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

Yi Chen - H.C. Wainwright.

Good morning, ladies and gentlemen and welcome to the Bio-Path First Quarter 2016 Financial Results 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 would like to welcome you to the Bio-Path Holdings conference call and webcast to review the company’s first quarter 2016 financial results and to provide an update on recent pipeline and corporate development.

Earlier today, we issued a press release, which outlines the topics that we plan to discuss today and the release is available at www.biopathholdings.com. With me today from Bio-Path are Peter Nielsen, Bio-Path’s CEO; and Dr. Ulrich Mueller, COO.

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 then 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 will now turn the call over to Bio-Path’s CEO Peter Nielsen. .

Thanks, Will. Good morning everyone and thank you for joining us today. This year has already proven to be a truly pivotal year for Bio-Path, as we’ve made significant progress with both our own clinical development programs in oncology and with the initiation of strategic research collaborations.

We are very encouraged by the positive safety data from our lead program’s Phase II study in AML and we are excited about our recently announced research collaborations as they validate the potential for our DNAbilize technology in a broader variety of indications.

DNAbilize is a proprietary neutral lipid technology that enables delivery for nucleic acid therapeutics, and facilitates their development.

Our delivery technology form structures 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 cells. Most importantly, there has been no evidence of toxicity associated with our technology.

These advances position us to expand both our clinical development programs and new oncology indications and attract interest in new partnership with both epidemics and drug developments. We are beginning to see the evolution of our DNAbilize technology platform as a viable drug delivery solution in a variety of important areas of unmet medical need.

Throughout the balance of 2016, we will continue to pursue this strategic plan of expansion. Now, let’s turn to a discussion of our lead candidate BP1001, a Liposomal Grb2 antisense currently in development for treatment of acute myeloid leukemia or AML.

In March, we announced positive results from the eighth and final cohort of the safety segment of our Phase II trial assessing the toxicity of BP1001 in combination with low-dose cytarabine or LDAC chemotherapy in patients with AML.

Patients were treated with 90 mg/m2 of BP1001 twice a week over a four-week period in combination with a standard regimen of frontline LDAC. Results were consistent with those seen in previous cohorts, demonstrating BP1001 to be safe and well tolerated with signs of anti-leukemia activity. We saw no adverse events attributable to BP1001 treatment.

In Cohort 8, we saw two AML patients achieve partial remission. With the closing of Cohort 8, the Phase II safety assessment of BP1001 in combination with LVAC was completed.

The safety assessment include two cohorts, Cohort 7 and Cohort 8 which is six patients evaluated with 60 milligrams per square meter and 90 milligram per square meter of BP1001 in combination with LVAC. No toxic side effects attributable to BP1001 treatment were observed at either dose.

Of the six evaluable patients included in both cohorts of the safety segment, two achieved complete remissions while two others achieved partial remission. In each of the responding patients their blood property showed improvement suggesting BP1001’s potential efficacy as a combination therapy.

These are very encouraging results that give us confidence moving forward in this indication for which there are few viable treatment options. As a result of these positive safety data, the FDA has given us the green light to move forward with the efficacy portion of this study in the second quarter.

And we believe that both safety and efficacy of our platform technology will be demonstrated. In addition, during the second quarter we plan to initiate a Phase II in our DNAbilize technology to treat chronic myeloid leukemia or CML patients in blast phase.

Similar to AML, we believe our technology offers great hope for patients suffering with this devastating disease, we look forward to keeping you posted as to our progress here and our equally confident that our technology will demonstrate both safety and efficacy.

Next, I’d like to turn to two important search collaborations we entered during the first quarter. In March, we announced a sponsored research agreement with The University of Texas Southwestern Medical Center to evaluate our clinical pipeline for its efficacy in down regulating immune response using systemic lupus erythematosus or SLE as a model.

SLE is a chronic autoimmune disorder that presents an array of symptoms, including skin lesions, heart inflammation, joint pain, kidney failure and neuropsychiatric disorders.

We also entered a sponsored research agreement with the University of Texas MD Anderson Cancer Center to evaluate DNAbilize technology platform for its ability to modulate pancreatic cancer. Testing will be performed in xenografts derived from malignant pancreatic tumors removed from patients at MD Anderson.

These collaborations are exciting because they may also offer the opportunity for additional collaborations and to new indication as the promise of DNAbilize continues to be borne out in these studies and captures the attention of both academic centers and drug developers.

Importantly, the collaboration with UT Southwestern underscores the potential of DNAbilize outside of oncology indication and opens a new avenue for out licensing opportunity.

In addition, we continue to develop a broader pre-clinical solid tumor testing program which will evaluate out DNAbilize platform in advanced ovarian cancer in triple negative inflammatory breast cancers and may be expanded to include combination therapies.

In order to sustain the advancement of our technologies, we are evaluating sustainable manufacturing processes including our second product candidate BP1002 in liposomal Bcl-2 antisense molecule.

To complete a drug that’s required for the chemistry, manufacturing and control section of the Investigational New Drug Application which we anticipate filing with the FDA by the end of 2016. We have leased laboratory space for a small lab to perform manufacturing and preclinical development.

The lab is not intended to be a full scale pre-clinical laboratory facility, but instead to focus on specific capabilities that will support advancement of preclinical and manufacturing development at a faster pace.

Turning to a brief review of our financials, the company reported a loss of $1.9 million for the quarter as compared with a net loss of $1.4 million in the same period last year. This increase was primarily due to preparation activities related to our Phase 2 clinical trial in BP1001 in AML.

Basic and diluted net loss per share was $0.02 for the three month period ended March 31, 2016 as compared with a basic and diluted net loss per share of 0.02 in the same period last year. Research and development expense for the quarter increased to $1 million compared to $0.6 million in the same period last year.

General and administrative expense for the quarter was $0.8 million consistent with the same period in 2015. As of March 31, 2016 the company had cash of $6.5 million compared with $8.9 million at December 31, 2015.

Net cash used in operating activities for the three months ended March 31, 2016 was $2.4 million compared to $1.4 million for the comparable period in 2015. So, in closing, we have a lot of exciting opportunities ahead of us. Our team is both excited and motivated to build on the momentum created thus far this year.

We look forward to continuing to advance our DNAbilize technology platform in a variety of important medical indications for which there are limited treatment options.

I would like to take this opportunity to thank both our dedicated team of professionals at Bio-Path and you, our loyal shareholders, for your support and encouragement as we create a new paradigm drug development with our neutral lipid delivery technology for antisense therapeutics. With that, operator, let's open the call to your questions..

Thank you. [Operator Instructions] And our first question is from Yi Chen of H.C. Wainwright. Your line is open..

Hi, thank you for taking my questions.

My first question is, can you give us some color on the patients being enrolled in the efficacy segment of the AML trial and whether the enrollment is on track to report entering results by the end of this year?.

Ulrich, would you field that question, please?.

Yeah. Hello, this is Ulrich Mueller. The patients that we are enrolling for the so-called [indiscernible] patients. These are patients that are not eligible for a full chemotherapy regimen. And we are on track to enrolling first patient in this month and should be on track to having some indications on efficacy by the end of the year. Yes..

Thanks.

Second question is regarding the partnership with MD Anderson and also Texas as a medical center, so are there any rough timeframes we can expect to have the preclinical readouts from the pancreatic cancer, pancreatic tumor model and also the lupus model?.

Go ahead, Ulrich. Please..

[Technical Difficulty].

Ulrich, could you repeat that please? Hello. Yi, I’m sorry. Ulrich may have lost his connection, but I think those are both underway, but I think it would probably be.

Right now, they’re determining what they’re going to test an array of our products and I think it’s probably in to 2017 before we start seeing some results -- the initial results of that preclinical work..

Okay.

Final question, so for R&D expenses and G&A expenses, is the numbers reported for the first quarter typical that, I mean, can we expect those numbers to kind of stabilize throughout the rest of the year?.

Well, I think as indicated in the formal speaking of this call, we did have some frontloading in the first quarter.

As you know, Yi, we have an excellent CRO, one of the top name ones and those folks require a lot of their anticipated expense for the trial to be paid upfront and likewise, we see in the manufacturing arena, we’re gearing up for finished product.

And so, I anticipate we’ll see some moderating of expenses in the second, third and fourth quarters because again we’ll have had the drug on hand to try to take those patients through in the CML trial.

When that starts, remember, that is just the safety component, which will be pre-evaluated over each cohort, two cohorts likely and that’s only 6 patients. So I would think it won’t be as robust beyond this first quarter for the rest of this year..

Got it. Thank you..

Thank you for your questions, Yi..

Thank you. And that does conclude our Q&A session for today. I would like to turn the call back to Mr. Peter Nielsen for any further remarks..

Well, thank you for joining us this morning and for your continued interest and support. I hope your call -- our call has given you a greater understanding of our progress and plans as we advance DNAbilize in multiple medical applications. We look forward to building on our momentum and to addressing you on our next quarterly update. Have a great day..

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