BioCardia Inc (BCDA) 2025 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia year-end 2025 financial results and business update conference call. (Operator Instructions)

各位女士、先生，感謝您稍候。下午好，歡迎參加 BioCardia 2025 年度年終財務業績與業務更新電話會議。(接線員指示)

Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call.

提醒本次電話會議的與會者，本次電話會議的音訊正透過網際網路進行即時直播，並同時錄音以供回放。本次電話會議的網路直播回放將於會議結束後約一小時提供。

I would now like to turn the conference over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.

現在我想將會議交給 BioCardia 投資人關係部的 Miranda Peto。Miranda，請開始。

Good afternoon and thank you for participating in today's conference call. Joining me from Biocardia's leadership team are Peter Altman, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address biocaria's expectations for future performance and operational results, references to management's intentions, beliefs, projections, outlook, analysis, and current expectations.

下午好，感謝各位參與今天的電話會議。與我一同出席的 BioCardia 管理團隊成員包括總裁兼執行長 Peter Altman，以及公司財務長 David McClung。在本次電話會議中，管理層將作出前瞻性陳述，包括涉及 BioCardia 對未來表現與營運結果的預期、對管理層意圖、信念、預測、展望、分析及目前預期的提及。

Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. For looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10k filed with the SEC today, March 24th, 2026.

此類因素包括但不限於：開發新產品與新技術以及取得監管核准所固有的不確定性。前瞻性陳述涉及風險及其他因素，可能導致實際結果與該等陳述存在重大差異。關於這些風險的更多資訊，請參閱 BioCardia 今日（2026 年 3 月 24 日）向美國證券交易委員會（SEC）提交的 Form 10-K 報告中所述的風險因素與警示性陳述。

The content of this call contains time sensitive information that is accurate only as of today, March 24th, 2026, except as required by law. The company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

本次電話會議內容包含具時效性的資訊，除法律另有要求外，僅截至今日（2026 年 3 月 24 日）為準且屬準確。公司不承擔任何義務公開更新或修訂任何資訊，以反映本次電話會議後發生的事件或情況。

It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

現在我很榮幸將電話會議交給 BioCardia 總裁兼執行長 Peter Altman 醫師。Peter，請開始。

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's mission is to develop and enhance therapies to treat cardiovascular disease. We are doing this today with three primary platforms our CardiA autologous minimally processed cell therapy. Our Carlo allogeneic, off the shelf mesenchymal cell therapy and our Helix transendocardial biotherapeutic delivery system, which is used by both our Caria and Cariallo cell therapy programs.

謝謝你，Miranda，也向所有參與本次電話會議的各位致上下午好。BioCardia 的使命是開發並提升治療心血管疾病的療法。我們目前透過三個主要平台來實現：我們的 CardiA 自體、最小處理細胞療法；我們的 Carlo 同種異體、即用型（off-the-shelf）間質細胞療法；以及我們的 Helix 經心內膜生物治療遞送系統，該系統同時用於我們的 Caria 與 Cariallo 細胞療法計畫。

Our lead program remains the cardiac cell therapy for roughly 1 million patients in the United States and 150,000 patients in Japan with ischemic heart failure, a reduced ejection fraction. These are patients who've had coronary disease, may have had a heart attack, and have subsequently developed heart failure characterized by a larger dilated heart that unfortunately pumps inefficiently.

我們的主力計畫仍是針對缺血性心衰竭且射血分率降低的心臟細胞療法；在美國約有 100 萬名患者，在日本約有 15 萬名患者。這些患者曾罹患冠狀動脈疾病，可能曾發生心肌梗塞，之後進展為心衰竭，其特徵為心臟擴大、擴張，且不幸地泵血效率低下。

Cardiac therapy includes CD34 and CD 133 cells that have long been recognized as endothelial progenitor cells that promote new capillary formation. Preclinical data also provides support that these cells reduce fibrosis in the heart. Based on these mechanisms to effectively treat microvascular dysfunction, Cartiam cell therapy is introducing a new therapeutic modality to the significant unmet need in ischemic heart failure that is primarily managed today by neurohormonal modulation.

Cardiac 療法包含 CD34 與 CD133 細胞，長期以來被認為是可促進新生毛細血管形成的內皮祖細胞。臨床前數據亦支持這些細胞可降低心臟纖維化。基於這些可有效治療微血管功能障礙的作用機制，Cartiam 細胞療法正為缺血性心衰竭這一重大未被滿足的醫療需求引入新的治療模式；而該疾病目前主要透過神經荷爾蒙調節進行管理。

The clinical outcomes with this approach have been excellent. We now have complete and final data from three clinical trials of the CardiAM therapy with the latest results from our Phase 3 CardiAM HF trial presented as a late breaking clinical trial at the Technology and heart failure therapeutics meeting this month.

採用此方法的臨床結果非常出色。我們目前已取得 CardiAM 療法三項臨床試驗的完整最終數據；其中最新的第三期 CardiAM HF 試驗結果，已於本月在 Technology and Heart Failure Therapeutics 會議上以最新突破性臨床試驗（late-breaking clinical trial）形式發表。

The presentation was titled Autologous Cell Therapy, May Curb Pathological ventricular remodeling and chronic ischemic heart failure of reduced ejection fraction patients selected for favorable cell characteristics. The key takeaway from these new results is in this title. The cardiac HF echocardiography clinical results, which measure heart chamber sizes over time by a truly blinded world-class echocardiography core laboratory, show reductions in left ventricular volume of disease when the heart ventricle is fully dilated with AP value of 0.06 and when the heart is fully contracted with AP value of 0.09.

該報告題為《自體細胞療法或可抑制病理性心室重塑，適用於依有利細胞特徵篩選之慢性缺血性心衰竭且射血分率降低患者》。本次新結果的關鍵重點已體現在標題中。Cardiac HF 的超音波心動圖臨床結果由真正盲法、世界級的超音波心動圖核心實驗室測量心腔大小隨時間的變化；結果顯示左心室容積在心室完全舒張時的疾病容積有所下降，AP 值為 0.06；在心室完全收縮時亦有所下降，AP 值為 0.09。

For the pre-specified subgroups of patients having elevated biomarkers of heart stress, the differences between the treated and controlled patients were both clinically meaningful, greater than 20 mL per meter squared and 15 ml per meter squared respectively. And statistically significant with AP value of 0.02 and p of 0.01 respectively.

對於預先指定之心臟壓力生物標記升高的患者亞組，治療組與對照組之差異在臨床上均具意義，分別大於每平方公尺 20 mL 與每平方公尺 15 mL。且在統計上顯著，AP 值分別為 0.02 與 p 值 0.01。

This echocardiographic data further supports our previous results of reduced fatal and non-fatal major adverse cardiac and cerebral vascular events and improved quality of life in the treated patients. They are similarly strongest in the prespecified subgroup of patients having elevated biomarkers of heart stress. When considered together with the significant reductions in left ventricular and systolic volume and left ventricular and diastolic volume in the treatment group versus the control group, these results provide a basis for linking intramyocardial mononuclear cell therapy with suppression of pathological ventricular remodeling and beneficial clinical outcomes.

這些超音波心動圖數據進一步支持我們先前的結果：治療患者的致死與非致死重大不良心臟及腦血管事件降低，且生活品質改善。同樣地，效果在預先指定之心臟壓力生物標記升高的患者亞組中最為顯著。當把這些結果與治療組相較對照組在左心室收縮末期容積與左心室舒張末期容積的顯著降低一併考量時，這些結果為「心肌內單核細胞療法」與「抑制病理性心室重塑」及「有利的臨床結局」之間的關聯提供了基礎。

This trial result is also considered consistent with observations from other. Heart failure of reduced ejection fraction therapies showing an association between suppression of pathological ventricular remodeling and improvement in mortality. This data is consistent across all three of our clinical studies which saw reduced major adverse cardiac and cerebrovascular events and improved heart function.

本試驗結果亦被認為與其他觀察一致。在射血分率降低之心衰竭治療中，已有研究顯示抑制病理性心室重塑與死亡率改善之間存在關聯。此數據在我們三項臨床研究中均一致，皆觀察到重大不良心臟及腦血管事件降低，且心功能改善。

I also note that two of these trials were randomized double-blinded clinical trials which provide the greatest scientific rigor and the least investigator bias to study outcomes. This is the data we will soon be discussing with the Food and Drug Administration in the United States and which we have been discussing with Japan's Pharmaceutical and Medical Devices Agency or PMDA regarding potential for approval with the rigorous post-marketing studies to collect further evidence with respect to both safety and efficacy.

我也要指出，其中兩項試驗為隨機、雙盲臨床試驗，能提供最高的科學嚴謹性，並將研究者偏差對研究結局的影響降至最低。這些數據將是我們即將與美國食品藥物管理局（FDA）討論的內容；同時我們也一直與日本醫藥品醫療機器綜合機構（PMDA）就潛在核准可能性進行討論，並規劃以嚴謹的上市後研究蒐集更多關於安全性與有效性的證據。

We expect to soon submit a Qub request on approvability of the Caria system to FDA Center for Biologics Evaluation and Research, or CEBR, based on the safety and compelling signals of patients benefits with elevated biomarkers of heart stress from our three clinical trials. This discussion is expected to focus on our already FDA approved Caria cell processing platform to extend existing labeling from in vitro diagnostic use to a therapeutic indication for ischemic heart failure of reduced ejection fraction.

我們預期將很快向 FDA 生物製劑評估與研究中心（CBER）提交關於 Caria 系統可核准性的 Qub 申請，依據我們三項臨床試驗所顯示的安全性，以及在心臟壓力生物標記升高患者中觀察到的具說服力之受益訊號。預期本次討論將聚焦於我們已獲 FDA 核准的 Caria 細胞處理平台，將其既有標示由體外診斷用途延伸至缺血性心衰竭（射血分率降低）的治療適應症。

The dedicated Helix transendocardial delivery catheter has a pre-submission. Actively under review by FDA Center for Devices and Radiological Health. In Japan We expect to soon have our formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from our three trials to show, to allow us to submit the CarAM system.

專用的 Helix 經心內膜遞送導管已完成預先提交（pre-submission）。目前正由 FDA 醫療器材與放射健康中心（CDRH）積極審查中。在日本，我們預期不久將進行正式的臨床諮詢，以與 PMDA 就我們三項試驗既有臨床數據的可接受性達成一致，從而使我們得以提交 CarAM 系統。

If PMDA determines that existing clinical data is acceptable with respect to safety and efficacy, submission for Shonan approval would likely soon follow. Byocardia is not alone in seeking approvals to provide therapeutic options to these patients and the physicians who care for them today. Japan has recently granted conditional approval to another allogeneic cell therapy for ischemic heart failure that involves the placement of sheets of cells on the surface of the heart in a surgical procedure.

若 PMDA 判定既有臨床數據在安全性與有效性方面可被接受，則很可能不久後便會提交申請以取得 Shonan 核准。Byocardia 並非唯一尋求核准、以便為這些患者及目前照護他們的醫師提供治療選項的公司。日本近期已對另一項用於缺血性心衰竭的同種異體細胞治療授予附條件核准；該療法涉及在外科手術中將細胞片置放於心臟表面。

A US listed company has announced that they will be filing for a biological licensing application for their allogeneic cell therapy to also treat patients in a surgical setting. We expect a third company will also soon be applying for approval for surgically delivered cells. The need here is great, and we wish each of these peers and potential future delivery partners every success ahead.

一家在美國上市的公司已宣布，將為其同種異體細胞治療提出生物製劑許可申請（BLA），同樣用於在手術情境下治療患者。我們預期第三家公司也將很快申請核准其以手術方式遞送的細胞療法。此處需求龐大，我們祝福每一位同業以及潛在的未來遞送合作夥伴在前路一切順利、成功。

In parallel to these efforts to wrap up the CardiA HF trial and seek approvals based on this data, we have initiated the Caria HF 2 confirmatory clinical study. CardiA HF 2 focuses on the patients who were the greatest responders in Cariac HF and applies all of our learnings with regard to endpoint and trial design.

在推進完成 CardiA HF 試驗並基於該數據尋求核准的同時，我們已啟動 Caria HF 2 確認性臨床研究。CardiA HF 2 聚焦於在 Cariac HF 中反應最顯著的患者，並將我們在終點設定與試驗設計方面的所有學習加以應用。

In October and November, University of Wisconsin at Madison and Henry Ford Health System in Detroit, Michigan enrolled their first patients in CardiE HF2 respectively. Emory University in Atlanta, Georgia has also been activated as a study site. With Morton Plant Mease in Clearwater, Florida, there are 4 centers actively enrolling in this study today.

於 10 月與 11 月，威斯康辛大學麥迪遜分校以及密西根州底特律的 Henry Ford Health System 分別在 CardiE HF2 中納入其首位受試者。喬治亞州亞特蘭大的 Emory University 亦已啟用為研究中心。加上佛羅里達州克利爾沃特的 Morton Plant Mease，目前共有 4 個中心正在積極招募本研究受試者。

If FDA supports an earlier approval, there is potential the trial design will be modified and become our postmarketing registry. There is also potential that the Cardium HF2 trial may benefit from the previous trial and a shorter pathway to approval be identified. We will have clarity here soon. We have made progress on our cardiac cell therapy clinical program for chronic myocardial ischemia and for our card allogeneic cell therapy for heart failure. The status of these efforts is in our earnings announcement today.

若 FDA 支持較早核准，試驗設計可能會被修改並成為我們的上市後登錄研究（postmarketing registry）。此外，Cardium HF2 試驗也可能受益於先前試驗，並找出較短的核准途徑。我們很快就會釐清。我們在慢性心肌缺血的心臟細胞治療臨床計畫，以及用於心衰竭的同種異體心臟細胞治療方面均已取得進展。這些工作的最新狀態已載於我們今日的財報公告中。

There could be significant upside from these clinical efforts in the near term. We have four catalysts before us in the next quarter. First, the FDA cardiac heart failure Q submission for approval pathway under breakthrough designation has been drafted and is under legal review. We are targeting submission as soon as possible.

這些臨床工作在短期內可能帶來顯著上行空間。未來一季我們面前有四項催化劑。第一，依突破性療法認定（breakthrough designation）之核准途徑所需的 FDA 心臟心衰竭 Q 提交文件已完成草擬，並正進行法務審閱。我們目標是儘快提交。

Second, we have a formal clinical consultation scheduled with Japan PMDA on approvability of Cariam cell therapy. Third, we have an FDA substantive feedback meeting scheduled on approvability of our Helix transomocardial delivery system via the de novo pathway. And fourth, we have an abstract on cardiac and chronic myocardial ischemia that has been accepted for oral presentation at Europ PCR in May.

第二，我們已安排與日本 PMDA 進行正式臨床諮詢，討論 Cariam 細胞治療的可核准性。第三，我們已安排與 FDA 進行實質回饋會議，討論我們的 Helix 經心肌遞送系統透過 de novo 途徑的可核准性。第四，我們有一篇關於心臟與慢性心肌缺血的摘要已獲接受，將於 5 月在 Europ PCR 進行口頭報告。

I will now pass the call to David McClung, our CFO, who will review our fourth-quarter 2025 financial results, David?

接下來我將把電話會議交給我們的財務長 David McClung，他將回顧我們 2025 年第四季的財務結果。David？

Thank you, Peter. Good afternoon, everyone. I'll now provide an overview of our financial results for the year end of December 30th, 2025. Total expense accrees approximately 3% year-over-year to $8.3 million in 2025 compared to 8.1 million in 2024. The primary driver of this change, research and development expense, increased to $5 million in 2025 compared to $4.4 million in 2024.

謝謝你，Peter。各位下午好。我現在將概述截至 2025 年 12 月 30 日止年度的財務結果。2025 年總費用約為 830 萬美元，較 2024 年的 810 萬美元年增約 3%。此變動的主要驅動因素為研發費用，2025 年增至 500 萬美元，較 2024 年的 440 萬美元增加。

The 13% increase was primarily due to the cost of closeout activities in the cardiac heart failure trial, inception of enrollment in the Caria HF2 trial during the year, and regulatory activities to advance Caria in Japan. We anticipate R&D expenses will increase modestly in 2026 as we continue advancing our therapeutic candidates in both the United States and Japan.

13% 的增幅主要來自心臟心衰竭試驗結案活動成本、年度內 Caria HF2 試驗開始收案，以及推進 Caria 在日本的法規相關活動。我們預期 2026 年研發費用將小幅增加，因我們將持續在美國與日本推進我們的治療候選項目。

Selling general and administrative expenses decreased 10% in 2025 to 3.3 million as compared to 3.7 million in 2024, primarily due to lower professional fees coupled with reduced share-based compensation expense. We expect 2026 SG&A expenses to remain close to these 2025 levels. Our net loss increased modestly to 8.2 million in 2025 from 7.9 million in 2024.

2025 年銷售、一般及行政費用（SG&A）較 2024 年下降 10%，降至 330 萬美元（2024 年為 370 萬美元），主要由於專業服務費降低，並伴隨以股份為基礎的薪酬費用減少。我們預期 2026 年 SG&A 費用將大致維持在 2025 年水準附近。我們的淨損小幅增加，2025 年為 820 萬美元，較 2024 年的 790 萬美元略增。

Net cash used in operations was approximately 7.5 million during the year in 2025. That's down from 7.9 million in 2024. The company ended the year with cash in cash equivalents totaling 2.5 million, very comparable to the 2.4 million as of December 30th, 2024. We expect our cash burn will be relatively consistent in 2026, continuing our track record for carefully managing the use of resources and capital.

2025 年全年營運活動使用的淨現金約為 750 萬美元。較 2024 年的 790 萬美元下降。公司年末持有現金及約當現金合計 250 萬美元，與截至 2024 年 12 月 30 日的 240 萬美元非常接近。我們預期 2026 年的現金消耗（cash burn）將相對一致，延續我們審慎管理資源與資本使用的紀錄。

This concludes management's prepared remarks. We are happy now to take questions from attendees.

以上為管理層預先準備的發言。我們現在很樂意回答與會者的提問。

(Operator Instructions) Joe Pantginis, H.C. Wainwright.

(接線員指示) Joe Pantginis，H.C. Wainwright。

Hello, everyone. This is Landed on for Joe. Thanks for the updates and thanks for taking our questions. We have a few. So, let me start with the Echo data presented at THT. So I wonder if you can provide some color on the P values for the diastolic and systolic volumes in the complete population and how do you think this data can support the narrative you're presenting to the PMDA?

各位好。我是代替 Joe 的 Landed on。感謝更新，也謝謝你們回答我們的問題。我們有幾個問題。我先從在 THT 發表的超音波（Echo）數據開始。我想請問你們能否補充一下在完整受試者族群中，舒張期與收縮期容積的 P 值情況，以及你們認為這些數據如何支持你們向 PMDA 所呈現的論述？

Hello. Sorry Landaron.Thank you for the question. Thank you for the question, and I really appreciate your eye on the echo data. So this data is remarkably lovely data. So and just I'll start off for everybody typically in these trials for all of these therapies, very few companies have long-term. Truly blinded echo data. It just, it's a very rare thing and we have it in this trial and the core laboratory at Yale University is world class.

你好。抱歉，Landaron。謝謝你的提問。謝謝你的問題，我也非常欣賞你對超音波數據的關注。這份數據非常漂亮。我先為大家說明，一般在這類療法的試驗中，很少有公司擁有長期的、真正盲態的超音波數據。這非常罕見，而我們在本試驗中具備；且耶魯大學的核心實驗室是世界一流。

And so your question, Landaron was across all patients, the P values are not statistically significant, but they're approaching it. But to even see that kind of trend is wonderful. So our expectation is that our approvals both in the United States and in Japan will not be for the full cohort, but will be for the subgroup with elevated NTPR BMP, and because those patients.

因此回到你的問題，Landaron：在所有患者合併分析下，P 值未達統計顯著，但已接近。然而，能看到這樣的趨勢就已非常令人振奮。因此我們預期，無論在美國或日本，我們的核准範圍都不會涵蓋整個隊列，而是針對 NTPR BMP 升高的亞組，因為那些患者。

NTRBMP is a marker that's released when the heart is under stress and so when you have high stress in the heart, it continues to dilate. And so what we're seeing is that most patients who are decompensated and are continuing to dilate, the mononuclear cell therapy appears to stop that process. So that's what's exciting about this data. So we see it across the full population.

NTRBMP 是一種在心臟承受壓力時會釋放的標記物，因此當心臟壓力很高時，它會持續擴張。因此我們看到的是，多數失代償且持續擴張的患者，單核細胞治療似乎能夠阻止這個過程。所以這就是這些數據令人振奮之處。我們在整體族群中都看到了這一點。

With AP value of just above the the key 0.05 threshold but in but in the subgroup we're looking at p value of 0.02 and 0.01 for echo measures and and these are large magnitude changes that were presented at the THT conference. Another value proposition above and beyond just talking to regulators with respect to this data on their own is this data is compelling to cardiologists who are trying to.

AP 值略高於關鍵的 0.05 門檻，但在我們所看的亞組中，超音波量測的 p 值為 0.02 與 0.01，而且這些是在 THT 會議上呈現的、幅度很大的變化。除了就這些數據本身與監管機構溝通之外，另一個價值主張是：這些數據對於試圖為其患者尋找先進療法的心臟科醫師而言也很有說服力。

Advanced therapies for their patients and the patients that we have treated are on guideline directed medical therapy, so the patients in this trial have already been advanced on everything that's available to them that's not extremely invasive, and they still are dying at a rate of approximately 10% per year. The big lament in heart failure is that nothing is changing mortality.

為患者提供先進療法，而我們治療過的患者都已接受指南導向藥物治療，因此本試驗中的患者已經在所有可用、且非高度侵入性的治療上都已經升級到極致，但他們仍以每年約 10% 的比率死亡。心衰竭領域最大的遺憾是，沒有任何事物正在改變死亡率。

And here we're seeing a therapy that not only appears at a high level to be reducing mortality in MC. But it's also showing these changes in left ventricular volumes that have a long history of being correlated with reduced mortality as well. So I think there'll be a lot of excitement in the cardiology community, and that will translate into excellent enrollment in the Caria heart failure 2 trial when we put our full weight behind it.

而在這裡我們看到一種治療，不僅在整體層面上似乎正在降低 MC 的死亡率。它也顯示左心室容積的變化，而這些變化長期以來被證實與死亡率降低相關。因此我認為心臟科社群會非常興奮，而當我們全力推動時，這將轉化為 Caria 心衰竭 2 試驗的優異收案表現。

Perfect. That's helpful. Yeah. So, and do you have an estimate of of the Cardia submission to the FDA if everything goes according to plan? And how are you thinking about the potential requirements for post-marketing studies and their execution?

很好。這很有幫助。是的。那麼，如果一切按計畫進行，你們是否能估計 Cardia 向 FDA 提交申請的時間？以及你們如何看待上市後研究的潛在要求與其執行方式？

So for Caria HF, we are, as I shared in my remarks. We're imminently going to file for a discussion on approvable pathways, so they already have all of the data from the trial. We will be providing other analyses that have been done, but that's imminent. I expect the timeline will be because this has FDA breakthrough designation, it'll be under a standard sprint discussion which I estimate is roughly a 45-day turnaround.

關於 Caria HF，如同我在發言中分享的。我們即將提交申請以討論可核准的途徑，他們已經擁有該試驗的所有數據。我們也會提供已完成的其他分析，但這將是近期就會進行。我預期的時程是，因為這項產品具有 FDA 突破性認定，將會採用標準的 sprint 討論流程，我估計大約是 45 天左右的回覆週期。

And then the subsequent, if they, if they're supportive, it will take time for all of the. Details regarding a submission to be put forward, and there's two approval pathways even though this is regulated by CBI. It is a device system and so the approval pathway again SEBR, the Center for Biologics Evaluation Research, the device pathway has both the PMA and the de novo pathway and because of the safety profile we see with Caria, it actually could go down the de novo pathway, which is really interesting.

接著，如果他們支持，仍需要時間把提交申請的所有細節整理提出，而且即使這是由 CBI 監管，也有兩條核准途徑。它是一個器械系統，因此核准途徑同樣是由 CBER（生物製劑評估與研究中心）負責；器械途徑同時包含 PMA 與 de novo 途徑，而基於我們在 Caria 看到的安全性概況，它其實可能走 de novo 途徑，這點非常有意思。

De novo is for devices that are safe and there's no safety issues I'm aware of right now with respect to cardiac. So if that's the door that's open and we decide to pursue it could be a very short timeline and relatively straightforward to secure approval, but if it's a PMA pathway which has certain strategic advantages. It could be a little longer.

De novo 適用於安全、且我目前所知在心臟方面沒有安全疑慮的器械。因此如果這扇門是開著的、而我們決定採取該途徑，時程可能非常短，且取得核准相對直接；但如果是 PMA 途徑，因其具有某些策略優勢。則可能會稍微久一些。

The key question for FDA and for Japan PMDA is this data acceptable for safety and efficacy for market release? Now your second part of the question, Landaron was, how do you think about the post-marketing study. So post marketing studies, you cannot have patients come in and not have an option to therapy. You can't truly randomize so we would expect these to be relatively extensive studies on many hundreds of patients that we would follow over time and we will be collecting.

FDA 與日本 PMDA 的關鍵問題是：這些數據在安全性與有效性方面是否足以支持上市放行？至於你問題的第二部分，Landaron，你問的是如何看待上市後研究。上市後研究中，你不能讓患者進來卻沒有治療選項。你也無法真正做到隨機分派，因此我們預期這會是相對大型的研究，涵蓋數百名患者並隨時間追蹤，我們也將收集。

Long-term survival data potentially echo data potentially biomarker data it's something to be discussed with respect to the agency's guidance on this from each area. Those measures I just identified are standard measures, so it wouldn't necessarily put an enormous undue burden on myocardia. Echo measures and NTR BMP measures and understanding survival could be done relatively cost effectively in an open label setting so that's how we think about it so clearly it's a partnership with the regulatory bodies on their past experience and securing their support based on this data is really the focus.

長期存活數據、可能的超音波數據、可能的生物標記數據；這些將依各地主管機關對此的指引再行討論。我剛提到的那些指標都是標準量測，因此不一定會對 myocardia 造成過度額外負擔。在開放標籤的情境下，超音波量測與 NTR BMP 量測，以及對存活的理解，都可以相對具成本效益地完成；這就是我們的思考方式。因此很明顯，這需要與監管機構合作，依其過往經驗來進行，而基於這些數據取得他們的支持，才是真正的重點。

Perfect. That makes sense. Yeah, thank you for that. And you already talked about this a little bit, but how do you see Cartium, the HF competing or not with other cell therapies for heart failure that are currently in regulatory discussions?

很好。這很合理。是的，謝謝你的說明。你剛才已經稍微談到一些，但你如何看待 Cartium（HF）與目前正在監管討論中的其他心衰竭細胞療法之間，會競爭或不競爭？

So, the, so, with respect to what are called the four pillars of therapy in heart failure, of the patients, that's guideline directed medical therapy that's established, all of the patients in our Cariam HF and in our Cardiam HF 2 trial are already on guideline directed medical therapy. So, it's not, Instead of but really it's in addition to and we're seeing these benefits in addition to with the newer cell therapies that are seeking approval in the United States they're all surgical delivery so far.

所以，關於心衰竭治療所謂的四大支柱，對患者而言，那就是已建立的指南導向藥物治療；我們的 Cariam HF 與 Cardiam HF 2 試驗中的所有患者都已經在接受指南導向藥物治療。因此這不是「取代」而是「加上去」，而我們看到的是在既有治療之上額外帶來的效益；至於那些正在美國尋求核准的新型細胞療法，目前為止都採手術式給藥。

I believe that they've all expressed interest publicly on pursuing different approaches for minimally invasive delivery such as we are pursuing and we could be helpful to them there. I see the competitive landscape. As one where, at the end of the day, I think Caria will always remain one of the leading therapies because of how straightforward it is and how cost effective it will be, at the same time.

我相信他們都曾公開表達有興趣追求不同的微創給藥方式，就像我們正在推動的那樣，而我們也可能在那方面對他們有所幫助。我看待競爭格局。是這樣的：歸根究柢，我認為 Caria 會一直是領先療法之一，因為它非常直接、且成本效益會很高；同時。

You know this is the nature of waves of therapeutic development. There will ultimately be head to head trials for different therapies, and it's good for patients if they have different therapeutic options and they're well studied. My sense is from an efficacy perspective. I actually think the cardiac therapy is amongst the most robust therapy therapeutic data that's out there. If you look at the magnitudes of changes we're seeing.

你知道，這就是治療開發浪潮的本質。最終會出現不同療法之間的頭對頭試驗；如果患者有不同的治療選項、且都被充分研究，這對患者是好事。就有效性而言，我的感覺是。我其實認為這項心臟治療在現有資料中屬於最強健的治療數據之一。如果你看我們所看到的變化幅度。

Compared to all of the pivotal trials for the guideline directed medical therapy, the magnitudes are compelling, and so, it's going to be interesting. I think the key thing is to continue to collect data, for evidence of both safety and efficacy and like all great therapies, things will evolve slowly over time. But I'm not concerned about the competitive issues.

相較於所有指南導向藥物治療的關鍵性試驗，這些幅度很有說服力，因此會很有意思。我認為關鍵是持續收集數據，以提供安全性與有效性的證據；而如同所有優秀療法一樣，事情會隨時間緩慢演進。但我不擔心競爭方面的問題。

I think it's great for these patients that there's a number of folks, pursuing therapies because the need here is enormous, in the United States, just in our indication, it's a million patients, so that's how we see things.

我認為對這些病患來說很棒，因為有不少人正在投入研發治療方法；這裡的需求非常龐大。在美國，光是就我們的適應症而言，就有一百萬名病患，所以我們是這樣看待的。

Yeah, awesome awesome well thank you so much thank you so much for clarifying this.

是的，很棒很棒，非常感謝，也非常感謝你釐清這點。

Thanks I appreciate the questions Landonon thank you so much of course thank you be well.

謝謝，我很感謝這些問題，Landonon，非常感謝；當然，謝謝你，保重。

James Molloy, Alliance Global Partners Corp.

James Molloy，Alliance Global Partners Corp.（聯盟全球合夥公司）

Hey guys, thank you for taking my questions. I was wondering if you could talk a little bit about, the enrollment in the HF2 trial. Maybe you have. A few patients enrolled, talk about sort of how the, how that's how that's building any anecdotal sort of stories from the enrollment, the challenges they're facing, or maybe the challenges you aren't facing and what sort of the best centers, best practices they're using to sort of get folks into this HF2 trial.

嗨，各位，謝謝你們回答我的問題。我想請你們談談 HF2 試驗的收案情況。也許你們已經提過了。目前有幾位病患入組，能否談談收案是如何逐步建立的、收案過程中有沒有一些軼事性的故事、他們面臨的挑戰，或是你們其實沒有遇到的挑戰，以及哪些中心表現最好、他們採用哪些最佳實務來讓更多人進入這項 HF2 試驗。

Yes, no, great question, Jim, and I really appreciate you being on the call. So if you actually look at our updated corporate presentation that just came out a little while ago, we have pictures of three of the clinical teams at these sites for Cardi MHF2. And we put the pictures in there, first off, because it's really the centers that do all the work.

是的，這是個很好的問題，Jim，也非常感謝你參與這通電話。如果你去看我們不久前剛更新發布的公司簡報，我們放了 Cardi MHF2 這些試驗中心三個臨床團隊的照片。我們把照片放進去，首先是因為真正做所有工作的其實是這些中心。

But second, because you can see everybody's smiling after these procedures and that's the signal of how how well it's going as we're doing these procedures and also the relationship. Chips around doing this work, enrollment numbers right now we haven't detailed, but we're starting this enrollment slowly because almost all of our clinical team is focused on the efforts, enormous efforts in taking a Phase 3 trial data set through for regulatory submission.

其次，因為你可以看到大家在這些手術後都在微笑，這就是一個訊號，顯示我們在執行這些手術時進展得多順利，以及彼此之間的合作關係。至於目前的收案數字我們還沒有詳細披露，但我們是以較慢的速度開始收案，因為我們幾乎整個臨床團隊都專注在一項龐大的工作：把第三期試驗的資料集推進到法規申請。

But all of that is coming to a head, and the beauty of this effort is that that data will be a primary driver in enrollment ahead. So our expectation is as soon as we complete these conversations with PMDA and FDA, we'll know whether or not the Cardiia HF2 trial should continue to be a randomized double blind trial or should be migrated to a potentially open label postmarketing study. And that impacts, our efforts.

不過這些工作都快要到關鍵點了，而這項努力的好處在於，這份資料將會成為後續收案的主要推動力。因此，我們預期一旦完成與 PMDA 與 FDA 的溝通，我們就會知道 Cardiia HF2 試驗是否應該繼續作為隨機雙盲試驗，或是轉為可能的開放標籤上市後研究。而這會影響我們的投入與推進方式。

And second, if it stays a randomized trial, our team will have the strength of this data set which will help on the enrollment side. So we have quite a few sites that are interested in getting involved in the study. It's primarily a bandwidth and a resource basis for why that has not gone faster, but that will come soon ahead. So, I hope that answers your question, Jim?

第二，如果它仍維持為隨機試驗，我們的團隊將擁有這份資料集的支撐，這會在收案端提供幫助。所以目前有相當多的中心有興趣參與這項研究。之所以沒有更快，主要是受限於人力帶寬與資源配置，但很快就會改善。所以，希望這回答了你的問題，Jim？

It does indeed thank you very much. And then, me moving over to the CMI, we're looking for the 6 month data here at the EUR PCR in Paris in May. What's sort of good, bad, equivocal, what would we be looking for as we're, as that data comes rolling out?

確實回答了，非常感謝。接著我轉到 CMI，我們預期在 5 月巴黎的 EUR PCR 看到 6 個月數據。當這些數據陸續公布時，我們應該關注哪些算是好、哪些算是不好、哪些可能是模稜兩可的結果？

So, I think that the data is as we, we've shared sort of a top-line. I think you'll get more visibility into the phys physician and patient experience in that trial and I think the interesting thing about the CMI trial is right now there's not a lot of options for patients with CMI. And the main value of, we're right now not driving forward aggressively in enrolling the randomized portion of that trial where we sort of put it on pause to focus on the heart failure program.

我認為這些數據就如同我們先前分享的那樣，屬於某種頂線（top-line）資訊。我想你會更清楚看到該試驗中醫師與病患的使用與治療體驗；而 CMI 試驗有趣之處在於，目前針對 CMI 病患的選項並不多。而我們目前的主要考量是：我們並沒有積極推進該試驗隨機部分的收案，因為我們暫停了它，以便專注在心衰竭計畫。

But, from a business development perspective, it effectively doubles the market potential of Cardi AHF. And so if we had resources we could very easily advance the Cardi AM CMI trial all the way through its pivotal cohort but you know those are some of the things that we're talking about in business development settings.

不過，從商務開發的角度來看，它實際上讓 Cardi AHF 的市場潛力加倍。因此，如果我們有資源，我們其實可以很容易把 Cardi AM CMI 試驗一路推進到其關鍵性（pivotal）隊列；但你知道，這些就是我們在商務開發場合正在討論的一些事情。

And how would you characterize the the environment for potential partnerships currently?

那你會如何描述目前潛在合作夥伴關係的環境？

That's a big question. Right now there's a lot of folks focused on different things. I'll keep you posted. I think in the past we've been, rather forthcoming on all the conversations we have with respect to our various assets and platforms, and, I think what will happen, Jim, is with it, the first cardiac cell therapy approved. In Japan on the 19th of February, this is still pretty brand new stuff for all of those folks in business development who are who are used to looking at years of a runaway with cash flow.

這是個很大的問題。目前有很多人把焦點放在不同的事情上。我會持續向你更新。我想過去我們對於就我們各項資產與平台所進行的各種對話，一直都相當坦率、也願意分享；而我認為接下來會發生的是，Jim，隨著日本在 2 月 19 日核准第一個心臟細胞治療，對於那些商務開發人士而言，這仍然是非常新的事物，因為他們習慣評估的是多年期、且有現金流的成熟產品。

I think there will be great interest. I think the interest in CardiAM CMI will primarily be driven by the interest in CardiA HF, and my sense is. With Cardiia HF on a path to potential an early approval in the US or in Japan, there will be great interest and support in CardiAM CMI as well as in Cario.

我認為會有很大的興趣。我認為對 CardiAM CMI 的興趣，主要會由對 CardiA HF 的興趣所帶動；而我的感覺是，隨著 Cardiia HF 走在可能於美國或日本取得較早核准的路徑上，市場將會對 CardiAM CMI 以及 Cario 也展現高度興趣與支持。

Thank you very much for taking the questions. Appreciate them, Jim. I really appreciate you being on the call.

非常感謝你回答這些問題。也謝謝你，Jim。我真的很感謝你參與這通電話。

Our question-and-answer session. I would like to turn the conference back over to Peter Altmann for any closing remarks.

我們的問答環節到此結束。我想把會議交回給 Peter Altmann，請他做任何結語。

Thank you, Nick. Our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment. Of microvascular dysfunction. Our base plan remains to complete the confirmatory Caria HF2 trial while we engage with FDA and PMDA on potential near-term approvals. On behalf of our entire biocardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you.

謝謝你，Nick。我們推進以細胞為基礎的缺血性心衰竭療法的努力，正透過治療微血管功能障礙，為病患帶來重要的效益。我們的基本計畫仍是完成確認性（confirmatory）的 Caria HF2 試驗，同時與 FDA 與 PMDA 就近期可能的核准進行溝通。我代表我們整個 BioCardia 團隊，感謝所有股東持續的支持，因為有你們，我們的努力才得以實現。謝謝。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

本次電話會議現在結束。感謝您參加今天的簡報。您現在可以掛線。