Bio-Path Q3 2023 Earnings Call Transcript

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November 15, 2023

There are 5 speakers on the call.

Operator

Good morning, ladies and gentlemen. Welcome to the Bio Path Holdings Third Quarter 2023 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 your questions. Please note, the call is being recorded.

Operator

I would now like to turn the call over to Will O'Connor of Stern Investor Relations. Please proceed.

Speaker 1

Thank you, operator. Welcome to the Bio Path Holdings conference call and webcast to review the company's Q3 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 release is available at biopathholding.com. With me today from Bio Path are President and CEO, Peter Nielsen and Senior Vice President of Finance, Accounting and Administration, Anthony Price.

Speaker 1

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 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 Path's CEO, Peter Nielsen.

Speaker 2

Thanks, Will. Good morning, everyone, and thank you for joining us. We entered the tail end of 2023 in a stronger position than ever. We have exceptionally promising data with prexigebersen AML and expect to generate even more data in 2024. Beyond prexigebersen, we continue to advance a robust clinical development program across a number of important programs that leverage our innovative DNAbilize platform technology to deliver RNAi nanoparticle Particle Therapeutics directly to cancer cells.

Speaker 2

We are forging a new path in DNA powered medicine that we believe made with our lead product candidate prexigebersen. As you know, we continue to be encouraged by the positive interim results From Stage 2 of our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia or AML. In combination with frontline therapy decitabine and venetoclax, this is meaningful because these patients are at the end of the line of treatment options. Note, most have already relapsed or essentially everything in the treatment Armaumentarium currently available. So a drug like prexigebersen can give hope to these patients.

Speaker 2

Recall the study is an amended Stage 2 of our Phase 2 trial in AML. It is an open label, 2 stage, multicentered study of prexigebersen in combination with decitabine venetoclax in 2 cohorts of patients with previously untreated AML and relapsed resistant AML. The 3rd cohort includes treating relapse resistant AML patients who are venetoclax resistant or intolerant with the 2 drug combination of prexigebersen and decitabine. The primary endpoint of 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 hematologic recovery. As a recap, of these very promising results we achieved, there were 14 newly diagnosed patients evaluable in Cohort 1 and treated with at least one cycle of the prexigebersen decitabine and venetoclax combination therapy.

Speaker 2

All patients in this cohort were adverse risk by 2017 European Leukemia Net or EON guidelines or secondary AML. Truxantivirsen was well tolerated and adverse events were generally consistent With decitabine and venetoclax treatment and or for AML, 12 of the 14 evaluable patients or 86% 100% of the evaluable patients had a response to treatment. The complete remission rate of 86% For the evaluable patients in Cohort 1 is significantly higher than completion rates of 62% for newly diagnosed patients treated With the frontline combination treatment of decitabine and venetoclax, this result is further highlighted by the high risk rating 14 refractory relapse evaluable AML patients In Cohort 2, we're treated with at least one cycle of prexigebersendecitabine and venetoclax combination therapy. All patients in this cohort were adverse risk by 2017 ELN guidelines or secondary AML. Prexigebersen was well tolerated and AEs were generally consistent with decitabine and venetoclax treatment and or for AML.

Speaker 2

8 of the 14 evaluable patients or 57% achieved complete remission, 2 patients or 14% achieved partial remission and 3 patients or 22% achieved stable disease. In total, 93% of the evaluable patients had a response to treatment. The complete remission rate of 57% of the evaluable refractory and relapsed patients In Cohort 2, it's significantly higher than complete remission rate of 21% for refractory relapse patients Treated with combination treatment of decitabine and venetoclax, as with newly diagnosed patients in Cohort 1, This result is further highlighted by the high risk rating of Bio Path's Cohort 2 evaluable patients and the inclusion of secondary AML patients. Efficacy data from the initial interim analysis of Cohort 1 And Cohort 2 are compelling and show that prexigebersen based combination therapy was not only safely administered In Cohort 1 and Cohort 2, the high risk newly diagnosed and refractory relapse AML patients considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals Significantly better than current therapies. This is particularly encouraging as relapsed refractory patients are a challenging population in which current treatment options are suboptimal.

Speaker 2

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 front. In October, we hosted a key opinion leader event to discuss the evolving treatment landscape in AML.

Speaker 2

We were privileged to have Doctor. Jorge Cortez and Doctor. Merrill Ohanian, True luminaries in the hematologic and oncology space as our guest speakers. The discussion was illuminating and engaging, bolstering our conviction in the prexigebersen clinical development program As both physician experts were deeply encouraged by our interim results and further underscored The great unmet medical need for these relapse 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.

Speaker 2

Having this independent and expert point of view that support Bio Path's mission was inspiring. I encourage you all to listen to the archive of this event, which is available on our website. Turning now to our BP1002 program, which targets BCL-two. As you know, BCL-two is responsible for driving cell survival In up to 60% of all cancers, the high expression of BCL-two has been correlated with poor prognosis for patients diagnosed with AML. Venetoclax has shown activity against anti apoptotic protein BCL-two and works by neutralizing the proteins BH3 domain.

Speaker 2

It is an approved treatment for chronic lymphocytic leukemia for CLL patients and untreated AML patients. However, with the exception of some patients treated with Allogeneic and monopoietic cell transplantation disease relapse invariably occurs Oftentimes due to BH3 domain mutation over time. BP1002 also targets However, BP1002 activity is based on blocking The BCL2 messenger RNA and not the BH3 domain. As a result, We believe that BP1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who previously received venetoclax treatment. A total of 6 evaluable patients The approved treatment cycle is 2 doses per week over 4 weeks, resulting in 8 Dose is administered over 28 days.

Speaker 2

The Phase 1b portion of the study will commence After completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in Combination with decitabine and refractory relapsed AML patients, we expect cohort completion and initial data readout from this study in the coming months. Next, let's turn to our Phase 1, 1b study Clinical trial of BP100A in patients with solid tumors, including ovarian, endometrial, pancreatic And triple negative breast cancer, some of the most challenging cancers to treat with today's therapeutic toolkit. EP-one thousand and one A is a modified product from prexigebersen sharing the same drug substance With enhanced nanoparticle properties, the clinical trial is in the 2nd dose cohort. This trial is being conducted at several leading cancer centers and will initially evaluate the safety in 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.

Speaker 2

We look forward to cohort completion and data readout from this study in early 2024. Finally, let's review the progress we've made with BP1003, which targets the STAT3 protein. STAT3 is a transcription factor that regulates various tumorigenic processes such as tumor proliferation, metastasis and drug resistance. Its overexpression An aberrant activation characterized many cancers, including breast, lung, ovarian, liver and colon cancer. Activation of the STAT3 pathway in breast and ovarian cancer cells promotes tumor initiation, migration and taxol resistance.

Speaker 2

STAT3 also contributes to 5 FU resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 a potential cancer therapy target. BP1003 is a novel liposome incorporated STAT3 antisense Oligodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells, Intaxel and 5 FU. These results are in line with previous work in which BP1003 plus gemcitabine displayed enhanced antitumor activity in pancreatic ductal Adenocarcinoma. Together, these results strongly suggest that BP1003 combination therapy It's a novel strategy for patients with advanced solid tumors.

Speaker 2

We are particularly excited to launch With that, I'll now turn the program over to Anthony Price for a brief review of our financials along with balance Anthony?

Speaker 3

Thanks, Peter. The company reported a net loss of 3 point $2,000,000 or $0.32 per share for the 3 months ended September 30, 2023 compared to a net loss of 3,500,000 or $0.49 per share for the 3 months ended September 30, 2022. Research and development expense for the 3 months ended September 30, 2023 decreased to $2,300,000 compared to 2,400,000 For the 3 months ended September 30, 2022, primarily due to decreased manufacturing development expenses, partially offset by an increase in expense related to our clinical trial for prexigebersen in AML due to increased patient enrollment in 2023. General and administrative expense for the 3 months ended September 30, 2023 decreased to $1,000,000 compared to $1,200,000 for the 3 months ended September 30, 2022, primarily due to decreased legal fees. Change in fair value of the Company's warrant liability for the 3 months ended September 30, 2023 resulted in non cash income of $100,000 The company did not have the warrant liability in the comparable period for 2022.

Speaker 3

As of September 30, 2023, The company had cash of $2,400,000 compared to $10,400,000 as of December 31, 2022. Net cash used in operating activities for the 9 months ended September 30, 2023 was $9,700,000 compared to $10,100,000 for the comparable period in 2022. Net cash provided by financing activities for the 9 months ended

Speaker 2

Thanks, Anthony. It's been another exceptional quarter for Bio Path, particularly as the data we just discussed Cement our conviction and support of the advancement of these important programs. Despite the gloom in the financial markets, The excitement we see and feel in the clinical markets with progress such as we've made with prexigebersen 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 are ready to open the call for questions.

Operator

We will now begin the question and answer session. Our first question comes from Jonathan Aschoff with ROTH MKM. Please go ahead.

Speaker 4

Thank you. Good morning, Peter. I was curious, Was the 3rd cohort, prex, where there was no data yet available, it was a relref Hey, Amel, that was resistant or intolerant to venetoclax. Is there any update there, even if just on enrollment?

Speaker 2

Hi, Jonathan. Just harder to find patients for that. We actually have had 5 enrolled and we have 3 evaluable patients. What happens is oftentimes when a patient is on a borderline for that investigators Slip them into Cohort 2, so they can get the triple combination. But no, and we're treating them right now.

Speaker 2

We have patients continue to treat the other ones. We've reached or exceeded our A valuable milestone for this interim analysis. So we're backing off on those. But no, we continue with Cohort 3. It just takes longer to get them and get the patients and but Like the whole 2 that that will the bar is pretty low on that.

Speaker 2

The frontline comparison is the sentiment alone and That's a 16% to 20% CR. So I think That's a good one for us to pursue. So that's the status on that.

Speaker 4

Okay. And just a yes or no on this. I had a note or In my last note that we expect to see an ASH abstract from you guys, but there is none for PREX or PREXA, Just regular cracks.

Speaker 2

We're too late. So and we rushed Get out and but what we'll probably do, I'm sure we'll end up doing the full blown report Interim next year, but for the near term, we're pulling together to Try and meet ASCO and that's another good meeting. And 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 game plan, it's just time driven.

Speaker 4

Okay. Your last timing indication for prexay was full enrollment by the end of the year, which I think you just switched to data By early 2024, so that's fine. But for 100 and 2, the last timing you gave was Completion of the first cohort before the end of the year, is that still relevant for the Phase 1, 1b trial?

Speaker 2

Check my notes here. I think we mentioned that we were enrolling a couple of new sites For the lymphoma-one thousand and two and a couple of good ones and one of which is Einstein in New York. And We actually have that 3rd patient that close out the cohort next week. I think it finishes and We'll be able to do that because safety issues. So yes, that meets it and I'm pleased with that because we needed to Get to a higher dose from our starting of 20 mgs per square meter.

Speaker 2

The AML, in that, we've completed the patients for that first. We're just doing we have to schedule the safety meeting and all that. I mean these things take time, but do that and we should have something that I can put Before the end of the year. And the solid tumor, as I noted, We're already in the Q2. So we've graduated, and we've put a short release out on that And we're in the second.

Speaker 2

So we've gone from the starting. That one, the drug substance recall is Brexigebersen, different formulation, so it's treated as a different drug. But that It had started at 60 megs per square meter and now is in the 2nd cohort at 90 megs per square meter. And I think there's Real in that treatment. So that's a step of those.

Speaker 4

That's definitely helpful. Do you still expect In early 2024 filing for the IND for 1003?

Speaker 2

It won't be early. We do I think I won't go over the issues getting the detection for PK work. We have that. We actually have 2 sources and one is new and actually the other is one that we use for Drug, the actual nanoparticle characteristics, which we've found they have a division that can do GOP human plasma. And so we're going to get them online.

Speaker 2

So I think that we'll finally be able to Demonstrate that testing and of course you'd like to be able to, tongue in cheek, demonstrate that indeed you had drug substance And your safety studies. And so I think it'd be more Mid latter part, the hold up again is being to get the detection Of oligo, drug substance in Patient or in the animal study plasma because It's two points on that. 1, just to be able to again demonstrate that you had drug substance in your tox studies. And then of course going forward the issue is you need that to do 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's done.

Speaker 2

Then we just have to quickly do one study, which is a couple of months. And then We'll start compiling the IND and I'll bring on an outside consultant to help with that writing so we can move it along. So Best case would be late summer, I would think. Those INDs are a lot of data, as you know. So That's the status on that, but I feel better about that now since we are able to detect that.

Speaker 4

Lastly, did I mishear you? Were you developing 100 and 2 in AML or did I just mishear you say CLL?

Speaker 2

No, there's 2 separate INDs. It's the FDA. We had the CLL one going And patients enrolled and wanted to do the AML venetoclax failure patients sets a real opportunity for us. Venetoclax operating on the protein in the cytoplasm and as usually what happens with PKIs That's septic cycle. So eventually the drugs the patient becomes resistant.

Speaker 2

We're a natural step in behind that because we don't involve that kind of activity. We just block the expression Of the BCL-two, so that's a so anyway, submitted on that, but administratively the FDA Handles those two diseases in different divisions. So we had to file a separate IND For AML relapsed patients, it's generally AML relapsed resistance beyond just Beyond just AML, it's venetoclax resistant patients. But yes, And we have 2 clinical trials and 2 INDs for that. So both are will be announced here Shortly to 6 weeks for moving on to the next dosing cohort.

Speaker 4

Thank you for those details, Peter.

Speaker 2

You're welcome.

Operator

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

Speaker 2

Thank you again everyone for joining us and for your continued support of Bio Path. Have a great day.

Operator

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

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Earnings Conference Call
Bio-Path Q3 2023
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