Agenus Inc (AGEN) 2011 Q3 法說會逐字稿

Good morning, my name is Ashley and I'll be your conference operator today. At this time I would like to welcome everyone to the Third Quarter 2011 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be an question an answer session.

(Operator Instructions)

Ms. Barnes, you may begin your conference.

Thank you, Ashley. And thank you everyone for joining us. Welcome to Agenus' conference call to discuss the financial results for the third quarter and nine months 2011. With me today is Garo Armen, Chairman and CEO, and Shalini Sharp, CFO.

We hope that you've all had a chance to review press release that was issued this morning. During this call, we will review our financial results as well as provide a corporate update. We will then open up the call to a Q and A session.

But before we continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding the Company's cash position, timing of potential income streams, and development and commercialization efforts, timelines, availability of data, and potential efficacy with respect to products and product candidates of the Company and its partners. These forward-looking statements are subject to risks and uncertainties and could cause actual results to differ materially.

Reference to these risks and uncertainties is made in today's press release and they are disclosed in more detail in our most recent filings with the US Securities and Exchange Commission. These statements speak only as of the date of this call and Agenus undertakes no obligation to update or revise these statements.

All forward-looking statements are expressly qualified in their entirety by this cautionary statement. When evaluating Agenus' business and securities, investors should give careful consideration to these risks and uncertainties. As a reminder, this call is being recorded for audio replay.

With that, I will now turn the call over to Shalini to review our financial results for the third quarter and nine months 2011.

thank you, Jonae. The Company reported a net loss attributable to common stock holders of $5.7 million or $0.28 per share basic and diluted for the third quarter of 2011, compared to a net loss attributable to common stock holders in the third quarter of 2010 of $5.9 million or $0.36 per share basic and diluted.

For the nine months ended September 30, 2011, the Company incurred a net loss attributable to common stock holders of $17.8 million, or $0.92 per share basic and diluted, compared with a net loss attributable to common stock holders of $20.1 million, or $1.26 per share basic and diluted for the comparable period in 2010.

The Company's net cash burn, cash used in operating activities plus capital expenditures and dividend payments for the nine months ended September 30, 2011, declined to $12.7 million, compared with $14 million for the same period in 2010.

The 2011 net cash burn figure reflects primarily the Company's efforts to support the Prophage Series vaccines. Cash, cash equivalents and short term investments were $14.7 million as of September 30, 2011.

I would also like to report that during the quarter the Company closed an at-market underwritten offering of approximately $2.3 million primary shares of its common stock at a price of $3.06 per share on a post-split basis. Agenus received net proceeds of approximately $6.3 million.

In addition, Agenus regained compliance with the NASDAQ one dollar minimum bid price requirement following a one for six reverse stock split that became effective on October 3, 2011, and currently satisfies all requirements for continued listing on the NASDAQ Capital Market.

This concludes the financial portion of the call. Garo will now provide a brief corporate update.

Thank you Shalini and Jonae. The third quarter 2011 represents a truly transformational period for Agenus. In addition to increasing our financial position and enhancing our capital structure and securing continued listing on NASDAQ Capital Markets, as Shalini discussed, we made significant progress during the quarter with both our Saponin and heat shock protein technology platforms. These two represent the core of our Company's technologies.

With regard to our Saponin platform, I'm very happy to report that on October 18, the New England Journal of Medicine published results of a Phase III trial of Glaxo-Smith-Kline Biologics RTSS malaria vaccine candidate, which contains our QS-21 Stimulon adjuvant. QS-21 is a key component of AS01B, which is GSK's biologic's proprietary adjuvant system using RTSS and many other vaccines.

This is the first vaccine to demonstrate efficacy against a parasite. Importantly, this is also the first time a QS-21- containing vaccine has demonstrated efficacy in a very large Phase III trial. This represents a major milestone for Agenus and marks the beginning of a period in which 15 clinical stage products containing QS-21 are advancing. And more specifically, these are from two Phase III trials are expected next year.

With regard to this latest milestone relating to QS-21 and the RTSS vaccine, malaria parasites have been very difficult to target with a vaccine. To develop a successful vaccine, both arms of the immune system need to be mobilized - the antibody arm and the cellular arm. And this is exactly with QS-21 helps to deliver.

As I indicated, the results of the study were reported in the New England Journal of Medicine, and announced by GSK and the Gates foundation as a major breakthrough. The study included 6,000 children aged five to 17 months. It demonstrated that RTSS provided young children with significant protection against clinical and severe malaria, reducing risk by 56% and 47%, respectively.

Malaria, as you know, is responsible for close to 800,000 deaths each year, most of whom are children under five in sub-Saharan Africa. The efficacy and safety results in even younger children six- to 12-week-old infants from an ongoing RTSS Phase III trial are expected by the end of 2012. It is anticipated that the RTSS malaria vaccine candidate could be available as early as 2015.

QS-21 has been an important component of a substantial number of vaccines in clinical development. QS-21 works by enhancing the ability of the vaccine to elicit strong and durable immune responses. However, adjuvants by themselves do not generally receive FDA approval as stand-alone products, but rather as part of a vaccine adjuvant antigen combination.

To date, only two adjuvants have been used in vaccines licensed by the FDA dating back to the 1930s. In view of the fact that QS-21 is in four different Phase III vaccine candidates, we believe that it will be - this will represent the third adjuvant to be included in a commercial product.

As we have indicated, malaria is only the beginning of the QS-21 story. Agenus is entitled to receive milestone payments as QS-21-containing programs advance, as well as, very importantly, royalties on net sales for 10 years after commercial launch.

Given that QS-21 is being studied in clinical trials for 15 vaccine programs, including products targeting billions of dollars of market opportunity such as non-small cell lung cancer, melanoma, shingles, Alzheimer's Disease, and so on, this unique proprietary asset represents a significant and an unusually diversified value driver for our Company. The QS-21 programs are funded nearly substantially by our partners, eliminating the resource constraints and risks associated with small biotech companies.

While certainly not insignificant for a company of our market capitalization, the financial opportunity for malaria is more modest than the rest of the portfolio, especially compared with other potential blockbuster candidates which are in late stage development with QS-21-containing products. Nonetheless, we're very proud to be part of this socially responsible program that has the potential to prevent millions of cases of malaria and also, very importantly, because of the positive impact it can have on the medical system and the economies of Africa.

In addition, the positive Phase III data for malaria program highlights the potential promise of QS-21, and we anticipate data from Phase III as we spoke about in a bit - a little while ago, rather. Phase III pivotal trials of two additional vaccine candidates from GSK in 2012. They include their [MAJ A3] a three product for non-small cell lung cancer and MAJ A3 product candidate for melanoma.

I would also like to point out that in addition to benefiting from large pharmaceutical company partners underwriting the cost of some of these largest studies ever done in lung cancer, melanoma, shingles, malaria, and Alzheimer's Disease, if approved we also have the benefit of these substantial companies organizations launching, marketing, and selling these products. It is an extraordinary advantage for a company of our size to be in a position to benefit from the success of much larger established companies in this space.

I will now turn to some of Agenus' pipeline programs beginning with HerpV vaccine. HerpV is a recombinant, off-the-shelf therapeutic vaccine for the treatment of genital herpes which is caused by the herpes simplex virus 2, HSV-2. The vaccine is based on Agenus' heat shock protein technology platform. I am pleased to report that positive results from a randomized four-arm placebo-controlled Phase I study of HerpV, which contains also QS-21, were recently published in the peer review journal, Vaccine.

The data demonstrate for the first time that HSV's complex to a viral antigen, or antigens, can induce an antigen-specific t-cell response which includes both CD4 and CD8 cells in this clinical trial.

HerpV is the most advanced HSV-2 vaccine currently in clinical development for the treatment of genital herpes. We plan to advance the HerpV into a Phase II study in 2012 that will measure the effects of vaccination on viral shedding in individuals infected with HSV-2. Experts in the HSV-2 clinical research believe that a reduction in viral shedding could translate into clinical benefit of a reduction in recurrent outbreaks.

Given the significant unmet medical need represented by genital herpes, we believe that if HerpV is shown to be safe and effective, this clinical candidate has a true blockbuster potential.

Our Phase I trial showed that 100% of the evaluable patients receiving HerpV with QS-21 represented or demonstrated a specifically significant CD4 t-cell response to HSV-2 antigens. In addition, 75% of these patients also demonstrated a CD8 positive t-cell response. I would like to note that eliciting both of these types immune responses is a first of its kind achievement in herpes therapy.

Finally, I will now discuss our Prophage series vaccines. We're studying the Prophage G series vaccine in two different settings in glioma - newly diagnosed and recurrent disease. Glioma is the deadliest form of brain cancer with an average survival of six to 14 months. Results from a Phase II trial of Prophage G200 show that 93% of the patients were alive at more than 26 weeks after surgery with a median survival of 11 months, which is 47.6 weeks.

Importantly, measures of immune response post-vaccination with Prophage series G200 demonstrated a significant localized tumor-specific CD8 positive t-cell response, as well as innate immune responses as marked by significant increases in levels of circulating NK cells.

Promising overall survival results from this trial support advancement of Prophage series G200 into a randomized study using the combination regimen.

A Phase II trial testing the Prophage series vaccine G100 in patients with newly diagnosed glioma is also in active enrollment. In this trial, G100 is being used on top of the standard of care, which includes Temodar which is temozolomide, and radiation therapy. It is believed that the efficacy of the G100 could potentially be enhanced through this combination regimen. This trial has been expanded to include up to 10 prominent brain tumor research centers across the US It is anticipated that its expansion will aid in advancing the program more rapidly.

The Company continues to explore development in commercial partnerships for Prophage series of cancer vaccines, both on a global as well as on a regional basis.

In closing, I want to reiterate that this is a very exciting time for our Company. Between Agenus and its partners, there could be as many as eight upcoming milestone events that could be reported over the next 15 months. So that is by the end of 2012. All of which could be of great, great value to us and to our shareholders very importantly.

Thank you for your interest in our Company. We hope that you have found this update to be helpful.

Now I will conclude my formal remarks and open it up to questions.

(Operator Instructions). Our first question comes from the line of Bobby Cohen with Revolution Investment Management.

I'm very focused in reference to, obviously, the positive science that emanates from the Company. But what I do have a concern. And I don't only think the concern emanates from me but probably from other shareholders is that if the science is blockbuster was so good, and these are my words, how I critique - why is it that we have to continually always go back to the marketplace and just delude all of us, including yourself, Doc?

I mean, that seems troubling to me. And that's my only question because I'm a believer in the science, but if everyone thought it was great out there, all the big pharma and biotech, you would think they would be surrounding you and want to throw money at you. So, what am I missing. And you have the floor.

Thank you very much. This is a very insightful question. Obviously, it's something that concerns us and has concerned us for some period of time. Clearly, we live in unprecedented and challenging times. And I think that the orientation of the world, the investment community, the markets, towards what can you do for me this afternoon and tomorrow is not the way that we look at our business. And, clearly, that orientation and expectation of miracles to happen in the near term has made it very difficult for us to project the value of the Company to the world.

However, I must say that in terms of value creation and milestones we expect now to have major, major events occurring, certainly by the end of next year. Now for some, the next three to twelve months may be a long period of time to wait. But as you know, drug development is a very challenging undertaking. And the malaria vaccine that has been projected as a major, major achievement in this field - and it is - has taken over 25 years to develop. Glaxo actually started working on the malaria vaccine in the mid '80s. And 2S21 came into the equation with this vaccine in the mid-'90s.

So, we cannot satisfy the thirst of today's world of investors that want results tomorrow. But I am very confident, more than ever, that starting with the malaria breakthrough into next year - through the end of next year - we will have some very meaningful milestones from a commercial perspective that will put our Company on a very strong footing.

In the meantime, I share your frustration and remember that I am in the same position as many of our investors because I continue to invest I the Company with my own money and have done so as recently as the last offering and posted in market purchases of our Company's stock. And I expect that our long awaited efforts will finally bear fruit in the near term as defined as through the end of next year.

Thanks, Doc.

Our next question comes from the line of Brian[Haveks, a private investor.

Hi, Garo. Are you there?

Yes. Go ahead.

My question is can you give us an update on this dosing trial, the one you have where the immune response following the treatment of resectable renal cell carcinoma in the intermediate risk group? It's projected to be completed in February of 2012. Can you give us an update on that?

I don't know which trial you're referring to. However, with renal cell carcinoma, in general, we have basically slowed down our efforts from a registrational regulatory perspective because of the fact that to align our resources properly for programs that are likely to produce more near-term value drivers for us.

So, the only thing that we're doing with the renal cell program is still exploring the commercial opportunity in Russia. And we hope to see some progress in terms of the product being licensed to a local player in Russia so that we can see some revenues coming from this market and also explore potentially the development of this program in Russia in combination with other agents in renal cell carcinoma.

Other than that, we have pretty much slowed down or halted all the programs. That isn't to say they cannot be reignited once we have the appropriate resources coming from our own line of revenues and profits. But for now, it's the prudent decision for us to stop or slow down because any effort in renal cell carcinoma in the US and in Europe would not bear fruit for at least two to three years.

All right. Another question I was going to ask you is on HerpV. You have that as indicated in a therapeutic vaccine. But I was just curious, could this be applied in a prophylactic setting as well where you'd have a elevated CD4 and CD8 t-cell prior to viral exposure?

Yes. I think the answer to that question is absolutely. The reason we have chosen the therapeutics field to proceed with our HerpV is because it will be a smaller trial, it will be a shorter trial. And a company our size wouldn't at this point have the means to be able to do a very large prophylaxis trial with the same agent. But, as you said, there is absolutely no reason not to expect that if this works in the therapeutic setting it will certainly also work in the prophylactic setting.

Now, our expectation is that once we undertake our next trial, to be able to show a reduction in viral shedding post-vaccination in patients who have the disease, this will certainly be a very strong surrogate for the ultimate clinical demonstration of benefit. And at that point, it's conceivable that through partnerships with large companies we will also pursue the development of the product as prophylaxis.

Good. Good. Will you need to pay royalties to the University of Washington?

We do not because not based on the current product. While they've done clinical trials for us, they haven't really taken any role in the invention of the product. This is entirely an internal program.

I see. Another question I was going to ask is back in August this Seattle Genetics got approval - FDA approval - an accelerated approval for [Edcetras] for Hodgkin's lymphoma and anaplastic large cell lymphoma. And it's to be used after conventional therapies had failed and there was relapse. The big thing was that they got FDA approval on a single arm Phase II trial. Can you give us some of your thoughts on this? It seems like the FDA is kind of taking a new look at these single arm Phase II trials and how that can apply to us, or may apply to us in the G100 trial.

Certainly. I think that while there's always a chance, depending on what you see in Phase II, there's always a chance to negotiate with the agency. I believe personally, and based on our experience, it is a long shot. So we prefer to go through the traditional route until there are signals that suggest otherwise. And for that reason, the next steps for us would be to do a randomized trial in G200, which is the recurrent setting, with our Prophage series of vaccines, in combination with another agent.

And we are currently in active discussions with cooperative groups who could undertake a very significant portion of the study costs in doing such a randomized trial. So, I think by the next earnings release period we will certainly have a meaningful update on this program.

So you're kind of backing away from some of the language you've used in past conference calls where you've talked about accelerated approval.

There is a difference between - you know - for example, we have fast track status for a number of our indications with Prophage. This is different than what you're talking about because fast track approval simply means that once the data has been generated which is going to satisfy the regulatory agency, the fast track designation will simply allow us to get a very quick decision by the FDA. So, we've had fast track designation for quite some time.

And we've also had orphan status for a number of our products. The accelerated approval that you may be referring to is the effort that we undertook in Europe several years ago where we thought there was a chance under their newly constructed conditional approval provision for us to be able to get approval with data that would not be the typical traditional prospective based on the prospectively defined patient population.

And as you know, we did not succeed. Now, that is still an option for us to go back and see how we can pursue that program. But in my earlier discussion I made the comment that we don't have the real financial resources to justify doing that because we would not really get any credit for it until two or three years from now when there is a decision and it's positive.

So, it's too big a risk to take for us. And that's one of the reasons we have pretty much put that on the shelf for the time being.

During ASCO, [Doctor Tustori] stated that it'd take about two months to work on the protocol on the melanoma trial - the combination melanoma trial with ipilimumab. Do you know any status on that? Is there any update? Has he started?

Yes. We have a proposed protocol that we have availed to the group in Europe who does clinical trials. This is the - I think it's known - it's the EORTC. But there is an internal process for them to review these things and make decisions and define timelines and so on and so forth. But, suffice it to say there is clarity on our part and Doctor Tustori's part as to what the structure of this trial should be like.

Okay. And it's Prophage and ipilimumab?

Well, provided that the owner of ipilimumab agrees to avail this product, because we're certainly not going to spend $100,000 plus a pop to treat our patients in this combination. That would drive the study cost to exorbitant levels. So I think Bristol-Myers would have to be a willing participant in doing this trial with the consortium in Europe in order for us to be able to pull the trigger on it.

All right. Well, that's all the questions I have, Garo. Thank you very much. And you have a good holidays coming up and a good Thanksgiving.

Thank you.

Our next question comes from the line of Ren Benjamin with Rodman.

Good morning, guys. And thanks for taking he questions and congratulations on the QS-21 malaria results.

A couple of questions. Maybe just starting off with QS-21. You mentioned that the earliest we might be able to see this product, the vaccine, on the market could be as early as 2015. Can you take us through a little bit of why it should take so long to get to the market? Is there any sort of an accelerated pathway that GSK has talked to you about or might be exploring to get the vaccine to the market? And then one just related to the financial aspects of the vaccine.

I think that GSK has come out and publicly stated that they would be selling the vaccine to foundations like the Bill and Melinda Gates Foundation for essentially costs plus five percent or so. How does that affect you guys? Are you making your royalties off the plus five percent or the complete revenues? Can you just give us a sense of that?

Sure. A very, very pertinent good question. First of all, in terms of the timelines. This is a complicated process from a regulatory perspective. And I just want to clarify that we do not upon success of the Phase III program next year - the first time a QS-21 containing product will be marketed won't be 2015. It'll be much sooner than that.

The malaria product will take perhaps as long as 2015 because of several reasons. One is that the trial is still ongoing in some ways. The results we've seen are the first time a malaria vaccine has shown a significant efficacy in a very large population at one year data point. So, the trial continues they will look at the level of protection at two years, and then years. That's one reason it may take up to 2015.

Secondly, even though this is a life-saving, a potentially life-saving product and a product that could make a significant positive impact on the medical care system in Africa, and thereby the economies of Africa as I said, it will require approval of a number of agencies, including local government agencies in African. And as you may imagine when you're dealing with multiple countries, there isn't the EMA system in Africa. When you're dealing with multiple countries, there are bureaucracies and there are probably other interests in the process of rendering a decision.

So, I think 2015 is a good number, good date. Could it happen before that? If the two year data point is so fantastic that they decide to accelerate it, perhaps; but that's not really my judgment to make. It has to be made by GSK in collaboration with WHO and the African countries' regulatory agencies. So, that's the issue.

Now, the next question is the financial component of it. Just to clarify, we get a percentage of revenues, not profits. So even if, for example, GSK were to make no money on this vaccine at all we would still get a percentage of revenues. And they have not disclosed what their break even point in because they've said perhaps we'll make our cost plus five percent. But as I mentioned, this product has been in development since the mid-'80s. The cost associated with this product are quite significant. And so those pricing decisions will be made later on, I'm certain.

And as I said earlier, it won't be a huge revenue generator for them and it won't be a blockbuster product for us. But will it be meaningful given our size and scope? The answer is absolutely. But before this becomes a meaningful contributor, we expect and hope that blockbuster potential products will come to fruition as early as next year and that the economic benefit that accrue to us from those products will be significant and much more near term.

Ren Benjamin. And then just looking at the competitive landscape, it's clear that there seems to be now companies that are coming out and trying to make different versions of QS-21, or claiming to be making different versions of QS-21. In particular, those that are making or trying to make synthetic versions of QS-21, can you talk to us a little bit about whether this is as feasible idea?

And I guess where I'm going with that is typically when you obtain products - when you obtain compounds from natural products, there's a certain degree of uncertainty as to everything that's there and at what concentration. So, how easy is it to make a synthetic version of QS-21? And I guess the other question is how easy or hard is it to defend yourself against potential threats to QS-21?

This is a very, very good question because there's been a lot of noise made in recent days and weeks on this. And as you know once a success story develops, there are lots of look-alikes and me-toos that will come into the marketplace. And so that's part of what is happening. We have been aware of the synthetic QS-21 for a very long period of time. We're not concerned about it at all, vis a vis our own current portfolio product because, as I said earlier, FDA doesn't approve a adjuvant if it proves a product that contains an adjuvant.

So, it's taken 15 years for many of the products in the pipeline to get to where they are today. And if one were to use synthetic QS-21 from any source, or any other QS-21 look alike molecule, they'd have to rewind the clock 15 years and wait 15 years for product development.

And so, is there a threat from other sources with regard to our current portfolio that contains 15 clinical stage [4] products? The answer is absolutely not because no one in their right mind is going to rewind the clock 15 years and start a new development program for the sake of using a synthetic QS-21. That makes no business or financial sense whatsoever.

Now, having said this, there are also a couple of other considerations here. Even if one imagined that a new QS-21 by some miracle of regulatory dance was possible to be substitutable for QS-21 in the 15 products in the pipeline. That would take an absolute miracle to do. Even if that were to happen, however, in the very hypothetical case, our agreement with the companies are such that they can get QS-21 from any source they want except that they would still owe us the same royalty. There won't be any reduction in royalties. The same exact royalty that's due to us, including milestones, will still be due to us. So, that's in the very hypothetical case.

The third element of this, which is very important, is that to the best of our knowledge no one from any other source, including synthetic QS-21, has been able to demonstrate that the activity of their product is equivalent to our activity. We haven't seen any publications on this.

And, in fact, the work that's done on this suggests that so far, we believe, synthetically derived QS-21 may not have the same attributes as naturally derived QS-21 by our process. That doesn't mean that at some future date by some experimental and manufacturing tweaking, formulation tweaking, they cannot come up with a viable or a viable adjuvant that will show activity. I think that that could very well happen.

But once again, that will require studying the programs with preclinical research, toxicology, Phase I, Phase II, Phase III, and so on and so forth, to develop them. And that's a very lengthy and expensive process, as I said earlier.

So, just to sum this up, we do not expect any impact from synthetic QS-21 on our current business whatsoever. Could there be an impact for business of future acquisitions? The answer is possibly. But that's the issue. And also very importantly, there are no supply constraints for QS-21 that we have.

So, there would be very, very little incentive for somebody to go back and fiddle around with something else whereas we have shown significant activity, unprecedented activity, which has been the engine for these 15 vaccines in clinical development and many other programs in preclinical development.

Just a follow-up. To your best knowledge, there isn't necessarily a shortage of soap bark trees that are occurring?

No. In fact, we have pretty much secured the supply of the bark trees or the pulp that comes from the bark tree source to satisfy QS-21 needs for a very, very long period of time. And as you know, this is an agent that is used in microgram quantities. So, we're not looking to make this in several tons. Microgram quantities per dose would take very little of manufactured product from a single lot to be able to use in a very large commercial launch.

And just switching gears real quick to the HerpV program, it's still on schedule for the Phase II to start by the middle of 2012? Have you provided details of this trial, how big it'll be and how long it'll run?

It's not a secret. The reason the program will start around mid-year next year, give and take a couple of months, is because of the fact that we're in the process of securing the manufacturing of the 32 peptides and the recombinant [HR] protein 70. We will assemble this product in-house because we have substantial expertise in doing it ourselves. We will vial it in-house. And so that's the limiting factor right now. Otherwise, we'd be able to start the trial tomorrow.

Now, as far as the duration of the trial, it's a very quick trial. Probably inside of 12 months from start to getting those answers that we would look for. The trial is likely to enroll very quickly. There is a tremendous level of interest in a herpes vaccine. And as I said earlier, this is the most advanced herpes vaccine program anywhere in the world.

So, we get letters and emails almost daily from people pleading with us to be included in the clinical trial. This is a very tragic disease. You know, people don't carry banners on their sleeves talking about it, but it afflicts a very large population. And it does have a very, very tragic impact on many people's lives and their future lives and relationships, and so on and so forth.

And there are drugs out that are not really game changers for the course of this disease. So, a vaccine would be a very welcome addition. And I think it's reasonable to say that we can enroll very quickly and once successful, I think this product would be launched in a way that would be very, very meaningful for the people afflicted with the disease and also meaningful for us from a commercial perspective.

Okay. Just one final question regarding the Prophage series. Can you give us an update as to what's happening with the MP150 in the recurring and newly diagnosed pediatric brain tumors? What's the time frame for this? And then just an update with the G100 series for newly diagnosed glioma in that I know you had increased the number of sites. Where are we with enrollment and when do you think we could be seeing some data?

GP150 trial is still being pursued. The reason we haven't executed on this yet is because we had a substantial level of activity with the consortium who would consider potentially doing the randomized trial, Ren. So, given that we're only a company of 60 individuals now, it's very difficult to attend to a lot of projects.

We thought that the G200 combination trial in a randomized setting would be a very, very meaningful trial to do because it could lead to registration in glioma. And there's a substantial level of interest on this from the consortium that we're working with.

And so that has been accelerated, basically, in terms of emphasis. But that doesn't mean the pediatric trial is something we should ignore. It's just a bit on the back burner. Still moving, but we're not pushing it as much.

In terms of enrollment in the G100, the newly diagnosed patients, more centers have now signed on and come on board. So the enrollment has picked up now so we expect, hopefully, to complete enrollment there by the end of the first quarter of next year.

All right. Terrific. Thank you very much and congratulations.

And I'm currently showing that there are no further questions in the queue at this time.

Thank you very much, everyone, for you interest. We look forward to keeping you updated over the progress as we go along.