Humacyte Inc (HUMA) 2024 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Humacyte's second quarter results conference call. (Operator Instructions) As a reminder, this conference call is being recorded. I will now turn the call over to Lauren Marek, with LifeSci Advisors. Please go ahead.

下午好，女士們、先生們，歡迎參加 Humacyte 第二季業績電話會議。（操作員說明）謹此提醒，本次電話會議正在錄音。我現在將把電話轉給 LifeSci Advisors 的 Lauren Marek。請繼續。

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.

謝謝你，接線生。在我們進行電話會議之前，我想提醒大家，根據美國聯邦證券法，本次電話會議中所做的某些陳述屬於前瞻性陳述。這些陳述存在風險和不確定性，可能導致實際結果與歷史經驗或當前預期有重大差異。

Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements except as required by law.

有關可能導致實際結果與本次電話會議中的聲明不同的因素的更多資​​訊包含在我們向 SEC 提交的定期報告中。本次電話會議期間所做的前瞻性陳述僅代表截至本新聞稿發布之日的情況，除法律要求外，本公司不承擔更新或修改前瞻性陳述的義務。

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 Investors' page of the Humacyte website. Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Dale Sander, Chief Financial Officer and Chief Corporate Development Officer; and Dr. Heather Prichard, Chief Operating Officer.

本次電話會議中提供的資訊包含在我們今天早上發布的新聞稿和 10-Q 表格中，提交後可以從 Humacyte 網站的投資者頁面訪問。與我一起參加今天 Humacyte 電話會議的是總裁兼執行長 Laura Niklason 博士； Dale Sander，財務長兼首席企業發展長；以及營運長 Heather Prichard 博士。

Dr. Niklason will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended June 30, 2024. Following their prepared remarks, the management team will be available for your questions.

Niklason 博士將總結公司在本季度和最近幾週的進展，Dale 將審查該公司截至 2024 年 6 月 30 日的季度的財務業績。在準備好發言後，管理團隊將隨時回答您的問題。

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

我現在將把電話轉給尼克拉森博士。

Thank you, Lauren. Good morning, everyone, and thank you for joining us on our second quarter 2024 financial results and business update call. This has been a very productive time for Humacyte. Although we were surprised to learn that the FDA needs additional time to complete their review of the ATEV, BLA in vascular trauma, the entire Humacyte team continues to engage in commercial preparation to support our planned US market launch if approved.

謝謝你，勞倫。大家早安，感謝您參加我們的 2024 年第二季財務業績和業務更新電話會議。對於 Humacyte 來說，這是一個非常有成效的時期。儘管我們驚訝地發現 FDA 需要更多時間來完成對血管創傷中的 ATEV、BLA 的審查，但整個 Humacyte 團隊仍在繼續進行商業準備，以支持我們計劃在美國上市（如果獲得批准）。

In addition, the ATEV met its primary endpoint in the V007 Phase 3 trial in arteriovenous access for hemodialysis, and it demonstrated superiority over current standard of care. The ATEV also received its third regenerative medicine advanced therapy or RMAT designation from the FDA, this time in advanced peripheral artery disease. This supports ATEV's broad applicability across multiple indications. The BioVascular Pancreas, or BVP, was featured in a variety of medical and scientific presentations, which is highlighting its significant promise in type 1 diabetes.

此外，ATEV 在 V007 血液透析動靜脈通路 3 期試驗中達到了其主要終點，並證明了其優於目前護理標準。ATEV 也獲得了 FDA 的第三次再生醫學先進療法或 RMAT 指定，這次是針對晚期週邊動脈疾病。這支持了 ATEV 跨多種適應症的廣泛適用性。生物血管胰腺 (BVP) 在各種醫學和科學演講中得到了專題報導，突顯了其在 1 型糖尿病方面的重大前景。

And finally, we strengthened our Board of Directors with the addition of two seasoned experts, Dr. John Bamforth and Dr. Keith or Tony Jones. During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results. Then we'll be happy to open the call up to your questions.

最後，我們透過增加兩位經驗豐富的專家約翰·班福斯博士和基斯或託尼·瓊斯博士來加強我們的董事會。在今天的電話會議中，我將更詳細地回顧這些進展，然後再將電話轉給戴爾以審查我們的財務表現。然後，我們將很樂意透過電話解答您的問題。

I'll begin with our program in vascular trauma. On Friday, we announced that the FDA will require additional time to complete its review of the BLA that we submitted for the ATEV in the vascular trauma indication. We were surprised to receive this notification from the FDA CBER leadership, who apologized and noted that our ATEV is a first-in-class product.

我將從我們的血管創傷計畫開始。週五，我們宣布 FDA 將需要更多時間來完成對我們針對血管創傷適應症 ATEV 提交的 BLA 的審查。我們很驚訝地收到 FDA CBER 領導層的通知，他們道歉並指出我們的 ATEV 是一流的產品。

As a reminder, the BLA for the ATEV trauma program was submitted to the FDA in December of 2023. The FDA granted a priority review in February 2024, which allows only a six-month review cycle instead of the standard ten months for most products. The original assigned PDUFA date was August 10, 2024.

提醒一下，ATEV 創傷計畫的 BLA 已於 2023 年 12 月提交給 FDA。FDA 於 2024 年 2 月授予了優先審查權，僅允許六個月的審查週期，而不是大多數產品的標準十個月。最初分配的 PDUFA 日期是 2024 年 8 月 10 日。

Despite the FDA's delay, I want to emphasize that we remain confident in the approvability of the ATEV in vascular trauma based on our interactions with the agency to date. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and our clinical sites. They've also actively engaged with us in multiple discussions regarding the BLA filing, including post-approval marketing and labeling discussions.

儘管 FDA 有所延遲，但我想強調的是，根據我們迄今為止與 FDA 的互動，我們對 ATEV 在血管創傷中的批准仍然充滿信心。在 BLA 審查過程中，FDA 對我們的生產設施和臨床場所進行了檢查。他們也積極與我們就 BLA 備案進行多次討論，包括批准後行銷和標籤討論。

The FDA apologized for missing the August 10 PDUFA date and we do not yet have a revised action date. As we await an updated action date from the FDA, Humacyte continues to prepare for a planned US launch. As we discussed last quarter, we've implemented a companywide multi-disciplinary program designed to ensure US launch readiness. In June, we announced issuance of four new ICD-10 codes from the Centers for Medicare and Medicaid Services, or CMS.

FDA 對錯過 8 月 10 日 PDUFA 日期表示歉意，並且我們尚未確定修改後的行動日期。在我們等待 FDA 更新行動日期的同時，Humacyte 繼續為計劃中的美國上市做準備。正如我們上季度討論的那樣，我們已經實施了一項全公司範圍的多學科計劃，旨在確保美國的發布做好準備。6 月，我們宣布醫療保險和醫療補助服務中心 (CMS) 發布四個新的 ICD-10 代碼。

These codes will be effective for hospital discharges beginning in October 2024 and will cover procedures for replacing arteries in the upper or lower extremities using the ATEV. Humacyte also previously announced that we've hired Morgan Rankin as Vice President of Sales, joining Humacyte after 12 years at Teleflex Medical.

這些代碼將從 2024 年 10 月開始對出院有效，並將涵蓋使用 ATEV 更換上肢或下肢動脈的程序。Humacyte 先前也宣布，我們已聘請 Morgan Rankin 擔任銷售副總裁，他在 Teleflex Medical 工作 12 年後加入 Humacyte。

Morgan most recently served as VP of Sales, Trauma and Emergency Medicine at Teleflex, where she led a team of approximately 100 sales professionals. Our entire commercialization team is positioning Humacyte to be ready for commercial launch of the ATEV in vascular trauma upon approval by the FDA in the future.

Morgan 最近擔任 Teleflex 銷售、創傷和急診醫學副總裁，領導著一支由大約 100 名銷售專業人員組成的團隊。我們整個商業化團隊正在對 Humacyte 進行定位，以便在未來獲得 FDA 批准後，為 ATEV 在血管創傷領域的商業推出做好準備。

Turning now to our program in dialysis access. In July of 2024, we were incredibly pleased to announce positive results from the V007 Phase 3 trial of the ATEV for arteriovenous access in hemodialysis patients who have end stage renal disease.

現在轉向我們的透析訪問計劃。2024 年 7 月，我們非常高興地宣布 ATEV 用於末期腎病血液透析患者動靜脈通路的 V007 3 期試驗的積極結果。

As a reminder, this trial enrolled 242 patients and is a prospective, multicenter, randomized study designed to evaluate the usability of the ATEV for dialysis during the first 12 months after implantation. All participants will continue to be followed for a total of 24 months after implantation.

提醒一下，這項試驗招募了 242 名患者，是一項前瞻性、多中心、隨機研究，旨在評估 ATEV 在植入後前 12 個月內用於透析的可用性。所有參與者在植入後將繼續接受為期 24 個月的追蹤。

The primary endpoint assessed functional patency or usability for dialysis access at six months, as well as secondary patency or blood flow through the conduit at 12 months. These assessments were co-primary endpoints and were compared to arteriovenous fistula, which is the current standard of care in dialysis access.

主要終點評估 6 個月時透析通路的功能通暢性或可用性，以及 12 個月時經由導管的次要通暢性或血流量。這些評估是共同主要終點，並與動靜脈瘻管進行比較，動靜脈瘻管是目前透析通路的照護標準。

At six months, 81% of patients implanted with the ATEV had functional patency as compared to 66% of patients receiving fistula. At 12 months, 68% of patients implanted with the ATEV had secondary patency or blood flow through the conduit as compared to 62% of patients receiving an AV fistula.

六個月時，植入 ATEV 的患者有 81% 的功能通暢，而接受瘻管治療的患者比例為 66%。12 個月時，植入 ATEV 的患者中有 68% 的導管二次通暢或有血流，而接受 AV 瘺的患者為 62%。

The joint test for superiority of the ATEV versus AV fistula at 6 and 12 months was statistically significant. Patients who received the ATEV also utilized the conduit significantly longer for hemodialysis during the first 12 months as compared to fistula. There were more adverse events reported in patients on the ATEV treatment arm than on those in the dialysis fistula treatment arm, although the impact of this observation is not clear currently.

6 個月和 12 個月時 ATEV 與 AV 瘺的優越性聯合測試具有統計意義。與瘻管治療相比，接受 ATEV 的患者在前 12 個月內使用導管進行血液透析的時間也明顯更長。ATEV 治療組的患者報告的不良事件多於透析瘺治療組的患者，儘管目前尚不清楚這一觀察結果的影響。

We're highly encouraged by these results, and we believe that they demonstrate the potential of the ATEV to improve arteriovenous access in hemodialysis patients who are underserved by the current standard of care.

我們對這些結果感到非常鼓舞，我們相信它們證明了 ATEV 在改善當前護理標準服務不足的血液透析患者的動靜脈通路方面的潛力。

We look forward to presenting more detailed clinical results, including subgroup analysis, at upcoming medical meetings. We're also making progress in our program in Advanced Peripheral Arterial Disease or PAD. PAD is a cardiovascular disease of blood vessels most commonly affecting arteries in the legs. As many as 40% of patients who require a bypass to repair arteries of the lower leg do not have an autologous vein available for revascularization. Autologous vein is the standard of care for such patients.

我們期待在即將舉行的醫學會議上提出更詳細的臨床結果，包括亞組分析。我們的晚期週邊動脈疾病 (PAD) 計畫也取得了進展。PAD 是一種心血管疾病，最常影響腿部動脈。多達 40% 需要搭橋修補小腿動脈的患者沒有可用於血管重建的自體靜脈。自體靜脈是此類患者的標準治療方法。

In June of 2024, Dr. Todd Rasmussen and colleagues at the Mayo Clinic in Rochester, Minnesota, published the outcomes of arterial bypass using the ATEV in patients with chronic limb ischemia or severe PAD. In this paper, which appeared in the Journal of Vascular Surgery, all patients treated with the ATEV for severe PAD had no suitable vein of their own for bypass and were treated under an investigator sponsored trial.

2024 年 6 月，明尼蘇達州羅徹斯特 Mayo Clinic 的 Todd Rasmussen 博士及其同事發表了使用 ATEV 對慢性肢體缺血或嚴重 PAD 患者進行動脈搭橋的結果。在這篇發表在《血管外科雜誌》上的論文中，所有接受 ATEV 治療嚴重 PAD 的患者都沒有合適的靜脈進行搭橋，並在一項研究者資助的試驗下接受治療。

Outcomes for the ATEV patency or blood flow and limb salvage in patients with severe PAD having no vein were comparable to historical control patients having similar disease but having received a bypass using their own vein at the Mayo Clinic. Mayo investigators reported that patency and limb salvage were similar for patients receiving ATEV and patients receiving bypass with their own vein, historically.

無靜脈的嚴重 PAD 患者的 ATEV 通暢性或血流量和保肢結果與患有類似疾病但在 Mayo Clinic 使用自己的靜脈接受搭橋的歷史對照患者相當。梅奧研究人員報告稱，從歷史上看，接受 ATEV 的患者和接受自體靜脈搭橋的患者的通暢和保肢相似。

This result highlights the potential impact the Humacyte's ATEV may have on patients suffering from severe PAD and having no veins of their own to perform a bypass operation. inaudible July, the FDA also granted an RMAT designation for the ATEV in the PAD indication, following vascular trauma and AV access in hemodialysis.

這一結果凸顯了 Humacyte 的 ATEV 可能對患有嚴重 PAD 且沒有自己的靜脈進行搭橋手術的患者產生的潛在影響。 7 月，在血管創傷和血液透析中的 AV 路徑之後，FDA 也授予了 ATEV 用於 PAD 適應症的 RMAT 指定。

This marks the third indication for which the ATEV has been granted this RMAT designation. This designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life threatening diseases or conditions. This designation allows for close interactions with the FDA and potentially an expedited or priority review of any BLA.

這是 ATEV 獲得 RMAT 頭銜的第三個適應症。該頭銜旨在為針對嚴重或危及生命的疾病或病症的再生醫學療法的快速開發和審查提供途徑。這項指定允許與 FDA 密切互動，並可能對任何 BLA 進行快速或優先審查。

At the same time, we also received clearance for a newly issued IND for the ATEV in the PAD indication. To date, the ATEV has been evaluated in two Phase 2 trials in PAD with patients followed for as long as six years. In addition, the ongoing study at the Mayo Clinic is evaluating the ATEV in 30 patients with Chronic Limb Threatening Ischemia.

同時，我們也獲得了 PAD 適應症中 ATEV 新發布的 IND 批准。迄今為止，ATEV 已在 PAD 的兩項 2 期試驗中進行了評估，對患者進行了長達六年的追蹤。此外，梅奧診所正在進行的研究正在評估 30 名慢性肢體威脅性缺血患者的 ATEV。

All patients treated with the ATEV and PAD to date have had no autologous vein available for revascularization. And we believe the ATEV may represent an important therapeutic alternative for these patients.

迄今為止，所有接受 ATEV 和 PAD 治療的患者都沒有可用於血管重建的自體靜脈。我們相信 ATEV 可能代表這些患者的重要治療替代方案。

Returning now to diabetes. Results from an ongoing preclinical study of our BioVascular Pancreas or BVP product candidate continue to be featured in medical meetings. The BVP is designed to enable the delivery and survival of insulin producing islets as a potential treatment for type 1 diabetes.

現在回到糖尿病。我們的生物血管胰臟或 BVP 產品候選產品正在進行的臨床前研究的結果繼續在醫學會議上發表。BVP 旨在實現產生胰島素的胰島的輸送和存活，作為第 1 型糖尿病的潛在治療方法。

At the breakthrough T1D Beta Cell Consortium Meeting in June, scientists presented data in which stem cell-derived islets were observed to restore normal blood sugar in diabetic mice. In the mice, the stem cell islets survived and continued to produce insulin, with no evidence of adverse events from the stem cell-derived islets.

在 6 月舉行的突破性 T1D Beta 細胞聯盟會議上，科學家們展示了觀察到幹細胞衍生的胰島可以恢復糖尿病小鼠正常血糖的數據。在小鼠中，幹細胞胰島存活並繼續產生胰島素，沒有證據顯示幹細胞衍生的胰島出現不良事件。

These experiments were performed in collaboration with the Diabetes Research Institute at the University of Miami. In addition, we also presented results from a non-human primate study at the American Diabetes Association Annual Meeting in June. In this study, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study.

這些實驗是與邁阿密大學糖尿病研究所合作進行的。此外，我們也在六月的美國糖尿病協會年會上展示了一項非人類靈長類動物研究的結果。在這項研究中，靈長類動物 BVP 植入物在三個月的研究期間顯示胰島存活並持續產生胰島素。

Islets also developed capillaries to support survival of the insulin producing cells. This study was also performed in collaboration with the Diabetes Research Institute. We also presented results from studies of our small caliber, 3.5 millimeter diameter ATEV in the coronary artery bypass grafting, or CABG setting.

胰島也發育出毛細血管來支持胰島素產生細胞的存活。這項研究也是與糖尿病研究所合作進行的。我們也介紹了我們的小口徑、直徑 3.5 毫米 ATEV 在冠狀動脈繞道手術或 CABG 設定中的研究結果。

This presentation was at the Tissue Engineering and Regenerative Medicine Conference in June. Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small diameter ATEV into Phase 1 human clinical trials in CABG.

該演講是在六月的組織工程和再生醫學會議上進行的。在非人靈長類動物中進行了為期六個月的臨床前研究，以支持計劃將小直徑 ATEV 推進到 CABG 的 1 期人體臨床試驗。

We have observed remodeling of the ATEV to a diameter that closely matches that of the native coronary vessels, which is an outcome that has not been observed with any other conduit previously.

我們觀察到 ATEV 重塑為與天然冠狀血管直徑緊密匹配的直徑，這是先前在任何其他導管中未觀察到的結果。

This finding demonstrates the favorable biologic response of the host to the engineered human arteries in the coronary system. We're very pleased that the preclinical studies of the BVP and small diameter ATEV continue to show promising results, and we'll continue to update on the progress of this and other pipeline programs as they advance.

這項發現顯示宿主對冠狀動脈系統中的工程化人類動脈有良好的生物反應。我們非常高興 BVP 和小直徑 ATEV 的臨床前研究繼續顯示出有希望的結果，我們將繼續更新該項目和其他管道項目的進展。

Finally, last quarter we welcomed pharmaceutical industry veteran Dr. John P. Bamforth and the distinguished health system leader and physician, Dr. Tony Jones to the company's Board of Directors. John and Tony are both distinguished commercialization and health system leaders whose experience and perspectives will be extremely valuable as we prepare for planned commercial launch of the ATEV in vascular trauma.

最後，上季度我們迎來了製藥業資深人士 John P. Bamforth 博士和傑出的衛生系統領導者兼醫生 Tony Jones 博士加入公司董事會。約翰和托尼都是傑出的商業化和衛生系統領導者，當我們準備在血管創傷中計劃商業推出 ATEV 時，他們的經驗和觀點將非常有價值。

And with that, I'll now turn it over to Dale for a review of our financial results and other business developments

現在，我將把它交給戴爾，以審查我們的財務表現和其他業務發展

Thank you, Laura. Now, turning to the financial report that came out this morning, there were no revenues in any of the quarters or six-month periods reported today. Revenue, sorry, research and development expenses were $23.8 million for the second quarter of 2024 compared to $20.5 million for the second quarter of 2023, and were $45.0 million for the six months ended June 30, 2024, compared to $37.8 million for the six months ended June 30, 2023.

謝謝你，勞拉。現在，看看今天早上發布的財務報告，今天報告的任何季度或六個月期間都沒有收入。抱歉，2024 年第二季的研發費用為2,380 萬美元，而2023 年第二季的研發費用為2,050 萬美元；截至2024 年6 月30 日的六個月的研發費用為4,500 萬美元，而這六個月的研發費用為3,780 萬美元截至 2023 年 6 月 30 日。

The current period increases resulted primarily from increased materials and personnel expenses to support expanded research and development initiatives, primarily in the areas of expanding our manufacturing activities and in support of the FDA review of the BLA in vascular trauma.

本期成長主要是由於材料和人員費用增加，以支持擴大研究和開發計劃，主要是在擴大我們的製造活動和支持 FDA 對血管創傷 BLA 的審查領域。

General and administrative expenses were $5.7 million for the second quarter of 2024, compared to $6.2 million for the second quarter of 2023, and were $11.1 million for the six months ended June 30, 2024, compared to $11.4 million for the six months ended June 30, 2023. The decreases during 2024 resulted primarily from decreased non-cash stock compensation expense, partially offset by increased personnel expenses and increased professional fees.

2024 年第二季的一般及行政費用為570 萬美元，而2023 年第二季為620 萬美元；截至2024 年6 月30 日止六個月的一般及行政費用為1,110 萬美元，而截至6月30 日止六個月的一般及行政費用為1,140 萬美元，2023。2024 年的減少主要是由於非現金股票補償費用減少，但部分被人事費用和專業費用增加所抵銷。

Other net income or expense was net expense of $27.2 million for the second quarter of 2024, compared to net income of $4.0 million for the second quarter of 2023. For the six months ended June 30, 2024, other net expense was $32.5 million, compared to other net expense of $10.4 million for the six months ended June 30, 2023.

2024 年第二季的其他淨收入或支出為淨支出 2,720 萬美元，而 2023 年第二季的淨收入為 400 萬美元。截至2024年6月30日的六個月，其他淨費用為3,250萬美元，而截至2023年6月30日的六個月的其他淨費用為1,040萬美元。

The increase in other net expense for the second quarter of 2024 and for the six months ended June 30, 2024, compared to 2023 resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the company's August 2021 merger with Alpha Healthcare Acquisition Corp.

與2023 年相比，2024 年第二季和截至2024 年6 月30 日的六個月其他淨費用增加，主要是由於與該公司2021 年8 月與Alpha Healthcare Acquisition 合併相關的或有收益負債進行了非現金重新計量公司

Net loss was $56.7 million for the second quarter of 2024, compared to $22.7 million for the second quarter of 2023. Net loss was $88.6 million for the six months ended June 30, 2024, compared to $57 -- I'm sorry, $59.7 million for the six months ended June 30, 2023. The current period increase in net loss resulted primarily from the non-cash remeasurement of the contingent earnout liability and net operating expense increases described previously.

2024 年第二季的淨虧損為 5,670 萬美元，而 2023 年第二季的淨虧損為 2,270 萬美元。截至2024年6月30日的六個月的淨虧損為8860萬美元，而截至2023年6月30日的六個月的淨虧損為57美元——抱歉，淨虧損為5970萬美元。本期淨虧損的增加主要是由於對或有收益負債的非現金重新計量以及前述淨營業費用的增加。

The company reported cash and cash equivalents of $93.6 million as of June 30, 2024. Total net cash provided was $13.1 million for the first six months of 2024, compared to net cash used of $35.2 million for the first six months of 2023. The increase in net cash provided resulted primarily from the receipt of approximately $43 million in net proceeds from an underwritten public offering of common stock in March 2024 and $20 million in proceeds from an additional draw under our funding arrangement with Oberland Capital Management.

截至 2024 年 6 月 30 日，該公司的現金和現金等價物為 9,360 萬美元。2024 年前 6 個月提供的淨現金總額為 1,310 萬美元，而 2023 年前 6 個月使用的淨現金為 3,520 萬美元。所提供淨現金的增加主要是由於收到了 2024 年 3 月承銷的公開發行普通股的約 4,300 萬美元淨收益，以及根據我們與 Oberland Capital Management 的融資安排額外提取的 2,000 萬美元收益。

With that, I'd like to turn it back to Laura for some concluding remarks.

說到這裡，我想把它轉回給勞拉，讓她做一些總結性發言。

Thank you, Dale. We're very excited about the future of Humacyte. We're confident that the FDA approval of the ATEV in vascular trauma is coming soon. And we and our entire organization are continuing to prepare for commercialization of our first product, if approved.

謝謝你，戴爾。我們對 Humacyte 的未來感到非常興奮。我們相信 FDA 很快就會批准 ATEV 用於血管創傷治療。如果獲得批准，我們和我們的整個組織正在繼續為我們的第一個產品的商業化做準備。

We also remain committed to advancing our pipeline programs, which continue to demonstrate encouraging results and underscore the promise of the ATEV across a wide range of diseases, injuries and chronic conditions.

我們也繼續致力於推進我們的管道項目，這些項目繼續展示出令人鼓舞的成果，並強調了 ATEV 在廣泛的疾病、傷害和慢性病方面的前景。

This is a transformational period for us, and we're grateful for your continued support. Thank you for joining us on the call today. Operator, we're ready to take questions.

這對我們來說是一個轉型時期，我們感謝您的持續支持。感謝您今天加入我們的電話會議。接線員，我們準備好回答問題了。

(Operator Instructions) Ryan Zimmerman, BTIG.

（操作員說明）Ryan Zimmerman，BTIG。

Good morning. Thanks for taking our questions, Laura and Dale. Apologies for this myopic focus here on vascular trauma, but just a couple questions for me. First, if the FDA does communicate with you, I guess I'm curious, would they -- should we expect a new date for clearance, or will it simply provide a clearance at a future date as you understand it today? And then, as part of that, what impact does this have on your BLA submission timing for AV access, which I think is expected later this year. And I have one follow-up. Thank you.

早安.感謝勞拉和戴爾提出我們的問題。對於這裡對血管創傷的短視關注表示歉意，但只是有幾個問題要問我。首先，如果 FDA 確實與您溝通，我想我很好奇，我們是否應該期待一個新的批准日期，或者只是在您今天所理解的未來日期提供批准？然後，作為其中的一部分，這對 AV 訪問的 BLA 提交時間有何影響，我認為預計會在今年稍後提交。我還有一個後續行動。謝謝。

So, Ryan, this is Laura Niklason. Thanks for that question. As far as what to expect, as far as a new PDUFA date or timing on a decision, I wish I could provide more clarity for this group, but I can't. Again, the phone call from the senior leadership at CBER on Friday said simply that they need more time and they did not give us insight into a new date or how we would be informed.

瑞安，這是勞拉·尼克拉森。謝謝你提出這個問題。至於要期待什麼，就新的 PDUFA 日期或決定的時間安排而言，我希望我能為這個小組提供更清晰的信息，但我不能。週五，CBER 高級領導層再次打電話，只是表示他們需要更多時間，但沒有讓我們了解新的日期或如何通知我們。

That said, I would expect that within the next several months we will hear a decision, but the exact mechanics of that is very hard for me to predict. I just can't at this stage. With respect to the supplemental BLA that we had been planning and hoping to file in dialysis access, from my standpoint, that's still on track.

也就是說，我預計在接下來的幾個月內我們將聽到一個決定，但我很難預測其確切機制。我只是不能在這個階段。關於我們一直在計劃並希望在透析通道中提交的補充 BLA，從我的角度來看，這仍在按計劃進行。

The reality is that we just got top line results in our Phase 3 trial a couple weeks ago. We're still processing those results. Our plan had been -- assuming FDA approval in trauma in the second half of this year. Our plan had been to initiate commercial launch and then look at filing a supplemental BLA, perhaps sometime in 2025.

事實上，幾週前我們剛剛在第三階段試驗中獲得了最重要的結果。我們仍在處理這些結果。我們的計劃是——假設 FDA 在今年下半年批准創傷治療。我們的計劃是啟動商業發布，然後考慮提交補充 BLA，也許在 2025 年的某個時候。

So I don't think we've messaged the market that we were going to file a supplemental BLA in late '24. So from my standpoint -- barring any other changes in timing from the FDA, the communicated timing on BLA filing for dialysis kind of remains the same. Depending on conversations with the FDA, we would hope to file sometime in 2025. So that remains on track as near as I can tell.

因此，我認為我們並未向市場傳達我們將在 24 年末提交補充 BLA 的訊息。因此，從我的角度來看，除非 FDA 在時間上有任何其他變化，否則 BLA 透析申請的溝通時間保持不變。根據與 FDA 的對話，我們希望在 2025 年的某個時間點提交文件。據我所知，這仍然在正軌上。

Okay, very helpful. And then for Dale, how do you think about operating expenses and cash burn during this interim period, just given the delay impact? Are you pulling back anything, are you full steam ahead, foot on the gas? Help us understand kind of how you're managing your cash in this kind of limbo period that you're in right now as a result of Friday's update?

好的，非常有幫助。然後，對於戴爾來說，考慮到延遲的影響，您如何看待這段過渡時期的營運費用和現金消耗？你是否正在撤退，是否正在全速前進、踩油門？請幫我們了解一下，在周五的更新之後，您現在正處於這種不確定的時期，您是如何管理您的現金的？

Yeah. Ryan, I think the extrapolate from what Laura said, we don't know what the delay will be at this instance, but the entire BLA process has been one that's been very iterative. And so our expectation is that as these weeks unfold, we're going to have a better sense of what that timeline is based on our assessment of timeline to completing this process, then we will apply that knowledge and be prudent in terms of how we undertake new programs and how we manage operating expenses.

是的。Ryan，我認為根據 Laura 所說的推斷，我們不知道在這種情況下延遲會是多少，但整個 BLA 過程是一個非常迭代的過程。因此，我們的期望是，隨著這幾週的展開，我們將根據我們對完成這一過程的時間表的評估，更好地了解該時間表是什麼，然後我們將運用這些知識並謹慎地對待我們的方式開展新項目以及我們如何管理營運費用。

I think being essentially two working days out from the notice from the FDA, there's limits to what we know right now. We're certainly thinking about how we're going to respond to different potential outcomes in terms of what that timeline is, but it's a little early to give specifics in terms of how we might change our operations under different scenarios of timelines, but clearly we're looking at it very closely.

我認為距離 FDA 的通知基本上還有兩個工作日，我們目前所知的情況還很有限。我們當然正在考慮如何根據時間表來應對不同的潛在結果，但現在就如何在不同的時間表場景下改變我們的運營提供具體細節還為時過早，但顯然我們正在非常仔細地研究它。

Understand. Thank you for taking the question.

理解。感謝您提出問題。

Josh Jennings, TD Cowen & Company.

喬許‧詹寧斯 (Josh Jennings)，TD Cowen & Company。

Hi, good morning. Thanks for taking the questions, Laura and Dale. I wanted to just ask about the vascular trauma data set and just to call out that adverse events were higher in the ATEV study group. I don't think that you're disclosing much around that, but the efficacy was not impacted our assumption that these are minor adverse events in total. But just wanted to see if there's any other color you can share on that.

嗨，早安。感謝勞拉和戴爾提出問題。我只想詢問血管創傷資料集，並指出 ATEV 研究組的不良事件較高。我認為你沒有透露太多相關信息，但功效並沒有影響我們的假設，即這些總體上是輕微的不良事件。但只是想看看是否有其他顏色可以分享。

Sure. Yeah. So, Josh, just to clarify, that was on dialysis. That's not on trauma. Okay.

當然。是的。所以，喬希，澄清一下，那是透析。這不是關於創傷。好的。

Thank you. Sorry about that. I appreciate the correction.

謝謝。對此感到抱歉。我很感謝您的指正。

Yeah. I just don't want our listeners to think that was on trauma. Yeah. So on dialysis. Yeah, we're still digging into that. Most of these adverse events are minor, as you know, in dialysis access, these patients undergo a lot of procedures in general to maintain access patency. It's just how life is for these patients.

是的。我只是不想讓我們的聽眾認為那是關於創傷。是的。所以要進行透析。是的，我們仍在深入研究。這些不良事件大多很輕微，如您所知，在透析通路中，這些患者通常會接受大量手術以保持通路通暢。這就是這些患者的生活。

I will say very clearly that we have no new safety signals for this conduit. None. We have -- it's not like we've seen something new that we haven't seen before. So the increased number of adverse events, I'm not sure it could be related to the fact that our vessels were used for a longer period of time during the first year and got more needle punctures, or something else. So it's hard for us to -- for me to comment on right now, but we're in the process of sorting that out and we expect to share this information at medical meetings later this year.

我要非常明確地說，我們沒有針對該管道的新安全訊號。沒有任何。我們——這並不是說我們看到了以前從未見過的新東西。因此，不良事件數量的增加，我不確定這可能與我們的血管在第一年使用時間較長且針刺次數較多或其他原因有關。因此，我現在很難對此發表評論，但我們正在解決這個問題，我們預計將在今年稍後的醫學會議上分享這些資訊。

Understood. And the second one on the AV access indication and the top line data. Just how involved is Fresenius in terms of aggregating the data? How much are they seen? I guess, what's next steps in terms of that agreement and collaboration on two fronts. One, just continued collection of cost effectiveness data, and then two, I think down the line, Fresenius has agreed to use ATEV in any indication where clinical value has been demonstrated.

明白了。第二個是關於 AV 存取指示和頂行資料。費森尤斯在匯總數據方面的參與程度如何？他們有多少被看見？我想，就該協議和兩個方面的合作而言，下一步是什麼？一是繼續收集成本效益數據，二是我認為費森尤斯最終同意在任何已證明臨床價值的適應症中使用 ATEV。

Well, so certainly we've worked with a number of Fresenius centers, dialysis access centers as part of the V007 Phase 3 trial. That said, Fresenius is not active in aggregating or analyzing our data. That's a Humacyte endeavor for sure. But as you mentioned, our partnership with them really does focus on the health economics and the cost benefit analysis for different demographics of dialysis patients.

嗯，作為 V007 第三階段試驗的一部分，我們當然已經與許多費森尤斯中心、透析中心合作。也就是說，費森尤斯並沒有積極總結或分析我們的數據。這無疑是 Humacyte 的努力。但正如您所提到的，我們與他們的合作確實側重於健康經濟學和不同透析患者人口的成本效益分析。

So we are working closely with Fresenius, actually on putting together a publication on some of the costs that are incurred with patients who have multiple access failures and what that costs the system. And we're also working with them on a similar project in Europe. So they've been great partners for that.

因此，我們正在與費森尤斯密切合作，實際上是在整理一份出版物，介紹多次訪問失敗的患者所產生的一些費用以及系統的成本。我們也在歐洲與他們合作進行一個類似的計畫。所以他們在這方面一直是很好的合作夥伴。

And you're right, Fresenius, as part of our commercialization agreement, they have agreed to adopt the ATEV in dialysis for their centers in patients where the clinical results and the health economic results make sense.

你是對的，費森尤斯，作為我們商業化協議的一部分，他們已同意在其中心的患者透析中採用 ATEV，其中臨床結果和健康經濟結果是有意義的。

So working with them to identify those patient populations which where the health economics become really prohibitive for dialysis access, that's a key part of this, of our long-term market adoption strategy in the US, and they're working with us very closely on that.

因此，與他們合作，確定那些醫療經濟狀況確實禁止透析的患者群體，這是我們在美國長期市場採用策略的關鍵部分，他們正在與我們密切合作。

Great. Just one more to sneak in just on the PAD indication, and you've had some positive updates and RMAT designation. Just wanted to -- not sure if you did this earlier in the call in your prepared remarks, but just any next steps outline you can provide in terms of moving forward with initiation of a clinical trial in getting that up and running? Thanks a lot.

偉大的。只要再偷偷地了解 PAD 指示，您就已經獲得了一些正面的更新和 RMAT 指定。只是想 - 不確定您是否在電話會議的早些時候在準備好的發言中這樣做了，但是您可以提供任何後續步驟概述，以推進臨床試驗的啟動和運行？多謝。

Yes. Well, as I may have mentioned on prior calls, we've certainly had multiple requests from vascular surgeons to initiate a Phase 3 trial in PAD. I think there's a lot of excitement on the clinical vascular surgery side for looking at this as an option for patients who are facing potential amputation, and we are designing that trial. So we're doing the intellectual work around that. But I think that we're going to have to play it by ear in terms of the timing of the approval in trauma and our cash runway.

是的。嗯，正如我在之前的電話中提到的那樣，我們確實收到了血管外科醫生的多次請求，要求啟動 PAD 的 3 期試驗。我認為臨床血管外科方面對此感到非常興奮，認為這是面臨截肢的患者的一種選擇，我們正在設計該試驗。所以我們正在圍繞這個問題進行智力工作。但我認為，在創傷批准的時間和我們的現金跑道方面，我們必須見機行事。

Again, we remain a pre-revenue company. And so we'll just have to be holistic and mindful as we think about when to start a Phase 3 trial in PAD, given that, that would be a third Phase 3 program. So after trauma and dialysis. So it's something that we're thinking about very actively. But as Dale said, with respect to our finances and our cash runway, we're evaluating this month-over-month.

再次強調，我們仍然是一家尚未獲利的公司。因此，在考慮何時開始 PAD 的第 3 階段試驗時，我們必須保持整體性和謹慎性，因為這將是第三個第 3 階段計畫。所以在創傷和透析之後。所以這是我們正在非常積極地考慮的事情。但正如戴爾所說，就我們的財務狀況和現金跑道而言，我們正在逐月進行評估。

Understood. Thanks a lot.

明白了。多謝。

Allison Russell, Piper Sandler.

艾莉森·拉塞爾，派珀·桑德勒。

Hi, thank you. Good morning, and thanks for taking the questions. A couple from me, on the vascular trauma review. Just what's your sense of the area of the filing that the agency needs more time to review clinical, non-clinical, manufacturing, or something else. And then in terms of -- how much additional time FDA is going to need to complete their review?

你好，謝謝。早上好，感謝您提出問題。我的一些關於血管創傷回顧的文章。您對申請的領域有何看法，即該機構需要更多時間來審查臨床、非臨床、製造或其他方面。然後，FDA 需要多長時間才能完成審查？

I think, Laura, earlier you indicated this could take a couple of months. So just help us understand what feedback from the agency indicates that this will be wrapped up in months as opposed to days or weeks.

我想，勞拉，您之前曾表示這可能需要幾個月的時間。因此，請幫助我們了解該機構的回饋表明，這將在幾個月內完成，而不是幾天或幾週。

And then also, is it your sense that you will need to generate additional clinical data for FDA to be able to complete the review in vascular trauma? Or said another way, what gives you confidence that the clinical data package you submitted is sufficient for FDA to grant approval in trauma?

另外，您是否認為您需要為 FDA 產生額外的臨床數據才能完成血管創傷的審查？或者換句話說，是什麼讓您有信心您提交的臨床資料包足以讓 FDA 批准創傷治療？

So, Allison, I'll try to answer those questions as best as I can with the extremely limited knowledge that I have. So, with respect to the timeline, regarding days versus weeks versus months, the senior CBER leadership said this could take possibly take months that they were not sure.

所以，艾莉森，我將盡力用我所擁有的極其有限的知識來回答這些問題。因此，就時間表而言，無論是幾天、幾週還是幾個月，CBER 高級領導層表示，這可能需要幾個月的時間，但他們不確定。

And so we have messaged the market exactly what the FDA told us. So it might be sooner than that, it might. But what we didn't want to do is message the market that this would be weeks or days when it may not be. So you now have the full extent of my knowledge on this topic.

因此，我們向市場傳達的訊息與 FDA 告訴我們的完全一樣。所以可能會比這更早。但我們不想做的是向市場傳達這樣的訊息：這可能需要幾週或幾天的時間。現在您已經了解了我關於這個主題的全部知識。

With respect to what part of the file they were -- they feel like they need more time for. Again, I can't answer that. There was literally no insight provided on what parts of the file they were continuing to work on.

至於他們屬於文件的哪一部分——他們覺得需要更多時間。再說一遍，我無法回答這個問題。實際上沒有提供關於他們正在繼續處理文件的哪些部分的見解。

And thirdly, with respect to do we think we will need more clinical data? I did not hear that on the call and we have never gotten that indication in any part of the review, and I certainly didn't hear that on the call. And so that's where it stands.

第三，我們認為我們是否需要更多的臨床數據？我在電話中沒有聽到這一點，我們也從未在審查的任何部分得到這一指示，我當然也沒有在電話中聽到這一點。這就是現在的情況。

Got it. And then maybe just one follow-up question on the dialysis access data. Could you just clarify over what period adverse events are measured? Is that a comment in the press release talking about AEs over the entire 12 months of the study or just AEs during the time the ATEV or fistula was actually used for hemodialysis?

知道了。然後可能只是關於透析訪問數據的一個後續問題。您能否澄清一下不良事件是在什麼時期內測量的？新聞稿中的評論是談論整個 12 個月研究期間的 AE，還是僅談論 ATEV 或瘻管實際用於血液透析期間的 AE？

I believe that it's AEs over the entire study because that's the typical way that adverse events are reported for study outcomes. So it's the entirety of the data that we have in hand.

我相信這是整個研究中的不良事件，因為這是報告研究結果不良事件的典型方式。所以這是我們手頭上的全部數據。

Got it. Thank you.

知道了。謝謝。

(Operator Instructions) Kristen Kluska, Cantor Fitzgerald. Please go ahead.

（操作員說明）Kristen Kluska、Cantor Fitzgerald。請繼續。

Hi. Good morning, everybody. And congrats on the second positive Phase 3 trial result for you in the last year. So maybe I'll start with AV access. Can you talk about some of the subgroup analysis data that you're going to share and ultimately why you believe that's going to be helpful with future commercial considerations? And to be clear, I'm not asking for the data, just which analysis in general you are conducting.

你好。大家早安。恭喜您去年獲得第二個積極的 3 期試驗結果。所以也許我會從 AV 訪問開始。您能否談談您將要分享的一些亞組分析數據，以及為什麼您認為這些數據最終會對未來的商業考慮有所幫助？需要明確的是，我並不是要求數據，而是在詢問您正在進行的整體分析。

Yes, thanks, Kristen, for that question. So, as we've shared in previous quarterly calls and other presentations, it's clear from our work with Fresenius and other publications that there are certain subgroups of dialysis patients that tend to have a very hard time with dialysis access. They have a lot of failures and a lot of complications, and they're very expensive for the system.

是的，謝謝克里斯汀提出這個問題。因此，正如我們在先前的季度電話會議和其他演示中所分享的那樣，從我們與費森尤斯和其他出版物的合作中可以清楚地看出，某些透析患者亞群往往很難獲得透析服務。它們有很多故障和很多併發症，而且對於系統來說非常昂貴。

These patients are often women, often diabetic or obese women. These patients often will not mature their fistulas and are using synthetic grafts or catheters and for all of those reasons have higher complication rates and are more expensive. So it's known since this study compared our ATEV against arteriovenous fistula, it's known in the literature that there are certain demographics that have poorer maturation rates for their fistulas.

這些患者通常是女性，通常是患有糖尿病或肥胖的女性。這些患者的瘻管通常不會成熟，並且正在使用合成移植物或導管，由於所有這些原因，併發症發生率更高且更昂貴。因此，自從這項研究將我們的 ATEV 與動靜脈瘻管進行比較以來，文獻中就知道某些人口統計資料的瘻管成熟率較差。

So underrepresented minorities have different fistula maturation rates, the elderly, women, diabetics, et cetera. So built into our statistical analysis plan, we had pre-specified. Looking at these different subgroups to try to understand what the delta is between the ATEV and dialysis. Particularly in these subgroups, the ATEV and fistula, I'm sorry, particularly in these subgroups where fistula is known not to work very well.

因此，代表性不足的少數族群（老年人、女性、糖尿病患者等）的瘻管成熟率不同。因此，我們預先指定了統計分析計劃。看看這些不同的子群組，試著了解 ATEV 和透析之間的差異。很抱歉，特別是在這些亞群中，ATEV 和瘻管病，特別是在這些亞群中，已知瘻管病效果不佳。

So again, these are -- there's nothing magic here. This is just sort of the standard subgroups that are known in the literature to be problematic. And I think diving down into those groups will really give us a better sense of which patients are the most underserved currently and which can benefit the most from the ATEV and dialysis.

再說一次，這些——這裡沒有什麼神奇的。這只是文獻中已知的有問題的標準子群。我認為深入研究這些群體確實能讓我們更了解哪些患者目前服務最不足，哪些患者可以從 ATEV 和透析中受益最多。

Okay. Thanks. Appreciate that. And then just one on vascular trauma, it sounds like the clinical site and the manufacturing inspections occurred a few months ago. Can you just give us a sense of how those inspections went and in terms of the follow-up items that were required that -- is there anything in particular you were working with the FDA on addressing? Thank you, again.

好的。謝謝。很欣賞這一點。然後只是關於血管創傷的一項，聽起來臨床現場和製造檢查發生在幾個月前。您能否讓我們了解一下這些檢查的進展以及所需的後續項目—您正在與 FDA 合作解決哪些具體問題？再次謝謝你。

So we had a total of five inspections. I would say all of those inspections went very well. In terms of follow-up items, there are -- there's a small number of standard follow-up items on assays and CMC having to do with validation of certain methods. But these are sort of standard things that we've worked out with the agency. Some of those were completed pre-PDUFA. Some of those were slated for post-PDUFA.

所以我們一共進行了五次檢查。我想說所有這些檢查都進展順利。就後續項目而言，有少量關於測定和 CMC 的標準後續項目與某些方法的驗證有關。但這些都是我們與該機構共同製定的標準。其中一些是在 PDUFA 之前完成的。其中一些計劃在 PDUFA 後進行。

For example, one study is shipping the product during winter, and we couldn't do that until winter, so we agreed to do that in winter. So but these are sort of standard, I don't want to say cookie cutter, but these are standard validation and test procedures that we do not believe are impacting the timing of the file.

例如，一項研究是在冬季運送產品，而我們要到冬季才能做到這一點，所以我們同意在冬季這樣做。所以，但這些都是標準，我不想說千篇一律，但這些是標準驗證和測試程序，我們不認為會影響文件的時間。

Thanks again.

再次感謝。

Bruce Jackson, The Benchmark Company.

布魯斯傑克遜，基準公司。

Hi. Good morning, and thank you for taking my questions. I was hoping to get an update on the new technology add-on payment application. Are you still going to apply for it this October. And how does the delay in the FDA approval factor into that?

你好。早上好，感謝您回答我的問題。我希望獲得新技術附加支付應用程式的更新。今年10月還打算申請嗎？FDA 核准的延遲有何影響？

Bruce, that's a good question. Thank you very much. As you know, we got codes, ICD-10 codes, from CMS in June. And that's a prerequisite for filing an NTAP application. To the best of my knowledge, unless the rules have changed. But to the best of my knowledge, even without approval, we can file for an NTAP payment.

布魯斯，這是個好問題。非常感謝。如您所知，我們於 6 月從 CMS 獲得了代碼，ICD-10 代碼。這是提交 NTAP 申請的先決條件。據我所知，除非規則改變。但據我所知，即使未經批准，我們也可以申請 NTAP 付款。

During this cycle, NTAP applications are only allowed once per year, and they typically -- the deadline is typically around October 1. So we can file for an NTAP add-on payment. And so long as we have approval, I believe -- I believe before June of next year, then that NTAP payment would kick-in in October of 2025. So this delay on the front end with our PDUFA date, in my mind, does not change our plans for filing an NTAP application this October.

在此週期內，NTAP 申請每年僅允許一次，且截止日期通常為 10 月 1 日左右。因此我們可以申請 NTAP 附加付款。我相信，只要我們獲得批准，我相信在明年 6 月之前，NTAP 付款就會在 2025 年 10 月開始生效。因此，在我看來，我們 PDUFA 日期前端的延遲並不會改變我們今年 10 月提交 NTAP 申請的計劃。

Okay, great. That's it for me. Thank you.

好的，太好了。對我來說就是這樣。謝謝。

Thank you, sir. Ladies and gentlemen, we have reached the end of our question-and-answer session. And I would like to turn the call back to Dr. Niklason for closing remarks. Please go ahead.

謝謝您，先生。女士們先生們，我們的問答環節已經結束了。我想將電話轉回給 Niklason 博士，讓其致閉幕詞。請繼續。

Well, I'd like to thank everybody on the call, including our analysts and our investors and our -- and any Board members that might be on the call and our leadership. This has been a very interesting part of Humacyte's journey. Again, we have full confidence that we will receive approval in the trauma indication for ATEV.

嗯，我要感謝參加電話會議的所有人，包括我們的分析師、投資者、我們的董事會成員以及可能參加電話會議的任何董事會成員以及我們的領導層。這是 Humacyte 旅程中非常有趣的一部分。我們再次充滿信心，我們將獲得 ATEV 創傷適應症的批准。

We believe that ATEV provides important benefits for patients in terms of limb salvage, in terms of infection. We believe this is an important adjunct in therapy for both civilian and military trauma. And so we're pushing forward, and we -- we're looking forward to not only the trauma indication, but also future approvals and under other indications as well. I continue to be very excited about our prospects and it's going to be a very interesting journey. So thank you for coming along with us on the journey

我們相信，ATEV 在保肢和感染方面為患者提供了重要的益處。我們相信這是治療平民和軍事創傷的重要輔助。因此，我們正在向前推進，我們不僅期待創傷適應症，還期待未來的批准和其他適應症。我仍然對我們的前景感到非常興奮，這將是一個非常有趣的旅程。感謝您與我們一起踏上這段旅程

Thank you. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.

謝謝。女士們、先生們，今天的會議到此結束。感謝您加入我們。現在您可以斷開線路。