Q1 2022 Bio Path Holdings Inc Earnings Call

Good day and thank you for standing by welcome to the Bio Path Holdings, Inc. First quarter 2022 conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone please be advised today's conference.

May be recorded if you require any further assistance. Please press Star then zero I would now like to hand, the conference over to your host today will O'connor with Stern Investor Relations. Please go ahead.

Thank you operator, welcome to the bio path Holdings conference call and webcast to review the company's first quarter 2022 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 releases available at bio path Holdings Dot Com with me today from bio path are present.

And CEO , Peter Nielsen and senior Vice President of 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 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.

Yeah.

Thanks will.

Good morning, everyone and thank you for joining us.

2022 is off to a terrific start for bio path.

And I'm proud of the corporate and clinical progress we have made year to date.

The advancements we have made and will continue to make bring us one step closer to our goal of developing meaningful medicines to aid in the fight against cancer.

I'll begin with an important corporate highlights.

Last month, we were excited to announce the appointment of elite Sherwood to our board of directors.

Aileen this principle of science to communications and independent communications consultancy, providing strategic public relations and corporate Communications Council to life Science companies.

With her extensive background in Biotechnology Communications, Inc.

Liens synthesizers complex science into compelling messaging, which is instrumental in guiding our communications to both the clinical and financial communities.

She has already brought valuable industry insight to our team that will be increasingly important as we advance our D enable EIS platform in the fight against cancer.

Moving now to our clinical programs and our lead product candidates pressured your burleson.

We continue to make significant progress advancing stage two of our phase II clinical trial of proxies your person for the treatment of acute myeloid leukemia.

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Monster.

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Evolving landscape for standard of care in 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 evolved we adapted our trial design to a flat reflect these changes.

The amended stage two of this phase II trial in AML is an open label phase two two stage multicenter study of <unk> in combination with decitabine in banana collapsed in two cohorts of patients with previously untreated AML and relapsed or resistant AML.

A third cohort includes treating relapsed resistant AML patients, who are banana clacks resistant or intolerant with the two drug combination.

Practices, your berson and decitabine.

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.

An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment.

Next I'd like to turn to our planned phase one clinical trial of BP 1001 dash eight in patients with advanced solid tumors, including ovarian uterine pancreatic and hormone refractory breast cancer.

P. P 1001 dash a a force of bio path drug candidate is a modified product from praxis your borrowers and sharing the same drug substance with enhanced nanoparticle properties.

You'll recall that last year, the FDA cleared our investigational new drug or IND application to initiate a phase one would be clinical trial of BP 1001 dash eight in patients with solid tumors, including ovarian endometrial.

<unk> pen created in triple negative breast cancer.

This trial will be conducted at several leading cancer centers and is planned initially to evaluate the safety of practice do berson and solid tumor.

<unk> patients.

Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope that pressured your person may provide clinical benefit for such patients. We look forward to bringing this exciting program into the clinic in the coming weeks.

Turning now to <unk> 002, 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 Hyatt.

Hi expression of Bcl two has been correlated with poor prognosis for patients diagnosed with AML.

With that a class has also shown activity against anti pod Ptotic protein Bcl, two and works by neutralizing the proteins B H 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 genetic Yamato periodic cell transplantation disease relapse invariably occurs oftentimes due to <unk> domain mutation over time.

P. P 100 to also targets the Bcl two protein.

However, b P 1002 activity is based on blocking the Bcl two messenger RNA and not the BH III domain.

As a result, we believe that B P 1002 could provide an alternative for <unk> patients, who have relapsed, including AML patients, who previously received <unk> treatments.

We expect to initiate this clinical trial in coming weeks at several leading cancer centers in the United States.

Including the medical College at Cornell University, The University of Texas, MD, Anderson Cancer Center, and the Georgia Cancer Center.

A total of six evaluable patients will be treated with B P 1002 monotherapy in a standard three plus three design with a starting dose of 20 milligrams per square meter.

The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days.

Phase I B portion.

<unk> of the study will commence after completion of BP 1002, monotherapy cohorts and will assess the safety and efficacy of BP 1002 in combination with decitabine in refractory relapsed AML patients.

Finally, let's review the progress we've made with our third drug candidate <unk> 1003.

<unk>, which targets the stat three proteins.

<unk> is a transcription factor that regulate various tumorigenic processes, such as tumor proliferation metastasis and drug resistance, it's over expression and aberrant activation characterize many cancers, including breast lung ovarian.

In liver and colon cancer.

Activation of the stat, three pathway in breast and ovarian cancer cells promotes tumor initiation migration and taxol resistant.

Stat, three also contributes to resistance in colorectal cancer cells.

Its role in numerous malignancies made stat three potential cancer therapeutic agent.

Okay.

<unk> 1003 is a novel Liposome incorporated <unk> antisense oligo, the oxy nucleotide that efficiently reduces stat, three expression and enhances the sensitivity of breast and ovarian cancer cells to taxol.

These results are in line with previous work in which <unk> 003, plus Jim side have been displayed enhanced antitumor activity and pancreatic ductal adenocarcinoma.

Together. These results strongly suggest that <unk> 003 combination therapy as a novel strategy for patients with advanced solid tumors.

In April we were delighted to present supported preclinical data from this program at the 2022 American Association for cancer Research annual meeting before an audience of world, leading cancer researchers and physicians.

Dr. Maria Gagliardi, a research scientists on our team.

Highlighted preclinical studies of <unk> 1003 in combination with Paclitaxel or flora yourself as a potential treatment against breast and ovarian cancer itself.

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 for this very promising product candidate later this year.

With that I'll now turn the program over to Anthony price for a brief review of our first quarter 2022 financials, along with balance sheet highlights anthem.

Anthony.

Thanks Peter.

Company reported a net loss of $3 4 million or <unk> 47 per share.

The three months ended March 31st.

2022.

Compared to a net loss from $2 4 million or.

<unk> 43 per share for the three months ended March 31 2021.

Research and development expense for the three months ended March 31, 2022 increased to $2 1 million compared to $1 3 million for the three months ended March 31, 2021, primarily due to increased clinical trial expenses for startup costs related to our phase one clinical trial of BP.

One zero too.

In refractory relapsed AML patients and timing of activities for a phase one clinical trial of BP 1002 in lymphoma.

General and administrative expense for the three months ended March 31, 2022 increased to $1 3 million compared to $1 2 million for the three months ended March 31, 2021, primarily due to increased stock based compensation expense.

As of March 31, 2022, the company had cash of $21 2 million compared to $23 8 million as of December 31, 2021.

Net cash used in operating activities for the three months ended March 31, 2022 was $2 5 million compared to $1 6 million for the comparable period in 2021.

With that I will now turn the call back over to Peter.

Thanks Anthony.

The first quarter, we continued to advance our mission to deliver a better path for cancer patients.

With ongoing progress across multiple of our D. Enable EIS antisense RNA nanoparticle drug candidates, we are bringing a juggler solution to fight against cancers.

As we look to the balance of the year, we expect to build on this with a number of value, creating milestones, including several political trial initiations and I look forward to reporting our progress progress and the bumps ahead with.

That operator, we're ready to open the call for questions.

Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

If you have a question at this time. Please press Star then one.

Okay.

And our first question comes from the line of you Chen with H C. Wainwright. Your line is open. Please go ahead.

Alright, Thank you for taking my questions could.

Could you give us a.

To updates regarding enrollment status for three arms.

Our phase III AML trial.

Yeah.

The phase II enrollment status.

Were well in excess of 30 and.

And the trial is really taking off pretty well.

Treating eight patients right now and have seven additional patients that are waiting for slot. So.

As drug supply ramps up.

From the problems we had during the pandemic.

We expect to gain quite a quite a bit of momentum as we get into the second half of this year.

There's any has the potential to reach 19 evaluable patients during 2022.

Well I think.

Towards the end of the year beginning.

Beginning in the first quarter.

We expect to see.

Getting to the point, where we would have in terms of being able to do in terms of valuations to evaluate core.

Accelerating the trials so.

We're on schedule for that beginning of the end of the year.

Beginning in the first quarter.

Okay.

And with respect to.

The phase one trial of <unk>, one or two.

How long would it take.

Phase one portion.

Well of course that depends on enrollment we have had a lot of interest <unk>.

III <unk> III trial.

We'll start out of 'twenty.

We'd go 40 60 90.

And.

I don't know if we would go beyond that so.

But that would be I think a year at least depending on how fast we have some really good.

Institutions are sites that are interested so.

There is there has been some solid interest in that because.

The <unk> situation.

Patients who had been on banana clacks, who.

Become resistant.

Very short expect so.

Pushing to get that through.

I'll start that.

In this quarter and.

It's really a function of how quickly sites could turnaround there.

Tracks are being reviews and whatnot.

That's been a general slowdown that had trouble with <unk>.

People so.

But.

That's a trial that could go pretty fast, but I can't give you an exact readout of timelines there is a lot of variables in there.

Joel.

How many sites could be actively enrolling patients by the end of this quarter.

Okay.

Well by the end of this quarter, maybe a couple of I think the goal is more.

The people that we're working right now to sign up on that is.

Many of the school and their solid groups MD Anderson Cornell or both.

Yeah.

I think very interested in that and quite frankly, so as you see a lot.

Okay. Okay.

And with respect to <unk> zone three.

Is there going to be any additional data to be presented during the remainder of 2022 any preclinical data.

I think.

The plan on that of course, I think I've mentioned that we.

We had trouble with.

You always wanted to start out and get the PK studies done and those take detection of substance.

And the.

And animals.

And.

We think we have that.

<unk> now.

And that will allow us to.

We have to confirm that but then.

To do an additional rebate Tox study and that'll be the second species studied we need for the guy in it. So the immediate goal is.

As presented at.

Hopefully having been submitted by the before the end of the year now.

I could see where.

Perhaps a rabbit study and whatnot.

That data might get presented.

<unk>.

I'm not sure whether the next candidate would be ash for that so I'm not sure.

If that would happen, but those are the clinical studies that would go on so whether we do that by the end of the year I'm not sure.

Okay.

Alright, thank you.

Okay. Thank you.

Thank you and again if you have a question at this time. Please press Star then one.

And im showing no further questions and I'd like to turn the conference back over to Peter Nielsen for any further remarks.

Thank you.

Thank you everyone.

For joining us and for your continued support of bio path have a great day.

This concludes today's conference call. Thank you for participating you may now disconnect.

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