BioCardia Inc (BCDA) 2023 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the BioCardia 2023 third-quarter conference call. (Operator Instructions) Participants of this call are advised that the audio of this conference call is being broadcasted live over the Internet and is also being recorded for playback purposes. A webcast replay of this call will be available approximately one hour after the end of the call.

女士們、先生們，感謝你們的支持，並歡迎參加 BioCardia 2023 年第三季電話會議。 （操作員說明）本次電話會議的參與者請注意，本次電話會議的音訊正在透過網路進行現場直播，並且也被錄製以供回放之用。本次電話會議的網路廣播重播將在電話會議結束約一小時後進行。

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

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)。請繼續，米蘭達。

Good afternoon and thank you for participating in today's conference call. Joining me from BioCardia leadership team are Peter Altman, Ph.D., President and Chief Executive Officer and David McClung, our company's Chief Financial Officer.

下午好，感謝您參加今天的電話會議。與我一起加入 BioCardia 領導團隊的還有總裁兼執行長 Peter Altman 博士和我們公司的財務長 David McClung。

During this call, management will be making forward-looking statements, including statements that address BioCardia expectations for future performance and operational results, references to management intentions, and beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.

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、提及管理層意圖以及信念、預測、前景、分析和當前預期的聲明。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。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 report on Form 10-K filed on March 29, 2023, and in the company's subsequently filed quarterly reports on Form 10-Q. The content of this call contains time-sensitive information that is accurate only as of today, November 8, 2023. 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.

有關這些風險的更多信息，請參閱 BioCardia 於 2023 年 3 月 29 日提交的 10-K 表格報告以及該公司隨後提交的 10-Q 表格季度報告中描述的風險因素和警示性聲明。本次電話會議的內容包含時效性信息，僅截至今天（2023 年 11 月 8 日）準確。除非法律要求，否則公司不承擔公開更新或修改任何信息以反映此後發生的事件或情況的義務。稱呼。

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

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

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's current efforts are focused on advancing its autologous and its allogeneic cell therapy platforms to treat significant unmet cardiovascular and pulmonary diseases, specifically ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress syndrome. All of our cell-based therapies involve local delivery of the therapeutic to the heart or lungs where we intended to act locally. This mission has not changed, and all of these programs are still viable.

謝謝米蘭達，祝所有參加電話會議的人下午好。 BioCardia 目前的工作重點是推進其自體和異體細胞治療平台，以治療重大的未滿足的心血管和肺部疾病，特別是缺血性心臟衰竭、慢性心肌缺血和急性呼吸窘迫症候群。我們所有以細胞為基礎的療法都涉及將治療藥物局部輸送到我們打算局部發揮作用的心臟或肺部。這個使命沒有改變，所有這些計劃仍然可行。

This third quarter, we were thrown a curve ball with the Data Safety Monitoring Board for the CardiAMP Heart Failure Trial or BCDA-01 recommended that we paused enrollment in the study. We have followed the Data Safety Monitoring Board recommendation, and the last patients were randomized in the study in October.

今年第三季度，我們遇到了 CardiAMP 心臟衰竭試驗資料安全監測委員會（BCDA-01）的麻煩，建議我們暫停研究的招募。我們遵循了資料安全監測委員會的建議，最後一批患者於 10 月隨機參與研究。

We continue to monitor patients enrolled in this clinical study in which both patients and evaluating positions of blinded to the treatment group and expect to complete follow-up in this study in October of 2024.

我們將繼續監測參與這項臨床研究的患者，其中患者和評估人員對治療組均不知情，並預計在 2024 年 10 月完成這項研究的追蹤。

We have since come to understand that the trial design and endpoint we were advancing were unlikely to be successful, even as we have become aware that there were strong trends toward benefits across all patients, with a 37% relative risk reduction on heart death equivalent, and an 18% relative risk reduction in major adverse cardiac and cerebral vascular events or mix, which are at the top of the list.

從那以後，我們逐漸認識到，我們正在推進的試驗設計和終點不太可能成功，儘管我們已經意識到所有患者都受益的強烈趨勢，心死亡當量的相對風險降低了 37%，主要不良心腦血管事件或混合事件的相對風險降低18%，位居榜首。

In addition, the available interim data showed that for an important subset of patients, who presented at the screening baseline visit with higher levels of NT-pro BNP, a well-established biomarker of increased heart failure and stress to the heart, the reduction in the heart death equivalent and MACE were even greater. Of note, all current leading heart failure trials, where we have looked, require elevated NT-pro BNP for patients to be eligible to participate in these trials.

此外，現有的中期數據顯示，對於在篩選基線訪視時出現較高水平 NT-pro BNP（一種公認的心臟衰竭和心臟壓力增加的生物標記）的患者來說，心臟死亡當量和MACE甚至更大。值得注意的是，我們觀察到的所有目前領先的心臟衰竭試驗都要求患者 NT-pro BNP 升高，才有資格參加這些試驗。

In these patients, an analysis of all available data up to two years in the CardiAMP Heart Failure Trial shows improvements over controls, including a 59% relative risk reduction in mortality and a 54% relative risk reduction of MACE.

在這些患者中，對 CardiAMP 心臟衰竭試驗長達兩年的所有可用數據進行的分析顯示，與對照組相比有所改善，包括死亡率相對風險降低 59%，MACE 相對風險降低 54%。

Further, all clinical outcomes included in this subset analysis favored cell therapy, including improved quality of life as measured using the Minnesota Living with Heart Failure Questionnaire, reduction of NT-pro BNP levels, greater 6-minute walk distance, and improved echocardiography parameters of left ventricular ejection fraction, left ventricular end systolic volume, and left ventricular end diastolic volume. Both will reduce heart death equivalents, and improved quality of life outcomes, demonstrate statistically significant favoring therapy in this subset analysis.

此外，此子集分析中包含的所有臨床結果都支持細胞療法，包括使用明尼蘇達心臟衰竭生活問卷測量的生活品質的改善、NT-pro BNP 水平的降低、6 分鐘步行距離的增加以及超音波心動圖參數的改善左心室射血分數、左心室收縮末期容積及左心室舒張末期容積。兩者都將減少心因性死亡當量，並改善生活質量，在該子集分析中證明了具有統計學意義的有利治療。

Because of this data, we have initiated dialogue with the FDA and submitted a proposed CardiAMP Heart Failure II protocol for FDA review, which targets the patients with higher levels of NT-pro BNP and utilizes the different clinical endpoint based on the interim data available.

基於這些數據，我們已開始與FDA 對話，並向FDA 提交了擬議的CardiAMP 心臟衰竭II 方案供FDA 審查，該方案針對NT-pro BNP 水平較高的患者，並根據可用的中期數據利用不同的臨床終點。

Recent statistical calculations for this clinical study design support that a modestly sized clinical trial of 150 patients based on the interim results would achieve 90% power, which is another frame for probability of success if the data is representative of the population. Additional proposed modifications from the CardiAMP Cell Therapy Heart Failure Trial design include elements to simplify clinical site execution logistics and reduce the cost of performing the study.

這項臨床研究設計的最新統計計算表明，根據中期結果對 150 名患者進行的中等規模的臨床試驗將達到 90% 的功效，如果數據能夠代表人群，這是成功機率的另一個框架。 CardiAMP 細胞治療心臟衰竭試驗設計的其他建議修改包括簡化臨床現場執行物流和降低研究成本的要素。

Should the study protocol be approved by the FDA and advanced by BioCardia, it may be possible to significantly offset clinical costs with the Medicare reimbursement of up to $20,000, now in place, for both the control and treatment arms of this investigational therapeutic study.

如果該研究方案獲得 FDA 批准並由 BioCardia 推進，則有可能透過目前為該研究性治療研究的對照組和治療組提供高達 20,000 美元的醫療保險報銷來顯著抵消臨床費用。

We have been actively answering requests for information on CardiAMP's Cell Therapy System, also, by Japan's Pharmaceutical and Medical Device Agency or PMDA towards an approval for the indication of ischemic heart failure based on existing safety and efficacy data. Our formal consultation is scheduled for November 21, 2023. Subsequent interactions and consultations with PMDA are expected.

我們一直在積極回應有關CardiAMP 細胞治療系統的資訊請求，以及日本藥品和醫療器材管理局(PMDA) 的請求，以根據現有的安全性和有效性數據批准用於缺血性心臟衰竭的適應症。我們的正式磋商計劃於 2023 年 11 月 21 日進行。預計隨後將與 PMDA 進行互動和磋商。

The CardiAMP Cell Therapy System has potential to be the first minimally invasive, catheter-based cell therapy available in Japan. The CardiAMP Cell Therapy Trial for chronic myocardial ischemia or BC-02 is also a Phase III, multi-center, randomized, double-blinded, controlled study. And it's intended to include up to 343 patients at up to 40 clinical sites.

CardiAMP 細胞治療系統有可能成為日本第一個微創、基於導管的細胞療法。針對慢性心肌缺血或 BC-02 的 CardiAMP 細胞療法試驗也是一項 III 期、多中心、隨機、雙盲、對照研究。它計劃包括多達 40 個臨床中心的多達 343 名患者。

The company expects to complete enrollment in the rolling cohort of five patients in the fourth quarter of 2023 and begin the randomized phase of the trial. A number of leading investigators including both principal investigators in this trial believe that this to be the most compelling indication for this therapy.

該公司預計在 2023 年第四季完成由 5 名患者組成的滾動隊列的入組，並開始試驗的隨機階段。包括本試驗的兩位主要研究人員在內的許多主要研究人員認為，這是該療法最引人注目的適應症。

Planning for the randomization phase is already underway based on promising experience in the patients treated to date. Part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms of this investigational therapeutic study to offset the clinical costs.

根據迄今為止治療患者的有希望的經驗，隨機化階段的規劃已經在進行中。該計劃的一部分包括利用該研究性治療研究的對照組和治療組的醫療保險報銷來抵消臨床費用。

The company's CardiALLO, allogeneic cell therapy for ischemic heart failure or BC-03, is a Phase 1/2 clinical trial encompassing 69 patients. A number of patients have already been consented, and we anticipate enrolling first patients in the fourth quarter. This study is intended to build on three previous trials of mesenchymal stem cells in ischemic heart failure using the company's proprietary Helix delivery system, encompassing 93 patients treated, with no treatment emergent serious adverse events, and compelling early signals for benefit. Our strategy here is to seek partnerships and grant funding to advance this program.

該公司的 CardiALLO（用於治療缺血性心臟衰竭或 BC-03 的同種異體細胞療法）是一項包含 69 名患者的 1/2 期臨床試驗。許多患者已經獲得同意，我們預計在第四季度招募第一批患者。這項研究旨在建立在先前使用該公司專有的Helix 輸送系統進行的間質幹細胞治療缺血性心臟衰竭的三項試驗的基礎上，該試驗涵蓋了93 名接受治療的患者，沒有出現治療中出現的嚴重不良事件，並且具有令人信服的早期獲益訊號。我們的策略是尋求合作夥伴並提供資金來推進該計劃。

BioCardia is focusing its world-class biotherapeutics delivery team towards partnering its capabilities, utilizing our Helix biotherapeutic delivery system for intramyocardial delivery through long-term partnerships. It's an advanced therapeutic opportunity and help offset our base operational costs. Biotherapeutic delivery business development is active, and we are working to close multiple meaningful deals by the end of the year.

BioCardia 正在將其世界一流的生物療法藥物輸送團隊的重點放在合作能力上，透過長期合作夥伴關係，利用我們的 Helix 生物療法藥物輸送系統進行心肌內輸送。這是一個先進的治療機會，有助於抵消我們的基本營運成本。生物治療交付業務發展活躍，我們正努力在今年年底前完成多項有意義的交易。

In summary, we have increased confidence in the potential of our autologous CardiAMP Cell Therapy program in both the scheme of heart failure and in chronic myocardial ischemia based on the data we have before us. We are focused strategically on advancing these two clinical programs in a cash neutral fashion with the benefit of the Medicare reimbursement we already have in place.

總之，根據我們掌握的數據，我們對自體 CardiAMP 細胞治療計畫在心臟衰竭和慢性心肌缺血方面的潛力更有信心。我們的策略重點是利用我們現有的醫療保險報銷的好處，以現金中立的方式推進這兩個臨床項目。

Similarly, we are working on securing grants and partnerships around our allogeneic programs to support their clinical development and implementing a recurring revenue, biotherapeutic delivery partner model with our experienced world-class team and our Helix biotherapeutic delivery system. In the coming weeks, we anticipate feedback from both FDA and PMDA on our autologous CardiAMP Cell Therapy program and anticipate enrollment of patients in our allogeneic CardiALLO Cell Therapy program. We also expect positive news from business development activities.

同樣，我們正在努力確保同種異體計畫的撥款和合作夥伴關係，以支持其臨床開發，並與我們經驗豐富的世界一流團隊和 Helix 生物治療輸送系統實施經常性收入、生物治療輸送合作夥伴模式。在接下來的幾週內，我們預計 FDA 和 PMDA 都會對我們的自體 CardiAMP 細胞治療計劃提供回饋，並預計患者會加入我們的同種異體 CardiALLO 細胞治療計劃。我們也期待業務發展活動帶來正面的消息。

I will now pass the call to David McClung, our CFO, who will review our Q3 2023 financial results. David?

我現在將把電話轉給我們的財務長 David McClung，他將審查我們 2023 年第三季的財務表現。大衛？

Thank you, Peter, and good afternoon, everyone. Revenues were approximately $357,000 for the three months ended September 2023 as compared to approximately $212,000 for the three months ended September 31, 2022.

謝謝你，彼得，大家下午好。截至2023年9月31日止三個月的收入約為357,000美元，而截至2022年9月31日止三個月的收入約為212,000美元。

Expenses quarter over quarter decreased by approximately 10%. Research and development expenses were approximately $1.9 million for the three months ended September 2023, compared to approximately $2.1 million for the three months ended September 2022, reflecting cost reductions implemented after pausing the CardiAMP Heart Failure Trial in July.

費用較上季下降約 10%。截至2023 年9 月的三個月，研發費用約為190 萬美元，而截至2022 年9 月的三個月，研發費用約為210 萬美元，反映出7 月暫停CardiAMP 心臟衰竭試驗後實施的成本削減。

Selling, general, and administrative expenses were approximately $1.1 million in the third quarter of 2023 and in the second quarter of 2022. Our net loss was approximately $2.6 million in Q3 2023 as compared to $3.1 million in Q3 2022, due primarily to increases in revenue, coupled with reductions in research and development expenses during the quarter.

2023 年第三季和2022 年第二季的銷售、一般和管理費用約為110 萬美元。2023 年第三季我們的淨虧損約為260 萬美元，而2022 年第三季為310 萬美元，這主要是由於收入增加，加上本季研發費用的減少。

Net cash used in operations during the quarter was approximately $2.4 million as compared to approximately $2 million in the third quarter of 2022. BioCardia ended the quarter with approximately $1.8 million in cash and cash equivalents, providing runway into January without additional capital or non-dilutive funding for the business development and other activities.

本季營運中使用的淨現金約為240 萬美元，而2022 年第三季約為200 萬美元。BioCardia 在本季結束時擁有約180 萬美元的現金和現金等價物，為1 月份提供了無需額外資本或非稀釋性的資金支持為業務發展和其他活動提供資金。

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

管理層準備好的評論到此結束。我們很樂意回答與會者的問題。

(Operator Instructions) Joe Smith, Alpha Street.

（操作員指示）Joe Smith，阿爾法街。

Joe, your line is live into the call for your questions.

喬，您的問題電話正在直播。

Hello. Can you hear me?

你好。你聽得到我嗎？

Yes. Hello, Joe.

是的。你好，喬。

This is Lander on for Joe Pantginis from H.C. Wainwright.

這是蘭德為來自 H.C. 的喬·潘吉尼斯 (Joe Pantginis) 所做的演講。溫賴特。

Yes.

是的。

Thanks for taking our questions. So first of all, so for the original CardiAMP HF Trial, what's the plan regarding the patients that are still in the follow-up period? This will be analyzed and reported? What's the expectation when the totality of the data have been collected?

感謝您回答我們的問題。首先，對於最初的 CardiAMP HF 試驗，對於仍處於追蹤期的患者有何計畫？這會被分析和報告嗎？收集完全部數據後，期望是什麼？

The plan is to follow all patients out to at least the one-year endpoint, Joe. And then we will report out the full results for the trial. The expectation is that last patient will reach their endpoint in October of 2024. So late 2024, we should have some interesting data to review.

喬，計劃是追蹤所有患者至少達到一年的終點。然後我們將報告試驗的完整結果。預計最後一名患者將在 2024 年 10 月達到終點。因此，到 2024 年末，我們應該有一些有趣的數據可供回顧。

Okay, perfect. Thank you. Got it. And for the new CardiAMP HF Trial, what's the number of high-level pro-BNP patients that were identified to benefit from the treatment?

好的，完美。謝謝。知道了。對於新的 CardiAMP HF 試驗，有多少高水平 BNP 前體患者被確定可從治療中受益？

So for the CardiAMP Heart Failure II Trial, that's actually a design that's been proposed to the agency. We don't yet have feedback there yet, Joe. But what we are -- as we looked at our current interim data, more than half the patients actually were high NT-pro BNP in our study.

因此，對於 CardiAMP 心臟衰竭 II 試驗，這實際上是向該機構提出的設計。喬，我們還沒有收到回饋。但我們的情況是——當我們查看目前的中期數據時，我們研究中超過一半的患者實際上具有高 NT-pro BNP。

And so we've looked at the interim data that's available to us and analyzed it in a number of different ways. And it's actually pretty robust that the patients with high NT-pro BNP are just phenomenal responders.

因此，我們查看了可用的中期數據，並以多種不同的方式進行了分析。事實上，NT-pro BNP 較高的患者反應非常出色，這一點確實相當可靠。

As we've looked at this, the study design we have -- we've looked at our previous study designs. So we did not include NT-pro BNP as a pre-requisite in either our Phase 1 or Phase 2 work. However, in today's climate, almost all trials out there that we're aware of are requiring NT-pro BNP levels to be elevated.

正如我們所研究的那樣，我們已經研究了我們之前的研究設計。因此，我們沒有將 NT-pro BNP 作為第一階段或第二階段工作的先決條件。然而，在當今的環境下，我們所知的幾乎所有試驗都要求提高 NT-pro BNP 水平。

So we are not entirely sure, if perhaps, by not including it, we wound up having patients filtered out of our trial and sent to other trials that did require high NT-pro BNP. But our sense is including it going forward, is likely to have a pretty significant impact on the results, particularly, if the data that we have is in alignment with the data that we will generate ahead.

因此，我們並不完全確定，如果可能的話，由於不包括它，我們最終將患者從我們的試驗中篩選出來，並送到其他確實需要高 NT-pro BNP 的試驗。但我們的感覺是，將其納入其中，可能會對結果產生相當重大的影響，特別是如果我們擁有的數據與我們未來將產生的數據一致。

Awesome. Got it. Thanks for clarifying.

驚人的。知道了。感謝您的澄清。

No. I appreciate the question, Joe.

不，我很欣賞這個問題，喬。

(Operator Instructions) There are no further questions at this time, and I'll hand back to Peter for closing remarks.

（操作員說明） 目前沒有其他問題，我將交回給 Peter 進行結束語。

Thank you, kindly, Rachel. I want to thank everyone for participating in today's call and for your interest in BioCardia and our primary mission to treat heart disease. We look forward to sharing our continued progress.

謝謝你，雷切爾。我要感謝大家參加今天的電話會議，感謝大家對 BioCardia 以及我們治療心臟病的首要使命的興趣。我們期待分享我們不斷取得的進展。

Thank you. Stay healthy. Be kind and have a wonderful day.

謝謝。保持健康。友善一點，祝你有美好的一天。

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

電話會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。