BioCardia Inc (BCDA) 2023 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 second-quarter conference call. (Operator Instructions)

女士們先生們，謝謝你們的支持。下午好，歡迎參加 BioCardia 2023 年第二季電話會議。 （操作員說明）

Participants of today's 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 call -- a webcast replay of the call will be available approximately one hour after the end of the call through November 9, 2023.

今天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，並且也將進行錄製以供回放之用。網路廣播電話－電話會議的網路廣播重播將在電話會議結束後約一小時內提供，直至 2023 年 11 月 9 日。

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

這次，我想將會議交給 BioCardia 投資者關係部門的 Miranda Peto。請繼續，米蘭達。

Thank you very much. Good afternoon and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, PhD, President and CEO; and David McClung, the Company's Chief Financial Officer.

非常感謝。下午好，感謝您參加今天的電話會議。與我一起加入 BioCardia 領導團隊的是 Peter Altman 博士、總裁兼執行長；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, analogies, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals.

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，提及管理層的意圖、信念、預測、前景、類比和當前預期。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 these statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's reports on Form 10-K filed, March 29, 2023, and the company subsequently filed quarterly reports on Form 10-Q.

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。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 表格報告中描述的風險因素和警示性聲明，以及該公司隨後提交的 10-Q 表格季度報告。

The content of this time call contains time-sensitive information that is accurate only as of today, August 09, 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.

本次電話會議的內容包含時效性信息，僅截至今天（2023 年 8 月 9 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之後發生的事件或情況的義務。這個電話。

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 intend them 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遞送至心臟或肺部，我們希望它們在局部發揮作用。這個使命沒有改變，所有這些計劃仍然可行。

We had a solid second quarter of 2023, and our team delivered on the milestones promised. For our CardiAMP autologous cell therapy and heart failure or BCDA-01, we implemented the adaptive statistical analysis plan with the complete FDA review. We completed our submission in Japan towards approval based on existing data, and we are finally seeing a significant increase in enrollment, including a number of patients from Canada.

我們在 2023 年第二季表現出色，我們的團隊也實現了承諾的里程碑。對於我們的 CardiAMP 自身細胞療法和心臟衰竭或 BCDA-01，我們實施了自適應統計分析計劃並經過了 FDA 的完整審查。我們根據現有數據在日本完成了提交申請並獲得批准，我們最終看到入組人數顯著增加，其中包括一些來自加拿大的患者。

For our CardiAMP autologous cell therapy for chronic myocardial ischemia, we continue to make progress on enrolling in the rolling cohort in ways that we can enhance the trial. And for our CardiALLO allogeneic cell therapy in heart failure, first patients are about to be enrolled.

對於我們用於治療慢性心肌缺血的 CardiAMP 自體細胞療法，我們繼續在滾動隊列入組方面取得進展，以加強試驗。對於我們用於治療心臟衰竭的 CardiALLO 同種異體細胞療法，第一批患者即將入組。

BioCardia also closed on a modest financing of $2.6 million in which insiders participated, had a publication with our partner, CellProthera, on the importance of therapeutic delivery, had three invited scientific presentations, and advanced business development discussions.

BioCardia 還獲得了260 萬美元的適度融資，內部人士參與了融資，與我們的合作夥伴CellProthera 一起發表了一份關於治療交付重要性的出版物，並進行了三場受邀科學演講和高級業務發展討論。

Q2 was a good quarter. This third quarter, we were thrown a curve ball when the Data Safety Monitoring Board for the CardiAMP heart failure trial, or BCDA-01, recommended we pause enrollment in the study. We have detailed the recommendation in our July 24 press release, and I will read it for you here.

第二季是一個不錯的季度。今年第三季度，當 CardiAMP 心臟衰竭試驗（BCDA-01）的資料安全監測委員會建議我們暫停研究的招募時，我們遇到了麻煩。我們在 7 月 24 日的新聞稿中詳細介紹了該建議，我將在這裡為您閱讀。

Quote, Based on an analysis of the trial data, the primary FS composite endpoint assessment and a supplemental analysis presented on 7/19/23, unrelated to any emergent safety events, the DSMB recommends pausing new patient enrollment and any potential crossover patient procedures pending an outcomes analysis of patients currently completing the one-year follow-up as well as the patients completing their imminently scheduled treatment.

引用，根據對試驗數據的分析、主要 FS 綜合終點評估和 2023 年 7 月 19 日提交的補充分析，與任何緊急安全事件無關，DSMB 建議暫停新患者入組和任何潛在的交叉患者程序待定對當前完成一年追蹤的患者以及完成即將安排的治療的患者進行結果分析。

The DSMB recommends notifying currently enrolled patients completing their treatment sequence that the trial will be paused following their scheduled treatment to assess intermediate study results. The DSMB recommends the blind not be broken at this time to protect the integrity of the outcomes yet to be collected and to ensure that the study may be restarted without compromise after completion of the one-year data analysis. End quote.

DSMB 建議通知目前已完成治療序列的入組患者，試驗將在其預定治療後暫停，以評估中間研究結果。 DSMB 建議此時不要打破盲法，以保護尚未收集的結果的完整性，並確保在完成一年的數據分析後可以毫不妥協地重新啟動研究。結束報價。

It is confusing to us, as there were no treatment-emergent safety issues reported, patients in aggregate appear to be showing clinical improvement and enrollment had accelerated significantly in recent months. We have followed the Data Safety Monitoring Board recommendation. We continue to randomize and monitor patients enrolled in this clinical study, in which both patients and evaluating physicians are blinded to the treatment group.

這讓我們感到困惑，因為沒有報告治療引起的安全問題，但總體而言，患者似乎表現出臨床改善，並且近幾個月入組速度顯著加快。我們遵循了資料安全監控委員會的建議。我們繼續對參與這項臨床研究的患者進行隨機分組和監測，其中患者和評估醫生對治療組均不知情。

We need more information to decide next steps for this program, which could be to restart the trial to initiate a new trial protocol under the same regulatory submission, or to abandon the program completely. Today, we don't feel that the DSMB proposal to wait for 14 months to potentially restart the trial makes any sense. If we initiated a new trial protocol, there are changes we would like to include to simplify the performance of the trial and there are changes that the FDA has expressed interest in, including specifically a change to a different functional capacity measure for the third tier of Finkelstein-Schoenfeld composite endpoint.

我們需要更多資訊來決定該計劃的後續步驟，這可能是重新啟動試驗以在相同的監管提交下啟動新的試驗方案，或完全放棄該計劃。今天，我們認為 DSMB 提出的等待 14 個月才能重新啟動試驗的提議沒有任何意義。如果我們啟動新的試驗方案，我們希望進行一些更改以簡化試驗的執行，並且 FDA 表示有興趣進行一些更改，特別包括對第三層的不同功能能力衡量標準進行更改Finkelstein-Schoenfeld 複合終點。

If there are interesting signals in the trial that support a new trial protocol with a different endpoint, our sense is we could implement this very quickly. A second trial, if it makes sense, would also address the FDA saber desire to have two separate trials for an approval.

如果試驗中有有趣的訊號支持具有不同終點的新試驗方案，我們的感覺是我們可以很快實施這一點。如果有意義的話，第二次試驗也將滿足 FDA 的願望，即進行兩項單獨的試驗以獲得批准。

One of our first actions on receiving the Data Safety Monitoring Board recommendations was to confirm that the Data Safety Monitoring Board review materials were correct. The only data in the trial at this interim analysis that has been well monitored or cleaned is that for the primary composite endpoint, the survival data, the major adverse cardiac event data, and the functional capacity by six-minute walk data.

收到資料安全監測委員會建議後，我們的首要行動之一是確認資料安全監測委員會審查資料的正確性。在本次中期分析中，試驗中唯一得到良好監測或清理的數據是主要複合終點、存活數據、主要不良心臟事件數據以及六分鐘步行功能能力數據。

We engaged independent experienced data analysis and clinical consultants to review the primary endpoint analysis and secondary outcome measures. They will be able to see the information that the DSMB reviewed as well and assess whether a follow-up meeting with the DSMB is warranted.

我們聘請了經驗豐富的獨立數據分析和臨床顧問來審查主要終點分析和次要結果指標。他們還將能夠看到 DSMB 審查的信息，並評估是否有必要與 DSMB 舉行後續會議。

We have been advised to stay blinded during this process to preserve options should the data set be better with respect to the primary endpoints. Soon thereafter, BioCardia may have a segregated team review the primary endpoint based on the monitored clean data and the secondary endpoints based on the available unmonitored data.

我們被建議在此過程中保持盲目，以便在資料集相對於主要終點更好的情況下保留選擇。此後不久，BioCardia 可能會有一個獨立的團隊根據監測到的乾淨數據審查主要終點，並根據可用的未監測數據審查次要終點。

Additional sub-analyses on this interim data set will also likely take place to inform next steps. New material information will be shared publicly as appropriate.

也可能對該臨時資料集進行額外的子分析，以告知後續步驟。新的重大資訊將酌情公開分享。

On June -- our June submission of the CardiAMP Cell Therapy system to Japan's Pharmaceutical and Medical Device Agency, or PMDA, for a first formal consultation towards approval for the indication of ischemic heart failure with reduced ejection fraction was based on existing safety and efficacy data.

6 月，我們根據現有的安全性和有效性數據，向日本藥品醫療器材管理局(PMDA) 提交了CardiAMP 細胞治療系統，進行了第一次正式諮詢，以期獲得批准用於射血分數降低的缺血性心臟衰竭的適應症。

The submission was reviewed and accepted by the PMDA for formal consultation with some clarifying questions which have been addressed. The PMDA consultation could take up to four months to schedule for their normal review process although dates in September have been requested. Subsequent interactions with PMDA are expected.

PMDA 審查並接受了該提交資料，以進行正式磋商，並澄清了一些已解決的問題。 PMDA 諮詢可能需要長達四個月的時間來安排其正常審查流程，儘管已要求日期在 9 月。預計隨後會與 PMDA 發生相互作用。

To our knowledge, we have a great deal more safety and efficacy data than other cardiac cell therapies approved or reported to be seeking approval soon in Japan. We have 185 procedures performed to date in the CardiAMP Phase I, II, and III programs with good support for efficacy from the 63 patients where we have complete visibility into the data and apparently good safety from the additional 122 procedures to which we are still blinded.

據我們所知，與日本已批准或據報即將尋求批准的其他心臟細胞療法相比，我們擁有更多的安全性和有效性數據。迄今為止，我們已在CardiAMP I、II 和III 期計畫中執行了185 項手術，其中63 名患者的療效得到了良好的支持，我們對這些患者的數據有完全可見性，並且我們仍然對另外122項手術視而不見，但顯然安全性良好。

There are other compelling reasons for PMDA to support approval, and that the elements of the system already have first-world regulatory approvals in Japan, EU, and/or USA and the procedure is minimally invasive where other cardiac cell therapy offerings in Japan require surgical open chest access to the heart.

PMDA 支持批准還有其他令人信服的理由，該系統的組成部分已經在日本、歐盟和/或美國獲得了全球監管機構的批准，並且該程序是微創的，而日本的其他心臟細胞治療產品則需要手術打開胸腔進入心臟。

If approved, the CardiAMP Cell Therapy system has potential to be the first minimally invasive, catheter-based cell therapy available in Japan. PMDA has confirmed that should we be approved, other developers of cell therapies in Japan could also be enabled to use our delivery systems if we authorize it ahead, such that an approval of CardiAMP Cell Therapy could be an advance to the field as a whole.

如果獲得批准，CardiAMP 細胞治療系統有可能成為日本第一個基於導管的微創細胞療法。 PMDA 已確認，如果我們獲得批准，如果我們提前授權，日本的其他細胞療法開發商也可以使用我們的輸送系統，這樣 CardiAMP 細胞療法的批准可能是整個領域的進步。

As we work through the process of gathering more information to decide next steps for the BCDA-01 program and consult with PMDA, we expect important milestones for our other clinical programs.

當我們透過收集更多資訊來決定 BCDA-01 計畫的後續步驟並諮詢 PMDA 的過程時，我們預計我們的其他臨床計畫將取得重要的里程碑。

The CardiAMP Cell Therapy trial for chronic myocardial ischemia or BCDA-02 is a Phase III multicenter randomized double-blinded controlled study intended to include up to 343 patients at up to 40 clinical sites. 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 this to be the most compelling indication for this therapy.

針對慢性心肌缺血的 CardiAMP 細胞療法試驗或 BCDA-02 是一項 III 期多中心隨機雙盲對照研究，旨在包括多達 40 個臨床中心的多達 343 名患者。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。許多主要研究人員，包括本試驗的兩位主要研究人員，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, strategies of using the cell population analysis as a means to set patient dosing as opposed to excluding patients, and means to include more patients based on modifying baseline exclusion criteria are under consideration to enable more rapid enrollment.

基於迄今為止治療患者的有希望的經驗、使用細胞群分析作為設置患者劑量而不是排除患者的手段的策略以及基於修改基線排除來納入更多患者的手段，隨機化階段的規劃已經在進行中正在考慮標準，以便能夠更快地註冊。

Six additional centers are actively being onboarded. The company's CardiALLO allogeneic cell therapy for ischemic heart failure or BCDA-03 program is a Phase I/II clinical trial encompassing 69 patients. Clinical-grade cells have been manufactured at BioCardia are ready for use with the company's proprietary delivery system, also manufactured at BioCardia. The first clinical center has finalized its clinical study agreement and received conditional IRB approval. Cellular preparation test runs at the clinical site and the site activation vision are scheduled for this month. Patient enrollment is expected to begin in the third quarter.

另外六個中心正在積極加入。該公司針對缺血性心臟衰竭的 CardiALLO 同種異體細胞療法或 BCDA-03 計畫是一項包含 69 名患者的 I/II 期臨床試驗。臨床級細胞已在 BioCardia 生產，可與同樣在 BioCardia 生產的該公司專有的輸送系統一起使用。第一個臨床中心已敲定臨床研究協議並獲得IRB有條件批准。細胞準備測試將在臨床現場進行，現場活化視覺計畫將於本月進行。病患登記預計將於第三季開始。

This study builds 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. Previous trial results showed compelling early signals for benefit.

這項研究建立在先前使用該公司專有的Helix 輸送系統進行間質幹細胞治療缺血性心臟衰竭的三項試驗的基礎上，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。先前的試驗結果顯示了令人信服的早期獲益訊號。

The company's allogeneic cell therapy trial for acute respiratory distress syndrome or BCDA-04 has been deprioritized to focus current financial resources on the other programs. This decision was based on the greatly reduced population of patients with acute respiratory distress secondary to COVID. When resources permit, BioCardia intends to expand the current indication to a broader population beyond COVID-induced ARDS and to other pulmonary indications.

該公司針對急性呼吸窘迫症候群（BCDA-04）的同種異體細胞療法試驗已被取消優先順序，以將目前的財務資源集中在其他項目上。這項決定是基於新冠肺炎繼發急性呼吸窘迫患者數量的大幅減少。在資源允許的情況下，BioCardia 打算將目前的適應症擴展到新冠肺炎引起的 ARDS 以外的更廣泛人群以及其他肺部適應症。

BioCardia's Helix Biotherapeutic Delivery System, or Helix, delivers therapeutics into the heart muscle with a penetrating helical needle from within the heart. It enables local delivery of cell and gene-based therapies, including BioCardia's own cell therapies. It remains the safest, easiest to use, and most efficient means for the delivery of cells, genes, and proteins to the heart muscle.

BioCardia 的 Helix 生物治療輸送系統（或稱 Helix）透過一根穿透性螺旋針從心臟內將治療藥物輸送到心肌。它能夠在本地提供基於細胞和基因的療法，包括 BioCardia 自己的細胞療法。它仍然是將細胞、基因和蛋白質輸送到心肌的最安全、最容易使用和最有效的手段。

The delivery platform includes proprietary approved steerable guide systems, approved delivery catheters, and investigational imaging navigation. Business development is active around our Helix Biotherapeutic Delivery platform and in other areas, and we are working to close meaningful deals by the end of the year. These deals have potential to enable us to avoid financing.

此輸送平台包括經專有批准的可轉向引導系統、經批准的輸送導管和研究成像導航。我們的 Helix 生物治療交付平台和其他領域的業務發展非常活躍，我們正努力在年底前完成有意義的交易。這些交易有可能使我們避免融資。

Underlying our programs is extensive intellectual property. In June, the company announced that the Japan Patent Office granted a patent titled Radial and Transendocardial Delivery Catheter, with a patent term that will expire in 2034. The patent describes interventional biotherapeutic delivery catheters to deliver biologics to specific target sites within the heart chamber. The allowed claims cover BioCardia's helical needle tip catheter technology platform in existing products and in future products in active development with enhanced features.

我們的計劃的基礎是廣泛的智慧財產權。 6 月，該公司宣布日本專利局授予了一項名為「徑向和經心內膜輸送導管」的專利，專利期限將於2034 年到期。該專利描述了介入性生物療法輸送導管，可將生物製劑輸送到心室內的特定目標部位。允許的聲明涵蓋了 BioCardia 現有產品中的螺旋針尖導管技術平台以及正在積極開發的具有增強功能的未來產品。

Also in June, the European Patent Office issued an intention to grant for a patent titled Site Selection Entry and Update with Automatic Remote Image Annotation. The patent application describes techniques to bring previously obtained high-resolution, three-dimensional images of a patient's heart, such as from a magnetic resonance image, or MRI, into the cardiac catheterization procedure suite, and to merge this image with the X-ray images that the physician uses to navigate during the procedure. This approach has been compelling in preclinical studies and is expected to further enhance targeting ease of procedures and data collection compared to our current procedures.

同樣在 6 月，歐洲專利局發布了授予一項名為「使用自動遠端影像註釋進行網站選擇輸入和更新」的專利的意向。該專利申請描述了將先前獲得的患者心臟的高解析度三維圖像（例如來自磁振造影圖像或 MRI）帶入心導管插入手術套件中，並將該圖像與 X 射線合併的技術。醫生在手術過程中用於導航的圖像。這種方法在臨床前研究中非常引人注目，與我們目前的程序相比，預計將進一步提高程序和資料收集的針對性。

In summary, we have four significant compelling clinical programs and strategic assets around our three platforms of great value. We recognize that the market share price does not reflect this. We recognize that there's disappointment and confusion from the DSMB response, but there is a wealth of data and active programs generating more data, and products are built on data. We have significant near-term catalysts ahead from each of our three cardiac programs, as well as our business development activities.

總之，我們圍繞著三個具有巨大價值的平台擁有四個引人注目的重要臨床項目和策略資產。我們認識到市場股價並未反映這一點。我們認識到 DSMB 的回應令人失望和困惑，但有大量的數據和產生更多數據的活動計劃，並且產品是建立在數據之上的。我們的三個心臟項目以及我們的業務發展活動都具有重要的近期催化劑。

I will now pass the call to David McClung, our CFO, who will review our Q2 2023 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 年第二季的業績。大衛？

Thank you, Peter, and good afternoon, everyone. Revenues were approximately $43,000 for the three months ended June 2023, comparable to approximately $975 million for the first three months ended March 31, 2022, primarily due to the timing of collaboration agreement revenues.

謝謝你，彼得，大家下午好。截至 2023 年 6 月的三個月收入約為 43,000 美元，而截至 2022 年 3 月 31 日的前三個月收入約為 9.75 億美元，這主要是由於合作協議收入的時間安排。

Expenses quarter over quarter were remarkably similar. Research and development expenses were approximately $2.3 million for the three months ended June 2023 and for the three months ended June 2022. And selling, general and administrative expenses remained at approximately $1.2 million in the second quarter of 2023 comparable to the same amount in the second quarter of 2022.

每季的支出都非常相似。截至2023 年6 月的三個月及截至2022 年6 月的三個月，研發費用約為230 萬美元。2023 年第二季的銷售、一般及管理費用仍約為120 萬美元，與第二季度的相同金額相當。2022 年第四季。

Our net loss was approximately $3.4 million in Q2 2023, as compared to $2.5 million in Q2 2022, primarily due to the fluctuation in collaboration revenues. Net cash used in operations during the quarter was approximately $3.2 million, as compared to approximately $2.6 million in the second quarter of 2022.

我們 2023 年第二季的淨虧損約為 340 萬美元，而 2022 年第二季為 250 萬美元，這主要是由於合作收入的波動。本季營運使用的淨現金約為 320 萬美元，而 2022 年第二季約為 260 萬美元。

And BioCardia ended the quarter with approximately $4.3 million in cash and cash equivalents, which provides runway into November without additional capital or funding from the business development and other activities that Peter mentioned earlier.

BioCardia 在本季結束時擁有約 430 萬美元的現金和現金等價物，這為進入 11 月份提供了跑道，無需額外的資本或來自業務開發和 Peter 之前提到的其他活動的資金。

This concludes management's prepared comments, and we're happy to now take questions.

管理層準備好的評論到此結束，我們很高興現在回答問題。

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

（操作員說明）Joe Pantginis, H.C.溫賴特。

Hi, everybody. Good afternoon and thanks for taking the question. So, Peter, I want to focus on the DSMB review, because obviously, like you said, I mean, this is somewhat of a really unique situation. And I guess I want to reconcile something even though you don't have the answers yet and then look forward a little bit. So if the DSMB comes out and says that unblinded data are not likely to meet the primary endpoint, usually, you'd be in trial wind down activities right now and the study would be essentially done. But it's not, and that's the very unique aspect. So I guess, from that standpoint, how do you reconcile that comment with the study still ongoing and the -- that you've seen blinded improvements in patients?

大家好。下午好，感謝您提出問題。所以，Peter，我想專注於 DSMB 審查，因為顯然，正如您所說，我的意思是，這在某種程度上是一種非常獨特的情況。我想我想協調一些事情，即使你還沒有答案，然後向前看一點。因此，如果 DSMB 出面表示非盲數據不太可能滿足主要終點，通常情況下，您現在就處於試驗逐步結束活動中，並且研究將基本上完成。但事實並非如此，這就是非常獨特的面向。所以我想，從這個角度來看，您如何將這一評論與仍在進行中的研究以及您所看到的患者的盲目改善相協調？

And then the second aspect of that question is -- which I think is important for listeners, is then for patients that will be followed in a blinded fashion to the one-year benchmark, what are the benchmarks that we and investors should be looking for with regard to deltas and treatment effects?

然後這個問題的第二個方面是 - 我認為這對聽眾來說很重要，然後對於將以盲目方式跟踪一年基準的患者來說，我們和投資者應該尋找哪些基準關於增量和治療效果？

Well, thank you, Joe for the question on the DSM review and some of the nuances. I guess on the first part, I don't have great clarity and so I can only hypothesize. As I noted in our prepared comments, we are also a little confused, but we assembled the DSMB and it's a very solid group.

好吧，謝謝喬提出有關 DSM 審查和一些細微差別的問題。我想在第一部分，我不太清楚，所以我只能假設。正如我在準備好的評論中指出的那樣，我們也有點困惑，但我們組建了 DSMB，它是一個非常堅實的團隊。

And so as we try to read the proverbial tea leaves, there could be -- I'll just rehash it so folks who are not entirely aware, we have a very low mortality rate in the trial relative to what we've seen in the latest clinical trial setting for the latest guideline-directed therapy in the New England Journal of Medicine. And we appear to have a very low major adverse cardiac event rate. And those are two components of the primary Finkelstein-Schoenfeld three-tiered endpoint.

因此，當我們嘗試閱讀眾所周知的茶葉時，可能會出現——我只是重述一下，以便那些不完全意識到的人，相對於我們在試驗中看到的死亡率，我們在試驗中的死亡率非常低。 《新英格蘭醫學雜誌》中最新指南指導治療的最新臨床試驗設定。我們的主要不良心臟事件發生率似乎非常低。這些是主要 Finkelstein-Schoenfeld 三層端點的兩個組成部分。

The third element is six-minute walk. And so I can hypothesize that maybe there's something wrong with the six-minute walk distance measure in as this primary endpoint. We have -- because the levels are so low with respect to mortality and MACE events, the six-minute walk likely has a larger impact in this trial than we may have expected. And the nuance of how it's incorporated in the Finkelstein-Schoenfeld endpoint may have implications as well.

第三個要素是步行六分鐘。因此，我可以假設作為主要終點的六分鐘步行距離測量可能存在問題。由於死亡率和 MACE 事件的水平非常低，因此六分鐘步行在本次試驗中的影響可能比我們預期的要大。它如何融入 Finkelstein-Schoenfeld 終點的細微差別也可能產生影響。

And so that data, as I mentioned, is being analyzed -- it actually already has been analyzed by a separate group and we're confirming that the data that was provided to DSMB is the conclusions that they're drawing are from a substantially correct data analysis.

正如我所提到的，這些數據正在被分析——實際上已經由一個單獨的小組進行了分析，我們正在確認提供給 DSMB 的數據是他們得出的結論，這些結論基本上是正確的數據分析。

The other thing that we're doing is we have a clinical adviser, external to the company that we are going to have a look at all of the materials and assess whether or not a follow-on conversation is appropriate with DSMB to clarify, potentially altering the recommendation. I think right now, our sense is that the restart in 14 months, as I've detailed, does not make a lot of sense today to management. And so -- but we've been advised to stay blinded ourselves to the data to maximize potential going forward. Our expectation is that will evolve after these next steps. And so that's just where we are.

我們正在做的另一件事是，我們有一位公司外部的臨床顧問，我們將查看所有資料並評估是否適合與 DSMB 進行後續對話，以澄清可能的情況改變建議。我認為現在，我們的感覺是，正如我所詳述的那樣，14 個月後重啟對管理層來說沒有多大意義。所以——但我們被建議對數據保持盲目，以最大限度地發揮未來的潛力。我們的期望是，在接下來的步驟之後，情況將會改變。這就是我們現在的處境。

Now your second question, I think, was on trial wind down and --

現在你的第二個問題，我認為，是在審判結束時——

No, more of benchmarking - sorry. Forgive me, benchmarking at one year, yeah.

不，更多的是基準測試 - 抱歉。請原諒我，以一年為基準，是的。

Yes. So as far as trial wind down, the information we receive from this will impact the data that we have. So we are still randomizing patients today. And because all of the data supports that this is safe and all the past data that we see supports this is efficacious, we're still bullish on the direction that we're going. And so those patients will be randomized. Expectation is all the outstanding patients will be randomized in the next six weeks to eight weeks.

是的。因此，就審判結束而言，我們從中收到的資訊將影響我們現有的數據。所以我們今天仍然會對患者進行隨機分組。因為所有數據都支援這是安全的，並且我們看到的所有過去數據都支持這是有效的，所以我們仍然看好我們前進的方向。因此，這些患者將被隨機分組。預計所有優秀患者將在接下來的六週至八週內進行隨機分組。

And then we'll follow them for a period of a year before we get to the true data readout from this trial. The interim readout that we may have, if data is viewed, we'll have the challenges that many of the endpoints have not yet been monitored, and so they will be looking at that.

然後我們將追蹤他們一年的時間，然後才能從這次試驗中讀出真實的數據。我們可能擁有的臨時讀數，如果查看數據，我們將面臨許多端點尚未受到監控的挑戰，因此他們將關注這一點。

What I would expect to look for here is I follow the primary endpoint. I mean, the mortality data is going to be important. I mean, if we're losing on that for some reason that I can't explain, that would be a surprise. The MACE data will be this next thing to look at. And if we're losing on that, that will also be interesting to look at.

我希望在這裡尋找的是我遵循主要終點。我的意思是，死亡率數據將很重要。我的意思是，如果我們因為某種我無法解釋的原因而輸掉了比賽，那將是一個驚喜。接下來要關注的是 MACE 數據。如果我們在這一點上失敗了，那也會很有趣。

But I think the primary feature since those two are so low already in this treated population; I don't expect either of those to have any interesting signals. Again, I'm not privy to the data. So I'm providing you my best guesswork here all.

但我認為主要特徵是，因為這兩個特徵在接受治療的人群中已經很低了；我預計其中任何一個都不會產生任何有趣的信號。再說一遍，我對這些數據並不知情。所以我在這裡為您提供我最好的猜測。

And my expectation is that if there's something, it's the six-minute walk is problematic. When we look at the other pre-specified endpoints, quality of life, all of the extensive echo data we have from our core laboratory at Yale, there may be some interesting observations in there that enhance our comfort level.

我的期望是，如果有什麼問題的話，那就是六分鐘的步行是有問題的。當我們查看其他預先指定的終點、生活品質以及從耶魯大學核心實驗室獲得的所有廣泛回波數據時，可能會發現一些有趣的觀察結果，從而提高我們的舒適度。

And then also two-year data follow-up, we haven't really looked at two years, but understanding how these patients are doing long-term is also going to be really important. And I would, again, I'd look at the survival data, I'd look at the MACE data, and then I'd look at the functional endpoints of six-minute walk, quality of life, and all the -- actually all of the echocardiography data such as LV ejection fraction, LV end-diastolic dimensions, the end-systolic dimensions. And those are really important endpoints and are quite objective,

然後還有兩年的數據隨訪，我們還沒有真正關注兩年，但了解這些患者的長期表現也非常重要。我會再次查看生存數據，查看 MACE 數據，然後查看六分鐘步行的功能終點、生活質量以及所有——實際上所有超聲心動圖數據，如左心室射血分數、左心室舒張末期尺寸、收縮末期尺寸。這些都是非常重要的終點且非常客觀，

And we'll see where we go from there. I think right now, it's interesting. I mean, we don't have clarity on why they would pause it. If they don't think we're going to hit the primary endpoint, maybe their perception is these guys pause this and stopped this trial and restarted with another variable other than six-minute walk, maybe they'll be successful, I don't know. It's all guesswork.

我們將看看接下來的發展方向。我想現在，這很有趣。我的意思是，我們不清楚他們為什麼要暫停它。如果他們認為我們不會達到主要終點，也許他們的看法是這些人暫停並停止試驗並以六分鐘步行之外的另一個變量重新開始，也許他們會成功，我不這麼認為。我不知道。這都是猜測。

But we're being prudent as we're moving forward. We are stewards of the value that this trial has in it for all of our shareholders and for patients, and so we have to take the steps that we're taking and the order we're taking, and we're doing it with world-class folks, so that we'll get to the right answers hopefully sooner rather than later.

但我們在前進時會保持謹慎。我們是這項試驗對我們所有股東和患者的價值的管家，因此我們必須採取我們正在採取的步驟和我們正在採取的順序，我們正在與世界一起這樣做同學們，這樣我們就能盡快得到正確的答案。

Now, Peter, thanks a lot. I appreciate the color and the speculation for this pretty unique situation. And looking forward to the outcomes. Thanks a lot.

現在，彼得，非常感謝。我很欣賞這種非常獨特的情況的顏色和猜測。並期待結果。多謝。

Yeah, appreciate the question, Joe.

是的，謝謝這個問題，喬。

At this time, we are showing no further questioners in the queue, and this does conclude our question-and-answer session. I would now like to turn the conference back over to Peter Altman for any closing remarks.

目前，我們在隊列中沒有顯示更多提問者，這確實結束了我們的問答環節。現在我想將會議轉回由彼得·奧特曼（Peter Altman）發表閉幕詞。

I want to thank all of you 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, and as I always say, stay healthy, be kind, and have a wonderful day. Thank you

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步，正如我常說的，保持健康、友善，祝你有美好的一天。謝謝

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

會議現已結束。感謝您參加今天的演示，您現在可以斷開連接了。