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

Jason McCarthy - Maxim Group Roshni Mahadeo - Rodman & Renshaw.

Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings third quarter 2016 earnings conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up 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 third quarter 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; 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 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 the third quarter and in recent weeks, we have made meaningful progress across our clinical and corporate development programs. And I'm excited to report on these advancements this morning.

As a brief recap, DNAbilize is a proprietary antisense and mutual lipid technology that enables delivery for nucleic acid therapeutics and facilitates their development.

Our delivery technology form structure is similar to cellular membrane, therefore allowing the antisense drug to be incorporated within the lipid layers and to 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.

Turning now to the progress we’ve made with our acute myeloid leukemia, or AML program, we recently announced the enrollment and dosing of the first patients in the efficacy portion of our Phase II trial of BP1001 for the treatment of AML.

This trial was a multi-center study of BP1001, in combination with low-dose 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 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 mg/m2 of 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 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 BP1001, 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 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. Next, I’d like to turn to a recently regulatory milestone.

Earlier this month, we were pleased to report that BP1001 received orphan drug designation from the European Medicines Agency, or EMA, for the treatment of AML. This important milestone recognizes the urgent need for an effective treatment for AML and the potential of BP1001 to improve outcomes for patients facing this debilitating disease.

To receive orphan drug designations from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union.

Orphan drug designation provides incentives designed to facilitate development, including fee reductions for protocol assistance, scientific advice, and, importantly, may include up to ten years of market exclusivity in the EU following product approval.

Looking ahead to the remainder of this year, we will be presenting data at the 58th Annual – ASH annual meeting on Monday, December 5 in San Diego. Dr. Ana Tari Ashizawa, Director of Research of Bio-Path, will present preclinical and clinical data of BP1001 for the treatment of chronic myeloid leukemia, or CML.

To that end, we expect to enter the safety portion of our Phase II trial of BP1001 for the treatment of CML around year-end and we look forward to updating you on this program at that time. With that, I’ll now turn the call over to Anthony Price for a brief overview of our financials.

Anthony?.

Thank you, Peter. The company reported a net loss of $1.6 million or $0.02 per share for the three months ended September 30, 2016 compared to a net loss of $1.5 million or $0.02 per share for the same period last year.

The increase was primarily due to the release of drug material for our Phase II clinical trial for BP1001 in AML and associated clinical trial costs. Research and development expenses for the three months ended September 30, 2016 increased to $2.3 million compared to $1.0 million for the same period in 2015.

General and administrative expenses for the three months ended September 30, 2016 increased to $0.7 million compared to $0.5 million for the three months ended September 30, 2015. As of September 30, 2016, the company had cash of $11.3 million compared to $8.9 million at December 31, 2015.

Net cash used in operating activities for the nine months ended September 30, 2016 was $6.5 million compared $4.0 million for the comparable period in 2015..

Okay. With that overview, operator, we're ready to open the call for questions. .

Thank you. [Operator Instructions] And our first question comes from Jason Kolbert with Maxim Group. Your line is now open..

Hi, Peter. Actually, it’s Jason McCarthy for Jason Kolbert. Just two questions.

In the AML study, when you get to the 19 patients, what percent of CRs or PRs would you be looking for to move to registration? And if you don't hit it or get exactly what you want, would you take another look at 30 or 40 patients or do you have to go the full distance to 54 patients and what the timing of that could be? My second question is in CML.

Are you going to be enrolling relapsed refractory patients? And if so, how big do you believe that study would be, how many patients? Thanks for taking the questions..

Great. Great to hear from you, Jason. Ulrich, go ahead and – if you would please answer that..

Yes. On the AML trial, we’re looking for a response rate that is in the range – basically, it’s designed as a doubling of the existing response rate for low-dose therapy alone, which is about 18%. So, we're looking for a doubling of that to be – if we exceed that, then we would go for the accelerated approval.

The study is designed that if we don't quite have that after 19 patients, we will continue for the 54 patients. On the CML trial, the study is basically designed in similar fashion to the AML trial and it is designed to be about 44-patient trial.

Did I cover the questions?.

That’s perfect. Great. Thank you for taking those questions..

Thank you..

And our next question comes from Yi Chen with Rodman & Renshaw. Your line is now open..

Hi. This is Roshni Mahadeo calling on behalf of Yi Chen. Thanks for taking my questions.

Could you please give us some color on the expected timeframe of enrollment for the efficacy portion of the Phase II trial?.

Ulrich, go ahead and mention it..

So, at this point, we have four centers open. We will also expand this up to eight centers and potentially more. We expect to have the first 19 patients dosed and evaluable by the middle of next year..

Okay.

And will there be an interim data analysis?.

That will be the interim data analysis at that point..

Okay. Okay.

And when is the CML trial scheduled to start and when will data from that safety segment be available?.

The safety segment of that trial is scheduled to start around the year-end or beginning of 2017, very early. And we should have the safety portion completed by the middle of 2017..

Okay.

And then, is there any update for BP1002?.

The latest update is that we are continuing to work on our manufacturing and cleaning up the CMC for our IND. We expect to have that ready for filing to the FDA for opening the trial in early 2017..

Okay, thank you..

Thank you..

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

Thank you. And in closing, we’re pleased with the significant progress we’ve made executing our clinical strategies. We’re in a solid financial position from which to execute our plans and expect to achieve a number of key clinical milestones in the coming months that we believe should enhance our shareholder value.

Thank you for joining us this morning and for your continued interest and support. Have a great day. Thank you..

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