OXiGENE's (OXGN) CEO Peter Langecker on Q1 2014 Results - Earnings Call Transcript

May. 6.14 | About: Mateon Therapeutics, (MATN)

OXiGENE (OXGN) Q1 2014 Results Earnings Conference Call May 6, 2014 4:30 PM ET

Executives

Peter Langecker - CEO

Barbara Riching - CFO

Analysts

George Zavoico - H.C. Wainwright

Richard Cabot - Emertech Financial

Jay Goldstein - JBG Capital

Operator

Good afternoon. Welcome to OXiGENE's conference call to discuss first quarter 2014 financial and business results. Today's call is being recorded and webcast. Participating in today's call are Chief Executive Officer Dr. Peter Langecker; and Chief Financial Officer Barbara Riching.

Following this introduction, Dr. Langecker will provide a business and clinical update and Ms. Riching will review the company's financial results. Following introductory remarks, the company will take questions. OXiGENE’s first quarter 2014 financial results press release was issued today and is available on the company’s website at www.oxigene.com.

During the conference call, members of the OXiGENE management team will make certain forward-looking statements regarding the company's future plans and anticipated outcomes that involve risks and uncertainties that may cause the actual results or outcomes to be materially different from those anticipated and discussed on this conference call.

Factors that may cause such differences include, but are not limited to, those risks and uncertainties associated with the preclinical and clinical drug development processes, potential business and financing transactions, and the ability to obtain additional financing to fund the company's operations.

Please review the risks and uncertainties detailed on the company's annual report on Form 10-K for the year ended December 31, 2013, quarterly reports on Form 10-Q, and the company's other filings with the Securities and Exchange Commission.

Now, I'd like to turn the call over to OXiGENE's CEO, Peter Langecker.

Peter Langecker

Thank you, operator, and welcome to our call. This is a very exciting time at OXiGENE. During the past few months, we have significantly increased our cash position, and we have made important progress in our ongoing research and development programs, including announcing positive top line data with our lead clinical candidate, ZYBRESTAT, and presenting compelling preclinical results from some of our earlier research initiatives.

Before Barbara provides the financial update, I’ll make a few comments regarding the status of our R&D programs, starting with the clinical study of ZYBRESTAT in solid tumors. We continue to be highly focused on planning next steps related to the development of ZYBRESTAT as a treatment for recurrent ovarian cancer.

You will recall that during the first quarter, we announced that the GOG-186I Phase II trial of ZYBRESTAT combined with bevacuzimab in recurrent ovarian cancer met its primary endpoint for progression-free survival. These results clearly demonstrated for the first time clinically meaningful activity of ZYBRESTAT in this indication and strongly indicated that further investigation is warranted.

We look forward to presentation of the complete data later this year at an appropriate medical conference and we will confirm the presentation venue once scheduled. As highlighted in our top line announcement, these data showed a statistically significant increase in progression-free survival, or PFS, in return platinum-sensitive and platinum-resistant ovarian cancer patients.

The study evaluated patients who used ZYBRESTAT in combination with the anti-androgenic agent bevacuzimab, or Avastin, as compared to using Avastin alone. The results of a key secondary endpoint in the trial also showed that patients taking the combination achieved a higher objective response rate. However, this result was not statistically significant.

We’re currently planning next steps related to this indication. Our activities include seeking input from outside medical experts, both in the U.S. and in Europe, and planning for future regulatory interactions that we expect to begin later this year.

Our ongoing planning also involves outlining potential designs for the next studies, as well as taking into consideration the overall landscape in ovarian cancer treatment, which differs throughout the world. We are making progress on this front internally and with our outside advisors and we expect to have more details to share later this year.

We also look forward to full data presentation later this year in a scientific forum as we said, which we believe will further heighten awareness of the potential for VDAs, or vascular disrupting agents, among potential partners and the entire oncology community.

Also in ovarian cancer, we plan to support a combination study to evaluate ZYBRESTAT in combination with the oral VEGF receptor kinase inhibitor pazopanib, or Votrient. Consistent with our strategy to collaborate with outside investigators and research groups, this Phase IB/Phase II study will be led and funded by a U.K.-based nonprofit research organization although our support is pending completion of related agreements.

Given the potential complementary antivascular mechanism of ZYBRESTAT and Votrient, we believe that the scientific rationale for the study is also very sound. We believe recruitment for this trial will begin in the second half of this year, with a goal of enrolling up to 120 patients with recurrent ovarian cancer in Europe. Ovarian cancer continues to be an area of significant unmet need, with high patient mortality rates, so we’re eager to refine our plans to move forward with ZYBRESTAT in this indication.

In another exciting program and potential indication, we have made excellent progress towards initiating a Phase II trial of ZYBRESTAT given as a single agent in patients with gastrointestinal neuroendocrine tumors, or GI-NETs. During the first quarter, we finalized the study protocol, brought onboard a clinical research organization to help us with the study implementation, and ran the process of lining up the clinical type.

This Phase II study will evaluate ZYBRESTAT in approximately 20 Sandostatin-refractory GI-NET patients with increased biomarkers and/or clinical symptoms, using patients as their own control. We expect to enroll the first patient in the second half of 2014, and pending recruitment, obviously, we look forward to relatively fast readout of the study results.

Finally, on the ZYBRESTAT front, we continue to evaluate the potential future regulatory filing in Europe for anaplastic thyroid cancer, or ATC. ATC is a rare but serious form of thyroid cancer for which there are limited treatment options available.

You will recall that we have been in dialog with the European Medicines Agency about the possibility of using existing clinical results, including the results of the [unintelligible] study to support an MAA, or marketing authorization application filing in the European Union. We continue to evaluate the feedback that we have received to date, and will continue to compile and evaluate the necessary data for possible submission.

Turning to our earlier stage programs, I’d like to highlight some compelling preclinical data that published this past quarter, as reported at the recent American Academy of Cancer Research, or AACR, meeting in San Diego. You may recall that we have ongoing collaborations with various universities to discover novel anticancer agents.

During the first quarter, data from our collaborators at Aarhus University, Baylor University, and the University of Florida were presented on the Cathepsin L inhibitor research program. The findings further elucidate the role of this enzyme class and its effect on tumor growth and metastasis and strongly suggests that additional research on these highly specific inhibitors is warranted.

We plan to continue to support these important research activities as they underscore the value of our earlier stage pipeline, in addition to our later stage clinical candidates. We believe that the first quarter has been a highly productive time at OXiGENE and that we’re on track to achieve our goals for the year. We have significantly enhanced our financial position, enabling us to continue to pursue selected development opportunities.

We have shown positive results in the mid-stage clinical study of our lead product candidate, which we believe opens up a range of future development and potential collaborative opportunities. As we look towards the rest of 2014, we have renewed optimism about the potential to advance ZYBRESTAT in high-value indications.

And now, let me turn the call over to Barbara Riching, our chief financial officer.

Barbara Riching

Thanks, Peter. In addition to our strong clinical progress, the first quarter also marked important changes in OXiGENE’s financial standing, as we bolstered our cash position through an equity financing in February and from the exercise of warrants issued in the February financing and prior financings in 2013.

In the first quarter, we raised net proceeds of approximately $20.4 million. This resulted in a cash balance at March 31, 2014 of approximately $24.7 million, compared to approximately $7 million at December 31, 2013 and $4.6 million a year ago, at March 31, 2013.

We believe our cash balances should be sufficient to support operations through 2015, including the currently planned trials, as mentioned previously by Peter, but most likely will not be sufficient for any other follow on clinical trials.

So for the quarter ended March 31, 2014, OXiGENE reported a net loss of $2.6 million, compared to a net loss of $1.9 million for the comparable period in 2013. The increase in the net loss for the 2014 quarter was primarily related to an increase in R&D expenses. R&D expenses were $1.4 million for the quarter ended March 31, 2014, compared to $700,000 for the comparable period last year.

The R&D increase during the first quarter was primarily due to manufacturing costs for clinical and development drug lots related to our ongoing investment to advance our clinical stage pipeline.

Additionally, we maintained G&A expenses relatively flat to last year’s comparable period at $1.2 million for the quarter ended March 31, 2014, compared to $1.1 million for the quarter ended March 31, 2013.

Given the recent financing and exercise of warrants, I would also like to highlight our updated share count. As of March 31, 2014, common stock outstanding was 15,294,320 shares, and the warrants outstanding were approximately $4,548,000.

In other developments, we have recently secured a lease for our headquarters in South San Francisco. As we plan for the future, this will continue to serve as an important base for our ongoing operations and provide good access to a range of biotech business contacts.

I’d also like to mention that given the positive developments in the first quarter, we are increasingly excited about our future prospects at OXiGENE. Our cash position is stronger, and we have significant new Phase II data that opens up opportunities for future clinical development and exploring potential partnerships.

Peter and I have also met with many current and new potential shareholders recently. These interactions have been extremely helpful and informative. We look forward to meeting many more of you at future investor and medical conferences, and we thank you for your ongoing interest and support.

Also, our annual shareholder meeting will be held at our headquarters on June 10, and all shareholders are welcome to attend. I will now turn the call back to the operator to open up for questions.

Question-and-Answer Session

Operator

[Operator instructions.] And I’m showing our first question comes from the line of Jim [Donato] of [Donato] Associates. Your line is now open.

Jim Donato

One on patents and patent pendings. Where do we stand there?

Peter Langecker

Of course we always work hard to establish patents and patent protection for the compounds that we work on. For ZYBRESTAT, we have composition of matter patents that reach out to 2021. Since we’ve been in development for such a long time, we believe that we are eligible for full patent term restoration out to 2026.

For some of the new indications, we have filed additional use patents. So, we have filed patents for the use of ZYBRESTAT in neuroendocrine tumors that would, if granted, go out to 2033. And we have filed additional patents for our second generation compound, OXI-4503, in indications like AML, myeloid leukemias, that go out to 2028, plus patent term restoration.

So I think we have, in the past and now, worked hard on these patents.

Jim Donato

The other question was about our competition moving out the other day on their [endostat]. Has that moved your plans more forward than you were looking?

Peter Langecker

Not really. I think each molecule has its own advantages and merits. We are, of course, aware of the competition, but that’s not necessarily a driver for our efforts. We’re always interested in seeing something work for patients.

That’s the biggest driver for us to move and continue our development. We believe that the strategy that we have is based on our molecule and takes advantage of its properties, both in terms of dosing, in terms of schedule, and where we have the indications where we’re working now.

So I wish it had worked for the other company in renal cell cancer, because in a way, it would also have validated [unintelligible]. We don’t know what the reason is, why that study has failed.

Operator

And our next question comes from the line of George Zavoico of H.C. Wainwright.

George Zavoico - H.C. Wainwright

Barbara, you mentioned financing through 2015, and you said that it covers the trials that are planned that Peter mentioned earlier in the call, which presumably means the next recurrent ovarian cancer trial. However, it seems like you don’t quite yet have a protocol for that. I don’t imagine that starting until either later this year or early next year, in which case it probably would run longer than 2015. So do you mean you have enough to get it started, but not to complete it?

Barbara Riching

I was referring to the two trials that we plan to start, one in GI-NETs and the trial that we hope to do with a U.K. based nonprofit that’s in combination with Votrient. And most of the costs for that trial will be borne by the nonprofit organizations. You are correct, though, that those trials probably will last past 2015. But hopefully, the amount that we would be contributing should not be that significant. For the follow-on trials, the cash will not cover any type of additional trials.

George Zavoico - H.C. Wainwright

And as long as you’re talking about GI-NET, could you just go over the rationale for the NET trial and why you’re picking that particular indication?

Peter Langecker

Yeah, for two reasons. A, we have, in the past, filed the acquisition of interesting IP data in that space that is based on some preclinical research, and we have presented an abstract at the AACR EORTC NCI meeting in Boston that actually showed very nice effect of ZYBRESTAT on an insulinoma model that was conducted at Albert Einstein Montefiore, by Steve Libutti.

So he’s one of the experts in that field, and it showed a very nice, over 90%, reduction in the levels of insulin in this tumor model. And that, to some degree, unexpectedly showed an over 80% reduction in tumor size. So we think that this was an interesting reason to pursue this.

Secondly, we think that neuroendocrine tumors lend themselves to relatively quick readout. Of course, the ultimate path to registration is probably progression-free survival, but I think the early decision making can be done on biomarker data, and on the symptom data that we plan to record. And so from that perspective, I think it allows us to decide relatively quickly whether we want to move forward with this indication.

George Zavoico - H.C. Wainwright

And you mentioned, in the answer to the previous question, 4503, but you didn’t update that in your prepared remarks. Could you say where you are right now with that in the AML trial?

Peter Langecker

Obviously, this is an interesting indication. OXI-4503 is a dual mechanism drug that works as a tubilin targeting, vascular disrupting agent, but its metabolite is an [unintelligible], so it forms [biometabolization], actually by oxidation, in the bloodstream. And the tubulin targeting effect releases the leukemic stem cells from the bone marrow, that then turn up in the peripheral blood, where the newly formed [unintelligible] has been shown to basically kill these leukemic stem cells.

There was a very nice publication in Blood, with an editorial that actually showed this effect in the three positive transgenic mouse models. So that was the rationale for this study. It’s a Phase I dose escalation study. The protocol itself calls for relatively slow escalation, every patient has to be completely finished, before they can enroll a new patient.

So enrollment has been relatively slow. It’s an investigator initiated study, so from that perspective, we are also not necessarily in control of how fast the study enrolls. We’re glad it’s an ongoing study, and the results were actually presented at the last ASH meeting in New Orleans.

But there isn’t really that much interim data from December until now that would have warranted much. It’s an ongoing study, and a very interesting study, and a very unusual mechanism, but we have to see that we get more patients onto the study over the course of the year.

George Zavoico - H.C. Wainwright

You’re basically looking for safety and NPD in this trial?

Peter Langecker

Yes, that’s the purpose. It’s a safety study. If we see activity, that’s of course interesting. We did report in December one patient with a complete bone marrow response and a normocytic bone marrow, and we have one partial responder and two stable diseases, even at doses that are probably around 30% of where we had shown activity in solid tumors with this molecule in early Phase II trials. So we think we still have a ways to go in increasing the doses and maybe also then not only record safety and the right dose, but also maybe see some more evidence or activity.

George Zavoico - H.C. Wainwright

And one more question about the protocol. Is it for recurrent AML?

Peter Langecker

Yes, these are really, really relapsed AML. They’ve had everything. This is sort of the last chance to have a treatment. It’s very advanced AML.

George Zavoico - H.C. Wainwright

And Barbara, one more question for you regarding the raise. What proportion of the raise was the raise, and what proportion of it was sales and warrants?

Barbara Riching

The raise, the gross proceeds were $12 million and the exact amount of the proceeds from the warrants, it will be pretty much detailed out in our 10-Q, but I think you can kind of do the math there.

Operator

And our next question comes from the line of Richard Cabot of Emertech Financial.

Richard Cabot - Emertech Financial

I have four brief questions. The first would be what are the chances of getting a quicker filing in the E.U. for ATC? Are there any obstacles that prevent filing before the end of the year, other than manpower?

Peter Langecker

Good question. Unfortunately, no. The real driver for the submission is of course that we believe there’s a path, but secondly, it is manufacturing. In order to file, we will have to have stability data. Usually, you have to have three registration lots, that is, commercial lot size manufacturing of your drug product, and stability of one year, for these three lots. So that’s the key driver for the timing.

Richard Cabot - Emertech Financial

Once that is done, that would also apply for your trying to file for ovarian cancer in the E.U. also, wouldn’t it?

Peter Langecker

Yes, that is correct. Any filing that we do would in essence hinge on manufacturing of commercial lots.

Richard Cabot - Emertech Financial

So you could pretty much file for ovarian cancer pretty soon after ATC, if you wanted to.

Peter Langecker

If the data was there, yes. The theoretical advantage of filing with ATC would be that ovarian cancer would then possibly be a second indication or label extension, or as the Europeans call it, a variation, for ZYBRESTAT.

Barbara Riching

But of course we’re still looking into the appropriate regulatory path based on feedback from the FDA as well as various advisory [unintelligible].

Peter Langecker

As I had mentioned during the call, we are still evaluating feedback that we’ve received with regard to the ATC trial, this Phase II trial that we have done in anaplastic thyroid cancer, as to the suitability of that for a filing in Europe. There’s some additional analysis that we’re conducting. We are getting external feedback, and we have requested and received feedback from some of the reporting countries from EMA. So that’s an ongoing process that hasn’t finished, and we haven’t concluded and decided yet whether the chance of getting approval warrants pursuing it.

Richard Cabot - Emertech Financial

I have a question on Endocyte’s recent Phase III trial in vintafolide. Would it be possible at least scientifically that ZYBRESTAT could be a combined therapy with that drug and possibly improve the efficacy?

Peter Langecker

Interesting question. Obviously, by targeting the vasculature, not targeting the tumor itself, ZYBRESTAT has mechanisms that we believe allow it to be useful to be used in conjunction with other therapies. So it’s really not cannibalizing, it’s actually an add-on, which we’ve shown to work nicely in conjunction with Avastin, for instance. So that actually is a confirmatory aspect of that study that we really liked.

And theoretically, and the way we are pursuing that with the planned study, are to combine ZYBRESTAT with pazopanib, a [unintelligible] kinase inhibitor. So whether a folate targeted compound [unintelligible] would work, possibly, I think that, at least, might be interesting to do a preclinical experiment in that direction. But I think from a scientific point of view, I don’t see why that wouldn’t be something to test. Whether it’s promising, I don’t know, and whether this is along the lines of what Merck is planning, I have no idea.

Richard Cabot - Emertech Financial

The other question I had on the Votrient trial, is there any effect right now, because apparently there’s a deal underway where GSK will be selling Votrient to Novartis over the next six or 12 months. Will that have any effect on this trial?

Peter Langecker

We asked that question, and apparently, everything is going forward as planned.

Richard Cabot - Emertech Financial

And my last question involves OXI-4503. Are there other possible indications other than AML that you would still consider the drug for? Or are you pretty much looking towards the future for strictly blood cancers?

Peter Langecker

I think strategically, we have decided to look at primarily in leukemias, of the myeloid lineage. So it would include, theoretically at least, also CML and myelodysplastic syndrome. It would be, in some ways, patent life wise, and otherwise, competing with ZYBRESTAT, but it would be further behind, so it didn’t look as if it made a whole lot of sense to continue in solid tumors with this product.

Richard Cabot - Emertech Financial

I guess my last question would be, what I see you have is tremendous opportunities across the board, in a lot of indications, with more than one drug. But obviously, your company is way too small to take advantage and go to fruition with all of these indications. What do you see as the probability of a major partnership deal for at least one of these drugs in the next 12 months?

Peter Langecker

I’m not sure I can answer that question. I can tell you that we’re a lean and mean company, we’re very efficient. And in some ways, we’re also leveraging and working with outside organizations, like, for instance, the GOGs, so that has allowed us to do a lot of things that we could not have handled on our own, with our resources.

The pazopanib study is another example of where we leverage the national health system of the U.K., that will actually pay for much of the patient treatment, where additionally, Cancer Research U.K. is funding part of the study. Yes, we’re supporting it finally, and yes, we’re providing drugs, and yes we supported the NCI [unintelligible] with FGOG, with additional funding of the drug.

And as you mentioned, the study with 4503 in AML is actually financially supported to a great extent both by the University of Florida and by the Leukemia and Lymphoma Society. So again, outside research and outside funding and outside resources have helped us move this program along. It’s not just the people here, and we plan to continue to use these kind of arrangements to bolster what we can do as a company.

The question of partnering, obviously we’re always interested in talking to other companies. And certainly, the Phase II data has increased the level of attention that we’re getting from potential partners. But if there’s something going on, I wouldn’t be able to comment here in this forum anyway. These things are typically very confidential. But I think these are all good questions.

Operator

And our next question comes from the line of Jay Goldstein of JBG Capital.

Jay Goldstein - JBG Capital

Peter, if you wouldn’t mind just framing for everybody why progression free survival is used as the primary endpoint for the ovarian indication, and from your and the perspective of OXiGENE, the differentiations between the success you had and the implications as to whether or not OS matters, and maybe some scenario analysis for what it would mean in the U.S. versus the Europe and the rest of the world, and the differentiation of value associated with how you view what different meanings, based on how the overall OS comes in, and the success you have in hand with progression free survival, and maybe even potentially why it’s viewed in the ovarian indication, why progression free survival was chosen as the primary endpoint and continues to gain as a market share in terms of why it’s the main thrust of recent testing by people seeking ovarian indications.

Peter Langecker

I think you point to a key question in ovarian cancer that I think a lot of people are grappling with. I think this question of whether overall survival is going to be a necessary requirement for drug approval in ovarian cancer. It may help to just look back a little bit. Of the drugs that are currently approved, none of them in ovarian cancer, and especially for recurrent ovarian cancer, have been approved based on overall survival.

If you look at liposomal doxorubicin, it was approved on three open label Phase II studies. Gemcitabine was approved on progression free survival and response rate. And, actually, if you look at vintafolide, the drug that was pursuing a pivotal trial in ovarian cancer, the primary endpoint was progression-free survival for that study.

So even Merck, at this point, for this indication, for that setting, apparently had guidance - at least that’s my interpretation. You know, I don’t think they would have started a 600-patient study without some guidance from the FDA, as to what the primary endpoint is. So from that perspective, I think that for certain settings, especially in the refractory setting, progression-free survival may still be a viable endpoint.

This study that we just conducted, of course, had progression-free survival as the primary endpoint also, because it’s the more manageable endpoint for a Phase II study to see [unintelligible] activity. There is, however, a long term follow up for overall survival, but the study wasn’t sample sized for this as a primary endpoint. So I don’t think there’s an expectation that you will see any type of P value surrounding overall survival for that particular study.

And with regard to U.S. versus Europe, you saw that the early approval for vintafolide, basically for a somewhat narrower population than we would pursue, was granted on progression-free survival. So I think it’s not a uniform standard. I think there’s value in these compounds.

And if you look at the decrease in value in Endocyte following the announcement of the data, that basically wiped out $400 million off their balance sheet for a while. They may recoup it. They have other indications, but I think to many people, they’re looked at as a driver, ovarian cancer, looked like a driver for the valuation.

So I think there’s also going to be more analysis on why that study failed. I’m sure people will not give up that easily. But I think that progression-free survival is still a viable endpoint, we believe, to getting approval for at least the very refractory patients who have failed carboplatin paclitaxel, who failed gemcitabine and other indications.

Jay Goldstein - JBG Capital

And just in terms of any sort of timing, I understand what you said earlier about the manufacturing as being the dependent variable. Is there any sort of timing associated with when you guys think you might have this issue addressed?

Peter Langecker

Part of the money that we’re spending, that is actually geared towards manufacturing of API, which is the drug product, the drug substance, that is used for drug product [in the vials], we are spending money on manufacturing, so that we are ready in the future to have these commercial lots for registration.

We should also say, the Phase II study, I don’t believe anybody would interpret that as a pivotal trial at this point. We will have to do additional studies, which will also take time, will require extra funding, and I think are beyond the 2015 timeframe. So from that perspective, I think once these studies started, I don’t think that manufacturing will be on the critical path. It will be then the actual studies.

Jay Goldstein - JBG Capital

So when we look at Avastin, for example, being approved in Japan recently in an ovarian setting, and already having the off label use in Europe, is it reasonable to think that…

Peter Langecker

Actually, in Europe it is approved. It is approved for first line therapy in combination with carboplatin paclitaxel and it’s approved in combination with gemcitabine. And it’s actually approved as a single agent maintenance therapy for up to 15 months. So Europe is a different scenario than the U.S. You’re right, in the U.S., Avastin currently is not approved.

Roche just, I guess the publication for the [unintelligible] study just came out, which is an interesting study that used three different chemotherapies in conjunction with Avastin, and in particular the weekly paclitaxel plus Avastin data looked really good, even including good hazard ratio for overall survival. The data was presented, I think, at ESMO, and at an early ASCO meeting. Right now, that detail isn’t in the publication.

And I think I wouldn’t assume that it is a permanent situation where Avastin is not approved in ovarian cancer in the U.S.

Jay Goldstein - JBG Capital

So just from the standpoint of Avastin and all the different places that it’s approved currently, without having an OS, but having a very strong PFS, and you obviously increasing PFS relative to Avastin, is it logical to assume that those other places, where Avastin had been approved without an OS and a PFS that was sufficient, that we should expect a similar approach by you guys in terms of trying to move to…

Because you guys were given orphan designation last spring for Avastin plus ZYBRESTAT, so getting the PFS and knowing that Avastin is approved on PFS, isn’t it somewhat of a straightforward logic that you ought to be able to submit under the same type of an approach, and then to the extent that you can, how big of a market is that without the U.S., with the U.S.?

And then also, if you could just parenthetically comment on what you think in terms of extending Avastin’s patent life as maybe Avastin plus that would have some kind of an effect in terms of differentiating Avastin in its patent life today versus what would happen if ZYBRESTAT were approved and the combination therapy would have some additional value in the marketplace?

Peter Langecker

These are obviously complex questions. Obviously, we are very encouraged by the data that we have in combination with Avastin, and we believe that Avastin is a product that will have its place, and will have continued usage. And Roche being Roche, we’ll have continued expansion of its indications as a matter of principle.

So from that perspective, we think it’s something to reckon with, and we like the fact that our data seems to improve outcomes. So I think this is something that one would expect to pursue in the future. I can’t really comment on what Roche’s plans are and I can’t really comment on what our detailed plans are.

We’re in the middle of organizing advisory panels with experts in the U.S. and Europe and we’ll get a lot of feedback. These include investigators who are part of some of the larger clinical trials with Avastin, obviously. And so I think we’ll get really good feedback in terms of what future trial designs should be and could be.

And I think a drug that shows utility will always have a presence in the market with regard to patent filings. That’s outside my area, and something probably outside of what we can discuss at an earnings call. We always try to look for patents. On the other hand, the combination for Avastin or [unintelligible] and VDAs is a very old one that goes back to [unintelligible], if you wish. I’m not sure that that particular combination would still be patentable. But that is a whole different area of expertise that would be required and so I wouldn’t want to speculate on that.

But I think you’re raising good questions. I think this is an exciting time to be able to actually consider these kinds of things for this molecule. I think it provides a lot of opportunity, not only with Avastin, but with a lot of other compounds, and we are very excited about that prospect.

Operator

At this time, I’m showing now further questions in the queue. I would like to turn the call back to management.

Peter Langecker

Well, I thank you for participating in our earnings call. I think this was an interesting call. Thank you, again, for everybody who had questions. These were very interesting questions for us, and certainly help us think about future things, what to do with our products. And it’s interesting to see the kind of level of interest. We hope to see you again at upcoming meetings, and we want to thank you for the call, and for participating in our call.

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