Curis Inc (CRIS) 2010 Q3 法說會逐字稿

Good day, ladies and gentlemen and welcome to the third-quarter 2010 Curis earnings conference call. My name is Madge and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will be conducting a Q&A session towards the end of this conference. (Operator Instructions). As a reminder, this conference is being recorded for replay purposes. I would now like to turn the presentation over to your host for today's call, Mr. Mike Gray. Please proceed.

Thanks, Madge. Good morning, everyone and thanks for joining us as always. Today, we will provide a corporate update and discuss our third-quarter 2010 financial results.

Before we begin, also as always, I would like to advise you that this conference call contains forward-looking statements regarding Curis's future expectations, plans and prospects within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expected progress of our ongoing Phase Ib expansion trial and our planned Phase I study in head and neck cancer of our clinical development candidate, CUDC-101, as well as our timetable for selecting additional development candidates from our targeted cancer programs.

Statements regarding our and our collaborators' expectations concerning the further development of hedgehog pathway inhibitor compound, GDC-0449, under collaboration with Genentech and Roche, as well as our Hsp90 technologies that are licensed to Debiopharm, including the timetable for the clinical trial design and regulatory filings and other clinical development milestones under those programs.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to the following -- our ability to successfully advance the research and clinical development of our targeted cancer programs, including CUDC-101; Genentech's ability to successfully advance clinical trials of GDC-0449; and Debiopharm's ability to progress Debio 0932 through Phase I clinical testing; competitive pressures; our ability to maintain our proprietary rights; our ability to successfully continue our collaborations with Genentech and Debiopharm, as well as to enter into new collaborations on favorable terms, if at all; unplanned operating expenses; our need to raise additional funds to finance our operations; and other risk factors described in our quarterly report on Form 10-Q for the quarter ended June 30, 2010 and in other reports that we periodically file with the SEC.

We caution you that we are making these forward-looking statements as of today and that we may not update any of these statements even if events and developments subsequent to the date of this call cause these estimates and expectations to change. With that, I would now like to introduce Dan Passeri, Curis's President and CEO, who will discuss our corporate highlights and will provide an update on our pipeline. Following Dan's remarks, I will return to review our financial results for the third quarter of 2010 and then we will open the call to any questions. Dan?

Yes, thanks, Mike and good morning and thank you for joining us today. Curis has had a productive and encouraging third quarter, highlighted by important developments with our lead proprietary drug candidate, CUDC-101, which is a first-in-class, HDAC, EGFR and Her2 inhibitor.

In August, we announced the initiation of a Phase Ib expansion trial of CUDC-101 in patients with specific tumor types, including gastric cancer, breast cancer, liver and head and neck cancers. To date, we have treated 14 patients in this study and we are very encouraged by the pace of enrollment thus far.

Also, earlier this month, we amended our protocol of the expansion study to allow us to add 10 non-small-cell lung cancer patients to the patient population so that a total of approximately 50 patients will be treated in this trial. We are hopeful that we will continue to enroll this trial at the pace that we are going through completion and at the results, we will provide substantive and meaningful data to guide further development of CUDC-101.

In addition to this Phase Ib study, we also expect to initiate a Phase I study of CUDC-101 in combination with cisplatin and radiation in head and neck cancer patients later this year or early in 2011. And assuming that an acceptable safety profile is achieved in this study, we would plan to initiate a Phase II trial in this indication in 2011. We also continue to advance our preclinical research efforts and anticipate that we will select a new development candidate later this year or early in 2011.

Our partnered programs continue to advance as well. We are quite pleased to announce that Genentech's recent initiation of a Phase II clinical trial in patients with operable nodular basal cell carcinoma, or BCC, which we believe demonstrates Genentech's ongoing commitment to exploring the treatment of various forms of BCC with GDC-0449. Genentech and Roche are also developing GDC-0449 in advanced BCC, which represents a severe form of the disease that includes cutaneous BCCs considered inoperable by the treating physician and BCCs that have metastasized to other tissues and/or organs.

Additionally, our partner, Debiopharm, has advanced our Hsp90 inhibitor, designated Debio 0932 and it is ongoing Phase I clinical trial and we received a $3 million payment in August upon Debiopharm's treatment of the fifth patient in this study during the third quarter.

Turning to a full review of our pipeline, let me now go through each of these programs in more detail prior to turning the call back over to Mike to review our third-quarter financial results.

With the initiation of the Phase II clinical trial of GDC-0449 as a single agent therapy for patients with operable BCC, Genentech expects to evaluate the drug in approximately 50 patients with operable nodular BCC in a US-based open-label two cohort clinical trial. All patients will receive an oral dose of GDC-0449 of 150 milligrams daily for 12 weeks. For cohort 1, the primary outcome measure is the rate of complete histological clearance of the target nodular BCC lesions at the time of tumor excision, which may occur up to 12 weeks following initiation of treatment.

For cohort 2, the primary outcome measure is the rate of durable complete clearance of target nodular BCC lesions at the time of excision, which may occur up to 36 weeks following initiation of treatment. The secondary outcome measure for both cohorts is to determine the time to complete histological clinical clearance of target nodular BCC lesions.

In addition to conducting a trial of GDC-0449 in patients with operable BCC, Genentech and Roche are continuing to develop 0449 as a treatment for advanced BCC. Genentech previously reported compelling proof of concept data from a Phase I clinical trial of 0449 in patients suffering from advanced BCC, including the observation of a 55% response rate in a 33 advanced BCC patient cohort.

In the Phase I study of 0449, the most frequent adverse events included muscle spasm, altered taste, weight loss and hyponatremia, which is a sodium imbalance. Genentech and Roche have completed enrollment in 100 patient pivotal Phase II clinical trial of 0449 in advanced BCC and have indicated that they are expecting data from this study in the first half of 2011 and assuming successful results, they could file regulatory submissions in 2011.

I just want to underscore that there is currently no standard of care for patients with these types of BCC. And we would be extremely proud to be part of a potential therapeutic alternative that could benefit these patients.

Under a collaborative relationship with the National Cancer Institute, or NCI, 0449 is also being tested in a number of other cancers through several NCI-sponsored trials, including several trials in pancreatic cancer, small-cell lung cancer, esophageal, stomach, breast and prostate cancer, among others.

Genentech also recently informed us that it has completed further analysis of results from its recently completed Phase II trial of 0449 in advanced ovarian cancer, noting that the median time to disease progression in the Phase II study was 7.5 months for patients who received 0449 compared to 5.8 months for patients who received placebo.

Genentech has concluded that these results, however, did not demonstrate sufficiently clinically meaningful improvement in progression-free survival to warrant additional clinical testing of 0449 in ovarian cancer and that further research is needed to determine whether there is a role for 0449 in the treatment of appropriately selected patients with ovarian cancer. No obvious new safety signals were observed in ongoing trials and other tumor types have not been impacted by this decision. Further details for all GDC-0449 clinical trials are available at clinicaltrials.gov.

I would like to now briefly turn to our other partnered program, which is a synthetic small molecule Hsp90 inhibitor designated as Debio 0932. This candidate is being developed by our licensee, Debiopharm, under our August 2009 agreement. Under this agreement, we granted Debiopharm a worldwide exclusive royalty-bearing license to all of our Hsp90 inhibitor technologies, including Debio 0932. Debiopharm initiated a Phase I clinical trial of Debio 0932 in April of 2010. In July, Debiopharm notified us that they had treated the fifth patient in this clinical trial and as a result, we earned a $3 million payment for the achievement of this development objective.

This transaction represents an important source of non-dilutive capital to Curis as we have to date already received a total of $3 million in proceeds. The next milestone we are eligible for under this agreement is upon Debiopharm's treatment of the fifth patient in a Phase II clinical trial, assuming that the compound successfully completes the ongoing Phase I trial and that Debiopharm advances 0932 into Phase II clinical testing. We continue to be highly impressed with Debiopharm's professionalism and its efforts to date and we look forward to providing you with further development updates regarding Debio 0932 in the future.

I will now provide you an update of CUDC-101, which is our proprietary lead candidate from our network targeted cancer programs. We believe that CUDC-101 is exemplary of our overall approach to designing drug candidates in which we aim to enhance the therapeutic effect and durability of clinical response by designing molecules that attack cancer cells at multiple points of intervention.

In April of 2010, we completed a Phase I dose-escalation clinical trial with this molecule in patients with advanced refractory solid tumors and we plan to present data from this study at the 22nd EORTC-NCI-AACR meeting, which is being held in November of this year in Berlin, Germany.

As I mentioned earlier, in August, we initiated a Phase Ib expansion study at the maximum tolerated dose, or MTD, of 275 milligrams per meter squared in 40 patients with either gastric, breast, liver or head and neck cancer. And in October, we amended the protocol to add an additional 10 non-small-cell lung cancer patients for a total of approximately 50 patients expected to be studied in this trial, this Phase Ib expansion trial.

We are very pleased with our rate of enrollment to date and we expect that the study will take place at five to eight study centers. The primary objectives of this study are to compare the safety and tolerability of CUDC-101 at the MTD in subjects with specific advanced solid tumor types when the drug is administered either on a five day per week schedule, which would be one week on, one week off, etc. or a three times a week schedule, which would be three weeks on, one week off.

The secondary study objectives are to evaluate the efficacy of CUDC-101 in subjects with advanced and refractory solid tumors to assess pharmacokinetics and to evaluate the pharmacodynamic biomarkers of CUDC-101 in this patient population.

I also mentioned that we are planning to initiate a Phase I clinical trial of CUDC-101 in head and neck cancer patients at the end of 2010, all within the first quarter of 2011. The primary objectives of the Phase I study are to evaluate the safety and tolerability of CUDC-101 when administered in combination with cisplatin and radiation, which represents the current standard of care for this indication.

On the termination of the MTD, we intend to conduct a randomized Phase II two-arm trial in which head and neck patients will receive cisplatin and radiation plus or minus CUDC-101. The Phase II study will seek to evaluate whether the addition of CUDC-101 can improve the efficacy and durability of the current standard of care for this indication, that is cisplatin and radiation therapy.

We have selected head and neck cancer as our first indication for Phase I and potential Phase II testing for several reasons. Firstly, CUDC-101 demonstrated biological activity on two patients with head and neck cancer in our Phase I study, including a mixed response in a head and neck cancer patient at 150 milligrams per meter squared dose level, demonstrating a tumor reduction of approximately 40% of the target lesion and a tumor reduction of over 20% after just four weeks or two cycles of study drug administration in another head and neck cancer patient at 275 milligrams per meter squared dosing level.

Secondly, our internal in vitro and in vivo preclinical data demonstrated strongly activity in head and neck cancer cell lines and it was exemplified by data in seven head and neck cancer cell lines that include some of the highest potency observed with this drug in all the cell lines tested.

We also believe that our internal data is supported by published literature demonstrated that both EGFR and Her2 are often implicated in head and neck cancers, as well as published literature suggesting that HDAC inhibition may be synergistic with radiation therapy. We are working very diligently to complete the protocol of this Phase I study and look forward to our anticipated announcement of trial initiation. We are also working on the Phase II protocol at this time and expect to finalize that during the first half of 2011.

With regard to our preclinical pipeline, our research group continues to advance two primary classes of molecules, including a series targeting HDAC and PI3 kinase and mTOR and another class that targets HDAC and Bcr-Abl. And we expect to select a development candidate for our preclinical programs either in late 2011 or early -- I'm sorry -- late 2010 or early 2011. I would now like to turn the call back over to Mike for a financial discussion and following Mike's remarks, we will open the call for questions. Thank you.

Okay, thanks, Dan. Just briefly run through the third-quarter results. For the third quarter of 2010, we reported a net loss of $1.5 million, or $0.02 per share on both the basic and fully diluted share outstanding basis as compared to a net loss of $4.1 million, or $0.06 per share on both the basic and fully diluted share outstanding basis for the same period in 2009.

Revenues for the third quarter of 2010 were $3.2 million as compared to $800,000 for the same period in 2009. As Dan mentioned, we received a $3 million contingent payment from Debiopharm during the third quarter of 2010 upon Debiopharm's treatment of the fifth patient in its ongoing Phase I clinical trial of Debio 0932.

Operating expenses for the third quarter of 2010 were $5 million as compared to $4.9 million for the same period in 2009. R&D spending was $3 million for the third quarter of 2010 as compared to $2.3 million for the same period in 2009. The increase was primarily attributable to increased spending on CUDC-101 as we continue to enroll patients in the Phase Ib expansion trial. The increase is primarily related to outside costs, including costs related to CROs, patient costs, manufacturing costs associated with the CUDC-101 clinical material.

In addition, spending on our other targeted programs, our preclinical targeted programs that is, increased from the prior year, primarily due to increased employee-related costs, including salaries, lab, supplies, facilities as employees that were previously working on Debio 0932 program where we reassigned to continue our ongoing efforts to select additional preclinical candidates for future clinical development.

G&A spending was $2 million for the third quarter of 2010 as compared to $2.6 million for the same period in 2009. The decrease was primarily due to nonrecurring consulting fees and legal costs. We incurred legal costs during the third quarter of 2009 related to an arbitration proceeding that was settled earlier this year.

Other income of $250,000 for the third quarter of 2010 primarily represents the change in the fair value of a warrant liability established in connection with our January 2010 registered direct offering.

As of September 30, 2010 our cash, cash equivalents and marketable securities totaled $43.7 million and there were 75.6 million shares of our common stock outstanding.

And that wraps up the prepared remarks for today. We would now like to open the call up for questions. Operator?

(Operator Instructions). Joe Pantginis, ROTH Capital Partners.

Hi, guys, good morning and thanks for the update. A couple quick questions, if you don't mind. First on your clinical assets and then maybe a follow-up on your preclinical. For 101, Dan, what was the rationale the prompted you guys to add lung cancer patients? And then secondly on 101, as you are looking towards the Phase II in head and neck cancer, I was just wondering if you could sort of set up a bit of a profile with regard to what the benchmark is with regard to this head and neck population?

Sure. So the rationale for adding the non-small-cell lung cancer is basically attributed to the fact that this is a patient population that is known to be an EGFR overexpressing population. There is a subgroup of approximately 10% that respond well to erlotinib or Tarceva where there is a known mutation in that group that responds well. The majority tend to develop resistance or are just refractory.

So we felt it was a good patient population to compare with a known standard of care. So we want to basically see how the drug is responding in those patients with the mutation or those stations that are refractory to erlotinib. So just to get a survey of how the drug is behaving in that patient cohort because it is something we would like to further develop. It's just that a deep study of that patient population would require a statistical representation that is beyond what we would want to do right now.

And then on the head and neck cancer patient population, there are two subgroups. One is a group that has -- so first of all, head and neck is an attractive indication for us to be focusing on for a Phase I/Phase II principally because, as I stated, they are known to be EGFR and Her2 overexpressers. Then there is a subgroup where there is an HPV involvement. The HPV group responds better than the non-HPV group. So we are looking at studying those two subgroups in the head and neck cancer to see how the drug may be adding to efficacy and durability of response.

Great, thank you, Dan. And just a quick question. You obviously lifted two potential preclinical candidates, PI3K-mTOR and also Bcr-Abl. Your discovery platform obviously had the ability to come up with multiple combinations. What has been driving your decision to come up with these two as sort of your lead preclinical candidates and what will drive your decision as to decide which will be the actual lead to drive into the clinic?

Yes, important question. So what has led to those two programs sort of pulling ahead of others is really just the rate of development, the synergy that we saw early on and the depth of preclinical data that we have. I would say, at this point, it is quite likely that the next lead candidate that we will be selecting for development in the US will be a PI3 kinase HDAC inhibitor. We are seeing some very interesting preclinical results. We are likely to be initially focusing on some hematological cancers, principally lymphoma based on some activity that we have seen. And we have had some external expert consultants look at the various profiles of preclinical data. So we are confident that that is most likely going to be the next development candidate.

The Bcr-Abl HDAC has demonstrated really good activity and excellent synergy. The issue for us there is it is a very crowded field, principally treating CML. You look at drugs like Gleevec that have been very successful. So there is a very high hurdle here in the states. So we are contemplating the prospects of developing that drug candidate for the Asia market first to demonstrate proof of concept in a number of cancer types prior to pulling that one here in the states.

Thanks a lot, Dan.

Jason Kantor, RBC Capital Markets.

Hi, it's Adnan on Jason's behalf. A couple of questions. First, on 101, can you tell us if all the centers are enrolling at this time? It is a pretty nice pace, so when do you think we might see some results? Secondly, can you remind us of the dose being used, as well as the rationale behind the two different dosing schedules?

I will take the first one. This is Mike. So without naming the centers, there are two primary centers that are really accruing most of the patients. So if the other centers are able to start accruing at a faster rate -- I mean there is a potential that we could even accrue faster. This is actually faster than we had forecasted accruing patients, so we are very encouraged by the accrual rate. If we kept at the current rate, the trial would be fully enrolled sometime in Q2. So data probably early second half of next year from the study.

The second half of the question has to do with the dosing level used and the schedule. And I think you are inquiring as to why we are looking at two different dosing schedules.

Yes.

So the dosing that we are starting off at is at the maximum tolerated dose, which is 275 milligrams per meter squared and we are surveying two different dosing schedules, primarily to gain some insight as to whether or not there is any difference in the drug exposure. Therefore, efficacy profile of the two different doses. The Phase I dosing escalation cohort that was completed in April, that was five times a week, so it is once a day, five days on, five days off.

What we want to do now is we are going to do an every other day, so it is three times a week for three straight weeks, then with one week off and we want to look at whether we are able to enhance the exposure of the drug and have a longer durable therapeutic outcome as a result of increasing the exposure for three straight weeks.

The PK analysis in the Phase I looked very attractive so that we saw that as you double the dose, you double exposure. So what we are now trying to do is see if we continue the patient being exposed for a longer period of time, three weeks on, are we seeing a different response between those two dosing cohorts. So we are just trying to serve a principally for going forward with the Phase I/Phase II in head and neck cancer, but also gain some insight on possible responses in a broader set of cancers.

Okay. Can you remind us how many head and neck patients were in the first cohort? You mentioned two responses.

In the Phase I dose escalation?

Yes.

I think there were three.

Three, yes.

A small number.

Okay. And Mike, a question for you. Can you say anything about the current cash position and the run rate going forward?

So we had $43.7 million at the end of the quarter. We are projecting that that will get us at least two years. Again, that is with nothing -- no additional cash inflows. We have some fairly significant potential milestones, particularly from Genentech, on assuming good data from the advanced basal cell study that we will report out in the first half of next year the potential for regulatory submissions and approval milestones under the Genentech collaboration that are significant to us.

We also have a milestone that should be within that cash timeframe from our partner, Debiopharm, on treating the fifth patient in the Phase II study. But right now, we feel like we're pretty well-capitalized to keep moving along with our current CUDC-101 efforts, as well as selecting this next compound shortly here and advancing that to the clinic as well.

Okay, thanks. I will get back in queue.

Ted Tenthoff, Piper Jaffray.

Great, thank you very much. I guess -- and I apologize if some of these questions have been asked, but following some of the data that has come out with the hedgehog program with Genentech this year, I know that they have started the new study in basal cell, which I think is very interesting and certainly still shows that commitment to the drug. Are there any learnings from either the colorectal or the ovarian data that may drive future decisions in terms of how to develop this drug or not develop this drug in any indication? So what else do you guys kind of have on the burner there?

So what we can communicate at this juncture is, with colorectal, there was no distinction between the treated and untreated. And I am not sure we can learn anything there other than extrapolation. So debulking with a chemotherapy may affect the amount of hedgehog signal, but it is premature to conclude that. In other words, when you traumatize a tumor cell with a chemotherapy, it is possible that the amount of hedgehog being produced for paraffin communication to the stromal cell is altered.

On the ovarian, that was a different study. That was a single agent maintenance therapy and albeit, we did see some statistical difference between the two arms, I am not sure they are statistically relevant at this juncture. The numbers aren't deep enough. So at this point, we really can't comment any further to provide further light on that. Genentech is continuing to do some preclinical research, trying to understand the biology better and I think at this point, we are just waiting to see what emerges from the various NCI trials to see if we can learn something from that setting that can shed further light on the observations made with the colorectal in ovarian.

That's a good point. I know it is always a little tricky with the NCI, but when do you think we will start to see some of those multiple studies start reporting and when do you think might be the first or which should we focus on?

That is a tough question and we don't have clarity on it. So what I am going to say is really just a best guesstimate on timing. We have several trials in pancreatic cancer under different treatment regimens and scenarios. I think that is a likely one to have a readout earlier than some of the others.

And an interesting mechanism there too, so that should be good.

Yes.

Some of those studies have been ongoing on the longer end of the NCI studies as well, but it is speculation right now as to when they report on it.

So I think we could see something by end of year, but we really don't know.

(inaudible) we look forward to that and I'll see you over in Berlin.

Okay, thank you.

(Operator Instructions). Ren Benjamin, Rodman.

Hi, good morning, guys. Thanks for taking the questions. I guess just very quickly, could you review for us the sort of response rate that you would expect from the ongoing inoperable BCC study and what would be a clinically meaningful outcome? What is it that -- obviously you're looking for statistical significance, but can you help frame sort of what you and Genentech think is the current standard of care would produce versus how GDC-0449 could do in this trial?

Yes, I think the first issue to underscore, Ren, is, in that patient population, there is no current standard of care.

Ren, just to clarify here, are you asking about the operable BCC?

Inoperable.

Inoperable. Okay. Right, there is no standard of care for the inoperable. These are patients that have gone beyond the prospects of doing surgical excision. So we have seen in the Phase I expansion cohort where they treated 33 patients, we saw a 55% response rate. I think it is approximately 90% clinical benefit. I mean these are very encouraging data. So I think if we see in the pivotal numbers that approximate that or even anything even south of that, it is still very encouraging because these are patients that have no alternative at this point.

Okay. And then just regarding operable, when do you think that that -- when do you think enrollment in that trial could be completed?

I think we need to hold off on that, Ren. We haven't gotten guidance from Genentech yet. They just treated the first patient a couple weeks ago here. So I think we need to get a better feel or Genentech needs to get a better feel of how the study is enrolling and we need to work with them. I think it, in theory, should be a reasonably short study. It is only 50 patients and the duration of therapy isn't all that long, but it is tough for me to give anything more concrete than that right now. Sorry.

And then just going off one of Ted's questions regarding what we have learned, can you make any comments at all regarding the expression of hedgehog in cancer stem cells or the inhibition of hedgehog and it's effect on cancer stem cells based on any of the data that you have seen? And then also is there ongoing work at either Curis or Genentech that is further digging into, let's say, the ovarian study, which showed some tantalizing results in certain arms? Is there anyone who is doing that further studies there or has that pretty much been shelved and it is all eyes on BCC?

So let me take the second part first and then we will go to the stem cell question. So in terms of further studies and continued research activity, Genentech continues to study the pathway. It continues to look at the biology and the putative role in various settings in tumor biology. So we are pleased about that and encouraged. So they still are very supportive of the pathway and are trying to understand the data that has emerged from their two clinical trials in solid tumors. And as I stated, I think they are probably going to be watching the emergence of data as it unfolds from the NCI trials. But they do continue -- they are continuing to look at various preclinical models and trying to understand the biology as best they can. We are not actively looking at the hedgehog pathway internally. Our efforts are on the network disruption platform.

On the first half of that question, which had to do with tumor stem cell involvement, I think most of that data, Ren, is anecdotal. It is preclinical studies that have shown stem cell populations where hedgehog is involved. It is known that hedgehog as a developmental morphogen is involved in progenitor cell and tumor cell proliferation -- I'm sorry -- in stem cell proliferation. And there have been some tumor stem cell studies pre-clinically that have shown an involvement of hedgehog. So I think it is extrapolation from this preclinical setting and extrapolating from what is known in developmental biology. I am not aware of any clinical data where they have isolated tumor, human tumors stem cells from patients and have shown hedgehog pathway up regulation.

Okay. And just switching gears very quickly to the Hsp90 inhibitor program. Obviously, you had received a milestone once the fifth patient was treated. Can you give us any sort of an update as to how enrollment is going? Obviously, it is an open-label study. Has Debiopharm conveyed anything regarding this study so far? Can you tell us maybe what dose you have gone up to, any additional color?

Unfortunately, we can't provide additional color on it simply because of the confidentiality of the relationship.

I was just going to say probably the one thing that we can share right now is that the study is actually enrolling faster than anticipated. I think we will be closer to data or data from the Phase I study should be sooner than Debiopharm originally anticipated. So everything is going in an encouraging way and there are no significant surprises I guess with the study. But I think beyond that, we need to hold off until Debiopharm is ready to communicate a little bit more.

Do you know or could you tell us when Debiopharm initially thought that they could report some data? Was it second half of 2011?

It was probably around the middle of '11 or second half, yes. It will be sooner than that.

Thank you, guys and good luck.

There are no more questions in the queue. I would now like to turn the call back over to Dan Passeri for final thoughts. Please proceed.

We want to thank you for joining us on our call today. We would like to thank our employees for their commitment and ongoing dedication to our various programs, our directors and finally and not least, our investors for their continued support, and we look forward to providing you with further updates in the coming months for our various programs. Thank you very much for your attention.

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