Bio-Path Q1 2023 Earnings Call Transcript

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May 12, 2023

There are 5 speakers on the call.

Operator

Good morning, ladies and gentlemen. Welcome to the Bio Path Holdings First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. Following the formal remarks, we'll open the call up for your questions. Please also note today's event is being recorded.

Operator

At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Sir, please proceed.

Speaker 1

Thank you, operator. Welcome to the Bio Path Holdings conference call and webcast to review the company's Q1 2023 financial results And to provide an update on recent pipeline and corporate developments. 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. 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, I'd like to remind you that today's discussion will contain forward looking statements that involve risks 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.

Speaker 1

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's CEO, Peter Nielsen.

Speaker 2

Thanks, Will. Good morning, everyone, and thank you for joining us. Throughout the Q1 and in recent weeks, we continue to make important progress advancing our clinical programs as we await top line results from several key cohorts. Despite advances in the field, cancer deaths continue to rise. We believe our DNAbilize platform can overcome the challenges with current treatment options to address the urgent need for safe and effective new treatments.

Speaker 2

I'll begin with a review of our Phase 1, 1b clinical trial of BP1001a 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 There's a modified product from prexigebersen 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 or 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 around mid year.

Speaker 2

Next, let's turn to the progress we have made with our lead product candidate, We continue to make significant progress advancing Stage 2 of our Phase 2 clinical trial prexigebersen for the treatment of acute myeloid leukemia or AML In combination with frontline therapy decitabine and venetoclax. The amended Stage 2 of this Phase 2 trial in AML is an open label, 2 stage, multicenter study of prexigebersen in combination with decitabine and venetoclax in 2 cohorts of patients with previously untreated AML and relapsed resistant AML. A third Cohort includes treating relapsed resistant AML patients who are venetoclax resistant Intolerant with the 2 drug combination of prexigebersen and decitabine. The primary endpoint with incomplete hematologic recovery and complete remission with partial In the coming weeks around mid year, we will assess the initial safety and efficacy of this combination therapy with the potential to qualify Turning now to our BP1002 program, which targets BCL-two. Too.

Speaker 2

As you know, BCL-two is responsible for driving cell survival in up to 60% of all cancers. High expression of BCL-two has been correlated with poor prognosis for patients diagnosed with AML. Venetoclax has shown activity against anti apoptotic protein BCL-two and works by neutralizing the proteins BH3 domain. It is an improved treatment for chronic lymphocytic leukemia or CLL patients and untreated AML patients. However, With the exception of some patients treated with allogeneic hematopoietic cell transplantation, disease relapse invariably occurs oftentimes due to VH3 domain mutation over time.

Speaker 2

BP1002 also targets the BCL-two protein. However, BP1002 activity is based on blocking the Bcl-two messenger RNA and not the BH3 domain. As a result, we believe that BP1002 could provide an alternative for venetoclax patients who have relapsed, including AML patients who have previously received venetoclax treatments. A total of 6 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. The improved treatment cycle is 2 doses per week or 4 weeks.

Speaker 2

The Phase 1b portion of the study will commence After completion of BP1002 monotherapy cohorts and we'll assess the safety and efficacy of BP1002 in combination with decitabine in refractory relapsed 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 genetic processes, such as tumor proliferation, metastasis and drug resistance. Its overexpression and aberrant activation characterize many cancers, including breast, lung, ovarian, promotes tumor initiation, migration and taxol resistance.

Speaker 2

STAT3 also promotes 5 FU resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 Incorporated STAT3 antisense oligodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxol and five FU. These results are in line with previous work in which BP1003 plus gemcitabine Together, these results strongly suggest that BP1003 combination therapy is a novel strategy 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 IND application With that, I'll now turn the program over to Anthony Price for a brief review of our financials along with balance sheet highlights.

Operator

Anthony?

Speaker 3

Thanks, Peter. The company reported a net loss of $5,300,000 or $0.66 per share for the 3 months ended March 31, 2023, compared to a net loss of $3,400,000 or $0.47 per share for the 3 months ended March 31, 2022. Research and development expense for the 3 months ended March 31, 2023 increased to $4,000,000 compared to $2,100,000 for the 3 months ended March 31, 2022, primarily due to manufacturing expenses related to drug product releases during the quarter. General and administrative expense for both the 3 months ended March 31, 2023 and March 31, 2022 was 1,300,000 As of March 31, 2023, the company had cash of $6,700,000 compared to $10,400,000 as of December 31, 2022. Net cash used in operating activities for the 3 months ended March 31, 2023 was $3,700,000 compared to $2,500,000 for the comparable period in 2022.

Speaker 3

With that, I'll now turn the call back over to Peter.

Speaker 2

Thanks, Anthony. Throughout the Q1, We continue to advance our mission to deliver a better path for cancer patients. With ongoing progress across The multiple of our DNAbilize antisense RNAi nanoparticle drug candidates, we are bringing a gentler solution With that operator, we are ready to open the call for questions.

Operator

Ladies and gentlemen, at this time, we'll begin the question and answer session. Our first question today comes from Jonathan Aschoff From ROTH MKM, please go ahead with your question.

Speaker 3

Great. No problem.

Speaker 4

Thank you, guys. Can you please give me any timing For data coming from the 1,002 trial, in lymphomaCLL, at those various centers where

Speaker 2

That was hard to predict, but we've added 2 more sites. And at this point, I'm saying that I would like to complete that first cohort, which is just one more patient And we previously 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.

Speaker 4

Okay. Given this Connection is pretty bad. I'll just try to get through this quick. How about progress on making any better assay to detect 1003 in blood?

Speaker 2

We have that now. We've selected the supplier and we will start that We'll be able to do our pharmacokinetics and then complete that remaining tox study so that we can The rest of 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 2.

Speaker 4

Okay. Is cash runway still Q1 2024?

Speaker 2

Well, we're going to raise more cash. With the existing supply I have, It'd be into the start of the Q4, but we plan to raise more cash.

Speaker 4

Okay. The last one is that, in a note I wrote last, I said that the 2023 R and D less in 2022, but is that true or did some manufacturing costs from late 2022 fall into the Q1 of 2023? And I guess if that's true and that's why that's such a big number, what does total R and D spend look like over 2023. We

Speaker 2

think for 2Q is 2.1000000. There's a small interval around that, but that's Midpoint expected value. So that's down a bit from 1Q. Again, what drives that number Has been the buildup, ramp up in drug supply once we got our manufacturers to where they could start delivering. It's a long time our interval for a batch from start, let alone the queue of getting to That is about 9 months because you have to have a batch of drug substance, the antisense Get done.

Speaker 2

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 release, it drops to expense. Again, Our final product doesn't have monetary value even though it's Hard for me to accept because it's not an approved drug.

Speaker 2

So once that product releases to us completely, Then it drops to expense. So just the timing of the manufacturing buildup recovering from the Difficulties we had with our manufacturers in the COVID environment, that's what created the kind of a blurb. We should be able to start getting back to normal rhythms, so to speak, And like I said, the estimated value is 2.9, which should be down, $1,000,000 from the prior quarter.

Speaker 4

I thought you said $2,100,000 would be the R and D then this quarter.

Speaker 2

For 2.2nd

Speaker 4

quarter of 2023, I thought you said 2.1. What you mean is 2.9?

Speaker 2

Yes.

Speaker 4

Okay. Thank you very much, Peter. That was good clarity.

Speaker 2

You're welcome.

Operator

And ladies and gentlemen, at this time, I'm Showing no additional questions, I'd like to turn the floor back over to the management team for any closing remarks.

Speaker 2

Thank you again everyone for joining us and for your continued support of Bio Path. Have a great day.

Operator

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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Earnings Conference Call
Bio-Path Q1 2023
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