HUMA

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 8:00 a.m. ET President and Chief Executive Officer - Laura Niklason Chief Commercial Officer - Jim Mercadante Chief Financial Officer and Chief Corporate Development Officer - Dale Sander Operator: Good morning, ladies and gentlemen, and welcome to Humacyte's second quarter 2026 earnings conference call. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Thomas Johnson: 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? Laura Niklason: 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 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'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 which -- leaving many women being 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 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. 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, which was bioengineered to be suitable for CABG surgery. CTEV has been tested in large animals for more than 5 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. Jim Mercadante: 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? Dale Sander: Thank you, Jim. Commercial sales were $0.4 million in the second quarter of 2026, which is 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. 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 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 $8.1 million (sic) [ $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 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. 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 $80.3 million (sic) [ $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. Laura Niklason: 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. Operator: [Operator Instructions] Our first question is from Ryan Zimmerman with U.S. Bank Corp BTIG. Ryan Zimmerman: 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 kind of what you're seeing from that kind of can give us improved assurances that we could see a commercial inflection in trauma. Laura Niklason: So, yes. So Ryan, thank you for that. You know, I'll sort of answer the pre-Jim question and then I'll let Jim sort of talk about the changes that he's put in place just in the last 3, 4 months. You know, I think that our commercial uptake in vascular injury was not as rapid as we'd been hoping. And so that led us last fall actually to move our prior Chief Commercial Officer out. And then we began a search and then, you know, Jim began in April of this year. You know, 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. And so one of the ways we sought to address that is to bring in Rasmussen and really increase our contacts with thought leaders in the industry. But 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 a sales executives and leaders who have really deep, strong connections with very active practicing vascular surgeons. And while some of our people had that, a lot of our people did not. And so that made sort of breaking in with this fundamentally new product more challenging than it had to be, and I think that's one of the things that Jim saw immediately when he joined us, and I'll let him take it from here. Jim Mercadante: Thanks, Laura. I appreciate it. Great question. And 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 relationships. This is a 90% of the call point is vascular surgery for what we're trying to do here. And so the people that we're bringing in are people that have deep vascular surgery relationships and have built something from nothing. There's a difference. And those are the type of people that are used to what I call doing therapy development or new product launches. And 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. And 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: And if I can follow up and turn to dialysis access for a minute here and just ask, you know, 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 kind of what you're doing to de-risk that. Give us maybe a little tenor of the conversations with the agency around submission for ATEV in dialysis access and kind of how you think about, you know, potentially bringing that to the market. If you have any thoughts on timing too, certainly those are appreciated. Laura Niklason: Yes, so again, we have had multiple discussions with the FDA over the years on dialysis access. And 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. And so, you know, 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, and so we do not anticipate any pushback on filing. 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. We would expect to launch at the end of Q2 in 2027. 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. It's 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 especially, well, 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, and we're also looking at Medicare claims data to really nail that argument to the wall 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. That's how we're thinking about it. Ryan Zimmerman: Yes. And certainly best of luck on the submission this fall. Operator: Our next question is from Josh Jennings with TD Cowen. Please proceed. Joshua Jennings: I was hoping to just follow up on some of the details on the rebuild of the commercial effort. And with 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? And 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 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: So, let me see if I can at least get a few of your questions here and start to answer them. So, 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, we made it a little more open so it's quicker adopted. 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. And the second piece to that is you need a national account strategy. And when I came in, there wasn't a national account strategy. So we hired a very specific individual who's done this with me in the past to build out that national account strategy so you can get access to another 1,000 hospitals in the United States, which we currently didn't have. So those are some key elements in any commercialization to have a national account strategy to streamline the VAC process, et cetera. And the creation of introductory pricing is because, you know, surgeons -- what I love about surgeons in general and vascular in particular, they really want to know how it behaves in their patients and they want to try it. And 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. One of the key principles is just to be easy to do business with, and we've changed our philosophy in how we're interacting with administrations of healthcare systems. I can tell you right now, we've 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's not to mention everything else that we're working. Hopefully that answers your question. Joshua Jennings: Yes, that helps. Thank you. And I'm sorry for loading you up with a three-level question, but just on the sales force numbers, have they been reduced? Are they stable? Are they increasing for the vascular trauma build? And then how are you thinking about the commercial strategy for the AV access indication and what's that like opens up and will Fresenius play any role in terms of helping drive the initial commercial push, at least at their vascular surgery centers? Jim Mercadante: 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're ready day one. So everything that leads up to that is, you know, if you really look at our strategy, we're using vascular injury now to get into a healthcare system. And we are seeing adoption of that. I mean, it's certainly a great product. And for the right patient, of course. And it's always about patient selection. But that prepares us for dialysis because if you're already in the healthcare system and you're through the VAC process and already on the shelf and you have another indication, that will accelerate launch when we do launch dialysis. So that's the strategy. The strategy is we're utilizing our current indication and that's what we're selling on, 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. And that's what we're preparing for. Now, we're also looking at, you mentioned Fresenius. It's a great question. I will say this. Besides Fresenius, we're looking at probably 5 or 6 other strategies and particular verticals for dialysis in the U.S. So I think it's going to be much broader than just working with Fresenius, while we would love to work with Fresenius and will. But 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. Operator: Our next question is from Bruce Jackson with The Benchmark Company. Please proceed. Bruce Jackson: So with the 20 new hospital systems that you're looking at right now, how many actual hospitals are associated with those systems? Jim Mercadante: They're going to range. It could be anywhere from 5 to 50. So, it just depends on the 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've been able to transform from what I call dabbling and using it every once in a while to weekly usage. So there's a natural progression on the adoption of this product. As I said earlier, vascular surgeons -- 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. And so, you know, it's a process that can be repeated, healthcare system to healthcare system. And as these healthcare systems adopt, they tend to share their experience with other healthcare systems and other vascular surgeons in the community. So it becomes, after a while, after you get some mass, it starts to, you know, duplicate itself naturally. Hopefully that answers your question. Bruce Jackson: It does. Thank you. And then 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? Jim Mercadante: Are you asking in particular Q2 or in the back half? Bruce Jackson: Just 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 pickup or break in the trend because of the transition with the sales force? Jim Mercadante: 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, et cetera, across everything, sales, marketing, national accounts. And we did it pretty fast. I mean, 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 have been really quick. But we started to see a minor uptick, but the uptick is really in the back half. Operator: Our next question is from Swayampakula Ramakanth with H.C. Wainwright. Please proceed. Swayampakula Ramakanth: A couple of quick questions. I'm sorry if you've given some of this information in the opening remarks because I've 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? And also in terms of the label, can you elaborate a little bit about what you're 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: Hi, RK. This is Laura. Thank you for the question. Yes, so 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 priority review. So 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. So that's kind of the bracketing of the timing that we see. Of course, as you know, the FDA doesn't always hit their PDUFA dates, but that's just what we would be expecting. As far as -- gosh, what was the second half of your question, RK? I'm sorry. Swayampakula Ramakanth: At-risk males. So do you think... Laura Niklason: Ah, yes, yes. Yes, so we are, again, the specific label language is always a subject of negotiation with the FDA. 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'll put into our application. But again, the final indication remains to be worked out with the FDA. Swayampakula Ramakanth: Yes, yes. And then regarding the Fresenius relationship, how do you foresee them helping on your launch especially given the third amendment that returned the worldwide rights, and also based on that, should we expect some royalty step-down thresholds, especially in the United States? Laura Niklason: So, I'm honestly not sure what you mean about step-down thresholds, but Fresenius does have, I mean, 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. And so that's why we're 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're also even expensive for dialysis centers. Dialysis centers get docked if they -- by CMS if they have too many catheter patients. So we expect that relationship with Fresenius to continue. It's also germane to point out that they get a royalty on every vessel that we sell in any indication in the U.S. So there's a lot of aligned motivations for broader adoption in the U.S. Does that get at your questions? Swayampakula Ramakanth: Yes, yes. And then the last question from me is on the CTEV study that you recently got FDA to sign off on. Anything on the timing of the study? And also, how does manufacturing of that, does that impact anything with your commercial product manufacturing right now on the ATEV? Laura Niklason: 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. I mean, this Phase IIa study is only 10 patients. The smallest batch we can make is 100 vessels. So we may make 1 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. And then it's a question of identifying the correct patients. You know, what's really important for this study is that we have the right patient and that we get outstanding outcomes. And so that's really what we're focused on. Luckily we have two surgeons who are participating in the 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. 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 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 3 or 4 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 also for 2027 and beyond. But in addition to rebuilding the current commercial infrastructure, we've also made great progress on two future indications. So we're firing on all cylinders, and I'm 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: This concludes today's conference. You may disconnect at this time, and thank you for your participation. Before you buy stock in Humacyte, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Humacyte wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes – – Publication provides peer-reviewed validation for V007 Phase 3 data, and complements recent release of Phase 3 V012 data showing ATEV outperformed standard of care for women on dialysis – DURHAM, N.C., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication of one-year results from the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients in The Lancet Digital Health, a leading peer-reviewed journal in the Lancet family. The publication, titled "A Multi-center Randomized Trial of a Bioengineered Acellular Tissue Engineered Vessel versus Autogenous Fistula for Hemodialysis Access," demonstrates the positive findings from Humacyte's V007 trial, previously presented at major medical conferences, showing the superiority of the ATEV over autogenous arteriovenous fistula (AVF) for hemodialysis vascular access after one year of follow up, particularly for all female patients and male patients with obesity and diabetes, groups that often face higher rates of AVF failure. "Reliable hemodialysis access is critical for patients with end-stage kidney disease, yet remains a challenge for many, especially those with higher risk profiles," said Mohamad A. Hussain, M.D., Ph.D., lead author of the publication and Vascular and Endovascular Surgeon at Heart and Vascular Institute, Mass General Brigham and Associate Professor of Surgery at Harvard Medical School. "This publication in The Lancet Digital Health provides additional validation of these results and highlights the potential of ATEV as an alternative for patients who may be less likely to benefit from AV fistulas.” “Publication in The Lancet Digital Health is a significant milestone for Humacyte and an important validation of our Phase 3 dialysis data. These results demonstrate that the ATEV can offer a better option for the patients who need it most, particularly all women and men with obesity and diabetes, who too often face poor outcomes with traditional fistulas,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “With the V007 and V012 results we believe we have built a compelling case to bring this technology to the patients who stand to benefit most.” Positive two-year results from the V007 Phase 3 trial, announced in November 2025 at the American Society of Nephrology’s Kidney Week 2025, further demonstrated the durability of ATEV's benefits over time. Additionally, Humacyte reported top-line interim results from its V012 Phase 3 study June 11, 2026 at the Society of Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM) in Boston. V012 is specifically focused on female patients with end-stage renal disease (ESRD) needing hemodialysis — a population in which the V007 one-year data already showed meaningful advantages for ATEV over traditional fistulas. Aa a result of meeting the primary superiority endpoint in V012, Humacyte plans to submit a supplemental Biologics License Application (sBLA) to expand the Symvess® label to include a second indication in AV access for hemodialysis in the second half of 2026. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended June 30, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors [email protected]@humacyte.com Humacyte Media Contact:Rich LuchettePrecision [email protected]@humacyte.com

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Humacyte (NasdaqGS:HUMA) reported Phase 3 dialysis access data showing its acellular tissue engineered vessel outperformed standard of care for female patients. The company plans to file a supplemental Biologics License Application based on the female cohort results from the dialysis access trial. The FDA accepted an Investigational New Drug application for Humacyte’s new coronary vessel candidate, allowing clinical development to proceed. This progress at Humacyte is part of a wider push to apply advanced biotech and AI tools across healthcare, so it can be useful to compare this story with peers exposed to similar trends through 43 healthcare AI stocks. Humacyte is a US biotech company working on off the shelf, implantable bioengineered human tissues, so this dialysis and coronary vessel work sits at the core of its effort to build a broader platform across multiple therapeutic areas. With a market cap of $191.4 million, the company is positioned as an early stage player in a specialized corner of vascular and tissue engineering. Beyond the headline: 3 risks and 1 thing going right for Humacyte that every investor should see. The Humacyte Narrative centers on whether its off the shelf vessels can move from niche trauma use into larger, chronic indications that support recurring procedures and more efficient use of its manufacturing platform. This dialysis and coronary update goes directly to that expansion premise. Read the full Humacyte narrative to see the case behind these numbers For that thesis, the Phase 3 female dialysis data and planned supplemental BLA address the key question of access to a large chronic market rather than one off trauma cases. If regulators accept the data, dialysis could become the clearest test of whether Humacyte can build recurring procedure volumes and better utilize its existing capacity. The new coronary vessel IND also links back to the Narrative’s view that extending Symvess into CABG can broaden the cardiovascular opportunity beyond dialysis, where companies like Gore and Terumo are active. Set against Humacyte’s small revenue base and recent net loss, this product news leans into the growth side of a story that still carries dilution and volatility risks flagged by analysts. For you as an investor, stitching news like this into a clear Narrative for Humacyte is what turns scattered headlines into a coherent decision framework To ensure you're always in the loop on how the latest news impacts the investment narrative for Humacyte, head to the community page for Humacyte to never miss an update on the top community narratives. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include HUMA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed slower-than-expected Symvess uptake to an underestimation of the educational challenges required for the first new vascular conduit in 40 years. The commercial team was remodeled to prioritize sales executives with deep, long-term relationships with active vascular surgeons to drive therapy development. Phase III V012 trial results for female dialysis patients showed 91 more catheter-free days compared to the standard of care, addressing a historically underserved demographic. The company is shifting its commercial philosophy to be 'easy to do business with,' introducing flexible pricing and national account strategies to streamline hospital approvals. Strategic hires of a Chief Commercial Officer and Chief Surgical Officer were made to align peer-to-peer medical education with regulatory guidance and clinical use cases. Manufacturing for the new Coronary Tissue Engineered Vessel (CTEV) has been integrated into existing commercial-scale facilities, leveraging the company's platform technology. Humacyte plans to file a supplemental BLA for the dialysis indication in November 2026, targeting a potential PDUFA date in May 2027 under priority review. The dialysis launch strategy focuses on a 'value story' for insurers, utilizing Medicare claims data to demonstrate cost savings from reduced catheter-related infections. Management expects a commercial inflection for Symvess in the second half of 2026 as results from the rebuilt sales team and new hospital system adoptions materialize. A Phase IIa study for CTEV in coronary artery bypass grafting is expected to commence in the current quarter following FDA IND acceptance. The company is preparing for a mid-2027 dialysis launch by using current vascular injury approvals to secure 'on-the-shelf' access in major healthcare systems. A $0.7 million inventory reserve was recorded in Q2 2026 to adjust inventory to net realizable value, alongside expenses for unused production capacity. Net loss fluctuations were primarily driven by non-cash remeasurements of contingent earn-out and derivative liabilities rather than operational cash burn. The company reported $80.1 million in cash as of June 30, 2026, with an increase in cash provided by equity sales and reduced operational spending. The Israel Ministry of Health is currently conducting a 180-day review for Symvess arterial injury repair based on existing FDA approvals. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that 20 major healthcare systems are currently in the process of adopting Symvess in the back half of 2026. The new strategy includes a national account lead to target 1,000 hospitals that the company previously could not access. Introductory pricing incentives were implemented to allow surgeons to 'test' the product's behavior before full practice adoption. The proposed label will target patients at elevated risk of fistula failure, specifically naming women and men with risk factors like obesity and diabetes. Management believes the total exposure of over 1,000 patient-years across three Phase III trials de-risks the upcoming sBLA filing. The company is engaging with 5 to 6 different dialysis verticals beyond Fresenius to ensure broad market access at launch. Fresenius remains committed to adopting the vessel as a standard of care where economic benefits, such as getting patients off catheters, are clear. Management confirmed that Fresenius receives a royalty on every vessel sold in the U.S. across all indications, aligning their interests with Humacyte's success.

– Breakthrough results from V012 dialysis access Phase 3 study, where ATEV was observed to outperform AV fistula; supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug Administration (FDA) during the second half of 2026 – – FDA accepted IND for first-in-human clinical study of CTEV for CABG with Phase 2a study expected to start Q3 2026 – – Second quarter sales of Symvess® were $0.4 million in 2026 compared to $0.1 million in 2025 – – Conference call today at 8:00 am ET – DURHAM, N.C., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the second quarter ended June 30, 2026 and provided a business update. “Our second quarter and recent weeks have been a transformative period for Humacyte and our pipeline expansion, led by the presentation of breakthrough top-line interim results from our V012 Phase 3 trial in female dialysis access patients at the Society of Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM) in Boston,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Results from this trial exceeded our expectations, and our acellular tissue engineered vessel (ATEV) outperformed autologous arteriovenous (AV) fistula, the current standard of care for patients on dialysis. We look forward to using this data to file a supplemental BLA with the FDA later this year. We are also pleased that the FDA recently accepted our Investigational New Drug (IND) application for our coronary tissue engineered vessel (CTEV), and plan to initiate a Phase 2a study in coronary artery bypass grafting (CABG) during the third quarter. No new off-the-shelf conduits have been introduced for CABG in the past 40 years, and our preclinical results suggest that the CTEV may be a promising off-the-shelf alternative to saphenous vein grafts in CABG.” The Company’s operational progress was highlighted by Jim Mercadante, Humacyte’s recently appointed Chief Commercial Officer, who said, “We intentionally focused our second quarter on rebuilding our commercial effort for Symvess, along with implementing an enterprise-wide transformation. Our goal was to drive hospital product adoption and product usage, and to better position Humacyte for sustained growth.” He then addressed the Company’s evolution, “We have remodeled our commercial team to ensure members have relevant longstanding relationships in the vascular surgery space. Beyond team capabilities, we have refined introductory pricing incentive programs, professional-to-professional education, and streamlined our value analysis committee process to drive Symvess adoption. These combined initiatives are creating a growth platform to drive approvals, utilization and revenue growth for this category-defining product. As we move into the second half of 2026, we are already seeing results from this approach with influential hospitals adopting Symvess and utilization strengthening across the board.” Second Quarter 2026 and Recent Corporate Highlights Breakthrough Phase 3 Results of ATEV in Dialysis Support Planned BLA Filing Superior Results Reported from V012 Phase 3 Study in Women: In June 2026, breakthrough results from the V012 Phase 3 trial in female dialysis patients were presented at the Society for Vascular Surgery's Vascular Annual Meeting. In a pre-specified interim analysis of the first 80 patients from the study, the ATEV was observed to outperform AV fistula, the current standard of care, significantly reducing usage of infection-prone catheters. Women who received the ATEV achieved an average of 91 more catheter-free days than those receiving AV fistula and the difference was statistically significant (p=0.00070), meeting the primary efficacy endpoint of the study. Infections were also less common in patients receiving the ATEV, and patients receiving the ATEV had 6 infections per 100 patient years compared with 23 per 100 patient years for patients who received an AV fistula. Women experience up to two times the rate of fistula maturation failure compared to men, leaving many reliant on infection-prone catheters. The V012 study, focused on female dialysis patients, demonstrates that a biologic conduit has the potential to address this longstanding disparity. Planned BLA Filing: The above V012 results, combined with results from the V007 Phase 3 trial reported previously, suggest that the ATEV could represent the first major advance in dialysis access in decades, offering surgeons an alternative option for patients whose risk factors make AV fistula maturation difficult. Based on these results, Humacyte plans to submit a supplemental Biologics License Application to the FDA in the second half of 2026. Appointed Key Nephrologists as Advisors to Prepare for Planned Dialysis Commercialization: Robert J. (Rob) Kossmann, MD, FACP, FASN and Prabir Roy-Chaudhury, MD, PhD, FASN have been appointed as advisors to Humacyte. These leading nephrologists will help prepare for the planned commercialization of the ATEV in dialysis access, if approved by the FDA, contribute to the development of health economic, reimbursement and market access strategies as well as provide peer-to-peer scientific support and medical education. Virtual KOL Event Highlights Need for ATEV in AV Access: The April 2026 event featured Prabir Roy-Chaudhury MD, PhD, FASN (University of North Carolina (UNC) Kidney Center, Salisbury VA Medical Center), and Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS (Brigham & Women's Hospital, Center for Surgery and Public Health, Harvard Medical School), who joined Humacyte management to discuss the unmet need and current surgical access landscape for the nearly 500,000 U.S. patients currently on dialysis. First Human Study in CABG Coronary Tissue Engineered Vessel (CTEV) Progresses Toward First Human Study: The FDA has accepted the IND application for a first-in-human clinical study of the CTEV in coronary artery bypass grafting. Humacyte plans to initiate a Phase 2a study of the CTEV in CABG patients during the current quarter. To support this planned study, Humacyte has completed the first large-scale manufacturing lot of CTEV in its commercial-scale production facilities. Symvess U.S. and International Commercialization Appointed Industry Veteran James Mercadante as Chief Commercial Officer: Mr. Mercadante is a seasoned commercial executive with a track record of successful leadership across medical devices, diagnostics, and healthcare technology. Over his career, he and his teams have launched over 50 new products and delivered millions of dollars in growth for multiple technologies, including high-end peripheral vascular and aortic devices. Mr. Mercadante is overseeing all aspects of the Company's commercial strategy, including sales, marketing, and market access, as Humacyte continues to expand the U.S. launch of Symvess and prepares for potential future commercial indications. Appointed Renowned Vascular Surgeon Dr. Todd E. Rasmussen as Chief Surgical Officer: Dr. Rasmussen joined Humacyte with extensive expertise as a vascular surgeon, including a 28-year career in the U.S. Air Force during which he deployed multiple times during the Iraq and Afghanistan Wars. A recognized leader in peripheral vascular surgery and trauma repair, at Humacyte he is focusing on providing professional-to-professional scientific support, medical education, and technical insights to surgeons and other healthcare providers. He brings an experienced surgical perspective and leadership to the development of education and clinical support materials aligned with regulatory guidance to optimize the safe, appropriate, and effective implantation of Humacyte products. Marketing Authorization Application for Symvess in Israel Accepted for Review: The Company’s Marketing Authorization Application (MAA) for approval of Symvess for arterial injury repair was accepted for review by the Israel Ministry of Health in April 2026. The Ministry of Health set a 180-working-day review period for the MAA due to the existing FDA approval of Symvess in extremity vascular injury. New U.S. Department of Defense Funding for Procurement of Bioengineered Blood Vessels: The FY 2026 U.S. Department of Defense Appropriations Act includes dedicated funding to support the evaluation and incorporation of biologic vascular repair technologies for the warfighters suffering from traumatic vascular injuries. The Company is working with leaders in the military and the Pentagon to ensure that American service personnel will have access to Symvess. Corporate Update Public Offering: In June 2026 Humacyte raised aggregate gross proceeds of $57.5 million from a public offering of its common stock. Humacyte intends to use the net proceeds from the offering to fund the commercialization of Symvess, the planned filing of a Biologics License Application supplement in a dialysis indication, and related activities, the development of the product candidates in its pipeline, and for working capital and general corporate purposes. Cost Reduction: In May 2026, Humacyte implemented a restructuring of its workforce to reduce total headcount by approximately 45 employees through a reduction in force and by deferment of planned hires. Humacyte estimates net savings due to the workforce reductions and operating cost reductions, net of termination severance and benefits, totaling approximately $14.3 million during 2026. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Second Quarter 2026 Financial Highlights Commercial sales of Symvess were $0.4 million in the second quarter of 2026 compared to $0.1 million in 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 meaningful 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 was $1.2 million for the second quarter of 2026 compared to $0.2 million for the second quarter of 2025. In 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 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. Research and development expenses for the three months 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. General and administrative expenses were $8.0 million and $16.0 million for the three months and six months ended June 30, 2026, respectively, consistent with the $7.8 million and $16.0 million for the same periods in 2025. Other net income (expense) was net expense of $9.8 million and net income of $1.5 million for the three months and six months ended June 30, 2026, respectively, compared to net expense of $7.9 million for the three months ended June 30, 2025 and other net income of $54.4 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 year periods resulted primarily from the non-cash remeasurement of the contingent earnout liability and other derivative liabilities. Net loss was $36.8 million and $54.4 million for the three months 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 above. The Company had cash, 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. The increase in total net cash provided for the six months ended June 30, 2026 resulted from higher proceeds from sales of common stock and a reduction in net cash used in operations. Conference Call and Webcast Details A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. INDICATION Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Graft Rupture Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic Failure Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess. Transmission of Infectious Diseases Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; the timing and expected benefits of the commitment to purchase Symvess to facilitate a clinical evaluation and outreach program in the KSA; our ability to realize the benefits of the DoD’s funding in the DoD Appropriations Act; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended March 31, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors [email protected]@humacyte.com Humacyte Media Contact:Rich LuchettePrecision [email protected]@humacyte.com

This article first appeared on GuruFocus. Commercial Sales (Q2 2026): $0.4 million, compared to $0.1 million in Q2 2025. Commercial Sales (H1 2026): $0.9 million, compared to $0.2 million in H1 2025. Contract Revenue: None in Q2 or H1 2026, due to completion of a research collaboration project in the prior year; $0.2 million and $0.6 million in Q2 and H1 2025, respectively. Cost of Goods Sold (Q2 2026): $1.2 million, compared to $0.2 million in Q2 2025; included a $0.7 million inventory reserve and overhead related to unused production capacity. Cost of Goods Sold (H1 2026): $3.3 million, compared to $0.4 million in H1 2025; included a $2.3 million inventory reserve and expenses related to unused production capacity. Research and Development Expenses (Q2 2026): $8.1 million, compared to $22.0 million in Q2 2025. Research and Development Expenses (H1 2026): $37.6 million, compared to $37.4 million in H1 2025. Selling, General and Administrative Expenses (Q2 2026): $8.0 million, consistent with $7.8 million in Q2 2025. Selling, General and Administrative Expenses (H1 2026): $16.0 million, consistent with $16.0 million in H1 2025. Other Net Expense/Income: Net expense of $9.8 million in Q2 2026, compared to net expense of $7.9 million in Q2 2025; net income of $1.5 million in H1 2026, compared to net income of $54.5 million in H1 2025. Net Loss: $36.8 million in Q2 2026, compared to $37.7 million in Q2 2025; $54.4 million in H1 2026, compared to net income of $1.5 million in H1 2025. Cash Position: Cash equivalents and restricted cash of $80.3 million as of June 30, 2026. Net Cash Provided: $29.4 million for H1 2026, compared to net cash used of $6.9 million in H1 2025. Warning! GuruFocus has detected 6 Warning Signs with HUMA. Is HUMA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Humacyte Inc (NASDAQ:HUMA) reported highly statistically significant positive interim results from its VO12 Phase III trial, showing the ATEV provided 91 more catheter-free days than the standard-of-care AV fistula in female dialysis patients (p=0.0007). The company is advancing its pipeline with FDA acceptance of an IND for a first-in-human study of its coronary tissue-engineered vessel (CTAV) in CABG, with the study expected to begin in the current quarter. Humacyte Inc (NASDAQ:HUMA) has strengthened its commercial team with experienced leadership, including a new Chief Commercial Officer and Chief Surgical Officer, and is seeing early signs of adoption and increased utilization among influential hospitals. The company is preparing for a supplemental BLA submission for dialysis access in the second half of 2026, with a target filing in November and potential priority review, which could lead to a launch as early as mid-2027. Humacyte Inc (NASDAQ:HUMA) has secured dedicated U.S. Department of Defense funding to support the evaluation and incorporation of its vascular repair technology for warfighters, enhancing its military market potential. Humacyte Inc (NASDAQ:HUMA) reported very low commercial sales of only $0.4 million in Q2 2026, reflecting a rebuilding quarter and slower-than-expected uptake in the vascular injury indication. The company recorded a $0.7 million inventory reserve in Q2 and $2.3 million for the six months, along with expenses related to unused production capacity, indicating inefficiencies in manufacturing. Humacyte Inc (NASDAQ:HUMA) continues to incur significant net losses, with a net loss of $36.8 million in Q2 2026 and $54.4 million for the first half, driven by non-cash remeasurement of contingent liabilities. The commercial team underwent a complete rebuild, which disrupted momentum and delayed tangible results, with management acknowledging that the impact of new strategies will only be visible in the second half of 2026. The company faces uncertainty regarding FDA review timelines and label negotiations for the dialysis indication, with potential delays if priority review is not granted, pushing launch to later in 2027. Q: What were the key results from the VO12 Phase III trial in dialysis access, and what are the next steps for regulatory submission? A: Laura Niklason (President and CEO) reported that the pre-specified interim analysis of the first 80 patients showed women receiving the ATEV achieved 91 more catheter-free days than those receiving an AV fistula (p=0.0007), meeting the primary efficacy endpoint. Infections were also lower (6 vs. 23 per 100 patient-years). The company plans to submit a Supplemental BLA to the FDA in November 2026, requesting priority review. If granted, they anticipate a PDUFA date in May 2027 and a potential launch at the end of Q2 2027. Q: Can you elaborate on the commercial strategy rebuild and what tangible results are being seen from the changes? A: Jim Mercadante (Chief Commercial Officer) explained that the rebuild focused on hiring sales executives with deep, long-standing relationships in vascular surgery, which was identified as a critical gap. The team also refined introductory pricing incentives and streamlined the Value Analysis Committee (VAC) approval process to make it easier for hospitals to adopt the product. Laura Niklason added that the company underestimated the educational challenges of launching the first new conduit in 40 years. Jim noted that at least 20 major healthcare systems are currently in the process of adopting Symvess in the back half of 2026, with results expected to materialize then rather than in Q2. Q: What is the company's strategy for preparing for the dialysis access launch, and how does the relationship with Fresenius factor in? A: Laura Niklason stated that the company is focused on building a strong health economics and reimbursement story, particularly around getting patients off expensive, infection-prone catheters. They are developing a budget impact model and analyzing Medicare claims data to demonstrate cost savings to insurers. Jim Mercadante added that the current vascular injury launch is a strategic precursor: by getting Symvess adopted and on the shelf in healthcare systems now, they will have instant access to dialysis patients upon approval. While they hope to work with Fresenius, they are also evaluating five or six other verticals and strategies for the dialysis launch. Q: What is the status of the CTAV program for coronary artery bypass grafting (CABG), and what are the next steps? A: Laura Niklason confirmed that the FDA has accepted the IND for a first-in-human study of CTAV in CABG. The company has completed the first large-scale manufacturing lot of CTAVs. The Phase 2A study will enroll 10 patients, and the company expects to open the study in August 2026. The focus is on identifying the right patients to ensure outstanding outcomes, with two highly experienced cardiac surgeons who performed the large animal work leading the study. Q: What were the key financial results for the second quarter of 2026? A: Dale Sander (CFO) reported commercial sales of $0.4 million in Q2 2026, up from $0.1 million in Q2 2025. R&D expenses decreased to $8.1 million from $22.0 million year-over-year, primarily due to reduced manufacturing runs and clinical trial expenses. SG&A expenses were consistent at $8.0 million. The net loss was $36.8 million for the quarter. The company ended the quarter with $80.3 million in cash, equivalents, and restricted cash. Q: How is the company addressing the challenge of slow adoption for Symvess in the vascular trauma indication? A: Laura Niklason acknowledged that the commercial uptake was slower than hoped, leading to the departure of the prior CCO. She noted that the company underestimated the educational hurdles for a fundamentally new product. To address this, they brought in Jim Mercadante and appointed Dr. Todd Rasmussen as Chief Surgical Officer to provide peer-to-peer scientific support and medical education. Jim Mercadante emphasized the importance of having a sales force with deep vascular surgery relationships and a national account strategy to access more hospitals. Q: What is the anticipated label for the ATEV in dialysis access, and how is the RMAT designation being used? A: Laura Niklason stated that the anticipated label would be for hemodialysis access in patients at elevated risk of fistula failure or non-maturation, potentially specifying women and men with risk factors like obesity and diabetes. The final label language is subject to FDA negotiation. The company will use its RMAT designation, along with its existing approval in another indication, to request priority review for the sBLA. Q: Can you provide more detail on the number of hospitals associated with the 20 healthcare systems currently adopting Symvess? A: Jim Mercadante explained that the number of hospitals per system can range from 5 to 50. He noted that adoption typically starts with one or two surgeons and then expands to the entire department. He highlighted several cases where usage has transformed from occasional "dabbling" to weekly usage, and he expects this adoption process to naturally duplicate itself as healthcare systems share their experiences with peers. Q: Was there a slowdown in hospital approvals during Q2 due to the commercial team transition? A: Jim Mercadante clarified that the company was "literally rebuilding the entire commercial team," including personnel, strategy, and tactics, which was accomplished in about three months. He stated that the results of this transformation were not expected to show in Q2, but rather in the back half of the year. While there was a minor uptick in Q2, the significant growth is anticipated in the second half of 2026. Q: How will the manufacturing of CTAVs impact the production of the commercial ATEV product? A: Laura Niklason confirmed that CTAVs are made on the same platform and in the same machines as the commercial ATEVs. However, the demand for CTAVs is very low for the next year or two, as the Phase 2A study only requires 10 patients. Since the smallest batch size is 100 vessels, they may only need to make one more CTAV batch next year, which will not strain the production system. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Humacyte, Inc.? Here are five stocks we like better. Dialysis expansion: Interim Phase III data showed ATEV patients had 91 more catheter-free days and fewer infections than those receiving standard AV fistulas. Humacyte plans to file a supplemental BLA with the FDA around November 2026, targeting a potential launch in mid-to-late 2027. Commercial rebuild: Second-quarter sales rose to $0.4 million from $0.1 million a year earlier as Humacyte revamped its SYMVESS sales strategy. At least 20 major U.S. health systems are working to adopt the product, while the company aims to expand access to roughly 1,000 additional hospitals. Pipeline and finances: The FDA accepted Humacyte’s application for a first-in-human coronary bypass study, with a 10-patient Phase IIa trial expected to begin in the current quarter. The company reported a $36.8 million quarterly net loss and ended June with $80.3 million in cash and restricted cash. Humacyte (NASDAQ:HUMA) reported second-quarter commercial sales growth while outlining plans to expand adoption of its SYMVESS vascular repair product, submit a supplemental biologics license application for dialysis access and begin a first-in-human coronary bypass study. Commercial sales totaled $0.4 million in the quarter ended June 30, up from $0.1 million a year earlier. Sales for the first six months of 2026 were $0.9 million, compared with $0.2 million in the prior-year period. The company reported a second-quarter net loss of $36.8 million, compared with a $37.7 million loss in the same quarter of 2025. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat President and Chief Executive Officer Dr. Laura Niklason said Humacyte presented interim data in June from its V012 Phase III trial of its Acellular Tissue Engineered Vessel, or ATEV, in female dialysis patients. In a pre-specified interim analysis of the study’s first 80 patients, women receiving ATEV had 91 more catheter-free days than patients receiving an autologous arteriovenous fistula, the current standard of care. The company said the difference met the study’s primary efficacy endpoint, with a p-value of 0.0007. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Humacyte also reported six infections per 100 patient-years among ATEV patients, compared with 23 infections per 100 patient-years among patients who received an AV fistula. Niklason said the company believes the V012 findings, together with previously reported V007 Phase III results, could represent a significant advance in hemodialysis access. The company plans to submit a supplemental BLA to the FDA for dialysis access during the second half of 2026. During the question-and-answer session, Niklason said Humacyte’s current target is a November filing and that the company intends to request priority review. If granted, she said the company would expect a PDUFA date around May 2027 and would target a launch near the end of the second quarter of 2027. Without priority review, the expected PDUFA date could extend into August, she said. → First Solar’s Profit Engine Faces a New Policy Test in Washington Humacyte has scheduled a pre-BLA meeting with the FDA, which Niklason said is expected to focus on the filing’s structure rather than whether the company can submit the application. She said the submission is expected to include data from three Phase III studies and several Phase II studies, representing more than 1,000 patient-years of exposure. The company appointed Robert J. Kossmann, MD, and Prabir Roy-Chaudhury, MD, PhD, as advisors to support reimbursement, health economics and market-access planning for the prospective dialysis launch. Chief Commercial Officer Jim Mercadante said the second quarter focused on rebuilding Humacyte’s commercial organization for SYMVESS, which is approved in the U.S. for extremity vascular injury repair. Mercadante said the company remodeled its sales team to emphasize personnel with established vascular-surgery relationships, while refining introductory pricing programs, physician education and engagement with hospital value analysis committees. He said Humacyte is beginning to see increased utilization and adoption at hospitals during the second half of 2026. Niklason said the company had underestimated the education needed to introduce a new vascular conduit to surgeons. She also said Humacyte needed commercial leaders with deeper relationships among practicing vascular surgeons. Mercadante said Humacyte has at least 20 major U.S. healthcare systems in the process of bringing SYMVESS into their systems during the second half of the year. He said the systems range in size from roughly five to 50 hospitals. The company also hired an executive to develop a national-account strategy intended to expand access to approximately 1,000 hospitals where Humacyte previously lacked access. Humacyte’s marketing authorization application for SYMVESS in acute injury repair was accepted for review by Israel’s Ministry of Health in April. The ministry established a 180-working-day review period, according to the company. The company also appointed Dr. Todd Rasmussen as chief surgical officer. Rasmussen, a former U.S. Air Force vascular surgeon, will provide scientific support, medical education and technical guidance to physicians, Humacyte said. Humacyte said the FDA accepted its investigational new drug application for a first-in-human study of its Coronary Tissue Engineered Vessel, or CTEV, in coronary artery bypass grafting. The CTEV is a smaller-diameter version of the company’s ATEV designed for bypass procedures. The company completed its first large-scale manufacturing lot of CTEVs and plans to initiate a Phase IIa trial during the current quarter. Niklason said the study is expected to enroll 10 patients and could open during August, subject to completing institutional review board processes and related paperwork. She said the CTEV study’s manufacturing needs are not expected to meaningfully affect production of commercial ATEV products because the trial requires relatively few vessels. Cost of goods sold rose to $1.2 million in the second quarter from $0.2 million a year earlier. The company said $0.2 million was associated with units recognized as sales during the period, while the remainder primarily reflected a $0.7 million inventory reserve and expenses tied to unused production capacity. Research and development expense fell to $8.1 million from $22 million, primarily due to reduced non-commercial manufacturing runs and lower clinical trial expenses. Selling, general and administrative expense was $8 million, compared with $7.8 million a year earlier. For the first six months, Humacyte reported a net loss of $54.4 million, compared with net income of $1.5 million in the prior-year period. The company attributed the change primarily to non-cash remeasurement of its contingent earnout liability and other derivative liabilities. Humacyte ended June with $80.3 million in cash equivalents and restricted cash. Total net cash provided during the first six months was $29.4 million, compared with net cash used of $6.9 million in the comparable 2025 period, driven by higher equity-sale proceeds and lower net cash used in operations. Humacyte, Inc is a clinical-stage biotechnology company focused on the development and manufacturing of off-the-shelf, regenerative human acellular vessels (HAVs) designed to address critical vascular access needs. The company's proprietary vessels are engineered from human donor cells and then decellularized to create a biocompatible scaffold capable of integrating with a patient's own tissue. Humacyte's primary business activities encompass process development, large-scale manufacturing, and clinical evaluation of HAVs for use in end-stage renal disease, peripheral arterial disease and other vascular repair applications. The company's lead product candidate, the HAV, has advanced through multiple clinical trials for arteriovenous access in hemodialysis patients, demonstrating durability, reduced infection rates and compatibility with repeated cannulation. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Humacyte Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

DURHAM, N.C., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the Company will release its financial results for the three months and six months ended June 30, 2026, on Wednesday, August 12, 2026. Management will host a webcast and conference call at 8:00 a.m. Eastern Time to provide a corporate and financial update. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for Symvess, the acellular tissue engineered vessel (ATEV), in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). The Company is preparing for human clinical study in coronary artery bypass graft surgery, and preclinical development is also underway in the treatment of type 1 diabetes, pediatric heart disease, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended March 31, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors [email protected]@humacyte.com Humacyte Media Contact:Rich LuchettePrecision [email protected]@humacyte.com

Amgen (AMGN) came out with quarterly earnings of $6.29 per share, beating the Zacks Consensus Estimate of $5.6 per share. This compares to earnings of $6.02 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +12.32%. A quarter ago, it was expected that this world's largest biotech drugmaker would post earnings of $4.73 per share when it actually produced earnings of $5.15, delivering a surprise of +8.88%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Amgen, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $10.05 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.52%. This compares to year-ago revenues of $9.18 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Amgen shares have added about 15.8% since the beginning of the year versus the S&P 500's gain of 11%. While Amgen has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Amgen was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $5.71 on $9.69 billion in revenues for the coming quarter and $22.31 on $37.73 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Humacyte, Inc. (HUMA), is yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of +58.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Humacyte, Inc.'s revenues are expected to be $1.39 million, up 363.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amgen Inc. (AMGN) : Free Stock Analysis Report Humacyte, Inc. (HUMA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

– Positive results from the V012 Phase 3 study were presented at the Society for Vascular Surgery's Vascular Annual Meeting in Boston – – Women who received Humacyte's ATEV experienced an average of three more months without a dialysis catheter than women who received AV fistula, the current standard of care – – Company to hold investor event today, June 15th, at 5:00 p.m. ET – DURHAM, N.C., June 15, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology company that develops bioengineered human tissues, presented detailed results from its V012 Phase 3 study showing that the Company’s bioengineered blood vessel – the acellular tissue engineered vessel, or ATEV – outperformed autologous arteriovenous (AV) fistula, the current standard of care, for women on dialysis. The results were presented at a Women’s Health seminar during the Society for Vascular Surgery's (SVS's) Vascular Annual Meeting (VAM) in Boston. “For too long, women on dialysis have had to settle for access options that often don’t work well for them,” said Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. “This study shows that our bioengineered blood vessel can keep patients off catheters longer than the current standard of care, with fewer infections. That is a meaningful difference for patients, and we look forward to using this data to file a supplemental BLA with the FDA later this year.” “Every day a patient spends on a catheter is a day at higher risk of infection,” added Shamik Parikh, MD, Chief Medical Officer of Humacyte. “Giving women an average of three more months without a catheter is exactly the kind of improvement these patients need. The Phase 3 results we shared at VAM tell a clear, compelling, and consistent story.” Patients on dialysis need a reliable, long-lasting connection to their bloodstream so a machine can draw out blood, clean it, and return it. The most common approach today is an AV fistula, a connection a surgeon creates between an artery and a vein. But AV fistulas often fail to develop the way they should, especially in women. When that happens, patients rely on catheters, tubes placed in the body that carry a high risk of infection. In the V012 study, women who received the ATEV were able to avoid catheter use three months longer than women who received the standard of care. Over the first year, women with the ATEV averaged 220 days free of a catheter, compared with 129 days for women who received an AV fistula, and the difference was statistically significant (p=0.00070). Infections were also less common in patients receiving the ATEV: patients had about 6 infections per 100 patient years, compared with 23 per 100 patient years for patients who received an AV fistula. None of the infections in the ATEV group were tied to the blood vessel itself, compared with three in the fistula group, and no ruptures occurred in either group. “Fistulas often fail to develop in women, which forces too many patients to rely on catheters and risk the infections that often come with them,” said Mohamad A. Hussain, MD, PhD, a vascular and endovascular surgeon-scientist at Heart and Vascular Institute, Mass General Brigham and Associate Professor of Surgery at Harvard Medical School. “An option that is ready to use off the shelf and that keeps patients off catheters will fill a real gap in how we care for these patients today.” In V012 the ATEV was also observed to have consistent advantages over AV fistula in the secondary efficacy endpoints for the study. Six-month catheter-free days averaged 88 days for ATEV compared to 32 days for AV fistula (p=0.00009). Functional patency over 12 months averaged 250 days for ATEV compared to 152 days for AV fistula (p=0.00057). Six-month secondary patency was 87.5% for ATEV compared to 65.0% for AV fistula (p=0.0013). Twelve-month secondary patency was 77.5% for ATEV compared to 62.5% for AV fistula (p=0.16). “Time on a catheter is time at risk, so keeping patients catheter-free for longer really matters,” added Young M. Erben, MD, a vascular surgeon at Mayo Clinic in Jacksonville, Florida, and Professor of Surgery at Mayo Clinic College of Medicine and Science. “A dependable, readily available access option could be especially valuable for women and others who are not good candidates for a fistula.” The safety profile in both groups was comparable, with the ratio of all adverse events reported below adjusted for patient years of use. Serious adverse events were 1.73 for ATEV compared to 4.77 for AV fistula. Adverse events of special interest (AESI) were 2,71 for ATEV compared to 3.88 for AV fistula. Within AESIs, thrombotic events were 0.75 for ATEV compared to 0.51 for AV fistula, and 75.0% of ATEV thrombosis cases successfully resolved compared to 37.5% for AV fistula. Stenotic events were 1.62 for ATEV compared to 2.29 for AV fistula. In accordance with the study protocol, as a result of meeting the primary superiority endpoint of catheter-free days, study enrollment will terminate and existing patients will continue to be followed as per protocol. Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026. The currently planned target indication is focused on adult patients with end-stage kidney disease who are at increased risk of AV fistula maturation failure. Humacyte will host an investor event today, June 15, 2026 at 5:00 p.m. ET to discuss the V012 Phase 3 results and what they mean for patients, with registration information listed below. Reporters interested in an interview with Humacyte leadership about the V012 results should contact Rich Luchette at [email protected]. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans, anticipated timeline and ability to file applications for, and obtain marketing approvals from, the FDA and other regulatory authorities, including the European Medicines Agency, for our ATEVs and product candidates; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs and the public perception thereof; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended March 31, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors [email protected]@humacyte.com Humacyte Media Contact:Rich LuchettePrecision [email protected]@humacyte.com