Q2 2024 Bio-Path Holdings Inc Earnings Call
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Speaker Change: [inaudible]
Speaker Change: Good morning, ladies and gentlemen. Welcome to the Biopath Holdings second quarter 2024 earnings conference call.
Speaker Change: At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up to your questions.
Speaker Change: At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Please proceed.
Will O'Connor: Thank you, Operator. Welcome to the Biopath Holdings conference call and webcast to review the company's second quarter 2024 financial results and to provide an update on recent pipeline and corporate developments.
Speaker Change: 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. With me today from Biopath are President and CEO, Peter Nielsen, and Senior Vice President of Finance, Accounting, and Administration, Anthony Price.
Speaker Change: Before I begin the call, I'd like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties.
Speaker Change: 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 BioPath CEO, Peter Nielsen.
Peter Nielsen: Thanks, Will.
Peter Nielsen: Good morning, everyone, and thank you for joining us.
Speaker Change: The first half of 2024 was an undeniably productive period for biopaths.
Peter Nielsen: I am extremely proud of our team, which continues to efficiently operate on all cylinders and has executed our strategy to achieve both clinical and corporate objectives.
Peter Nielsen: I'll begin this morning with the progress we have made with our lead product candidate, Prexige Burson.
Peter Nielsen: In June, we were honored to have a presence at two of the most prestigious medical meetings in the field of oncology.
Peter Nielsen: the American Society of Clinical Oncology, or ASCO, annual meeting in Chicago, and the European Hematology Association, or EHA, Congress, in Madrid.
Peter Nielsen: At both meetings, we showcased interim results from our Phase 2 study of prexigivoracin in combination with frontline therapy to citabin and venetoclax for the treatment of acute myeloid leukemia, or AML.
Peter Nielsen: At ASCO, we were recognized with an oral presentation of our results.
Peter Nielsen: As you know, the study is an amended stage 2 of our phase 2 trial in AML.
Peter Nielsen: It is an open-label, two-stage, multi-center study of Prexinger-Burrison in combination with Decidabine and Venetoclax in two cohorts of patients with previously untreated AML and refractory relapsed AML.
Peter Nielsen: A third cohort includes the treatment of refractory relapsed AML patients who are venetoclax-resistant or intolerant with the two-drug combination of prexigibiracin and dicitamine.
Peter Nielsen: The primary endpoint for this study will be the number of patients who achieve complete remission, which includes complete remission with incomplete hematologic recovery and complete remission with partial hematologic recovery.
Peter Nielsen: The interim efficacy data presented at ASCO and EHA were from the initial interim analysis of Cohort 1 and Cohort 2.
Peter Nielsen: These compelling data showed that prexatriburacin-based combination therapy was not only safely administered in Cohort 1 and Cohort 2 to high-risk, newly diagnosed, and refractory relapsed AML patients,
Speaker Change: considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals.
Speaker Change: better than current therapies.
Speaker Change: This is particularly encouraging as refractory relapse patients are a challenging population in which current treatment options are suboptimal.
Speaker Change: It was a pleasure to present these data to an audience of world-leading oncologists who treat AML patients and understand the continued great need for new therapeutic options.
Speaker Change: During the second quarter, we also announced the exciting development of a molecular biomarker package to accompany prexigeverosin treatment.
Speaker Change: The goal here is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program.
Speaker Change: The Emerging Role of Biomarkers
Speaker Change: has enhanced cancer treatment development over the past decade and has become a more common companion to many oncology programs. We will keep you up to date as this cutting-edge project advances.
Speaker Change: Turning now to BP 1002 program, which targets BCL-2.
Speaker Change: As you know, BCL-2 is responsible for driving cell survival in up to 60% of all cancers.
Speaker Change: High expression of BCL-2 has been correlated with poor prognosis for patients diagnosed with AML.
Speaker Change: Venetoclax has shown activity against the anti-apoptotic protein BCL-2 and works by neutralizing the protein's BH3 domain.
Speaker Change: It is an improved treatment for Chronic Lymphocytic Leukemia, or CLL, patients, and untreated AML patients. However, it is not effective.
Speaker Change: with the exception of some patients treated with allogenetic and monopoietic cell transplantation, disease relapse invariably occurs, oftentimes due to BH3 domain mutation over time.
Speaker Change: BP-1002 also targets the BCL-2 protein.
Speaker Change: However...
Speaker Change: BP1002 activity is based on blocking the BCL2 messenger RNA and not the BH3 domain.
Speaker Change: As a result, we believe that BP1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who previously received venetoclax treatments.
Speaker Change: During the second quarter, we announced completion of the second dose cohort for the dose escalation portion.
Speaker Change: of our Phase 1.1b clinical trial of BP1002 to treat relapsed, refractory relapsed AML, including venetoclax resistant patients.
Speaker Change: A total of three evaluated 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.
Speaker Change: The first dose cohort consisted of a starting dose of 20 mg per square meter, and there is no dose limiting toxicity.
Speaker Change: The approved treatment cycle is 2 doses per week over 4 weeks for a total of 8 doses administered over 28 days.
Speaker Change: The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts.
Speaker Change: and will assess
Speaker Change: the safety and efficacy of BP1002 in combination with the citabine and refractory relapsed AML patients. We look forward to keeping you apprised of our progress here.
Speaker Change: Next, let's turn to our Phase 1.1.b clinical trial of BP-1001-A in patients with solid tumors.
Speaker Change: including ovarian, endometrial, pancreatic, and triple negative breast cancer. Some of the most challenging cancers to treat with today's therapeutic toolkit.
Speaker Change: BP-1001-A is a modified product from Prexatriburacin sharing the same drug substance with enhanced nanoparticle properties.
Speaker Change: This trial is being conducted at several leading cancer centers and will initially evaluate the safety in solid tumor patients.
Speaker Change: Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes.
Speaker Change: And it is our hope that we may provide clinical benefits to such patients. We look forward to cohort completion and data readout from this study, potentially later this year.
Speaker Change: Finally, let's review the progress we've made with BP1003 which targets the STAT3 protein.
Speaker Change: STAT3 is a transcription factor that regulates various tumorogenic processes such as tumor proliferation, metastasis, and drug resistance.
Speaker Change: Its overexpression and aberrant activation characterize many cancers, including breast, lung, ovarian, liver, and colon cancer.
Speaker Change: Activation of a STAT3 pathway in breast and ovarian cancer cells promotes tumor initiation, migration, and taxol resistance.
Speaker Change: STAT3 also promotes 5-FU resistance in colorectal cancer cells.
Speaker Change: Its role in numerous malignancies made STAT3 a potential cancer therapeutic target.
Speaker Change: BP-1003 is a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide that efficiently reduces STAT3
Speaker Change: expression and enhances the sensitivity of breast and ovarian cancer cells to Taxel and 5-FU.
Speaker Change: These results are in line with previous work in which BP1003
Jim Seidman: Plus, Jim Seidman displayed enhanced anti-tumor activity in pancreatic ductal adenocarcinoma.
Jim Seidman: Together, these results strongly suggest BP-103 combination therapy is a novel strategy for patients with advanced solid tumors.
Jim Seidman: after an extended period of testing.
Speaker Change: We have identified a method for oligodetection in plasma that we expect will enable us to complete final safety testing needed to finalize an investigational new drug, or IND, application for submission to the FDA.
Speaker Change: 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: Before I turn the call over to Anthony for a review of our financial quarter results, I'd like to highlight that we've strengthened our balance sheet in recent weeks with a four million dollar financing.
Speaker Change: This additional funding provides the financial underpinning from which to execute our clinical development plan.
Anthony Price: 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?
Anthony Price: Thanks, Peter.
Anthony Price: The company reported a net loss of $1.9 million, or $1.16 per share, for the three months ended June 30, 2024.
Anthony Price: compared to a net loss of $4.2 million, or $10.64 per share, for the three months ended June 30, 2023.
Anthony Price: Research and development expense for the three months ended June 30th, 2024 decreased to $1.9 million compared to $3.1 million for the three months ended June 30th, 2023.
Anthony Price: primarily due to decreased manufacturing expenses related to drug product releases, partially offset by an increase in expense related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in 2024.
Anthony Price: General and administrative expense for the three months ended June 30, 2024 and June 30, 2023 was $1.2 million.
Anthony Price: As of June 30, 2024, the company had cash of $4.0 million compared to $1.1 million as of December 31, 2023.
Anthony Price: Net cash used in operating activities for the six months ended June 30, 2024 was $4.3 million, compared to $6.9 million.
Anthony Price: for the comparable period in 2023. Net cash provided by financing activities for the six months ended June 30, 2024 was $7.2 million.
Anthony Price: With that, I'll now turn the call back over to Peter.
Peter Nielsen: Thanks, Anthony.
Peter Nielsen: As you can see from the data we presented last quarter, we are well on our way to establishing our de-enablized platform as a better path for cancer patients.
Speaker Change: We are paving the way for a revolutionary treatment of disease by taking a gentler path.
Speaker Change: As positive data continues to flow from our clinical trials.
Speaker Change: We're becoming even more excited about bringing these potentially life-saving therapies to some of the most fragile oncology patients.
Speaker Change: We know this is an ambitious commitment.
Speaker Change: But we have confidence in our approach and conviction in our mission to give previously untreatable cancer patients a fighting chance.
Speaker Change: With that, operator, we are ready to open the call for questions.
Speaker Change: [inaudible]
Speaker Change: Ladies and gentlemen, at this time we'll begin the question and answer session. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two.
Speaker Change: If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality.
Speaker Change: Once again, that is star and then one to join the question series.
Speaker Change: will pause momentarily to assemble the roster.
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Speaker Change: Thank you for watching, and I'll see you in the next video.
Speaker Change: And ladies and gentlemen, we appear to have no questions today, so I will turn the floor back over to Peter Nielsen for any closing comments.
Peter Nielsen: Thank you again for joining us and for your continued support of BioPath. Have a great day.
Peter Nielsen: And ladies and gentlemen, thank you again for joining us today.
Peter Nielsen: This concludes today's presentation. We do thank you for joining.
Peter Nielsen: Have a great rest of the day.