Ladies and gentlemen, thank you for standing by and welcome to the BioCardia 2023 Third 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 this call are advised that the audio of this conference call is being broadcasted live over the Internet and is also being recorded for playback purposes. A webcast replay of this 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..

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 Chief Executive Officer; and David McClung, our 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 those statements.

For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia’s reports on Form 10-K filed on March 29, 2023, and in the company’s subsequently filed quarterly reports on Form 10-Q.

The content of this call contains time-sensitive information that is accurate only as of today, November 08, 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.

This third quarter we were thrown a curveball when the Data Safety Monitoring Board for the CardiAMP heart failure trial or BCDA-01 recommended that we pause enrollment in the study. We have followed the Data Safety Monitoring Board recommendation and the last patients were randomized from the study in October.

We continue to monitor patients enrolled in this clinical study in which both patients and evaluating physicians are blinded to the treatment group and expect to complete follow up in this study in October 2024. We have since come to understand that the trial design and endpoint we were advancing were unlikely to be successful.

Even as we have become aware that there were strong trends toward benefits across all patients with a 37% relative risk reduction on heart death equivalent and an 18% relative risk reduction in major adverse cardiac and cerebral vascular events or MACE, which are at the top of the list.

In addition, the available interim data showed that for an important subset of patients who presented at the screening baseline visit with higher levels of NT-proBNP, a well-established biomarker of increased heart failure and stress to the heart. The reduction in heart-death equivalent in MACE were even greater.

Of note, all current leading heart failure trials where we have looked require elevated NT-proBNP 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 CardiAMP heart failure trial shows improvements over controls, including a 59% relative risk reduction in mortality and a 54% relative risk reduction of MACE.

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-proBNP levels, greater 6-minute walk distance and improved echocardiography parameters of left ventricular ejection fraction, left ventricular end systolic volume, and left ventricular and diastolic volume.

Both the reduced heart death equivalents and improved quality of life outcomes demonstrated statistically significant favoring therapy in this subset analysis.

Because of this data, we have initiated a dialogue with the FDA and submitted a proposed cardiac heart failure true protocol for FDA review which targets the patients with higher levels of NT-proBNP and utilizes a different clinical endpoint based on the interim data available.

Recent statistical calculations for this clinical study design supported a modestly sized clinical trial of 150 patients based on the interim results would achieve 90% power, which is another frame for probability of success if the data is representative of the population.

Additional proposed modifications from the CardiAMP Cell Therapy heart failure trial design include elements to simplify clinical site execution logistics and reduce the cost of performing the study.

Should the study protocol be approved by the FDA and advanced by BioCardia, it may be possible to significantly offset clinical costs with the Medicare reimbursement of up to $20,000 now in place for both the control and treatment arms of this investigational therapeutic study.

We have been actively answering requests for information on CardiAMP Cell Therapy system also by Japan’s Pharmaceutical and Medical Device Agency or PMDA, towards an approval for the indication of ischemic heart failure based on existing safety and efficacy data. Our formal consultation is scheduled for November 21, 2023.

Subsequent interactions and consultations with PMDA are expected. The CardiAMP Cell Therapy system has potential to be the first minimally invasive catheter based cell therapy available in Japan.

The CardiAMP Cell Therapy trial for chronic myocardial ischemia or BCO2 is also a Phase 3 multicenter randomized double blinded controlled study and it’s intended to include up to 343 patients at up to 40 clinical sites.

The company expects to complete enrollment in the rolling cohort of five patients in the fourth quarter of 2023 and begin the randomized phase of the trial. A number of leading investigators, including both principal investigators in this trial believe that this to be the most compelling indication for this therapy.

Planning for the randomization phase is already underway based on promising experience 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.

The company’s CardiALLO allogeneic cell therapy for ischemic heart failure or BCD03 is a Phase I/II clinical trial encompassing 69 patients. A number of patients have already been consented and we anticipate enrolling first patients in the fourth quarter.

This study is intended to build on three previous trials of mesenchymal stem cells in ischemic heart failure using the company’s proprietary Helix Delivery System, encompassing 93 patients treated with no treatment emergency, serious adverse events, and compelling early signals for benefit.

Our strategy here is to seek partnerships and grant funding to advance this program. BioCardia is focusing its world class biotherapeutics delivery team towards partnering its capabilities utilizing our Helix Biotherapeutic delivery system for intramyocardial delivery through long-term partnerships.

It’s an advanced therapeutic opportunities and help offset our base operational costs. Biotherapeutic delivery business development is active and we are working to close multiple meaningful deals by the end of the year.

In summary, we have increased confidence in the potential of our autologous CardiAMP Cell Therapy program in both ischemic heart failure and in chronic myocardial ischemia, based on the data we have before us.

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 clinical development and implementing a recurring revenue biotherapeutic delivery partnering model with our experienced world class team and our Helix Biotherapeutic delivery system.

In the coming weeks, we anticipate feedback from both FDA and PMDA on our autologous cardiac cell therapy program and anticipate enrollment of patients in our allogeneic CardiALLO cell therapy program. We also expect positive news from business development activities.

I will now pass the call to David McClung, our CFO, who will review our Q3 2023 financial results. David? Thank you, Peter and good afternoon everyone. Revenues were approximately $357,000 for the three months ended September 2023 as compared to approximately $212,000 for the three months ended September 31, 2022.

Expenses quarter-over-quarter decreased by approximately 10%. Research and development expenses were approximately $1.9 million for the three months ended September 2023, compared to approximately $2.1 million for the three months ended September 2022, reflecting cost reductions implemented after pausing the CardiAMP heart failure trial in July.

Selling, general and administrative expenses were approximately $1.1 million in the third quarter of 2023 and in the second quarter of 2022.

Our net loss was approximately $2.6 million in Q3 2023 as compared to $3.1 million in Q3 2022 due primarily to increases in revenue coupled with reductions in research and development expenses during the quarter.

Net cash used in operations during the quarter was approximately $2.4 million as compared to approximately $2 million in the third quarter of 2022.

BioCardia ended the quarter with approximately $1.8 million in cash and cash equivalents providing runway into January without additional capital or non-dilutive funding from the business development and other activities. This concludes management’s prepared comments. We are happy to take questions from attendees..

Thank you. [Operator Instructions] Your first question comes from Joe Smith [ph] with Alpha Street [ph]. Please go ahead. Hi Joe, your line is live and so call for your question..

Hello, can you hear me?.

Yes, hello Joe..

Oh this is [indiscernible] for Joe Pantginis from H.C. Wainwright..

Yes..

Thanks for taking our questions. So first of all, so for the original CardiAMP trial, what’s the plan regarding the patients that are still in the follow up period? These will be analyzed and reported.

What’s the expectation when the totality of the data have been collected?.

The plan is to follow all patients out to at least the one year endpoint Joe and then we will report out the full results for the trial. The expectation is that last patient will reach their endpoint in October of 2024, so late 2024 we should have some interesting data to review..

Okay, perfect. Thank you, got it.

And for the new CardiAMP patent trial, what’s the number of high level m? What’s the number of high level proBNP patients that were identified to benefit from the treatment?.

So for the CardiAMP heart failure two trial, that’s actually a design that’s been proposed to the Agency. We don’t yet have feedback there yet Joe. But what we are -- as we looked at our current interim data, more than half the patients actually were high NT-proBNP in our study.

And so we’ve looked at that interim data that’s available to us and analyzed it a number of different ways and it’s actually pretty robust that the patients with high NT-proBNP are just phenomenal responders.

As we’ve looked at this, the study design we have, we’ve looked at our previous study designs and we did not include NT-proBNP as a prerequisite in either our Phase 1 or Phase 2 work. However, in today’s climate, almost all trials out there that we’re aware of are requiring NT-proBNP levels to be elevated.

So we are not entirely sure if perhaps by not including it we wound up having patients filtered out of our trial and sent to other trials that did require high NT-proBNP.

But our sense is including it going forward is likely to have a pretty significant impact on the results, particularly if the data that we have is in line with the data that we will generate ahead..

Awesome, got it. Thanks for clarifying..

I appreciate the questions Joe..

[Operator Instructions] There are no further questions at this time and I’ll hand it back to Peter for closing remarks..

Thank you, kindly, Rachel. I want to thank everyone 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. Thank you. Stay healthy, be kind and have a wonderful day..

The conference call has now concluded. Thank you for attending today’s presentation. You may now disconnect..