Q4 2023 BioCardia Inc Earnings Call

Participants

Miranda Peto Benvenuti; IR; BioCardia Inc

Peter Altman; President, CEO, & Director; BioCardia Inc

David McClung; Chief Financial Officer, Member of the Management Team; BioCardia Inc

Brent Pearson

George Hill

Presentation

Operator

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia 2023 Year End Financial Results and Business Update Conference Call. (Operator Instructions) Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after 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

Thank you, Rocco. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia leadership team are Peter Altman, PhD, 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 and projections, outlook, analyses and current expectations. Such factors include among others, the inherent uncertainties associated with developing new product 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 this morning, and the contents of this call contains time-sensitive information that is accurate only as of today, March 27th, 2024. Except as required by law, the Company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that events occur after this call.
It is now my pleasure to turn the call over to Peter Altman, Phd, BioCardia's, President and CEO. Peter, please go ahead.

Peter Altman

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia's current efforts are focused on advancing its autologous and allogeneic cell therapy platforms to treat significant unmet cardiovascular diseases, specifically a scheme of heart failure and chronic myocardial ischemia. All of our cell-based therapies involve local delivery of the therapeutic to the heart where we intend them to act locally. Our lead cardiac autologous cell therapy is targeted to treat the scheme of heart failure have reduced ejection fraction today. Heart failure of reduced ejection fraction remains a significant unmet clinical need as none of the recently approved therapies reduced mortality, which remains at approximately 10% per year. And put this into context, it has been reported that heart failure is as malignant as some common cancers.
Men with heart failure have a worse five year survival than do men with either prostate or bladder cancer. Women with heart failure have been shown to have a worse 5-year survival than women with breast cancer. Heart failure also impacts more than 5 million patients in the United States and is growing in our lead cardiac cell therapy. The patient has cells taken from their bone marrow process at point of care in our disposable cell processing kit and delivered through our minimally invasive steerable catheter system to 10 targeted regions around damage in the heart. We now have three clinical trials in the treatment for heart failure with the cardiac cell therapy that lends support for both safety and therapeutic efficacy for patients having a scheme of heart failure, I've reduced ejection fraction. Our recent experience in missing the primary prespecified endpoint in our cardiac heart failure clinical trial, while not our chosen path is not a unique experience for those developing therapies for this disease are world-class executive steering committee and a distinguished cardiologist on our Data Safety Monitoring Board see that the results just presented from the cardiac heart failure trial are compelling as evidenced by our investigators and our data safety monitoring board continuing to support and be involved in the program.
The interim data presentation from the cardiac heart failure trial presented scientifically earlier this month shows 37% relative risk reduction in our debt equivalents, 9.2% relative risk reduction in non-fatal, major adverse cardiac and cerebral vascular events, reduced cardiac arrhythmias, enhanced heart function and treated patients relative to the control patients. In addition, the available interim data showed it for an important subset of patients who presented at the screening baseline visit with higher levels of NT Pro-BNP, a well established biomarker of active heart failure and stress to the heart, the reduction in heart death equivalents were even greater. Of note, all current leading heart failure trials where we have looked require elevated NT Pro-BNP for patients to be eligible to participate in these trials in these patients, an analysis of all available data up to two years in the cardiac heart failure trial with a mean of 20 months follow-up shows improvements over controls, including an 86% relative risk reduction in mortality and a 24% relative risk reduction of nonfatal major adverse cardiac and cerebral vascular events. Further, all clinical outcomes included in this subset analysis favored cell therapy, including improved quality of life as measured using the Minnesota Living with Heart Failure Questionnaire, reduction of NT Pro-BNP levels, greater six-minute walk, test distance and improved echocardiography parameters of left ventricular ejection fraction left ventricular end systolic volume and left ventricular end diastolic volume. Both reduced heart death equivalents and improve quality of life outcomes demonstrate statistical significance favoring therapy in this subset analysis. This is the subgroup we have designed a cardiac heart failure to confirmatory trial around, which was approved by FDA in December, activated in February and approved for reimbursement by Medicare in March. We continue to monitor patients enrolled in the cardiac heart failure clinical study in which both patients and evaluating physicians are blinded to the treatment group, and we expect to complete follow-up in this study in October 2024 as we already have more than 90% of the patient follow-up data that we will ultimately have in the final analysis, we don't expect the results to change significantly this final data on the patients already treated is expected to be provided to Japan's Pharmaceutical and Medical Device Agency toward approval for the indication of ischemic heart failure.
Our formal consultation in November 2023 has suggested that if the data remains as good as it currently appears to be at the final analysis, they are inclined to support approval based on this data without requiring a trial in Japan. Subsequent interactions and consultations with Japan, pharmaceutical and medical device AGENCY are expected confirmatory cardiac heart failure, two study approved by FDA in December 2023 is a Phase three multicenter randomized, double-blind controlled study of up to 250 patients with NT Pro-BNP levels greater than 500 picograms per milliliter at up to 40 centers in the United States. Primary endpoint is an outcomes composite score based on a three-tiered Finkelstein shown, so hierarchical analysis, the tiers starting with the most serious events would be Tier all1 cause death, including cardiac death equivalents such as heart transplant or a left ventricular assist device placements ordered by time to have Tier two nonfatal major adverse coronary and cerebral vascular events and tier three change from baseline and quality of life at a minimum of 12 months and a maximum of 24.
The trial is designed has a greater than 90% powered for statistical probability of success to meet the primary endpoint based on the cardiac heart failure trial interim results, we are actively working with our heart failure network and leaders in cardiology to enroll and complete this study as soon as possible. We expect additional news throughout the year on this study, our cardiac cell therapy trial for chronic myocardial ischemia or BCDO. two. It's a Phase three multicenter randomized double-blinded control study intended to clear up to 343 patients at up to 40 clinical sites. The Company expects to complete enrollment in the rolling cohorts soon and begin the randomized phase of the trial, a number of leading investigators, including both principal investigators in this trial believe this to be the most compelling indication for the Cardiome autologous cell therapy planning for the randomization phase continues based on promising experienced in the patients treated to date part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms of this investigational therapeutic study to offset the clinical costs company's CAR-T allo or allogeneic cell therapy for a scheme of heart failure or BCDAO. three is a Phase one two clinical program, encompassing 69 patients. We have reported first patient enrolled in the fourth quarter of 2024 at the technology and heart failure Therapeutics Meeting earlier this month, it was also reported that there have been no adverse events and follow-up CAR-T allo heart failure study is intended to build on three previous trials of messing time of stem cells in ischemic heart failure using the company's proprietary Helix delivery system encompassing 93 patients treated with no treatment emergent serious adverse events and compelling early signals for benefit.
This is a precision medicine study as we are focusing this therapy for the first time on patients who have elevated NT Pro-BNP and elevated high sensitivity C-reactive protein, a marker of inflammation that has been reported for patients with heart failure, most responsive to immunomodulatory message kinds of stem cells. Our strategy to advance our cardiology HF program is to seek partnerships and grant funding as it will not have the benefit of Medicare reimbursement in the United States. We intend to Phase two portion of the study to be performed in both the United States and in Japan. It has potential to receive conditional approval based on this one trial in 2023, we evolved our Helix biotherapeutic delivery Partnering business to focus on long-term partnerships where BioCardia shareholders participate meaningfully in the value created our Helix trends. endocardial biotherapeutic delivery system is a therapeutic enabling platform for minimally invasive targeted delivery of biologic agents to the heart. This platform enables all of our therapeutic development efforts and it empowers a seamless transition from bench to commercialization for partners. Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of patients suffering from heart disease, offset the cost of biotherapeutic delivery for our own therapeutic programs and provide our shareholders with meaningful revenue sharing should our partnering efforts contribute to successful therapeutic development.
In September 2023, our biotherapeutic delivery partner cell Procera announced completion of enrollment in their Phase one two cell therapy study and post myocardial infarction and results are expected soon. In March 2024, we announced a biotherapeutic delivery partnerships with stem Cardia for a long term partnerships to advance them CAR-T as investigational pluripotent stem cell product candidates for the treatment of heart failure initially through a Phase one two clinical study. Two additional premier biotherapeutic delivery partnerships are expected in 2024. Our Morse access Innovations business is based on the steerable catheter systems through which we perform all of our Helix procedures for bio therapeutic intervention. We are working to obtain FDA approval in Q three, 2024 for a product family of more D & A steerable sheath introducers and a variety of sizes and lengths with clinical indications for use in the heart and peripheral vasculature. Biocartis is actively exploring pathways for commercializing these products in the second half of the year.
In summary, we have increased confidence in the potential of our autologous CAR-T cell therapy programs in both the scheme of heart failure and in chronic myocardial ischemia. Based on the data we have before, we are focused strategically on advancing these two clinical programs in a cash neutral fashion. With the benefit of the Medicare reimbursement, we already have in place. Similarly, we are working on securing grants and partnerships around our allogeneic programs to support their continued clinical development and implementing a recurring revenue biotherapeutic delivery partnering model that includes revenue sharings with our experienced world-class team and our Helix biotherapeutic delivery system in the coming weeks, we anticipate enrollment of patients in our cardiac heart failure to confirmatory study, and we will be working on a number of business development activities, which have potential to be impactful in our payment plans for staying listed on NASDAQ.
I will now pass the call to David McClung, our CFO, who will review our Q4 2023 financial results.

David McClung

Thank you, Peter, and good afternoon, everyone. Revenues were $0.5 million in 2023 compared to $1.4 million in 2022, primarily due to the timing of revenue earned from new and existing collaborative partners, coupled with the fulfillment of performance obligations in 2022.
Expenses year over year decreased by 9%. Research and development expenses decreased to $7.7 million in 2023 compared to $8.8 million in 2022, primarily due to the completion of enrollment in the cardiac heart failure trial, coupled with reduced expenses and clinical and related supporting functions.
Selling, general, and administrative expenses were unchanged at $4.4 million in both 2023 and 2022. Our net loss in 2023 was $11.6 million compared to $11.9 million in 2022.
We used $10 million in cash for operations in 2023 compared to $10.6 million in 2022, and BioCardia ended the year with $1.1 million in cash and cash equivalents, which together with financing proceeds in the first quarter of 2024, provide runway into the second quarter of 2024.
As disclosed in our recent SEC filings, the company has received a determination letter from Nasdaq advising us that the Company is not in compliance with listing standards and is subject to delisting. BioCardia intends to remain listed in Nasdaw Capital Markets.
Accordingly, BioCardia's appealing the decision has requested a hearing where the company will submit its plan to regain compliance. Fuel has stayed in a de-listing or suspension of the Company's securities pending the hearing.
This concludes management's prepared comments, and we're happy to take them questions from attendees.

Question and Answer Session

Operator

(Operator Instructions) Joe Smith, Alpha Street. It appears we lost Mr. Smith's connection.
Brent Pearson, a private investor.

Brent Pearson

Good afternoon, gentlemen. And I saw that in Q4 you filed a $50 million prospectus. Is that planned to get funding through your BCD. oh one and oh two trials for the next few years as part of that to be put into a ramp up if devices get approved or if you get approval in Japan and you need to ramp up production. Could you give us any commentary that would help us understand the intention for that $50 million?

Peter Altman

[Go on, David.]

David McClung

This is -- we have our -- an estuary we had on file that expired in October. This is simply just refreshing our estuary again. So we have another another one on file to typical resource, and we want to have available to us. We use for ATMs and other other things as we need.

Brent Pearson

Understood. Okay. Well, I appreciate the color there. So it's just it's more along the lines of pumping along an existing perspective that you want to keep open.
And in terms of your capital needs throughout the rest of the year, I assume you're going to look at it, the market financings as as things are become apparent. And I assume that you don't expect to have a much different capital usage than you had through 2023. Is that something that we can count on?

Peter Altman

Joe, these are great questions. And as where we are right now, this is actually this is sort of the eye of the storm on our ongoing business development activities, as we've shared on interWAVE with this. And so we are we are proceeding with really all options on the table on and things will evolve in the coming months as we have our discussions with NASDAQ. And so I think that's probably the best way to describe it.
As far as your second follow-up question our cash needs, I would actually say that our cash needs today are modest. We have publicly disclosed that our burn rate has been significantly reduced as we turn down the spend on the clinical trial that we're now doing follow up on and the spend could go back up as we get accelerate in the cardiac heart failure two to be closer to what it was last year. And the variety of partnerships that are coming together could actually will result in non-dilutive reduction in our burn rate. So these are the forces that are playing here right now. And I don't expect a significant increase in the burn rate from even if we had no revenues on primarily because of the Medicare reimbursement and the stage of the three programs. We're advancing the first to have the reimbursement. And then the third program is still in the phase one dose escalation phase, which is on more limited so we are seeking significantly nondilutive financing for them.
And Brent, forgive me. I have heard you as Joe earlier. My apologies.

Brent Pearson

No worries. I appreciate the color there. I guess my last question was we had seen that there were some partner developments mentioned in Q2 and Q3. Does the horizon look about the same or is there any color that you can provide on that front?

Peter Altman

Yes. So I did share that we expect to have and two additional biotherapeutic on partnerships this year. And I even believe we have one targeted to be completed this next quarter on The Hub. But I'd have you think about it in this fashion when we do work with a partner, oftentimes we create a very significant dataset that takes a period of a year or two to develop. And then they think about how to take that forward into the clinic or they are in a clinic already. They think about how to take that to the next stage of development. And so each time we partner, we receive revenues, but the amount of resources being spent on the program is far more significant by by our partners. One of the things that we're choosing to do is we're focused completely on long-term partnerships. We do not sell delivery systems we partner. And that means that if there's value created from the collaboration and then we meaning the Biocartis shareholders will ultimately benefit from that, even if BioCardia does not actually wind up commercializing alongside our partners in the future, which if we do the value for our shareholders would be quite significant. And that's really our goal at the end of the day, but we don't if we're going to do the work with a partner, enable them access to our technology and know-how and experience team. And we not only need to get paid for the work we do along the way and the products we provide, but the value creation on the therapeutic side, we also need to participate in. And and so that's a new structure that we're having going forward and it makes sense. It doesn't cause it's a little different, but it doesn't cause anyone any undue concern.

Brent Pearson

Understood. Thank you so much.

Peter Altman

I appreciate the questions, Brent. Thank you.

Operator

George Hill, no company given.

George Hill

Yes. Thanks for taking my questions on TTR. Just had actually you just answered most of those forces that use provided most of the inflammation that were regarding partnerships. But I guess it looks like you picked up an additional partner this year per the press release this afternoon, there were two at the end of last year and it looks like you have two and then in the press release them party came out, but then you have two additional partners kits that are lined up for this year. Is that accurate?

Peter Altman

And right now we have so of broad-brush. Look, we have our three programs that we're advancing. And we have two partners under this structure that we've been public about. There's other folks we do work with that. We're not public about and the other two players are cell process, try and stem CAR-Ts. But we have said in the press release in the targeted milestones that we expect to enter into two additional biotherapeutic delivery partnerships in the year ahead. And I think we've also said that the first one of those we expect to close in Q2 two of this year, no. So that's the idea is to create this long-term value and everything that we do is trying to we have these platforms. And the challenge is always how do you create all the value that's inherent in the platform and how do you.
So for cardiac, it goes in a number of indications or advancing two of those for our allogeneic platform. It goes in many directions and we're focused in on the one where we have the most experience and data, but we've had discussions around taking that into a number of indications already on.
And the third on the platform we have is our Helix biotherapeutic delivery platform. And this is this biotherapeutic Partnering business. And what's nice is it the data I shared with our lead program, utilizes our Helix platform. And so that safety data is really compelling for folks developing their own. It was gene or protein-based therapy for the heart. And these clinical indications we're going after are so enormous that is in our investors' interest and it's in our ethical interests as a group trying to help these patients to enable these partners.
I like to say that at the end of the day, if there's two therapeutics competing for the same patient, I think that the market penetration will accelerate because the clinical consideration will be not should I treat or should I not treat, but which should I treat with when and how often will become the new mindset. So that's sort of the nature and the partnering. And then the last piece. This is we're talking partnering and getting value from platforms. Our Helix system uses are state of the art, more G & A steerable introducer platform for all of its procedures.
So every Helix procedure and every cell therapy procedure we're advancing uses are more FDA-cleared product. And so we are going to be securing this year a product family based on that design for some broad indications in cardiac and peripheral vascular disease. And although it doesn't have the same value proposition as our biotherapeutic development efforts, it's a way we can take our existing product because it's already FDA cleared and expanded that platform design into other indications. We're going to have value. And I share with you on with a previous version of this. We've done more than 10,000 procedures with our more platform, and we had a great relationship with the customer that just didn't make sense and financially. But today, we've done some things that this has potential to have some really nice legs on it. So it shows you that even though our cash is extremely tight and we are getting enormously valuable things done for shareholders.

George Hill

Thank you. I appreciate that information. It clears up a lot on. I just had one other question regarding BCVA. One, with the interim data that was presented at the Heart conference this month, there was a reduction in India with me for the treated group. And I was curious, is there any thought of why why that reduction where those results came from. I know that was something like the University of Washington had worked on years ago on trying to reduce that, reduce that with the stem cells on any thoughts there or that you can provide?

Peter Altman

I do. So George and I have a great question on the arrhythmia signals actually on a pretty strong signal in our data spend. It's remarkable. We presented safety data, but one of the in this field where people are putting things cells, genes and proteins into the heart, one of the greatest concern from a safety issue is the arrhythmia. And if you trigger a cardiac arrhythmia, it actually can be life threatening. That's basically what a heart attack is. It's a cardiac arrhythmia caused by the obstruction in a blood vessel that once you start start talk start stimulating, you have basically two minutes to live because you're not pumping blood anymore. So that arrhythmia data is compelling data on our investigators have been quite excited about it. Reduction in cardiac arrhythmias will be a pre-specified secondary endpoint, the cardiac heart failure trial, because that's an efficacy claim in its own right. And you mentioned the group in Seattle on interesting enough that that's the same group. I expect that's behind STEM cardio on the the idea with some of those other cell types. The great concern has been for Rhythmia is because when you and ourselves don't become heart cells.
But when you put a cell into the heart and it becomes a heart cell, all heart cells have what they call automaticity. And that means that can create what's called an ectopic foci and trigger an arrhythmia. And so the fact that we can go into the heart with ourselves in cardiac or BCDO. one and delivered 10 different locations on I think we've shared some, let's just say, hundreds of millions of cells and we don't have any issues with the redness, but rather we're seeing a great reduction in arrhythmias suggests that perhaps I'm just I'm going to hypothesize here because you asked perhaps what's happening is the the enhanced and microvascular impacts of what we're delivering, increases the healthiness of the cells locally so that we're reducing the number of ectopic Flowcast in our own patients without trying to make heart cells. I also note that that result that reduced arrhythmia burden that we see in the patients could also be supporting why we have reduced mortality and reduced major adverse cardiac events in these studies.
Now all of these things are linked together, but I'm sort of going out on a limb here. And one of the difficulties in medicine is often proving why something is happening one way. I guess the end result of that signal is it's a nice signal. It has excited our investigators and we think it's quite valuable for these patients.

George Hill

That's great. That's all for me. Thank you. Best of luck.

Peter Altman

I appreciate it, George.

Operator

(Operator Instructions) Joe Smith, Alpha Street.

Hi, good afternoon, everyone. Can you hear me?

Peter Altman

Yes, we can, Joe.

Hi. This is Landon on for Joe Pantginis from H.C. Wainwright. Thanks for taking our questions. So I wanted to ask if you can provide some color on the estimated time lines from data readouts, especially from CAR TMHF. two trial, which has minimum follow-up period of 12 months. Is there any chance that we may have an interim data readout or preliminary data?
We'd had before those time points during 2024. And so there's always possibility right now, we're focused on enrolling in that trial. And my sense is it is the great question when will everything be done?

Peter Altman

I would say in 2024, we're going to have the primary readout on BCO. one trial we've just completed and we're aiming to take that to Japan. I think that's the biggest near term news, and we'll Gymbucks post how we're doing in enrollment in the cardiac heart failure to confirmatory study, as I'm sure you can appreciate we have one of the centers around the United States that have great experience. They can see that they help their patients in the last trial.
That's very helpful to us in enrollment. We also expect that we've done some things in the trial design to eliminate interim visits that we don't see as necessary now that we have such a great safety dataset. And so the trial will be easier to perform. And we also have the advantages that COVID is not on the present these days. So we also think that's going to significantly enhance our enrollment activities. I can share an anecdote that at some of the centers, one of the biggest lead times and contracting a center on a clinical trial is actually the contract and our contract for this study at the centers we've just been active has potential to be as short as a half a page, and that's a much easier contract to get done. And so we'll be advancing cardiac heart failure to arm, and we'll be sharing as we enroll patients and we add sites on whether or not we introduce an interim analysis on is TBD I have for now and have you assume that we will not come because I think we've got some pretty good clarity on the direction to go with respect to this, and we've got a lot going on and implementing that adaptive design review last year was a huge effort and it was a huge accomplishment on the by our team, even though it did not, it will result in no great victory. And but it did provide us with the value proposition that we have today that we have a very large datasets that we're using and we're on target. And we have hypotheses as to why some of the study design issues did not go our way, but I think that, you know, we can't we're not trying to prove why things went wrong. We're trying to prove why this therapy is right, and that's where we're going to.

Perfect. That's helpful. Thanks for the update. I appreciate the question, but that's all on the warm regards go.

Operator

Thank you. Our next question is a follow-up from George Hill. Please go ahead.

George Hill

Peter, I'm sorry, I've got a few already mentioned this, and maybe I just didn't hear it is BioCardia is still on track to have a consultation with Japan the second or third quarter of this year?

Peter Altman

We have said that we will have some additional consultations with Japan PMDA. I haven't I'm not currently tracking exactly when it's going to happen on my focus today has been around the completion of the data on. But as we get closer to home mid Q2, we will be assessing when we're going to be meeting with them in a process where you need to submit the requisite information and then they will schedule it a few weeks out. So we don't exactly have perfect control on when that occurs, but they've been very sophisticated in all our interactions with PMDA, and we've been very impressed by them.

George Hill

Okay, great. Thanks, sorry about that.

Peter Altman

No worries, George.

Operator

Thank you. And that concludes our question-and-answer session. I'd like to turn the conference back over to Dr. Peter Altman for closing remarks.

Peter Altman

Thank you, Rocco. Our therapeutic candidates and technologies have significant potential to help millions of patients with heart disease. We now have five RTS biotherapeutic programs in development, including our biotherapeutic delivery parts. Each of these programs has the potential to provide meaningful returns for our investors. I thank all of you for participating in today's call for your interest in bio Cardia and support you provide for our primary mission to treat heart disease. Have a great afternoon, and thank you, sir.

Operator

This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.