Prepared remarks
Good day, everyone, and welcome to the BIOCARDIA Q2 2026 Financial Results and Corporate Update Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then 1 on your touch-tone telephones, or keypads. To withdraw your question, you may press star and then 2. 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 at press 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.
Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter A. 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, future performance and operational results, references to management's intentions, beliefs, projections, outlook, analysis and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technology, and obtaining regulatory approval. Forward-looking statements involve risks and 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 reports on Form 10-Ks filed with the SEC on 03/24/2026, and in our subsequently filed quarterly reports on Form 10-Q. The contents of this call contains time-sensitive information that is accurate only as of today, 08/12/2026. 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 A. Altman, BioCardia's President and CEO. Peter, please proceed.
Thank you, Miranda. Good afternoon to everyone on the call. The highlights of this second quarter have been the positive outcomes of three important meetings with regulatory agencies in Japan and the United States on the approvability of our cardiac 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 Pharmaceuticals and Medical Devices Agency, or PMDA, provided the consultation record of advice which supports our advancing to Shonin premarket 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 the 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. 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 that cardiac cell therapy has potential to be an enormously valuable therapy. While these two 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 note that there are approximately 300,000 patients in Japan with ischemic heart failure today. Japan's world-class interventional cardiologists performed 250,000 cardiac catheterization interventions per year. 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 two publicly traded peer companies in Japan advancing cardiac cell therapies each have market capitalizations of roughly $250 million and, to our knowledge, BioCardia has performed more than 20 times 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 confirm that the ongoing CARDiAmp Heart Failure II trial may support premarket approval or market clearance. This was significant as previously the FDA had not provided the support that one 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 expect 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 two are scheduled for their procedures this month. There have been no safety issues of which management is aware. 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 two pathways for Helix marketing clearance and raised no concerns on Helix safety, 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 do not have the formal meeting minutes from this meeting, which were expected June 12th. We did hear from FDA this morning by email 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 five 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 therapy for inflammatory heart failure to market clearance as well. Such a deal would enhance our efforts in the United States on all three 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 Heart 3D fusion imaging. We are working diligently with our respected partner, CARTO, to bring this 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 therapy. In parallel to the deals we are working to realize, a modest financing with long-term 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?
Thank you, Peter, and good afternoon, everyone. I will now review the highlights of our financial results for the quarter and six months ended June 30, 2026. Net cash used in operations during the three months ended June 2026 was approximately $1.7 million, increased slightly from the $1.6 million used in the three months ended June 2025. Net cash used in operations for the six months ended June 2026 of $3.4 million increased slightly from the $3.3 million used in the six 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, providing runway into 2027. As we ended the quarter, we had $2.7 million in equity, which we believe keeps us compliant now with NASDAQ listing standards. Total expense decreased by $400 thousand 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 six months ended June 2026, total expense decreased $900 thousand to $3.9 million from $4.8 million. The primary driver of these changes: research and development expense decreased $500 thousand to $900 thousand in the second quarter of 2026 compared to $1.4 million in the second quarter of 2025, and it decreased $800 thousand to $2.1 million for the six 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 $700 thousand quarter-over-quarter. For the six-month period ended June 2026, SG&A decreased slightly to $1.8 million from $1.9 million for the six 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 six-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 are now ready to take questions from attendees.
Questions and answers
Ladies and gentlemen, at this time, we will begin the question-and-answer session. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, you may press star and then 2. At this time, we will pause momentarily to assemble the roster. Our first question today comes from Joe Pantginis from H.C. Wainwright. Please go ahead with your question.
Hi, guys. Good afternoon. Thanks for taking the questions. So Peter, a couple of 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 will wait to see what they say, but what would you say are the key points that are outstanding?
Hello, Joe, it is great to speak with you, and thank you for the question. The first element on this is the nuances for the de novo submission for Helix. 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. Really the only thing we need clarity on is them to say yes, that is 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. They have found ways to do that historically with other routes of administration, but our conversation with them was approaching it head on: this is what we are trying to do, this is what the data says. Our expectation is that their internal processes are so rigid that we are going to have to also do a similar approach for our approval for this catheter system. We have the data to support it and the experience to support it. So it is a de novo, because there is no other catheter approved with this route of administration. For those on the call who may not be entirely familiar with the Helix transendocardial catheter, it is 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. We have also raised with the agency that there are many folks pursuing routes of administration for their therapeutic development that either makes no sense or is driven by the desire to not have an investigational delivery platform woven into their efforts. I think 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 is easy for them, straightforward. But I think they also recognize that by not having an approved delivery system, they are hampering the whole field of development for all biologic interventions in cardiology. My expectation and hope is that Helix will be the first such product. The downside of a de novo for BioCardia is that it does enable others to then file a 510(k) referencing our de novo, but our expectation is they will have to demonstrate some of the performance characteristics that we can demonstrate, which will still present a significant barrier to entry.
So two more questions if you do not mind. Going now to the focus — the first is two-pronged: 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? And the second part is, obviously, you mentioned the reimbursement that ReHeart is 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 and contrast beyond what your prepared comments said.
Sure. So on the 20,000 patients for the initial indication, I think the way that expands is by success in the post-marketing study. In Japan today, the patients that we will be treating truly have few options. They do not do a lot of heart transplantation in Japan because of cultural reservations about receiving another person's organ, which is an advantage for our autologous cell therapy. That also means left ventricular assist devices, which are implanted devices, have some reservations among the patient community. The key thing to expand that 20,000-patient estimate is to have the post-marketing study go as smoothly as possible, to have the physician experience be akin to what it is today in the U.S., and we think we can deliver that. 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. Our sense is that with 250,000 percutaneous coronary intervention procedures done per year, Japan has a very active interventional cardiology community for new therapies and a very large patient population that has no real options. By delivering a great experience in this post-marketing study and educating physicians, working with PMDA, we believe the indication can expand in short order. Regarding the differences between CARDiAmp and the other ReHeart therapy: ReHeart requires surgical implantation — the patient's chest is opened, and the cells are laid on the surface of the heart. Because their product is not autologous, our expectation is they will require chronic immunosuppression, and immunosuppression in patients who have just had cardiac surgery can introduce other issues. Thirdly, our approach is minimally invasive and autologous. The data we have is robust; we have not seen their full data, but my expectation is they have treated a small number of patients historically. Going in there with our experience and data becomes compelling, and the reimbursement they received gives us a lot of room to have reasonable pricing. If they are reimbursed at that level, that is good for the field and for patients, but it also presents an opportunity where they are educating and learning as we work through our regulatory process. We may also be able to help them on delivery; they are pursuing a different delivery approach today, but we have a deep experience in delivery and could be a partner as well as a competitor. Our approach is an autologous mononuclear cell preparation; theirs is an induced pluripotent stem cell preparation intended to become cardiomyocytes, although they describe their mechanism more as triggering an angiogenic response. There is still a lot we will learn about both approaches, but I am confident CARDiAmp has a real role in Japan and can help quite a few patients.
Thank you, Peter, for that. Can you hear me? My call actually dropped off and I was able to get back on quickly, so I heard your answers. I'm glad it stayed connected. My last question is regarding Japan but more broadly: if you get approved in Japan and with the discussions and data you have with the FDA, how might that be applicable to additional geographies?
Great question, Joe. Japan is a first-world regulatory jurisdiction and their inspection of our facilities and approval of CARDiAmp will weigh favorably in other countries around the world. We have already had conversations around potential relationships in Brazil and the United Arab Emirates, which could follow after success in Japan. Japan has potential to be much bigger both domestically and in terms of signaling to the rest of the world, tied to harmonization on inspection work. I think it has great potential.
Our next question comes from James Molloy from Allianz Global Partners. Please go ahead with your question.
Hi, guys. Good afternoon. Thank you for taking my questions. I want to follow up a little more on Joe Pantginis' question about Japan. Can you walk me through sort of how the designated marketing authorization holder partnership works? Is it like a traditional partnership where they sell and you get a royalty? Can you break down how that will work? And is that partner, which you said you hope to sign soon, guaranteed to be signed or what are the next steps should we anticipate there?
Appreciate the question, Jim. The DMAH, the designated marketing authorization holder, is a nuanced element of submission in Japan. This is a party that we contract with who essentially works for BioCardia to represent all of the regulatory and quality responsibilities associated with the cardiac cell therapy in Japan. When you do a distribution deal or a partnership in Japan, partners will often want to own the authorization because it becomes harder to transfer. A designated marketing authorization holder is transferable, so it does not prevent us from doing distribution or licensing deals downstream. It is a party that BioCardia will pay to support us from a regulatory perspective. There will be other parties involved in doing the good clinical practice audits of our information to support them so they have confidence as they help us pull together our dossier for the submission. We have already met with the DMAH, are talking specifics, and are working on budgeting and contracts. They are plugged into the group we are working with in Japan today, and we have confidence we have the right people to work with downstream.
And how does it look financially if you sell into this 20,000 market? If reimbursed at $326,000, that becomes a very large opportunity. Does the DMAH sell and then you get a royalty, or how would that typically work?
They handle fundamentally the regulatory and quality responsibilities. We can actually go and sell in Japan and work with local distributors; every hospital in Japan has localized distributors that often take up to 10% of total product value. Fundamentally, our plan is to be the ones selling CARDiAmp for the post-marketing study, which could be anywhere from a couple hundred patients to a thousand patients, and we are relatively agnostic to that because it is substantially the same work. It will be easier than our U.S. trials because every patient in Japan will be treated; there is no control arm in the post-marketing setting, and much of the research science we have done behind the scenes will not be taking place in Japan. Japan is not an enormous country geographically, so a small team can cover it. We have strong leadership support among Japanese cardiologists and PMDA consultants who want to be involved in this post-marketing study. After submission, we will work with selected centers to educate and train them, and we will attend Japanese society meetings to expose physicians to products and data. By the time approval and reimbursement are in place, those centers should be ready, and the post-marketing study should proceed relatively quickly. We have said previously that we expect the adoption profile to be roughly on par or superior to that of percutaneous aortic valves. Our procedure is more straightforward than percutaneous valve implantation, and the patient population does not have surgical options, so adoption could be quite compelling.
Okay, great. Final question for me. You noted the CARDiAmp HF2 trial: four sites enrolled and actively recruiting, three additional patients expected to qualify this month. Any updates on whether it is four centers total currently enrolling, and how many patients have enrolled in the trial to date?
We are not putting out the total number of patients. Enrollment is not progressing at blazing speeds. We have four centers all actively enrolling and with patients in the queue. We have conversations with a number of other centers who want to come on board and we are working through that process. Our clinical team is also addressing issues for PMDA, so enrollment will continue to accelerate over time. Our top priority is getting the PMDA submission in, which is happening. We also mentioned we are engaging with the FDA on the primary outcome measure — the third tier in our composite is quality of life so that every patient contributes to the endpoint. That third tier has had criticism in the scientific community in the last six months. The FDA has pushed back on some criticism and there are sophisticated ways of handling that data; the FDA knows best how to handle that endpoint. We will engage with FDA to get guidance on how to specify the use of that endpoint in our primary outcome measure. We are planning on streamlining the trial to really focus on that primary outcome measure, which should also enhance enrollment. By not having many centers on board at this point, it makes it easier for us to change these nuances before we roll out more broadly.
Star and then 1. Our next question comes from Deepankar Roy from Brookline Capital Markets. Please go ahead with your question.
Hi, good afternoon. Thanks for taking our questions. We had two questions. One about the PMDA specific outstanding requests: how much incremental work would this require? Is this pulling data from already collected records or would it require new source data verification? We believe this could push the Q4 2026 Shonin submission timeline as well.
Right. Thanks, Deepankar. We feel we have all of the data PMDA would like to see pretty readily available. One of the nuances is guideline-directed medical therapy. For those who work in heart failure, that typically means the four pillars of heart failure therapy — four drugs that all patients should be on unless there is a reason not to be. In our trial, we had better compliance than many leading trials of the same era; we have great physician compliance to prescribing per guideline-directed therapy, so we are very comfortable there. The second nuance is that in some patients we do not have the exact details on why they were not on guideline-directed medical therapy; that is the data we are collecting now. I believe it totals about eight or nine instances across patients where we need to document the reason for not being on a drug. We are chasing that down because it is part of PMDA's question. We do not expect new clinical procedures or new types of source data verification beyond collecting those missing reasons and completing the documentation. That should be relatively straightforward.
Alright, thank you. One more: on DMAH selection, what is the expected cost structure for that relationship and would the submission timeline depend on having that relationship formalized before the submission can proceed?
The DMAH cost relationship is relatively straightforward and not expected to be significant. We already have a dossier pulled together and have been developing it with regulatory consultants. We will separately be doing the good clinical practice audits with another group that the DMAH is close to, and those two pieces will come together. They are relatively straightforward and not expensive in our view. I do not expect delays. We have already met face to face with the DMAH and have common contacts, so we have high confidence in the relationship. I do not think the Shonin submission timeline will be affected; we still need to complete the good clinical practice audit and provide answers to PMDA questions. Preparing CDISC-formatted data is probably the longest pole in the tent. While CDISC has not been explicitly requested, we are preparing data in that format as if we were doing an FDA submission, which we think is beneficial and will also support CARDiAmp HF2.
And with that being our final question, we will be turning the floor back over to Dr. Altman for any closing comments.
Thank you, James. 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 have 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, and for our shareholders. 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.
The conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.