Infinity Pharmaceuticals Inc (INFI) 2007 Q3 法說會逐字稿

Good day, everyone, and welcome to the Infinity Pharmaceuticals third quarter results conference call. Today's call is being recorded. At this time I would like to turn the conference over to the Vice President of Finance, Mr. Steven Kafka. Please go ahead, sir.

Thank you, and good morning from the proud capital of Red Sox nation. My name is Steven Kafka, Vice President of Finance for Infinity Pharmaceuticals. Here with me today are CEO, Steve Holtzman; Chief Scientific Officer, Julian Adams and Chief Business Officer, Adelene Perkins. Today we will be discussing our R&D and business progress and review our financial results for the third quarter of 2007. The press release detailing our results was issued last evening and is available on our website at IPI.com. This conference call will be archived on our website for 30 days.

On this call we will be discussing our future discovery and development efforts, our collaborations, our financial position and other future expectations. These remarks constitute forward-looking statements for purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act. It is possible that our actual results may differ from what we project today due to the factors which are described in the risk factors section of our most recent 10-Q, which was filed with the SEC on August 9th. 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 are not taking on an obligation to do so.

So with that, I will now turn the call over to our CEO, Steve Holtzman.

Thanks, Steve, and good morning, everyone. And thanks for joining us on the call today. As you know, Infinity is a cancer drug discovery and development company dedicated to discovering, developing and delivering to patients important new medicines. We have a pipeline of novel anti-cancer agents, great R&D and business teams led by respectively Julian and Adelene and a strong financial position. Now today I am delighted to share with you the momentum we are generating in our pipeline. Several value enhancing developments have recently occurred.

These include first, that IPI-504, our lead Hsp90 inhibitor, has now demonstrated biological activity in a second solid tumor indication, namely non-small cell lung cancer. Next, we've identified our preferred Phase II dose and schedule for IPI-504 which will now be used in multiple clinical trials targeting many additional tumors. Third, we've entered the expansion phase of our clinical trial in GIST and are progressing rapidly toward a potential registration trial. Fourth, we've been issued a broad patent covering the composition of matter of our Hsp90 drug candidates. Now, this news comes hard on the heels of our announcement last quarter that equally strong patent protection has been granted on the composition of matter of our Hedgehog pathway drug candidates. And finally, we ended the quarter with over $116 million in cash and cash equivalents.

Now before I turn the show over to Julian and Adelene to share with you a more detailed report, I want to take a few moments to reflect on why I think this is an ideal time to inaugurate or augment an investment commitment in Infinity. Everyone on this call knows that biotech investing can be a risky business and in the case of emerging biotech firms with earlier stage programs, assessing value is doubly difficult. So do you simply say well, this is too risky. All Phase I trials and all young biotechs are created equal and are equally poor investments, so I will just wait on the sideline until late stage clinical trial results are in.

Now I for one, and I know several of you don't ascribe to this way of thinking. Even in its earliest stages you can tell a quality biotech company. You look to its selection of targets, the quality of the company's science, its R&D leadership team's track record of creating and getting approval for new drugs, the business management team's track record of generating value for shareholders and finally, you examine the culture of the company to establish that it provides an environment in which highly talented, passionately committed individuals can flourish and therefore are likely to stay for the long haul. Most of all, you look for hard and tangible evidence of real and steady progress in the company's pipeline.

What we've shared with you in the past and certainly what we will share with you today and over the coming weeks and months is such hard evidence. For sure, we are early on our path, but in ways clearly discernible to those of you who look, brick by brick Infinity is systematically paving our path to a successful future. Early in development we take the care and time necessary to ensure that we have drug candidates with the best possible product profiles and have identified optimal doses and schedules of administration. Once we've laid this type of solid foundation as we've done recently on our Hsp90 program, we rapidly launch multiple trials designed both to achieve registration rapidly and to provide real evidence of broad clinical potential. We are following up initial successes with second and third generation projects to provide and ensure that patients will have clinically more flexible options. We are obtaining and solidifying our intellectual property and regulatory positions to create the best possible market opportunities. And as we pave this pathway forward we share our progress, both our successes, as well as the inevitable bumps in the road with you, our current and future shareholders so that you may judge for yourself whether this team is worthy of your backing.

So with that I will turn the proceedings over to Julian and then Adelene to review for you our progress over the last quarter.

Thanks, Steve. You know, there is an incredible and palpable sense of momentum at Infinity. We are making tangible progress in the clinic and in the lab. I want to touch on four topics this morning. First, we have new evidence of biologic activity in lung cancer for IPI-504, as Steve shared with you; two, acceleration of our efforts towards a potential registration trial in GIST; three, great progress toward the clinic with our oral Hsp90 program; and finally, we are seeing absolutely outstanding science in the Hedgehog program.

I have been around R&D my whole career, and this place, like the Red Sox, really rocks. Let's begin with the exciting news from our lung cancer study. Our PI from Mass General, Lecia Sequist, shared data at the EORTC meeting last week in San Francisco. These data show biological signal in our second solid tumor indication and embolden our strategy to seek a rapid path to registration as a single agent in a refractory setting, while we are also pursuing combination therapy to move up in the treatment paradigm. Allow me to elaborate briefly on the Phase I data.

The preliminary Phase I data in non-small cell lung cancer provides evidence of biological activity. This Phase I trial is in a heavily pretreated TKI refractory population. We dose escalated on a four-week schedule of twice-weekly dosing. Seven of nine evaluated patients had stable disease by RECIST criteria. We also saw encouraging evidence of activity by PET. Four of four of the patients evaluated responded. This is a meaningful indicator given tumor heterogeneity in this disease.

One patient of note who had failed multiple prior therapies was on IPI-504 for more than six months. This specific result meets the expansion criteria for the Phase II. Where do we go from here? We expect to dose patients in the Phase II portion within a few short weeks. The trial has two arms, mutant and wild-type EGFR and patient [each]. We will dose at 400 milligrams per meter squared on a three-week cycle. This provides greater total exposure to 504 as well as patient convenience and compliance. We will enroll up to 19 additional patients per arm if we meet the expansion criteria, which includes either a partial response or stable disease for greater than 12 weeks. And we are working with multiple centers around the US, and we expect to enroll rapidly and provide further updates as the data mature in 2008.

My second topic is an update on progress in GIST. We are in active consultation with the FDA and our international panel of investigators. You will recall that GIST is an area of high unmet need with no approved therapies in the refractory setting. We are encouraged by the preliminary safety and activity data we have seen to date, and we continue to believe that we have a path forward for potential registration trial for IPI-504 in refractory GIST. Let me remind you why we are so optimistic about 504 in GIST.

We have very encouraging experience from our Phase I trial. In the dose escalation portion 16 of 21 evaluated patients or 76% had the [best] response of stable disease. We also saw durability. Many patients were on drug for five or more cycles. You will recall from a retrospective of the Gleevec approval trial that overall survival for patients with stable disease is exactly the same as those who had partial response. Moreover, in the Sutent approval trial only seven patients, 7% of patients, experienced a partial response, but the median time to progression improved fourfold versus placebo. So as patients experience later lines of treatment in GIST, responses are measured -- as measured by tumor shrinkage are indeed rare, so the expected endpoint is really stable disease leading to an improved progression free survival.

While the data are early, evidence from the Phase I emboldens us to think about our next steps. So where are we heading in GIST? We are in active discussions with the FDA and with our advisors. We have established a recommended Phase II dose, and we are already well into the enrollment of the expansion phase of the GIST trial. We will enroll up to 20 additional patients to confirm safety and activity at the Phase II dose. The trial is accruing well, and we anticipate that we will complete enrollment this quarter. We expect to provide you further detail on our plans early next year. We have made great progress and remain optimistic about our path forward with IPI-504.

The third area where I'm pleased to report great progress over the past few weeks is in our oral Hsp90 program. In our last update we shared that we had initiated IND-enabling activities for a second oral Hsp90 inhibitor called IPI-493. Like IPI-504, 493 is based on the geldanamycin pharmacophore. Both molecules demonstrate potent and selective inhibition of Hsp90 in preclinical models. With this discovery by Infinity scientists we have an enhanced opportunity to bring the best in class oral Hsp90 inhibitor to market, particularly in what we now know is an increasingly crowded oral development landscape.

We've been busy on oral Hsp90 since our last call. We have been comparing the preclinical results of oral 504 and 493 to evaluate our best path forward into clinical studies. The goal of this rigorous comparison is to ensure that we put the strongest possible profile into clinical testing. We are looking carefully at critical differentiators like pharmacokinetics and half-life. This is critically important for distinguishing our molecules from the wholly synthetic competitor molecules also in development. We are near completion of our beauty contest and expect to file an IND in our oral lead clinical candidate in early '08.

Before leaving our discussion on Hsp90, I'd like to briefly recap two additional important milestones with 504. First, we've been granted a patent on Hsp90 inhibitors including IPI-504. This includes composition of matter, pharmaceutical composition, method of treatment and synthetic method claims directed to IPI-504 and other hydroquinone-containing ansamycin analogues. We've also announced in collaboration with MedImmune that we've received orphan drug designation for IPI-504 for the treatment of GIST in both the US and in Europe. As you know, this designation provides market exclusivity following drug approval for seven years in the US and 10 in Europe.

Finally, I remain tremendously enthusiastic about our Hedgehog program. We believe that the Hedgehog pathway plays a critical role in numerous insidious cancers for which there are very few treatment options. Recall that there are two types of cancers implicated in this area. First, cancers where there is a genetic mutation and therefore addiction to the Hedgehog pathway. And second, the aberrant up-regulation of Hedgehog in many solid tumors. Earlier this year we selected IPI-926 as our lead clinical candidate, and we have an issued patent with broad claims. IPI-926 continues to show potent and selective inhibition of the pathway, excellent oral bioavailability and a prolonged half-life in multiple species.

We have an exciting few months ahead for IPI-926. We anticipate sharing data with you. First, we expect to see data at ASH from Bill Matsui at Johns Hopkins who has studied an earlier Infinity Hedgehog molecule in certain hematologic malignancies. Second, we anticipate data from a number of in vivo animal models at the AACR annual meeting in April 2008 in San Diego. We are moving forward rapidly with IND enabling activities and anticipate entering human clinical studies with 926 in '08.

Let me wrap up this morning by providing an update on our upcoming milestones. We expect to begin dosing the Phase II portion of our non-small cell lung cancer trial within a few weeks. By year-end we will wrap up the enrollment in the expansion portion of the Phase I GIST study and expect to report final data by early summer '08. With the Phase II dose in hand, we expect to initiate at least one additional Phase II solid tumor trial and one combination study with IPI-504 by year's end. And several additional trials are on track to begin in the early part of '08. We anticipate filing an IND in the oral Hsp90 program again in early '08 and finally we expect to share additional details of our next steps for IPI-504 and GIST in the early part of 2008.

So in summary, it has been a really productive and exciting quarter here at Infinity. We've made great progress on all fronts with our lead molecules, and there is an exciting pipeline of discovery programs not far behind. With that said, now I will turn over to Adelene who will provide you with a business and financial update. Thank you.

Good morning, everyone, and thanks for joining us on the call. I am tremendously excited by the news that we've shared with you today on our R&D progress. Delivering data is the key value driver for our business, and we are doing that with an increasing volume of news to come as we look to enter 2008. As our third-quarter results show, we continue to enjoy a very strong financial position, enabling us to fund our R&D efforts to these value creation milestones.

Specifically, as of September 30, 2007 we had over $116 million in cash and short-term investments so we continue to be on track for our goal of starting 2008 with more than $100 million in cash. I am particularly pleased to report that we have now completed our obligation to deliver novel compounds to Novartis under our diversity oriented synthesis or DOS technology access agreement. The acceptance of compounds by Novartis was one of the key drivers that helped increase our revenues in the third quarter up to $7.5 million. This successful completion marks a very important milestone for the company. Our three partnerships around the DOS platform were fundamental building blocks in the early days of Infinity, serving as a nondilutive source of $65 million. And, the DOS compound libraries remain a valuable discovery asset for Infinity. DOS compounds served as the genesis of our Bcl-2 program, and we expect to use our novel compound collection in future discovery efforts.

Our expenses for the third quarter, which are detailed in the press release we issued last night, are consistent with the prior quarter and reflect our ongoing aggressive prosecution of development programs. Infinity's net loss for the third quarter of 2007 was $2 million or $0.10 a share as compared to a net loss of $4.2 million or $0.21 a share for the second quarter of 2007. The decrease in net loss is primarily due to the increase in collaborative research and development revenue.

As our results and outlook show, we are in a strong financial position with a well controlled burn rate. We can and will therefore continue to aggressively invest in our pipeline of internal candidates, and we are reiterating today our guidance that in the absence of any additional financing or business development activities, we have capital sufficient to support our operating plan through at least the end of 2009.

I'd also like to offer a brief update on our MedImmune collaboration. With Hsp90 our terrific and productive working relationship continues. In particular, this relationship has allowed us to pursue a more expansive and aggressive development strategy for IPI-504 than we would have been able to do on our own. For the Hedgehog program as you heard from Julian, we continue to make excellent progress with our lead clinical candidate, IPI-926. As we've shared with you previously, a provision of our collaboration agreement with MedImmune provided that if AstraZeneca, which acquired MedImmune, had their own pre-existing Hedgehog research program, they were required to gain our consent in order to be able to continue or they would need to divest it. AstraZeneca does have a Hedgehog program and has expressed interest in continuing it. As such, they've asked us to consider conditions under which we would allow the program to move forward. We are in active discussions and continue to work in the same collaborative spirit that has defined the working relationship to date. We will report back to you when we have a definitive agreement which we expect will be within a month.

In summary, I'm exceptionally proud of the excellent progress we are making on our pipeline and of the important milestones we are on track to achieve over the coming months. We see a great future and look forward to continuing to discuss our progress with you on future calls. Finally, we appreciate your continued support. With that, we would be glad to answer any questions you may have as long as we can wrap it up before the Red Sox rolling rally at noon. Thank you.

(OPERATOR INSTRUCTIONS) Eun Yang, Jefferies & Co.

This is Molly on for Eun this morning. Thanks for taking the question. My first question has to do with expenses. With so much progress in multiple programs starting up for 4Q and through 2008 can you give any guidance as to the magnitude we might see an increase, especially with R&D coming in fairly flat and SG&A a little bit lower in third quarter, quarter over quarter?

As you know, the expenses, our R&D expenses are offset by reimbursement for MedImmune. So while our R&D expenses appear to be flat even year-over-year of 2006 to 2007, they actually increased from $9.3 million in the third quarter of 2006, up to $11.7 million in third quarter of 2007. So there is an increase in spending. It is just not fully reflected because of the offset from the MedImmune reimbursement. In terms of looking forward, the guidance that we are providing is that our $100 million in cash that we have going into 2008 will cover our burn through all of 2008 and through the end of 2009. And that will cover our increased spending on our program.

Thanks for that. And can I ask one other question? I was wondering about the maximum tolerated dose you guys saw in the lung cancer trial with 225 milligrams per meter squared. What made your side effects limited going up to the 300 milligrams per meter squared dose in that trial?

You are quite correct. On the schedule, the uninterrupted schedule, the uninterrupted treatment of twice weekly, we escalated the dose and saw that patients were having a hard time both with the schedule, namely no holiday and no respite from treatment. And what we were noticing was that there was a significant amount of fatigue and recorded some grade 3 fatigue in several patients. And when we compared it to our schedule A, which we've looked at in the GIST trial with the two weeks on, one week off schedule, patients are able to comfortably receive 400 milligrams per meter squared. So if you look at the total dose over a cycle we actually are giving a much higher dose of 1600 milligrams per meter squared per cycle compared with 1350 milligrams per meter squared with schedule B.

(OPERATOR INSTRUCTIONS) Ted Tenthoff, Piper Jaffray.

Thank you very much for taking my question. Congrats on the EORTC data. Let me just doublecheck. Maybe you can give us a little bit more understanding of where AstraZeneca is in developing their program and what might be the outcome? Would there be any additional money that would go to you guys? Would there be a prioritization of programs? How does that work?

Appreciate your interest in the AstraZeneca situation and as you know, there is nothing I would love to do more than to discuss it with you in depth. But as you can appreciate, while we're in the midst of those discussions it is not the right time for us to go into any more detail other than to tell you that we will look forward to reporting out within a month. And I think the other thing that is very important is that we have a great relationship with MedImmune and AstraZeneca on our Hsp90 program. And the spirit of that is very much influencing these discussions where we are working to ensure that we come up with a solution that is in the best interest of both parties.

That's fair enough. When it comes to the trials that we are seeing going into next year, in particular this lung cancer data, I think one of the trickiest things in lung right now is with so many compounds in development sort of charting the path. So how would you, how would monotherapy in refractory kind of fit into where we will be in a year or two in the regulatory process for lung cancer?

Great question, Ted. So let me begin by saying what we expect is that our treatment population will be in the TKI refractory mutant EGFR population. And as you know, with subsequent lines of treatment with TKIs it is really diminishing returns. So Hsp90 provides really a new mechanism to approach the EGFR mutant population. And certainly as a salvage therapy, and of course we haven't completed the trial, it is still early days, there really is a potential for single agent activity.

However, just as you pointed out, we are mindful of the fact that lung is a much more complicated arena. And we are already taking steps to start examining combination therapies, and particularly where we see synergy in the laboratory. And we will be reporting on that in months to come. You may see something at AACR or ASCO.

Next month. That will be very exciting. Thanks, Julian.

Michael King, Rodman & Renshaw.

Thanks for taking my question. I also had a follow-up on lung and I was wondering, guys, will you be able to at some point show us some PFS data out of this study? Will it not, is it not powered, is it not constructed to show PFS?

No. It is a single-arm study, Mike, and so PFS is sort of --.

I know it is nebulous, but I mean --

Without a comparator arm, it is not going to be meaningful. But what our PIs and what we know from this patient population who have failed multiple lines of therapies including multiple TKIs and chemotherapy, that anything a stable disease like what we have reported for six months and partial responses is going to be considered very meaningful in this setting.

Okay, and turning to GIST for a second, I am just wondering if there is -- I know you guys have talked a fair bit about sunitanib and stable disease in that setting. But I'm wondering if there is anything that can be learned from the recent approval of nilotinib in the refractory setting and what lessons Infinity might have learned with regard to 504 for that indication.

Thanks for your question, Mike. I am glad you brought it up. And first of all, congratulations to Novartis for the approval of nilotinib in CML.

I thought you were going to congratulate me on the appointment of Joe Girardi as a manager of the Yankees being that we are going to be talking a lot about baseball here.

That was coming next.

Did something big happen recently? I must have missed it.

Yes, the dynasty continues.

Your powers of observation remain intact, Mike.

As you pointed out, nilotinib or Tasigna is approved for CML. There is not yet an approval in GIST although it is being used in third line settings in GIST. I will remind you that many of our patients actually experienced and failed nilotinib, as well. So together with our investigators and in discussions internally, again we believe that multiple TKIs provide diminishing returns of clinical benefit for patients. So we would rather posit that a new mechanism would actually represent real progress in this disease and potential patient benefit. I hope that gets to your point.

To some extent, yes. Just as far as the, is there going to be a final presentation of the GIST data with all patients followed through either to progression or death sometime next year? Are you going to have an ASCO presentation or AACR next year?

I'm not sure if the data will be sufficiently mature by ASCO, but we will follow the 20, the expansion of 20 patients. And we will follow them throughout the length of their treatment and eventual clinical outcome and of course report on it.

Right. I will get back in queue. Thank you.

Phil Nadeau, Cowen & Company.

Good morning. Thanks for taking my question. My first question is on GIST. At various points in the presentation you said you are hoping to move into a pivotal study just very soon and also that you would update us on the status of the next program early in '08. But you never actually guaranteed a GIST pivotal study to start early in '08. What is it that you need to know I guess before starting that trial? Is it just sign-off from the FDA, or is there additional data from these 20 patients that will better inform that decision?

It is a great question. Thank you. It's both actually. We are in discussions with the FDA and don't want to preview the outcome of those discussions, of course, until we've actually sat down and come to agreement. And secondly, the expansion phase of 20 patients gives us further insight into safety and activity of the drug. So of course, this continuously mining of the data, discussions with our investigators, discussions with the FDA, we will be able to give better guidance early in the new year as to the potential for that registration study.

I think it is worth reiterating that in the evaluated patients so far during the dose escalation phase we saw a 76% rate of stable disease. And we saw meaningful durability of response, median durability of response, which as Julian suggested, we think gives us the basis for sitting down with the FDA and our investigators to design and get agreement on what could be a pivotal full registration trial. As Julian mentioned, having hit the recommended Phase II dose we are in the midst of rapidly expanding in that broader cohort. We are seeing results there consistent with what we saw at the upper doses in the dose escalation phase. So I guess what I wouldn't want to say is that without prejudging the results of our discussion with the FDA, without prejudging the results of the expansion phase we are feeling very, very bullish about the design. And we hope to see implementation of a controlled full registration trial.

That's a very helpful answer. Second, is a question on the lung cancer poster that was presented last week. In the conclusions on the poster it is noted that two of four patients who were [evaluated] by PET had a partial response. Can you talk a little bit about PET partial responses in the EORTC criteria? How well validated is that criteria for PR, and I guess how meaningful are those responses?

It's a great question. Let me be very clear that partial response by EORTC criteria means a diminution of 25% of the radiotracer, the metabolic showing reduced metabolic activity of the tumor. And while it is less well-established in lung and other diseases, unlike GIST where it is extremely well-established, the EORTC has developed these criteria to look at early biomarkers for biological activity. So what I can say is all four patients, in fact, showed some level of response by PET, with two patients actually showing a meaningful -- again, by EORTC criteria -- reduction of metabolic activity of the tumor. And that should presage upon prolonged treatment the eventual shrinkage of that tumor or at least stable disease.

And it is worth pointing out that in the NIH or FDA critical path initiative in the biomarkers component where PET is a key biomarker they are examining, they have chosen two tumor types as the highest priority based on evidence to date of its utility and one of those is in fact lung cancer.

That's very helpful. Thank you.

Michael King.

Just wanted to -- Adelene, with regard to the AstraZeneca decision-making process I thought I read, correct me if I'm wrong, on the recent 8-K that said they have until the end of November to make their decision. Is that true, or is that referring to something else?

No, Mike you are right. We did put in the Q that we have granted them an extension on the date for which we have to have this resolved, so that we will -- we are working into November.

Okay, great, so one way or the other we should hear?

That's exactly right.

And then on Hedgehog, Julian can you talk about the strategy there? Are you willing to discuss it now in terms of enriched -- I know you talk about addiction and overexpression, but can you talk about whether you're going to do enriched or focused Phase I trials?

That is a very good point. Right now we're focused on really how to get to a Phase II dose. And so we are talking with a number of investigators of what is the best way to get to a relevant Phase II dose. Since this is much less charted territory, we want to probably explore a number of schedules. And we will enrich certain patient populations with solid tumors where it has been described in the literature that they are expressing the Hedgehog pathway. For some of the genetically related tumors, there may be actually a different dose response relationship, and we may contemplate different types of trials in those patients. And that is being informed by some of our preclinical data.

Okay, so you won't have to wait for a Phase II dose for that or you will have to just do that once you've decided a Phase II dose and schedule, I presume?

It is not yet clear. We may have staggered Phase I dose selections in different populations. And again, we will come out and tell you the whole story once we have really fully digested our preclinical data and make those decisions. And again, in consultation with our collaborators.

Thank you.

Chris Raymond, Robert W. Baird & Co.

Thanks for taking the question. Just another sort of nitpicky question on the AstraZeneca announcement that you guys had. I think I remember reading in the original MedImmune agreement language that you had that MedImmune can opt out by giving six months notice. Sort of on that with regard to the Hedgehog news, when they give you a decision would that be a six month notice decision in terms of their cost-sharing, or is there something different there?

Let me maybe separate because there have been a couple of questions on the AstraZeneca situation. They are really two distinct issues. One is the Infinity Hedgehog program. If MedImmune or AstraZeneca were in the absence of the issue of them having their own program would choose to opt out, then they would provide us notice of that and they would continue to fund their 50% for six months after that.

The issue that we are now addressing with AstraZeneca and the Hedgehog program is that they do have a program in the space and the way our agreement was structured is they had six months from the acquisition of MedImmune to either get our consent to move forward with the program or to shut it down or divest it. The six-month clock ended on October 22. They have asked us for an extension on that for us to provide a mechanism to give them permission to let that program continue. And so we faced the choice October 22 do we force them to shut the program down, or can we find an outcome which has greater value for both of us? And we believe that there is a better outcome than just forcing them to shut down their program, and that is what we are in discussions around right now.

So when we next hear it won't necessarily be that they -- if indeed they opt out for example, it wouldn't necessarily be the beginning of a six-month clock, it might be something different from what is publicly available from your MedImmune deal?

When you enter a negotiation like that you look at all the leverage that you have in terms of what is a better outcome for AstraZenica and what is a better outcome for Infinity. So we are in the midst of coming up with what we think is the best solution.

Great. Thank you.

We did suggest they give us $0.5 billion in order to let them continue with their early research, but they didn't think that was a good idea. So stay tuned.

And that is all the time we have for questions. I will turn the conference back over to Mr. Kafka for any additional or closing remarks.

Thanks, operator. We would just like to thank everybody again for joining us today. And as always, we are available to answer additional questions that you may have. And again, we appreciate your continued interest and support of Infinity. Thank you. Have a great day.

That does conclude our conference for today. Thank you all for your participation.