Will O'Connor - Stern Investor Relations Peter Nielsen - President, Chief Executive Officer Anthony Price - Director of Finance and Accounting.

Jason McCarthy - Maxim Yi Chen - H.C. Wainwright Jason Kolbert - Maxim.

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings Second Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. I would now like to turn the call over to Will O'Connor of Stern Investor Relations. Please proceed..

Thank you, Operator. My name is Will O'Connor of Stern Investor Relations. I would like to welcome you to the Bio-Path Holdings conference call and webcast to review the company's second quarter 2017 earnings 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; and Anthony Price, Director of Finance and Accounting.

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..

Thanks, Will. Good morning everyone, and thank you for joining us today. We made encouraging corporate and clinical progress during the first half of 2017.

Significantly expanding our leadership team greatly expanding the intellectual property positioned of our DNAbilize scientific platform and making meaningful progress across each of our pipeline programs.

As you know, DNAbilize is a proprietary antisense and neutral lipid technology that enables delivery for nucleic acid therapeutics and facilitates their development.

Our delivery technology forms structures similar to the cellular membrane, therefore allowing the antisense drug to be incorporated within the lipid layers and be delivered to the disease cells with high uptake into the cell. Most importantly, there has been no evidence of toxicity associated with our technology.

Let's begin with our clinical program for the treatment of acute myeloid leukemia or AML. We continue to make steady progress enrolling our Phase 2 study of prexigebersen, previously known as BP1001, for the treatment of AML.

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 60 milligram per square meter of prexigebersen in combination with LDAC, compared to historical response rates documented for LDAC alone.

Evaluable patients will receive an initial dose IV infusion of prexigebersen over 60 minutes and every three days thereafter, as eight doses per 28-day cycle of 60 milligram per square meter prexigebersen, and will be administered LDAC as a subcutaneous injection, twice daily for 20 consecutive doses per 28-day cycle.

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 results.

The full trial design includes approximately 54 evaluable patients with an interim analysis performed after 19 patients. In the event the interim results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, we may seek to convert the trial into a registration trial for accelerated approval.

We remain on track to report data from this interim analysis by the end of the year. The results of this interim analysis are important, as they will help to inform our clinical development path moving forward. Beyond the AML, we are advancing our plans to expand our DNAbilize technology platform in other important oncology indications.

We have finalized our plans to begin the toxicity portion of our Phase 2 trial of prexigebersen in CML, and expect that study to begin in the coming few weeks. This is a particularly promising opportunity for us, because we've seen early efficacy signals from previous studies across the spectrum of hematological cancers.

In addition, preclinical data support the mechanism of action in this indication, encouraging us to further pursue CML. As with AML, there is a great need for better treatment options for advanced CML patients. And we believe our DNAbilize technology will provide an innovative approach to providing improved outcomes.

In addition, to our prexigebersen program our second drug BP1002 makes steady progress towards IND submission or Phase 1 trial in lymphoma. Our third drug candidate has shown excellent results in animal studies of pancreatic cancer and our fourth drug successfully completed their first round of animal studies in glioblastoma.

Bio-Path has pipeline of four truly exciting drug candidates targeting major disease indications which we believe have the potential to make a significant contributions to treating cancers and infectious with significant unmet need. In July, we were pleased to further bolster our intellectual property portfolio for DNAbilize.

We received a notice of allowance from the United States Patent and Trademark Office were key U.S. composition of matter of patent for our proprietary liposomal delivery and antisense technology, DNAbilize.

The new patent, titled P-Ethoxy Nucleic Acids for Liposomal Formulation will provide broad protection for application of the DNAbilize technology in the treatment of a variety of cancers, as well as autoimmune and infectious diseases.

This patent shows up our strong and intellectual property position and helps strengthens - strengthen the foundation of our scientific platform as we continue to expand into new therapeutic areas and grow Bio-Path into a leading biopharmaceutical company.

Finally, we were very excited to report the appointment of Mark Colonnese to Bio-Path's Board of Directors. Mark is currently the Chief Financial Officer of Aviragen Therapeutics, a NASDAQ listed public biotech company.

His wide ranging experience in the financial and biotech industries will be invaluable to Bio-Path as we grow our company and expand our therapeutic programs. Earlier in his career Mark served as Chief Financial Officer in a number of biotechnology companies including Stealth BioTherapeutics, Transgenomic Inc. and AtheroGenics Inc.

He also served as Vice President of Financial Operations at Schering-Plough Corporation, now part of Merck one of the world's largest pharmaceutical companies.

In these roles he was responsible for various financings and partnerships and directed two companies through their initial public offerings, we are thrilled to welcome him to the Bio-Path team. With that, I'll now turn the call over to Anthony Price for a brief overview of our financials.

Anthony?.

Thanks Peter. The Company reported a net loss attributable to common stockholders of $3.0 million, or $0.03 per share, for the three months ended June 30, 2017 compared to a net loss attributable to common stockholders of $1.9 million, or $0.02 per share, for the three months ended June 30, 2016.

The increase was primarily due to the deemed dividend related to the warrant conversion of $1.0 million during the period.

The Company reported a net loss attributable to common stockholders of $3.4 million, or $0.04 per share, for the six months ended June 30, 2017, compared to a net loss attributable to common stockholders of $3.8 million, or $0.04 per share, for the six months ended June 30, 2016.

The decrease was primarily due to total other income related to the change in fair value of the Company's warrant liability and the loss on extinguishment of the liability totaling $1.9 million.

Research and development expenses for the three months ended June 30, 2017 increased to $1.5 million, compared to $1.2 million for the three months ended June 30, 2016. For the six months ended June 30, 2017, research and development expenses increased to $2.5 million, compared to $2.2 million for the six months ended June 30, 2016.

General and administrative expenses for both the three months ended June 30, 2017 and June 30, 2016, were $0.8 million. For the six months ended June 30, 2017, general and administrative expenses increased to $1.8 million, compared to $1.6 million for the six months ended June 30, 2016.

As of June 30, 2017, the Company had cash of $6.2 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the six months ended June 30, 2017 was $4.2 million compared to $4.6 million for the comparable period in 2016.

Net cash used in investing activities for the six months ended June 30, 2017 was $0.5 million. Net cash provided by financing activities for the six months ended June 30, 2017 was $1.5 million..

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

Thank you. [Operator Instructions] And our first question comes from the line of Jason McCarthy from Maxim. Your line is open..

Good morning guys, hi Peter..

Hey, hi Jason..

Good morning. Can you give us a sense of the speed of enrollment any AML, yeah, but where are you in terms of getting to the first 19 patients.

And can you remind us what the expected complete remission rate is historically and how far over that you need to get to be able to go to the FDA and expense or registration study?.

The enrollment rate is moving very nicely now. We have six and you know we don't want to get specific into the numbers on that, but as we said we think will be fully enrolled and have our analysis complete by the end of the year, so you can confirm from that that we're doing pretty well now.

It took us a while to get going, but we had some institutions that were just slow getting their bureaucratic in shored up, so we're doing well in that.

The response rates held back alone treatments of these de novo patients, fragile patients is around 18% complete remission in this context being bone marrow blast being less than 5%, so 18% on that basis and on the successful basis I have the confidence intervals you want to be almost a lay down, we'd like to be in 36% that's what we feel if we get into that range that it will be very compelling for the FDA to allow us to switch..

Okay, great.

And just one more question and you're going to start the CML study in the coming weeks, how big is the study, what are endpoints to that study likely to be?.

Well again it's going to be a remission, a complete remission. We are very close to doing that in fact, we have a site mission that's scheduled for tomorrow, which would open up and go from there.

The first portions of it we break it in segments, the safety segment of it and it's similar to what we did we'll see AML program the safety portion, we did two cohorts, because of course in the Phase I it was mono therapy, so we never tested the combination, this is going to be to sit with our drug, and so to be three patients in the first cohort at 60 milligram per square meter of prexigebersen in the standard [indiscernible] therapy and then will step up to 90 and so will do six patients in total over two and you know it's always a function of getting the patients, but we think we're ready to go on that on in terms of the patients that are to this will just be at MDS, so and I think with Dr.

Cortez as you know him, he's one of the leading CML people that's a good chance for us to get the patients we need..

Okay, great. Thank you for taking the questions Peter..

Thank you Jason, appreciate your support..

Thank you, and our next question comes from Yi Chen from H.C. Wainwright. Your line is open..

Hi, thank you for taking my question..

Hi Yi, how are you?.

Good thanks.

So is the IND that's going to be filed for BP1002 for the indication of non-Hodgkin's lymphoma?.

Yes at this time that's our current plans, you know possible we might even like to add some other things to it, it's a Bcl2 is the of course the target of that drug, and it's a very popular target involved to the process and a large degree of cancers and tumors, but at this point the packages, the tox packages and efficacies were done in that lymphoma and you know for your reference if recall that we took the paper results on that work to be last ACR meeting on aggressive, in fact aggressive non-Hodgkin's lymphoma..

Okay.

And at this point would you be able to give us some more color on the third and four candidates?.

Well, as you know we're it's a big help that we finally have our composition of matter that's a big step for us of course that's our new protection of earnings and also of course now we can meaningfully really have something to talk about in the partnering arena, because there's some protection there and likewise from that derivatively the third four candidates we want to have protection on it.

So we still have a little bit of quiet time on that until we're further along on processing patents in those areas, but the third candidate you know without being specific of what that target is at this point, it's frankly a very well-known target, but it has many applications and it like I said has been we're leading with it was leading researcher down at who was MD Anderson is now go to market, but in the pancreatic models, and what's very important in those animal studies was showing evidence and in fact our delivery technology was we think able to get to deliver our drugs into the pancreatic cancer cells, so that was an important thing.

But it is a target that's involved in many large cancers non-small cell lung is another that would be a candidate to go with, so but specifically naming it at this point, we want just wait a little bit longer to firm up our intellectual property on it..

Got it, thanks.

My second question is that shall we expect additional news to be announced regarding prexigebersen in solid tumors in late of this year or early 2018?.

You know it's funny.

I didn't put and I thought about it, so as looking at the final draft in my prepared remarks prexigebersen is as you've referenced is being studied in solid tumors and advanced ovarian and of course those pathways when they get very advanced seem to have similarly and triple negative and so that's kind of handling those two recall in the MD Anderson program advanced ovarian and triple negative or in same bullet point.

And I can tell you that in animal models, we have some really exciting results or researchers were very excited in terms of reduction at tumor size. So we're moving that along I think there are some additional things areas that just because of wanting to get the efficacy indication not anything that's holding this up in that.

But we've seen some excellent results.

As you know we've spent the last year, year and a half engineering our DNAbilize to be able to get smaller nanoparticle outcomes, which if you're going to seriously try to have a solid tumor treatment you want to be able to have the prospect of that number of your particles going through those vascular post spaces, and so we've done that and we think it's showing up in our results.

That's one of the reasons recall why BP1002 has been delayed a year, because that's another one its solid tumor and we frankly is a product person you want to make sure that you can have the best product possible for the treatments you're go forward.

And so we've made some real progress in reducing our liposome nanoparticle size population to have a real chance to be solid tumor treatments and it seems to be showing up..

Okay, very good. Thank you very much, Peter..

You're very welcome. Thank you..

Thank you. And our next question comes from the line of Jason Kolbert from Maxim. Your line is open..

Good morning Peter, good morning Ulrich, how are you?.

Hey, Jason how are you?.

Good, thank you.

So just want to talk with you guys about some practical things, I mean the stocks has not performed well, it's really gone down a lot, and I wanted to understand since you have so much good data, you've made so many exciting technological advances and I definitely see the platform value particularly on the delivery side of the vehicle, what are you doing to get the message out there to kind of raise awareness and you know help turn the stock around for the investors and particularly the retail guys who've been so active and the name? Thanks..

Good question Jason, of course, we're all very frustrated with the stock price that doesn't in the current sense doesn't reflect the inherent or intrinsic value in our opinion of the stock transitioning down here, it's been a couple of things last year, I think it really started and you know the way it works with pre revenue biotech companies when the market and there's groups out there they do this that anticipate when a biotech has to raise funds, they'll start shorting the stock because they know that of course, stock is going to be sold at a discount and it tends to pull the stock down.

And so we started out at $3.20 in March of 2016 very frustrating, and it gets pulled down to go to a direct offering, which we did and in the middle of last year.

And then from there you get to where you turning over some of the volume related to the people in the stock purchasing into clean their position, and then we had the Russell experience, and people anticipate that we would be coming off the Russell and so we had believe it or not over seven million shares that had to transition off of the company those are some of course that offer the Russell index and component let it may have to hold the shares we make it up in the portfolio, so we went through that transition, so we're at a point where we've been moving side wise tremendous volume, I mean you look at this stock and think about how many people want to buy this stock, it's amazing.

So now what pulls us out are several things always have to first of all rely on your next wave of milestones and we have those coming up over the next several months here, so that's an important thing.

CML will get efficacy reach out on that will have the 19 patients coming here and we have some other things going on which are exciting, which will come out. But more importantly on that we've undertaken meetings at the retail level organized through some groups to arrange lunch meeting type events with the new potential retail clients.

We're doing dealer Roadshows with more of the institutional investors, just to let us know a lot of them you know the institutional they know about this company, so the thing is going in and reminding people that this is a heck of a buy right now. And again I think that's what we some might we get the volume we get.

We've also been doing things in the area, and I don't know if you've seen them, but we're far enough along with data now that we can have articles published in some of the frontline media journals, and we've had one on that which was really more the history of antisense therapeutics but it just could be a promotional back, but a legit article, but of course then we were in there and as I've always said we'll go for that because the facts are in our favor, and so it was a very good article, we have another one coming out so or we're increasing awareness in that fashion.

So we have many things going on we're being very proactive and eventually as you've seen before Jason we get down to these low spots we move sideways milestones or whatever start the company to move and once that happened the shorts start to have to reverse their positions and we start moving up quite steadily. So we're not going to be here forever.

We don't like it. And we're going to change it..

Peter, we did right here to come into the firm and spend some time with retail guys, we'd also love to talk to a little bit about the China initiatives which we think open up a very, very big market opportunity whether do a lot of interest. But thank you so much for the comprehensive answer..

Yeah, and as you know I've come in and I think you've coordinated before, and I enjoy doing the presentation, so we'll have to get offline on that and it will become in the New York again in September, and we could maybe do something like that would be great, appreciate the offer..

Okay. Thank you..

Thank you. This concludes today's Q&A session. And I would now like to turn the call back over to Peter Nielsen, Chief Executive Officer, for closing remarks..

In closing, we're very pleased with the significant progress we've made thus far in 2017. Our clinical trials are on track to report data that we expect will reflect the encouraging results we've seen to date with our DNAbilize technology.

Last quarter's appointment of William Hahn as Vice President of Clinical Development has already shown results of the streamlining of our clinical programs and we are confident in the future execution of our clinical development plans.

We look forward to near term clinical progress and believe that the steps we took in the first half of 2017 position us continue achieving our corporate objectives. Thank you again for joining us and for your continued interest and support. Have a great day..

Ladies and gentlemen thank you for participating in today's conference. This does conclude the program. And you may all disconnect. Everyone have a great day..