Bio-Path Holdings, Inc.
Q2 2016 Earnings Call Transcript

Published: 10 Aug 2016

[Operator:]

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings’ Second Quarter 2016 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.

[William O'Connor:]

Thank you, operator. My name is Will O'Connor of Stern Investor Relations. I'd like to welcome you to the Bio-Path Holdings conference call and webcast to review the company's second quarter 2016 financial results and to provide an update on recent pipeline and corporate developments. Earlier today, we issued a press release, which outlines the topics that we plan to discuss today. The release is available at biopathholdings.com. With me today from Bio-Path are President and CEO Peter Nielsen, COO Dr. Ulrich Mueller, COO and Anthony Price, Director of Finance and Accounting. Before we begin the call, 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 vary 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.

[Peter Nielsen:]

Thanks, Will. Good morning everyone, and thank you for joining us today. Throughout the second quarter we continue to build on the achievements we’ve made in the first quarter. And I’m excited to report on the progress we’ve made advancing our exciting DNAbilize platform for the treatment of a variety of cancers of unmet need. As a brief recap, DNAbilize is a proprietary antisense and neutral lipid technology that enables delivery of nucleic acid therapeutics and facilitates their development. Our delivery technology formed structure similar to cellular membrane, therefore allowing the antisense drug to be incorporated within lipid layers and be delivered to the disease cells with high uptake into the cell. Most importantly, there have been no evidence of toxicity associated with our technology. The progress we’ve made during the first half of 2016 is very encouraging for our clinicians and exciting for Bio-Path and it’s investors. Looking now to the progress we’ve made with our Phase II program, the BP1001 as a treatment for AML. We are particularly pleased to report that we’ve selected an optimal dose for our Phase II clinical trial that BP1001 in AML. Analysis of a patient data package of Cohort 7 and 8 from a safety segment and the study, including late arriving pharmacokinetic data from Cohort 8 resulted in a conclusion that 60 milligram per square meter versus 90 milligram per square meter was the best dose for use in the efficacy portion of the trial. Re-documentation of the protocol and resubmission of documents for approvals slowed the initiation of this portion of the trial by several months, but we feel we have a more robust study as a consequence. I am pleased to report that this efficacy portion of the Phase II clinical trial of BP1001 in combination with low dose cytarabine is now open and we have four institutions by their open floor enrollment or in the last stages for a site initiation. We expect to have up to seven clinical trial sites open for this study and are confident that this expansion will allow the trial to move rapidly enroll patients allowing us to stay on target to complete our next milestone of enrollments of 19 patients by spring of next year, which if results are positive should allow us to switch to a registration trial for accelerating improvement. We continue to validate our DNAbilize platform with key opinion leaders at prestigious institutions. In May, Dr. Anna Ashizawa delivered a presentation titled, “Clinical Studies of BP1001, a drug candidate utilizing DNAbilize Antisense DNA Technology, in Hematologic Malignancies” at the 18th Annual TIDES

[Anthony Price:]

Thank you, Peter. Company reported a net of $1.9 million or $0.02 per share for the three months ended June 30, 2016 compared to a net loss of $1.1 million or $0.01 per share for the same period of 2015. This increase was primarily due to the release of drug material in preparation for our Phase II clinical trial for BP1001 in AML. Research and development expense for the three months ended June 30, 2016, increased to $1.2 million compared to $0.6 million for the same period in 2015. General and administrative expense for the three months ended June 30, 2016 increased to $0.8 million compared to $0.6 million for the same period in 2015. As of June 30, 2016, the company had cash of $4.2 million compared with $8.9 million at December 31, 2015. Net cash used in operating activities for six months ended June 30, 2016 was $4.6 million compared to $2.8 million for the comparable period in 2015. As Peter noted earlier, the company recently completed a $10 million registered direct offering. Note, that these results do not include funds raised from the offering.

[Peter Nielsen:]

With that overview operator, we are ready to open the call for questions.

[Operator:]

Thank you. [Operator Instructions] Our first question comes from Jason McCarthy with Maxim. Your line is open.

[Jason McCarthy:]

Hi Peter, how are you? We’re looking forward to the trial in AML initiating in that first patient dose. Can you tell us, once you hit that 19 patient mark how long will it take to see data and what is it going to take to convert potential to a registration study and how many patients would that be?

[Peter Nielsen:]

Let me have, Ulrich, maybe you can specifically respond to those parameters that Jason is asking.

[Ulrich Mueller:]

Yes, I’d be happy to. So, once we have the 19 patients enrolled with dose we should be able to do the analysis fairly quickly within about a month or two. We will be working with the regulatory agency prior to that to make sure that to design a trial that’ll be moving to the registration trial right now. So looking – if we go into the registration file with a control arm it would exactly about 196 patients.

[Jason McCarthy:]

Okay, thank you. And could you just remind us and walk us through plans for 1002, and where that program or just an update on that program?

[Ulrich Mueller:]

Yes, that program is continuing to proceed towards I&D filing, we are in the process of finalizing the CMC for the I&D, so we look to have that filed up towards the end of the year or in 2017.

[Jason McCarthy:]

Okay, thank you Ulrich. Thanks for taking the question.

[Operator:]

Thank you. Our next question comes from Yi Chen with H.C. Wainwright. Your line is open.

[Yi Chen:]

Hi, thank you for taking my questions. Can you give us an update on BP1001 for the treatment of CML? Is it going to be a Phase II safety segment trial starting soon?

[Peter Nielsen:]

Great question. Again Ulrich, would you take that please?

[Ulrich Mueller:]

Yes, yes. Yeah, the protocol has been submitted to the [indiscernible] for review so we hope we are being in the safety portion of that trial, they’re running to the full Phase II within a month or two.

[Yi Chen:]

Okay. And also could you give us an additional color regarding FDA’s perspective, so as I understand – if I understand correctly, so for the ultimate approval for BP1001 for the treatment of AML you still need to show survival benefits in the registration trial, correct?

[Ulrich Mueller:]

Yes.

[Yi Chen:]

Okay. So, but with the 19 patients, if there is a good response result for the 19 patient and FDA is okay that you can switching to – converting to a registration trial?

[Ulrich Mueller:]

Yeah, subsequent.

[Yi Chen:]

Okay, thank you.

[Operator:]

Thank you. I’m showing no further questions. I’d like to turn the call back to Peter Nielsen for closing remarks.

[Peter Nielsen:]

Well, thank you. Thank you all for joining us this morning and for your continued interest and support. We look forward to building on our momentum and addressing you in our next quarterly update. Have a great day.

[Operator:]

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