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

Analysts:.

Good morning ladies and gentlemen. Welcome to the Bio-Path Holdings third quarter 2018 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. Welcome to the Bio-Path Holdings conference call and webcast to review the company’s third quarter 2018 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 biopathholdings.com. With me today from Bio-Path are President and CEO, Peter Nielsen, and Vice President of Finance and Accounting, Anthony Price. Before we begin, 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 CEO, Peter Nielsen..

Thanks Will. Good morning everyone and thank you for joining us today. Throughout the third quarter, we continued to make meaningful progress advancing and expanding our robust clinical development pipeline of RNAi nanoparticle drugs to bring innovative new treatments to cancer patients with high unmet medical need.

The progress we have made this year provides the foundation for a number of value creating milestones in 2019 and beyond. I’ll start with a review of our clinical programs. As you know, the DNAbilize platform 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 structure, allowing the antisense drug to be delivered to the diseased cells with high uptake into the cell via incorporation into the lipid layers. There has been no evidence of toxicity associated with our technology.

We are extremely enthusiastic about the potential of our DNAbilize platform for developing novel treatments for patients suffering from disease with high unmet medical need. Let’s dive into an overview of our lead product candidate, prexigebersen.

Earlier this year, we presented exciting interim results from our Phase 2 study of prexigebersen 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.

The trial is open label with a two-stage design to assess the safety profile, pharmacokinetics, pharmacodynamics, and efficacy of prexigebersen in combination with LDAC or decitabine, compared to historical response rates documented for LDAC or decitabine 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.

In our interim analysis from this ongoing Phase 2 study, our results show that 47% of the 17 evaluable patients showed some form of response to the combination treatment, including four patients with complete remission or 23%, and four patients with stable disease, including one patient who achieved a leukemia-free status and one patient who had significantly reduced bone marrow blasts.

During the third quarter, we initiated Stage 2 of the trial, implementing dosing modifications and adding a cohort of patients being treated with decitabine, based on new positive data with that compound.

We are excited about the potential of the Phase 2 expansion to show the benefit of prexigebersen in this vulnerable patient population as well as in cohorts being treated with LDAC. We dosed our first patient in the prexigebersen trial expansion this August. We look forward to updating you on our progress with this trial.

Additionally, we were invited to present an analysis of the interim Phase 2 results at the American Society of Hematology, or ASH annual meeting and exposition this December. The results will be presented by Maro Ohanian, Assistant Professor of the Department of Leukemia at the University of Texas MD Anderson Cancer Center.

On top of that, we are also progressing a second Phase 2 study of prexigebersen in chronic myeloid leukemia, or CML. Enrollment is now open in this study, which is a global multi-center trial. Finally, earlier this year we presented pre-clinical data on prexigebersen for the treatment of solid tumors in gynecologic malignancies.

Importantly, prexigebersen decreased tumor burden and multi-nodular burden in mice compared to control with no apparent toxicity. We plan to initiate a Phase 1 trial of prexigebersen in several solid tumor types, including ovarian tumors. In addition to prexigebersen, we’re excited to bring our second product candidate forward into the clinic.

As you may recall, we have seen positive pre-clinical results for our second drug candidate, BP1002, which targets the Bcl-2 protein. We plan to initiate a Phase 1 trial of Bcl-2 in the treatment of lymphoma and chronic lymphocytic leukemia, or CLL. We plan to file an IND for BP1002 around year-end.

We are also progressing our third drug candidate, BP1003, which targets the Stat3 protein. We are initially studying BP1003 for the treatment of pancreatic cancer in a patient-derived tumor model. Previous models have shown the drug 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 platform and expect to initiate a series of IND-enabling studies for BP1003 in 2019, with a goal to enter a first-in-human trial with this very promising product candidate in 2020.

As always, we continue to evaluate opportunities to expand our DNAbilize technology platform to other oncology indications. Now on to corporate updates. This quarter we were excited to welcome Dr. Jason Fleming to our scientific advisory board. Dr.

Fleming is a world leading gastrointestinal cancer expert and currently serves as Chair and Program Director of the Department of Gastrointestinal Oncology at the Moffitt Cancer Center. Dr Fleming developed a novel patient-derived pre-clinical tumor model for pancreatic cancer which Bio-Path has used in its own pre-clinical work. Dr.

Fleming offers substantial insight to our scientific leadership as we seek to advance prexigebersen and BP1003 towards the clinic for the treatment of pancreatic cancer. Finally, during the third quarter we successfully raised $1.5 million in a registered direct offering.

This financing further strengthened our cash position and enables us to continue executing on our clinical development plans for our three promising therapeutic candidates. With that, I’ll now turn the call over to Anthony Price for a brief overview of our financials.

Anthony?.

Thanks Peter. The company reported a net loss of $3.1 million or $0.27 per share for the three months ended September 30, 2018 compared to a net loss of $2.5 million or $0.25 per share for the three months ended September 30, 2017.

Research and development expenses for the three months ended September 30, 2018 increased to $2.3 million compared to $1.6 million for the three months ended September 30, 2017 primarily due to costs related to the release of drug material for our Phase 2 clinical trial for prexigebersen in AML and CML.

General and administrative expenses for the three months ended September 30, 2018 decreased to $0.7 million compared to $0.9 million for the three months ended September 30, 2017, primarily due to decreased legal and audit fees. As of September 30, 2018, the company had cash of $2.3 million compared to $6.0 million at December 31, 2017.

Net cash used in operating activities for the nine months ended September 30, 2018 was $4.8 million compared to $5.7 million for the comparable period in 2017. Net cash provided by financing activities for the nine months ended September 30, 2018 was $1.2 million. With that, I’ll now turn the call back over to Peter..

Thanks Anthony. In closing, we are encouraged by the meaningful progress we’ve made this quarter with both our clinical development efforts and towards strengthening the business as a whole.

We continue to move our three DNAbilize product candidates through the clinic in support of our mission of developing important medicines for patients with limited available treatment options. We are working diligently to advance our clinical programs and our R&D pipeline and look forward to several value creating milestones in 2019 and beyond.

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

I’m currently showing no questions at this time. I’d like to turn the call back over to Peter Nielsen for closing remarks..

Thank you again for joining us and for your continued interest and support of Bio-Path. Have a great day..

Ladies and gentlemen, this concludes today’s conference. Thanks for your participation and have a wonderful day..