f Executive Officer
Anthony Price – Director of Finance and Accounting
Analysts
Yi Chen – H.C. Wainwright
Operator
Good morning, ladies and gentlemen and welcome to the Bio-Path Holdings Third Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we’ll open up the call to 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 2017 earnings results and to provide an update on recent pipeline and corporate developments. Yesterday, we issued a press release, which outlines the topics that we plan to discuss on today’s call. The release is available at www.biopathholdings.com. With me today from Bio-Path are President and CEO, Peter Nielsen; and Director of Finance and Accounting, Anthony Price.
Before we begin the call, I would 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.
Peter Nielsen
Thanks Will. Good morning everyone and thank you for joining us today. Throughout the third quarter, we continue to build on the accomplishments we achieved during the first half of the year and made important strides advancing our research and clinical development programs. We expanded our current product candidates into new indications and also introduced our third drug candidate BP1003 for the treatment of pancreatic cancer, which increases our range of druggable targets.
Our DNAbilize technology platform continues to show encouraging results in developing treatments for diseases with high unmet need and we look forward to the growth of our pipeline in quarters to come.
Recall DNAbilize is a proprietary antisense RNAi nanoparticle technology that facilitates the development of nucleic acid therapeutics and enables their delivery. Our delivery technology form structures similar to the cellular membrane, therefore allowing the antisense drug to incorporate within the lipid bilayer and be delivered to the diseased cells with high uptake into the cell. Most importantly, there has been no evidence of toxicity associated with our technology.
Let’s start the call with an overview of the Phase 2 clinical program for the treatment of acute myeloid leukemia or AML. We continue to make steady progress in knowing the study and look forward to providing an interim update before the end of the year. As a reminder this trial is a multi-center study of prexigebersen in combination with low-dose cytarabine, or LDAC, in patients with previously untreated AML who are not otherwise eligible for standard or high-intensity chemotherapy regimens or who have elected a low-intensity regimen. The trial is a single arm, open label, two-stage design to assess the safety profile, pharmacokinetics, pharmacodynamics, and efficacy of prexigebersen in combination with LDAC, compared to historical response rates documented for LDAC alone.
The primary endpoint of the study is complete remission, including patients who achieve incomplete hematologic recovery and complete remission with incomplete platelet recovery. Secondary endpoints will assess the safety and efficacy of prexigebersen, including overall survival, time to response, duration of response, and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory tests.
The full trial design includes approximately 54 evaluable patients with an interim analysis performed after 19 patients are evaluable. In addition to the demonstrating a clean safety profile we are hopeful that this interim analysis will show an early therapeutic signal noting that this study was not powered to show efficiency in such a small patient sample.
Outside our AML program we continue to expand our DNAbilize technology platform to other important oncology indications. This month we selected our third drug candidate BP1003 for a preclinical development for the treatment of pancreatic cancer. BP1003 targets the Stat3 protein. It is currently being studied in a patient-derived tumor model, and previous models have shown it to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments. We are excited to begin tackling the solid tumors with our proprietary technology platform.
On that note we also recently demonstrated promising preclinical results for our lead candidate prexigebersen. Prexigebersen is currently in the Phase 2 development for the treatment of blood cancers and has demonstrated clinical benefit as both a monotherapy and in combination with standard frontline treatments.
Earlier this month we announce that prexigebersen, which targets the Grb2 protein, also showed ovarian tumor penetration in recent preclinical studies. We plan to initiate a Phase 1 trial of prexigebersen in several solid tumor types in 2018 including ovarian tumors. We are highly encouraged by prexigebersen’s clinical and preclinical results and remain on track to begin enrollments in the safety portion of a Phase 2 trial in CML before the end of 2017.
In addition to our prexigebersen program, we recently reported encouraging preclinical results for our second drug candidate BP1002. In November, we announced that, BP1002, which targets the Bcl2 protein, demonstrated strong anti-nonHodgkin’s lymphoma activity in cell lines and in an animal model. We expect to initiate a Phase 1 trial in lymphoma in 2018.
Finally, we continue to build our intellectual property portfolio, which further protects our ability to develop and expand our exciting technology platforms to their fullest capabilities. In July, we received a notice of allowance from the United States Patent and Trademark Office for a key U.S. composition of matter of patent for DNAbilize. The new patent provides broad protection for the application of DNAbilize technology in the treatment of a variety of cancers as well as autoimmune and infectious diseases. We believe that our DNAbilize technology will prove an innovative approach to improve outcomes for patients and our strong and growing patent estate will provide barriers to would be competitors and may allow us to monetize these assets in areas outside our strategic correction.
With that, I’ll now turn the call over to Anthony Price for a brief overview of our financials.
Anthony Price
Thanks Peter. The company reported a net loss attributable to common stockholders of $2.5 million or $0.02 per share for the three-months ended September 30, 2017 compared to a net loss attributable to common stockholders of $1.6 million or $0.02 per share for the three-months ended September 30, 2016. The increase was primarily due to the benefit received from the change in fair value of the warrant liability in 2016.
The Company reported a net loss attributable to common stockholders of $5.9 million, or $0.06 per share, for the nine months ended September 30, 2017, compared to a net loss attributable to common stockholders of $5.4 million, or $0.06 per share, for the nine months ended September 30, 2016. The increase was primarily due to the deemed dividend related to the warrant conversion of $1.0 million during the period.
Research and development expenses for the three months ended September 30, 2017 decreased to $1.6 million, compared to $2.3 million for the three months ended September 30, 2016. For the nine months ended September 30, 2017, research and development expenses decreased to $4.1 million, compared to $4.5 million for the nine months ended September 30, 2016. The decreases were primarily due to the release of drug material for our Phase 2 clinical trial prexigebersen in AML in 2016.
General and administrative expenses for the three months ended September 30, 2017 increased to $0.9 million, compared to $0.7 million for the three months ended September 30, 2016. For the nine months ended September 30, 2017, general and administrative expenses increased to $2.7 million, compared to $2.3 million for the nine months ended September 30, 2016.
As of September 30, 2017, the company had cash of $4.6 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the nine months ended September 30, 2017 was $5.7 million compared to $6.5 million for the comparable period in 2016. Net cash used in investing activities for the nine months ended September 30, 2017 was $0.5 million. Net cash provided by financing activities for the nine months ended September 30, 2017 was $1.5 million.
Peter Nielsen
Thank you, Anthony. With that overview, operator we’re ready to open the call for questions.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from Yi Chen with H.C. Wainwright.
Yi Chen
Hi. Thank you for taking my question. My question is that has the 19 patients already being treated in the Phase 2 trial of BP1001?
Peter Nielsen
Just overview statistics, we’ve evaluated in the screen at least 50 patients now. And I will say that we have 19 enrolled but remember when we treat – I think really asking is do we have 19 evaluable. And we’re not at that point yet. It takes four months to be evaluable. We enroll a patient and as you can imagine sometimes they just give up or whatever. I mean, I know there’s one that someone pointed out to me was in the pre-treatment side of course just decided to go to a hospital. We have treated them in-patients yes.
Yi Chen
So can we currently expect that these – my conclusion is it could be evaluable in January results in first quarter of 2018?
Peter Nielsen
Well I would – I haven’t seen the results of data, but I would expect so. I think we’re a lot closer. But we have to get all of them evaluable, we have to go into our database and determine that indeed they are evaluable. And then we can do our analysis on that. But I mean, where could we go on, when we do the interim update before the end of the year, I have plan to give people a sense of where we are, how much we’ve done and do that. But at this point I would think so, which just depends on how long the analysis. And these are complicated patients, no doubt about that.
Yi Chen
Okay. And if the result from the interim analysis is positive the next step would be to have a meeting with the FDA to discuss the potential next step whether to continue this trial to enroll the 54 patients or the possibility period to – escalators trying to pivotal trial. Is that the idea?
Peter Nielsen
Yes. I think that was the original plan was to use those to point if we have a strong enough treatment benefit to try that to escalate the program. And answer to your question is yes, we would take the results of the analysis and review it with the FDA to see what the next outcomes are.
Yi Chen
Okay. Thank you.
Peter Nielsen
You’re welcome.
Operator
And I’m not showing any further questions at this time. I’d like to turn the call back over to Peter.
Peter Nielsen
Thank you. In closing, we’re particularly pleased with the progress we’ve made this quarter and throughout 2017. In advancing and expanding our pipeline in the near-term and in building the foundation for our business to the long-term. We continue to believe our DNAbilize clinical development programs represent significant opportunities for Bio-Path. These programs are important engine for creating both near and long-term value for our shareholders. Our clinical and regulatory team continues to work diligently to advance these important programs across a number of indications where there are significant medical needs, limited treatment options and large markets. As such, we remain focused on the execution of our clinical development plans and look forward to reporting our near-term clinical progress.
Thank you again for joining us and for your continued interest and support of Bio-Path. Have a great day.
Operator
Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect. And have a wonderful day.
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