Humacyte Inc (HUMA) 2025 Q3 法說會逐字稿

Good morning ladies and gentlemen, and welcome to the Humacyte third quarter results conference call.

女士們、先生們，早安，歡迎參加Humacyte第三季業績電話會議。

(Operator Instructions)

（操作說明）

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

現在我將把電話轉給 LifeSci Advisors 的 Tom Johnson。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. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

謝謝接線生。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。有關可能導致實際結果與本次電話會議中所作陳述存在差異的因素的更多信息，請參閱我們向美國證券交易委員會提交的定期報告。

The forward-looking statements made during this call speak only 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 10Q, which after filing may be accessed from the investor page of the Humacyte website.

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。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, and Dale Sander, Chief Financial Officer and Chief corporate and Development Officer.

今天與我一起參加 Humacyte 公司電話會議的有總裁兼執行長 Laura Niklason 博士，以及財務長兼首席企業和發展長 Dale Sander。

Dr Niklason will provide a summary of the company's progress for the third quarter in recent weeks, and Dale will review the company's financial results for the quarter ended September 30, 2025.

尼克拉森博士將總結公司最近幾週第三季的進展情況，戴爾將回顧該公司截至 2025 年 9 月 30 日的季度財務業績。

Now I turn the call over to Dr Niklason.

現在我把電話交給尼克拉森醫生。

Thank you, Tom. Good morning, everyone, and thank you for joining us for our third quarter 2025 financial results and business update call.

謝謝你，湯姆。各位早安，感謝各位參加我們2025年第三季財務業績及業務更新電話會議。

I'm pleased to report that our third quarter was a productive period for Humacyte and continued execution of our commercial launch with Symvess and also with advancement of our other bioengineered vessel programs.

我很高興地報告，第三季度對於 Humacyte 來說是一個富有成效的時期，我們繼續推進 Symvess 的商業化上市，並取得了其他生物工程船舶項目的進展。

During today's call, I'll review progress across our commercial and development programs before turning the call over to Dale for a review of our financial results for the third quarter.

在今天的電話會議上，我將回顧我們商業和開發專案的進展情況，然後將電話會議交給戴爾，由他來回顧我們第三季度的財務表現。

Beginning with our commercial launch of Symvess, we're pleased by the traction we continue to gain in our interactions with surgeons and hospitals.

自 Symvess 正式上市以來，我們很高興看到我們在與外科醫生和醫院的互動中不斷取得進展。

To date, 25 hospitals and or healthcare systems have completed the value analysis Committee or VAC process and have approved the purchase of Symvess. Since these VAC approvals include multi-hospital networks, approvals obtained thus far represent 92 civilian hospitals now eligible to purchase Symvess. An additional 45 VAC committees at hospitals or health systems are currently conducting reviews of Symvess.

迄今為止，已有 25 家醫院和/或醫療保健系統完成了價值分析委員會 (VAC) 流程，並批准了 Symvess 的收購。由於這些 VAC 批准包括多個醫院網絡，迄今為止獲得的批准代表 92 家民用醫院現在有資格購買 Symvess。目前，醫院或醫療系統的另外 45 個 VAC 委員會正在對 Symvess 進行審查。

Along with the progress in VAC reviews and approvals in the third quarter, product sales improved to $703,000 a significant increase over the $100,000 that we reported last quarter.

隨著第三季 VAC 審查和批准的進展，產品銷售額提高到 703,000 美元，比上一季報告的 100,000 美元大幅增長。

Our active engagement with surgeons and clinicians continues to grow, and we're observing an increased number of hospitals placing orders and reordering Symvess.

我們與外科醫生和臨床醫生的積極互動不斷增加，我們觀察到越來越多的醫院訂購和重新訂購Symvess產品。

This active physician engagement is complemented by our steady drumbeat of strong publications that support Symvess and our technology platform.

這種積極的醫生參與，輔以我們持續不斷的高品質出版物，這些出版物支持 Symvess 和我們的技術平台。

As you know, in July we announced that Symvess had been awarded the electronic catalog or ECAT listing approval from the US Defense Logistics Agency, which provides the Department of Defense and other federal agencies with access to manufacturers and distributors' products.

如您所知，我們在 7 月宣布，Symvess 已獲得美國國防後勤局的電子目錄或 ECAT 清單批准，該批准使國防部和其他聯邦機構能夠訪問製造商和分銷商的產品。

ECAT approval makes Symvess available to healthcare professionals treating military service members, veterans, and other patients receiving care at military treatment facilities. And the US Department of Veterans Affairs hospitals.

ECAT 的批准使得 Symvess 可供治療現役軍人、退伍軍人和其他在軍事醫療機構接受治療的患者的醫療保健專業人員使用。還有美國退伍軍人事務部醫院。

Since obtaining ECAT approval, we recorded our first commercial sale to US military facilities.

自從獲得 ECAT 批准以來，我們實現了向美國軍事設施的第一筆商業銷售。

And we have great interest in improving medical options available to healthcare professionals who are treating military personnel and their families, and we look forward to advancing our discussions with additional DOD affiliated hospitals.

我們對改善為軍人及其家屬提供醫療服務的醫護人員的醫療選擇非常感興趣，並期待與更多國防部附屬醫院推進討論。

Our commercial rollout of Symvess was supported by the recent publication of three studies demonstrating the potential of this product in vascular trauma.

最近發表的三項研究證明了該產品在血管創傷治療中的潛力，這為我們Symvess的商業推廣提供了支持。

First, a publication entitled Bioengineered Human Blood Vessels to Treat Hospital Acquired Vascular Complications was published recently in the Journal of Vascular Surgery. This publication describes the outcomes of using Symvess in the treatment of arterial injuries that are sustained in the process of medical care rather than injuries that are sustained in the community.

首先，最近在《血管外科雜誌》上發表了一篇題為《生物工程人類血管治療醫院獲得性血管併發症》的文章。本出版物描述了使用 Symvess 治療在醫療過程中發生的動脈損傷（而不是在社區中發生的損傷）的結果。

Complications of surgery and vascular procedures, including iatrogenic injuries, planned oncologic tumor resections, and what have you, are increasingly common in modern medical care and comprise up to 30% of patients requiring vascular injury repairs.

手術和血管手術的併發症，包括醫源性損傷、計劃性腫瘤切除術等，在現代醫療中越來越常見，佔需要血管損傷修復患者的 30%。

Harvesting of autologous vein to address these consequences and complications produces additional injury for the patient, and suitable vein may not always be accessible.

為解決這些後果和併發症而採集自體靜脈會對患者造成額外的傷害，而且合適的靜脈可能無法總是獲得。

This publication describes the outcomes of patients with hospital-acquired iatrogenic injuries or complications of vascular surgery procedures, which was a subgroup of our V5 pivotal phase 2-3 clinical study that we conducted in the US and Israel.

本出版物描述了醫院獲得性醫源性損傷或血管外科手術併發症患者的治療結果，這是我們在美國和以色列進行的 V5 關鍵性 2-3 期臨床研究的一個亞群。

At the end of an average of follow-up of 23.3 months, 92% of the patients retained secondary patency or had blood flow in the conduit.

在平均追蹤 23.3 個月後，92% 的患者保持了二次通暢或在導管內有血流。

None of the patients suffered an amputation, and there were 0 infections of Symvess.

所有患者均未發生截肢，且無一例發生 Symvess 感染。

Patients experiencing hospital-acquired vascular complications represent an important subset of vascular trauma patients, and it's gratifying to see that the outcomes in this study show that Symvess can provide limb salvage and durable patency.

發生醫院獲得性血管併發症的患者是血管創傷患者中的重要群體，令人欣慰的是，本研究的結果表明，Symvess 可以挽救肢體並保持血管通暢。

Another publication in the Oxford academic journal Military Medicine described positive long-term results from our humanitarian program using Symvess to treat wartime vascular injuries in Ukraine.

牛津學術期刊《軍事醫學》上的另一篇文章描述了我們的人道主義計劃使用 Symvess 治療烏克蘭戰爭中的血管損傷所取得的積極長期成果。

This publication reported on 17 patients suffering combat-related extremity vascular trauma from gunshot wounds, blasts, and shrapnel.

該出版物報告了 17 例因槍傷、爆炸和彈片造成的與戰鬥相關的肢體血管創傷患者。

Up to 18 months, after up to 18 months of follow-up, physicians observed 0 deaths, 0 infections, and 0 amputations in these treated patients in Ukraine.

在長達 18 個月的追蹤後，醫生觀察到烏克蘭接受治療的這些患者中，沒有出現死亡、感染和截肢病例。

Furthermore, Symvess had a high patency of 87.1% and no instances of immunologic rejection.

此外，Symvess 的通暢率高達 87.1%，且未發生免疫排斥反應。

These outcomes demonstrate the long-term durability of Symvess in the treatment of real world combat injuries.

這些結果表明，Symvess 在治療現實世界中的戰鬥傷勢方面具有長期的持久療效。

And finally, the Trauma Surgery and Acute Care Open Journal published results of a new study comparing clinical outcomes of Symvess to those resulting from autologous vein in the treatment of extremity arterial trauma.

最後，《創傷外科和急性護理開放期刊》發表了一項新研究的結果，該研究比較了 Symvess 與自體靜脈在治療肢體動脈創傷的臨床結果。

This analysis leveraged data from two clinical trials, Humacyte phase 2-3 V005 study and the humanitarian V0017 study in Ukraine.

該分析利用了兩項臨床試驗的數據，分別是 Humacyte 的 2-3 期 V005 研究和在烏克蘭進行的人道主義 V0017 研究。

And matched Symvess patients in those trials to patients who had suffered similar injuries and who were previously treated with vain. The matching patients who were previously treated with vain were obtained from the Prospective Observational Vascular injury Treatment, or prove it registry, which is the world's largest vascular trauma database.

並將這些試驗中的 Symvess 患者與遭受類似損傷且先前接受過靜脈注射治療的患者進行配對。先前接受過血管內治療的配對患者來自前瞻性觀察血管損傷治療（Prospective Observational Vascular injury Treatment，簡稱Prove it）註冊庫，該註冊庫是世界上最大的血管創傷資料庫。

The comparison between Symvess and vein outcomes found that patients who were treated with Symvess had statistically similar outcomes to patients from the proven registry who received autologous vein.

Symvess 與靜脈移植的療效比較發現，接受 Symvess 治療的患者與已證實註冊研究的接受自體靜脈移植的患者在統計學上療效相似。

Secondary patency for Symvess versus the autologous vein group was 91% versus 97.7%. The amputation rate was 7.5% versus 8.2%. The conduit infection rate was 1.5% versus 0%, and the death rate was 4.5% for both groups respectively. There were no significant differences that were noted between the two groups for any of these outcomes that were assessed.

Symvess 組與自體靜脈組的二次通暢率分別為 91% 及 97.7%。截肢率分別為 7.5% 和 8.2%。導管感染率分別為 1.5% 和 0%，兩組的死亡率均為 4.5%。在所評估的所有結果中，兩組之間均未發現顯著差異。

The use of autologous vein to repair an injured blood vessel is the current standard of care because it offers excellent long-term patency and low infection rates.

使用自體靜脈修復受損血管是目前的標準治療方法，因為它具有良好的長期通暢率和較低的感染率。

However, in many cases, suitable autologous vein may not be available due to extreme limb damage, prior surgeries, or poor vein quality.

然而，在許多情況下，由於肢體嚴重受損、先前手術或靜脈品質差，可能無法獲得適當的自體靜脈。

Even when available, harvesting the vein is a time-consuming procedure and may not be an option for patients with severe traumatic injuries.

即使有合適的靜脈，取靜脈也是一個耗時的過程，對於遭受嚴重創傷的患者來說可能並非可行的選擇。

We believe that the results of this study underscore Symvess's potential as a much needed, effective, and life saving alternative as a treatment for patients where autologous vein is not feasible.

我們相信，這項研究的結果凸顯了 Symvess 作為一種急需的、有效的、能夠挽救生命的替代療法的潛力，適用於自體靜脈移植不可行的患者。

We're very pleased with the study results, and as Symvess is increasingly adopted by surgeons, we're confident that we will continue to see the benefits of this product validated by further research. In addition, we have another publication of the long-term results of Symvess in vascular trauma in a civilian setting, that will be forthcoming soon.

我們對研究結果非常滿意，隨著 Symvess 越來越受到外科醫生的青睞，我們相信，透過進一步的研究，我們將繼續看到產品的益處得到驗證。此外，我們還有一篇關於 Symvess 在平民環境下治療血管創傷的長期結果的文章即將發表。

I'll turn now to the program that is our next priority, which is dialysis access.

接下來，我將介紹我們下一個優先項目，即透析通路。

Positive 2-year results from the V007 phase 3 trial of the ATEV in dialysis patients were presented last weekend at the American Society of Nephrology's Kidney Week 2025, which is the premier nephrology meeting.

上週末，在腎臟病學會 2025 年腎臟週（腎臟病學界最重要的會議）上，公佈了 ATEV 在透析患者中​​ V007 3 期試驗的積極 2 年結果。

The ATEV demonstrated superior duration of use over 24 months as compared to autogenous fistula in high need subgroups that have historically poor outcomes with ATEV fistula procedures. The significantly longer duration of ATEV use over 2 years in patients with this high unmet need could greatly reduce reliance on catheters for dialysis access, which are a major cause of complications, morbidity, and costs for dialysis patients.

在以往 ATEV 瘻管手術效果不佳的高需求亞群中，ATEV 的使用壽命超過 24 個月，優於自體瘻管。對於這種未滿足需求量很大的患者而言，ATEV 的使用時間顯著延長至 2 年以上，可以大幅減少對透析通路導管的依賴，而透析通路導管是導致透析患者併發症、發病率和費用的主要原因。

Women and men with diabetes and obesity make up more than half of the dialysis access market and are historically underserved by the current standard of care. It's been known for decades that women in particular suffer low rates of fistula maturation, lower rates of fistula maturation than do men, but a lack of better alternatives has limited progress for these patients.

患有糖尿病和肥胖症的男女佔透析通路市場的一半以上，但長期以來，他們並未得到當前標準護理的充分服務。幾十年來人們都知道，女性的瘻管成熟率尤其低，比男性低，但由於缺乏更好的替代方案，這些患者的治療進展受到限制。

We believe that the efficacy and safety results in this subgroup combined with the approximately 50% failure rate of fistulas in this subgroup makes women and high-risk men an important population for Humacyte to target.

我們認為，該亞組的療效和安全性結果，加上該亞組中約 50% 的瘻管失敗率，使得女性和高風險男性成為 Humacyte 的重要目標族群。

We look forward to publication of the results from the V07 phase 3 trial in a major peer-reviewed medical journal.

我們期待V07 3期試驗結果能在主要的同儕審查醫學期刊上發表。

Before we file a supplemental BLA for the ATEV and dialysis axis, our plan is to complete a pre-specified interim analysis of the currently ongoing trial, which is the V012 phase 3 trial, which is being conducted in women on hemodialysis.

在我們為 ATEV 和透析軸提交補充 BLA 之前，我們的計劃是完成目前正在進行的 V012 3 期試驗的預先指定的期中分析，該試驗正在接受血液透析的女性中進行。

The V12 trial compares the ATEV to women receiving fistula for hemodialysis access.

V12 試驗將 ATEV 與接受動靜脈瘻管進行血液透析的婦女進行比較。

A total of 109 patients have been enrolled to date in the V012 phase 3 clinical trial, and an interim analysis is planned when the first 80 patients reach 1 year of follow-up, meaning that the interim analysis results should be available around April of 2026.

截至目前，V012 3 期臨床試驗已招募了 109 名患者，計劃在首批 80 名患者完成 1 年追蹤後進行中期分析，這意味著中期分析結果應該在 2026 年 4 月左右公佈。

Subject to those interim results, our plan is to submit a supplemental BLA in the second half of 2026, including data from V012, which is ongoing, and the VO7 phase 3 pivotal studies in order to add dialysis access as an indication for the ATEV.

根據這些中期結果，我們的計劃是在 2026 年下半年提交一份補充生物製品許可申請 (BLA)，其中包括正在進行的 V012 的數據和 VO7 3 期關鍵性研究的數據，以便將透析通路作為 ATEV 的適應症。

Finally, I'll briefly discuss one of our earlier stage programs that we're also very excited about, our coronary tissue engineered vessel or CTAEV for use in coronary artery bypass grafting or CABG.

最後，我將簡要介紹我們早期階段的一個項目，我們也對此感到非常興奮，那就是用於冠狀動脈旁路移植術（CABG）的冠狀動脈組織工程血管（CTAEV）。

Positive results of a pre-clinical study evaluating the CTEV as a coronary artery bypass graft in a non-human primate model were published in September of 2025 in JACC Basic Translational Science, which is a specialist journal launched by the Journal of the American College of Cardiology.

一項在非人靈長類動物模型中評估 CTEV 作為冠狀動脈旁路移植物的臨床前研究的積極結果於 2025 年 9 月發表在 JACC 基礎轉化科學雜誌上，該雜誌是由美國心臟病學會雜誌創辦的專業期刊。

In this study, the CTV was observed to sustain blood flow, recellularize with the animal's host cells, and remodeled to bring the diameter of the CTV in line with the animal's native coronary artery.

在本研究中，觀察到 CTV 能夠維持血流，以動物的宿主細胞進行再細胞化，並進行重塑，使 CTV 的直徑與動物本身的冠狀動脈保持一致。

We're on track with our plan to advance CTEV into first in human study in CABG in 2026.

我們正按計劃推進 CTEV 在 2026 年進入 CABG 人體試驗階段。

We have filed an IND with the with the FDA for the CABG indication, and if successful, the CTA would be the first novel conduit to be tested in CABG in the US in decades.

我們已向 FDA 提交了 CABG 適應症的 IND 申請，如果成功，CTA 將成為幾十年來美國第一個在 CABG 中進行測試的新型導管。

Before turning the call over to Dale, I'll mention last the expansion of our intellectual property estate and the grant of a new US patent covering the composition of a bioengineered esophagus. This new patent provides protection into 2041 for key structural and mechanical attributes for an esophageal replacement, including size, strength, and methods of production.

在將電話交給戴爾之前，我最後提一下我們智慧財產權的擴張以及一項涵蓋生物工程食道成分的新美國專利的授予。這項新專利為食道替代物的關鍵結構和機械特性（包括尺寸、強度和生產方法）提供保護，有效期至 2041 年。

Our tubular prosthesis patent family now encompasses granted claims for the composition and methods for engineered trachea, engineered urinary conduits, and engineered esophagus.

我們的管狀假體專利族現在涵蓋了工程氣管、工程尿道和工程食道的組成和方法的授權權利要求。

So our third quarter has been very productive for Humacyte as we've continued to grow our commercial launch and continued to publish strong supportive data for our for our vessel Symvess in multiple indications. We also look forward to continuing to share our progress going forward.

因此，對於 Humacyte 而言，第三季成果豐碩，我們繼續擴大商業化推廣，並繼續發布強有力的支持數據，證明我們的藥物 Symvess 在多種適應症中有效。我們也期待繼續與大家分享我們未來的進展。

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

接下來，我將把電話交給戴爾，讓他回顧我們的財務表現和其他業務發展。

Thank you, Laura, and good morning everyone.

謝謝你，蘿拉，大家早安。

Revenue for the three months ended September 30, 2025 was $0.8 million, of which $0.7 million related to the US sales of Symvess.

截至 2025 年 9 月 30 日止三個月的收入為 0.8 百萬美元，其中 0.7 百萬美元與 Symvess 在美國的銷售額有關。

The remaining $0.1 million resulted from a research collaboration with a large medical technology company.

剩餘的 0.1 百萬美元來自與一家大型醫療技術公司的研究合作。

Revenue for the nine months ended September 30, 2025 was $1.6 million, of which $0.9 million related to US sales of Symvess and $0.6 million resulted from the research collaboration.

截至 2025 年 9 月 30 日的九個月期間，收入為 160 萬美元，其中 90 萬美元與 Symvess 在美國的銷售有關，60 萬美元來自研究合作。

There was no revenue either for the 3 or 9 months ended September 30, 2024.

截至 2024 年 9 月 30 日的 3 個月或 9 個月期間，均無收入。

Cost of goods sold were $0.3 million and $0.6 million for the three and nine months ended September 30, 2025 respectively which includes overhead related to unused production capacity that was recorded as an expense in the applicable periods.

截至 2025 年 9 月 30 日止的三個月和九個月期間，銷售成本分別為 30 萬美元和 60 萬美元，其中包括與未使用的生產能力相關的間接費用，該費用已在適用期間計入支出。

There was no cost of goods sold for either the 3 or 9 months ended September 30, 2024.

截至 2024 年 9 月 30 日止的 3 個月或 9 個月期間，均無銷售成本。

Research and development expenses were $17.3 million for the three months ended September 30, 2025, compared to $22.9 million for the five for the prior year period and we're $54.7 million for the nine months ended September 30, 2025 compared to $67.9 million for the same period in 2024.

截至 2025 年 9 月 30 日止三個月，研發費用為 1,730 萬美元，而上年同期為 2,290 萬美元；截至 2025 年 9 月 30 日止九個月，研發費用為 5,470 萬美元，而 2024 年同期為 6,790 萬美元。

The decrease in research involvement expenses for the third quarter of 2025 compared to 2024, primarily related to the capitalization of material and overhead costs associated with the commercial manufacturing of Symvess.

2025 年第三季研發投入費用較 2024 年下降，主要原因是與 Symvess 商業化生產相關的材料和管理費用資本化。

And cost reductions implemented during the quarter ended June 30, 2025.

以及在截至 2025 年 6 月 30 日的季度內實施的成本削減措施。

The decrease in research and development expenses for the nine months ended September 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 combined with the wind down of certain clinical trial programs.

截至 2025 年 9 月 30 日的九個月，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，以及某些臨床試驗項目的逐步結束。

Partially offset by higher non commercial production runs.

部分被較高的非商業生產量所抵銷。

Selling general and administrative expenses were $7.6 million for the three months ended September 30, 2025 compared to $7.3 million for the prior year period.

截至 2025 年 9 月 30 日止三個月的銷售一般及行政費用為 760 萬美元，而去年同期為 730 萬美元。

And we're $23.6 million for the nine months ended September 30, 2025, compared to $18.4 million for the same period in 2024.

截至 2025 年 9 月 30 日的九個月，我們的營收為 2,360 萬美元，而 2024 年同期為 1,840 萬美元。

The increase in 2025 expenses compared to the prior year periods resulted primarily from the US commercial launch of Symvess and the vascular trauma indication, including increased personnel expenses.

2025 年支出較去年同期增加，主要原因是 Symvess 在美國上市並獲準用於治療血管創傷，其中包括人員支出增加。

Other net income for the three months ended September 30, 2025 was $6.9 million, compared to net expense of $9.0 million for the prior year period.

截至 2025 年 9 月 30 日止三個月的其他淨收入為 690 萬美元，而去年同期淨支出為 900 萬美元。

And other net income was $61.3 million for the nine months ended September 30, 2025, compared to other net expense of $41.5 million for the same period in 2024.

截至 2025 年 9 月 30 日的九個月內，其他淨收入為 6,130 萬美元，而 2024 年同期其他淨支出為 4,150 萬美元。

The increase in other net income for the 3 and 9 months into September 30, 2025, compared to the prior year periods, resulted primarily from the non-cash rear measurement.

截至 2025 年 9 月 30 日的第 3 個月和第 9 個月的其他淨收入較上年同期有所增加，這主要是由於非現金後備計量造成的。

Of the contingent earnout liability associated with the company's August 2021 merger with the Healthcare acquisition corps.

與公司 2021 年 8 月與醫療保健收購公司合併相關的或有獲利負債。

Net loss was $17.5 million for the three months ended September 30, 2025, compared to a net loss of $39.2 million for the prior year period.

截至 2025 年 9 月 30 日止三個月，淨虧損為 1,750 萬美元，而上年同期淨虧損為 3,920 萬美元。

And net loss was $16.0 million for the nine months ended September 30, 2025 compared to a net loss of $127.8 million for the same period in 2024.

截至 2025 年 9 月 30 日的九個月，淨虧損為 1,600 萬美元，而 2024 年同期淨虧損為 1.278 億美元。

The decrease in net loss for the three and nine months ended September 30, 2025, compared to the prior year periods, was primarily due to non-cash-free measurement of the contingent earnout liability described previously.

截至 2025 年 9 月 30 日止三個月及九個月的淨虧損較上年同期有所減少，主要是由於先前所述的或有或有負債採用非現金計量方式所致。

Combined with current period decreases in operating expenses and a decrease in loss from operations.

結合當期營運費用下降和營運虧損減少。

We had cash equivalents and restricted cash of $19.8 million as of September 30, 2025.

截至 2025 年 9 月 30 日，我們擁有現金等價物及受限現金 1,980 萬美元。

In addition, subsequent to September 30, 2025, we completed the sale of common stock and warrants that added an additional net proceeds to our cash position of approximately $56.5 million.

此外，截至 2025 年 9 月 30 日，我們完成了普通股和認股權證的出售，使我們的現金淨收益增加了約 5,650 萬美元。

As will further be discussed in the 10Q to be filed later today we believe that gives us cash runway exceeding 12 months from today's date.

正如我們將在今天稍後提交的 10Q 文件中進一步討論的那樣，我們相信這將使我們的現金儲備能夠維持超過 12 個月。

Total net cash used in operating expenses was $78.9 million for the first nine months of 2025 compared to cash net cash used of $71.5 million for the first nine months of 2024.

2025 年前九個月的營運費用淨現金使用總額為 7,890 萬美元，而 2024 年前九個月的淨現金使用總額為 7,150 萬美元。

The increase in net cash used for operating activities during the first nine months of 2025 compared to the prior year resulted primarily from the buildup of inventory associated with the commercial launch of inventory, partially offset by a reduced loss from operations.

2025 年頭九個月經營活動所用淨現金較上年同期增加，主要原因是庫存商業化推出導致庫存積壓，部分被經營虧損減少所抵銷。

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

接下來，我將把電話交給勞拉。

Thank you, Dale. With our strong commercial execution, our promising pipe pipeline programs, and our dedicated team we remain committed to delivering truly transformative regenerative medicine solutions to improve patient outcomes.

謝謝你，戴爾。憑藉我們強大的商業執行力、前景廣闊的管道項目以及敬業的團隊，我們將繼續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。

We believe that we are positioned for growth and value generation in the remainder of 2025 and beyond.

我們相信，我們已做好準備，在 2025 年剩餘時間及以後實現成長和價值創造。

Thank you all for joining us today.

感謝各位今天蒞臨。

Operator, we're now ready to take questions.

接線員，我們現在可以開始回答問題了。

(Operator Instructions)

（操作說明）

Matt (Mixick) with Barclays.

馬特（米克西克）在巴克萊銀行。

One of the first questions we just kinda wanted to ask was, Q2 you mentioned that 12 of the 45 hospitals had initiated the back process and now you've said that 16 had started ordering. How many of those that have started ordering have begun the reorder process and have you disclosed that data?

我們最先想問的問題之一是，Q2 中您提到 45 家醫院中有 12 家啟動了回程流程，現在您又說有 16 家已經開始訂購。已開始訂購的客戶中，有多少人已經開始再次訂購？你們是否公佈了這些數據？

We have not disclosed that data previously, but I believe the majority have reordered.

我們之前沒有披露過這些數據，但我相信大部分已經重新排序了。

Okay, and then just as a quick follow-up, now that you have this new data from the trial for V007 how it does that your cha how does that change your view for the potential for Symvess and dial dialysis.

好的，那麼作為一個快速的後續問題，既然您有了 V007 試驗的新數據，這對您如何改變對 Symvess 和透析潛力的看法？

Well, we believe that the that the very strong results in duration of usability in these subgroups of patients with a high unmet need going out to 2 years is very strong data, most studies in dialysis access have follow-up time periods of a year. So showing continued sustained benefit in these high needs subgroups going out to 2 years versus the gold standard of current care we believe is very important and we believe it will be a strong support when we eventually file our supplemental BLA application and dialysis access.

我們認為，在這些未滿足需求較高的患者亞群中，可用性持續時間長達 2 年的非常強有力的結果是一個非常有力的數據，而大多數透析通路研究的追蹤時間僅為一年。因此，我們認為，證明這些高需求亞組在長達 2 年的時間內持續獲益，與當前護理的黃金標準相比，這一點非常重要，我們相信這將在我們最終提交補充 BLA 申請和透析通路申請時提供強有力的支持。

And again, these subgroups are not small. It's, if you combine all women with men having these risk factors, it's more than half of the dialysis population.

而且，這些小組的規模都不小。如果將所有具有這些風險因素的女性與男性加在一起，那麼透析患者總數將超過透析人口的一半。

Ryan Zimmerman with BTIG.

Ryan Zimmerman，BTIG。

Just to start out, on the launch that you, the progress with the launch so far. Out of the units that you've been, purchased, I was curious what is or how many of those have been used versus what are initial stocking orders at these hospitals.

首先，關於您此次的發布，目前為止的發布進度如何？在您購買的這些設備中，我很好奇有多少台已經投入使用，而這些醫院最初的庫存訂單又是多少台。

It's very hard to answer that question succinctly. What I can tell you and what we've messaged the market before is that initial stocking orders, range from 1 to 3 units. There are a couple hospitals who are ordering on an as needed basis, although that's less common. Typically what we're starting to see with usage and repeat usage is that as hospitals, use the vessel and then they come down to their par, then they will reorder when they hit their, when they fall below their par level, whether that's 1 or 2 or 3 units. So we have been, again we've been getting good feedback from surgeons as far as how happy they are, using the product. Surgeons tell us that it's easy to handle and that they're pleased with its function in the OR.

這個問題很難簡潔地回答。我可以告訴你們，我們之前也向市場傳達過，初始庫存訂單數量為 1 至 3 台。雖然不太常見，但也有幾家醫院是按需訂購的。通常情況下，我們看到的使用情況和重複使用情況是，醫院會使用容器，然後當容器數量降至標準水平時，他們會在低於標準水平時重新訂購，無論是 1 個、2 個還是 3 個單位。所以，我們再次收到了外科醫生們的良好回饋，他們對使用該產品非常滿意。外科醫生告訴我們，它易於操作，並且他們對其在手術室中的作用感到滿意。

I would also say, although you didn't ask this question. That we have several, presentations on the function of our vessel that are being presented at the VIS meeting, which is the large annual vascular surgery meeting, in New York every year. Those presentations are going to be coming online next week.

雖然你沒有問這個問題，但我還要說。我們在每年於紐約舉行的血管外科年會（VIS）上發表了幾篇關於我們血管功能的演講。這些簡報將於下週上線。

That's helpful, Laura, and I believe last quarter you called out the fact that the price has come down for Symvess. I was curious what, benefits you've seen from that if it's accelerated any of the adoption or if even decrease the time it's taking for these hospitals to get through their back approvals.

勞拉，這很有幫助。我相信上個季度你也提到Symvess的價格已經下降了。我很好奇，您從中看到了哪些好處，例如是否加快了採用速度，或者是否縮短了這些醫院完成後續審批所需的時間。

Yes and yes.

是的，沒錯。

The market is price sensitive now. That's certainly true. As we've discussed before, in the post-covid era, hospitals are looking much more closely at budgets. And so the price sensitivity is something that we found to be important.

目前市場對價格非常敏感。的確如此。正如我們之前討論過的，在新冠疫情后時代，醫院正在更加嚴格地審視預算。因此，我們發現價格敏感度是一個重要的因素。

With this, lower price point, what we've seen is that hospitals are, moving through the VAC process quicker. There are some hospitals and groups of hospitals that did not consider us at our original price point, but with further discussions on price, they've now reinstituted the VAC process and so that has reopened other doors. And the VAC process tends to be moving a little bit more quickly, so this is still a process that takes time. And once the VAC approvals are obtained, then there's a 1 or 2 or 3 month contracting process that happens with each hospital. So you know there is a time factor here, but we've definitely seen an acceleration, both of VAC, submissions and also an acceleration to time for approval.

由於價格降低，我們看到醫院正在更快地完成VAC流程。有些醫院和醫院集團最初沒有考慮我們最初的定價，但經過進一步的價格討論，他們現在已經重新啟用 VAC 流程，這為我們打開了其他大門。而且VAC流程往往進展得更快一些，但這仍然是一個需要時間的過程。一旦獲得 VAC 批准，接下來將與每家醫院進行 1 到 2 個月或 3 個月的合約簽訂程序。所以你知道，這裡存在時間因素，但我們確實看到VAC提交速度加快，審批時間也加快了。

That's helpful, thank you. And if I could squeeze in just one more for Dale, I believe you guys have called out some cost savings initiatives that have been put in place for 2025 and 2026 for about $50 million in total savings. I was curious if you're still feeling comfortable with this level or if we should expect any changes as we start to think about next year. Thanks for taking the questions and congrats again on the progress.

這很有幫助，謝謝。如果我可以再為戴爾補充一點，我相信你們已經提到了一些為 2025 年和 2026 年實施的成本節約計劃，總共可以節省約 5000 萬美元。我很好奇你是否仍然對目前的水平感到滿意，或者當我們開始考慮明年時，是否應該預期會有任何變化。感謝您回答問題，再次恭喜您的進展。

Yeah, thanks Izzy and no absolutely we are seeing those savings, obviously it's part of the kind of the formal GAAP reporting out of our financial results we compare to the prior year, but if you just compare our expense levels to last quarter, we're seeing those drops already. Research and development in the second quarter was $22 million we've dropped that to $17 million so almost $5 million reduction in R&D there.

是的，謝謝伊茲。當然，我們已經看到了這些節省，這顯然是我們按照 GAAP 正式編制的財務報告的一部分，我們會將財務業績與前一年進行比較。但如果你只比較我們與上個季度的支出水平，我們已經看到了這些下降。第二季的研發投入為 2,200 萬美元，我們已將其降至 1,700 萬美元，研發投入減少了近 500 萬美元。

SG&A costs were pretty flat, maybe $200,000 down. So our operating expenses quarter over quarter.

銷售、一般及行政費用基本持平，可能減少了 20 萬美元。所以我們的營運費用是月減了。

We're reduced by about $5 million so we are already experiencing those cost reductions and expect us to continue out and, achieve that full $50 million in cost savings that we targeted when we announced our second quarter results.

我們的成本減少了約 500 萬美元，因此我們已經感受到了這些成本削減，並預計我們將繼續努力，實現我們在公佈第二季度業績時設定的 5000 萬美元的成本節約目標。

Josh Jennings with TD Cowen.

Josh Jennings 與 TD Cowen。

Hi, good morning, Lauren Dale. Thanks for taking the questions. I was hoping to just, you guys have generated some strong supportive evidence for some this in the vascular trauma indication, and it sounds like this question's already been answered, but it, how impactful has that been just in terms of getting that processes started and then moving through the process and just remind us if you would just how real world outcomes are going to be tracked. Is there. A post-approval registry study and I think it will take some time for that to formulate, but when could we see any results from any registry, real world registry outcomes?

你好，早安，勞倫戴爾。謝謝您回答問題。我希望你們能提供一些強有力的證據來支持血管創傷適應症的研究，雖然這個問題似乎已經得到了解答，但我想問的是，這些證據在啟動和推進相關流​​程方面究竟產生了多大的影響？能否也提醒一下我們，實際結果將如何追蹤？有沒有。上市後註冊研究，我認為還需要一些時間才能製定出來，但我們什麼時候才能看到任何註冊研究的結果，也就是真實世界的註冊研究結果呢？

Yeah Josh, those are good questions.

是的，喬什，這些都是很好的問題。

Thank you. So you know the steady drumbeat of publications that have been coming out and frankly are going to continue has certainly been helpful in terms of providing additional assurance to surgeons as we speak to them at hospitals. Our initial endpoint for the V005 and V0017 studies was the 30 days and so having these long-term outcomes that are now out in the public domain that we can share has been very powerful in terms of bringing surgeons on board. So, and again we're going to continue to lean into that.

謝謝。所以你知道，不斷湧現的出版物，而且坦白說還會繼續湧現，這無疑有助於我們在醫院與外科醫生交談時，為他們提供額外的信心。V005 和 V0017 研究的最初終點是 30 天，因此，這些現在已公開的長期結果，我們可以與公眾分享，這對吸引外科醫生參與非常有影響力。所以，我們將繼續朝著這個方向努力。

And your second question?

你的第二個問題是什麼？

Oh, just about the just real world outcomes and how those are being tracked and what's processed there.

哦，主要是關於現實世界的結果，以及如何追蹤這些結果並進行處理。

Sure, so there is a post approval study that that we've agreed to with the FDA as part of our FDA approval in trauma since we're a first in class product, so this will be a follow-up registry study in, 100 trauma patients following at least 100 patients for at least a year. We have not kicked that trial off. In fact, we're continuing discussions about the specifics of the trial design with the FDA. The FDA's been a little bit slower in part because of the shutdown and some other changes, and so we're still working through that, but we expect to kick off this, postmarketing study sometime in the first half of 2026, and we expect data to come out from that, 6 or 12 months after that. It certainly won't be a full data set, but there will be some information forthcoming. But frankly, I think that that there will be more information forthcoming just from individual surgeon publications and reports on their experience, whether it's case reports or short series, and some of that we're even going to see at the V next week.

當然，由於我們是同類首創產品，所以我們與 FDA 達成了一項上市後研究協議，作為我們獲得 FDA 創傷治療批准的一部分，這將是一項後續註冊研究，對至少 100 名創傷患者進行至少一年的隨訪。我們尚未啟動該試驗。事實上，我們正​​在與FDA繼續討論試驗設計的具體細節。由於政府停擺和其他一些變化，FDA 的進展稍慢了一些，我們仍在努力解決這個問題，但我們預計將在 2026 年上半年啟動這項上市後研究，並預計在 6 到 12 個月後公佈相關數據。這肯定不會是完整的數據集，但會有一些資訊公佈。但坦白說，我認為會有更多資訊來自外科醫生個人發表的論文和關於他們經驗的報告，無論是病例報告還是短篇系列報告，其中一些我們甚至將在下週的 V 會議上看到。

Excellent and wanted to ask about some invest in the in the ATEV is indication, congratulations on the two year results presented at ASN.

非常好，我想問一下關於在ATEV進行一些投資的問題，這表明，祝賀你們在ASN上公佈的兩年業績。

In terms of the BLA process and this interim analysis, I mean, should we be thinking that if the interim analysis for the 1st 80 patients in V012, kind of those results mirror the 1 in 2 results in females from V007, that that that the package will be robust enough for the FDA to consider approval.

就 BLA 流程和這項中期分析而言，我的意思是，如果 V012 中前 80 名患者的中期分析結果與 V007 中女性患者 1/2 的結果相似，我們是否應該認為該方案足夠有力，值得 FDA 考慮批准？

Yes, we believe so. I mean the way we would approach this is that the lead, the lead study would be the study in women, the prospective head to head randomized study versus fistula in women. If we met our, endpoint at the interim analysis, this would be a very strong indication of superiority of our vessel compared to the gold standard fistula in dialysis.

是的，我們認為是這樣。我的意思是，我們採取的方法是，主要研究將是針對女性的研究，即針對女性瘻管的前瞻性頭對頭隨機研究。如果我們在中期分析中達到了終點，這將非常有力地表明，與透析中的黃金標準動靜脈瘺相比，我們的血管具有優越性。

So we would then lead with that publication and the VO7 publication the VO7 data. Which includes data from all comers, as but but which has an important subgroup analysis in women and high risk men. We anticipate that would be supporting data. So this would then be two prospective studies, basically, of course, pending the results of the VO 12, analysis, of course, but in that situation we would have two prospective randomized studies, supporting the same message in these patient subgroups.

因此，我們將首先發布該出版物和 VO7 出版物以及 VO7 數據。其中包括所有參與者的數據，但對女性和高風險男性進行了重要的亞組分析。我們預計這將提供佐證數據。因此，基本上這將是兩項前瞻性研究，當然，這取決於 VO 12 分析的結果，但在這種情況下，我們將有兩項前瞻性隨機研究，支持這些患者亞組中的相同資訊。

Jason Colbert with Dawson James Securities.

Jason Colbert，來自 Dawson James Securities。

Hey, good morning. Congrats on all the progress and transitioning to being a commercial entity. I'd like to just ask you a little bit about what's involved in transitioning the sales force as you start looking towards hemodialysis and essentially the work you're doing now kind of creating the awareness in the marketplace, how do you transition that into the commercial opportunity for dialysis?

嘿，早安。恭喜你們取得的所有進展以及成功轉型為商業實體。我想問您一些關於銷售團隊轉型的問題，當您開始關注血液透析時，以及您現在所做的在市場上提高認知度的工作，您是如何將其轉化為透析的商業機會的？

Thank you Jason. That's a great question. So, as your team probably knows, we've done the initial launch in trauma with a fairly small sales force, about 12 agents who are out in the field, in different territories that are essentially high value territories with large metropolitan areas and a lot of trauma centers. We are looking, as we've messaged the market, we're looking at strategically adding a small number of additional sales representatives in other geographies right now, we're in the process of doing that. But again, as we've mentioned, there's only about 3,000 vascular surgeons in the United States, and as we continue our sales efforts during 2025 and then through 2026, we anticipate having touch points with a large fraction of these surgeons.

謝謝你，傑森。這是一個很好的問題。所以，正如你們團隊可能知道的那樣，我們在創傷治療領域最初的推廣工作是由一支規模較小的銷售隊伍完成的，大約有 12 名代理人在不同的地區進行實地推廣，這些地區基本上都是高價值地區，擁有大型都市區和許多創傷中心。正如我們向市場傳達的訊息，我們目前正在考慮在其他地區策略性地增加少量銷售代表，我們正在進行這項工作。但是，正如我們之前提到的，美國祇有大約 3000 名血管外科醫生，隨著我們在 2025 年和 2026 年繼續進行銷售工作，我們預計將與其中很大一部分外科醫生建立聯繫。

The vascular surgeons who perform trauma operations are the same surgeons who also perform dialysis access operations. And so the visibility with this surgeon cohort we think it's going to be tremendously supported by our trauma efforts in 2025 and 2026. That said, if the results in V12 are positive and if we file the supplemental BLA in the second half of 2026, we would aim for approval sometime in early 2027 and by that time we would probably bring on an additional sales force. This would not be a huge sales force and we haven't given specific numbers, but there might be, I'm making this up, there might be another 10 or 20 reps because we would be targeting the same surgeons, but we would be targeting additional call points, because, dialysis access is primarily an outpatient procedure. It's the same surgeons but it's slightly different facility.

進行創傷手術的血管外科醫師與進行透析通路手術的外科醫師是同一批人。因此，我們認為，在 2025 年和 2026 年，我們在創傷治療方面的努力將大大提高外科醫生群體的知名度。也就是說，如果 V12 的結果積極，並且我們在 2026 年下半年提交補充 BLA，我們的目標是在 2027 年初獲得批准，到那時我們可能會增加一支銷售團隊。這不會是一支龐大的銷售隊伍，我們也沒有給出具體數字，但可能會有，我只是舉個例子，可能會有 10 到 20 名銷售代表，因為我們的目標客戶仍然是同一批外科醫生，但我們會拓展其他拜訪點，因為透析通路主要是一種門診手術。是同一批外科醫生，但診所略有不同。

Yeah, that makes a lot of sense.

是的，這很有道理。

Thank you. Can you talk also a little bit just because I'm fascinated by it, what you're doing towards the virtual, well, the actual replacement esophagus, trachea, and the urinary conduit. How did those programs proceed and how aware are you of all the prior data done by companies like Harvard Apparatus almost a decade ago?

謝謝。您能否也談談您在這方面所做的工作，因為我對此很感興趣，例如虛擬的，或者說實際的替代食道、氣管和泌尿道。這些項目是如何進行的？您對哈佛儀器公司等企業在近十年前所做的所有先前數據了解多少？

Yeah, so, the, these other indications are indications that Huicide has sought intellectual properties on and obtained intellectual property. I would say we do not have active pre-clinical programs advancing those those indications right now. Frankly, we're going to prioritize that, as our revenues increase and as our cash position improves, but right now. We're not doing active studies there. But of course, from my from my long standing work in this field, I'm very aware of the Harvard apparatus outcomes and some of the problems that have occurred in the with the esophagus and with airway replacements.

是的，所以，這些其他跡象表明，Huicide 已經尋求並獲得智慧財產權。我認為我們目前還沒有針對這些適應症的積極臨床前計畫。坦白說，隨著收入增加和現金狀況改善，我們將優先考慮這一點，但就目前而言。我們並未在那裡進行積極的研究。當然，憑藉我長期在該領域的工作經驗，我非常了解哈佛裝置的成果以及在食道和氣道置換方面出現的一些問題。

Very aware of those. Those are clinically challenging environments. And, some of the earlier failures of other technologies, I believe, were driven by, frankly, a failure to consider the proper design criteria for the implant. I would hope that, as we continue to develop these products in the future, that we would. We would make better con we would make better conduits. We would, have, meet better design criteria, but we'll have to see.

我非常清楚這些。這些都是臨床上具有挑戰性的環境。而且，我認為，其他一些技術早期的失敗，坦白說，是由於沒有考慮植入物的正確設計標準造成的。我希望，隨著我們未來繼續開發這些產品，我們能夠做到這一點。我們會製造出更好的騙局，我們會製造出更好的管道。我們本來可以滿足更好的設計標準，但還需要觀察。

Bruce Jackson with Benchmark Company.

Bruce Jackson，來自 Benchmark 公司。

Hi, good morning, thanks for taking my questions. Wanted to follow-up on the NTP submission. Have you, reconsidered the strategy and is there a plan to resubmit?

您好，早安，感謝您回答我的問題。想跟進一下NTP的提交狀況。您是否重新考慮過策略，並制定了重新提交的計劃？

Yeah, Bruce, thank you for that. We've considered this carefully and we've actually opted not to resubmit for the NTA in trauma, the decision by CMS that in that our conduit and trauma is not novel, was obviously very surprising for us as we messaged to the market, last quarter, and in reviewing sort of their thinking, that that they, the CMS took a very reductionist approach to this and said because we are a conduit that conducts blood we are not novel because there are other conduits that conduct blood. We decided that it was probably not, a good use of our resources to go back at that again, instead, as we have had some price reductions, actually from around the time of the N tap decision and the reduction in price has helped to drive activity in the market so we don't really see the, we don't see it as a good use of effort to reapproach NTA at this time.

是的，布魯斯，謝謝你。我們仔細考慮過這個問題，實際上我們決定不再重新提交創傷方面的 NTA 申請。 CMS 認為我們的導管和創傷治療並非創新產品，這項決定顯然讓我們非常驚訝，正如我們在上個季度向市場傳達的訊息一樣。在回顧他們的想法時，我們發現 CMS 對此採取了一種非常簡化主義的方法，他們認為因為我們是一種輸血導管，所以我們不具有創新性，因為還有其他輸血導管。我們認為，現在再去爭取NTA可能不是明智之舉，因為自從N水龍頭計畫決定以來，我們已經進行了一些降價，降價也促進了市場活動，所以我們認為，現在再去爭取NTA並不是明智之舉。

Bruce, another consideration is that out of the vascular trauma patients only about 4% are covered by Medicare, so that was another consideration.

布魯斯，還有一點要考慮的是，血管創傷患者中只有大約 4% 的人享有醫療保險，所以這也是需要考慮的因素。

The other question I had was around the, just some anecdotal information about the reorders and the marketing efforts. So in the multi-ho approvals that you've gotten, have you seen, additional hospitals ordered the product and, in the hospitals, where you are selling right now, oftentimes there's a single surgeon who's your champion who does the initial implants. Have you seen, any expansion beyond your initial implanting physicians?

我的另一個問題是關於補貨和行銷工作的一些軼事資訊。所以，在你獲得的多家醫院批准中，你是否注意到，其他醫院訂購了該產品？而且，在你目前銷售產品的醫院裡，通常會有一位外科醫生是你的擁護者，負責進行最初的植入手術。您是否見過除最初植入手術醫生之外的其他任何擴展方案？

We have in a couple of the hospitals, I don't want to name them specifically, but in a couple trauma hospitals we have seen usage beyond, our initial champion. As it is with any new surgical product, as you, as there's typically an, a lead champion who will use and reuse, and then as his colleagues see those outcomes, they will continue to adopt. So we have seen that in several hospitals as far as the hospital systems.

我們在幾家醫院（我不想具體點名）看到了這種療法，但在幾家創傷醫院，我們看到它的使用範圍超過了我們最初的倡導者。就像任何新的外科產品一樣，通常會有一個帶頭的倡導者會使用並重複使用，然後當他的同事看到這些結果時，他們就會繼續採用。所以，我們已經在幾家醫院以及醫院系統中看到了這種情況。

You know when we when we get a VAC approval for a hospital system there's still individual contracting that we must do with each individual hospital, so the, while having a a blanket VAC approval helps with an important step in that process we're we are undergoing contract negotiations right now in multiple hospitals that are covered by some of these chains that we've gotten approvals in if that makes sense.

你知道，當我們獲得醫院系統的 VAC 批准後，仍然需要與每家醫院單獨簽訂合約。因此，雖然獲得一攬子 VAC 批准有助於完成這一過程中的重要一步，但我們現在正在與一些我們已獲得批准的連鎖醫院旗下的多家醫院進行合約談判，希望這能說得通。

RK with HC Wainwright.

RK 與 HC Wainwright。

Thank you. Good morning, Laura and Dale. Congratulations. Couple of questions, from me. The first one being, how do you, Initiate your conversations and maintain your conversations on value proposal, to the folks on committees and what are the things that resonate, with them, especially, when you have to still dislodge, the autologous, vein grafts that's question number 1.

謝謝。蘿拉和戴爾，早安。恭喜。我有幾個問題。第一個問題是，如何與委員會成員就價值提案展開對話並保持對話，以及哪些內容能引起他們的共鳴，尤其是在你仍然需要推翻自體靜脈移植的情況下，這是第一個問題。

On the second question. Dale, it looks like, there's some good operational excellence being done here, so you reduced your cash borne. Is this the new expectations from here onwards and also with the $76 million in the bank now, how long of a runway are you going to have, and does that include the BLA submission for the dialysis syndication.

關於第二個問題。戴爾，看來你們這裡在營運方面做得非常出色，所以你們減少了現金支出。從現在開始，這就是新的預期嗎？另外，現在銀行有 7,600 萬美元，你們還能維持多久？這是否包括透析聯合體的 BLA 申請？

So I'll take the first, question, with regard to the value proposition to VACs and hospitals, as our, or you may remember we published a budget impact model in March of this year in the Journal of Medical Economics that budget impact model contemplated our initial list price of 29,500, and in that model we showed that. By virtue of decreasing amputations and conduit infections.

那麼，我先回答第一個問題，關於對 VAC 和醫院的價值主張，因為，或者您可能還記得，我們​​在今年 3 月在《醫學經濟學雜誌》上發表了一個預算影響模型，該預算影響模型考慮了我們最初的標價 29,500，並且在該模型中，我們展示了這一點。透過減少截肢和導管感染。

Relative to plastic graphs but also relative to other types of graphs like cryovein and xenograph because we decrease those complication costs, we actually came in cheaper even at our initial 2,029,500 price point. With the reduction in price point that economic argument becomes even stronger. And so when we lay that out to VAC, it is compelling.

與塑膠圖表相比，也與其他類型的圖表（如冷凍靜脈和異種圖表）相比，因為我們降低了這些複雜性成本，即使在我們最初的 2,029,500 定價點上，我們的價格實際上也更低。隨著價格的降低，這種經濟論點就更有說服力了。因此，當我們向 VAC 闡述這一點時，它很有說服力。

What we see though is that some hospitals because of changes in Medicaid, I will say that there are. Some hospitals who are despite the compelling budget impact model, occasionally hospitals will still look at just the initial acquisition price and say even if it's going to save us money in the longer-term, I have to think about what I'm spending today. And in some hospitals there is still some pushback, but the majority of cases, in the majority of our VAC submissions, those are now going through successfully. I think because these arguments around decreased cost of amputation, decreased cost of infection are really driving home, especially at our new price point.

不過我們看到，由於醫療補助計畫的變化，有些醫院的情況有所不同，我必須說確實如此。儘管預算影響模型很有說服力，但有些醫院仍然會只專注於初始購置價格，並表示即使從長遠來看可以省錢，我也必須考慮今天的支出。在一些醫院，仍然存在一些阻力，但大多數情況下，在我們提交的大多數 VAC 申請中，現在都已成功通過。我認為，正是因為這些關於截肢成本降低、感染成本降低的論點真正深入人心，尤其是在我們新的定價策略下。

Yeah, regarding, spend levels, I mean, obviously quarter over quarter order we've reduced expenses quite a bit. I think, both operating expenses and loss from operations have come down by about $5 million going out. I think we expect SG&A to be somewhat constant. I think we'll continue to see some reductions in the R&D area.

是的，關於支出水平，我的意思是，很明顯，與上一季相比，我們已經大幅降低了支出。我認為，營運支出和營運虧損都減少了約 500 萬美元。我認為我們預期銷售、管理及行政費用會保持相對穩定。我認為研發領域的投入會持續減少。

As will be further disclosed in our 10Q file probably later today, we expect that the cash on hand based on how we expect to operate takes us.

正如我們將在今天稍後發布的 10Q 文件中進一步披露的那樣，根據我們預期的營運方式，我們預計手頭上的現金將足以支撐我們。

Beyond 12 months from where we are today. and in terms of what milestones that that means as part of your later question, we believe that takes us past.

從我們今天的位置算起，超過 12 個月的時間。至於你後面提出的問題，這意味著哪些里程碑，我們認為這將使我們超越這個期限。

Having the interim results from our V0012 study and dialysis and based upon those raw results taken us past the BLA filing and dialysis and also taken us past the commencement of human testing and in a cardiac bypass graft surgery. So it takes us past some and there'll be a lot else happening in the company also, but it certainly is sufficient to take us past some very key milestones.

我們從 V0012 研究和透析中獲得了中期結果，並基於這些原始結果，我們完成了 BLA 申請和透析，也完成了人體試驗和心臟繞道手術。所以它能幫助我們跨越一些階段，公司裡還有很多其他事情發生，但它確實足以讓我們跨越一些非常關鍵的里程碑。

Perfect, thank you both for taking my questions.

太好了，謝謝你們兩位回答我的問題。

Thank you, ladies and gentlemen, we've come to the end of our time allowed for questions. I'll turn the floor back to Dr Niklason for any final comments.

謝謝各位，提問時間到此結束。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 very much. We really appreciate, the time that that our investors and our analysts have taken to, catch up with us on our call this quarter. We've continued to execute on the goals that we've said we would execute on.

非常感謝。我們非常感謝投資者和分析師們抽出時間參加本季的電話會議。我們一直在努力實現我們之前承諾要實現的目標。

We've continued to expand our commercial launch and we're continuing to get to get traction in the clinical marketplace as surgeons continue to use our vessel in trauma. So we're very excited with our progress and we look forward to catching up with you again next quarter.

我們不斷擴大商業推廣規模，隨著外科醫生繼續在創傷治療中使用我們的血管，我們在臨床市場上也持續獲得認可。我們對所取得的進展感到非常興奮，期待下個季度再次與您會面。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time.

謝謝。今天的電話會議到此結束。您可以在此時斷開線路。

Thank you for your participation.

感謝您的參與。