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Achieve Life Sciences, Inc. (ACHV)

Q1 2016 Earnings Call· Thu, May 12, 2016

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the OncoGenex First Quarter 2016 Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the call over to Jim DeNike, Senior Director, Corporate Communications. Please begin.

Jim DeNike

Analyst

Thanks, Latoya, 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, Chief Medical Officer. Jaime Welch, our Vice President of Marketing and Corporate Communications will also be available for the Q&A. Before we begin, I’d 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’s documents filed with the SEC concerning factors that could affect the company, copies of which are available on the website. I’ll now turn the call over to Scott.

Scott Cormack

Analyst

Thanks, Jim. On today’s call, we will provide an update on our clinical development programs with near-term milestones that we believe have the potential to create significant value for the company over the next 12 months. Since Custirsen and Apatorsen are advancing toward commercialization, we wanted to review our perspectives on the evolving prostate, lung and bladder markets and the potential opportunities for our product candidates to fulfill the need for new treatments in these diseases. Following our program update, John will provide an overview of our strong financial position that will carry us through upcoming milestones without the need for additional funding. Let me start with our most advanced clinical asset, Custirsen. Custirsen is currently being evaluated in two phase 3 clinical trials, one for prostate cancer and the other for lung cancer. This compound is highly specific inhibitor of the protein clusterin that is designed to improve survival in patients with advanced cancer by disabling the fundamental cellular repair mechanism used by tumor cells. We have two randomized phase 3 trials expected to read out over the next year or so. The first is our AFFINITY trial. AFFINITY is a phase 3 clinical trial evaluating the survival benefit for Custirsen in combination with cabazitaxel as second-line chemotherapy in approximately 630 men with castrate-resistant prostate cancer. In December 2015, an independent data monitoring committee recommended continuing the trial as planned based on the interim analysis. Both the independent data monitoring committee and OncoGenex remain blinded to all interim analysis data. Depending on timing of the events, final results for the overall study population are expected in the third quarter of this year. As we look at the role for Custirsen in the treatment of advanced prostate cancer, it is important to note that the five-year survival rate for men…

John Bencich

Analyst

Thanks, Scott. Our cash position remains very strong and will allow us to achieve the important data milestones that Scott just summarized without the need to raise additional capital. As of March 31, 2016, our cash, cash equivalents and short term investments were $46.1 million compared with $55.2 million as of December 31, 2015. Based on our current expectations, we believe that our cash position will be sufficient to fund our currently planned operations into the third quarter of 2017. Depending on timing of enrollment or event-driven final analyses, the expected key milestones and activities include: announcement of the phase 3 AFFINITY trial results in the third quarter of 2016; announcement of the phase 2 Borealis-2 trial results in the second half of 2016; announcement of the phase 2 Spruce trial results for the overall survival endpoint in the second half of 2016; completion of a submission-ready IND application for Apatorsen treatment in patients with non-muscle invasive bladder cancer; and announcement of the phase 3 ENSPIRIT trial in the first half of 2017. Revenue for the three months ended March 31, 2016 and 2015 were $2.9 million and $1.4 million, respectively. The increased revenue in 2016 as compared to 2015 was due to higher collaboration revenue recognized as a result of higher ENSPIRIT trial costs. This was partially offset by a decrease in revenue recognized for the AFFINITY trial as a result of a decrease in associated clinical activities as this trial nears completion. Total operating expenses for the three months ended March 31, 2016 and 2015 were $7.4 million and $6.4 million, respectively. Net loss for the three months ended March 31, 2016 and 2015 was $3.7 million and $4.5 million, respectively. That concludes the summary of our first quarter financial results. I’d like to now turn the call back over to Scott. Scott?

Scott Cormack

Analyst

Thanks, John. The second half of this year includes a number of significant catalysts including results from our phase 3 AFFINITY trial of prostate cancer as well as important data from our Borealis-2 bladder cancer trial. And as we look out into the first half of next year, we expect results from our phase 3 ENSPIRIT trial in lung cancer, a pivotal study that has already successfully completed a final and more rigorous interim futility analysis. At the prostate, lung and bladder cancer markets continue to expand and call for more treatment options, we believe Custirsen and Apatorsen are uniquely positioned to provide a meaningful difference to patients. We are excited about these opportunities and we look forward to additional data to be gained in the third quarter this year. Thank you again for your continued interest in OncoGenex and we look forward to speaking with you again soon. I’d now like to invite the operator, Latoya, to open the call for questions.

Operator

Operator

[Operator Instructions] The first question is from Katherine Xu of William Blair.

Katherine Xu

Analyst

I’m just wondering, Scott, you talked about the FIRSTANA study potentially moving Jevtana to the front-line. But if you’re considering Custirsen in combination with Jevtana in that setting, are you going to see [indiscernible] prognostic factors?

Scott Cormack

Analyst

Cindy, you are online, I believe, this afternoon and I think that’s probably a great question for you to consider for Katherine.

Cindy Jacobs

Analyst

One of the things that we would be considering is obviously if successful with AFFINITY showing that Custirsen in combination with Jevtana has improved survival over Jevtana alone, we would be looking at moving it into first-line most likely with patients that could have more poor prognostic features and have those discussions with the FDA to look at such a trial.

Katherine Xu

Analyst

Thank you. And all the best with the Q3 AFFINITY release.

Scott Cormack

Analyst

Thanks a lot, Katherine. Looking forward to it. There is a lot coming up in the second half of this year.

Operator

Operator

We have another question from Danielle Brill of Needham & Company.

Danielle Brill

Analyst

I’m on for Chat this evening. I just wanted to clarify, the IND you’re preparing for the intravesical administration of Apatorsen is you’re not planning on running any trial on your own; you’re seeking a partner for any development. You’re just preparing the IND, is that correct?

Scott Cormack

Analyst

Yes. Right now, we are preparing the IND and the plan for future development will depend a lot on our second half of the year actually. Clearly if AFFINITY is positive and we start moving towards commercialization, then I think our ability to conduct a trial of that nature is obviously much easier than it would be if the trial is not successful. In the alternative, obviously we’d be looking more for partnering strategies and the like. So I think it’s you’ll have to see how the back half of this year shapes up for us and that will help determine how we execute on that plan.

Danielle Brill

Analyst

Best of luck to you.

Scott Cormack

Analyst

Thank you very much.

Operator

Operator

[Operator Instructions]

Jim DeNike

Analyst

Latoya, this is Jim. If I could just insert one thing before we close out the call. As Scott was reading the discussion about our estimated treatable patients for non-muscle invasive bladder cancer patients, there was a little bit of a break in the audio. So I, just for the record, just wanted to restate that number and we estimate that number to be approximately 90,000 treatable non-muscle invasive bladder cancer patients in the US. So I just wanted to make sure that was restated correctly.

Scott Cormack

Analyst

Thanks, Jim. Didn’t realize we had a break in the audio.

Jim DeNike

Analyst

Yeah, I just wanted to make sure, thanks, Scott.

Scott Cormack

Analyst

Latoya, do we have any other questions queued up?

Operator

Operator

There are no questions in the queue. I’ll turn the call back over to Scott for closing remarks.

Scott Cormack

Analyst

Great, thank you very much. And thank you again for participating in our call this afternoon. We look forward to sharing additional results with you from our phase 3 AFFINITY trial and our phase 2 Borealis-2 and Spruce trials later this year. We expect all of those to occur in the second half. Thank you very much for participating. Bye for now.

Operator

Operator

Thank you. Ladies and gentlemen, this concludes today’s conference. You may now disconnect. Good day.