Bio-Path Holdings, Inc.
Q3 2020 Earnings Call Transcript

Published: 13 Nov 2020

[Operator:]

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings’ Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Will O’Connor of Stern Investor Relations. Please proceed.

[Will O’Connor:]

Thank you, operator. Welcome to the Bio-Path Holdings conference call and webcast to review the company’s third quarter 2020 earnings results and to provide an update on recent pipeline and corporate developments. Earlier, 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 and Accounting and Administration, Anthony Price.

[Peter Nielsen:]

Thanks, Will. Good morning everyone and thank you for joining us today. This has been an exceptional year for Bio-Path. We have achieved several significant milestones, most notably, the initiation of Stage 2 of our Phase 2 study of prexigebersen in AML. And we have done so in an unprecedented environment. While we are still managing the impact of COVID-19 on our lives and business, I’m continually impressed by our team and their ability to deftly maneuver around the challenges we’ve been presented with. As a result of their hard work, we are in a very strong corporate position as we close out 2020 and enter 2021. I’ll begin with our lead product candidate, prexigebersen where we continue to make meaningful progress. In the third quarter, we dosed the first patient in Stage 2 of our Phase 2 of prexigebersen for the treatment of acute myeloid leukemia or AML in combination with frontline therapy decitabine and venetoclax. As we have previously reported, Phase 2 clinical development of prexigebersen in AML commenced with Stage 1 of the Phase 2 clinical trial, which was open-label and treated de novo AML patients with a combination of prexigebersen and low-dose cytarabine or LDAC. The combination of prexigebersen and LDAC was shown to be safe and more efficacious to treat this class of patients than with LDAC alone. As many of you know, there has been an evolving landscape for standard of care in AML. Despite these new therapies, there are still patients who are refractory or resistant, and those are the patients we aim to help. As standard of care evolved, we adapted our trial design to reflect these changes. Feedback from treating physicians pointed to a preference for decitabine. The recent approval of frontline therapy venetoclax provided an opportunity for adding prexigebersen to the newly approved frontline two-drug combination of venetoclax and decitabine for the treatment of previously untreated AML patients. Prior to finalizing our plans, we performed preclinical testing in AML cancer cell lines to assess prexigebersen’s increased benefit to efficacy. Preclinical testing of prexigebersen with the frontline treatment of decitabine and venetoclax demonstrated the potential to enhance efficacy of the frontline treatment combination. In the studies, four AML cancer cell lines were treated with three different combinations of decitabine, venetoclax and prexigebersen.

[Anthony Price:]

Thanks Peter. The company reported a net loss of $3.0 million or $0.80 per share for the three months ended September 30, 2020, compared to a net loss of $2.2 million or $0.78 per share for the three months ended September 30, 2019. Research and development expenses for the three months ended September 30, 2020 increased to $2.0 million compared to $1.4 million for the three months ended September 30, 2019, primarily due to increased enrollment for our Phase 2 clinical trial of prexigebersen in AML, as well as increased preclinical study expenses. General and administrative expenses for the three months ended September 30, 2020 increased to $1.0 million, compared to $0.9 million for the three months ended September 30, 2019, primarily due to increased franchise tax expense. As of September 30, 2020, the company had cash of $12.1 million, compared to $20.4 million at December 31, 2019. Net cash used in operating activities for the nine months ended September 30, 2020 was $8.4 million, compared to $6.1 million for the comparable period in 2019. Subsequent to September 30, 2020, Bio-Path issued 850,000 shares of its common stock for gross proceeds of approximately $4.6 million through our at-the-market offering agreement with H.C. Wainwright.

[Peter Nielsen:]

Thanks, Anthony. Despite 2020 being a challenging year, we have made considerable progress across our programs. We look forward to continuing to enroll Stage 2 of our Phase 2 clinical trial of prexigebersen to treat AML in combination with a now current standard of care and expect to show significant safety and efficacy. Moreover, we think the addition of prexigebersen to this regimen will be particularly important for those patients who have relapsed or are recalcitrant to venetoclax or decitabine. In addition, we look forward to initiating our first in-human Phase 1 program of BP1002 to treat advanced lymphoid malignancies, another oncologic indication that continues to elude current treatments. Before opening the call up for questions, I’d like to take this opportunity to thank our dedicated team who have remained steadfast throughout the pandemic and who have continued to perform under these unique circumstances. The advances we have made and will make in the coming months are a testament to their perseverance and professionalism. Importantly, we thank you, our loyal shareholders for your continued support as we advance these important programs. With that, operator, we’re ready to open the call for questions.

[Operator:]

We have a question or comment from the line of Yi Chen from H.C. Wainwright, your line is open.

[Boobalan Pachaiyappan:]

Hi, this is Boobalan dialing in for Yi Chen. Can you hear me okay?

[Peter Nielsen:]

Yes.

[Boobalan Pachaiyappan:]

Okay, thank you. Other than what is stated on your prepared remarks, can you provide additional color on the enrollment progress for the Stage 2 trial; especially we are in the midst of the rise in coronavirus cases?

[Peter Nielsen:]

I’m sorry, that last sentence, please? Especially in…

[Boobalan Pachaiyappan:]

In the middle of the rise, because we are in the rise – these coronavirus cases are increasing. So I’m just curious whether it affected your enrollment progress.

[Peter Nielsen:]

Yes. Yes. Well, COVID-19 issues that we look for patient enrollment, as you know, a new – compromised patients are very susceptible to advanced problems if they contact this COVID-19, and in particular, our patients, a lot of them, they come to the institution, travel to it to receive their treatment. So to-date, our enrollment has actually been very good in this Phase 2. And so, typically, that means it’s – I think, some people see some benefit. However, as we keep – I mean, as these new cases go up, it creates a risk here and risk your environment and so I can’t tell you what it will be like over the next couple of cases – months as we get into the winter. But for now, we’re not seeing that effect on enrollment.

[Boobalan Pachaiyappan:]

That’s clear. Thank you. And just to get some clarification on this. Have patients been enrolled in each of the three cohorts and do you have an estimated timeframe when you will reach the 19 evaluable patients in each cohort? Thank you.

[Peter Nielsen:]

Well, it’s just – I mean it’s too hard to do that. I can tell you that in one of the cohorts, we have over half of our patients, and I think in another cohort we’re not far behind that. So we’re doing well. So, assuming we don’t have any catastrophes out there in the environment, we could see some interim evaluations or at least reaching our threshold next year. But we’ll have to wait and see. There’s just a lot of variables out there that we don’t control.

[Boobalan Pachaiyappan:]

Got it. And one final from me. So when do you plan to start the Phase 1 study for BP1002? I think I might have missed it in your remarks.

[Peter Nielsen:]

Where we – excuse me, say that again, please.

[Boobalan Pachaiyappan:]

When do you plan to start the Phase 1 study of BP1002?

[Peter Nielsen:]

Well, it’s been – we received IND last year, provided, however, additional – they wanted some new testing. It seems the FDA always want something new. So we had to develop some new tests to validate it one time. So we were cleared on all of that and we’re open and we think you’ll hear some news on that fairly shortly.

[Boobalan Pachaiyappan:]

That’s it from me. Thank you so much.

[Peter Nielsen:]

You’re very welcome.

[Operator:]

Thank you. I’m showing no other questions in the queue at this time. I’d like to turn the call back over to management for any closing remarks.

[Peter Nielsen:]

Thank you. We thank you again for joining us and for your continued support of Bio-Path. We appreciate it very much. Have a great day.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone have a wonderful day.