Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 Second Quarter Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of today’s 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 through November 9, 2023. At this time, I would like to turn the conference over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.

Thank you very much. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia’s leadership team are Peter Altman, Ph.D., President and CEO; 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, outlook, analogies 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 these statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia’s reports on Form 10-K filed, March 29, 2023, and the company subsequently filed quarterly reports on Form 10-Q The content of this time call contains time-sensitive information that is accurate only as of today, August 09, 2023. 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 Peter Altman, Ph.D, BioCardia’s President and CEO. Peter, please go ahead.

Thank you, Miranda, and good afternoon to everyone on the call. BioCardia’s current efforts are focused on advancing its autologous and its allogeneic cell therapy platforms to treat significant unmet cardiovascular and pulmonary diseases, specifically ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress syndrome. All of our cell-based therapies involve local delivery of the therapeutic to the heart or lungs, where we intend them to act locally. This mission has not changed and all of these programs are still viable. We had a solid second quarter of 2023, and our team delivered on the milestones promised. For our CardiAMP Autologous Cell Therapy and Heart Failure or BCDA-01, we implemented the adaptive statistical analysis plan with the complete FDA review. We completed our submission in Japan towards approval based on existing data, and we are finally seeing a significant increase in enrollment, including a number of patients from Canada. For our Cardiac autologous cell therapy for chronic myocardial ischemia, we continue to make progress on enrolling in the rolling cohort in ways that we can enhance the trial. And for our cardio allogeneic cell therapy in heart failure, first patients are about to be enrolled. BioCardia also closed on a modest financing of $2.6 million in which insiders participated, had a publication with our partner, CellProthera, on the importance of therapeutic delivery had three invited scientific presentations and advanced business development discussions. Q2 was a good quarter. This third quarter, we were thrown a curve ball when the Data Safety Monitoring Board for the CardiAMP heart failure trial or BCDA-01 recommended we pause enrollment in the study. We have detailed the recommendation in our July 24 press release, and I will read it for you here. "Based on an analysis of the trial data, the primary FS composite endpoint…

Thank you, Peter, and good afternoon, everyone. Revenues were approximately $43,000 for the three months ended June 2023, comparable to approximately $975 million for the first three months ended March 31, 2022, primarily due to the timing of collaboration agreement revenues. Expenses quarter-over-quarter were remarkably similar. Research and development expenses were approximately $2.3 million for the three months ended June 2023 and for the three months ended June 2022. And selling, general and administrative expenses remained at approximately $1.2 million in the second quarter of 2023 comparable to the same amount in the second quarter of 2022. Our net loss was approximately $3.4 million in Q2 2023, as compared to $2.5 million in Q2 2022, primarily due to the fluctuation in collaboration revenues. Net cash used in operations during the quarter was approximately $3.2 million, as compared to approximately $2.6 million in the second quarter of 2022. In BioCardia ended the quarter with approximately $4.3 million in cash and cash equivalents, which provides runway into November without additional capital or funding from the business development and other activities that Peter mentioned earlier. This concludes management's prepared comments, and we're happy to now take questions

Thank you. At this time, we will open up the call to questions. [Operator Instructions] Today's first question comes from Joe Pantginis with H.C. Wainwright. Please proceed.

Hi, everybody. Good afternoon and thanks for taking the question. So, Peter, I want to focus on the DSMB review, because obviously, like you said, I mean, this somewhat of a really unique situation. And I guess I want to reconcile something even though you don't have the answers yet and then look forward a little bit. So if the DSMB comes out and says that unblinded data are not likely to meet the primary endpoint, usually, you would be in trial wind down activities right now and the study would be essentially done. But it's not, and that's the very unique aspect. So I guess, from that standpoint, how do you reconcile that comment with the study still ongoing and the -- that you've seen blinded improvements in patients? And then the second aspect of that question is, which I think is important for listeners is then for patients that will be followed in a blinded fashion to the one-year benchmark. You know what are the benchmarks that we and investors should be looking for with regard to deltas and treatment effects?

Well, thank you, Joe for the question on the DSM review and some of the nuances. I guess on the first part, I don't have great clarity and so I can only hypothesize. As I noted in our prepared comments, we are also a little confused, but we assembled the DSMB and it's a very solid group. And so as we try to read the proverbial tea leaves, there could be -- I'll just rehash it so folks who are not entirely aware, we have a very low mortality rate in the trial relative to what we've seen in the latest clinical trial setting for the latest guideline directed therapy in the New Journal of Medicine. And we appear to have a very low major adverse cardiac event rate. And those are two components of the primary Finkelstein-Schoenfeld three-tiered end point. The third element is six-minute walk. And so I can hypothesize that maybe there's something wrong with the six-minute walk distance measure in as this primary endpoint. We have -- because the levels are so low with respect to mortality and MACE events, the six-minute walk likely has a larger impact in this trial than we may have expected. And the nuance of how it's incorporated in the Finkelstein-Schoenfeld endpoint may have implications as well. And so that data, as I mentioned, is being analyzed. It actually already has been analyzed by a separate group and we're confirming that the data that was provided to DSMB is the conclusions that they're drawing are from a substantially correct data analysis. The other thing that we're doing is we have a clinical adviser, external to the company that we are going to have a look at all of the materials and assess whether or not a follow-on conversation as appropriate with DSMB to clarify potentially altering the recommendation. I think right now, our sense is that the restart in 14 months, as I've detailed, does not make a lot of sense today to management. And so -- but we've been advised to stay blinded ourselves to the data to maximize potential going forward. Our expectation is that will evolve after these next steps. And so that's just where we are. Now your second question, I think, was on trial wind down and

No, more of benchmarking – sorry. Forgive me that margin one year, yeah.

Yes. So as far as trial wind down, the information we receive from this will impact the data that we have. So we are still randomizing patients today. And because all of the data supports that this is safe and all the past data that we see supports this is efficacious, we're still bullish on the direction that we're going. And so those patients will be randomized, expectation is all the outstanding patients will be randomized in the next six weeks to eight weeks. And then we'll follow them for a period of a year before we get to the true data readout from this trial. The interim readout that we may have, if data is viewed, we'll have the challenges that many of the endpoints have not yet been monitored, and so they will be looking at that. What I would expect to look for here is I follow the primary endpoint. I mean, the mortality data is going to be important. I mean, if we're losing on that for some reason that I can't explain, that would be a surprise. The MACE data will be this next thing to look at. And if we're losing on that, that will also be interesting to look at. But I think the primary feature since those two are so low already in this treated population; I don't expect either of those to have any interesting signals. Again, I'm not privy to the data. So I'm providing you my best guess work here all. And my expectation is that if there's something, it's the six-minute walk is problematic. When we look at the other pre-specified endpoints, quality of life, all of the extensive echo data we have from our core laboratory at Yale, there may be some interesting observations in there that…

Peter, thanks a lot. I appreciate the color and the speculation for this pretty unique situation and looking forward to the outcomes. Thanks a lot.

Yeah, appreciate the question, Joe.

At this time, we are showing no further questioners in the queue, and this does conclude our question-and-answer session. I would now like to turn the conference back over to Peter Altman for any closing remarks.

I want to thank all of you for participating in today's call and for your interest in BioCardia and our primary mission to treat heart disease. We look forward to sharing our continued progress, and as I always say, stay healthy, be kind and have a wonderful day. Thank you.

The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.