Q1 2024 Bio-Path Holdings Inc Earnings Call
Operator: Good morning, ladies and gentlemen. Welcome to the Bio Path Holdings Fresh 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. I would now like to turn the call over to Will O'Connor of Stern Investor Relations. Please proceed, sir. Thank you, operator.
Good morning, ladies and gentlemen, welcome.
Welcome to the bio path holdings first quarter for three or four earnings conference call.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: Following the formal remarks, we will open the call up for your questions.
Speaker Change: As a reminder, today's conference is being recorded.
Speaker Change: I would now like to turn the call over to will O'connor of Stern Investor Relations. Please proceed sir.
Will OConnor: Thank you operator welcome.
Will OConnor: 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 development. Earlier, we issued a press release that outlines the topics that we plan to discuss on today's call. The release is available at biopathholdings.org.
Speaker Change: 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.
Speaker Change: Earlier, we issued a press release, which outlines the topics that we plan to discuss on today's call. The release is available at bio path Holdings Dot Com with me today from bio path are president and CEO, Peter Nielsen and senior Vice President of Finance and accounting and administration Anthony price.
Will OConnor: 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 uncertainty. 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 CEO Peter Nielsen.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: With that I'll now turn the call over to bio paths CEO Peter Nielsen.
Speaker Change: Thanks will.
Peter H. Nielsen: Good morning, everyone.
Peter H. Nielsen: 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 I'll begin with an exciting update on our growing patent estate. Last month, we announced the receipt of newly issued patents in Mexico, Australia, and Japan.
Peter H. Nielsen: And thank you for joining us.
Peter H. Nielsen: 2024.
Peter H. Nielsen: Off to a terrific start.
Peter H. Nielsen: And the progress we made throughout the first quarter and in recent weeks, it's creating the momentum necessary to help advance our goal to deliver a better path for cancer patients.
Peter H. Nielsen: We made important advancements across all areas core to our business clinics.
Peter H. Nielsen: Clinical corporate and financial.
Peter H. Nielsen: I'll begin with an exciting update from our growing patent state.
Peter H. Nielsen: Last month, we announced the receipt of newly issued patents in Mexico, Australia and Japan.
Peter H. Nielsen: We expanded our intellectual property portfolio by filing patent applications applicable to our technology and business strategy. Bio Path's patent portfolio currently includes 5 issued patents in the U.S. 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 competence.
Peter H. Nielsen: We expanded our intellectual property portfolio.
Peter H. Nielsen: But filing patent applications are applicable to our technology and business strategy.
Peter H. Nielsen: While past patent portfolio. Currently includes five issued patents in the U S and 54 issued patents in foreign jurisdictions, providing protection in 21 countries.
Peter H. Nielsen: We continue our efforts to build protection around our platform.
Peter H. Nielsen: Is it safe guards, our technology is a deterrent to would be competitors and creates value around our core competencies.
Peter H. Nielsen: Turning now to the progress we have made with our lead product candidate, Prexinger Burris. As you know, last year we reported positive interim results from stage two of our phase two clinical trial of Prexigibiracin for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy of citamin and venetoclax. Recall, the study is in amended stage two of our phase two trial in A.M. It is an open-label, two-stage, multi-center study of prexigibriracin in combination with dicitamin and benetoclax in two cohorts of patients with previously untreated AML and refractory relapse AML.
Peter H. Nielsen: Turning now to the progress we have made with our lead product candidate corrections your burleson.
Peter H. Nielsen: As you know last year, we reported positive interim results from stage two of our phase two clinical trial of Brexit your person for the treatment of acute myeloid leukemia or AML in combination with frontline therapy decided man and banana coax.
Peter H. Nielsen: Recall. This study is an amended stage two of our phase II trial in AML.
Peter H. Nielsen: It is an open label two stage Multicenter study of Brexit Your Burleson in combination with decitabine in Burnet o'clock in two cohorts of patients.
Peter H. Nielsen: With previously untreated AML and refractory relapsed AML.
Peter H. Nielsen: A third cohort will treat refractory relapsed AML patients who are venetoclax-resistant or intolerant to a two-drug combination of prexigerboracin and decidoprotein. 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 showed that prexigerboracin-based combination therapy was not only safely administered in cohort one and cohort two to high-risk, newly-diagnosed, and refractory relapsed AML patients but also demonstrated efficacy signals better than current therapy.
Peter H. Nielsen: A third cohort includes treating refractory relapsed AML patients who are venetic lax resistant.
Peter H. Nielsen: Or intolerant with the two drug combination of Brexit your Burleson and decided that.
Peter H. Nielsen: The primary endpoint for this study will be the number of patients who achieved complete remission.
Peter H. Nielsen: Which includes complete remission with incomplete hematologic recovery and complete remission with partial hematologic recovery.
Peter H. Nielsen: Efficacy data from the initial interim analysis of cohort, one and cohort two were compelling.
Peter H. Nielsen: And show that proxies your Burleson based combination therapy was not only safely administered in cohort, one and cohort two to high risk newly diagnosed and refractory relapsed AML patients considered suitable for standard chemotherapy.
Peter H. Nielsen: But also demonstrated efficacy signals better than current therapies.
Peter H. Nielsen: This is particularly encouraging as refractory relapse patients are a challenging population in which current treatment operates suboptimally. On the strength of these data, we currently plan to pursue U.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
Peter H. Nielsen: This is particularly encouraging as refractory relapsed patients or challenging population in which current treatment options are sub optimal.
Peter H. Nielsen: Well the strength of these data we are currently.
Peter H. Nielsen: We currently plan to pursue U S food and drug administration or F. T E X.
Peter H. Nielsen: Expedited programs for fast track designation for bio path Brexit Berson.
Peter H. Nielsen: Bell treatment.
Peter H. Nielsen: Patients.
Peter H. Nielsen: Who are unable to receive intensive chemotherapy without unacceptable side effects.
Peter H. Nielsen: Patients tend to be elderly.
Peter H. Nielsen: 60 years of age and older.
Peter H. Nielsen: 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. We look forward to keeping you apprised of our progress on the regulatory front. Turning now to our BP-1002 program, which targets BCL-5. As you know, Bcl-2 is responsible for driving cell survival in up to 60% of all... High expression of BCL-2 has been correlated with a poor prognosis for patients diagnosed with AML.
Peter H. Nielsen: If left untreated these patients have a medium survival of only five to 10 months.
Peter H. Nielsen: It represents a clear and serious unmet need with bio path meats.
Peter H. Nielsen: We look forward to keeping you apprised of our progress on the regulatory front.
Peter H. Nielsen: Turning now to our BP 1002 program, which targets Bcl two.
Peter H. Nielsen: As you know Bcl two is responsible for driving cell survival and up to 60% of all cancers.
Peter H. Nielsen: Hi expression of Bcl two has been correlated with poor prognosis for patients diagnosed with AML.
Peter H. Nielsen: Venetoclax has shown activity against the 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.
Peter H. Nielsen: But that a class has shown activity against the anti apoptotic protein Bcl, two and works by neutralizing the proteins B H three domain.
Peter H. Nielsen: It is an improved treatment for chronic lymphocytic leukemia or C. L O patients and untreated AML patients. However, with the exception of some patients treated with allo genetic hematopoietic cell transplantation.
Peter H. Nielsen: These relapse invariably occurs.
Peter H. Nielsen: Often times due to be H three domain mutation overtime.
Peter H. Nielsen: BP1002, also targets the BCL-2 protein. However, BP-1002 activity is based on block, the BCO2 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 treatment last month.
Peter H. Nielsen: P P 100 too.
Peter H. Nielsen: Also targets the Bcl two protein. However, P. P 1002 activity is based on blocking the Bcl two messenger RNA and not the BH three domain.
Peter H. Nielsen: As a result, we believe that B P 1002 could provide an alternative for banana clacks patients, who have relapsed, including AML patients, who previously received genetic class creep up.
Peter H. Nielsen: Last month we.
Peter H. Nielsen: 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 valuable patients per dose cohort are scheduled to be treated with BP1002 monotherapy in a standard 3 plus 3 design, unless there is a dose-limiting toxicity, which would require an additional three patients The first dose cohort considered, a starting dose of 20 milligrams per square meter, and there was no dose-limiting toxicity.
Peter H. Nielsen: We announced completion of the second dose cohort of the dose escalation portion of our phase one one b clinical trial, a b P 1002 to treat refractory relapsed AML, including vanilla clacks resistant patients.
Peter H. Nielsen: A total of three evaluable patients for dosing cohort are scheduled to be treated with BP once around zero two mono therapy in a standard three plus three design.
Peter H. Nielsen: Unless there is a dose limiting toxicity, which would require an additional three patients tested.
Peter H. Nielsen: The first dose cohort considered it.
Speaker Change: Starting dose of 20 milligrams per square meter.
Speaker Change: And there was no dose limiting toxicity.
Speaker Change: The approved treatment cycle is two doses per week over four weeks for a total of eight doses administered over 28 days.
Peter H. Nielsen: 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 citabine 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.
Speaker Change: Phase one D. B portion of the study is expected to commence after completion of B P 100 to bottle therapy cohorts and will assess the safety and efficacy of BP 1002 in combination with decitabine in refractory relapsed AML page.
Speaker Change: Yes.
Speaker Change: In January we announced completion of the first dose cohort of the dose escalation portion of a phase one clinical trial of B P 100 to evaluating B P 1002 for the treatment of refractory relapsed lymphoma in refractory relapsed chronic.
Speaker Change: Lymphocytic leukemia.
Speaker Change: L L.
Peter H. Nielsen: The total of six available patients will be treated with BP1002 monotherapy over two dose cohorts in a standard 3 plus 3 design, with a starting dose of 20 mg per square mile. 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 in the second dose cohort of 40 mg per sq. ml.
Speaker Change: A total of six evaluable patients will be treated with B P 1002 monotherapy over two dosing cohorts in a standard three plus three design with a starting dose of 20 milligrams per square meter.
Speaker Change: The approved treatment cycle, there's two doses per week or four weeks, resulting in eight dose doses administered over 28 days enrollment is now opened for patients for the second dose cohort of 40 milligrams per square meter.
Peter H. Nielsen: 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. Next, let's turn to our Phase 1.1b clinical trial of BP1001-A in patients with Solid Tumor, ovarian, endometrial, pancreatic, and triple negative breast cancer, some of the most challenging cancers to treat with today's therapeutic tools. BP-1001-A is a modified product from Prexigeviracin sharing the same drug subtype but with Enhanced Nanoparticle Properties.
Speaker Change: The primary objective of the study is to evaluate the safety and Tolerability.
Speaker Change: Of escalating doses of beat P. 1002, we look forward to keeping you apprised of our progress here.
Speaker Change: Next let's turn to our phase one <unk> clinical trial.
Speaker Change: P. P 1001 Dash E P.
Speaker Change: Patients with solid tumors, including ovarian endometrial pancreatic and triple negative breast cancer. Some of the most challenging cancers to treat with the today's therapeutic tool kit.
Speaker Change: B P 1001 dash eight is a modified product from praxis your birth, some sharing the same drug substance with enhanced nanoparticle properties.
Peter H. Nielsen: This trial is being conducted at several leading cancer centers and will initially evaluate the safety and Solid Tumor Patients. Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes, and it is our hope that we may provide clinical benefit for such patients.
Speaker Change: This trial is being conducted at several leading cancer centers and will initially evaluate the safety and <unk>.
Speaker Change: <unk> tumor patients.
Speaker Change: 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.
Peter H. Nielsen: 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. Stat three is a transcription factor that regulates various tumorogenic 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.
Speaker Change: Finally.
Speaker Change: Let's review the progress we've made with B P 1003, which targets the step three protein.
Speaker Change: Step three is a transcription factor that regulates various tumor orogenic processes, such as tumor proliferation.
Speaker Change: Taxes and drug resistance.
Speaker Change: Over expression and Everett activation characterize many cancers, including breast lung ovarian liver and colon cancer.
Speaker Change: Activation of the stat, three pathway in breast and ovarian cancer cells promotes tumor initiation migration and taxol resistance stat. Three also promotes.
Peter H. Nielsen: STAT III also promotes 5-FU resistance in colorectal cancer cells. Hence, its role in numerous malignancies has made STAT3 a potential cancer therapeutic target. BP-1003 is a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to Paxil and 5-FU. 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 combined therapy is a novel strategy for patients with advanced solid tumors.
Speaker Change: Dash after you resistance in colorectal cancer itself.
Speaker Change: Its role in numerous malignancies made stat, three a potential cancer therapeutic target.
Speaker Change: P. P 1003 is a novel Liposome incorporated <unk> antisense, although all to go to the oxy nucleotide debt efficiently reduces stat three expression.
Speaker Change: Enhances the sensitivity of the breast and ovarian cancer cells with paxil and five dash if you.
Speaker Change: These results are in line with previous work and which B P 1003, plus Jim side have been displayed enhanced antitumor activity and pancreatic ductal adenocarcinoma.
Speaker Change: Together. These results strongly suggest that B P 1003 combination therapy is a novel.
Speaker Change: <unk> for patients with advanced solid tumors.
Peter H. Nielsen: After an extended period of testing, we have identified a method for oligodetection 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 and an especially challenging cancer indication that has limited treatment options.
Speaker Change: After an extended period of testing we have identified a method for all ago detection and plasma that we that will enable us to complete final safety testing needed to finalize an investigational new drug or I N D application for submission to the F D. A.
Speaker Change: We are particularly excited to launch our first in human validation of this cutting edge therapy, internet, especially challenging cancer indication that has limited treatment options.
Peter H. Nielsen: Before I turn the call over to Anthony for a review of our first quarter financial... I'd like to highlight that we've strengthened our balance sheet in recent weeks with a 1.2 million dollar registered direct offering and 2.3 million through our at-the-market offering agreement. 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.
Speaker Change: Before I turn the call over to Anthony for a review of our first quarter financials.
Anthony Price: Like to highlight that we've strengthened our balance sheet in recent weeks with a $1.2 million registered direct offering.
Anthony Price: 2.3 million through our aftermarket offering agreement.
Anthony Price: These additional funding provides.
Anthony Price: Provides the financial underpinning from which to execute our clinical development plan.
Anthony Price: With that I'll now.
Anthony Price: Now I'll turn the program over to Anthony price for a brief review of our financials, along with balance sheet highlights Anthony.
Anthony Price: Thanks, Peter. The company reported a net loss of $3.2 million, or $4.88 per share, for the three months ended March 31, 2024, compared to a net loss of $5.3 million, or $13.25 per share, for the three months ended March 31, 2023. Research and development expense for the three months ended March 31, 2024 decreased to $2.3 million compared to $4.0 million for the three months ended March 31, 2023, primarily due to decreased manufacturing expenses related to drug product releases, partially offset by an increase in expenses related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in the first quarter of 2024.
Anthony Price: Thanks, Peter the company reported a net loss of $3 2 million or 488 per share for the three months ended March 31, 2024, compared to a net loss of $5 3 million or <unk> 25 per share for the three months ended March 31 2023.
Anthony Price: Research and development expense for the three months ended March 31, 2024 decreased to $2 3 million compared to 4.0 million.
Anthony Price: The three 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 B P. 1002 in lymphoma due to increased patient enrollment in the first quarter of 'twenty.
Anthony Price: 24.
Anthony Price: 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 31, 2024, the company had cash of $0.2 million compared to $1.1 million as of December 31, 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.
Anthony Price: General and administrative expense for the three months ended March 31, 2024 increased to $1 4 million compared to $1.3 million for the three months ended March 31 2023.
Anthony Price: Merrily due to increased legal fees.
Anthony Price: As of March 31, 2024, the company had cash of <unk> 2 million compared to $1 1 million as of December 31, 2023.
Speaker Change: Net cash used in operating activities for the three months ended March 31, 2024 was 1.0 million compared to $3 7 million for the comparable period in 2023.
Anthony Price: 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.
Speaker Change: As Peter earlier noted.
Speaker Change: Following the close of the quarter. The company received gross proceeds of $3 5 million through our aftermarket offering agreement in April 2024 registered direct offering.
Speaker Change: With that I'll now turn the call back over to Peter.
Peter H. Nielsen: Thanks Anthony.
Peter H. Nielsen: 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 by 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 cancer. With that, Operator, we are ready to open the call for questions. Thank you, sir. And if you would like to ask a question...
Peter H. Nielsen: 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.
Speaker Change: I cannot understate how important the work we are doing is the patients waiting for effective treatments.
Speaker Change: The progression of the deadly cancers.
Speaker Change: This is why we're so encouraged with the positive data reading out from our various studies.
Speaker Change: 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 Change: With that operator, we are ready to open the call for questions.
Operator: Thank you, sir. If you would like to ask a question, please press star then 1 on your telephone keypad. If your question has already been answered and you'd like to remove yourself from the queue, please press star then 2. Once again, ladies and gentlemen, that's stars and one if you have a question. And we'll stand by for just a moment while we wait for questions. And, ladies and gentlemen, this concludes the question and answer session. I'd like to turn the conference back over to Peter Nielsen for his closing remarks.
Speaker Change: Thank you Sir if you would like to ask a question. Please press Star then one on your telephone keypad.
Speaker Change: Yes. My question has already been addressed and like to remove yourself from queue. Please press Star then two.
Speaker Change: Once again, ladies and gentlemen that stars and why don't you have a question.
Speaker Change: And we will stand by for just a moment, while we wait for questions.
Speaker Change: And ladies and gentlemen, this concludes our question and answer session I would like to turn the conference back over to Peter Nielsen for closing remarks.
Peter H. Nielsen: Thank you.
Peter H. Nielsen: Thank you again, everyone, for joining us and for your continued support of Bio Path. Have a great day.
Peter H. Nielsen: 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.
Speaker Change: Thank you Sir.
Speaker Change: Today's conference call. Thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
Speaker Change: Okay.
Speaker Change: [music].