Poniard Pharmaceuticals Inc Q4 2007 Earnings Call Transcript

Poniard Pharmaceuticals Inc (OTCPK:PARD) Q4 2007 Earnings Call February 28, 2008 5:00 PM ET

Executives

Brendan Doherty - Manager of IR and PR

Jerry McMahon - Chairman and CEO

Ronald Martell - President and COO

Caroline Loewy - CFO

Analysts

Katherine Xu - Credit Suisse

Bret Holley - Oppenheimer

Matt Osborne - Lazard Capital

William Slattery - Deerfield Partners

Howard Liang - Leerink Swann

George Zavoica - Cantor Fitzgerald

David Garrett - Fortis Securities

Operator

Good day everyone, and welcome to the Poniard Pharmaceuticals Q4 Financial Results Conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Brendan Doherty, Manager, Investor Relations and Public Relations. Please go ahead, sir.

Brendan Doherty

Thank you and welcome to Poniard Pharmaceuticals fourth quarter and yearend 2007 financial results and achievements call. On the call today from Poniard are Dr. Jerry McMahon, Chairman and CEO; Ronald Martell, President and Chief Operating Officer; and Caroline Loewy, Chief Financial Officer. And Dr. Robert De Jager, Chief Medical Officer.

Before we begin, I would like to remind you that various remarks that we make on this call, including those about our financial results and operations, product development programs and goals, timing and results of clinical trials, and future prospects, growth opportunities and competitive position constitute forward-looking statements for the purposes of Safe Harbor provisions of the Private Securities Litigation Reform Act. These forward-looking statements and all other statements that may be made on this call that are not historical facts are subject to a number of risks and uncertainties that may cause actual results to differ materially. We refer you to our annual report on Form 10-K, as amended, and to our most current quarterly report on Form 10-Q filed with the SEC, in particular, to the section entitled "Risk Factors," for additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date of this presentation, and we disclaim any obligation to update these forward-looking statements.

With that, I will turn the call over to Dr. Jerry McMahon.

Jerry McMahon

Thank you all for joining us today. We are pleased to share with you our fourth quarter financial results and accomplishments. After my introductory comments and recap of recent milestones, Caroline will provide an overview of our fourth quarter 2007 financials, and then I will conclude with a summary of important goals for 2008.

2007 was a very busy and exciting year for Poniard during which we achieved several significant clinical milestones in our picoplatin development program. The results support our belief that picoplatin has the potential to become a platform product with broad utility and multiple indications. These results also support our strategy to move picoplatin as quickly as possible towards an NDA filing and small cell lung cancer.

As many of you know, picoplatin is our lead product candidate. It is a new generation platinum chemotherapy agent with an improved safety profile compared to existing platinum-based chemotherapeutics. Moreover, it was designed to delay time to relapse and overcome platinum resistance, a significant treatment limiting problem with the use of existing platinum's.

We are currently studying intravenous picoplatin in three solid tumor indications and advanced trials -- small cell lung cancer, colorectal cancer, and prostate cancer. Our most advanced study is the pivotal Phase 3 SPEAR trial, or Study of Picoplatin Efficacy After Relapse, in small cell lung cancer. We are actively evaluating picoplatin in Phase 2 studies in both metastatic colorectal cancer and hormone-refractory prostate cancer. We are also evaluating an oral formulation of picoplatin in an ongoing Phase 1 trial in patients with solid tumors.

In September 2007, picoplatin received Fast Track Designation from the US Food and Drug Administration for second-line treatment of small cell lung cancer, which enables the rolling NDA filing and may qualify for priority review. Also in 2007, picoplatin was granted Orphan Medicinal Product designation from the European Union for the treatment of small cell lung cancer. This is in addition to the US Orphan Drug Designation, which was granted earlier in the year.

To strengthen our clinical development team, we've appointed Dr. Robert De Jager as our Chief Medical Officer. Dr. De Jager has an extensive background in drug development in numerous companies including Conforma, Biogen Idec, Daiichi, Rgene, Sanofi and others.

In addition, he has spent years at top clinics and in academia and has experience with platinum therapies. He was a principal investigator and lead author of the early studies of cisplatin in lung cancer. His expertise in developing and registering novel cancer therapeutics in global markets is an asset to Poniard as we continue to advance Picoplatin toward commercialization to treat solid tumors.

We presented safety data from our Phase 1 dose-escalation study of picoplatin, in patients with metastatic colorectal cancer at the ASCO Gastrointestinal Cancer Symposium. Results showed that none of the patients treated with picoplatin exhibited a great to or higher neuropathy that data supported the initiation of the Phase 2 trial, which is enrolling.

We also presented encouraging safety and efficacy data from our Phase 1 dose-escalation study of picoplatin in patients with hormone-refractory prostate cancer at ASCO's Genitourinary Cancer Symposium. Results showed that 65% of the 31 evaluable patients exhibited responses of at least 50% reduction in prostate specific antigen or PSA in patients treated with picoplatin and full-dose docetaxel. These encouraging results compare favorably with published literature citing PSA response rates of 45% with docetaxel alone. These data support the initiation of the Phase 2 trial, which has already enrolled.

In addition, we announced topline data from our Phase 1 trial showing bioavailability of our oral formulation. In this study, picoplatin has been shown to have between 30% and 40% bioavailability. We will present details of this program at scientific conferences this year.

Let's take a closer look at each of our picoplatin programs starting with our Phase 3 SPEAR trial in small cell lung cancer. Our Phase 3 trial is focused on platinum-refractory and resistant patients. These patients had disease, which did not respond or has progressed within six months of completing a first-line platinum treatment. These are the poorest prognosis small cell lung cancer patients.

Our trial is an international, multi-center, randomized control study that compares the efficacy and safety of intravenous picoplatin plus best supportive care compared to best supportive care alone in this group. The primary endpoint is overall survival and the analysis is event-driven. The trial is currently powered at 90% to show a 50% improvement in survival with a hazard ratio of 0.67. The FDA granted us an SPA for this sole Phase 3 registrational trial including its design, endpoint and geography.

As I mentioned, Dr. Robert De Jager recently joined our management team as Poniard's Chief Medical Officer. Under his guidance and leadership, we have closely analyzed our SPEAR trial with regard to timing of completion of the study and analysis of the data. We now have more data on enrollment, site initiation and its impact on event rates.

Based on that data, we now expect our topline results, which are event-driven in mid 2009 and plan to file our NDA in 2009. Nearly, all of our plan centers are open and actively recruiting patients. We have initiated several programs to accelerate the timing of completion of the trial including the addition of more sites, we are confident our ability to complete this trial.

Independent and internal audits support our belief that the quality of our trial and the data we are generating is high. During the fourth quarter at our request the best supportive care monitoring committee audited the study and confirmed that it was being conducted according to protocol.

Additionally, an internal clinical QA site audit was performed and the findings from the audit were favorable with no actions or corrections needed, and the study is being performed in compliance with good clinical practice. It's important to note that the SPEAR trial is being conducted in the same patient population and at some of the same size as our Phase 2 trial of small cell lung cancer. This Phase 2 trial was completed on schedule and generated positive results.

Interim results from this trial were presented at ASCO of last June. These results were confirmed at the end of the trial and supported by the final analysis, which was presented at the International Association for the Study of Lung Cancer.

It's important to note that our three other picoplatin trials are enrolling on schedule. Our Phase 2 in hormone-refractory prostate cancer patient has already enrolled, our Phase 2 trial in metastatic colorectal cancer is on track to complete enrollment in first half of this year, and our oral program is enrolling well.

Data, to date, on over 900 patients have shown that picoplatin is safe and well-tolerated, has brought activity and potential application to many tumor types. We have clinical strategy in place to provide proof-of-concept data to support further development.

In addition to the recently generated data supporting the safety profile of picoplatin, we have a significant body of data in many solid tumor types that include positive activity data in non-small cell lung cancer, ovarian, bladder, pancreatic and upper GI cancers. We believe that these reinforce picoplatin as a potential platform product.

During the fourth quarter, we made advancements in our metastatic hormone-refractory prostate cancer program. We completely enrolled our Phase 2 trial of intravenous picoplatin in the first-line treatment of metastatic hormone-refractory. Prostate cancer is a multi-center open label single-arm trial with 30 patients in which picoplatin is administered every three weeks with full recommended dose of docetaxel plus prednisone, which is the standard of care in the first-line setting. The primary endpoint is PSA response and we're also evaluating overall survival, tumor response, time to progression and progression free survival in addition to safety and tolerability.

In our colorectal cancer program, we believe that lower neurotoxicity of picoplatin may make it a preferred platinum replacement to oxaliplatin, which has significant dose related neurotoxicities. Based on encouraging Phase 1 results, we initiated this Phase 2 study in which we are evaluating intravenous picoplatin as a first-line treatment with 5-fluorouracil and leucovorin, the combination regimen called FOLPI. We are comparing this regimen against the standard of care FOLFOX regimen, which includes oxaliplatin in a 100 patient randomized trial.

As I mentioned, we're on-track and expect to fully enroll this trial there in the first half of 2008. We plan to present emerging Phase 2 clinical data from both the colorectal and the prostate cancer trial at scientific meetings throughout the year.

In November, we announced positive preliminary bioavailability data from ongoing Phase 1 trial of oral picoplatin in patients with solid tumors. These findings support the further development of an oral formulation of picoplatin as with our intravenous formulation, we intend to fully develop oral picoplatin for the treatment of multiple types of cancers. We expect to present more complete data from this trial at scientific meetings throughout the year.

We recognized that a product with IV and oral formulations, utility and multiple indications including a rapid route to market and emerging proof-of-concept data from Phase 2 colorectal and prostate cancer indication has broad applicability and would be attractive to potential partners.

Ronal Martell and Robert De Jager joined our management team over the past several months believing in the potential for picoplatin to become a platform product. Ron's expertise in commercializing our oncology products and Robert's expertise in research and trials in oncology will help Poniard execute on it's strategy to make that a reality. We are committed and confident in our ability to execute on our clinical strategy.

I will now turn the call over to Caroline, who will review the financial results and provide guidance for 2008.

Caroline Loewy

Thank you, Jerry, and good afternoon. Today, we released our financial results for the fourth quarter ended December 31, 2007. I will cover some of the highlights of these results.

With respects to our consolidated statement of operations, we reported a net loss of 9.6 million for the fourth quarter of 2007, compared to a net loss of $6.1 million for the same period in 2006.

Total operating expenses for the fourth quarter 2007 were $10.4 million, compared to $6.5 million for the 2006 quarter. The increase in expenses in the fourth quarter of 2007 was primarily due to increased clinical costs associated with our four ongoing clinical trials and the picoplatin drug supply.

On our balance sheet, we ended the quarter with cash and investment securities of $92.6 million compared to cash and investment securities of $97.1 million at the end of the third quarter. The net cash used in operations during the fourth quarter of 2007 was $6.4 million.

We believe that our existing cash and investment securities will provide adequate resources to fund our operations at least through the second quarter of 2009

With that, I'll now turn the call back over to Jerry.

Jerry McMahon

Thank you, Caroline. In recent months, we've advanced every segment of our picoplatin program, evaluating multiple indications, combinations, and formulations. Our executive team continues to execute on our strategy and has set substantial value driving goals for 2008. Throughout the year, we will continue to diligently pursue completion of our Phase 3 SPEAR trial in small cell lung cancer and a successful NDA filling.

We'll expect to enroll our Phase 2 colorectal cancer trial in the first half of 2008 and anticipate data and plan to present data at scientific meetings. We plan to present the Phase 2 hormone-refractory prostate cancer trial at scientific meetings, and, finally, we plan to present data from our Phase oral picoplatin study scientific meetings.

We continue to build an organization skilled to execute on our strategy of developing picoplatin as a platform product. We anticipate further important advancements of our clinical development programs and milestones for picoplatin with the continuing goal of building shareholder value.

On behalf of the management team, we thank you for your interest and look forward to communicating with you in our progress throughout the year. Thank you for participating in this call.

Operator please poll for questions.

Question-and-Answer Session

Operator

(Operator instructions)

We'll go first to Katherine Xu of Credit Suisse.

Katherine Xu - Credit Suisse

Hi, good afternoon.

Jerry McMahon

Good afternoon.

Katherine Xu - Credit Suisse

Jerry, I'm just curious, during around JPMorgan in January you said, from what your estimates, you could have the topline data from the SPEAR trial by the end of this year and then now is going to be mid '09. So what happen between then and now that made you change the estimate on the timeline?

Jerry McMahon

Well, obviously we have more data so we closely analyzed our trial with respect to the data that we have since then and look at the timing of completion of the study and more importantly we really focused our analysis on the enrollment and its impact on event rates.

And when we looked at the event rates based on the data that we now have, we would expect our topline data emerging from the trial in the middle of 2009, which still allows us to file our NDA as quickly as possible. We obviously have a longer lead time on our NDA filing process and we feel very confidently that we'd be able to file the NDA in 2009.

Katherine Xu - Credit Suisse

Is the recruitment on target? I mean, basically, there are potentially two components to this one is that you are not recruiting as quickly as you anticipated. The other one is that you are prolonging safe survival and then you have less event rates kicking in right now. So I mean, to the extent that you can comment, what is--

Jerry McMahon

Yeah. I mean obviously, with our focus on event race, which is the appropriate focus? There are factors that go into that analysis and one of the factors, of course, is enrollment. We previously stated that some of the sides were slower to come up and come online than we had hoped, but now nearly all of the plan sites are up and running.

So with respect to the initial planned sites, and if we now feel that they are all online, but the impact of the lower number of sites that were up, did have an effect on enrollment and, of course, that influences our event rate even tough we now know that the vast majority of those sites are up and active. There was an impact of the slower number of event upsides that were up in running and so we did have an effect of that.

But, I think that's well under control now and, in fact, we are adding additional sites, and we think that is part of our remediation to make sure that we get the event rates that we need.

Katherine Xu - Credit Suisse

Okay. The other question is with regard to potential partnership. What are your thoughts right now on this (inaudible)?

Jerry McMahon

Very good question and I'll turn that over to Ron, since he is setting up most of that effort.

Ronald Martell

Hi, Katherine.

Katherine Xu - Credit Suisse

Hi.

Ronald Martell

Well, we certainly are considering partner opportunities that present us with the best opportunity to recognize the global potential for picoplatin and specifically picoplatin as a platform product. And as a reminder, there we do have worldwide rights to this compound and so recognizing that there is a global opportunity for this partnership, and so we are considering those opportunities.

Katherine Xu - Credit Suisse

Is it going to be maybe a 2008 event, or 2009 after you see this SPEAR data?

Jerry McMahon

Sure. That's a good question and one of the things to consider here are the Phase II clinical trials that we're conducting this year, and the data that they would generate as proof-of-concept and we think that those two clinical trials are value drivers for potential partners, and could potentially enable the partnership or enhance the value of a partnership based upon those data.

I think different partners have different models for when they would like to enter into a partnership whether it's before or after the Phase III, but we certainly think if those Phase II data from this year could enhance the value proposition for our shareholders, as it relates to a partnership.

Katherine Xu - Credit Suisse

Great. Thank you.

Operator

We'll go next to Bret Holley with Oppenheimer.

Bret Holley - Oppenheimer

Yeah. Hi, thanks for taking my question. Just a follow-up on the question of event rates in SPEAR, you guys have seen some proportion of winded data for the trial was to median survival consistent in the small number of patients you had so far with your expectations regarding your powering assumptions and things like that?

Jerry McMahon

Yeah, I think the assumptions that went into this Bret, have not changed from the beginning, we are not seeing anything with respect to our original assumptions around events and the trial. There has actually been no change in those assumptions. It's purely timing. It's when those events would emerge, but there is no change in terms of the original model or the projections. Does anybody else want to follow up with that? No. Okay.

Bret Holley - Oppenheimer

So I guess, it really just amounts to the enrollment, just was a little bit slower…

Jerry McMahon

Enrollment is the major factor that's influencing the emergence of events in our trial. As you also know, the statistic build considerations for our trial have certain mathematical targets for event rates that we're focused on.

Ronald Martell

Bret, this is Ron. I think it's important to make two points here, and one is that the impact on enrollment is largely been driven by the site initiations, and that thereby ultimately impacts the events rate. So I want to make certain we're very clear that we have not done an analysis of the event rate and based upon data we're seeing, because that data are blinded to us. We have not done an analysis of that event rate and thereby what we're seeing for events or the timing of those events in the trial making their projections here. So you're absolutely correct. It is largely driven by the enrollment.

I think it's important to point out here that the enrollment from this clinical trial is actually going very well. When we look at the sites that are enrolling patients and how they are enrolling patients as a metric based on our Phase II clinical trial. This is trial is actually enrolling faster than what our Phase II clinical trial did. So we're able to identify sites that can conduct good clinical practice for clinical trials and sites that can identify patients to enroll in this trial, primarily driven by the timing of initiating all of these sites.

Bret Holley - Oppenheimer

Okay. And then I guess one other question I had is when is the earliest possible date on which we can get the initial top line data from the Phase II colorectal cancer trial. It was my understanding before mid 2008 perhaps the ASCO was a reasonable timeline for that. Is that still the case?

Jerry McMahon

Yes, that is the case. Obviously it won't be every patient that is involved in the Phase II would have data that would be part of that analysis at ASCO as an example, but obviously there would be a enough data, I think, to be of interest if our abstract is accepted for ASCO. We would also expect more mature data to emerge in the second half of the year and we will be looking for other medical conferences to present near more complete data on the Phase II experience in both colorectal as well as prostate cancer. But you are right abstracts have been submitted for both the Phase II prostate and the Phase II colorectal for the presentation in Chicago.

Bret Holley - Oppenheimer

Okay, great. And then just one point of clarification you have not this time committed to raising the number of patients enrolled in SPEAR at all. This is a simply a matter of time there is a no change in the number of patients or in your planned enrollment?

Jerry McMahon

Yeah, exactly right. The sample size and all the assumptions in the original design in this trial are maintaining it’s a timing of when those events would occur.

Bret Holley - Oppenheimer

Okay. Thanks so much guys.

Operator

We'll go next to Matt Osborne, Lazard Capital.

Matt Osborne - Lazard Capital

Hi guys. Just one follow-up on the enrollment, was there any challenge with topotecan, perhaps patients receiving that in some of these regions.

Ronald Martell

No. As you may remember from the design of this clinical trial was against our supportive care and the investigators who are participating, as well as the national FX review committees. I mean the countries that are participating in this study, approved the design of this study and the implementation of this study and recruitment of patients to this study. And the oral topotecan took as a reminder with a US approval.

Matt Osborne - Lazard Capital

Okay. And then, can you give us a sense of the number sites then perhaps you've gone from I think it was 25 perhaps is the goal. Have you increased that to say 30 or are we within that range?

Jerry McMahon

Of the SPEAR trial, remember the number of sites is approximately a hundred clinical sites which stood for the Phase III trial. So when we say that most of those sites are now active in recruiting patients, that's the guidance, we're giving on that. And of course we'll be looking to add additional sites into held properly -- accelerate the enrollment of this trial as well. But the original target was approximately 100 clinical sites.

Matt Osborne - Lazard Capital

Okay. And then, quickly on colorectal. Should we anticipate mostly response rate data or some patients with time to tumor progression data at ASCO in general?

Ronald Martell

I'm sure the -- this is Ron. Should the abstract be accepted at ASCO, it would be response rate at this time as we're actively enrolling on that study. There is the possibility should it be accepted at other scientific meetings later in the year, that we may have additional efficacy data at that time.

Matt Osborne - Lazard Capital

Great. Then last question, is there still a possibility you would begin a Phase III trial based on time to tumor response from this trail or would you wait for overall survival while beginning Phase III?

Jerry McMahon

Oh, I certainly thing there are a couple of different things that go into and I'm assuming you're still talking about colorectal.

Matt Osborne - Lazard Capital

Yeah.

Jerry McMahon

There is a number of different things that would go into potentially the design and implementation of a Phase III, and time to tumor response or overall response rate are one of the significant pieces that would enable us to size a Phase III trial. The other is the endpoint of neuropathy, and the magnitude of the benefit of the neuropathy sparing a factor picoplatin and it's ability to size an endpoint for the clinical trial, and so that really is the design of the Phase II is to have proof-of-concept from both the safety and efficacy standpoint in colorectal and enable us to use that data to size a Phase III.

Matt Osborne - Lazard Capital

Great, thank you.

Operator

We'll go next to William Slattery with Deerfield Partners.

William Slattery - Deerfield Partners

Good morning, Jerry. I would imagine that the metastatic colorectal cancer findings are going to be of extreme importance to potential partners, and I'm anxious to best understand what your current conversations from a partnering point of view are suggesting as it relates to when the data are best represented to those potential partners, what are the metrics that are most critical to their decision making? And just in general what are some of the timeframes that you believe are most reasonable as it relates the generation of the Phase II colorectal cancer data and potential partner?

Ronald Martell

Good afternoon, Bill. This is Ron. While you are spot on with your value creation ability, if you will, from the Phase II clinical trials or partners that obviously colorectal is a significant marketplace and one that is dominated by oxaliplatin and one that presents a significant opportunity if we are able to present data with similar efficacy to oxaliplatin but spare the neuropathy that is dose-limiting for these patients. And so partners are keenly interested in that data, and key opinion leaders suggest that if we are able to significantly reduce the level of neuropathy in this patient population, then we have a real opportunity to become the preferred platinum in this space.

So to that end, there are a lot of eyes on the data as you suggest. And from a partnership standpoint, it's important to note that while we maybe publicly limited in our ability to discuss those data and limited to the scientific forums that are available to us to discuss those, these studies are not blinded to us and, thereby, in a confidential fashion, we would be able to have discussions with partners about data. So those discussions could take place in real time.

William Slattery - Deerfield Partners

A quick follow up, and I know it's impossible because there is a second party to contend with, or parties to contend with, but if you were to speculate based on the maturity of the data, when would a reasonable partner have a sufficient data set to be able to really, in your opinion, analyze the data in an objective fashion?

Jerry McMahon

I think sometime probably after the mid-year. Again, if the response rates are in the ballpark of oxaliplatin and the neuropathy based on the trial, is at a significant difference, then that is probably predictive enough for significant discussions to really engage a partner in that. So I would say probably beginning mid-year.

William Slattery - Deerfield Partners

Right then. Thank you.

Operator

We'll go to Howard Liang with Leerink Swann.

Howard Liang - Leerink Swann

Thanks. Just a question on the ASCO data in colorectal cancer Phase II data. I just wanted to get an idea how substantial that will be can you give us an idea how many patients will expect to see data on?

Ronald Martell

It's difficult to predict, as you might know, the range of timing, if we're doing scans at the eight-week interval, some patients respond early, some patients respond later but the number at this point is probably north of 30 that I think we have confidence that we could have response rate data of the 100 in the study at that point in time. And again, it all depends upon the timing of the response for a given patient.

Howard Liang - Leerink Swann

Okay, great. Also for ASCO, should we expect to see the Phase II for prostate cancer as well?

Ronald Martell

Yes. As a reminder that study is fully enrolled in the fourth quarter of last year, so that data set are more mature.

Howard Liang - Leerink Swann

Okay, great. And then just on -- see if you can get some granularity on the enrollment of SPEAR. You mentioned that was primarily the initiative sites. Is it primarily finding the site or finding good and experienced sites versus just slow in getting IRB approval?

Ronald Martell

It was not the site selection. It really had to do with national regulatory and ethics approval process if you will. And a couple of cases we ran into countries that were joining the EEU as an example and until they went through the processes of joining the EEU, all things were on hold. So some of those things that were a bit unforeseen for us from a timing perspective that created delays that we didn't anticipate.

Howard Liang - Leerink Swann

Okay, great. Thanks a lot that was very helpful.

Operator

(Operator Instructions). We'll go next to George Zavoica with Cantor Fitzgerald.

George Zavoica - Cantor Fitzgerald

Hi Jerry, hello everyone. Nice call, thanks for taking the question. Caroline, you mentioned that your -- from the costs are increased on picoplatin drug supply, you're earning a lot of clinical trials now. Do you have enough drug now to finish the trials for the year or you have to make more sometime during the year?

Caroline Loewy

We are continuing to manufacture product on an ingoing basis and, but we're confident that we do have sufficient supply available to us. That's something that we're scaling at commensurate with our increased clinical trial activity. So there is nothing unusual going on. We have more patients on drug, more trials enrolling, and so we would just expect to be using more drug and we feel confident that we have the supply in place for increased clinical activity, as well as putting in place all the necessary supply for commercialization when that time comes.

George Zavoica - Cantor Fitzgerald

Okay. Thank you for that. You've got a lot of trials ongoing this year and waiting for results. Any chance that or any planning to begin any new Phase II trial, say no varying in other places that your platinum drugs are used. I know at one point you were mentioning that or talking about that possibility.

Jerry McMahon

Well, I think what I could say is that we're obviously very excited about the broader potential of the product and the list of tumors that we indicated today will vary in non-small cell and all the other indications and obviously our discussions with partners are focused on some of these additional indication opportunities that we haven't focused on today. So I think given the nature of our discussions with partners that's probably going to take precedent over us in at least from the short-term self initiating any new trials. I think that along with some discussions with corporative groups are probably the two main areas that allow us to enter into new trials. So focusing on corporative group activities as well as obviously trying to spell outs with some of these new trials could be with partners is the area of focus right now.

George Zavoica - Cantor Fitzgerald

Okay, thanks then finally. I know you have the collaboration going with Scripts or new target, do you think within sometime in 2008, you might announce a lead candidate or start the [IND] enabling studies, or is that still too early?

Jerry McMahon

Where we are focused right now is really completing our collaboration with Scripts, licensing the compounds that we work on together, and then once those compounds are in-house, is really focusing then as you pointed out on identifying an IND candidate. And at this point until we've completed the license, we really don't want to give any guidance with respect to when that clinical candidate would emerge. But we're obviously very excited about the collaboration and have been for the last couple of years, and once we complete that license, we would then focus our attention on identifying that clinical candidate.

George Zavoica - Cantor Fitzgerald

Fair enough. Thank you very much.

Operator

We'll go next to David Garrett with Fortis Securities.

David Garrett - Fortis Securities

Hi, everyone. Just a quick clarification, I think this question is probably for Ron. Could you give just a bit more specific answer as to when you would expect the full PFS analysis on the Phase II colorectal based on what you're seeing so far? Thanks.

Ronald Martell

Sure. Hi, David. I would anticipate that based upon, again, the enrollment of that study and the history of colorectal cancer that PFS would be late this year.

David Garrett - Fortis Securities

Thank you.

Operator

And that does conclude today's question-and-answer session. At this time, I'd like to turn the call back to Dr. McMahon for any additional or closing comments.

Jerry McMahon

Yeah, I don't have any specific items. I'd just like to thank everybody for their participation and joining us on the call today. Thank you.

Operator

Once again that does conclude today's conference call. Thank you for your participation. You may disconnect at this time.

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