Humacyte Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 12, 2026

Key Takeaways

  • Positive Sentiment: V012 Phase III interim results exceeded expectations in female dialysis patients: ATEV recipients had 91 more catheter-free days than AV fistula patients, with significantly fewer infections. Humacyte plans to file a supplemental BLA in November 2026 and is targeting a potential launch in late Q2 2027 if priority review is granted.
  • Positive Sentiment: Humacyte is rebuilding its SYMVESS commercial organization with vascular-surgery-focused sales personnel, a national accounts strategy, streamlined hospital value-analysis processes, and introductory pricing. At least 20 major U.S. healthcare systems are reportedly in the process of adopting the product, although meaningful benefits are expected mainly in the second half of 2026.
  • Positive Sentiment: The FDA accepted Humacyte’s IND for its smaller-diameter CTEV vessel in coronary artery bypass grafting, and the company expects to begin a 10-patient Phase IIa study during the current quarter. Management said initial CTEV manufacturing will not materially constrain ATEV commercial production.
  • Negative Sentiment: Financial results continued to reflect commercialization and manufacturing costs: second-quarter revenue was only $0.4 million, cost of goods sold reached $1.2 million including a $0.7 million inventory reserve, and net loss was $36.8 million. Cash, cash equivalents, and restricted cash totaled $80.3 million at June 30, 2026, supported in part by equity-sale proceeds.
AI Generated. May Contain Errors.
Earnings Conference Call
Humacyte Q2 2026
00:00 / 00:00

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Operator

Good morning, ladies and gentlemen, and welcome to Humacyte's second quarter 2026 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.

Tom Johnson
Director Corporate Communications at 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. The 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.

Tom Johnson
Director Corporate Communications at LifeSci Advisors

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 in recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with SYMVESS commercial launch. 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?

Laura Niklason
Laura Niklason
President and CEO at Humacyte

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. 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 30th.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

As a reminder, our goals for 2026 include the advancing of the U.S. and global commercial launch of SYMVESS, completion of our V012 Phase III pivotal trial of our ATEV in dialysis access, and 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 am happy to report that our second quarter and recent weeks were a transformative period for Humacyte across all of these fronts. With that, let us 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.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

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. Consistent with our expectations for ATEV and hemodialysis, infections of catheters and surgical access wounds were also less common. There were six 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 being forced to rely on infection-prone plastic catheters and grafts.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

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 BLA, to the FDA in the second half of this year. To help prepare for that planned commercialization in dialysis access, we have appointed Robert J. Kossmann, MD, and Prabir Roy-Chaudhury, MD, PhD, as advisors to Humacyte. Dr. Kossmann previously served as Executive Vice President and the 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.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Both Robert and Prabir are contributing to our health, economic reimbursement, and market access strategies, and 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 our first in-human clinical study of CTEV in coronary artery bypass grafting, or CABG. As you will recall, the CTEV is a smaller diameter version of the ATEV, which was 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.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

In at least the last 40 years, 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. We plan to initiate the phase IIa study of CTEV in CABG patients during the current quarter. With that, I will now turn it over to Jim for an update on our progress with the global SYMVESS commercialization.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

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 vascular surgery space. We have also refined our introductory pricing incentive programs, professional education, and a value analysis committee engagement to better drive SYMVESS adoption. These initiatives are designed to create 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.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

Surgeon feedback on patient use cases has been excellent. We look forward to assisting these physicians as they share their success stories with their colleagues. Elsewhere on the commercial front, our Marketing Authorisation Application for approval of SYMVESS for acute injury repair was accepted for review by the Israel Ministry of Health in April of 2026. The Ministry set 180-day working period for the MAA through the existing FDA approval of SYMVESS in extremity vascular injury. Last quarter, we also highlighted the fiscal 2026 U.S. Department of Defense Appropriations Act included dedicated funding to support the evaluation andcorporation of biological vascular repair for the war fighters suffering traumatic vascular injuries. We are continuing to work with leaders in the military and Pentagon to ensure appropriate access to SYMVESS for American service personnel.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

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 28-year career in the U.S. Air Force, during which he deployed multiple times to 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, technical insights to surgeons and other healthcare professionals. He adds 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?

Dale Sander
Dale Sander
CFO and Chief Corporate Development Officer at Humacyte

Thank you, Jim. Commercial sales were $0.4 million in the second quarter of 2026, which was really 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.

Dale Sander
Dale Sander
CFO and Chief Corporate Development Officer at Humacyte

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 were 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 recorded as an expense in the period. 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.

Dale Sander
Dale Sander
CFO and Chief Corporate Development Officer at Humacyte

Research and development expenses for the three and six months of 2026 were $8.1 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 million for the three and six months ended June 30, 2026, respectively, consistent with the $7.8 million and $16 million recorded for the same periods in 2025.

Dale Sander
Dale Sander
CFO and Chief Corporate Development Officer at Humacyte

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 periods, resulted primarily from the non-cash remeasurement of our contingent earnout liability and other derivative liabilities.

Dale Sander
Dale Sander
CFO and Chief Corporate Development Officer at Humacyte

Net loss was $36.8 million and $54.4 million for the three and six months ended June 30, 2026, respectively, 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 earnout liability described earlier. We had cash equivalents, and restricted cash of $80.3 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.

Dale Sander
Dale Sander
CFO and Chief Corporate Development Officer at Humacyte

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.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Thank you, Dale. We are very pleased with the progress we have 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 are positioned for growth and value generation for the balance of 2026 and beyond. Operator, we are ready to take questions.

Operator

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. You may press star two if you would like to remove your question from the queue. For a participant choosing speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Ryan Zimmerman with BTIG. Please proceed.

Ryan Zimmerman
Ryan Zimmerman
Analyst at BTIG

Good morning, and thank you for taking our question. 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 utilization picking up since you've made some of those changes. Can you share with us what you're seeing from that front that can give us improved assurances that we could see a commercial inflection in trauma?

Laura Niklason
Laura Niklason
President and CEO at Humacyte

So, Ryan, thank you for that. I'll sort of answer the pre-Jim question, and then I'll let Jim talk about the changes that he's put in place just in the last three, four months. I think that our commercial uptake in vascular injury was not as rapid as we had been hoping. That led us last fall, actually, to move our prior chief commercial officer out. Then we began a search, and then Jim began in April of this year. What I can say is that as a new conduit, the first new conduit to enter vascular surgery in the last 40 years, and I had said this multiple times, I think that the education challenges were something that I think we underestimated as a company.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

One of the ways we sought to address that is to bring in Todd Rasmussen and really increase our contacts with thought leaders in the industry. In addition, something that I think we didn't appreciate is that if you have something fundamentally new and transformative in the space, you really need sales executives and leaders who have really deep, strong connections with very active, practicing vascular surgeons. While some of our people had that, a lot of our people did not. That made sort of breaking in with this fundamentally new product more challenging than it had to be. I think that's one of the things that Jim saw immediately when he joined us. I'll let him take it from here.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

Thanks, Laura. I appreciate it. Great question. I'll echo Laura's comments here. One of the key things when you're looking at a technology like this, and this is the reason why I'm here, I believe this technology is going to revolutionize open surgery for sure over time. But you have to have deep vascular surgery relationship. 90% of the call point is vascular surgery for what we're trying to do here. The people that I'm bringing in are people that have deep vascular surgery relationships and have built something from nothing. There's a difference. Those are the type of people that are used to what I call doing therapy development or new product launches. This is a new concept and product going to vascular surgery, but it's being, I will say, well-accepted once the story is told.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

It's certainly welcomed, and we're already starting to see that uptick just a few months in. Hopefully, that answers your question.

Ryan Zimmerman
Ryan Zimmerman
Analyst at BTIG

Yeah. Thank you. 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 for clearance potentially in the future. So, Laura, maybe you can just talk about what you're doing to de-risk that. Give us maybe a little tenor of the conversations with the agency around submission for ATEV and dialysis access and how you think about potentially bringing that to the market. If you have any thoughts on timing too, certainly those are appreciated. Thank you.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Yeah. Again, we have had multiple discussions with the FDA over the years on dialysis access. We actually have scheduled a pre-BLA meeting, which is happening in the very near future, which we're excited about. But the structure of that meeting is really not around whether to file, but around the structure of the file. Our anticipation is that we will include data from essentially all of our phase III studies, and we've done three of them, as well as a number of phase II studies. The total exposure that we have in our patient population is well over 1,000 patient years. This is the most studied conduit ever in dialysis access. So we believe that the data that we have is not only strong, but there's a lot of it. We do not anticipate any pushback on filing.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

It's really about how we structure the file and the overall safety experience. So that gives us a high index of confidence that this will go forward. I'll tell you our plan. We've said second half filing. Our target right now is that we'll file in November, because there is a lot of data to pull together. When we file, we anticipate that we'll ask for a priority review. We anticipate that we should receive a priority review because, again, this is a supplemental BLA, and we have multiple priority indications for dialysis access. If we're 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.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

As far as what we're doing to prepare for the launch, there's really a tremendous focus on reimbursement and on creating the value story for insurers, both CMS and private insurers. Dialysis is a huge expenditure for Medicare and for private insurers, and as you know, there's a lot of downward price pressure on reimbursement. But our data from all of our phase III trials really show that there are patients who get off catheter quicker and more reliably with our vessel than with any other method. And there's cost savings to be shown there. So we're putting together a budget impact model, and we're also looking at Medicare claims data to really nail that argument to the wall.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Because there are many high-risk patients who sit around on catheter for a long time and are extremely expensive to the system and cost an extra $20,000, $30,000, $40,000 per year every year. So by getting those patients off catheter with a low infection conduit, we'll be able to save the system money and also just generate better patient outcomes. So I know that's a long answer, Ryan.

Ryan Zimmerman
Ryan Zimmerman
Analyst at BTIG

No.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

But that's how we're thinking about it.

Ryan Zimmerman
Ryan Zimmerman
Analyst at BTIG

It's very appreciated. Yes. Thank you so much, and certainly best of luck on the submission this fall. Thank you.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Thank you.

Operator

Our next question is from Josh Jennings with TD Cowen. Please proceed.

Josh Jennings
Josh Jennings
Analyst at TD Cowen

Thanks for taking the questions, Laura, Dale, and Jim. I was hoping to just follow up on some of the details on the rebuild of the commercial effort. Any help just thinking about, I guess, number of reps that are pushing ATEV in the vascular trauma channel today versus prior, and how that could potentially ramp up. Then also any help just thinking about introductory pricing incentives that you've called out and streamlining the VAC process. Sorry, three questions in one, but what does streamlining mean and how many, I guess, 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?

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

Let me see if I can at least get a few of your questions here and start to answer them. First, what I'll say is when you look at the submission process for a VAC approval, there's several ways to go about it. We've streamlined it because we became more flexible in the process. Made it a little more open so it's quicker adopted. When you couple that with vascular surgery relationships, major KOLs across the U.S. that want to try the product, want to use the product, that's how it really speeds up. The second piece to that is you need a national account strategy. When I came in, there wasn't a national account strategy.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

We hired a very specific individual who has done this with me in the past to build out that national account strategy so we can get access to another 1,000 hospitals in the U.S., which we currently did not have. Those are some key elements in any commercialization, to have a national account strategy, to streamline the VAC process, et cetera. The creation of introductory pricing is because surgeons, what I love about surgeons in general, and vascular surgeons in particular, is they really want to know how it behaves in their patients, and they want to try it. You really need to create a system where it becomes easy for them to be able to try it on several patients before they start to adopt it and put it into their practice.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

One of the key principles is the business to be easy to do business with, and we have changed our philosophy on how we are interacting with administrations at healthcare systems. I can tell you right now, we have got at least 20 major healthcare systems in the U.S. in the process of bringing it into their healthcare systems in the back half of this year. That is not to mention everything else that we are working on. Hopefully that answers your question.

Josh Jennings
Josh Jennings
Analyst at TD Cowen

Yeah. That helps. Thank you. I am sorry for loading you up with a three-level question. Just on the Salesforce numbers, have they been reduced? Are they stable? Are they increasing for the vascular trauma SYMVESS? How are you thinking about the commercial strategy for the AV access indication and once that opens up? Will Fresenius play any role in terms of helping drive the initial commercial push, at least at their vascular surgery centers? Thanks for taking all the questions.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

Sure. Let me just start with the dialysis one. We have already begun preparation, no matter when we receive approval, on what that launch will look like, so we are ready day one. Everything that leads up to that is, if you really look at our strategy, we are using vascular injury now to get into a healthcare system. We are seeing adoption of that. It is certainly a great product, and for the right patient, of course. It is always about patient selection. That prepares us for dialysis because if you are already in the healthcare system and you are through the VAC process and you are already on the shelf and you have another indication, that will accelerate launch when we do launch dialysis. That is the strategy.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

The strategy is we're utilizing our current indication, and that's what we're selling on, but also preparing for dialysis because if we have it already adopted into these healthcare systems and it's on the shelf and we launch in dialysis, that's instant access to dialysis patients. That's what we're preparing for. We're also looking at, you mentioned Fresenius. It's a great question. I will say this. Besides Fresenius, we're looking at probably five or six other strategies and particular verticals for dialysis in the U.S. I think it's going to be much broader than just working with Fresenius. While we would love to work with Fresenius and will, I think we have to work with some others as well, as we look to launch this in a major way, mid-2027. So long we have the approvals that are needed.

Josh Jennings
Josh Jennings
Analyst at TD Cowen

Thanks again.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

No problem.

Operator

Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.

Bruce Jackson
Bruce Jackson
Analyst at The Benchmark Company

Hi. Thank you for taking my questions. With the 20 new hospital systems that you are looking at right now, how many actual hospitals are associated with those systems?

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

They are going to range. It could be anywhere from five to 50. It just depends on healthcare system. Right now, I can tell you that when they start to adopt and they start to expand utilization, it starts usually with a surgeon or two, and then it usually transforms itself into the entire department. We have several cases right now that we have been able to transform from what I call dabbling and using it every once in a while to weekly usage. There is a natural progression on the adoption of this product. As I said earlier, vascular surgeons in general, like to try it out first. They want to touch it, they want to feel it, they want to sew, and they want to see how it performs in their particular patient set. It is a process that can be repeated healthcare system to healthcare system.

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

As these healthcare systems adopt, they tend to share their experience with other healthcare systems and other vascular surgeons in the community. It becomes, after a while, after you get some mass, it starts to duplicate itself naturally. Hopefully that answers your question.

Bruce Jackson
Bruce Jackson
Analyst at The Benchmark Company

It does. Thank you. Then one other question on the transition of the sales and marketing effort. Was there any change in the number of contracted hospitals or VAC approvals where there is potentially a slowdown during this quarter?

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

Are you asking me in particular Q2 or in the back half?

Bruce Jackson
Bruce Jackson
Analyst at The Benchmark Company

Just for looking at Q2. We had a certain number of contracted hospitals in the first quarter, and I think we were all sort of looking for some sort of a trend going from first quarter to second quarter. Was there any kind of hiccup or break in the trend because of the transition with the sales force?

Jim Mercadante
Jim Mercadante
Chief Commercial Officer at Humacyte

Well, I don't know if there was a hiccup or break. It was more of a, I think you heard earlier, we were literally rebuilding the entire commercial team, not only with personnel, but strategy, tactics, across everything, sales, marketing, national accounts. We did it pretty fast. It's pretty unheard of to do that within 3 months, but we did it and transformed the whole thing. What you'll see is, you'll see those results in the back half. You didn't see them in Q2, that would've been really quick, but we started to see a minor uptick, but the uptick is really in the back half.

Bruce Jackson
Bruce Jackson
Analyst at The Benchmark Company

Okay. All right. Thank you very much.

Operator

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

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

Thank you. Good morning. This is RK from H.C. Wainwright. A couple of quick questions. I am sorry if you had given some of this information in the opening remarks, because I missed a few minutes of it. On the supplemental BLA for the 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 are trying to seek on the label, and would you also look to see if you can get at-risk males within that label?

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Hi, RK. This is Laura. Thank you for the question. Yes, we do have the RMAT designation in dialysis access, and we will use that, along with the fact that we already have approval in another indication to request a priority review. That means if we file our sBLA sometime in November, which is our current plan, then we would hope, under best case, to get a PDUFA date sometime in May of 2027. That would allow us, best case, to launch in the back end of second quarter 2027. If we do not get a priority review, then that would push our PDUFA date sometime into August. That is kind of the bracketing of the timing that we see. Of course, as you know, the FDA does not always hit their PDUFA dates. But that is just what we would be expecting. As far as.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

What was the second half of your question, RK? I am sorry.

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

At-risk males. Do you think you will.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Yes, yes. Again, the specific label language is always a subject of negotiation 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. And in parentheses, it might say, "I.e., women and men with risk factors such as obesity and diabetes." So that is the indication language that we will put into our application. Again, the final indication remains to be worked out with the FDA.

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

Yeah. Regarding the Fresenius relationship, how do you foresee them helping on your launch, especially given that third amendment that returned the worldwide rights and

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

Also based on that, should we expect some royalty step-down thresholds, especially in the U.S.?

Laura Niklason
Laura Niklason
President and CEO at Humacyte

I am honestly not sure what you mean about step-down thresholds, but Fresenius does have. We remain in the commercialization agreement with Fresenius, and that has a couple of clauses. One is that they have pledged to adopt this as standard of care in their dialysis access centers for patients in whom we have an indication and for whom the economic benefit makes sense. That is why we are doing a tremendous amount of work on the health economics of particularly getting patients off of catheters, because catheters are expensive for the system, for capitated patients, and they are also even expensive for dialysis centers. Dialysis centers get docked by CMS if they have too many catheter patients. We expect that relationship with Fresenius to continue. It is also germane to point out that they get a royalty on every vessel that we sell in any indication in the U.S.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

There is a lot of aligned motivations for broader adoption in the U.S.

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

Okay.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Does that get at your questions?

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

Yes. The last question from me is on the CTEV study that.

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

You recently got FDA to sign off on. Anything on the timing of that study, and also, how does manufacturing of that, does that impact anything with your commercial product manufacturing right now on the ATEV?

Laura Niklason
Laura Niklason
President and CEO at Humacyte

Yes. So you're right, RK, in that the vessels that we make for the CTEV studies are in the same machines, because this is a platform, in the same machines as make our commercial vessels. However, the requirements for numbers of CTEVs are very low 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 one more CTEV batch next year, but it's not like it's a drain on the system at all. As far as when we expect the trial to start, we're working on getting through the IRB and finishing up that paperwork now that we have FDA sign-off on the IND. So I would expect that study to open up sometime this month. Then it's a question of identifying the correct patients.

Laura Niklason
Laura Niklason
President and CEO at Humacyte

What's really important for this study is that we have the right patient and that we get outstanding outcomes. So that's really what we're focused on. Luckily, we have two surgeons who are participating in this study who have also done all of our large animal work with CTEV and are also, obviously, extremely experienced cardiac surgeons. So we feel like this is in good hands.

Ramakanth Swayampakula
Ramakanth Swayampakula
Analyst at H.C. Wainwright

Perfect. Thanks for taking all my questions, Laura.

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
Laura Niklason
President and CEO at Humacyte

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 or four months, especially on the commercial side. We are 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 also for 2027 and beyond. In addition to rebuilding the current commercial infrastructure, we have also made great progress on two future indications. We are firing on all cylinders and I am very pleased that we are where we are now, and I look forward to continuing to share our quarterly updates with this group going forward. Thank you very much, everybody.

Operator

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

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