BioCardia - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 was operationally strong: DSMB cleared CardiALLO to proceed with no treatment-emergent adverse events, Helix delivery showed clean safety in HF procedures, and CardiAMP HF II began enrolling at three sites; financially, revenue was $0 with net loss of $2.7M and cash used in operations of $1.6M.
• EPS of -$0.59 missed the S&P Global consensus of -$0.39, and revenue remained at $0; burn remains modest but cash ended the quarter at $0.95M prior to a small post-quarter ATM financing.
• Management is prioritizing regulatory paths: FDA and PMDA consultations for CardiAMP HF within roughly six months, plus U.S. Helix submission; CardiAMP HF II aims to fully enroll over ~2 years with quality-of-life replacing 6MWD in composite endpoints.
• Near-term stock catalysts: PMDA acceptance to submit CardiAMP in Japan, U.S. Helix approval steps, CardiAMP HF II site activation/enrollment updates, and CardiALLO dose-escalation progress.

What Went Well and What Went Wrong

What Went Well

• CardiALLO HF DSMB low-dose review reported no treatment-emergent adverse events (arrhythmias, rejection, allergic responses) and recommended the study proceed, de-risking allogeneic platform safety.
• Helix delivery safety in CardiAMP HF showed no procedure-related deaths, embolism, or need for surgical/endovascular repair, supporting a U.S. approval submission.
• CardiAMP HF II trial is actively enrolling at three U.S. sites, with FDA-blessed design tweaks (QoL in composite endpoint; personalized dosing to include more patients), improving power and enrollment feasibility; physician feedback on Morph DNA was notably positive (“I love Morph DNA”).

What Went Wrong

• CardiAMP HF I did not meet the primary endpoint due to the third-tier 6MWD component despite strong Tier 1/2 signals; the composite reached significance only in NT-proBNP-elevated subgroup with QoL as Tier 3 (p=0.02), necessitating HF II confirmation.
• Financially, revenue remained $0 while net loss widened YoY ($2.7M vs $2.3M), and EPS missed consensus; cash balance was low at quarter-end, requiring post-quarter ATM financing.
• Balance sheet showed stockholders’ equity deficit (-$1.52M) and current liabilities > current assets, highlighting financing risk amid ongoing development timelines.

Transcript

Operator (participant)

Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call. I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.

Miranda Peto Benvenuti (Investor Relations Consultant)

Thank you, Dave. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's Leadership Team are Peter Altman, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, references to management's intentions, beliefs, projections, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-K filed with the SEC on March 26, 2025, and in subsequently filed reports on Form 10-Q.

The content of this call contains time-sensitive information that is accurate only as of today, May 14, 2025. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

Peter Altman (President and CEO)

Thank you, Miranda, and good afternoon to everyone on the call. In March of this year, the CardiAMP heart failure trial results demonstrated both safety and meaningful benefits of CardiAMP cell therapy for heart failure patients who still have elevated biomarkers of heart stress despite being on maximal guideline-directed medical therapy. This therapy has potential to have a positive impact on the enormous unmet clinical need for approximately 1 million Americans with heart failure currently expected to have a 10% mortality per year. Our top priority this second quarter of 2025 is all about sharing this data with the Food and Drug Administration and Japan's Pharmaceutical and Medical Device Agency to align on pathways to make this therapy available for physicians and their patients, as well as sharing this data with the broader clinical community in more detail in the form of a peer-reviewed manuscript.

We are also continuing to gather evidence to support this therapy, and the CardiAMP heart failure II trial is actively enrolling patients at three clinical sites. This trial has a similar design with some important changes intended to confirm the results we have from this therapy and also result in enhanced enrollment. We expect this trial to be fully enrolled over the next two years and have a primary readout when the last patient reaches their one-year follow-up endpoint. This past quarter, final data from the last roll-in cohort patient in the CardiAMP cell therapy and chronic myocardial ischemia trial, or BCDA-02, became available, and we are working towards both scientific presentation and publication of this data. We have also had a successful Data Safety Monitoring Board review of the safety outcomes in the low-dose cohort in our CardiALLO allogeneic esenchymal stem cell therapy in ischemic heart failure, or BCDA-03.

The absence of any adverse events in these very ill patients was great news to confirm for this off-the-shelf therapy. On the Helix biotherapeutic delivery partnering front, we are actively preparing for submission for approval of this product, which is expected to be valued by therapeutic partners. Helix has potential to be the first-approved transendocardial biotherapeutic delivery system in the United States because of the CardiAMP heart failure data. We continue to be focused on partnerships where our contributions to the success of partners will reward our shareholders. One element of the Helix delivery system is our proprietary FDA-approved MorphDNA steerable introducer platform. We are continuing to detail its advantages to physicians and partners who may benefit from these products.

The largest market procedures are in cardiac electrophysiology for our transseptal Avance product, but just yesterday, a procedure was detailed in the superior mesenteric artery, which would be a peripheral procedure. On the business development front, we believe partnering can create meaningful value for shareholders with respect to each of our four platforms: CardiAMP, CardiALLO, Helix, and MorphDNA. For CardiAMP cell therapy business development, we expect the final data from CardiAMP heart failure and clarity on anticipated approvals ahead to enhance interest by distribution partners and strategics. For CardiALLO cell therapy business development, our allogeneic cell therapy, we have the ability to manufacture our clinical-grade cells at a cost profile that we expect is likely less than all of our peers. We are also open to partnerships broadly in the many indications we are not currently pursuing.

For our Helix biotherapeutic delivery platform, potential biotherapeutic delivery partners who wish to have access to our delivery experience, products, and support capabilities remain in active discussions. Current partners realize that minimally invasive delivery not only enhances future commercialization, but it is also seen as a critical means for clinical development, enabling much faster enrollment, thus significantly reducing operational costs by shortening timelines for therapeutic development. Lastly, partner therapeutics are expected to benefit enormously from our threefold efficiency of delivery and the enhanced pharmacokinetics with our Helix system supported by data from many groups. We believe this advantage underlies our positive CardiAMP heart failure data and is due to the stability of the Helix in the beating heart and the self-sealing helical pathway into the tissue. On the Morph front, the recent FDA approval has us open for business in a competitive but real market.

Recently, the greater than $10 billion per year electrophysiology market, primarily focused on treating arrhythmias in the atria of the heart, is expanded to treat arrhythmias in the ventricles of the heart, where we deliver our cell therapies. This is a more tortuous region of the heart to access and typically involves a 180-degree turn of the catheter system, regardless of which route of access is required: trans-aorta or transmitral and down through the mitral valve. Our MorphDNA design presents significant advantages in these orientations, which is exactly where it is being used today for our therapeutic procedures. Looking forward, we are working to complete the following important efforts for our therapeutic programs: one, submit CardiAMP HF results and request consultation with FDA and Japan PMDA; two, activate multiple sites in CardiAMP heart failure II and drive enrollment in this trial.

For BCDA-02, we intend to deliver top-line data in the roll-in cohort, and lastly, for BCDA-03, we're going to complete the next dosing cohort ahead. After the end of the recent quarter, management chose to do a small financing at the market with minimum dilution to deliver on the milestones before us. We don't have a large burn rate as a company today, and this gives us greater flexibility as we choose the best pathways to fund value creation for our shareholders. We have some large milestones expected very soon. I will now pass the call to David McClung, our CFO, who will review our first quarter 2025 financial results. David?

David McClung (CFO)

Thank you, Peter. Good afternoon, everyone. I will now review highlights of our financial results for the quarter ended March 31, 2025. Total expenses increased by $396,000 quarter over quarter to $2.7 million in the first quarter of 2025, compared to $2.3 million in the same quarter of 2024. The primary driver of this change, research and development expense, increased $289,000 to $1.5 million in the first quarter of 2025 versus $1.2 million in the first quarter of 2024. The increase relates to expenses incurred closing out and obtaining final data for the CardiAMP heart failure trial, coupled with the inception of enrollment in the new CardiAMP heart failure II trial during the first quarter of 2025. We anticipate R&D expenses will increase modestly in 2025 as we continue advancing our therapeutic candidates in the United States and in Japan.

Selling general and administrative expenses increased modestly to $1.2 million for the three months ended March 2025, as compared to $1.1 million for the three months ended March 2024. We expect 2025 SG&A expenses to track closely to these 2024 levels. Our net loss was $2.7 million in Q1 2025, compared to $2.3 million in Q1 2024. Net cash used in operations was $1.6 million for the first quarter of 2025, comparable to the $1.5 million recognized in the same quarter in 2024. The company ended the quarter with cash and cash equivalents totaling $949,000, before we did the modest financing and brought in some additional capital, as Peter just mentioned. We will continue our track record for carefully managing the use of capital. This concludes management's prepared comments, but we're happy now to take questions from attendees.

Operator (participant)

At this time, we will now begin the question and answer session. To ask a question, you may press *1 on your touchpad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star *1 then *2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Joe Pantginis with H.C. Wainwright. Please go ahead.

Joe Pantginis (Managing Director of Equity Research)

Hey, guys. Good afternoon. Thanks for taking the question. Peter, I'd like to start with, I mean, you mentioned business development a lot. I mean, I know it's obviously hard to predict when deals may be consummated, but maybe can you discuss sort of the levels of maturity? I'm sure it's wide-ranging.

Peter Altman (President and CEO)

Wow. Yeah. I think right now I would talk about our capabilities as opposed to the stage of a deal discussion. I've been in deal discussions where I thought the deal was going to be inked the next day, and literally 18 months later, it wasn't done. For example, the publicly traded company CareDx, which has a market cap of $1.8 billion, that financing took 18 months to close. It takes a long time, even when you're in the final steps. Sometimes it can go quickly. I think the key takeaway is we have products that are established. If we work up the value proposition, the MorphoAccess Pro product family is approved and being used in clinical cases today, both in our trials and in other physicians' hands.

I've guided folks to that this would be a long process as physicians gained experience and strategics became more interested. We have a couple of active discussions ongoing with large-cap strategics today around the Morph product opportunity. The beauty of this is it's not an opportunity related to our core business necessarily. It's additional value from what investors might expect. I did detail the cardiac electrophysiology market. It's an enormous market that's growing at 30% per year, and a technology like the Morph can help folks get to the location and do these procedures. It's a high-value opportunity. Moving up the food chain on the Helix side, Joe, I'll walk through them. Helix is needed for biotherapeutic delivery partnering.

I noted in our corporate deck, you'll see there is one peer company that is seeking approval in Japan probably in the year ahead, and that's Heartseed. We wish them well, and we like their strategy. They're cracking people's chests to deliver the cells intramyocardially. At some point in time, that's got to change. I know that Novo Nordisk has said publicly that they're working on a catheter system. We have a lot of intellectual property out there, and we've done 500 cases, and I think Helix is going to soon be approved. That is just one potential partner in the cell and gene therapy space in the heart. On CardiALLO, we have a clinical data set now demonstrating safety in the heart, which is probably one of the more sensitive places to go. We're having manufacturing relatively well dialed in.

We've come up with some really nice advances on how to manufacture these cells in a small footprint manufacturing that actually would enable us to do deals with other parties seeking to go after other clinical indications. Today, we're focused on cardiac and pulmonary, but these same cells are being pursued or very similar cells are being pursued commercially at a price point of $800,000 per treatment by Mesoblast and by Helios in acute respiratory distress, where we have approved IND in the United States. There are many other indications for these cells out there, and we're open for partnering with clinical-grade cells with clinical data behind them. On the CardiAMP front, we are focused on the approval process in Japan. We've been having ongoing discussions with the regulators and with potential distributors now for a few years.

As we get closer to the door of, "Hey, this is going to be a product, who's going to distribute it?" and by being reasonable and rational in the partnering, I think we'll see progress there. I can't give a specific timeline. I just think that investors should appreciate all four of these platforms are ready for deals today, and they do line up with really significant opportunities. I guess that's where it's at. You'll hear me continue to say this until as we ink deals and partners, take some of the value that we've been investing in and grow it further.

Joe Pantginis (Managing Director of Equity Research)

Of course. No, I appreciate that call. It surely sounds like you're very busy with this. Good luck in bringing a deal forward. If we focus a little bit, obviously, I think maybe I'm overstating this, but the majority of people would be focused on the U.S. opportunities. I think an unsung opportunity and focus is Japan. You've talked a lot about this. If the Japan PMDA allows you to submit the CardiAMP cell therapy system for the heart failure indication after they review the clinical data, I mean, is it safe to assume that this is similar to the FDA accepting of BLA? What do you feel as the importance of that inflection point and how it might get to the market in Japan? Thanks.

Peter Altman (President and CEO)

Thank you, Joe. Joe, it's a great question. I'm aligned with you. I do agree. It is the same thing as the FDA saying they'll accept the BLA. In Japan, they're extremely rigorous. They've gone through all of our data, I think, four times already. There will be additional data review as we go into our clinical consultations. We're looking at roughly, I'd say, a six-month time frame on the outside to have clarity on, are we going to be allowed to submit for approval? At that point, I view it as pretty sure that we're going to go through that approval process unless they find something fundamentally wrong with what we've done or what we've said. Them allowing us to submit for approval also provides clarity for all of the distribution partners we're talking to.

That puts it on a timeline for approval, and it becomes critical to then begin doing physician outreach and getting ready for how to train this, how to introduce this into a commercial channel. It will start slowly in Japan, but I do think that the value proposition for BioCardia is enormous. I know we have two peers in Japan. I mentioned Heartseed earlier, and I have a lot of respect for Heartseed and their basic strategy. They have treated 10 patients, and they have a market capitalization of about $350 million with open chest surgical delivery. There is another peer in Japan, Cuorips, C-U-O-R-I-P-S. They are delivering cells to the surface of the heart, again, through an open chest surgical procedure. I'm not a big fan of their strategy, I must say, but their efforts, they're going after approval in Japan based on eight patients treated total.

I note that it took them many, many years to get those eight patients, much as it took Heartseed many, many years to get their 10 patients. Here we are with roughly 200 patients in the CardiAMP cell therapy trial, including two randomized placebo-controlled trials, minimally invasive delivery and autologous cell therapy. Them saying that they will accept our application in Japan, I think will help us close the gap in valuation between where BioCardia is today and where those companies are in terms of their valuation, if not even exceed their valuation over time as folks become more aware of the differences in the therapy, in the level of evidence, in the safety profile, and so on. A long answer, Joe, but I think it's a great question, and it's central to our strategy to get that PMDA submission in place.

Joe Pantginis (Managing Director of Equity Research)

No, that's fantastic. I appreciate that color, especially with the level of data relative to the comps. So appreciate all the color, Peter.

Peter Altman (President and CEO)

Thank you, Joe.

Operator (participant)

The next question comes from Chris Stevens, private investor.

Chris Stevens (Analyst)

Hello. Hi, Peter. How are you?

Peter Altman (President and CEO)

I'm doing well, Chris.

Chris Stevens (Analyst)

Great. My question, it pertains to the CardiAMP, the BCDA-01, the confirmatory trial. That's ongoing. That's starting up. You're enrolling patients in. Can you kind of give some comments on how that would play into this other activity in which you're submitting to the FDA to see if there's a potential pathway to approval? It's kind of like you're running a trial, but at the same time, you're also submitting to the FDA for approval at the same time.

Peter Altman (President and CEO)

Absolutely. That's a great question, Chris, and I appreciate it. I know it may be a disconnect, but when you believe in your therapy, you're constantly going to be developing levels of evidence. We know that we had a great clinical trial that we just reported, but it did not hit its primary endpoint. That does introduce really significant risks to the approval pathway ahead. We have built this heart failure network in the United States in CardiAMP HF. The investigators have the data before them, which excites them. That will help us on enrollment ahead. Remember that CardiAMP HF1 and HF2 are both reimbursed today by Medicare. The cost to us in doing a second trial is not nearly as significant as it would be if we were not reimbursed by Medicare. We are advancing that program.

We will generate additional data. It's focusing in on the patients who are the greatest responders in CardiAMP HF. There are a couple of other subtleties that we're weaving into the trial. We are using our new MorphDNA platform in this trial. I can tell you that the physician who did the first case sent me a very short text that said, "I love MorphDNA." Just so you can appreciate how the physicians are responding to that. We also have a strategy woven into CardiAMP heart failure II, where the FDA has blessed our usage of the pre-procedure screening assay to change the dosing in the patients so that we can include more patients in CardiAMP heart failure II than we included in CardiAMP heart failure. That's going to be a nice aspect of it.

Lastly, CardiAMP heart failure II will be using the very similar composite endpoint, which is the three-tier Finkelstein-Schoenfeld analysis. Instead of using six-minute walk in the third tier, where we had some issues in CardiAMP HF, we're going to be using a quality of life metric, a self-assessment question. The beauty of that change is that's not an assay or assessment, if you will, that is effort-based. Everybody will complete it the same every time. In CardiAMP HF, we had patients fall out because they hurt their knee, and so they couldn't do the six-minute walk distance. It also avoids patient fallout for certain measures, which enhances the power of the trial. Those are the big changes in CardiAMP HF2. It's active at three centers today. There'll be news flow as it's expanded out to other centers.

It does not have an adaptive statistical analysis plan. It is a 250-patient trial with one-to-one randomization. We are hopefully to completely enroll it in two years.

Chris Stevens (Analyst)

Gotcha. Okay. That's great. That's good info. Just one follow-up, if I may. I know this is very new, but the tariffs, the best price policy or best nation price policy that just came out, is there anything in CardiAMP that would follow, anything within that treatment that would fall within any of these tariff concerns or even the best price policy that is being talked about just within the last day or two? I know it's very new, but.

Peter Altman (President and CEO)

No, no. I'm tracking it. It's the most favored nation status that folks are in the U.S. based on most favored nation. The answer to that is no today. Right now, on the most favored nation, we are not actively selling CardiAMP outside the U.S. We hope to be soon. If we do, we're actually hoping to benchmark it based on our current U.S. reimbursement. We're trying to turn that equation around, if you will. We'd like others to be signing up to that U.S. pricing as well, and that may come into play. The tariffs is such a complicated landscape, and there's so much that we don't know. For investors, I can share that we only have a few components that we use in our manufacturing here at BioCardia that are manufactured overseas.

We do some of our molding work outside the United States, very low cost, not expected to have any impact to our business. Everything else we manufacture here in the United States. We manufacture the Morph products here at the facility I'm standing in. We manufacture Helix in the facility I'm standing in. We manufacture CardiAMP cell clinical cells in the facility I'm standing in here in Sunnyvale, California. The CardiAMP disposables are manufactured on a contract basis for us, but they're also manufactured in the continental United States. I don't expect tariffs to have an impact on what we might ultimately sell in the United States. Tariffs go both ways. Other countries applying tariffs broadly to medical products out of the United States could impact our reimbursement OUS and the U.S.

Government saying they're only going to pay what others pay, it's who gets to pay the lowest is always a challenge. I think that we are also involved in that discussion about what the pricing will be. Nicely, we price based on value. In the cardiac cell therapy arena, there's been one reimbursed cardiac cell therapy at $124,000 per patient in Japan. I just shared we're trying to get the reimbursement that we have in the United States, which is closer to $20,000. We can have very large margins at $20,000. Frankly, I don't think any of the other cardiac cell therapy in development or even gene therapies in development are even considering a value pricing that low. For BioCardia, based on how we're doing CardiAMP, we actually think we can have greater than 90% margins at that price point.

We think we can price on value, and we're not so concerned about those issues. Again, we're not as sophisticated as many of the folks on the street in Washington are on these issues. We thought them through at a high level. Forgive the long-winded answer. I'm just trying to be very transparent on what our internal discussions have been.

Chris Stevens (Analyst)

No, that's great. I appreciate the info. All right. Thank you. Good luck.

Peter Altman (President and CEO)

Good question. Thank you.

Operator (participant)

Our next question comes from James Molloy with Alliance Global Partners. Please go ahead.

Laura Suriel (Equity Research Associate)

Hello. This is Laura Suriel on.

Peter Altman (President and CEO)

I'm sorry?

Operator (participant)

Her line dropped.

Peter Altman (President and CEO)

Okay. No worries. Why don't we wrap it here, Dave?

Operator (participant)

Yeah.

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