Q3 2024 Bio-Path Holdings Inc Earnings Call

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Good morning, and welcome to the Bio path Holdings incorporated third quarter 2024 conference call all participants will be in listen only mode.

Operator: Good morning, and welcome to the Bio Path Holdings Incorporated third quarter 2024 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad.

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Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded.

Speaker Change: Being recorded I would now like to turn the conference over to will O'connor of Stern Investor Relations. Please go ahead.

Will O'Connor: I would now like to turn the conference over to Will O'Connor of Stern Investor Relations. Please go ahead.

Will O'Connor: Thank you operator, welcome to the bio path Holdings conference call and webcast to review the company's third quarter 2024 financial results and to provide an update on recent pipeline and corporate developments earlier, we issued a press release, which outlines the topics we plan to discuss on today's call in their press release is available at bio path Holdings Dotcom.

Will O'Connor: Thank you, Operator.

Will O'Connor: Welcome to the Bio Path Holdings conference call and webcast to review the company's third quarter 2024 financial results, and to provide an update on recent pipeline and corporate developments. Earlier, we issued a press release which outlines the topics we plan to discuss on today's call, and that press release is available at biopathholdings.com.

Will O'Connor: With me today from bio path are president and CEO, Peter Nielsen and senior Vice President of Finance accounting and administration Anthony price before.

Will O'Connor: 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 the call, I'd like to remind you that today's discussion will contain four looking statements that involve risks and uncertainty. These risks and uncertainties are outlined in today's press release and in the company's recent filing 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.

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.

Will O'Connor: 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.

Will O'Connor: Our actual results may differ materially from what is discussed on today's call.

Peter Nielsen: With that, I'll now turn the call over to Bio Path's CEO, Peter Nielsen. Thanks, Will. Good morning, everyone, and thank you for joining us. As we approach the end of 2024, I look back with pride on all we have achieved. Importantly, we continue to live on our promise to usher in a new era of DNA-powered medicine.

With that I'll now turn the call over to bio paths CEO Peter Nielsen.

Peter Nielsen: Thanks will.

Peter Nielsen: Good morning, everyone.

Peter Nielsen: And thank you for joining us.

Peter Nielsen: As we approach the end of 2024, I look back with pride on all we ever cheap.

Peter Nielsen: Fortunately, we continue to deliver on our promise to usher in a new era of DNA powered medicine.

Peter Nielsen: I'll begin this morning with an exciting development that expands the utility of our de-enablized platform beyond oncology. Last month, we announced the initiation of our clinical development program for BP1001-A as a treatment for obesity and related metabolic disease. This marks the first application of our de-enablized platform for development of a non-cancer application, which highlights the broad therapeutic potential of this technology. BP-1001-A is a modified product from Plexiglasburosine sharing the same drug substance with enhanced nanoparticle properties. The disease pathology leading to obesity suggests that BP1001-A, which suppresses the adapter protein GRB2 has the potential to treat insulin resistance, a major contributor to obesity, type 2 diabetes, and other related metabolic diseases.

Peter Nielsen: I'll begin this morning, with an exciting development that expands the utility of our DNA D enable EIS platform beyond oncology.

Peter Nielsen: Last month, we announced the initiation of our clinical development program for BP 1001, Dash eight as a treatment for obesity and related metabolic diseases.

Peter Nielsen: This marks the first application of our D enable EIS platform for development of a non cancer application, which highlights the broad therapeutic potential of this technology.

Peter Nielsen: P. P 1001 dash eight is a modified product complexity person sharing the same drug substance with enhanced nanoparticle properties.

Peter Nielsen: The disease pathology, leading to obesity suggest that BP 1001, dash, eight which suppresses the adapter protein.

Peter Nielsen: G. R. B two has the potential to treat insulin resistance a major contributor to obesity type two diabetes and other related metabolic diseases.

Peter Nielsen: Based on our review of published research, we expect down-regulating GRB2 expression with BP1001-A will enhance insulin sensitivity. Preclinical studies to confirm these assumptions will kick off this quarter, and we expect these findings will provide crucial insights into the mechanism and efficacy of BP1001-A in enhancing insulin sensitivity and reveal its therapeutic potential for obesity and type 2 diabetes.

Peter Nielsen: Based on our review of published research, we expect Downrate regulating G. R. B two expression with BP 1001, there Jay.

Peter Nielsen: Hans insulin sensitivity.

Peter Nielsen: Preclinical studies to confirm these assumptions will kick off this quarter and we expect these findings will provide crucial insights into the mechanism and advocacy of BP 1001, dash, eight and enhancing insulin sensitivity and reveal its therapeutic potential.

Peter Nielsen: For obesity and type two diabetes.

Peter Nielsen: Diabetes.

Peter Nielsen: Yeah.

Peter Nielsen: Beyond obesity, we also continue. to advance a Phase 1.1b clinical trial of BP1001-A 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. 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. We look forward to the next dose cohort completion and data readout from this study, potentially early next year.

Peter Nielsen: Beyond obese obesity, we also continue to.

Peter Nielsen: To advance a phase one would be clinical trial a P. P 1001 dash eight 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 tool.

Peter Nielsen: Yeah.

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

Peter Nielsen: 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.

Peter Nielsen: We look forward to the next dose cohort completion and data readout from this study potentially early next year.

Peter Nielsen: Turning now to the progress we have made with our lead product candidate Craxi Your burleson.

Peter Nielsen: Turning now to the progress we have made with our lead product candidate, Prexy Gibberish. We continue to advance the amended Stage 2 of our Phase 2 trial in AML. It is an open-label, two-stage, multi-center study of Plexiglasburosine in combination with the citabine and venetoclax in two cohorts of patients with previously untreated AML and refractory relapsed AML. A third cohort includes the treatment of refractory relapsed AML patients who are venetoclax-resistant or intolerant with the two-drug combination of Plexiglasburosine and the citabine. The primary endpoint for this study will be the number of patients who achieve complete remission, which includes with incomplete hematologic recovery and complete remission with partial hematologic recovery.

Peter Nielsen: We continue to advance the amended stage two of our phase III trial in AML.

Peter Nielsen: As an open label two stage Multicenter study of practices your burleson in combination with decitabine in vanilla class in two cohorts of patients with previously untreated AML and refractory relapsed AML a third cohort includes the treatment of refractory.

Peter Nielsen: AML patients, who are vanilla clacks resistant or intolerant with the two drug combination of Brexit and your birth and decided then.

Peter Nielsen: The primary endpoint for this study will be the number of patients who achieved complete remission which include <unk>.

Complete remission.

Peter Nielsen: With incomplete hematologic recovery and complete remission with partial hematologic recovery.

Peter Nielsen: We also made considerable progress advancing our phase one one b clinical trial, a BP 1002 in refractory relapsed AML patients.

Peter Nielsen: We also made considerable progress advancing our Phase I-Ib clinical trial of BP1002 in refractory relapsed AML patients. BP-1002 targets the BCL-2 protein. However, BP-1002 activity is based on blocking the BCL-2 messenger RNA and not the BH3 domain, which is the mechanism of treatment for the frontline drug, venetoclax. BCL-2 is responsible for driving cell survival in up to 60% of all. high expression of BCL-2 has been correlated with poor prognosis for patients diagnosed with AML. 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.

Peter Nielsen: P. P 1002 targets the Bcl two protein. However, b P 1002 activity is based on blocking the Bcl two messenger RNA and not to be a three domain, which is the mechanism of treatment for the frontline drug banana.

Peter Nielsen: Class B.

Bcl two is responsible for driving cell survival and up to 60% of all cancers.

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

Peter Nielsen: As a result, we believe that B P 1002 could provide an alternative for banana clacks patients who have relapsed, including AML patients who previously received didn't had a class treatments.

Peter Nielsen: By targeting the key protein involved in the banana class treatment, that's the messenger RNA level B P 100 too.

Peter Nielsen: By targeting the key protein involved in a venetoclax treatment at the messenger RNA level, BP-1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Banetoclax has shown activity against the anti-apoptotic protein BCL2 and works by neutralizing the protein's BH3 domain. It is an improved treatment for Chronic Lymphocytic Leukemia, or CLL, patients and untreated AML patients. However, with the exception of some patients. treated with allogenetic hematopoietic cell transplantation. Relapse invariably occurs, oftentimes due to BH3 domain mutation over time. A total of three evaluable patients per dosing cohort are scheduled to be treated with BP-1002 monotherapy in a standard 3 plus 3 design, unless there is a dose-limiting toxicity, which would require an additional three patients tested.

Peter Nielsen: They overcome and prevent some of the mechanisms of resistance.

Peter Nielsen: Fact, vanadic clacks treatment.

Peter Nielsen: The net of class has shown activity against the anti apoptotic protein Bcl, two and works by neutralizing the proteins ph three domain.

Peter Nielsen: It is an approved treatment for chronic lymphocytic leukemia or C O L patients and untreated AML patients. However, with the exception of some patients treated with allogeneic hematopoietic cell transplantation.

Yeah.

Peter Nielsen: Yeah.

Speaker Change: Relapse invariably incurs oftentimes due to be H <unk> domain mutation over time.

Speaker Change: A total of three evaluable patients for dosing cohort are scheduled to be treated with B P. 1002 mono therapy in a standard three plus three design unless there was a dose limiting toxicity, which would require an additional three patients tested.

Speaker Change: The first dose cohort consistent with a starting dose of 20 milligrams per square meter and there were no dose limiting toxicity.

Peter Nielsen: The first dose cohort consisted of a starting dose of 20 mg per m2 and there were no dose limiting toxins. The approved treatment cycle is 2 doses per week over 4 weeks, with a total of 8 doses administered over 28 days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohort. and will assess the safety and efficacy of BP1002 in combination with the citabine in refractory relapse AML patients. After the FDA completed its review of data from the first dosing cohort, we initiated enrollment for the third higher dosing cohort of 60 milligrams per square meter.

Speaker Change: The approved treatment cycle is two doses per week over four weeks with a total of eight doses administered over 28 days.

Speaker Change: The phase <unk> portion of the study is expected to commence after completion of BP 1002 monotherapy cohorts.

Speaker Change: And we will assess the safety and efficacy of B P 1002 in combination with decitabine in refractory relapsed AML patients.

Speaker Change: After the FDA completed its review of data from the first dosing cohorts.

Speaker Change: We initially we initiated enrollment for the third higher dosing cohort of 60 milligrams per square meter.

Peter Nielsen: Enrollment was completed within six weeks, faster than projected, which underscores the continued need for new treatment options in this vulnerable patient population.

Enrollment was completed within six weeks faster than projected which underscores the continued need for new treatment options in this vulnerable patient population.

Finally, let's review the progress we've made with BP 1003, which targets the stat three proteins.

Peter Nielsen: Finally, let's review the progress we've made with BP1003, which targets the STAT3 protein. DATS3 is a transcription factor that regulates various tumorogenic processes. such as tumor proliferation, metastasis, and drug resistance. Overexpression and aberrant activation characterize many cancers, including breast, lung, ovarian, liver, and colon cancer. Activation of Staff Three. in breast and ovarian cancer cells promotes tumor initiation, migration, and taxol resistance. STAT III also promotes 5-FU resistance. colorectal cancer cells. Its role in numerous malignancies made STAT-3 a potential cancer therapeutic target. BP-1003 is a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to Taxol and 5-FU.

Speaker Change: That's three is a transcription factor that regulates various tumorigenic processes such as tumor proliferation.

Speaker Change: Fastest says and drug resistance.

Speaker Change: It's over expression and aberrant activation characterize many cancers.

Speaker Change: Including breast lung ovarian liver and colon cancers.

Speaker Change: Activation of staff free.

Speaker Change: Half way in breast and ovarian cancer cells promotes tumor initiation migration and taxol resistance.

Speaker Change: Step three also promotes five dash F you resistance in colorectal cancer cells.

Its role in numerous malignancies mates that 310.

Central cancer therapeutic target.

P. P 1003 is a novel Liposome incorporated <unk> antisense oligo D oxy nucleotide that efficient.

Wyszynski efficiently reduces staff free expression and enhances the sensitivity of breast and ovarian cancer cells.

Speaker Change: Tax all five dash after you.

Peter Nielsen: In September, we announced a publication highlighting the therapeutic potential of BP1003 in a variety of cancer types in the peer-reviewed journal Biomedicine. The article describes the broad anti-tumor effect of BP-1003 in numerous preclinical solid tumor models, including breast, ovarian, and pancreatic cancer. After an extended period of testing, we have identified a method for oligodetection in trace quantities in plasma that we expect will enable us to complete final safety needed finalized an Investigational New Drug, or IND, application for submission to the FDA.

Speaker Change: In September we announced the publication highlighting the therapeutic potential of V. P 1003 in a variety of cancer types in the peer reviewed journal bio medicines.

Speaker Change: The article describes the broad antitumor effect of B P 1003, and numerous preclinical solid tumor models, including breast ovarian and pancreatic cancer.

Speaker Change: After an extended period of testing we have identified a method for all ago detection and trace quantities in plasma that we expect will enable us to complete final safety needed to.

Speaker Change: To finalize an investigational new drug or I N D application for submission to the F D. A.

Peter Nielsen: 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.

Speaker Change: We were particularly excited to launch our first in human validation of this cutting edge therapy, internet, especially challenging cancer indication that has limited treatment options.

Speaker Change: Yeah.

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

With that.

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

Anthony Price: Anthony? The company reported a net loss of $2.1 million, or $0.70 per share, for the three months ended September 30, 2024, compared to a net loss of $3.2 million, or $6.36 per share, for the three months ended September 30, 2023. Research and development expense for the three months ended September 30, 2024 decreased to $1.3 million compared to $2.3 million for the three months ended September 30, 2023, primarily due to decreased manufacturing expenses related to drug product releases, as well as a decrease in expense related to our clinical trial for BP1001 in AML due to timing of patient enrollment during the quarter.

Speaker Change: Tony.

Anthony Price: Thanks Peter.

Speaker Change: <unk> reported a net loss of $2 1 million or <unk> 70 per share for the three months ended September 32024, compared to a net loss of $3 2 million or <unk> 36 per share for the three months ended September 32023.

Speaker Change: Research and development expense for the three months ended September 32024 decreased to $1 3 million compared to $2 3 million for the three months ended September 30th 2023, primarily due to decreased manufacturing expenses related to drug product releases as well as a decrease.

Speaker Change: And expense related to our clinical trial for B P 1001 in AML due to timing of patient enrollment during the quarter.

Speaker Change: General and administrative expense for the three months ended September 32024.

Anthony Price: General and administrative expense for the three months ended September 30, 2024 increased to $1.3 million compared to $1.0 million for the three months ended September 30, 2023 primarily due to increased legal fees and salaries and benefits expense.

Speaker Change: Increased $1 3 million compared to 1.0 million for the three months ended September 32023, primarily due to increased legal fees and salaries and benefits expense.

Speaker Change: As of September 30th 2024, the company had cash of <unk> 6 million.

Anthony Price: As of September 30, 2024, the company had cash of $0.6 million, compared to $1.1 million as of December 31, 2023. Net cash used in operating activities for the nine months ended September 30, 2024 was $7.7 million, compared to $9.7 million for the comparable period in 2023. Net cash provided by financing activities for the nine months ended September 30, 2024, was $7.2 million.

Speaker Change: <unk> to $1 1 million as of December 31, 2023.

Speaker Change: Net cash used in operating activities for the nine months ended September 32024 was.

Speaker Change: Seven 7 million.

Speaker Change: To $9 7 million for the comparable periods in 2023.

Speaker Change: Net cash provided by financing activities for the nine months ended September 30th 2024 was.

Speaker Change: Seven 2 million.

Peter Nielsen: With that, I'll now turn the call back over to Peter. Thanks, Anthony. As you can see, we continue to make meaningful progress, both advancing and expanding our de-enablized platform. Our oncology programs continue to enroll, moving us one step closer towards our mission to deliver a better path for cancer patients. We are excited by our expansion into the obesity and metabolic space and look forward to keeping you apprised of our plans as they unfold. Collectively, the progress we are making across our pipeline is setting the stage for a strong finish to the year as we work to bring new medicine to the table.

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

Speaker Change: Yeah.

Thanks Anthony.

Speaker Change: As you can see we continued to make meaningful progress, both advancing and expanding our DNA belies platform.

Speaker Change: Our oncology programs continue enroll moving us one step closer towards our mission to deliver a better path for cancer patients.

Speaker Change: We are excited by our expansion into the obesity and metabolic space and look forward to keeping you apprised of our plans as they unfold.

Speaker Change: Collectively the progress we are making across our pipeline is setting the stage for a strong finish to the year as we work to bring new medicines.

Peter Nielsen: patient in need of, while creating value for our stakeholders.

Patients in need while creating value for our stakeholders.

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

Operator: With that, operator, we are ready to open the call for questions. We will now begin the question and answer session. To ask a question, you may press star and one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. Again, it is star then one to ask a question.

Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then.

Speaker Change: One on.

Speaker Change: On your telephone keypad.

Speaker Change: If you're using a speaker phone.

Speaker Change: Please pickup your handset before pressing the keys.

Speaker Change: If at any time your question has been addressed and you'd like to withdraw your question. Please press Star then chin.

Speaker Change: It is star then one to ask a question.

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

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

Speaker Change: This concludes our question and answer session I would like to turn the conference.

Operator: This concludes our question and answer session.

Peter Nielsen: I would like to turn the conference back over to Peter Nielsen for any closing remarks. Thank you. Thank you again, everyone, for joining us and for your continued support of Bio Path.

Speaker Change: Back over to Peter Nielsen for any closing remarks.

Peter Nielsen: Thank you.

Peter Nielsen: Okay.

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

Peter Nielsen: Have a great day.

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

Operator: The conference has now concluded. Thank you for attending today's presentation.

Operator: You may now disconnect. © BF-WATCH TV 2021

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