Humacyte Inc (HUMA) 2026 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Humacyte first-quarter 2026 earnings conference call. (Operator Instructions) As a reminder, this conference call is being recorded.

各位女士、先生，早安，歡迎參加 Humacyte 2026 年第一季財報電話會議。(接線員指示) 提醒各位，本次電話會議將被錄音。

I'll now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead, Tom.

現在我將把電話交給 LifeSci Advisors 的 Tom Johnson。Tom，請開始。

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

謝謝，接線員。在我們開始之前，我想提醒各位，本次電話會議中所作的某些陳述，依據美國聯邦證券法屬於前瞻性陳述。這些陳述存在風險與不確定性，可能導致實際結果與歷史經驗或目前預期存在重大差異。有關可能導致實際結果與本次電話會議陳述不同之因素的更多資訊，載於我們向 SEC 提交的定期報告中。

The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise 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.

本次電話會議中的前瞻性陳述僅截至本日有效，公司不承擔更新或修訂任何前瞻性陳述之義務，法律另有規定者除外。本次電話會議所提供的資訊，包含於我們今早發布的新聞稿以及我們的 Form 10-Q 中；該文件在完成申報後，可於 Humacyte 官網的投資人頁面查閱。

Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the first quarter and in recent weeks, and Dale will review the company's financial results for the quarter ended March 31, 2026.

今天與我一同參與電話會議的 Humacyte 代表包括：總裁兼執行長 Laura Niklason 博士，以及財務長兼企業發展長 Dale Sander。Niklason 博士將概述公司第一季及近幾週的進展，Dale 則將回顧截至 2026 年 3 月 31 日止季度的財務結果。

I will now turn the call over to Dr. Niklason. Laura?

現在我將把電話交給 Niklason 博士。Laura？

Thank you, Tom, and good morning, everyone, and thank you for joining us for our first quarter financial results and business update call for 2026. To remind this audience, Humacyte's key corporate goals for this year include advancing the US and global commercial launch of Symvess, completion of the V012 Phase 3 pivotal trial of our ATEV in dialysis access, the planned 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.

謝謝你，Tom，各位早安，也感謝各位參加我們 2026 年第一季財務結果與業務更新電話會議。提醒各位，Humacyte 今年的主要公司目標包括：推進 Symvess 在美國及全球的商業上市、完成我們 ATEV 用於透析通路的 V012 第 3 期關鍵性試驗、計畫就透析適應症向 FDA 提交補充 BLA，以及啟動我們冠狀動脈組織工程血管（CTEV）用於冠狀動脈繞道手術（CABG）的人體研究。

During today's call, I'll review progress across those commercial and developmental programs before turning the call over to Dale for a review of our financial results for the quarter. During our first quarter and in recent weeks, we continue to make progress in our US market launch of Symvess as well as expand commercialization into international markets.

在今天的電話會議中，我將先回顧上述商業化與研發計畫的進展，之後再把電話交給 Dale 回顧本季的財務結果。在第一季以及近幾週，我們持續推進 Symvess 在美國市場的上市，同時也擴展至國際市場的商業化。

First quarter sales of Symvess were $0.5 million in 2026 as compared to $0.1 million in the first quarter of 2025. While we've seen expansion in the commercial uptake of Symvess, we also recognize that more rapid product uptake and sales growth is necessary and is warranted based on Symvess' tremendous potential.

2026 年第一季 Symvess 銷售額為 50 萬美元，相較於 2025 年第一季的 10 萬美元。雖然我們看到 Symvess 的商業採用正在擴大，但我們也認知到需要、且基於 Symvess 的巨大潛力也值得更快速的產品採用與銷售成長。

To that end, we recently announced substantial new hires in senior commercial and clinical leadership positions. Industry veteran, James Mercadante has been brought in as our new Chief Commercial Officer, while Dr. Todd Rasmussen has been brought in as our Chief Surgical Officer. Jim is an accomplished medtech commercial leader with an extensive track record of field-specific success in vascular and cardiothoracic surgery markets. Dr. Rasmussen is one of the trailblazers of modern vascular surgery, particularly vascular trauma and peripheral artery disease, and he will be instrumental in guiding our education strategy for Symvess going forward.

為此，我們近期宣布在商業與臨床高階領導職位上進行大幅度的新聘任。我們延攬產業資深人士 James Mercadante 擔任新的商務長（Chief Commercial Officer），並延攬 Todd Rasmussen 博士擔任我們的首席外科長（Chief Surgical Officer）。Jim 是一位成就卓著的醫療科技商業領導者，在血管與心胸外科市場具備豐富且可驗證的第一線成功經驗。Rasmussen 博士是現代血管外科的先驅之一，尤其在血管創傷與周邊動脈疾病領域；他將在未來引導我們的 Symvess 教育策略方面扮演關鍵角色。

We're also adding commercial talent that will more thoroughly cover important US markets and will engage directly with large integrated delivery networks or IDNs. We look forward to working with this new revamped and restructured commercial and clinical leadership team to accelerate and expand patient access to Symvess in the US and globally.

我們也正在增補商業人才，以更完整覆蓋美國重要市場，並直接與大型整合式醫療服務網（IDN）互動。我們期待與這個全新改造並重新架構的商業與臨床領導團隊合作，加速並擴大 Symvess 在美國及全球的病患可近性。

In parallel with our US launch of Symvess, we're also taking steps to expand the commercialization into international markets. In March, we submitted a marketing authorization application, or MAA, with the Israeli Ministry of Health for Symvess for arterial injury repair. In April, our MAA was accepted for review by the Israel Ministry of Health. The Ministry of Health has set a 180 working-day review period for our MAA.

在推進 Symvess 美國上市的同時，我們也採取措施將商業化擴展至國際市場。3 月，我們向以色列衛生部提交 Symvess 用於動脈損傷修復的上市許可申請（MAA）。4 月，我們的 MAA 已獲以色列衛生部受理並進入審查。衛生部為我們的 MAA 設定了 180 個工作天的審查期。

International interest has also been highlighted by the $1.475 million purchase commitment that we announced for the Kingdom of Saudi Arabia. This funding will facilitate clinical evaluation and outreach programs in hospitals within the Kingdom. The planned clinical evaluation will be conducted in parallel with ongoing negotiations with a Kingdom-based entity for establishment of a joint venture and license to commercialize Symvess within country.

國際市場的興趣也反映在我們宣布的、來自沙烏地阿拉伯王國 147.5 萬美元的採購承諾上。這筆資金將促進在王國境內醫院的臨床評估與推廣計畫。規劃中的臨床評估將與我們目前正與王國境內某實體進行的談判同步進行，該談判旨在成立合資企業並取得在國內商業化 Symvess 的授權。

Also, as previously announced, the US Department of Defense has dedicated funding for evaluation and incorporation of new biologic vascular repair technologies. In appropriating this funding, lawmakers demonstrated that they recognize the need for human-derived bioengineered vessels to save life and limb on the battlefield. We believe this historic first-of-its-kind federal investment will help ensure that our soldiers continue to have access to cutting-edge treatments and state-of-the-art care whenever and wherever they need it. We look forward to working with leaders in our military and at our military health facilities to ensure that the American service personnel will have access to this groundbreaking technology.

此外，如先前所宣布，美國國防部已編列專款，用於評估並導入新的生物性血管修復技術。在撥付此項資金時，立法者展現其認知：戰場上需要源自人體的生物工程血管，以挽救生命與肢體。我們相信，這項具歷史意義、首創的聯邦投資，將有助於確保我們的士兵在任何時間、任何地點需要時，都能持續取得尖端治療與最先進的照護。我們期待與軍方領導人及軍事醫療機構合作，確保美國軍人能夠使用這項突破性技術。

Also, in May of 2026, Humacyte implemented a restructuring of its workforce and to reduce total headcount by 45 employees or roughly 25%. We did this by trimming some current staff and by deferring some planned hires for this year. Other operating expenses were also trimmed, and this was enabled by the successful completion of multiple technical and clinical projects at Humacyte over the past year. These spending reductions were done thoughtfully, and Humacyte has retained personnel, resources and initiatives to meet its key corporate goals and milestones.

另外，在 2026 年 5 月，Humacyte 實施了人力重整，將員工總數減少 45 人，約占 25%。我們透過精簡部分現有人員，並延後今年部分原定招募來達成。其他營運費用也有所削減，這得益於 Humacyte 在過去一年成功完成多項技術與臨床專案。這些支出削減是經過審慎規劃的；Humacyte 仍保留達成關鍵公司目標與里程碑所需的人員、資源與計畫。

These key corporate goals include, as mentioned earlier, advancing the US and global commercial launch of Symvess, completion of the V012 Phase 3 trial in dialysis, the planned filing of our supplemental BLA in dialysis in the US and the commencement of a first-in-human study of CTEV in CABG. With this reorganization, we've grown the support for the commercial mission by taking advantage of prior successes in the technical sphere that have allowed Humacyte to reduce run costs while maintaining our laser focus on medical education, sales and marketing.

如先前所述，這些關鍵公司目標包括：推進 Symvess 在美國及全球的商業上市、完成透析領域的 V012 第 3 期試驗、計畫在美國就透析適應症提交補充 BLA，以及啟動 CTEV 用於 CABG 的首次人體試驗。透過此次重組，我們利用先前在技術領域的成果，讓 Humacyte 在維持對醫學教育、銷售與行銷的高度聚焦之同時，降低營運成本，並強化對商業任務的支援。

As a result of the restructuring, Humacyte estimates that we'll incur aggregate charges representing a onetime cash expenditure for severance and other employee termination benefits of approximately $0.8 million, of which the majority is expected to be incurred during the second quarter of 2026. We further estimate a savings for the remainder of 2026 of approximately $14.3 million, which is net of the severance and benefits.

因應此次重整，Humacyte 預估將產生合計費用，代表一次性現金支出，用於資遣費及其他員工終止聘僱福利，約為 80 萬美元，其中大部分預期將於 2026 年第二季發生。我們亦預估 2026 年剩餘期間可節省約 1,430 萬美元，該金額已扣除資遣與福利成本。

I'll turn now to the program that's our next priority, which is dialysis access, which will reach an exciting milestone later this quarter. Further illustrating the platform nature of Humacyte's technology, we're nearing the presentation of top line interim results for our Phase 3 trial in dialysis access. These results should be ready for presentation by June 11, 2026, at the Vascular Annual Meeting in Boston. Thus far, a total of 120 patients have been enrolled to date in the V012 Phase 3 clinical trial, which is designed to assess the efficacy and safety of the ATEV in dialysis access in comparison to AV fistulas in female patients. We're currently working to complete a prespecified interim analysis of our ongoing V012 trial, which is being conducted in women.

我現在轉到我們下一個優先項目的計畫，也就是透析通路，該項目將在本季稍晚達成一個令人振奮的里程碑。進一步彰顯 Humacyte 技術的平台特性，我們即將發表透析通路適應症之第 3 期試驗的期中主要（top line）結果。這些結果預計可於 2026 年 6 月 11 日在波士頓舉行的 Vascular Annual Meeting 上準備好進行發表。截至目前，V012 第 3 期臨床試驗已累計納入 120 名患者；該試驗旨在女性患者中，評估 ATEV 用於透析通路相較於 AV 瘻管（AV fistulas）的有效性與安全性。我們目前正著手完成對進行中的 V012 試驗之預先規劃（prespecified）期中分析，該試驗是在女性受試者中進行。

These top line interim results are expected to be available for reporting around June 11, as I mentioned, in Boston. Subject to the results, our plan is to submit a supplemental BLA in the second half of 2026 to add dialysis as an indication for Humacyte's ATEV. The compelling unmet needs for hemodialysis access among female and other underserved patients were also highlighted in a key opinion leader event that we hosted on April 28. featuring Dr. Prabir Roy-Chaudhury of the University of North Carolina and Dr. Mohamad Hussain of the Brigham and Women's Hospital at Harvard Medical School. This was a very well-attended event, which we believe speaks to the interest in alternatives to the current treatments for access in hemodialysis patients.

如我所提，這些期中主要結果預期將在約 6 月 11 日於波士頓可供報告。視結果而定，我們計畫在 2026 年下半年提交補充 BLA，以將透析新增為 Humacyte 的 ATEV 之適應症。我們於 4 月 28 日主辦的一場關鍵意見領袖（KOL）活動也強調了女性及其他服務不足患者在血液透析通路方面迫切且未被滿足的需求；與會講者包括北卡羅來納大學的 Prabir Roy-Chaudhury 醫師，以及哈佛醫學院布萊根婦女醫院的 Mohamad Hussain 醫師。這是一場出席非常踴躍的活動，我們認為這反映出市場對於血液透析患者通路現行治療替代方案的高度興趣。

Next, I'll briefly discuss one of the pipeline programs that we're also very excited about. Our coronary tissue engineered vessel or CTEV, for use in coronary artery bypass grafting or CABG. We are on track to commence our Phase 1/2 trial of CTEV in CABG in the second half of 2026. In support of Humacyte's first-in-human study in CABG, we submitted an investigational new drug application, or IND, to the FDA late in 2025. Also for this study, we initiated the first large-scale manufacturing lot of CTEV in our commercial production facility, which is -- and this production is now nearing completion.

接下來，我將簡要談談我們同樣非常期待的一項研發管線計畫。也就是我們的冠狀動脈組織工程血管（CTEV），用於冠狀動脈繞道手術（CABG）。我們正按計畫在 2026 年下半年啟動 CTEV 用於 CABG 的第 1/2 期試驗。為支持 Humacyte 在 CABG 的首次人體試驗，我們已於 2025 年底向 FDA 提交研究用新藥申請（IND）。此外，針對本研究，我們已在商業化生產設施啟動 CTEV 的首批大規模製造批次，而該生產目前已接近完成。

Our CTEV vessels have a diameter of 3.5 millimeters, which is suitable for the coronary circulation and which is smaller than the FDA-approved 6-millimeter vessels that are being used in the limbs. We plan to commence the CABG study in the second half of 2026 upon completion of manufacturing and clearance by the FDA.

我們的 CTEV 血管直徑為 3.5 毫米，適用於冠狀循環，且小於目前用於四肢、已獲 FDA 核准的 6 毫米血管。在製造完成並獲 FDA 放行後，我們計畫於 2026 年下半年啟動 CABG 研究。

I'll now turn this over to Dale for a review of our financial results for the first quarter.

接下來我把時間交給 Dale，請他回顧我們第一季的財務結果。

Thank you, Laura, and good morning, everyone. Commercial sales of Symvess were $0.5 million or 29 units in the first quarter of 2026 compared to $0.1 million or 5 units in the first quarter of 2025. Contract revenue from a research collaboration with a large medical technology company was $2,000 in the first quarter of 2026 compared to $0.4 million in the first quarter of 2025, this decrease related to the completion of this phase of the collaboration.

謝謝你，Laura，各位早安。2026 年第一季 Symvess 的商業銷售額為 50 萬美元（29 個單位），相較之下，2025 年第一季為 10 萬美元（5 個單位）。與一家大型醫療科技公司之研究合作所產生的合約收入，2026 年第一季為 2,000 美元，相較於 2025 年第一季的 40 萬美元；此一下降與該合作此階段的完成有關。

Cost of goods sold were $2 million for the first quarter of 2026 compared to $0.1 million for the first quarter of 2025. For the first quarter of 2026, $0.2 million of the cost of goods sold related to cost of units recorded as sales revenue during the quarter, and the remainder was primarily comprised of a $1.6 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.

2026 年第一季銷貨成本為 200 萬美元，相較於 2025 年第一季的 10 萬美元。2026 年第一季中，銷貨成本有 20 萬美元與本季認列為銷售收入之單位成本相關，其餘部分主要包括 160 萬美元的存貨備抵（inventory reserve），用以將部分存貨餘額調整至其估計可變現淨值（net realizable value），以及與未使用產能相關的製造間接費用（overhead），並於本期認列為費用。

Research and development expenses for the first quarter of 2026 were $19.5 million compared to $15.4 million for the first quarter of 2025. The increase related to $4.3 million in material costs, primarily from noncommercial manufacturing runs associated with CTEV production as well as process improvement designed to improve future cost of goods sold.

2026 年第一季研發費用為 1,950 萬美元，相較於 2025 年第一季的 1,540 萬美元。增加主要來自 430 萬美元的材料成本，主要源於與 CTEV 生產相關的非商業化製造批次，以及為改善未來銷貨成本而進行的製程改良。

General and administrative expenses for the first quarter of 2026 were $7.9 million, consistent with the $8.1 million incurred in the first quarter of 2025.

2026 年第一季一般及行政費用為 790 萬美元，與 2025 年第一季的 810 萬美元大致一致。

Other net income was $11.3 million for the first quarter of 2026 compared to $62.3 million for the first quarter of 2025. The decrease in 2026 of other net income compared to the prior year resulted primarily due to a decrease in noncash income from the remeasurement of the contingent earn-out liability.

2026 年第一季其他淨收益為 1,130 萬美元，相較於 2025 年第一季的 6,230 萬美元。2026 年其他淨收益較前一年下降，主要是因為或有對價追加給付負債（contingent earn-out liability）重新衡量所產生的非現金收益減少。

Net loss was $17.6 million for the first quarter of 2026 compared to net income of $39.1 million for the first quarter of 2025. The increase in 2026 net loss compared to the prior year period was primarily due to the decrease in noncash income from the remeasurement of the contingent earn-out liability I described earlier.

2026 年第一季淨損為 1,760 萬美元，相較於 2025 年第一季淨利 3,910 萬美元。2026 年淨損較前一年同期增加，主要是由於我先前提到的或有對價追加給付負債重新衡量所產生的非現金收益減少。

We had cash, cash equivalents and restricted cash of $48.9 million as of March 31, 2026. Net cash used was $2.0 million for the first three months of 2026 compared to net cash provided of $17.9 million for the first three months of 2025. The increase in net cash used for the first quarter of 2026 resulted from $47.0 million in net proceeds from a public offering completed in March 2025, partially offset by $23.3 million in net proceeds from sales of shares during 2026.

截至 2026 年 3 月 31 日，我們持有的現金、約當現金及受限制現金為 4,890 萬美元。2026 年前三個月淨現金使用為 200 萬美元，相較於 2025 年前三個月淨現金流入 1,790 萬美元。2026 年第一季淨現金使用增加，係因 2025 年 3 月完成公開發行所取得的 4,700 萬美元淨募資款在本期不再存在，部分由 2026 年期間出售股份取得的 2,330 萬美元淨收入所抵銷。

With that, I'll turn the call back to Laura.

接下來我把電話會議交回給 Laura。

Thank you, Dale. With our outstanding and augmented commercial and medical team, our strong commercial execution, our very promising pipeline programs and our dedicated employees at Humacyte, we remain committed to delivering truly transformational regenerative medicine solutions that will improve patient outcomes and lives. We believe we are positioned for growth and value generation for 2026 and beyond.

謝謝你，Dale。憑藉我們卓越且擴編的商業與醫療團隊、強勁的商業執行力、極具前景的研發管線計畫，以及 Humacyte 全體員工的投入，我們仍致力於提供真正具變革性的再生醫學解決方案，以改善患者的治療結果與生活。我們相信，我們已為 2026 年及其後的成長與價值創造做好布局。

Thank you all for joining us today. Operator, we're ready to take questions.

感謝各位今天加入我們。接線員，我們準備開始提問。

(Operator Instructions) Matt Miksic, Barclays.

(接線員指示) Matt Miksic，Barclays。

So I wanted to ask about the commercial efforts that you're putting in place to sort of drive greater adoption in the, I guess, the US market for trauma away from some of the government contracts that you've established, which are great. But what can you tell us about the sort of the pace that we should expect the trajectory of revenues that we might see from those efforts? And I have a follow-up.

我想請教你們正在推動的商業化措施，如何在美國創傷市場帶動更高的採用率，並在某種程度上降低對你們已建立的政府合約（這些很棒）的依賴。那麼，關於這些措施可能帶來的營收成長軌跡與速度，你們可以分享我們應該期待什麼？我還有一個追問。

Yeah, Matt, this is Laura Niklason. Thank you so much for the question. I do think we're still a little too early to provide guidance for 2026. I personally am hoping to provide guidance by the end of the year. But we have restructured the commercial team, and we've strengthened it and grown it.

好的，Matt，我是 Laura Niklason。非常感謝你的提問。我確實認為現在要提供 2026 年的指引仍稍嫌過早。我個人希望能在今年年底前提供指引。不過我們已重整商業團隊，並且強化與擴編了團隊。

And the approach that we're taking to driving commercial uptake is really much more customer focused now. Our customers are primarily vascular and trauma surgeons. And we are revamping how we approach the customer and how we educate them about Humacyte and about the products, but also about our platform and potential future indications.

而我們用來推動商業採用的做法，現在確實更以客戶為中心。我們的客戶主要是血管外科與創傷外科醫師。我們正在重整我們接觸客戶的方式，以及我們如何教育他們了解 Humacyte 與相關產品，同時也包括我們的平台與未來潛在適應症。

We've -- I think one learning that we've taken away over the last year is that we have to provide better education on the technology, which we've been doing. But we also have to view the new technology from the surgeon's perspective and help show them the ways in which the technology can help their patients now, but also in future as we gain additional indications. So we have -- we've really revamped the team with a very experienced medical device sales team that has worked for decades in high-end vascular and aortic devices and procedures.

我們——我想過去一年我們得到的一個重要學習是：我們必須對這項技術提供更好的教育，而我們也一直在做。但我們也必須從外科醫師的角度來看待這項新技術，並協助他們看見這項技術現在如何幫助病患，以及在我們取得更多適應症後未來如何幫助病患。因此我們——我們確實已用一支非常有經驗的醫療器材銷售團隊來重整團隊；該團隊在高階血管與主動脈器材及手術領域有數十年的經驗。

So we think we've really targeted the correct team. And now we have to change the way we engage with surgeons. And I believe those will result in accelerating revenues during 2026, but it's too early for us to predict the shape of that ramp.

所以我們認為我們確實鎖定了正確的團隊。而現在我們必須改變與外科醫師互動的方式。我相信這將在 2026 年帶來營收加速，但現在要我們預測那個爬坡曲線的形狀還太早。

Sure. No, that's understandable. And from your comments, it sounds like a shift or a pivot, I don't want to say away from, but the emphasis maybe this time last year was working your way through that value analysis committees and approvals and hospital contracts and establishing that sort of first use. And now it sounds from your comments, almost just to repeat what you talked about is more call point service and education to support the use or encourage the use of the device in the appropriate setting. Is that fair?

了解。不，這可以理解。從你的評論聽起來像是一個轉向或調整——我不想說是遠離——但大概在去年這個時候，重點可能是一路推進價值分析委員會（VAC）與核准流程、醫院合約，並建立那種首次使用。而現在從你的說法聽起來——幾乎只是重述你剛才談的——更像是加強拜訪觸點的服務與教育，以支持或鼓勵在適當情境下使用該器材。這樣理解公平嗎？

Yes, I think that is fair. I mean we're certainly working. We've still got, I think, I don't know how many exactly, but roughly 45 VAC applications in various funnels. So we are still working on getting on the board or getting on the shelf in hospitals. And we're certainly not happy with the number of hospitals where we are on the shelf.

是的，我認為這樣說是公平的。我的意思是，我們當然仍在努力。我們目前仍有——我想我不確定確切數字——但大約有 45 件 VAC 申請在不同的管道流程中。所以我們仍在努力讓產品進入醫院的委員會、或讓它上架到醫院的貨架上。而且我們當然對目前上架的醫院數量並不滿意。

But what's become clear is that just getting it on the shelf, but then not providing additional surgeon support and education and sort of letting them see the value of the product for its approved indications, not just now but in the future. I think that's something that we're really leaning into a lot more in addition to trying to expand how many hospitals where we're on the shelf.

但現在很清楚的是：僅僅把產品放到貨架上，卻沒有提供額外的外科醫師支援與教育，也沒有讓他們看到產品在已核准適應症上的價值——不只是現在，也包括未來——我認為這是我們在持續擴大上架醫院數量之外，正在更大力投入的一件事。

And as part of the geographical expansion, we're also revamping our territories, and we're bringing on some additional salespeople with a lot of experience with integrated delivery networks. So it's leaning into both aspects. But I would say you're correct, Matt, that leaning into surgeon support and education and viewing the product and the product experience from their eyes is a critical pivot for us.

此外，作為地理擴張的一部分，我們也在重整我們的銷售區域，並增聘一些在整合式醫療交付網路（IDN）方面經驗非常豐富的業務人員。所以我們同時在兩個面向加大投入。但我會說你說得對，Matt：加強外科醫師支援與教育，並從他們的角度來看產品與產品使用體驗，對我們而言是一個關鍵的轉向。

Okay. And then just one follow-up, if I could, on this process experience in Symvess and the trauma center and how -- what you've taken from that or how investors should expect the eventual introduction into the dialysis indication to be -- or do you learn that's applicable? And how will that be different perhaps would be helpful color.

好的。那我再追問一個問題：關於 Symvess 在創傷中心的流程與使用經驗——你們從中學到了什麼？或投資人應該如何看待未來導入到透析適應症時的情況——有哪些可套用的學習？以及可能會有哪些不同？如果能提供一些補充說明會很有幫助。

Yeah. So what we've learned about use and uptake in trauma centers and in very difficult and infected and contaminated cases is that most surgeons are very happy with how the product works. I think we're going to have a series of case reports coming out this year of cases where surgeons thought that patients were essentially unreconstructible and had no other means to sustain life.

好的。所以我們在創傷中心、以及非常困難且有感染與污染的病例中，對於使用與採用所學到的是：多數外科醫師對產品的效果都非常滿意。我想今年我們會發表一系列病例報告，內容是一些外科醫師原本認為病患基本上無法重建、也沒有其他方式維持生命的案例。

And in many cases, not all, but in many cases, our product was able to reconstruct their vasculature. And so the word is getting around that the product works even in the most difficult circumstances. One of our goals with engaging with surgeons is to get them to think about this not just for the most difficult cases, but for more standard cases because the outcomes are so much better than many of their alternatives.

而在許多案例中——不是全部，但在許多案例中——我們的產品能夠重建他們的血管系統。因此，市場上逐漸傳開：即使在最困難的情況下，這個產品也能發揮作用。我們與外科醫師互動的一個目標，是讓他們不要只把它用在最棘手的病例上，也要考慮用在更標準的病例上，因為其結果比他們許多替代方案好得多。

As far as dealing with -- or what we've learned in trauma and how that will apply to dialysis, certainly, many -- not all, but many of the surgeons who we talk to about trauma and peripheral vasculature are also doing dialysis access on Wednesday mornings or what have you. And so the awareness of the product translates directly over there.

至於——或我們在創傷領域學到的、以及這將如何應用到透析：當然，許多——不是全部，但許多——我們在談創傷與周邊血管的外科醫師，也會在週三早上之類的時間做透析通路手術。因此，對產品的認知會直接延伸到那邊。

In fact, we have a lot of enthusiasm from surgeons who are very eager to hear about these top line results that are coming out in just a few weeks because the -- particularly the problem of dialysis access in women, which is a chronic problem that folks have never been able to solve and also the problem of infected dialysis grafts that need to be removed and where you need to restore some sort of conduit, but -- and you don't want to put a catheter in. Those are really recalcitrant difficult problems that dialysis surgeons are really hoping to get a better answer for.

事實上，許多外科醫師都非常熱切想聽到幾週後即將公布的這些主要結果，因為——特別是女性透析通路的問題，這是一個長期難題，過去一直無法被解決；以及感染的透析移植物需要移除、而你又需要恢復某種導管通路，但——同時你又不想放置導管（catheter）。這些都是非常頑固、非常困難的問題，透析外科醫師真的希望能有更好的解決方案。

So I think that the fact that our vessel has done so well in some of these very challenging vascular injury reconstructions just helps inform the same surgeons about how we'll do in dialysis provided the data are positive.

所以我認為，我們的血管在一些極具挑戰性的血管損傷重建中表現如此良好，若數據為正面，這將有助於讓同一批外科醫師理解我們在透析領域可能會有的表現。

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

Laura, on the unit volume growth, you did see sequential growth this quarter from fourth quarter, which was encouraging to see on Symvess. I'm just curious of the existing users, maybe if you could talk a little bit about just the repeat usage from some of your early adopters? Are you seeing that versus maybe new account growth? And again, I know you're going through this transition commercially with how you approach the market. But I'm just curious kind of within the existing usage of Symvess, what that looks like?

Laura，關於單位出貨量（unit volume）的成長，你們本季相較第四季確實看到連續成長，看到 Symvess 這樣的表現令人鼓舞。我想請教一下，針對既有使用者，你是否能談談一些早期採用者的重複使用情況？你們看到的是這種重複使用，還是更多來自新客戶／新帳戶的成長？另外我知道你們在商業面正處於轉型期，調整你們切入市場的方式。但我想了解的是，在 Symvess 的既有使用情況中，實際看起來是什麼樣子？

And then I have a couple of other questions on some other components.

然後我還有幾個關於其他部分的問題。

Yes. Well, we're talking about 30 or more sites. And so it's a little bit to sort of have a blanket. It's a little difficult to have a blanket response, but I'll try. In most of the sites that are using, in the last quarter, what we've seen is examples of -- because as with any new technology or device, typically, there's one surgeon that's using at the site and then other surgeons start to pick it up.

是的。嗯，我們談的是 30 個以上的據點。所以要——概括來說——要給一個一概而論的回答有點困難，但我會試著回答。在大多數正在使用的據點，在上一季我們看到一些例子——因為如同任何新技術或器材，通常一開始是某一位外科醫師在該據點使用，然後其他外科醫師才會開始跟進採用。

In the last quarter, we've seen more of that where it's not just the index surgeon at a particular site that's using, but some of his colleagues are also starting to do cases. We've seen that at multiple of our high-use sites, which to me speaks to confidence, growing confidence at these individual hospitals.

在上一季，我們看到更多這樣的情況：不只是某個據點的首位使用外科醫師在用，他的一些同事也開始做病例。我們在多個高使用量據點都看到這種情況；對我而言，這反映出這些個別醫院的信心正在提升。

But I think what we're also seeing is that we have product on the shelf in some institutions. But I think because of insufficient support, the product isn't getting pulled. And so that's really sort of a missed opportunity for us that I think our behavior as a commercial team can improve upon.

但我認為我們也看到的是，在某些機構裡，我們的產品已經上架了。但我認為因為支援不足，產品並沒有被拉動使用。因此，這對我們來說確實算是一個錯失的機會；我認為我們作為商業團隊的行為是可以改進的。

Okay. That's helpful. And then as we look ahead to AV access, I'm curious, we're going to get interim results at the meeting in June, I believe it is SVS. And so as you think about submitting for AV access, one, how similar is that to your trauma application? Is it easier because you have the trauma indication now?

好的。這很有幫助。接著展望 AV 通路（access），我想了解的是：我們會在 6 月的會議上拿到期中結果，我相信那是 SVS。因此當你們考慮提交 AV access 的准入申請時，第一，它和你們的創傷（trauma）申請有多相似？因為你們現在已經有創傷適應症了，是否會更容易？

I guess what I -- what investors would want to understand is how derisked you think clearance is for the AV access indication and what you think about in terms of the risk or potential timing when that comes to market? And then just one more on operating expenses when you're done.

我想投資人會想了解的是：你們認為 AV access 適應症的核准（clearance）風險降低到什麼程度？以及你們如何看待其中的風險或可能的時間點，何時能上市？然後最後再問一個關於營運費用的問題，等你回答完這些。

Yes. Thank you. That's a good set of questions. So again, I just want to preface with the fact that I never know what the FDA is going to do. I would never sit here and tell you what I think the FDA is going to do.

是的。謝謝。這是一組很好的問題。所以我再重申一下前提：我永遠不知道 FDA 會怎麼做。我不會坐在這裡告訴你我認為 FDA 會怎麼做。

I can only tell you what I anticipate and what I hope will happen. So if the results are positive on the interim analysis, which we're announcing in several weeks, then by prespecification in the protocol, the trial stops because if -- by analyzing half the patients, if we have a clear superiority over standard of care, which is fistula, then it's probably not even ethical to continue the study.

我只能告訴你我預期以及我希望會發生什麼。所以如果期中分析結果是正面的——我們會在幾週後公布——那麼依照試驗方案中事先規定（prespecification）的設計，試驗會停止，因為如果——在分析一半的病人後——我們相較於標準治療（也就是瘻管 fistula）呈現明確優效，那麼繼續研究可能甚至不符合倫理。

So if we hit our endpoint, the study stops. At which point, we will analyze data on all of the patients that have been enrolled and followed up. And that will be the lead -- the V012 study will be the lead clinical file that will go into the BLA. But the BLA will be supplemented with our prior V007 study, which also compared our vessel to fistula in catheter-dependent patients.

所以如果我們達到終點，研究就會停止。屆時，我們會分析所有已入組並完成追蹤的病人資料。而這將成為——V012 研究將成為納入 BLA 的主要臨床檔案。但 BLA 也會補充我們先前的 V007 研究，該研究同樣在導管依賴（catheter-dependent）的病人中，將我們的血管與瘻管進行比較。

Only the V007 study was in both men and women. And so these -- if both studies are positive since the last study was positive, then these are two positive prospective randomized head-to-head studies done in the United States that would show superiority of Symvess or our ATEV to the standard of care.

而且 V007 研究同時納入男性與女性。因此——如果兩項研究都呈現正面（因為上一項研究已經是正面），那麼這將是兩項在美國完成的、前瞻性、隨機、頭對頭比較研究，顯示 Symvess 或我們的 ATEV 相較於標準治療具有優效性。

So even with all of the FDA turmoil, which continues day after day, still the most conservative stance by the Center for Biologics has been that they like to see two prospective randomized head-to-head trials showing similar outcomes, which I believe if our outcomes in V012 are positive, I think that's what we'll have. In addition, the -- because it's the same product as what is already approved in trauma, there are parts of the BLA application like the manufacturing pieces and the preclinical and the safety and toxicity and what have you, all of that is essentially the same from what we've already filed and they've already reviewed.

所以即便 FDA 的動盪仍在持續、日復一日，生物製劑中心（Center for Biologics）最保守的立場仍是：他們希望看到兩項前瞻性、隨機、頭對頭試驗顯示相近的結果；我相信如果 V012 的結果是正面，我們就能符合這點。此外——因為這是與已在創傷適應症獲批的相同產品，BLA 申請中的某些部分，例如製造相關內容、臨床前資料、安全性與毒理等，基本上都與我們先前已提交且他們已審查過的內容相同。

So it will really be a matter of reviewing the clinical data, which we expect to submit before the end of the year. If we were to submit, say, I'm making this up, I'm making this up. But if we were to submit in November, then they would have two months to accept the file, which would put us in January. We would ask for -- because we have an RMAT designation, we would ask for an accelerated review, which would be a six-month review, which would put us in July of 2027. We may or may not get that accelerated review.

因此，主要就會是審查臨床資料，而我們預期會在年底前提交。如果我們提交——我只是舉例，我只是隨口假設。但如果我們在 11 月提交，那他們會有兩個月時間受理檔案，這樣就會落在 1 月。我們會申請——因為我們有 RMAT 指定——我們會申請加速審查，這會是 6 個月的審查期，時間點就會落在 2027 年 7 月。我們可能會、也可能不會獲得這個加速審查。

Right. Okay. That's very helpful, Laura. And Dale, just on the reduction in operating expenses, I appreciate the savings estimates. Is that evenly spread through the remainder of the year? Or does that build towards the tail end of the year just as you wind down some of those expenses?

了解。好的。這非常有幫助，Laura。Dale，關於營運費用的下降，我很感謝你提供的節省金額估算。這會在今年剩餘期間平均分布嗎？還是會在年底尾端更明顯，因為你們逐步結束其中一些費用？

Yes, Ryan, it's relatively evenly spread across the remainder of 2026. I mean, clearly, there's a severance period, which comes in. And obviously, when you take these measures, for example, in May, there's costs that have already been incurred. But for the second half of 2026, you could expect that the $14.3 million in savings that's estimated will be spread pretty evenly over that period.

是的，Ryan，這在 2026 年剩餘期間大致會相對平均地分布。我的意思是，很明顯會有一段資遣（severance）期間，相關費用會在那時發生。而且顯然當你在例如 5 月採取這些措施時，有些成本已經發生了。但就 2026 年下半年而言，你可以預期估計的 1,430 萬美元節省金額會在那段期間相當平均地分攤。

Josh Jennings, TD Cowen.

Josh Jennings，TD Cowen。

I was hoping to just follow up on Ryan's question around the BLA submission. Are you able to share any recent kind of color from the FDA just on this path, the submission path? And then also, just curious if the Fresenius clinical team or regulatory team is involved in any way in terms of this BLA submission for AV access?

我想就 Ryan 關於 BLA 提交的問題再追問一下。你們是否能分享 FDA 近期對於這條路徑、提交路徑的任何最新看法或補充資訊？另外也想請教，Fresenius 的臨床團隊或法規團隊是否以任何方式參與這次針對 AV access 的 BLA 提交？

So thanks for that, Josh. So in terms of the Fresenius contribution, they have certainly -- we've certainly worked with multiple Fresenius sites because some of the key data in this clinical trial is how dialysis patients are doing, whether or not they have a -- they're dependent on catheter or whether the dialysis center is able to take the catheter out. And so we've had to partner pretty closely with a lot of Fresenius centers where a lot of our patients are being treated to collect that data.

謝謝你，Josh。就 Fresenius 的貢獻而言，他們確實——我們確實與多個 Fresenius 站點合作，因為這項臨床試驗的一些關鍵資料在於透析病人的狀況，例如他們是否——是否依賴導管，或透析中心是否能夠把導管移除。因此，我們必須與許多 Fresenius 中心相當緊密地合作；我們有很多病人是在那裡接受治療，以便收集這些資料。

And so they've certainly been part of this process. I would not say they're part of the BLA filing. That's really held entirely by Humacyte, but they've certainly been supportive partners in gathering the data for this indication.

所以他們確實是這個流程的一部分。但我不會說他們是 BLA 申報的一部分。那完全是由 Humacyte 主導，但他們在為這個適應症收集資料方面，確實是很支持的合作夥伴。

As far as recent discussions with the FDA, we have not had recent discussions -- on dialysis access, we had discussions with them regarding our plan for executing on the V012 trial. And if that was positive, we let them know that we would plan to file a supplemental BLA. But we had that meeting about 12, 18 months ago. Certainly, we are looking at preparing an application for a pre-BLA meeting should these results be positive. At the pre-BLA meeting, we would then really lay out our top line results and our strategy for filing, and we get a little bit more clarity there.

至於近期與 FDA 的討論，我們近期沒有——就透析通路（dialysis access）而言，我們曾與他們討論過執行 V012 試驗的計畫。並且如果結果是正面，我們也告知他們我們計畫提交補充 BLA（supplemental BLA）。但那次會議大約是在 12 到 18 個月前。當然，如果這些結果是正面的，我們正在準備申請召開 pre-BLA 會議的申請。在 pre-BLA 會議上，我們會提出主要結果（top line results）以及我們的申報策略，並在那裡獲得更清楚的方向。

I will say that despite all of the turnover at the FDA, which continues, as we know, the clinical review team in the Center for Biologics, which has reviewed our trauma application and which also will review our dialysis application has remained relatively intact. We had a meeting with the -- with that clinical team on another indication in PAD just a couple of months ago. And many of the reviewers are the same. So I do believe there will be some continuity there, which is good for us.

我想說的是，儘管 FDA 的人事更迭仍在持續——我們都知道——生物製劑中心負責臨床審查的團隊，該團隊曾審查我們的創傷申請、也將審查我們的透析申請，仍相對保持完整。我們在幾個月前就 PAD 的另一個適應症與該臨床團隊開過會。而且許多審查人員都是同一批。所以我確實相信會有一定的延續性，這對我們是好事。

And just my follow-up, I wanted to better understand the funding allocated by the Department of Defense. What are the next steps for Humacyte with the Department of Defense? And how do you see the path to potentially procurement orders and stockpiling and relative timing, if there is anything you could share there? Appreciate you taking the time.

另外我想追問一下，我想更清楚了解國防部所分配的資金。Humacyte 與國防部接下來的步驟是什麼？以及您如何看待未來可能出現採購訂單與戰備儲備（stockpiling）的路徑與相對時程，如果有任何可以分享的話？感謝您撥冗回答。

Yes. So we have -- our Executive VP of Strategy, who used to work in federal government for 20 years in procurement has really been spearheading this effort. This is a collaborative effort between Humacyte, the Department of Defense and several surgeons at different military treatment facilities or MTFs. It's difficult for me to give precise timing. We are hoping to have this purchase completed by around September.

是的。我們的策略執行副總裁過去在聯邦政府採購領域工作了 20 年，一直在主導推動這項工作。這是一項由 Humacyte、國防部以及多個軍事醫療機構（MTF）的外科醫師共同合作的計畫。我很難給出精確的時間點。我們希望大約在 9 月前後完成這次採購。

The purchase would then be involved in training surgeons and in clinical use at different MTFs. But as with the FDA, it's very difficult for me to sit here and predict timing on DoD actions.

之後，這次採購將用於外科醫師訓練，並在不同的 MTF 進行臨床使用。但就像 FDA 一樣，我很難在這裡預測國防部行動的時程。

Peter Spanogiannopoulos, Piper Sandler.

Peter Spanogiannopoulos，Piper Sandler。

Following the recent amendment of the Fresenius agreement, what is your current priority for international commercialization? If you could elaborate on your ex US strategy, specifically regarding any plans for the European market and the steps you're taking to advance those initiatives?

在最近修訂 Fresenius 協議之後，您目前對國際商業化的優先事項是什麼？能否請您進一步說明美國以外（ex-US）的策略，特別是針對歐洲市場的任何規劃，以及您正在採取哪些步驟來推進這些計畫？

Dale, do you want to take that?

Dale，你要回答這題嗎？

Yes, absolutely. So clearly, the reacquisition of our ex-US rights due to the -- as a result of the amendment of Fresenius creates a lot of opportunities for us. We had already initiated a number of efforts within the Middle East, and those continue and will likely expand. So that's just an area that for a variety of reasons, in part due to the current conflict and in part due to some longer-term interest we've had from that region.

好的，當然。很明顯地，因 Fresenius 協議修訂而重新取得我們的美國以外權利，為我們帶來了許多機會。我們先前已在中東啟動多項工作，這些工作仍在持續，且很可能會擴大。這個區域之所以成為重點，原因有很多，一部分與目前的衝突有關，另一部分則是我們長期以來一直收到該地區的興趣。

We continue to push that forward extensively.

我們也持續大力推進這些工作。

As you infer, we also have the ability now to pursue European or other major region ex US partners, including Japan or Europe and have initiated outreach to commence those discussions.

如你所推測，我們現在也有能力在美國以外尋求歐洲或其他主要區域的合作夥伴，包括日本或歐洲，並已開始對外接觸以啟動相關討論。

Bruce Jackson, StoneX.

Bruce Jackson，StoneX。

I'd like to ask a question about the dialysis market. And in particular, I'd like to ask about the CMS End-Stage Renal Disease Quality Incentive program for 2026, which provides some incentives to use fistulas or grafts instead of catheters. And in particular, the long-term catheter rate is a key measure. So does this provide any kind of incentive for more rapid uptake in the dialysis market compared to trauma? And does this also dovetail with the applicability in the female population?

我想問一個關於透析市場的問題。特別是 CMS 在 2026 年的末期腎臟病（ESRD）品質獎勵計畫（Quality Incentive program），該計畫提供一些誘因，鼓勵使用瘻管或移植物（grafts）而非導管（catheters）。其中，長期導管使用率是一項關鍵指標。那麼，這是否會相較於創傷（trauma）市場，為透析市場帶來更快速採用的誘因？另外，這是否也與女性族群的適用性相呼應？

Yes, Bruce, thank you for that, although I'm still getting used to the whole StoneX thing. So -- but forgive me, anyway, yes, absolutely. So as you mentioned and as we are well aware, CMS has instituted a payment system whereby dialysis clinics who maintain large numbers of patients on catheters actually suffer in terms of their reimbursement. And so dialysis centers for reasons of patient care, but now also for reasons of reimbursement, are eager to get patients off of catheter.

是的，Bruce，謝謝你的問題，雖然我還在適應 StoneX 這個新名稱。不過請見諒，總之，是的，完全正確。如你所提到、也如我們非常清楚的，CMS 已建立一套支付制度：若透析診所讓大量病人長期使用導管，在給付上會受到影響。因此，透析中心基於病人照護的考量，但現在也基於給付的考量，都很希望讓病人停止使用導管。

And for women in particular, as we know, if you look at the USRDS, nearly 1 in 3 women dialyzes in the US on a catheter. Many of these are not by choice. It's because they cannot get a fistula to mature and surgeons are unwilling to put a graft in the patient typically because of infection risk. And so this is a hard number to get unstuck because there have been no other alternatives, particularly for women in decades.

而就女性而言，如我們所知，若看 USRDS 的資料，在美國接受透析的女性中，幾乎每 3 人就有 1 人使用導管。其中許多人並非出於自願。原因是她們的瘻管無法成熟，而外科醫師通常也不願意為病人放置移植物，主要是因為感染風險。因此，這個數字很難下降，因為數十年來一直沒有其他替代方案，尤其是對女性而言。

So we believe that, that is going to be the sweet spot for patient care and patient outcomes and also for reimbursement for dialysis centers. If we can target women who are remaining on catheter and suffering all those complications and all that expense, we believe we can improve outcomes while decreasing costs.

所以我們相信，這將會是病人照護與治療結果，以及透析中心給付面向的「甜蜜點」。如果我們能鎖定那些仍在使用導管、並承受各種併發症與高昂費用的女性，我們相信可以在降低成本的同時改善治療結果。

The cost of an average hospitalization for a catheter infection can be nearly $30,000. And patients who are on catheter who then get a fistula, but the fistula fails, the cost of that patient in the first year is $45,000 because of all the return trips to the operating room and rehospitalization. So remaining on catheter is expensive.

因導管感染而住院的平均費用可能接近 30,000 美元。而使用導管的病人若之後改做瘻管但瘻管失敗，該病人在第一年的成本會達到 45,000 美元，因為需要多次回到手術室並再次住院。因此，持續使用導管的成本很高。

Trying to get off catheter and failing is even more expensive. So we believe that Symvess may offer an alternative that will reliably work in women that won't fail to mature and that will have a low infection rate. And so that, I think, could represent a real benefit for this population.

嘗試停止使用導管但又失敗，成本更高。因此我們相信，Symvess 可能提供一個替代方案：在女性身上能可靠地發揮作用、不會因無法成熟而失敗，且感染率低。因此我認為，這可能為這個族群帶來實質效益。

At this time, I'll turn the floor back to management for closing remarks.

接下來我把時間交還給管理團隊做結語。

Well, I'd like to thank the analysts for their thoughtful and insightful questions this morning and also to the audience for listening to us. We've had -- we have had a tremendous number of developments and Humacyte, I would say, is firing on all cylinders to both expand our current commercial footprint in the US and worldwide, but also to take advantage of the huge number of opportunities that this platform technology is affording us.

我想感謝各位分析師今天早上提出周到且具洞見的問題，也感謝聽眾收聽。我們已經——我們在多個面向都有非常多的進展；我會說 Humacyte 正全速運轉，一方面擴大我們目前在美國及全球的商業版圖，另一方面也把握這項平台技術所帶來的大量機會。

I am impressed and grateful to the people at Humacyte who have been so incredibly productive and have accomplished so much over these past several years. And I'm very excited about what the rest of 2026 is going to bring. And thank you for your attention.

我對 Humacyte 的同仁們印象深刻並心懷感激，他們在過去幾年中展現了極高的生產力並完成了許多成果。我也非常期待 2026 年接下來將帶來的發展。謝謝各位的關注。

Thank you. Ladies and gentlemen, this will conclude today's conference. You may disconnect your lines at this time, and have a wonderful day.

謝謝。各位女士、先生，今天的會議到此結束。您現在可以掛斷電話線，祝您有美好的一天。