Q4 2023 Bio-Path Holdings Inc Earnings Call
[music].
Yes.
Operator: Good morning, ladies and gentlemen, and welcome to the Bio Path Holdings full year 2023 earnings conference call. At this time, all participants are in a listen-only mode.
Good morning, ladies and gentlemen, and welcome to the bio path Holdings full year 2023 earnings conference call.
At this time all participants are in a listen only mode.
Operator: Following the 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.
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.
Will OConnor: Thank you, operator. Welcome to the Bio Path 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 that outlines the topics that we plan to discuss on the 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. 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 CEO Peter Nielsen. Thanks, Will. Good morning, everyone.
Thank you operator.
Welcome to the bio path 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 are the.
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 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. Please.
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 paths CEO Peter Nielsen.
Thanks will.
Good morning, everyone.
Peter H. Nielsen: And thank you for joining us. Genetic Approaches to the Treatment of Cancer are getting the air time they deserve as these technologies are finally making meaningful clinical advances, and our de-enablized 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 or clinical trials to date, which is in contrast to other lipid delivery technologies with dose-limiting toxicity. This is what continues to excite us, and the data we saw throughout 2023 corroborates.
And thank you for joining us.
Genetic approaches to the treatment of cancer.
We're getting there can be observed.
These technologies are finally, making meaningful clinical advances in our DNA realized platform is the 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 and high doses the target cells in 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 toxicity.
This is what continues to excite us and the data we saw throughout 2023 corroborate that.
[laughter] excuse me.
Peter H. Nielsen: I'll begin with the progress we have made with our lead product candidate, Freixitriburus. 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 Cytabine and Venetoclast. Recall, the study is an amended stage two of our phase two trial at AML. It is an open-label, two-stage, multi-center study of Prexigibiracin in combination with dicitamin and venetoclax in two cohorts of patients with previously untreated AML and relapsed resistant AML. The third cohort will treat relapse-resistant AML patients who are venetoclax-resistant or intolerant to the two-drug combination of prexigibriracin and decidabine. 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.
I'll begin with the progress we have made with our lead product candidate Brexit Your burleson.
As you know last year, we reported positive interim results from stage two of our phase II clinical trial.
Thank you Bruce for the treatment of acute myeloid leukemia or AML.
In combination with frontline therapy decided but it's been en o'clock.
We call. This study is an amended stage two of our phase III trial in AML.
It is an open label two stage Multicenter study.
Thank you Bruce and in combination with decitabine in vanilla coax and two cohorts of patients with previously untreated AML and relapsed or resistant AML.
The third cohort includes treating relapsed or resistant AML patients for banana coax resistant or intolerant with the two drug combination package your birth and decided that.
Yeah.
The primary endpoint.
This study will.
It will be the number of patients who achieved complete remission, which includes complete remission with incomplete and butter collagic recovery and complete remission with partial hematologic recovery.
Peter H. Nielsen: Advocacy data from the initial interim analysis of Cohort 1 and Cohort 2 were compelling and showed that Prexiger-Burrison-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 therapy. This is particularly encouraging as refractory relapse patients are 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, Prexigibirus, 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 We look forward to keeping you apprised of our progress on the regulatory front in October.
Efficacy data from the initial interim analysis of cohort, one and cohort two were compelling.
And show that pressured your birth based combination therapy with not only safely administered in cohort one and two.
High risk newly diagnosed in refractory relapsed AML patients considered unsuitable for standard chemotherapy.
But also demonstrated efficacy signals better than current therapies.
This is particularly encouraging as refractory relapsed patients.
<unk> population.
Current treatment options are.
Are suboptimal.
On the strength of these data we currently plan to pursue U S food and drug administration O F D. A.
Expedited programs for fast track designation for bio path proxy <unk> 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.
These patients have a medium survival of only five to 10 months and represent a clear and serious unmet need that bio path meats.
We look forward to keeping you apprised of our progress progress.
The regulatory floor.
Yeah.
In October.
Peter H. Nielsen: 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. Maro Ohanian, two luminaries in the hematology oncology space, as our guest speakers. The discussion was illuminating and engaging, bolstering our conviction in the Prextige-Burrison 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 Bio Path's mission was inspiring. I encourage you all to listen to the archive of this event, which is available on our website.
We hosted a key opinion leader event.
To discuss the evolving treatment landscape.
A M L.
We were privileged to have Dr. Jorge Cortes and Dr Merrill heading in to luminaries in the hematology.
Ecology space as our guest speakers.
The discussion was illuminating and engaging bolstering our conviction in the practice of your birth and clinical development program.
Both physician experts, we're deeply encouraged by our interim results and further underscored.
Great unmet medical need of these patients.
It was heart warming to have these AML specialists highlight the fact that results of this magnitude are simply not seen in these patients.
Having this independent expert point of view.
Ports bio paths mission was inspiring.
I encourage you all to listen to the archives of this event.
<unk>, which is available on our website.
Peter H. Nielsen: Turning now to BP 1002, 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.
Turning now to beat P 1002 program, which targets Bcl two.
As you know Bcl two is responsible for driving.
Cell survival and up to 60% of all cancers.
Hi expression of Bcl two has been correlated with poor prognosis for patients diagnosed with AML.
Peter H. Nielsen: Venetocoax 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, with the exception of some patients treated with allogenetic hematopoietic cell transplantation.
Panetta coax has shown activity against the anti apoptotic protein Bcl, two and works by neutralizing the proteins ph three domain.
As an approved treatment for chronic lymphocytic leukemia, or CML patients and untreated AML patients.
However, with the exception of some patients.
He did with Allergan that it can bottle poetic cell transplantation.
Peter H. Nielsen: Disease relapse invariably occurs, oftentimes due to BH3 domain mutation over time. BP1002, also targets BCL-2 protein.
These relapse invariably occurs often times due to be age three domain mutation over time.
<unk> zero zero too.
Also targets the Bcl two.
Protein.
Peter H. Nielsen: However, BP1002 activity is based on blocking the BCL2 messenger RNA and not the BH3 domain. As a result, we believe BP-1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who have previously received venetoclax treatment. In December, we announced completion of the first dose cohort of the dose escalation portion of our Phase 1.1b clinical trial of BP1002 to treat refractory relapse AML, including venetoclax resistant patients. A total of three evaluable 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 The first dose cohort, consisting of a starting dose of 20 milligrams per square meter, and there were no dose-limiting toxicity. 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.
However.
P. P 1002 activity is based on blocking the Bcl two messenger RNA and not the big three domain.
As a result, we believe BP 1002 could provide an alternative burnet o'clock patients who have relapsed, including AML patients, who previously received <unk> treatments.
In December we announced the completion of the first dose cohort of the dose escalation portion of our phase one would be critical trial.
1002 to treat refractory relapsed AML, including <unk> resistant patients.
A total of three evaluable patients per dosing cohort are scheduled to be treated with BP 1002 mono therapy in a standard three plus three design.
Yes, 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 milligram per square meter.
The approved treatment cycle, it's two doses per week over four weeks were a total of eight doses administered over 28 days.
Peter H. Nielsen: 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 citabin 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. The 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.
The phase <unk> portion of this study is expected to commence after completion of BP 1002, monotherapy cohorts and will assess the safety and efficacy of <unk> two 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 one clinical trial of BP, one girls to evaluating.
<unk> two.
For the treatment of refractory relapsed lymphoma, and refractory relapsed chronic lymphocytic leukemia or C O L.
The total of six evaluable patients will be treated with BP 1002, monotherapy over two dosing cohorts and a standard three plus three design with.
With a starting dose of 20 milligram per square meter.
The approved treatment cycle, there's two doses per week over four weeks, resulting in eight doses administered over 28 days.
Peter H. Nielsen: Enrollment is now open for patients for the second dose cohort of 40 milligrams 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 1.1.b clinical trial of BP1001-A in payment for 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 Prexiger-Burrison, sharing the same drug substance with enhanced nanoparticle properties. This trial is being conducted at several leading cancer centers and will initially evaluate its safety in solid tumor patients. Patients diagnosed with recurrent ovarian and medial 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,
<unk> is now opened for patients for the second dose cohort of 40 milligram per square meter.
The primary endpoint of the study is to evaluate the safety and Tolerability of escalating doses of <unk> 100 too.
Look forward to keeping you apprised of our progress here.
Now, let's turn to our phase one would be clinical trial of <unk> 1001, dash eight and payment in patients with solid tumors, including ovarian.
Andrew Metrial pancreatic and triple negative breast cancer.
The most challenging cancers to treat with todays therapeutic tool kit.
B P 1001 batch a.
A modified product from practices your births in sharing the same drug substance with enhanced nanoparticle properties.
This trial is being conducted at several leading cancer centers.
We 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.
Look forward to.
Heart completion and data readout from this study potentially later this year.
Yeah.
Finally.
Peter H. Nielsen: 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 SAT3 pathway in breast and ovarian cancer cells promotes tumor initiation, migration, and taxol resistance. STAT3 also promotes 5-FU resistance in colorectal cancer cells. Hence, its role in numerous malignancies has made STAT3 a potential cancer therapeutic target.
Let's review the progress we've made with BP was zero, three which targets the stat III protein.
That's right, it's a transcription factor that regulates various tumors allogeneic processes, such as tumor proliferation metastasis and drug resistance.
It's over expression and Albert aberrant activation characterize many cancers.
<unk> breast lung ovarian liver and colon cancer.
Activation of the SaaS three pathway in breast and ovarian cancer cells promotes tumor initiation migration and taxol resistance.
Step three also promotes five dash F you resistance in colorectal cancer cells.
Its role at numerous malignancies made stat three potential cancer therapeutic target.
Peter H. Nielsen: 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 TAXL and 5-FU. These results are in line with previous work in which BP1003 plus gemcitabine displayed enhanced antitumor activity in pancreatic ductal adenocarcino 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.
B P 1003 is a novel Liposome incorporated <unk> antisense Oligo D oxy nucleotide debt.
Efficiency efficiently, we do some stat, three expression and enhances the sensitivity of breast and ovarian cancer cells. The tax so in five days yet.
These results are in line with previous work and which V. P 1003, plus Jim cited then.
Slade enhanced antitumor activity.
Pancreatic ductal adenocarcinoma.
Together these results strongly suggest.
<unk> 1003 combination therapy is a novel strategy for patients with advanced solid tumors.
After an extended period of testing we have identified a method for all ago detection and plasma that we believe will enable us to complete final safety testing needed.
Penalize, an investigational new drug application or an eye in D C.
Our submission to the FDA.
Anthony Price: 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.
We are particularly excited to launch our first in human validation of this cutting edge therapy in an.
Especially challenging cancer indication.
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.
Anthony Price: Thanks, Peter. The company reported a net loss of $16.1 million, or $33.63 per share, for the year ended December 31, 2023, compared to a net loss of $13.9 million, or $38.12 per share, for the year ended December 31, 2022. Research and development expense for the year ended December 31, 2023 increased to $11.6 million compared to $9.2 million for the year ended December 31, 2022, primarily due to manufacturing expenses related to drug product releases in 2023, as well as an increase in expenses related to our clinical trial for prexigibiracin 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 The change in fair value of the company's warrant liability for the year ended December 31, 2023 resulted in a non-cash loss of $0.3 million. The company did not have the warrant liability in 2022.
Thanks Peter.
We reported a net loss of $16 1 million or $33 63 per share for the year ended December 31, 2023, compared to a net loss of $13 9 million or 38, <unk> 12 per share for the year ended December 31 2022.
Research and development expense for the year ended December 31, 2023 increased to 11 6 million compared to $9 2 million for the year ended December 31, 2022, primarily due to manufacturing expenses related to drug product releases in 2023 as well as an increase.
<unk> and expense related to our clinical trial for proxy giberson in AML due to increased patient enrollment in 2023.
General and administrative expense for the year ended December 31, 2023 decreased to $4 2 million compared to $4 7 million for the year ended December 31 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 31, 2023 resulted in a noncash loss of <unk> 3 million.
The company did not have the warrant liability in 2022.
Anthony Price: As of December 31st, 2023, the 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 31, 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 31, 2023 was $2.2 million.
As of December 31, 2023 company had cash of $1 1 million compared to $10 4 million as of December 31, 2022.
Net cash used in operating activities for the year ended December 31, 2023 was $11 5 million.
<unk> to $15 1 million for the comparable period in 2022.
Net cash excuse me net cash provided by financing activities for the year ended December 31, 2023 was $2 2 million.
Peter H. Nielsen: With that, I'll now turn the call back over to Peter. 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-enablized programs. As we look to the months and year ahead, we expect to build on this clinical progress to bring potentially life-saving new medicines to patients battling cancer. With that, operator, we're ready to open the call for questions. 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 on a touch-tone telephone. To withdraw your question, 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.
With that I'll now turn the call back over to Peter.
Thanks Anthony.
Cause I hope you'll agree 2023 was a year of focused execution for bio path as evidenced by the continued progress across our pipeline of D enable EIS programs.
As we look to the months and year ahead, we expect to build on the clinical progress.
<unk> to date to bring potentially life saving new medicines to patients battling cancer.
With that operator, we're ready to open the call for questions.
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 touchtone telephone to withdraw your question you May Press Star two.
If you are using a speaker phone, we do ask that you. Please pick up your handset prior depressing the numbers to ensure the best sound quality.
Operator: Again, that is a star and then one to join the question. Our first question today comes from Jonathan Aschoff from Roth MKM. Please go ahead with your question. Thank you. Good morning, Peter.
That is star and then one judge.
And the question queue.
Our first question today comes from Jonathan Ashcroft from Roth M. Kam. Please go ahead with your question.
Thank you good morning, Peter.
Jonathan Matthew Aschoff: My first question is about PREX. Now, you say you look for fast-track patients who can't tolerate intensive chemo. So, what's the, you know, in AML, what's the size of that market, and is anything currently happening right now with the clinical development of PREX, or is it awaiting that fast track designation? to, you know, specifically target patients who can't tolerate intensive chemo. I think our drug is pretty unique in being able to treat fractal patients. You know, ours is, of course, a genetic approach. We're not a toxic or poison designed to kill cells.
My first question is about cracks now you say it looks for fast track patients who can't tolerate chemo. So what's you know in AML, what's the size of that market and is there anything currently happening right now with clinical development of Praxair isn't a weighting that fast track designation.
Okay, Cana, specifically targeted to they can't tolerate intensive chemo.
I think our drug is pretty unique in being able to treat them.
Fragile patients you know ours is of course, a genetic approach, we're not a toxic or poison designed to kill cells and so.
Peter H. Nielsen: And so inherently, it makes our patients, you know, have a better shot in terms of tolerability. It's interesting, we've paused our... Cohort One, to new enrollment as we complete wrap-up this first phase, the Phase 2, Stage 2. And we have, I noted, we have two patients who have had seven months of treatment and one patient who has eight months. And it just has that benefit.
Inherently it makes our Ah patients.
You don't have a better shot at terms of Tolerability.
Interesting.
You know paused or.
Cohort one.
Two new enrollment as we complete wrapping up.
This first phase.
The phase two stage two.
And we have I noted we have two patients in.
And seven months of treatment and one patient in eight months and it just has that.
Benefit.
Peter H. Nielsen: I can't recall the numbers off. I think it's in the 10,000 range in patients. A lot of them are older than 60 patients, which have a more difficult time and, Like I said in the notes, if they can't tolerate Banana Quacks, their survivability is not very good.
I can't recall the numbers up I think it's in the 10000 range in patients.
A lot of it is.
Older than 60 patients, which Uh huh.
Have a a more difficult time and the like.
Like I said in the notes.
If they can't tolerate.
The chemotherapy.
Without a coax.
There.
Peter H. Nielsen: We think it's a good market, and it specializes in obviously enhancing the Venetoclax treatment because all we do is make that job easier with our messenger RNA treatment. There are fewer BC... BCL-2 proteins for Venetoclax to operate on. So I wouldn't be surprised if, in maturing the treatment, you probably might see some extension of the effectiveness of venetoclax before you get to the point where... a different approach to addressing BCL-2 protocols has to be used. Okay, on 1002, what... 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 Neuronal Therapy in CLL lymphoma.
Survivability.
Not very good so we think it's a it's a good market.
And it specializes obviously we enhance.
The banana coax treatment and because all we do is make that job easier because.
With our Oh messenger, RNA treat but theres less B C.
Bcl two proteins for vanilla clacks operate on them, so I wouldn't be surprised.
And the maturation of the retreat, but that in fact, you probably might see some extension.
The effectiveness.
Banana clacks before.
Get to the point that Oh.
A different approach to addressing the bcl two protein.
So it has to be used.
Okay on a 1002.
What.
What dosing started at for what I assume would be a subsequent combo therapy trial after you're done with 20 and 40 milligrams.
Well I understand.
L L lymphoma trial.
Peter H. Nielsen: Yeah, that's both the CML and AML. We started at 20 milligrams per square meter, which is a, you know, pretty safe starting point. And, 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.
Yeah that both the CML in AML.
We started at 20 milligrams per square meter, which as you know.
Pretty safe starting point and.
And you're basically the you know the one would be the one is whether you think the dose of course with the monotherapy.
And you know that should be 60.
Be great to see it up to 90 milligram per square meter so that'd be jumping up.
Peter H. Nielsen: You know, the 60 B3 jump, the 4 to 90. And then once that happens, the 1B is when you then.!!ha!!1!!
63 jumped four to 90.
And then once that happens the one b is when you then.
Assess.
The.
The combination therapy.
Peter H. Nielsen: you know, the safety of combination therapy and how to use it actually Combination Therapy. So, you know, it's hard to say right now. It should be 60 to 90, I would think. And, you know, we'll, but, you know, we have to do the testing to have that confirmed. Okay, and on PREX-A and 1003, what cohorts would you be referring to from PREX-A that would read out in 2024, and is this also still the year for a 1003 IND? My, you know, my recollection is on the toxicity of the solid tumor. So that's Dash A. And, you know, there's a lot of interest in that trial, and we're ready to enroll and treat patients in those two. I think we had three lined up, but one had to back out because of couldn't.
Therapy safety and use it actual.
Combination therapy. So you know it's hard to say right now.
It should be 62.
To 90 I would think.
And do you know.
But we have to do the testing.
Confirmed.
Okay and on on perhaps a and a 103, what cohorts when you're referring to from perhaps a yeah that would read out in 2024 and is this also still the year for a one O L. Three IND filings.
My my.
Recollection is on the toxicity on the solid tumor piece.
That's a bad strategy.
And.
A lot of interest in that trial.
And.
Already.
Enrolling and treating patients in dose to the.
We had three lined up one had to back out because of.
It could.
Or too sick and.
Peter H. Nielsen: And so that's the one we're talking about getting. And that one, recall, starts at a higher dose because it uses Prexiger-Burrs, for which there is 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 way, it'd go up to 135. So, you know, 90 is what it ends up being, 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 what we end up settling on.
So that's the one where we're talking about the.
Getting in and that one recall.
Starts at a higher dose.
Because it's using Brexit your birth, so much there's a lot of obviously safety evidence in the <unk>.
Phase III AML trial, so that would start at 60, it's at 90 now if it goes another it go up to 135 so.
You know 90 is what 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 do in the world. So I would think that could ramp and be reported on it that's where we are.
We end up settling on 90 beds per square meter.
Jonathan Matthew Aschoff: Okay, Peter, thank you very much. That was it. Thank you, Jonathan. And, ladies and gentlemen, with that, and having shown no additional questions, I'd like to turn the floor back over to Peter for any closing remarks. Thank you, operator. Thank you again, everyone, for joining us and for your continued support of Bio Path. Have a great day. Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your line.
Okay. Peter Thank you very much that was my question.
Thank you Jonathan.
And ladies and gentlemen, with that and showing no additional questions I'd like to turn the floor back over to Peter for any closing remarks.
Thank you operator.
Thank you again, everyone for joining us and for your continued support of bio path.
Have a great day.
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.