Humacyte Inc (HUMA) 2025 Q2 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Humacyte second quarter 2025 results conference call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the call over to Tom Johnson with Lifesci Advisors. Please go ahead.

女士們、先生們，早安，歡迎參加 Humacyte 2025 年第二季業績電話會議。（操作說明）提醒各位，本次會議正在錄音。現在我將把電話轉交給 Lifesci Advisors 的 Tom Johnson。請繼續。

Thank you, operator. Before we proceed with the call, I'd like to remind everyone that certain statements 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.

謝謝接線生。在正式開始電話會議之前，我想提醒大家，本次電話會議中的某些陳述屬於美國聯邦證券法意義上的前瞻性陳述。這些聲明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 in 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所述內容不同的因素的更多信息，請參閱我們向美國證券交易委員會提交的定期報告。本次電話會議中所作出的前瞻性陳述僅代表截至本次會議之日的信息，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 the filing may be accessed on the Investor page of the Humacyte website. Joining me today on today's call are from Humacyte, Dr. Laura Niklason, President and Chief Executive Officer; Dale Sander, Chief Financial Officer and Chief Corporate Development Officer; and BJ Scheessele, Chief Commercial Officer. Dr. Niklason will provide a summary of the company's progress for the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended June 30, 2025. Following their prepared remarks, BJ will have joined Laura and Dale for a Q&A session.

本次電話會議中提供的資訊已包含在我們今天早上發布的新聞稿和我們的 10-Q 表格中，提交後可在 Humacyte 網站的投資者頁面上查閱。今天與我一起參加電話會議的有來自 Humacyte 的 Laura Niklason 博士（總裁兼執行長）、Dale Sander（財務長兼首席企業發展長）和 BJ Scheessele（商務長）。Niklason 博士將總結公司本季和最近幾週的進展情況，Dale 將回顧該公司截至 2025 年 6 月 30 日的季度財務業績。在發表事先準備好的演講後，BJ 將與 Laura 和 Dale 一起參加問答環節。

I'll now turn the call over to Dr. Laura Niklason. Go ahead, Laura.

現在我將把電話交給勞拉·尼克拉森博士。請繼續，勞拉。

Thank you, Tom, and good morning, everyone, and thank you for joining us for our second quarter 2025 financial results And business update call. Following the landmark success of obtaining FDA approval of Symvess for the treatment of extremity vascular trauma last year, we continue to execute on the commercial launch of this groundbreaking product.

謝謝湯姆，大家早安，謝謝各位參加我們2025年第二季財務業績及業務更新電話會議。繼去年 Symvess 獲得 FDA 批准用於治療四肢血管創傷這一里程碑式的成功之後，我們將繼續推進這款突破性產品的商業化上市。

Progress during our second quarter and recent weeks was marked by continued expansion of our value analysis committee or VAC approvals. This has led to a major expansion of the number of approvals that are now able to purchase Symvess. Recently, we also announced that the US Defense Logistics Agency granted electronic catalog or ECAT listing approval to Symvess.

第二季及最近幾週，我們的價值分析委員會（VAC）的批准數量持續增加，這標誌著我們取得了進展。這導致現在能夠購買 Symvess 的批准數量大幅增加。最近，我們也宣布美國國防後勤局授予 Symvess 電子目錄或 ECAT 清單認證。

Going along with this, we have recorded our first sale to a US military facility. We did encounter some headwinds during April and May due to unsubstantiated public attacks by certain detractors. However, we've seen an acceleration in VAC approval activity and commercial sales in June and July, coupled with the continued advancement of our acellular tissue engineered vessel or ATEV, in our pipeline programs.

同時，我們實現了向美國軍方機構的第一筆銷售。在四月和五月期間，由於某些批評者毫無根據的公開攻擊，我們確實遇到了一些阻力。然而，我們看到 6 月和 7 月 VAC 審批活動和商業銷售加速成長，同時，我們的無細胞組織工程血管 (ATEV) 在我們的研發管線專案中也持續取得進展。

We believe that we're positioned for growth and value generation in 2025 and beyond. 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. BJ Scheessele, our Chief Commercial Officer, will then join us to help answer your questions.

我們相信，我們已做好準備，在 2025 年及以後實現成長和價值創造。在今天的電話會議上，我將更詳細地回顧這些進展。在將電話轉給戴爾，讓他回顧我們的財務表現之前。我們的首席商務長 BJ Scheessele 隨後將加入我們，協助解答您的問題。

Beginning with our commercial launch of Symvess, we're pleased by the traction that we've continued to gain in our interactions with civilian hospitals. To date, a total of 13 organizations have completed the VAC process and have approved the purchase of Symvess because some of these VAC approvals include multi-hospital networks, a total of 82 civilian hospitals are now eligible to purchase Symvess. This is an enormous increase from the five civilian hospitals that were eligible to purchase Symvess at our last quarterly earnings call.

自 Symvess 正式上市以來，我們很高興在與民用醫院的互動中不斷取得進展。迄今為止，共有 13 個組織完成了 VAC 流程並批准購買 Symvess，因為其中一些 VAC 批准包括多醫院網絡，現在共有 82 家民用醫院有資格購買 Symvess。與上一次季度財報電話會議上有資格購買 Symvess 的五家民用醫院相比，這是一個巨大的增長。

Furthermore, an additional 40 VAC sites are currently conducting reviews of Symvess, and we expect that the number of hospitals eligible to purchase Symvess will continue to grow. After VAC approval, contracting and negotiations with each individual hospital are completed before sales and shipments to that hospital can commence. Currently, our sales team is actively targeting high-volume sensors, having VAC approval for contracting negotiations.

此外，目前還有 40 個 VAC 站點正在對 Symvess 進行審查，我們預計符合購買 Symvess 條件的醫院數量將繼續增長。在獲得VAC批准後，與每家醫院完成合約簽訂和談判，然後才能開始向該醫院銷售和發貨。目前，我們的銷售團隊正積極瞄準大批量感測器市場，並已獲得VAC認證，可以進行合約談判。

July product sales of approximately $0.3 million exceeded the total sales that we recorded for the first half of the year. Also in July, we announced that Symvess was awarded the electronic catalog or ECAT listing approval from the US Defense Logistics Agency. ECAT is an Internet system that provides the Department of Defense and other federal agencies with access to manufacturers and -- I'm sorry, distributors products.

7 月份產品銷售額約為 30 萬美元，超過了我們上半年的總銷售額。同樣在 7 月，我們宣布 Symvess 獲得了美國國防後勤局頒發的電子目錄或 ECAT 清單認證。ECAT 是一個互聯網系統，它為國防部和其他聯邦機構提供訪問製造商和——抱歉，分銷商產品的途徑。

The ECAT approval makes Symvess available to health care professionals treating military service members, veterans, and other patients receiving care at approximately 35 military treatment facilities and approximately 160 US Department of Veterans Affairs hospitals. With ECAT approval in place, it's not generally necessary to also obtain VAC approval at the military treatment facilities or VA sites. Instead, purchases facilitated directly through the ECAT system.

ECAT 的批准使得 Symvess 可供在約 35 個軍事醫療機構和約 160 家美國退伍軍人事務部醫院接受治療的軍人、退伍軍人和其他患者的醫療保健專業人員使用。有了 ECAT 批准，通常就不需要在軍事治療機構或 VA 機構再獲得 VAC 批准了。相反，購買行為直接透過 ECAT 系統完成。

Since obtaining ECAT approval just a few weeks ago, we've already recorded our first commercial sale to a US military facility. This facility is a state-of-the-art medical complex located on a major US military base and provides health care to approximately 200,000 active duty service personnel, retirees, and their family members.

自從幾週前獲得 ECAT 批准以來，我們已經完成了對美國軍方設施的第一筆商業銷售。該設施是位於美國主要軍事基地內的先進醫療綜合體，為約 20 萬名現役軍人、退休人員及其家屬提供醫療保健服務。

Subsequent to the initial shipment, this facility has also reordered Symvess. We have great interest in improving the medical options that are available to health care professionals who are treating military personnel and their families. And we're actively advancing our discussions with additional military treatment facilities. In August, we were notified that the centers for Medicare and Medicaid Services, or CMS, declined to approve our application for the new technology add-on payment, or NTAP, for Symvess.

繼首批貨物交付後，該工廠又重新訂購了Symvess產品。我們非常關注如何改善為軍人及其家屬提供醫療服務的醫護人員所能獲得的醫療選擇。我們正積極推動與更多軍事醫療機構的諮詢。8 月，我們接到通知，醫療保險和醫療補助服務中心（CMS）拒絕批准我們為 Symvess 申請的新技術附加支付（NTAP）。

Our application was submitted in October of 2024. And along with the majority of applications that were submitted to CMS this cycle, our application was also denied. The reason provided by CMS was that Symvess does not have a unique mechanism of action as compared to veins or synthetic graphs and therefore, did not qualify for their newness criterion. This conclusion was extremely surprising to us.

我們的申請於2024年10月提交。與本週期提交給 CMS 的大多數申請一樣，我們的申請也被拒絕了。CMS給出的理由是，與靜脈或合成圖相比，Symvess沒有獨特的作用機制，因此不符合他們的新穎性標準。這個結論令我們非常驚訝。

We believe that the potential impact of the NTAP on our commercial success is fairly limited because only about 4.3% of vascular trauma patients who are falling within our approved indication are covered under Medicare reimbursement. Because private pay insurers are the most common source of reimbursement for vascular trauma patients that are falling within our indication. We're engaging in discussions with private payers about supplemental reimbursement for Symvess in the trauma indication.

我們認為，NTAP 對我們商業成功的潛在影響相當有限，因為只有約 4.3% 的符合我們批准適應症的血管創傷患者可以獲得醫療保險報銷。因為對於符合我們適應症的血管創傷患者來說，自費保險公司是最常見的報銷來源。我們正在與私人支付方討論 Symvess 在創傷適應症方面的補充報銷事宜。

We believe that the results of our budget impact model, or BIM, which we published several months ago, along with our published clinical trial results, will encourage supplemental reimbursement from private payers.

我們相信，我們幾個月前發布的預算影響模型（BIM）的結果，以及我們發布的臨床試驗結果，將鼓勵私人支付方提供補充報銷。

I'll now turn to the ATEV program, which is our next priority, which is the dialysis access for patients with end-stage kidney failure. We're pleased to see that results from our V007 Phase III trial were presented in a plenary session at the Society of Vascular Surgery Annual Meeting in June.

接下來，我將介紹 ATEV 項目，這是我們的下一個重點，即為末期腎衰竭患者提供透析通路。我們很高興地看到，我們的 V007 III 期試驗結果在 6 月舉行的血管外科協會年會全體會議上進行了展示。

The V007 results presentation that was focused on patients at high-risk fistula non-maturation was one of only three selected for special mention by the society in their own announcement. The V007 clinical trial enrolled a total of 242 patients, of which 110 were considered to be at high risk of fistula non-maturation.

V007 研究結果報告聚焦於高風險瘻管未成熟患者，是該學會在其公告中特別提及的三個報告之一。V007 臨床試驗共招募了 242 名患者，其中 110 名患者被認為有較高的瘻管不成熟風險。

Among this high-risk cohort functional patency at 6 months and secondary patency at 12 months were significantly higher in ATEV recipients as compared with fistula. Duration of access usability over the first year was also significantly higher in the ATEV group at 8 months versus only 4.5 months for arteriovenous fistula with a p-value of 0.0002.

在這群高風險族群中，與瘻管相比，ATEV 接受者在 6 個月時的功能性通暢率和在 12 個月時的繼發性通暢率明顯更高。在第一年，ATEV 組的血管通路可用性持續時間也明顯高於動靜脈瘻管組，分別為 8 個月和 4.5 個月，p 值為 0.0002。

Results of the V007 trial have also been accepted for presentation at the Annual Kidney Week meeting for 2025 later this year. Women and men having diabetes and obesity, make up more than half of the dialysis access market. Patients with a high-risk official non maturation have historically been underserved by the current standard of care since waiting for fistula maturation can result in prolonged catheter exposure, increased risk of infection, and additional procedures performed to assist in the maturation of the nonfunctioning fistula.

V007 試驗的結果也已被接受，將於今年稍後在 2025 年腎臟週年紀念會上進行展示。患有糖尿病和肥胖症的女性和男性佔透析通路市場的一半以上。對於高風險的官方未成熟患者而言，由於等待瘻管成熟可能導致導管暴露時間延長、感染風險增加以及為幫助無功能瘻管成熟而進行的額外手術，因此，目前的護理標準一直未能充分滿足這些患者的需求。

Because of these risks, patients with fistula non maturation have a high unmet medical need. We believe that the efficacy and safety results of the V007 subgroup, combined with the approximately 50% fish failure rate in this high-risk group, means that this is an excellent population for us to target in the market. We look forward to publication of the results from the V007 Phase III trial in a major peer-reviewed medical journal later this year.

由於這些風險，瘻管未成熟的患者存在很大的未滿足醫療需求。我們認為，V007 亞組的療效和安全性結果，加上該高風險組約 50% 的魚失敗率，意味著這是一個非常適合我們在市場上瞄準的目標人群。我們期待今年稍晚在一家主要的同行評審醫學期刊上發表 V007 III 期試驗的結果。

After discussions with the FDA about a supplemental BLA filing in dialysis access, we're planning to target the general subgroup of patients at high-risk fistula non-maturation. Before we file a supplemental BLA, which we anticipate later in 2026, our plan is to complete the interim analysis of the currently ongoing V012 Phase III trial that's being conducted only in women and which compares the ATEV to fistula for hemodialysis access.

在與 FDA 討論關於透析通路補充 BLA 申請後，我們計劃將目標鎖定在高風險瘻管未成熟的患者群體。在我們提交補充生物製品許可申請（預計在 2026 年稍後提交）之前，我們的計劃是完成目前正在進行的 V012 III 期試驗的中期分析。該試驗僅在女性進行，旨在比較 ATEV 與動靜脈瘺在血液透析通路的效果。

To date, a total of 100 patients have been enrolled in the V012 Phase III trial out of a target of approximately 150 patients. An interim analysis is planned when the first 80 patients reach one year of follow-up, and this enrollment threshold was achieved in April of 2025.

截至目前，V012 III 期試驗已招募了 100 名患者，目標招募人數約 150 名患者。計劃在首批 80 名患者完成一年追蹤後進行中期分析，而這項入組門檻已於 2025 年 4 月達到。

Subject to these interim results, Humacyte plan is to submit a supplemental BLA in the second half of 2026, including data from V012 and the V007 Phase III pivotal studies to expand the Symvess label and add AV access for hemodialysis as an indication.

根據這些中期結果，Humacyte 計劃在 2026 年下半年提交補充生物製品許可申請 (BLA)，其中包括 V012 和 V007 III 期關鍵性研究的數據，以擴大 Symvess 的適應症，並將血液透析的動靜脈通路作為一項適應症。

We're pleased with the progress that we're making in 2025, and we look forward to sharing our progress with all of you as the rest of the year unfolds. With that, I'll now turn it over to Dale for a review of our financial results and other business developments.

我們對 2025 年的進展感到滿意，並期待在今年餘下的時間裡與大家分享我們的進展。接下來，我將把發言權交給戴爾，讓他來回顧我們的財務表現和其他業務發展。

Thank you, Laura. We reported $0.3 million in revenue for the second quarter of 2025, of which $0.1 million related to US sales of Symvess. The remaining $0.2 million resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications.

謝謝你，勞拉。我們報告稱，2025 年第二季收入為 30 萬美元，其中 10 萬美元與 Symvess 在美國的銷售額有關。剩餘的 0.20 萬美元來自與一家大型醫療技術公司進行的研究合作，旨在評估我們生物工程人體組織在特定心血管應用中的潛在用途。

Revenue for the six months ended June 30, 2025, was $0.8 million, of which $0.2 million related to US sales of Symvess, and $0.6 million resulted from the research collaboration. There was no revenue for either in the second quarter over the six months ended June 30, 2024.

截至 2025 年 6 月 30 日的六個月期間，收入為 80 萬美元，其中 20 萬美元與 Symvess 在美國的銷售有關，60 萬美元來自研究合作。截至 2024 年 6 月 30 日的六個月第二季度，這兩項業務均無收入。

Cost of goods sold was $0.2 million for the second quarter of 2025 and $0.4 million for the six months ended June 30, 2025, and included overhead related to unused production capacity, which was recorded as an expense in the period. There was no cost of goods sold for either the second quarter of 2024 for the six months ended June 30, 2024.

2025 年第二季的銷售成本為 20 萬美元，截至 2025 年 6 月 30 日的六個月的銷售成本為 40 萬美元，其中包括與未使用的產能相關的間接費用，該費用已在當期計入支出。2024 年第二季及截至 2024 年 6 月 30 日的六個月期間均無銷售成本。

As previously discussed, during the second quarter of 2025, we implemented a plan to reduce our workforce by 30 employees, defer additional planned new hires, and reduce other operating expenses. These cost reductions were made to extend our cash runway and to better align our organizational structure with our top business objectives.

正如之前討論過的，在 2025 年第二季度，我們實施了一項計劃，裁員 30 人，推遲了計劃中的新員工招聘，並減少了其他營運費用。這些成本削減措施旨在延長我們的現金流，並使我們的組織結構更能與我們最重要的業務目標保持一致。

These reductions remain thoughtfully and we retain key personnel, resources, and initiatives to meet our key corporate goals and milestones. These key objectives include the commercial launch of Symvess, including sales, marketing and manufacturing, completion of the V012 Phase III pivotal study (inaudible) dialysis and the planned filing of a supplemental BLA with the FDA in the dialysis indication, and also the filing of an IND to commence human study of the small diameter ATEV in CABG.

這些裁員措施經過深思熟慮，我們將保留關鍵人員、資源和舉措，以實現我們的關鍵企業目標和里程碑。這些關鍵目標包括 Symvess 的商業化上市，包括銷售、行銷和生產，完成 V012 III 期關鍵性研究（聽不清楚）透析，並計劃向 F​​DA 提交透析適應症的補充 BLA，以及提交 IND 以開始對小直徑 ATEV 在 CABG 中進行人體研究。

We estimate that we have incurred and will incur aggregate charges representing one-time cash expenditures for severance and other employee termination benefits of approximately $0.7 million, the majority of which was incurred during the second quarter of 2025. We estimate net savings due to workforce reductions, operating cost reductions, and reduced capital expenditures, net of this termination severance and benefits totaling approximately $3.8 million in 2025.

我們估計，我們已經並將繼續產生總計約 70 萬美元的一次性現金支出，用於支付遣散費和其他員工離職福利，其中大部分支出發生在 2025 年第二季。我們估計，由於裁員、營運成本降低和資本支出減少，扣除終止遣散費和福利後，到 2025 年淨節省額約為 380 萬美元。

Net savings are estimated to be up to approximately $38 million in 2026 for a total estimated savings of over $50 million in 2025 and 2026 relative to the original budget forecast. Due to the timing of the cost reduction plan, any anticipated savings are expected to occur after June 30, 2025.

預計到 2026 年淨節省額將達到約 3,800 萬美元，與原預算預測相比，2025 年和 2026 年的總節省額預計超過 5,000 萬美元。由於成本削減計劃的時間安排，任何預期節省都將在 2025 年 6 月 30 日之後實現。

Research and development expenses were $22.0 million for the second quarter of compared to $23.8 million for the second quarter of 2024 and were $37.4 million for the six months ended June 30, 2025. A compared to $45.0 million for the six months ended June 30, 2024. The decrease in R&D expenses for the second quarter of 2025 compared to 2024, primarily related to capitalization of overhead costs associated with the commercial manufacturing of Symvess, offset by higher noncommercial production rents.

2024 年第二季的研發費用為 2,200 萬美元，而 2024 年第二季為 2,380 萬美元；截至 2025 年 6 月 30 日的六個月的研發費用為 3,740 萬美元。相比之下，截至 2024 年 6 月 30 日的六個月期間，該數字為 4,500 萬美元。2025 年第二季研發費用較 2024 年下降，主要原因是與 Symvess 商業化生產相關的間接成本資本化，但被更高的非商業化生產租金所抵銷。

The decrease in R&D expenses for the six months ended June 30, 2025, compared to 2024, resulted primarily from decreased material costs as the company began capitalizing expenditures for inventory following the commercial launch of Symvess, as well as the capitalization of overhead costs associated with this commercial manufacturing.

截至 2025 年 6 月 30 日的六個月研發費用較 2024 年同期有所下降，這主要是由於公司在 Symvess 商業化推出後開始將庫存支出資本化，導致材料成本下降，以及與該商業化生產相關的間接費用資本化。

Selling, general and administrative expenses were $7.8 million for the second quarter of 2025 compared to $5.7 million for the second quarter of 2024 and were $15.9 million for the six months ended June 30, 2025, compared to $11.1 million for six months ended June 30, 2024. The increase in 2025 expenses compared to the prior year resulted primarily from the US commercial launch of Symvess in the vascular coma indication, including increased personnel expenses.

2025 年第二季的銷售、一般及行政費用為 780 萬美元，而 2024 年第二季為 570 萬美元；截至 2025 年 6 月 30 日的六個月期間，銷售、一般及行政費用為 1590 萬美元，而截至 2024 年 6 月 3010 萬美元的六個月期間為 3010 萬美元。2025 年支出較前一年增加的主因是 Symvess 在美國上市用於治療血管昏迷，其中包括人員支出增加。

Other net income or expense for the second quarter of 2025 was a net expense of $7.9 million compared to a net expense of $27.2 million for the second quarter of 2024. And other net income of $54.4 million for the six months ended June 30, 2025 compared to other net expense of $32.5 million for the six months of -- ended June 30, 2024. The decrease in other net expense for the second quarter of 2025 and the increase in other net income for the six months ended June 30, 2025, compared to prior year results resulted primarily from the noncash remeasurement of the contingent earn-out liability associated with our August 2021 merger without the health care acquisition core.

2025 年第二季其他淨收入或支出為淨支出 790 萬美元，而 2024 年第二季淨支出為 2,720 萬美元。截至 2025 年 6 月 30 日的六個月，其他淨收入為 5,440 萬美元，而截至 2024 年 6 月 30 日的六個月，其他淨支出為 3,250 萬美元。與去年同期相比，2025 年第二季其他淨支出減少，截至 2025 年 6 月 30 日的六個月其他淨收入增加，主要是由於對我們 2021 年 8 月合併（不包括醫療保健收購核心）相關的或有盈利能力負債進行了非現金重新計量。

Net loss was $37.7 million for the second quarter of 2025 compared to a net loss of $56.7 million for the second quarter of 2024. And net income was $1.5 million for the six months ended June 30, 202,5 compared to a net loss of $88.6 million for the six months ended June 30, 2024. The decrease in net loss for the second quarter of 2025 and the increase in net income for the six months ended June 30, 2025 compared to prior year periods, was primarily due to the noncash remeasurement of the contingent earn-out liability described above.

2025 年第二季淨虧損為 3,770 萬美元，而 2024 年第二季淨虧損為 5,670 萬美元。截至 2025 年 6 月 30 日的六個月，淨收入為 150 萬美元，而截至 2024 年 6 月 30 日的六個月，淨虧損為 8,860 萬美元。2025 年第二季淨虧損減少，截至 2025 年 6 月 30 日的六個月淨收入較上年同期有所增加，這主要是由於上文所述的或有或有負債的非現金重新計量所致。

We had cash, cash equivalents and restricted cash of $88.4 million as of June 30, 2025. Total cash used was $6.9 million for the six months of 2025 compared to net cash provided of $13.1 million for the first six months of 2024. The net cash used for the first six months of 2025 included $46.7 million in net proceeds from a public offering completed in March 2025.

截至 2025 年 6 月 30 日，我們擁有現金、現金等價物及受限現金 8,840 萬美元。2025 年上半年現金使用總額為 690 萬美元，而 2024 年上半年現金淨流入為 1,310 萬美元。2025 年上半年使用的淨現金包括 2025 年 3 月完成的公開發行所得淨收益 4,670 萬美元。

The total cash provided for the first six months of 2024 included $43.0 million in net proceeds from a public offering completed in March 2024 and the receipt of $20 million in proceeds from the draw under a loan arrangement that did not occur -- reoccur in 2025.

2024 年上半年提供的現金總額包括 2024 年 3 月完成的公開發行所得淨收益 4,300 萬美元，以及根據一項未在 2025 年再次發生的貸款安排提取的 2,000 萬美元收益。

With that, I will turn it over to Laura for some closing remarks.

接下來，我將把發言權交給勞拉，請她作總結發言。

Thank you, Dale. The approval and launch of Symvess is a powerful example of our commitment to delivering truly transformative regenerative medicine solutions to improve patient outcomes. With our strong commercial execution, our promising pipeline and our dedicated team, we're confident in our ability to continue making a positive impact. Thank you for joining our call today. And operator, we're now ready to take questions.

謝謝你，戴爾。Symvess 的核准和上市有力地證明了我們致力於提供真正具有變革意義的再生醫學解決方案，以改善患者的治療效果。憑藉我們強大的商業執行力、前景廣闊的產品線和敬業的團隊，我們有信心繼續產生積極的影響。感謝您今天參加我們的電話會議。操作員，我們現在可以開始回答問題了。

(Operator Instructions) Ryan Zimmerman, BTIG.

（操作說明）Ryan Zimmerman，BTIG。

Good morning. Thanks for taking my question, Laura, and Dale. Appreciate it. Maybe just to start on some of the dynamics commercially, Laura. If you think about second-quarter volume versus what's taken place in July and you noted that uptick, has anything changed in your view that you think you can identify in July that now becomes kind of more part of your commercial strategy in terms of launching Symvess?

早安.謝謝勞拉和戴爾回答我的問題。謝謝。勞拉，或許我們可以先從商業動態方面著手。如果你回顧第二季度的銷量與7月份的銷量對比，並注意到銷量有所增長，那麼你認為7月份的銷量增長是否對你推出Symvess的商業策略產生了影響？

Thank you financial for that, Ryan. A lot of it is just passage of time. We really embarked on the VAC process in late February, early March, and many of these committees just take months and months. So part of it was that.

瑞恩，謝謝你的財務支持。很多時候只是時間流逝的結果。我們在二月底、三月初正式啟動了 VAC 流程，而這些委員會的工作往往需要幾個月的時間。所以，部分原因在於此。

Part of the uptick in hospitals eligible to purchase invest was the fact that we did have several hospital systems approve the product in their VAC process. But I would also say we're looking at -- we've looked at decreasing the price of Symvess from $29,500 to $24,250. This decrease in price still allows us to have good margins on the product. But by coming in below $25,000, this has increased the ease with which VAC committees can review our product and agree to bring it on to the shelf.

符合購買投資條件的醫院數量增加的部分原因是，我們確實有幾家醫院系統在其 VAC 流程中批准了該產品。但我還要說，我們正在考慮——我們已經考慮過將 Symvess 的價格從 29,500 美元降至 24,250 美元。價格下降後，我們仍然可以獲得良好的產品利潤。但由於價格低於 25,000 美元，這使得 VAC 委員會更容易審查我們的產品並同意將其上架銷售。

Yeah. You -- actually, that was my next question around pricing strategy, just looking at kind of the unit volumes versus the revenue. And is that now something that you're making standard across all facilities? I guess, how do we think about kind of your pricing strategy over time? And if this is kind of the new price point that we should think about going forward?

是的。實際上，我接下來要問的就是定價策略方面的問題，就是看看銷售量與收入之間的關係。現在這是你們所有工廠的標準做法嗎？我想問的是，我們該如何看待你們的長期定價策略？如果這就是我們今後應該考慮的新價格點呢？

I think, this is the new price point that we should think about. This was a price point that we put into place on July 1. So that certainly -- that had some overlap with the uptick in sales. I don't think that was the entire thing, though. But because we clearly had centers that were buying before the decrease in price. But the decrease in price will now be standard for the next year. And then just as with any other medical products, we will consider annual price increases on a yearly basis.

我認為，這是我們應該考慮的新價格點。這是我們於7月1日實施的價格策略。所以，這確實與銷售額的成長有一定的重疊之處。但我認為這並非事情的全部真相。但因為我們清楚看到，有些中心在價格下降之前就開始採購了。但明年價格下降將成為常態。然後，就像其他任何醫療產品一樣，我們將每年考慮價格上漲事宜。

Alright. Thanks for taking my questions. I'll head back in queue.

好吧。謝謝您回答我的問題。我這就回去排隊。

Josh Jennings, TD Cowen.

喬什·詹寧斯，TD Cowen。

Hi, good morning, Laura and Dale. Thanks for good questions. I wanted to just ask -- I know you talked about some of the headwinds in -- early in the year from substantiated tax by the (inaudible). And I was just wanted to review just the accrual of real-world evidence and any registry data that would build over the coming quarters, years that would significantly very any detractor noise?

嗨，勞拉和戴爾，早安。謝謝大家提出的好問題。我想問一下—我知道您年初談到了一些不利因素，例如經證實的稅務問題。（聽不清楚）我只是想回顧一下未來幾季、幾年內累積的真實世界證據和任何註冊數據，這些數據將大大消除任何反對者的噪音？

Well, I think -- so as we've mentioned to the market, we do have some post approval commitments with the FDA to essentially create a registry of trauma patients and follow at least 100 patients for a year. We're still working on that protocol with the FDA. So that registry hasn't officially kicked off yet, but we're still -- we are on time. We're meeting our time lines and our milestones for that.

嗯，我認為——正如我們向市場所提到的，我們與 FDA 有一些獲批後的承諾，即建立一個創傷患者登記冊，並對至少 100 名患者進行一年的隨訪。我們仍在與美國食品藥物管理局 (FDA) 合作制定此方案。雖然登記工作尚未正式啟動，但我們仍然——我們按時完成。我們正按時完成各項任務和里程碑。

But I actually think that the real-world evidence is going to continue to accrue in different hospitals that are using the product. Multiple hospitals have reordered the product. And there are people who are using it with a tremendous amount of success. So I think that, that word of mouth, but also publications from real-world use of the product will definitely help to solidify our commercial position.

但我認為，在使用該產品的不同醫院中，實際應用的證據將會持續累積。多家醫院已再次訂購該產品。而且有些人使用它取得了巨大的成功。所以我認為，口碑傳播以及來自產品實際使用情況的出版物，肯定有助於鞏固我們的商業地位。

Quick Josh, it's BJ here. I was just going to jump in and add to what Laura was saying. Obviously, we had published our budget impact model, but we continue to publish our trauma data both civilian and military, be it the US and work in Ukraine.

快點，喬希，我是BJ。我本來想插話，補充一下勞拉剛才說的話。顯然，我們已經公佈了預算影響模型，但我們將繼續公佈平民和軍人的創傷數據，無論是在美國還是在烏克蘭的工作。

First, it was 30-year data, have upcoming one-year data to continue to show the durability of our product. I think that's important. And just to round out around the public attacks, how that has played out and was somewhat to Ryan's point, too, is that it's just really slowed the approval process.

首先，這是 30 年的數據，接下來還有一年的數據，將繼續證明我們產品的耐用性。我認為這很重要。最後總結一下公眾的攻擊，正如瑞安所說，這確實減緩了審批過程。

The majority of the effect is it's just now taking longer to get through hospitals, but have been able to overcome that. And I think that's also -- the tough economy has made it tougher for any new products. You talked to other companies that have launched new products recently. And it's just, in general, a longer process. But given our full funnel and working through this process and the success that we had ended June and beginning of July, feel that we're turning the corner.

目前最大的影響是就醫時間延長了，但我們已經克服了這個問題。我認為這也是因為──嚴峻的經濟情勢使得任何新產品的推廣都更加艱難。你和其他一些近期推出新產品的公司進行了交流。而且總的來說，這是一個更長的過程。但鑑於我們目前的銷售管道暢通，並且我們一直在努力推進這一流程，以及我們在六月底和七月初取得的成功，我們感覺我們正在迎來轉機。

Thanks for that. And wanted to touch on the inclusion on the electronic catalog and open up access to the 190 military treatment facilities. Any help just see you through the commercial effort in this VA hospital channel to drive increased traction? I know you've had your first order, but wanted to kind of get help thinking about back half of the year in this channel and into 2026 and how you guys can go on offense more fully here?

謝謝。還想談談將 190 家軍事醫療機構納入電子目錄並開放存取權限的問題。有什麼辦法能幫助我順利完成在退伍軍人醫院通路的商業推廣工作，以提高市場佔有率嗎？我知道你們已經接到了第一單，但我想請教一下大家，關於今年上半年以及2026年的發展，你們該如何更全面地展開攻勢？

Yeah. Kind of how I look at it is both the individual hospital work and then obviously, collection of hospitals or some type of larger purchase. And here in the near term with the ECAT again, opens up the military treatment facilities. I'd say a good number of them are targets of ours. And then a much larger number of VAs, but it will be more selective targets within the VAs where they obviously perform trauma procedures, so a minority of them -- we've had the initial order, reorder. We've been able to meet with some of the other major facilities, some that were involved in our clinical work. Others that we've had peer-to-peer discussion, those that have used it in the military introducing us to other hospitals and surgeons.

是的。我的看法是，這既包括單一醫院的工作，也包括多家醫院的合併或某種規模更大的收購。而就目前來看，隨著 ECAT 的再次啟動，軍事治療設施也將重新開放。我認為其中相當一部分人都是我們的目標。然後還有數量更多的退伍軍人事務部 (VA)，但目標會更加有選擇性，尤其是在那些顯然會進行創傷手術的退伍軍人事務部，所以只有少數——我們已經有了最初的命令，重新命令。我們已經有機會與其他一些主要機構會面，其中一些機構曾參與我們的臨床工作。還有一些人，我們與他們進行了同行交流，他們在軍隊中使用它，並向我們介紹了其他醫院和外科醫生。

And so I think through the rest of this year, we'll be penetrating those hospitals, those hospitals of targets of ours. But then in parallel, there is obviously, the procurement process for some type of bulk purchase stockpiling that we are working in parallel. And I believe as we have more successful military experience, it's -- that in concert with work in the procurement process as we end the year and roll into next year that the larger purchase becomes more viable for us.

因此，我認為在今年剩餘的時間裡，我們將逐步滲透到我們目標醫院的網路中。但同時，顯然我們也正在並行推進某種類型的批量採購儲備的採購流程。我相信，隨著我們擁有更多成功的軍事經驗，再加上我們在年底和明年年初的採購流程方面的努力，更大的採購對我們來說將變得更加可行。

Thank you for that as well. And then just lastly, on the AV access syndication, you secured the 80 patients enrolled for that impact in April and have 100 today. It sounds -- is it okay to kind of forecast enrollment completion for the trial for the 150 patients by year-end 2025? And maybe just kind of review the time lines for interim analysis once you get the last patient -- 12-month follow-up in April 2026 and how that could play out next year? Thanks for taking on the questions.

也謝謝你。最後，關於 AV 接取聯合推廣，你們確保了 4 月報名參加該計畫的 80 名患者，現在又增加了 100 名。聽起來——可以大致預測到 2025 年底完成 150 名患者的試驗招募嗎？或許可以在完成最後一例患者的治療後，重新審視中期分析的時間表——例如，在 2026 年 4 月進行 12 個月的隨訪，以及明年可能會出現什麼情況？感謝您回答這些問題。

Yeah, Josh. So we're going to aim to complete 150 patients by the end of the year. So it's always hard to know -- it's very hard to predict trial enrollment. So it could be before the end of the year, it could be a little after the end of the year, hard to know.

是的，喬許。因此，我們的目標是在年底前完成 150 名患者的治療。所以總是很難知道——很難預測試驗的入組情況。所以可能在年底前，也可能在年底之後，很難說。

But regardless, the interim analysis is now fixed, as you mentioned, in April of 2026. So I would imagine we will have top line results from that. It's certainly by May or June for that interim analysis. And then we would be able to share those results with the market. As far as the way the trial is designed, the way it was originally written is that if we are successful on the interim analysis. And if our vessel is superior to fistula with those 80 patients, then we're done.

但無論如何，正如您所提到的，中期分析的時間已經確定為 2026 年 4 月。所以我認為我們會從中獲得一些初步結果。中期分析報告肯定會在五月或六月發布。然後我們就可以與市場分享這些結果。就試驗的設計方式而言，最初的設計是，如果我們在中期分析中取得成功。如果我們的血管對這 80 位病人來說都優於瘻管，那麼我們就大功告成了。

The trial is successful and we move on. In that situation, we would then, as we've said, anticipate filing a supplemental BLA in the second half of 2026. If we don't hit that interim analysis, then we just continue following the 150 patients and we would feel pretty confident that we're going to hit the analysis at 150. And since all of those patients would already have been enrolled, the additional time lag there would be, I don't know, six or eight months, something like that.

試驗成功，我們繼續下一步。在這種情況下，正如我們所說，我們預計將在 2026 年下半年提交補充生物製品許可申請 (BLA)。如果我們沒有達到中期分析的目標，那麼我們將繼續追蹤這 150 名患者，並且我們很有信心能夠達到 150 名患者的分析目標。由於所有這些患者都已經入組，因此額外的延遲時間大概是六個月或八個月左右。

RK, HC Wainwright.

RK，HC Wainwright。

Laura and Dale, a couple of quick questions from me. The first question is, looking back at the first quarter press release, you guys setting if hospitals had initiated the VAC process. So how many of those have actually ordered at this point? And also, any insight into what the time line is in general for getting through the VAC to the ordering process itself?

蘿拉和戴爾，我有幾個問題想問你們。第一個問題是，回顧第一季的新聞稿，你們當時是否確定醫院已經啟動了VAC流程。那麼目前為止，這些人中有多少已經下單了呢？另外，能否透露一下從VAC審核到最終下單流程的大致時間安排？

Laura, I can jump on --

蘿拉，我可以跳上去--

Yeah, why don't you take that, BJ, you'll be better. Yes.

是啊，BJ，你為什麼不吃點藥呢？你會好起來的。是的。

Feel free to add. So it is a mix of hospitals that we started early and then hospitals that we've approached more recently that a mix of them that have worked through the process to then have the approval to then be able to sell into. But as we stated in the press release, we've had 12 hospitals to date order Symvess, and then a number of them actually already having reordered.

歡迎補充。所以，我們既包括早期就開始合作的醫院，也包括最近才開始接觸的醫院，這些醫院都經過了相關流程，獲得了批准，然後才能向我們出售產品。但正如我們在新聞稿中所述，迄今為止已有 12 家醫院訂購了 Symvess，其中一些醫院實際上已經再次訂購。

So our success rate with back is strong. As I mentioned before, in Q2, some of the public attacks did slow us down with value-analysis committees, and that's where I was mentioning that kind of from my commercial experience, you could think of three to six months to get through a value-analysis committee and then obviously contracting on the back end. We view that as six to nine-plus months now, one in general because of the economy, but then also some of the attacks on us.

所以我們背部手術的成功率很高。正如我之前提到的，在第二季度，一些公開的攻擊確實拖慢了我們價值分析委員會的進度，我之前也提到過，根據我的商業經驗，完成價值分析委員會的工作可能需要三到六個月，然後顯然還要在後期簽訂合約。我們認為這種情況會持續六到九個月甚至更久，一方面是因為經濟形勢，另一方面也是因為我們遭受了一些攻擊。

But as I also mentioned, we have a full sales funnel and not all of them take the upper end and not all of them in the lower end. So if you have a full funnel, you always have something coming through on the back end to -- with approval and then be able to sell into. But that's something that we've accounted for and as I mentioned, believe that we're turning the corner on.

但正如我之前提到的，我們有一個完整的銷售漏斗，並非所有客戶都選擇高端產品，也並非所有客戶都選擇低階產品。所以，如果你有一個完整的銷售漏斗，你總是會在後端收到一些資訊——經過批准後，你就可以進行銷售了。但我們已經考慮到了這一點，而且正如我所說，我們相信我們正在扭轉局面。

Thank year over yearfor that. The second question is regarding the negative decision by the CMS. So what sort of an impact, if any, would it have on the private payers' reimbursement decisions?

每年都為此感謝。第二個問題是關於 CMS 的否定決定。那麼，這會對私人支付方的報銷決定產生什麼樣的影響呢？

Yeah, Laura can jump in on that one, too, and feel free. As Laura had mentioned, obviously, a disappointment for us. Newness, I think we can kind of all agree that our product knew and one-of-one type. But we were denied, that was disappointing. There are pathways that we think you can refile. That's something that we will look at and consider. But when it rolls to -- and again, private payers are the ones that pay the majority of these vascular trauma repair type of procedures in these patients.

是的，勞拉也可以參與進來，別客氣。正如勞拉所說，這顯然讓我們很失望。新穎性，我想我們都能認同，我們的產品是獨一無二的。但我們的請求被拒絕了，這令人失望。我們認為您可以透過某些途徑重新提交申請。我們會研究並考慮這個問題。但到了後來——而且再次強調，這些患者的血管創傷修復手術的大部分費用都是由私人支付者支付的。

We believe that our product is new, but more importantly, how private payers view in essence, being able to pay for a product and writing procedures behind that is really based on your clinical and health economic data. And so not only of what we've gathered, but published peer reviewed, both on the clinical side and following these patients over time, and our budget impact model that is also published of reducing costly complications like infections and amputations versus products that are used today that private insurers will see this as about a strong value proposition and work with them to get them to incrementally pay for our product.

我們相信我們的產品是全新的，但更重要的是，私人支付方如何看待產品，以及能否為產品付費並制定相應的流程，實際上取決於您的臨床和衛生經濟數據。因此，我們不僅收集了相關信息，還發表了同行評審的研究成果，包括臨床方面和對這些患者的長期跟踪研究，以及我們已發表的預算影響模型，該模型顯示，與目前使用的產品相比，我們的產品可以減少感染和截肢等代價高昂的並發症。私人保險公司會認為這是一個強而有力的價值主張，並會與他們合作，讓他們逐步為我們的產品付費。

Thanks for taking my questions.

謝謝您回答我的問題。

I guess I would add to that, RK, that our success rate with VACs has been pretty good and we've gotten into an enormous number of hospitals just in the last couple of months, up to 84, which is very exciting for us. But when hospitals look at the financial prospects for a product, they're really just looking at the puts and takes on that initial hospitalization because this is a DRG process.

我想補充一點，RK，我們的VAC成功率相當不錯，而且在過去的幾個月裡，我們已經進入了大量的醫院，多達84家，這讓我們非常興奮。但是，當醫院考慮某種產品的財務前景時，他們實際上只是在考慮最初住院治療的收益和回報，因為這是一個DRG流程。

And so hospitals are focused on the cost to take care of that patient just during the hospitalization. Payers, on the other hand, are on the hook for longer-term complications. So particularly with infection and amputation, which drive a lot of costs in the initial hospitalization but which continue to drive cost after discharge because of readmissions, because of physical therapy, because of repeated procedures, insurance companies are on the hook for all of that.

因此，醫院只關注住院期間照顧該病人的成本。另一方面，支付方則要承擔長期併發症的責任。因此，特別是感染和截肢，雖然在最初的住院治療中會產生很多費用，但出院後由於再次入院、物理治療、重複手術等原因，仍然會產生費用，保險公司要承擔所有這些費用。

And so I believe that our financial case for providing a supplemental payment for Symvess and trauma is going to be even stronger with private payers. So we've got our ducks in a row. We're lining up private payers, and we're going to go out and start having those conversations very soon.

因此，我認為，對於私人支付方而言，我們為 Symvess 和創傷提供補充支付的財務理由將會更加充分。我們已經做好萬全準備了。我們正在聯繫私人付費方，很快就會開始與他們進行洽談。

Bruce Jackson, the Benchmark Company.

布魯斯傑克遜，基準公司。

Hi, good morning, and thank you for taking my question. I was wondering if we could get an update on the coronary artery bypass graft program?

您好，早安，感謝您回答我的問題。我想了解冠狀動脈繞道手術計畫的最新進展？

Yes, absolutely. We have a paper that's been accepted for publication about our primate results in coronary artery bypass that we expect to publish in the near future, and we'll put out a press release with that when that happens.

是的，絕對的。我們有一篇關於我們靈長類動物冠狀動脈繞道手術結果的論文已被接受發表，我們預計在不久的將來發表，屆時我們將發布新聞稿。

We're also making excellent headway on our IND filing with the FDA. So we're in the process of pulling that filing together, and we expect to have that in -- later in 2025 as we've messaged the market previously. After we submit the IND, we anticipate that the FDA will spend some time looking at it, we're a first-in-class product. And we're going into the human coronary system. So we expect that there will be some review time. But once they approve that, and I certainly anticipate that they will, then we would start our clinical trial sometime in 2026. So everything is on track with what we've messaged the market previously.

我們在向FDA提交IND申請方面也取得了非常好的進展。所以我們正在整理這份文件，預計在 2025 年稍後提交，正如我們之前向市場傳達的那樣。提交IND申請後，我們預計FDA會花一些時間來審查，因為我們是同類首創產品。接下來我們要進入人體冠狀動脈系統。因此，我們預計會有一些審核時間。但一旦他們批准了，而且我當然預計他們會批准，那麼我們將在 2026 年的某個時候開始臨床試驗。所以一切都在按計劃進行，與我們之前向市場傳達的訊息一致。

Okay. Great. Thank you. That's it for me.

好的。偉大的。謝謝。就這些了。

Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Dr. Niklason for any final comments.

女士們、先生們，我們的問答環節到此結束。我把發言權交還給尼克拉森博士，請他作最後的總結發言。

Thank you, everyone, for joining us this morning. Our fantastic commercial team has continued to execute during this exciting time. I personally am very excited by the fact that so many hospitals and both civilian and military treatment facilities and VAs are now eligible to purchase our product, more than 200 facilities if we compare that to the five facilities that were untapped to purchase our product just three months ago. I think this is huge progress.

謝謝大家今天早上收看我們的節目。我們優秀的商務團隊在這個令人興奮的時期繼續保持著高效率的執行力。我個人非常高興地看到，現在有這麼多醫院、民用和軍用醫療機構以及退伍軍人事務部 (VA) 有資格購買我們的產品，與三個月前只有 5 家機構有資格購買我們的產品相比，現在有 200 多家機構符合條件。我認為這是一個巨大的進步。

So we're going to continue working on the contract negotiations and continue shipping and selling product. It's make products, sell product and that's where our focus is, and I'm so glad that we're getting traction here. So I appreciate your time, and I look forward to sharing more results with you later this year.

因此，我們將繼續進行合約談判，並繼續出貨和銷售產品。我們專注於生產產品、銷售產品，我很高興我們在這方面取得了進展。感謝您抽出時間，我期待今年稍後與您分享更多成果。

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。您可以在此時斷開線路。感謝您的參與。