Humacyte Inc (HUMA) 2023 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Humacyte 2023 fourth quarter year-end results conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded.

早安，女士們、先生們，歡迎參加 Humacyte 2023 年第四季年終業績電話會議。目前，所有參與者都處於僅監聽模式。稍後，我們將進行問答環節，屆時將有說明。謹此提醒，本次電話會議正在錄音中。

I will now turn the call over to Lauren Marek with LifeSci Advisors. Please go ahead.

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. Information presented on this call is contained in the press release we issued this morning and in our Form 10-K which after filing may be accessed from the Investors page of the Humacyte website.

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，本公司不承擔更新或修改前瞻性陳述的義務，除非法律要求。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-K 表格中，提交後可以從 Humacyte 網站的投資者頁面訪問。

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. Dr. Niklason will provide a summary of the company's progress during the year and recent weeks, and Dale will review the company's financial results for the quarter and year ended December 31, 2023. Following their prepared remarks, the management team will be available for your questions.

與我一起參加今天 Humacyte 電話會議的有總裁兼執行長 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。Niklason 博士將總結公司今年和最近幾週的進展，Dale 將審查該公司截至 2023 年 12 月 31 日的季度和年度的財務表現。在他們準備好發言後，管理團隊將回答您的問題。

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 for our 2023 financial results and business update call. Our fourth quarter and the start of 2024 have been highly productive for Humacyte. Importantly, Humacyte completed submission of our BLA in December, and the FDA accepted our biologics license application for the HAV in the vascular trauma indication in February of this year.

謝謝你，勞倫。大家早安，感謝您參加我們的 2023 年財務表現和業務更新電話會議。Humacyte 的第四季和 2024 年初的生產力非常高。重要的是，Humacyte 在 12 月完成了 BLA 的提交，FDA 於今年 2 月接受了我們針對血管創傷適應症的 HAV 生物製劑許可申請。

Over the course of 2023, we also made progress on our broader HAV pipeline, including the completion of enrollment of our Phase 3 trial in dialysis access, presentation and publication of clinical trial results in peripheral arterial disease and publication of preclinical results for our small caliber HAV in the juvenile heart model.

2023 年，我們在更廣泛的 HAV 研發管線上也取得了進展，包括完成透析通道 3 期試驗的入組、介紹和發布外周動脈疾病的臨床試驗結果以及發布小口徑的臨床前結果幼年心臟模型中的HAV。

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 up the call to your questions.

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，我們將很樂意接聽您的提問。

I'll begin with our HAV program in vascular trauma. In December 2023, we submitted our BLA to the FDA. This was supported by a robust data package that included positive results from our V005 Phase 2/3 clinical trial. The BLA package also included real-world evidence from the treatment of wartime injuries in Ukraine under the humanitarian aid program that was supported by the FDA.

我將從我們的血管創傷 HAV 計畫開始。2023 年 12 月，我們向 FDA 提交了 BLA。這得到了強大的數據包的支持，其中包括我們 V005 2/3 期臨床試驗的積極結果。BLA 一攬子計劃還包括根據 FDA 支持的人道主義援助計劃在烏克蘭治療戰時受傷的真實證據。

Our data package showed that the HAV had higher rates of patency and lower rates of amputation and infection as compared to historic synthetic graft benchmarks. In the two trials combined, the 30 day patency or presence of blood flow for the HAV was 91.5% for extremity patients compared to 78.9% historically reported for synthetic grafts.

我們的資料包顯示，與歷史合成移植物基準相比，HAV 的通暢率更高，截肢率和感染率更低。在這兩項試驗中，四肢患者的 HAV 30 天通暢率或血流存在率為 91.5%，而歷史報告的合成移植物為 78.9%。

The HAV also demonstrated lower amputation rates with a rate of 4.5% as compared to 24.3% for synthetic grafts. And furthermore, the HAV had lower infection rates at 30 days, with a rate of 0.9% as compared to 8.4% historically for synthetic grafts. In other words, patients treated with the HAV were only 40% is likely to lose blood flow through their conduit after one month, which is a key period for recovery after traumatic injury.

HAV 的截肢率也較低，為 4.5%，而合成移植物的截肢率為 24.3%。此外，HAV 在 30 天時的感染率較低，為 0.9%，而歷史上合成移植物的感染率為 8.4%。換句話說，接受HAV治療的患者只有40%可能在1個月後經由導管失去血流，這是創傷後復原的關鍵時期。

HAV patients were also only 1/5 is likely to suffer an amputation and only 1/9 is likely to have an infection of their graft as compared to patients who were treated with the synthetic graft. These results were also provided in November at multiple presentations at the VEITH Symposium, which is a major vascular surgery meeting held in New York.

與接受合成移植物治療的患者相比，HAV 患者也只有 1/5 的患者可能會截肢，只有 1/9 的患者可能會感染移植物。這些結果也在 11 月在紐約舉行的 VEITH 研討會上的多次演講中提供，該研討會是在紐約舉行的大型血管外科會議。

In February of 2024, the FDA accepted our BLA and vascular trauma, also granting priority review and establishing a Prescription Drug User Fee Act, or PDUFA, goal date for action of August 10, 2024. The FDA's decision to grant priority review aligns with their prior grant of a regenerative medicine advanced therapy or RMAT designation for the HAV for urgent arterial repair.

2024 年 2 月，FDA 接受了我們的 BLA 和血管創傷，同時給予優先審查並制定了處方藥使用者付費法案 (PDUFA)，目標行動日期為 2024 年 8 月 10 日。FDA 授予優先審查的決定與他們先前授予 HAV 緊急動脈修復再生醫學先進療法或 RMAT 指定一致。

We believe this also reflects their recognition that many patients with severe injuries are underserved by the current standards of care. Priority review is also consistent with the priority designation that was given by the Secretary of Defense under a law enacted to expedite the FDA's review of products that are intended to diagnose, treat or prevent serious life-threatening conditions that are facing American military personnel.

我們相信這也反映了他們認識到許多重傷患者在當前的護理標準下得不到充分服務。優先審查也與國防部長根據一項法律給予的優先指定一致，該法律旨在加快 FDA 對旨在診斷、治療或預防美國軍事人員面臨的嚴重危及生命的疾病的產品的審查。

The BLA acceptance brings us another step closer to our goal of providing an innovative regenerative medicine product for patients who are suffering traumatic vascular injury. Based on the strength of the data package, from our V005 trial in vascular trauma, combined with data from the humanitarian experience in Ukraine, we look forward to the PDUFA date with confidence.

BLA 的接受使我們離為遭受創傷性血管損傷的患者提供創新的再生醫學產品的目標又近了一步。基於我們 V005 血管創傷試驗的資料包的強度，結合烏克蘭人道主義經驗的數據，我們充滿信心地期待 PDUFA 日期。

In preparation for an anticipated FDA approval, Humacyte is also working to build out the commercial team as part of our go-to-market strategy. Health economic models have been developed which are derived from large national databases of traumatic injury care in the US. Based upon historical results for synthetic graft outcomes, it's clear that the HAV can provide important health benefits as well as important economic benefits for the healthcare system.

為了準備預期的 FDA 批准，Humacyte 也致力於建立商業團隊，作為我們進入市場策略的一部分。已開發出源自美國大型國家創傷性損傷護理資料庫的健康經濟模型。根據合成移植結果的歷史結果，很明顯，HAV 可以為醫療保健系統提供重要的健康益處以及重要的經濟效益。

Cost of conduit infection, sepsis and amputation are extremely high adding tens or even hundreds of thousands of dollars to the cost of trauma care. Avoidance of these costly complications will, we believe, help to drive market uptake of this revolutionary product candidate in the care of traumatically injured patients.

導管感染、敗血症和截肢的費用非常高，使創傷照護費用增加數萬甚至數十萬美元。我們相信，避免這些代價高昂的併發症將有助於推動市場對這種革命性候選產品在照顧創傷患者方面的採用。

Turning now to our program in peripheral artery disease. In the fall, results were presented from an FDA regulated and investigator-sponsored clinical study that's being conducted at the Mayo Clinic of the HAV in patients with chronic limb-threatening ischemia, which is the end stage of PAD. Most patients treated as part of the program required bypass surgery below the knee, which is a type of disease that is typically not well treated with stents and angioplasty procedures.

現在轉向我們的周邊動脈疾病計畫。今年秋天，FDA 監管並由研究者資助的一項臨床研究結果公佈，該研究正在 HAV 梅奧診所針對慢性肢體威脅性缺血（PAD 的末期）患者進行。作為該計劃的一部分接受治療的大多數患者需要進行膝蓋以下的搭橋手術，這種疾病通常無法透過支架和血管成形術得到很好的治療。

Treated patients did not have suitable vein of their own to perform a needed bypass procedure. And so receive the HAV to revascularize their critically ischemic lower limbs. In presentations at the VEITH Symposium and at the Midwestern Vascular Conference, researchers observed that in the clinical study, the HAV was a safe, resilient and effective conduit for arterial bypass and limb salvage in patients who did not have vein to provide a conduit to restore blood flow.

接受治療的患者本身沒有適當的靜脈來執行所需的搭橋手術。因此，接受 HAV 來使嚴重缺血的下肢血管重建。In presentations at the VEITH Symposium and at the Midwestern Vascular Conference, researchers observed that in the clinical study, the HAV was a safe, resilient and effective conduit for arterial bypass and limb salvage in patients who did not have vein to provide a conduit to restore血流.

This is an important result since approximately 40% of patients requiring lower extremity bypass do not have saphenous vein available for revascularization. With regard to publications, in October of 2023, a publication in the Journal of Thoracic and Cardiovascular Surgery described a preclinical study showing the potential for the investigational small diameter HAV to treat Tetralogy of Fallot.

這是一個重要的結果，因為大約 40% 需要下肢搭橋的患者沒有可用於血管重建的隱靜脈。關於出版物，2023 年 10 月，《胸腔和心血管外科雜誌》上的一篇出版物描述了一項臨床前研究，顯示研究中的小直徑 HAV 具有治療法洛氏四合症的潛力。

This is a heart condition that affects one in every 2,000 babies born in the US each year. In this preclinical study, researchers from Nationwide Children's Hospital in Columbus, Ohio, implanted 3.5 millimeter diameter HAVs into a juvenile large animal model of pediatric heart disease. In long-term follow-up in these animals, the 3.5 millimeter HAVs remained patent for up to six months and showed evidence of cellular repopulation by host cells, which is similar to what's been observed in human patients.

這種心臟病每年在美國出生的嬰兒中，每 2,000 名中就有一人患有這種疾病。在這項臨床前研究中，俄亥俄州哥倫布市全國兒童醫院的研究人員將直徑 3.5 毫米的 HAV 植入小兒心臟病的幼年大型動物模型中。在對這些動物的長期追蹤中，3.5 毫米 HAV 保持長達六個月的專利狀態，並顯示出宿主細胞進行細胞再增殖的證據，這與人類患者中觀察到的情況類似。

The pediatric heart study also demonstrated the extension of Humacyte's manufacturing platform, adding the 3.5 millimeter vessels to the 6-millimeter vessels that have been manufactured for more than a decade. As a reminder, our 3.5 millimeter vessels are currently being evaluated in IND enabling preclinical studies in large animals, to support future advancement of the HAV into human clinical trials in coronary artery bypass.

兒科心臟研究也展示了 Humacyte 製造平台的擴展，將 3.5 毫米血管添加到已經製造了十多年的 6 毫米血管中。提醒一下，我們的 3.5 毫米血管目前正在 IND 中進行評估，從而能夠在大型動物中進行臨床前研究，以支持未來將 HAV 推進到冠狀動脈搭橋的人體臨床試驗中。

We've previously reported excellent long-term six month results in coronary artery bypass in large animals. And cardiac implantations are continuing this year as we gather data in support of an IND filing in heart bypass surgery. In July, results of a preclinical study were also published in the Journal of Vascular Surgery Vascular Science. This study provides a scientific basis for the low rates of infection that have been observed in our clinical trials of the HAV.

我們之前曾報道大型動物冠狀動脈繞道手術的長期六個月結果非常出色。今年，隨著我們收集數據以支持心臟繞道手術的 IND 備案，心臟植入手術仍在繼續。7月，一項臨床前研究的結果也發表在《血管外科血管科學期刊》。這項研究為我們在 HAV 臨床試驗中觀察到的低感染率提供了科學基礎。

Researchers found that compared to synthetic grafts, the HAV had a significantly lower bacterial infection rate. The infection resistance maybe due to the HAVs native-like tissue structure that supports superior compatibility with the body zone immune cells. These results have broad implications for all of our intended HAV indications and further support the HAVs potential as a solution to the limitations of synthetic grafts in a wide range of medical conditions.

研究人員發現，與合成移植物相比，HAV 的細菌感染率明顯較低。感染抵抗力可能是由於 HAV 類似天然的組織結構支持與身體區域免疫細胞的卓越相容性。這些結果對我們所有預期的 HAV 適應症具有廣泛的影響，並進一步支持 HAV 作為解決合成移植物在多種醫療條件下局限性的解決方案的潛力。

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

現在，我將把它交給戴爾，以審查我們在其他業務發展方面的財務表現。

Thank you, Laura. We had cash and cash equivalents of $80.4 million as of December 31, 2023. We also completed two transactions in early 2024, which added substantially to our cash balances. On March 5, 2024, we closed an underwritten public offering of common stock and raised net proceeds of approximately $43.1 million. In addition, on March 11, 2024, we've received $20 million in proceeds from an additional draw under our revenue purchase agreement with Oberland Capital.

謝謝你，勞拉。截至 2023 年 12 月 31 日，我們的現金和現金等價物為 8,040 萬美元。我們還在 2024 年初完成了兩筆交易，這大大增加了我們的現金餘額。2024 年 3 月 5 日，我們完成了普通股承銷公開發行，籌集了約 4,310 萬美元的淨收益。此外，2024 年 3 月 11 日，根據我們與 Oberland Capital 的收入購買協議，我們從額外提款中收到了 2,000 萬美元的收益。

Total net cash used was $69.0 million for the year ended December 31, 2023, compared to $67.7 million for the year ended December 31, 2022. We believe that our cash and cash equivalents are adequate to finance operations well past the currently anticipated timelines for FDA approval and commercialization of the HAV in the vascular trauma indication.

截至2023年12月31日止年度的淨現金使用總額為6,900萬美元，而截至2022年12月31日止年度為6,770萬美元。我們相信，我們的現金和現金等價物足以為業務提供資金，遠遠超過目前 FDA 批准 HAV 血管創傷適應症和商業化的預期時間表。

There was no revenue for the fourth quarters of 2023 and 2022, and there were no revenue for the year ended December 31, 2023. Revenue was $1.6 million for the year ended December 31, 2022, and was related to a grant supporting the development of the HAV that was completed during 2022. Research and development expenses were $20.2 million for the fourth quarter of 2023 compared to $15 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023 compared to $63.3 million for the year ended December 31, 2022.

2023年和2022年第四季沒有收入，截至2023年12月31日止年度也沒有收入。截至 2022 年 12 月 31 日止年度的收入為 160 萬美元，與 2022 年完成的支持 HAV 開發的補助金有關。2023年第四季的研發費用為2,020萬美元，而2022年第四季的研發費用為1,500萬美元；截至2023年12月31日止年度的研發費用為7,660萬美元，而截至2022年12月31日止年度的研發費用為6,330萬美元。

The 2023 increases resulted primarily from increased personnel, external services expenses and materials expenses supporting the expanded research and development initiatives in our clinical studies, including the completion of our V005 Phase 2/3 trial, NRB017 Ukraine humanitarian trial for use of HAV and extremity vascular trauma as well as our BLA filing in December and the clinical development of the HAV for use in dialysis access.

2023 年的成長主要是由於人員、外部服務費用和材料費用的增加，以支持我們臨床研究中擴大的研發計劃，包括完成我們的V005 2/3 期試驗、NRB017 烏克蘭使用HAV 和四肢血管的人道主義試驗創傷以及我們 12 月的 BLA 備案以及用於透析通路的 HAV 的臨床開發。

General and administrative expenses were $6 million for the fourth quarter of 2023 compared to $5.8 million for the fourth quarter of 2022 and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022. The 2023 slight net increases in G&A expenses resulted primarily from increased personnel costs, primarily driven by preparation of the planned commercial launch of HAV in the vascular trauma indication.

2023年第四季的一般及行政費用為600萬美元，而2022年第四季為580萬美元；截至2023年12月31日止年度的一般及行政費用為2,350萬美元，而截至2022年12月31日止年度為2,290萬美元。2023 年一般管理費用略有淨增長，主要是由於人員成本增加，這主要是由於準備計劃在血管創傷適應症中商業推出 HAV。

Other net income or expense was net income of $1.1 million for the fourth quarter of 2023 compared to net income of $17.1 million for the fourth quarter of 2022 and was net expense of $10.7 million for the year ended December 31, 2023, compared to net income of $72.6 million for the year ended December 31, 2022.

其他淨收入或支出：2023 年第四季的淨收入為110 萬美元，而2022 年第四季的淨收入為1,710 萬美元；截至2023 年12 月31 日止年度的淨支出為1,070 萬美元，而淨收入則為1,070 萬美元。

The reduction in other net income in the fourth quarter of 2023 and the increase in other net expense for the year ended December 31, 2023, resulted primarily from the non-cash remeasurement of the contingent earn-out liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $25.1 million for the fourth quarter of 2023 compared to $3.7 million for the fourth quarter of 2022. The net loss was $110.8 million for the year ended December 31, 2023 compared to $12 million for the year ended December 31, 2022. The 2023 increases in net loss resulted primarily from the non-cash remeasurement of the contingent earn out liability and increased operating expenses, both described above.

2023年第四季其他淨利的減少及截至2023年12月31日止年度其他淨費用的增加，主要是由於對與2021年8月合併相關的或有盈餘負債進行非現金重新計量所致Alpha Healthcare Acquisition Corp. 2023 年第四季的淨虧損為2,510 萬美元，而2022 年第四季的淨虧損為370 萬美元。截至2023年12月31日止年度的淨虧損為1.108億美元，而截至2022年12月31日止年度的淨虧損為1,200萬美元。2023 年淨虧損的增加主要是由於上述或有盈餘負債的非現金重新計量和營運費用增加所致。

With that, I'll turn it back to Laura for concluding remarks.

說到這裡，我將把它轉回給勞拉做總結發言。

Thank you, Dale. This is a very exciting time for Humacyte and all of our stakeholders. I'd like to take a moment to thank the Humacyte team as well as our partners for their continued commitment to our programs. The entire team has worked incredibly hard to reach this point, and we are approaching what could be a transformational time not only for the company, but for patients suffering from a variety of vascular diseases and complications.

謝謝你，戴爾。對於 Humacyte 和我們所有的利害關係人來說，這是一個非常令人興奮的時刻。我想花點時間感謝 Humacyte 團隊以及我們的合作夥伴對我們專案的持續承諾。整個團隊為實現這一目標付出了難以置信的努力，我們正在接近一個轉型時期，這不僅對公司而言，而且對患有各種血管疾病和併發症的患者而言也是如此。

Across our clinical programs, the HAV has already accumulated more than 1,200 patient years of experience, including in vascular trauma repair, dialysis access and peripheral artery disease. And we are continuing to study the HAV in our earlier programs in order to maximize the full potential of our technology platform and its value. We look forward to keeping you updated with our progress and thank you all for joining us today. Operator, we are ready to take questions.

在我們的臨床計畫中，HAV 已經累積了超過 1,200 患者年的經驗，包括血管創傷修復、透析通路和周邊動脈疾病。我們正在繼續研究早期專案中的 HAV，以便最大限度地發揮我們技術平台的全部潛力及其價值。我們期待向您通報我們的最新進展，並感謝大家今天加入我們。接線員，我們準備好回答問題。

(Operator instructions) Ryan Zimmerman, BTIG.

（操作員說明）Ryan Zimmerman，BTIG。

Good morning. Can you hear me okay?

早安.你聽得到我說話嗎？

We can hear you.

我們能聽到你的聲音。

Good morning. Congrats on the progress. It’s so close. You can reach out and touch it. Maybe just to start, as we think about commercial preparation, Dale, you alluded to some of the health economic work you’re doing. I think one of the questions that investors have is kind of where the HAV lives economically in the spectrum of product offerings and kind of how you think about where you’d like it to be priced at? And to the extent that you can elaborate on kind of what the target opportunity looks like and the ramp that we should be thinking about as you prepare for commercial activity?

早安.祝賀取得的進展。距離如此之近。你可以伸手去觸摸它。也許只是為了開始，當我們考慮商業準備時，戴爾，你提到了你正在做的一些健康經濟工作。我認為投資者面臨的問題之一是，HAV 在產品供應範圍內的經濟地位如何，以及您如何看待您希望其定價的位置？您能否詳細說明目標機會是什麼樣的，以及在您準備商業活動時我們應該考慮的斜坡？

Yes. Thanks, Ryan, and I’ll try to take those in somewhat order. But obviously, the HAV is the biologic, which has produced clinical results which are far superior to the comparable standard of care today, particularly synthetic grafts, it’s going to be priced at higher acquisition costs than the current standard of care.

是的。謝謝瑞安，我會盡力按順序處理這些問題。但顯然，HAV 是生物製品，其臨床結果遠遠優於當今的同類護理標準，特別是合成移植物，其定價將比目前的護理標準更高。

But we believe that our budget impact models, which are largely developed at this stage will show that due to the reduction in complications such as amputations and infections and in the case of saphenous vein reperfusion injury and other complications like that, that are very expensive for the providers. In this case, the hospitals that the overall cost of treating a patient with HAV will be very favorable.

但我們相信，現階段主要開發的預算影響模型將表明，由於截肢和感染等併發症的減少，以及大隱靜脈再灌注損傷和其他類似併發症的發生，這對患者來說是非常昂貴的。提供者。在這種情況下，醫院治療一名甲型肝炎患者的整體費用將會非常優惠。

And as you know, pricing itself is usually determined and announced at the time of launch because you don’t want to do that in a vacuum. You want to do that in combination with the clinical story and the health economic story. But I think as we’ve talked about in the past, if you look at our earliest SEC filings, we had suggested something in the $25,000 range for the product to be somewhat lower, could be somewhat higher, but wherever it falls within that range.

如您所知，定價本身通常是在發佈時確定和宣布的，因為您不想在真空中這樣做。您需要結合臨床故事和健康經濟故事來做到這一點。但我認為，正如我們過去所討論的那樣，如果您查看我們最早向SEC 提交的文件，我們建議該產品的價格在25,000 美元範圍內稍低一些，也可能稍高一些，但無論它屬於該範圍內，範圍。

Clearly, the health economic benefits that are going to be demonstrated due to this reduction of complications is going to be meaningful and certainly will support the pricing of the product. Beyond that, I think you had a question about market size. There’s around 80,000 vascular trauma cases each year within the United States.

顯然，由於併發症的減少而帶來的健康經濟效益將是有意義的，並且肯定會支持產品的定價。除此之外，我認為您對市場規模有疑問。美國每年約有 8 萬件血管創傷病例。

And when we drill down and look very specifically at kind of the low-hanging fruit and the ones that are most immediately applicable to the HAV by looking at hospital billing codes and other information like that. There’s at least 26,000 cases, we believe, that are clear candidates for the HAV to be used within the United States, which suggest that this is a market that could be somewhere in the $600 plus million range dependent upon pricing. So hopefully, I’ve answered your questions, but point out that you can admit.

當我們深入研究並非常具體地透過查看醫院帳單代碼和其他類似資訊來尋找容易實現的目標以及最直接適用於 HAV 的目標時。我們相信，至少有 26,000 個案例明確適合在美國使用 HAV，這表明這個市場的價格可能在 600 多百萬美元之間，具體取決於定價。希望我已經回答了你的問題，但指出你可以承認。

No, no. Thank you, Dale. It’s still early, I know these are not fully flushed out. As you get closer, I think more clarity will emerge there. The other question is just around cash burn guidance. I think pro forma with the recent equity offering and some of the tranches from Oberland. I think you’re around the 140 range as of today, if I’m not mistaken, about 143, and that’s based on the gross proceeds from the recent equity offering. So I’m just curious what you can say for 2024 around cash burn, maybe any directional commentary on operating spend as you do kind of prepare for this commercial launch?

不，不。謝謝你，戴爾。現在還早，我知道這些還沒完全清除。當你越來越接近時，我認為那裡會變得更加清晰。另一個問題與現金消耗指引有關。我認為透過最近的股票發行和 Oberland 的一些部分進行準備。我認為截至今天，您的股價大約在 140 左右，如果我沒記錯的話，約為 143，這是基於最近股票發行的總收益。所以我只是好奇你對 2024 年的現金消耗有何看法，也許在你為這次商業發布做準備時對營運支出有任何定向評論？

Yeah, certainly. I think your math is right. The way we look at it is we ended December 31 with a little more than well, right around $81 million in cash. And when we add on the $63 plus million that we achieved through the equity financing as well as the additional draw into our Oberland facility. That means we’re entering the year with about $144 million in cash, which leaves us very well positioned.

是的，當然。我認為你的數學是正確的。我們的看法是，截至 12 月 31 日，我們的現金略多於 8,100 萬美元左右。再加上我們透過股權融資以及 Oberland 設施的額外提款獲得的超過 63 萬美元。這意味著我們今年將擁有約 1.44 億美元的現金，這使我們處於非常有利的位置。

Our net cash burn for 2023 rounded to about $69 million. But if you back out the effect of some net financing transactions from an operating cash point of view and from a capital expenditure point of view, we’ve burned about $73.5 million in 2023 in those activities. So suggesting we’re very well positioned with the cash that we have on hand right now.

我們 2023 年的淨現金消耗四捨五入至約 6,900 萬美元。但如果從營運現金的角度和資本支出的角度排除一些淨融資交易的影響，我們在 2023 年的這些活動中燒掉了約 7,350 萬美元。因此，這表明我們目前手頭上的現金處於非常有利的位置。

In terms of how we’ll proceed in the upcoming year, we haven’t given super specific guidance, but I’ll share what we’ve guided in the past is that certainly, we expect to expand our commercialization activities during the year, including near the time of launch, bringing on a relatively small sales force to address this very concentrated market. So we will have, obviously, higher commercialization expenses during this year.

就我們來年的進展而言，我們還沒有給出非常具體的指導，但我會分享我們過去的指導，那就是，我們當然希望擴大我們的商業化活動在這一年中，包括在產品發布前後，我們引入了相對較小的銷售團隊來應對這個非常集中的市場。因此，顯然今年我們的商業化費用將會更高。

But we do also have a wind down of certain clinical costs during the year with the V005 study just in long-term follow-up and not as intensive activities as we had during 2023 as we prepared for the close out of that study and for filing of the BLA. And then also our dialysis trial [V007] will be winding down in the second half of the year, too.

但我們在這一年中也確實減少了某些臨床成本，因為 V005 研究只是長期隨訪，而不是像 2023 年那樣密集的活動，因為我們為結束該研究和提交文件做準備BLA 的。然後我們的透析試驗 [V007] 也將在今年下半年結束。

So we expect somewhat of an increase in overall cash burn for the upcoming year, but not to a great extent on a net basis. And we believe that the cash on hand is certainly adequate to take us well past the commercial launches in trauma and AV access and well passed or certainly through 2026. So we certainly don’t have any cash concerns at this point in time.

因此，我們預計來年的​​整體現金消耗將會增加，但淨值不會大幅增加。我們相信，手頭上的現金肯定足以讓我們順利度過創傷和 AV 接入領域的商業發布，並順利度過或肯定持續到 2026 年。因此，目前我們當然沒有任何現金問題。

Very helpful, Dale. Thank you for all the information.

非常有幫助，戴爾。感謝您提供的所有資訊。

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·費茲傑拉。

Hi everyone. Good morning and congrats as well on the progress. I wanted to touch on manufacturing as this is often something that FDA scrutinizes on very closely during PDUFA and drug approval. So I wanted to ask how you’re feeling about your manufacturing? And also anything you’re doing to prepare for upcoming inspections and meetings that the FDA will be conducting?

大家好。早上好，也祝賀您的進展。我想談談製造，因為這通常是 FDA 在 PDUFA 和藥物批准期間非常密切審查的事情。所以我想問一下你們對你們的製造業感覺如何？您正在為 FDA 即將舉行的檢查和會議做哪些準備？

Yes, Kristen, this is Laura Niklason. Thank you for that question. So yes, certainly, after the BLA file was accepted and we got our PDUFA date in August, the FDA moved rapidly to begin scheduling interim meetings and also our inspection, which is upcoming in the near future. As far as what we’ve been doing to prepare for this, we’ve actually run two mock inspections, one last summer and one just last month in February, where we brought consultants in to Humacyte who were all ex-FDA inspectors.

是的，克莉絲汀，這是勞拉·尼克拉森。謝謝你提出這個問題。所以，是的，當然，在 BLA 文件被接受並且我們在 8 月收到 PDUFA 日期之後，FDA 迅速採取行動，開始安排臨時會議以及我們的檢查，這將在不久的將來進行。就我們為此所做的準備而言，我們實際上進行了兩次模擬檢查，一次是去年夏天，另一次是上個月二月，我們聘請了 Humacyte 的顧問，他們都是前 FDA 檢查員。

And they really did a deep dive on two separate occasions, really helping us be as prepared as possible for this upcoming inspection. I would say that since we began preparing for this last summer, we’ve really been able to execute on all of the remediations that were picked out, certainly from 2023.

他們確實在兩個不同的場合進行了深入研究，確實幫助我們為即將到來的檢查做好了盡可能的準備。我想說，自從我們去年夏天開始為此做準備以來，我們確實能夠執行所挑選的所有補救措施，當然從 2023 年開始。

And we’re feeling very confident about how this inspection is going to go. We believe that the facility is in great shape. Our manufacturing processes are well characterized and well understood. Obviously, with the Center for Biologics, you’re right, a big focus is always on manufacturing and the facility and the robustness of the process. But we believe we’re in good shape.

我們對這次檢查的進展非常有信心。我們相信該設施狀況良好。我們的製造流程具有明確的特徵並且易於理解。顯然，對於生物製品中心，您是對的，重點始終是製造、設施以及流程的穩健性。但我們相信我們的狀況良好。

Great. And then the preclinical study that you talked about in the juvenile animal model, it seems to highlight the different applications of the HAV platform. So how are you thinking about the flexibility for your current platform as it relates to different vessels and how you might go about implementing this on pilot or larger-scale program?

偉大的。然後你談到的幼年動物模型的臨床前研究，似乎凸顯了HAV平台的不同應用。那麼，您如何考慮當前平台與不同船舶相關的靈活性，以及​​如何在試點或更大規模的專案中實施這一點？

So the one of the beauties of the platform, and this was designed with intention is that our LUNA manufacturing machines each of which right now can make up to about 1,040 centimeter HAVs per year. Those were designed specifically so as to be modular and flexible. So using the same machine, we can grow tissues of different diameters and different lengths without changing the machinery itself.

因此，該平台的優點之一是我們的 LUNA 製造機器每年可以製造約 1,040 公分的 HAV，這也是我們精心設計的。它們經過專門設計，具有模組化和靈活性。因此，使用同一台機器，我們可以在不改變機器本身的情況下生長不同直徑和不同長度的組織。

It really only involves changing some of the plastic bag sizes and some of the tubing. So as we mentioned in the call, we’ve been making 3.5 millimeter vessels that are suitable for heart bypass and pediatric heart surgery we’ve been making those in our current system for the last couple of years, and we’ve been testing them in animals.

它實際上只涉及改變一些塑膠袋尺寸和一些管道。正如我們在電話中提到的，我們一直在製造適合心臟搭橋和小兒心臟手術的 3.5 毫米血管，過去幾年我們一直在現有系統中製造這些血管，而且我們已經一直在動物身上進行測試。

It’s also, for us, we believe, a short hop to modify our system and make 6 millimeter vessels, but that are shorter or longer, shorter vessels may have added utility in the trauma indication in the future because many traumatic injuries don’t require 40 centimeters of conduit. They can utilize a shorter vessel.

我們相信，對我們來說，修改我們的系統並製造6 毫米血管也是一個短暫的跳躍，但更短或更長，更短的血管可能會在未來的創傷適應症中增加實用性，因為許多創傷性損傷不會不需要 40 公分的導管。他們可以使用較短的船隻。

Conversely, in peripheral arterial disease, where we’re also working pretty actively with our Phase II programs, it may be that in the future, some patients would benefit from a longer vessel, which can extend from the growing down to below the knee and we believe that we can also make longer vessels, again, using the same equipment. So we were very intentional when we designed the platform so that we could pivot and make vessels of different shapes and sizes.

相反，在周邊動脈疾病方面，我們也非常積極地開展 II 期項目，未來一些患者可能會受益於更長的血管，該血管可以從生長向下延伸到膝蓋以下我們相信，我們還可以使用相同的設備製造更長的船。因此，我們在設計平台時非常有意，以便我們可以旋轉並製造不同形狀和尺寸的容器。

And I would say we’re already doing that. And that will be after approval, going forward, follow-on product candidates will be manufactured in our same system just using slight modifications of the tubing.

我想說我們已經在這樣做了。獲得批准後，後續候選產品將在我們的同一系統中生產，只需對管道進行輕微修改即可。

Great. Thanks for taking the question.

偉大的。感謝您提出問題。

Josh Jennings, TD Cowen.

喬許·詹寧斯，TD·考恩。

Hi, good morning. Laura and Dale thanks for taking the questions. I wanted to just follow up on Ryan’s question on health economics data, thanks for the download there. But just wanted to better understand any if there’s any color on preliminary discussions with payers and just how you expect Medicare and private payer reimbursement for HAV and the vascular trauma indication to evolve the DRGs is in place. And just any color as you think about launch time and then how reimbursement and payment can evolve from there?

早安.勞拉和戴爾感謝您提出問題。我想跟進 Ryan 關於健康經濟學數據的問題，感謝您的下載。但只是想更了解與付款人的初步討論是否有任何色彩，以及您如何期望醫療保險和私人付款人對 HAV 進行報銷，以及發展 DRG 的血管創傷指示是否到位。當您考慮啟動時間以及報銷和付款如何演變時，可以使用任何顏色嗎？

Yes. Yes, certainly. So in parallel to date, we’ve had discussions with hospital administrators, interactions with CMS and also interactions with private payers. And those discussions will are intensifying with the data in hand. And as we start rolling out our budget impact model. The budget impact model itself, which really supports the value proposition of HAV and the implications of using the HAV and the extent to which you can save the cost of other complications.

是的。是的，當然了。因此，迄今為止，我們與醫院管理人員進行了討論，與 CMS 進行了互動，也與私人付款人進行了互動。隨著數據的掌握，這些討論將會更加激烈。當我們開始推出預算影響模型時。預算影響模型本身，真正支持 HAV 的價值主張以及使用 HAV 的影響以及您可以在多大程度上節省其他併發症的成本。

It is essentially will essentially be presented and then published through the course of the year, presumably in advance of launch. Beyond that, though, specific your specific questions around reimbursement, how the HAV is reimbursed is going to be dependent upon the indication and also where the patient is being served.

它基本上將在一年中呈現並發布，大概是在發布之前。不過，除此之外，關於報銷的具體問題，HAV 的報銷方式將取決於適應症以及患者接受服務的地點。

So specifically with regards to trauma, that’s an inpatient surgical setting. And so the hospitals are generally going to be reimbursed on a DRG or a fixed price basis as you implied. And so the HAV would be an acquisition cost by the hospital, which is not separately reimbursed at its core, which is why the health economic implications of HAV, the ability to save the cost of these complications is so important.

特別是對於創傷而言，這是住院手術環境。因此，正如您所暗示的那樣，醫院通常會以 DRG 或固定價格獲得報銷。因此，HAV 將成為醫院的購置成本，其核心並不單獨報銷，這就是為什麼 HAV 的健康經濟影響以及節省這些併發症成本的能力如此重要。

But keep in mind that as a new technology and also as a biologic HAV, we believe, will qualify for an NTAP or new technology add-on payment reimbursement, which will give the hospitals an additional reimbursement that they would not get under the normal DRGs. And clearly, the HAV qualifies for an NTAP reimbursement because it’s innovative and because it provides a meaningful patient benefit.

但請記住，我們相信，作為一項新技術和生物 HAV，將有資格獲得 NTAP 或新技術附加付款報銷，這將為醫院提供在正常 DRG 下無法獲得的額外報銷。顯然，HAV 有資格獲得 NTAP 報銷，因為它具有創新性，並且可以為患者帶來有意義的利益。

But I think both CMS and then private payers who can provide the equivalent of an NTAP reimbursement will be motivated to do so because not only are the savings associated with the HAV present during the time the patients in the hospital. But once the patient leaves the hospital, the reduction in amputations and other complications, we’ll save the payers a substantial amount of money in terms of ongoing rehabilitation and prosthetics and other costs like that.

但我認為 CMS 和能夠提供相當於 NTAP 報銷的私人付款人都會有動力這樣做，因為患者住院期間不僅可以節省與 HAV 相關的費用。但是，一旦患者出院，截肢和其他併發症的減少，我們將為付款人節省大量資金，包括持續的復健、義肢和其他類似費用。

So we believe that within the existing DRGs the use of HAV will be very favorable because of the production and complications, but that we will also get NTAP in the equivalent from private pay due to the innovative nature of the product and the savings that it provides once the patient leaves the hospital.

因此，我們相信，在現有的 DRG 中，由於生產和複雜性，HAV 的使用將非常有利，但由於該產品的創新性及其提供的節省，我們也將從私人支付中獲得同等的 NTAP一旦病人離開醫院。

Excellent.

出色的。

Dale. And the only thing I would add there, and that this is also in the public domain, but as part of applying for the NTAP, it’s necessary to obtain an ICD-10 code from CMS. And we had a recent meeting with CMS that was in the public domain on the ICD-10 coding and CMS has recommended that the HAV be given a unique code. And so that’s an important step. It’s an important precursor to filing for the NTAP application later this year. So I just wanted to say that from a CMS standpoint, in terms of coding and reimbursement we’re definitely on track. And I also want to reiterate Dale’s points, which I think are very important for CMS and for all private payers and Medicaid also is that the initial hospital costs for severe traumatic injury, the initial hospital costs are only part of the equation.

戴爾.我唯一要補充的是，這也是公共領域的，但作為申請 NTAP 的一部分，有必要從 CMS 取得 ICD-10 代碼。我們最近與 CMS 舉行了一次關於 ICD-10 編碼的公共領域會議，CMS 建議為 HAV 指定一個唯一的代碼。因此，這是重要的一步。這是今年稍後提交 NTAP 申請的重要前提。所以我只想說，從 CMS 的角度來看，在編碼和報銷方面，我們絕對走在正軌上。我還想重申戴爾的觀點，我認為這對 CMS 以及所有私人付款人和醫療補助非常重要，而且嚴重創傷的初始住院費用只是等式的一部分。

Readmissions and complications due to the amputation and infection and sepsis are huge cost drivers and the insurers are going to understand this. And the case for providing add-on payments to support HAV adoption in trauma, I think, is going to be very strong.

由於截肢、感染和敗血症導致的再入院和併發症是巨大的成本驅動因素，保險公司會理解這一點。我認為，提供附加付款以支持在創傷中採用 HAV 的理由將非常充分。

Excellent. Thanks for that. And just a follow-up on the AV access indication. And you’ve done work with Fresenius taking through their large data set on patients that could benefit most from HAV as well as health economics, I’m not sure if there’s any details you can share from that or timing of when more intel could come from that collaboration? And then just also remind us how you can leverage the vascular trauma indication in the filing for the AV access indication as we move down the year here? Thanks.

出色的。感謝那。這只是 AV 存取指示的後續操作。您已經與費森尤斯合作，研究了他們的大量患者數據集，這些患者可以從 HAV 以及衛生經濟學中受益最多，我不確定您是否可以分享任何細節或時間安排什麼時候可以從這種合作中獲得更多情報？然後也提醒我們，當我們今年倒下時，您如何利用申請中的血管創傷指示來獲得 AV 通路指示？謝謝。

Well, as we’ve said on several calls, we’re looking forward to sharing that information I think we have so I can say that we’re going to do a KOL event actually next week, where we’re going to present a lot of the Frenova data that we’ve gathered with our partner, Fresenius for more than a year, that really paints a very clear picture of how costly some of the most costly patients are and who those patients are.

嗯，正如我們在幾次電話中所說的那樣，我們期待著分享我認為我們掌握的信息，這樣我就可以說我們將在下週舉辦一場 KOL 活動，我們將在那裡舉辦我們將展示我們與合作夥伴費森尤斯(Fresenius) 一年多來收集的大量Frenova 數據，這些數據確實清晰地描繪了一些花費最高的患者的費用以及這些患者的身份。

So we’re really looking forward to that, and that will be next week. As far as how the trauma data will be leveraged for a potential follow-on BLA supplement in dialysis access. As you know, the agency tends to look at safety and efficacy data within indication, that will be their primary focus. Although, of course, the long-term safety updates that we’re going to be providing as part of our drug safety update report and also just trauma follow-on, I’m sure we’ll be part of that file.

所以我們真的很期待這一點，那就是下週。至於如何利用創傷數據作為透析訪問中潛在的後續 BLA 補充。如您所知，該機構傾向於查看適應症範圍內的安全性和有效性數據，這將是他們的主要關注點。當然，儘管我們將作為藥物安全更新報告的一部分提供長期安全更新，也只是創傷後續行動，但我確信我們將成為該文件的一部分。

But just realistically, I think that particularly from an efficacy standpoint, since dialysis really is a different indication from trauma. I think the efficacy focus will be on the dialysis data, but I would anticipate that safety information from all indications, but especially from trauma would factor into the FDA’s thinking.

但實際上，我認為特別是從功效的角度來看，因為透析確實是與創傷不同的適應症。我認為功效重點將放在透析數據上，但我預計所有適應症的安全訊息，尤其是創傷的安全訊息將成為 FDA 考慮的因素。

Excellent. And also I you can, I was my assumption is you can leverage the modules on manufacturing and preclinical [indiscernible].

出色的。我也可以，我的假設是你可以利用製造和臨床前模組[音頻不清晰]。

Oh yes, of course. Absolutely. Yes. Thank you for that. Yes. No, the since the product is identical, all of the preclinical and all of the shelf life and manufacturing data are identical. Yes, that would all be leveraged. So that will be very helpful. And efficiency generating.

哦，是的，當然。絕對地。是的。謝謝你。是的。不會，因為產品是相同的，所以所有臨床前數據以及所有保質期和製造數據都是相同的。是的，這一切都會被槓桿化。這將非常有幫助。並產生效率。

Excellent. Okay. Thanks so much.

出色的。好的。非常感謝。

Suraj Kalia, Oppenheimer.

蘇拉吉·卡利亞，奧本海默。

Hi, Laura and Dale. This is Seamus on for Suraj. Just to start, I know the HAV for dialysis access has been almost a year fully enrolled. I guess, at this point, when could we expect some topline results filing? Any updates you can give us on that? Thank you.

嗨，勞拉和戴爾。這是 Seamus 為 Suraj 發言。首先，我知道用於透析的 HAV 已全部註冊近一年了。我想，在這一點上，我們什麼時候可以期待一些重要的結果報告？您可以向我們提供有關這方面的任何更新嗎？謝謝。

Sure. So our enrollment completed actually in late April last year. So technically, we’ll hit the 12 month point next month. This is a large trial that went on for a while. It started pre-COVID at many centers. So it’s going to take us several months to pull this data together. So what we’ve guided the market is that we would expect topline results on the V007 trial in dialysis sometime in the third quarter of this year.

當然。所以我們的招生其實是在去年四月下旬完成的。因此從技術上講，我們將在下個月達到 12 個月的點。這是一個持續了一段時間的大型試驗。許多中心在新冠疫情爆發之前就開始了這種情況。因此，我們需要花費幾個月的時間來收集這些數據。因此，我們引導市場的是，我們預計 V007 透析試驗的主要結果將在今年第三季的某個時候公佈。

Got it. Thank you. And then just thinking through the initial sales force for trauma. I know you’ve said somewhere around 20 individuals. How should we think about kind of the ramp for hiring as you do what you’ll have roughly around the PDUFA date? Any updates you can give us there where you would be and I guess, percentage wise of those 20 people?

知道了。謝謝。然後考慮一下針對創傷的最初銷售人員。我知道您曾說過大約 20 個人。當您大約在 PDUFA 日期前後進行招募時，我們應該如何考慮招募的進度？您可以提供我們任何最新情況嗎？

Yes. Go ahead, Dale.

是的。繼續吧，戴爾。

Go ahead.

前進。

No, you go ahead.

不，你繼續吧。

Yeah, I think we’ve indicated with a relatively concentrated market in level one trauma centers. There are up 200 of them within the United States that we expect the sales force somewhat less than 20 to be able to reach that market. In terms of when that group will be brought on the exact sizing will be probably more specific around that as we get closer to launch. But much of the infrastructure for the sales team is being built right now in terms of the management of that team and complementing our current commercialization group in terms of the actual sales reps.

是的，我認為我們已經表明一級創傷中心的市場相對集中。美國境內有 200 家這樣的公司，我們預計不到 20 人的銷售人員就能夠進入該市場。至於該組何時上線，隨著我們距離發布越來越近，確切的規模可能會更加具體。但銷售團隊的大部分基礎設施目前正在建設中，以管理該團隊，並在實際銷售代表方面補充我們目前的商業化團隊。

They will be brought on much, much closer to the exact time of approval as opposed to too far in advance. We’ll make a decision as to whether that entire team will be brought on day one to accommodate the launch or whether it will be layered into one or two segments that facilitate the launch that way.

它們將在非常接近批准的確切時間進行，而不是提前太久。我們將決定是在第一天召集整個團隊來適應發布，還是將其分成一個或兩個部分以這種方式促進發布。

But those are decisions that are under active discussion right now, and we’ll decide as we get close.

但這些決定目前正在積極討論中，我們將在接近時做出決定。

Understood. Thank you. And just one last quick one for me. The NTAP cycle, do you guys believe it’s going to be a 2025 event or 2026? Thank you for taking our questions.

明白了。謝謝。對我來說，這只是最後一件事。NTAP 週期，你們認為這將是 2025 年還是 2026 年舉行？感謝您接受我們的提問。

So based on the revised rules for when you can file an NTAP application, our earliest that we can file will be October of this year. Typically, decisions are made a couple of quarters after that. And but then the NTAP reimbursement would be scheduled to kick in, I believe, to the best of my knowledge in October of 2025. Again, we expect an NTAP application to be successful, but the our earliest date when we can apply is this October.

因此，根據修訂後的 NTAP 申請提交時間規則，我們最早可以在今年 10 月提交。通常情況下，決策是在那之後幾季做出的。但據我所知，NTAP 報銷計畫將於 2025 年 10 月開始實施。同樣，我們預計 NTAP 申請會成功，但我們最早可以申請的日期是今年 10 月。

Allison Russell, Piper Sandler.

艾莉森·拉塞爾，派珀·桑德勒。

Hey. Good morning. Congrats on all the progress and thank you for taking my question. Really just one for me. A follow-up on the dialysis vascular access setting. Just on the V007 trial reading out in Q3, could you just remind us kind of what you see as the bar for success that would lead to the HAV being widely adopted for dialysis access. What do you hope to show when that trial reads out? And then just related, how does the ongoing trial in female patients just play into your plans for filing and commercialization in that indication? Thank you.

嘿。早安.恭喜所有的進展，並感謝您提出我的問題。對我來說真的只是一件。透析血管通路設定的後續行動。就在第三季公佈的 V007 試驗中，您能否提醒我們您認為成功的標準是什麼，這將導致 HAV 被廣泛應用於透析治療。當審判宣讀時，你希望展示什麼？然後，相關的是，正在進行的針對女性患者的試驗如何影響您針對該適應症的申請和商業化計劃？謝謝。

Yes, Allison, thanks for these questions. So again, the V007 trial is a prospective randomized blinded trial that compares the HAV to Fistula in a broad range of patients at more than 20 sites in the US. So the primary endpoints for this trial are looking at usability for dialysis and patency at six and 12 months, and this is a superiority trial.

是的，艾莉森，謝謝你提出這些問題。再次強調，V007 試驗是一項前瞻性隨機盲法試驗，在美國 20 多個地點的廣泛患者中對 HAV 與瘻管進行比較。因此，該試驗的主要終點是考察 6 個月和 12 個月時透析的可用性和通暢性，這是一項優效性試驗。

Again, we are blinded, and we don’t have topline, so we don’t know how it’s going to go. Obviously, our goal and our hope is that across the board, we will have superiority across the whole trial and for all patient groups. However, it’s possible that we would have subgroups that would show more superiority or increased beneficial effects as compared to other groups.

再一次，我們被蒙蔽了，我們沒有頂線，所以我們不知道事情會如何發展。顯然，我們的目標和希望是，我們將在整個試驗和所有患者群體中擁有優勢。然而，與其他群體相比，我們的子群體可能會表現出更多的優勢或增加的有益效果。

Again, it’s very hard to predict in advance of the data. And so I don’t want to give specific guidance here, but I would hope that if we had superiority in either across the trial or within a subgroup, that, that clinical data in combination with an already approved HAV product in the trauma indication, our hope that would be that would be sufficient to file a supplemental BLA perhaps sometime in 2025 for the dialysis indication.

同樣，提前對數據進行預測是非常困難的。因此，我不想在這裡給出具體指導，但我希望，如果我們在整個試驗中或在亞組內具有優勢，那麼臨床數據與已批准的 HAV 產品在創傷適應症中的結合，我們希望這足以在2025 年的某個時候針對透析適應症提交補充BLA。

As far as the female-only trial, that’s a trial that we’ve very newly initiated that really focuses on it’s a smaller trial, and it focuses on women comparing the HAV to fistula in women. And again, we’re going to be discussing this more at the KOL event next week. And so I don’t want to get ahead of the information and the story here on this call.

就女性限定的試驗而言，這是我們最近發起的一項試驗，真正關注的是它是一項規模較小的試驗，它重點關注女性，將 HAV 與女性瘻管進行比較。再次強調，我們將在下週的 KOL 活動中進一步討論這個問題。因此，我不想在這次電話會議上透露更多資訊和故事。

But again, based on our health economic data and looking at the complications that are suffered by dialysis patients, it’s become clear from our work with Frenova that women in general, and there are certain subsets of women that have extraordinarily high complication rates and are extraordinarily expensive system. And we believe that the Frenova data in combination with additional data that we’re going to get on our clinical trials will really help make the health economic case around the HAV in female patients who have very high complication rates.

但同樣，根據我們的健康經濟數據以及對透析患者所遭受的併發症的觀察，我們與 Frenova 的合作清楚地表明，一般女性以及某些女性亞群的併發症發生率極高並且是非常昂貴的系統。我們相信，Frenova 數據與我們將在臨床試驗中獲得的其他數據相結合，將真正有助於為併發症發生率極高的女性患者提供有關 HAV 的健康經濟案例。

Excellent. Thanks so much.

出色的。非常感謝。

Vernon Bernardino, H.C. Wainwright.

伯納迪諾，H.C.溫賴特。

Hi, Laura and Dale. Thanks for taking my question and congrats on the progress. Definitely looking forward to the approval later this year and launch. Just wanted to follow-up on a few questions. One of them being the expenses rising according to what you said, Dale, this year. You anticipate more you said there’s probably going to be a ramp down as far as R&D maybe. And so therefore, maybe most of the ramp-up and OpEx would be from G&A? And do you anticipate that will be mostly heavily weighted towards the back of the year, of course, because that’s when the expected launch would be? And then I have a follow-up question.

嗨，勞拉和戴爾。感謝您提出我的問題並祝賀我的進展。絕對期待今年晚些時候獲得批准並推出。只是想跟進幾個問題。其中之一是根據戴爾你所說，今年的費用增加。你預計研發方面的支出可能會下降。因此，也許大部分的成長和營運支出將來自 G&A？當然，您是否預計這將主要集中在今年年底，因為那是預期的發佈時間？然後我有一個後續問題。

Yes, you’re right. Much of I mean we do have a very meaningful commercial team in place right now, which is undertaking much of the activities that are longer lead time to get ready for a successful launch. And those include the budget impact model and the applications for ICD-10 codes and other activities like that, that are ongoing, but much of the heavy increase in terms of commercialization expenses will come in the second half of the year with the addition of the sales force. And you’re right, there is somewhat of a wind down of certain R&D expenses in part because certain of the clinical trials are winding down and also in part because everything we do from a manufacturing point of view kind of rolls into R&D expense to date.

是的，你是對的。我的意思是，我們現在確實有一個非常有意義的商業團隊，他們正在進行許多需要較長準備時間的活動，為成功發布做好準備。其中包括預算影響模型和 ICD-10 代碼的應用以及其他類似活動，這些活動正在進行中，但商業化費用的大幅增加將在今年下半年出現，此外銷售團隊。你是對的，某些研發費用有所減少，部分原因是某些臨床試驗正在結束，部分原因是我們從製造角度所做的一切都轉入了研發費用日期。

But as we move towards commercialization, a number of those manufacturing costs are going to be appearing in cost of sales, which has the effect of reducing R&D expense. So with that, we expect on an overall net basis, just really a slight increase in overall burn for 2024 compared to 2023.

但隨著我們走向商業化，其中一些製造成本將出現在銷售成本中，這將降低研發費用。因此，我們預計，在整體淨值基礎上，2024 年的整體燃燒量將比 2023 年略有增加。

And then regarding Laura, you had alluded to using the same manufacturing and so on. Do you anticipate margins improving over time since you’re using the same equipment regardless of whether or not you’re making, let’s say, mostly large versus small or whatever mix of diameter of what HAVs?

關於勞拉，您提到使用相同的製造流程等等。您預計利潤率會隨著時間的推移而提高嗎？

Yes. There are two main sources of decreasing COGS over time. And I would say that both apply regardless of whether we’re making a 40 centimeter vessel or, say, a short vessel in the future, for example, down the road. The first is just a more efficient use of our facility. Right now, we have built out only a fraction of our manufacturing floor because we have eight LUNA’s installed, although we have room for 40.

是的。隨著時間的推移，銷貨成本下降有兩個主要來源。我想說的是，無論我們是在製造一艘 40 公分的船隻，還是將來製造一艘較短的船隻，兩者都適用。首先是更有效地利用我們的設施。目前，我們只建造了生產車間的一小部分，因為我們安裝了 8 個 LUNA，儘管我們有容納 40 個的空間。

So we’re essentially amortizing all of the facility costs across a smaller amount of production as production increases, that inherent overhead obviously will fall linearly. But in addition, we believe that there are additional reductions in COGS that will result from efficiencies of how we use our raw materials, how we prepare and bring in our raw materials, which as we go to greater scale and as we’re able to negotiate improved contracts with some of our suppliers, some of those cost inputs will also come down.

因此，隨著產量的增加，我們基本上將所有設施成本分攤到較小的產量中，固有的開銷顯然會線性下降。但除此之外，我們相信，隨著我們規模的擴大和能力的提高，我們如何使用原材料、如何準備和引入原材料，這將導致銷貨成本進一步降低。 ，其中一些成本投入也會下降。

So it’s we anticipate that regardless of what type of product we’re making COGS should fall at a fairly predictable rate.

因此，我們預計，無論我們生產哪種類型的產品，銷貨成本都應該以相當可預測的速度下降。

And one further follow-up, if I may. Regarding, let’s say, the launch this year. I know that with vascular trauma, you would expect not to really have insight into a really much longer than, let’s say, a short-term vision of need. But do you have any idea of vision, let’s say, that you might have, at some point, what you could describe as an inventory patients who need something such that you could predict the need for example, much longer than, let’s say, the next week, two weeks, maybe even a month, but longer term, two or three months. Or is that really just going to be for when you have the AV access and PAD and CABG markets where HAV has approval for application? Thank you.

如果可以的話，還有進一步的後續行動。比如說今年的發布。我知道，對於血管創傷，您可能不會真正了解比短期需求願景更長的時間。但是你是否有任何願景，比如說，你可能在某個時候擁有你可以描述為庫存患者的東西，他們需要一些東西，這樣你就可以預測需求，例如，比，讓…比如說，下週、兩週，甚至一個月，但更長遠的是兩三個月。或者，當您擁有 AV 准入以及 HAV 批准申請的 PAD 和 CABG 市場時，這真的會發生嗎？謝謝。

So, Vincent, I’m going to try to answer your question. I’m not completely sure I understood the question, but let me take a shot. So certainly, trauma care, there is some variability. There’s some seasonal variability. But overall, it’s not a hugely variable market in the aggregate. There are some centers that will have more trauma some months than others.

所以，文森特，我將嘗試回答你的問題。我不完全確定我理解了這個問題，但讓我試試看。當然，創傷護理存在一些可變性。有一些季節性變化。但總體而言，這並不是一個總體上變化巨大的市場。有些中心在幾個月內會比其他中心遭受更多的創傷。

But in the aggregate, it’s not a hugely variable market. So we have shared in some of our filings that and on this call that we think the total addressable market in trauma is about 26,000 patients. Of those, we would expect to capture at full saturation at three or five or seven years at full market saturation, we would expect to capture a reasonable fraction of those.

但總體而言，這並不是一個變化巨大的市場。因此，我們在一些文件中分享了這一點，並且在這次電話會議上，我們認為創傷領域的總潛在市場約為 26,000 名患者。其中，我們預計將在市場完全飽和的三年、五年或七年後實現完全飽和，我們預計將獲得其中合理的比例。

Might be 30%, might be 50% of those patients, could be more. So and we’ve shared that we expect market penetration in dialysis and peripheral artery disease, ultimately at full penetration to be at around 20% because we again, we are targeting the HAV toward patients who do not have their needs met by the current standard-of-care. But trauma overall, even though it’s locally episodic is globally a little bit more predictable. So we believe we’ll be able to ramp production, tracking demand, we’ll be able to ramp production and add more LUNA capacity and meet that as it grows. Does that answer your question?

可能是這些患者的 30%，可能是 50%，也可能更多。因此，我們預計透析和周邊動脈疾病的市場滲透率最終將達到 20% 左右，因為我們再次將 HAV 瞄準了目前的需求無法滿足的患者。但總體而言，創傷雖然是局部偶發的，但在全球範圍內更容易預測。因此，我們相信我們將能夠提高產量，追蹤需求，我們將能夠提高產量並增加更多的 LUNA 產能，並隨著其成長而滿足這項要求。這是否回答你的問題？

No, that’s perfect. And by the way, it’s Vernon and Vincent is my evil twin. So thank you for taking my questions.

不，那是完美的。順便說一句，這是弗農，文森特是我的邪惡雙胞胎。謝謝你回答我的問題。

I’m sorry Vernon.

我很抱歉弗農。

That’s okay. My evil twin and I, again, in each other way, I’m looking forward to your KOL event and thanks again for taking my question.

沒關係。我和我的邪惡雙胞胎，再次以彼此的方式，我期待著您的 KOL 活動，並再次感謝您提出我的問題。

Thank you.

謝謝。

Thank you. I’m showing no further questions in the queue at this time. This will conclude the Humacyte 2023 results conference call. Thank you all for participating.

謝謝。目前，我在隊列中沒有顯示任何其他問題。Humacyte 2023 年業績電話會議到此結束。感謝大家的參與。