Bio Path Holdings Inc (NASDAQ:BPTH) Q1 2023 Earnings Call dated May. 12, 2023.
Corporate Participants:
Will O’Connor — Managing Director
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
Anthony Price — Senior Vice President of Finance, Accounting and Administration
Analysts:
Jonathan Aschoff — ROTH Capital Partners — Analyst
Presentation:
Operator
Good morning, ladies and gentlemen. Welcome to the Bio Path Holdings First Quarter 2023 Earnings Conference Call. [Operator Instructions]
At this time, I’d like to turn the floor over to Will O’Connor of Stern Investor Relations. Sir, please proceed.
Will O’Connor — Managing Director
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 development. 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 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.
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
Thanks, Will. Good morning, everyone. And thank you for joining us. Throughout the first quarter and in recent weeks, we continued 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 it’s our hope that we may provide clinical benefit for such patients. We look forward to cohort completion and data readout from this study around midyear.
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 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 multicenter 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/intolerant with the two-drug combination of Prexigebersen and decitabine [Phonetic]. The primary endpoint for this study will be the number of patients who achieve complete remission, which includes complete remission, incomplete hematologic recovery, and complete remission with partial hematologic recovery. An interim analysis will be performed on each cohort to assess the safety and efficacy of the treatment. In the coming weeks, around midyear, 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 protein, 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 three plus three design with a starting dose of 20 milligrams per square meter. The improved treatment cycle is two doses per week over four weeks. [Technical Issues]. 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 midyear.
Finally, let’s review the progress we’ve made with BP1003, which targets the STAT3 protein. STAT3 is a transcription factor that regulates various tumorogenetic 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 STAT3 pathway in breast and ovarian cancer cells promotes tumor initiation, migration, and taxol resistance. STAT3 also promotes 5-Fu resistance in colorectal cancer cell. Its role in numerous malignancies made STAT3 a potential cancer therapeutic 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 in 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?
Anthony Price — Senior Vice President of Finance, Accounting and Administration
Thanks, Peter. The company reported a net loss of $5.3 million, or $0.66 per share, for the three months ended March 31st, 2023, compared to a net loss of $3.4 million, or $0.47 per share, for the three months ended March 31st, 2022. Research and development expense for the 3 months ended March 31st, 2023, increased to $4.0 million compared to $2.1 million for the three months ended March 31st, 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 31st, 2023, and March 31st, 2022, was $1.3 million. As of March 31st, 2023, the company had cash of $6.7 million compared to $10.4 million as of December 31st, 2022. Net cash used in operating activities for the 3 months ended March 31st, 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.
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
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.
Questions and Answers:
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
[Operator Instructions] First question today comes from Jonathan Aschoff from ROTH MKM. Please go ahead with your question. Mr. Aschoff, you may ask your question.
Jonathan Aschoff — ROTH Capital Partners — Analyst
Thank you. So whatever was happening is done happening.
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
No problem.
Jonathan Aschoff — ROTH Capital Partners — Analyst
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?
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
That was hard to predict, but we’ve added two more sites, and at this point, I think that we’d just like to complete that first cohort, which is just 1 more patient this year [Phonetic]. 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.
Jonathan Aschoff — ROTH Capital Partners — Analyst
Okay. Given this connection is bad, I’ll just try to get through this quick. How about progress on making any better assay to detect 1003 in blood?
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
We have that now. We’ve selected the supplier. And we will start that [Technical Issues] having that 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.
Jonathan Aschoff — ROTH Capital Partners — Analyst
Okay. Is cash runway still first quarter ’24?
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
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.
Jonathan Aschoff — ROTH Capital Partners — Analyst
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 cost 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?
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
That number we think for 2Q is $2.1 million. There’s a small interval around that, but that’s the 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 into 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’s finally released, it drops to expense. Again, our final product doesn’t have monetary value, even though 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 buildup recovering from the difficulties we had with our manufacturers in the COVID environment, that’s what created the blurb. We should be able to start getting back to normal rhythms, so to speak, in the R&D expense. And like I said, the estimated value is $2.9 million, which should be down I think $1 million from the prior quarter.
Jonathan Aschoff — ROTH Capital Partners — Analyst
I thought you said $2.1 million would be the R&D then this quarter. For second quarter ’23, I thought you said $2.1 million. What you mean is $2.9 million.
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
Yes.
Jonathan Aschoff — ROTH Capital Partners — Analyst
Okay. Thank you very much, Peter. That was good clarity.
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
You’re welcome.
Operator
[Operator Instructions] And ladies and gentlemen, at this time in showing no additional questions. I’d like to turn the floor back over to the management team for any closing remarks.
Peter H. Nielsen — Chairman, President, Chief Executive Officer and Chief Financial Officer
Thank you, again, everyone for joining us and for your continued support of Bio Path. Have a great day.
Operator
[Operator Closing Remarks]
