Infinity Pharmaceuticals Inc (INFI) 2009 Q3 法說會逐字稿

Welcome to the Infinity Pharmaceuticals Q3 2009 results conference call. Just a quick reminder, today's call is being recorded. Now at this time, I'll turn things over to our host Mr. Gerald Quirk, Vice President of Corporate Affairs. Please go ahead,sir.

Thank you, Bob, and good afternoon, everyone. Welcome to today's call. My name is Gerald Quirk, Vice President of Corporate Affairs at Infinity. With me on the call today are Adelene Perkins, our President and Chief Business Officer, Julian Adams, our President of R&D and Chief Scientific Officer and Steve Holtzman, our Chair and CEO. In today's call, we'll be discussing our recent R&D and business highlights and reviewing our financial results for the third quarter of 2009. The press release detailing our results was issued earlier today and is available on our website at INFI.com.

During today's call we may make forward-looking statements about our future expectations and plans including clinical development milestones and financial projections. It's possible that our actual results may differ materially from what we project today due to the factors described in the risk factors section of our most recent Form 10-Q. While these forward-looking statements represent our views as of today, they should not be relied upon in the future as representing our then current views. We may update these statements in the future but we're not taking on an obligation to do so.

Let me now turn the call over to Adelene Perkins to start us off. Thank you, Gerald, and good afternoon, everyone. Thanks for joining us today.

We are now more than 3/4 of the way through the year, so it's a particularly good time to gauge our progress. In the last several months Infinity has taken important steps forward in advancing our clinical and preclinical programs and building upon our strong operational capabilities, both of which we believe are necessary to achieve our mission of sustainable discovering, developing and delivering to patients important new medicines that will make a meaningful difference in their lives. We are now up and running again with all of our Hsp90 Chaperone Inhibitor clinical studies. Julian will describe these trials in some detail but let me say that our efforts to get back in the clinic quickly have been very important for us as we work to determine the optimal development path for our innovative agents. It's critical that we define the specific patient populations in which our drugs will show benefit.

As an industry, we're making significant progress in understanding the complexities of cancer. At Infinity we've undertaken a significant effort to integrate this understanding into our clinical development strategies to ensure that we are not only able to deliver the greatest benefit to our patients, but that clinical development is as efficient as possible in both time and cost. Even with these efforts clinical development remains expensive and so it is essential that we have access to the capital we'll need to move our programs forward. Infinity is in the advantageous position of having the financial resources to enable us to invest aggressively in our pipeline. Notably, we have asked to seek financial resources while retaining valuable rights to all of the products in our portfolio. We retain full worldwide ownership of our Hsp90 Chaperone Inhibitor program which will be recognized next week by Windhover and Campbell Alliance as one of the industry's top-10 [unpartnered] oncology program.

In addition, we have US commercialization rights for our entire oncology portfolio and are entitled to substantial worldwide royalties on our FAAH program. Our financial strength is made up of several components. First, we ended the third quarter with approximately $140 million in cash and investments. Second, we have access to a $50 million line of credit on attractive terms through our relationship with Purdue and Mundipharma that we can use for any corporate purpose and third, Purdue and Mundipharma have committed to fund 100% of our Hedgehog, FAAH and discovery programs up to $65 million for 2010. We reiterate today that we expect a 2009 net burn of between 20 to $30 million a year-end cash balance of between 127 to $137 million not including the line of credit. Aggregating our existing funds and sources of funding for 2010 we anticipate kicking off 2010 with capital and committed funding exceeding $240 million on a 26 million share basis. In the absence of any business development this financial position provides a cash runway for our current operating plan into 2013. In summary, the coupling of Infinity's innovative pipeline with our financial strength gives us a very distinctive profile. I'll now pass the call over to Julian to walk us through our pipeline. Julian.

Thanks, Adelene. Infinity has made strong progress in advancing our Hsp90 Chaperone Inhibitor program in the last quarter. We received approval of protocol amendments for our studies of IPI-504 our IV candidate which included modifications to dose and schedule. I'm happy to report that we have started re-enrolling in all of our studies with IPI-504 as well as our oral candidate IPI-493. I want to use our time today to walk you through the status of each of our Hsp90 Chaperone Inhibitor studies and when we plan to report data. Then I'll provide an overview on where we are with our early clinical and discovery stage programs.

The first trial to discuss is an ongoing Phase II study of IPI-504 in combination with Herceptin in patients with HER2 positive metastatic breast cancer, 504 is being administered once weekly at 300 milligrams per meter squared with Herceptin being administered every three weeks at its standard dose. We are very interested in this setting given the data we've seen with the related Hsp90 Chaperone Inhibitor in a similar patient population. In addition, we've presented preclinical data demonstrating that the administration of 504 results in the rapid degradation of HER2 in both Herceptin sensitive and Herceptin resistant mouse models. In these models IPI-504 administration also produced a substantial tumor growth inhibition. We're pleased to be enrolling patients in this study again and anticipate reporting preliminary data from the Phase II study in 2010.

Next we're evaluating IPI-504 in a Phase IB study in combination with Taxotere. At ASCO, we showed that a combination of 504 and Taxotere was generally well tolerated in patients with advanced solid tumors. Additionally, IPI-504 did not affect the clearance of Taxotere or vice versa. The objectives of this study are to evaluate the safety and tolerability of the combined agents and to determine the optimal dose and schedule for Phase II development. IPI-504 is being administered at 300 milligrams per meter squared on two schedules. First, on a four-week cycle consisting of once weekly 504 plus Taxotere administration for three weeks followed by one week off and second, on the three week uninterrupted cycle consisting of 504 administration once weekly and Taxotere administration every three weeks. We're currently focused enrollment in this study in patients with non-small cell lung cancer, a setting where Taxotere is commonly used. Also, in non-small cell lung cancer we have completed enrollment of a Phase II study of IPI-504 as a single agent. Based on the preliminary data we presented earlier this year, we have undertaken a significant effort in molecular pathology to understand the underlying genetic profiles of the responding patients with wild-type EGFR non-small cell lung cancer. In addition, we're consulting with many thought leaders in lung cancer including Tom Lynch, the new director of the Yale Cancer Center who joined our Board last month. The output of both these activities will help us determine the optimal clinical development strategy for 504. In 2010 we anticipate commencing further clinical development of 504 non-small cell lung cancer and publishing the full results in the Phase II study.

Next we intend to initiate a Phase II clinical study of IPI-504 in patients with advanced dedifferentiate liposarcoma, a form of soft tissue sarcoma. At a previous ASCO meeting we reported a partial response in a patient with dedifferentiate liposarcoma in our Phase I study of 504 in patients with refractory GIST and other soft tissue sarcomas. This patient experienced a tumor reduction of 43% over eight cycles or 24 weeks. The objectives of the Phase II study are to determine the safety profile and overall response rate of IPI-504 in this malignancy. Beginning in early 2010 we anticipate enrolling approximately 40 patients. IPI-504 will be administered on a three week cycle at 225 milligrams per meter squared, twice weekly for two weeks followed by one week off. I also want to reiterate that we expect to report the final results from the Phase III RING trial in early 2010. We will let you know in advance where and when this will be.

In addition to the development of IPI-504, we are continuing to evaluate the potential for our oral agent IPI-493. We are enrolling patients in a Phase I dose-escalation study in patients with advanced solid tumors. The objectives of this study are to evaluate safety and tolerability of 493 and to determine the optimal dose regimen for subsequent studies. Our oral candidate is being evaluated on multiple schedules of administration and we expect to present preliminary data from the Phase I in 2010. Informed by this experience we also anticipate initiating additional clinical development of 493 next year. In summary, our Hsp90 program is moving forward on all fronts. Stay tuned.

Turning now to the rest of our pipeline, our Hedgehog Pathway Inhibitor IPI-926 is currently in a Phase I dose-escalation trial in patients with advanced solid tumors. This study is designed to evaluate safety and tolerability and anti-tumor activity of IPI-926. We've previously presented data demonstrating significant anti-tumor activity of 926 in a number of preclinical studies including in mouse models of pancreatic, small cell lung and ovarian cancers as well as medulloblastoma. We are very pleased with how our Phase I study is progressing and anticipate presenting preliminary data in 2010. In addition, we believe we are on track to initiate Phase II development next year. Behind our Hedgehog program our neuropathic pain program targeting Fatty Acid Amid Hydrolase or FAAH is moving along very nicely. We are on track to meet our goal with being IND ready with our oral agent IPI-940 by the end of the year and we anticipate initiating Phase I development by early 2010.

Lastly, we continue to evaluate internal and external opportunities that could strategically enhance our pipeline. All characterized by high quality science and distinctive product profiles. We have dedicated discovery and clinical teams that are evaluating many attractive opportunities in emerging areas of oncology including cancer cell metabolism, protein homeostasis and apoptosis. We believe many of these areas will yield exciting new product candidates over the coming years.

With that let me now hand the call over to Steve to wrap us up. Steve.

Julian, thank you and thanks, Adelene and Gerald and let me wrap up really quickly today. As you've heard from Julian, our Hsp90 Chaperone Inhibitor program is now fully back up and running. Also, our Hedgehog FAAH and early stage discovery programs are all moving ahead smartly and as you've heard from Adelene, we continue to be in an exceptionally strong financial position. This allows us to aggressively develop our pipeline while also positioning us to evaluate additional strategic opportunities. Finally and not last or least, we have a strong with Purdue and Mundipharma and we have retained high value product commercialization rates in our products. So in summary, Infinity today is exceptionally well positioned to progress and to achieve our long-term mission.

We thank you for listening and with that I'll turn the call over to the operator to open it up for Q&A. Beau, it's all yours.

Thanks you, Mr. Holtzman. (Operator Instructions). We will first go to Simos Simeonidis with Rodman Renshaw.

Hi, guys. I know you said you were going to publish the RING data at some time next year but is it possible to get some kind of clarity between number of deaths or [SAAs] between the two arms?

No. We're not releasing that data yet. In fact, the database is being unlocked shortly and we actually don't have that data on hand and again to preserve the ability to present the data publicly we're not releasing any data before that public disclosure.

Okay. In terms of when you look at the lung cancer patients you've treated and the molecular profiling work you've done, in addition to the wild type EGFR have you been able to find any additional genetic or molecular markers that may help you in patient selection and future development in lung?

Another excellent question and I have to plead the fifth again. We believe we found some very interesting things, but we're still undoing some ongoing analysis and statistical validity of what we're finding and we'll be reporting on our plans early in the year.

What's important, Simos, is when we have the data we're ready to reveal we want to couple it exactly with what we're going to be doing on a go forward basis as well, so we're waiting until we got all that thinking completed.

And finally, if I can jump in, Simos, that lung cancer trial was a 504 as a single agent heavily advanced lung cancer patients. We've also given a lot of thought to other lung cancer patients and combination kinds of studies as well. So I think as we're thinking about lung, it's not narrowly defined only by what we have done to date in that specific population.

All right. So let me get one for Adelene. If I remember correctly, I think Mundipharma has the opt-in by the first of next month for R&D spending for 2011 of 85 million given that you haven't announced that I'm assuming they haven't opted in yet, but do you have any idea where those thoughts are?

Sure. So our relationship with Purdue and Mundi continues to go very well. As you correctly highlighted, we are already in the fully committed relationship for 2010 and they will be funding all of our Hedgehog FAAH and discovery programs up to 65 million. There's not ever an opt-in right. Our expectation is that we are in partnership indefinitely during the development of these programs. There is, however, the ability if Purdue or Mundi choose to exit a program that that's a decision they can make. We will know that as you said, by the first of December this year and that would influence our 2011 funding, but as of this point we're moving full steam ahead and the relationship is just going beautifully.

Take our next question now from Ted Tenthoff with Piper Jaffray.

Great. Thank you very much. I couldn't hear that well. So congratulations on getting the dosing back on track and looking for data next year. How has this year's delays adjusted how you're thinking about the overall development of IV versus oral? Is there more reason to focus on the oral compound now or do you still like the properties of the IV and having kind of both of them and how has this changed your thinking about the --

It's a great question, Ted. We actually ask ourselves this quite often. We actually like both products independently and they have very different behaviors and very different pharmacologies and we're learning more and more about the timing and dosing of the IV versus the oral and there are settings where the IR product would be preferred and there are settings where the oral product will be preferred. So we are independently running these experiments and learning as we go along. We've learned a tremendous amount about in particular having treated almost 300 patients now the safety and schedule and we feel very well poised to have these programs back on track in the right disease indications.

Great. Excellent and I really look forward to some insights into those lung cancer findings. So that should be very interesting.

Thank you.

Go next now to Eun Yang with Jefferies & Company.

Hey, thank for taking my question. This is a question for Julian. Obviously, Genentech has a similar program about a step ahead. Can you talk about kind of how would you guys base how the program progresses kind of based on their successes and failure and how the two is maybe differentiated a save,fail say in a certain occasion would you guys feel confident in going after it would you kind of follow more in their footsteps?

It's a great question. The Hedgehog Pathway is just a fascinating target in cancer research today. I would say, not to be coy, but we are at an embryonic level of understanding of the breadth and possibilities of this pathway. So the success that -- the early success that Genentech has had is actually very validating for some of the work we've done here as well and though they've focused narrowly in basil cell carcinoma and medulloblastoma, the genetic diseases, we believe there's that potential but even greater potential in solid tunes and the data we published in pancreatic cancer, for example, or small cell lung cancer gives us a distinct clinical path forward as well. I think the agents are substantially different. As you know, we are a semi synthetic derivative of a natural product cyclopamine. We have very different pharmacologies and half lives and volumes of distribution and forgive me for being too technical, but our drugs distribute very differently in the body, to put it simply, and I think that may open up very different development paths for the different drugs. So we wish them well and we have great confidence that we're doing the right studies with 926 on our end.

Thanks very much. That's very useful. And just a follow-up question, we saw sequential quarter-over-quarter declines in both R&D and SG&A costs. I'm just wondering if we should use the run rate this quarter going forward or should this be more of a one time event?

Yes. Well, we had reductions in our R&D investment primarily driven by the closure of the RING trial. So for the second quarter we were really focused on closure costs and a lot of those were wrapped up by the third quarter. So we -- now that we are back in the clinic, you could fully expect that our R&D investment is going to increase commensurate with enrolling patients in the active Hsp90 and Hedgehog trials that we have underway.

All right. Thank you.

Go next now to Andrew Vaino with Roth Capital Partners.

Thanks for taking my call, just a quick question on the restarted 504 studies. How many patients have been dosed in those restarted studies so far?

We're not -- I actually don't know the answer to that, but we wouldn't disclose the numbers of patients in enrolling in trials. We'll tell you (Inaudible).

Okay, thank you.

Ladies and gentlemen, it appears we have no further questions. Ms. Perkins, I'll hand the conference back to you, ma'am.

Thank you, operator, and thank you for all of your questions. As I think you've heard today, Infinity is well capitalized and aggressively investing in the development of its robust pipeline. We believe that 2010 is going to be an exciting year for us and we'll move forward on all fronts of our R&D business. We look forward to hearing from you and continuing to report to you the progress we're making. Thank you again and have a good evening.

Thank you. That does conclude our conference. We thank you for joining us and again, wish you all a good afternoon. Good-bye.