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 up for your questions. As a reminder, today's conference is being recorded.

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

Thank you operator. Welcome to the Bio-Path Holdings conference call and webcast to review the company's first quarter 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 biopathholdingscom. With me today from Bio-Path 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 Bio-Path's CEO, Peter Nielsen..

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 first quarter 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. 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. Bio-Path's patent portfolio currently includes five issued patents in the US and 54 issued patents in foreign jurisdictions, providing protection in 21 countries.

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, two-stage, multi-center study of Prexigebersen in combination with Decitabine and Venetoclax in two cohorts of patients with previously untreated AML and refractory relapse AML.

A third cohort includes treating refractory relapsed AML patients who are Venetoclax resistant or intolerant with the two-drug combination of Prexigebersen and Decitabine.

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.

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 US Food & Drug Administration or FDA expedited programs for Fast Track designation for Bio-Path Prexigebersen 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 five to ten 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. Turning now to our BP1002 program, which targets Bcl-2.

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 shown activity against the 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 allogeneic hematopoietic cell transplantation, disease relapse invariably occurs oftentimes due to BH3 domain mutation over time. BP1002 also targets the Bcl-2 protein.

However, BP1002 activity is based on blocking the Bcl-2 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 second 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. A total of three evaluable patients per dosing cohort are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design.

Unless there is a dose limiting toxicity, which would require an additional three patients tested. The first dose cohort considered a starting dose of 20 milligrams per square meter and there was no dose limiting toxicity. The approved treatment cycle is two doses per week over four weeks for a total of eight 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 first 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.

A total of six evaluable patients will be treated with BP1002 monotherapy over two dosing cohorts in a standard 3+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.

Enrollment is now open for patients for the second dose cohort of 40 milligrams per square meter. The primary objective of the study is to evaluate the safety and tolerability of escalating doses of BP1002. We look forward to keeping you apprised of our progress here.

Next, let's turn to our Phase 1/1b clinical trial of BP1001-A 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.

Finally, let's review the progress we've made with BP1003, which targets the STAT3 protein. STAT3 is a transcription factor that regulates various tumorogenic processes, such as tumor proliferation, metastases and drug resistance.

Its over-expression 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.

Its role in numerous malignancies made STAT3, a potential cancer therapeutic target. BP1003 is a novel liposone incorporated STAT3 antisense oligodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxol and 5-FU.

These results are in line with previous work in which BP1003 plus gemcitabine displayed enhanced antitumor activity and 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.

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.

Before I turn the call over to Anthony for a review of our first quarter financials, I'd like to highlight that we've strengthened our balance sheet in recent weeks with a $1.2 million registered direct offering and $2.3 million 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?.

Thanks, Peter. The company reported a net loss of $3.2 million or $4.88 per share for the three months ended March 31st, 2024, compared to a net loss of $5.3 million or $13.25 per share for the three months ended March 31st, 2023.

Research and development expense for the three months ended March 31st, 2024, decreased to $2.3 million compared to $4.0 million for the three months ended March 31st, 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 first quarter of 2024.

General and administrative expense for the three months ended March 31st, 2024, increased to $1.4 million compared to $1.3 million for the three months ended March 31st, 2023, primarily due to increased legal fees. As of March 31st, 2024, the company had cash of $0.2 million compared to $1.1 million as of December 31st, 2023.

Net cash used in operating activities for the three months ended March 31st, 2024, was $1.0 million, compared to $3.7 million for the comparable period in 2023.

As Peter earlier noted, following the close of the quarter, the company received gross proceeds of $3.5 million 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..

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

Thank you sir. [Operator Instructions] And ladies and gentlemen this concludes the question-and-answer session. I'd like to turn the conference back over to Peter Nielsen for closing remarks..

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

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..

End of Q&A:.