Achieve Life Sciences, Inc. (ACHV) Q1 2010 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to the OncoGenex first quarter 2010 conference call. At this time, all participants are in a listen-only mode. Later we will conduct question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Jason Spark. You may begin.

Thank you. Good afternoon, everyone. Thank you for joining us for OncoGenex Pharmaceuticals first quarter conference call. The company issued a press release today containing a financial results for the first quarter and three months ended March 31 2010 as well as the review of the company's highlights for the first quarter of 2010. This release is available on the Investor Relations’ page of the company's website at www.oncogenex.com. As a reminder, this call is being and broadcast live on Investor Relation page of the company’s website and the replay of the webcast will be available for 90 days. Before we begin, I would like to remind everyone that some of the statements made today include predictions, estimates and other information that might be considered forward-looking. These statements are based on current expectations and assumptions that are subject to risks and uncertainties. Actual results could differ materially from our predictions and estimates, as a result of various risk factors, including those identified in our Annual Report on Form 10-K for 2009 filed on March 8, 2010 and our quarterly report on Form 10-Q filed earlier today, copies of which can be accessed on our website. I will now turn the call over to Scott Cormack, President and CEO of OncoGenex.

Thank you, Jason. Good afternoon, everyone and thank you all for joining us. On the call with me today are members of the OncoGenex Senior Management Team, including Cameron Lawrence, our Principal Financial Officer and Dr. Cindy Jacobs, our Executive Vice President and Chief Medical Officer. Cameron will begin today's call with a review of our financial statements for the first quarter. Following Cameron's overview, I will provide the summary of company's achievements for the first quarter 2010 and we'll discuss our near term goal. Cameron.

Thank you Scott. Recall the end of 2009, we had $26.5 million on our balance sheet as deferred collaboration revenue, which represented the remaining amount we are obligated to contribute to OGX-011 development plan under our agreement our with Teva. As previously discussed when we contribute to the OGX-011 development plan, the deferred collaboration revenue balance will decrease and be recognized it's revenue. We expect to advertise the remained deferred collaboration revenue over the expected performance period of deliverables under this agreement. We currently expect this performance period to the end of fourth quarter 2012. In the first quarter of 2010, we contributed $1.9 million of OGX-011 development cost and a quarterly recognized its amount, its revenue which further reduces our deferred collaboration revenue balance to $24.6 million as of March 31, 2010 and additional $2.8 million was recorded in the first quarter of 2010 relating to OGX-011 manufacturing the cost incurred by the company, which are reimbursable from Teva on a cash basis and are included in the accounts receivable as of March 31, 2010, by comparison for the three month ended March 31, 2009, no revenues were recorded. Research and development expenses for the first quarter ended March 31, 2010 were $6.4 million compared to $1.7 million in the corresponding period of 2009. The increase research and development expenses in the first quarter of 2010 result from our contribution to the OGX-011 phase III clinical trials in the amount of $1.9 million and manufacturing cost in the amount of $2.8 million, the ladder which is reimbursable from Teva. General and administrative expenses for the first quarter of 2010 were $1.4 million compared to $0.8 million in the corresponding period of 2009. The increase in our first quarter of 2010 was due mainly to higher employee expenses including severance charges, professional fees for legal and accounting services, employee recruitment costs and stock based compensation expense. The net loss for the first quarter of 2010 was $3 million, compared to $2.4 million in the corresponding period of 2009. The increase large was predominately due to the higher general and administrative cost previously discussed. We finish first quarter of 2010 with $47.6 million in cash, cash equivalent and short-term investment, compared to $64.6 million as of December 31, 2009. This $70 million decrease in cash, cash equivalents and short-term investments is predominately due to the $10 million payment to Isis mainly in the first quarter of 2010, which was included in accounts payable as at December 31, 2009 as well as, costs incurred in first quarter of 2010 relating to the OGX-011 development plan with Teva, of which $2.8 million is reimbursable from Teva on a cash basis. After considering the $10 million payment to Isis and the $2.8 million reimbursable from Teva, the remaining cash utilization for the quarter was $4.2 million. We anticipate that we will incur operating expenses of between $30 million and $32 million in 2010, which is an increase from our prior guidance and as a result of additional manufacturing responsibilities allocated to the company under the OGX-011 development plan. These additional manufacturing costs are reimbursable from Teva and consequently there will be a corresponding increase in revenue for 2010. We continue to anticipate ending the year with cash, cash equivalents, short-term investments and amounts receivable of between $29 million and $31 million and believe this will sufficient to fund our current fund operations into 2012, at which time we expect to have both phase for the three phosphate cancer trial fully equip. That includes our financial review and now I'll turn the call back to Scott.

Thank you, Cam. So far in 2010, we had advanced towards achieving our objectives for both OGX-011 and OGX-027 and have added substantial biopharmaceutical experience to our Board of Director. The new board members standing for election at this year’s Annual General Meeting have extensive pharmaceutical industry experience, having held all of our currently holding position is Chief Executive Officer, President and/or Director for Teva Pharmaceutical Company. Among other experience is Dr. Jack Goldstein, our Chairman of the Board served as President and Chief Operating Officer at Chiron Corporation until its acquisition by Novartis in April 2006 for total $5 billion. Stewart Parker previously served as President and Chief Executive Officer at Targeted Genetics Corporation and Dr. Martin Mattingly is a Chief Executive Officer of Trimeris Inc. He has also held various Senior Leadership position at Ambrx, Agouron and Pfizer. We are very excited to bring this level of expertise to our Board, as we continue to transform the organization to establish capabilities; we believe will be necessary to advance towards product commercialization. I’d like to now focus on our product development achievements during the past quarter, and discuss earlier term goals. We are very pleased that the European Medicine Agency confirms their agreement on our phase III development plans for OGX-011 in patient for castrate-resistant prostate cancer with together with fast track designations and special protocol assessments received from the FDA represent agreement with our global regulatory strategy for OGX-011 in prostate cancer. We remain on target to initiate the OGX-011 phase III trial evaluating OGX-011 with docetaxel retreatment and second-line therapy for prostate cancer patient in the second quarter of 2010. We are now referring to this trial at the prostate cancer set of [ph] trial. The phase III trial evaluating OGX-011 with first line docetaxel retreatment in prostate cancer continue to be on track for initiation in the third quarter of 2010 and a phase III trial evaluating OGX-011 referred by chemotherapy in non-small cell lung cancer is a plan to initiate in early 2011. Significant progress has also been made on a further event on the OGX-427 as Grant funding was secured for investigator sponsors randomized phase II trial for the treatment of castrate resistant prostate cancer as monotherapy. This randomized control phase II studies is designed to determine the potential benefit of OGX-427 by evaluating the number of patient to our without disease progression at 12-week post study treatment with or without OGX-427. This trial will also measure the direct effect of OGX-427 on PSA levels. Times progression by PSA are measurable disease, number of deferred rated [ph] tumor cells and other secondary end points. We continue to expect this clinical trial will initiate in the second half of 2010. Two peer-reviewed manuscripts have recently been published that provide additional insight into the function of heat shock protein 27 and its role in promoting tumor resistance to cancer treatment. As a reminder, OGX-427 is designed to reduce level heat shock protein 27, a protein that is over produced in response to many cancer treatment including hormone ablation therapy, chemotherapy and radiation therapy. These peer-reviewed manuscripts described a thickening path wind by which heat shock protein 27 mediates tumor cell revival, providing additional rationale bringing heat shock protein 27 as therapeutic approach for cancer treatment. Dr. Martin Gleave, the company's Chief Scientific Advisor was a Co-author of the manuscripts. We look forward to presenting final results from our phase III trial of OGX-427 patient results here on June 7th, 2010 at the American Society of Clinical Oncology 2010 annual meeting. That concludes our formal comment. With that I would now like to open up the lines for questions. Operator?

(Operator Instructions) Our first question comes from Simos Simeonidis from Rodman & Renshaw. Your line is open. Simos Simeonidis – Rodman & Renshaw: Hey, guys thanks for taking the question. Scott, could you please comment on your decision to sequence the trials the way you did, the prostate cancer trials meaning going with the second line first versus third – versus the second – first line?

Yeah. Simos, first of all good afternoon and thanks for the question. Really this is, I think more in a situation of preparedness the two protocol that you know were going through a development timelines with FDA through the FDA processors at slightly different times and its second line protocol happen to be developed and ready to do, that we, kind of, feel forward. There is no other real strategic reason for the two to be slightly out of sync other then it make sense to stagger them by basically a quarter, we don't know over tax in human resources to initiate the trials. Simos Simeonidis – Rodman & Renshaw: Okay. Also would you be able to give us any update on number of centers for each trial and our especially percent that's going to be U.S. North America versus ex-U.S North America?

Sure. Cindy, did you want to comment on that one?

So the second line prostate cancer study, we're looking at around 50 to 55 sites of that in North America, 40 – about 45 sites in North America with 5 to 10 in Europe and in North America, predominately in the U.S. was about 10 or so site left in Canada. So the first line, Teva is looking at sites that are interested in Europe and getting many sites that they're interested in Western Europe, the sites obviously in Canada and the U.S. that are participating in 10 would be off, the conciliation [ph] study would be offered into first line study as well. Those sites probably, the number of sites will be around a 100 to 120 sites worldwide.

Yeah. May be I'll just add onto that as you probably recall our previous discussions and communication to the respect of the first line trial – where really the North American strategy that was before we had EMA response and certainly before we had (inaudible) as a partner, so the two advancement and it allows to go into more of a global strategy, of course, our EMA response contain that partnership. In that regards, it’s a pretty big move for us to go that ways, should help our accrual substantially. Simos Simeonidis – Rodman & Renshaw: That makes sense. Thanks. One last question and I'll then jump back in the queue. You mentioned the additional responsibilities in manufacturing, there was a little shift there. Could you give us any granularity any color what does it means and the rationale behind the change?

Yeah. Its' not a material change from I guess, who do we like, it's always been the two parties that we've been working together on the manufacturing. This is really the accounting function that our relationship with our contract manufacture was going through us. And consequently, the expenses were close to our books. And that's why that our reimbursement turn on that side of the equation. We are looking and making that change the accounting close directly through Teva and to not too distant future and until that is done the numbers will run through our book. Now, I think you probably gather from our review of the financials, there's really not a matter of fact from this, because although we book as an expense it does come back in as revenue, so the net access (inaudible) it's really just on a accounting treatment. Simos Simeonidis – Rodman & Renshaw: Okay. Thanks for taking the questions.

Thank you, Simos.

Thank you. Our next question comes from Stephen Willey of Thomas Weisel Partners. Your line is open. Stephen Willey – Thomas Weisel Partners: Hi, good afternoon.

Hi, good afternoon, Stephen. Stephen Willey – Thomas Weisel Partners: I was just wondering, if you could comment on – if there's being any additional conversation around what a phase III lung cancer trial might look like?

Cindy, did you want to comment on that one?

Nothing, it's specific obviously, Teva is contacting and coordinating discussion with advisors in lung cancer as well as then we will have further discussion, nothing that I can formally say right now and how that study will look like. Stephen Willey – Thomas Weisel Partners: Just kind of what’s your opinion on kind of – on the chemo regiment, that’s going to be combined with 011, it’s a docetaxel base, correct?

Well, I mean, with that as one of the thing we are still discussing on what will be the best first line chemotherapy given that this will again be a worldwide trial. Stephen Willey – Thomas Weisel Partners: And then, did, I mean, I you mentioned, how big the phase II 427 trial is going to be with respect to patient?

It’s only about the randomized one in prostate. It’s planned for no more than 72 patients enrolled to get valuable patients of about 64. Stephen Willey – Thomas Weisel Partners: And then but you talked about collecting, obviously, PSA data and looking at doubly times but we know I think in prostate that progression had necessarily been best of proxy. So may be just wondering what you are expecting to kind of get out of those data.

Yeah. I can address that one for you, Stephen. It’s a part of the rationale for looking at PSA in OGX-427 study is because Hsp27 the target of that drug is involved in response to activation, and drive the antigen receptors of PSA should get rid of activity through that specific pathway. And then you’ll be staying on right, the PSA when you are looking at biologic correlation to survival or other clinical benefits, if you are looking for regulatory approval there is law and establish connection as we’ve seen in many clinical trials. But I think when you are looking at mechanism that drive the antigen receptors in PSA can be a useful target to know whether or not you are having an instrument [ph] from the target. So that’s why interested in PSA and that particular study, not that we are now suggesting (inaudible) correlates to the survival benefits and I just want to remind all of those that, although there is bad effect on antigen receptors we talked about for the PSA interface. There are other mechanisms that are unique and they think they go beyond the PSA response too. Stephen Willey – Thomas Weisel Partners: Great. That’s help. Thanks. And looking forward to data last year.

Great. Thanks a lot, Stephen.

Thank you. (Operator Instructions) Our next question is from Mark Monane from Needham & Company. Your line is open. Pardon me, Mr. Mark Monane, your line is open. If your line is on mute, please unmute it. Mark Monane – Needham & Company: Hello. Do you hear me?

Yeah.

Great. Mark, thanks. Mark Monane – Needham & Company: Hi. It’s Mark. Good afternoon from New York City. I just saw bird pigeon fly by and then I think that seem like just a little while ago you presented the data at ASCO talking about that generate all excitement from the Phase II trial. I am thinking what has happened in Europe and in terms of the treatment of prostate cancer, since your first treated that – since you first present that data at ASCO and how is that formed the Phase III trial that you have gone forward?

Well, that’s a big question, Mark. As you well know, they feel the prostate cancer, I think has undergone some substantial changes in the last, 12 to 14 months, probably, immediately proceeding the data announcement at ASCO itself obviously trigger was picked up as by going into new hands of big pharma. The other material event for us, I think generally is the feel and then I don’t think we need to spend an off-water time and this is obviously the program’s approval, very good news for prostate cancer patients. I think we’ve had separate discussions with many people about the influence of potential and now regulatory strategy and I think, it was part of your question just now Mark. Mark Monane – Needham & Company: Yes.

We don’t actually see that change in our strategy. I think as you know, our program was directed at metastatic minimally symptomatic or asymptomatic patients. So it’s really nice to between hormone theraphy and chemotherapy, if you will. And our Phase III study for OGX-011 is at least in the first line that is in combination with chemotherapy, while patients may repeat program advantage [ph] of our strategy. We don’t see that it will materially change either our commercial capability or regulatory strategy and again, I think you know, in the program’s data patients basically progress roughly on the same timeline in either arm, which means that when those patients do progress the natural question is what are they going to go on to and we feel either chemotherapy will still look for the very valuable place in the treatment paradox [ph] there and therefore no change in our plans are necessarily. I think, yeah, the big one that was a blow for in prostate cancer patient and patient and the field generally with of course the vast in data that read out not that long ago. There was some hope to that would render positive results and of course, I think, as everybody now knows that the results from that trial ended up being negative, that, was an interesting one from our business perspective because Avastin was being evaluated in combination with docetaxel [ph] and probably represented the most near-term potential change, I think that we were thinking should have been successful. So we have adopted now, not in the field of prostate cancer, it get very much opened up the space for us with a pretty clear path for combination with chemotherapy. I think those two were probably the biggest one for last 12 months. Obviously, some other ones are coming along in the early studies. I think we shift over to the Sanofi-aventis space with Cabazitaxel in second line phase, and again, we are not looking to shift our strategy there. Again, I think, as you know, docetaxel retreatment is going through some paradigm shift in how it get to use in the treatment of prostate cancer, a most notably that’s a retreatment paradigm. So if we kind of look at how patients are being treated, those patients which have good responses or stabilization but do not progress while on docetaxel are getting retreated after basically a holiday on treatment. And it make sense to continue to employ that strategy and not shift to, I think, what will become the only available solutions for these patients which is Cabazitaxel. You wouldn’t want to shift into the treatment of last resort too early otherwise I think you limit the treatment choices for the patient. So we are not looking to make a shift in our second line strategy, retreatment with docetaxel with other phase restrategy in the second line space. I could probably keep on going for few minutes on the paradigm shift that are going, I think, all this is to say that fortunately all the changes that are going on in the prostate field are probably going on any further part of the disease a quite a bit later, in the part of the disease but nothing that is directly impacting the combination of chemo at this point. Mark Monane – Needham & Company: All right. And how about the potential of the patients who are in the first-line study, should be in the second-line study, is that something that’s going to be excluded here or will it allow patients’ improvement?

Cindy, do you want to…

Yeah. Okay. But, sorry, they would be excluded. Mark Monane – Needham & Company: They would be excluded. Okay. And in terms of thinking about the Antisense compound, a number of the targets that you are developing are actually in solid tumors. Do you believe that the target you show also may work in liquid tumors as well and those have relatively quick read out in terms of clinical trial efficacy. What are your thoughts there?

Yeah. For the most part, a lot of the targets have a role in other chemo type as well, solids and liquids, I think we previously discussed some of the opportunity that exist with respect to cost trend particularly does have a role in liquid tumors. From our perspective as we think about development path generally we tend to be driven by data, that data generally begins with, is there reason to believe or data that just, target is over expressed and involved in tumor development and in the various tumor types and then we want to see obviously preclinical data that supports rationale strategy that can be deployed, because, particularly, Martin Gleave, who is at the Prostate Centre Vancouver general, he is predominantly a group involved in the solid tumor, so we typically have more data around solid tumors and we do liquid. But it certainly doesn’t preclude our interest in going after liquid. It is something that we have been exploring pre-clinically certainly with the 011 compound and I think you can look forward to us continuing into look at that in the future 247 and another compounds as well. Mark Monane – Needham & Company: And then on the pain progression, the pain outcome, most studies that I have seen involve speaking about pain progression, and we’ve seen in other cancers trial. Here the – in the second approach it somewhat different, can you go over, this is specific of how you measuring pain there in that trial and then I’ll talk about any market research you have done to think about the applicability or how physician should think about that in the real world.

Sure. I’ll turn the phone over to Cindy from a protocol perspective, but you are right to sort of frame it. I mean, we are looking at pain as an end point, this, developed for pain palliation. So we want to start with patients that have a base line level of pain and your are looking to decrease that and decrease use of both this as an end point and that is very different in looking at pain as a composite in progression. Cindy, do you want to go into some more detail on the pain protocol.

Yeah. We have multiple discussions regarding durable pain palliation or reduction in time to pain progression and as you know the time to pain progression is our secondary efficacy end point. I think everyone involve though they agree both end points were important durable pain palliation for 12 weeks or more is a more positive end point or more positive outcome as well as the cleaner outcome as far as determining duration of pain palliation versus the timing of when pain progression occurs which is a time to vent analysis that have obviously problems with that. So for all those reasons, we reviewed pain palliation but it have to be durable and we chose 12 weeks or greater for a clearly positive and clinical meaningful end point for the study.

Now with respect to the markets are the equation, prostate cancer is well known to be, it’s mechanism for metastasis is really tick over to the bone and prostate cancer with bony metastasis is one of the most painful indication that you could imagine, patient typically will end up on OGX and because of not only the pain but the OGX use, plenty of license materially effected. So to speak to the market issue from both a clinical perspective as in the clinician as well as the patient perspective, if we can expect by far the most important symptomatic feature of prostate cancer and that is pain, that is a very meaningful end point to work for the diseases and quite frankly, I think, if we can achieve what we are trying to do in our few phase III which is extent survival and affect pain palliation to living longer presumably with better quality of life that really is the ideal outcome for treating patients with prostate cancer and that’s really what these two trials are all about and it’s obviously supported by the phase II data center. Mark Monane – Needham & Company: Thank you very much for the added information and we look forward to future events.

Thanks a lot Mark. Appreciate your question.

Thank you. Our next question comes from Ted Tenthoff from Piper Jaffray. Your line is open. Ted Tenthoff – Piper Jaffray: I have two question. Obviously, we’ve got the pivotal programs well under way and – but I’m curious about it, sort of, what’s next for OncoGenex and how can you guys take this advantage in terms of validation of antigen progress you are doing in tumor biology broadly and really broadening reach the pipeline. What are your thoughts along those lines?

Yeah. Thanks a lot for the question, Ted. This is we, I think, very important question for us, because I think everybody knows we’ve been really consumed with time we spend a lead program, right. As you know, in previous discussions we were facing last year, of course really good data coming out of ASCO first or long data in our lead program, but that – on the other side of that, put together our real difficult challenge and that is how do you finance $170 million development plan. Ted Tenthoff – Piper Jaffray: Yeah.

And especially in 2009, so having result that, really to have a partnership we got, basically the two programs, the prostate and non-small cell lung, look after through that partnership and that current structure. But now you turn to the rest of the pipeline and say what else. We really do firmly believe, we’ve got a great team capable of advancing a number of other assets. We do have four other product candidates in the pipeline and obviously, we expect a fair bit of time, time to educate the market with respect to the next most advanced which OGX-427. Ted Tenthoff – Piper Jaffray: Yeah.

Which frankly has probably as much or even maybe potential than OGX-011 does, it similarly has capacity to be involved in treatment resistance, most of different tumor types, ovarian, endometrial, breast, prostate, bladder, lung, skin, head, neck, et cetera. And we’re only touching the (inaudible), so far. So hopefully we will be able to advance across array of different tumor types and unfold the strategy, similar to what we have done with 011. Going beyond that, we still have SN2310 that we’ve talked about the prodrug of SN-38 that does have phase I data. We have indicated to the market that that something that we would look to out licensed rather than develop internally. And then we have got two other asset that we really very excited about that were in the pre-clinical space that we would need to do the R&D enabling (inaudible) talks and then move into the clinic. So it’s hard to adjust asset base, what’s in our current pipeline, there is a lot there to really expand the growth potential of this story and we haven’t obviously talked – touched on the other more strategic opportunities that exist in the marketplace with respect to bringing in other assets. Ted Tenthoff – Piper Jaffray: Okay. Well, that’s helpful. Good luck. Looking for to hearing more about that.

Great. Thanks a lot, Ted. I appreciate the question.

Thank you. (Operator Instructions) I’m showing no further questions in the queue.

Good. Thank you, operator. At this point, we’ll close down the questions, and I certainly like to thank everybody for joining us today. We look forward to updating you on our progress in the very near future.

Thank you. Ladies and gentlemen, this does conclude conference for today. You may all disconnect and have a wonderful day.