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

Jason McCarthy - Maxim Group, LLC Yi Chen - H.C. Wainwright & Co., LLC.

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings First 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 first 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; COO, Dr. Ulrich Mueller; 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 vary 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. 2017 is off to a great start highlighted by both clinical and corporate progress that advances our DNAbilize technology platform.

As you know, DNAbilize is a proprietary antisense and neutral lipid technology that enables delivery of 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 a discussion of the status of our clinical program for the treatment of acute myeloid leukemia or AML. Enrollment continues at pace in our Phase 2 study of prexigebersen, previously known as BP1001, our compound using DNAbilize technology 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 BP1001 in combination with LDAC, compared to historical response rates documented for LDAC alone.

Evaluable patients will receive an initial dose IV infusion of BP1001 over 60 minutes and every three days thereafter, as eight doses per 28-day cycle of 60 milligram per square meter BP1001, 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.

Moreover, 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 AML, as you know, we are advancing our plans to expand our DNAbilize technology platform in other important oncology indications.

We continue to finalize our plans to begin the toxicity portion of our Phase 2 trial of prexigebersen in CML, and expect that study to initiate in the coming months. 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, we were pleased to present preclinical data demonstrating BP1002 as a potential treatment for aggressive non-Hodgkin's lymphoma at the American Association for Cancer Research Annual Meeting. In an in vitro study, lymphoma cell lines were incubated with BP1002.

It was determined that BP1002 induced greater than 50% inhibition in 11 of the 15 cell lines tested. In two in vivo mice studies, BP1002 enhanced survival of mice over untreated and control arms.

We are now preparing to submit an investigational new drug or IND application for BP1002 in preparation for Phase 1 clinical trial in lymphoma by the end of this year. Finally, I'm delighted to report an important corporate update. In April, Dr. William Hahne joined Bio-Path team as Vice President of Clinical Research.

During his career, Bill has develop extensive expertise in management of oncology and hematology, drug trials as well as valuable experience managing regulatory applications in the U.S., Canada and Europe.

His experience directing clinical research programs, maximizing product pipelines and managing medical affairs teams makes him a valuable addition to our team. We look forward to leveraging his years of experience as we continue to advance our clinical programs in our DNAbilize platform across a multitude of disease states.

With that, I'll now turn the call over to Anthony Price for a brief overview of our financials..

Thank you, Peter. Company reported a net loss of $0.4 million or $0.01 per share for the three months ended March 31, 2017, compared to a net loss of $1.9 million or $0.02 per share for the same period in 2016. The decrease was primarily due to a non-cash change in the fair value of the company's warrant liability during the period of $1.6 million.

Research and development expenses for both the three months ended March 31, 2017 and March 31, 2016 were $1.0 million.

General and administrative expenses for the three months ended March 31, 2017 increased to $1.0 million, compared to $0.8 million for the same period in 2016, primarily due to increased stock-based compensation expense during the period.

Change in fair value of the company's warrant liability for the three months ended March 31, 2017 resulted in non-cash income of $1.6 million. The company did not have the warrant liability in the comparable period for 2016. As of March 31, 2017, the company had cash of $7.1 million, compared to $9.4 million at December 31, 2016.

Net cash used in operating activities for the three months ended March 31, 2017 was $1.8 million compared to $2.4 million for the comparable period in 2016. Net cash used in investing activities for the three months ended March 31, 2017 was $0.4 million..

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

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

Hi, guys. Thanks for taking the question. Peter, can you give me a sense of the complete response rate that you need to see in the Phase 2 portion of the study, to bring to the FDA and have them grant you permission to expand to a registration trial? Thanks..

Hey, Jason, sure.

Ulrich, could you give the answer for that, please?.

Yes. Good morning, Jason. We are looking for doubling of the complete response rate compared to the historical response rate of low dose Ara-C alone, which is in the 18% to 20% frame. So basically, we are looking for doubling of that to achieve what we expect for our endpoint..

Great.

And for registration trial, can you give us a sense of how many patients you would expect to enroll?.

Our analysis suggests that it would be 196 patients per registration trial..

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

You're welcome..

And Jason, just to note, that would be a double arm, so there would be a control arm in that..

[Thank you for that one] [ph]..

Thank you. [Operator Instructions] Our next question comes from the line of Yi Chen from H.C. Wainwright. Your line is open..

Hi, thank you for taking my question.

Could you give us an update regarding the CML trial, is the trial still going to start this quarter?.

Ulrich?.

We are finalizing our agreement with MD Anderson Cancer Center to initiate the trial and expect it to start in the new few months..

Okay, once this trial starts how much impact you expect on the R&D expenses line?.

Well, that - the trial is - that's one reason why we can start it this year not significantly impact our resources until we do our next fundraise. The safety portion of the Phase 2 is, recall two cohorts of three patients each. And so, it's not a significant amount of drug.

And I think most of it would be done at MD Anderson, which is our most cost effective institution for patient cost. So we budgeted for it in our plan and it would probably be in the $400,000 range. And recall also that drug supply will come out for the main batches that we have going for our Phase 2.

So we are - we plan for it and it is not a significant item..

Okay. Got it.

Regarding BP1002, we can still expect to see the drug enter clinic in probably by the end of this year, right?.

Well, Ulrich, can you give the timing on that?.

Yes. That's our expectation. You're correct..

Okay. Got it. Thank you..

Thank you. [Operator Instructions] I'm showing no questions in the queue at this time. I would like to turn the call over to Peter Nielsen for closing remarks..

Thank you. In closing, we are 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 data we have seen to date with our DNAbilize technology. Importantly, with the addition of Dr.

Hahne, we now have the team in place to enhance the execution of our clinical development plans. We look forward to near-term data readouts from our ongoing programs as well as initiating new clinical studies in the coming months.

We believe that the progress we have made to date well positions us to achieve a number of important clinical and corporate milestones throughout the balance of the year. Thank you for joining us, and for your continued interest and support, without which we could not have made this progress. Have a great day..

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day..