Bio-Path Holdings Inc

Good morning, ladies and gentlemen. Welcome to the Biopath Holdings third quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. Following the formal remarks, we will open the floor for your questions. As a reminder, this conference call is being recorded. I now would like to turn the conference over to Will O'Connor of Stern Investor Relations. Please proceed.

Thank you, Operator. Welcome to the Biopath Holdings conference call and webcast to review the company's third quarter 2022 financial results and to provide an update on recent pipeline and corporate development. 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. 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 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.

Thanks, Will. Good morning, everyone, and thank you for joining us. I'm particularly pleased with the progress we made throughout the third quarter. as highlighted by the initiation of our Phase 1, Phase 1B study of BP1002 in refractory relapsed acute myeloid leukemia and made significant inroads in preparation for the initiation of our Phase 1 study of BP1001-A for the treatment of solid tumors later this year. These are exciting times at BioPath as our clinical progress is bringing us closer to achieving our mission to deliver meaningful new medicines to the most challenged cancer patients. Let's start with the progress we've made with our lead product candidate, Prexager-Burison. We continue to make significant progress advancing stage two of our phase two clinical trial of Prexager-Burison for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy to cytamine and venetoclax. The amended stage 2 of this phase 2 trial in AML is an open-level, two-stage, multi-center study of prexatubrosin in combination with the cytamin and venaglax in two cohorts of patients with previously untreated AML and relapsed resistant AML. A third cohort includes treating relapsed resistant AML patients who are venaglax resistant or intolerant with the two drug combinations, of Prexager-Burrison and Decidivin. The primary endpoint for the study will be the number of patients who achieve complete remission, which includes complete remission with incomplete hematologic recovery and complete remission with partial hematology recovery. An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment. As I mentioned earlier, we are also making progress towards initiation of a Phase I clinical trial, BP1001-A, in patients with advanced solid tumors, including ovarian, uterine, pancreatic, and hormone refractory breast cancer, some of the most challenging cancers to treat with today's therapeutic toolkit. BP1001-A, a fourth biopath drug candidate, is a modified product from Prexager-Borosin sharing the same drug substance with enhanced nanoparticle properties. In the coming weeks, we expect to initiate a Phase I-1B clinical trial of BP1001-A in patients with solid tumors, including ovarian, endometrial, pancreatic, and triple negative breast cancer. This trial will be conducted at several leading cancer centers and is planned initially to evaluate the safety of Prexagiviricin in solid tumor patients. Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes and it is our hope that Prexagiviricin may provide clinical benefit for such patients. Turning now to BP1002, our second therapeutic candidate, 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 the anti-apoptotic protein BCL-2 and works by neutralizing the protein's BH3 domain. It is an approved treatment for chronic lymphocytic leukemia, or CLL, patients and untreated AML patients. However, 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. BP1002 also targets the BCL2 protein. However, BP1002 activity is based on blocking the BCL2 messenger RNA and is 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 treatments. A total of six valuable patients will be treated with BP1002 monotherapy in a standard 3 plus 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 administered over 28 days. 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 the cytamine and refractory relapse AML patients. We hope to be able to provide incremental updates on this program as we establish safety first, followed then by efficacy in the smaller patient cohorts. Finally, Let's review the progress we've made with our initial third drug candidate, BP1003, which targets the STAT3 protein. STAT3 is a transcription factor that regulates various tumor genetic processes, such as tumor proliferation, metastasis, and drug resistance. Its overexpression and aberrant activation characterize 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. STAT3 also promotes 5-FU resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 a potential cancer therapeutic target. BP1003 is a novel liposome incorporated STAT3 antisense oligonucleotide that efficiently reduces STAT3 expression and enhances the sensitivity breast and ovarian cancer cells, to Taxel and 5-FU. These results are in line with previous work in which BP1003 plus gemcitabine displayed enhanced anti-tumor 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. Our goal is to file an IND application for this very promising product candidate in the first half of next year. The timing is determined by finalizing preclinical testing of drug substance presence in the animal species used in testing. Before turning the call over to Anthony, I'd like to highlight the considerable progress we have made bolstering our intellectual property portfolio. At BioPath, we have executed a global patent strategy aimed at building a fortress of protection for our DNA de-enabilized platform technology worldwide. I'm delighted to report that BioPath has five patents issued and six pending patent applications in the United States. Outside the United States, BioPath has four applications that have completed the grant process, and additional five applications have been allowed and are now completing the grant process. Finally, over 60 foreign applications remain pending. So, why is this so important? First, these protections are vital as we advance our programs through the clinic and begin to capture the attention of outside parties, which would be competitors and more. In addition, a strong patent position puts us in a strong negotiating position for any future partnership or licensing agreements. Importantly, These patent grants underscore the novelty of our innovative approach to fighting cancer with our de-enabilized technology. With that, I'll now turn the program over to Anthony Price for a brief review of our third quarter 2022 financials, along with balance sheet highlights.