Q2 2022 Bio Path Holdings Inc Earnings Call
and efficacy of BP 1002 in combination with the Cidamine and Refractory Relapse AML patients. We hope to be able to provide incremental updates on this program as we establish safety first followed then by efficacy in these smaller patient cohorts. Finally let's review progress we've made with our third drug candidate BP 1003 which targets the STAT3 program. STAT3 is a transcription factor that regulates various tumorogenic processes such as tumor proliferation, metastasis, 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. The STAT3 also contributes and promotes 5-FU resistance in colorectal cancer cells. Its role in numerous malignancies makes STAT3 a potential cancer therapeutic agent. BP 1003 is a novel liposome incorporated STAT3 antisense oligo deoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxol.
and 5-FU. These results are in line with previous work in which BP1003 plus Jim Sideman displayed enhanced anti-tumor activity in pancreatic ductal adenocarcinoma. Together these results strongly suggest that BP1003 combination therapy is a novel strategy that changes our lives.
In April , we were delighted to present supportive preclinical data from this program at the 2022 American Association of Cancer Research Annual Meeting before an audience of world-leading cancer researchers and physicians.
Dr. Maria Gagliardi, a research scientist on our team.
highlighted preclinical studies of BP1003 in combination with paclitaxel or fluorouracel as a potential treatment against breast and ovarian cancer cells.
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.
Our goal is to file an IND application for this very promising product candidate late in the fourth quarter or the first quarter of 2023.
The timing is determined by finalizing preclinical testing of drug substance presence.
in the animal species used in testing.
With that, I'll now turn the program over to Anthony Price for a brief review of our second quarter 2022 financials along with balance sheet highlights.
Anthony?
Thanks, Peter. The company reported a net loss of $3.0 million, or $0.42 per share, for the three months ended June 30, 2022, compared to a net loss of $1.8 million, or $0.26 per share, for the three months ended June 30, 2021.
Research and development expense for the three months ended June 30, 2022 increased to $1.9 million compared to $0.8 million for the three months ended June 30, 2021.
primarily due to manufacturing expenses related to drug product releases in the second quarter of 2022 and increased patient enrollment related to our Phase II clinical trial for Prexy Jiberson in AML.
General and administrative expense for the three months ended June 30, 2022 was $1.2 million, an increase of $0.1 million compared to the three months ended June 30, 2021, primarily due to increased legal fees.
As of June 30, 2022, the company had cash of $17.0 million compared to $23.8 million at December 31, 2021.
Net cash used in operating activities for the six months ended June 30, 2022 was $6.7 million compared to $4.2 million for the comparable period in 2021.
With that, I'll now turn the call back over to Peter.
Thanks, Anthony.
I trust today's update leaves you as excited as we are for the future as we are making and will continue to make good progress advancing these important clinical trials in cancers where current therapies are woefully inadequate or where life-signing new therapies are greatly needed.
Our team remains steadfast in our commitments to advancing our de-enabled platform technology.
as we seek to deliver a better path for cancer patients worldwide.
with that operator.
We are ready to open the call for questions.
Ladies and gentlemen, at this time we'll begin the question and answer session.
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Once again, that is star and then one to ask a question.
Our first question today comes from...
Yi Chen from HC Wainwright. Please go ahead with your question.
Thank you for taking my questions. Could you provide an update on the number of enrollment in-group patients in each three cohorts of the Phase II trial of BP1001?
Well, I think I'd mentioned here we had a
the trial was slowed down in the
last year and a half previously from manufacturing issues related to COVID and just the environment. But we have...
across the cohorts now picked up.
the
enrolling and treating and in fact we've
I think it mentioned that we were doubling our supply chain of the key manufacturing plants, our oligo manufacturer and then our final drug product manufacturer. And these are all that plan is coming to fruition as we are adding more drug supplies and able to treat more patients. That's the principle reason that you saw the R&D expense jump up. I think as we talked about many times on these calls.
as we produce
new drug product for treating patients.
It accumulates on the balance sheet prepaid and then when it's done and released to the company for use in the trial, it drops to an expense.
overall I'd say
We're about halfway in the cohorts.
Some may be a little bit faster than the others. But we continue to think that we're looking towards being able to start interim results.
in the late fourth quarter or more likely in the first quarter of 2023. At that point,
will assess, you know.
efficacy and safety and as appropriate move with the FDA to see if there's any opportunities for expedited programs.
So just to clarify, you think the trial will reach 19 available patients for entering analysis at the end of this year or the first quarter of 23, right?
Yes, I think that, you know, or it just depends on how quickly we can treat those and get the valuable patients. But you know, that has been going pretty well. So 19, you know, it's a safer to say that we'll be in the middle of doing that in the first quarter and evaluating. So
It just depends on how quickly we can treat those and get the valuable patients. But that individual has been going pretty well. So 19, it's a safer to say that we'll be in the middle of doing that in the first quarter and evaluating them. So. Got it. Got it.
And during the remainder of 2022,
Shall we expect to see preliminary data from the phase one trial of PT1001-A and PT1002?
Well, we...
I think as we indicated, we've completed the work now of getting that trial, both of those trials open.
And so...
We've generated
I think a lot of interest in the trial. I think there's six sites for the dash A and three real quality sites for the
resistant AML. So you know you can never tell how fast they come in but you know I'd like to think we'd hit at least one cohort for both of those trials in 2022.
and we'll report on that.
Thanks. And lastly, is there any additional preclinical study for BP1003 that needs to be concluded before the drug can enter clinical trial?
I think you know of course we just did the ACR and
We are working on.
A lot of our focus in preclinical right now is on AML, banana-clack resistant cells.
So we may have something coming out on that and.
So other than that, I really don't want to.
reference any of our programs.
our research group stays pretty active in doing preclinical work that's supportive of the
products that we're trying to advance.
Okay, thank you.
Once again, if you would like to ask a question, please press star and one. Our next question comes from Jonathan Ashcroft from Roth. I'll give you a vote with your question.
Thank you. I just had one question, Peter. You know, the world's seen clinical experience with 1001 and, you know, you are certainly talking about the difficulty in getting low doses, getting doctors interested in low doses of 1002. Excuse me, I have COVID. My question is...
you know, 1001A being kind of similar to 1001, do we expect 1001A?
to have that kind of low dose, low enrollment that you're now experiencing and you know have been for a while with 1002 or can it piggyback?
at all.
the earlier 1001 experience because it is a highly similar agent.
Yeah, the substance is the same too. That's a good question and you're right. Because of the body and experience we have with Proxigibrozum, we're able to start at a higher dose, 60 milligram per square meter. So that's the dose in AML. Do a cohort at that and then go on to 90. So yeah, we don't have to go through the 20 milligram of our words.
That's helpful to know. Do you disclose that earlier or is that the first time you said that you can start at 60 with A?
Well, I think I've...
It's certainly been in our documents.
So I don't know.
specifically mentioned that but haven't I know documents because you know obviously as you pointed out that's a real feature that we can start out at 60.
Yeah, that's helpful to know. Thank you very much, Peter.
And ladies and gentlemen, at this time, in showing no additional questions, I would like to turn the conference call back over to Mr. Nielsen for any closing remarks.
Thank you again everyone for joining us and for your continued support of Biopath.
you again everyone for joining us and for your continued support of Biopath. Have a great day.
Bye.
And ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining.
You may now disconnect your lines.