바이오카디아(BCDA) 2026년 2분기 실적 발표 콘퍼런스 콜: 카디앰프 일본 승인 신청 및 FDA 진행 상황

바이오카디아(BioCardia, NASDAQ: BCDA)는 2026년 2분기 실적 발표 컨퍼런스 콜에서 카디AMP(CardiAMP) 세포 치료제와 헬릭스(Helix) 경심근 전달 카테터의 규제 승인 진전에 초점을 맞췄습니다. 회사는 비용과 순손실을 전년 동기 대비 줄였으며, 시장조달방식(ATM) 유상증자를 통해 현금 소진 시점(캐시 런웨이)을 2027년까지 연장했습니다.

핵심 요약

• 일본 의약품의료기기종합기구(PMDA)와의 협의를 통해 카디AMP 세포 치료제의 쇼닌(Shonin) 시판 전 승인 신청 추진이 뒷받침되었습니다. 바이오카디아는 다음 분기 신청을 준비 중이며, 초기 적응증 대상 환자 수를 약 2만 명으로 예상하고 있다고 밝혔습니다.
• 미국 식품의약국(FDA) 회의록에 따르면 진행 중인 카디AMP 심부전 II(CardiAMP Heart Failure II) 임상이 시판 전 승인을 뒷받침할 수 있음이 확인되었습니다. 경영진은 FDA가 이 임상을 주로 효능에 초점을 맞춘 확증적 임상 3상으로 보고 있다고 전했습니다.
• 카디AMP 심부전 II 임상은 현재 4개 기관에서 적극적으로 환자를 모집 중입니다. 2026년 8월 중 추가로 3명의 환자가 자격을 갖출 것으로 예상되었고 2건의 시술이 예정되어 있었으며, 경영진이 파악한 안전성 문제는 없었습니다.
• 2분기 순손실은 전년 동기 200만 달러에서 160만 달러로 줄었습니다. 총비용은 주로 연구개발(R&D) 지출 감소에 힘입어 210만 달러에서 160만 달러로 감소했습니다.
• 바이오카디아는 ATM 프로그램을 통해 주당 평균 1.22달러에 약 490만 달러의 순수익금을 조달했습니다. 경영진에 따르면 분기 말 기준 현금 및 현금성 자산은 410만 달러로, 2027년까지의 자금 운용 기간을 확보했습니다.
• FDA는 헬릭스에 대해 카디AMP와 동시 승인 및 디노보(De Novo) 경로 가능성을 포함한 두 가지 잠재적 승인 경로를 제시했습니다. 공식 회의록은 아직 나오지 않았으나, 바이오카디아는 FDA의 이메일을 통해 논의 내용에 대한 이해를 확인했다고 밝혔습니다.

주요 재무 데이터

바이오카디아는 분기 말 자본금 270만 달러를 기록했으며, 경영진은 이를 통해 나스닥 상장 요건을 충족하고 있는 것으로 판단합니다.

사업 및 영업 성과

일본 내 카디AMP 규제 경로

PMDA는 임상 참가자들이 가이드라인에 따른 약물 치료를 받고 있었으며 혈관 재개통술 대상이 아니라는 점에 대한 확인을 요청했습니다. 또한 사망, 심장 이식, 좌심실 보조 장치(LVAD) 삽입에 대한 추가 정보와 함께 시판 후 조사에 대한 초기 제안서를 요구했습니다.

바이오카디아는 요청된 정보의 대부분을 이미 보유하고 있다고 밝혔습니다. 경영진은 115명의 환자 중 4가지 가이드라인 권장 약물 중 하나를 투여받지 않은 이유에 대해 추가 문서화가 필요한 사례가 약 8~9건 파악되었다고 전했습니다.

신청 준비 사항으로는 전자 임상 마스터 파일(eTMF) 완료, 일본 의약품 임상시험 관리기준(GCP) 감사 실시, 임상 데이터의 CDISC 표준 전환, 지정마케팅승인보유자(DMAH) 선임 등이 포함됩니다. 경영진은 CDISC 전환 작업이 남아있는 업무 중 가장 오래 걸리는 작업이라고 설명했습니다.

회사는 일본에서의 초기 적응증 대상 환자 수가 약 2만 명에 달할 것으로 예상합니다. 경영진은 규제 당국의 심사에 따라 쇼닌 신청 완료 후 약 12개월 뒤에 승인이 이뤄질 수 있다고 밝혔습니다. 보험 급여 논의는 승인 후에 진행될 예정입니다.

바이오카디아는 일본 내 연간 허혈성 심부전 환자가 약 30만 명, 심장 카테터 중재 시술이 25만 건에 달한다고 인용했습니다. 또한 동일한 적응증에 대해 또 다른 세포 치료제가 2026년 7월 치료당 32만 6000달러의 보험 급여를 받았다고 언급했습니다. 경영진은 이 수치들이 카디AMP의 잠재적 시장 기회를 설명하기 위한 배경 자료일 뿐, 바이오카디아의 가격 책정 지침은 아니라고 제시했습니다.

미국의 카디AMP 심부전 II

FDA는 카디AMP 심부전 II가 시판 전 승인을 뒷받침할 수 있으며 심부전 적응증에 대한 확증 임상 역할을 할 수 있음을 확인했습니다. 경영진은 향후 논의가 모든 원인으로 인한 사망 및 비치명적 주요 심장 부작용에 이은 복합 1차 평가변수의 세 번째 단계인 삶의 질 항목에 초점을 맞출 것이라고 밝혔습니다.

바이오카디아는 1차 평가변수를 중심으로 연구를 간소화할 계획입니다. 경영진은 임상팀이 일본 내 승인 신청을 최우선으로 진행함에 따라 환자 등록이 주로 투입 자원에 의해 제한을 받아 빠른 속도로 진행되지 않고 있다고 설명했습니다. 현재 추가 임상 기관을 온보딩(등록)하는 중입니다.

헬릭스 전달 카테터

FDA는 사전 신청 회의에서 헬릭스의 안전성, 기기 성능 또는 일반적인 치료제 범주와의 적합성에 대해 우려를 제기하지 않았습니다. FDA가 선호하는 경로는 카디AMP와의 동시 승인이었으나, 추후 사전 신청을 통해 독립적인 디노보(De Novo) 승인을 추진할 가능성도 있습니다.

바이오카디아는 헬릭스가 약 500명의 환자를 대상으로 한 10여 개 이상의 임상시험에서 사용되었으며, 이전 유럽 시장 출시를 위한 CE 마크를 획득했다고 밝혔습니다. 경영진은 FDA 승인이 치료제 제휴를 지원하고 향후 규제 승인 절차를 간소화할 수 있을 것으로 보고 있습니다.

상업화 및 파트너십

바이오카디아는 자사의 심혈관 치료제와 관련해 아시아·태평양 지역에서 적극적인 사업 개발 논의를 진행하고 있습니다. 경영진은 잠재적인 거래가 만성 심근 허혈 대상 카디AMP 및 염증성 심부전 대상 카디알로(CardiALLO) 세포 치료제의 자금 조달에 도움이 될 수 있다고 밝혔으나, 확정된 계약은 발표되지 않았습니다.

일본의 예비 DMAH는 상업적 라이선스 보유자 역할을 하기보다는 규제 및 품질 관련 지원을 제공하게 됩니다. 바이오카디아는 현재 수백 명에서 최대 1,000명의 환자가 포함될 수 있는 시판 후 조사 기간 동안 카디AMP를 직접 판매할 계획입니다. 현지 병원 유통업체는 제품 가치의 최대 10%를 수수료로 받을 수 있습니다.

경영진은 또한 일본에서의 승인이 성공적으로 이루어진 이후 브라질 및 아랍에미리트(UAE)에서의 잠재적 제휴 관계에 대한 예비 논의도 언급했습니다.

경영진 전망

경영진은 기존 자본금이 중대한 전환점이 될 PMDA 신청 마일스톤을 완료하기에 충분하다고 판단합니다. 또한 바이오카디아는 장기 투자자가 참여하는 소규모 자금 조달을 통해 카디AMP 심부전 II 프로그램을 가속화할 수 있다고 밝혔습니다.

회사는 규제 심사 기간 동안 일본 의료진 교육 및 시판 후 조사 물류망 구축을 진행할 것으로 예상합니다. 경영진은 카디AMP가 승인 및 보험 급여를 받을 경우 비교적 빠른 채택이 이루어질 것으로 전망하지만, 이 전망은 규제 승인, 임상 기관 준비 상태 및 시판 후 조사의 성공적 실행에 달려 있습니다.

리스크 및 주요 관전 포인트

• 치료 관련 문서화 및 상세 임상 사건 기록 등 PMDA의 미결 요청 사항은 쇼닌 신청 전 또는 신청 절차의 일부로 해결되어야 합니다.
• CDISC 형식 데이터 완료, 일본 GCP 감사 및 전자 임상 마스터 파일(eTMF) 완성이 제출 시기에 영향을 미칠 수 있습니다.
• 카디AMP 심부전 II 환자 등록은 여전히 자원 투입 상황에 좌우되며, 경영진은 전체 환자 모집 수치를 제시하지 않았습니다.
• 임상의 삶의 질 평가변수에 대한 FDA와의 논의가 계속 진행 중이므로 임상시험 계획서나 통계적 변경 가능성이 존재합니다.
• 헬릭스 사전 신청 회의에 대한 FDA의 공식 회의록은 예상일이었던 6월 12일을 넘어 지연되었습니다.
• 바이오카디아는 미국 내 확증 임상을 가속화하기 위해 추가 자금 조달을 모색할 수 있으며, 이로 인해 주주 지분 가치가 추가로 희석될 수 있습니다.
• 일본 내 승인, 보험 급여, 시판 후 조사 설계 및 광범위한 상업화는 규제당국의 심사 및 운영상의 실행 능력에 따라 달라질 수 있습니다.

애널리스트 Q&A 주요 내용

애널리스트들은 일본 내 규제 승인 및 상업화 경로에 주로 집중했습니다. 경영진은 시판 후 조사에서 의사와 환자에게 긍정적인 경험이 확인될 경우, 초기 2만 명 대상 적응증이 확대될 수 있다고 밝혔습니다.

바이오카디아는 자사 카디AMP의 최소 침습적 자가 세포 접근법을 경쟁 치료제인 리하트(ReHeart) 치료법과 대조했습니다. 경영진은 리하트가 수술적 이식과 잠재적인 만성 면역억제제 투여가 필요한 치료제라고 설명했습니다. 경영진은 또한 카디AMP가 더 광범위한 임상 경험을 보유하고 있음을 강조했으나, 가격 책정 가이던스는 제공하지 않았습니다.

DMAH와의 관계에 대해 경영진은 바이오카디아가 규제 및 품질 서비스에 대해 해당 기관에 비용을 지불할 것이라고 분명히 밝혔습니다. 승인 권한은 양도 가능한 상태로 유지되어 향후 라이선스 또는 유통 계약에 대한 유연성을 확보할 수 있습니다.

헬릭스와 관련해 경영진은 주요 미결 과제가 디노보(De Novo) 신청에 필요한 수정 사항에 대한 명확성이라고 밝혔습니다. 디노보 승인에 성공하면 헬릭스는 해당 투여 경로로 FDA 승인을 받은 최초의 카테터가 될 수 있지만, 동시에 경쟁사들이 해당 승인을 참조하여 510(k) 허가를 추진할 수 있게 됩니다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good day everyone and welcome to the BioCardia Q2 2026 Financial Results and Corporate Update Conference Call. [Operator Instructions] 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 1 hour after the end of today's conference.

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

Miranda Benvenuti

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 BioCardia's expectations for future performance and operational results, references to management's intention, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approval.

Forward-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 10-K filed with the SEC on March 24, 2026, and in our subsequently filed quarterly reports on Form 10-Q. The contents of this call contain time-sensitive information that is accurate only as of today, August 12, 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. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please proceed.

Peter Altman

Thank you, Miranda, and good afternoon to everyone on the call. The highlights of this second quarter have been the positive outcomes of 3 important meetings with regulatory agencies in Japan and the United States on the approvability of our CardiAMP Cell Therapy for the treatment of ischemic heart failure and on the approvability of our Helix transendocardial delivery catheter, which we use in our therapeutic programs. Let's take each of these in turn.

In May, we announced that Japan's Pharmaceutical and Medical Device Agency, or PMDA, provided the consultation record of advice, which supports our advancing to Shonin pre-market regulatory submission for approval of the CardiAMP cell therapy. PMDA noted that the positive outcomes seen in our CardiAMP trials were credible. We have remaining questions to address before and as part of the submission for regulatory approval for this therapy. Specifically, PMDA requested BioCardia demonstrate that enrolled patients were on guideline-directed medical therapy and not eligible for revascularization procedures, both of which were required per the CardiAMP heart failure trial clinical protocol.

They also requested additional details for each incidence of all-cause death, heart transplantation, or left ventricular assist device implantation. PMDA also provided guidelines and requested an initial proposal for further developing the post-marketing study with details on center selection, physician selection, training, and outcomes to be assessed. BioCardia believes these requests will be addressed to PMDA's satisfaction and a post-marketing study to be developed together with PMDA and Japanese medical societies will be straightforward. In addition to answering these questions in great detail, BioCardia is preparing for the Shonin regulatory submission in Japan next quarter.

We are working to complete the electronic trial master file, conduct third-party Japanese good clinical practice audits to PMDA standards, and structure clinical research data in accordance with CDISC standards, which support data consistency, traceability, and regulatory compliance. We are reviewing extensive product documentation internally and expect to soon sign an agreement with a Designated Marketing Authorization Holder, or DMAH, to help finalize the submission as they will act as the local regulatory representative to enable BioCardia sales of CardiAMP cell therapy in Japan. Our expected initial indication will be for approximately 20,000 patients in Japan, with approval approximately 12 months after we complete our Shonin submission.

During this period, we would expect to be educating physicians and finalizing the details of the post-marketing study and its logistics so that we are ready to begin at all centers as soon as reimbursement has been established. Reimbursement in Japan follows Shonin approval and will be determined based on discussions with the Ministry of Health, Labor and Welfare. In Japan, another cell therapy for the same indication was approved in March of this year and has received confirmation that they have been approved for reimbursement in July at $326,000 per treatment. This underscores the need recognized in Japan for such a therapy. That cardiac cell therapy is now a real market in Japan, and the CardiAMP cell therapy has potential to be an enormously valuable therapy.

While these 2 cell therapies are different, we believe the minimally invasive delivery and autologous nature of CardiAMP, coupled with its greater clinical experience, will be attractive to both physicians and their patients. With approval and reimbursement, we would expect adoption to be relatively rapid in the post-marketing study with world-class physician leaders who have already been generous in their support of our efforts.

Although our initial approval is only expected to be for 20,000 patients in Japan, we know that there are approximately 300,000 patients in Japan with ischemic heart failure today. Japan's world-class interventional cardiologists perform 250,000 cardiac catheterization interventions per year. Our enhancing both physician and patient success in the post-marketing study, where there will be reimbursement, is likely to result in a significant business that has a very positive impact on patients and society in Japan.

Shonin approval of CardiAMP cell therapy, which includes the Helix biotherapeutic delivery catheter, may also help other developers of cardiac biologic therapy in Japan. It is worth noting that the 2 publicly traded peer companies in Japan advancing cardiac cell therapies each have market capitalizations of approximately $250 million. And to our knowledge, BioCardia has performed more than 20x as many clinical procedures as both of these firms combined. Each is pursuing a different catheter delivery approach, but we do feel we could be a valuable partner if we have not entered into an exclusive development agreement with a competitive party. We also have important issued patents on delivery in Japan.

In June, we announced the results of our second significant regulatory discussion, our Q-Sub Meeting with FDA's Center for Biologics Evaluation and Research. The meeting minutes from FDA confirmed that the ongoing CardiAMP Heart Failure II trial may support premarket approval for market clearance. This was significant as previously the FDA had not provided the support that 1 trial should be sufficient for approval for this large clinical indication. FDA said the data was interesting, and the message we are hearing is that the CardiAMP Heart Failure II trial is viewed as a confirmatory trial. There were no questions on safety or on delivery in the meeting, and our sense is that for the agency, the confirmatory trial is all about the efficacy of the study.

We are expected to have additional discussions with the agency on the outcome measures in the study, in particular around the third tier of the composite outcome of quality of life. We continue to actively enroll in the CardiAMP Heart Failure II trial to take this study to completion as our confirmatory Phase III study. Four clinical sites have enrolled in the study and are actively recruiting patients. Three additional patients are expected to qualify for the study this month, and 2 are scheduled for their procedures this month. There have been no safety issues of which management is aware. The rate of enrollment here is driven primarily by resources deployed, and we are actively onboarding additional centers.

In May, we had our third regulatory interaction on the De Novo Pre-Submission with FDA for the Helix transendocardial delivery catheter system. FDA agreed that there are 2 pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance or compatibility with general classes of agents. FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the De Novo pathway.

However, we still don't have the formal meeting minutes from this meeting, which were expected June 12. We did hear from FDA this morning by e-mail that confirms our understanding, and FDA has said that they would have the formal minutes sent to us soon. Our assessment is that the Helix transendocardial delivery catheter system has the best safety, efficiency and ease of use of any catheter of its kind. It takes years to generate this level of data, which we have for more than a dozen clinical trials with approximately 500 patients. We feel it is unlikely that another transendocardial delivery system will be able to have this amount of data within the next 5 years. This catheter has been previously CE marked and approved for market release in Europe.

The key value propositions for the FDA approval of Helix are enhanced partnering for BioCardia around Helix and simpler regulatory submissions for therapeutic approvals, including our CardiAMP cell therapy in heart failure. On the business development front, we have active conversations in the Asia-Pacific region on our cardiovascular therapeutics. While BioCardia fully expects to have boots on the ground in Japan for the post-marketing study, as we transfer all of our experience to Japanese physician centers, the DMAH is transferable, and the broader commercialization will be enhanced by an experienced team.

Our expectation is that any deal has potential to include funding to advance CardiAMP for its second indication for chronic myocardial ischemia and our allogeneic CardiALLO cell therapy for inflammatory heart failure to market clearance as well. Such a deal would enhance our efforts in the United States on all 3 of these programs. Business development on biotherapeutic delivery is also active. We believe we can help many of those in development, particularly for gene-based therapy. There is a great deal more possible with intramyocardial delivery that is not well appreciated by many firms today. These possibilities are enhanced by the potential of Heart3D fusion imaging, which we are working diligently with our respected partner, CART-Tech, to bring to the clinic and to the market as soon as possible.

Today, we believe we have the capital to complete the significant and potentially transformative milestone of PMDA submission of CardiAMP cell therapy. And parallel to the deals we are working to realize, a modest financing with long investors would accelerate the confirmatory CardiAMP Heart Failure II program.

With that, I will now pass the call to David McClung, our CFO, who will review our second quarter 2026 financial results. David?

David McClung

Thank you, Peter, and good afternoon, everyone. I'll now review the highlights of our financial results for the quarter and 6 months ended June 30, 2026. Net cash used in operations during the 3 months ended June 2026, was approximately $1.7 million, increased slightly from the $1.6 million used in the 3 months ended June 2025. Net cash used in operations for the 6 months ended June 2026, of $3.4 million increased slightly from the $3.3 million used in the 6 months ended June 2025. These small increases are primarily due to the timing of supplier payments.

During the second quarter, BioCardia raised net proceeds of approximately $4.9 million under our "At-The-Market" facility at an average price of $1.22 per share. Funding from this facility has a lower cost of capital than traditional financing vehicles and does not involve the issuance of stock warrants or other dilutive securities. The company ended the quarter with cash and cash equivalents totaling $5.4 million (sic) [ $4.1 million ], providing runway into 2027. As we ended the quarter with -- we ended the quarter with $2.7 million in equity, which we believe keeps us compliant now with NASDAQ listing standards.

Total expense decreased by $0.4 million quarter-over-quarter to $1.6 million in the second quarter of 2026 compared to $2.1 million in the same quarter of 2025. For the 6 months ended June 2026, total expense decreased $0.9 million to $3.9 million from $4.8 million. The primary driver of these changes, research and development expense, decreased $0.5 million to $0.9 million in the second quarter of 2026 compared to $1.4 million in the second quarter of 2025. And it decreased $0.8 million to $2.1 million for the 6 months ended June 2026 compared to $2.9 million for that same period in 2025. The decreases relate primarily to the closeout of the CardiAMP Heart Failure Trial, partially offset by expenses for early enrollment in the CardiAMP Heart Failure II Trial and continuing regulatory activities to advance CardiAMP in Japan.

Selling, general, and administrative expenses remain consistent at $0.7 million quarter-over-quarter. For the 6-month period ended June 2026, SG&A decreased slightly to $1.8 million from $1.9 million for the 6 months ended June 2025. Our net loss was $1.6 million for the second quarter of 2026 compared to $2.0 million in the second quarter of 2025. For the 6-month period ended June 2026, our net loss was $3.9 million compared to $4.9 million for that period in 2025. The June SEC proposal to eliminate the baby shelf limitation that constrains access to registered offerings and ATM programs for smaller companies is expected to be beneficial for BioCardia when implemented. It would be great if this were available to BioCardia in Q1 2027.

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

Operator

[Operator Instructions] Our first question today comes from Joe Pantginis from H.C. Wainwright.

질의응답

Joseph Pantginis

So Peter, a couple things, I guess spanning geographies. Let me go backwards with regard to your prepared comments. So with regard to the pending FDA minutes, obviously, we'll wait to see what they say, but what would you say are the key points that are outstanding?

Peter Altman

Well, hello, Dr. Pantginis. It's great to speak with you, Joe, and thank you for the question. On the first element on this is the nuances for the De Novo submission for Helix. So we have some good clarity on how this has potential to be the first transendocardial biotherapeutic delivery catheter approved by FDA via the De Novo route. And really, the only thing we need clarity on is them to say, yes, that's the tweak for submission. The key issue with FDA is they have a very challenging time approving a delivery system for a biologic for a clinical indication and a route of administration for which no therapeutic has yet been approved. And they've found ways to do that with sort of a skirt around with other firms, with other routes of administrations historically.

Our conversation with them was approaching it head on, saying, look, this is what we're trying to do. This is what the data says. Our expectation is that their internal processes are so rigid that we're going to have to also do a similar end around for our approval for this catheter system. And we have the data to support it and the experience to support it. So it is a De Novo, so there is no other catheter approved with this route of administration. But for those on the call who may not be entirely familiar with the Helix transendocardial catheter, it's based on a design of active fixation pacing leads, which have been used in a million patients. And our data is second to none as published by independent parties.

So I've also -- we've raised with the agency that there are many folks who are pursuing routes of administration for their therapeutic development that either makes no sense or is driven by the great desire to not have an investigational delivery platform woven into their efforts. And so I think we can -- the agency appreciates the value proposition of enabling approval of Helix. As I said in my prepared comments, their first choice would be approval with the CardiAMP cell therapy. That's easy for them. That's easy for them, that's straightforward for them.

But I think they also recognize that by not having an approved delivery system, they're basically hampering the whole field of development. And so for all biologic interventions in cardiology. And my expectation and hope is that the Helix will be the first such product. The downside of a De Novo for BioCardia is that does enable others to then file a 510(k) referencing our De Novo, but our expectation is they'll have to demonstrate some of the performance characteristics that we can demonstrate. And so that will be a pretty significant barrier to entry still.

Joseph Pantginis

Got it. No, I appreciate that color a lot. So 2 more questions, if you don't mind, but going now to focus.

Peter Altman

Please. Welcome, Joe.

Joseph Pantginis

So the first one is 2-pronged. So if you get approval in Japan, you said the initial target market is about 20,000 patients. What efforts or what kind of components would be considered to expand that market, number 1. And the second part is, obviously you mentioned important, I guess, derivative there with regard to ReHeart and the reimbursement that they're getting for about $326,000. I know it's hard to talk about comps sometimes, but maybe you could do a bit of a compare-contrast beyond what your prepared comments said.

Peter Altman

Sure. So, on the 20,000 patients for the initial indication, I think the way that is expanded is by success in this post-marketing study. In Japan today, the patients that we will be treating truly have few options. They don't do a lot of heart transplantation in Japan because they don't like the concept of implantation of other people's organs in another patient. And that's an advantage for our autologous cell therapy. But it also means that left ventricular assist devices, which is an implanted device, also has some reservations by the patient community there. So the key thing to expand that 20,000 patients is to have this post-marketing study go as smoothly as possible to have the physician experience be akin to what it is today in the United States. And we think we can deliver that.

So that's, as we go to Japan, PMDA has said they want us to stay with this program as it advances. And we will definitely be involved as this post-marketing study is initiated and performed. But our sense is, with 250,000 percutaneous coronary intervention procedures done per year, they have a very hungry interventional cardiology community for new therapies, and they have a very large patient population that has no real options. And so our sense is that just by delivering a great experience in this post-marketing study and beginning to educate the physicians that working with PMDA, the indication will expand in short order.

And on the second comment on the -- how does this play with respect to the reimbursement and what are the differences between CardiAMP and the other ReHeart therapy that's approved. Well, today, ReHeart requires surgical implantation, which means that patient's chest has to be opened up as if you were doing a coronary artery bypass procedure or a heart transplantation procedure. And then the cells are laid on the surface of the heart. Because they are not autologous, our expectation is that they will require chronic immunosuppression. And immunosuppression in these patients who have just had cardiac surgery can introduce other issues.

Thirdly is what we're doing with our approach. The data we have is pretty robust. And their data -- we haven't seen their data, but my expectation is they have a total of 8 patients they've treated historically. So I think going in there with our experience and our data become compelling. And so as we look at their reimbursement that gives us a lot of room to have reasonable pricing. And my sense is that our confidence that our pricing will be strong for BioCardia is there completely. If they're reimbursed at that level, that's great for them and we wish their patients every positive. But I think it presents an opportunity where they're educating and they'll be learning over the next year as we will be working through the regulatory process.

And I think on the other side of this, they will be a great peer company. We may also actually, Joe, be able to help them on delivery. I mentioned that they're pursuing a different delivery approach today, but we have a great depth of experience. And so they are a potential partner to us as well as arguably a competitor today with a different cell therapy approach. Our approach, interestingly, is an autologous mononuclear cell preparation. Theirs is an induced pluripotent stem cell preparation where the cells are intended to become cardiomyocytes. But they don't speak of their mechanism of action as one of replacing heart cells, but rather of triggering an angiogenic response. So there's still a lot that we're going to learn about them and that they'll learn about us ahead and hopefully the physician community as well. But I'm pretty confident that CardiAMP has a real role in Japan and can help quite a few patients.

Joseph Pantginis

Thank you, Peter, for that. Can you hear me?

Peter Altman

Yes, I can, Joe.

Joseph Pantginis

Perfect. Because my call actually dropped off. I was able to get back on real quick, so I heard your answers. So I'm glad it was still connected. So my last question is regard to Japan, but more, I guess, expanding the concept. If you do get approved in Japan plus all the discussions and data that you have with Japan, how that might be applicable to additional geographies?

Peter Altman

It's a great question, Joe. Great question. So, Japan is considered a first world country. And I think we've said previously that their inspection of our facilities and their approval of CardiAMP carries weight in other countries around the world. So we have already had conversations around potential relationships in Brazil and United Arab Emirates, and those would arguably follow after we were successful with an approval in Japan. So I think Japan has potential to be much bigger than it is both in Japan, but also in rest of world. And it's tied into some of the harmonization on the inspection work that's been done, but yes, I think it has great potential.

Operator

Our next question comes from James Molloy from Alliance Global Partners.

James Molloy

I want to follow up a little more on Joe Pantginis's question about Japan. Can you walk me through sort of how the Designated Marketing Authorization Holder, how their partnership works? Is it like a traditional partnership you would have with a partner in any other geography where they sell, you get a royalty? Can you break down how that will work? And is that partner -- I think you say in the prepared remarks, hoping to sign them soon. Is that partner guaranteed to be signed? Or what sort of the next steps we should anticipate there?

Peter Altman

So, appreciate the question, Jim. Appreciate you being on the call. The DMAH, the Designated Marketing Authorization Holder, is a nuanced element of submission in Japan. So in this situation, this is actually a party that we contract with who essentially works for BioCardia to represent all of the regulatory and quality issues associated with the CardiAMP Cell Therapy in Japan. This is -- when we -- when you do a distribution deal or a partnership in Japan, oftentimes partners will want to own the authorization. They will want to be the marketing authorization holder because it becomes harder to transfer. But when you have a Designated Marketing Authorization Holder, it is completely transferable. So it does not prevent us from doing distribution deals or licensing deals more likely for these therapies and enable others to advance them.

And it's a party that we've already met with, we're already talking about the specifics, and we're working on budgeting and contracts, but it is a party that BioCardia will pay to support us from a regulatory perspective. And there'll be other parties that are involved on doing the good clinical practice audit of our information to support them so that they have a great deal of confidence as they help us pull together our dossier for the submission, that they will know that their related entities have done this work. And although we are not working with them yet today, they are plugged into this group that we are working with in Japan today. So through that, we have a good relationship and a high confidence that we have the right people that we're going to be working with downstream.

James Molloy

And how does it look, if you sell into this 20,000 patient market, $326,000, $6 billion if that was the math right, opportunity, that's probably a little high. But if you sell $100 million, does the Japanese partner, the DMAH, do they sell that and then they -- then you get a royalty of that? Or how does that work?

Peter Altman

No, actually, we -- yes, so they, they handle really fundamentally the regulatory and quality responsibilities. We can actually go and sell in Japan and work with -- so each and every hospital in Japan has a localized distributor. Even if you are a distributor of products, you still have to go through these localized distributors that take up to 10% of the total product value. But fundamentally, BioCardia at present, our plan is we will be the ones selling CardiAMP for the post-marketing study, which could be anywhere from a couple hundred patients to 1,000 patients, and we're relatively agnostic to that because we're doing substantially the same thing in all instances. And it'll be a great deal easier than what we're doing in CardiAMP trials in the United States because there's no control arm. Every patient is a treated patient, and some of the research science that we've done behind the scenes will not be taking place in Japan.

So it'll be much easier than what we're doing today, and it'll be relatively straightforward. Japan's not an enormous country geographically, so a small team can get around the country quite readily. And we haven't figured out all the logistics and nuances of it yet, but in Japan, I've said previously that when we had our meeting with PMDA, all -- we had a number of really distinguished, wonderful cardiologists in the room, both on our side of the table trying to help us and on PMDA's side of the table as their consultants helping them. And everybody in the room wants to be involved in this post-marketing study, which is a huge advantage because there's real leadership in the Japanese cardiovascular community in that room. So that's always the hardest part is to get the leadership support for advancing a program, and I think we've already got it very, very strongly.

So my sense is we'll work with PMDA and determine exactly how many centers will be in this post-marketing study. And after the submission is in, we'll work with those centers to educate them and train them and get them experience and aware. We'll also be attending Japanese society meetings for both the Japanese Heart Failure Society and the Cardiovascular Interventional Therapeutics Society and enabling physicians to conveniently be exposed to products and the data. And then by the time we have the approval and the reimbursement, all of those centers should be ready to go. And so we'll -- the post-marketing study should happen relatively quickly.

I've said in our corporate presentation or we've said in our corporate presentation, that we expect the adoption profile to be roughly on par or superior to that of what it has been for the percutaneous aortic valves. It's a new intervention for the interventionalists, but it's a therapy that treats a population. In fact, we may have an even more rapid adoption because I would describe our procedure is far more straightforward than the implantation of a valve percutaneously and that the patient population doesn't have the option of surgical delivery. And there's no surgeons who are competing with the interventionalists on those procedures for those patients. So I think the adoption profile will be actually quite compelling.

James Molloy

Great. And the final question for me, you do note that the CardiAMP HF II Trial, 4 sites enrolled in the study, actively recruiting 3 additional patients supposed to go in this month. Any updates on -- is it 4 centers total currently that are enrolling? And any updates on how many patients have enrolled in the trial to date?

Peter Altman

Yes, we're not putting out the total number of patients. The enrollment is not going at blazing speeds. We have these 4 centers all actively enrolling, all have patients in the queue. We have conversations with a number of other centers who want to come on board, and we're working through that process. And it's being done while our clinical team is addressing all of these issues for PMDA. So it will continue to accelerate over time, but really the main effort right now, milestone that we've got as our top priority is getting this PMDA submission in.

So -- and it's happening. We also mentioned -- and I mentioned in the call, that we're having conversations with the FDA on the primary outcome measure. The third tier in our composite. So we have 3 tiers, all-cause mortality, non-fatal cardiac MACE and then the third tier is quality of life, so that every patient contributes to the endpoint. And that third tier has had a lot of criticism in the scientific community in the last 6 months. And the FDA has pushed back on that criticism. But there's ways of handling data that are pretty sophisticated.

And we know that the FDA knows more about how best to handle that endpoint than anybody else on the planet. And so we're going to be engaging with the FDA and hopefully get some guidance from them on exactly how to specify the use of that endpoint within our primary outcome measure. We're also planning on streamlining the trial to really focus on that primary outcome measure, which will also enhance enrollment. And by not having all these other centers on board at this point, it just makes it easier for us to change these little nuances before we roll out more broadly.

Operator

[Operator Instructions]

Our next question comes from Deepankar Roy from Brookline Capital Markets.

Deepankar Roy

We had 2 questions. One about the PMDA's specific outstanding requests. So the question is how much incremental work would this require compiling this documentation? Is this pulling data from already collected? Or would it require like new source data verification? Because we believe this could push the Q4 2026 Shonin submission time line as well.

Peter Altman

Right. So this is -- so with -- so first, Deepankar, thank you for joining the call. I appreciate the question. The nuance here is we feel we've got all of the data that they would like to see pretty ready to us. One of the nuances of it, I think, one of the hardest things is on the guideline-directed medical therapy. So there are a couple of little things that we're chasing. So in our study, guideline-directed medical therapy, for those who work in heart failure, primarily means that they're on, today, the 4 pillars of heart failure therapy care. And those 4 pillars are 4 drugs that all patients should be on. In our trial, unless there's certain reasons one might not be on that -- on those medications.

So in our trial, we had better compliance than any of the other leading trials of the same era that we've looked at. So we definitely have great compliance, physician compliance to prescribing per the guideline-directed medical therapy. So that's the first thing. Very comfortable there.

The second thing is some of the patients, we don't have the exact details on why they weren't on guideline-directed medical therapy. And that is data that we are collecting. I think it totals out of the 115 patients on the 4 drugs, I think there's a total of like 8 patients or so or 9 patients where they each have 1 drug each we have to chase down because there's not the evidence in the record on exactly why they weren't on that. We don't know that we need it, we just know it's part of the PMDA question, so I think that's the only data that we don't already have in hand that we're chasing down and we think it's relatively straightforward to gather.

Deepankar Roy

All right. And my next question is on the DMAH selection. So what is the expected cost structure for that relationship? And would the Shonin submission time line depend on having that relationship before the submission can proceed?

Peter Altman

Tell me I understand the cost relationship. I'm missing. Can you repeat the question?

Deepankar Roy

The cost of having the DMAH...

Peter Altman

DMAH, yes, yes. I thought you said DMA. So it's relatively straightforward. It's not a significant cost. It will be a -- the initial cost -- so we already have a dossier that's pulled together but we've been developing with our regulatory consultants, and we'll separately be doing the good clinical practice audits with another group that our DMAH is close to. And so those 2 pieces will come together, and they're relatively straightforward. Not expensive, and I don't expect any delays. We've already met face-to-face. And we have common friends, so I think it's relatively straightforward.

Deepankar Roy

So the Shonin submission time line would not be affected?

Peter Altman

I don't think it will be affected. We have -- again, we have to complete the efforts to enable the good clinical practice audit. We've got to enable the PMDA to go through the answers to the questions that we've got. And then we need -- we are preparing formal CDISC data as if we were doing an FDA submission for approval. And I think the CDISC data is probably the longest pole in the tent. It hasn't been asked for, but we think it's good just as we put a bow on CardiAMP HF with the idea that it is also going to support what we do for CardiAMP HF II, we're going to put it in that format. So I think the CDISC format is the longest pole in the tent at present.

Operator

And with that being our final question, we'll be turning the floor back over to Dr. Altman for any closing comments.

Peter Altman

Thank you, Jamie. So for all on the call, our efforts advancing our cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. The positive regulatory interactions we've just discussed for approval in Japan and the United States introduce potentially transformative milestones that are meaningful for patients, the physicians who are caring for them, but also for our shareholders. So on behalf of our entire BioCardia team, I thank all for their continued support. You make what we do possible, and I wish you all a great afternoon. Take care.

Operator

The conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.