Will O’Connor - Stern Investor Relations Peter Nielsen - President and CEO Ulrich Mueller - COO.

Jason McCarthy - Maxim Group Yi Chen - Rodman & Renshaw.

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings Year-End 2016 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. My name is Will O’Connor of Stern Investor Relations. I’d like to welcome you to the Bio-Path Holdings conference call and webcast to review the Company’s year-end 2016 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. The release is available at biopathholdings.com. With me today from Bio-Path are President and CEO, Peter Nielsen; and COO, Dr. Ulrich Mueller.

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. Throughout 2016, we made considerable progress advancing our DNAbilize technology in a number of important oncology indications.

We were delighted to be select to deliver our promising clinical and scientific data in important oncology medical meetings during the year, including ASCO and ASH among others. As an overview, DNAbilize is a proprietary antisense and mutual lipid technology that enables delivery of nucleic acid therapeutics and facilitates their development.

Our delivery technology form structure similar to 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.

We are very encouraged by the opportunity for prexigebersen to rate AML based on data on the safety segment of our Phase 2 trial. Of the six evaluable patients in this segment, four patients completed more than two cycles of treatment. Three patients achieved complete remission and two patients achieved partial remission.

We call these are refectory patients where they are limited or note treatment options.

Beyond the safety cohort, the ongoing efficacy portion is a multicenter study of prexigebersen in combination with low dose for cytarabine, or LDAC, in patients with previously untreated AML who were 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 mg/m2 of prexigebersen in combination with LDAC compared to historical response where it's documented for LDAC alone.

Evaluable patients will receive an initial dose IV infusion of prexigebersen over 60 minutes for every three days thereafter, as eight doses per 28-day cycle of 60 mg/m2 of 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 the number of patients who achieve complete remission, including with 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.

Importantly, the full trial design includes approximately 54 evaluable patients with an interim analysis performed after 19 patients.

In the event the interim results achieve the primary endpoint in a number of patients that meets or exceeds statistical significance, we will be in a position to seek breakthrough designation from the FDA, which would convert this study into a registration directed trial for accelerated approval.

We are also encouraged by the advancements we have made. To-date we have six important clinical sites actively evaluating and enrolling patients.

Feedback from our key opinion leaders and expert consultants encourage us to believe that this pathway is viable, especially given the particularly positive preclinical and early human clinical data we’ve demonstrated with prexigebersen in AML.

In addition to the progress we’ve made in AML, we continue to move forward in other important oncology indications. Plans with the indication initiation of the toxicity portion of our Phase 2 trial of prexigebersen CML continue at pace that we now expect that study to initiate in coming months.

We are particularly excited for this indication as we have seen efficacy signal from earlier studies across the spectrum of hematological cancers. As with AML, there is a great need for better treatment options for advanced CML patients, and we believe our DNAbilize technology will provide a novel approach to providing better outcomes.

Further advancing our leadership position as an innovator in oncology developments, we are delighted to add Dr. Craig Hooper to our Scientific Advisory Board. Dr. Hooper is the Professor of Cancer Biology and Neurological Surgery at Thomas Jefferson University, an world renowned researcher in the area of glioblastoma.

He has published over 140 papers in peer reviewed journals and serves on editorial boards of the Journal of Immunology Research Scientific Reports and the Journal of Immunology. In 2016, he was inducted into the National Academy of Inventors. With someone of Dr.

Hooper's caliber to join the Scientific Advisory Board of an emerging growth biotechnology company, speaks to his belief that our DNAbilize technology platform can make a difference in the lives of patients. Further, Dr. Hooper's extensive experience in immuno-oncology is expected to bode well with our pre-clinical immuno therapy work.

He is excited as we are to move these programs forward and we look forward to reporting these advancements. In the near-term, we will be presenting exciting preclinical data at the upcoming 2017 American Association for Cancer Research or AACR Annual Meeting on Wednesday April 5th, in Washington D.C. Dr.

Ana Tari Ashizawa, our Director of Research, will present data from BP1001 program or Liposomal Bcl-2 antisense, our second drug candidate for the treatment of aggressive non-Hodgkin's lymphoma. These data are excited and as they continue to support the strong potential of our DNAbilize platform technology and hematologic cancers of unmet need.

Further supporting this program; preclinical studies are in progress, which when completed, are expected to allow for an IND submission to the FDA to initiate a Phase 1 clinical trial. We have a year's work of additional developments to support the DNAbilize drug particle properties needed to excel BP1002 as a potential solid tumor treatment.

Finally, we are delighted to have opened a new research and development laboratory in Houston, fully outfitted for new drug candidates testing and evaluation. We’re confident that this new facility will expedite drug discovery and potential asset value creation in the years to come. With that, and I'll now turn to a brief overview of our financials.

The Company reported a net loss of $6.8 million or $0.07 per share for the year ended December 31, 2016 compared to a net loss of $5.5 million or $0.06 per share for the year-ended December 31, 2015.

The increase was primarily due to the release of drug material for the Company's Phase 2 clinical trial for prexigebersen AML and associated clinical trial cost. Research and developments expenses for the year ending December 31, 2016 increased to $5.5 million compared to $3 million for the year-ended December 31, 2015.

General and administrative expenses for the year-ended December 31, 2016 increased to $3 million compared to $2.5 million for the year-ended December 31, 2015. Change in fair value of the Company's warrant liability for the year-ended December 31, 2016 resulted in a non-cash income of $1.7 million.

We did not have a warrant liability in the comparable period of 2015. As of December 31, 2016, the Company had cash of $9.4 million compared to $8.9 million at December 31, 2015. Net cash used an operating activities for the year-ended December 31, 2016, was $8.1 million compared to $5 million for the comparable period in 2015.

Net cash used in investing activities was $0.3 million for the year ended December 31, 2016. The Company did not use any cash in investing activities for the comparable period of 2015. Net cash provided by financing activities for the year-ended December 31, 2016, was $9 million. That completes the financial overview.

In closing, throughout the balance of 2017, we will remain committed to advancing our novel DNAbilize technology across a variety of important oncology indications, included AML, CML, non-Hodgkin's lymphoma and glioblastoma. We believe we are well positioned for success and look forward to achieving a series of near-term value creating milestones.

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

Thank you, sir [Operator Instructions]. Our first question comes from the line of Jason Kolbert from Maxim Group. Please proceed..

Good morning, Peter its Jason McCarthy for Jason Kolbert.

Just couple of questions for the -- how many patients are currently enrolled in the AML study? And can you give us a sense of the timing for interim data, really how many CRs you need to see to take that data and go to the FDA to break there?.

Ulrich, would you handle that question please..

So, we are, as Peter mentioned, we are now open at six excellent sites and we are on track to have completed our interim analysis by the end of the year. Basically, the number for us for the endpoint is a doubling of the existing CRA, which is right now at 18% and 19%..

And if you do get, if you get to that rate or you hit that rate and you do get to expand to registration study.

Would you have to have a study larger than the total 54 patients? And if so, how big do you think you need it to be?.

Yes, it would need to be larger, because we would need to add a control arm, and our current analysis indicates it would be about 196 patient study..

Including the interim patients?.

No, I would say, it would be a fresh study with, yes..

Thank you [Operator Instructions]. Our next question will comes from the line of Yi Chen with Rodman & Renshaw. Please proceed..

Could you give us some update regarding the status of the Phase 2 trial of CML, and also what's the current preclinical or IND preparation status will be BP1002.

Thank you?.

So, the CML trial is currently finalizing preparation with MD Anderson Cancer Center, and we expect to open within the next few months. The Bcl-2 study, we are completing some animal studies based on new composition and new formulation, and we expect to be able to file that IND later this year..

Do you expect any significant change in R&D or G&A expenses within 2017?.

Yi, this is Peter. We’re going to -- we’re focusing during 2017 principally on the AML study that’s a value creation study. So, we would pull those back some a little bit the other programs and support to key things. The AML, we do want to do the tox piece of the CML.

But then not take on any new preclinical activities certainly complete the commitments we’ve made in preclinical programs. So that in fact we can have things that conform to about an $8 million spend during the year 2017.

And of course as we create value points, we'll then look to do our next round in bringing in funds, and when we do that we'll open that up to aggressively expanding on the opportunities that we have.

But for now, we’re going to focus on the main things that can bring in the value creation as the AML fragile Phase 2 and secondarily the CML tox piece Phase 2..

Thank you. Since there are no further questions in the queue, it is now my pleasure to hand the conference over to Mr. Peter Nielsen, Chief Executive Officer, for closing comments or remarks.

Sir?.

Thank you everyone for joining us this morning, and for your continued interest and support. And have a great day..

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude the program. And you may all disconnect. Everybody, have a wonderful day..