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

Laura Engel – Stonegate Capital Partners.

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings First Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open 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. Welcome to the Bio-Path Holdings conference call and webcast to review the company’s first 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 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, 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’ve made tremendous progress so far in 2018 and these important advancements have positioned us for continued success throughout the balance of this year.

We’ve recently reported exciting interim data from our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia, which I’ll review in further detail later on the call.

We also continue to pursue the expansion of prexigebersen into additional indications and presented promising data at AACR 2018 for the treatment of solid tumors in gynecologic malignancies. Finally, we have strengthened our corporate leadership with the addition of Dr.

Anas Younes to be our Scientific Advisory Board; and Paul Aubert to our Board of Directors. Looking forward Bio-Path has never been better positioned as to execute on our corporate mission of helping patients. Now let’s discuss our clinical programs.

I’ll start off by reviewing 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 the 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.

We’ve recently reported exciting interim results for our Phase II study of prexigebersen for the treatment of acute myeloid leukemia, or AML. As a reminder 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.

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. We’ve recently reported interim results from this ongoing Phase II study.

Our results showed that 47% of evaluable patient showed some form of response to the combination treatment including four patients with complete remission of 23% and four patients with stable disease.

Of the 17 evaluable patients, four patients achieved complete responses, one patient achieved a leukemia free status, one patient had significantly reduced bone marrow blasts and three patients achieved stable disease.

Based on the recommendations of the principal investigators of the study, after the reporting of these results, we are making a small protocol amendment in the ongoing study.

We are changing the dosing schedule to that used in the Phase 1b study in relapsed and refractory AML patients, in which a higher dose of prexigebersen was administered prior to LDAC treatment starting at day ten, instead of LDAC treatment starting at day four as was the case in the study to date.

In addition, we are endorsing the inclusion of decitabine cohort based on relatively new and positive data with this compound. We look forward to updating you on our progress with this trial. On top of that, we’re also studying prexigebersen in additional indications. We are advancing a Phase 2 trial in prexigebersen in chronic myeloid leukemia or CML.

We also presented preclinical data on prexigebersen at the American Association for Cancer Research Annual Meeting for the treatment of solid tumors in gynecologic malignancies. Importantly, prexigebersen decreased tumor burden by 86% and multinodular burden in mice compared to control, with no apparent toxicity.

We plan to initiate a Phase 1 trial of prexigebersen in several solid tumor types, including ovarian tumors. Finally, we’re pleased that data from the Phase 1 trial of prexigebersen and AML patients was published and selected for expert commentary in the lancet hematology.

This represents a validation of our early clinical results and we hope that this and further publications can raise the profile of this important indication. In addition to the prexigebersen, we are excited to bring forward two additional molecules into the clinic.

As you may recall, we reported positive preclinical results for our second drug candidate, BP1002, which targets the BCL-2 protein. We plan to initiate a Phase 1 trial of BP1002 for the treatment of non-Hodgkin’s lymphoma. We’re also progressing our third drug candidate BP1003, which targets the Stat-3 protein.

We have initiated preclinical development of BP1003 for the treatment of pancreatic cancer in a patient derived tumor model. Previous models have shown it to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments.

We are excited to begin tackling solid tumors with our proprietary technology platform and expect to initiate a series of IND-enabling studies for BP1003 in 2018 with a goal to enter first in-human trial with this very promising product candidate in 2019.

We continue to evaluate opportunities to expand our DNAbilize technology platform to other oncology indications. Finally, beyond our clinical progress we also made key additions to our leadership team. Last week, we appointed Dr. Anas Younes to our Scientific Advisory Board. Dr.

Yunus is a Professor and Chief of Lymphoma Service at Memorial Sloan Kettering Cancer Center and one of the world’s leading lymphoma experts. This expertise will be particularly valuable in guiding Bio-Path’s BP1002 program in lymphoma and solid tumors. Additionally, we appointed Paul Aubert to our Board of Directors.

Paul Aubert’s transactional experience and expertise in corporate law, will provide important insight 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 of $1.9 million, or $0.17 per share for the three months ended March 31, 2018, compared to a net loss of $0.4 million, or $0.04 per share for the three months ended March 31, 2017.

The increase in net loss in 2018 was primarily due to other income of $1.6 million recognized in 2017 related to the change in the fair value of the Company’s warrant liability.

Research and development expenses for the three months ended March 31, 2018 decreased to $0.9 million, compared to $1.0 million for the three months ended March 31, 2017 primarily due to decreased stock-based compensation expense. General and administrative expenses for both the three months ended March 31, 2018 and March 31, 2017, were $1.0 million.

As of March 31, 2018, the Company had cash of $4.3 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the three months ended March 31, 2018 was $1.7 million compared to $1.8 million for the comparable period in 2017. With that, I’ll now turn the call back over to Peter..

Thanks, Anthony. In closing, 2018 is looking to be a bright year for Bio-Path as we continue to make meaningful progress, advancing our DNAbilize product candidates through the clinic. We believe we are well positioned to move our pipeline forward and to provide important medicines for patients in need, which is the core of our corporate mission.

Looking at the year ahead, we have several important clinical milestones. We expect to implement the protocol amendments of our Phase 2 clinical trial of prexigebersen with a treatment of acute myeloid leukemia. We will initiate a Phase 1 clinical trial of BP1002 in lymphoma around year-end.

We are finalizing plans to begin enrollment of the Phase 1 clinical trial of prexigebersen in solid tumors. And lastly, we will initiate several IND enabling studies for BP1003 and pancreatic cancer. Overall, we continue to work diligently to advance our clinical development programs and look forward to updating you again soon.

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

Thank you. [Operator Instructions]. Our first question is from Laura Engel with Stonegate Capital Partners..

Good morning. Thank you for the update. I just had a quick question on BP1002 for lymphoma.

And as far as the additional safety study, I guess to have been mentioned on the last call, could you just give us an update on that and then it sounded like, I guess at the end of your comment, you did say you thought that was likely first – second half of 2018 to begin enrollment of that Phase 1..

Yeah, the second half. So, the study will start in the summer, it means a 30-day study in rabbits, a typical second species. And so it’s just a timing issue. We’re ready to go, but you have to get in the queue 30 days to do that study. And then you got to wait for the report. We’ll have the IND all set.

And then we should be able to file that at the beginning of the fourth quarter. And so as you know, there is a 30-day time response requirement of the FDA and assuming we’ve hit all the buttons. We get the IND, which of course, automatically opens the Phase 1 trial.

I don’t know if I’ve mentioned on these calls before, but we filed the briefing package with the FDA in December. So we wanted to file and did not file the whole IND, and it’s good thing we didn't.

So that we could get a conference call with the FDA, which we had early in the first quarter to give us feedback and what they want, and they’ve kind of insisted the policy service.

We do a second species even though we’ve tested 60 patients, we’ve never had a problem of safety with our – but the rules are rules so I guess that’s what we’re going to do..

Okay. Great.

And then just in general with the busy – in second half of 2018 and then looking into 2019, just comment on current cash levels versus current run rate, what’s expected with some of these other things ramping up much later in the year?.

We have – as I’ve mentioned before, we think we’re around 1.5 and 1.6, you kind of get timing of recording events at the end of the quarter about what your cash flow shows. But we know, we have enough insufficient cash to fund our key milestones through the end of the year. But clearly, we will look for other funding to support the programs in 2019.

We call a lot of these are time driven preclinical studies, which it’s a lot of activity, but not necessarily cash absorbing.

When you get finally get into trials, patient treatment costs at the cancer centers, CRO expense per patient of those who thinks that start driving cash consumption and those won’t really kick in the new programs until the beginning of 2019 even though that will be open, we might have the front end of that, but – so we think it’s manageable.

but we know that we will raise more money, but we’ve got enough progress, we’re looking for hopefully better ways to raise that funds to keep some of these transactional rhythm techno funds of our stock..

Got it. Well, great. Thanks for answering my questions, and I will get back in the queue..

Thank you..

And I’m showing no further questions. I would now like to turn the call back to Peter Nielsen for any further remarks..

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

Ladies and gentlemen, thank you for participating in today’s conference. You may now disconnect. Everyone, have a great day..