Infinity Pharmaceuticals Inc (INFI) 2013 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals Conference Call to discuss the Company's financial results for the third quarter of 2013. My name is Kevin, and I'll be your operator for today's call.

At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised this call is being recorded at Infinity's request. At this time, I would like to introduce your host for today's call, Ms. Jaren Madden, Director of Investor Relations and Corporation Communications at Infinity. Please go ahead.

Thank you, Kevin, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review our third quarter 2013 financial results. With me here today are Adelene Perkins, President and Chief Executive Officer; Julian Adams, President of R&D; and Larry Bloch, CFO and CBO. Following our remarks, we'll open up the call for Q&A.

The press release issued earlier today details our results and is available on our website at Infi.com. Please note that during this call, we may make forward-looking statements about our future expectations and plans including clinical development milestones, the therapeutic potential of our product candidates, and financial projections. It is possible that our actual results may differ materially from what we project today due to the considerations described in the Risk Factor section of the Form 10-Q for the third quarter of 2013 filed this afternoon. 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. They may update the statements in the future but are not taking on an obligation to do so.

And now I'd like to turn the call over to Adelene.

Thanks, Jaren. Welcome, everyone, and thank you for joining us on the call today. 2013 has been an important year for Infinity, as we move closer to our vision of becoming a fully integrated biopharmaceutical company that discovers, develops, and also delivers important new therapies to patients.

While we had hoped for positive data from our Hsp90 study, we are benefiting from our balanced approach to building a portfolio product candidate. In July of 2010, we in-licensed IPI-145, our PI3 kinase delta gamma inhibitor. PI3 kinase delta was a validated target, and we believe the ability of IPI-145 to inhibit both the PI3 kinase delta and gamma could lead to a differentiated clinical profile. Today IPI-145 is poised to enter Phase 3 development this quarter.

We are also continuing our R&D efforts to further elucidate the potential of IPI-145 and to build a portfolio of PI3 kinase inhibitors targeting delta and gamma. We are looking forward to presenting pre-clinical data as well as additional clinical data from our Phase 1 study of IPI-145 in patients with hematologic malignancies at the American Society of Hematology, or ASH, annual meeting in December.

These abstracts were published online this morning, and Julian will review the data in the abstract shortly.

We continue to be very excited about IPI-145, which we believe has the potential to be the best-in-class PI3 kinase inhibitor for the treatment of hematologic malignancies. We recognize that several of the indications we are studying are part of a competitive and rapidly evolving landscape. With that in mind, we are moving as aggressively as possible.

Earlier this year we initiated a Phase 2 monotherapy trial in indolent non-Hodgkins lymphoma and are on track to initiate a Phase 3 monotherapy study and COL by the end of this year. Monotherapy offers an important treatment option for patients, and we believe these trials may provide the fastest path to registration and approval.

In addition to our monotherapy studies, we are planning for additional trials including combination approaches designed to continue to differentiate IPI-145 from other agents and developments.

As we advance towards late-stage development registration, we are continuing to strengthen our clinical development expertise and build our medical affairs function.

In September Dr. David Roth joined Infinity as Senior Vice President of Clinical Development and Medical Affairs. David joined Infinity from Pfizer where he most recently served as Vice President in Pfizer's Oncology business unit, and he brings over 20 years of experience in hematology and oncology research and development.

David holds a distinguished track record and has contributed to the successful regulatory approval of several products including Bosulif, Xyntha, ReFacto and BeneFIX. With experience in academia as well as across the drug development continuum in the industry, we are thrilled to have David on our team.

And, with that, let me turn the call over to Julian for an R&D update.

Thank you, Adelene. I would also like to warmly welcome David, who is a great addition to our team.

We are very excited about the upcoming ASH meeting and are pleased to have five abstracts representing both clinical and pre-clinical data accepted for presentation.

Before I review our abstract and summarize the kind of information you can expect to see in our presentation next month, I would like to put our IPI-145 Phase 1 program in context.

We are really encouraged with the data we've recorded to date, which show that IPI-145 is well tolerated and highly active across a range of hematologic malignancies at 25 mg b.i.d., or twice daily. We believe that IPI-145 has the potential to be the best-in-class PI3 kinase inhibitor for both IMHL and CLL. And we are moving forward with an aggressive development plan in these two indications designed to further differentiate IPI-145 from other targeted agents in development for the treatment of these malignancies.

As many of you know, we are continuing to enroll patients in our Phase 2 study of IPI-145 in indolent non-Hodgkin's lymphoma and are on track to start our Phase 3 study in CLL later this quarter.

Turning now to our ASH abstracts, IPI-145 continues to show promising signs of efficacy and the data we are planning to report next month further support our ongoing and planned studies at the 25 mg b.i.d. dose.

We are pleased that our clinical abstract focused on CLL was selected for an oral presentation and for review at an ASH-sponsored media briefing. It's important to note that the data came out for our abstracts occurred in July and therefore our clinical abstract represents incremental data since ASCO. The actual ASH presentations next month will reflect a more advanced data set than what is represented in these abstracts.

In our clinical abstract describing data from the Phase 1 study of IPI-145 in patients with CLL the reported overall response rate is measured by IW CLL criteria is 52%, which is similar to the response rate reported in June. Notably, we have also now reported our first complete response in CLL, which we believe serves to further differentiate us from other PI3 kinase inhibitors in development, which have not yet shown complete responses as monotherapy.

The abstract states that the nodal responses occurred in 79% of patients after two cycles of treatment indicating that IPI-145 has a rapid onset of activity. We also report that 145 continues to be well tolerated with no dose-related increase in frequency or severity of adverse events.

As I mentioned, one of our investigators, Ian Flynn, will present updated Phase 1 CLL data for IPI-145 during an oral session at ASH on Monday, December 9th. We expect this presentation to include the following -- an update on activity of IPI-145 at 25 mg b.i.d. dose in terms of nodal responses, partial responses, and complete responses as well as an analysis of lymphocytosis in addition to an update on the activity of IPI-145 at 75 mg b.i.d.

An update on activity of IPI-145 in patients with advanced CLL will have P53 mutations, or 17 P deletions. Our first early analysis of the activity observed in treatment naive, elderly, and high-risk cohort. An early report on the activity of IPI-145 in a small number of patients who progressed while (inaudible) of treatment prior to entry in our study. And, finally, we also expect to provide a safety update.

Over the course of our presentations, we also expect to provide updated top-line Phase 1 data on the activity of IPI-145 in patients with indolent Hodgkin's lymphoma and T-cell lymphoma. For INHL we expect to provide an update on response rate and durability at doses less than or equal to 25 mg b.i.d. We expect these data to focus on the 25 mg b.i.d. dose, as this is our dose being evaluated in our current Phase 2 study.

For T-cell lymphoma we plan to provide top-line update on activity. We are planning to submit an abstract for presentation at a medical meeting in January that is focused exclusively on T-cell lymphoma, so we hope to share a more comprehensive update on our Phase 1 experience in T-cell lymphoma at that time.

In addition to our clinical data, we will have four scientific poster presentations, which reflect our commitment to better elucidating the mechanism of action of PI3 kinase delta and gamma across a range of hematologic malignancies. These pre-clinical and translational presentations will include data evaluating a range of serum markers in CLL and indolent lymphoma patients. These data suggest that IPI-145 has a biologic effect on several important cytokines and chemokines necessary for the homing, migration, and survival of malignant cells and demonstrates similarities and differences in how these two malignancies respond to inhibition of PI3 kinase delta and gamma.

Data on the role of combined PI3 kinase delta and gamma inhibition in CLL. Data showing the sensitivity of diffuse large B-cell lymphoma or DL BCO, cell lines to IPI-145 as well as data showing a potential mechanistic rationale for the combined PI3 kinase delta gamma and BTK inhibition.

And, finally, data supporting the clinical potential of IPI-145 in adult T-cell acute lymphoblastic leukemia.

As I mentioned earlier, our initial focus is on two monotherapy studies with the potential for registration. Patient enrollment is ongoing in the first of these trials, which is a Phase 2 open label single arm study designed to evaluate the safety and efficacy of IPI-145 administered at 25 mg twice daily in approximately 120 patients with indolent non-Hodgkin's lymphoma.

These patients are refractoried to radioimmunotherapy or to both rituximab and chemotherapy and must have progressed within six months of receiving their last therapy. A primary endpoint in this study is response rate.

Our second potential registration study, which is on track to begin this quarter is a Phase 3 trial in patients with CLL. This is a global, randomized monotherapy study designed to evaluate the safety and efficacy of IPI-145 administered 25 mg twice daily. In this study, approximately 300 patients with relapsed refractory CLL will be randomized to either IPI-145 or ofatumumab. A primary endpoint is progression pre-survival as assessed by central independent radiological review.

In addition, these two trials, we are -- in addition to these two trials, we are planning for combination studies designed to further differentiate IPI-145 and enable broader use by physicians and patients. We are supporting an ongoing investigative sponsored Phase 1b open label dose escalation study of 145 in patients with advanced hematologic malignancies. The study is designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in combination with rituximab, bendamustine, or both rituximab and bendamustine. We expect to provide additional details about our combination strategy in the coming months.

Beyond hematologic malignancies, there is a strong biological rationale for developing IPI-145 in inflammation, in which we have two clinical trials underway. We are continuing to enroll patients in the [esvira] study, a Phase 2 double blind placebo-controlled trial designed to evaluate the efficacy, safety, and pharmacokinetics of three different dose levels of IPI-145 given twice daily on a background of methotrexate versus placebo plus methotrexate in more than 300 patients with moderate to severe rheumatoid arthritis. The primary efficacy endpoint measured at 12 weeks is the ACR 20 response rate.

We are also conducting a Phase 2a trial of IPI-145 in patients with mild allergic asthma and expect to provide an update on this study by the end of the year.

In summary, 2013 has been an important year for IPI-145. We are excited about the clinical potential for this product candidate and look forward to updating you in our continued progress at ASH.

With that, let me turn the call over to Larry to review our financial results.

Thank you, Julian. I, too, am looking forward to ASH next month and on Sunday, December 8th, we'll host an investor event in New Orleans with presentations by both management and investigators.

As our clinical presentation was selected for review at the ASH-sponsored media briefing on Sunday morning, we will be able to discuss our Phase 1 data with you ahead of the oral presentation on Monday evening.

During the investor meeting, we will also review the pre-clinical data that will be presented during the Saturday evening poster session. We look forward to discussing our data with you in greater detail on December 8th.

With IPI-145 rapidly advancing more than $250 million in cash and investments at the start of the quarter and worldwide commercial rights to our PI3K delta gamma programs, Infinity is in a very strong position today.

I'll now briefly review our financial results for the third quarter of 2013. We did not receive any revenue during the quarter or the third quarter 2012. R&D expense for the quarter was $26.9 million compared to $21.5 million for the same period in 2012.

This increase in R&D expense in the quarter compared to the same period in 2012 reflects costs associated with continued development of IPI-145 including our ongoing Phase 2 trial in indolent non-Hodgkin's lymphoma and preparations for our Phase 3 trial in CLL.

G&A expense was $7.3 million for the quarter compared to $6.3 million for the same period in 2012. The increase in G&A expense in the quarter compared to the same period in 2012 was primarily related to increased noncash stock-based compensation expense as well as market research and early pre-commercialization activities as IPI-145 advances into late-stage development.

Net loss for the quarter was $33.9 million or a basic and diluted loss per common share of $0.71 compared to $18.4 million, or a basic earning per common share of $0.57 and diluted earnings per common share of $0.52 for the same period in 2012.

As of September 30, 2013, we had total cash, cash equivalents and available for sale securities of $250.9 million compared to $277.2 million as of June 30, 2013.

With that, I'll turn the call over to our operator for questions.

(Operator Instructions) Michael Yee, RBC Capital Markets.

Hi, this is John on behalf of Michael Yee, thanks for taking my question. Julian, I first wanted to clarify in your comments, are we not getting any data on durability of response in the CLL subset?

We are still crunching through data, and I can't be more specific than the comments I made in the prepared remarks. But, obviously, we're looking at all of the aspects of activity for IPI-145.

I see. Then, do you think we'll be at least able to kind of tell that whether the six PRs in the four stable disease patients from ASH just one year ago are still responding?

Our hope is to provide as comprehensive a picture on all our patients at the ASH meeting, yes.

Okay, and just lastly, I was just looking at the abstract today, especially on the four new respiratory and infectious adverse events, could you provide any color on whether these occurred in the higher 75 mg cohort and whether it occurred despite mandating prophylaxis, or did they occur before prophylaxis? Thank you.

I can't comment. Again, we're still crunching through data, and I can't comment on patient-specific, but we have instituted prophylaxis, as we think this is the best approach, and we will see how that translates.

Recall that the prophylaxis is designed to prevent serious bacterial infections and Zoster and CMV infections but does not cover, necessarily, milder infections like rhinovirus. So stay tuned for the full description at ASH.

Matthew Andrews, Wells Fargo.

This is Shin calling in for Matthew. My question is at what point do you think you will have enough data to make a decision on whether to pursue high-risk relaxed refractory CLL as a path to market for 145?

Well, we are currently examining those very patients, and we will take under advisement when we see an abundance of data, over time, and make appropriate decisions.

Okay. Just to be clear -- in the presentation at ASH will you break out the overall response rate for 25 mg for dual refractory indolent NHL patients?

We will have an update of the INHL, and I can't tell you exactly in which presentation it's going to be at the moment, but we promise to have an update on the INHL.

But, Shin, it will heavily focus on the patients at the 25 mg b.i.d. dose, so that's right.

Joel Sendek, Stifel.

I have two questions -- first of all, on indolent, the Phase 2, I'm just wondering how enrollment is going there and with regard to the CLL Phase 3 that you intend to start, I'm wondering what kind of timeline you would expect to -- in that study.

So the study is going well. I'm not providing any numbers on this call. So the Phase 2 study is enrolling very well. And for the CLL study, which is yet to start, the enrollment characteristics, it's just a little too early to call. It is a fairly large study and internationally focused, so it will be a function of getting all the sites up and ex-US sites will take a little longer to get up than US sites. That's just normal regulatory procedure.

But we are on track, as Julian mentioned earlier, to dose the first patient this year.

Okay, and then just quickly -- did I hear you correctly that you won't have any data on T-cell lymphoma at ASH this year?

No, we'll provide a high-level update, but we'll concentrate on submitting an abstract for a T-cell meeting in San Francisco on the 23rd of January -- 23rd, 24th of January.

Jason Kantor, Credit Suisse.

Jeremiah, filling in for Jason. Thank you for taking the questions. In terms of internal work that you might have done looking at possible combinations with 145, can you maybe shed any light onto the possibility of combining 145 with just one other agent to have broad applicability to multiple tumor types? Or is it going to be more like a very specific combination for a given disease?

Both, I think. Depending on the mechanism, depending on the disease, we're exploring [pair-wise] combinations and will -- they should translate into future clinical trials. We're announcing at ASH the first data that we've recorded in DLBCO with a (inaudible).

And then going back to the prophylaxis that you mandated previously, can you give us any terms of the timeline when that happened and then, roughly, is there like a -- is there a certain set of patients that have started after that that you could kind of -- at least -- and what was released in that abstract today that you could provide us (inaudible) on that?

All I can give you is sort of general sense that is was prior to ASCO and, of course, there are patients that were enrolled post-ASCO. So I can't give you precise numbers, but -- I can say that, to the extent that we did experience these early infections in patients that weren't prophylaxed, this has taught us a great deal about how to manage patients. So I actually think, for a Phase 1 study, we're getting a very comprehensive picture of safety and, of course, activity as well. So I think it's all for the better of patients and the better knowledge of how to use the drug.

Catherine Xu, William Blair.

Hi, this is actually John in for Catherine. A couple of quick questions about potential partnerships given how the spaces have all being maybe trying to get some of the IPI-145 out quicker. And the second question I had is other potential studies may be exploiting potential T-cell maybe in Phase 3 or other pivotal studies, if you can comment on that.

This is Larry. In regard to the partnering question, we've had inbound discussions and interest since we got the rights back from Purdue Mundipharma over a year ago, and we've had those ongoing discussions. And the real plan for us was to have a -- kick the tires and make sure that we had the very best plan in place. And, to date, we've really been focused as Julian was giving an overview on the speed to market with registration under monotherapy.

We are also enabling through IST, as Julian described, combination therapy. And once we've broadly enabled combination therapy, there will be a plethora of more trials that we could be pursuing. While we're still in monotherapy, there really hasn't been an opportunity for a partner to articulate how things would go faster, better, broader, than we can do independently. But we could imagine sometime, from the time we enable broad combination therapy.

So, for example, the time we have our RA Phase 2 readout, those could be opportunities where a partner could make a compelling case that together we could do things even faster than we're doing independently.

And then, John, your second question was on T-cell and whether we might see that as an opportunity to go to Phase 3 trials. We're always data-driven, and so as that data mature and our team looks at it, we'll decide whether or not there is a compelling path forward.

(Operator Instructions) Yigal Nochomovitz.

I have a duration question. So from my analysis, it seems that the duration in the 25 mg pool actually went down a bit. So I just want to understand that a little bit better given that I would have expected it to go up with another two and a half months of therapy and the new -- the three new patients at 25 mg doesn't seem to be enough to pull it down. So if you could discuss that.

And then given that you've got 43% of the patients still on the study, I'd be curious to know of the patients that have dropped out where are they coming from? Are they mainly from the PR pool that has progressed, or is it coming from nodals that have dropped out? Thanks.

I'd love to give you a more comprehensive answer to the question, which is a pretty detailed comprehensive question. You're clearly following our data very closely, Yigal.

So it's a very stochastic process. We have also -- we haven't identified specific patients who have had AEs and come off studies and link them to their response rate. So it's not possible within our abstract, and I don't want to comment on patient-specific details. But it's not uncommon for -- to see a fluctuation in time on study in this way. Remember, that it is a Phase 1 study, and we're governed by Phase 1 rules. The patients coming off study for AEs may otherwise be much better managed in a Phase 2 setting when we have different rules for dose interruptions and continuation on study.

Okay. Can you say anything more about the one CR? Are they still on the study? Anything about the durability, and I'd be curious to know, based on the ASCO data, there's an 80% chance that they had adverse cytogenetics. So it would be interesting to know if, in fact, they did.

I will love to tell you that. Come to our ASH presentation, and specifically we will highlight that for you.

Okay, and then one question on the safety side. I just was a little confused because you said in the abstract you had 20% transient neutropenia, but then in the ASCO poster you had 39% grade 3-4 neutropenia. And even if you take into account the dilution from the additional 10 patients enrolled, assuming they didn't have neutropenia, that wouldn't be enough to push it down to 20%. So maybe it's something about the definition of transient, which I'm missing. But if you could shed some light on that, that would be great. Thank you.

Neutropenia, which plagued us early and was defined early, we have subsequently learned that it is a function of the background of disease. And so we now know that we can continue to have patients on study with neutropenia. In fact, we have allowed patients with grade 4 neutropenia to enter study. So there's no restriction to neutropenia, and there's no dose interruption in neutropenia. There have really been no sequelae to the neutropenia recorded. But as with all lab values, we record them all, and we report them faithfully.

If I could just sneak in one final question. You mentioned you'd have an update on asthma by the end of the year. So does that mean that the data is coming then or is it given dose escalation the nature of that study -- is it going to be later? Thank you.

We are committed to providing just a top-line summary, and so you will hear an update by the end of the year.

I am not showing any further questions at this time. I'd like to turn the conference back over to Adelene for closing remarks.

Thank you, everyone, for joining us on the call today. We are looking forward to seeing many of you at ASH and to providing further updates on IPI-145 in the coming month. Thanks, Operator.

Ladies and gentlemen, that concludes today's presentation. You may now disconnect and have a wonderful day.