Q1 2025 BioCardia Inc Earnings Call
Ladies and gentlemen, thank you for standing by good afternoon, and welcome to the bio Cardia first quarter financial results and business update conference call.
Participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your touch tone.
Phone to withdraw your question. Please press Star then two.
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.
Webcast replay of the call will be available approximately one hour. After the end of the call I would now.
Speaker Change: I'd like to turn the call.
Speaker Change: Paul over to Miranda, Okay. So Oh Cardia Investor Relations. Please go ahead Miranda.
Speaker Change: Yeah.
Miranda: Thank you, Dave and good afternoon, and thank you for participating in today's conference call. Joining me from Biochar T. His leadership team are Peter Coleman, President and Chief Executive Officer, and David <unk>, The company's Chief Financial Officer. During this call management will be making.
Miranda: We're looking statements, including statements that address myocardial expectations for future performance and operational results.
Miranda: References to management's intentions beliefs projections.
Miranda: Oh, jeez and current expectations.
Miranda: Such factors include among others.
Miranda: Parents, uncertainties associated with developing new product technology, and obtaining regulatory approvals.
Miranda: 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 and Biochar News report on Form 10-K filed with the E on March two.
Miranda: 620, 25 and in subsequently filed reports on Form 10-Q.
Miranda: The content of this call contains time sensitive information that is accurate only as of today may 14 2025.
As required by law the company company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.
Speaker Change: It is now my pleasure to turn the call over to Dr. Peter Oh Man Biochar Diaz, President and CEO. Peter Please go ahead.
Peter: Thank you Miranda and good afternoon to everyone on the call.
Peter: In March of this year, the cardiac heart failure trial results demonstrated both safety and meaningful benefits of cardiac cell therapy for heart failure patients, who still have elevated biomarkers of heart stress despite being on maximum guideline directed medical therapy.
Peter: This therapy has the 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.
Peter: Our top priority in the 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.
Peter: Clinical community in more detail in the form of a peer reviewed manuscript.
Peter: We are also continuing to gather evidence to support the therapy and the cardiac heart failure to trial is actively enrolling patients at three clinical sites.
Peter: 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.
Peter: We expect this trial to be fully enrolled over the next two years and have a primary read out when the last patient reaches their one year follow up endpoint.
This past quarter final data from the last rolling cohort patient in the cardiac cell therapy, and chronic myocardial ischemia trial or B C. D. E. O two became available and we are working towards both scientific presentation and publication of this data.
Peter: We have also had a successful data safety monitoring Board review of the safety outcomes in the low dose cohort in our Carty Allo allogeneic mesenchymal stem cell therapy in ischemic heart failure, where B C. D E O three.
Peter: The absence of any adverse events in these very ill patients was great news to confirm for this off the shelf therapy.
Peter: On the helix biotherapeutic delivery partnering front, we're actively preparing for submission for approval of this product, which is expected to be valued by therapeutic partners.
Peter: Helix has potential to be the first approved trans endocardial biotherapeutic delivery system in the United States because of the cardiac heart failure data.
Peter: We continue to be focused on partnerships, where our contributions to the success of partners will reward our shareholders.
Peter: One element of the helix delivery system is our proprietary FDA approved morph dna's durable introduced their platform.
Peter: We are continuing to detailed its advantages to physicians and partners, who may benefit from these products.
Peter: Larger market procedures are in cardiac electrophysiology for our trans septal advanced product, but just yesterday a procedure was detailed in the superior mesenteric artery, which would be a peripheral procedure.
Peter: On the business development front, we believe partnering can create meaningful value for shareholders.
Peter: With respect to each of our four platforms cardiac carty.
Peter: Carty Allo helix and morph DNA.
For Cardiome cell therapy business development, we expect the final data from cardiac heart failure and clarity on anticipated approvals ahead to enhance interest by distribution partners and strategics.
Peter: For Carty Allo cell therapy business development, our allogeneic cell therapy, we have the ability to manufacture our clinical grade sells at a cost profile that we expect is likely less than all of our peers. We.
Peter: We are also opened up partnerships broadly in the many indications we are not currently proceeds pursuing.
Peter: For our helix biotherapeutic delivery platform potential biotherapeutic delivery partners, who wished to have access to our delivery experience products and support capabilities remain in active discussions.
Peter: Current partners realize the minimally invasive delivery not only enhances future commercialization, but it is also seen as a critical means for clinical development, enabling much faster enrollment.
Peter: Thus significantly reducing operational costs by shortening timelines for therapeutic development.
Peter: Lastly partner Therapeutics are expected to benefit enormously from our three fold efficiency of delivery and the enhanced pharmacokinetics with our helix system supported by data from many groups. We believe this advantage underlies our positive cardiac heart failure data and is due to the stability of the helix.
Peter: The beating heart and the self sealing helical pathway into the tissue.
Peter: On the more front. The recent FDA approval has this opened for business in a competitive but real market.
Peter: Recently, the greater than $10 billion per year electrophysiology market, primarily focused on treating a rid me is in the atrium of the heart.
Peter: Is expanded to treat a rid me is in the ventricles of the heart.
Peter: Where we deliver our cell therapies.
Peter: This is a more tortuous region of the heart to access and typically involves a 180 degree turn of the catheter system, regardless, which route of access is required.
Peter: Trans aorta or trans mitral and down through the mitral valve.
Peter: Our morph DNA designed presents significant advantages in these orientations, which is exactly where it is being used today for our therapeutic procedures.
Peter: Looking forward.
Peter: We are working to complete the following important efforts for our therapeutic programs.
Peter: One the MIT cardiac H F results and request consultation with FDA and Japan P. M D. A.
Peter: To activate multiple sites in cardiac heart failure to and drive enrollment in this trial.
Peter: For <unk>, we intend to deliver topline data in the rolling cohort.
Peter: And lastly for BCD three we're going to complete the next dosing cohort ahead.
After the end of the recent quarter.
Peter: Management chose to do a small financing at the market with minimum dilution to deliver on our milestones before us.
Peter: 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.
Peter: We have some large milestones expected very soon.
Speaker Change: I will now pass the call to Dave Mcclung, Our CFO, who will review our first quarter of 2025 results.
Speaker Change: David.
David: Thank you Peter good afternoon, everyone.
Speaker Change: I will now review highlights of our financial results for the quarter ended March 31 2025.
Speaker Change: Total expenses increased by 396000 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.
Speaker Change: The primary driver of this change research and development expense increased 289000 to $1 5 million in the first quarter of 2025.
Speaker Change: Versus $1 2 million in the first quarter of 2024.
Speaker Change: The increase relates to expenses incurred closing now in obtaining final data for the cardiac heart failure trial, coupled with the inception of enrollment and the new cardiac heart failure trial during the first quarter of 2025.
Speaker Change: Anticipate R&D expenses will increase modestly in 2025, as we continue advancing our therapeutic candidates in the United States and in Japan.
Speaker Change: 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.
Speaker Change: We expect 2025 SG&A expenses to track closely to the 'twenty 'twenty four globally.
Speaker Change: Our net loss was $2 7 million in Q1, 'twenty 25, compared to $2 3 million in Q1 2024.
Speaker Change: 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.
Speaker Change: The company ended the quarter with cash and cash equivalents totaling 949000 before we did the modest financing and brought in some additional capital as Peter just mentioned.
Peter: We will continue our track records were carefully managing the use of capital.
Speaker Change: This concludes management's prepared comments, but we're happy now to take questions from attendees.
Speaker Change: At this time, we will now begin the question and answer session to ask a question you May Press Star then one on your touch touch pad.
Speaker Change: If you're using a speaker phone 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 one.
Speaker Change: And third to at this time, we will pause momentarily to assemble our roster.
Speaker Change: Alright first question comes from Joe <unk>.
Speaker Change: Goodness with H C. Wainwright. Please go ahead.
Speaker Change: Hey, guys. Good afternoon, thanks for taking the question.
Speaker Change: Peter I would like to start with I mean, you mentioned business development a lot. So I mean, I know, it's obviously hard to predict when.
Speaker Change: Deals may be consummated, but maybe can you discuss sort of the levels of maturity and I am sure its wide ranging.
Speaker Change: Oh Wow, yeah, its a I.
Speaker Change: 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 in the next day and and literally 18 months later it wasn't done for example, the publicly traded company care Dx, which has a market cap of $1 8 billion net.
Speaker Change: <unk> financing took 18 months to close.
Speaker Change: And and it takes a long time, even when you are in the final final steps, but sometimes it can go quickly I think the key takeaway is.
Speaker Change: We have products that are established so if we if we work up the value proposition the more.
Speaker Change: More.
Speaker Change: Axis Pro product family is approved and being used in clinical cases today, both in our trials and in other physicians hands and I've I've guided folks to that this would be a long process as physicians gain experience and strategics became more interested.
Speaker Change: We have a couple of active discussions ongoing with large cap strategics today around.
Speaker Change: The more.
Speaker Change: Product opportunity and again the beauty of this is it's not an opportunity related to our core business necessarily so additional value from what investors might expect and I did detailed a cardiac electrophysiology market. It's an enormous market that's growing at 30% per year and the technology like the more can helpful.
Speaker Change: Get to the location and do these procedures. So it's a high value opportunity moving up the food chain helix side Joe.
Speaker Change: Walk through all helix is needed for biotherapeutic delivery partnering I noted in our corporate deck Youll see there is one a peer company that is seeking approval in Japan.
Speaker Change: Probably in the year ahead, and Thats heartbeat, and we wish them well and we like their strategy.
Speaker Change: They're cracking people's tests to deliver the cells inter myocardial.
Speaker Change: 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 and you know we have a lot of intellectual property out there and we've done 500 cases, and I think helix was going to soon be approved so that's just one potential partner in the cell and gene therapy.
Speaker Change: And the and the heart on Carty Allo.
Speaker Change: We have a clinical data set now demonstrating safety in the heart, which is probably one of the more sensitive places to go and we're having manufacturing relatively well dialed in we caught some some really.
Speaker Change: Nice advances on how to manufacture these cells and a small footprint manufacturing did actually would enable us to do deals with other parties seeking to go after other clinical indications. So today, we're focused on cardiac and pulmonary but these seem same cells are being pursued or very similar cells are being pursued.
Speaker Change: <unk>.
Speaker Change: Commercially at a price point of $800000 per treatment by MISO blast and by Helios in.
Speaker Change:
Speaker Change: Acute respiratory distress, where you know we moved I N D in the United States. So there's many other indications for these cells out there and and we're open for partnering with clinical grade cells with clinical data behind it and then on the cardiac upfront.
Speaker Change: 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.
Speaker Change: As we get closer to the door of Hey, this is going to be a product, whose going to distribute it and by being reasonable and rational and the partnering I think we will see progress there. So.
Speaker Change: I can't give a specific timeline I just think that investors should appreciate all four of these platforms.
Speaker Change: Already for deals today, and they do lineup with really significant opportunities. So I guess that that's where it's at and you'll you'll hear me continue to say this until as we as we inked deals and partners take some of the value that we've been investing in and grow it further.
Speaker Change: Of course, no I appreciate that color, that's surely surely sounds like you're very busy with it. So good luck in bringing a deal forward. So if we focus a little bit obviously I think.
Speaker Change: Maybe I'm overstating this but the majority of people would be focused on the U S opportunity it's been I think.
Speaker Change: And on Sun opportunity and focus is Japan, and you've talked a lot about this so if Japan, if the Japan P. M. D. A allows you to submit the cardiac cell therapy system for the heart failure indication. After they review the clinical data I mean, this is safe to assume that this is similar to the FDA accepting a BLA.
Speaker Change: And you know what do you feel as the importance of that inflection point and how it might get to the market in Japan. Thanks.
Speaker Change: Thank you Joe Joe It's a great question.
Speaker Change: And I I'm aligned with you I do agree. It is it is the same thing as the FDA, saying they'll accept the BLA.
Speaker Change: In Japan, they are extremely rigorous they've gone through all of our data I think four times already.
Speaker Change: And there'll be additional data review as we go into our clinical consultations.
Speaker Change: But.
Speaker Change: We're looking at roughly I would say a six month timeframe on the outside to have clarity on.
Or 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 and what we've said.
Speaker Change: And then allowing us to submit for approval.
Speaker Change: <unk> 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 hold out.
Speaker Change: Introduce this into.
Speaker Change: Our commercial channel and so it will start slowly in Japan, but I do think that the value proposition for Biochar Dia is enormous.
Speaker Change: Note, we have two peers in Japan, I mentioned heart seed earlier, and I have a lot of respect for heart seed in there their basic strategy.
Speaker Change: Sure.
Speaker Change: They have treated 10 patients and they have a market capitalization of about $350 million.
Speaker Change: With open chest surgical delivery.
Speaker Change:
Speaker Change: There is another peer in Japan, KUOW Rip C U O. Our Ips they are delivering cells to the surface of the heart.
Speaker Change: Again through an open chest surgical procedure.
Speaker Change: Not a big fan of their strategy I must say.
Speaker Change: But their efforts.
Speaker Change: No.
Speaker Change: We're going after approval in Japan based on eight patients treated total and I note that it took many many years to get those eight patients much as it took heart seed many many years to get there 10 patients here.
Speaker Change: Here, we are with roughly 200 patients in the car T cell therapy trial, including two randomized placebo controlled trials minimally invasive delivery, an autologous cell therapy, and so them, saying that they will accept our our.
Speaker Change: Patients in Japan, I think will help us close the gap in valuation between where Biochar D 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 and the level of evidence and the safety profile and so on.
Speaker Change: So a long answer Joe, but I think it's a it's a great question and it's central to our strategy to get that P. M. B a submission in place now.
Joe: Fantastic I appreciate that color, especially with the level of data relative to the comps. So I appreciate all the color Peter.
Joe: Thank you Joe.
Speaker Change: And the next question comes from Chris Stevens.
Chris Stevens: Private investor.
Joe: Yes.
Joe: Hello, Hi, Peter how are you.
Joe: I'm doing well Chris.
Joe: Great.
Joe: My question pertains to the.
Joe: The cardiac the B C D E O one the confirmatory trial that's.
Joe: Ongoing that's starting up youre enrolling patients and can you kind of give some comments on how that would play into.
Joe: This other activity in which you're submitting to the FDA to see if there is a potential pathway to approval. So it's kind of like you have.
Joe: You're running a trial, but at the same time, you're also submitting to the FDA for approval.
Joe: At the same time.
Joe: Absolutely that's a that's a great question, Chris and I appreciate it and I know it may be a disconnect but.
Joe: When do you believe in your therapy, you're constantly going to be developing levels of evidence and we know that we had a great clinical trial that we just reported but it did not.
Joe: Mary.
And so that's that.
Speaker Change: You know introducing really figured out the express approval pathway ahead, and we have built this heart failure network in the United States in the cardiac the Hs.
Speaker Change: The investigators have the data before them, which excites them. So that will help us on a pole going ahead and remember the cardiac E F. One.
Our both reimbursed today by Medicare So the cost to us and doing a second trial are not nearly as significant as it would be if if we were not reimbursed by Medicare and so we're advancing that program. It will generate additional data it's focusing in on the peak.
Speaker Change: Who are the greatest responders and coffee M H F.
Speaker Change: There are a couple other subtleties that we're weaving into the trial.
Speaker Change: We are using our new Morpheus platform in this trial and I can tell you that the.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Sent me a very short taxes said I love morph DNA.
Speaker Change: So just so you can appreciate how the physicians are responding to that we also have a strategy woven into cardiac heart failure to where the FDA has blessed our usage of the pre procedure screening assay.
Speaker Change: Change the dosing in the patients. So that we can include more patients and cardiac heart failure to then we include and cardiac heart failure and so that's going to be a nice aspect of it and lastly, cardiac heart failure Q, we'll be using a very similar.
Speaker Change: Posit endpoint, which is the three tier finkelstein schoenfeld and that does but instead of using six minute walk in the third tier where we had some issues in cardiac H F. We're gonna be using a quality of life metric itself is a good question and the beauty of that change is thats not a assay.
Speaker Change: <unk> assessment, if you will that is effort based you know everybody will completed the same every time and in cardiac paycheck, we had patients fallout because you know they they hurt their need and so they couldnt do the six minute walk distance. So it also avoids patient fallout for certain measures, which enhances the power of the trial.
Speaker Change: So so those are the big changes in cardiac <unk>.
Speaker Change: H F. Due.
It's active at three centers today, and and there'll be news flow as its expanded out to other centers. It does not have an adaptive statistical analysis plan.
Speaker Change: And it's a 250 patient trial with one to one randomization.
Speaker Change: So.
Speaker Change: Well hopefully to completely enroll it in two years.
Speaker Change:
Speaker Change: Gotcha, Okay. That's great. That's good info just one follow up if I may and I know this is very new but.
Speaker Change: The tariffs.
The best price policy or destination price policy that just came out.
Speaker Change: Is there anything in cardiac that would follow anything within that treatment that would fall within.
Speaker Change: Any of this tariff.
Speaker Change: Concerns or even the best price policy that is being talked about just within the last day or two I know that I know, it's very new but.
Speaker Change: No no I'm I'm tracking its a most favored nation status that folks are.
Speaker Change: Eric.
Speaker Change: Basically most of it.
Speaker Change: And.
Speaker Change: And the answer to that is no today.
Speaker Change: So right now so on the most favored nation, we're not actively selling carty amp.
Speaker Change: Outside the United States.
Speaker Change: We hope to be soon.
Speaker Change: If we do we're actually hoping to bench market based on our current U S. Reimbursement. So we're trying to turn that equation around if you will we'd like.
Speaker Change: Other other 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 but for investors I can share that we only have a few components that we use in our manufacturing here at Biochar yet.
Speaker Change: That are manufactured overseas, we do some of our molding work.
Speaker Change: Outside the United States.
Speaker Change: Very low costs not expected to have any impact too.
Our business.
Speaker Change: Everything else, we manufacture here in the United States. So we manufacture the more product here at the facility outstanding in we manufactured helix in the facility I'm standing in and we manufactured cardiac so clinical sells in the facility I am standing in here in Sunnyvale, California.
Speaker Change: Carty Amp disposables are manufactured on a contract basis for us, but there are also manufactured in the continental United States and so I don't expect.
Speaker Change: Tariffs to have an impact on what we might ultimately sell in the United States, but tariffs go both ways and so other countries you know applying tariffs broadly too.
Medical products out of the United States.
Speaker Change: Impact our reimbursement O U S and the U S government, saying, they're only going to pay what others pay.
Speaker Change: It's who gets to pay the lowest is always a challenge and I think that you know we are also involved in that discussion about what the pricing will be and nicely we price based on value.
Speaker Change: And so in the cardiac cell therapy arena, there's been one reimburse cardiac cell therapy at 124000 U S per patient in in Japan now.
Speaker Change: Just shared we're trying to get the reimbursement that we have in the United States, which is closer to 20000, we can have very large margins of 20000, and frankly I don't think any of the other cardiac cell therapy in.
Speaker Change: In development or even gene therapies in development or even considering a value pricing that low but for Biochar D out based on how we're doing cardiac we actually think we can have greater than 90% margins at that price point.
Speaker Change: So.
Speaker Change: So we think we can price on value and we're not so concerned about those issues, but again were not as sophisticated as many of the folks on the street in Washington or on these issues and we just we thought them through at a high level and forgive the long winded answer I'm, just trying to be very transparent on.
Speaker Change: What our internal discussions have been.
Speaker Change: No that's great I appreciate the info alright. Thank you good luck.
Speaker Change: Thank you.
Speaker Change: And our next question comes from James Molloy with Alliance Global Partners. Please go ahead.
Laura Cereal: Hello, This is Laura cereal.
James Molloy: I'm sorry.
Laura Cereal: Hi.
Laura Cereal: Wind drop.
Laura Cereal: Okay No worries.
Laura Cereal: Yeah.
Laura Cereal: Why don't we wrap it here Dave.
Laura Cereal: Yeah.
Laura Cereal: Yeah.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Okay.