Oncternal Therapeutics Inc (ONCT) 2009 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the third quarter 2009 GTx, Inc. earnings conference call. My name is Shaquanna, and I will be your coordinator for today. At this time all participants are in a listen-on mode. We will facilitate a question-and-answer session towards the end of this conference. (Operator Instructions)

I would now like to turn the presentation over to your host for today's call, Mr. McDavid Stilwell, Director of Corporate Communications. Please proceed, sir.

Thank you and good morning. On behalf of GTx, I'd like to welcome you to our third quarter 2009 corporate results conference call. We released our financial results early this morning through the news wires. If you do not have a copy of our release, you'll find it on our website at www.gtxinc.com. We will have a replay of this call available on your website until November 23, 2009.

With me today are Dr. Mitchell Steiner, Vice Chairman and Chief Executive Officer; Marc Hanover, President and Chief Operating Officer; and Mark Mosteller, Chief Financial Officer.

Before we begin I'll remind you that Information discussed on this call may will include forward looking statements and such statements are subject to the risks and uncertainties we discuss in detail in our reports filed with the Securities and Exchange Commission, including in our quarterly report on Form 10-Q filed on August 10, 2009. We expressly disclaim any obligation to release publicly any updates to forward looking statements during this call.

I will now turn the call over to Dr. Steiner.

Thank you, McDavid, and thank you all for joining us today. At the end of October, we received a complete response letter from the FDA regarding the new drug application for toremifene 80-milligram. The letter was the subject of a conference call we held last Monday, and that call is accessible through the Investor Relations section of our web site through November 16th. We look forward to working with the agency to determine next steps to bring toremifene 80-milligram treatment to prostate cancer patients on ADT who are at risk for fractures. We plan to update you once we've met with the FDA.

As for the toremifene 20-milligram clinical development program, the last patient will complete a three year Phase III high-grade PIN clinical trial in February of 2010 and we expect to report results in the second quarter.

Our SARM program with Merck is also making good progress. We and Merck are finalizing our plans to initiate a Phase II clinical trial evaluating Ostarine in patients with chronic obstructive pulmonary disease who also have muscle wasting. We expect the clinical trial to begin by the end of first quarter 2010. And we and Merck are also finalizing plans to initiate the Phase IIb clinical trial evaluating Ostarine for chronic sarcopenia in 2010.

Our newest product candidate, GTx-758, is an oral LH inhibitor for first line treatment of advanced prostate cancer. We recently completed a Phase I multiple ascending dose clinical trial with 60 subjects. GTx-758 was well tolerated in this clinical trial and we're planning to initiate a Phase II clinical trial in the first quarter of 2010. Like our SARM program, GTx-758 was discovered in our laboratories and is the third product candidate that we have taken from discovery and preclinical research into clinical development and man. We look forward to sharing more information about this unique oncology product candidate soon.

I'll turn the call over to Marc Hanover for a brief review of the financial performance. Marc.

Good morning. The details of our financial results for the third quarter 2009 are included in this morning's press release and are available on our website. I will focus on the highlights. The net loss for the third quarter this year was $12.8 million compared with a net loss of $11.9 million for the same period in 2008. Revenues for the third quarter of 2009 were $3.6 million compared to $3 million for the same period last year. Revenues included net sales of Fareston 60-milligram marketed for the treatment of metastatic breast cancer in post menopausal women and collaboration revenue from our partnerships with Ipsen and Merck. Net sales of Fareston were $719,000 and $315,000 for the three months ended September 30, 2009 and 2008, respectively. Collaboration revenue was $2.9 million and $2.7 million for the third quarter of 2009 and 2008, respectively.

For the three months ended September 30, 2009 and 2008, research and development expenses were $8.1 million and $9.2 million, respectively. General and administrative expenses increased during the three months ended September 30, 2009 to $8 million from $6.1 million in the three months ended September 30, 2008. At September 30, 2009, GTx has cash and cash equivalents in short-term investments of $55.5 million. We have the potential in 2010 to add as much as $55 million to our balance sheet from milestone payments from our partners Ipsen and Merck.

Now I will turn the call back to Mitch.

Thanks, Marc. Operator, we'll take the first question.

(Operator Instructions) Your first question comes from the line of Joel Sendek with ALC Capital Markets. Please proceed.

Yes, it's Joel Sendek from Lazard Capital Markets. A couple of questions. The first is since you had the call last week, I'm wondering if you had any more time to think about how you'll answer the questions that the FDA posed, whether you have any more confidence that you have some or all of that data available as opposed to having to perform additional clinical work?

The question is, now, a week later, do we have any further thoughts? We really need to meet with the FDA and understand what their thoughts are and then we'll have a better understanding about what our strategy will be. This drug is safe and it's effective. We had a good trial. The drug's been out there for two decades. Really, we're trying to get our arms around a path to approval and whether it can be done immediately, whether it can be done with a delay, we just have to better understand where the FDA's head's at, as they say. So once we know that, we'll report back to everybody and provide a very clear next step sport so we can at least plan.

Okay. And then on the Ipsen relationship, two questions there. Have you had a chance to meet with them? Does the complete response letter have any impact on their filing plans? And, Marc, you mentioned some milestone potentially from them next year. Can you give us some sense of how confident you are you will get that from Ipsen?

Marc, why don't you comment on the milestone and your confidence and then I'll come back and talk about Ipsen and their filing.

So Joel, the milestones that I referenced in our comments, we are confident that we can achieve those milestones. In fact, we're confident that we can achieve them and they include milestones from both Merck and Ipsen. Of course, there are risks associated with both of those milestones, but we do feel good about it. We do have a very close relationship with both Ipsen and Merck and feel like the partnerships will continue to move as they have in a very positive way.

And then back to the question about Ipsen and what they're doing. Ipsen, as I told you, Ipsen filed a letter about a year and a half ago with the EMEA asking about the 80-milligram toremifene and whether or not it would qualify for innovative marketing approval which means it goes through the central EMEA and will allow for eight years of data protection and ten years of market protection, and we were told yes, it would. So really the clock doesn't start in Europe until in the they get marketing authorization, in which case you get a full ten years. With that said, to do that, it has to be filed as an independent NDA or NDA equivalent which means that all the information has to be pulled together and not referenced as we did in the US. We have provided Ipsen the full NDA and we are working very closely with Ipsen as they move forward in their filing. We will use the information we learned from the FDA to help them with a better filing. Ipsen has been very close to GTx. We meet on a regular basis and we will meet again to have a debrief on what we learned from the FDA and hopefully this will help them as they move forward.

Okay. Thank you.

(Operator Instructions) Your next question comes from the line of Howard Liang with Leerink Swann. Please proceed.

Thanks very much. Question on the timing with the PIN trial. I think you said in the press release it's in 2010. But I think the last patient is going to be finishing up in the first quarter, it's likely much before the end of 2010 for the data?

Could you say that last? I got you up to the finishing up in the first quarter, what was that second part of your question?

Basically is there better clarity on the timing of the PIN data beyond 2010? Would it be likely in the first half or the second half?

Got you. So I said in my comments that the last patient out is in February and then, at that point, we scrub down the database and answer all the queries and get the data back, so we're looking to see the data in the second quarter of 2010.

Okay. Great. And have you had further discussions with agency about the analysis, there was somewhat change of the plan in the final analysis in terms of timing, was that discussed with the agency?

Are you talking about PIN?

Yes.

As you know, we did not deviate from the final analysis that was described and agreed upon with the agency. As I mentioned previously, we left the option of whether we looked at the study early or did we just wait till the end when the trial was complete. So the SAP, statistical analysis plan, has not changed and we're following it exactly as agreed upon with the agency.

Okay. And lastly, regarding Fareston do you expect generic version of Fareston? So far it doesn't look like there's any.

The question is for Fareston 60 milligrams, do we expect a generic version of it. As you know, the Fareston 60 milligram market is about $1 million to $2 million a year and we have not heard anything about a generic trying to get into that small market at this time.

Great. Thanks very much.

At this time I would like to turn the call over to Dr. Steiner for closing remarks.

Thank you. We'd like to thank you all for your interest in GTx and we look forward to providing you with updates in our future progress. Thank you again for joining us on today's call.

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect and have a great day.