Bio-Path Holdings Inc. Q3 2023 Earnings Call

Okay.

[music].

Good morning, ladies and gentlemen, welcome to the bio path Holdings third quarter 'twenty to 'twenty three earnings conference call.

At this time all participants are in a listen only mode should you need assistance. Please signal for a conference operator by pressing star zero.

Following the formal remarks, we will open the call up for your questions.

Please note the call is being recorded I would now like to turn the call over to Venlo corner 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 2023 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'll plan to discuss on today's call. The.

The release is available at bio path Holdings Dotcom.

With me today from bio path are president and CEO, Peter Nielsen and senior Vice President of Finance accounting and administration Anthony price.

We begin the call I'd like to remind you that today's discussion will contain forward looking statements that involve risks and uncertainties. Please.

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.

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.

Thank you for joining us.

We ended up the tail end of 2023 stronger position than ever.

We have exceptionally promising data with parts of the person that they have.

Bell and expect to generate even more data in 2024.

Beyond practice is diverse and we continue to advance our robust clinical development program.

A number of important programs that leverage our innovative D enable EIS platform technology to deliver RNA I nanoparticle article therapeutics directly to cancer cells.

We are forging a new path and DNA powered medicine that we believe will give patients a fighting chance to be difficult to treat cancers.

I'll begin with the progress we have made with our lead product candidate proxies are bullish.

As you know.

Continue to be encouraged by the positive interim results from stage two of our phase III clinical trial practices or person for the treatment of acute myeloid leukemia or AML.

In combination with frontline therapy decided then venetic lax.

This is meaningful because these patients are at the end of the line of treatment options.

No most of already relapsed or essentially everything.

Everything in the treatment armamentarium currently available.

So a drug like parts of the person.

Give hope to these patients.

We call. This study has been amended stage two of our phase II trial in AML.

It is an open label two stage multi centered study.

Your birth in combination with decitabine in Bezeq coax.

The two cohorts of patients with previously untreated AML and relapsed or resistant AML.

Excuse me the.

Third cohort.

Include creating relapsed or resistant AML patients, who are gonna clocks resistant or intolerant with the two drug combination approaches the burleson and decided that.

The primary endpoint of this study will be the number of patients.

Who achieved complete remission, which includes complete remission with incomplete hematologic recovery.

Complete remission partial hematologic recovery.

As a recap.

Of these very promising results. We achieved there were 14 newly diagnosed patients evaluable in cohort one.

With at least one cycle of the practices the person beside them.

<unk> combination therapy.

All patients in this cohort were adverse risk, but 2017 European leukemia or.

Or E L F guidelines.

Or secondary AML.

Boxes, the person was well tolerated and adverse events were generally consistent with decided then and then I have a clock street <unk> for AML.

12 of the 14, evaluable patients or 86%.

We have complete remission and two or 14% achieved partial remission.

Total a 100% of the Evaluable patients had a response to treatment.

The complete remission rate of 86%.

The evaluable patients in cohort, one and significantly higher completion rates of 62% for newly diagnosed patients treated with the frontline combination treatment of decided then and vanilla clocks.

This result is further highlighted by the high risk rating of our cohort one evaluable patients.

Losing a secondary AML patients both of which are classes of patients with very difficult to treat disease.

[laughter].

14, refractory relapse and valuable AML patients in cohort two were treated with at least one cycle of practices. Your person decided that they had a class combination therapy.

Patients in this cohort were adverse risk by 2017 E L F guidelines or secondary AML.

Proxies your Burleson was well tolerated at Haynes were generally consistent with decided then banana Clark's Creek mine and ore for Annabel.

Eight of the 14, evaluable patients or 57%.

We've complete remission, two patients or 14%.

Partial remission and three patients or 22% achieved stable disease, and total 93% of Evaluable patients had a response to treatment.

The completion rate the complete remission rate of 57% of the Evaluable refractory or relapsed patients in cohort two is significantly higher than in complete remission rate of 21% for refractory relapsed patients treated with combination treatment of decided then in Connecticut.

Next.

As with newly diagnosed patients in cohort one.

Result is further highlighted by the high risk rating a biomass cohort two evaluable patients.

Inclusion of secondary AML patients.

Efficacy data from the initial interim analysis of cohort, one and cohort two are compelling.

And show that person to person based combination therapy with not only safely administered in cohort, one and cohort two to high risk newly diagnosed in refractory relapsed AML patients considered.

Suitable for standard chemotherapy, but also demonstrated efficacy signals significantly better than current therapies. This is particularly encouraging as relapsed refractory patients or a challenging population in which current treatment options are sub optimal.

On the strength of these data we currently plan to pursue U S food and drug administration or FDA expedited programs for fast track and breakthrough therapy designations. We look forward to keeping you apprised of our progress on the regulatory path.

In October we hosted a key opinion leader of that.

To discuss the evolving treatment landscape in AML.

We were privileged to have Dr. Jorge Cortes and Doctor Merrell had.

True luminaries in the hematologic oncology space as our guest speakers.

The discussion was illuminating and engaging bolstering our conviction and the practices your birth and clinical development programs as both physician experts were deeply encourage by yearend term results and further underscored the great unmet medical need for these relapsed patients.

It was heartwarming to have these AML specialists highlight the fact that results of this magnitude are simply not seen in this patient population.

Having this independent expert point of view that support bio path mission was inspiring.

I encourage you all to listen to the archives of this event, which is available on our web website.

Turning now to our V P 1002 program, which targets Bcl two.

As you know Bcl two is responsible for driving cell survival at up to 60% of all cancers.

High expression of Bcl, two that's been correlated with poor prognosis for patients diagnosed with AML.

Is that a class has shown activity against anti apoptotic protein Bcl, two and works by neutralizing the proteins VX three domain.

It is an approved treatment for chronic lymphocytic leukemia or C O L patients.

Untreated AML patients however, with the exception of some patients treated with allogeneic hematopoietic cell transplantation disease relapse invariably occurs often times due to the age three domain mutation overtime.

P. P 1002 also targets.

D C L P protein however.

1002 activity is based on blocking the Bcl two messenger RNA and not the BH three domain.

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

A total of six evaluable patients will be treated with BP 1002 monotherapy.

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 the phase <unk> portion of the study.

We'll commence.

After completion of BP 1002, monotherapy cohorts and will assess the safety and efficacy of the P. P 1002 in combination with decitabine and <unk>.

Relapsed AML patients.

We expect cohort completion and initial data readout from this study in the company's box.

Next let's turn to our phase one what would be study clinical trial of VB 1008 in patients with solid tumors, including ovarian endometrial pancreatic and triple negative breast cancer. Some of the most challenging cancers treated with <unk>.

Todays therapeutic tool kit.

1001 dash, a modified product complexity person sharing the same drug substance with enhanced nanoparticle properties.

The clinical trial is that the second dose cohort.

This trial is being conducted at several leading cancer centers and will initially evaluate the safety and solid tumor patients.

Patients diagnosed with recurrent ovarian and endometrial cancer.

Often have poor outcomes and it is our hope that we may provide clinical benefit for such patients.

Look forward to cohort completion and data readout from this study in early 2024.

Finally, let's review the progress we've made.

1003, which targets the step pretty protein.

<unk> three is a transcription factor that regulate various tumorigenic processes.

As tumor proliferation metastasis and drug resistance.

It's over expression and Abbott activation characterize many cancers, including breast lung ovarian liver and colon cancer.

Activation of the stat, three pathway in breast and ovarian cancer yourselves promotes promotes tumor initiation migration and tax all resistance staph. Three also contributes five dash U resistance and Colorado colorectal cancer cells.

It's rolling numerous malignancies made staff free of potential cancer therapies.

One zero.

Zero three.

It's a novel Liposome incorporated statutory antisense.

I'll go dig oxy nucleotide that efficiently reducing staff free expression enhances the sensibility of breath.

In ovarian cancer cells, and taxol and five days after you.

These results are in line with previous work and which beat the one zero so free plus Jim cited display enhanced anti tumor activity.

Creon Ductal adenocarcinoma.

Together. These results strongly suggest that BP, one zero ozone free combination therapies as a novel strategy for patients with advanced solid tumors.

We are particularly excited to launch our first in human validation of this cutting edge therapy, internet, especially challenging cancer indication that has.

Limited treatment options.

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

Yeah.

Thanks, Peter the company reported a net loss of $3 2 million or 32 cents per share for the three months ended September 32023.

Compared to a net loss of $3 5 million or <unk> 49 per share for the three months ended September 32022.

Research and development expense for the three months ended September 30th 2023 decreased to $2 3 million compared to $2 4 million for the three months ended September 32022.

Primarily due to decreased manufacturing development expenses, partially offset by an increase in expense related to our clinical trial for Brett proxy giberson in AML due to increased patient enrollment in 2023.

General and administrative expense for the three months ended September 32023 decreased 1.0 million compared to $1 2 million for the three months ended September 32022.

Primarily due to decreased legal fees.

Change in fair value of the company's warrant liability for the three months ended September 32023 resulted in noncash income of $1 million.

The company did not have the warrant liability in the comparable period for 2022.

As of September 32023, the company had cash of $2 4 million compared to $10 4 million.

As of December 31, 2022.

Net cash used in operating activities for the nine months ended September 32023 was $9 7 million compared to $10 1 million for the comparable period in 2022.

Net cash provided by financing activities for the nine months ended September 32023 was $1 7 million.

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

Thanks Anthony.

It's been another exceptional quarter for bio path, particularly as the data we just discussed cement our conviction in support of the advancement of these important programs.

Despite the gloom in the financial markets, the excitement, we see and feel and the clinical markets with progress such as we've made with proxy giberson Spurs on to continue the good fight.

As such we remain committed to our mission to delivering a better path for cancer patients.

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

We will now begin the question and answer session to ask a question you May Press Star then one on you touched on its own if you're using a speakerphone. Please pick up your handset before pressing the keys.

If at any time. Your question has been actress and you would like to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

Our first question comes from Jonathan Aschoff with Roth M. Kim. Please go ahead.

Thank you and good morning, Peter I was curious.

The third cohort.

Cracks.

Uh Huh, where there was no data yet available it was rail grass AML is the most resistant or intolerant class is there any update there even if just on enrollment.

Just Uh huh.

Hi, Jonathan just harder to find patients for that.

We actually have had five enrolled and we have three evaluable patients.

What happens is.

Often times.

When a patient is on the border line so that the investigators are.

Yeah.

Slip them into cohort two so they couldn't get the triple combination, but no and we're treating them right now we have patients continue to treat the other ones, we've reached our reached or exceeded or.

Valuable milestone for this.

Germ analysis so.

Were backing off on those but no. We we continue with cohort three.

It just takes longer to get them in.

And good for patients and but you.

Like cohort to.

That'll the.

Bar is pretty low on that you know the the.

The frontline comparison is decided by the law.

That's.

16% to 20% CR. So you know I think.

That's a good one for us to pursue so that's the status on that.

Okay, and just say, yes, or no on this I had a note or sanctions.

My last name.

Do you see in ash.

Abstract from you guys, but there there there is none for cracks or <unk>.

Just regular cracks.

We're too late so okay.

And we rushed to get out and yeah, but.

What we'll probably do I'm sure we'll end up doing.

But full blown report interim next year, but oh for for the nearer term are well.

We're pulling together to.

Try and need to ask though and that's a good another good meeting and we.

We presented there before and in fact, I think we had a session where we had an oral several years back. So that's the that's the game plan or just time driven.

Okay, you're our last timing indication for Brexit was full enrollment by the end of the year, which I think you just got.

Switch to data.

By early 2024, so that's that's fine but for one or two.

The last timing you gave was completion of the first cohort before the end of the year is that still relevant for for the phase one b trial.

Check my notes here, but you know I think we mentioned.

That we were enrolling a couple of new sites for the lymphoma 1002 and.

A couple of good ones and one of which is Einstein in New York and we actually have that a third patient to close out the cohort.

Next week I think it finishes and we'll be able to do that safely do so yeah. There are.

That means it and I'm pleased with that because we needed to get to a higher dose from our starting at 20 Megs per square meter.

The.

AML and that.

We've completed the patients for that first we're just doing we have to schedule. The safety meeting and all of that I mean, these things take time, but to do that and we should have something.

But I can put a rig on it even before the end of the year.

In the solid tumor.

As I noted.

We're already in the second quarter. So we've graduated.

We put a short release out on that.

And we're in the second so we've gone from starting that won the drug substance recall as Bret.

Proxy friction jabbar or something different formulation, so it's treated as a different drug but.

That.

Had started at 60 Megs per square meter and now it's in the second cohort at the <unk>.

90 Meg.

<unk> per square meter and I think there is.

Oh really.

In that treatment. So that's the state those.

That's definitely helpful. Do you still expect an early 2020 for filing for the IMD for while luxury.

It won't be early we do I think you know I won't go over that.

The issue you know.

The detection for PK work, we have that we actually have two sources and wants to do and actually the other is one that we use for.

Drug.

The actual nanoparticle characteristics, which we've found they have a division.

They can do G O P human plasma.

And so we're going to get them online so I think that.

We'll finally be able to demonstrate that testing and of course, you'd like to be able to.

Yep tongue in cheek.

It demonstrates that indeed, you had drug substance and your.

And your safety studies.

I think it's it would be more <unk>.

Latter part the old hold up again is being to get the.

Detection.

Of Oh logo drug substance.

And Ah patient or you know is the.

Animal study.

Plasma.

Because you know it's two points on that one just to be able to again demonstrate that you had drug substance and years Tox studies.

And then of course going forward he issue as you need that to be your pharmacokinetics. So the answer is no we won't.

Have all of that submitted and done because.

Once we have this PK.

Detection work done.

Then we just have to quickly do one study, which is a couple of months and then we'll.

We will start compiling a b I N D N.

I'll bring an outside consultant to help with that writing so we can move it along so.

Best case would be.

You know late summer I would think those Ids or.

A lot of data as you know so that's the status on that but I am I feel much better about that now since.

We are able to detect that.

Lastly, I did I mishear, you will you developing one or two in an email or did I just miss year, you say CLO.

No there's two separate ind's.

It's the S. P. A you know we had the C O L. One going.

And patients enrolled and.

And wanted to do the.

AML.

Vanilla clacks failure patients so that's a real opportunity for us.

Clacks operating on the beef protein in the in the <unk>.

<unk> Plaza and as usually happens with Teekay is that.

That captures site.

So eventually the drugs.

The patient becomes resistant.

We're a natural step in behind that because we don't have all that kind of activity. We just block the expression of the Bcl two so that's a.

So anyway submitted on that but the administrative leave the F D. A.

Handles those two diseases in different divisions, so we had to file.

But separate I M D.

For AML relapsed patients it's generally.

A M L.

Elapsed resistance beyond just or beyond just a bell, it's a vanilla clacks.

Resistant patients, but yes, and we have two clinical trials in two ind's for that so.

Both are will be announced here.

Shortly to six weeks.

For.

Moving on to the next dosing cohort.

Thank you for those details Peter.

Youre welcome.

Yeah.

This concludes our question and answer session and I would now like to turn the call over to Peter for any closing remarks.

Thank you again, everyone for joining us.

And for your continued support of bio path.

Great day.

The conference has now concluded. Thank you for attending today's presentation you may all now disconnect.