Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q1 2023 Earnings Call Transcript
Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q1 2023 Earnings Call Transcript May 12, 2023
Bio-Path Holdings, Inc. misses on earnings expectations. Reported EPS is $-0.52 EPS, expectations were $-0.45.
Operator: Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, will open the call up for your questions. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Sir, please proceed.
Will O'Connor: Thank you, operator. Welcome to the Bio-Path Holdings conference call and webcast to review the company's first quarter 2023 financial results and to provide an update on recent pipeline and corporate developments. Earlier this morning, we issued a press release, which outlines the topics that we plan to discuss on today's call and that press release is available at biopathholdings.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 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-Path CEO, Peter Nielsen.
Peter Nielsen: Thanks, Will. Good morning, everyone, and thank you for joining us. Throughout the first quarter and in recent weeks, we continue to make important progress advancing our clinical programs as we await top-line results from several key cohorts. Despite advances in the field, cancer deaths continue to rise. We believe our DNAbilize platform can overcome the challenges with current treatment options to address the urgent need for safe and effective new treatments. I'll begin with a review of our 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.
BP1001-A is a modified product from prexigebersen sharing the same drug substance with enhanced nanoparticle properties. 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 or endometrial cancer often have poor outcomes and is our hope that we may provide clinical benefit for such patients. We look forward to cohort completion and data readout from this study around mid-year. Next, let's turn to the progress we have made with our lead product candidate, prexigebersen. We continue to make significant progress advancing Stage 2 of our Phase 2 clinical trial of prexigebersen for the treatment of the acute myeloid leukemia, or AML, in combination with frontline therapy decitabine and venetoclax.
The amended Stage 2 of this Phase 2 trial in AML is an open label two stage multi-center study of prexigebersen in combination with decitabine and venetoclax in two cohorts of patients with previously untreated AML and relapsed resistant AML. A third cohort includes treating relapsed resistant AML patients who are venetoclax resistant and intolerant with the two drug combination of prexigebersen and decitabine. 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. An interim analysis will be performed on each cohort to assist the safety and efficacy of the treatment. In the coming weeks around mid-year, we will assess the initial safety and efficacy of this combination therapy with the potential to qualify for expedited program status.
Turning now to our BP1002 program, which targets Bcl-2. As you know, Bcl-2 is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. Venetoclax has shown activity against anti-apoptotic Bcl-2 and works by neutralizing the proteins 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 allogeneic hematopoietic cell transplantation, disease relapse invariably occurs oftentimes due to BH3 domain mutation over time. BP1002 also targets the Bcl-2 protein. However, BP1002 activity is based on blocking the Bcl-2 messenger RNA and not the BH3 domain.
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As a result, we believe that BP1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who have previously received venetoclax treatments. A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design with a starting dose of 20 milligrams per square meter. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses [indiscernible]. 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 in refractory relapsed AML patients. We expect cohort completion and initial data readout from this study around mid-year. 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 and aberrant activation characterized many cancers, including breast, lung, ovarian, liver and colon cancer. Activation of STAT3 pathway in breast and ovarian cancer cells, promotes tumor initiation, migration and Taxol resistance. STAT3 also promotes 5-FU resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 a potential cancer therapeutic [agent] (ph) 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 to Taxol 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 is 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. We look forward to filing an IND application for this very promising product candidate later this year or early 2024. 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. The company reported a net loss of $5.3 million or $0.66 per share for the three months ended March 31, 2023, compared to a net loss of $3.4 million or $0.47 per share for the three months ended March 31, 2022. Research and development expense for the three months ended March 31, 2023 increased to $4.0 million compared to $2.1 million for the three months ended March 31, 2022, primarily due to manufacturing expenses related to drug product releases during the quarter. General and administrative expense for both the three months ended March 31, 2023 and March 31, 2022 was $1.3 million. As of March 31, 2023, the company had cash of $6.7 million compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the three months ended March 31, 2023 was $3.7 million compared to $2.5 million for the comparable period in 2022. With that, I'll now turn the call back over to Peter.
Peter Nielsen: Thanks, Anthony. Throughout the first quarter, we continued to advance our mission to deliver a better path for cancer patients. With ongoing progress across the multiple of our DNAbilize antisense RNAi nanoparticle drug candidates, we are bringing a gentler solution to fight against cancers. We have a data-rich year ahead and I look forward to reporting on our progress. With that, operator, we are ready to open the call for questions.
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