BCDA

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Investor Relations - Miranda Peto Benvenuti President and Chief Executive Officer - Peter A. Altman Chief Financial Officer - David McClung Operator: Good day, everyone, and welcome to the BIOCARDIA Q2 26 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 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. Miranda Peto Benvenuti: 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. Peter A. Altman: Thank you, Miranda. 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 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 transcendo cardio 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 premarket regulatory submission for approval of the CARDiAmp cell therapy. PMDA noted that the positive outcomes seen in our CARDI AMP 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 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 quarter. 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 C DISC 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 CARDI amp cell therapy in Japan. Our expected initial indication will be for approximately 20 thousand 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 thousand 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 2 cell therapies are different, we believe the minimally invasive delivery and autologous nature of CARDiA Amp. 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 thousand patients in Japan, We note that there are approximately 300 thousand patients in Japan with ischemic heart failure today. Japan's world-class interventional cardiologists performed 250 thousand cardiac catheterization interventions per year. Are 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. Shown in approval of CARDI Amp cell 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 $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 confirm 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 cardiac CardiAmp Heart Failure II trial to take this study to completion as our confirmatory Phase III study. 4 clinical sites have enrolled in the study and are actively recruiting patients. 3 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. 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 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 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 CARDI amp 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 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 heart 3 d fusion imaging we are working diligently with our respected partner, CARTO, 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 therapy. In parallel to the deals we are working to realize, a modest financing with long investors would accelerate the confirmatory cardiac heart failure 2 program. With that, I will now pass the call to David McClung, our CFO who will review our second quarter 26 financial results. David? David McClung: Thank you, Peter, and good afternoon, everyone. I will 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 providing runway into 2027. As we ended the quarter with ended the quarter with $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 26 compared to $2.1 million in the same quarter of 2025. For the 6 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 26 compared to $1.4 million the second quarter of 25 and it decreased $800 thousand to $2.1 million for the 6 months ended June 2026 compared to $2.9 million for that same period in 2025. The decreases relates primarily to the closeout of the CardiAmp heart failure trial partially offset by expenses for early enrollment in the CARDI Amp heart failure 2 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 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 26 compared to $2 million in the second quarter of 25. 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 27. This concludes management's prepared comments. And we are now ready to take questions from attendees. Operator: 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, 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. Joe Pantginis: 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? Peter A. Altman: Well, hello, Doctor. Pantginis. it is great to speak with you, Joe, and thank you for the question. 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 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. And they have 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 are trying to do. This is what the data says. Our expectation is that there internal processes are so rigid that we are 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 is based on a design of active fixation pacing leads, which have been used in 1 million patients. And our data is second to none as published by independent parties. So I have also-- we have 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 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 is easy for them. that is straightforward for them. But I think they also recognize that by not having an approved delivery system, they are basically hampering the whole field of development. And so for all biologic interventions, in cardiology. And then 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 will have to demonstrate some of the performance characteristics that we can demonstrate. And so that will be a pretty significant barrier to entry still. Got it. Got it. No, I appreciate that color a lot. Joe Pantginis: So 2 more questions if you do not mind, but going now to the focus-- please, welcome Joe. Hey. So, the first 1 is 2-pronged. So if you get approval in Japan, you said the initial target market is about 20 thousand 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 are getting for about $326 thousand. I know it is hard to talk about comps sometimes, but maybe you could do a bit of a compare and contrast beyond what your prepared comments said. Peter A. Altman: Sure. So on the 20 thousand patients for the initial indication, I think the way that has expanded is by success in this 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 they do not like the concept of implantation of other people's organs in another patient. And that is 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 thousand 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 is-- 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 thousand 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 re heart therapy that is 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 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 are doing with our approach You know, the data we have is pretty robust. And their data-- we have not seen their data. But my expectation is they have a total of 8 patients they have treated historically. So I think going in there with our experience and our data becomes compelling. And so as we look at, you know, their reimbursement, you know, that gives us a lot of room to have reasonable pricing And my sense is you know, that our confidence that our pricing will be strong for BIOCARDIA is there completely. If they are reimbursed at that level, that is great for them, and we wish their patients every positive. But I think it presents an opportunity where they are educating and they will 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 are pursuing a different delivery approach today, but, you know, 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, the cells are intended to become cardiomyocytes. But they do not speak of their mechanism of action as 1 of replacing heart cells, but rather of triggering an angiogenic response. So there is still a lot that we are going to learn about them and that they will learn about us ahead. And hopefully, the physician community as well. But I am pretty confident that CardiAmp has a real Role In Japan. And can help quite a few patients. Joe Pantginis: Thank you, Peter for that. Can you hear me? Yes, I can, Joe. Oh, perfect. Because my call actually dropped off. I was able to get back on real quick, so I heard your answers. So I am 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 the FDA, how that might be applicable to additional geographies? Peter A. Altman: it is a great question, Joe. Great question. So Japan is considered a first world country. And I think we have said previously that their inspection of our facilities and their approval of CardiAmp weighs in other countries around the world. So we have already had conversations around potential relationships in Brazil and United Arab Emirates. And, you know, 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 is tied into some of the harmonization on the inspection work that is been done. But, yeah, I think it has great potential. Thanks for the added color, Peter. Thank you, Joe. Appreciate the questions. Operator: Our next question comes from James Molloy from Allianz Global Partners. Please go ahead with your question. James Molloy: 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, 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 your prepared remarks, hoping to sign them soon. Is that partner, like, guaranteed to be signed or what are the next steps should you anticipate there? Peter A. 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 cardiac cell therapy in Japan. This is-- 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 is a party that we have already met with. We are already talking about the specifics, and we are working on budgeting and contracts. But it is a party that Biocardia will pay to support us from a regulatory perspective. And there will 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, you know, 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 are going to be working with downstream. James Molloy: And how's that how does it look if you sell into this 20 thousand market, $326 thousand -- $6 billion, if I have my math right, opportunity. And that is 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-- No. Peter A. Altman: Actually, we yeah. So they handle really fundamentally the regulatory and quality responsibilities. We can actually go and sell in Japan and work with-- each and every hospital in Japan has a localized distributor. Even if you are a distributor of products, you still have to go to these localized distributors that take up to 10% of the total product value. Fundamentally, Biocardia at present, our plan is we will be the ones selling CardiAmp for the post marketing study. Which you know, could be anywhere from a couple hundred patients to a thousand patients, and we are we are relatively agnostic to that. Because we are doing substantially the same thing in all instances. And it will be a great deal easier than what we are doing in CardiAmp trials in The United States because there is no control Every patient's a treated patient. And some of the research science that we have done behind the scenes will not be taking place in Japan. So it will be much easier than what we are doing today And, and it will be relatively straightforward. Japan's not an enormous country geographically. So a small team can get around the country quite readily. And, we have not figured out all the logistics and nuances of it yet, but you know, in Japan, I have 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 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 you know, there is real leadership in the Japanese cardiovascular community in that room. So that is always the hardest part is to get the leadership support for advancing a program, and I think we have already got it very strongly. So my sense is we will work with PMDA and determine exactly how many centers we will be in this post marketing study. And after the submission is in, we will work with those centers to educate them and train them and get them experienced and aware. We will also be attending, Japanese society meetings for both the Japanese Heart Failure Society and the Cardiovascular Interventional Therapeutic Society. And enabling physicians to conveniently you know, 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 the post-marketing study should happen. Relatively quickly. I have said in our corporate presentation or we have said in our corporate presentation that we expect the adoption profile to be roughly on par superior to that. Of what it has been for percutaneous aortic valves. it is a new intervention for the interventionalists. But it is a therapy that treats a population. In fact, we may have an even more rapid adoption because I would describe our procedure as far more straightforward than the implantation of a valve percutaneously and that the patient population does not have the option of surgical delivery. And there is 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: Okay. Great. Final question for me. You do note, the CardiAmp HF2 trial, 4 sites enrolled in the study, actively recruiting, 3 additional patients are 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 A. Altman: Yeah. Yeah, we are not putting out the total number of patients. The enrollment is not going in 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 are working through that process And, you know, it is it is 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 have got is our top priority is getting this PMDA submission in. So and it and it is happening. We also mentioned and I mentioned in the call that we are having conversations with the FDA on you know, the primary outcome measure The third tier in our composite-- so we have 3 tiers. All cause mortality, nonfatal 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 are 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 are 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 are also planning on streamlining the trial to really focus on that primary outcome measure, which will also enhance enrollment And by not having this 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. Thank you for taking the questions. Appreciate them, Jim. Be well. Operator: Star and then 1. Our next question comes from Deepankar Roy from Brookline Capital Markets. Please go ahead with your question. Deepankar Roy: Hi, good afternoon. Thanks for taking our questions. We had 2 questions. 1 about the PMDA specific outstanding requests. So the question is how much incremental work would this require? You know, 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 timeline as well. Peter A. Altman: Right. So, this is-- with-- so first Deepankar, thank you for joining the call. I appreciate the question. The nuance here is we feel we have got all of the data that they would like to see pretty readily available to us. 1 of the nuances of it, I think 1 of the hardest thing is on the guideline directed medical therapy. So there are a couple of little things that we are chasing. So in our study, guideline directed medical therapy for those who work in heart failure primarily means that they are 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 is certain reasons 1 might not be on those medications. So in our trial, we had better compliance than any of the other leading trials of the same era that we have looked at. So we definitely have great compliance, physician compliance to prescribing per the guideline directed medical therapy. So that is the first thing. Very comfortable there. The second thing is some of the patients, we do not have the exact details on why they were not 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 is 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 is not the evidence in the record on exactly why they were not on that. We do not know that we need it. We just know it is part of the PMDA question. So I think that is the only data that we do not already have in hand that we are that we are we are chasing down, and, and we think it is relatively straightforward together. Deepankar Roy: Alright. Thank you and No. No worries. Question DMA selection. So what is the expected cost structure for the relationship? And would this the shortened submission timeline depend on having that relationship before the submission can proceed. Peter A. Altman: The tell me to understand the cost relationship. I am I am missing-- can you repeat the question? The DMH yes. Yes. Yeah. I thought you said DMA. So the it is relatively straightforward. it is not a significant It will be a you know, the initial the initial cost so we already have a dossier that is pulled together, but we have been developing with our regulatory consultants. And we will separately be doing the good clinical practices audits with another group that our DMAH is close to. And so those 2 pieces will come together, and they are relatively straightforward. Not expensive, and I do not expect any delays. We have already met face to face and we have common friends. So I think it is relatively straightforward. So the, shown in submission timeline would not be affected I do not think it will be affected. We have, again, we have to complete the efforts to enable the good clinical practice audit. We have gotta enable the PMDA to go through you know, the answers to the questions that we have got. And then 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 has not been asked for, but we think it is good just as we put a bow on Cardiamp HF with the idea that it is also gonna support what we do, for CardiAmp HF2. We are gonna put it in that format. So I think the CDISC format is the longest pole in the tent at present. Deepankar Roy: Right. Thanks for taking my questions. Peter A. Altman: No, I appreciate them Deepankar. Thank you. Operator: And with that being our final question, we will be turning the floor back over to doctor Altman for any closing comments. Peter A. Altman: Thank you, James. 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 have just discussed for approval in Japan and The United States introduced potentially transformative milestones that are meaningful for patients, the physicians who are caring for them, but also 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. Operator: The conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines. 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This article first appeared on GuruFocus. Net Cash Used in Operations (Q2 2026): Approximately $1.7 million, slightly up from $1.6 million in Q2 2025. Net Cash Used in Operations (H1 2026): $3.4 million, slightly up from $3.3 million in H1 2025. ATM Facility Proceeds (Q2 2026): Raised net proceeds of approximately $4.9 million at an average price of $1.22 per share. Cash and Cash Equivalents (End of Q2 2026): Totaled $5.4 million, providing runway into 2027. Total Expense (Q2 2026): Decreased by $0.4 million quarter-over-quarter to $1.6 million, compared to $2.1 million in Q2 2025. Total Expense (H1 2026): Decreased by $0.9 million to $3.9 million, compared to $4.8 million in H1 2025. Research and Development Expense (Q2 2026): Decreased by $0.5 million to $0.9 million, compared to $1.4 million in Q2 2025. Research and Development Expense (H1 2026): Decreased by $0.8 million to $2.1 million, compared to $2.9 million in H1 2025. Selling, General and Administrative (SG&A) Expense (Q2 2026): Remained consistent at $0.7 million quarter-over-quarter. SG&A Expense (H1 2026): Decreased slightly to $1.8 million, compared to $1.9 million in H1 2025. Net Loss (Q2 2026): $1.6 million, compared to $2.0 million in Q2 2025. Net Loss (H1 2026): $3.9 million, compared to $4.9 million in H1 2025. Warning! GuruFocus has detected 1 Warning Sign with BCDA. Is BCDA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive regulatory outcomes in Japan and the US support the approvability of BioCardia's cardiac cell therapy and Helix delivery catheter. PMDA's consultation record supports advancing to a Shonin pre-market submission for CardiAMP cell therapy in Japan, with a potential initial market of 20,000 patients. FDA confirmed that the ongoing CardiAMP Heart Failure 2 trial may support premarket approval, viewing it as a confirmatory trial. FDA agreed on two pathways for Helix marketing clearance, including a de novo pathway, with no concerns on safety or device performance. BioCardia has a strong cash position with $5.4 million in cash, providing runway into 2027, and raised $4.9 million via an ATM facility at a low cost of capital. PMDA requested additional data on guideline-directed medical therapy compliance and revascularization eligibility, requiring extra documentation and audits. The FDA has not yet provided formal meeting minutes for the Helix de novo pre-submission, causing delays in clarity for the approval pathway. Enrollment in the CardiAMP Heart Failure 2 trial is slow, with only four active sites and no disclosed patient numbers, potentially delaying the confirmatory study. The company faces uncertainty regarding the primary outcome measure, particularly the third tier of the composite endpoint, which has faced scientific criticism. BioCardia's cash runway is limited, and the company may need additional financing to accelerate the CardiAMP Heart Failure 2 program, despite current capital sufficiency for the PMDA submission. Q: What were the key outcomes of BioCardia's regulatory meetings with the PMDA and FDA during Q2 2026?A: Peter Altman, President and CEO, highlighted three significant regulatory interactions. The PMDA in Japan provided a consultation record supporting advancement to a Shonin pre-market submission for the CardiAMP cell therapy, requesting additional details on guideline-directed medical therapy compliance and patient eligibility. The FDA confirmed that the ongoing CardiAMP Heart Failure 2 trial may support premarket approval, marking a shift in the agency's stance on a single confirmatory trial. Additionally, the FDA agreed on two pathways for the Helix delivery catheter's marketing clearance, with its preferred route being simultaneous approval with the cardiac cell therapy system. Q: What is the timeline and market potential for the CardiAMP cell therapy approval in Japan?A: Peter Altman stated that BioCardia is preparing for the Shonin regulatory submission in Japan next quarter, with approval expected approximately 12 months after submission. The initial indication targets approximately 20,000 patients, though there are around 300,000 patients with ischemic heart failure in Japan. The company expects adoption to be relatively rapid in the post-marketing study, especially given that a competing cell therapy received reimbursement approval in July at $326,000 per treatment, validating the market opportunity. Q: How does the CardiAMP therapy compare to the recently approved competing cell therapy in Japan?A: Peter Altman explained that the competing therapy requires surgical implantation with chest opening, while CardiAMP uses minimally invasive transendocardial delivery. The competitor's therapy is not autologous and may require chronic immunosuppression, whereas CardiAMP is an autologous mononuclear cell preparation. BioCardia has performed more than 20 times as many clinical procedures as both publicly traded peer companies in Japan combined, and the company believes its minimally invasive delivery and greater clinical experience will be attractive to physicians and patients. Q: What are the outstanding items regarding the FDA's de novo pathway for the Helix delivery catheter?A: Peter Altman noted that the FDA's formal meeting minutes are still pending, though the agency confirmed understanding via email. The key issue is that the FDA has difficulty approving a delivery system for a biologic when no therapeutic has yet been approved for that route of administration. The FDA's preferred route is simultaneous approval with the cardiac cell therapy system, but they also suggested a follow-on pre-submission that could enable Helix approval via the de novo pathway. BioCardia believes the Helix has the best safety, efficiency, and ease of use of any catheter of its kind, with data from approximately 500 patients across more than a dozen clinical trials. Q: What is the current enrollment status of the CardiAMP Heart Failure 2 trial?A: Peter Altman reported that four clinical sites are actively enrolling and recruiting patients, with three additional patients expected to qualify this month and two scheduled for procedures. There have been no safety issues. Enrollment is driven primarily by resources deployed, and the company is actively onboarding additional centers. The company is also engaging with the FDA on the primary outcome measure, particularly around the third tier of the composite outcome related to quality of life, and plans to streamline the trial to focus on that primary outcome measure. Q: How does the Designated Marketing Authorization Holder (DMAH) relationship work in Japan?A: Peter Altman explained that the DMAH is a contracted party that represents BioCardia's regulatory and quality issues in Japan, acting as the local regulatory representative. Unlike traditional distribution partnerships, the DMAH is completely transferable, which does not prevent future distribution or licensing deals. The cost is not significant, and BioCardia has already met with the party face-to-face. The company expects to sign the agreement soon, and this relationship should not affect the Shonin submission timeline. Q: What is BioCardia's strategy for expanding beyond the initial 20,000-patient market in Japan?A: Peter Altman stated that expansion will be driven by success in the post-marketing study. Japan has a large patient population with few options, as the country performs limited heart transplants and has reservations about LVADs. With 250,000 percutaneous coronary intervention procedures performed annually, there is a hungry interventional cardiology community for new therapies. The company expects that delivering a great experience in the post-marketing study and educating physicians will lead to indication expansion in short order. Additionally, Japan's approval could carry weight in other countries, with conversations already underway in Brazil and the United Arab Emirates. Q: What were BioCardia's financial results for Q2 2026?A: David McClung, CFO, reported that net cash used in operations was approximately $1.7 million for Q2 2026, slightly up from $1.6 million in Q2 2025. The company raised approximately $4.9 million under its at-the-market facility at an average price of $1.22 per share. Total expenses decreased by $0.4 million quarter-over-quarter to $1.6 million, and the net loss was $1.6 million compared to $2.0 million in the prior year quarter. The company ended the quarter with $5.4 million in cash, providing runway into 2027, and $2.7 million in equity, keeping it compliant with Nasdaq listing standards. Q: How much incremental work is required to address the PMDA's outstanding requests?A: Peter Altman explained that most of the requested data is already available. The main challenge involves chasing down documentation for approximately eight or nine patients out of 115 where the exact reasons for not being on guideline-directed medical therapy are not fully documented. The company had better compliance with the four pillars of heart failure therapy than other leading trials of the same era. The CDISC data formatting is expected to be the longest pole in the tent for the submission timeline, but the company does not expect significant delays. Q: What is the status of business development activities?A: Peter Altman noted active conversations in the Asia Pacific region for cardiovascular therapeutics, with potential deals that could include funding to advance CardiAMP for its second indication for chronic myocardial ischemia and the allogeneic CardiALLO cell therapy for inflammatory heart failure. Business development on biotherapeutic delivery is also active, particularly for gene-based therapy developers. The company is working with partner CARTech to bring heart 3D fusion imaging to the clinic and market. Management believes current capital is sufficient to complete the PMDA submission milestone, though a modest financing with long-term investors would accelerate the CardiAMP Heart Failure 2 program. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Secured a consultation record of advice from Japan's PMDA supporting a Shonin premarket regulatory submission for CardiAmp cell therapy, with the agency noting trial outcomes were credible. Confirmed with the FDA that the ongoing CardiAmp Heart Failure II trial serves as a confirmatory Phase III study, potentially supporting a Premarket Approval (PMA) with a single trial. Identified a significant market opportunity in Japan following the reimbursement approval of a peer cardiac cell therapy at $326,000 per treatment, validating the commercial landscape. Positioned the HELIX transendocardial delivery catheter as a best-in-class system with safety data from approximately 500 patients across a dozen clinical trials, creating a high barrier to entry for competitors. Attributed recent R&D expense decreases to the closeout of the initial CardiAmp heart failure trial, partially offset by startup costs for the confirmatory HF2 study. Maintained a lean operational structure with a net loss reduction of $1 million for the first half of 2026 compared to the prior year period. Focused strategic positioning on the autologous nature and minimally invasive delivery of CardiAmp, which management believes is superior to surgical alternatives requiring immunosuppression. Anticipates completing the Shonin regulatory submission in Japan following the completion of CDISC data formatting and third-party GCP audits. Expects initial Japanese approval for approximately 20,000 patients within 12 months of submission, with potential for rapid adoption through a post-marketing study involving leading interventionalists. Plans to engage a Designated Marketing Authorization Holder (DMAH) in Japan to act as the local regulatory representative while maintaining transferability for future licensing deals. Aims to streamline the CardiAmp HF2 trial by refining the quality-of-life endpoint in coordination with the FDA to accelerate enrollment and focus on primary outcome measures. Projects that current cash and cash equivalents of $5.4 million provide an operational runway into 2027, covering the transformative PMDA submission milestone. PMDA requested additional data on patient compliance with guideline-directed medical therapy and specific details on all-cause death and heart transplants to finalize the submission. FDA minutes for the HELIX catheter de novo submission were delayed, though recent email correspondence confirmed the agency's alignment on potential approval pathways. Management noted that while a de novo approval for HELIX establishes a first-of-its-kind route, it could eventually allow competitors to file 510(k) applications referencing BioCardia's data. The company is monitoring a June SEC proposal to eliminate 'baby shelf' limitations, which could significantly improve capital access for smaller firms by Q1 2027. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained the FDA prefers simultaneous approval with the CardiAmp therapy but is open to a de novo pathway for the catheter alone. The primary challenge is the FDA's historical difficulty approving a delivery system for a biologic route where no therapeutic has yet been cleared. BioCardia believes their extensive safety data, based on active fixation pacing lead designs used in 1 million patients, provides a unique advantage. Management highlighted that the competitor's therapy requires invasive surgery and chronic immunosuppression, whereas CardiAmp is autologous and minimally invasive. BioCardia claims to have performed more than 20 times as many clinical procedures as their two primary Japanese peer companies combined. The $326,000 reimbursement price for the peer product sets a high value benchmark for BioCardia's future pricing negotiations. The longest lead time for the submission is the conversion of clinical data into CDISC format to meet international regulatory standards. Management is chasing down specific records for approximately 8-9 patients to explain minor deviations from guideline-directed medical therapy to satisfy PMDA queries. The DMAH relationship is described as a standard regulatory contract that will not impede future distribution or licensing partnerships.

SUNNYVALE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter 2026 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2026 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. “This second quarter, BioCardia had three important positive meetings with regulatory agencies in Japan and the United States,” said Peter Altman, PhD, Chief Executive Officer of BioCardia. “Japan’s Pharmaceutical and Medical Device Agency (PMDA) has said it supports regulatory submission for approval of our CardiAMP Cell Therapy for Ischemic Heart Failure, the U.S. Food and Drug Administration (FDA) has said the CardiAMP HF II trial may be sufficient for approval in the United States, and the FDA has said DeNovo approval of Helix is possible.” Dr. Altman continued, “We are preparing the CardiAMP cell therapy PMDA submission for the fourth quarter, actively enrolling in the CardiAMP HF II trial, and awaiting FDA minutes on the DeNovo Pre-Submission for approval of the Helix transendocardial delivery catheter held with FDA in May. We are engaged in business development around our cell therapies and separately our experience and technologies for delivery of cardiac biologics which our therapies utilize. We are proud of our demonstrated efficient use of capital while executing on significant goals and expect success in these activities to deliver meaningful benefits for patients and stockholders.” Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In May, we announced the Japan’s Pharmaceutical and Medical Device Agency (PMDA) Consultation Record of Advice supports Shonin pre-market regulatory submission for approval based on the three completed clinical trials. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients. PMDA noted that the positive outcomes seen in the trial were credible. PMDA requested BioCardia demonstrate that enrolled patients were on guideline-directed medical therapy (GDMT) and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation. PMDA also provided guidelines for developing the post marketing study. 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 June, we announced receipt of FDA minutes from our Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. BioCardia is preparing for regulatory submission in Japan in Q4 2026. We are working to complete the electronic trial master file, conduct 3rd 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. We expect to soon engage a Designated Marketing Authorization Holder, or DMAH, as the local regulatory representative to enable BioCardia sales of CardiAMP Cell Therapy in Japan. BioCardia continues to actively enroll in the CardiAMP HF II trial. 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. CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) In May, primary results of this cohort were presented at Euro PCR, a world-leading course in interventional cardiovascular medicine. Results presented showed that the minimally invasive CardiAMP Cell Therapy procedure was well-tolerated with no treatment emergent major adverse cardiac events. Patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through 2 years follow-up. Prior to treatment, all patients were on GDMT and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment. Helix™ Biotherapeutic Delivery System In May, BioCardia had a De Novo Pre-Submission meeting with FDA on approvability of the Helix transendocardial delivery catheter. As is customary, BioCardia provided draft minutes to FDA on May 12th with expectation that formal revised minutes from FDA or notification that the minutes are accepted and final would be provided on or before June 12th. FDA has advised us that we would receive these minutes soon and we anticipate submitting the follow-on pre-submission incorporating agency advice which could enable Helix approval via the DeNovo pathway. Heart3D™ Fusion Imaging In April, the Company announced the allowance of Japanese Patent, “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation.” This patent adds further protection to BioCardia’s proprietary Heart3D™ Fusion Imaging (Heart3D) software intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures. Heart3D is being advanced towards regulatory approval via the software as a medical device 510(k) submission route. It has been in discussions with many developers of gene and cell-based therapies on its potential to enhance others development efforts. Second Quarter 2026 Financial Results: Net cash used in operations for the three months ended June 2026 increased to $1.7 million, as compared to $1.6 million for the three months ended June 2025, and increased to $3.4 million for the six months ended June 2026, as compared to $3.3 million for the six months ended June 2025, 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. The Company ended the quarter with cash and cash equivalents totaling $4.1 million, providing anticipated runway into 2027. Research and development expenses decreased to $0.9 million for the three months ended June 2026 from $1.4 million for the three months ended June 2025 and decreased to $2.1 million for the six months ended June 2026 from $2.9 million for the six months ended June 2025, primarily due to close out of the CardiAMP HF Trial, partially offset by early enrollment in the CardiAMP HF II Trial and regulatory activities to advance CardiAMP in Japan. Selling, general and administrative expenses remained consistent at $0.7 million for both the three months ended June 2026 and June 2025, and decreased to $1.8 million for the six months ended June 2026 compared to $1.9 million in the six months ended June 2025. Our net loss decreased to $1.6 million for the three months ended June 2026 compared to $2.0 million for the three months ended June 2025, and to $3.9 million for the six months ended June 2026 compared to $4.8 million for the six months ended June 2025, primarily due to lower research and development expenses. ANTICIPATED UPCOMING MILESTONES AND EVENTS: Shonin Submission of CardiAMP Cell Therapy to Japan PMDA (Q4 2026) Continued CardiAMP Cell Therapy development in the USA with FDA engagement Strategic partnership / licensing progress in Helix/Heart3D for cell, gene, and protein delivery to the heart Strategic partnerships / licensing around our clinical allogeneic MSC platform Conference call access: Participants can register for the conference by navigating to https://dpregister.com/sreg/10211154/104a4f51d2e. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial-in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=ufQzaenK. A webcast replay of the call will be available approximately one hour after the end of the call at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-855-669-9658 (toll free domestic/Canada) and 1-412-317-0088 (international toll) by using access code 3063624. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the sufficiency of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: [email protected]: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: [email protected]: 650-226-0120

– Positive CardiAMP CMI Trial open-label cohort results demonstrated opportunity for locally delivered cell therapy to enhance therapeutic options for patients with severely symptomatic refractory angina and validate continued clinical development – Novel therapeutic approach targets a critically important unmet medical need for patients who have debilitated quality-of-life and have exhausted all available treatment options SUNNYVALE, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ: BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the oral presentation of the results of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial (CardiAMP CMI) preliminary open label cohort at EuroPCR, a leading interventional cardiovascular medicine conference held in Paris. The presentation was made by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health. Results presented by Dr. Raval, on behalf of the CardiAMP CMI Investigators, showed that the minimally invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events and patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through 2 years follow-up. Prior to treatment, all patients were on guideline-directed medical therapy (GDMT) and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment. Dr. Raval’s presentation is here: EuroPCR2026. “Chronic ischemic heart disease results in considerable limitations of daily life activities due to chest discomfort, shortness of breath, and related disabling symptoms despite optimal medical therapy,” said Carl Pepine, MD, MACC, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida at Gainesville. “A cell-based approach, added to this medical therapy, has potential to better manage these symptoms and improve the quality of life.” “We are thankful for the physician scientists who contributed their great experience to this program as well as the patients who participated,” said Peter Altman, PhD, BioCardia President and CEO. “These results support this CardiAMP cell therapy approach which has potential to help patients suffering from refractory angina. To our knowledge, only cell therapy has had a positive impact on both exercise tolerance and angina episodes in these patients.” About Chronic Myocardial Ischemia with Refractory Angina Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1.8 million patients in the United States. Up to 15% of patients who have ischemia or angina and undergo cardiac catheterization are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients. About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures.  CAUTION - Limited by United States law to investigational use. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies.  For more information visit https://www.biocardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements may include, among other things, statements relating to the continued development, ability to offset clinical costs utilizing Medicare reimbursement and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: [email protected] Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: [email protected]: 650-226-0120

Image source: The Motley Fool. May 15, 2026, 4:30 p.m. ET President and Chief Executive Officer — Peter Altman, Ph.D. Chief Financial Officer — David McClung Need a quote from a Motley Fool analyst? Email [email protected] Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead. Operator: Dr. Altman, this is the operator. Perhaps your line is muted. Peter Altman: Thank you. Thank you, Miranda, and good afternoon to everyone on the call. We have had significant accomplishments this last quarter for our CardiAMP Cell Therapy for the treatment of ischemic heart failure. This is a significant unmet clinical need for which we have FDA breakthrough designation and Medicare reimbursement at $20,000 per treatment procedure today. I'm going to share these accomplishments as they happen, so you can appreciate the dynamics of the recent developments. First, the blinded echocardiography data from the CardiAMP Heart Failure trial presented at the Technology and Heart Failure Therapeutics Conference in Boston in early March was excellent. We described this data readout in our last call, but it bears repeating as the clinical data underlies the value we are creating in the regulatory meetings that have been happening in parallel. This echocardiography data analyzed by the world-class Echo Core Laboratory at Yale University is data which few, if any, advanced therapies for heart failure have in their trials, and it is long-term, truly blinded, contrast-enhanced echocardiography. The CardiAMP Heart Failure echocardiography results showed compelling signals of enhanced heart function in the treated patients relative to the control patients over time. More specifically, the heart volumes of both full heart relaxation and maximum heart contraction did not increase over time in the treated subjects, but did increase in the control subjects who did not receive therapy. Increased heart volumes is the normal course for these patients and results in the heart becoming more spherical and losing its pumping efficiency. Increased volumes have long been known to be correlated with poor long-term outcomes. In CardiAMP-HF, the treated patients did not experience this negative remodeling. In the subgroup having elevated biomarkers of heart stress, these heart function benefits for both full relaxation and full contraction were statistically significant and aligned with the 3 tiers of the composite outcome of: one, living longer without heart replacement therapy such as LVAD or transplant; two, having fewer major adverse events such as heart attacks, strokes and hospitalizations; and three, having a better quality of life. This composite endpoint also achieved statistical significance. All of the patients were on maximum guideline-directed medical therapy. And these benefits seen with CardiAMP Cell Therapy were in addition to those provided by the established therapy. This underlines that the CardiAMP Cell Therapy is likely driving a new mechanism of action of microvascular repair, promoting new capillary growth and reducing tissue fibrosis in the heart. This is the data we have been discussing with Japan's Pharmaceutical and Medical Devices Agency regarding potential for approval with a rigorous post-marketing study to collect further evidence with respect to both safety and efficacy. I am delighted today to share that in our formal clinical consultation with Japan's Pharmaceutical and Medical Devices Agency, they have said that they are inclined to accept this data as the basis for regulatory submission and approval in Japan for an initial indication aligned closely with the trial results. They have noted that there is an unmet need in Japan that the CardiAMP Cell Therapy may address. In our 10-Q report today, we also detail that we have received the draft written advisory record from the agency, and it is in alignment with this meeting. BioCardia is already actively preparing for the formal Shonin premarket application for approval in Japan, which we expect will take approximately 7 months to prepare and submit to the agency for review. We will provide additional updates on this time line ahead. This is excellent news for patients, BioCardia and our investors. We also completed a Q-Sub meeting with FDA Center for Biologics Evaluation and Research on this CardiAMP heart failure data. This discussion focused on our already FDA-approved CardiAMP cell processing platform to extend existing labeling from in vitro diagnostic indication to a therapeutic indication for ischemic heart failure of reduced ejection fraction. FDA made clear that they view the appropriate approval pathway as a premarket approval. FDA had no concerns on the safety of the CardiAMP Cell Therapy and the conversation focused on the efficacy results, which FDA found intriguing. We discussed the potential of advancing to a premarket application based on this data. FDA encouraged BioCardia to complete the ongoing CardiAMP HF II trial to provide support for the premarket application. FDA did also agree to engage on certain elements of the study statistical analysis based on nuances of our composite endpoint and has provided other meaningful advice to BioCardia on the study. The 4 activated centers in the ongoing CardiAMP Heart Failure II study have continued to enroll patients. The trial is designed as a 250-patient study where 160 patients are needed to have 80% power. We have additional centers interested in participating that we are onboarding and have plans to expand as fast as resources allow. Completing the CardiAMP Shonin premarket application for approval in Japan and enrolling CardiAMP Heart Failure II are our top priorities. Results also from our second clinical program of the CardiAMP Cell Therapy in chronic myocardial ischemia have been accepted for oral presentation next week at the prestigious EuroPCR meeting. We expect these results will be available on Wednesday. We have also completed the pre-submission meeting with FDA on the approval of the Helix Transendocardial Delivery System in recent weeks. 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 presubmission incorporating agency advice could enable Helix approval via the de novo pathway as a stand-alone delivery system. We have delivered now on all 4 catalysts detailed on our last call, having 3 positive regulatory interactions and are very pleased with the outcomes. For the second quarter of 2026, looking ahead, we expect to complete one or more transactions that will fund Japan PMDA submission for approval and the CardiAMP Heart Failure II trial. I will now pass the call to David McClung, our CFO, who will review our first quarter 2026 financial results. David? David McClung: Thank you, Peter. Good afternoon, everyone. Here are the highlights of our financial results for the quarter ended March 31, 2026. Total expense decreased by $460,000 quarter-over-quarter to $2.3 million in the first quarter of 2026 compared to $2.7 million in the same quarter of 2025. The primary driver of this change, research and development expense decreased $295,000 to $1.2 million in the first quarter of 2026 versus $1.5 million in the first quarter of 2025. The decrease relates 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 regulatory activities to advance CardiAMP in Japan. Selling, general and administrative expenses decreased to $1.0 million for the 3 months ended March 2026 as compared to $1.2 million in the quarter ended March 2025, primarily due to lower professional service fees. Our net loss was $2.3 million for the first quarter of 2026 compared to $2.7 million in Q1 2025. Net cash used in operations was $1.7 million for the first quarter of 2026 compared to $1.6 million in the same quarter in 2025, with the change relating primarily to the timing of supplier payments. The company ended the quarter with cash and cash equivalents totaling $951,000. We will continue to carefully manage our use of capital while still delivering our milestones and objectives. This concludes management's prepared comments. We're now ready to take questions from attendees. Operator: Our first question today is from Jim Molloy with Alliance Global Partners. Laura Suriel: This is Laura on for Jim Molloy. So maybe just provide a bit more insight into the regulatory process in Japan? Like what additional work do you think you might need to do alongside the Shonin application that you mentioned from now until submission this year? And also, what's the timing of when you'll hear back from the agency after filing? Peter Altman: Laura, thank you for the question. The dynamics in Japan for submission are rather extensive. So we have already prepared a large STED document, which they've already been reviewing as part of this process, which is essentially a template for the actual submission. But the process ahead will involve auditing our clinical data, auditing our manufacturing and literally going through every thread associated with the submission process. They have gone through the data here quite a bit already. So they're pretty sophisticated on what we have. And my expectation is it should go relatively straightforward. This was run under good clinical trial practices. So the submission itself, we have to do some pre-audit work on our own with Japan representatives that will hold our regulatory submission for us under BioCardia's control. And then we will complete the submission in roughly 7 months, I would expect. And then the process after that is about a year-long review process similar to what's done in the United States for a PMA, where they audit all of the data and the manufacturing and the sterility and all that goes into it. And at the end of the day, we would expect to have approval. Just so everybody on the call is aware, BioCardia, even though we're a small company, we actually have roughly 100 FDA-cleared interventional products here in our Morph platform, and we previously had products approved in Europe. So we have pretty good systems for quality and manufacturing in place, and I don't expect any significant issues. The most significant issue was, of course, the clinical data. That is usually the case. And our expectation is if things go as planned in roughly 19 months, we'll be approved and in the market in Japan. On the other side of that approval, there will be a post-marketing study. And the post-marketing study is actually really important, but also valuable for us. We will collect additional procedural safety data. We will establish sort of standard of care outcomes that we track, and this will be done in conjunction with the medical societies in Japan and with Japan's Pharmaceutical and Medical Device Agency. There will be reimbursement during that post-marketing study. So it will be -- think of it as an early marketing launch, but we'll be doing it with -- under the auspices of all the leading societies in Japan. And these societies are the Japan Circulation Society, The Japan Heart Failure Society and the Cardiovascular Interventional Therapeutics Society. We had leadership from all of those attending our PMDA session and folks on both sides of the table in that session express interest in participating in that post-marketing study, and we're supportive of the efforts ahead. So that's the high level. If you have follow-ups, Laura, that I didn't get anything appropriately, I welcome them. Laura Suriel: Yes, just as a follow-up, maybe you just talk about more about the market opportunity in Japan. You mentioned how CardiAMP may cover an unmet medical need in the region. So how may you see CardiAMP integrating into the treatment regimen in Japan? Peter Altman: Right. So this -- and by the way, Laura, there is an enormous amount of work going through every single drug and therapy that's approved in Japan and demonstrating that there's -- the standard of care there is almost identical to the standard of care here in the United States. There are subtle differences, but nothing that's really that meaningful from our perspective. But from the regulatory perspective, they are meaningful. So the market opportunity, I think initially, there's roughly 300,000 patients in Japan with ischemic etiology heart failure who could be appropriate candidates. Initial market though will be much smaller than that. It will be very limited to what we call appropriate use conditions, and we would expect it to be on the order of 20,000 patients. But it's also what we view as a reachable market. And we expect -- historically, in Japan, they have reimbursed a cardiac cell therapy that -- at a reimbursement of around $124,000 per procedure. Now we don't expect that level of reimbursement for what we do because one of the advantages of the CardiAMP Cell Therapy is it can be a cost-effective therapy. But if we use the math of what is our reimbursement today in the United States and what is the expected indication we would have approval for in Japan of 20,000 patients and the $20,000 reimbursement in the United States, that becomes pretty quickly a $400 million market. Operator: [Operator Instructions] Showing no further questions, this concludes our question-and-answer session. I would like to turn the conference back over to Peter Altman for any closing remarks. Peter Altman: Thank you, Gary. Our efforts advancing cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. The positive regulatory interaction for approval in Japan is a transformative milestone, and we will continue to keep investors current on our progress towards submission and approval. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you very much. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Before you buy stock in BioCardia, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and BioCardia wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the current strategic momentum to blinded echocardiography data showing CardiAMP prevents negative heart remodeling, a typical progression in heart failure patients. The therapy is believed to drive a new mechanism of action involving microvascular repair and new capillary growth, rather than just symptom management. A formal clinical consultation with Japan's PMDA resulted in an inclination to accept existing trial data for regulatory submission, addressing a specific unmet need in the region. Operational focus has shifted toward the formal Shonin premarket application in Japan while simultaneously advancing the CardiAMP Heart Failure II trial in the U.S. The FDA Q-Sub meeting confirmed a premarket approval (PMA) pathway for the cell processing platform, with no safety concerns raised regarding the therapy. Strategic positioning of the Helix delivery system is being evaluated through two potential pathways: simultaneous approval with the cell therapy or a stand-alone de novo pathway. Management expects to complete and submit the Shonin premarket application in Japan within approximately 7 months, followed by a roughly one-year review period. The company anticipates securing one or more transactions in Q2 2026 to fund the Japan regulatory submission and the ongoing Heart Failure II trial. The CardiAMP Heart Failure II trial is designed for 250 patients, with 160 required for 80% power, and plans are in place to expand clinical centers as resources allow. Approval in Japan is expected to include a post-marketing study that will provide procedural safety data and establish standard-of-care outcomes while generating reimbursement revenue. Future clinical catalysts include the presentation of results from the chronic myocardial ischemia program at the EuroPCR meeting in late May 2026. The company ended the quarter with $951,000 in cash, necessitating near-term financing to meet regulatory and clinical milestones. R&D expenses decreased by $295,000 primarily due to the closeout of the initial CardiAMP Heart Failure trial, though this was partially offset by new trial enrollment costs. Management highlighted that while Japan has historically reimbursed cardiac cell therapies at high levels (up to $124,000), BioCardia intends to position its therapy as a more cost-effective alternative. The regulatory strategy in Japan involves a 'representative' entity that will hold the submission under BioCardia's control to navigate local auditing requirements. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The Shonin application involves extensive auditing of clinical data, manufacturing, and sterility, which management expects to take about 19 months total until market entry. A mandatory post-marketing study will be conducted in conjunction with Japanese medical societies, during which the therapy will receive active reimbursement. Management identified an initial reachable market of approximately 20,000 patients under 'appropriate use' conditions within a broader population of 300,000 ischemic heart failure patients. Based on current U.S. Medicare reimbursement of $20,000 per procedure, the company estimates a potential $400 million market opportunity in Japan.

This article first appeared on GuruFocus. Release Date: May 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioCardia Inc (NASDAQ:BCDA) received FDA breakthrough designation and Medicare reimbursement of $20,000 per treatment for their cardiac cell therapy. The CARDIAMP heart failure trial showed compelling signals of enhanced heart function in treated patients, with statistically significant benefits in heart function and quality of life. Japan's Pharmaceutical and Medical Devices Agency is inclined to accept BioCardia's data for regulatory submission and approval, recognizing an unmet need in Japan. BioCardia completed a Q-sub meeting with the FDA, which found the efficacy results intriguing and encouraged the completion of the ongoing CardiAmp HF2 trial. BioCardia's financial management resulted in a decrease in total expenses and net loss compared to the previous year, demonstrating effective cost control. BioCardia Inc (NASDAQ:BCDA) ended the quarter with cash and cash equivalents totaling only $951,000, indicating limited financial resources. The regulatory process in Japan is extensive, requiring a seven-month preparation for submission and a year-long review process. The CardiAMP Heart Failure II trial is still ongoing, requiring significant resources and time to complete. The market opportunity in Japan, while promising, is initially limited to 20,000 patients, which may restrict immediate revenue potential. BioCardia's net cash used in operations increased slightly compared to the previous year, reflecting ongoing financial challenges. Warning! GuruFocus has detected 1 Warning Sign with BCDA. Is BCDA fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more insight into the regulatory process in Japan for the Shonen application and the expected timeline for approval? A: The process in Japan involves preparing a large STED document, auditing clinical data and manufacturing, and completing the submission in about seven months. The review process is expected to take about a year, similar to a PMA in the U.S. We anticipate approval in roughly 19 months, followed by a post-marketing study with reimbursement, involving collaboration with Japanese medical societies. Dr. Peter Altman, CEO Q: Could you elaborate on the market opportunity for CardiAmp in Japan and its integration into the treatment regimen? A: The initial market opportunity in Japan includes approximately 300,000 patients with ischemic heart failure, with an initial target of 20,000 patients. The therapy is expected to be cost-effective, with potential reimbursement around $20,000 per procedure, leading to a $400 million market opportunity. Dr. Peter Altman, CEO Q: What are the financial highlights for the first quarter of 2026? A: Total expenses decreased by $460,000 to $2.3 million, driven by a reduction in R&D expenses. The net loss was $2.3 million, and cash and cash equivalents totaled $951,000. We continue to manage capital carefully while achieving milestones. David McClung, CFO Q: How does the CardiAmp therapy address unmet medical needs in Japan? A: CardiAmp therapy addresses the unmet need for treating ischemic heart failure by preventing negative heart remodeling and improving heart function, which aligns with the unmet needs identified by Japan's regulatory agency. Dr. Peter Altman, CEO Q: What are the next steps for BioCardia in terms of regulatory submissions and trials? A: Our top priorities include completing the CardiAMP Shonen pre-market application for Japan and enrolling patients in the CardiAMP Heart Failure II trial. We also plan to complete transactions to fund these initiatives. Dr. Peter Altman, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

SUNNYVALE, Calif., May 15, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the first quarter 2026 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2026 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In February, PMDA provided additional questions for BioCardia, in line with those addressed and discussed in three preliminary clinical consultations, on the evidence supporting safety and efficacy of CardiAMP Cell Therapy System and scheduled our Formal Clinical Consultation. We addressed these questions in advance of the Formal Clinical Consultation with PMDA. In March, our CardiAMP HF clinical data presented at the Technology and Heart Failure Therapeutics (THT) late breaking clinical trials session showed the CardiAMP cell therapy positively impacts the lives of patients, particularly those having elevated markers of heart stress. These patients experienced statistically significant improvement in heart function. This aligned with the three tiers of the composite outcome of (1) living longer without heart replacement therapies such as LVAD or transplant, (2) having fewer major adverse events such as heart attacks, strokes, and hospitalizations, and (3) having a better quality of life, which also achieved statistical significance. In April, during the Formal Clinical Consultation with PMDA attended by six world class cardiologists, PMDA determined that the clinical safety and efficacy evidence for the CardiAMP® Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Alignment was achieved on the acceptability of the foreign clinical data developed in the United States, the indications for use in patients, the approach for introduction of the therapy in Japan, approaches for defining Appropriate Use Conditions, the need for continued post marketing studies in Japan, and how these post marketing studies are to be developed. In May, we received the preliminary Advisory Record from PMDA which is in line with expectations. We are preparing answers to outstanding questions and advancing towards Shonin submission, the formal application process for Pre-Market Approval (PMA) required to register the CardiAMP Cell Therapy System in Japan. In May, we had our Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). FDA expressed no concerns on safety, agreed the benefits for patients who received therapy in the CardiAMP HF Trial were intriguing, and confirmed that Premarket Approval (PMA) continues to be the appropriate regulatory pathway. The FDA considered advancement of the PMA submission based on the currently available data. FDA recommended continuing the ongoing CardiAMP HF II trial as the confirmatory study to support a successful PMA and pledged ongoing support for the trial. Throughout the first quarter, patients have also been screened, consented, and randomized at the four active CardiAMP HF II clinical sites: University of Wisconsin, Morton Plant Mease Hospital, Emory University and Henry Ford Health. CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) Primary results of this cohort have been accepted for oral presentation at Euro PCR, a world-leading course in interventional cardiovascular medicine on May 20, 2026. Helix™ Biotherapeutic Delivery System In February, we announced a Pre-Submission to the FDA under its Q-Submission program for the approval of our Helix Transendocardial Delivery Catheter (Helix) for intramyocardial therapeutic and diagnostic agent delivery. In May, BioCardia had this Pre-Submission meeting with FDA. FDA agreed that there are two 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 DeNovo pathway. Intellectual Property The Company’s intellectual property portfolio is robust, with more than 60 patents and patent applications worldwide. In March, the Company announced that the Japan Patent, “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation.” This patent adds further protection to BioCardia’s proprietary Heart3D™ Fusion Imaging (Heart3D) software intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures. The allowed Japanese patent has claims on the use of Heart3D fusion imaging configured for transposing a preoperative three-dimensional image obtained by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) of the patient’s heart onto two orthogonal two-dimensional images to generate a combined three-dimensional model reconstruction of the heart on a display within or adjacent to a sterile field for navigating delivery systems and recording procedural locations. “It has been a tremendous quarter, and we are thankful for the extensive interactions with PMDA and FDA in reviewing the CardiAMP HF clinical trial data and for their continued support. CardiAMP Cell Therapy for the treatment of ischemic heart failure is now advancing towards an expected initial regulatory approval in Japan, where cardiologists would be able to treat an estimated 20,000 patients annually having no treatment options.” said BioCardia CEO Peter Altman, Ph.D. “We have also secured FDA support for the ongoing confirmatory CardiAMP HF II trial and FDA guidance on market clearance of our best-in-class Helix Transendocardial Delivery System. Our work with our world class physician partners has potential to ultimately help millions of patients suffering from ischemic heart failure and chronic myocardial ischemia with few current therapeutic options.” First Quarter 2026 Financial Results: Net cash used in operations in the three months ended March 2026 was approximately $1.7 million, compared to approximately $1.6 million in the three months ended March 2025, primarily due to the timing of supplier payments. The Company ended the quarter with cash and cash equivalents totaling $951,000. Research and development expenses decreased to approximately $1.2 million in the three months ended March 2026, compared to approximately $1.5 million in the three months ended March 2025, primarily due to closeout of the CardiAMP HF Trial, partially offset by early enrollment in the CardiAMP HF II Trial and regulatory activities to advance CardiAMP in Japan. Selling, general and administrative expenses decreased to approximately $1.0 million in the three months ended March 2026 compared to approximately $1.2 million in the three months ended March 2025, primarily due to lower professional service fees. Our net loss was approximately $2.3 million in the three months ended March 2026, compared to approximately $2.7 million in the three months ended March 2025. ANTICIPATED UPCOMING MILESTONES AND EVENTS: CardiAMP for Chronic Myocardial Ischemia, Oral Presentation at Euro PCR – Q2 2026 Japan PMDA Shonin Submission for Approval – Q4 2026 Conference call access: Participants can register for the conference by navigating to https://dpregister.com/sreg/10209272/104069d5d88. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial-in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=Rt7kKGAp. A webcast replay of the call will be available approximately one hour after the end of the call at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-855-669-9658 (toll free domestic/Canada) and 1-412-317-0088 (international toll) by using access code 4737992. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. BioCardia also acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the sufficiency of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor Relations Email: [email protected] Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial Officer Email: [email protected] Phone: 650-226-0120