Bio-Path Holdings Inc

Good morning, ladies and gentlemen. Welcome to the Biopath Holdings first quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. Following the former 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 first quarter 2021 financial results. and to provide 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, 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. 2021 is off to a terrific start. marked by substantial progress across our portfolio of targeted nucleic cancer drugs. We are excited by the advances we've made, but are even more excited by what is to come for Biopath. Let me now turn to discuss these advances and opportunities in greater detail. I'll begin with our lead product candidate, Prexager Burrison, where we continue to make solid progress. In April, we were delighted to publish an analysis highlighting the potential of Prexagibiricin within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal Biomedicines. In addition, stage two of our phase two clinical trial of Prexagibiricin for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy, Decidamin and Venetoclax continues. As we have previously reported, Phase II clinical development of Prexagibiricin and AML commenced with Stage I of our Phase II clinical trial, which was open-label and treated de novo AML patients with a combination of Prexagibiricin and low-dose Cytaribin, or LDAC. The combination of Prexagibiricin 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. The amended stage two of this phase two trial in AML is an open-label Phase II two-stage multicenter study of Prexager-Burison in combination with Decidamin 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 Prexager-Burison and Decidamin. The full trial design plans have approximately 54 evaluable patients for the cohort-treating relapsed refractory AML patient with the triple-combination treatment of Prexagibiricin, Decitamin, and Venetoclax, and the cohort-treating AML patients who are Venetoclax-resistant or intolerant with the two-dose combination of Prexagibiricin 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 a triple combination treatment of Prexagibiricin, Decidivin, and Venetoclax, with a preliminary review of the cohort performed after 19 evaluable patients, and a formal interim analysis after 38 available patients. The higher number of patients in the folder 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 hematologic recovery. An interim analysis will be formed on each cohort to assess the safety and efficacy of the treatment. In April, we were excited to announce the successful completion of a study run-in of stage two of the phase two, which had a clean side effect profile and lack of toxicity. We are also very encouraged by the efficacy signal shown in this data set, with five of the six evaluable relapse, refractory, and newly diagnosed AML patients demonstrating clinical activity. We look forward to advancing this study, as we believe its unique design provides us with several definable registration pathways. As I mentioned on our last call, The United States Patent and Trademark Office issued a third patent in our family of platform intellectual property that offers expanded defense of our de-enabilized platform technology. In addition, we were pleased to receive the issuance of a patent related to Prexager Burrison in combination with either cytodyne analogs such as dacitamin or the BCR-abled tyrosine kinase inhibitors, dasatinib and nilotinib. This addition further strengthens our intellectual property portfolio and completes our already granted patents. These new patents protect 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. As I have said before, we will continue our efforts to build a fortress of protection around our technology as it safeguards our platform technology and target-specific technology and is a deterrent to would-be competitors and creates value around our core competencies. Next, I'd like to turn to our planned phase one clinical trial in Prexager-Burison-A in patients with advanced solid tumors, including ovarian, uterine, pancreatic, and hormone refractory breast cancer. Prexigerboricin-A, a fourth biopath drug candidate, is a modified product from Prexigerboricin 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 Prexigerboricin in solid tumor patients. Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes, and it is our hope that Prexager-Burison may provide clinical benefit for such patients. Turning now to BP1002, our second therapeutic candidate, which targets BCL2. In April, we presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research annual meeting. BP1002 targets the protein BCL2, which 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. The data presented in the AACR poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with the cytamine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies. 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, 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. 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. 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 are aiming to file an IND application with this very promising product candidate later this year. With that, I'll now turn the program over to Anthony Price for a brief review of our first quarter 2021 financials, along with balance sheet highlights. Anthony?