BioCardia Q3 2023 Earnings Call Transcript

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November 8, 2023

Key Takeaways

  • BioCardia paused enrollment in its CardiAMP Heart Failure trial after the DSMB review and identified that patients with elevated NT-proBNP experienced up to a 59% relative risk reduction in mortality and a 54% reduction in MACE.
  • The company submitted a revised CardiAMP Heart Failure II protocol to the FDA targeting high NT-proBNP patients in a 150-patient study, leveraging up to $20,000 in Medicare reimbursement per arm to reduce trial costs.
  • A formal consultation with Japan’s PMDA for CardiAMP cell therapy in ischemic heart failure is set for November 21, 2023, with the potential to become the first minimally invasive catheter-based cell therapy approved in Japan.
  • The Phase 3 trial for chronic myocardial ischemia (BCD02) will complete its five-patient rolling cohort in Q4 2023 and transition to the randomized phase across up to 343 patients at 40 sites.
  • With $1.8 million in cash at quarter end and a Q3 net loss of $2.6 million, BioCardia’s cash runway extends only into January 2024 absent additional capital or non-dilutive funding.
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Earnings Conference Call
BioCardia Q3 2023
00:00 / 00:00

There are 5 speakers on the call.

Operator

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. To ask questions. 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 1 hour after the end of the call.

Operator

I would now like to turn the call over to Miranda Pitot of Biokardia Investor Relations. Please go ahead, Miranda.

Speaker 1

Good afternoon and thank you for participating in today's conference call. Joining me from BioKardia's leadership team are Peter Altman, PhD, 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 BioKardia's expectations for future performance and operational results, References to management's intentions, beliefs, projections, outlook, analyses and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, 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 BioKardia's report on Form 10 ks filed on March 29, 2023, and in the company's subsequently filed quarterly reports on Form 10 Q.

Speaker 1

The content of this call contains time sensitive information This is accurate only as of today, November 8, 2023. Except as required by law, the company This claims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

Speaker 2

It is

Speaker 1

now my pleasure to turn the call over to Peter Altman, Ph. D, BioKardia's President and CEO. Peter, please go ahead.

Speaker 2

Thank you, Miranda, and good afternoon to everyone on the call. BioKardia'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 multiple 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 Q3, we were thrown a curveball when the Data Safety Monitoring Board for the Cardiamp Heart Failure Trial Or BCBA-one recommended that we pause enrollment in the study.

Speaker 2

We have followed the Data Safety Monitoring We have since come to understand that the trial design and endpoint we were advancing were unlikely to be With a 37% relative risk reduction on heart death equivalent and an 18% 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 2 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 And improved echocardiography parameters of left ventricular ejection fraction, left ventricular and systolic volume And left ventricular and diastolic volume.

Speaker 2

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 dialogue with the FDA and submitted a proposed Cardiac Heart Failure II 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 this study protocol be approved by the FDA In Advanced Biobial Cardia, 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.

Speaker 2

We have been actively answering requests for information on Cardium Cell Therapy System also by Advanced 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 1st minimally invasive catheter based cell therapy available in Japan. The Cardiamp cell therapy trial for chronic myeloid ischemia or BCD02 is also a Phase 3 multicenterrandomized Double blinded controlled study and it's intended to include up to 343 patients at up to 40 clinical sites.

Speaker 2

The company expects to complete enrollment in the rolling cohort of 5 patients in the Q4 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 The plan 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 Cardialo, allogeneic cell therapy for ischemic heart failure or BCD03 is a Phase onetwo clinical trial encompassing 69 patients.

Speaker 2

A number of patients have already been consented and we anticipate enrolling 1st patients in the Q4. This study is intended to build on 3 previous trials of mesenchymal stem cells in ischemic heart failure using the company's proprietary HELIX delivery encompassing 93 patients treated with no treatment emergent 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.

Speaker 2

In summary, we have increased confidence in the Our autologous Cardium 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 2 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 partner 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.

Speaker 2

I will now pass the call to David McClung, our CFO, who will review our Q3 2023 financial results. David?

Speaker 3

Thank you, Peter, and good afternoon, everyone. Revenues were approximately $357,000 for the 3 months ended September 2023, as compared to approximately $212,000 for the 3 months ended September 31, 2022. Expenses quarter over quarter decreased by approximately 10%. Research and development expenses were approximately $1,900,000 for the 3 months ended September 2023 compared to approximately $2,100,000 for the 3 months ended September reflecting cost reductions implemented after pausing the Cardium heart failure trial in July. Selling, general and administrative expenses were approximately $1,100,000 in the Q3 of 2023 and in the Our net loss was approximately $2,600,000 in Q3 2023 as compared to $3,100,000 in Q3 2022 due primarily to increases in revenue coupled with Reductions in research and development expenses during the quarter.

Speaker 3

Net cash used in operations during the quarter was approximately $2,400,000 as compared to approximately $2,000,000 in the Q3 of 2022. Biocardia ended the quarter with approximately 1,800,000 Cash and cash equivalents providing runway into January without additional capital or non dilutive funding for the business development and other activities. This concludes management's prepared comments. We are happy to take questions from attendees.

Operator

Thank If your question has been answered and you wish to withdraw your request, you must do so by pressing star then 2. If you're using a speaker Your first question comes from Joe Smith with Alpha Street. Please go

Speaker 4

ahead.

Operator

Hi, Joe. Your line is live into the call for your question.

Speaker 4

Hello, can you hear me? Yes. Hello, Joe. This is Landar on for Joe Pantginis from A2MBryde.

Speaker 2

Yes.

Speaker 4

Thanks for taking our questions. So first of all, so for the original Cardiamp HF trial, What's the plan regarding the patients that are still in the follow-up period? This will be analyzed and reported. What's the expectation when the totality of the data have been collected?

Speaker 2

The plan is to follow all patients out to at least the 1 year endpoint, Joe, and then we will Report out the full results for the trial. The expectation is that last patient We'll reach their endpoint in October of 2024. So late 2024, we should have Some interesting data to review.

Speaker 4

Okay, perfect. Thank you, got it. And for the New Cardiampage F trial, what's the number of high level proBNP patients that were identified to penetrate from the treatment?

Speaker 2

So for the Cardiamp Heart Failure II 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 the Interim data that's available to us and analyzed in a number of different ways. And it's actually pretty robust that the patients with high NT proBNP Just phenomenal responders.

Speaker 2

As we've looked at this, the study design we have, we've looked at our previous designs and we did not include NT proBNP as a prerequisite in either our Phase 1 or our 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 alignment with the data that we will generate ahead.

Speaker 4

Awesome. Got it. Thanks for clarifying.

Speaker 2

No, I appreciate the questions, Joe.

Operator

There are no further questions at this time. I'll now hand back to Peter for closing remarks.

Speaker 2

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 We look forward to sharing our continued progress. Thank you. Stay healthy, be kind and have a wonderful day.

Operator

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

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