Prepared remarks
Good morning, ladies and gentlemen, and welcome to Humacyte's second quarter 2026 earnings conference call. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors.
Thank you, operator. Before we begin with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. 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 the forward-looking statements except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the investor page of the Humacyte website.
Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Jim Mercadante, Chief Commercial Officer; and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the second quarter and recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with the Symvess commercial launch. And Dale Sander will review the company's financial results for the quarter ended June 30, 2026. With that, I'll now turn the call over to Dr. Niklason. Laura?
Thank you, Tom. Good morning, everyone, and thank you all for joining us for our second quarter financial results and business update call. During today's call, I'll review progress across our development programs for the quarter and recent weeks, and then I'll turn the call over to Jim Mercadante for a review of our commercial progress for our Symvess launch in the vascular injury indication. As you know, Jim was appointed as our Chief Commercial Officer in April and is a seasoned commercial executive with a track record of successful leadership across medical devices, diagnostics, and healthcare technology. We're pleased to have him with us on today's call. After Jim's update, Dale will review our financial results for the quarter and six months ending June 30. As a reminder, our goals for 2026 include advancing the U.S. and global commercial launch of Symvess, completion of our V012 Phase III pivotal trial of our ATEV in dialysis access, filing of a supplemental BLA with the FDA in the dialysis indication, and the commencement of a human study of our Coronary Tissue Engineered Vessel, or CTEV, in coronary artery bypass grafting.
I'm happy to report that our second quarter and recent weeks were a transformative period for Humacyte across all of these fronts. And with that, let's begin. In June, we presented breakthrough top-line interim results from our V012 Phase III trial in female dialysis patients at the Vascular Annual Meeting in Boston. Results from this trial exceeded our expectations, showing that our acellular tissue engineered vessel outperformed autologous fistula, which is the current standard of care. In a pre-specified interim analysis of the first 80 patients from the study, women who received the ATEV achieved 91 more catheter-free days than those receiving AV fistula. This difference was highly statistically significant with a p-value of 0.0007, thereby meeting the primary efficacy endpoint of the study and consistent with our expectations for ATEV in hemodialysis. Infections of catheters and surgical access wounds were also less common.
There were 6 infections per 100 patient-years with ATEV as compared to 23 infections per 100 patient-years for patients receiving the AV fistula. We believe these data from our V012 study are a breakthrough for women who have historically been left behind by the fistula procedure, leaving many women forced to rely on infection-prone plastic catheters and grafts. Combined with results from the V007 Phase III trial that we reported previously, we believe that the ATEV could represent a major advance in hemodialysis, the largest advance in decades. As I stated earlier, we plan to submit a supplemental Biologics License Application, or sBLA, to the FDA in the second half of this year. And to help prepare for that planned commercialization in dialysis access, we have appointed Robert Kossmann, M.D., and Prabir Roy-Chaudhury, M.D., Ph.D., as advisors to Humacyte. Dr. Kossmann previously served as Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America.
Dr. Roy-Chaudhury is the immediate past president of the American Society of Nephrology and is co-director of the UNC Kidney Center. Both Robert and Prabir are contributing to our health economic reimbursement and market access strategies. They will also provide peer-to-peer scientific support and medical education as we prepare for the planned hemodialysis access launch. Turning to our pipeline, we recently announced that the FDA has accepted our Investigational New Drug Application, or IND, for a first-in-human clinical study of CTEV in Coronary Artery Bypass Grafting, or CABG. As you'll recall, the CTEV is a smaller diameter version of the ATEV, bioengineered to be suitable for CABG surgery. CTEV has been tested in large animals for more than five years, and these results have supported the FDA's approval of our IND study. There have been no new off-the-shelf conduits that have been prospectively tested in CABG in the U.S. in at least the last 40 years, and our preclinical results suggest that CTEV may be a promising off-the-shelf alternative to Saphenous Vein Grafts.
To support this Phase IIa study, we completed the first large-scale manufacturing lot of CTEVs in our commercial-scale production facilities, and we plan to initiate the Phase IIa study of CTEV in CABG patients during the current quarter. And with that, I'll now turn it over to Jim for an update on our progress with the global Symvess commercialization.
Thank you, Laura, and good morning, everyone. It is a pleasure to be speaking with you all. Our second quarter was focused on rebuilding our commercial effort for Symvess designed to drive product adoption by hospitals, expand product usage, and to strengthen the site for sustained growth. To that end, we have remodeled our commercial team to ensure that all members have relevant long-term relationships in the vascular surgery space. We've also refined our introductory pricing incentive programs, professional education, and Value Analysis Committee engagement to better drive Symvess adoption. These initiatives are designed to create a scalable engine that converts interest in our first-in-class product into approvals, utilization, and sustained revenue growth. As we move into the second half of 2026, results are beginning to materialize with influential hospitals adopting Symvess and utilization is increasing.
Surgeon feedback on patient use cases has been excellent, and we look forward to assisting these physicians as they share their success stories with their colleagues. Elsewhere on the commercial front, our Marketing Authorization Application for approval of Symvess for arterial injury repair was accepted for review by the Israel Ministry of Health in April of 2026. The Ministry set a 180-day working period for the MAA through the existing FDA approval of Symvess in extremity vascular injury. Last quarter, the fiscal 2026 U.S. Department of Defense Appropriations Act included dedicated funding to support the evaluation and incorporation of biological vascular repair for the warfighter suffering traumatic vascular injuries. We are continuing to work with leaders in the military and Pentagon to assure appropriate access to Symvess for American service personnel. During our second quarter, we also strengthened our team with the appointment of Dr. Todd Rasmussen as our Chief Surgical Officer.
Todd has extensive experience and expertise in vascular surgery, gained over a 28-year career in the U.S. Air Force, during which he deployed multiple times to the Iraq and Afghanistan wars. He is a recognized leader in peripheral vascular surgery and trauma repair. At Humacyte, his focus is providing peer-to-peer scientific support, medical education, and technical insights to surgeons and other healthcare professionals. He has experience, surgical perspective, and leadership to our educational clinical support programs and will help us align regulatory guidance with the safe, appropriate, and effective use of Symvess. With that, it is my pleasure to hand the call over to Dale for the review of our second quarter results. Dale?
Thank you, Jim. Commercial sales were $0.4 million in the second quarter of 2026, which was a rebuilding quarter, compared to $0.1 million for the second quarter of 2025. For the six months ended June 30, 2026, commercial sales of Symvess were $0.9 million compared to $0.2 million for the six months ended June 30, 2025. There was no contract revenue in either the three or six months ended June 30, 2026, due to completion of a research collaboration project in the prior year, compared to $0.2 million and $0.6 million for the three and six months ended June 30, 2025, respectively. Cost of goods sold were $1.2 million for the second quarter of 2026 compared to $0.2 million for the second quarter of 2025. During the second quarter of 2026, $0.2 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and the remainder was primarily comprised of a $0.7 million inventory reserve recorded to reduce certain inventory balances to their estimated net realizable value, as well as overhead related to unused production capacity, which was reported as an expense in the period.
The cost of goods sold was $3.3 million for the six months ended June 30, 2026, compared to $0.4 million for the six months ended June 30, 2025. During the six months ended June 30, 2026, $0.5 million of cost of goods sold related to the cost of units recorded as sales revenue during the period, and the remainder was primarily comprised of a $2.3 million inventory reserve and expenses related to unused production capacity. Research and development expenses for the three and six months of 2026 were $18.1 million and $37.6 million, respectively, compared to $22.0 million and $37.4 million for the same periods in 2025. The decrease in research and development expenses during the second quarter of 2026 was primarily due to a reduction in non-commercial manufacturing runs and reduced clinical trial expenses. Selling, general and administrative expenses were $8.0 million and $16.0 million for the three and six months ended June 30, 2026, respectively, consistent with the $7.8 million and $16.0 million recorded for the same periods in 2025.
Other net income or expense was a net expense of $9.8 million and net income of $1.5 million for the three and six months ended June 30, 2026, respectively, compared to a net expense of $7.9 million for the three months ended June 30, 2025, and other net income of $54.5 million for the six months ended June 30, 2025. The increase in other net expense for the three months ended June 30, 2026, and the decrease in other net income for the six months ended June 30, 2026, compared to the prior period, resulted primarily from the non-cash remeasurement of our contingent earn-out liability and other derivative liabilities. Net loss was $36.8 million and $54.4 million for the three and six months ended June 30, 2026, compared to a net loss of $37.7 million for the three months ended June 30, 2025, and net income of $1.5 million for the six months ended June 30, 2025. The increase in net loss for the six months ended June 30, 2026, compared to the prior year period, was primarily due to the non-cash remeasurement of the contingent earn-out liability described.
We had cash, cash equivalents, and restricted cash of $80.1 million as of June 30, 2026. Total net cash provided was $29.4 million for the first six months of 2026 compared to total net cash used of $6.9 million for the first six months of 2025. The increase in total net cash provided for the six months ended June 30, 2026, resulted from higher proceeds from sales of equities and a reduction in net cash used in operations. With that, I will turn the call back to Laura.
Thank you, Dale. So we're very pleased with the progress we've made this past quarter and with the excellent progress in our pipeline programs and our reinvigorated commercial execution. With our dedicated team, we remain committed to delivering truly transformative regenerative medicine solutions that will improve patient outcomes. We believe we're positioned for growth and value generation for the balance of 2026 and beyond. Operator, we are ready to take questions.
Questions and answers
Our first question is from Ryan Zimmerman with U.S. Bank Corp BTIG.
Maybe to start, a question for either Laura or Jim. Around the commercial changes that you're making, maybe you could reflect on what was challenging prior to Jim coming in and taking over. What needed to be refined and what you're seeing tangibly? I think Jim you talked about picking up since you've made some of those changes. Can you share with us what you're seeing that could give us improved assurances that we could see a commercial inflection in trauma?
So, Ryan, thank you for that. I'll answer the pre-Jim question and then I'll let Jim talk about the changes he's put in place in the last three to four months. I think that our commercial uptake in vascular injury was not as rapid as we'd been hoping. That led us last fall to move our prior Chief Commercial Officer out. We began a search and Jim began in April of this year. As a new conduit—the first new conduit to enter vascular surgery in the last 40 years—the education challenges were something we underestimated as a company. One way we sought to address that is to bring in Dr. Rasmussen and increase our engagement with thought leaders in the industry. In addition, if you have something fundamentally new and transformative, you need sales executives and leaders who have deep, long-standing relationships with active practicing vascular surgeons. While some of our people had that, many did not, which made breaking in with this fundamentally new product more challenging than it needed to be. That's one of the things Jim saw immediately when he joined us, and I'll let him take it from here.
Thanks, Laura. Great question. One of the key things when you're looking at a technology like this, and the reason I'm here, is that I believe this technology is going to revolutionize open surgery over time. But you have to have deep vascular surgery relationships. This is primarily a vascular surgery call point for what we're trying to do. The people we're bringing in have deep vascular surgery relationships and experience building something from nothing. Those are the people used to therapy development and new product launches. This is a new concept and product in vascular surgery, but it is well-accepted once the story is told. We're already starting to see an uptick just a few months in.
And if I can follow up and turn to dialysis access for a minute here and just ask, we're in that window of getting the BLA submission into the agency. Laura, maybe you can talk about what you're doing to de-risk that. Give us a tenor of the conversations with the agency around submission for ATEV in dialysis access and how you think about potentially bringing that to market. If you have any thoughts on timing too, those are appreciated.
Yes. We have had multiple discussions with the FDA over the years on dialysis access, and we have scheduled a pre-BLA meeting in the very near future. The structure of that meeting is about the structure of the file rather than whether to file. Our anticipation is that we will include data from essentially all of our Phase III studies—we've done three of them—as well as a number of Phase II studies. The total exposure in our patient population is well over 1,000 patient-years. This is the most studied conduit ever in dialysis access. We believe the data we have is not only strong but abundant, and so we do not anticipate any pushback on filing; it's really about how we structure the file and the overall safety experience. We have said we will file in the second half of the year; our current target is to file in November because there is a lot of data to pull together. When we file, we anticipate requesting priority review.
We expect to be granted priority review because this is a supplemental BLA and we have priority indications for dialysis access. If granted priority review, then we would see a PDUFA date sometime in May, and we would expect to launch at the end of Q2 in 2027. If not granted priority review, that would push the PDUFA into August. As far as preparing for launch, there is intense focus on reimbursement and creating the value story for insurers, both CMS and private payers. It's a large expenditure for Medicare and private insurers, and there is downward pressure on reimbursement. Our trial data show patients get off catheters quicker and more reliably with our vessel than with other methods, and there are cost savings to be shown. We're preparing a budget impact model and analyzing Medicare claims data to substantiate the argument because many high-risk patients remain on catheter for a long time and are extremely costly to the system—$20,000, $30,000, $40,000 per year in some cases. By getting those patients off catheter with a low-infection conduit, we'll be able to save the system money and generate better patient outcomes. That's how we're thinking about it.
Yes. And certainly best of luck on the submission this fall.
Our next question is from Josh Jennings with TD Cowen.
I was hoping to follow up on some of the details on the rebuild of the commercial effort. Any help thinking about the number of reps that are pushing Symvess in the vascular trauma channel today versus prior and how that could potentially ramp up? And then help thinking about the introductory pricing incentives you've called out and streamlining the Value Analysis Committee process. What does streamlining mean, how many processes are in play right now, how many centers could be on the adopter list by the end of this year and heading into 2027?
Let me start. When you look at the VAC approval process, there are several ways to go about it. We've streamlined it by becoming more flexible in the process and making it quicker to adopt. Couple that with vascular surgery relationships and major KOLs across the U.S. who want to try the product, and that speeds adoption. The second piece is you need a national account strategy. When I came in, there wasn't a national account strategy, so we hired an individual who's done this with me in the past to build out that strategy so you can get access to another 1,000 hospitals in the United States, which we didn't have. Those are key elements: national accounts, streamlining VAC engagement, and introductory pricing. Surgeons want to know how it behaves in their patients and they want to try it; you need a system that makes it easy for them to try it on several patients before they adopt it. One key principle is to be easy to do business with, and we've changed our philosophy in how we interact with healthcare system administrations. Right now, we've got at least 20 major healthcare systems in the U.S. in the process of bringing it into their systems in the back half of this year. That's not to mention everything else we're working on.
Thank you. Sorry for the multi-part question. On sales force numbers: have they been reduced, are they stable, or increasing for the vascular trauma build? And how are you thinking about the commercial strategy for the AV access indication when that opens up? Will Fresenius play any role in helping drive the initial commercial push, at least at their vascular surgery centers?
On dialysis, we've already begun preparation for whatever launch timing we face so we're ready day one. Our strategy is to use vascular injury to get into healthcare systems. We are seeing adoption of that indication, which prepares us for dialysis because if you're already in a system, through the VAC process, on the shelf, another indication accelerates a dialysis launch. That's the strategy: utilize our current indication and prepare for dialysis so that if it's already adopted and on the shelf when approved, we get instant access to patients. Regarding Fresenius, we are looking at likely five or six other strategies and verticals for dialysis in the U.S. while we would welcome working with Fresenius and will, we expect the launch approach to be broader than a single partner.
Our next question is from Bruce Jackson with The Benchmark Company.
With the 20 new hospital systems that you're working with right now, how many actual hospitals are associated with those systems?
They will range. It could be anywhere from 5 to 50 hospitals per system, depending on the healthcare system. When adoption starts, it often begins with a surgeon or two and can transform into department-wide usage. We have several cases where utilization has evolved from occasional use to weekly usage. Surgeons typically want to try it, touch it, sew with it, and see how it performs in their patient sets. It's a repeatable process across systems, and as systems adopt and achieve scale, they tend to share experiences with other systems and surgeons in the community, which drives broader adoption.
It does. Thank you. One other question on the transition of the sales and marketing effort: is there any change in the number of contracted hospitals or VAC approvals where there's potentially a slowdown during this quarter?
I wouldn't call it a hiccup so much as a rebuild. We rebuilt the entire commercial team, including personnel, strategy, and tactics across sales, marketing, and national accounts—and we did it quickly. You won't see the full results in Q2 because those changes take time to translate, but you're starting to see a minor uptick and you'll see more meaningful results in the back half of the year.
Our next question is from Swayampakula Ramakanth with H.C. Wainwright.
A couple of quick questions. On the supplemental BLA for dialysis, how are you planning to use the RMAT designation that you have? Also in terms of the label, can you elaborate a little bit about what you're trying to seek on the label? Would you also look to include at-risk males within that label?
Hi, RK. We do have RMAT designation in dialysis access, and we will use that along with the fact that we already have approval in another indication to request priority review. If we file our sBLA in November, our current plan, we would hope to get a PDUFA date sometime in May 2027 under best-case timing, which would allow a launch in the back end of Q2 2027. If we do not get priority review, the PDUFA date could move into August. As for label language, the specific wording is negotiated with the FDA, but our anticipated label is that ATEV or Symvess would be indicated for hemodialysis access in patients who are at elevated risk of fistula failure or non-maturation, potentially noting in parentheses examples such as women and men with risk factors like obesity and diabetes. The final indication will be worked out with the FDA.
Regarding the Fresenius relationship, how do you foresee them helping on your launch given the amendment that returned worldwide rights, and should we expect any royalty step-down thresholds, especially in the United States?
We remain in a commercialization agreement with Fresenius that includes clauses where they have pledged to adopt this as standard of care in their dialysis access centers for patients within our indication when the economic benefit makes sense. That's why we're doing extensive work on health economics, particularly focused on getting patients off catheters because catheters are expensive for the system and for dialysis centers. Dialysis centers face penalties from CMS for high catheter rates. We expect the relationship with Fresenius to continue. It is also pertinent that they receive a royalty on every vessel we sell in any indication in the U.S., so there are aligned motivations for broader adoption.
On the CTEV study you recently got FDA sign-off for: anything on the timing of the study? Also, does manufacturing of CTEV impact manufacturing for your commercial ATEV product?
The vessels we make for the CTEV studies are produced on the same machines as our commercial vessels because this is a platform. The CTEV requirements are very small for the next year or two—the Phase IIa study is only 10 patients. The smallest batch we can make is 100 vessels, so we may make another CTEV batch next year, but it is not a drain on manufacturing capacity. Regarding timing, we're finishing IRB paperwork now that we have FDA sign-off on the IND, and I would expect the study to open sometime this month. Identifying the correct patients is important; we want outstanding outcomes. We have two surgeons participating in the study who did our large animal work with CTEV and are experienced cardiac surgeons, so we feel confident about execution.
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.
Thank you very much everyone for listening to this second quarter 2026 Humacyte update and conference call. We have done a tremendous amount of rebuilding in the last three to four months, especially on the commercial side, and we're very pleased with the new strategy and the new team that we have in place. I believe it will be transformative for Humacyte going into the second half of this year and for 2027 and beyond. In addition to rebuilding the current commercial infrastructure, we've also made great progress on two future indications. We're firing on all cylinders, and I'm very pleased with where we are now. I look forward to continuing to share our quarterly updates with this group going forward. Thank you very much, everybody.
This concludes today's conference. You may disconnect at this time, and thank you for your participation.