Q2 2023 Bio-Path Holdings Inc Earnings Call

Speaker 1: Good morning ladies and gentlemen. Welcome to the Biopath Holdings Second Quarter 2023 earnings conference call.

Speaker 1: At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions.

Speaker 1: I would now like to turn the call over to Willow Connor of Stern Investor Relations. Please proceed.

Speaker 2: Thank you operator. Welcome to the Backpack Holdings conference call and webcast.

Speaker 2: 6th of May, 2020, 2nd Quarter, 2023 Financial Risk, and to provide an update on recent pipeline and corporate developments.

Speaker 2: Earlier, we issued a press release which outlines the topics that we plan to discuss on today's call. The release is available at biopathholdings.com.

Speaker 3: Beyond Prexis-Jeburson, we continue to advance our robust clinical development program across a number of important programs that leverage our innovative de-enableized platform technology to deliver RNAi nanoparticle therapeutics directly to cancer cells. We're forging a new path in DNA powered medicine that we believe will give patients a fighting chance to beat these difficult to treat cancers. I'll begin with the progress we have made with our lead product candidate, Prexis-Jeburson.

Speaker 3: As I mentioned, we recently announced positive interim results from Stage 2 of our Phase 2 clinical trial, Prexy Jibirizin for treatment of acute myeloid leukemia or AML.

Speaker 3: combination with frontline therapy to

Speaker 3: The amended stage two of the phase two trial in AML is an open label two-stage multi-center study of Prexitaburicin in combination with the Cidamid and Venetoclax in two cohorts of patients.

Speaker 3: Previously untreated AML and relapse resistant AML. A third cohort includes treating relapse resistant AML patients who are a Venetoclax resistant.

Speaker 3: or intolerant with the two-drug combination of Prexygiburacin and Decidimid. The primary endpoint for this study will be the number of patients who achieved complete remission.

Speaker 3: which includes complete remission with incomplete hematologic recovery and complete remission with partial hematology recovery.

Speaker 3: 14 newly diagnosed patients were evaluable in Cohort 1 and treated with at least one cycle of prexytubericin, decidivin, and venetoclax combination therapy.

Speaker 3: All patients in this cohort were adverse risk by 2017 European Leukemia Net or ELN guidelines or secondary AML.

Speaker 3: Prexyjibiracin was well tolerated and adverse events were generally consistent with the Cidaben and Venetoclax treatment and or AML.

Speaker 3: 12 of the 14 invaluable patients or 86%.

Speaker 3: achieved complete remission, and 2, or 14%, achieved partial remission, or PR.

Speaker 3: In total, 100% of the valuable patients had a response to treatment.

Speaker 3: The complete remission rate of 86% for the evaluable patients.

Speaker 3: of our Cohort 1, Evaluable Patients, and the inclusion of secondary AML patients, both of which are classes of patients which are difficult to treat. 14 Refractory Relapsed, Evaluable AML patients in Cohort 2, were treated with at least one cycle of Prexyzibirus and Decidibin and Venetoclax combination therapy. All patients in this cohort were adverse risk by 2017 ELN guidelines or secondary AML.

Speaker 3: Prexytubericin was well tolerated and AEs were generally consistent with the Cidamine and Venetoclax treatment and or for AML.

Speaker 3: achieved complete remission. Two patients, or 14%, achieved partial remission, and three patients, or 22%, achieved stable disease. In total, 93% of the evaluable patients had a response to treatment. The complete remission rate of 57% for the evaluable, refractory, and relapsed patients in cohort two is significantly higher than complete remission rate of 21% for refractory, relapsed patients treated with the combination treatment.

Speaker 3: of decidivine and venetoclax. As with newly diagnosed patients in cohort 1, this result is further highlighted by the high risk rating.

Speaker 3: of Biopass Cohort 2, evaluable patients, and the inclusion of secondary AML patients. Efficacy data for the initial interim analysis of Cohort 1 and 2 are compelling and show that Prexygibiracin based combination therapy was not only safety administered in Cohort 1 and Cohort 2.

Speaker 3: to high-risk newly diagnosed and refractory relapsed AML patients, considered suitable for standard chemotherapy, but also demonstrated efficacy signals.

Speaker 3: significantly better than current therapies.

Speaker 3: This is particularly encouraging as refractory relapse patients.

Speaker 3: or a challenging population in which current treatment options are sub-optimal.

Speaker 3: As a result of the interim review, we have demonstrated the superiority of Prexygibberish and combination therapy in treating AML patients and currently plan to pursue U.S. Food and Drug Administration or FDA expedited programs for fast track and breakthrough therapy designations.

Speaker 3: Fast Track Design Design Design to expedite the development and review of drugs.

Speaker 3: to treat serious conditions and to fulfill an unmet medical need.

Speaker 3: Breakthrough therapy designation is a process designed to expedite the development and review of drugs that may demonstrate substantial improvement over available therapies.

Speaker 3: We look forward to keeping you apprised on our progress on the regulatory front. Turning not the BH3 domain. As a result,

Drug delivery programs that we.

We have to support here in the near term so we're pretty much set with that now.

Okay, and I think I'd ask you about the drugs that you did a very good job in early August .

<unk> gone through the current state.

Everything that you had that seem pretty complete so where youll find it yes.

You'll be pleased to know that I think we mentioned in the last quarter that we had two new sites coming in on our lymphoma.

100.

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They are ready now and in fact.

But I think we can roll the patient from one that would be a third patient in that cohort.

It did get us after that first dose cohort so.

And those programs are starting to kick in the AML part of 100 too.

It is also we've had three times the third patient those are very sick people issue recall, they're coming off of another coax.

And they are very short survival, but we have we're now thats been dosed.

Hopefully that'll make.

The last one for that first dose cohort.

Right and that gets them out of 'twenty and puts them into what was the next dose was it.

Yes.

$2040 $60 90, 40 right okay.

Okay. Thank you very much Peter.

You are very welcome Jonathan.

And with that we will conclude our question and answer session I would like to turn the conference back over to Peter Nielsen for any closing remarks.

Thank you operator.

Well. Thank you again, everyone for joining us and for your continued support of bio path.

Have a great day. Thank you.

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