Q1 2023 Bio-Path Holdings Inc. Earnings Call
Speaker 1: And.
Speaker 2: Following the formal remarks, we'll open the call up for your questions.
Speaker 2: We also note today's event is being recorded.
Speaker 2: At this time I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Sir, please proceed.
Speaker 3: Thank you operator. Welcome to the Biopath Holdings conference call and webcasts to review the company's first quarter 2023 financial results and to provide an update on recent pipeline and corporate developments.
Speaker 3: Earlier this morning we issued a press release which outlines the topics that we plan to discuss on today's call, and that press release is available at biopathholdings.com.
Speaker 3: We're seeing today from Biopath our President and CEO , Peter Nielsen, and Senior Vice President of Finance, Accounting and Administration, Anthony Price.
Speaker 3: Before we begin, I'd like to remind you that today's discussion will contain four looking statements that involve risks and uncertainties.
Speaker 3: 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 3: With that, I'll now turn the call over to Biopath CEO , Peter Nielsen.
Speaker 4: Thanks for watching. Thanks for watching.
Speaker 4: Good morning, everyone.
Speaker 4: everyone and thank you for joining us.
Speaker 4: Throughout the first quarter and in recent weeks, we continue to make important progress advancing our clinical programs as we await top-line results from several key cohorts.
Speaker 4: Despite advances in the field, cancer deaths continue rise. We believe our de-enableized platform can overcome the challenges.
Speaker 4: with current treatment options to address the urgent need for safe and effective new treatments.
Speaker 4: I begin with a review of our Phase 1-1B clinical trial of BP1001-A in patients with solid tumors, including ovarian, endometrial, pancreatic, and cripple negative breast cancer. Some of the most challenging cancer.
Speaker 4: drug substance.
Speaker 4: with enhanced nanoparticle properties.
Speaker 4: This trial is being conducted at several leading cancer centers.
Speaker 4: and will initially evaluate the safety in solid tumor patients.
Speaker 4: Patients diagnosed with recurrent ovarian or endometrial cancer often have poor outcomes.
Speaker 4: and it is our hope that we may provide clinical benefit for such patients.
Speaker 4: We look forward to cohort completion and data readout from this study around mid-year.
Speaker 4: Next, let's turn to the progress we have made with our lead product candidate, Prexy Jibberish.
Speaker 4: We continue to make significant progress advancing stage 2 of our Phase 2 clinical trial of Preciousoriented Urinal Integra
Speaker 4: continue to make significant progress advancing stage 2 of our Phase 2 clinical trial of Precious ???oma to the 31nd November .
Speaker 4: acute myeloid leukemia or AML
Speaker 4: in combination with frontline therapy, the CITAMIN and BANETICAL acts.
Speaker 4: is an open-label, two-stage, multi-center study of Prexy Jibberis and in combination with the Cidaben and Venetoclax in two cohorts of patients.
Speaker 4: with previously untreated AML and relapse resistant AML.
Speaker 4: A third cohort includes treating relapse, resistant AML patients who are a veneer-clax resistant index, and bleibenble joint.
Speaker 4: intolerant with the two drug combination of Prexygibiracin and Decidibin. The primary endpoint for this study will be the number of patients who achieve complete remission, which includes complete remission with incomplete hematologic recovery.
Speaker 4: complete remission with partial hematology.
Speaker 4: recovery. An interim analysis will be performed on each cohort to assist the safety and efficacy of the treatment.
Speaker 4: In the coming weeks around mid-year, we will assess the initial safety and efficacy of this combination therapy with the potential to qualify for expedited program status.
Speaker 4: Turning now to our BP 1002 program, which targets BCL-2.
Speaker 4: As you know, BCL-2 is responsible for driving cell survival in up to 60% of all cancers.
Speaker 4: I expression of BCL2 has been correlated with poor prognosis for patients.
Speaker 4: The type of infection of BCL2 has been correlated with poor prognosis for patients diagnosed with AML.
Speaker 4: Nodical axis shown activity against anti-ophototic protein BCL2 and works by neutralizing the protein's BH3 domain. It is an improved treatment for chronic lymphosimulopenia or CLL patients.
Speaker 4: Nodical axis shown activity against anti-ophoptotic protein BCL2 and works by neutralizing the protein's BH3 domain. It is an improved treatment for chronic lymphocemia or CLL patients and untreated AML patients.
Speaker 4: However, with the exception of some patients treated with allergenetic and modipleletic cell transplantation,
Speaker 4: Disease relapse invariably occurs oftentimes due to VH3 domain mutation over time.
Speaker 4: BP 1002 also targets the BCL2 protein.
Speaker 4: also targets the Bcl-2 protein. However,
Speaker 4: BP-1002 activity is based on blocking the BCO2 messenger RNA and not the BH3 domain.
Speaker 4: As a result, we believe that BP 1002 could provide an alternative for venetoclax patients.
Speaker 4: who have relapsed including AML patients who have previously received Venetoclax treatments.
Speaker 4: A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3 plus 3 design with a starting dose of 20 milligrams per square meter.
Speaker 4: The approved treatment cycle is two doses per morning or four.
Speaker 4: Phase 1B portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with the
with the Cytobin and Refractory Relapse AML patients.
We expect cohort completion and initial data readout from this study around mid-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 tumor-ogenetic processes.
such as tumor proliferation, metastasis, and drug resistance.
It's overexpression and aberrant activation characterized many cancers.
including breast, lung, ovarian, liver, and colon cancer.
Activation of 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.
malignancies made step three of potential cancer therapeutic target.
BP1003 is a novel liposome incorporated STAT3 antisense oligodioxynucleotide 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 BP-1003 plus the gem did some side amends.
displayed enhanced anti-tumor activity in pancreatic ductal adenocarcinoma.
Together, these results strongly suggest that BP1003 combination therapy is a novel strategy for patients with advanced solid tumors.
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.
We look forward to filing an I&D application for this very promising product candidate later this year or early 2024.
With that, I'll now turn the program over to Anthony Price for a brief review of our financials along with balance sheet highlights. Anthony?
Thanks, Peter. The company reported a net loss of $5.3 million, or $0.66 per share, for the three months ended March 31, 2023, compared to a net loss of $3.4 million, or $0.47 per share, for the three months ended March 31, 2022.
Research and development expense for the three months ended March 31, 2023 increased to 4.0 million compared to 2.1 million for the three months ended March 31, 2022, primarily due to manufacturing expenses related to drug protocol leases during the quarter. General and administrative expense for both the three months ended March 31, 2023.
2023 was 3.7 million compared to 2.5 million for the comparable period in 2022.
With that, I'll now turn the call back over to Peter. Thanks, Anthony. Throughout the first quarter, we continue to advance our mission to deliver a better path for cancer patients. With ongoing progress across the multiple of our de-enabled antisense RNAi nanoparticle drug candidates, we are bringing a gentler solution.
to fight against cancers. We have a data-rich year ahead and I look forward to reporting on our progress.
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. 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 the handset prior to pressing numbers to ensure the best sound quality.
Once again that is star and then one to join the question queue.
Our first question today comes from Jonathan Ashkoff from RothMKM. Please go ahead with your question.
Once again, if you would like to join the question queue, please press star and one.
Phone.
Mr. Ashcroft, you may ask your question.
Thank you. So whatever was happening is done happening?
Thank you. So whatever was happening is done happening?
No problem. Thank you guys. Can you please give me any timing for data coming from the 1-0-0-2 trial in lymphoma for HCLL at those various centers where it's occurring?
That was hard to predict, but we've added two more sites. And at this point, the...
You know, I'm saying that I would like to complete that first cohort, which is just one more patient. You know, this and
We previously had a third patient, but that one ended up...
had a third patient but that one ended up not...
past screening. So hard to predict, but we do have a couple of new sites that are coming on. So we get this next patient, we'll be able to go up a dose level. Okay, given this connection is pretty bad, I'll just try to get through this quick. How about progress on making any better assay?
TECT1003 in blood.
We have that now. We've selected the supplier and we will start that.
We have that now. We've selected the supplier and we will start that.
We've selected the supplier and we will start that.
having that assay, we'll be able to do our pharmacokinetics and
then complete that remaining tox study so that we can rest the IND work has been done so we can get going on it. So the answer is it's selected. We can start within the next month or two.
Okay, is cash runway still first quarter 24?
Well, we're going to raise more cash. You know, with the existing supply I have, you know, it'd be into the start of the fourth quarter. But, you know, we plan to raise more cash. You know, we plan to raise more cash.
raise more cash. Okay the last one is that in a note I wrote last I said that the 2023 R&D would be less than 2022 but is that true or did some manufacturing costs from late 2022 fall the first quarter of 23?
And I guess if that's true, and that's why that's such a big number, you know, what does total R&D spend look like over 2023? The number, I think, for 2Q is 2.1 mil.
There's a small interval around that, but that's the midpoint expected value. So that's down a bit from one Q. Again, what drives that number has been the build up, ramp up in drug supply once we got to...
our manufacturers to where they could start delivering. You know, it's a long time our interval for a batch from start let alone the queue of getting that is about nine months because you have to have a batch of
of drug substance, the antisense, get done. It takes a couple of months to have that reviewed.
and then released and then that releases as basically.
raw material input into the final drug product manufacturing.
And that goes and that has at least a couple of months for it. So all of that is carried in
the prepaid drug product for testing on the balance sheet, and then once it finally released.
it drops to expense. Again, our final product doesn't have
it drops to expense. Again, our final product doesn't have monetary value.
even though
you know, hard for me to accept because it's not an approved drug. So once that product releases to us completely, then it drops to expense. So just the timing of the manufacturing build-up, recovering from the difficulties we had.
with our manufacturers in the COVID environment. That's what created the kind of the.
blurb, we should be able to start getting back to normal rhythms, so to speak, in the R&D expense.
we should be able to start getting back to normal rhythms, so to speak, in the R&D expense.
Estimated value is 2.9, which would be down, I think, a million from the prior quarter. I thought you said 2.1 million would be the R&D, then this quarter.
For 2.1, second quarter of 23, I thought you said 2.1. What do you mean is 2.9?
For two for one second quarter of 23, I thought you said 2.1. What you mean is 2.9 – Yes.
Okay, thank you very much Peter, that was good clarity.
You're welcome. Once again if you would like to ask a question please press star and one to withdraw your questions you may press star and two. And ladies and gentlemen at this time in showing no additional questions I'd like to turn the floor back over to the manager.