Q4 2025 Humacyte Inc Earnings Call

March 27, 2026

Speaker #2: Additional information concerning factors that could cause actual results to differ from statements made in this call is contained in our periodic reports filed with the SEC.

Speaker #2: Forward-looking statements made during this call speak only as of the date hereof, and the company takes no obligation to update or revise these forward-looking statements except as required by law.

Speaker #2: Information presented on this call is contained in the press releases issued this morning and in our Form 10-K, which, after filing, may be accessed from the investor page of the Humacyte website.

Speaker #2: Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer and Chief Development Officer.

Speaker #2: Dr. Niklason will provide a summary of the company's progress for the fourth quarter and in recent weeks, and Dale will review the financial results for the quarter and year ended December 31, 2025.

Speaker #2: I will now turn the call over to Dr. Niklason. Laura?

Speaker #3: Thank you, Tom. Good morning, everyone, and thank you for joining us for the 2025 fourth quarter and year financial results and business update call. I'm pleased to report that our fourth quarter and recent weeks have been a productive period for Humacyte, with continued execution of our commercial program for CIMBESS and the advancement of other bioengineered vessel programs.

Speaker #3: During today's call, I'll review progress across our commercial and development program before turning the call over to Dale for a review of our financial results for the year.

Speaker #3: I'll begin with the commercial launch of CIMBESS. We continue to execute our U.S. market launch of CIMBESS, and in parallel, we've taken major steps to expand the commercialization of the product into international markets.

Speaker #3: To date, there are a total of 27 VAC approvals for CIMBESS in the U.S. Furthermore, an additional 43 VAC committees are currently conducting their review process.

Speaker #3: Our rate of success with VAC submissions is roughly 70%, which is a good success rate. To date, 27 hospitals have ordered CIMBESS, with the majority of these hospitals placing reorders.

Speaker #3: Four-quarter product sales were $0.4 million for the year, for the quarter, and $1.4 million for the year. We're pleased that the U.S. Defense Department has dedicated funding for evaluation and incorporation of new biologic vascular repair technology.

Speaker #3: In appropriating funding, lawmakers demonstrated that they recognize and understand the need for human-derived bioengineered blood vessels to save life and limb on the battlefield.

Speaker #3: We believe this historic, first-of-its-kind federal investment will help ensure that our soldiers continue to have access to cutting-edge treatments and state-of-the-art care wherever and whenever they need it.

Speaker #3: We look forward to working with leaders in our military and in the DOD to ensure that American service personnel will have access to this groundbreaking technology.

Speaker #3: Internationally, interest in CIMBESS has been highlighted by two recent announcements. Early this month, we received a $1.475 million purchase commitment that will facilitate the clinical evaluation and outreach program in hospitals within the Kingdom of Saudi Arabia.

Speaker #3: The planned clinical evaluation program is going to be conducted in parallel with ongoing negotiations with the Kingdom-based entity for establishment of a joint venture and a license to commercialize CIMBESS within country.

Speaker #3: Also, in March, we submit a marketing authorization application, or MAA, with the Israeli Ministry of Health for CIMBESS for arterial trauma repair. In response to surgeon requests, we're also pursuing a mechanism for making CIMBESS available in Israel, on a hospital-by-hospital basis, even in advance of MAA approval.

Speaker #3: Commercial adoption of CIMBESS was further supported by publication of several important papers, including long-term safety data from our V005 Phase 2/3 trial in the Journal of Vascular Surgery Cases, Innovations and Techniques.

Speaker #3: These data were also presented last January by Dr. Michael Curie of the New Jersey Medical School at the annual winter meeting of the Vascular and Endovascular Surgery Society.

Speaker #3: Among those treated in the V005 study were 54 patients who underwent extremity vascular repair with CIMBESS, for whom treatment with autologous vein, which is the standard of care, was not feasible.

Speaker #3: Within this patient population, once early complications from the traumatic injuries resolved, the rates of conduit infection, limb salvage, and patient survival plateaued and remained relatively constant through the three years of follow-up.

Speaker #3: CIMBESS maintained an infection-free rate of 92.9% from months 3 to 36, with no infections after day 37. Limb salvage rates were 87.3% at 12 months and 82.5% at 24 months.

Speaker #3: Despite a severely injured trauma cohort, long-term mechanical durability was also demonstrated during the V005 study, with CIMBESS diameters maintained constant over three years of follow-up.

Speaker #3: And importantly, no deaths, amputations, or mechanical failures were attributed to CIMBESS in this high-risk trauma population. There was no evidence of spontaneous ruptures or structural failures in any patient throughout the follow-up period.

Speaker #3: These outcomes point to the potential of CIMBESS to provide meaningful benefits for patients who are facing life- or limb-threatening injuries. Where autologous reconstruction is not an option, in addition, durability data in the military trauma setting was highlighted in an October 2025 publication in Oxford Academics' Military Medicine, which describes positive long-term results from a humanitarian program using CIMBESS to treat wartime vascular injuries in Ukraine. The publication reported on 17 trauma patients with wartime extremity injuries.

Speaker #3: Patients who were treated with CIMBESS were followed for up to 18 months. These wartime patients were observed to have a high CIMBESS patency rate of 87.1% and also 100% limb salvage, showing the durability of CIMBESS in the treatment of real-world combat injuries.

Speaker #3: Also in October, a new study comparing the clinical outcomes of CIMBESS to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma, or the AAST's, Trauma Surgery & Acute Care Open Journal.

Speaker #3: This study showed that, in comparison to the registry pre-existing patients, autologous vein treated with CIMBESS experienced similar short-term outcomes for patency, limb salvage, and infection.

Speaker #3: In fact, there were no significant differences for any of these outcomes between patients who were treated with CIMBESS and the prior registry patients who had been treated with autologous vein.

Speaker #3: I'll now turn to our program, which is our next priority, which is dialysis access. As we reported last quarter, positive two-year results from the V007 Phase 2 trial of the A7 dialysis patients were presented at the American Society of Nephrology's Kidney Week.

Speaker #3: The A7 demonstrated superior duration of use over 24 months compared to the gold standard autogenous fistula, particularly in high-need subgroups that have historically had poor outcomes with AV fistula procedures.

Speaker #3: In particular, women who received AV dialysis access had approximately two months of usability of the access as compared to fistula. This is a dramatic and significantly longer duration of ATEV use, over two years in female patients.

Speaker #3: And this observation could greatly reduce the reliance on catheters for dialysis access for these patients. Catheters are a major cause of complications, morbidity, and cost for dialysis patients.

Speaker #3: Especially women in the U.S., where nearly 30% rely on catheters for dialysis. The complications from dialysis catheters result in excess costs of tens of thousands of dollars per year, per patient.

Speaker #3: Indeed, the catheter use nationwide in the U.S. has been rising for both men and women since 2019. Women and men with obesity and diabetes make up more than half of the dialysis access market and are historically underserved by fistulas.

Speaker #3: Which fail to mature or become usable in these patients. It's been known for decades that women suffer lower rates of fistula maturation than do men.

Speaker #3: As evidenced by the fact that only 50% of women dialyze with a fistula nationwide, compared to more than 60% of men. However, a chronic lack of better access options has limited progress for these high-risk and expensive patients.

Speaker #3: We believe that the efficacy and safety results in these high unmet need groups, combined with the approximately 50% failure rate of fistulas, make women in high-risk men a potentially important population for treatment with ATEV.

Speaker #3: We're nearing an exciting milestone, and we're currently working to complete a pre-specified interim analysis of our ongoing V12 Phase 3 trial. That is being conducted in women specifically.

Speaker #3: The V12 trial compares the ATEV to fistula hemodialysis access in female patients. A total of 116 patients have been enrolled to date in the trial.

Speaker #3: The planned interim analysis will be conducted when the first 80 patients reach one year of follow-up, and the top-line interim results will be reported by early June 2026.

Speaker #3: Subject to these interim results, our plan is to submit a supplemental BLA in the second half of 2026, which will include data from VOO12 and the VOO7 Phase 3 pivotal studies, to add dialysis—which is a major market—as an indication for the ATEV.

Speaker #3: And finally, I'll briefly discuss one of our earlier-stage programs that we're also very excited about: our coronary tissue engineered vessel, or CTEV, for use in coronary artery bypass grafting.

Speaker #3: Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft in a non-human primate model were published in September of 2025.

Speaker #3: In that study, the CTEV was observed to sustain blood flow, recellularize with the animal's cells, and remodel to bring the diameter of the CTEV in line with the animal's native coronary artery.

Speaker #3: We're on track with our plan to advance CTEV into first-in-human use in coronary artery bypass grafting, later in 2026. We submitted an Investigational New Drug application to the FDA for the indication late last year, in the fourth quarter.

Speaker #3: To support this planned study, we initiated the first large-scale manufacturing of CTEV in our commercial-scale manufacturing facility. We plan to commence the first-in-human Phase 1/2 study in coronary artery bypass in the second half of 2026, upon completion of manufacturing and clearance by the FDA.

Speaker #3: And with this, I'll turn it over to Dale.

Speaker #2: Thank you, Laura. There was $0.5 million in revenue for the three months ended September 30, 2025, of which $0.4 million related to U.S. sales of 25 Synvisc units.

Speaker #2: The remaining revenue resulted from research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications.

Speaker #2: Revenue for the year ended December 31, 2025, was $2.0 million, of which $1.4 million related to U.S. sales of 61 Synvisc units, and the remainder resulted from the research collaboration.

Speaker #2: There was no revenue for either the three months or the year ended December 31, 2024. Cost of goods sold was $9.1 million and $9.7 million for the three months and the year ended December 31, 2025, respectively.

Speaker #2: Cost of sales for both periods included a reserve of $8.9 million to reduce inventory to its net realizable value, as consistent sales history has not yet been established, and we were required under financial accounting standards to essentially reduce inventory to the level equivalent to our 2025 historic sales.

Speaker #2: Cost of sales also included overhead related to unused production capacity, which was recorded as an expense in the period incurred. There were no cost of goods sold for either the three months or the year ended December 31, 2024.

Speaker #2: Research and development expenses were $14.6 million for the three months ended December 31, 2025, compared to $20.7 million for the three months ended December 31, 2024, and were $69.3 million for the year ended December 31, 2025, compared to $88.6 million for the year ended December 31, 2024.

Speaker #2: The decrease reflects, in part, the transition from development activities to commercial operations following the FDA approval of Synvisc in December 2024. This includes the current year allocation of manufacturing costs to inventory and cost of sales, which in prior years were included within research and development expenses.

Speaker #2: In addition, during 2025, clinical study costs decreased due to the completion or winding down of certain clinical programs, including the B005 study in trauma.

Speaker #2: Selling, general, and administrative expenses were $7.6 million for the three months ended December 31, 2024, compared to $7.4 million for the three months ended December 31, 2023, and were $31.2 million for the year ended December 31, 2025, compared to $25.8 million for the year ended December 31, 2024.

Operator 1: Good morning, ladies and gentlemen, and welcome to Humacyte Q4 and Full Year 2025 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Operator: Good morning, ladies and gentlemen, and welcome to Humacyte Q4 and Full Year 2025 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

Speaker #2: The increase in 2025 expenses compared to the prior year periods resulted primarily from the U.S. commercial launch of Synvisc in the vascular trauma indication, including increased personnel expenses.

Thomas Johnson: Thank you, operator. Before we proceed with the call, I'd like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. Forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise these forward-looking statements except as required by law. Information presented on this call is contained in the press release that was issued this morning and in our Form 10-K, which, after filing, may be accessed from the investor page of the Humacyte website.

Speaker #2: Other net income for the three months ended December 31, 2025, was net income of $6.0 million, compared to $7.1 million for the three months ended December 31, 2024. Other net income was $67.3 million for the year ended December 31, 2025, compared to other net expenses of $34.3 million for the year ended December 31, 2024.

Speaker #2: The increase in other net income for the year ended December 31, 2025, primarily resulted from $98.2 million in non-cash gains consisting of a $59.5 million fair market remeasurement of our contingent earnout liability, and a $38.8 million fair market remeasurement of derivative liabilities.

Thomas Johnson: Information presented on this call is contained in the press release that was issued this morning and in our Form 10-K, which, after filing, may be accessed from the investor page of the Humacyte website.

Thomas Johnson: Joining me on today's call are from Humacyte Dr. Laura Niklason, President and Chief Executive Officer, and Dale Sander, Chief Financial Officer and Chief Development Officer. Dr. Niklason will provide a summary of the company's progress for the Q4 and in recent weeks, and Dale will review the financial results for the quarter and year ended December 31, 2025. I will now turn the call over to Dr. Niklason. Lora.

Speaker #2: Partially offset by a $22.3 million loss on extinguishment of debt. Net loss was $24.8 million for the three months ended December 31, 2025, compared to a net loss of $20.9 million for the three months ended December 31, 2024. Net loss was $40.8 million for the year ended December 31, 2025, compared to a net loss of $148.7 million for the year ended December 31, 2024.

Laura Niklason: Thank you, Tom. Good morning, everyone, and thank you for joining us for our 2025 Q4 and year financial results and business update call. I'm pleased to report that our Q4 and recent weeks have been a productive period for Humacyte, with continued execution of our commercial program for Symvess and the advancement of other bioengineered vessel programs. During today's call, I'll review progress across our commercial and development program before turning the call over to Dale for a review of our financial results for the year. I'll begin with the commercial launch of Symvess. We continued to execute our US market launch of Symvess, and in parallel, we've taken major steps to expand the commercialization of the product into international markets.

Speaker #2: The increase in net loss for the three months ended December 31, 2025, primarily resulted from the inventory reserve, partially offset by a decrease in operating expenses.

Speaker #2: The decrease in net loss for the year ended December 31, 2025, resulted primarily from the increase in other net income and the decrease in operating expenses, partially offset by the inventory reserve.

Speaker #2: We had cash and cash equivalents of $50.5 million as of December 31, 2025. Subsequent to December 31, 2025, we raised an additional $18.4 million in net proceeds from a registered direct offering of common stock and net proceeds of $4.6 million from the sale of common stock through our at-the-market facility.

Laura Niklason: To date, there are a total of 27 VAC approvals for Symvess in the US, and furthermore, an additional 43 VAC committees are currently conducting their review process. Our rate of success with VAC submissions is roughly 70%, which is a good success rate. To date, 27 hospitals have ordered Symvess, with the majority of these hospitals placing reorders. Q4 product sales were $0.4 million for the quarter and $1.4 million for the year. We're pleased that the U.S. Department of Defense has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating the funding, the lawmakers demonstrated that they recognize and understand the need for human-derived bioengineered blood vessels to save life and limb in the battlefield.

Speaker #2: In December 2025, we entered into a credit facility with a fund of the Avenue Capital Group, providing up to $77.5 million in new financing.

Speaker #2: The credit agreement, which has a term of four years, includes an initial tranche of $40 million, which was fully funded at close, and an additional two tranches of up to an aggregate of $37.5 million available to Humacyte, subject to the satisfaction of certain revenue, regulatory, and liquidity conditions.

Speaker #2: Proceeds from the initial $40 million tranche were used primarily to retire our existing debt facility. Total net cash used was $44.4 million for the year ended December 31, 2025, compared to total net cash provided of $14.5 million for the year ended December 31, 2024.

Laura Niklason: We believe this historic, first of its kind federal investment will help ensure that our soldiers continue to have access to cutting-edge treatments and state-of-the-art care wherever and whenever they need it. We look forward to working with leaders in our military and in the DoD to ensure that the American service personnel will have access to this groundbreaking technology. Internationally, interest in Symvess has been highlighted by two recent announcements. Early this month, we received a $1.475 million purchase commitment that will facilitate the clinical evaluation and outreach program in hospitals within the Kingdom of Saudi Arabia. The planned clinical evaluation program is going to be conducted in parallel with ongoing negotiations with a kingdom-based entity for establishment of a joint venture and a license to commercialize Symvess within country.

Speaker #2: The increase in net cash used in 2025 resulted primarily from the 2025 debt extinguishment and an additional debt draw during 2024 that did not occur in 2025.

Speaker #2: With that, I will turn the call back over to Laura.

Speaker #1: Thank you, Dale. And I think, as you can see, we've had a very busy and productive 2025, as well as early 2026. We're continuing to execute on our commercial activities, and we are continuing to expand into international markets and also expand our pipeline, both clinically and pre-clinically.

Laura Niklason: Also in March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for Symvess for arterial trauma repair. In response to surgeon requests, we're also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis, even in advance of MAA approval. Commercial adoption of Symvess was further supported by publication of several important papers, including long-term safety data from our V005 Phase 2/3 trial in the Journal of Vascular Surgery Cases, Innovations, and Techniques. These data were also presented last January by Dr. Michael Curry of the New Jersey Medical School at the annual winter meeting of the Vascular and Endovascular Surgery Society. Among those treated in the V005 study were 54 patients who underwent extremity vascular repair with Symvess, for whom treatment with autologous vein, which is the standard of care, was not feasible.

Speaker #1: I think at this point, operator, we can take questions.

Speaker #3: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker #3: You may press star two if you would like to remove your question from the queue, and for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker #3: Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Speaker #4: Good morning. Thanks for taking our questions, Lauren Dale. Certainly, a lot of different directions to go on the questions here, but I guess I want to stick with trauma just because it is kind of the present-day topic.

Speaker #4: In terms of commercialization, so just one, how are sites responding to the new pricing of Synvisc? And then the second question—again, appreciate that you're looking forward to dialysis access.

Speaker #4: But what do you expect, and what are your thoughts on the year ahead within trauma adoption, and any forward commentary? I know, again, it's still early to guide, but any forward commentary is appreciated.

Laura Niklason: Within this patient population, once early complications from the traumatic injuries resolved, the rates of conduit infection, limb salvage, and patient survival plateaued and remained relatively constant through the 3 years of follow-up. Symvess maintained an infection-free rate of 92.9% from months 3 to 36, with no infections after day 37. Limb salvage rates were 87.3% at 12 months and 82.5% at 24 months, despite a severely injured trauma cohort. Long-term mechanical durability was also demonstrated during the V005 study, with Symvess diameters maintained constant over 3 years of follow-up. Importantly, no deaths or amputations or mechanical failures were attributed to Symvess in this high-risk trauma population. There was no evidence of spontaneous ruptures or structural failures in any patient throughout the follow-up period.

Speaker #1: Yeah, it is too early to guide, Ryan. Thank you very much. But we have seen a positive response to the new price point of $17,000.

Speaker #1: This puts us in a price range that is not that different from other products that are used by vascular and aortic surgeons. Certainly, some aortic stents and other reconstruction devices can be upwards of $20,000.

Speaker #1: So this price point of $17,000, it puts us in a good range, and in my personal communications with surgeons, and also those of the surgical sales force, that's been a uniform commentary.

Speaker #1: So the result is there has been a higher rate of VAC approvals, a higher percentage. So we're above 70% now. And also, we're getting more usage and more repeat usage because surgeons are less hesitant to pull the product because it's "expensive." The timelines as far as VAC committees continue to be what they have been—fairly long, six to nine months.

Laura Niklason: These outcomes point to the potential of Symvess to provide meaningful benefits for patients who are facing life or limb-threatening injury, where autologous reconstruction is not an option. In addition, durability data in the military trauma setting was highlighted in an October 2025 publication in Military Medicine, which describes positive long-term results from a humanitarian program using Symvess to treat wartime vascular injuries in Ukraine. The publication reported on 17 trauma patients with wartime extremity injuries who were treated with Symvess and were followed for up to 18 months. These wartime patients were observed to have a high Symvess patency rate of 87.1% and also 100% limb salvage, showing the durability of Symvess in treatment of real-world combat injuries.

Speaker #1: Which is followed by contracting. What I didn't mention is that we are beginning to engage with group purchasing organizations, GPOs, and working to get on contract with larger GPOs that cover many hospitals.

Speaker #1: If you get on contract with GPOs, then that doesn't eliminate the VAC process, but it eliminates the subsequent contracting process that we've heretofore been doing with individual hospitals.

Speaker #1: We also are working with several IDNs. We have VAC approvals in several integrated delivery networks, or IDNs. So, while we can't really guide for 2026, I do think that the price difference has made an important impact.

Laura Niklason: Also in October, a new study comparing the clinical outcomes of Symvess to autologous vein in the treatment of extremity arterial trauma was published in the American Association for the Surgery of Trauma, or the AAST's, Trauma Surgery & Acute Care Open. This study showed that in comparison to trauma registry pre-existing patients who were treated with autologous vein, patients who were treated with Symvess experienced similar short-term outcomes for patency, limb salvage, and infection. In fact, there were no significant differences for any of these outcomes between patients who were treated with Symvess and the prior registry patients who had been treated with autologous vein. I'll now turn to our program, which is our next priority, which is dialysis access.

Speaker #1: The publication of long-term data has made an important impact, and showing that our outcomes are similar to Vein has also made an important impact with surgeons.

Speaker #1: So, we're just going to continue growing.

Speaker #4: Understood, Laura. Thank you. And then as you look ahead to dialysis access, I think a lot of people will be focused on the interim top-line results of the QUEUE.

Speaker #4: But once you get past that, maybe just talk to us about kind of the submission for the BLA for dialysis access. What do you—what's on your list to check off?

Speaker #4: How are you de-risking that now, and as you think about what you need to do to submit and subsequently get a clearance for dialysis access in the second half of this year?

Speaker #1: Sure. Well, we've actually already got a team focused on this. The timeline for all the document submissions—again, what's helpful for us here is that the clinical data will be different in dialysis, but all of the pre-clinical and the toxicity and the CMC data will all be the same.

Laura Niklason: As we reported last quarter, positive 2-year results from the V007 Phase 3 trial of the ATEV in dialysis patients were presented at the American Society of Nephrology's Kidney Week. The ATEV demonstrated superior duration of use over 24 months compared to the gold standard autogenous fistula, particularly in high-need subgroups having historically poor outcomes with AV fistula procedures. In particular, women who received ATEV for dialysis access had approximately 6 additional months of usability of the access as compared to fistula. This is a dramatic and significantly longer duration of ATEV use over 2 years in female patients. This observation could greatly reduce the reliance on catheters for dialysis access for these patients. Catheters are a major cause of complications, morbidity, and cost for dialysis patients, especially women in the US, where nearly 30% rely on catheters for dialysis.

Speaker #1: It's all already been submitted and reviewed and approved by the agency. We've had some submissions to update the CMC, but all of those have gone through, and we really have no sort of standing queries with the agency right now.

Speaker #1: So, it'll really be about the clinical package. So, after we get the top-line results—which, based on VO7, we anticipate will be positive. I don't know the results, but based on VO7, if they're similar to VO7, they'll be positive.

Speaker #1: Then we will schedule a pre-BLA meeting with the agency and advise them as to the structure of the clinical data content in the BLA.

Speaker #1: We will Will also , we have a priority designation in AV access , so we'll also ask for a six month review cycle .

Laura Niklason: The complications from dialysis catheters result in excess costs of tens of thousands of dollars per year per patient. Indeed, the catheter use nationwide in the US has been rising for both men and women since 2019. Women and men with obesity and diabetes make up more than half of the dialysis access market and are historically underserved by fistulas, which often fail to mature or become usable in these patients. It's been known for decades that women suffer lower rates of fistula maturation than do men, as evidenced by the fact that only 50% of women dialyze with a fistula nationwide, compared to more than 60% of men.

Speaker #1: Once the BLA has been accepted by the agency—and that usually takes about two months.

Speaker #2: Thank you Laura

Speaker #3: Our next question is from Jason Culbert with Deborah Capital. Please proceed.

Speaker #4: Hi . Good morning . And congratulations on all the progress . Laura , could you talk us through a little bit about how important the sales cycle is and where I'm asking the question , is .

Speaker #4: It's in relation to S , G and a , and what I'm wondering is if you were to spend , you know , put more resources and more aggressively build the sales force , will that more aggressively ramp the sales number ?

Laura Niklason: However, a chronic lack of better access options has limited progress for these high-risk and expensive patients. We believe that the efficacy and safety results in these high unmet need groups, combined with the approximately 50% failure rate of fistulas, makes women and high-risk men a potential important population for treatment with ATEV. We're nearing an exciting milestone, and we're currently working to complete a pre-specified interim analysis of our ongoing V012 Phase 3 trial that is being conducted in women specifically. The V012 trial compares the ATEV to fistula for hemodialysis access in female patients. A total of 116 patients have been enrolled to date in the trial. The planned interim analysis will be conducted when the first 80 patients reach one year of follow-up, and the top line interim results will be reported by early June 2026.

Speaker #4: And where would you focus those efforts? What percentage would be domestic? What percentage would be international? Thanks.

Speaker #1: Right . So we're focusing in both places . And I would say we're looking at adding to the sales team . And I've communicated to this list to the market before .

Speaker #1: We're looking at adding to the sales team domestically . We already have added some medical , medical affairs people . We're looking at adding salespeople to extend our reach to more metropolitan areas But in addition , the , the , the Israeli and the Saudi commercialization efforts , we see those more as partnered .

Speaker #1: We have a putative partner for commercialization in Israel and also 1 in 1 in Saudi . I can't share names right now , but but we have we have putative partners who are very excited about the product and the technology and getting it in country So we would imagine that in terms of in terms of sort of additional G&A hires , there would probably be more educational hires , medical affairs hires that would be deployed in those countries that we would support .

Laura Niklason: Subject to these interim results, our plan is to submit a supplemental BLA in H2 2026, which will include data from V012s and the V007 phase 3 pivotal study to add dialysis, which is a major market, as an indication for the ATEV. Finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about. Our coronary tissue engineered vessel, or CTEV, for use in coronary artery bypass grafting. Positive results of a preclinical study evaluating the CTEV as a coronary artery bypass graft in a non-human primate model were published in September 2025. In that study, the CTEV was observed to sustain blood flow, recellularize with the animal cells, and remodel to bring the diameter of the CTEV in line with the animal's native coronary artery.

Speaker #1: And provide. But we anticipate that a lot of the sales would be—sales personnel would be provided by our distributors in-country.

Speaker #4: Gotcha . That makes a lot of sense . And the other part of the question is , once you're in an institution , they're kind of going through the learning curve .

Speaker #4: How long does it take for them to be really users and adopters ? I mean , that process is at a year . Is it 18 months ?

Speaker #4: Is it six months from your experience? What are you seeing, like at a given institution, that you're really focused on?

Speaker #1: Yeah . Well , we've only been on the market for a year , so and in a lot of these places , we've been on the shelf for less than six months because of it , because of the VAC cycle .

Laura Niklason: We're on track with our plan to advance CTEV into first-in-human use in coronary artery bypass grafting later in 2026. We submitted an investigational new drug application to the FDA for this indication late last year in Q4. To support this planned study, we initiated the first large-scale manufacturing of CTEV in our commercial scale manufacturing facility. We plan to commence the first-in-human Phase 1/2 study in coronary artery bypass in H2 2026 upon completion of manufacturing and clearance by the FDA. With this, I'll turn it over to Dale.

Speaker #1: So, it's hard for me to answer that question. But you know, what I can say is that once it's on the shelf and pulled by a surgeon, they will tend to use it.

Speaker #1: Watch the first patient for a little while . A month or two , and then they begin pulling it again . So it's just like any other new medical device or implantable technology Surgeon's a new surgeon will typically want to watch the first patient and then reuse .

Speaker #1: And that's what we've been seeing. You know, we've really had— we've really had no blowback as far as how the vessel is being used.

Speaker #1: I can tell you it's being used in extraordinarily difficult cases where things are challenging, and I can tell you that from reports I've heard from surgeons, we are absolutely saving limb and life.

Dale Sander: Thank you, Laura. There was $0.5 million in revenue for the three months ended 31 December 2025, of which $0.4 million related to US sales of 25 Symvess units. The remaining revenue resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications. Revenue for the year ended 31 December 2025 was $2.0 million, of which $1.4 million related to US sales of 61 Symvess units, and the remainder resulted from the research collaboration. There was no revenue for either the three months or the year ended 31 December 2024. Cost of goods sold were $9.1 million and $9.7 million for the three months and the year ended 31 December 2025, respectively.

Speaker #1: There is no question

Speaker #4: Yeah, I think that's the title of my next note. Thank you so much. Look forward to more updates.

Speaker #1: Thank you .

Speaker #3: Our next question is from Ali Bretzel with Piper Sandler. Please proceed.

Speaker #5: Good morning , and thank you for taking my question . This is Peter Gianopoulos on for Ali from Piper Sandler . On the commercial front for invest , you noted that 27 hospitals have ordered to date with the majority reordering .

Speaker #5: Could you break down what proportion of Q4 sales came from newly onboarded accounts versus reorders? And within those reordering hospitals, are you seeing utilization expand beyond the initial champion surgeon to other trauma surgeons?

Speaker #5: Thank you .

Speaker #1: I'm sorry, I don't have the level of granularity to accurately answer the first part of your question. Although, we could come back to you—folks from our commercial team could come back to you for the answer.

Dale Sander: Cost of sales for both periods included a reserve of $8.9 million to reduce inventory to its net realizable value, as a consistent sales history has not yet been established, and we were required under financial accounting standards to essentially reduce inventory to the level equivalent to our 2025 historic sales. Cost of sales also included overhead related to unused production capacity, which was recorded as an expense in the period incurred. There were no cost of goods sold for either the three months or the year ended December 31, 2024.

Speaker #1: With that As far as as far as growth to other surgeons , beyond the initial sort of champion , we're definitely seeing that in some of our busier centers and it's it's definitely a word of mouth type thing as it is with all new , new devices in some centers , we have three and four surgeons using in the majority of centers , we probably still just have one surgeon using , but that's that's changing every week , every month

Speaker #5: Thank you

Dale Sander: Research and development expenses were $14.6 million for the three months ended 31 December 2025, compared to $20.7 million for the three months ended 31 December 2024, and were $69.3 million for the year ended 31 December 2025, compared to $88.6 million for the year ended 31 December 2024. The decrease reflects in part the transition from development activities to commercial operations following FDA approval of Symvess in December 2024, including the current year allocation of manufacturing costs to inventory and cost of sales, costs that in prior years were included within research and development expenses. In addition, during 2025, clinical study costs decreased due to the completion or winding down of certain clinical programs, including the V005 study in trauma.

Speaker #3: Our next question is from Matt Miksic with Barclays. Please proceed.

Speaker #6: Hi. Thanks so much for taking the questions, and congrats, Laura and Dale, again on the really impressive progress on the clinical front.

Speaker #6: And with some of the developments around , around sort of defense oriented and Middle Eastern contracts , it's great So on that front , I was wondering if you could talk a little bit about how some of those contracts we should expect to kind of fall into into the revenue flow , you know , as soon as you sort of like lumpy orders or gradual orders or , you know , contracts , to order and sort of wait and see on revenues , how would you describe it

Speaker #1: I think the way we're working with, in particular, our Saudi partners, our commercialization partners over there, the initial orders will be chunky.

Dale Sander: Selling, general, and administrative expenses were $7.6 million for the three months ended December 31, 2024, compared to $7.4 million for the three months ended December 31, 2024, and were $31.2 million for the year ended December 31, 2025, compared to $25.8 million for the year ended December 31, 2024. The increase in 2025 expenses compared to the prior year periods resulted primarily from the US commercial launch of Symvess in the vascular trauma indication, including increased personnel expenses.

Speaker #1: So so the 1.475 million order will will be realized as a as a single order . The goal is to get quite a bit of product in country and , and distributed to multiple leading academic medical centers in Saudi Arabia .

Speaker #1: So that multiple surgeons can be trained and really understand the utility of the vessel. There's a tremendous amount of trauma in Saudi Arabia.

Speaker #1: It has more car accidents than any other country in the world. And, in addition to that, there's also a large PAD market.

Dale Sander: Other net income for the three months ended 31 December 2025 was net income of $6.0 million. Compared to $7.1 million for the three months ended 31 December 2024, other net income was $67.3 million for the year ended 31 December 2025, compared to other net expenses of $34.3 million for the year ended 31 December 2024. The increase in other net income for the year ended 31 December 2025 primarily resulted from $98.2 million in non-cash gains, consisting of a $59.5 million fair value remeasurement of our contingent earn-out liability, and a $38.8 million fair value remeasurement of derivative liabilities, partially offset by a $22.3 million loss on extinguishment of debt.

Speaker #1: So there's a tremendous opportunity , opportunity for us in Saudi . And so the strategy with our partner is that in , in parallel with submitting for , for full approval with the Saudi FDA , we're also initiating this physician trialing period , not a clinical trial per se , but a trial period after approval .

Speaker #1: We would imagine further chunky orders because some , you know , some medical acquisitions come from individual hospitals , certainly in Saudi , but some also come directly from the Ministry of Health .

Speaker #1: And those can be larger, chunky orders. And I don't know exactly how that's going to look yet.

Speaker #6: That's fair . That's fair . But helpful . And then on back on sort of the hospital , you know , where you are with back approvals and the , you know , 43 articles in kind of review process or accounts and review process , you know , are we getting to a point where , you know , I know you have a certain set of target hospitals in the US , you know , focusing on vascular trauma .

Dale Sander: Net loss was $24.8 million for the three months ended 31 December 2025, compared to a net loss of $20.9 million for the three months ended 31 December 2024, and net loss was $40.8 million for the year ended 31 December 2025, compared to a net loss of $148.7 million for the year ended 31 December 2024. The increase in net loss for the three months ended 31 December 2025 primarily resulted from the inventory reserve, partially offset by a decrease in operating expenses. The decrease in net loss for the year ended 31 December 2025 resulted primarily from the increase in other net income and the decrease in operating expenses, partially offset by the inventory reserves.

Speaker #6: Do you feel like we're getting to a plateau or , or the or maybe the opposite in terms of , you know , the pricing and the and the continued in clinical data starting to feel more like increasing momentum .

Speaker #6: How would you describe , you know , the , the , where we are in that list of whatever 120 centers ?

Speaker #1: Yeah . Thank you for that . No , it , it feels again , it feels it's lumpy for sure . But it feels like it's accelerating .

Speaker #1: We're getting , we're getting more sort of spontaneous inbound calls from surgeons even before they have it on the shelf . If they have VAC approval or even before they have VAC approval , the , the word is getting out in the surgical community .

Dale Sander: We had cash and cash equivalents of $50.5 million as of 31 December 2025. Subsequent to 31 December 2025, we raised an additional $18.4 million in net proceeds from the registered direct offering of common stock and net proceeds of $4.6 million from the sale of common stock through our at-the-market facility. In December 2025, we entered into a credit facility with a fund of the Avenue Capital Group, providing up to $77.5 million in new financing. The credit agreement, which has a term of four years, includes an initial tranche of $40 million, which was funded fully at close, and an additional two tranches of up to an aggregate of $37.5 million available to Humacyte, subject to the satisfaction of certain revenue, regulatory, and liquidity conditions.

Speaker #1: I mean , some surgeons post social media on on their use of the vessel and they go back and forth with the with each other on , on their experiences .

Speaker #1: And so, there's a lot of sort of organic word of mouth that's happening across medical centers. And that's driving enthusiasm for the product.

Speaker #1: So , you know , we're in terms of level one and level two trauma centers , I think that I don't know the exact number , but it's probably around 50 level one and level two trauma centers where we have VAC approvals .

Speaker #1: There's a total of 200 level ones. And, uh, and three or four hundred level twos. So I still think that we're— we're just, I don't want to say we're scraping the surface, but we're still at the beginning.

Speaker #1: And , and the rate , the excitement about the product and the rate of usage , I feel is increasing .

Speaker #6: Okay, that's super helpful. Well, thanks again for the questions, and congrats on the progress.

Dale Sander: Proceeds from the initial $40 million tranche were used primarily to retire our existing debt facility. Total net cash used was $44.4 million for the year ended 31 December 2025, compared to total net cash provided of $14.5 million for the year ended 31 December 2024. The increase in net cash used in 2025 resulted primarily from the 2025 debt extinguishment and an additional debt draw during 2024 that did not occur in 2025. With that, I will turn the call back over to Laura.

Speaker #1: Thank you .

Speaker #3: Our next question is from Swayam Rahmana from H. Wainwright. Please proceed.

Speaker #7: Good morning , Laura and Dale . This is Aki from Wainwright . A couple of quick questions from me regarding the DoD procurement that that that you're you're expecting since I believe this this particular funding got initiated sometime in February , early February .

Speaker #7: And as we know , the budget year ends in September . Do you have any any insight into when some of these procurement could happen , or is do you think this could bleed into 2027 budget year or , you know , for 2027 ?

Laura Niklason: Thank you, Dale. I think as you can see, we've had a very busy and productive 2025 as well as early 2026. We're continuing to execute on our commercial activities, and we are continuing to expand into international markets, and also expand our pipeline both clinically and pre-clinically. I think at this point, operator, we can take questions.

Speaker #7: Is it a completely new application all over again?

Speaker #1: Yeah , no . So it's so I'll do my best to answer your question . So we anticipate that this funding will be spent in calendar 2026 .

Speaker #1: It may bleed over into fiscal 2027 . But but the the the funding is really designed to both procure SIM vest , probably more than half of the funding is for military procurement .

Speaker #1: And then the balance we've we've drafted a plan working with some with some leading surgeons in military treatment facilities in the US who are who are current , who are currently soldiers in in the military .

Operator 2: Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Operator: Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Ryan Zimmerman: Good morning. Thanks for taking our questions, Laura and Dale. Certainly a lot of different directions to go on the questions here, but I guess I want to stick with trauma just because it is kind of the present day, you know, topic in terms of commercialization. Just, you know, one, how are sites responding to the new pricing of Symvess? And then, the second question, you know, again, appreciate that you're looking forward to dialysis access. But what do you expect and what are your thoughts on the year ahead within trauma adoption? And, you know, any forward commentary? I know again, it's still early to guide, but any forward commentary is appreciated.

Speaker #1: And we've designed a plan where a little bit more than half of the funding will be utilized for procurement, and the balance will be utilized for training.

Speaker #1: So there are roughly 40 vascular surgeons in the US military, and probably 4 or 5 of them have used SIM best in their patients.

Speaker #1: But that that leaves a large number who still remain to be trained in addition to trauma surgeons . So our we really designed this not just as procurement , but also training .

Speaker #1: And we're hoping to execute all of that during calendar 2026 . In addition , we are working with some of our some of our congressional delegation looking at perhaps a larger procurement for the next fiscal year in the budget , but that's still a work in progress .

Laura Niklason: Yeah, it is too early to guide, Ryan. Thank you very much. You know, we have seen a positive response to the new price point of $17,000. You know, this puts us in a price range that is not that different from other products that are used by vascular and aortic surgeons. Certainly some aortic stents and other reconstruction devices can be upwards of $20,000. This price point of $17,000 puts us in a good range. In my personal communications with surgeons and also those of the surgical sales force, that's been a uniform commentary. The result there has been a higher rate of VAC approvals, a higher percentage. We're up above 70% now.

Speaker #7: Thank you for all that . You know , regarding the the VAC approvals , you know , between Q3 announcement and now , you know , two , two additional backup rules came on board .

Speaker #7: I'm just trying to understand , you know , a couple of things . One is the VAC approval time is is the time got extended because of some of the holidays and stuff or and also what's the conversion ?

Speaker #7: Is the conversion getting better between VAC approval and procurement of the product itself?

Laura Niklason: Also we're getting more usage and more repeat usage, because surgeons are less hesitant to pull the product because it's quote-unquote expensive. The timelines as far as VAC committees continue to be what they have been, fairly long, 6 to 9 months, which is followed by contracting. What I didn't mention is that we are beginning to engage with group purchasing organizations, GPOs, and working to get on contract with larger GPOs that cover, you know, many hospitals. If you get on contract with GPOs, that doesn't eliminate the VAC process, but it eliminates the subsequent contracting process that we've heretofore been doing with individual hospitals. We also are working with several IDNs. We have VAC approvals in several integrated delivery networks or IDNs.

Speaker #1: So, I do think—I'm not exactly sure why, why the VAC approval slowed down. I don't think it represents anything fundamental.

Speaker #1: I think it was probably more to do with holidays and meeting cycles during the holidays. VACs tend to meet less often, and they often have a backlog of cases.

Speaker #1: So I don't see this as fundamental at all . The low number of additional approvals in terms of in terms of the conversion from VAC approval to getting product on the shelf , I do think that the lower price point has really increased the rate of the speed of that , you know , it's much easier to get on the shelf and negotiate the contract and get on the shelf after the VAC approval at the current price point .

Speaker #1: So that in addition to improving the success rate in vacs , which is over 70% , all told , it's also , I think , speeding , getting product on the shelf , you know , at the at the higher price point in the very early times , our approval rate was less than 50% .

Laura Niklason: You know, while we can't really guide for 2026, you know, I do think that the price difference has made an important impact. The publication of long-term data has made an important impact. Showing that our outcomes are similar to vein has also made an important impact with surgeons. We're just gonna continue growing.

Speaker #1: So this has had a meaning. The price shift has had a meaningful input in our ability to get product into hospitals.

Speaker #7: Okay , one last question , if I may . Regarding the Saudi Arabia opportunity , do you can you maintain the 17,000 price point there or do you have to re I mean , negotiate a price over in Saudi Arabia and given the demand or the expected market over there , which is higher than than here in the United States , do you do you do you have to kind of Come up with a certain formula for for the pricing ?

Ryan Zimmerman: Understood, Laura. Thank you. You know, as we look ahead to dialysis access, I think, you know, a lot of people will be focused on the interim top-line results in Q2. Once you get past that, maybe just talk to us about kind of the submission for BLA for dialysis access. What do you know, what's on your list to check off? How are you know, de-risking that now and, you know, as you think about kind of what you need to do to submit and subsequently get a clearance for dialysis access in H2 this year?

Speaker #1: Yeah. So, we have not begun negotiating with the Ministry of Health yet in Saudi. So I think it's a little too early for me to answer your question explicitly.

Laura Niklason: Sure. Well, we've actually already got a team focused on this with a timeline for all the document submissions. You know, again, what's helpful for us here is that the clinical data will be different in dialysis, but all of the preclinical, the toxicity, and the CMC data will all be the same. It's all already been submitted and reviewed and approved by the agency. We've had some submissions to update the CMC, but all of those have gone through. We really have no sort of standing queries with the agency right now. It'll really be about the clinical package.

Speaker #1: I would say that that our expected pricing is probably somewhat above current US pricing because of just the , the additional logistics of getting product in country , going through the approval process , doing the distribution process .

Speaker #1: You know , right now we do , we do our own distribution . So we're going to have to be paying in distributor .

Speaker #1: So I think that there will . It certainly will not be less than 17 . You know , there will be some additional real world costs that that will that will be additive there .

Speaker #1: I don't I don't want to know what the final number will be . But again , I , I strongly believe that our continued excellent data in trauma and , and the published data that we've seen in phase two trials in pad will , will , will mean that this is a , this is an important addition to the Saudi medical armamentarium .

Laura Niklason: After we get the top-line results, which based on V007, we anticipate will be positive, I don't know the results, but based on V007, if they're similar to V007, they'll be positive. We will schedule a pre-BLA meeting with the agency and advise them as to the structure of the clinical data content in the BLA. We have a priority designation in AV access, so we'll also ask for a six-month review cycle once the BLA has been accepted by the agency, and that usually takes about two months.

Speaker #1: I mean , amputation in Saudi is a big problem between trauma and pad . It's a . And and diabetes . It's a big problem .

Speaker #1: So, I think we can do a lot of good in the country.

Speaker #7: Thank you. Thanks for taking all my questions. Laura

Speaker #3: Our final question is from Josh Jennings with TD Cowen. Please proceed.

Ryan Zimmerman: Thank you, Laura.

Operator 2: Our next question is from Jason Kolbert with D. Boral Capital. Please proceed.

Operator: Our next question is from Jason Kolbert with D. Boral Capital. Please proceed.

Speaker #8: Yeah . Hi , it's John . John on for Josh . Thank you for taking the question . Certainly helpful commentary on the VAC approval process and the response to pricing .

Jason Kolbert: Good morning and congratulations on all the progress. Laura, could you talk us through a little bit about how important the sales cycle is? Where I'm asking the question is, it's in relation to SG&A. What I'm wondering is, if you were to spend, you know, put more resources and more aggressively build the sales force, will that more aggressively ramp the sales number? Where would you focus those efforts? What percentage would be domestic? What percentage would be international? Thanks.

Speaker #8: Just revisiting the for Q and your commentary on 2026 . Certainly appreciate that . It's too early to provide formal guidance or you're likely not to , but just any color you could provide on , you know what may have caused the shortfall between street expectations .

Speaker #8: And again, thank you for the puts and takes around some of the revenue components in the year ahead. But do you feel the Street is accurately modeling, directionally, what the year will look like?

Speaker #8: And just had one quick follow-up.

Speaker #1: Yeah . So again , it's hard for me to comment on what the street is saying without giving projections . And so as you know , it's a little bit of a tightrope , but also , as you know , different analysts have have , have come out with a , with a broad range of expectations .

Laura Niklason: Right. We're focusing in both places, and I would say we're looking at adding to the sales team, and I've communicated this to the market before. We're looking at adding to the sales team domestically. We already have added some medical affairs people. We're looking at adding sales people to extend our reach to more metropolitan areas. In addition, the Israeli and the Saudi commercialization efforts, we see those more as partnered. We have a putative partner for commercialization in Israel and also one in Saudi. I can't share names right now, but we have putative partners who are very excited about the product and the technology and getting it in country.

Speaker #1: The higher ones , I think are probably not in line with reality . I think that , you know , like we , I if , if there's an analyst that says we're going to sell 30 million next year , I think that's probably not true .

Speaker #1: So I think our , our growth is going to be more , more gradual than that . But , you know , I think that we all the analysts learned a lot .

Speaker #1: And I think we learned a lot in this first year of commercial launch . We learned a lot about how to how to approach vex better , how to approach the pricing better , how to approach surgeons better .

Laura Niklason: We would imagine that, in terms of sort of additional G&A hires, there would probably be more educational hires, medical affairs hires, that would be deployed in those countries that we would support and provide. We anticipate that a lot of the sales personnel would be provided by our distributors in country.

Speaker #1: So , so we're a much more effective commercial team now than we were 12 months ago . And , you know , some of those learnings are just hard to predict .

Speaker #1: I mean, that's probably not a satisfactory answer, but that's what I've got.

Speaker #8: No, that's very helpful. And then, just following up on that, cash in the quarter came in essentially right in line with the pre-announcement.

Jason Kolbert: Got you. That makes a lot of sense. The other part of the question is, once you're in an institution, they're kind of going through the learning curve. How long does it take for them to be really users and adopters? I mean, that process, is it a year? Is it 18 months? Is it 6 months? From your experience, what are you seeing, like, at a given institution that you're really focused on?

Speaker #8: But just as you go through this commercialization process , do you see an opportunity to maybe reduce your cash burn rate ? Probably too early to talk about , you know , maybe a steady state growth profile , but what does tablet look like in the quarters ahead ?

Speaker #1: Yeah . Again , we're not going to give guidance on burn , but certainly we're looking very closely at burn . You know , we as as you know , we did a reduction in force last year around May .

Laura Niklason: Yeah. Well, we've only been on the market for a year, so and in a lot of these places, we've been on the shelf for less than 6 months because of the VAC cycle. It's hard for me to answer that question. You know, what I can say is that once it's on the shelf and pulled by a surgeon, they will tend to use it, watch the first patient for a little while, a month or two, and then they begin pulling it again. It's just like any other new medical device or implantable technology. A new surgeon will typically wanna watch the first patient and then reuse, and that's what we've been seeing. You know, we've really had no blowback as far as how the vessel is being used.

Speaker #1: And that saved us a total of $50 million in projected burn for 2025 . And for this year , 2026 , we're continuing to look at spend very , very closely .

Speaker #1: We understand that that that the biotech financing market has been challenging . And we understand that that the growth ramp for sales is something that we're going to have to continue to work on .

Speaker #1: So we're definitely looking at the spend side.

Speaker #8: Okay, great. Thank you very much.

Speaker #4: In addition to that, we're also looking at business development opportunities. We've had a great deal of interest in our platform from preclinical to clinical.

Speaker #4: I think that's evidenced by the interest we're seeing internationally . Just for SMS . But we're also seeing a great deal of interest on our other pipeline programs , which is why we made the announcement yesterday about adding a business development executive and have to help field the inquiries and interest we're getting across our platform in terms of licensing and partnering opportunities , which can help with Non-dilutive funding

Laura Niklason: I can tell you it's being used in extraordinarily difficult cases where things are challenging. I can tell you that from reports I've heard from surgeons, we are absolutely saving limb and life. There is no question.

Jason Kolbert: Yeah. I think that's the title of my next note. Thank you so much. Look forward to more updates.

Speaker #8: Okay, great. Thank you so much.

Laura Niklason: Thank you.

Speaker #3: We have reached the end of our question and answer session. I would like to turn the conference back over to Laura for closing remarks.

Operator 2: Our next question is from Allison Bratzel with Piper Sandler. Please proceed.

Operator: Our next question is from Ali Bratzel with Piper Sandler. Please proceed.

Peter Stavropoulos: Good morning, and thank you for taking my question. This is Peter Stavropoulos for Ali Brazell from Piper Sandler. On the commercial front for Symvess, you noted that 27 hospitals have ordered to date, with the majority reordering. Could you break down what proportion of Q4 sales came from newly onboarded accounts versus reorders? And within those reordering hospitals, are you seeing utilization expand beyond the initial champion surgeon to other trauma surgeons? Thank you.

Peter Stavropoulos: Good morning, and thank you for taking my question. This is Peter Stavropoulos for Ali Bratzel from Piper Sandler. On the commercial front for Symvess, you noted that 27 hospitals have ordered to date, with the majority reordering. Could you break down what proportion of Q4 sales came from newly onboarded accounts versus reorders? And within those reordering hospitals, are you seeing utilization expand beyond the initial champion surgeon to other trauma surgeons? Thank you.

Speaker #1: Thank you . Operator and thank you for the the analysts and all of the attendees on this call . Humacyte is continuing just just an incredible journey .

Speaker #1: I am so proud to have brought this first in class . Unbelievably effective product in into the surgical market . It is a thunderclap in vascular surgery .

Speaker #1: We are changing the way vascular surgery is practiced right now , and we're going to continue to do so . And this is this is a very exciting time .

Laura Niklason: I'm sorry. I don't have the level of granularity to accurately answer the first part of your question, although we could come back to you, folks from our commercial team could come back to you for the answer with that. As far as growth to other surgeons beyond the initial sort of champion, we're definitely seeing that in some of our busier centers. It's definitely a word-of-mouth type thing as it is with all new devices. In some centers, we have three and four surgeons using. In the majority of centers, we probably still just have one surgeon using, but that's changing every week, every month.

Speaker #1: And I'm very proud of our employees. And I'm very proud of our sales force. And we're just going to keep pushing ahead.

Speaker #1: So, thank you very much for your time.

Peter Stavropoulos: Thank you.

Operator 2: Our next question is from Matt Miksic with Barclays. Please proceed.

Operator: Our next question is from Matt Miksic with Barclays. Please proceed.

Matt Miksic: Hi. Thanks so much for taking the questions. Congrats, Laura and Dale again on the really impressive progress on the clinical front and with some of the developments around sort of the, you know, defense-oriented and Middle Eastern contracts. It's great. On that front, was wondering if you could talk a little bit about how some of those contracts we should expect to kind of fall into the revenue flow. You know, since these are sort of like lumpy orders or gradual orders or, you know, contracts to order-

Laura Niklason: Yeah.

Matt Miksic: Sort of wait and see on revenues. How would you describe it?

Laura Niklason: The way we're working with, in particular, our Saudi partners, our commercialization partners over there, the initial orders will be chunky. The $1.475 million order will be realized as a single order. The goal is to get quite a bit of product in-country and distributed to multiple leading academic medical centers in Saudi Arabia so that multiple surgeons can be trained and really understand the utility of the vessel. There's a tremendous amount of trauma in Saudi Arabia. It has more car accidents than any other country in the world. In addition to that, there's also a large PAD market. There's a tremendous opportunity for Symvess in Saudi.

Laura Niklason: The strategy with our partner is that in parallel with submitting for full approval with the Saudi FDA, we're also initiating this physician trialing period. Not a clinical trial per se, but a trial period. After approval, we would imagine further chunky orders, because some, you know, some medical acquisitions come from individual hospitals certainly in Saudi, but some also come directly from the Ministry of Health, and those can be larger chunky orders. I don't know exactly how that's gonna look yet.

Matt Miksic: That's fair, but helpful. Then on back on sort of the hospital, you know, where you are with VAC approvals and the, you know, 43 hospitals in kind of review process or accounts in review process. You know, are we getting to a point where, you know, I know you have a certain set of target hospitals in the US, you know, focusing on vascular trauma. Do you feel like we're getting to a plateau or maybe the opposite in terms of, you know, the pricing and the continued experience in clinical data starting to feel more like increasing momentum? How would you describe, you know, the where we are in that list of whatever, 120 centers?

Laura Niklason: Yeah. Thank you for that. No. It feels. Again, it feels. It's lumpy for sure, but it feels like it's accelerating. We're getting more sort of spontaneous inbound calls from surgeons even before they have it on the shelf if they have VAC approval or even before they have VAC approval. The word is getting out in the surgical community. I mean, some surgeons post social media on their use of the vessel, and they go back and forth with each other on their experiences. There's a lot of sort of organic word-of-mouth that's happening across medical centers, and that's driving enthusiasm for the product.

Laura Niklason: you know, in terms of Level 1 and Level 2 trauma centers, I think I don't know the exact number, but it's probably around 50 Level 1 and Level 2 trauma centers where we have VAC approvals. There's a total of 200 Level 1s and 300 or 400 Level 2s. I still think that we're just, I don't wanna say we're scraping the surface, but we're still at the beginning, and the excitement about the product and the rate of usage, I feel is increasing.

Matt Miksic: Okay. That's super helpful. Well, thanks again for the questions and congrats on the progress.

Laura Niklason: Thank you.

Operator 2: Our next question is from Swayampakula Ramakanth from H.C. Wainwright. Please proceed.

Operator: Our next question is from Swayampakula Ramakanth from H.C. Wainwright. Please proceed.

Swayampakula Ramakanth: Good morning, Laura and Dale. This is RK from H.C. Wainwright. Couple of quick questions from me. Regarding the DoD procurement that you are expecting, since I believe this particular funding, you know, got initiated sometime in February, early February, and as we know, the budget year ends in September, do you have any insight into when some of this procurement could happen? Or do you think this could bleed into 2027 budget year? Or, you know, for 2027, is it a completely new application all over again?

Laura Niklason: Yeah. No. I'll do my best to answer your question, RK. We anticipate that this funding will be spent in calendar 2026. It may bleed over into fiscal 2027, but the funding is really designed to both procure Symvess, probably more than half of the funding is for military procurement. Then the balance, we've drafted a plan working with some leading surgeons in military treatment facilities in the US who are currently soldiers in the military. We've designed a plan where a little bit more than half of the funding will be utilized for procurement, and the balance will be utilized for training.

Laura Niklason: There's roughly 40 vascular surgeons in the US military, and probably four or five of them have used Symvess in their patients, but that leaves a large number who still could remain to be trained in addition to trauma surgeons. We've really designed this not just as procurement, but also training, and we're hoping to execute all of that during calendar 2026. In addition, we are working with some of our congressional delegation, looking at perhaps a larger procurement for the next fiscal year in the budget, but that's still a work in progress.

Swayampakula Ramakanth: Thank you for all that. You know, regarding the VAC approvals, you know, between Q3 announcement and now, you know, 2 additional VAC approvals came on board. I'm just trying to understand, you know, a couple things. One, is the VAC approval time, is the time got extended because of some of the holidays and stuff? Or, and also, what's the conversion? Is the conversion getting better between VAC approval and procurement of the product itself?

Laura Niklason: I do think I'm not exactly sure why the VAC approval slowed down. I don't think it represents anything fundamental. I think it was probably more to do with holidays and meeting cycles. You know, during the holidays, VACs tend to meet less often, and they often have a backlog of cases. I don't see this as fundamental at all, the low number of additional approvals. In terms of the conversion from VAC approval to getting product on the shelf, I do think that the lower price point has really increased the rate of the speed of that, you know. That it's much easier to get on the shelf, negotiate the contract and get on the shelf after the VAC approval, at the current price point.

Laura Niklason: In addition to improving the success rate in VACs, which is over 70% all told, it's also, I think, speeding getting product on the shelf. You know, at the higher price point in the very early times, our VAC approval rate was less than 50%. The price shift has had a meaningful input in our ability to get product in the hospital.

Swayampakula Ramakanth: One last question, if I may. Regarding the Saudi Arabia opportunity, can you maintain the $17,000 price point there, or do you have to, I mean, negotiate a price over in Saudi Arabia? Given the demand, or the expected market over there, which is higher than here in the United States, do you have to kind of come up with a certain formula for the pricing?

Laura Niklason: Yeah. We have not begun negotiating pricing with the Ministry of Health yet in Saudi. I think it's a little too early for me to answer your question explicitly. I would say that our expected pricing is probably somewhat above current US pricing because of just the additional logistics of getting product in country, going through the approval process, doing the distribution process. You know, right now we do our own distribution, so we're gonna have to be paying a distributor. I think it certainly will not be less than $17. You know, there will be some additional real-world costs that will be additive there. I don't want to know what the final number will be.

Laura Niklason: I strongly believe that our continued excellent data in trauma and the published data that we've seen in Phase 2 trials in PAD will mean that this is an important addition to the Saudi medical armamentarium. I mean, amputation in Saudi is a big problem. Between trauma, PAD, and diabetes, it's a big problem. I think we can do a lot of good in country.

Swayampakula Ramakanth: Thank you. Thanks for taking all my questions, Laura.

Operator 2: Our final question is from Josh Jennings with TD Cowen. Please proceed.

Operator: Our final question is from Josh Jennings with TD Cowen. Please proceed.

[Senior Analyst] (TD Cowen): Yeah. Hi, it's John on for Josh. Thank you for taking the question. Certainly helpful commentary on the VAC approval process and the response to pricing. Just revisiting the Q4 and your commentary on 2026, certainly appreciate that it's too early to provide formal guidance or you're likely not to. But just any color you could provide on, you know, what may have caused the shortfall between street expectations and again, thank you for the puts and takes around some of the revenue components in the year ahead, but do you feel the Street is accurately modeling directionally what the year will look like? Just had one quick follow-up.

[Analyst] (TD Cowen): Yeah. Hi, it's John on for Josh. Thank you for taking the question. Certainly helpful commentary on the VAC approval process and the response to pricing. Just revisiting the Q4 and your commentary on 2026, certainly appreciate that it's too early to provide formal guidance or you're likely not to. But just any color you could provide on, you know, what may have caused the shortfall between street expectations and again, thank you for the puts and takes around some of the revenue components in the year ahead, but do you feel the Street is accurately modeling directionally what the year will look like? Just had one quick follow-up.

Laura Niklason: Yeah. It's hard for me to comment on what the Street is saying without giving projections. As you know, it's a little bit of a tightrope. Also as you know, different analysts have come out with a broad range of expectations. The higher ones I think are, you know, probably not in line with reality. I think that, you know, if there's an analyst that says we're gonna sell $30 million next year, I think that's probably not true. I think our growth is gonna be more gradual than that. You know, I think that we all, the analysts, learned a lot, and I think we learned a lot in this first year of commercial launch.

Laura Niklason: We learned a lot about how to approach VACs better, how to approach the pricing better, how to approach surgeons better. We're a much more effective commercial team now than we were 12 months ago. You know, some of those learnings are just hard to predict. I mean, that's probably not a satisfactory answer, but that's what I got.

[Senior Analyst] (TD Cowen): No, that's very helpful. Then just following up on that, cash for the quarter came in essentially right in line with the pre-announcement. Just as you go through this commercialization process, do you see an opportunity to maybe reduce your cash burn rate? Probably too early to talk about, you know, maybe a steady-state growth profile, but what does cash burn look like in the quarters ahead?

[Analyst] (TD Cowen): No, that's very helpful. Then just following up on that, cash for the quarter came in essentially right in line with the pre-announcement. Just as you go through this commercialization process, do you see an opportunity to maybe reduce your cash burn rate? Probably too early to talk about, you know, maybe a steady-state growth profile, but what does cash burn look like in the quarters ahead?

Laura Niklason: Yeah. Again, we're not gonna give guidance on burn, but certainly, we're looking very closely at burn. You know, as you know, we did a reduction in force last year around May, and that saved us a total of $50 million in projected burn for 2025 and for this year, 2026. We're continuing to look at spend very, very closely. We understand that the biotech financing market has been challenging, and we understand that the growth ramp for sales is something that we're gonna have to continue to work on. We're definitely looking at the spend side.

[Senior Analyst] (TD Cowen): Okay, great. Thank you very much.

[Analyst] (TD Cowen): Okay, great. Thank you very much.

Dale Sander: Yeah. In addition to that, we're also looking at business development opportunities. We've had a great deal.

Laura Niklason: Yes.

Dale Sander: Of interest in our platform from preclinical to clinical. I think that's evidenced by the interest we're seeing internationally just for Symvess, but we're also seeing a great deal of interest on our other pipeline programs, which is why we made the announcement yesterday about adding a business development executive, and that's to help field the inquiries and interest we're getting across our platform in terms of licensing and partnering opportunities, which can help with non-dilutive funding.

[Senior Analyst] (TD Cowen): Okay, great. Thank you so much.

[Analyst] (TD Cowen): Okay, great. Thank you so much.

Operator 2: We have reached the end of our question and answer session. I would like to turn the conference back over to Laura for closing remarks.

Operator: We have reached the end of our question and answer session. I would like to turn the conference back over to Laura for closing remarks.

Laura Niklason: Thank you, operator, and thank you for the analysts and all of the attendees on this call. Humacyte is continuing just an incredible journey. I am so proud to have brought this first-in-class, unbelievably effective product into the surgical market. It is a thunderclap in vascular surgery. We are changing the way vascular surgery is practiced right now, and we're gonna continue to do so. This is a very exciting time, and I'm very proud of our employees, and I'm very proud of our sales force, and we're just gonna keep pushing ahead. Thank you very much for your time.

Operator 2: Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

Operator: Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

Q4 2025 Humacyte Inc Earnings Call

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