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

Laura Engel - Stonegate Capital Partners.

Good morning, ladies and gentlemen and welcome to the Bio-Path Holdings Full Year 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 for your questions. I would now like to turn the conference 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 full year 2017 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 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..

Thanks, Will. Good morning everyone and thank you for joining us today. The progress we made throughout 2017 has laid the foundation for us to achieve a number of important milestones in 2018 and beyond. In particular, we’ve made considerable progress with our lead product candidate prexigebersen and towards expanding our clinical development programs.

We recently reported exciting interim data on our Phase 2 clinical trial of Prexigebersen for the treatment of acute myeloid leukemia which I will discuss in further detail later in the call.

We also initiated a Phase 2A clinical trial of Prexigebersen in chronic myeloid leukemia patients and continue to preserve the expansion of Prexigebersen into additional indications including solid tumors. In addition to our clinical progress, we also made inroads advancing our business fundamentals.

This year, we made several key additions to Bio-Path’s management team. In April, we appointed William Hahne as Vice President of Clinical Research. Dr. Hahne has already been invaluable and integrated Bio-Path’s clinical teams and will continue to expedite the company’s clinical development process.

We also appointed Mark Colonnese to our Board of Directors this past July. Mr. Colonnese is an expertise in the biotechnology industry particularly in finance continues to support our efforts to grow the company and its scope.

Over the last year, we also enhanced our intellectual property portfolio with a key US composition of Matter Patent or DNAbilize providing broad protection for the application of DNAbilize technology in the treatment of a variety of cancers, as well as autoimmune and infectious diseases.

Now let’s turn to a discussion of our clinical programs and plans. Let me begin with a review of our DNAbilize platform, which is our proprietary antisense RNAi nanoparticle technology which we use for the creation of nucleic acid therapeutics.

DNAbilize therapeutics integrate with the cellular membrane, because of their unique structures allowing the antisense growth to be delivered to the diseased cells with a high uptake into the cell being in cooperation into the liquid layers. [Injectors] has been no evidence of toxicity associated with our technology.

We are extremely encouraged by the results of our DNAbilize platform and developing exciting treatments for diseases with high unmet medical need. Turning now to a discussion of our progress advancing prexigebersen in our lead product candidate.

This morning, we were pleased to report interim data from our Phase 2 study of prexigebersen in combination with LDAC 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.

This 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.

As we reported today, in our interim update of the 17 evaluable patients, more patients achieved complete responses, one patient achieved leukemia pre-stage, but we’ll remove and send after two cycles of treatments. One patient had significantly reduced bone marrow blast and 4 patients achieved stable disease.

In total, 47% of the evaluable patient showed some form of response to the combination treatment including 4 patients achieving complete remission, which is a 23% response rate and 4 patients having stable disease.

Based on the recommendations of the principal investigators of the study, we plan to amend the protocol of this study to change 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 10 versus LDAC treatment starting at day 4 as was the case with BP1001, 201 study today.

In addition, investigators endorsed the inclusion of decitabine cohort based on relatively new and positive data with this compound. We look forward to advancing the planned protocol amendments and to updating you on our progress.

We were also pleased to report the data from the Phase 1 trial of prexigebersen and AML patients was recently published and selected for expert commentary in the lancet hematology.

We [are throw] [ph] to this validation of our early clinical results and hope that this and further publications and raise the profile at this patient population with such high unmet medical need. We are studying prexigebersen in additional indications as well. We have initiated a Phase 2 trial of prexigebersen in chronic myeloid leukemia or CML.

This year, we demonstrated promising pre-clinical results for prexigebersen in ovarian tumors. We plan to initiate a Phase 1 trial of prexigebersen in several solid tumor types potentially in 2018 including ovarian tumors.

Additionally, we will be presenting pre-clinical data at the 2018 AACR Annual Meeting on the use of prexigebersen for the treatment of gynecologic malignancies. We are very enthused by prexigebersen's clinical and pre-clinical results. In addition to prexigebersen, we are excited to be advancing two additional molecules through the clinic.

Previously we reported positive pre-clinical results for our second drug candidate BP-1002 which targets the BCL-2 protein. Our plan is to initiate the Phase 1 trial using BP-1002 to treat lymphoma which is supported by both invitro and in vivo studies that demonstrated the compound's strong anti-non-Hodgkin's lymphoma activity.

We also have plans to advance our third drug candidate BP-1003 which targets the Stat-3 protein. We have initiated pre-clinical development of BP-1003 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 platforms and expect to initiate a series of INV enabling studies for BP-1003 in 2018 with a goal to enter first in-human trial with this very promising product candidate in 2019.

We look forward to continuing to expand our DNAbilize technology platform to other important and oncology indications. With that, I’ll now turn the call over to Anthony Price for a brief overview of our financials.

Anthony?.

Thanks Peter. The company recorded a net loss attributable to common stockholders of 8.1 million or $0.80 per share year ended December 31st 2017 compared to net loss attributable to common stockholders of 6.8 million or $0.73 per share for the year ended December 31st 2016.

The increase was primarily due to the deemed dividend related to the warrant conversion in 2017. The per share amounts have been adjusted to give effect to the one for 10 reverse stock split that occurred on February 8th 2018. Research and development expenses were 5.5 million for both the years ended December 31st 2017 and December 31st 2016.

General and administrative expenses for the year ended December 31st 2017 increased to 3.5 million compared to 3.0 million for the year ended December 31st 2016. The increase was primarily due to increased legal and audit fees. As of December 31st, 2017, the company had a cash of 6.0 million compared to 9.4 million at December 31st 2016.

Net cash used in operating activities for the year ended December 31st 2017 was 8.0 million compared to 8.1 million for the comparable period in 2016. Net cash used in investing activities for the year ended December 31st 2017 was 0.5 million. Net cash provided by financing activities for the year ended December 31st was 5.1 million.

I’ll now turn the call back over to Peter..

Thanks Anthony, overall, we’re thrilled with the progress we’ve made throughout 2017. We’re moving our product candidates through the clinic, advancing our pre-clinical development programs and building a strong business for the long-term.

We have a number of important clinical milestones ahead, where we believe will position us for continued growth and expansion. Let me summarize our expected plans for the coming year ahead. First, we expect to implement the protocol amendments to our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia.

Second, can we see FDA approval and potentially initiate Phase 1 clinical trials of BP1002 lymphoma by year-end. Three, just finalize plans and FDA approval to begin enrollment of the Phase 1 clinical trial of prexigebersen in solid tumors. And finally, to begin a series of IND enabling studies for BP1003 in pancreatic cancer.

We continue to have great confidence in the potential of our DNAbilize platform technology to produce therapeutics that will have a meaningful impact on patients.

The success of these programs represents a core or Bio-Path core mission and we continue to execute our business strategy to advance these programs and number of indications with significant unmet medical need. With that operator, we are ready to open the call for questions. .

Thank you. [Operator Instructions]. And our first question comes from Laura Engel with Stonegate Capital Partners. Your line is now open. .

One if you just ask about, so you have a busy 2018 it sounds like. If you could just comment on current cash burn versus what you’re expecting, it sounds some of this activity might fall in the lateral half of the year if I’m correct. And so, based on that and some of the information in the K that was filed.

Are you expecting a little bit of the reduction your cash burn in the first part of the year and maybe bump up with this activity in the second half?.

Well, first of all as we report, we have explained on hand at least reasonably expect 1.5 million in quarter. So, we have the money to been achieve our core milestones for year. We spent a little bit of overlap money last year and some overlap into this year on the drug supply.

So, we have quite a bit of drug product on-hand for testing and as you know that’s a significant component of our R&D expense and cash needs. In terms of the actual timing of things we are redoing as you know will be doing two arms now with the chance for two cohorts in the AML trial, LDAC and prexigebersen and now LDAC with [indiscernible].

But those take a couple of months to gear up, so you’re correct in your assessment on the timing of that clinical testing. CML is a safety program, it’s Phase 2 run in if you will. So that’s a 3 plus 3 study, so that’s 6 patients. So that’s not terribly consuming with cash.

The other programs which are very exciting as well prexigebersen potentially in solid tumors this year and Bcl2, BP1002 latter part of those.

Those things are timed on working with the FDA and so you’re correct in your assessment as well with those things, by the time we get approvals and all of that kind of things probably wouldn’t ramp up until towards the end of the year.

And the other things are preclinical studies which cost money, some of those have been funded already the BP1003, the Stat3 and pancreatic that would be a new round of studies, but again that’s manageable. So, we have the money, the fund is necessary to advance our programs for 2018, we understand pretty well our cash and how to manage it.

So, we’ll be fine. .

Okay. And you actually addressed my other questions, so I appreciate it and congrats on a great report and really looking forward to this year so I’ll get back in the queue..

Thank you. [Operator Instructions]. And I’m showing no further questions at this time. I’d like to turn the conference back over to Peter Nielsen for any closing remarks..

Thank you, operator. Thank you again for joining us today, again we’re very excited about what we have accomplished, but real exciting things are in front of us. So, thank you for your continued support for Bio-Path and thank you. .

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..