Q3 2023 BioCardia Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the bio thought he had 323 third quarter conference call.
Speaker 1: Ladies and gentlemen, thank you for standing by. Welcome to the Biocardia 2023 third quarter conference call. At this time, all participants are going to Those are just some of the things we want to be talking about at some point.
At this time all participants are in a listen only mode.
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After today's presentation there'll be an opportunity to ask questions.
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Speaker 1: 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.
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.
Speaker 1: A webcast replay of this call will be available approximately one hour after the end of the call.
A webcast replay of this call will be available approximately one hour after the end of the call.
Speaker 1: I would now like to turn the call over to Miranda Pito of Bio-Cardia, Vista Relations. Please go ahead, Miranda.
I would now like to turn the call arbitrary random nature of Biochar, Yeah. They stimulations. Please go hidden Miranda.
Good afternoon, and thank you for participating in today's conference call. Joining me from Biochar. His leadership team are Peter Amen, 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 include.
Speaker 2: Good afternoon and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Omen, PhD, President and Chief Executive Officer and David McClellan, 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.
Statements that address myocardial expectations for future performance and operational results references to management's intentions beliefs projections outlook analogies and current expectations.
Speaker 2: references to management's intentions, beliefs, projections, outlooks, analyses, and current expectations.
Speaker 2: Such factors include, among others, the inherent uncertainties associated with developing new products and technologies in obtaining regulatory approvals.
Such factors include among others, the inherent uncertainties associated with developing new products.
Oh, jeez and obtaining regulatory approvals forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
Speaker 2: forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
Speaker 2: For more information about these risks, please refer to the risk factors and cautionary statements described in biocarvious reports on form 10K filed on March 29, 2023, and in the company's subsequently filed quarterly reports on form 10Q. The content of this call contains time sensitive information that's accurate only as of today, November 8, 2023.
More information about these risks please refer to the risk factors and cautionary statements described and Biochar. Its report on Form 10-K filed on March 29, 2023 and in the company 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 eight 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 that.
Speaker 2: Except this required by law, the company disclaims any obligation to publicly update, overvise any information to reflect, finance or circumstances that occur after this call. It is now my pleasure to turn the call over to Peter Altman, THD, BioCardia's President and CEO . Peter, please go ahead.
Carl.
It is now my pleasure to turn the call over to Peter Holt and ph D myocardial <unk> President and CEO. Peter Please go ahead.
Speaker 3: Thank you, Miranda, and good afternoon to everyone on the call.
Thank you Miranda and good afternoon to everyone on the call.
Myocardial current efforts are focused on advancing its autologous and allogeneic cell therapy platforms to treat significant unmet cardiovascular and pulmonary diseases specifically.
Speaker 3: Biocardial current efforts are focused on advancing its autologous and its allogeneic cell therapy platform.
Speaker 3: to treat significant unmet cardiovascular and pulmonary disease.
Speaker 3: specifically ischemic heart failure, chronic myocardial ischemia, and acute respiratory distress syndrome.
Specifically ischemic heart failure, chronic myocardial ischemia and acute respiratory distress syndrome.
Speaker 3: All of our cell-based therapies involve local delivery of the therapeutic to the heart or lungs where we intend them to act locally.
All of our cell based therapies involve multiple delivery of the therapeutic to the heart or lungs, where we intend them to act locally.
Speaker 3: This mission has not changed and all of these programs are still viable.
This mission has not changed and all of these programs are still viable.
This third quarter, we were thrown a curve ball when the data safety monitoring board for the cardiac heart failure trial, where B C E O.
Speaker 3: This third quarter, we were thrown a curve ball when the data safety monitoring board Cardiant Part Failure Trial, or BCDA01, recommended that we pause enrollment in the study.
One recommended that we pause enrollment in the study.
We have followed the data safety monitoring board recommendation and the last patients were randomized in the study in October.
Speaker 3: We have followed the Data Safety Monitoring Board recommendation and the last patients were randomized in the study in October .
Speaker 3: We continue to monitor patients enrolled in this clinical study in which both patients and evaluating physicians are blinded for the treatment group and expect a complete follow-up from this study in October 2024.
We continue to monitor patients enrolled in this clinical study in which both patients and evaluating positions are blinded to the treatment group and expect to complete follow up and this study in October 2024.
Speaker 3: We have since come to understand that the trial design and endpoint we were advancing were unlikely to be successful.
We have since come to understand that the trial design and endpoint, we were advancing were unlikely to be successful.
Speaker 3: 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 bascular events or makes, which are at the top of the list.
Even as we have become aware that there were strong trends toward benefits across all patients with a 37% relative risk reduction in heart deaths equivalent and an 18% relative risk reduction major adverse cardiac and three will 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 N G probes N T.
Speaker 3: In addition, the available interim data showed that for an important subset of patients who presented it to screening baseline visit with higher levels of NTPO-BNP, a well-established biomarker of increased heart failure and stress to the heart. The reduction in heart death equivalent in MACE were even greater.
Well established biomarker or increased heart failure and stress to the heart the reduction in heart death equivalent inmates were even greater.
Speaker 3: of note all current leading heart failure trials where we have looked, require elevated M.T. ProBMP for patients to be eligible to participate in these trials.
Of note all current leading heart failure trials, well, we have looked require elevated NT Kobe M. P for patients could be eligible to participate in these trials.
Speaker 3: In these patients, an analysis of all available data up to two years and 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.
In these patients and analysis on all available data up to two years and the cardiac heart failure trial shows improvements over control, 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.
Speaker 3: included in this subset analysis, favored self therapy, including improved quality of life as measured using the Minnesota living with heart failure questionnaire, reduction of NT-ProBMP levels.
Reduction of N T Probie M P levels greater six minute walk distance.
And improved Echocardiographer parameters of left ventricular ejection fraction left ventricular end systolic volume and left ventricular end diastolic volume.
Speaker 3: and improved echocardiography parameters of left ventricular ejection fraction, left ventricular end systolic volume, and left ventricular end diastolic volume.
Both the reduced heart death equivalents and improved quality of life outcomes demonstrated statistically significant.
Speaker 3: both the reduced heart death equivalence and improved quality of life outcomes, demonstrated statistically significant favorite therapy.
Favoring therapy in this subset analysis.
Speaker 3: Because of this data, we have initiated dialogue with the FDA and submitted a proposed cardiac heart failure.
Because of this data we have initiated a dialogue with the FDA and submitted a proposed cardiac heart failure to protocol for FDA review, which targets the patients with higher levels of N T Pro BNP and utilizes a different clinical endpoint based on the interim data are available.
Speaker 3: protocol for FDA review, which targets the patients with higher levels of NT-ProBMP and utilizes a different clinical endpoint based on the interim data available.
Speaker 3: recent statistical calculations for this clinical study design support that a modestly sized clinical trial of 150 patients based on the interim results would achieve 90 percent power, which is another frame for probability of success. If the data is representative of the population.
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 cardiac cell therapy heart failure trial design include elements to simplified clinical site execution logistics and reduce the cost of performing the study.
Speaker 3: Additional proposed modifications from the Cardiamps South Therapy Heart Failure Trial Design include elements to simplify clinical site execution logistics and reduce the cost of performing the study.
Speaker 3: Should this study protocol be approved by the FDA and advanced by Bialcardia? It may be possible to significantly offset clinical costs with a Medicare reimbursement of up to $20,000 now in place for both the control and treatment arms of this investigational therapeutic study.
Should the study protocol will be approved by the FDA and advanced by Biochar to yet.
May be possible to significantly offset clinical costs with the Medicare reimbursement of up to $20000 now in place for both the control and treatment arms of this investigational therapeutic study.
Speaker 3: We have been actively answering requests for information on CardiM South Therapy System also by Japan's pharmaceutical and medical devices.
We have been actively answering requests for information on Cardiome cell therapy system also by Japan's pharmaceutical and medical device agency or P. M. D E towards an approval for the indication of ischemic heart failure based on existing safety and efficacy data.
Speaker 3: or PMDA towards an approval for the indication of a Schema cart failure based on existing safety and efficacy data.
Speaker 3: Our formal consultation is scheduled for November 21st, 2020.
Our formal consultation is scheduled for November 21, 2023.
Speaker 3: Subsequent interactions and consultations with PMDA are expected.
Subsequent interactions in consultations with P. M D are expected.
Speaker 3: Cardium South Therapy System has potential to be the first minimally invasive catheter-based South Therapy available.
The cardiac cell therapy system has potential to be the first minimally invasive catheter based cell therapy available in Japan.
Speaker 3: The Cardiampsal Therapy Trial for Chronic Mild-Colored Schemia, or BCO2, is also a phase three multi-center randomized double-blinded control study. And it's intended to include up to 343 patients at up to 40 clinical sites.
The cardiac cell therapy trial for chronic myocardial ischemia or Bcl. Two is also a phase three multi center randomized double blinded controlled study and its intended to include up to 343 patients at up to 40 clinical sites.
Speaker 3: The company expects the complete enrollment in the Rowland cohort of five patients in the fourth quarter of 2023 and begin the randomized stays of the trial.
The company expects to complete enrollment in the role in cohort five patients in the fourth quarter of 2023 and begin the randomized phase of the trial.
Speaker 3: A number of leading investigators, including both principal investigators in this trial, believe that this to be the most compelling indication for this there.
A number of leading investigators, including both principal investigators in this trial believed 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.
Speaker 3: Planning for the randomization phase is already underway based on promising experience in the patient's treated today.
Speaker 3: Part of this planning includes utilizing the Medicare reimbursement in place for both the control and treatment arms for this investigational therapeutic study to offset the clinical cost.
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.
Speaker 3: The company's Cariallo, Allogeneic Cell Therapy for Schema Card Failure or BC-03, is a Phase-12 Clinical Trial in Composing 69.
The company's cardiac <unk> allogeneic cell therapy for ischemic heart failure or BCD three is a phase one two clinical trial encompassing 69 patients.
Speaker 3: A number of patients have already been consented and we anticipate enrolling first patients in the fourth quarter.
A number of patients have already been consented and we anticipate enrolling the first patients in the fourth quarter.
Speaker 3: This study is intended to build on three previous trials of mesenchymal stem cells in a schema cart failure using the company's proprietary helix delivery system and composing 93 patients treated with no treatment emergency serious adverse events and compelling early signals for bench.
This study is intended to build on three previous trials of messing time will stem cells in ischemic heart failure, using the company's proprietary <unk> delivery system encompassing 93 patients treated with no treatment emergent serious adverse events and compelling early signals for benefit.
Speaker 3: Our strategy here is to seek partnerships and grant funding to advance this probe.
Our strategy here is to seek partnerships in grant funding to advance this program.
Speaker 3: Bio-cardia is focusing its world-class biotherapy X delivery team towards partnering its capabilities utilizing our CLX biotherapy delivery system for intramile cardio delivery through long-term partners.
Biochar he is focusing its world class biotherapeutics delivery team towards partnering its capabilities utilizing our helix biotherapeutic delivery system for inter myocardial deliveries through long term partnerships.
Speaker 3: and advance therapeutic opportunities and help offset our base operation.
Vance therapeutic opportunities and help offset our base operational costs.
Speaker 3: Biote therapeutic delivery business development is active and we are working to close multiple meaningful deals by the end of the year.
Biotherapeutic delivery business development is active and we are working to close multiple meaningful deals by the end of the year.
Speaker 3: In summary, we have increased confidence in the potential of our autologous cardiac and self therapy program in both the Schema Card Failure and in chronic mild carloschemia based on the data we have before.
In summary, we have increased confidence in the potential of our collagen cardiome cell therapy program in both ischemic heart failure and in chronic myocardial ischemia based on the data we have before us we.
Speaker 3: We are focused strategically on advancing
We are focused strategically on advancing these two clinical programs in a cash neutral fashion, but the benefit the Medicare reimbursement, we already have in place.
Speaker 3: 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.
Similarly, we are working on securing grants and partnerships around our allogeneic programs to support their clinical development and implementing our recurring revenue biotherapeutic delivery partner model with our experienced world class team and our helix biotherapeutic delivery system.
Speaker 3: In the coming weeks, we anticipate feedback from both FDA and PMDA on our Autologous Cardiants Self-AirBee Program and anticipate enrollment of patients in our Allogeneic Cardiants Self-AirBee Program. We also expect positive...
In the coming weeks, we anticipate feedback from both F. D. A N P. M D E on our autologous car T cell therapy program and anticipate enrollment of patients in our allogeneic car T Allo cell therapy program.
We also expect positive news from business development activities.
Speaker 3: I will now pass the call to David McClung, our CFO , who will review our T3 2023 financial results. David. Thank you, Peter.
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.
Speaker 4: Revenants were approximately $357,000 to the three months in its September , 2023, as compared to approximately $212,000 for the three months in its September 30, 2022.
Revenues were approximately $357000 for the three months ended September 2023, as compared to approximately $212000 for the three months ended September 31 2022.
Speaker 4: Expenses, quarter over quarter, decreased by approximately 10%.
Expenses quarter over quarter decrease by approximately 10%.
Speaker 4: Research and development expenses will 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 Cardi Amp, heart failure trial within July .
Research and development expenses were approximately $1 $9 billion because 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 cardio heart go to trial in July.
Selling general and administrative expenses were approximately $1 $1 billion in the third quarter of 2023.
Speaker 4: Selling general and administrative expenses will approximately $1.1 billion in the third quarter of 2023 and in the end in the second quarter of 2022.
And in the second quarter for 2022.
Our net loss was approximately $2 $6 million in Q3, 2023, as compared to $3 $1 million in Q3, 2022, due primarily to increase.
Speaker 4: Our net loss was approximately $2.6 million in Q3 2023 as compared to $3.1 million in Q3 2022. Through primarily to increase.
Speaker 4: increases in revenue coupled with reductions in research and development expenses during the quarter.
<unk> and revenue coupled with reductions in research and development expenses during the quarter.
Speaker 4: 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.
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.
Speaker 4: BioCardia ended the quarter with approximately $1.8 million in cash and cash equivalents, providing runway into January without additional capital or non-diluted funding from the business development and other activities. This concludes management's prepared comments.
Bob accordion ended the quarter with approximately $1 8 million in 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.
Yeah.
Thank you should you wish to ask a question on today's call. Your next Christa and one on your telephone.
Speaker 1: Thank you. So do you wish to ask a question on today's call? You'll need to press star, then one on your telephone. If your question has been answered and you would just want to withdraw your request, you must do so by pressing star, then two.
Question has been answered and he was just what's to withdraw your request you must do so christine stuffed into it.
Speaker 1: If you're using a speaker phone, please pick up the handset before entering your request and speaking on the call. Your first question comes from Joe Smith with Alpha Street. Please go ahead.
If youre using a speakerphone please pick up the handset before entering your question speaking on the call.
Your first question comes from Joe Smith with Alpha straight.
Please go ahead.
Okay.
Okay.
Okay.
Yeah.
Hi, Joe Your line is live in the call for your question.
Yeah.
Hello can you hear me.
Yes.
Speaker 5: Hello, Joe. Oh, this is landed on for Joe. And genius from A to N ride.
Hello, Joe.
This is land that only for job ingenious from H C. Wainwright.
Yeah.
Yes.
Speaker 5: Thanks for taking our questions. So first of all, so called the original Cardi Amp HF 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?
Thanks for taking our questions. So first of all something called the Norwegian Encore DIAM Paychex try out what's the plan regarding the patients that are still in the follow up period.
Will be analyzed and reported.
What's your expectation when the totality of the data being collected.
Speaker 3: The plan is to follow all patients out to at least the one-year end point, Joe, and then we will report out the full results for the trial. The expectation is that last patient will reach their end point in October of 2024. So late 2024, we should have some interesting data to report.
The plan is to follow all patients out to at least the one year end point, Joe and then we will report out the full results for the trial.
The expectation is that last patient will reach their end point in October of 'twenty 'twenty four so late 'twenty 'twenty four we should have some some interesting data to review.
Speaker 5: Okay. Perfect. Thank you. Got it. And for the new CAR TMPHF trial, what's the number of high-level pro-BNP patients that were identified to penetrate from the treatment?
Okay perfect. Thank you bought it and for the.
New car T unpaid shapes try out what's the number of high level pro BNP patients that were identified to penetrate from the treatment.
Speaker 3: So for the Cardiant Partifilier 2 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 look at our current interim data.
So so for the cardiac heart failure to 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.
What we are as we looked at our current interim data more than half the patients actually were high NT Pro BNP in our study.
Speaker 3: More than half the patients actually were high NT-ProBMP in our study. And so we've looked at the interim data that's available to us and analyzed it a number of different ways. And it's actually pretty robust. The patients with high NT-ProBMP are just phenomenal.
And so we've looked at that interim data that's available to us and analyzed at a number of different ways and it's actually pretty pretty robust.
Patients with high end Chi pro BNP or just.
Nominal responders or as we've looked at this the study design we have we've looked at our previous study designs and we did not include anti Probie M. P is a prerequisite in either our phase one or phase two work. However in today's climate almost all trials out there that we're aware of.
Speaker 3: are, 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-ProBMP as a prerequisite in either our phase one or our phase two.
Speaker 3: However, in today's climate, almost all trials out there that we're aware of are requiring NT pro.
Ah requiring N T.
Speaker 3: BMP 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 NPP or BMP, 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.
BNP 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 the other trials that did require high N T Pro BNP.
But our sense is including that going forward.
Is likely to have a pretty significant impact on our results, particularly if the data that we have is in alignment with the data that we will generate at.
Yeah.
Awesome got it thanks for clarifying.
Speaker 3: No, I appreciate the questions, Joe.
No I appreciate the question Joe.
Once again, if you wish to ask a question. Please press Star then one.
Speaker 1: There are no further questions at this time and I'll hand back to Peter for closing remarks.
There are no further questions at this time I'll now hand back to Peter for closing remarks.
Thank you kindly Rachel.
Speaker 3: 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.
Want to thank everyone for participating in today's call and for your interest in Biochar, yet and our primary mission to treat heart disease.
We look forward to sharing our continued progress.
Speaker 3: Thank you, stay healthy, be kind, and have a wonderful day.
Thank you stay healthy be kind and have a wonderful day.
Speaker 1: The conference call is now concluded. Thank you for attending today's presentation. You may now disconnect.
The conference call has now concluded. Thank you for attending today's presentation you may now disconnect.
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