Earnings Labs

Achieve Life Sciences, Inc. (ACHV)

Q1 2015 Earnings Call· Thu, May 14, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the OncoGenex First 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, today's call is being recorded. I would now like to turn the call over to Jim DeNike, Senior Director of Corporate Communications. Please go ahead.

Jim DeNike

Analyst

Thanks Nicholas, and thanks everyone for joining us. With me today from OncoGenex are Scott Cormack, President and Chief Executive Officer; and John Bencich, Chief Financial Officer. Cindy Jacobs, our Chief Medical Officer is currently traveling and will not be available on today's call. Before we begin, I'd like to remind everybody 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'll now turn the call over to Scott.

Scott Cormack

Analyst

Thanks, Jim. Good afternoon and thank you for joining us. Today I will provide an update on several - our key clinical programs, including a preview of data through presented later this month at the American Society of Clinical Oncology Annual Meeting in Chicago. John will then conclude with a review of our financial results for the first quarter and then we’ll open the call to questions. Our two clinical stage assets, Custirsen and Apatorsen are currently being evaluated in two Phase 3 studies and five Phase 2 studies respectively across a variety of cancer indications. Both of these programs have multiple clinical data readouts in the near term making the coming months very exciting. We now have substantial clinical evidence indicating that our products have the potential to improve survival in the most vulnerable patients, those who have an increased risk for poor outcomes. Recent data have shown that patients in the SYNERGY and Borealis-1 trials who had poor prognosis live longer when treated with Custirsen and Apatorsen. I'm pleased to announce the data for both of these trials will be presented at the ASCO Annual Meeting in a couple of weeks along with updates on the Borealis-2 and Cedar trials that will be highlighted as trials in progress. The abstracts are now available on ASCO's website. Let me start with the data to be presented on SYNERGY and how that reinforces our ongoing belief that Custirsen benefits patient's with the greatest therapeutic need. These findings are significant, as our ongoing AFFINITY and ENSPIRIT Phase 3 Custirsen trials include a higher percentage of patients who are at risk - increase risk for poor outcomes. Results from the Phase 3 SYNERGY trial and subsequent exploratory analysis to be presented at ASCO show Custirsen provided a meaningful benefit in men who…

John Bencich

Analyst

Thanks Scott. We ended the first quarter with approximately $40.4 million in cash, cash equivalents and short-term investments. This cash amount does not include the $23.2 million received from Teva on April 27, 2015 in connection with the termination agreement. Based on our current expectations, we believe that our cash, cash equivalents, short term investments and amounts subsequently received from Teva in connection with the termination agreement will be sufficient to fund our currently planned operations into the third quarter of 2016, which includes announcement of Phase 3 AFFINITY trial results expected late 2015 or early 2016, continuation of the ENSPIRIT trial through late 2015 or early 2016, including the final interims utility analysis expected in the next few months, completion of enrollment in the Phase 2 Borealis 2-trial and second line bladder cancer, announcement of the Phase 2 Spruce trial results in non-small cell lung cancer, continued enrollment in the Phase II Cedar trial in squamous lung cancer, announcement of Phase 2 Rainier trial results in pancreatic cancer, and finally continued enrollment in the Phase II Pacific trial in prostrate cancer. Revenue for the first quarter of 2015 was $1.4 million compared with $11.7 million in the first quarter of 2014. Revenue earned in first quarter of 2015, consist of reimbursable clinical trial, manufacturing and preclinical costs incurred by us under our prior collaboration agreement with Teva. Total operating expenses for the first quarter were $6.4 million compared with $19.7 million for the first quarter of 2014. Net loss for the first quarter was $4.5 million or $0.20 per diluted common share compared with $8.6 million or $0.59 per diluted common share for the first quarter ended March 31, 2014. In February of this year, we announced the execution of new lease agreements enabling the relocation of our Bothell, Washington headquarters, yielding significant savings through 2017. That concludes our discussion of our financial results. I will now turn the call back over to Scott for closing remarks.

Scott Cormack

Analyst

Thanks John. In conclusion we believe we have sufficient financial resources to fund our operations into the third quarter of 2016. With numerous trials across multiple tumor types, stages of disease and in combination with various therapies, we are in the midst of an exciting time as we are nearing key enrollment and data milestones. Thank you again for joining us today. And at this time, I'd like to invite the operator Nicholas to open the line for questions.

Operator

Operator

[Operator Instructions] And our first question will come from the line of Stephen Willey with Stifel. Your line is now open. Please proceed with your question.

PrakharVerma

Analyst

Hi, this is Prakhar on for Steve today. Thank you for taking my questions. So first question on AFFINITY. So do you expect any delay in the readout given that you're going to be discussing a modification in the trial with the FDA or another authority next month?

Scott Cormack

Analyst

No, we shouldn't actually. We are expecting that the primary analysis would still flow in the backend of this year or early part of 2016. And then as we look towards ITT analysis, that would obviously flow a little bit later for looking at that versus sort of the subgroup population that we've discussed.

PrakharVerma

Analyst

But if you do modify, that will be a co-primary endpoint, right?

Scott Cormack

Analyst

That's correct.

PrakharVerma

Analyst

Okay. So do you know at this point what the population looks like right now in the AFFINITY trial, with respect to the poor prognostic factors that you talked about?

Scott Cormack

Analyst

No, we don't as can probably be appreciated what we need to do is make sure we get before the FDA early enough in this process before we start doing any of the analytics on the study. So, that's why there is an urgency to move this as quickly as we possibly could to the FDA, which is also why the FDA granted a Type A meeting which put us into next month.

PrakharVerma

Analyst

Okay. All right, thank you.

Operator

Operator

[Operator Instructions] Our next question comes from the line of Katherine Xu with William Blair. Your line is now open. Please proceed with your question.

Katherine Xu

Analyst · William Blair. Your line is now open. Please proceed with your question.

Great, hi, good afternoon. A few questions here. So for ENSPIRIT, if you look at the data from - recently from the huge [check points] [ph], second-line versus docetaxel, at least in the PDL expressers, the HR could get as low as 0.5. So just in light of that data, what do you think - how ENSPIRIT would fit into that future treatment paradigm?

Scott Cormack

Analyst · William Blair. Your line is now open. Please proceed with your question.

Yes, thanks Katharine. So as you know from the biology of Custirsen, we have a fair bit of data to substantiate an ability to combine with multitudes of therapies whether they’re chemotherapies, hormone radiation et cetera and we don't see anything within the context of the immune modulator platform that would be contraindicated in the context of this drug. So to the extent that there is a strategy that says chemotherapy plus, custirsen plus some of the immune modulators we think that's certainly feasible strategy to evaluate as we go forward. So yes, I think there is - as those programs start to move forward there's an opportunity to evaluate our potential combination.

Katherine Xu

Analyst · William Blair. Your line is now open. Please proceed with your question.

Okay. And on Pacific, just curious, it looks like again, it's a smaller study, 80 patients, seems like it's going a little bit slow. You said the data is not going to come out in the first half of 2016, just curious how that is going?

Scott Cormack

Analyst · William Blair. Your line is now open. Please proceed with your question.

So the Pacific trial as you may recall we're looking specifically looking for patients that were on Zytiga and we’re having rising PSAs but not yet having the another manifestation of progression. And as that trial was starting, we were having the introduction of Zytiga obviously in the post chemo market and then the pre-chemo market and then Xandi was introduced into the marketplace and so on. So, during that time period the accrual was sort of shifting around as new therapies were coming into the marketplace and we didn’t want to obviously modify the inclusion criteria given some of the shifts. So there was a bit of a slow during that period but the trial was continuing and hopefully inline to have that data set as indicated.

Katherine Xu

Analyst · William Blair. Your line is now open. Please proceed with your question.

Okay. And then lastly on the CTZ analysis for ENSPIRIT, previously you said mid-2015 and then in the press release you also said mid-2015, but in the prepared remarks both you and John said in the next few months. I just wanted to make sure, is it next - mid-2015 is kind of in one month versus in the next few months. Just curious is there some longer delay?

Scott Cormack

Analyst · William Blair. Your line is now open. Please proceed with your question.

No, I think the mid from our perspective and there is a mid plus or minus a month is still in the mid part of the year. So I think that's consistent with the next few months and we said - we're saying by the next few months.

Operator

Operator

Thank you. And at this time, there are no further questions. So I’d like to turn the call back over to Scott Cormack for closing remarks.

Scott Cormack

Analyst

Great. Thank you, Nicholas. As we approach the ASCO timeline, we look forward to seeing those that will be participating at ASCO and certainly as the year goes forward and we have the various material events that we've talked about in respect of our two clinical programs we look forward to providing you with the updates at those times. Thank you again.