Madrigal Pharmaceuticals Inc (MDGL) 2010 Q3 法說會逐字稿

Good day and welcome to the Synta Pharmaceuticals third-quarter 2010 financial results conference call. Today's conference is being recorded and webcast. At this time for opening remarks I would like to turn the call over to Rob Kloppenburg, Vice President of Investor Relations and Corporate Communications at Synta Pharmaceuticals. Please go ahead, Sir.

Good morning and thank you all for taking the time to join us today. With me are Dr. Safi Bahcall, our Chief Executive Officer; Keith Ehrlich, our Chief Financial Officer; and Dr. Vojo Vukovic, Synta's Chief Medical Officer.

This morning we issued a press release that reported results for the third quarter of 2010. This release can be found on our website at www.SyntaPharma.com.

Before we begin I would like to point out that we will be making forward-looking statements based on our current intent, belief and expectations. They are subject to certain risks and uncertainties and I encourage everyone to look at the SEC filings for additional detail. I will now turn the call over to Dr. Bahcall after which we will open the floor to questions. Safi?

Thanks, Rob, and thank you all for joining us today. I'll begin with a brief overview of the progress we've made with our two lead programs -- STA-9090 and Elesclomol -- and then Keith will take you through the financial update.

Our trials for 9090 have enrolled a cumulative total of just over 270 patients. That includes our nine Phase II trials and four Phase I trials. We've been encouraged both by the consistent safety profile and by the clinical activity observed across these trials.

Most encouraging have been the results from our lung cancer trial. In September we announced that the trial was being expanded from up to 69 patients to up to 146 patients based on the results seen in the cohort which represents the largest population of lung cancers, the EGFR and KRAS wild types.

Both the Stage 1 and Stage 2 portions of this cohort, and approximately half of the 35 patients in the expansion cohort, have been enrolled. We should complete enrollment by the end of the year and have detailed results to present at a medical meeting in the first half of next year.

We're also actively enrolling patients in the combination arm of this trial which is 9090 plus docetaxel. The safety results from this trial so far mirror the safety findings from our Phase I trials. The drug is well tolerated and we're not seeing the serious liver toxicity seen with first generation is Hsp90 inhibitors or the common ocular toxicities seen with second-generation Hsp90 inhibitors.

The efficacy results from this trial have been encouraging on both the single agent arm and the combination arm. In the single agent arm of this trial we've seen several patients who have achieved significant prolonged tumor shrinkage which is, of course, a clear sign of clinical activity in the highly refractory patient population we have in this trial.

The combination arm is for patients who have received treatment as single agent and there's reason to believe they may benefit from combining with docetaxel. To illustrate by example, we have a patient whose main lesions shrunk with 9090 as a single agent and stabilized that way for about nine months, but then had small new lesions develop that were not being controlled by 9090. This patient entered the combination arm.

The first set of scans following combination treatment showed that the new lesions reversed course and began to shrink. In other words, we're getting more full disease control and response with the combination.

This example illustrates an important goal of this trial which is to characterize two potential registration paths for 9090. The first path is as a single agent in patients with specific gene mutation profiles that have high sensitivity to treatment with 9090. We are seeing some initial hints from the data that there may be this type of correlation. We are gathering additional data to confirm these findings.

The second path is in combination in a more broad patient population. For that we are assessing the safety and activity in combination with docetaxel for which there is strong preclinical and scientific support for the combination. We expect to have a lot more data on both of these questions over the next several months and should be able to discuss more details about our plans early next year.

A quick summary of where we are with other 9090 trials. The hematology studies will be reporting some preliminary results at ASH. This is primarily from the dose escalation phase of those trials where we have seen some signals of activity. We're reviewing the results with our investigators to determine the most appropriate next steps in this population.

The GIST trial completed enrollment of Stage 1 and the go/no go criteria for advancing to Stage 2 were achieved. We took biopsies during this trial, we are conducting some translational experiments with those biopsies and are currently discussing with investigators the optimal path forward including exploring some additional possible modifications based on the new preclinical and clinical data.

The IST program is moving along well with substantial data expected by mid-2011 and several new trials expected to start by early 2011 including prostate cancer, breast cancer and several new combination studies.

To summarize, our primary focus in 2011 is to advance 9090 into registration enabling studies and we believe we are well on track to do that by mid-next year.

On the partnership front, we're in active discussions at the term sheet stage with several potential partners. We're aiming to balance the long-term goal of maintaining ownership and control of our product with a long-term goal of minimizing dilution to shareholders that would come from additional financing of development costs. There are ways to do that, for example, regional partnerships which take some time to negotiate and we expect to announce progress on that front by the first half of next year.

With respect to our Elesclomol program, I won't spend much time on this portion of the call discussing that program; I'll leave that to Q&A. I'll just say that we are very pleased with the decision of the Gynecological Oncology Group to initiate a Phase II trial in ovarian cancer. Both the study itself and the funding from the National Cancer Institute are strong third-party validation. We expect the first patient will be enrolled in this trial early next year.

Elesclomol has a novel mechanism of action unlike almost anything else in oncology today. Three randomized trials have shown that there is a predictive biomarker, also novel, that can guide as to the most responsive patient population for this compound. So we are very happy to see the program move forward and expect quite a bit more from it next year. I'll now turn the call over to Keith Ehrlich to provide a financial update.

Thank you, Safi, and good morning, everyone. Before I provide a financial review, let me begin with a brief update on our CRACM research program with Roche. As you may recall, our partnership with Roche consists of two elements. The first is a two-year research collaboration under which Roche funds all research undertaken by Synta. Second is a licensing agreement under which compounds discovered in the research component will be advanced by Roche and we will receive milestones and royalties based on the progress of those compounds.

The research component of this agreement will conclude as scheduled at the end of this year. As a result of the conclusion of the funded research phase we will be making appropriate adjustments to our operations which will include a decrease in our investment in this program.

Now let me move on to the financial update. In September we obtained a $15 million term loan from General Electric Capital Corporation, the net proceeds of which are included in our cash balance as of September 30. The loan has a three-year term with interest only through June of 2011 and equal monthly installments of principal plus interest thereafter.

In October we also entered into a $35 million committed equity line of credit with Azimuth Opportunities Limited. Under the equity line we may require Azimuth to periodically purchase our common stock.

Earlier this week we were informed that all four of our applications under the Federal Government's Therapeutic Discovery Tax Credit Program were approved. We were awarded a total of approximately $1 million under this program which will be paid to us and recognized as revenue in the fourth quarter of this year.

Total collaboration revenue in the third quarter of 2010 was $3.4 million. Collaboration revenue in the same period of 2009 was $130.4 million which included $114.6 million of revenue accelerated upon the conclusion of the GSK collaboration.

In the third quarter of 2010 our research and development expenses were $11 million as compared to $9.1 million for the same period of 2009. Our third-quarter general and administrative expenses were $2.6 million as compared to $3.1 million for the comparable period in 2009.

In the third quarter our net loss was $10.3 million or $0.22 per basic and diluted share as compared to net income of $118.1 million or $3.49 per basic share and $3.48 per diluted share in the same period of 2009.

As of September 30, 2010 we had $54.1 million of cash resources on hand. Based upon current operations together with the remaining Roche research and development reimbursements and the therapeutic discovery tax credit award, we anticipate our cash balance at year end will be in the range of $43 million to $45 million.

Based on the current operating plan we expect our cash resources together with the remaining reimbursements from Roche will be sufficient to fund operations into 2012. This estimate assumes no additional funds from new partnership agreements, cost or risk sharing agreements, equity financing events or use of the $35 million equity line of credit.

Certain new clinical programs contemplated for 2011 would be conducted subject to the availability of additional financial resources. I'll now turn the call back to Safi.

Thanks, Keith. We'll now open the call for questions and discussions.

(Operator Instructions). Andrew Vaino, Roth Capital Partners.

Hello, thanks for taking my question. I was wondering if briefly you could go over the physical chemical rationale for the synergy between 9090 and docetaxel.

Sure, I'll turn that over to Vojo to discuss.

Hi, Andrew. Well, there are certainly several reasons, several molecular pathways on which these two drugs intersect. I could name a few here, but I'm also happy to discuss this off-line. Besides some molecular events there's also the potential for 9090 to change the tumor micro environment which would then in turn enable docetaxel to work much better.

Okay. How big -- I assume that in preclinical cell-based assays you saw a big synergistic effect with these two agents in combination?

Absolutely. We have seen this effect not only in [in vitro] experiments in multiple models, but also in a series of animal treatment (inaudible) models. But also I think most importantly we have also seen recently some evidence in the clinic that the synergy actually might work.

Okay. Is there any way to quantify degree of synergy there?

It's still early.

Okay. And then just a quick financial question. What's the interest rate on the GE Cap loan?

The stated interest rate is 9.75%.

Okay. Thank you.

Shiv Kapoor, Morgan Joseph.

I've got a couple of questions on STA-9090. First, on the lung cancer trial, so are we going to see no data towards the end of the year or first quarter of next year? I thought we were going to see some data at one of these conferences in either December or January.

We will have some 9090 data at ASH in December that's from the hematology studies. In terms of -- there is a lung meeting in February and we may well have data at that meeting, it's still a little too early to say. But more likely for the lung trial would be Q1.

Okay. The combination trial that you're planning on starting with the STA-9090, can you talk about those? What kind of combinations are you going to be going into?

Yes, I think the -- you can see from the work that we're doing now, we have two studies evaluating the combination with docetaxel. We've done a lot of preclinical work in-house, we've tested many different agents for quite a long time and we've seen the most spectacular synergy between the taxanes and 9090 at a very high level. Some of those results have been published and presented already. And that's been seen with other compounds.

As Vojo said, there are many strong underlying scientific reasons of why you see such strong synergy, especially the cell cycle affect, the complimentary effects on cell cycle of the two drugs. So that's the combination we're most likely to take forward into larger trials next year.

Okay. And a couple of financial questions. The loan amount and the equity line that you have talked about, one from GE Capital and the other one from Azimuth, are there restrictions on the use of that cash? And are you feeling comfortable that you will likely have cash for a couple of years given that you might be starting a partnership, a regional partnership yourself?

In terms of the restrictions on the cash, Keith, do you want to address that?

Yes, there are no restrictions on the use of the cash under the GE loan. Should we use any of the ELOC that's available to us, there are no restrictions on the equity line cash either.

In terms of the run rate, as you know, you've followed the Company for a long time -- we tend to run a pretty fiscally conservative operation, we tend to make sure we have enough cash on the balance sheet to give us a very healthy run rate. So we don't plan for more than we can afford. We're in multiple partnership discussions and are pretty optimistic we can make good progress on that by the first half of next year. Any of those would substantially extend our run rate.

Okay. And one last question and I'll ask Vojo. You've been presenting lately some interesting data on subset analysis from several of the trials, Elesclomol, in the past. Are these data -- are we going to see a publication of these data anytime?

Yes, we will -- we're currently working on publications from these clinical trials and they will be published next year.

First half next year, second half?

It's difficult to know, difficult to know. But we'll publish both the melanoma data and the non-small cell lung cancer data.

Okay, great. Thanks a lot.

Jason Kantor, RBC Capital Markets.

Thanks for taking my question, guys. A couple of things. Could you give us some ideas as to why you've taken the initial path with Elesclomol and to ovarian specifically? And then also why that's -- why not go straight into some kind of randomized study given all the data, the safety data and the efficacy data that you have, just to get something more definitive in terms of an efficacy readout on the product?

Yes, okay, I'll try to address that. The specific reason why GOG, Gynecologic Oncology Group, is interested is because of the unique and novel signs that open up new therapeutic possibilities, particularly for these patients for which there's a huge unmet medical need. And I think that we're also very much encouraged by some of our Phase I data that included an ovarian cancer patient who actually responded well to this combination. That's now being tested in the GOG trial.

And the reason why GOG feels confident about running a not randomized study is because they have a system that allows them to run trials in a very reproducible way, so they feel very confident they can compare both the safety and activity of different drugs in different trials.

But I mean, from your corporate perspective to actually get a data set that can inform you better in terms of how to run a pivotal study, don't you think that controlled Phase II studies at this point are the more appropriate way to move a program forward -- especially one that's got that much data behind it already?

Absolutely. We're big proponents of the randomized study. We -- that question actually came up -- was a subject of quite a bit of discussion with GOG, with the cooperative group. They felt very strongly -- they've run many of these kinds of trials and they felt very strongly that they would get the information they need for their purposes. It's a third-party sponsored trial and so we accept that. And we do have a lot of confidence in the physicians and the cooperative group that they can make appropriate judgments for their patients.

If and when we would do company sponsored trials or trials in other indications, for example in lung cancer, we would very much be in favor of a randomized controlled study. The three trials that we have that showed benefit for Elesclomol in the normal LDH population, they were all randomized controlled studies. And what we want to do now is do a prospective randomized controlled study in the normal LDH patient population. The data that we have to date is very suggestive and very encouraging for that. And exactly as you say, that would be the most definitive and convincing.

You might have said on the call, but I jumped on late, what is the timing or is the likely indication for you -- or what's the gating factor for you to make that decision to do that study yourself?

So the ovarian and AML trials are ongoing, they've been initiated, they're getting started now. We're in discussion with a number of investigators on other trials, for example lung cancer and prostate cancer. Investigators have gotten very interested in the mechanism, very interested in the clinical data and the preclinical data.

The gating factor is just balancing the portfolio of demands and the resources that we have, as well as moving those discussions along and converging on a protocol. We'll probably have quite a bit more to say about it in the first half of next year.

And then just one last question on STA-9090. I mean, obviously you guys are the beneficiaries of a lot of other companies getting out of the space and you've got a lot of data potentially coming. I mean, how would you want to set people's expectations in terms of -- what would be considered good data at this point for an Hsp90 inhibitor? What can we hope to see from some of these studies and what would you consider to be a good result versus a result that would be difficult to interpret?

Let me take the first crack at it. I see Vojo is jumping off his chair, he wants to answer that question. But the most important thing for now -- exactly what you said given the safety findings with these other drugs would be very high ocular toxicity rates of 89% of all patients at NTD with another drug showed high ocular toxicity. Another company just published abstract online, it will be presented at the triple meeting of high ocular toxicity.

It's really remarkable. It rarely happens in drug development that you have let's say three companies working in a field with such high scientific interest. And there's such a stark contrast in safety profile. So what you should look for is what is the level of ocular toxicity with our agent certainly relative to the other agents. And is there clinical activity?

You know, you could spend some time on the underlying science or biology or pathways or what's causing ocular tox and what isn't and we and others have done work on that. But the most critical and relevant question for getting a drug approved is, is it safe and is it effective?

We are seeing as a single agent 9090 is causing substantial tumor regressions in highly refractory patients who have failed other drugs. That's clinical activity. We are seeing, and we've treated 270 patients, that there is a very low, if any, level of ocular toxicity with our drug.

So what people should look for is, when the data gets presented is what's ocular toxicity with the other agents, what kind of activity did they see? And what is the ocular toxicity with our agent and did we see convincing signs that there's an active drug here?

And we believe from what we've seen we have very convincing signs that we have an active agent and it's really now designing the right trials to enhance that, bring out that signal in a way that's a registration enabling program.

Thank you.

Ryan Martins, Barclays Capital.

Good morning and congrats on the progress with 9090. You said you were planning on initiating a registration enabling trial in the middle of next year. I was wondering if we should maybe expect anything in terms of a partnership potentially prior to an initiation of a registration enabling trial?

Yes, our goal -- we're in a number of ongoing discussions and our goal is to make a lot of progress on that in the first half of next year.

Okay, thanks. And I believe in your press release and in your prepared comments you stated that you may initiate new clinical programs next year subject to availability of additional financial resources. And I was wondering if you could maybe provide some additional color on this? Is this something that's apart from the Azimuth equity lines?

Yes, sure. We are -- Hsp90 has such a high level of interest in the scientific and medical community that we are pretty regularly approached, especially since June when the other companies working in the field reported such high levels of ocular tox and we didn't see it and we were showing single agent activity.

That we've been approached by quite a lot of investigators in a number of therapeutic areas, some of them are pretty -- kind of the obvious ones based on the first-generation experience, for example breast cancer, myeloma and so on, prostate cancer in addition to lung cancer. So we've been approached by a lot of investigators with a lot of requests for -- ideas for trials, but some single agent, some combination.

That's reflected in the fact that we've chosen some of those for ISTs from investigator sponsored studies. And it's something that we'll consider. If and when we conclude a partnership and there's more capital available we would consider some of these additional clinical programs.

Okay, and just to confirm. You haven't accessed your equity line as of today?

That's correct. We have not accessed the equity line of credit as of today.

And just finally, in terms of the CRACM program with Roche. Is it still on track for IND filing next year?

It's hard for us to say right now. So we have actually taken that out of our projections just because we've had very recent new discussions with Roche about this program, so until we get a little bit more visibility on the program we're not going to give any particular guidance on the preclinical development.

We did a lot of, I think, very impressive work on the research side by our group and their team. We've developed some very promising compounds that they now have a license to and the development of those compounds is in their hands. So over the next few months as we hear more from them about their specific choices we'll let you know.

The gating factors (inaudible) Roche selecting one or more compounds you will progress into development work?

Yes, they have a process like many pharmaceutical organizations of compound selection and nomination and preclinical development and they go through that process and we'll be informed as the compounds are making their way through the process. And when we get good visibility on what we think the likely timelines are that would affect our financials in a material way we'll report those.

Okay, thanks for taking the questions.

Joel Sendek, Lazard Capital.

Hi, thanks. A couple questions. First, I think when you're talking about 9090 and the potential registration pathways, either single agent or a combination, you're referring to lung cancer. Is that right or would this be the potential registration pathway for any indication?

Generally what we would do is while we're in the middle of ongoing planning discussions and discussions with investigators, until things are finalized we wouldn't want to get too specific about a particular tumor type, a particular trial design, a particular choice of dose or schedule a combination until things have really finalized.

But the concept, the more general concept that we're outlining is there are really two approaches with a drug like this, a drug that has a very good safety profile that allows it to combine with a number of agents, a drug that has been tested by us and others preclinically and shown a lot of synergy with a lot of interesting agents, there are two approaches.

One is that kind of combination approach and one is when you do see some real tumor responders, patients who have failed everything and start responding to your drug and you know you have a targeted agent, you ask the question, what is it about that patient? And so we're doing those experiments.

We don't have, I would say, enough data right now that's mature to announce that we're going in direction A or direction B. What we're doing is simply outlining where we are which is that both are plausible approaches, both are supported by the scientific data, we're gathering the data real-time in these trials to answer those questions and then we'll make a decision when the data is very clearly pointing us in one direction or the other.

Okay, good. Thank you for that. And then with regard to the lung trial specifically, you have all the subgroups, whether it's wild type or mutant and the other ones as well. Can you give us any view as to which group is doing the best? And if you can't, can you maybe give us some idea as to what your prediction would be based on your modeling of how the drug would work in each of those subgroups?

Yes, so I'll take that question. We have seen a clear signal of activity in one of the cohorts of the lung cancer trial, that's a cohort that's wild type for EGFR and KRAS basically in non-mutations. That's where the signal is the strongest and that's where we're expanding the trial.

And in addition to that we're also doing lots of translational research, we're looking at genetic profiles which, as Safi mentioned in the previous question, will help us inform the future course of upcoming trials whether to go into specific patient populations based on genetic profiles or whether to go into a combination trial that would be somewhat broader.

Okay, thanks. And then just a quick financial question. With regard to this tax credit that you received, you described it in the press release as a grant. So I'm just confused as to whether it's a credit or it's a grant? Is it coming on the revenue line or how does that work?

Yes, it's a cash grant. We are in the next -- I think if it's not already in the bank in the next few days that funds will flow into the bank and it's permanently ours and it will appear as revenue in the fourth quarter.

So why do they call it a tax credit?

Well, there were two aspects to it. There actually was, for companies who were profitable, they had the option to take it as a reduction of their tax liability in the immediate year. For companies who were not profitable and had continuing losses it became an immediately refundable credit.

Understood, thanks.

George Zavoico, MLV.

Hi, everyone, good quarter. Thanks for taking my call. I'm intrigued by the -- first question is 9090 in the combination trial. I'm intrigued by the additional information you provided, Safi and Vojo. You said that you are putting it into patients who were stable for a period of time and then showed some new lesions and then the new lesions reversed course.

The question is, what happened to the original lesion? And number two, do you attribute the shrinkage of the new lesions to solely the docetaxel or do you think that is a combination effect of the two drugs?

Hi, George. This is Vojo. I'm going to take that question. Yes, you are right; I mean what we are doing on the existing non-small cell lung cancer trial, all patients are starting treatment with 9090 as single agent. And then in some patients, based on the treating physician's opinion, they decide to use the combination in order to optimize the treatment effect.

In this particular patient that Safi outlined there was a clear anti-tumor effect by 9090 as single agent. Then we saw some new lesions coming up and then the treating physician decided to use the combo. As a result, the existing lesions they remained stable, they remained as they were and the new lesions that popped up they were effectively stopped. Of course, it is difficult for us to know whether this was a purely docetaxel effect or a combo effect.

But the patients remained -- I mean it was a combination that remained on 9090, of course, right?

Yes, absolutely, it was a combo. And patients now entering the 11th month of treatment, which is I think very encouraging for highly refractory, heavily pretreated patients.

Yes, yes, in non-small cell lung cancer for sure. Now in speaking about new trials coming up and combination trials, would you start with a combination or would you look for the same sort of serial effect or serial administration of 9090 as a single agent and then, if appropriate, go to docetaxel? Or would you start with a combination from the very beginning?

Yes, we are still looking to this. There are certain advantages to both approaches. The first one, up front combination, would be simpler and easier to conduct. So we are still gathering the data, we are still evaluating the data, and we will be making the right choices when the time is right.

Okay. Thanks. With regard to the GOG trial. So with GOG I imagine all the sites are in US, maybe Canada. And can you say how many sites there are and perhaps how many patients the GOG is aiming to enroll?

Sure. Yes, the trial will be conducted in the US. It's a corporate group trial, so they're sending out the tender to all participating centers so they haven't finalized the number. We are anticipating it will be probably something around eight centers, but we don't know for sure. And the number of patients that will be included in this trial -- there are approximately 55.

Okay. Okay, great. Thank you very much for taking my questions. I appreciate it.

[David Harmon], UBS.

Hi. A couple questions here. On the CRACM, essentially is this over for Synta? I mean, you're letting the people go and you haven't indicated that Roche is definitely going to continue the program internally.

No, absolutely not. Firstly, the program continues through the end of the Roche reimbursement of research. Support at Synta continues through the end of this year (multiple speakers). So we're going to meet our obligations.

We've developed some very promising compounds which Roche has a license to and that's kind of how these things work. We think they have a license to a -- what some people have characterized as a small sliver of the potential chemical IP space, or intellectual property space.

There is a large room to create additional compounds and all of the compounds that have been created over the last two years in this program that are not licensed by Roche, which is many compounds, Synta retains 100% rights to and is free to repartner starting January 1.

So we're actually -- I've seen a lot of research programs at Synta and this is a very strong research program, a very sophisticated operation with terrific biologists and chemists, a terrific process, they've done phenomenal work that's been recognized at many levels at Roche, it's produced some very exciting compounds.

We have seen a lot of interest in the industry in the CRAC program, and therefore this actually creates a very interesting opportunity for us to repartner, to get a second partnership with annual upfront and work with someone else to continue to advance the programs that we own today.

I mean there's an obvious question. If it's terrific then why would Roche terminate?

Well, Roche -- well, obviously I can't speak for Roche and you'd have to discuss with them. They got some set of compounds around a particular area of intellectual property space from this collaboration. They are of course -- many people may have read that Roche is doing some cuts globally around in their -- in particular in research. We have been told they're focusing on development more than research.

Other than that I really couldn't comment on Roche's decision. I can just comment that we've observed -- there's a very high level in the industry in CRAC inhibitors we retain all the rights to everything developed over the last two years with all the effort put in on both sides of the team and we are excited to see what we can do with those compounds.

The 10-Q says that, "Roche may terminate upon providing advanced written notice." It does not mention any financial compensation termination. So that would indicate that they're -- unlike the Glaxo deal, for example, there's no money coming in for what they've taken away. Is that correct?

To clarify, there's no termination. There are two different -- there are two agreements with Roche, one is the research funding for 24 months and that's exactly what they did and that contract completed. The question was whether to renew the contract and they made a decision based on their own research priorities that they're not going to renew the contract for further research.

The license agreement continues. So they have an exclusive license to the small molecule drug candidates that were produced for them as part of this 24 months. That license continues, it's not terminated, any development they do on the compounds they've licensed they will need to pay Synta milestones and royalties.

Okay. The good news that I see here in Boston is that there's a doctor who's very prominent in lung cancer research who's told a colleague of his that 9090 would be very exciting, but it's too early to tell.

Obviously what stockholders want is that four letter phrase of "too early to tell" to change to the two letter phrase, "it works". You've indicated today that it could be quite a while, I mean perhaps a year or two years, before that two letter phrase could come into being. Is that a correct assumption or are there other indications that you may know before two years?

Not quite sure how to answer that question, David. I think -- I can't really comment on what an individual physician says or doesn't say.

No, I'm saying -- obviously I'm quoting a particular person high up in the lung cancer research industry in Boston here. But I'm interested more in what all of us -- or what your interpretation would be -- sort of a variation on a previous question. Is there any indication of when you'll have decisive data or data that's sufficiently good to be able to say there's a high probability it works as opposed to it's too early to tell? Do you have any sort of a timeframe in here?

I think what we mentioned earlier is we'll be presenting the data from our -- the data that's mature from our lung cancer trial at a medical meeting that will come up pretty soon and at that point we can talk about the data that's presented.

Okay. You had previously indicated, or the Company had previously indicated that they would -- there was a high probability that they would be presenting at the lung cancer conference in December. Now there seems to be a low probability. Is there any explanation?

I think what -- I think you've spent time with our IR folks and I think they've consistently communicated that there are lung meetings throughout the year. There's one in December, there's one in February and no decisions have been made. Today it's much more likely that we will be presenting at the one in February and not at the one in December.

Okay. The Company has previously put out an interesting piece that one of the drug trials has the potential for a quick pass-through approval. And that that could open up other uses of the various 9090 drugs at an earlier than anticipated time. Is that phrase still applicable to any of your drugs?

Not totally sure what you're referring to, David. I think -- we did talk about two different paths, one is a broad all comers combination study, sort of a Phase IIb/III trial designs, and one is a single agent study in specific biomarker definers, patients with a certain gene mutation profile. That second one can often be a faster path to registration, as other companies have done. So if that's what you're referring to, that's one of the options on the table.

Okay. Thank you.

(Operator Instructions). There appear to be no further questions. That concludes the question-and-answer session. I will now turn the conference back over to Dr. Bahcall for closing remarks.

Thank you all for your time and attention today. That will conclude the call.

Ladies and gentlemen, this concludes today's call. You may now disconnect your lines.