Bio-Path Holdings Inc

Good morning, ladies and gentlemen, and welcome to the Biopass Holding Second Quarter 2021 Earnings Conference Call. At this time, all participants are in listen-only mode. Following the formal remarks, we'll open the call up for your questions. I would now like to turn the call 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 second quarter 2021 financial results and to grab an update on recent pipeline and corporate developments. 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 the call, 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. The first half of 2021 was very productive for Biopath, and I'm pleased to provide an update on our recent progress. Over the course of the last six months, we have made meaningful progress in our pursuit of delivering a portfolio of targeted nucleic cancer drugs to patients in need. I'll begin with our lead product candidate, Prexager-Burleson, where we continue to make significant progress advancing Stage 2 of our Phase 2 clinical trial of Prexager-Burrison for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy, Decidibin, and Venetoclax. As we have previously reported, Phase 2 clinical development of Prexager-Burrison and AML commenced with Stage 1 of the Phase 2 clinical trial, which was open-label and treated de novo AML patients with a combination of Prexidibiricin and low-dose Cytarabin, or LDAC. The combination of Prexidibiricin and LDAC was shown to be safe and more efficacious to treat this class of patients than with LDAC alone. As many of you know, there has been an evolving landscape for standard of care in AML. Despite these therapies, there are still patients who are refractory or resistant. And those are the patients we aim to help. As standard of care evolved, we adapted our trial design to reflect these changes. The amended stage two of this phase two trial in AML is an open-label phase two, two-stage, multi-center study of Prexager-Burison in combination with Decidivin and Benetoclax 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 or intolerant with the two-drug combination, prexidabiricin and decitabine. The final trial design plans have approximately 54 evaluable patients for the cohort treating relapsed-refractory AML patients with the triple combination treatment of Prexagiviricin, Decitamin, and Venetoclax, and the cohort treating AML patients who are Venetoclax-resistant or intolerant with the two-drug combination of Prexagiviricin and Decitamin, with a review of both cohorts performed after 19 evaluable patients. The full trial design plans have approximately 98 evaluable patients for the cohort treating untreated AML patients, with the triple combination treatment of Plexigemuris and Decidamin and Venetoclax, with a preliminary review for the cohort performed after 19 evaluable patients and a formal interim analysis after 38 evaluable patients. The higher number of patients in the full trial design for the untreated AML patient cohort is due to the higher baseline response of the frontline therapy with previously untreated AML patients. 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 hematology recovery. An interim analysis will be formed on each cohort to assess the safety and efficacy of the treatment In the second quarter, we were excited to announce the successful completion of the safety run-in of the Stage 2 of the Phase 2, and we look forward to advancing this study as we believe its unique design provides us with several definable registration pathways. Next, I'd like to turn to our plan to Phase 1 clinical trial of Prexagibiricin-A in patients with advanced solid tumors. including ovarian, uterine, pancreatic, and hormone refractory breast cancer. Prexagiviricin-A, a fourth biopath drug candidate, is a modified product from Prexagiviricin sharing the same drug substance with enhanced nanoparticle properties. 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 Prexidubiracin may provide clinical benefit for such patients. Turning now to BP1002, our second therapeutic candidate, which targets BCL2. As you know, BCL2 is responsible for driving cell survival in up to 60% of all cancers. High expression of BCL2 has been correlated with poor prognosis for patients diagnosed with AML. Venetoclax has also shown activity against 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, 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 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. In a Phase I trial, refractory relapsed CLL patients, including those who have failed or relapsed from venetoclax-based frontline therapy, as well as refractory relapsed lymphoma patients, are being treated with BP1002. This trial is being conducted at several cancer centers. We expect to initiate a Phase I-IB clinical trial of BP1002 in refractory relapsed AML patients to be conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University and the University of Texas MD Anderson Cancer Center. In the AML trial, initially, a total of six evaluable patients are scheduled to 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 excitement in refractory relapsed AML patients. Finally, let me briefly review progress we've made with our third drug candidate, BP1003, which targets the STAT3 protein. This program has shown promising preclinical data, and we are very excited for the future of this program. We are studying BP103 for the treatment of pancreatic cancer in a patient-derived tumor model. Previous models have shown the drug to successfully penetrate pancreatic tumors, and enhance the efficacy of standard frontline treatments. We are particularly excited to launch our first inhuman validation of this cutting-edge therapy in an especially challenging cancer indication that has limited treatment options. We are aiming to file an IND application with this very promising product candidate later in 2021 or 2022. In June, we announced that the United States Patent and Trademark Office has granted a new patent relating to our BP1003 program. The new patent builds on earlier patents that have been granted that protect the platform technology for DNAvalize. As I have said before, we continue our efforts to build a fortress of protection around our technologies, as it safeguards our platform technology and target-specific technology, is a deterrent to would-be competitors, and creates value around our core competencies. With that, I'll now turn the program over to Anthony Price for a brief review of our second quarter 2021 financials, along with balance sheet highlights. Anthony?