales force as you start looking towards hemodialysis and essentially the work you're doing now kind of creating the awareness in the marketplace, how do you transition that into the commercial opportunity for dialysis?

A: We have a small sales force in trauma, looking to strategically add reps. Vascular surgeons performing trauma also do dialysis access, so visibility with this cohort supports both efforts.

Q: Have you reconsidered the strategy regarding the NTAP submission? And is there a plan to resubmit it?

A: We've opted not to resubmit for NTAP in trauma, as CMS's decision was surprising, and price reductions have helped drive market activity.

Q: How do you initiate your conversations and maintain your conversations on value proposal to the folks on the VAC committees? And what are the things that resonate with them, especially when you had to still dislodge the autologous vein grafts?

A: We used a Budget Impact Model showing cost savings from decreased amputations and infections. The reduction in price point makes this economic argument stronger, helping with VAC approvals.

Q: It looks like there's some good operational excellence being done here. So you reduced your cash burn. Is this the new, I mean, cash use expectations from here onwards? And also with the $76 million in the bank now, how long of a runway are you going to have? And does that include the BLA submission for the dialysis indication?

A: Cash runway exceeds 12 months from Q3 2025 date, including enough cash to cover milestones like V012 interim analysis, BLA submission for dialysis, and CTEV first-in-human study.