Bio-Path Holdings Inc

Good morning, ladies and gentlemen. Welcome to the BioPath Holdings third quarter 2020 earnings conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will 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 third quarter 2020 earnings results and to provide an update on recent pipeline and corporate developments. Earlier, we issued a press release which outlined 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 and 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 for 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 today. This has been an exceptional year for BioPath. We have achieved several significant milestones, most notably the initiation of Stage 2 of our Phase 2 study of Prexager-Burrison and AML, and we have done so in an unprecedented environment. While we are still managing the impact of COVID-19 on our lives and business, I'm continually impressed by our team and their ability to Deftly Maneuver around the challenges we've been presented with. As a result of their hard work, we are in a very strong corporate position as we close out 2020 and enter 2021. I begin with our lead product candidate, Prexa Jabourosan, where we continue to make meaningful progress. In the third quarter, we dosed the first patient in stage two of our phase two of Prexedubiracin for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy decided in venetoclax. As we have previously reported, phase two clinical development of Prexedubiracin and AML commenced with stage one of the phase two clinical trial, which was open and treated de novo AML patients with a combination of Prexidubiracin and low-dose Cytaribin, or LDAC. The combination of Prexidubiracin 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 new 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. Feedback from treating physicians pointed to a preference for Decidivant. The recent approval of frontline therapy, Venetoclax, provided an opportunity for adding Prexagerburicin to the newly approved frontline two-drug combination, of Venetoclax and Decidamin for the treatment of previously untreated AML patients. Prior to finalizing our plans, we performed preclinical testing in AML cancer cell lines to assess Prexagerboricin's increased benefit to efficacy. Preclinical testing of Prexagerboricin with the frontline treatment of Decidamin and Venetoclax demonstrated the potential to enhance efficacy of the frontline treatment combination. In the studies, four AML cancer cell lines were treated with three different combinations of dacitamin, venetoclax, and prexagerburicin. Decrease in AML cell viability was a primary measure of efficacy. The triple combination of dacitamin, venetoclax, and prexagerburicin showed significant improvement in efficacy in three of the four AML cell lines. Based on these results, we believe that adding Prexagibiricin to the treatment combination of Decidivin and Venetoclax could lead to improved efficacy in AML patients. Excuse me. The amended stage two of this phase two trial in AML is an open-label phase two, two-stage, multi-center study of Prexetaburicin in combination with the Cytamin 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 or intolerant. with the two-drug combination of Prexagiviricin and Decidivine. The full trial design plans have approximately 54 evaluable patients for the cohort treating relapsed refractory AML patients with the triple combination treatment of Prexagiviricin, Decidivine, and Venetoclax, and the cohort treating AML patients who are Venetoclax-resistant or intolerant with the two-drug combination of Prexidibiricin and Decidamin, 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 Prexidibiricin, 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 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. In the event these results exceed the primary endpoint in a number of patients that meets or exceeds Statistically Determined Thresholds, we plan to seek to convert the trial into a registration trial for accelerated approval. In October, we announced that the United States Patent and Trademark Office issued a notice of allowance for claims related to Prexager-Burleson in combination with either cytidine analog, such as dacitabine or BCR-ABL tyrosine kinase inhibitors, dasatinib, and nilotinib. The addition further strengthens our intellectual property portfolio and complements already granted patents. Our growing patent estate continues to be a valuable asset for BioPath as it provides protection, not only for our core product portfolio, and research efforts, but now also offers broad protection in combination with established frontline therapies. This new patent protects the unique therapy combination and supports our ongoing investment in this program to bring a new treatment option to patients with AML who have limited treatment options. Next, I'd like to turn to our planned Phase I clinical trial of Prexagiviricin-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 is expected to be conducted at several leading cancer centers and is planned initially to evaluate the safety of Prexagibrosin-A in solid tumor patients. Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes and it is our hope that Prexagibrosin-A may provide clinical benefit for such patients. We filed an Investigational New Drug Application, or IND, and remain on track to open this study by year end. Turning now to plans for BP1002, our second therapeutic candidate, which targets BCL2. Last year, we filed an IND application for our second pipeline candidate, BP1002. Venetoclax, has also shown activity against anti-apoptotic protein BCL2 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 hematopoietic cell transplantation, Disease relapse invariably occurs oftentimes due to BH3 domain mutation over time. BP102 also targets the BCL2 protein. However, BP102 activity is based on blocking the BCL2 messenger RNA and not the BH3 domain. As a result, we believe that BP102 could provide an alternative for venetoclax patients who have relapsed, including AML patients who previously received venetoclax treatments. In 2019, the FDA granted us IND clearance to study BP-102 as a potential treatment for CLL, including venetoclax relapses and lymphoma. We plan to file an IND to treat AML venetoclax relapses with BP1002. The planned modification of our Phase II clinical program in AML to include venetoclax combination treatment with Prexager-Burrison will give us early experience with treating BCL2-driven anti-apoptosis in these patients. We expect to begin our first inhuman study of BP1002 in lymphoma CLL in the coming weeks. Finally, let me briefly review the 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 BP1003 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. The potential for our STAT3 program is compelling for a number of reasons. Signal transduction and activator transcription 3, or STAT3, though typically inactive in normal cells, is aberrantly active in cancer cells. The abilities of tumor cells to proliferate uncontrollably, resist apoptosis or cell death, induce vasculature formation, and invade distant organs are well-recognized hallmarks of cancer. STAT3 is a regulator of the genes involved in these cancer processes. Most recently, the capability of tumors to evade immune surveillance and avoid destruction by the immune system has gained significant acceptance in the cancer research field. STAT3, which is a point of convergence for many oncogenic pathways, has emerged as a critical mediator of tumor immune evasion at multiple levels. We are particularly excited to launch our first in-human validation of this cutting-edge therapy and especially challenging cancer indication that has limited treatment options. Moving forward, we are undertaking IND-enabling studies for BP-103 this year with a goal to file an IND application with this very promising product candidate in 2021. With that, I'll now turn the program over to Anthony Price for a brief review of our third quarter 2020 financials, along with balance sheet highlights. Anthony?