Bio-Path Holdings Inc

Thank you for standing by. Welcome to the Biopath Holdings, Inc. First Quarter 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1 on your telephone. Please, the advice of today's conference may be recorded. If you require any further assistance, please press star then 0. I would now like to hand the conference over to your host today, Will O'Connor with Stern Investor Relations. Please go ahead.

Thank you, Operator. Welcome to the Biopath Holdings conference call and webcast to review the company's first quarter 2022 financial 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, 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's CEO, Peter Nielsen.

Thanks, Will. Good morning, everyone, and thank you for joining us. 2022 is off to a terrific start for Biopath, and I'm proud of the corporate and clinical progress we have made year to date. The advancements we have made and will continue to make bring us one step closer to our goal of developing meaningful medicines to aid in the fight against cancer. I'll begin with an important corporate highlight. Last month, we were excited to announce the appointment of Aileen Sherwood, to our board of directors. Aileen is principal of Scienta Communications, an independent communications consultancy providing strategic public relations and corporate communications counsel to life science companies. With her extensive background in biotechnology communications, Aileen synthesizes complex science into compelling messaging. which is instrumental in guiding our communications to both the clinical and financial communities. She has already brought valuable industry insight to our team that will be increasingly important as we advance our de-enabilized platform in the fight against cancer. Moving now to our clinical programs and our lead product candidate, Prexager Burrisen. We continue to make significant progress advancing stage two of our phase two clinical trial of plexigyboricin for the treatment of acute myeloid lipid Involving 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 2 of this Phase 2 trial in AML is an open-label Phase 2 two-stage multicenter study of Prexabiracin in combination with Decitamin 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 pretragerbericin and decitabine. The primary endpoint for this study will be the number of patients who achieved 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. Next, I'd like to turn to our planned Phase I clinical trial of BP1001-A in patients with with advanced solid tumors, including ovarian, uterine, pancreatic, and hormone refractory breast cancer. BP1001-A, a fourth biopath drug candidate, is a modified product from Prexagiviricin sharing the same drug substance with enhanced nanoparticle properties. You will recall that last year, the FDA cleared our investigational new drug, or IND, application 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 prextubaricin in solid tumor patients. Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes, and it is our hope that Prexager-Burson may provide clinical benefit for such patients. We look forward to bringing this exciting program into the clinic in the coming weeks. Turning now to BP1002, our second therapeutic candidate, which targets BCL2. 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 also shown activity against 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 hematopoietic cell transplantation, disease relapse invariably occurs, oftentimes due to BH3 domain mutation over time. BP1002 also targets the BCL2 protein group. 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. We expect to initiate this clinical trial in coming weeks at several leading cancer centers in the United States, including the Medical College at Cornell University, the University of Texas MD Anderson Cancer Center, and the Georgia Cancer Center. A total of six evaluable 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 Ib 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 in refractory relapsed AML patients. Finally, let's review the progress we've made with our third drug candidate, 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 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 contributes to resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 a potential cancer therapeutic agent. 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. These results are in line with previous work in which BP1003 plus gemcitamin 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. In April, we were delighted to present supportive preclinical data from this program at the 2022 American Association for Cancer Research annual meeting. before an audience of world-leading cancer researchers and physicians. Dr. Maria Gagliardi, a research scientist on our team, highlighted preclinical studies of BP1003 in combination with paclitaxel or fluorouracil as a potential treatment against breast and ovarian cancer cell. We are particularly excited to launch our first in-human validation of this cutting-edge therapy and an especially challenging cancer indication that has limited treatment options. We are aiming to file an IND application for 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 2022 financials, along with balance sheet highlights. Anthony?