Q3 2022 Bio Path Holdings Inc Earnings Call

Good morning, ladies and gentlemen, welcome to the bio path Holdings third quarter 2022 earnings conference call. At this time all participants are in listen only mode. Following the formal remarks, we will open the floor for your questions.

As a reminder, this conference call is being recorded and now I'd like turn the conference over to well Conor 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 2022 financial results and to provide an update on recent pipeline and corporate development earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call. The release, it's available at bio path Holdings Dot com.

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

Before we begin 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.

Everyone. Thank you for joining us.

I'm, particularly pleased with the progress we've made throughout the third quarter.

Highlighted by the initiation of our phase one phase one B study.

1002 in refractory relapsed acute myeloid leukemia and made significant inroads in preparation for the initiation of our phase one study of BP 100 Award.

For the treatment of solid tumors later this year.

These are exciting times at bio path as our clinical progress is bringing us closer to achieving our mission to deliver meaningful new medicines to the most challenged cancer patients.

Let's start with the progress we've made with our lead product candidates proxy Jeff Berson.

We continue to make significant progress advancing stage two of our phase II clinical trial approaches you burst and from the treatment with acute myeloid leukemia or AML in combination with frontline therapy decided venetic lax.

Stage two of this phase II trial.

Open label two stage Multicenter study of <unk> in combination with Decitabine medical acts 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 genetically <unk> resistant or intolerant with the two drug combination of trucks each person decided.

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.

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

Uh huh.

As I mentioned earlier, we are also making progress towards the initiation of a phase one clinical trial of VB 1001 dash eight.

<unk> with advanced solid tumors, including ovarian and uterine pancreatic and hormone refractory breast cancer. Some of the most challenging cancers to treat with today's therapeutic tool kit.

<unk> 001 dash eight.

Fourth bio path drug candidate is a modified product or proxy would you borrow some sharing the same drug substance with enhanced banana partner properties.

In the coming weeks, we expect to initiate a phase one would be clinical trial BP 1001 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.

Valuate safety approaches you're burst in solid tumor patients patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes and it is our hope that pressured your birth 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.

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

Yeah, but it had a class has shown activity against the Hana op Aptotic protein Bcl, two and works by neutralizing the proteins B H three domains.

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 allogeneic hematopoietic cell transplantation disease relapse invariably occurs often.

At times due to be H Street domain mutation over time.

P. P 1002 also targets the Bcl two protein.

However, E. P 1002 activity is based on blocking the Bcl two messenger RNA and Theres not a V H three domain.

As a result, we believe that D. P 1002 could provide an alternative for banana class patients, who have relapsed, including AML patients, who previously received no matter Clarke Street.

A total of six evaluable patients will be treated with B P 1002 mono therapy.

Excuse me.

Standard three plus three design with a starting dose of 20 milligram per square meter.

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

Phase one b portion of the study will commence after completion of BP 1002, monotherapy cohorts and will assess the safety and efficacy of BP 100 too.

Combination with decitabine in refractory relapsed AML patients we.

We hope to be able to provide incremental updates on this program as we establish safety first followed then by efficacy and the smaller patient cohorts.

Finally, let's review the progress we've made with our initial third drug candidate <unk> 103, which targets the stat three protein.

Step three is a transcription factor that regulates various tumoral genetic processes, such as tumor proliferation metastasis and drug resistance is over expression and aberrant activation character characterize many cancers, including breast lung.

One ovarian liver and colon cancer.

Activation of the SaaS III, Pat pathway in breast and ovarian cancer cells.

Promotes tumor initiation migration and taxol resistance stat. Three also promotes five F. You resistance in colorectal cancer cells, It's Rob.

Raul and numerous malignancies made staff free a potential cancer therapeutic target.

B P 1003 is a novel Liposome incorporated <unk> antisense oligonucleotide.

[laughter] efficiently reduce staff three expression and enhances the sensitivity breast and ovarian cancer cells to taxol and five S U.

These results are in line with previous work and which V. P 1003, plus Gen side have been displayed enhanced antitumor activity and pancreatic ductal adenocarcinoma together. These results strongly suggest that V. P 1003 comp.

The nation 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 in an especially challenging cancer indication.

That has limited treatment options.

Our goal is to file an IND application for this very promising product candidate.

First half next year.

The timing is determined by finalizing preclinical testing of drug substance presence in the animal species used in testing.

Before turning the call over to Anthony I'd like to highlight the considerable progress we have made both strength our intellectual property portfolio.

At bio path, we have executed a global patent strategy aimed at building a fortress of protection for our DNA D enable EIS platform technology worldwide.

<unk> to report it.

I'll pass has five patents issued and six pending patent applications in the United States outside the United States Bio path is for applications that have completed the grant process and additional five applications have been allowed and are now completing the grant process.

Finally over 64 applications remain pending.

So why is this so important.

First these protections are vital as we advance our programs through the clinic and begin to capture the attention of outside parties.

Would be competitors and more in addition, strong patent position puts us in a strong negotiating position for any future partnership or licensing agreements.

Importantly, these patent grants underscore the novelty of our innovative approach to fighting cancer with our D N enable EIS technology.

With that I'll now.

Now I'll turn the program over to Anthony price for a brief review of our third quarter 2022 financials, along with balance sheet highlights Anthony.

Thanks Peter.

Company reported a net loss of $3 5 million or <unk> 49 per share for the three months ended September 32022, compared to a net loss of $2 1 million or 29 cents per share for the three months ended September 32021.

Research and development expense for the three months ended September 32022.

Increased to $2 4 million compared to 1.0 million for the three months ended September 32021, primarily due to manufacturing expenses related to drug product releases in the third quarter of 2022 as well as startup costs related to our phase one clinical trial for B P 1001.

Hey in solid tumors.

General and administrative expense for the three months ended September 30th 2022 was $1 2 million an increase of <unk> 1 million compared to the three months ended September 32021, primarily due to increased legal fees.

As of September 30th 2022.

We had cash of $13 7 million compared to $23 8 million at December 31, 2021.

Net cash used in operating activities for the nine months ended September 32022 was $10 1 million compared to $7 1 million for the comparable period in 2021 with that I'll now turn the call back over to Peter.

Thanks Anthony.

As we approach the close of the year and look forward towards 2023.

Couldn't be prouder of the progress we've made to or be more excited for our future having recently initiated our phase one <unk> study.

<unk> 002 in refractory relapsed acute myeloid leukemia.

And look forward to initiating.

Our phase one study of BP 100.

One dash hey for the treatment of solid tumors later this year.

We expect to have a series of near term value, creating inflection points.

More importantly, as we advance these programs. We believe we are giving hope to patients with cancer.

Who have limited treatment options.

While this may sound a lofty goal.

It is what drives our team every day.

And why we are so excited about the progress we have made.

With that operator, we.

We are ready to open the call for questions.

Thank you.

At this time, we will begin the question and answer session.

Ask a question you May press Star then one on your Touchtone phone.

If youre using a speakerphone please pick up your handset before pressing the case.

Just try your question. Please press Star then zero at.

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

And the first question comes from Jonathan Aschoff with Roth Capital Partners.

Hi, good morning, Peter.

I was curious when will we see the initial phase one results both for one O to O two and perhaps say in the phase II results in the initial phase III results for cracks.

Well the phase two.

Again, our work.

Well into that study and our goal is to have interim readouts.

By the end of the quarter first quarter next year.

Call that there's really three clinical trial.

Cohorts and.

We have now.

Really establish momentum as we worked our way through.

The problems.

Co bid created for our two main manufacturing.

<unk> facilities, so we have accumulated quite a bit of the.

Or is it.

That allows us to really treat all the patients so.

In the first quarter seeing at least.

Those cohorts face to face.

The once phase one is oh.

100 too.

Is the relapsed.

AML.

I would think I mean, we've already.

Dosed in that.

The first cohort with three patients.

So I would.

We've had interest in that so I would think we'd have something by the first quarter next year of that first what would you be.

The first dose level III patient readout.

We're close we only need one more patient add one more patient all of the.

Lip balm a portion of that.

Our phase one and a separate trial, but.

And I would think that we should be able to do that it's harder to find patients for that.

Yes.

There is attractive.

T cell program out there that is enrolling a lot of patients.

We have not started yet we're open.

1001 dash eight in solid tumors, but.

My clinical team tells me that we have a lot of interest in that study.

And that is open now and Oh.

They are screening patients, so I, absolutely think which.

The first cohort.

Uh huh.

Evaluated released information on by that first quarter.

So youre, saying, perhaps a you'll you'll have data next quarter.

It's only three patients.

So just let alone zero-zero too first quarter next year like those are both worth of data yeah. Those are both three plus three dose escalation trials.

But we're allowed we.

We report on it.

Alright, where is it.

As to prep study in its enrollment.

Well, we have a more than one.

So I don't know.

Want to get into specifics on enrollment, but it's well past 50.

Well past 50 patients or 50%.

Patients.

Okay.

That's all I had thank you very much.

Youre welcome Jonathan.

Thank you and the next question comes from <unk>, Chen with H C. Wainwright.

Thank you for taking my questions could you give us a.

Some additional details regarding our which cohorts.

Three.

If the phase III trial.

And now perhaps with your personal.

Wrote that most patients so far.

Well, they're all doing about the same.

So.

I think the performance has been.

Reasonably well.

So the patients are being enrolled and we have.

Good institutions, but my sense right now.

They're all well.

Well.

I just I can't speculate at this time, which ones will come in first.

Okay. Okay.

But you do expect that the there should be a.

19 evaluable patients.

At the end of first quarter next year right.

Well that's the goal yes, I mean are you know.

Great.

Uh huh.

As we're able to build a much stronger on that now because of drug supply.

Got it got it and for the the.

Solid tumor trial.

Presley diverse a dash eight.

Which type of solid tumor or do you expect to grow the most.

Great.

Chris.

Well certainly ovarian.

Advanced ovarian that's been the one that we've worked along with.

But the way that strategy.

For that trial.

One dash or slash wouldn't be was to open.

<unk>.

Open.

<unk>.

Dose escalation portion because that's monotherapy to pretty much all the solid tumors.

In that area, it's faster and more just looking for the safety evaluation.

And then once you get to the one b. That's when you get of course to specific types of won't be in.

Advanced ovarian and endometrial won't.

It won't be in.

Pancreatic.

And.

What would be the year.

No.

Is the triple negative.

Cancer and those are all remember combination therapies. So.

What you wanted to combination to go cross sell they all have their specific ones.

Okay got it.

The company currently has.

Sufficient capital to fund operations to the point of starting.

While for BP One Oh.

Great.

I believe so I think that.

Should be ready to go next year, that's our goal I think as I've mentioned last time were.

Uh huh.

Redoing the.

Drops drug substance detection Ah.

We could finish that.

Last talk studying rabbits and where.

Where man, if we remanufacture half pretty much straight manufactured.

The drug for that and get it off to the.

Charles River.

Finish that up so I mean.

Our goal is certainly as we said.

In our releases and whatnot is there.

It should be.

And the first six months of each year.

And once that happens we can get.

Our R&D trials, so that everything is done so.

And we have.

Sufficient cash.

Two requirements runway.

That was.

No.

Noted.

September we just added that with a small strategic raise to make sure we kept that runway out there.

Past October next year, so that we continue to demonstrate that viability.

Okay. Thank you.

Youre welcome.

Thank you and the next question comes from Laura Engel with Stonegate capital partners.

Good morning, how are you.

I'm doing well how are you Laura good to have you back you Oh. Thanks, Yeah. Thanks for taking my call.

That's my questions have been answered, but you did mention them.

Discussions with partners and the strength of the patent portfolio any notable updates there anything any discussions that are progressed to the point you want to talk about it for therapeutic areas either in cancer or even outside the realm of cancer.

No nothing I think you know the only time, we do do something is if we actually had something.

Concrete that had happened and.

So we just think it's too speculative to talk about.

People's interest and whatnot is there has been in the past and.

It has to be the right time, I think you know past some of these things that are going on.

Starting at the end of the first quarter next year, you don't make prompt some interest.

That could finalize but you know.

I cant be definitive on that right now, but our main focus recall.

As to be a.

Company that.

<unk> develops these.

These DNA.

Enable is drug products.

That.

<unk> more difficult to treat.

Ah patients diseases right.

And some people will have interest in that but our model is.

Not to be a pharma company that would.

Pull those into the commercialization so.

Therefore, we need to focus on making more of those kinds of products that are.

Can help us hard to treat populations and so.

That's why we've spent we've had some pretty good advisors, helping us identify not only of course the U S patents.

Foreign patents that you need that you're a bigger companies typically want.

To be interest in a license for the technology, they've got to have those four components to.

And so that's why we've been spending time developing those.

All right well, great progress and again I appreciate you taking my call.

I'll get back in queue. Thanks, Peter.

<unk>.

Thank you and this concludes our question and answer session I would like to turn the call it off Peter Nielsen for any closing comments.

Okay.

Thank you again, everyone for joining us and for your continued support of bio path holdings have a great day.

Bye now.

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