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spk08: Good morning, ladies and gentlemen, and welcome to the Biopath Holdings Full Year 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following formal remarks, we will open the call for your questions. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Please proceed.
spk06: Thank you, Operator. Welcome to the Biopath Holdings conference call and webcast to review the company's full year 2023 financial results and to provide an update on recent pipeline and corporate developments. Earlier today, we issued a press release which outlines the topics that we plan to discuss on the 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 CEO, Peter Nielsen.
spk05: Thanks, Will. Good morning, everyone, and thank you for joining us. Genetic approaches to the treatment of cancer are getting the airtime they deserve as these technologies are finally making meaningful clinical advances, and our de-enabilized platform is a perfect example of that. We made significant progress throughout last year across our pipeline, and I'm excited to share these updates with you today. Our antisense DNA can be delivered in high doses to target cells through the blood and lymphatic system with no evidence of toxicity in patients in clinical trials to date, which is in contrast to other lipid delivery technologies with dose-limiting toxicities. This is what continues to excite us, and the data we saw throughout 2023 corroborates that. Excuse me. I'll begin with the progress we have made with our lead product candidate, Prexager Burrison. As you know, last year we reported positive interim results from stage two of our phase two clinical trial of Prexager Burrison for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy to Cytabine and Venetoclax. Recall, The study is an amended stage two of our phase two trial in AML. It is an open-label, two-stage, multi-center study of Prexigibiricin in combination with the Cytamin and Venetoclax in two cohorts of patients with previously untreated AML and relapsed-resistant AML. The third cohort includes treating relapsed-resistant AML patients who are Venetoclax-resistant or intolerant with the two-drug combination of Prexagirboricin and Dacitamin. 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. Advocacy data. from the initial interim analysis of cohort one and cohort two were compelling and show that Prexager-Burison-based combination therapy was not only safely administered in cohort one and two 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.S. Food and Drug Administration, or FDA, expedited programs for fast-track designation for Biopass, Prexagibros, and AML treatment in patients who cannot tolerate intensive chemotherapy treatments without unacceptable side effects. The outcome in these AML patients who are unable to receive intensive chemotherapy remains dismal. These patients have a medium survival of only five to 10 months and represent a clear and serious unmet need that Biopath meets. We look forward to keeping you apprised of our progress on the regulatory front. In October, we hosted a key opinion leader event to discuss the evolving treatment landscape in AML. We were privileged to have Dr. Jorge Cortes and Dr. Meryl O'Hanion, two luminaries in the hematology oncology space, as our guest speakers. The discussion was illuminating and engaging, bolstering our conviction in the Prechtiger-Burris and Clinical Development Program as both physician experts were deeply encouraged by our interim results and further underscored the great unmet medical need of these patients. It was heartwarming to have these AML specialists highlight the fact that results of this magnitude are simply not seen in these patients. Having this independent and expert point of view that supports BioPath's mission was inspiring. I encourage you all to listen to the archive of this event, which is available on our website. Turning now to 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 BCL2 has been correlated with poor prognosis for patients diagnosed with AML. 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. BP1002 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 BP1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who previously received venetoclax treatments. In December, we announced completion of the first dose cohort of the dose escalation portion of our Phase I-Ib clinical trial of BP1002 to treat refractory relapse 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 plus 3 design, unless there is a dose limiting toxicity, which would require an additional three patients tested. The first dose cohort consisting of starting dose of 20 milligrams per square meter, and there were no dose limiting toxicities. Enrollment is now open for patients for the second dose cohort of 40 milligrams per square meter. The approved treatment cycle is two doses per week over four weeks for a total of eight doses administered over 28 days. The phase 1D 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 the cytamine in refractory relapsed AML patients. In January, we announced completion of the first dose cohort of the dose escalation portion of our Phase I 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 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. Enrollment is now open for patients for the second dose cohort of 40 mg per square meter. The primary endpoint 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. Now let's turn to our Phase 11B clinical trial of BP1001-A in payments 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 Prexagibiricin 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. 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. We look forward to cohort completion and data readout from this 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 tumorigenic processes, such as tumor proliferation, metastasis, and drug resistance. It's overexpression and aberration Aberrant activation characterized 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 liposome-incorporated STAT3 antisense oleodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxel and 5-FU. These results are in line with previous work in which BP1003 plus gemcitabine 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. After an extended period of testing, we have identified a method for oligo detection in plasma that we believe will enable us to complete final safety testing needed to finalize an investigational new drug application, or an IND, 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. With that, I'll now turn the program over to Anthony Price for a brief overview of our financials, along with balance sheet highlights. Anthony?
spk07: Thanks, Peter. The company reported a net loss of $16.1 million, or $33.63 per share, for the year ended December 31st, 2023, compared to a net loss of 13.9 million or 38.12 per share for the year ended December 31st, 2022. Research and development expense for the year ended December 31st, 2023 increased to 11.6 million compared to $9.2 million for the year ended December 31st, 2022, primarily due to manufacturing expenses related to drug product releases in 2023, as well as an increase in expense related to our clinical trial for Prexigibircin in AML due to increased patient enrollment in 2023. General and administrative expense for the year ended December 31st, 2023 decreased to $4.2 million, compared to $4.7 million for the year ended December 31st, 2022, primarily due to decreased salaries and benefits expense, as well as franchise tax expenses. Change in fair value of the company's warrant liability for the year ended December 31st, 2023 resulted in a non-cash loss of $0.3 million. The company did not have the warrant liability in 2022. As of December 31st, 2023, company had cash of 1.1 million compared to 10.4 million as of December 31st, 2022. Net cash used in operating activities for the year ended December 31st, 2023 was 11.5 million compared to 15.1 million for the comparable period in 2022. Net cash provided by financing activities for the year ended December 31st, 2023, was 2.2 million. With that, I'll now turn the call back over to Peter.
spk05: Thanks, Anthony. As I hope you'll agree, 2023 was a year of focused execution for BioPath, as evidenced by the continued progress across our pipeline of de-enabilized programs. As we look to the months and year ahead, we expect to build on the clinical progress achieved to date to bring potentially life-saving new medicines to patients battling cancers. With that, operator, we're ready to open the call for questions.
spk08: Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two If you are using a speakerphone, we do ask that you please pick up your handset prior to pressing the numbers to ensure the best sound quality. Again, that is star and then one to join the question queue. Our first question today comes from Jonathan Ashcroft from Roth MKM. Please go ahead with your question.
spk01: Thank you. Good morning, Peter. My first question is about Prex. Now, you say you look for fast track patients who can't tolerate intensive chemo. in AML, what's the size of that market and is anything currently happening right now with clinical development of PREX or is it awaiting that fast track designation to specifically target it to the can't tolerate intensive chemo?
spk05: I think our drug is pretty unique in being able to treat the fragile patients. Ours is Of course, a genetic approach. We're not a toxic or poison designed to kill cells. And so inherently, it makes our patients have a better shot in terms of tolerability. It's interesting. We've paused our cohort one and two new enrollment as we complete wrapping up. this first phase of the phase two, stage two. And we have, I noted, we have two patients in seven months of treatment and one patient in eight months. And it just has that benefit. I can't recall the numbers off. I think it's in the 10,000 range in patients. A lot of it is older than 60 patients, which have a a more difficult time and like I said in the notes if they can't tolerate the chemotherapy venetoclax their survivability is not very good so we think it's a good market and it specializes obviously we enhance the venetoclax treatment and Because all we do is make that job easier because with our messenger RNA treatment, there's less BCL2 proteins for venetoclax to operate on. So I wouldn't be surprised that in maturation of the treatment that, in fact, you probably might see some extension of the effectiveness of venetoclax before
spk04: you get to the point that a different approach to addressing BCL-2 protein has to be used.
spk01: Okay. On 1002, what dose do you start at for what I assume would be a subsequent combo therapy trial after you're done with 20 and 40 milligrams in monotherapy in the CLL lymphoma trial?
spk05: Yeah, both the CML and AML were started at 20 milligrams per square meter, which is a, you know, pretty safe starting point. And you basically, you know, the 1-1-B, the one is where you're finding the dose, of course, of the monotherapy. And, you know, that should be 60. It'd be great to see it up to 90 milligrams per square meter. So that'd be jumping up... you know, the 60 would be three jumps, uh, four to 90. And then once that happens, the one B is when you then, uh, assess, you know, the, uh, the combination, uh, therapy safety and use it actual, uh, combination therapy. So, uh, you know, it's hard to say right now. It should be 60, uh, to 90, I would think.
spk04: Um, and, uh, But we have to do the testing to have that confirmed.
spk01: Okay. And on PREX A and 1003, what cohorts were you referring to from PREX A that would read out in 2024? And is this also still the year for a 1003 IND filing?
spk05: you know, my recollection is on the toxicity on the solid tumor piece. So that's dash a, and, uh, you know, there's a lot of interest in that trial and, uh, we're already, uh, enrolling and treating patients in dose two. And, uh, I think we had three lined up. One had to back out because of, uh, it couldn't, uh, or too sick. And, uh, So that's the one we're talking about getting. And that one, recall, starts at a higher dose because it's used in prexin tuberosum, which there's a lot of, obviously, safety evidence in the Phase II AML trial. So that one started at 60. It's at 90 now. If it goes another, it'd go up to 135. So... You know, 90 is what it ends up being. You know, we certainly should be able to do that because, like I said, we already have one patient in that second cohort, dose cohort at 90, and another one that's trying to enroll. So I would think that could wrap and be reported on if that's where we end up settling on 90 meds per square meter.
spk01: Okay, Peter, thank you very much. That was it for my question. Thank you, Jonathan.
spk08: And, ladies and gentlemen, with that, in showing no additional questions, I'd like to turn the floor back over to Peter for any closing remarks.
spk05: Thank you, Operator. Thank you again, everyone, for joining us and for your continued support of BioPath. Have a great day.
spk08: Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines. you Thank you. Bye.
spk00: Thank you.
spk08: Good morning, ladies and gentlemen, and welcome to the BioPath Holdings Full Year 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following formal remarks, we will open the call for your questions. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Please proceed.
spk06: Thank you, Operator. Welcome to the Biopath Holdings conference call and webcast to review the company's full year 2023 financial results and to provide an update on recent pipeline and corporate developments. Earlier today, we issued a press release which outlines the topics that we plan to discuss on the 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 CEO, Peter Nielsen.
spk05: Thanks, Will. Good morning, everyone, and thank you for joining us. Genetic approaches to the treatment of cancer are getting the airtime they deserve as these technologies are finally making meaningful clinical advances, and our de-enabilized platform is a perfect example of that. We made significant progress throughout last year across our pipeline, and I'm excited to share these updates with you today. Our antisense DNA can be delivered in high doses to target cells through the blood and lymphatic system with no evidence of toxicity in patients in clinical trials to date, which is in contrast to other lipid delivery technologies with dose-limiting toxicities. This is what continues to excite us, and the data we saw throughout 2023 corroborates that. Excuse me. I'll begin with the progress we have made with our lead product candidate, Prexager Burrison. As you know, last year we reported positive interim results from stage two of our phase two clinical trial of Prexager Burrison for the treatment of acute myeloid leukemia, or AML, in combination with frontline therapy to Cytabine and Venetoclax. Recall, The study is an amended stage two of our phase two trial in AML. It is an open-label, two-stage, multi-center study of Prexigibiricin in combination with the Cytamin and Venetoclax in two cohorts of patients with previously untreated AML and relapsed-resistant AML. The third cohort includes treating relapsed-resistant AML patients who are Venetoclax-resistant or intolerant with the two-drug combination of Prexagirboricin and Dacitamin. 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. Advocacy data. from the initial interim analysis of cohort one and cohort two were compelling and show that Prexager-Burison-based combination therapy was not only safely administered in cohort one and two 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.S. Food and Drug Administration, or FDA, expedited programs for fast-track designation for Biopass, Prexagibros, and AML treatment in patients who cannot tolerate intensive chemotherapy treatments without unacceptable side effects. The outcome in these AML patients who are unable to receive intensive chemotherapy remains dismal. These patients have a medium survival of only five to 10 months and represent a clear and serious unmet need that Biopath meets. We look forward to keeping you apprised of our progress on the regulatory front. In October, we hosted a key opinion leader event to discuss the evolving treatment landscape in AML. We were privileged to have Dr. Jorge Cortes and Dr. Meryl O'Hanion, two luminaries in the hematology oncology space, as our guest speakers. The discussion was illuminating and engaging, bolstering our conviction in the Prexen-Gibberson Clinical Development Program as both physician experts were deeply encouraged by our interim results and further underscored the great unmet medical need of these patients. It was heartwarming to have these AML specialists highlight the fact that results of this magnitude are simply not seen in these patients. Having this independent and expert point of view that supports BioPath's mission was inspiring. I encourage you all to listen to the archive of this event, which is available on our website. Turning now to 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 BCL2 has been correlated with poor prognosis for patients diagnosed with AML. 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. BP1002 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 BP1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who previously received venetoclax treatments. In December, we announced completion of the first dose cohort of the dose escalation portion of our Phase I-Ib clinical trial of BP1002 to treat refractory relapse 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 plus 3 design, unless there is a dose limiting toxicity, which would require an additional three patients tested. The first dose cohort consisting of starting dose of 20 milligrams per square meter, and there were no dose limiting toxicities. Enrollment is now open for patients for the second dose cohort of 40 milligrams per square meter. The approved treatment cycle is two doses per week over four weeks for a total of eight doses administered over 28 days. The phase 1D 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 the cytamine in refractory relapsed AML patients. In January, we announced completion of the first dose cohort of the dose escalation portion of our Phase I 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 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. Enrollment is now open for patients for the second dose cohort of 40 mg per square meter. The primary endpoint 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. Now let's turn to our Phase 11B clinical trial of BP1001-A in payments 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 Prexagibiricin 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. 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. We look forward to cohort completion and data readout from this 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 tumorigenic processes, such as tumor proliferation, metastasis, and drug resistance. It's overexpression and aberration Aberrant activation characterized 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 liposome-incorporated STAT3 antisense oleodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxel 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 we believe will enable us to complete final safety testing needed to finalize an investigational new drug application, or an IND, 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. With that, I'll now turn the program over to Anthony Price for a brief overview of our financials, along with balance sheet highlights. Anthony?
spk07: Thanks, Peter. The company reported a net loss of $16.1 million, or $33.63 per share, for the year ended December 31st, 2023, compared to a net loss of 13.9 million or 38.12 per share for the year ended December 31st, 2022. Research and development expense for the year ended December 31st, 2023 increased to 11.6 million compared to $9.2 million for the year ended December 31st, 2022, primarily due to manufacturing expenses related to drug product releases in 2023, as well as an increase in expense related to our clinical trial for Prexigibircin in AML due to increased patient enrollment in 2023. General and administrative expense for the year ended December 31st, 2023 decreased to $4.2 million, compared to $4.7 million for the year ended December 31st, 2022, primarily due to decreased salaries and benefits expense, as well as franchise tax expenses. Change in fair value of the company's warrant liability for the year ended December 31st, 2023 resulted in a non-cash loss of $0.3 million. The company did not have the warrant liability in 2022. As of December 31st, 2023, company had cash of 1.1 million compared to 10.4 million as of December 31st, 2022. Net cash used in operating activities for the year ended December 31st, 2023 was 11.5 million compared to 15.1 million for the comparable period in 2022. Net cash provided by financing activities for the year ended December 31st, 2023 was 2.2 million. With that, I'll now turn the call back over to Peter.
spk05: Thanks, Anthony. As I hope you'll agree, 2023 was a year of focused execution for BioPath, as evidenced by the continued progress across our pipeline of de-enabilized programs. As we look to the months and year ahead, we expect to build on the clinical progress achieved to date to bring potentially life-saving new medicines to patients battling cancers. With that, operator, we're ready to open the call for questions.
spk08: Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two If you are using a speakerphone, we do ask that you please pick up your handset prior to pressing the numbers to ensure the best sound quality. Again, that is star and then one to join the question queue. Our first question today comes from Jonathan Ashcroft from Roth MKM. Please go ahead with your question.
spk01: Thank you. Good morning, Peter. My first question is about Prex. Now, you say you look for fast track patients who can't tolerate intensive chemo. what's, you know, in AML, what's the size of that market, and is anything currently happening right now with clinical development of PREX, or is it awaiting that fast-track designation to, you know, specifically target it to the cancer-tolerating intensive chemo?
spk05: I think our drug is pretty unique in being able to treat the fragile patients. You know, ours is of course, a genetic approach. We're not a toxic or poison designed to kill cells. And so inherently, it makes our patients have a better shot in terms of tolerability. It's interesting. We've paused our cohort one and two new enrollment as we complete wrapping up. this first phase of the phase two, stage two. And we have, I noted, we have two patients in seven months of treatment and one patient in eight months. And it just has that benefit. I can't recall the numbers off. I think it's in the 10,000 range in patients. A lot of it is older than 60 patients, which have a a more difficult time and like I said in the notes if they can't tolerate the chemotherapy venetoclax their survivability is not very good so we think it's a good market and it specializes obviously we enhance the venetoclax treatment and Because all we do is make that job easier because with our messenger RNA treatment, there's less BCL2 proteins for venetoclax to operate on. So I wouldn't be surprised that in maturation of the treatment that, in fact, you probably might see some extension of the effectiveness of venetoclax before
spk04: you get to the point that a different approach to addressing BCL-2 protein has to be used.
spk01: Okay. On 1002, what dose do you start at for what I assume would be a subsequent combo therapy trial after you're done with 20 and 40 milligrams in monotherapy in the CLL lymphoma trial?
spk05: Yeah, both the CML and AML were started at 20 milligrams per square meter, which is a, you know, pretty safe starting point. And you basically, you know, the 1-1-B, the one is where you're finding the dose, of course, of the monotherapy. And, you know, that should be 60. It'd be great to see it up to 90 milligrams per square meter. So that'd be jumping up... you know, the 60 would be three jumps, the four to 90. And then once that happens, the one B is when you then, uh, assess, you know, the, uh, the combination, uh, therapy safety and use it actual, uh, combination therapy. So, uh, you know, it's hard to say right now. It should be 60, uh, to 90, I would think.
spk04: Um, and, uh, But, you know, we have to do the testing to have that confirmed.
spk01: Okay. And on PREX A and 1003, what cohorts were you referring to from PREX A that would read out in 2024? And is this also still the year for a 1003 IND filing?
spk05: you know, my recollection is on the toxicity on the solid tumor piece. So that's dash a, and, uh, you know, there's a lot of interest in that trial and, uh, we're already, uh, enrolling and treating patients in dose two. And, uh, I think we had three lined up. One had to back out because of, uh, it couldn't, uh, or too sick. And, uh, So that's the one we're talking about getting. And that one, recall, starts at a higher dose because it's used in Prexidubirizum, which there's a lot of, obviously, safety evidence in the Phase II AML trial. So that one started at 60. It's at 90 now. If it goes another, it'd go up to 135. So... You know, 90 is what it ends up being. You know, we certainly should be able to do that because, like I said, we already have one patient in that second cohort, dose cohort at 90, and another one that's trying to enroll. So I would think that could wrap and be reported on if that's where we end up settling on 90 meds per square meter.
spk01: Okay, Peter, thank you very much. That was it for my question. Thank you, Jonathan.
spk08: And, ladies and gentlemen, with that, in showing no additional questions, I'd like to turn the floor back over to Peter for any closing remarks.
spk05: Thank you, Operator. Thank you again, everyone, for joining us and for your continued support of BioPath. Have a great day.
spk08: Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.
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