Bio-Path Q2 2023 Earnings Call Transcript

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Provided by Quartr
August 15, 2023

There are 6 speakers on the call.

Operator

Morning, ladies and gentlemen. Welcome to the Bio Path Holdings Second Quarter 2023 Earnings Conference Call. I would now like to turn the call over to Will O'Connor of Stern Investor Relations. Please proceed.

Speaker 1

Thank you, operator. Welcome to the Backpack Holdings conference call and webcast, we will discuss the company's Q2 2023 financial results and to provide an update on recent pipeline and corporate developments. Call, we issued a press release, which outlines the topics that we plan to discuss on today's call. The 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.

Speaker 1

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's CEO, Peter Nielsen.

Speaker 2

Thanks, Will. Good morning, everyone, and thank you for joining us. We continued to make tremendous progress throughout the first half of twenty twenty three and in recent weeks as highlighted by the compelling interim results stage 2 of our Phase 2 study of prexigebersen as a treatment for acute myeloid leukemia the end of the quarter, we are pleased with the

Speaker 3

progress we made in blood cancer, which there

Speaker 2

are limited treatment options and for which the prognosis is grave. The data showed prexigebersen demonstrating meaningful clinical improvement with a tolerable safety profile in these high risk patients. The strength of these data, we now plan to file for regulatory designations that may accelerate the pathway For bringing this potentially life expanding therapy to patients battling this deadly hematologic cancer. Beyond prexigebersen, we continue to advance our robust clinical development program across a number of important programs That leverage our innovative DNAbilize platform technology to deliver RNAi nanoparticle therapeutics call directly to cancer cells. We're forging a new path in DNA powered medicine that we believe time, we'll give patients a fighting chance to beat these difficult to treat cancers.

Speaker 2

I'll begin with the progress we have made with our lead product candidate prexigebersen. As I mentioned, we recently announced positive interim results From Stage 2 of our Phase 2 clinical trial of apraxigebersen for treatment of acute myeloid leukemia In combination with frontline therapy decitabine and venetoclax. The amended Stage 2 of the Phase 2 trial in AML is an open label 2 stage multi center study prexigebersen in combination with decitabine and venetoclax in 2 cohorts of patients with previously untreated AML A 3rd cohort includes treating relapse resistant AML patients 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 hematology recovery. 14 newly diagnosed patients were evaluable in Cohort 1 and treated with at least one cycle of prexigebersen, decitabine the Venetoclax combination therapy, all patients in this cohort were adverse risk by 2017 the European Leukemia Net or ELN guidelines for secondary AML. Prexigebersen was well tolerated And adverse events were generally consistent with decitabine and venetoclax treatment and or AML.

Speaker 2

12 of the 14 evaluable patients or 86% achieved complete remission and 2 or 14% achieved the Partial remission or PR. In total, 100% of the evaluable patients had a response to treatment. The complete remission rate of 86% for the evaluable patients in Cohort 1 is significantly higher than complete remission rates time, 62% for newly diagnosed patients treated with frontline combination treatment of decitabine and venetoclax. This result is further highlighted by the high risk rating of our Cohort 1 evaluable patients And the inclusion of secondary AML patients, both of which are classes of patients which are difficult to treat. 14 refractory relapsed evaluable AML patients in Cohort 2 were treated with at least one cycle of prexigebersen decitabine All patients in this cohort were adverse risk by 2017 ELN guidelines or secondary AML, prexigebersen was well tolerated and AEs were generally consistent With decitabine and venetoclax treatment and or for AML, 8 of the 14 evaluable patients conference call, 50 7 percent achieved complete remission, 2 patients or 14% achieved the Partial remission and 3 patients or 22% achieved stable disease.

Speaker 2

In total, the 93% of the evaluable patients had a response to treatment. The complete remission rate of 57% For the evaluable refractory and relapsed patients in Cohort 2 is significantly higher than complete remission rate of 21% time, we are pleased to report that we are in the range of the 2nd quarter 2023 earnings conference call. At this time, we are pleased to report that we are in the range of approximately $1,000,000 As with newly diagnosed patients in Cohort 1, this result is further highlighted by the high risk rating of BioPass Cohort 2 the evaluable patients and the inclusion of secondary AML patients. Efficacy data for the is not only safety administered in Cohort 1 and Cohort 2 to high risk newly diagnosed and refractory relapsed the AML patients considered suitable for standard chemotherapy, but also demonstrated As a result of the interim review, we have demonstrated the superiority of prexigebersen combination therapy in treating AML patients and currently time, we plan to pursue U. S.

Speaker 2

Food and Drug Administration or FDA expedited programs for Fast Track and Breakthrough Therapy

Speaker 3

the end of the call,

Speaker 2

we will be conducting a few questions. Fast Track Designation is designed to expedite the development and review of drugs to treat serious conditions and to fulfill An unmet medical need, breakthrough therapy designation is a process designed to expedite the development and review of drugs It may demonstrate substantial improvement over available therapies. We look forward to keeping you apprised Turning now to our BP1002 program, which targets the BCL-two, as you know, BCL-two is responsible for driving cell survival in up 60% of all cancers, high expression of BCL-two has been correlated with poor prognosis for patients Venetoclax has shown activity against the anti apoptotic the protein BCL-two and works by neutralizing the protein's BH3 domain. It is an approved treatment for chronic lymphocytic leukemia or CLL patients and untreated AML patients. However, With the exception of some patients treated with stem cell transplantation, disease relapse invariably occurs oftentimes due to BH3 domain mutation over time.

Speaker 2

The BP1002 also treats BCL2 protein. However, BP1002 time, we believe BP1002 could provide an alternative for venetoclax patients who have relapsed, including will be treated with BP1002 monotherapy in a standard 3 plus 3 design with starting dose of 20 milligram per square meter. The approved treatment cycle is 2 doses per week over 4 weeks, resulting in 8 doses administered over 28 days. 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 this AML patients, we expect completion of the cohorts initial cohorts in the next few months. Next, let's turn to 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.

Speaker 2

BP1001 A is a modified product from prexigebersen sharing the same drug substance with enhanced nano particle properties. This trial is being conducted at several leading cancer centers and will initially evaluate the safety of solid tumor patients. Patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes and it is our hope We may provide clinical benefits for such patients. We have completed Cohort 1 And head of advanced to Cohort 2 of the study. Finally, let's review the progress we've made with BP100 this time, we are executing on the regulatory framework for the

Speaker 3

regulatory approval. We are also executing on the

Speaker 2

regulatory framework for the regulatory framework. We are also executing on the regulatory time, we are pleased to report that the Its overexpression and aberrant activation characterized many cancers, including breast, In breast and ovarian cancers, promotes tumor initiation, migration and taxol resistance. STAT3 also promotes 5 FU resistance in colorectal cancer cells. Its role in numerous malignancies make STAT3 a potential cancer therapeutic target. The BP1003 is a novel liposome incorporated STAT3 antisense oligonodeoxynucleotide That effectively reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxyl the N5 Efu, these results are in line with previous work in which BP1003 Plus gemcitabine displayed enhanced antitumor activity in pancreatic ductal adenocarcinoma.

Speaker 2

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 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?

Speaker 4

Thanks, Peter. The company reported a net loss time, we recorded a net loss of $4,200,000 or $0.53 per share for the 3 months ended June 30, 2023 compared to a net loss of 3,000,000

Speaker 3

end of the quarter,

Speaker 4

we recorded a $0.42 per share for the 3 months ended June 30, 2022. Research and development expense call, for the 3 months ended June 30, 2023 increased to $3,100,000 compared to $1,900,000 the 3 months ended June 30, 2022, primarily due to manufacturing expenses related to drug product releases during the Q2 of 2023 And increased patient enrollment related to our Phase 2 clinical trial for prexigebersen in AML. General and administrative expense for both the 3 months ended June 30, 2023 June 30, 2022 end of the call, we recorded a reconciliation of $1,200,000 As of June 30, 2023, the company had cash of $3,400,000 compared to $10,400,000 as of December 31, 2022. Net cash used in operating this time, our earnings call for the Q4 of 2018 was $6,900,000 compared to $6,700,000 With that, I'll now turn the call back over to Peter.

Speaker 2

Thanks, Anthony. As you can see, we have made meaningful progress and the encouraging interim data from our prexigebersen study this, we will now begin to discuss our regulatory designations that could accelerate our path to approval. While these are challenging financial markets, we strengthened our balance sheet In order to have the funds needed to bring these important programs to fruition, because there is no greater challenge this time, we are pleased to announce that we are in the battle against these deadly cancers. This is what drives us every day. These positive interim results give us further confidence that our DNAbilize platform is ushering in a new path in DNA powered medicine With that operator, we're ready to open the call for questions.

Operator

This time, we will now begin the question and answer session. And our first question here will come from Jonathan Aschoff with ROTH MKM. Please go ahead.

Speaker 5

Thank you. Good morning. Hi, Peter. I was curious about the cash runway. If you can give us a little guidance on that.

Speaker 5

It looks like $5,100,000

Speaker 2

Yes, we had $3,170,000 reported end of June. We did a small raise at the beginning of August. So we've got cash on hand that can take us out time, we're at the point now where we have to pause to communicate with the FDA. We also want to get our Expedited filings in place. So clearly, we'll need to raise more cash.

Speaker 2

And as we step up after we come out of what hopefully regulatory pathways we have moving forward to speed us up. So we've got cash to operate. These are tough times And we're a pretty darn good story and we're ready for co development at this point. This, we're going to go to ASH. We've got a molecular biomarker program that will go with our program, We have a very good story to tell And we'll get the funds that we need to ramp up.

Speaker 5

So would you expect a further contraction in the second half of the year for R and D spend or pretty much a flattening of both operating expenses?

Speaker 2

That's a good insight on the R and D. It was a big number, but it's because as we talked about, we were we needed to build up supply Our drug is not approved. So therefore, once it's completed, it resides in prepayment expense. And then once it's released to us, it's not an approved product, so therefore it has no value and it drops time, we have had such big numbers because we have really built up a supply the end of the quarter, we will support principally our Phase 2. So the end of the quarter, it

Speaker 5

would make sense that the R and D would drop closer to $2,000,000 than it's currently it's very close to $3,000,000 You think that would this time, you know materially closer to $2,000,000 a quarter for the next couple of quarters than the current $3,000,000

Speaker 3

Is

Speaker 5

that accurate?

Speaker 2

Yes. It's going to drop. So we don't have any major drug delivery programs We have to support here in the near term. So we're pretty much set with that now.

Speaker 5

Okay. And I think I'd ask you about the drugs, but you did a very good job early August, I think going through the current state of everything that you had that seemed pretty complete. So, just change that finance yes?

Speaker 2

Time, you'll be pleased to know that I think we mentioned the last quarter that we had 2 new sites coming in on our lymphoma, BP1002. This time, they're ready now. And in fact, I think we enrolled a patient from That would be a 3rd patient in that cohort, which would get us off of that first dose cohort. So Those programs are starting to kick in. The AML part of 1002 is also we've had three times The 3rd patient, those are very sick people as you recall, they're coming off venetoclax and they have very short survival, but we have one now that's

Speaker 5

Right. And that gets them out of 20 and puts them into what was the next dose? Was it what was

Speaker 3

it

Speaker 5

for 2? 20, 40, 60, 90, 40. Right. Okay. Thank you very much, Peter.

Speaker 2

You're very welcome, Jonathan.

Operator

This time, we will conclude our question and answer session. I'd like to turn the conference back over to Peter Nielsen for any closing remarks.

Speaker 2

Thank you, operator. Well, thank you again everyone for joining us and for your continued support of Bio Path.

Operator

This conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.

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Key Takeaways

  • Interim Phase 2 data for prexigebersen in AML showed 86% complete remission in newly diagnosed high-risk patients and 57% complete remission in relapsed/refractory patients, both significantly above historical benchmarks.
  • Bio Path plans to seek FDA Fast Track and Breakthrough Therapy designations for prexigebersen to accelerate its development and review.
  • The BP1002 anti-BCL2 program is advancing through Phase 1 monotherapy cohorts with completion expected in the coming months, followed by a Phase 1b combination study with decitabine in refractory AML patients.
  • The BP1001a solid tumor trial has completed Cohort 1 and moved into Cohort 2, evaluating safety in ovarian, endometrial, pancreatic and triple-negative breast cancer patients.
  • In Q2, Bio Path reported a net loss of $4.2 million and cash of $3.4 million as of June 30, 2023; R&D spend is expected to moderate toward ~$2 million per quarter, though additional funding will be required to support ongoing programs.
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Earnings Conference Call
Bio-Path Q2 2023
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