Bio-Path Q1 2024 Earnings Call Transcript

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May 15, 2024

There are 4 speakers on the call.

Operator

Good morning, ladies and gentlemen. Welcome to the Bio Path Holdings First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call for your questions. As a reminder, today's conference is being recorded.

Operator

I would now like to turn the call over to Will O'Connor of Stern Investor Relations. Please proceed, sir.

Speaker 1

Thank you, operator. Welcome to the Bio Path Holdings conference call and webcast to review the company's Q1 2024 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 Bio Path are President and CEO, Peter Nielsen and Senior Vice President of Finance, Accounting and Administration, Anthony Price.

Speaker 1

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 Bio Path's CEO, Peter Nielsen.

Speaker 2

Thanks, Will. Good morning, everyone, and thank you for joining us. 2024 is off to a terrific start and the progress we made throughout the Q1 and in recent weeks is creating the momentum necessary to help advance our goal to deliver a better path for cancer patients. We made important advancements across all areas core to our business, clinical, corporate and financial. I'll begin with an exciting update from our growing patent estate.

Speaker 2

Last month, we announced the receipt of newly issued patents in Mexico, Australia and Japan. We expanded our intellectual property portfolio by filing patent applications applicable to our technology and business strategy. BioPass patent portfolio currently includes 5 issued patents in the U. S. And 54 issued patents in foreign jurisdictions, providing protection in 21 countries.

Speaker 2

We continue our efforts to build protection around our platform as it safeguards our technology is a deterrent to would be competitors and creates value around our core competencies. Turning now to the progress we have made with our lead product candidate prexigebersen. As you know, last year we reported positive interim results from Stage 2 of our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia or AML in combination with frontline therapy decitabine and venetoclax. Recall, the study is an amended Stage 2 of our Phase 2 trial in AML. It is an open label, 2 stage, multi setter study of prexigebersen in combination with decitabine and venetoclax in 2 cohorts of patients with previously untreated AML and refractory relapsed AML.

Speaker 2

A third cohort includes treating refractory relapsed AML patients who are venetoclax resistant or intolerant with the 2 drug combination of prexigebersen 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 hematologic recovery. Efficacy data from the initial interim analysis of Cohort 1 and Cohort 2 were compelling and show that prexigebersen based combination therapy was not only safely administered in Cohort 1 and Cohort 2 to high risk newly diagnosed and refractory relapsed AML patients considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals better than current therapies. This is particularly encouraging as refractory relapse patients are a challenging population in which current treatment options are suboptimal. On the strength of these data, we currently plan to pursue U.

Speaker 2

S. Food and Drug Administration or FDA expedited programs for fast track designation for biopath prexiviracin AML treatment in patients who are unable to receive intensive chemotherapy without unacceptable side effects. These patients tend to be elderly, 60 years of age and older. If left untreated, these patients have a medium survival of only 5 to 10 months and represent a clear and serious unmet need that Bio Path meets. We look forward to keeping you apprised of our progress on the regulatory front.

Speaker 2

Turning now to our BP1002 program, which targets BCL2. As you know, BCL2 is responsible for driving cell survival in up to 60% of all cancers. High expression of BCL-two has been correlated with poor prognosis for patients diagnosed with AML. Venetoclax has shown activity against the anti apoptotic protein BCL-two and works by neutralizing the proteins BH3 domain. It is an improved treatment for chronic lymphocytic leukemia or CLL patients and untreated AML patients.

Speaker 2

However, with the exception of some patients treated with allogeneic hematopoietic cell transplantation, disease relapse invariably occurs oftentimes due to BH3 domain mutation over time. BP1002 also targets the BCL-two protein. However, BP1002 activity is based on blocking the Bcl-two 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. Last month, we announced completion of the 2nd dose cohort of the dose escalation portion of our Phase 1, 1b clinical trial of BP1002 to treat refractory relapsed AML, including venetoclax resistant patients.

Speaker 2

A total of 3 evaluable patients per dosing cohort are scheduled to be treated with BP1002 monotherapy and a standard 3 plus 3 design, unless there is a dose limiting toxicity, which would require an additional 3 patients tested. The 1st dose cohort considered a starting dose of 20 milligrams per square meter and there was no dose limiting toxicity. The approved treatment cycle is 2 doses per week over 4 weeks for a total of 8 doses administered over 28 days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory relapsed AML patients. In January, we announced completion of the 1st dose cohort of the dose escalation portion of our Phase 1 clinical trial of BP1002 evaluating BP1002 for the treatment of refractory relapsed lymphoma and refractory relapsed chronic lymphocytic leukemia or CLL.

Speaker 2

A total of 6 evaluable patients will be treated with BP1002 monotherapy over 2 dosing cohorts in a standard 3 plus 3 design with a starting dose of 20 milligrams per square meter. The approved treatment cycle is 2 doses per week over 4 weeks, resulting in 8 doses administered over 28 days. Enrollment is now open for patients for the 2nd dose cohort of 40 milligrams per square meter. The primary objective of the study is to evaluate the safety and tolerability escalating doses of BP1002. We look forward to keeping you apprised of our progress here.

Speaker 2

Next, let's turn to our Phase 1,1b clinical trial of BP1001a in patients with solid tumors, including ovarian, endometrial, pancreatic and triple negative breast cancer, some of the most challenging cancers to treat with today's therapeutic toolkit. BP1001 A is a modified product from prexigebersen sharing the same drug substance with enhanced nanoparticle properties. This trial is being conducted at several leading cancer centers and will initially evaluate the safety in solid tumor patients. The patients diagnosed with recurrent ovarian and endometrial cancer often has poor outcomes and it is our hope that we may provide clinical benefit for such patients. We look forward to cohort completion and data readout from the study potentially later this year.

Speaker 2

Finally, let's review the progress we've made with 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 promotes 5 FU resistance in colorectal cancer cells.

Speaker 2

Its role in numerous malignancies made STAT3 a potential cancer therapeutic target. 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 taxyl and five 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. After an extended period of testing, we have identified a method for oligo detection in plasma that will enable us to complete final safety testing needed to finalize an investigational new drug or IND application for submission to the FDA.

Speaker 2

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. Before I turn the call over to Anthony for a review of our Q1 financials, I'd like to highlight that we've strengthened our balance sheet in recent weeks with a $1,200,000 registered direct offering and $2,300,000 through our at the market offering agreement. These additional funding provides the financial underpinning from which to execute our clinical development plan. With that, I'll now turn the program over to Anthony Price for a brief review of our financials along with balance sheet highlights. Anthony?

Speaker 3

Thanks, Peter. The company reported a net loss of 3,200,000 or $4.88 per share for the 3 months ended March 31, 2024 compared to a net loss of $5,300,000 or $13.25 per share for the 3 months ended March 31, 2023. Research and development expense for the 3 months ended March 31, 2024 decreased to $2,300,000 compared to $4,000,000 for the 3 months ended March 31, 2023, primarily due to decreased manufacturing expenses related to drug product releases, partially offset by an increase in expense related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in the Q1 of 2024. General and administrative expense for the 3 months ended March 31, 2024 increased to $1,400,000 compared to $1,300,000 for the 3 months ended March 31, 2023, primarily due to increased legal fees. As of March 31, 2024, the company had cash of $200,000 compared to $1,100,000 as of December 31, 2023.

Speaker 3

Net cash used in operating activities for the 3 months ended March 31, 2024 was $1,000,000 compared to $3,700,000 for the comparable period in 2023. As Peter earlier noted, following the close of the quarter, the company received gross proceeds of $3,500,000 through our at the market offering agreement and April 2024 registered direct offering. With that, I'll now turn the call back over to Peter.

Speaker 2

Thanks, Anthony. We have an exciting year ahead and expect to continue to report updates on our important clinical programs, while being good stewards of our resources. I cannot understate how important the work we are doing is to patients waiting for effective treatments to halt the progression of these deadly cancers. This is why we are so encouraged with the positive data reading out from our various studies. We thank you, our loyal shareholders, for supporting us on this journey to discover, develop and deliver new medications for patients suffering with cancers.

Speaker 2

With that operator, we are ready to open the call for questions.

Operator

Thank you, I'd like to turn the conference back over to Peter Nielsen for closing remarks.

Speaker 2

Thank you. Thank you again everyone for joining us and for your continued support of Bio Path. Have a great day.

Operator

Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

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Earnings Conference Call
Bio-Path Q1 2024
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