Humacyte (HUMA) 2026 年第 2 季法說會：洗腎 sBLA 目標定於 11 月

重點摘要

• 2026 年第二季商業銷售額從去年同期的 10 萬美元增加至 40 萬美元。上半年 Symvess 銷售額從 20 萬美元增至 90 萬美元。
• Humacyte 的 V012 第三期臨床試驗中期分析顯示，接受 ATEV 治療的前 80 名女性透析患者，其無導管天數比接受自體動靜脈瘻管的患者多出 91 天，達到主要療效終點，p 值為 0.0007。
• 管理層預計於 2026 年 11 月提交透析管道的補充生物製品許可申請 (sBLA)。若獲得優先審查，公司預期潛在的 PDUFA（處方藥使用者付費法案）目標日期為 2027 年 5 月，並於 2027 年第二季末附近上市。
• 第二季淨虧損為 3,680 萬美元，去年同期則為 3,770 萬美元。截至 2026 年 6 月 30 日，Humacyte 持有 8,010 萬美元的現金、現金等價物與受限制現金。
• Humacyte 重組了 Symvess 商業團隊，並表示美國至少有 20 個大型醫療系統正在進行 2026 年下半年的採納引進程序。
• 美國食品藥物管理局 (FDA) 已受理 Humacyte 用於冠狀動脈繞道移植術的 CTEV 人體首次臨床試驗申請 (IND)。管理層預計包含 10 名患者的 IIa 期臨床試驗將於 2026 年 8 月展開。

關鍵財務數據

截至 2026 年 6 月 30 日止的前六個月，商業銷售額為 90 萬美元，去年同期為 20 萬美元。銷貨成本為 330 萬美元，其中包括 230 萬美元的存貨跌價準備與未利用產能費用。上半年淨虧損為 5,440 萬美元，而去年同期為淨利潤 150 萬美元，主要歸因於非現金負債重測算。

2026 年上半年淨流入現金總額為 2,940 萬美元，去年同期則為淨流出 690 萬美元。管理層將此轉變歸因於股權融資收益增加以及營運活動使用的淨現金減少。

業務與營運表現

透析管道專案

V012 第三期中期分析涵蓋前 80 名女性患者。除了無導管天數增加 91 天外，ATEV 的感染率為每 100 患者年 6 起，而自體動靜脈瘻管則為每 100 患者年 23 起。

Humacyte 表示，其透析管道申請預計將包含來自三項第三期試驗和多項第二期研究的數據，代表超過 1,000 患者年的暴露量。公司亦正在開發專注於減少導管使用及其相關成本的健保給付與健康經濟學資料。

擬議的適應症預計涵蓋具有瘻管失敗或無法成熟高風險患者的血液透析管道，可能包括具有肥胖與糖尿病等風險因子的女性與男性。管理層強調，最終標示文字仍需與 FDA 進行溝通協商。

Symvess 商業化進程

Humacyte 表示，Symvess 初期上市進展比預期緩慢，主因是公司低估了推廣新型血管管道所需進行的教育培訓，且部分商業團隊缺乏與血管外科領域的深入合作關係。

重組後的團隊現在著重於招募具備經驗的血管外科銷售人員、關鍵意見領袖 (KOL) 參與、推廣試用價格、專業教育訓練以及簡化的價值分析委員會 (VAC) 審查流程。全新的全國客戶策略旨在將潛在通路擴展至額外約 1,000 家美國醫院。

管理層表示，2026 年下半年至少有 20 個大型醫療系統正著手將 Symvess 引進其醫療網路中。單一系統可能涵蓋 5 至 50 家醫院。公司還報告指出，部分醫院的使用情況已從偶爾手術發展為每週定期使用。

Humacyte 在以色列提出的 Symvess 用於動脈損傷修復的上市許可申請於 2026 年 4 月獲受理審查，工作審查期為 180 天。公司亦持續與美國軍方及五角大廈領導層進行討論，爭取在創傷性血管損傷領域的應用。

CTEV 產品管道

FDA 受理了 Humacyte 用於冠狀動脈繞道移植術的 CTEV IND 申請。計劃中的 IIa 期研究將招募 10 名患者，且公司已完成首批大規模 CTEV 生產製造。

CTEV 與商業化的 ATEV 產品採用相同的製造平台。管理層表示，近期研究的需求量較小，預計不會對產能造成重大負擔；最小批次規模為 100 條血管。

管理層展望

Humacyte 預計於 2026 年 11 月提交 ATEV 在透析管道適應症的 sBLA，並計劃利用其突破性先進療法 (RMAT) 認定以及現有的血管損傷批准，申請優先審查。

若獲得優先審查，管理層預期 PDUFA 目標日期可能落在 2027 年 5 月，並於 2027 年第二季末附近進行商業上市。若未獲得優先審查，潛在的 PDUFA 日期可能延至 2027 年 8 月。這些時程仍取決於 FDA 的受理情況、審查進度與主管機關的時程安排。

公司正利用現有的血管損傷適應症，在潛在透析產品上市前取得醫院審查批准與上架資格。管理層認為，一旦新適應症獲批，既有的醫院通路將有助於加速產品採納。

風險與關注焦點

• Symvess 的商業市場採納速度慢於管理層最初預期，且重組銷售團隊的好處尚未體現在第二季財報中。
• 第二季銷貨成本高於商業銷售額，反映出存貨跌價準備金與未利用產能相關的費用。
• 透析 sBLA 能否獲得優先審查仍無法保證，且管理層坦承 FDA 並非總能如期達成 PDUFA 目標日期。
• 最終的透析適應症與標籤用語仍需與 FDA 進行協商。
• 產品採納程度取決於醫師教育培訓、患者篩選、醫院委員會審查批准、健保給付以及經濟效益證據。

分析師問答集錦

管理層表示，商業團隊的重組在約三個月內涵蓋了銷售、行銷與全國客戶部門。第二季的初期改善效果有限，預計 2026 年下半年將出現更顯著的採納進展。

在透析管道方面，Humacyte 正於獲得批准前籌備上市基礎設施。策略包括善用現有的 Symvess 醫院批准、與費森尤斯醫藥 (Fresenius Medical Care) 合作，並爭取拓展額外五至六個以美國透析為重點的通路或垂直市場。

Humacyte 表示，費森尤斯仍受商業化協議約束，並已承諾在符合經濟效益的適應症患者中，將該產品採用為標準療法。此外，費森尤斯還可從 Humacyte 在美國跨適應症售出的每條血管中獲得權利金。

法說會逐字稿全文

完整財報電話會議逐字稿

管理層陳述

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.

分析師問答

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.