Half Year 2023 BioCardia Inc Earnings Call
Ladies and gentlemen, thank you for standing by.
Good afternoon, and welcome to the bio cardiac 2023 second quarter conference call.
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At this time I would like to turn the conference over to Miranda peso of bio cardiac Investor Relations. Please go ahead Miranda.
Thank you very much good afternoon, and thank you for participating in today's conference call.
Joining me from Biochar D. His leadership team are Peter Amen Ph D, President and CEO and David Mcclung, The company's Chief Financial Officer.
During this call management will be making forward looking statements, including statements that address myocardial expectation for future performance and operational results references to management's intentions beliefs projections outlook analyses and current expectations.
Such factors include among others, the inherent uncertainties associated with developing new products.
Knowledge is.
And obtaining regulatory approvals forward.
Forward looking statements involve risks and other factors that may cause actual results to differ materially from these statements for more information about these risks. Please refer to the risk factors and cautionary statements described and bio cardio as reports on Form 10-K filed March 29th 2023.
And 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 August nine 2023, except as required by law. The company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.
It is now my pleasure to turn the call over to Peter out men ph D. Biochar. He is president and CEO . Peter Please go ahead.
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 ischemic heart failure, chronic myocardial ischemia and acute respiratory distress syndrome.
All of our cell based therapies involve local delivery of the therapeutic to the heart or lungs, where we intend them to act locally.
This mission has not changed and all of these programs are still viable.
We had a solid second quarter of 2023, and our team delivered on the milestones promised for our cardiac autologous cell therapy in heart failure or Bcl, one we implemented the adapter statistical analysis plan with the complete FDA review.
We completed our submission in Japan towards approval based on existing data and we were finally seeing a significant increase in enrollment, including a number of patients from Canada.
For our cardiac autologous cell therapy for chronic myocardial ischemia, we continue to make progress on enrolling in enrolling cohort in ways that we can enhance the trial and for our Carty Allo allogeneic cell therapy in heart failure.
First patients or about to be enrolled.
Myocardial also closed on a modest financing of $2 6 million and which insiders participated.
Had a publication with our partner sell pro Thera on the importance of therapeutic delivery had three invited scientific presentations and advance business development discussions.
Q2 was a good quarter.
This third quarter, we were thrown a curve ball when the data safety monitoring board for the cardiac heart failure trial or Bcl, one recommended we pause enrollment in the study.
We have detailed the recommendation in our July 24th press release, and I will read it for you here.
Yeah.
Based on an analysis of the trial data the primary composite endpoint assessed meant and a supplemental analysis presented on 719 23.
Unrelated to any emergent safety events, the DSM V recommends pausing, new patient enrollment and any potential crossover patient procedures pending and outcomes analysis of patients currently completing the one year follow up as well as the patients completing their imminently scheduled treatment.
The D. S. M. B recommends notifying currently enrolled patients completing their treatment sequence, but the trial will be paused following their scheduled treatment to assess intermediate study results.
The DSM V recommends the blind not be broken at this time to protect the integrity of the outcomes yet to be collected and to ensure that the study may be restarted without compromise after completion of the one year data analysis.
And to quote.
It is confusing to us.
There were no treatment emergent safety issues reported patients in aggregate appear to be showing clinical improvement and enrolment and accelerated significantly in recent months.
We have followed the data safety monitoring board recommendation.
We continue to randomize and monitor patients enrolled in this clinical study in which both patients and evaluating physicians are blinded to the treatment group.
Yeah.
We need more information to decide next steps for this program, which could be to restart the trial to initiate a new trial protocol under the same regulatory submission or two abandoned the program completely.
Today, we don't feel that the D. S. M. B proposal to wait for 14 months to potentially restart the trial makes any sense.
If we initiated a new trial protocol. There are changes we would like to include to simplify the performance of the trial and there are changes that the FDA has expressed interest in including specifically a change to a different functional capacity measure for the third tier of our finkelstein schoenfeld composite endpoint.
If there are interesting signals in the trial that support a new trial protocol with a different endpoint. Our sense is we could implement this very quickly.
A second trial if it makes sense would also address the FTA seeber desire to have two separate trials for an approval.
Okay.
One of our first actions on receiving the data safety monitoring board recommendations was to confirm that the data safety monitoring Board review materials were correct.
The only data in the trial at this interim analysis and its been well monitored where clean does that for the primary composite endpoint the survival data the major adverse cardiac event data and the functional capacity by six minute walk data.
We engaged independent experienced data analysis and clinical consultants to review the primary end point analysis and secondary outcome measures.
They will be able to see the information that the SMB reviewed as well and assess whether a follow up meeting with the D. S N V as warranted.
We have been advised to stay blinded during this process to preserve options should the data set be better with respect to the primary endpoints.
Soon thereafter Biochar you may have a segregated team reviewed the primary endpoint based on our monitoring clean data and the secondary endpoints based on the available Unmonitored data.
Additional sub analysis on this interim dataset will also likely take place to inform next steps.
New material information will be shared publicly as appropriate.
On June or June submission of the cardiac cell therapy system to Japan's pharmaceutical and medical device agency or P. M. D. A for our first formal consultation towards approval for the indication of ischemic heart failure with reduced ejection fraction was based on existing safety and efficacy data.
The submission was reviewed and accepted by the P. M da for formal consultation with some clarifying questions, which have been addressed.
The P M D. A consultation could take up to four months to schedule per their normal review process. Although dates in September have been requested.
Subsequent interactions with <unk> are expected.
To our knowledge.
We have a great deal more safety and efficacy data than other cardiac cell therapies approved are reported to be seeking approval soon in Japan.
We have 185 procedures performed to date and the cardiac phase one two and three programs with good support for efficacy from the 63 patients where we have complete visibility into the data and apparently good safety from the additional 122 procedures to which we are still blinded.
There are other compelling reasons for <unk> to support approval and that the elements of the system already have first world regulatory approvals in Japan, EU, <unk> USA and the procedures minimally invasive where other cardiac cell therapy offerings in Japan requires surgical open chest access to the heart.
Yeah.
If approved the Cardiome cell therapy system has potential to be the first minimally invasive catheter based cell therapy available in Japan.
P. M. D. A has confirmed that should we be approved other developers of cell therapies in Japan could also be enable to use our delivery systems. If we authorize it ahead.
That an approval of car T cell therapy could be in advance to the field as a whole.
As we work through the process of gathering more information to decide next steps for the <unk>, one program and consult with P. MDA, we expect important milestones for our other clinical programs.
The cardiac.
Therapy trial for chronic myocardial ischemia or BCD O. Two is a phase III multicenter randomized double blinded controlled study intended to include up to 343 patients at up to 40 clinical sites.
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.
A number of leading investigators, including both principal investigators in this trial believe this to be the most compelling indication for this therapy.
Planning for the randomization phase is already underway based on promising experienced in the patients treated to date.
Strategies of using the cell population analysis as it means to set patient dosing as opposed to excluding patients and means to include more patients based on modifying baseline exclusion criteria are under consideration to enable more rapid enrollment.
Six additional centers are actively being on boarded.
Yeah.
Yeah.
The company's Carty Allo allogeneic cell therapy for ischemic heart failure or BCD L. Three program is a phase <unk> clinical trial encompassing 69 patients.
Clinical grade cells have been manufactured at Biochar D and are ready for use with the Companys proprietary delivery system also manufactured of Biochar deal.
The first clinical center has finalized its clinical study agreement and received conditional IRB approval.
Cellular preparation test runs at the clinical site and the site activation visit are scheduled for this month.
Patient enrollment is expected to begin in the third quarter.
This study builds on three previous trials of message panel stem cells in ischemic heart failure, using the company's proprietary helix delivery system encompassing 93 patients treated with no treatment emergent serious adverse events.
Previous trial results showed compelling early signals for benefit.
The company's allogeneic cell therapy trial for acute respiratory distress syndrome, or BCD four has been de prioritize to focus current financial resources on the other programs.
This decision was based on the greatly reduced population of patients with acute respiratory distress secondary to COVID-19.
When resources permit biochar intends to expand the current indication to a broader population beyond COVID-19 induced ards and two other pulmonary indications.
Myocardial helix biotherapeutic delivery system or helix delivers therapeutics into the heart muscle with penetrating helical needle from within the heart.
It enables local delivery of cell and gene based therapies, including <unk> own cell therapies.
It remains the safest easiest to use and most efficient means for the delivery of cells genes and proteins to the heart muscle.
The delivery platform includes proprietary approve steer will guide systems approved delivery catheters and investigational imaging navigation.
Business development is active around our helix biotherapeutic delivery platform and in other areas and we are working to close meaningful deals by the end of the year.
These deals have potential to enable us to avoid financing.
Underlying our programs is extensive intellectual property.
In June the company announced that the Japan patent office granted a patent titled radial and Trans Endocardial delivery catheter.
The patent term that will expire in 2034.
The patent describes interventional biotherapeutic delivery catheters to deliver biologics to specific target sites within the heart chamber.
The allowed claims cover biocatalyst helical needle tip catheter technology platform and existing products and in future products in active development with enhanced features.
Also in June the European Patent office issued an intention to grant for a patent titled site selection entry and update with automatic remote image annotation.
The patent application describes techniques to bring previously obtained high resolution three dimensional images of patients heart such as from a magnetic resonance imaging or MRI into the cardiac catheterization procedures suite and to merge this image with the X Ray images the physician uses to navigate during the procedure.
This approach has been compelling in preclinical studies and is expected to further enhance targeting ease of procedures and data collection compared to our current procedures.
In summary, we have four significant compelling clinical programs and strategic assets around our three platforms of great value.
We recognize that the market share price does not reflect this.
We recognize that there is disappointment in confusion from the D. SMB response, but there is a wealth of data and active programs generating more data and products are built on data.
We have significant near term catalysts ahead from each of our three cardiac programs as well as our business development activities.
I will now pass the call to David Mcclung, Our CFO , who will review our Q2 2023 results.
David.
Thank you Peter and good afternoon, everyone rare.
Revenues were approximately $43000 for three months ended June 2023 comparable to approximately $975000 for the first three months ended March 31, 2022, primarily due to the timing of collaboration agreement revenues.
Expenses quarter over quarter were remarkably similar research and development expenses were approximately $2 3 million for the three months ended June 2023.
And for the three months ended June 22 2022.
Selling general and administrative expenses remained at approximately $1 $2 million in the second quarter of 'twenty three 'twenty three comparable to the same amount in the second quarter of 2020 tubes.
Our net loss was approximately $3 $4 million in Q2, 2023, as compared to $2 $5 million in Q2, 2022 primarily due to the fluctuation in collaboration revenues.
Net cash used in operations during the quarter was approximately $3 2 million as compared to approximately $2 $6 million in the second quarter of 2022.
And Biochar do you ended the quarter with approximately $4 3 million in cash and cash equivalents.
This provides runway into November without additional capital or funding from the business development and other activities that Peter mentioned earlier.
This concludes management's prepared comments and we're happy to now take questions.
Thank you at this time, we will open up the call to questions.
Should you wish to ask a question on today's call. As a reminder, you will need to press Star then the number one on your telephone.
If your question has been answered and he wished we wish to withdraw it you may do so by pressing the pound key followed by the number too.
We will pause now one moment to assemble our roster.
Yeah.
Today's first question comes from Joe pin generous with H C. Wainwright. Please proceed.
Hi, everybody good afternoon, and thanks for taking the question.
Peter I wanted to focus on the D. S. M. B review, because obviously like you said I mean this is somewhat of a really unique situation and I guess I wanted to reconcile something even though you don't have the answers yet and then look forward a little bit. So if the D. S. It'd be comes out and says that unblinded data or not.
Lee to meet the primary endpoint, usually you'd be in trial wind down.
You know activities right now in this study would be essentially done, but it's not and that's the very unique aspects. So I guess you know from that standpoint, how do you reconcile that comment with you know the study is still ongoing and the that you've seen blinded improvements in patient.
And then the second aspect of that question is which I think is important for listeners is then for patients that'll be followed in a blinded fashion to the one year benchmark you know what are the benchmarks that we and investors should be looking for with regard to our delta is in treatment effects.
Well. Thank you Joe for the question on on the DSM review and some of the nuances I guess.
On the first part.
I I don't have great clarity.
And so I can only hypothesize.
As I noted in our prepared comments.
We are also a little confused.
But we we assembled the SMB and then it's a very solid group and so as we try to read the proverbial tea leaves.
The there could be a I'll.
Just rehash it so folks are not entirely aware, we have a very low mortality rate in the trial relative to what we've seen in the latest.
Clinical trial setting for the latest guideline directed therapy in the New England Journal of Medicine, and we appear to have a very low a major adverse cardiac events right and those are two components of the primary finkelstein schoenfeld three tier <unk>.
Endpoint the third element is six minute walk.
So.
I can hypothesize that maybe there is something wrong with the six minute walk distance measure.
As this primary endpoint.
We have.
Because the levels are so low with respect to.
Mortality and mace events, the six minute walk likely has a larger impact in this trial than than we may have expected.
And the the nuance of how it's incorporated in the Finkelstein Schoenfeld.
Endpoint.
They have implications as well and so that data as I mentioned is being analyzed it actually already has been analyzed by a separate group and we are confirming that the data that was provided to DSM b.
Is is.
The conclusions that they're drawing or from a substantially correct data analysis. The the other thing that we're doing is we havent clinical advisor external to the company that we are going to have look at all of the materials and assess whether or not a follow on conversation as appropriate with the SMB.
To clarify.
Potentially.
During the recommendation I think right now our sense is that the restart in 14 months as I've detailed does does not make a lot of sense today to management.
And so but we have been advised to stay blinded ourselves to the data to maximize.
Potential going forward.
Spectation is that will evolve after these next steps.
And.
And so that's just where we are now your second question I think was on trial wind down.
No more.
Sorry, I forget any one.
One year, yes.
Yeah, so as far as trial wind down the information we received from this will will impact.
The the data that we have so we are still randomized patients today and.
Cause all of the data supports that this is a safe and all the past data that we see supports this is efficacious.
We're still bullish on the direction that we're going and so those patients will be randomized expectation is all of the outstanding patients will be randomized in the next.
Six weeks to eight weeks.
And then we'll follow them for a period of.
A year before we get to the the true data readout from this trial.
The the interim readout that we may have if we if data is viewed will have the challenges that the many of the endpoints has not yet been monitor and so there'll be looking at that what I would expect to look for here is I followed the primary endpoint.
The mortality data is going to be important I mean, if we're losing on that for some reason that.
I can't explain that.
That would be a surprise.
The mace data will be this next thing to look at and if we're losing on that that will also be interesting and to look at but I think the primary feature since those two are so low already and this treated population I don't expect either of those to have any.
Interesting signals again.
I I'm not.
I'm not privy to the data so I'm, providing you my best guess work here all and my expectation is that if there is something it's the six minute walk as problematic.
When we look at the other.
Prespecified hierarchical endpoints quality of life.
All of the extensive echo data, we have from our core laboratory at Yale There may be some interesting observations in there that enhance our our comfort level.
And then also two year data follow up and we haven't really looked at two years, but understanding how these patients are doing long term is also going to be really important and I would again I would look at the the survival data I'd look at that Mace data and then I look at the a functional endpoints in six minute walk quality of life.
And all the L D.
All of the echocardiographic data such as Lv ejection fraction Lv end diastolic.
Dimensions, the end systolic dimensions, and those are really important endpoints center are quite objective.
And we'll see where we go from there.
I think right now it's.
It's it's it's interesting I mean, we don't have clarity on.
Why they would pause it.
If they don't think were going to hit the primary endpoint maybe their perception is.
Guys pause this and stop this trial and restarted another variable other than six minute walk maybe there'll be successful I don't know, it's all guesswork, but we're being prudent as we're moving forward. We are we are stewards of the value that this trial has in it for all of our shareholders and for patients and so we have to take the steps that we're taking in the order, we're taking and we're.
<unk> it with World class folks so that.
We will get to the right answers and hopefully sooner rather than later.
Now Peter Thanks, a lot I appreciate the color on the speculation for this pretty unique situation and looking forward to the outcomes. Thanks a lot.
Yeah I appreciate the question Joe.
At this time, we're showing no further questioners in the queue and this does conclude our question and answer session I would now like to turn the conference back over to Peter Altman for any closing remarks.
I want to thank all of you for participating in today's call and for your interest in <unk> and our primary mission to treat heart disease.
We look forward to sharing our continued progress.
And as I always say stay healthy declined and have a wonderful day.
<unk>.
The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.
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