Q2 2020 BioCardia Inc Earnings Call

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Operator: Thank you for standing by. Good morning, and welcome to the BioCardia Mid-Year Update Conference. At this time, all participants are in a listen-only mode. If you need assistance, please call 1-800-634-9483 or call 1-800-634-9483. Please stand by for conference specials by pressing the star key followed by After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad.

Good morning, and welcome to the bio cardio midyear update conference call.

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Operator: This call is advised that the audio of the conference call is being broadcast live over the internet and is also being recorded for playback. A webcast replay of the call will be available approximately one hour after the end of the call. I'd now like to turn the call over to Scott Gordon, President of CoreIR, the company's investor relations firm. Please go ahead, Scott.

That's a replay of the call will be available approximately one hour after the call through November 13th 2020.

Oh, no <unk> President of course, they are the company's Investor relations.

Go ahead Sir.

Thank you Keith good morning, and thank you for participating in today's conference call. Joining me from bio Cardenas leadership team are Dr., Peter <unk>, President and Chief Executive Officer, and got David Mccollum, Chief Financial Officer.

Scott Gordon: Thank you, Keith. Good morning and thank you for participating in today's conference. Joining me from BioCardia's leadership team are Dr. Peter Altman, President and Chief Executive Officer, and David McClung, Chief Financial Officer. During this call, management will be making forward-looking statements, which are subject to many risks and uncertainties, forward-looking statements include, among other things, references to the enrollment of our clinical trials, the availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, anticipated milestones, and other statements regarding our intentions, beliefs, projections, outlook, and Al Fuse. Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia, such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia's business and product development plans and overall market condition, may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control.

During this call management will be making forward looking statements, which are subject to many risks and uncertainties forward. Looking statements include among other things references to the enrollment of our clinical trials the availability of data from our clinical trials filings with the FDA FDA clearances, the efficacy and safety.

Products therapies anticipated milestones and other statements regarding our intentions beliefs projections outlooks.

Analyses.

Our current expectations such risks and uncertainties include among others. The inherent uncertainties associated with developing new products are technologies regulatory approvals unexpected expenditures the ability to raise the additional funding needed to continue to pursue party cardiac business in product development plans and overall market.

Conditions.

We may find it difficult to enroll patients in our clinical trials do them any factors some of which are outside our control.

Well were then targeted enrollment could delay completion of our clinical trials and away.

Scott Gordon: Lower-than-targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of today, and BioCardia assumes no obligation to update these forward-looking statements. We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, or approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements.

<unk> Clark therapeutic candidates. These forward looking statements are made as update today and buyer party assumes no obligation to update forward looking statements. We may use terms such as believes estimates anticipates expects plans intends to make quick might well should approximately or other words that convey.

The uncertainty of future events or outcomes to identified these forward looking statements. Although we believe we have reasonable baseline basis for each forward looking statement contained.

Scott Gordon: Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this copy. As a result of these factors, we cannot assure you that such forward-looking statements will prove to be accurate. Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia, filed with the SEC, including our recent filings on Form 8K, 10K, and Form 10Q, particularly any statements under the caption entitled RISC. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements. Acceptance may be required by law.

We caution you that forward looking statements are not guarantees of future performance and that our actual results may differ materially from a forward looking statements contained in this conference call. As a result of these doctors we cannot assure you that forward looking statements will prove to be accurate.

Additional factors that could materially affect actual results can be found documented filed with the FCC, including our recent filings on form 8-K, 10-K, and form 10-Q, particularly any statements under the caption entitled risk factors.

Cardiac stats in disclaims any intention or obligation to update these forward looking statements, except as may be required by law.

Now my pleasure to turn the call up and Dr., Peter often the company's president and CEO. Peter. Please go ahead.

Peter A. Altman: It's now my pleasure to turn the call over to Dr. Peter Altman, the company's president and CEO. Peter, please go ahead. Thanks, Scott, and good morning to everyone on the call. I am pleased to join you today to provide you with our Meteor update on the progress we have made towards our clinical and operational goals. We have made great progress advancing both our autologous and our allergenic bone marrow derived cell therapies this past year. The Cardiac Cell Therapy Platform has an intended mechanism of action to activate the natural healing process where bone marrow cells home to the heart in an injury, rather than turning into heart cells. We are doing this with a comprehensive approach that includes a unique potency to identify the patients most likely to benefit from therapy, a point-of-care cell processing platform to preserve cell viability and enable high doses from a small tissue sample, and our proven helix biotherapeutic delivery system.

Thanks, Scott and good morning, everyone on the call.

I'm pleased to joining today to provide you with our midyear update on the progress we have made towards our clinical and operational goals.

We've made great progress advancing both our autologous and our allergenic bone marrow derived cell therapies this past quarter.

On autologous cell therapy from.

Cardiac cell therapy platform has an intended mechanism of action to activate the natural healing process.

Oh and marrow cells home to the heart in an injury.

Rather than turning into heart cells.

We're doing this.

With a comprehensive approach that includes a unique potency assay to identify the patients most likely to benefit from therapy.

<unk> point of care cell processing platform to preserve cell viability and enable high dose it gets must small tissue sample.

And our proven helix biotherapeutic delivery system.

Oh, autologous cardiac heart failure program or B C. L. One.

Peter A. Altman: Our Autologous Cardi-AMP Heart Failure Program, or BCDA-01, began the quarter with a positive recommendation from the Independent Data Safety Monitoring Board to continue enrollment, and ended the quarter continuing to treat patients at centers who had paused elective procedures due to COVID-19. 77 patients have been randomized today. As a result of the COVID pandemic, the company has taken steps to implement new FDA guidance for clinical trials, including addressing unavoidable protocol deviations and implementing additional control measures, clinical sites remaining engaged, and our resuming elective enrollment. We are still targeting an important data safety monitoring board review at the end of this year and completion of enrollment next year. This past quarter, we also activated our CARDI-AMP chronic myocardial ischemia program, or BCD-02, a pivotal trial for a second indication for cardiac cell therapy. The University of Florida is the first study center and has completed its site initiation visit.

Began the quarter with a positive recommendation from the independent data safety monitoring board to continue enrollment.

Ended the quarter continuing to treat patients centers, who we paused elective procedures due to cold at 19.

77 patients have been randomized to date.

As a result of the covert pandemic. The company has taken steps to implement new after your guidance for clinical trials, including a dressing unavoidable protocol deviations and implementing additional control measures.

Clinical sites remaining engaged.

And I resuming elective enrollment activities, we're still targeting an important data safety monitoring Board review at the end of this year and completion of enrollment next year.

This past quarter, we also activated our cardiac chronic myocardial ischemia program, where bcl two pivotal trial for a second indication the cardium cell therapy.

The University of Florida is the first study center and it's completed at site initiation visits.

This program has many of the same features as our leading heart failure program and the effective dosage of Cdthirty four cells in this trial is compelling.

Peter A. Altman: This program has many of the same features as our leading heart failure program, and the effective dosage of CD34 cells in this trial is compelling. We will soon announce the leadership of this clinical study, which includes world-class physician-scientists with extensive experience in our Allogenic Cell Therapy. Our cells are provided by a younger

We will soon announce the leadership of this clinical study, which includes world class position scientists with extensive experience in this field.

On our allergenic cell therapy front.

Our cells are provided by a younger donor selected based on the presence of the neuro kind in one receptor and then expanded to provide for many dosage forms.

Peter A. Altman: Selecting based on the presence of the NeuroKinin-1 receptor, and then expanded to provide for many doses, the Intended Mechanism of Action is similar to cardiac cell therapy but also is expected to benefit from the anticipated enhanced interaction with Substance P, a key first responder to most noxious and extreme stressors, such as those with the potential to compromise biologic integrity. Substance P is regarded as an immediate defense, stress, repair, and survival, and we are selecting our cells based on the neurokinin receptor to which it binds. Allogenic, Neurokinin-1, receptor-positive mesenchymal stem cell, or BCO3 investigational new drug application response was completed and submitted to the FDA. This initial program is targeted to treat patients with heart failure who don't have the right cell potent for Cardi The agency provided feedback and requested additional data and clarification. And although the interaction is ongoing, we see no insurmountable issues so far.

The intended mechanism of action is similar to Cardium cell therapy.

But also is expected to benefit from the anticipated enhanced interaction with substance P. A key first responder to most noxious an extreme stresses such as those with the potential to compromise biologic integrity.

Substance P is regarded as an immediate defense stress repair survival system, and we are selecting ourselves based on the neural kind in receptor two which it lives.

Our allergenic neuro cod in one receptor positive messing camel stem cell program, where B C. O three investigational new drug application response was completed and submitted to the FDA.

This initial program is targeted to treat patients with heart failure.

Don't have the right sell potency for Cardium cell therapy.

You can see provided feedback and requested additional data in clarifications and although the interaction is ongoing we see no insurmountable issue so far.

The animal safety data, we have supports efficacy in terms of increased heart function as measured by echocardiography from both low and high dose groups at short and long term follow up.

Peter A. Altman: The animal safety data we have supports efficacy in terms of increased heart function as measured by echocardiography from both low and high doses, short and long-term followers. We are looking forward to the agency's assessment of our updated manufacturing controls, which we have not yet... We also initiated preclinical work this quarter to pursue a program with these cells to treat acute respiratory distress developing from COVID-19 or BCDL4. This is something we have planned to advance as these cells will be primarily localized in the lungs and are expected to have an anti-inflammatory effect. We continue our partnerships with other biotherapeutic companies, using our Helix Biotherapeutic Delivery system, which remains the safest, easiest to use, and most efficient local therapeutic delivery system available for cardiac application.

We're looking forward to the agencies assessment of our updated manufacturing controls, which we have not yet received.

We also this quarter initiated the preclinical work to pursue a program with these cells to treat acute respiratory distress developing from cobot 19 or BC deal for.

This is something we have planned to advance as these cells will be primarily localized in the lungs and are expected to have an anti inflammatory effect.

We continue our partnerships with other biotherapeutic firms using our helix biotherapeutic delivery system, which remains the safest easiest to use and most efficient local therapeutic delivery system available for cardiac applications.

That's therapeutic delivery platform underlies both the safety and efficacy results, we seek to demonstrate in our three clinical cardiac programs and an additional broad patent issued protecting this product this past quarter.

Peter A. Altman: This therapeutic delivery platform underlies both the safety and efficacy results we seek to demonstrate in our three clinical cardiac programs. Additionally, an additional broad patent issued protecting this product this past past. I am also personally excited by our anticipated target market release of our advanced transepto-guide catheter, which was approved by FDA in 2019. This cardiology product addresses a competitive and well-established $500 million market. We believe it is best in class due to its unique rotating pull wire technology that results in the same catheter mechanical performance regardless of catheter orientation.

I am also personally excited by our anticipated target market release of our a bomb Transseptal guide catheter, which was approved by FDA in 2019.

Yes, cardiology product addresses a competitive and a well established 500 million dollar market.

We believe it is best in class due to its unique rotating pull wire technology that results in the same catheter mechanical performance regardless of catheter orientation.

It also has potential to have a valuable role in enabling a much larger each real fibrillation therapy and mitral valve markets.

Peter A. Altman: It also has potential to have a valuable role in enabling a much larger atrial fibrillation therapy and mitral valve. I'm also pleased to report that the company closed a public offering of its common stock for gross proceeds of $11.5 million, including the exercise of the underwriter's over-allotment option. This bodes well for our continued progress and is a testament to our continued execution. Pantginis, David McClung, Miranda Peto, David McClung, Miranda Benvenuti, BioCardia Inc. Pantginis, The legal proceedings are related to patents, patent applications, and trade secrets, which BioCardia asserts were misappropriated by a former employee that founded a catheter company named Envision.

I'm also pleased to report that the company close to public offering of its common stock for gross proceeds of 11.5 million, including the exercise of the underwriters' overallotment option.

This bodes well for our continued progress and as a testament to our continued execution.

Lastly, the company entered into a litigation funding agreement.

For the purpose funding the legal proceedings relating to the case caption, Boston Scientific Corp, al versus Bio Carty, Inc.

The legal proceedings are related to patents patent applications and trade secrets, which bio party asserts where misappropriated by a former employee the founded a catheter company named envision.

By all parties May claims, including the proceeds from the sale of envisioned to Boston scientific and reported 275 million dollar deal rightfully along to bio cardia because they were the direct result of the employees breach of her obligations to assign to buy olkaria the patents and.

Peter A. Altman: BioCardia has made claims, including that the proceeds from the sale of Envision to Boston Scientific in a reported $275 million deal rightfully belong to BioCardia because they were the direct result of the employee's breach of her obligations to assign to BioCardia the patents and patent applications and the use of misappropriated biocardia. This non-dilutive litigation financing now in place gives BioCardia the wherewithal to pursue its claims in court and preserves our investment focus on advancing our important cell therapy product pipeline. I will now pass the call to David McClung, our CFO, who will provide some financial perspective on the second quarter. Thank you, Peter.

Patent applications and the use of misappropriated bio cardio trade secrets.

This non dilutive litigation financing now in place gives bio party the wherewithal to pursue its claims in court and preserves our investment focused on advancing our important cell therapy product pipeline.

I will now pass the call David Mcclung, our CFO, who will provide some financial perspective on the second quarter David.

Thank you Peter.

First of all covered the high points that are statement of operations before moving onto the balance sheet them into our cash flows.

David Mcclung: First, I'll cover the high points in our statement of operations before moving on to the balance sheet and then to our cash flow. Overall, BioCardia's financial results in Q3 2020 were consistent with the second quarter of 2019. Our net loss... 3.6 million compared to 3.8 million in the second quarter of 2019.

Overall bio cardio financial results in Q2 thousand 20 work.

Second quarter 29 senior.

Our net loss in Q2.

Was 3.6 million compared to 3.8 billion and the second quarter 29 team.

We are diligently pursuing collaboration commercial and partnering activities in support of our growth objectives, while still carefully using our resources or the lean organization.

David Mcclung: We are diligently pursuing collaboration, commercial, and partnering activities in support of our growth objectives while still carefully using our resources in a lean organization. Our primary efforts to date have been advancing our own investigational programs and those of our partners, and our revenues to date have been historically very modest. We're now in transition to our next generation products and therefore had no net revenue in the second quarter of 2020. The net product revenue for the remainder of 2020 is expected to be limited, but will depend on the level of customer demand for revolves and the timing and the size of the commercial launch that Peter just noted.

Our primary airports today that the advancing our own investigational programs in those partners and our revenues today have been historically very modest.

Now in transition to our next generation products and therefore had no net revenue in the second quarter 2020, but net product revenue for the rate or 2020 is expected to be limited, but will depend on the level of customer command pools, and the timing and the size of the commercial launch the Peter just.

Well I'm just not expected to have significant financial effect in 2020, but it's still a meaningful margin in future years can enable possible partnering in licensing arrangements.

David Mcclung: Lawrence is not expected to have a significant financial effect in 2020, but it still could have a meaningful margin in future years and enable possible partnering and licensing arrangements. It's important to note that Avance is essentially a variation of the next generation of a component of our biotherapeutic delivery system. So the cost for BioCardia... grows and advances, but the advance to date has been negligible. Research and development expenses were $3.2 million in the second quarter of 2020, identical to the $2.2 million in the second quarter of 2019.

It's important to note at the boss is essentially a variation of the next generation of a component of our biotherapeutic delivery system. So the cost for bio cardium to grow in advance the boss today has been negligible.

Research and development expenses or 3.2 million in the second quarter 2020 identical to the 2.2 million in the second quarter 20 Bolton.

The second quarter expenses reflect cost incurred wall conducting a football cardiac trial, the new pivotal party of chronic myocardial scanned go to trial and further developing our eligible program.

We expect R&D expenses will increase modestly year over year in 2020, primarily due to the costs will incur in the heart failure true trial.

David Mcclung: These second quarter expenses reflect costs incurred while conducting the Pivotal Cardiac Heart Failure Trial, the new Pivotal Cardiac Chronic Myocardial Tischemia Trial, and further developing our allergenic program. We expect R&D expenses will increase modestly year over year in 2020, primarily due to the costs we will incur in the heart failure trial. Selling general administration expenses in the second quarter of 2020 totaled $1.4 million, comparable to the $1.4 million recognized in the second quarter of 2019.

Selling general administration expense in the second quarter 2020 totaled 1.4 billion comparable to the 1.4 billion recognizable second quarter 20 minutes.

We do expect us to convey the decrease modestly this year as we continue to streamline our administrative functions and improve our efficiencies.

Now on the balance sheet with June financing proceeds and the P.T. glow. We ended the quarter was 11.1 billion in cash and 7.3 million in stockholders' equity.

This brings us back in compliance with NASDAQ requirement for a minimum was 2.5 molded cheryls shareholders' equity for continued listing.

David Mcclung: We do expect SG&A to decrease modestly this year as we continue to streamline our administrative functions and improve our efficiency. Now, on the balance sheet, with the June financing proceeds and the PPP loan, we ended the quarter with $11.1 million in cash and $7.3 million in stockholders' equity. This brings us back in compliance with NASDAQ's requirement for a minimum of $2.5 million in shareholders' equity per continued listing. Net cash used in operations in the second quarter of 20 was only $2.3 million, also identical to the $2.3 million we used in the second quarter of 2019.

Net cash used in operations in the second second quarter 20 was only 2.3 million. It's also identical to the 2.3 million we used in the second quarter 29 chain.

I expect our cash burn to increase very modestly over the years, that's our programs.

I do want to highlight house of actions, we've taken to strengthen our runway in reduce your cash outlay by converting board compensation management bonus payouts to equity.

This alone say this more than 1 million in cash during the second quarter to settle obligations from prior years.

At our current burn rate absent additional funding or other source of capital such as revenue litigation settlement partnering opportunities.

Provide a cash run it one way up to the end of Q2 2020 War.

David Mcclung: We expect our cash flow to increase very modestly over the years as we advance our program. I do want to highlight now some actions we've taken to strengthen our balance sheet and reduce our cash outlay by converting board compensation and management bonus payouts to equity. This alone saved us more than $1 million in cash during the second quarter to settle obligations from prior years.

I'll now pass the call back to Peter for some final thoughts before we open the call to questions.

Peter.

Thanks, David.

Even as our primary efforts around enrollment in our two pivotal programs, we have and we have a number of meaningful milestones in the near future to share.

During the third quarter, we're working towards two milestones.

Peter A. Altman: At our current earn rate, absent additional funding or other sources of capital, such as revenue, litigation, settlement, and partnering opportunities, this could provide a cash run in one way up to the end of Q2 2021. I will now pass the call back to Peter for some final thoughts before we open up the call to questions. Thanks, David.

First is the treatment of a first patient in cardiac chronic myocardial ischemia trial or beat video too.

Second is the FDA acceptance of our investigational new drug application for cardiac oil neuro kind of one receptor positive mesenchymal stem cell therapy or BCD three.

In the fourth quarter.

We anticipate or milestones.

First the data safety monitoring Board review looking at the utility based on first efficacy data in our leading cardiac heart failure program or BCD L. One.

Peter A. Altman: Even as our primary efforts are around enrollment in our two pivotal programs, we have a number of meaningful milestones in the near future to share during the third quarter. We are working towards two miles. First is the treatment of the first patient in the cardiac chronic myocardial ischemia trial or BCDO2. Second, is the FDA acceptance of our investigational new drug application for Cardiallo Neurokinin-1 receptor positive mesenchymal stem cell therapy, or BCDAO3, in the fourth quarter. We anticipate four milestones. First,

Second is the first safety read out in our pivotal trial studying cardiac cell therapy in chronic myocardial ischemia or bcl two.

Third the FDA acceptance of our investigational new drug application for our neuro cod in one receptor positive mesenchymal stem cell therapy for the treatment of acute respiratory distress syndrome. As a result of cobot 19 or be seal for.

And board is the targeted commercial availability of our bonds transseptal sheet product offering.

Peter A. Altman: Data Safety Monitoring Board Review looking at futility based on first efficacy data in our leading cardiac heart failure program, or BCD01. Second, is the first safety readout in our pivotal trial studying cardiac cell therapy in chronic myocardial ischemia, or BCO2. Third is the FDA acceptance of our investigational new drug application for our NeuroKindin-1 receptor-positive mesenchymal stem cell therapy for the treatment of acute respiratory distress syndrome as a result of COVID-19 or BCO4, and fourth is the targeted commercial availability of our advanced transeptal sheath product offering. We also have papers, patents, and partnerships that are being advanced, and we'll share these when they have been realized. And with that, we are now ready to take questions. Operator.

We also have papers patents and partnerships that are being advanced and we'll share. These when they have been realized.

With that we're now ready to take questions.

Operator.

Yes. Thank you at this time, we will open the call to questions should you wish asked a question on today's call you any depressed starkey than the number one on your telephone.

Your questions on dry dressed and you would like to withdraw. It you made you saw a pressing star and number two.

If you're using speakerphone, please pick up your hands out before entering your request speaking on the call OMAM. Please for the first question.

And the first question comes from Kumar Roger was lying capital markets.

Hi, congratulations on all the programs and thanks for taking my questions.

So with regard to the patient enrollment who are kind of thing probably are you seeing income profile pre screening of patients.

Operator: Yes, thank you. At this time, we will open the call to questions. If you wish to ask a question on today's call, you will need to press the star key, then the number 1 on your telephone. If your question is unaddressed, and you would like to withdraw it, you may do so by pressing star. If you are using a speakerphone, please pick up your handset before entering your request and speaking on the call.

How do you think the patient enrollment is going to Erle time, Oh, what are you seeing in different parts of the country.

Kumar well. Thank you for the question. It is a central question to our thinking here a bio cardiac every single day and as it's one of our primary objective secondary only to safety.

We are working diligently on it.

You're correct and that around the country. There are centers that are still under essentially locked down or stay in shelter, but the coordinators are still reaching out to patients and progressing on a number of aspects of the trial that will likely result, and.

Peter A. Altman: And the first question comes from Kumar Raja with Buckeye Capital. Hi, congratulations on all the progress and thanks for taking my questions. So with regard to patient enrollment, what kind of trends are you seeing in terms of pre-screening patients? How do you think patient enrollment is going to evolve over time? What are you seeing in different parts of the country?

Increased enrollment when they come back online.

At a number of centers. We are we are enrolling I can't speak specifically to regional variations or specifically to enrollment numbers and patient scheduled for treatment of which I am aware today are our approach here has been to with each.

Peter A. Altman: Kumar, well, thank you for the question. It is a central question to our thinking here at BioCardia every single day. And as it's one of our primary objectives, secondary only to safety, we are working diligently on it. You're correct in that around the country, there are centers that are still under essentially lockdown or stay in shelter, but the coordinators are still reaching out to patients and progressing on a number of aspects of the trial that will likely result in increased enrollment when they come back online. At a number of centers, we are enrolling students.

Report of the status of the trial the share where we're at today. We're at 77 patients I expect next time, we have a press release, the number will go up and a and so on and so forth as we move forward. Our goal here. Our goal is to complete enrollment in this trial next year and so all of the activity.

These were pursuing and implementing all of the FDA guidance.

For the Kobin 19 clinical efforts has been completed and will benefit the restart at different sites around the country.

Peter A. Altman: I can't speak specifically to regional variations or specifically to enrollment numbers and patients scheduled for treatment, of which I am aware today. I will report on the status of the trial to share where we're at. Today we're at 77 patients. I expect next time we have a press release, the number will go up, and so on and so forth as we move forward.

So it's it's a that's about the best answer I can give you today, but you'll be able to track. This as we give updates to our activities moving forward.

I mean, Tom felt club Ethiopia, our portal a ought to warranty the timeline for the preclinical data and what can we expect than that if at least.

Peter A. Altman: Our goal here is to complete enrollment in this trial next year, and so all of the activities we're pursuing and implementing all of the FDA guidance for the COVID-19 clinical efforts have been completed and will benefit the restart at different sites around the country. So that's about the best answer I can give you today.

Thank you.

Thank you Kumar so.

Do you feel for which is our allergenic mesenchymal therapy for the treatment of acute respiratory distress that has developed secondary to cope with 19 is a program that we're advancing our following our cardiac low program with the same cells.

Peter A. Altman: But you'll be able to track this as we give updates on our activities moving forward. And in terms of PCO or ARS, what is the timeline for the preclinical data, and what can we expect when that is released? Thanks.

So as folks on the call. We're just updated you know we not only have submitted an eye Andy but we submitted a response to the FDA has questions on the I Indeed.

And things are going relatively well all of that data because it's related to the exact same cells is fundamentally supportive of what we're doing with P.C.D.A.O. for an acute respiratory distress the timeline I had for.

Peter A. Altman: Thank you, Kumar. DCO4, which is our allogenic mesenchymal therapy for the treatment of acute respiratory distress that has developed secondary to COVID-19, is a program that we're advancing following our Cardi-ALLO program with the same cells. So, as folks on the call were just updated, you know, we not only have submitted an IND, but we've submitted a response to the FDA's questions on the IND, and things are going relatively well. All of that data, because it's related to the exact same cells, is fundamentally supportive of what we're doing with BCDA04 in acute respiratory distress. The timeline ahead for preclinical data is rather short for us and for the FDA, but I think our modus operandi would be to have it presented and published at a scientific session, so that will likely be further out before the rest of the world gets to see it in all its color.

The preclinical data is rather short for us and for the F.D.A., but I think our modus operandi would be to habit.

Presented and published in a scientific session. So that will likely be further out before the rest of the world gets to see it knowledge color. So I think the the intent here.

As to have this I M D.

Accepted by the agency by the end of this year and so with that in mind, we need to have clinical data well invent a preclinical that excuse me well in advance of that so I think with those sort of metrics you can get a sense of of where we're at.

Peter A. Altman: So I think the intent here is to have this IND accepted by the agency by the end of this year. And so with that in mind, we need to have preclinical data well in advance of that. So I think with those sort of metrics, you can get a sense of where we're at, and the next question... Thank you, Kumar. I was just thanking Kumar.

Okay. Thank you.

And then next question thanks to Mark.

I'm sorry.

I was just thinking Kumar Okay. Thank you and the next question comes from Jason Kolbert with John Awesome James.

Hey, Peter Congratulations a bunch of corn and Jason Good morning, how are you a bunch of questions.

One of the BFX lawsuit is actually really interesting and now that you you know you sound excited and that there are some revenue allocated to.

Peter A. Altman: The next question comes from Jason Colbert with Joplin. Hey Peter, congratulations. A bunch of questions. Good morning, Jason. How are you?

Fighting that fight do you have any idea on what the next step will be in the courts to understand where you're at.

Peter A. Altman: A bunch of questions. One, the BFX lawsuit is actually really interesting. Now that you, Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia, where you're at. So, I do have complete clarity on where we're at, however, because it's a lawsuit, I'm not taking specific questions on that. I do know that a lot of the materials related to the lawsuit are publicly available via the federal court's information system, and I would just have folks look for that as this moves downstream.

So I do I have complete clarity on a where we're at however, because it's a lawsuit.

I'm not taking specific questions on that I do know that a lot of the materials related to the the law suit our publicly available via the federal courts information system and I would I would just have folks.

Look for that as this moves downstream.

Okay, we sure well and my understanding is and yeah. The last quarter, we were talking about the potential to have up to 50 patients randomized and it sounds like you really exceeded that goal at 77. So it's.

Peter A. Altman: We sure will. And my understanding is that, in the last quarter, we were talking about the potential to have up to 50 patients randomized, and it sounds like you really exceeded that goal at 77. The trial is actually enrolling pretty well. Is that the right interpretation? Well, I don't feel that way.

Trial is actually enrolling pretty well is that the right interpretation.

Well I don't feel that way I think we are enrolling on the other side to covert I mean, so folks can appreciate.

Peter A. Altman: I think we are enrolling on the other side of COVID. I mean, folks can appreciate, you know, elective procedures stopped in the United States almost completely for a short period of time. And so it's a little like restarting the trial.

No elective procedures stopped in the United States almost completely for a short period of time and so it's a little like restarting. The trial. We've had a few patients that we treated this quarter, we actually feel patients were treated every month this quarter.

We are treating patients today, so we're not happy with the enrollment yet, but we shouldn't be there should be you know a hockey stick growth on this and we're working to deliver that okay. I understand then and can we take a few minutes and just talk a little bit about the endpoint, the Minnesota heart failure quality of life assessed.

Peter A. Altman: We've had a few patients that we've treated this quarter. We actually have a few patients that we treat every month this quarter. We are treating patients today, so we're not happy with the enrollment yet. But we shouldn't be.

Peter A. Altman: There should be hockey stick growth on this, and we're working to deliver that. Okay. I understand. And can we take a few minutes and just talk a little bit about the endpoint, the Minnesota heart failure quality of life assessment, and kind of where your discussions are with the FDA, you know, fast-forwarding and assuming that we meet those endpoints and we have data? Absolutely, so for folks who are new to Cardi-Amp, the primary endpoint in this heart failure trial is a Finkelstein-Schoenfeld hierarchical composite endpoint, and it includes three tiers, major adverse cardiac events, and functional capacity as measured by a 6-minute walk. We met this end point in our phase two trial. We are greater than 90% powered to hit this end point if we have half of the treatment effect we saw in our phase two trial.

Men and kind of where your discussions are with the F.D. I assume you know fast forwarding and assuming that we meet those endpoints and we have data where does that position the company.

Absolutely. So so for folks who are new to cardiac the primary endpoint in this heart failure trial is a finkelstein schoenfeld hierarchical composition endpoint and it includes three tiers death may.

Major adverse cardiac events and functional capacity as measured by six minute walk.

We met this endpoint in our phase two trial.

We are greater than 90% powered to hit this endpoint if we have half of the treatment effect, we saw in our phase two trial.

So it's a rigorous outcomes endpoint, we feel it has value for.

Peter A. Altman: So it's a rigorous outcomes endpoint, we feel it has value for, clinicians to understand that this is a robust outcome, and we feel that payers will support it as well. And I note that this is a pivotal trial for product registration, and the endpoints are selected primarily for, first, approval, but second, approval and reimbursement and labeling. And so there are hierarchical endpoints, as I think you're noting, Jason. After we meet the primary endpoint, then we roll down to pre-specified secondary hierarchical endpoints to preserve the statistical power, or alpha. And fundamentally, the way this works is we hit the primary, we roll down to a first safety secondary endpoint, we meet that endpoint, which we met in the phase two, then we roll down to a next, more refined safety endpoint, which we also met in the phase two, and then we roll into other efficacy endpoints, and that next one there is the quality of life on that enhances quality of life, even if it has increased mortality, we are interested in hearing about it.

Clinicians to understand that this is a robust outcome and we feel that payers will supported as well and I note that this is a pivotal trial for product registration and the endpoints are selected primarily for first approval, but second.

[noise] approval, and a reimbursement and labeling and so there are hierarchical endpoints as as I think you're you're you're noting Jason after we meet the primary endpoint, Dan we roll down to pre specified secondary hierarchical endpoints to preserve the statistical power or alpha and fundamentally the.

Away. This works as we hit the primary we roll down to a first safety secondary endpoint, we meet that endpoint, which we met in the phase. Two then we roll down to a neck and that's next more refined safety and plant, which we also met in the phase two and then we roll into other efficacy endpoints and.

That next one there is the quality of life read out.

When we first began this trial nobody thought the FDA or whatever support a quality of life endpoint for heart failure trial. However, I believe it was in mid 2018, the FDA I'll put out something that said listen if you have something for heart failure that enhances quality of life.

Even if it has increased mortality we are interested in hearing about it and so that's that's a couple of things one that next pre specified hierarchical endpoint of quality of life is important second it says it. This is a real problem the sta patients and physicians are looking.

Peter A. Altman: And so that says a couple of things. One, that next pre-specified hierarchical endpoint of quality of life is important. Second, it says that this is a real problem. The FDA, patients, and physicians are looking for therapies that can help these patients. And so it's a delight to be in this fight and to be advancing something that we feel has great safety, has a great risk-benefit profile for these patients, and frankly, doesn't hurt the societal economic pocketbook so hard because it's really going to be a cost-effective, And so with the totality of that data package, there certainly seems like there would be a window of opportunity for approval versus requiring a second trial, although I understand it's early to speculate on that.

For therapies that can help these patients and so it's a it's a delight to be in this fight and to be advancing something that we feel has great safety has a great risk benefit profile for these patients and frankly doesn't.

Hurt the the suicidal economic pocket book, so hard because it's a really going to be a cost effective therapy.

And so with the totality of that data package. There certainly seems like there would be a window of opportunity for approval farces, requiring a second trial, although I understand it's early to speculate on that.

Oh, absolutely. So this is that's a great point this is designated and qualified by the FDA already as.

Peter A. Altman: Oh, actually, so this is a great point. This is designated and qualified by the FDA already as a pivotal trial. It meets the requirements. Now, clearly, the FDA will look at the totality of data, and we can't guarantee what those outcomes are because this is a, you know, randomized, controlled, blinded trial. But yeah, this is intended to be the trial for product registration. Okay.

A pivotal trial it meets the requirements now clearly the F.D.A., we'll look at the totality of data and we can't guarantee what those outcomes are because this is a you know randomized controlled blinded trial.

But yeah. This this is intended to be the trial for product registration.

Okay and last thing is can you talk a little bit about other funding measures I know youve received a lot of support from CMS and I know that there was probably other funding sources out there or are you you know still looking at how to bring in those types of non dilutive free sources.

Peter A. Altman: And last thing, can you talk a little bit about other funding measures? I know you've received a lot of support from CMS, and I know that there are probably other funding sources out there. Are you still looking at how to bring in those types of non-dilutive resources? Thank you for that question. So the short form is, always.

[laughter]. So thank you for that question. So there's the short form is yes always but for folks on the call as Jason notes we have.

Peter A. Altman: But for folks on the call, as Jason notes, we have CMS reimbursement for the CARDI-AMP heart failure trial and for the CARDI-AMP chronic myocardial ischemia trial. And what that means is that CMS, under a Category B IDE approval and categorization, will pay for patient screening. They will pay for patient treatment, and they will reimburse centers for BioCardia's investigational CARDI-AMP cell therapy system. And they will pay for standard of care follow-up. That doesn't mean that running these clinical trials is free, but it is extremely more capital efficient than any of our peers in this space. And that is a value proposition.

CMS reimbursement in the Cardium heart failure trial and in the cardiac chronic myocardial ischemia trial and what that means is that CMS under a category B I D E approval and categorization.

We'll pay for patient screening they will pay for patient treatment. They will reimburse centers for bio cardio is investigational cardiac cell therapy system and they will pay for standard of care fall that doesn't mean, they're running these clinical trials is free but it is extremely more capital efficient then.

Any of our peers in this space and that is a value proposition yeah, no I'd also like.

Peter A. Altman: We also feel... Yeah, no, it explains how you've gotten so much done, Peter, with pretty limited resources, but just used incredibly efficiently. Thank you. Thank you, Jason. And the next question comes from Jason McCarthy with Max. Hey, thanks for taking my question. It's a vape on the line for Jason.

How you've gotten so much done Peter with what you know pretty limited resources, but just used incredibly efficient way. Thank you.

Thank you Jason.

Thank you.

And then as far as kind of Jason Mccarthy with Maxim Group.

Hey, Thanks for taking my question that.

Hey bond aligned for.

Doing well or just a quick question here I look at the open any clinical trial sites in Europe, and Asia, and I'd be had any discussions with regulators and those are perspective regions.

Peter A. Altman: I hope you guys are doing well. Just a quick question here. Are you looking to open any clinical trial sites in Europe and Asia? And have you had any discussions with regulators in those respective regions? So, at present, we're not sharing our plans for international efforts for Cardi-Amp. However, I can share with you that we are friendly and on good terms with folks in Europe, Canada, and Japan, and we understand the regulatory timeframes for advancing clinical development of the current program in those regions. The challenge is...

So at present.

Where we're not sharing our plans for international efforts for cardiac however, I can share with you that we are friendly and on good terms with folks in Europe, Canada in Japan.

And we understand the regulatory time frames.

For advancing clinical development of the current program in those regions.

Peter A. Altman: Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia. We don't benefit from the same Medicare reimbursement that I just detailed, although the advantages of those regions are that those are all very important markets that we intend to address in the future. And so nicely they all accept U.S. data, and we expect that there will be efforts in those regions in the future. Great, that's really a helpful thing. And then just one other quick question here.

The challenges.

In those regions is that.

We don't benefit from the same Medicare reimbursement that I just detailed although the advantages of those regions is that those are all I'm very important markets that we intend to address in the future and so nicely they all except U.S. data.

And we expected that there will be efforts in those regions in the future.

Great. That's that's really helpful. Thanks, and then just one other quick question here can you shed some color on any mitigating measures we've taken to compensate for any koby 19 related difficulties.

Peter A. Altman: Can you shed some light on any mitigating measures you've taken to compensate for any COVID-19-related difficulties with respect to pipeline progression, like any difficulties you might have had with patient recruitment or anything like that? Thanks. Yeah, no, no worries.

Back to pipeline progression like any difficulties there might have bad what the patient recruitment or anything like that thanks.

Yeah, No no worries I'm. So the FDA has draft guidance out for Cobot, 19, and they're they're really primarily concerned as they should be about patient safety. The patients that we're treating in these programs are at risk patients from cobot 90, and so element.

Peter A. Altman: And so the FDA has draft guidance out for COVID-19, and they're, they're really primarily concerned, as they should be, about patient safety. The patients that we are treating in these programs are at-risk patients for COVID-19, and so elements of the protocol have been modified to utilize screening for COVID-19 as part of the clinical program. The other efforts that have continued even through COVID-19 are, you know, as we've all been doing quite a few Zoom calls, the coordinators and the investigators involved in this program have, if anything, been a little bit more available and engaged because they don't have their ongoing duties at their various centers. A number of centers have been quite challenged, and there have been periods where it's been quiet.

Since of the.

Protocol have been modified to utilize center.

Screening for Covidien 19, as part of the clinical program. The other efforts that have continue even through a covert 19 as you know as we've all been doing quite a view zoom calls.

The coordinators and the investigators involved in this program have if anything been a little bit more available and engaged because they don't have their ongoing duties.

There are various centers.

Number of centers have been quite challenge and they've been periods, where it's been quiet, but the efforts that the team has implemented.

Peter A. Altman: But the efforts that the team has implemented are, frankly, all in our protocols and regulatory documents, which are confidential, and I can't be specific to, although I can share that a number of centers, you know, have required many of the changes that we've already implemented so that, you know, if anything, we are helping teach centers how to come back online on the other side and addressing issues that the institutional review boards for clinical efforts at these centers have asked And it's nice that the FDA was proactive in providing guidance so that we could also be proactive with some of the requests that the institutional review boards had. That's really helpful.

Our frankly, all in our protocols and regulatory documents, which are confidential and I I can't be specific to although I can share that a number of centers have required many of the changes that we've already implemented. So that you know if anything we are helping teach centers.

Come back online on the other side and addressing issues that the institutional review boards for clinical efforts at these centers have asked for and it's nice that the FDA was proactive in providing guidance. So that we could also be proactive to some of the request that the institutional review boards.

Hi, Matt.

Great. That's really helpful. Thanks, a lot for the additional clarity.

Peter A. Altman: Thanks a lot for the additional clarification. Thank you, and the next question comes from Jason Molloy with Alliance Global. Hey guys, good morning.

Thank you and the next question comes from Jason along the lines Global partners.

Hey, guys. Good morning. Thanks, taking my question I said, Oh, the DSMB be looks in Q4 offer or want to know too.

Peter A. Altman: Thanks for taking my question. I said the DSMB looks in Q4 for 01 and 02. You know, any expectations for what we should expect to see there or what sort of game in the outcomes you might expect to hear back from the DSMBs? Well, so the significant GSMB, Data Safety Monitoring Board, review that we will have at the end of this year includes, for the first time, a significant cohort of patients that have been randomized already past their primary efficacy readout. And so the futility analysis there, which will be on the totality of patients that have been enrolled by the end of the fourth quarter, will also include the readout on those patients that have already been treated.

You know any expectations, what we should expect to see there or what sort of the gaming the outcome he might tick hear back into the SMB.

Well so the the significant.

D S M b.

Review data safety monitoring Board review that we will have at the end of this year includes for the first time, a significant cohort of patients that have been randomize already passed their primary efficacy readout.

And so the futility analysis, there, which will be on the totality of patients that had been enrolled by the ended the fourth quarter will also include the read out on those patients that have already been treated.

And it's it's a significant milestone for trial of vis a vis import for product registration. So we're pretty excited about it.

Peter A. Altman: And it's a significant milestone for a trial of this import for product registration, so we're pretty excited about it. I don't have clarity on what the results will be. Remember I said earlier that we had to show we're powered 90% to see half the improvement we saw in Phase 2, which is lovely. Our Phase 3 rolling cohort had data that was approximately three times better than our Phase 2 data. So if that continues, we're in a very good place. And the recent Data Safety Monitoring Board review that we already had on March 31st. We had a clean bill of health. They said, "Get this trial done." So we're pretty excited about it. I don't expect, and I get questions on this, I do not expect this trial to be stopped early. It's a pivotal heart failure trial, and so there are 260 patients all in all. That's a major accomplishment.

I don't have clarity on what the results will be I don't have any predictions, but I do note that our are rolling cohort data, which was open label on only 10 patients was.

Number I said earlier that we had to show we have we're powered 90% to see the half the improvement we saw in phase two which is lovely our phase three rolling cohort had data that was approximately three times better than our phase two data. So we're.

If that continues we're in a very good place and the recent data safety monitoring Board review that we've already had on March 31st as we entered into the current Q2, we had clean below help they said get this trial done. So we're pretty excited about it I don't expect and I guess.

Lessons on as I do not expect this trial to be stopped early.

It you know, it's a pivotal heart failure trial and so it's 260 patients all in.

That's a major accomplishment.

Safety profile, we have is excellent so far but I think that that the DSMB be review in Q4 should really significantly de risked. This this trial because.

Peter A. Altman: The safety profile we have is excellent so far, but I think that the DSMB review in Q4 should really significantly de-risk this trial because the company will know that they're looking at the efficacy data, which is great. Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Miranda Benvenuti, BioCardia. But so then on the ARDS, the COVID-19 ARDS trial, what should we anticipate that sort of looking like, assuming it gets accepted by the FDA and you start kicking it off in your first quarter of 21? So, again, the target right now is to secure the IND acceptance for acute The funding to advance that trial has not been defined, and it is not budgeted for today.

We'll we'll know that they're looking at the efficacy data which is great.

Yes, understood I can see I was going asked about the early stoppage like it's really understand that's not something when it got to in any way or expect given that we're working with there.

But so then on the air or do you have to coordinate King Air DS trial, which we anticipate that sort of looking like assuming it gets accepted by the FDA and started you start kicking that off your first quarter 21.

So.

Again, the we're going to the target right now is to secure the I.M.D. acceptance for acute respiratory distress secondary to cope with 19 for the same cells that we are.

Manufacturing.

Still it intended for our Carty Aloe program under the I, India the agencies reviewing.

The funding to advance that trial has not been defined.

And is not budgeted for today. However, there are significant non dilutive resources out there for compelling therapeutic strategies to treat covert 19, so I really can't lay out a timeline for that ahead I can detailed at many of the cobot 19 trials have.

Peter A. Altman: However, there are significant non-dilutive resources out there for compelling therapeutic strategies to treat COVID-19, so I really can't lay out a timeline for that ahead. I can detail that many of the COVID-19, pivotal heart failure, and chronic myocardial ischemia trials. And so there are certain advantages inherent in that from starting trials to completing them. Also, I note that the FDA is reportedly quite responsive with respect to COVID-19 IND approaches. And all of the feedback we have and the efforts we have for the same cells for our other indication are appropriate for this indication. So we will be going into the agency with a very similar package, shall we say. Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Unknown Attendee, Kumaraguru Raja, David McClung, Miranda Peto, Yeah, I'll throw out a prediction.

Much shorter follow up times then.

Our.

Pivotal heart failure, and chronic myocardial ischemia trials and so there are certain advantages inherent in that from starting trials to completing them.

Also I note that the FDA is reportedly quite responsive with respect to.

Covert 19, I, India approaches and and all of the feedback we have and the efforts. We have four are the same sells for our other indication are appropriate.

For this indication so we will be going into the agency with a very.

Similar packet shall we should shall we say.

Understood you I know that certainly lot quicker on the Coca Nike's well they should the how would you care to talk a little bit maybe you didn't talk later on in this forum. Some expectations are for you might see Foura mesoblast, rather score coming up your second half here.

Yeah, I'll I'll throw out a prediction I think they're gonna get approved for their graft versus host disease indication I've looked at the data I think it's great and I wish them every success I also wish them success in there and they're cardiac programs. The cells that have are exciting cells, they're not too dissimilar from what were.

Peter A. Altman: I think they're going to get approved for their graft births and psoas disease indication. I've looked at the data. I think it's great, and I wish them every success. I also wish them success in their cardiac programs. The cells they have are exciting cells. They're not too dissimilar from what we're advancing with respect to our allogenic program. I think a primary differentiator is how we select and expand the cells.

Advancing.

With respect to our Allergenic program I think a primary differentiator is how we select and expand the cells I do note that we have completed and published three separate clinical trials in a scheme at heart failure with our partners using culture expanded.

Peter A. Altman: I do note that we have completed and published three separate clinical trials in ischemic heart failure with our partners using culture-expanded mesenchymal cells. We have a lot of data that's going into the programs we're advancing, so I feel pretty confident about what we're doing with expanded mesenchymal cells in the indication of ischemic heart failure. And frankly, the cardiac cells were superior. Our trials and our technology are fundamentally different from what they're doing. You know, we are using different cells. We're using a patient selection approach that gives us a huge advantage in seeing efficacy. We have a delivery system that's been published to have about 3.5 times the efficiency of delivery of their delivery system and which has been published to have a significantly superior safety profile to the delivery system that they used in their phase three program.

Mesenchymal cells and so we have a lot of data that's going into the programs were advancing.

So I feel pretty confident about what we're doing and I note that in our trials, we actually ran head to head programs of cardiac versus.

Expanded mesenchymal cells in the a scheme of heart failure indication and frankly, the cardium cells were superior our trials and our technology are fundamentally different from what they're doing.

We are using different cells were using a patient selection approach that gives us a huge advantage.

To see efficacy, we havent delivery system. That's been published to have about 3.5 times the efficiency of delivery of their delivery system, and which has been published to have a significantly superior safety profile to the delivery system that they used in their phase three program and our clinical trial endpoint is it continue.

Peter A. Altman: And our clinical trial endpoint is a continuous composite endpoint that includes functional capacity interwoven with adverse events and with mortality. You know, their trial is an event-driven MACE trial which has difficulties when the trial is not as large as it potentially could be. So I wish them well. I think their cells are very interesting cells. I think they have a great team. But that said, I think their success will help us. I don't think that if they miss on their data readouts, that that has a negative implication for us per se.

Yes composite endpoint that includes functional capacity interwoven with adverse events and with mortality. Their trial is a is a event driven mace trial, which has difficulties when the trial is not as large as it could potentially could be so I wish them well.

I think there cells are very interesting cells I think they have a great team and but that said you know I think their success will help us I don't think that if they if they miss on there on their data readouts that that has a negative implication for us per se.

Understood. Thanks for taking the questions.

Peter A. Altman: Thank you for taking the question. I appreciate the call. Thank you. And as there are no more questions, I would like to return the floor to Dr. Altman for any closing comments. Thank you, Keith. I want to thank all of you. Thank you for participating in today's call and for your interest in BioCardia. We look forward to sharing our continued progress. Thanks, and have a great day! Thank you. The conference is now concluded. Thank you for attending today's presentation.

Appreciate the call.

Thank you.

Yes, I would like to return the four to Dr. often for any closing comments.

Thank you Keith I want to thank all of you for participating on today's call and for your interest in bio cardia.

We look forward to sharing our continued progress.

Thanks, and have a great day.

Thank you the conference. This all concluded thank you for Ginnie today's presentation.

Got your lines.