Will O’Connor – Stern Investor Relations Peter Nielsen – President and Chief Executive Officer Anthony Price – Vice President-Finance and Accounting.

Laura Engel – Stonegate Capital.

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings’ Second Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later following the formal remarks, we will open up the call for your questions. I’d now like to turn the call over to Will O’Connor of Stern Investor Relations. Please proceed..

Thank you, operator. Welcome to the Bio-Path Holdings conference call and webcast to review the company’s second quarter 2018 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 www.biopathholdings.com. With me today from Bio-Path are President and CEO, Peter Nielsen; and Vice President 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..

Thanks Will. Good morning everyone and thank you for joining us today. We are particularly pleased with the progress we have made during the first six months of 2018, which was transformational in terms of advancements in our clinical development programs.

Throughout the second quarter, we continue to successfully execute on both the ongoing clinical trials of our lead product candidate prexigebersen as well as the upcoming IND filing for our second product candidate, BP1002.

We have a number of exciting milestones ahead and are well positioned to make substantial advances to our pipeline during the remainder of this year. I will begin with a brief overview of our DNAbilize platform, which is our proprietary antisense RNAi nanoparticle technology, which we use for the creation of nucleic acid therapeutics.

DNAbilize therapeutics integrates with a cellular membrane, because of their unique structure allowing the antisense drug to be delivered to the diseased cells with high uptake into the cell via incorporation into lipid layers. There’s been no evidence of toxicity associated with our technology.

We are more excited than ever about the potential of our DNAbilize platform and developing exciting treatments for diseases with high unmet medical need. Let’s turn to discussion of our lead product candidate, prexigebersen.

During the second quarter, we’ve reported encouraging interim results from our Phase 2 study of prexigebersen for the treatment of acute myeloid leukemia, or AML.

Recall this trial is a multi-center study of prexigebersen in combination with low-dose cytarabine, or LDAC, in de novo 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 was open label with a 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.

We are also adding a second cohort to this trial testing prexigebersen in combination with decitabine compared to historical response rates to decitabine 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 and time to response, duration of response and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory results.

Our interim results showed that 47% of evaluable patients showed some form of response to the combination treatment including four patients with complete remission of 23% and four patients with stable disease including one patient who achieved a leukemia free status and one patient who had significantly reduced bone marrow blasts.

We look forward to updating you on our progress with this trial. We are also excited to be enrolling the patients in a second Phase II study of prexigebersen as a treatment for chronic myeloid leukemia or CML.

Recall this study is a Phase Ib 2a multi-center study of prexigebersen in combination with dasatinib, or Das, in patients with CML, who are in accelerated or blast phase. Das has been a well established therapeutic regimen in the treatment of CML patients, who are in accelerated or blast phase.

The hope is that the combination of prexigebersen and Das will provide a benefit to CML patients in accelerated or blast phase, who typically do not respond to the frontline treatment in dasatinib.

The rationale supporting this program is based on the fact that the Grb2 gene has been mapped to the human chromosome region that is duplicated in leukemias and solid tumors, which may result in an increased copy number of the Grb2 gene protein.

Inhibition of Grb2 may have a significant impact on leukemias and prexigebersen may be able to inhibit the cells from making Grb2. Our aim in this study is to show that without this protein the leukemia cells will die.

We are currently enrolling for this study and hope to complete enrollment by year end 2019 and to have top-line data for the first half of 2020. In addition, we presented pre-clinical data on prexigebersen at the American Association for Cancer Research, or AACR, annual meeting for the treatment of solid tumors and gynecologic malignancies.

Here prexigebersen showed decreased tumor burden and multinodular burden in mice compared to control, with no apparent toxicity. Based on these compelling mechanism of action data, we plan to initiate a Phase 1 trial of prexigebersen’s several solid tumor types, including ovarian and pancreatic tumors by year end.

Beyond prexigebersen, we are excited to bring our second product candidate, BP1002, forward into the clinic. Note that we previously reported encouraging pre-clinical results for BP1002, which targets the BCL-2 protein. In an in vitro study, cell lines of various types of non-Hodgkin’s lymphoma were incubated with BP1002.

After four days, it was determined that BP1002 induced greater than 50% inhibition in 11 or 15 cell lines tested. In two animal studies, none of the untreated or controlled mice survive beyond 39 days. In the BP1002 arms, a combined 87% of the treated mice survived until the end of the five-week studies.

Based on these compelling findings, we intend to initiate a Phase 1 trial of BP1002 for the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, or CLL. We plan to file an IND by year end. Finally, we are also progressing our third drug candidate BP1003, which targets the Stat3 protein.

We are currently studying BP1003 for the treatment of pancreatic cancer in a patient derived tumor model. Previous models have shown the drug to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments. These findings give us confidence to pursue this unmet need in solid tumors such as pancreatic.

We expect to initiate a series of IND enabling studies for BP1003 by year end with a goal filing an IND for the first in-human trial of this very promising product candidate in 2019. 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 $1.7 million, or $0.15 per share, for the three months ended June 30, 2018, compared to a net loss attributable to common stockholders of $3.0 million, or $0.31 per share, for the three months ended June 30, 2017.

The decrease in net loss was primarily due to the deemed dividend related to the warrant conversion of $1.0 million in 2017.

Research and development expenses for the three months ended June 30, 2018 decreased to $0.8 million, compared to $1.5 million for the three months ended June 30, 2017, primarily due to decreased clinical, manufacturing and salaries and benefits expenses.

General and administrative expenses for the three months ended June 30, 2018 were $0.9 million, compared to $0.8 million for the three months ended June 30, 2017. As of June 30, 2018, the Company had cash of $2.6 million, compared to $6.0 million at December 31, 2017.

Net cash used in operating activities for the six months ended June 30, 2018 was $3.4 million compared to $4.2 million for the comparable period in 2017. With that I’ll now turn the call back over to Peter..

Thanks, Anthony. In closing, I’d like to take a moment to recognize the efforts of our entire team. Each of whom has been instrumental in the progress we’ve made in the first six months of this year and who will continue to drive our achievements in the coming year ahead.

Our entire team is dedicated and passionate about advancing our clinical development programs. And share our collective goal of paving a new path in DNA-powered medicine. Thank you all for your continued support, which has allowed us to continue to build our DNAbilize technology into lifesaving medicines to patients in need.

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

Yes sir. [Operator Instructions] Our first question comes from line Laura Engel from Stonegate Capital. You may begin. .

Good morning, Peter and Anthony. Thanks for taking my questions. And congratulations on an exciting quarter. Really just looking at kind of the drivers of the stock price maybe over the next six to 12 months you outlined it sounds like some big things we need to expect in the second half of the year.

Just give me your thoughts say next six to nine months, biggest star is the stock price and then with these initiatives you've outlined to achieve maybe by year end, just comment on current cash position and how that timing looks going forward?.

Okay thanks Laura. Good to have you on the call. As far as the stock price, I think, we're currently driven by the fact that number one, as you know, low cap, market cap biotech is in very choppy waters right now. But we have sufficient cash to continue to operate, but of course I will certainly mention that we’re in the process of remolding that.

At this low price, unfortunately there's a lot of speculative trading in the stock. Some investors like to go in and anticipate a deal being done that might lower the price in the near term. And so they might short against that and do other things. So there's a lot of that going on.

So I think one of the important things is to re-establish that in fact we have the liquidity necessary to keep our programs going forward. And we are in process of trying to remedy that situation. As clinical milestones are the things that ultimately, of course as you know, drive the value of the stock..

Right..

And so I’ll mention the nearest term is a couple of things, the prexigebersen AML trial that is going. And again we have to pathways in that that could potentially lead to approvals. We had the previous one combination with LDAC, which we were very pleased with the results.

The subsequent analysis and whatnot indicated that indeed we had very difficult patients. And we more than doubled the response rate based on previous history of LDAC alone. And so that will continue. Prexigebersen with decitabine can be another one. PIs as you know clinicians, oncologists in the U.S. like that drug a lot. And we had lot of….

Right..

We had a lot of encouragement from our principal investigators to add that cohort. So we are on that. And that certainly should enroll quickly. And we could be a readout looking at another interim readout in the first quarter of next year. That will be another thing that you recall in our last readout we had quite a large response in our stock.

So that's going on..

Right..

The CML study I mentioned overall timelines to enroll the entire study. But the reality is we have the safety portion and those are three-patient cohorts which once we get going can turn around efficacy minor or small patient population, efficacy readouts, as well as safety. And we may get that first one by the end of the year.

And you may recall when we did this in AML with the safety readouts, we got a lot of – we got some pretty nice results and that did some things for the value of the Company's stock..

Right..

So we’ll have that second cohort sometime in probably the end of the first quarter, beginning of the second quarter in 2019.

So I think just progressing of those things we have the ASH meeting coming up, which I don't have anything to announce on that, but certainly that's the main leukemia meeting and we can expect we might have something going on there. And of course the two new trials, the solid tumor starting that by before the end of the year we hope to do..

Right..

As we indicated and one of other things we're going to piggyback off of our current INDs to try to speed that. Those are advanced ovarian pancreatic and now I think even triple-negative breast cancer might be included in those solid tumors. And we plan to be able to open that before the end of the year. That could be a very, very important trial.

And of course BP1002, the target BCL-2 is a very popular target as you know. And our plan is to have that IND filed by the end of the year. We had a pre-call with that at the end of the year with the FDA and make sure we can get some feedback on do we have everything we need, they wanted the second species study in one-time near the FDA..

Right..

We think we'll have that going filed before the end of the year. And then assuming glitches, you wait 30 days if there's any kind of a FDA response and then you have the IND and your Phase 1 is open. So we have a lot of things we've been working on that will come to the floor and start producing more than just milestones out of one trial.

That’s kind of like know just waiting. .

Right..

And we have more things going on. We’ll eventually start getting milestones coming through from different clinical programs. So we're just about we think we’re at a spot where we can then be a pretty good story. And to put it in a near term completing funding and replenishing our liquidity is a very important thing.

And hopefully that will take some of the speculated trading away from the stock..

Great. Well it does sound like you have a lot going on exciting second half of the year and early 2019. So look forward to following the progress. And thank you for taking my questions..

You're very welcome. You do a great job on the research and we appreciate it..

Thank you. And I'm showing no further questions at this time. I like to turn the call back to Peter Nielsen for closing remarks..

Thank you, operator. So thank you again everyone for joining us and for your continued interest and support of Bio-Path. Have a great day today..

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..