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OncoGenex Pharmaceuticals' (OGXI) CEO Scott Cormack on Q4 2015 Results - Earnings Call Transcript
Mar. 9, 2016 9:39 PM ET| About: OncoGenex Pharmaceuticals Inc. (OGXI)
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Operator

Good day ladies and gentlemen and welcome to the OncoGenex fourth quarter 2015 conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this conference is being recorded.

I would like to introduce your host for today's conference, Mr. Jim DeNike, Senior Director of Corporate Communications. Sir, please begin.

Jim DeNike

Thanks Vance and thanks everyone for joining us. With me today from OncoGenex are Scott Cormack, President and Chief Executive Officer, John Bencich, Chief Financial Officer and Dr. Cindy Jacobs, our Chief Medical Officer.

Before we begin, I would like to remind everyone that today's conference call contains forward-looking statements based on current expectations. These statements are only predictions and actual results may vary materially from those projected. Please refer to OncoGenex documents filed with the SEC concerning factors that could affect the company, copies of which are available on the website.

I will now turn the call over to Scott.

Scott Cormack

Thanks, Jim. On today's call, we will provide an update on our clinical development programs with near-term milestones that we believe could create significant value for the company over the next 12 months. Following our program update, John will provide an overview of our financial position that includes steps we have taken to further strengthen our balance sheet.

These steps have extended our cash runway for additional six months, which now takes us into the third quarter of 2017. Our cash position will allow us to execute on our clinical development plans, including reporting of two Phase III clinical trials, two Phase II clinical trials and preparation of an investigational new drug application so that it would be submission ready for the FDA.

Let me take a few minutes to walk you through the status of each of these programs starting with the Apatorsen IND in non-muscle invasive bladder cancer. Our Apatorsen compound is a subject of four ongoing clinical studies designed to evaluate whether inhibition of Hsp27 can lead to improved treatment outcomes for cancer patients. The trials underway are designed to evaluate Apatorsen in bladder, lung and prostate cancer in combination with various treatments. They are being conducted in order to provide information for designing future Phase III trials and could be used as supportive studies for registration purposes.

Starting with bladder cancer. We have data in hand from two completed studies in advanced metastatic and non-muscle invasive bladder cancer. These data include results presented at ASCO 2015 from the Phase II Borealis-1 trial in which patients who were defined as having risk for poor survival outcome and received Apatorsen in combination with chemotherapy experienced a 27% reduction in risk of death compared to patients receiving chemotherapy alone. Data has also been presented from a Phase I trial evaluating patients with non-muscle invasive bladder cancer in which 33% of the patients treated had no pathologic evidence of disease following treatment with Apatorsen.

Based on these encouraging findings, we submitted a pre-IND package to the FDA for evaluation of intravesically administered Apatorsen in combination with BCG treatment in patients with non-muscle invasive bladder cancer. We recently received feedback from the FDA regarding our proposed trial protocol under this newly proposed IND. I am pleased to report that the FDA had no objection to our proposed study population or classification of subpopulations in the study design and concluded that the proposed definitions of primary and secondary endpoints were acceptable.

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