Q3 2021 Bio Path Holdings Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the bio path Holdings third quarter 2021 earnings Conference call. At this time all participants are in a listen only mode. Following the formal remarks, we will open the call up for questions I would now like to turn the call over will O'connor of Stern Investor Relations. Please proceed.
Thank you operator, welcome to the bio path Holdings conference call and webcast to review the company's third quarter 2021 financial results and to provide an update on recent pipeline and corporate developments.
Earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call. The release is available at bio path Holdings Dot com.
With me today from bio path are president and CEO, Peter Nielsen and senior Vice President Finance accounting and administration Anthony price.
Before we begin the call I'd like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we urge you to read our actual results may differ materially from what is discussed on today's call.
With that I'll now turn the call over to bio paths CEO Peter Nielsen.
Thanks will.
Good morning, everyone.
And thank you for joining us.
This third quarter was marked by significant progress across the board and was highlighted by an investigational new drug application clearances for two key clinical programs and our DNA obliged development pipeline.
These regulatory clearances allow us to advance these important clinical trials.
A variety of oncology indications for which there are limited treatment options and patients are facing life limiting prognoses.
Let me turn now to a more detailed description of these clinical programs and the progress we are making advancing them through the clinical and regulatory pathway.
I'll begin with our lead product candidate <unk>.
Where we continue to make solid progress.
We continue to make significant progress advancing advancing stage two of our phase III clinical trial of Brexit Your version for.
For the treatment of acute myeloid leukemia or AML.
In combination with frontline therapy decided then in venetic lax.
As we have previously reported phase II clinical development practices, you burst in AFL commenced with stage one of the phase III clinical trial.
Which was open label untreated de Novo AML patients with a combination of <unk> and low dose cytarabine or <unk>.
Combination of <unk>, and <unk> was shown to be safe and more efficacious to treat this class of patients than with <unk> alone.
As many of you know.
It's been an evolving landscape where standard care of AML.
Despite these new therapies, there are still patients who are refractory or resistant.
And those are the patients we aim to help.
As standard of care evolves.
Adapted arent trial designed to reflect these changes.
The amended stage of this phase III trial in AML is an open label phase two two stage multi center study of <unk> in combination with decided and vanilla coax and two cohorts of patients with previously untreated AML and relapsed <unk>.
<unk>.
Okay.
Cohort includes treating relapsed resistant AML patients, who are a banana clacks resistant or intolerant with the two drug combination.
Should you Brewers and decided that.
The full trial design plans have approximately 54 evaluable patients for the cohort treating relapsed or refractory.
Refractory AML patients and the triple combination treatment of <unk>, decitabine, and venetic lax and the cohort treating AML patients who are vanilla clacks resistance or intolerance with the two drug combination of Brexit you boroughs and then decided it was a review of both cohorts.
Performed after 19 Evaluable patients.
The full trial design plans have approximately 98 evaluable patients for the cohort treating untreated AML patients with the triple combination treatment approaches you're boroughs decided been in banana clacks with a preliminary review of the cohort performed after 19 evaluable patients.
Kind of a formal interim analysis after 38 evaluable patients.
The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline response.
The frontline therapy with previously untreated AML patients.
The primary endpoint for this study will be the number of patients who achieved complete remission, which.
Which includes complete remission with incomplete hematologic recovery and complete remission with partial hematology recovery.
An interim analysis will be performed on each cohort to assess the safety and efficacy as a treatment earlier.
Earlier this year, we were excited to announce the successful completion of the safety run in stage two of the phase III and we look forward to advancing this study as we believe its unique design provides us with several definable registration pathways.
In December Dr Merrill <unk>.
Danny.
Associate Professor of the department of leukemia at the University of Texas, MD Anderson Cancer Center will present, the safety and preliminary efficacy data from the ongoing phase II trial of <unk> before an audience of world, leading oncologist at the 60 <unk> annual.
American Society of hematology or Ash annual meeting.
Next I'd like to turn to our planned phase <unk> clinical trial of <unk> in dash eight in patients with advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer.
Praxis diverse and dash, a fourth bio path drug candidate.
Is it a modified product from practices, you Brewers and sharing the same drug substance with enhanced nanoparticle properties.
In October we were delighted to announce that the FDA had reviewed and cleared our investigational new drug or IND.
<unk> application to initiate a phase one one b clinical trial of <unk> in dash eight in patients with solid tumors, including ovarian endometrial pancreatic and triple negative breast cancer.
This trial will be conducted at several leading cancer centers and is planned initially to evaluate the safety of <unk> in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer.
Often have poor outcomes and do.
So I hope that <unk> dash eight may provide clinical benefit for such patients.
Turning now to BP 1002, our second therapeutic candidate, which targets Bcl two.
As you know Bcl two is responsible for driving cell survival and up to 60% of all cancers.
Hi expression of Bcl two has been correlated with poor prognoses for patients diagnosed with AML.
<unk> has also shown activity against the anti pop Ptotic protein Bcl, two and works by neutralizing the proteins ph three domain.
It is an improved treatment for chronic lymphocytic leukemia, or CML patients and untreated AML patients. However.
With the exception of some patients treated with allergen genetic model of poetic cell transplantation.
Disease relapse invariably occurs often times due to BH III domain mutation over time.
<unk> 002 also targets the Bcl two protein. However, <unk> 002 activity is based on blocking the Bcl two messenger RNA and not the <unk> domain.
As a result, we believe BP 1002 could provide an alternative for <unk> patients, who have relapsed, including AML patients, who previously received <unk> treatments.
In August we announced that the FDA has reviewed and cleared the IND application for BP One zero so to for an initial phase one b clinical trial that will evaluate the ability of BP 1002 to treat refractory relapsed AML.
<unk> patients.
We expect this clinical trial to be conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell.
Cornell University.
The University of Texas, MD, Anderson Cancer Center, and the Georgia Cancer Center.
Additionally, a total of six evaluable patients are scheduled to be treated with BP 1002 monotherapy in a standard three plus three design with a starting dose of <unk>.
Milligram per square meter.
The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days.
The phase <unk> portion of the study.
After completion of BP 1002, monotherapy cohorts, and we will assess the safety and efficacy of <unk> two in combination with decidedly in refractory relapsed AML patients.
Finally.
Let me briefly review the prognosis.
Made with our third drug candidate.
BP 1003, which targets the staff III protein.
This program has shown promising preclinical data and we are very excited for the future of this program.
We are studying <unk> three for the treatment of pancreatic cancer in a patient derived tumor model.
Previous models have shown the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.
We are particularly excited to launch our first in human validation of this cutting edge therapy in an especially challenging cancer indication that has limited treatment options. We are aiming to file an IND application with this very promising product candidates in 2022.
With that I'll now turn the program over to Anthony price for a brief review of our third quarter 2021 financials, along with balance sheet highlights Anthony.
Thanks Peter.
The company reported a net loss of $2 1 million or 29 cents per share for the three months ended September 32021, compared to a net loss of 3.0 or <unk> 80 per share for the three months ended September 32020.
Research and development expense for the three months ended September 32021 decreased to 1.0 million compared to 2.01 million for the three months ended September 32020, primarily due to timing of activities related to our clinical trial for proxy giberson in AML.
And timing of drug material manufacturing and shipping activities.
General and administrative expense for the three months ended September 32021 increased to $1 1 million compared to 1.0 million for the three months ended September 32020, primarily due to increased stock based compensation expense.
As of September 32021, the company had cash of $26 6 million compared to $13 8 million at December 31, 2020.
Net cash used in operating activities for the nine months ended September 32021 was $7 1 million compared to $8 4 million for the comparable period in 2020.
Net cash provided by financing activities for the nine months ended September 32021 was 20.0 million.
With that I'll now turn the call back over to Peter.
Thanks Anthony.
In the coming weeks, we are looking forward to the data to be presented at ash as they further support our enthusiasm for the potential of <unk> to treat AML and believe they will drive clinical interest from oncologists and Hematologists, we treat these very sick patients the.
Progress, we are making is bringing us one step closer to our goal to bring new medicines to patients in need and I could not be more excited about the opportunities ahead for bio path as we strive to make our vision for the DNA <unk> technology, a reality for patients battling a variety of cancers.
With opera with that operator, we are ready to open the call for questions.
Ladies and gentlemen, if you have a question or a comment at this time. Please press. The Star then the one key on your Touchtone telephone. If your question has been answered or you wish to move yourself from the queue. Please press the pound key.
First question comes from Laura Engel with Stonegate capital.
Good morning, how are you.
Hi, Laura I'm fine. Thank you.
So good news on the IMD for the practice to person.
Just wondering related to that trial, when you get to the point of enrollment.
Towards solid tumors.
Yes.
Can you explain to me.
The non scientific pilot work with the various cancers as far as which patients.
Our available to enroll.
Thank you al.
Got it does it end up being focused on.
Which patients come or do you take enrollment based on requirements for the various cancer types.
The trial, let's say.
Several ovarian patients.
Our enrollment do you balance it out or does it in that kind of be in that focused on one tumor or do you wait and see how the results come in based on the types of cancer does that makes sense.
Yes, that's a good question and the way it's set up is that.
Phase one portion of this.
Trial is it's opened to several tumor categories, we basically wanted to get the patients and do the model therapy.
And demonstrate the safety and the solid tumors. The phase one b component is when do you start focusing in to this.
Specific cancer areas or tumor areas of interest and those will be combination therapy.
Most of the early.
Clinical work preclinical work.
Was in advanced ovarian and endometrial second one of course is pancreatic, but we're going to start with the advanced ovarian endometrial and that'll be with its combination therapy.
Treatment.
<unk>.
And then following that and not in a linear fashion I would expect that.
Yes.
Simultaneous activity going on we would.
Probably proceed.
To the pancreatic area.
That would be stage four metastatic people with.
It's combination treatment side of it I think it is.
And then the third area to come would be.
I think getting into one of the triple negative breast areas I think thats the hormones.
So that's the strategy open in those areas to speed it up cross section, it's really safety and then you go into the specifics for treatments in combination therapy.
It would be likely that it would be more effective against one type of cancer versus another on solid tumors. Then you could potentially later focused on that type of cancer.
Like weather.
Yes, I think.
I know the advanced ovarian and <unk> had good results.
CR papers to the pancreatic.
I think was also.
ACR.
That would be a good one also.
Some of the interest in.
Is that pancreatic for example is that in this kind of unique.
Model.
<unk>.
That was referenced in my comments.
It's basically they take human.
Tumors.
We are adding tumors grasp of the device.
And what have the stroma forms around it so you really emulator human pancreatic tumor and it showed that we could penetrate that and so there was.
Some interest in that so at this point.
I can't.
Hypothesize, which would be more effectively we would hope that week.
Be able to benefit patients.
Both areas.
Alright.
Okay, great well, thanks for clarifying that.
Hope you all have a great weekend concern at all Dan will detail for us on today's call.
Youre very welcome thanks, Laura.
Our next question comes from Jonathan Aschoff with Roth Capital Partners.
Thank you good morning, Peter and I was wondering if you could update us on when enrollment for one or two.
Our AML might begin and how many monotherapy cohorts do you expect for the phase one portion to then be able to go into <unk>.
Phase III based on what you.
And of the molecule.
I think that.
On the one or two in the AML.
Starts in 'twenty political 40 60 90.
So that would be your number of cohorts in the model.
To prepay.
There.
You would then look on the.
Going forward I think.
With the company.
Ed.
But going forward.
In.
A phase II, so that would be.
That would be it's hard to say the timing of it would be in the first quarter. It's always the mundane stuff getting the documents through the.
The specific sites going up through their IRB.
All of that.
Thanks Todd.
So.
But we're in that process trying to push you off.
We should be.
Should we get going with those patients.
And the FERC.
Okay and actually in my question I Misspoke I meant for when you can start phase <unk> combination therapy, not not phase III.
The same answer I just gave me.
Yes.
Yes, the phase one piece of it the monotherapy.
Sure.
Three patients.
There could be.
We think there could be a real potential.
For this you probably I think knows that.
The.
Survivability.
The patients.
Sale, Vanadic lax or relapsed solid.
It is not good so there could be some real interest in it but I couldnt imagine we'd be through that it will be the second half of next year before we'd be ready to do the <unk>.
Okay.
Maybe I missed this but can you tell us what specific cohorts, you'll have data from I'm, assuming it's the more rapidly enrolling vanadic lacks failure in tolerance and any from the other two.
Yes, I think the intent is to report on the entire trial. So we will report on the three cohorts. Some respect I think we.
Those are really separate trials for all three of them. They are all active and all enrolling.
We have our supply chain.
Finally.
Recovering from the problems.
It occurred in fact.
We are doubling our supply chain drug so that will really get us going again.
But the intent.
Would be good too.
Specific.
On all three.
Okay, and lastly, I was just curious if you could give us solid sense of how many venetic class failures. There are in the U S alone every year.
I don't know that there is a report out there.
And that's something where you referenced at MD Anderson.
Did that add.
I think that's the one.
Okay.
Survivability.
Post.
Relapse.
Three months or less but I do not know what.
That number is but it's.
Genetically the treatment population.
Yes.
The occurrence, it's the mutation of <unk> III.
Can.
I think thats, a pretty broad occurrence frankly.
Okay. Thank you for that that was just asking because a lot of companies are targeting that specific.
Specific slides.
Thank you Peter.
It's a real need.
Yes, Sir Thanks, Joe again, ladies and gentlemen, if you have a question or a comment at this time. Please press. The Star then the one key on your Touchtone telephone.
Our next question comes from <unk> with HC Wainwright.
Thank you.
Hello, Yes, good questions Hi, Thank you for taking my questions So with respect to the.
The phase one trial of VB 102 in lymphoma and <unk>.
Could you.
Provide an update on whether the trial is still on track to report data in the first half of next year.
The.
We're continuing to deal with slow enrollment in that trial and there is two issues I think I've mentioned before.
The low starting dose that we have to do slide 20 milligram per square meter.
And the second thing is that.
There is some trials out there competing car T.
What we're doing it that is.
Looking at sites and frankly, we're also going to.
Look to use some areas.
Some groups that.
Their business is.
Generating quality quality candidates. So I think we have to establish that momentum.
Or that infrastructure, if you will once we do that then.
We can give a better.
Read out to you about.
Pace of.
Getting those patients going the treatments effective we've had good results.
And the preclinical and reporting so it's just.
Being able to get past.
Patients to get past this low.
Does colleges when there is a competing trials out there.
<unk> to put them on.
The.
Probability of.
Benefit for their patients at 20.
As it's problematic. So we're taking actions that we think will.
Alleviate that.
Sure.
Coming quarters, and we'll get it back into a better position.
Got it.
And for the Phase III phase II trial of <unk> person.
Email to Triple combo trial do you see.
Do you think there is still any chance to complete interim view before the end of this year or it's going to be a 2022 event.
It's got to be a 2022 event.
Hi.
We.
Reviving if you will.
Drug supply chain.
We've had problems on the front end of the drug substance.
Basically double that.
We basically doubled that kind of supply chain, adding new firms that are really good that have slots.
Yes.
So.
We think that that.
It will get us going again because.
People do want to enroll in that so I might add that.
You'll be pleased with this.
We've had a lot of.
The goal is to get us.
Back into Mds.
All of that treatment.
<unk>.
We will.
We're working to get that lined out we can't do Brexit you are with <unk> because <unk> is not.
Approved in Mds, but there is just a.
Feeling that.
But.
Brexit you Bruce decided.
Alone provide a better benefit in those patients.
You can look forward seeing something on that in the near future.
Got it.
And lastly, just to clarify that.
Both the phase one trial of <unk> in <unk>.
And the.
Phase one trial of <unk>, one or two AML are going to start patient dosing in 2022.
Yes, because they both been approved.
Of course solid tumors was fairly recent AML was.
Sooner than that but.
It's just getting everybody lined up paperwork wise, we've got our piece.
National <unk> that kind of thing lined out.
So but.
Just getting those.
Protocols approved by IRB isn't getting the contra.
Contract agreements signed and everything that you seem to take time.
Thank you.
Thank you.
And I'm not showing any further questions at this time I would like to turn the call back over to Peter for any closing remarks.
Thank you operator.
Thank you again, everyone for joining us and for your continued support of bio path.
Have a great day.
Bye.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
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Good morning, ladies and gentlemen, and welcome to the bio path Holdings third quarter 2021 earnings Conference call. At this time, all participants are in a listen only mode.
The formal remarks, we will open the call up for questions.
I'd like to turn the call over will O'connor of Stern Investor Relations. Please proceed.
Thank you operator.
Welcome to the bio path Holdings conference call and webcast to review the company's third quarter 2021 financial results and to provide an update on recent pipeline and corporate developments.
Earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call. The release is available at holding dot com.
With me today from bio path are president and CEO, Peter Nielsen and senior Vice President Finance accounting and administration Anthony price.
Before we begin the call I'd like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties.
These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we urge you to read.
Our actual results may differ materially from what is discussed on today's call.
With that I'll now turn the call over to bio paths CEO Peter Nielsen.
Thanks will.
Good morning, everyone.
And thank you for joining us.
This third quarter was marked by significant progress across the board that was highlighted by investigational new drug application clearances for two key clinical programs and our DNA Belive development pipeline.
These regulatory clearances allow us to advance these important clinical trials.
A variety of oncology indications for which there are limited treatment options and patients are facing.
Cutting prognoses.
Let me turn now to a more detailed description of these clinical programs and the progress we are making advancing them through the clinical and regulatory pathway.
I'll begin with our lead product candidate <unk>.
Where we continue to make solid progress.
We continue to make significant progress advancing advancing stage two of our phase III clinical trial of Brexit Your version for.
For the treatment of acute myeloid leukemia, or AML in combination with frontline therapy decided that and banana clacks.
As we have previously reported phase II clinical development practices, you burst in AFL commenced with stage, one phase III clinical trial.
Which was open label untreated de Novo AML patients with a combination of proxy <unk> and low dose cytarabine or <unk>.
Combination of <unk>, and then <unk> was shown to be safe and more efficacious to treat this class of patients than with <unk> alone.
As many of you know there has been an evolving landscape where standard care of AML.
Despite these new therapies, there are still patients who are refractory or resistant.
And those are the patients we aim to help.
As standard of care evolves.
Adapted our trial design to reflect these changes.
The amended stage two of this phase III trial in AML is an open label Phase II two stage multi center study of <unk> in combination with decitabine and <unk> in two cohorts of patients with previously untreated AML and relapsed <unk>.
Just about.
Okay.
Cohort includes treating relapsed resistant AML patients who are in banana clacks resistant or intolerant with the two drug combination.
Thank you Bruce and decided that.
The full trial design plans have approximately 54 evaluable patients for the cohort treating relapsed <unk> refractory.
Refractory AML patients and the triple combination treatment of practicing your Burleson decided event and venetic lax and the cohort trading AML patients, who are vanilla class resistance or intolerance with the two drug combination of Brexit you Borough. So then decided it was a review of both cohorts.
Performed after 19 Evaluable patients.
The full trial design plans have approximately 98 evaluable patients for the cohort treating untreated AML patients with the triple combination treatment of <unk> and decided better banana clacks with a preliminary review of the cohort performed after 19 evaluable patients.
And a formal interim analysis after 38 evaluable patients.
The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline bonds other frontline therapy with previously untreated AML patients.
The primary endpoint for this study will be the number of patients who achieved complete remission.
Which includes complete remission with incomplete hematologic recovery and complete remission with partial hematology recovery.
And interim analysis will be performed on each cohort to assess the safety and efficacy as a treatment.
Earlier this year, we were excited to announce the successful completion of this safety run in stage two of the phase III and we look forward to advancing this study as we believe its unique design provides us with several definable registration pathways.
In December Dr. Maro, Ohanian Associate Professor of the Department of leukemia at the University of Texas, MD Anderson Cancer Center will present, the safety and preliminary efficacy data from the ongoing phase II trial of <unk> before an audience of worldwide.
Oncologists at the 60, <unk> annual American Society of Hematology or Ash annual meeting.
Next I'd like to turn to our planned phase <unk> clinical trial of <unk>, a dash eight in patients with advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer.
Brexit Giberson Dash, a fourth bio path drug candidate.
Is there a modified product from <unk> and sharing the same drug substance with enhanced nanoparticle properties.
In October we were delighted to announce that the FDA had reviewed and cleared our investigational new drug or IND.
Patients to initiate a phase one one b clinical trial of <unk> in dash eight in patients with solid tumors, including ovarian endometrial pancreatic and triple negative breast cancer.
This trial will be conducted at several leading cancer centers and is planned initially to evaluate the safety of <unk> in solid tumor patients.
Patients diagnosed with recurrent ovarian and endometrial cancer.
Often have poor outcomes and do that.
So our hope that proxies you Bruce at Dash Eights may provide clinical benefit for such patients.
Turning now to BP 1002, our second therapeutic candidate, which targets Bcl two.
You know Bcl two is responsible for driving cell survival and up to 60% of all cancers.
Hi expression of Bcl two has been correlated with poor prognoses for patients diagnosed with AML.
<unk> has also shown activity against the anti pop Ptotic protein Bcl, two and works by neutralizing the proteins ph three domain.
It is an approved treatment for chronic lymphocytic leukemia, or CML patients and untreated AML patients. However.
With the exception of some patients treated with allo Jud genetic model of poetic cell transplantation.
Disease relapse invariably incurs oftentimes due to <unk> III domain mutation over time.
<unk> 002 also targets the Bcl two protein. However, <unk> 002 activity is based on blocking the Bcl two messenger RNA and not the BH three domain.
As a result, we believe the BP 1002 could provide an alternative for <unk> patients, who have relapsed, including AML patients, who previously received <unk> treatments.
In August we announced that the FDA has reviewed and cleared the IND application for BP 100 to four on an initial phase one <unk> clinical trial that will evaluate.
The ability of BP 1002 to treat refractory relapsed AML patients.
We expect this clinical trial to be conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University.
The University of Texas, MD, Anderson Cancer Center, and the Georgia Cancer Center.
Initially a total of six evaluable patients are scheduled to be treated with BP 1002 monotherapy in a standard three plus three design with a starting dose of <unk>.
<unk> milligram per square meter.
The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days.
The phase <unk> portion of the study will commence after completion of BP 1002, monotherapy cohorts and will assess the safety and efficacy of <unk> two in combination with decided that in refractory relapsed AML patients.
Finally.
Let me briefly review the prognosis, we've made with our third drug candidate.
BP 1003.
Which targets the staff III protein.
This.