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, will open the call up 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. Sir, please proceed..

Thank you, operator. Welcome to the Bio-Path Holdings conference call and webcast to review the company's first quarter 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 and uncertainties. These risks and uncertainties are outlined in today's press release and 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, and thank you for joining us. 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. 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.

I'll begin with a review of our Phase 1/1b clinical trial of BP1001-A 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 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 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. Next, let's turn to the progress we have made with our lead product candidate, prexigebersen.

We continue to make significant progress advancing Stage 2 of our Phase 2 clinical trial of prexigebersen for the treatment of the 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 two stage multi-center study of prexigebersen in combination with decitabine and venetoclax in two cohorts of patients with previously untreated AML and relapsed resistant AML.

A third cohort includes treating relapsed resistant AML patients who are venetoclax resistant and intolerant with the two drug combination of prexigebersen and decitabine.

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. An interim analysis will be performed on each cohort to assist the safety and efficacy of the treatment.

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. Turning now to our 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 Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. Venetoclax has shown activity against anti-apoptotic Bcl-2 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 BH3 domain mutation over time. BP1002 also targets the Bcl-2 protein. However, BP1002 activity is based on blocking the Bcl-2 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 six evaluable patients will be treated with BP1002 monotherapy in a standard 3+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 [indiscernible]. 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 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 tumorigenic processes, such as tumor proliferation, metastasis and drug resistance.

Its 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 [agent] (ph) target. BP1003 is a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide 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 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.

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. We look forward to filing an IND 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 product releases during the quarter.

General and administrative expense for both the three months ended March 31, 2023 and March 31, 2022 was $1.3 million. As of March 31, 2023, the company had cash of $6.7 million compared to $10.4 million as of December 31, 2022.

Net cash used in operating activities for the three months ended March 31, 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 continued 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 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. [Operator Instructions] Our first question today comes from Jonathan Aschoff from ROTH MKM. Please go ahead with your question. [Operator Instructions] Mr. Aschoff, you may ask your question..

Thank you. So, whatever was happening is done happening? Great..

No problem..

Thank you, guys.

Can you please give me any timing for data coming from the 1002 trial in lymphoma/CLL at those various centers where it's occurring?.

That was hard to predict, but we've added two more sites. And at this point, [indiscernible] we just like to complete that first cohort, which is just one more patient [indiscernible]. And previously, we 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 at dose levels..

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?.

We have that now. We've selected the supplier, and we will start that [indiscernible] having an assay, 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 two..

Okay.

Is cash runway still first quarter '24?.

Well, we're going to raise more cash. With the existing supply I have, it'd be into the start of the fourth quarter. But we plan to raise more cash..

Okay.

The last one is that, in a note I wrote last, I said that the 2023 R&D will be less than 2022, but is that true or did some manufacturing costs from late '22 fall into the first quarter of '23? And I guess if that's true and that's why that's such a big number, what does total R&D spend look like over 2023?.

That number, I think, for 2Q is $2.1 million. 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 build-up, ramp-up in drug supply once we got our manufacturers to where they could start delivering.

It's a long time [our interval] (ph) for a batch from start, let alone the queue of getting that is about nine months because you have to have a batch 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 then 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 monetary value even though it's 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 blurb. We should be able to start getting back to normal rhythms, so to speak, in the R&D expense.

And like I said, estimated value is $2.9 million, which should be down like $1 million from the prior quarter..

I thought you said $2.1 million would be the R&D then, this quarter?.

For....

Second quarter of '23, I thought you said $2.1. What you mean is $2.9 million..

Yes..

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

You're welcome..

[Operator Instructions] 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..

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..