BioCardia Inc (BCDA) 2024 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by.

女士們先生們，謝謝你們的支持。

Good afternoon.

午安.

And welcome to the BioCardia second quarter 2024 financial results and business update conference call.

歡迎參加 BioCardia 2024 年第二季財務業績和業務更新電話會議。

(Operator Instructions).

（操作員說明）。

I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations.

我現在想將電話轉給 BioCardia 投資者關係部門的米蘭達佩托 (Miranda Peto)。

Please go ahead, Miranda.

請繼續，米蘭達。

Thank you.

謝謝。

Good afternoon and thank you for participating in today’s conference call.

下午好，感謝您參加今天的電話會議。

Joining me from BioCardia’s leadership team are Peter Altman Ph.D., President and Chief Executive Officer; and David McClung, the company’s Chief Financial Officer.

與我一起加入 BioCardia 領導團隊的是總裁兼執行長 Peter Altman 博士；以及公司財務長 David McClung。

During this call, management will be making forward-looking statements, including statements that address BioCardia’s expectations for future performance and operational results, references to management’s intentions, beliefs, projections, outlook, analyses and current expectations.

在本次電話會議中，管理層將做出前瞻性聲明，包括涉及 BioCardia 對未來業績和營運結果的預期的聲明，以及管理層的意圖、信念、預測、展望、分析和當前預期。

Such factors include, among others, the inherent uncertainties associated with developing new products, technologies and obtaining regulatory approval.

這些因素包括與開發新產品、技術和獲得監管部門批准相關的固有不確定性等。

Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

前瞻性陳述涉及風險和其他因素，可能導致實際結果與這些陳述有重大差異。

For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia’s report on Form 10-K, filed with the SEC March 27, 2024, and in subsequently filed Form 10-Q.

有關這些風險的更多信息，請參閱 BioCardia 於 2024 年 3 月 27 日向 SEC 提交的 10-K 表報告以及隨後提交的 10-Q 表中描述的風險因素和警示聲明。

The content of this call contains time-sensitive information that is only accurate as of today, August 13, 2024.

本次通話的內容包含時效性訊息，僅截至今天（2024 年 8 月 13 日）準確。

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.

除法律要求外，本公司不承擔公開更新或修改任何資訊以反映本次電話會議後發生的事件或情況的義務。

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

現在我很高興將電話轉給 BioCardia 總裁兼執行長 Peter Altman 博士。

Peter, please go ahead.

彼得，請繼續。

Thank you, Miranda, and good afternoon to everyone on the call.

謝謝米蘭達，祝所有參加電話會議的人下午好。

This has been a tough quarter for our share price, even as we continue to deliver the milestones that underlie our business, with signs of both safety and patient benefit from each of our efforts.

對於我們的股價來說，這是一個艱難的季度，儘管我們繼續實現業務的里程碑，有跡象表明我們的每項努力都使安全和患者受益。

Our lead autologous cell therapy for the treatment of heart failure is being studied today in two clinical trials.

我們用於治療心臟衰竭的主要自體細胞療法目前正在兩項臨床試驗中進行研究。

The CardiAMP Heart Failure I trial expects last patient follow-up at the end of September this year.

CardiAMP 心臟衰竭 I 試驗預計在今年 9 月底進行最後一次患者追蹤。

We are hopeful that the monitored data on all patients will reflect the same results that we have seen with 90% of the patient follow-up data obtained in the interim review last year.

我們希望所有患者的監測數據能夠反映與去年中期審查中獲得的 90% 患者追蹤數據相同的結果。

Across all patients enrolled, this data showed trends in treated patients having improved survival, reduced major adverse cardiac events and improved quality of life.

在所有入組患者中，這些數據顯示接受治療的患者存活率提高、主要不良心臟事件減少且生活品質增加的趨勢。

The CardiAMP Heart Failure I trial is enormously important, particularly if these interim results are in line with the final results.

CardiAMP 心臟衰竭 I 試驗非常重要，特別是如果這些中期結果與最終結果一致的話。

The fully enrolled study is one of the largest cardiac cell therapy studies performed for the treatment of heart failure in the United States, with clinical results showing patient benefits that are meaningful for both patients and the physicians who care for them.

這項完全入組的研究是美國為治療心臟衰竭而進行的最大的心臟細胞療法研究之一，臨床結果顯示患者受益，這對患者和照顧他們的醫生都有意義。

Our team has been working to monitor sites and be prepared to lock the data for final readout this year.

我們的團隊一直在努力監測站點，並準備鎖定數據以供今年的最終讀數。

The data from this trial is intended to provide support for future product approvals and commercialization of the CardiAMP cell therapy in Japan and the United States.

該試驗的數據旨在為 CardiAMP 細胞療法在日本和美國的未來產品批准和商業化提供支持。

As we seek to complete CardiAMP Heart Failure I and confirm the final results are as good as we believe them to be, we are advancing a second confirmatory clinical trial in CardiAMP Heart Failure II, which focuses on the remarkable benefits in patients treated with elevated NTproBNP, a well-established biomarker of active heart failure.

當我們尋求完成CardiAMP 心臟衰竭I 並確認最終結果與我們認為的一樣好時，我們正在推進CardiAMP 心臟衰竭II 的第二項驗證性臨床試驗，該試驗重點關注接受升高的NTproBNP 治療的患者的顯著益處，一種成熟的活動性心臟衰竭生物標記。

Results in these patients presented at Technology and Heart Failure Therapeutics Conference in March 2024 showed a remarkable 86% relative risk reduction in heart death equivalents and a 24% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events.

2024 年3 月在技術與心臟衰竭治療會議上公佈的這些患者的結果顯示，心死亡當量的相對風險顯著降低了86%，非致命性主要不良心腦血管事件的相對風險顯著降低了24 %。

This is particularly exciting as therapies that are available today do not have a significant impact on mortality for these patients.

這是特別令人興奮的，因為目前可用的療法對這些患者的死亡率沒有顯著影響。

And unfortunately, mortality for these patients is still approximately 50% over a five-year period.

不幸的是，五年內這些患者的死亡率仍約為 50%。

The CardiAMP Heart Failure II trial is the only confirmatory pivotal trial of a cell therapy in heart failure that has ever been initiated.

CardiAMP 心臟衰竭 II 試驗是迄今為止啟動的唯一一項針對心臟衰竭細胞療法的驗證性關鍵試驗。

It has a greater than 90% power or statistical probability of success to meet the primary endpoint based on the CardiAMP Heart Failure trial interim results.

根據 CardiAMP 心臟衰竭試驗中期結果，其成功達到主要終點的效力或統計機率大於 90%。

The world-class cardiologists on the CardiAMP Heart Failure I Executive Steering Committee, on the Data Safety Monitoring Board and on the Clinical Events Committee are all continuing with us to support the CardiAMP Heart Failure II trial.

CardiAMP 心臟衰竭 I 執行指導委員會、資料安全監測委員會和臨床事件委員會的世界級心臟病專家都將繼續與我們一起支持 CardiAMP 心臟衰竭 II 試驗。

Two additional world-class heart failure clinicians have also joined our Executive Steering Committee.

另外兩位世界級的心臟衰竭臨床醫生也加入了我們的執行指導委員會。

The first is Dr. Wilson Tang, CardiAMP Heart Failure I trial investigator, Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, and Research Director of Heart Failure and Transplant in the Department of Cardiovascular Medicine.

第一個是 Wilson Tang 博士，CardiAMP 心臟衰竭 I 試驗研究者、克利夫蘭診所勒納醫學院醫學教授、心血管醫學繫心臟衰竭和移植研究主任。

The second is Dr. Leslie Miller, CardiAMP Heart Failure I trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida, and a former President of the International Society of Heart and Lung Transplantation.

第二位是 Leslie Miller 博士，他是佛羅裡達州克利爾沃特 BayCare Morton Plant 醫院 CHF 心臟功能診所的 CardiAMP 心臟衰竭 I 試驗研究員，也是國際心肺移植學會前主席。

Dr. Miller’s site is the first site activated in the CardiAMP Heart Failure II study, and it is reported that five patients have already been consented for the trial by his clinical research team.

Miller 博士的站點是 CardiAMP 心臟衰竭 II 研究中激活的第一個站點，據報道，他的臨床研究團隊已同意 5 名患者參加該試驗。

Combined, these 12 world-class cardiologists, all of whom have seen our data and have worked with us on CardiAMP Heart Failure I, are supporting the CardiAMP Heart Failure II study.

這 12 位世界級心臟科醫生都看過我們的數據並與我們合作研究 CardiAMP 心臟衰竭 I，他們正在支持 CardiAMP 心臟衰竭 II 研究。

We are more than thankful for each of their involvement, extensive experience, valuable advice and ongoing support.

我們非常感謝他們的每一次參與、豐富的經驗、寶貴的建議和持續的支持。

BioCardia intends to become an enrolling machine in the CardiAMP Heart Failure II clinical trial.

BioCardia 打算成為 CardiAMP 心臟衰竭 II 臨床試驗的招募機器。

Enrollment is expected to be significantly enhanced because of the positive data and experience from the CardiAMP Heart Failure I trial, which we feel is compelling for heart failure physicians and their patients.

由於 CardiAMP 心臟衰竭 I 試驗的積極數據和經驗，預計入組人數將顯著增加，我們認為這對心臟衰竭醫生及其患者來說非常有吸引力。

Enrollment will be further enhanced by efforts we have taken to streamline the clinical study and by the enormous experience in the broader CardiAMP clinical team.

我們為簡化臨床研究所做的努力以及更廣泛的 CardiAMP 臨床團隊的豐富經驗將進一步增加入組人數。

There are other advances to the CardiAMP autologous cell therapy that we hope to be announced soon, expected to further enhance enrollment in the CardiAMP Heart Failure II trial over that which was possible in CardiAMP Heart Failure I.

我們希望盡快公佈 CardiAMP 自體細胞療法的其他進展，預計將進一步提高 CardiAMP 心臟衰竭 II 試驗的入組人數，超過 CardiAMP 心臟衰竭 I 試驗的入組人數。

Beyond our lead autologous cell therapy program in heart failure, we have also made progress this quarter in other programs.

除了我們領先的心臟衰竭自體細胞治療課程之外，本季我們在其他項目上也取得了進展。

In April, open-label clinical results from CardiAMP cell therapy and chronic myocardial ischemia were shared with greater benefits than other established therapies.

今年 4 月，CardiAMP 細胞療法和慢性心肌缺血的開放標籤臨床結果被分享，其益處比其他既定療法更大。

We discussed this data in our last quarterly call and the last rolling cohort patient is now scheduled for treatment later this month.

我們在上一季電話會議中討論了這些數據，最後一名滾動隊列患者現已安排在本月稍後接受治療。

In May, our partner CellProthera announced the results of their cell therapy in the indication of acute myocardial infarction.

五月份，我們的合作夥伴 CellProthera 公佈了他們針對急性心肌梗塞的細胞療法的結果。

We discussed this result in our last quarterly call and are excited for CellProthera and their data.

我們在上一季的電話會議中討論了這一結果，並對 CellProthera 及其數據感到興奮。

These three programs and three distinct clinical indications of heart failure, chronic myocardial ischemia and acute myocardial infarction demonstrate the broad utility and performance of BioCardia’s Helix Delivery System for the delivery of biologics locally to heart tissue.

這三個項目以及心臟衰竭、慢性心肌缺血和急性心肌梗塞的三種不同的臨床適應症證明了 BioCardia 的 Helix 輸送系統在將生物製劑局部輸送到心臟組織方面的廣泛實用性和性能。

One element of the Helix Delivery System is our Morph DNA Steerable Introducer.

Helix 輸送系統的要素之一是我們的 Morph DNA 可操縱導引器。

This Morph DNA product design has performed well for our procedures and has potential to enhance many other clinical procedures as a commercial product with a broader product family configuration.

這種 Morph DNA 產品設計在我們的手術中表現良好，並且作為具有更廣泛產品系列配置的商業產品，有潛力增強許多其他臨床手術。

In late July, we announced that we had completed an FDA submission for market clearance for a broader product family of Morph DNA Steerable Introducers.

7 月下旬，我們宣布已完成 FDA 提交的更廣泛的 Morph DNA 可引導導引器產品系列的市場許可申請。

We are hopeful for market clearance at the end of this quarter.

我們希望在本季末獲得市場清理。

On the business development front, we have active partnering discussions with potential to be meaningful for our business with respect to all four of our platforms, CardiAMP, CardiALLO, Helix and Morph.

在業務發展方面，我們進行了積極的合作討論，這些討論可能對我們所有四個平台（CardiAMP、CardiALLO、Helix 和 Morph）的業務有意義。

For CardiAMP, our autologous cell therapy platform, the focus has been on discussions with potential distributors even as the therapy is not yet approved.

對於我們的自體細胞治療平台 CardiAMP，即使該療法尚未獲得批准，重點仍然是與潛在經銷商的討論。

Receiving approval in a first world country such as USA or Japan is also expected to enable distribution partnerships to be realized in other regions of the world.

在美國或日本等第一世界國家獲得批准也有望在世界其他地區實現分銷合作夥伴關係。

We have had a number of discussions this quarter around distribution partnerships in Japan, Brazil and the United Arab Emirates.

本季我們圍繞日本、巴西和阿拉伯聯合大公國的分銷合作夥伴關係進行了多次討論。

There is potential to enter into such distribution arrangements in advance of approval as this has the advantage for potential partners and that they can bring their experience to the table in positioning the therapeutic offering in their country of focus with respect to the physician community and payers.

有可能在批准之前達成此類分銷安排，因為這對潛在合作夥伴有利，並且他們可以將自己的經驗帶到桌面上，將治療產品定位在其關注的國家/地區，與醫生群體和付款人相關。

For CardiALLO, our allogeneic cell therapy, currently in the clinic for heart failure, we have extensive clinical experience from three trials.

對於目前用於心臟衰竭臨床的同種異體細胞療法 CardiALLO，我們從三項試驗中獲得了豐富的臨床經驗。

We have had discussions around partnering these cells for other clinical indications beyond our current plans in cardiac and pulmonary disease with one ongoing discussion this past month.

除了我們目前的心臟和肺部疾病計劃之外，我們還討論瞭如何將這些細胞用於其他臨床適應症，上個月正在進行討論。

For our Helix Biotherapeutic Delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products and support capabilities remain active in discussions.

對於我們的 Helix 生物治療交付平台，希望獲得我們的交付經驗、產品和支持能力的潛在生物治療交付合作夥伴仍在積極討論。

Current partners realize that minimally invasive delivery not only enhances future commercialization, but is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing their operational costs by shortening timelines for their own therapeutic development.

目前的合作夥伴意識到，微創給藥不僅可以增強未來的商業化，而且還被視為臨床開發的關鍵手段，可以加快註冊速度，從而透過縮短自己的治療開發時間來顯著降低營運成本。

Lastly, partner therapeutics are expected to benefit enormously from our three-fold efficiency of delivery and enhanced pharmacokinetics with our Helix system supported by data from many groups.

最後，合作夥伴療法預計將從我們三倍的遞送效率和增強的藥物動力學中受益匪淺，而我們的 Helix 系統得到了許多團體的數據支持。

We believe this advantage is due to the stability of the Helix in the beating heart and the cell-sealing helical pathway into the tissue.

我們相信這一優勢歸因於跳動心臟中螺旋的穩定性以及進入組織的細胞密封螺旋路徑。

We encourage all partners to perform pharmacokinetic studies, including a surgical delivery control, so that they will have their own data supporting what we have seen.

我們鼓勵所有合作夥伴進行藥物動力學研究，包括手術分娩控制，以便他們擁有自己的數據來支持我們所看到的結果。

To-date, we have participated in more than 20 development programs and partnerships with almost every well-known program, some of which are identified in our corporate presentation.

迄今為止，我們已經參與了 20 多個開發項目，並與幾乎所有知名項目建立了合作夥伴關係，其中一些項目已在我們的企業介紹中列出。

We are now evolving our business approaches with a higher bar for our involvement in therapeutic development, focusing on true partnerships, meaningful for our shareholders.

我們現在正在發展我們的業務方法，以更高的標準參與治療開發，專注於真正的合作夥伴關係，對我們的股東有意義。

This will take time to evolve, but as our experience and products advance and the field as a whole advances, we do expect to enter into meaningful relationships with other therapeutic partners.

這需要時間來發展，但隨著我們的經驗和產品的進步以及整個領域的進步，我們確實希望與其他治療合作夥伴建立有意義的關係。

Five biotherapeutic delivery partnership discussions have been ongoing throughout this quarter and all but one of these are previous customers who have positive data with our biotherapeutic delivery team and system.

本季度一直在進行五次生物治療交付合作夥伴討論，其中除了一位之外，所有這些都是以前的客戶，他們與我們的生物治療交付團隊和系統擁有積極的數據。

On the more front, the recent FDA submission for clearance is a first step towards revenue generation from these clinical products, which also enhance partnering interests.

從更重要的角度來看，最近 FDA 提交的核准申請是這些臨床產品創造收入的第一步，這也增強了合作夥伴的利益。

We expect to have labeling that is appropriate for interventional cardiologists who perform our Helix procedures, but also cardiac electrophysiologists, interventional radiologists and vascular surgeons, all of which may benefit from our Morph DNA Steerable Introducer platform.

我們希望標籤適合執行 Helix 手術的介入性心臟病專家，以及心臟電生理學家、介入放射科醫生和血管外科醫生，所有這些都可能受益於我們的 Morph DNA 可引導導引器平台。

We have had a few discussions here on selling off these products and extensive bench test data from multiple large firms has been generated that has been shared with us.

我們在這裡就出售這些產品進行了一些討論，並且已經產生了來自多家大公司的大量基準測試數據，這些數據已與我們分享。

It is my expectation that in the coming months, the decline in BioCardia share price will reverse as investors and partners better understand what we are accomplishing in our business, in our own therapeutic programs, in our biotherapeutic delivery partnering and licensing, and anticipated new FDA cleared Morph product family.

我預計，在接下來的幾個月裡，隨著投資者和合作夥伴更好地了解我們在業務、我們自己的治療項目、我們的生物治療交付合作和許可方面以及預期的新FDA 所取得的成就，BioCardia 股價的跌勢將會逆轉。

By the end of the current quarter, we intend to deliver on the following objectives.

到本季末，我們打算實現以下目標。

One, become compliant with Nasdaq listing requirements.

第一，符合納斯達克上市要求。

Two, complete the last patient visit for the CardiAMP Heart Failure I trial.

第二，完成 CardiAMP 心臟衰竭 I 試驗的最後一次病患訪視。

Three, submit CardiAMP Heart Failure for general consultation with Japan PMDA in preparation for a future clinical consultation.

三、向日本PMDA提交CardiAMP Heart Failure進行一般諮詢，為未來的臨床諮詢做準備。

Four, treat the first patients in CardiAMP Heart Failure II trial and begin demonstrating that we can enroll this trial quickly with our world-class clinical partners.

第四，治療 CardiAMP 心臟衰竭 II 試驗的第一批患者，並開始證明我們可以與世界一流的臨床合作夥伴一起快速加入這項試驗。

Five, dose the last rolling cohort patient for the CardiAMP chronic myocardial ischemia trial.

五、對 CardiAMP 慢性心肌缺血試驗的最後一個滾動隊列患者進行給藥。

And six, receive FDA clearance for the Morph DNA product family.

第六，Morph DNA 產品系列獲得 FDA 批准。

I will now pass the call to David McClung, our CFO, who will review our Q2 2024 financial results.

我現在將把電話轉給我們的財務長 David McClung，他將審查我們 2024 年第二季的財務表現。

David?

大衛？

Thank you, Peter, and good afternoon, everyone.

謝謝你，彼得，大家下午好。

Revenues were $3,000 for the three months ended June 2024, comparable to $43,000 for the three months ended June 2023.

截至 2024 年 6 月的三個月的收入為 3,000 美元，而截至 2023 年 6 月的三個月的收入為 43,000 美元。

Expenses quarter-over-quarter decreased by 53%.

費用季減 53%。

Research and development expenses decreased to $800,000 during the second quarter of 2024, compared to $2.3 million for the second quarter 2023.

2024 年第二季的研發費用降至 80 萬美元，而 2023 年第二季的研發費用為 230 萬美元。

Primarily due to completion of enrollment in the CardiAMP heart failure trial, coupled with related reductions in clinical and supporting function expenses.

主要是由於 CardiAMP 心臟衰竭試驗的入組完成，加上臨床和支持功能費用的相關減少。

Selling, general and administrative expenses decreased $852,000 for the three months ended June 2024, down from $1.2 million for the same period in 2023, primarily due to reduction in personnel-related expenses.

截至 2024 年 6 月的三個月，銷售、一般和管理費用減少了 852,000 美元，低於 2023 年同期的 120 萬美元，主要是由於人事相關費用減少。

BioCardia’s net loss decreased to $1.6 million for the second quarter of 2024, from $3.4 million from the prior year’s second quarter, primarily due to the reduction in expenses we just noted.

BioCardia 2024 年第二季的淨虧損從去年第二季的 340 萬美元降至 160 萬美元，這主要是由於我們剛剛注意到的費用減少。

We used $1.4 million in cash for operations in the second quarter 2024.

我們在 2024 年第二季使用了 140 萬美元現金用於營運。

That’s down from $3.2 million in the second quarter 2023.

這比 2023 年第二季的 320 萬美元有所下降。

We expect our cash burn will increase moderately as we advance our trials, continuing our track record of operating efficiently and carefully managing the use of capital.

我們預計，隨著我們推進試驗、繼續保持高效運作和謹慎管理資本使用的記錄，我們的現金消耗將適度增加。

This concludes management’s prepared comments.

管理層準備好的評論到此結束。

We are happy to now take questions from attendees.

我們現在很高興回答與會者的問題。

(Operator Instructions).

（操作員說明）。

Joe Pantginis, H.C. Wainwright

喬潘吉尼斯，H.C.溫賴特

Hi, guys.

嗨，大家好。

Good afternoon.

午安.

Thanks for taking the questions.

感謝您提出問題。

A few if you don’t mind.

如果你不介意的話，有一些。

So, first, was curious, with the Heart Failure II study, maybe a little more color if you don’t mind, how much or how much the data from Heart Failure I with regard to improvement of survival in MACE might be helping your enrollment for Heart Failure II?

所以，首先，我很好奇，如果您不介意的話，透過心臟衰竭 II 研究，也許可以多一點色彩，心臟衰竭 I 中有關 MACE 生存改善的數據可能會在多大程度上幫助您註冊心臟衰竭II？

Joe, good day, and thank you for the question.

喬，美好的一天，謝謝你的提問。

It’s a great question.

這是一個很好的問題。

I think it’s enormously valuable for us in the enrollment ahead.

我認為這對我們未來的招生來說非常有價值。

One of the challenges in these trials, which are where the procedure is performed by an interventional cardiologist, but it’s the heart failure physician who cares for the patient, is the evidence that we now have that supports that, one, this procedure can be done safely, and, two, that the signals we’re seeing of reduced major adverse cardiac and cerebrovascular events and reduced mortality, coupled with an enhanced quality of life, are sort of the holy trio for them.

這些試驗中的挑戰之一是，手術由介入心臟科醫生進行，但照顧患者的是心臟衰竭醫生，我們現在擁有的證據支持這一點：第一，該手術可以安全地完成，第二，我們看到的主要不良心腦血管事件減少、死亡率降低以及生活品質提高的信號對他們來說是神聖的三重奏。

So, for folks caring for these patients, there are no other therapies out there that actually have a meaningful impact on mortality and our data suggests that this cell therapy could have a meaningful impact, and particularly with the NTproBNP population that we’re targeting in Heart Failure II, we saw an 86% relative risk reduction in mortality.

因此，對於照顧這些患者的人來說，沒有其他療法能夠真正對死亡率產生有意義的影響，我們的數據表明這種細胞療法可能會產生有意義的影響，特別是對於我們針對的 NTproBNP 人群在在心臟衰竭II 中，我們發現死亡率相對風險降低了86%。

So, that’s a huge selling point for physicians to trust their patients into this investigational trial, and that’s another reason why we expect enrollment to move apace, and I note that the first center was just activated, a few weeks ago and they’ve already consented five patients.

因此，對於醫生來說，信任他們的患者參加這項研究試驗是一個巨大的賣點，這也是我們預計入組人數會迅速增加的另一個原因，我注意到第一個中心幾週前剛啟動他們已經同意了五名患者。

So, yeah, the data is going to be very important for us.

所以，是的，數據對我們來說非常重要。

Thank you.

謝謝。

Great question.

很好的問題。

No.

不。

I got it.

我得到了它。

Thank you for that.

謝謝你。

And then I know you alluded to maybe some additional details coming up, so I know you can’t discuss them yet about potential further streamlining of the study, but can you discuss what’s already in place or remind us?

然後我知道您提到了可能會出現的一些額外細節，所以我知道您還不能討論研究的潛在進一步簡化，但您能討論一下已經到位的內容或提醒我們嗎？

Yeah.

是的。

Joe, another great question.

喬，另一個好問題。

So, in designing the CardiAMP Heart Failure II trial, we have such a strong safety signal that many of the interim endpoints have been lightened.

因此，在設計 CardiAMP 心臟衰竭 II 試驗時，我們收到瞭如此強烈的安全訊號，以至於許多中期終點都被減輕了。

So, for example, our six-month follow-up visit and our 18-month follow-up visit can now be done by a phone call if the center wishes, and the value of that is by eliminating many of the standard follow-up elements at that time point.

例如，如果中心願意，我們的六個月追蹤和 18 個月追蹤現在可以透過電話完成，其價值在於消除了許多標準追蹤那個時間點的元素。

The first thing is that the coordinator is able to focus on new patients and not necessarily those patients at those time points, but there’s also the benefit for BioCardia that reduces our costs in the study and there’s a lot of places where we’ve looked to do that throughout the program.

首先，協調員能夠專注於新患者，而不一定是那些時間點的患者，但這對 BioCardia 也有好處，可以降低我們的研究成本，而且在很多地方都可以我們希望在整個計劃中做到這一點。

So, I think it’s going to be less expensive for the company to advance and it’s going to be easier for the clinical sites to work patients through the trial, and we do have some other things that we hope to share soon that we are not able to share yet today.

因此，我認為公司的推進成本將會更低，臨床中心也將更容易為患者提供試驗服務，而且我們確實還有其他一些事情希望與大家分享很快我們今天還無法分享。

So, yeah, it should be a much easier trial for us in the CardiAMP Heart Failure I and II trial, in part because the second time you do things, things get a lot easier, particularly if the data in the first one is as good as we think it is.

所以，是的，在CardiAMP 心臟衰竭I 和II 試驗中，這對我們來說應該是一個更容易的試驗，部分原因是第二次做事情時，事情會變得容易得多，特別是如果第一次的數據同樣好的話正如我們所認為的。

Got it.

知道了。

No.

不。

I appreciate that, and one last question, if you don’t mind.

我很感激，還有最後一個問題，如果你不介意的話。

I guess this has to do with trial logistics as well.

我想這也跟試驗物流有關。

So, if you look at Heart Failure I, it was really predominantly, I believe it was approximately 90% male population.

所以，如果你看看 I 型心臟衰竭，我相信大約 90% 是男性。

So, I’m just curious, when you’re looking to enroll about 250 patients, what can you do or what’s the expected ratio between men and women you’re targeting?

所以，我只是好奇，當您打算招募大約 250 名患者時，您可以做什麼，或者您的目標男性和女性之間的預期比例是多少？

So, that is a very savvy question.

所以，這是一個非常明智的問題。

It is one of the fundamental problems in much heart failure research today in that almost all of the trials tend to be heavily tilted towards a male population.

這是當今許多心臟衰竭研究的基本問題之一，因為幾乎所有試驗都傾向於嚴重偏向男性族群。

It’s something that we have worked on in CardiAMP Heart Failure I and we even presented on it early in the study and have encouraged centers to think broadly about equity, not only in terms of gender, but also different races, making it so that it’s a diverse population and that all patients are aware of it.

這是我們在 CardiAMP 心臟衰竭 I 中所做的工作，我們甚至在研究的早期就提出了這一點，並鼓勵各中心廣泛思考公平性，不僅在性別方面，而且在不同種族方面，使其如此是一個多元化的人群，所有患者都意識到這一點。

And that’s going to be an ongoing exercise in CardiAMP Heart Failure II.

這將是 CardiAMP 心臟衰竭 II 中的一項持續練習。

My sense is that the data will help us there.

我的感覺是，數據將在這方面為我們提供幫助。

I think physicians tend to be more protective of their female patients and so don’t advance them in the clinical trials as aggressively as they do a hearty male patient.

我認為醫生往往會更保護女性患者，因此不會像對待熱情的男性患者那樣積極地在臨床試驗中推進她們。

And I think because we have such compelling safety data with real nice signs of efficacy, that there will be a larger percentage of female patients in the trial.

我認為，由於我們擁有如此令人信服的安全數據和真正良好的療效跡象，因此試驗中女性患者的比例將會更高。

I would love it to be 50%, although the reality of how these trials are enrolled, that is unlikely.

我希望它是 50%，儘管這些試驗的招募方式在現實中不太可能實現。

But we’ll aim for 50% if we can achieve it.

但如果能夠實現的話，我們的目標是 50%。

Got it.

知道了。

Thank you for the added details.

感謝您添加的詳細資訊。

No.

不。

Great questions, Joe. Thank you so much for being on the call.

很好的問題，喬。非常感謝您接聽電話。

James Molloy, Alliance Global Partners.

詹姆斯·莫洛伊，聯盟全球合作夥伴。

Hello.

你好。

This is Laura on for James Malloy.

我是詹姆斯·馬洛伊的勞拉。

Thank you for taking the question.

感謝您提出問題。

So how’s the status right now in the process for submission of CardiAMP for approval specifically in Japan?

那麼，CardiAMP 在日本提交審批的流程目前進展如何？

And do you still plan on obtaining potential approval there next year?

您是否還計劃明年在那裡獲得潛在的批准？

So the status with CardiAMP in Japan for the treatment of ischemic heart failure is we had our last consultation with Japan’s Pharmaceutical and Medical Device Agency in November.

因此，CardiAMP 在日本治療缺血性心臟衰竭的現狀是我們在 11 月與日本藥品和醫療器材機構進行了最後一次諮詢。

As part of that discussion, they provided minutes with a whole series of questions and almost all of the questions ended with, please contain this information in your submission for approval, and none of the questions we felt were daunting.

作為討論的一部分，他們提供了包含一系列問題的會議紀要，幾乎所有問題都以“請在提交的內容中包含此信息以供批准”結尾，並且我們認為沒有一個問題令人畏懼。

One of the key things that we need to do is we need to have a general consultation addressing the differences in care in heart failure patients in Japan and in the United States.

我們需要做的關鍵事情之一是我們需要進行一般性諮詢，以解決日本和美國心臟衰竭患者護理方面的差異。

And then hopefully move to a clinical consultation with the final data from the CardiAMP Heart Failure II trial, which is one of the things that they would like to see.

然後希望能夠利用 CardiAMP 心臟衰竭 II 試驗的最終數據進行臨床諮詢，這是他們希望看到的事情之一。

The thought process we have is that we’re in pretty good shape to complete a submission if the data is as good as we think it is and we feel there’s a very good chance that Japan PMDA will support that submission for approval process and so that’s really where we’re focused.

我們的思考過程是，如果資料像我們想像的那樣好，我們就處於完成提交的良好狀態，並且我們認為日本 PMDA 很有可能支持該提交審批流程所以這才是我們真正關注的地方。

Once the submission is in, once they invite that process, there’s an enormous amount of details that they go through, including, I believe, a site visit to assess the manufacturing.

一旦提交完成，一旦他們邀請該流程，他們就會經歷大量細節，我相信包括現場訪問以評估製造情況。

But our sense is we’re ready for all of those questions and the key element is, will they allow us to submit for approval based on the CardiAMP Heart Failure I data?

但我們的感覺是，我們已經準備好應對所有這些問題，關鍵要素是，它們是否允許我們根據 CardiAMP 心臟衰竭 I 數據提交審批？

And the reasoning there, which I’ve said a few times in the past, that we think they will, is we’ve already treated approximately 20 times as many patients.

我過去曾多次說過，我們認為他們會這樣做，原因是我們已經治療了大約 20 倍的患者。

So 200 patients relative to 10 patients for other cardiac cell therapies that they’ve either approved or they’ve had discussions on approving after 10 patients.

因此，200 名患者相對於 10 名患者接受了他們已經批准的其他心臟細胞療法，或在 10 名患者之後就批准進行了討論。

Those three other cardiac cell therapies all require open chest procedures for delivery of the cells and ours is a minimally invasive therapy.

這三種其他心臟細胞療法都需要開胸手術來傳遞細胞，而我們的療法是一種微創療法。

I also note that our CardiAMP Cell Processing platform is already approved in Japan and being used for orthopedic applications.

我還注意到，我們的 CardiAMP 細胞處理平台已在日本獲得批准並用於骨科應用。

And our Delivery System has historically been approved in Europe under CE mark and so that’s sort of a badge of support for it as well.

我們的交付系統歷來在歐洲獲得了 CE 標誌的批准，因此這也是對其的支援徽章。

And then the last piece is we have reimbursement in the United States that will enable the Ministry of Health, Labor and Welfare to at least have an index for supporting CardiAMP cell therapy going forward.

最後一點是我們在美國得到了報銷，這將使厚生勞動省至少能夠有一個支持 CardiAMP 細胞療法未來的指標。

So all of those stars are what we are working to help make align and that’s why the CardiAMP Heart Failure I final data that the last patient follow-up visit expectancy end of September is so critically important for us.

因此，所有這些明星都是我們正在努力幫助調整的對象，這就是為什麼 CardiAMP 心臟衰竭 I 最終數據（最後一次患者隨訪預期為 9 月底）對我們來說至關重要。

Even though we have 90% of the data, until you have all of the final data, it’s an estimate of the outcome, not the final outcome and that will be coming shortly.

儘管我們擁有 90% 的數據，但在您獲得所有最終數據之前，這只是對結果的估計，而不是最終結果，而且很快就會出現。

Got it.

知道了。

Thank you for the clarity.

謝謝你的澄清。

And just one more question for me.

還有一個問題想問我。

How’s the collaboration going right now for cells this year, especially following now the recent Phase 2 trial?

今年細胞方面的合作進展如何，特別是在最近的 2 期試驗之後？

And when do you think you might start a subsequent Phase 3 trial with them, as well as any potential timelines or interim looks for this trial as well?

您認為您什麼時候可以與他們開始後續的第 3 階段試驗，以及該試驗的任何潛在時間表或臨時尋找？

Well, that’s a great question as well.

嗯，這也是一個很好的問題。

I’d rather point to the fact that that’s a clinical indication that there’s only two companies that have gone after intramyocardial delivery for that indication.

我寧願指出這樣一個事實：這是一個臨床跡象，表明只有兩家公司針對該適應症進行了心肌內輸送。

One was BioCardia.

其中之一就是 BioCardia。

We did a small study there ourselves many years ago and CellProthera.

許多年前，我們自己和 CellProthera 進行了一項小型研究。

And they benefit from much higher efficiencies of delivery than intracoronary artery infusion of their cells, which is what everybody else has done in the indication of acute myocardial infarction.

它們受益於比冠狀動脈內輸注細胞更高的輸送效率，這是其他人在急性心肌梗塞適應症中所做的事情。

And the value proposition of efficiency of delivery, I like to use the analogy that we have about 18-fold the retention relative to intracoronary delivery.

至於輸送效率的價值主張，我喜歡用這樣的類比：相對於冠狀動脈內輸送，我們的保留率約為 18 倍。

So if anybody on the call has had a headache, it’s the difference between taking 18 aspirin to get an effect versus one.

因此，如果電話會議中的任何人感到頭痛，那就是服用 18 顆阿斯匹靈與服用 1 顆阿斯匹靈產生效果的區別。

So I don’t speak typically to a partner’s efforts going forward.

因此，我通常不會談論合作夥伴未來的努力。

I can tell you that we’ve been working together for many years.

我可以告訴你，我們已經合作很多年了。

We have great respect for them as a team.

我們非常尊重他們作為一個團隊。

They’ve done a lot moving forward.

他們已經做了很多前進的事情。

They need to address their regulatory and strategic pathways forward, whether or not they wish to do a trial only in Europe, whether they wish to do a trial in Europe in the United States, whether they wish to do a trial in the United States only, and how they wish to roll it out with which investigators and we can be helpful to them on all fronts.

他們需要解決未來的監管和戰略路徑問題，無論他們是否希望僅在歐洲進行試驗，是否希望在美國進行歐洲試驗，是否希望僅在美國進行試驗，以及他們希望如何推出，哪些調查人員和我們可以在各方面為他們提供幫助。

So conversations are ongoing and it’s a really compelling program with a very real market and some nice data that they have in their Phase 2 program.

因此，對話正在進行中，這是一個非常引人注目的計劃，擁有非常真實的市場和他們在第二階段計劃中擁有的一些不錯的數據。

So I know that’s not exactly the question you wanted answered, Laura, but it’s about all I can share because we really try to be respectful of our partners and let them share their strategy going forward, as well as share their data going forward and it’s one of the challenges in this space is to be a great partner, you have to be trusted, and we work very hard on that every day.

所以我知道這並不完全是您想要回答的問題，勞拉，但這就是我能分享的一切，因為我們真的盡力尊重我們的合作夥伴，讓他們分享他們的未來策略，以及分享他們的數據不斷發展，這個領域的挑戰之一是成為一個偉大的合作夥伴，你必須值得信任，我們每天都在為此努力。

Understood.

明白了。

Thank you for seeing the questions.

感謝您看到問題。

No, I appreciate the question, Laura.

不，我很欣賞這個問題，蘿拉。

(Operator Instructions).

（操作員說明）。

The next question comes from Kevin Marshall.

下一個問題來自凱文·馬歇爾。

All right.

好的。

Thank you, everyone, for taking my question.

謝謝大家回答我的問題。

Dr. Altman, I know you mentioned, getting in compliance with the Nasdaq listing requirements.

Altman 博士，我知道您曾提到遵守納斯達克上市要求。

I’m just curious to know if you can shed any details on how the company’s planning on going about doing that and if that would have any bad effects on current shareholders?

我只是想知道您是否可以透露公司計劃如何實現這一目標的任何細節，以及這是否會對現有股東產生任何不良影響？

Kevin, that’s a great question.

凱文，這是一個很好的問題。

So, for Nasdaq, there are two requirements.

所以，對納斯達克來說，有兩個要求。

One is the share price being over a dollar a share, and the second is minimum equity requirements or market capitalization requirements.

一是股價超過每股一美元，二是最低股本要求或市值要求。

If you look at our financials that came out today, you will realize that we don’t have an enormous amount of resources in the bank today.

如果你看看我們今天公佈的財務數據，你會發現我們現在的銀行並沒有大量的資源。

So, we are exploring pathways to secure funding.

因此，我們正在探索獲得資金的途徑。

We have on Friday, there was an [S1] that was put on file, and I can’t speak to whether or not we’ll be doing anything under it, but our strategy is always to pursue all opportunities for success and ultimately select the one that makes the most sense for us.

我們週五有一個 [S1] 被歸檔，我不能說我們是否會根據它做任何事情，但我們的策略始終是追求所有成功的機會，最終選擇對我們最有意義的一個。

I would have folks think about dilution as, it is a significant issue, but as we advance, we historically have fought very hard as a company to avoid any dilutive impact for our shareholders.

我希望人們考慮稀釋，因為這是一個重大問題，但隨著我們的進步，我們作為一家公司一直在努力避免對股東產生任何稀釋影響。

And so, I think today our market cap is remarkably low.

因此，我認為今天我們的市值非常低。

I think that if as we advance the company, some of the milestones we have could be enormously valuable.

我認為，如果我們不斷推動公司發展，我們所取得的一些里程碑可能會非常有價值。

And so, we’re not talking about 2x or 3x.

因此，我們不是在談論 2 倍或 3 倍。

We’re talking multiples of that.

我們正在談論的是這個數字的倍數。

And so, as we go downstream, that’s something we need to deliver, and we always need to be cognizant, Kevin, of dilution.

因此，當我們走向下游時，這就是我們需要提供的東西，凱文，我們始終需要意識到稀釋。

But at the same time, we have to run the business.

但同時，我們也必須經營業務。

So, we’ll see it unfold and share it as it unfolds for everyone who has been supporting us and we do appreciate your support.

因此，我們將看到它的展開，並與所有一直支持我們的人分享它，我們非常感謝您的支持。

Thank you.

謝謝。

Appreciate it.

欣賞它。

Anytime, I appreciate the question, Kevin.

任何時候，我都很欣賞這個問題，凱文。

This concludes our question and answer session, and I would like to turn the conference back over to Dr. Elman for any closing remarks.

我們的問答環節到此結束，我想將會議轉回艾爾曼博士發表閉幕詞。

Thank you very much, Betsy.

非常感謝你，貝特西。

So, all that we have accomplished here at BioCardia so far is to the credit of our amazing BioCardia team, our incredible clinical partners, the hundreds of patients who have participated in our trials, to the FDA and the PMDA, which have been helpful in their reviews and input, and to the investors who have enabled our efforts.

因此，到目前為止，我們在 BioCardia 取得的所有成就都歸功於我們出色的 BioCardia 團隊、我們令人難以置信的臨床合作夥伴、參與我們試驗的數百名患者、FDA 和 PMDA，他們在他們的評論和意見，以及支持我們努力的投資者。

I thank everyone who has helped our mission to develop and enhance therapies to treat cardiovascular disease.

我感謝所有幫助我們開發和增強心血管疾病治療方法的人。

We expect to deliver a rewarding end to 2024 and an incredible 2025 if we are successful in our efforts.

如果我們的努力取得成功，我們預計將在 2024 年取得豐碩成果，並在 2025 年取得令人難以置信的成績。

Thank you for being on the call and have a great afternoon.

感謝您接聽電話，祝您下午愉快。

The conference has now concluded.

會議現已結束。

Thank you for attending today’s presentation.

感謝您參加今天的示範。

You may now disconnect.

您現在可以斷開連線。