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Edited Transcript of AGEN earnings conference call or presentation 8-Aug-19 12:30pm GMT

Q2 2019 Agenus Inc Earnings Call

LEXINGTON Aug 15, 2019 (Thomson StreetEvents) -- Edited Transcript of Agenus Inc earnings conference call or presentation Thursday, August 8, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Christine M. Klaskin

Agenus Inc. - Principal Accounting Officer & VP of Finance

* Garo H. Armen

Agenus Inc. - Founder, Executive Chairman & CEO

* Jennifer Buell

Agenus Inc. - COO

* Paisley Myers;Senior Scientist;Agenus

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Conference Call Participants

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* Harshita Polishetty

B. Riley FBR, Inc., Research Division - Analyst

* Robert Andrew

William Blair & Company L.L.C., Research Division - Research Analyst

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Presentation

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Operator [1]

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Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Agenus Second Quarter 2019 Conference Call. (Operator Instructions) Please note, this event is being recorded.

I would now like to turn the conference over to Dr. Jennifer Buell, Chief Operating Officer of Agenus. Dr. Buell. Please go ahead.

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Jennifer Buell, Agenus Inc. - COO [2]

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Thank you, Brandon. Today's call is being webcast and will be available on our website with our accompanying slide material for replay.

Before we start, we'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development plans and time lines for date of release and partnership opportunities and time lines. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. As a reminder, this call is being recorded for audio broadcast.

I'm Jennifer Buell, Chief Operating Officer of Agenus. Today, we are delighted to provide an update on our business. Joining me are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Paisley Myers, a member of our innovation team; and Christine Klaskin, our Vice President of Finance.

In the first half of 2019, we have continued to deliver new discoveries to the clinic and advanced our proprietary and partner programs with path breaking speeds. Let me expand on this progress.

In 2019, we have filed 2 INDs, and we're on track to file additional INDs before year-end. Our first filing this year was for our anti-CD137 molecule. This is AGEN2373 that includes important safety and efficacy advantages designed into the molecule. We spoke about this during our Q1 call and have now cleared the IND. This molecule, AGEN2373, is a fully human monoclonal antibody that boosts the immune response to cancer cells by enhancing CD137 co-stimulatory signaling in activated immune cells, both adaptive T-cells and innate NK cells. The potential to duly target innate and adaptive immunity makes CD137 a highly attractive target for cancer immunotherapy. Additionally, the unique binding properties of our molecule, AGEN2373, are designed to enhance efficacy while limiting the systemic toxicity observed with competitor molecules.

Now our second IND filing this year was for our proprietary phosphorylated antigen targeting vaccine designed with unique advantages to educate the immune system to seek out cancer cells carrying these antigens while sparing healthy cells. Dr. Paisley Myers, our expert on this platform technology is here to tell you more about our advancements. The platform represents a novel class of cancer neoantigens, which have unique advantages in therapies for cancer. These antigens are common and targetable and can be leveraged for a single product that can induce immune recognition across multiple different cancers. We've identified antigens from this target class to enable us to create off-the-shelf, multi-indication therapeutics or pan indication therapeutics for solid tumors as well as hematologic cancers. Dr. Myers will tell you more about this shortly.

Further, our proprietary CTLA-4 and PD-1 antibodies are advancing towards a planned BLA filing in 2020. Given our accrual status to date, we've recently triggered our interim analysis, which is now actively underway. As we've previously disclosed, our molecules are at least as clinically active as commercially available molecules, and we plan to present data before the end of the year. We expect to remain on track to file our first BLA earlier than anticipated in 2020. We also plan to commercialize our proprietary CTLA-4 and PD-1 in the U.S. and leverage partnerships for outside of the U.S.

Next, I want to share another update on our next-generation CTLA-4, AGEN1181, a molecule that I'm personally very excited about. Our scientists designed and developed this molecule to be best in class. Our antibody can address the shortcomings of the first-generation CTLA-4. We expect this product will expand the benefit of earlier approaches from less than 20% of patients who benefit to bring the majority of patients, more than 60% of patients, who otherwise experience a suboptimal response to first-generation CTLA-4s due to a genetic polymorphism. Our molecule, AGEN1181, is designed not only to address the current limitations of first-generation molecules but to substantially expand the commercial potential of our PD-1 beyond what first-gen CTLA-4 combinations offer. We anticipate early clinical readouts of our next-gen CTLA-4 by the end of the year. We plan to commence combination trials of our next-generation CTLA-4 with our own PD-1 in the second half of this year.

AgenTus, our cell therapy subsidiary, continues to build on the progress we shared during our last call. Most imminent is the IND filing for our proprietary allogeneic cell format for patients with solid tumors. AgenTus is unique and is differentiated from other cell therapy companies in that it has access to Agenus' proprietary checkpoint modulating antibodies for synergistic combinations as well as Agenus' broad and novel portfolio of vaccine therapies. We believe these combinations are necessary and critical in making cell therapies more effective and durable. Agenus is the only company who has all of these modulatory therapeutic approaches in-house.

Additionally, our proprietary phosphopeptide tumor targets, or PTTs, are highly prevalent across patients with solid and hematologic malignancies, and we are able to leverage these targets to generate self-therapy approaches, which we'll speak about shortly.

Finally, our unique allogeneic cell format is designed to improve tumor targeting and may eliminate the need for lymphodepletion.

Lastly, our earlier innovations continue to be important catalysts for at least one blockbuster product for our partners. Sales of GSK Shingrix vaccine, powered by our QS-21, has achieved over $1 billion in revenues in its first year of launch. It's on track to reach $1.3 billion in revenues this year. Through funding from the Bill & Melinda Gates Foundation, we are advancing the development of an alternative manufacturing process of QS-21 to ensure a continuous future supply of this very important adjuvant. Our preclinical results to date support complete biologic comparability between our revolutionary approach to the original source of material from the Chilean soap bark tree.

I will now turn the call over to Garo.

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [3]

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Thank you, Jen. As you can see, a lot is going on, and a lot must go on in order for us to defeat cancer. If it were easy to do it, it would have been done already. So by definition, it isn't. But Jen very well summarized all of our key accomplishments, including the attributes and design advantages of our immuno-oncology agents. While we have put a lot of emphasis on our checkpoint antibodies, deservedly so, because they are the most advanced in the clinic and there are a lot of them in our portfolio, we must also not overlook the significance of the rest of our portfolio of I-O innovations. These include our cell therapies, particularly our allogeneic cell format, about which we haven't talked very much, which includes our proprietary targets. We expect to file our first cell therapy IND this year. Also important in our portfolio is our off-the-shelf vaccines targeting our proprietary PTTs, you'll hear more about that in a bit. As Jen mentioned, we filed our first IND on these class of vaccines very recently.

Before I go on, I would like to refer you to the slide that exemplifies our innovation. So we're going to do things a little bit differently, we're going to reflect on some of what has happened operationally with Agenus and why there is a disconnect between our accomplishments and the value.

So the first thing, if I can refer you to the slide that exemplifies our innovation, manufacturing and development capabilities. This bar chart shows our performance. Relative to leading a much larger I-O companies, it represents the number of INDs filed in the past 3.5 years in immuno-oncology. And as you can see here, we are #1 in the number of INDs that have been filed in immuno-oncology. To be able to advance 13 INDs for a company of our size and resources is nothing short of a miracle. Certainly, we are pleased by our outperformance of the industry peers in delivering discoveries to patients. We are developing drugs and innovating science. We're doing this with tremendous speed and conviction. We control our performance, and frankly, we are damn good at it. As this chart displays, our progress is evident in our proprietary pipeline and our contributions to our partners, including Merck and Incyte, who are represented here as well, and our most recent partner, Gilead.

Our execution has generated milestones and milestone payments. As a matter of fact, before our call this morning, we announced the achievement of another milestone in our Gilead collaboration with the IND acceptance of AGEN2373, a differentiated CD-137, also known as 4-1BB molecule that Jen spoke about earlier.

Next, you may ask with such a stellar operational performance, why is it that Agenus' stock price and market cap has remained depressed. We have completed a detailed review of relative market caps of I-O companies that were valued at up to $500 million at the end of June. Here are the outperforming aspects of our company. So we have outperformed our peers in market cap of companies below $500 million in the last 12 months, we've gone from #8 to #1 in the past year. And I might add that some of the companies on this list had market caps of much higher values a year ago and 2 years ago. Of course, this is not a point of comfort for us. We believe the value of our company should be substantially higher based on our portfolio and our ability and resources to continue to innovate. However, it is important to know that the industry and the peer group performance has suffered due to lack of breakthrough innovations after the commercial successes of the first-generation immuno-oncology products. So the perception is that immuno-oncology has hit a wall. In fact, in our conversations most recently with some notable analysts on Wall Street, they've pretty much given up on expecting anything remarkable coming out of immuno-oncology. And the consensus is, perhaps, that there will be no more innovations in the field. We believe this perception is wrong. It is just as wrong as the pervasive perception was 10 years ago when people believed that immuno-oncology would never be a factor in the treatment of cancer.

Here is why the recent record of immuno-oncology and why we believe the perception is wrong. Of course, our believing the perception is wrong will not help the situation, but we will come to our solution in just a bit. The first-generation I-O agents comprise the low-hanging fruit. Companies went after targets that were well established like, CTLA-4 and PD-1, and well researched. The field of I-O is still young and the expertise in academic and research institutions as well as companies large and small is still relatively sparse. So innovation with second-generation immuno-oncology agents and, most importantly, the knowledge on how, where and when to use them, including determining the right combinations, has been slow in coming. Investors and venture capitalists engaged in a feeding frenzy because of the success of the first-generation products have been disappointed and the group has underperformed apart from select cell therapy companies, very few. In fact, if you look at the performance of immuno-oncology stocks, large and small alike, Agenus is the top 4 out of 29 I-O companies in the past 12 months.

Once again, yes, we have outperformed the traditional I-O group in the past year, but is that satisfying to us? The answer is absolutely no. So the next question is, what will change, you may ask, to get our value to where it belongs. We expect our broad and novel pipeline to be the key driver for value creation.

Our pipeline is shown in the following slide. Our engine has delivered 13 INDs and 11 are already in active clinical development today. The next 12 months or less will bring clinical data from these programs, and that is unprecedented in our history and, I believe, in the immuno-oncology industry to host so many potential data points coming up in such a short period of time. As you can see from our pipeline, we have a nice balance of partnered assets, which are advancing with no cash burden on us. There's a total of 6 partner antibodies, all in clinical development, but also, there are a significant number of wholly owned assets in our portfolio, shown in this pipeline slide. This balance, we expect, will drive additional collaborations going forward, some very significant. The implications of these collaborations for us will be transactions with upfront cash, some we expect to be substantial upfront. We expect future transactions will be increasingly ex U.S.-centric, meaning we expect more and more of our asset rights for the U.S. to remain with us in the future for Agenus to benefit from the potential blockbuster status of some of these agents, for Agenus to build a substantial commercial business to provide us with cash flows and profit needed to reinvest in the future of I-O with an intent to eradicate cancer and benefit all our stakeholders, including you.

Let me now switch gears and tell you how we have achieved the #1 status in IND filings for innovative therapies. Our integrated capabilities from antibody discovery to cell line development to GMP manufacturing are key to our ability to build a pipeline of products quickly and at lower costs. These advantages also allow us to manage a larger portfolio of discoveries and development programs at much lower cost and with higher quality and efficiencies that wouldn't have been possible without these internal capabilities. Our job is to invent and advance novel products.

A few highlights. At our last earnings call, we said we have advanced 11 INDs in the past 3.5 years and we plan on filing 3 more. In fact, we have already delivered on 2 of these INDs and expect to file 2 additional INDs before year-end. These include our allogeneic cell therapy IND, among the others.

In a few minutes, you will hear Dr. Paisley Myers speak about our platform for cancer antigen discovery, which is proprietary to us. These phosphorylated antigen targets are potentially powerful for immune education by our vaccines and also for cell therapy targets. They may be ideally suited for solid tumors both in terms of efficacy and safety.

As Jen mentioned, we plan to develop, register and launch our PD-1 and CTLA-4 in the U.S. with a first indication in second-line cervical cancer. We believe that we will explore the rest of the world partnerships to expand our footprint and also, very importantly, allow access to patients outside of the U.S. to our agents.

Cervical cancer is a difficult disease and the best available medicine delivers up to 15% responses with PD-1 monotherapy. Remember, we're not talking about cures, we're talking about 15% responses that are essentially relatively short-lived. We believe we have an opportunity to improve these response rates and perhaps even impart some cures with our combination strategy.

And on that note, we also plan on pursuing cancers beyond cervical cancer, specifically with our second-generation CTLA-4 combinations, which can potentially provide us with the opportunity to significantly expand the market for our own PD-1 and for our other agents by targeting these many other cancers.

Before I turn the call to Dr. Paisley Myers, a few words about a valuable acquisition that we made in 2015. This is PhosImmune. PhosImmune and the elegant proprietary science and technology from Dr. Don Hunt's lab, a team of world-class scientists are driving innovations that can have significant impact on cancer vaccines and cell therapies, all for cancer patients, the benefit of the cancer patients.

One of the scientists pursuing these innovations is Dr. Paisley Myers. She's with us today with her first earnings call appearance. Paisley will describe the features of this technology platform that can enable more effective medicines for patients with cancer. We believe this nasty disease can only be conquered with a dogged pursuance of pristine science and I-O. Paisley's work represents a sample of our pristine science.

Paisley?

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Paisley Myers;Senior Scientist;Agenus, [4]

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Thank you, Garo. I'm Paisley Myers. I'm a senior scientist at Agenus and an expert in the discovery of phosphorylated antigen targets that are unique to cancer. I completed my graduate research in the lab of Dr. Don Hunt at the University of Virginia where I focused on the discovery of unique tumor exposing antigens in patients with cancer. Cancer hides from the surveillance of the immune system. We can expose the cancer if we can make the tumor fingerprint visible to the immune system. We have a unique and proprietary set of antigens that can do just that. We refer to this class as possible peptide tumor targets, or PTTs. These targets represent an important class of druggable targets for patients with cancer. And for ease of understanding, you can think of these approachable targets like MSI signature in solid tumors. These are common, targetable and can be used to direct a single product for multiple different cancers.

My work at Agenus allows me to transform these targets into products that can benefit patients. Most importantly, Agenus is the only nimble immuno-oncology company that has the tools to bring combinations of immune-modulating antibodies with cell therapy and vaccines, the tools necessary to deliver high-impact for patients. Specifically, we can leverage these targets to develop proprietary allogeneic cell therapies that can address solid tumors through an approach that is highly specific and, therefore, expected to deliver without the toxic side effects observed with current therapies. We can combine our allogeneic cell therapy approaches with antibodies for optimal responses, and we can deliver off-the-shelf vaccines for hematologic or solid tumor.

PTTs are attractive targets for immunotherapeutic development for 3 reasons. First, PTTs are tumor-specific. The dysregulated cellular (inaudible) event, which leads to the fragmentation at the cell surface is a phenomenon that is specific to cancer. Therefore, these targets are not expressed on the surface of normal tissues. Thus, therapies -- these therapies are cancer-specific and, therefore, are likely to be delivered without the toxicity of current therapies.

Second, PTTs are highly shared among patients within a specific cancer as well as across cancer types. We have identified antigens that are common in the majority of patients with cancers. This means that these antigens could be widely applicable to a large portion of the affected population.

And lastly, PTTs are immunogenic. We have shown in preclinical studies that certain of these antigens are capable of generating an immune response against cancer, which leads to the specific killing of those targeted cancer cells.

Our first product moving into the clinic is a first of its kind PTT-targeting vaccine designed to create immune response in patients with AML and is designed to include antigens represented in 95% of patients with the disease. We expect that this multi [ethical] approach will stimulate a broad and robust antitumor immune response, minimizing the risk of residual disease and relapse.

In addition to this, our cell therapy company is developing a first of its kind fully human PTT-specific TCR. Our AgenTus scientists have shown that this TCR is exquisitely phosphopeptide-specific and very sensitive and is tumor killing in, in vitro models. Additionally, this TCR prevented tumor growth in an experimental mouse model, and we expect that this product will be in the clinic in 2020.

In conclusion, PTTs represent a proprietary and flexible set of products designed to create off-the-shelf therapies, which are designed to deliver anticancer benefit across tumors that carry the target.

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [5]

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Thank you very much, Paisley, for the very nice summary of the fantastic work that's going on with our antigen and T-cell discovery efforts with phosphopeptides.

As I mentioned, our strategy is to balance between monetizing a portion of our discoveries every year while increasingly keeping rights to North America for some of our very valuable assets. We expect to generate meaningful clinical data in the next 12 months on both partnered and wholly owned programs. This, we expect to help our efforts to monetize on our [XUS] rights with significant value consideration. Our strategy in this regard will be tested with our second-generation CTLA-4 antibody currently in clinical development with prospects of generating early but potentially meaningful clinical data by year-end.

Our ability to control key components of immuno-oncology combinations, that is checkpoint modulating antibodies; neoantigen vaccines, adjuvants and adaptive cell therapy approaches, both TCR and CAR-T based; all of these in-house, we believe, is a key advantage from a development, flexibility and pricing perspectives. Cancer is a complex disease, and we believe that the right combination will be key to delivering optimal benefit for patients. Our cell therapy business, AgenTus, has made important progress on the advancement of the pipeline with IND filings expected this year, as you heard before.

Before turning the call over to Christine for recapping our quarterly financial report, I wanted to summarize a few key strategic points. One, we have developed and have been successfully practicing a complete set of capabilities and immuno-oncology agents in our efforts to rapidly deliver high-impact products. We have an outstanding pipeline of novel and second-generation immuno-oncology agents that we expect will deliver substantial benefits to patients with cancer. Three, our operational excellence has put us on a path to a BLA filing that remains on track and could even be ahead of schedule. And four, we are emphasizing smaller focused trials to achieve high response rates, specifically targeting patients who are not being effectively treated today by first-generation immuno-oncology agents.

Now I will turn over to Christine Klaskin to provide a brief financial highlights summary.

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Christine M. Klaskin, Agenus Inc. - Principal Accounting Officer & VP of Finance [6]

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Thank you, Garo. We ended the second quarter of 2019 with a cash balance of $122 million as compared to $53 million at December 31, 2018. For the 6 months ended June 30, 2019, we reported a net loss of $34 million or $0.24 per share compared to a net loss for the same period in 2018 of $79 million or $0.76 per share.

During the first half of this year, we recognized revenue of $96 million, which includes revenue from our transaction with Gilead and noncash royalties earned. We also recorded $20 million of noncash interest expense due to our liability related to the sale of future royalties.

Our operating expenses for the first half of 2019 increased by $29 million as a result of the advancement of our programs.

For the second quarter ended June 30, 2019, we reported a net loss of $52 million or $0.38 per share compared to a net loss for the same period of 2018 of $25 million or $0.24 per share. Both of these periods' results include noncash items.

I now turn the call back to Garo.

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [7]

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Thank you, Christine. In closing, we expect the following key catalysts for 2019. One, completing accrual of PD-1 and CTLA-4 trials by year-end and sharing data from our preclinical or preplanned interim analysis, both of these are designed, that is a preplanned interim analysis is designed to lead the product approval in the U.S. on the data outcomes. Two, upon a successful outcome of these trials, we expect to file our first BLA in 2020. Three, we plan to initiate first-in-class combinations with our second-generation CTLA-4 with our proprietary PD-1 molecule in the next few months. Four, advance additional breakthrough discoveries and file at least 2 additional INDs for the remainder of 2019. Five, advance our next-generation best in class molecules into the clinic, including our selective Treg-depleting bispecific, AGEN1223, a very interesting product. Six, advance our cell therapy programs and have AgenTus funded independently. And seven, very importantly, we expect to complete one or more business development transactions in 2019.

We are committed to our mission of delivering for our patients and for all our stakeholders. Our efforts and staying power over the last 25 years speaks for this commitment. We always thank you for your staying the course and joining us on this journey.

Now we would be happy to entertain your questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Harshita Polishetty with B. Riley FBR.

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Harshita Polishetty, B. Riley FBR, Inc., Research Division - Analyst [2]

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Congrats on the tremendous progress this quarter. A couple of questions on my end. The first one is more of a general one with regards to your pipeline. I guess Agenus' pipeline is so extensive, it does provide the opportunity to unlock different opportunities in several areas of oncology. As you said in your prepared remarks, a lot is going on and the a lot must go on to defeat cancer, and I agree. But I guess the other side of the argument is that it's also sometimes hard to streamline your focus towards maybe what's key in the short term, while it is a bit of a hard question, I can imagine. Could you maybe help us understand what are the top 3 priorities for the company going into the rest of the year and into early 2020?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [3]

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Sure. Very good question, Harshita, and no arguments with your reflection on the fact that we need to focus on certain things. Just to start, remember, our focus is immuno-oncology, that is treating cancers using immuno-oncological tools. So to have the flexibility to be able to utilize our reagents, our tools, our treatments, maximally, gives us a major advantage. And so that's a very important point to consider because to go with a narrow process of saying, let's just concentrate on 1 or 2 leads, I think, is a recipe for failure. And perhaps, it is the reason why so many immuno-oncology companies have failed to deliver appropriate second-generation products, the next-generation of immuno-oncology. Our strategy is designed to not do that. And in fact, it's designed to maximize our probabilities of success. Now with regard to your specific question of concentrating on 3 things. If I were to pick 3 things to really focus on for the remainder of this year and into next year, among others, it would be, one, to complete the enrollment of our registrational trials, so we can file our BLA and we eventually become independent financially; two, advancing our next-generation CTLA-4 to generate very meaningful data as soon as possible, and we believe that product is going to be very value-added for us, for potential [XUS] partners as well as for patients; and three, to complete at least 1 or more important business development transactions that could help us in our pathway to financial independence going forward. So those are the 3 key priorities. Does that answer your question?

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Harshita Polishetty, B. Riley FBR, Inc., Research Division - Analyst [4]

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Yes. Yes, it does, Garo. That's very helpful. I guess just one more from me. Piggybacking off of what you just said, that the CTLA-4 and PD-1 readouts quickly approaching us. Are you able to provide a more crystallized time line on regulatory submissions and commercialization? Or do we have to wait till data comes out?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [5]

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It will -- I'll let Jen speak to that, but the regulatory filing will be in the second half of 2020. And commercialization shortly thereafter as soon as possible. But Jen, would you like to add to that?

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Jennifer Buell, Agenus Inc. - COO [6]

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Thanks, Garo. Thanks, Harshita, for your questions. That's absolutely correct. We mentioned during our last call that our accrual is going very well with our lead futility for PD-1. We anticipate filing the BLA earlier than we have previously disclosed, and we're on track to do that. So as I mentioned at the beginning of the call, we've now triggered the interim analysis and expect to be sharing data more publicly, relatively soon.

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Operator [7]

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Our next question comes from Matt Phipps with William Blair.

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Robert Andrew, William Blair & Company L.L.C., Research Division - Research Analyst [8]

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This is Rob Andrew on for Matt Phipps. Congrats on all the progress. So obviously just going back to the CTLA PD-1 combo trials, I know you mentioned the interim data is expected later this year. Just clarify, is that likely to be a medical conference? And can you give any further information on what data we can expect there with respect to kind of patient numbers? Any other details that you can provide at this time? And then secondly, can you provide any additional details on indications you guys are thinking about beyond second-line cervical for AGEN2034 and the PD-1 CTLA combo?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [9]

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Jen is the perfect person to answer that question, please.

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Jennifer Buell, Agenus Inc. - COO [10]

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Thanks very much. Thanks for your questions. So CTLA-4 and PD-1 data, the interim analysis, what we'll say is that will be a meaningful analysis with a meaningful number of patients. I hesitate to share with you right now the formal number. The data -- the interim analysis is underway actively now. This analysis will demonstrate -- it will share a more robust data set to demonstrate that our products are active in second-line cervical cancer. And just a reminder, this will be PD-1 as a monotherapy and PD-1 CTLA-4 as a combination therapy, where we believe we can expand the response rates and the durability of response in patients with second-line cervical cancer. We anticipate sharing these results out at a major conference. In the absence of that, we'll certainly inform the -- our stakeholders via mechanisms that are otherwise available. So we will be certain to publicize the data as soon as available. I'll also share that we anticipate sharing some additional data at some major medical conferences that will reveal the activity -- the clinical activity beyond second-line cervical cancer and other indications where we've seen activity that appears to be, what our experts call, unusual responses, in certain indications. So those data in cervical and beyond cervical will be presented at some major upcoming conferences. And all of these will support what Garo outlined is our top priority, and that will be to register and launch CTLA-4 PD-1 combination and PD-1 monotherapy for patients with second-line cervical cancer. We will develop, register and launch in the U.S. We will seek partners for ex U.S., and we will also enable access to these active agents to partners who have complementary technology who need access to active PD-1 and CTLA-4 molecules. So all of that activity will be updated in our next call as we continue to make progress.

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Operator [11]

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Our next question come from Brian Wisnoski, a private investor.

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Unidentified Participant, [12]

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My questions are threefold. One is regarding the BEST financing. If you could give us an update on that? The second part is, if you could maybe give us more color on the independent financing of AgenTus? How is that going? And also, third, maybe in a general sense, you could give us an idea, President Trump has mentioned that he's going to be putting forth right-to-try, and how that might be utilized by some of the immuno-oncology community. And if you can go ahead and maybe give us color, maybe if that can help accelerate any of the programs that you've outlined?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [13]

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Thank you very much. Let me answer the first 2 questions, and then I'm going to make a comment on the third one, and then have Jen address it in more detail.

So the first question is about BEST. As you know, we announced BEST, which, by the way, is a very innovative financing mechanism. And I know there was a lot of confusion at the time as to whether or not Agenus is going into the cryptocurrency business. And I am sorry about the fact that there was this confusion that impeded our ability to take it forward at that time combined with, obviously, the stigma associated with so-called cryptocurrencies. And so we slowed down the process. And in our last earnings call, I made a statement that we expect to complete a financing with BEST or with any other mechanism that is designed for project financing by the end of the year, and that remains on track. Now we believe BEST will have utility in many different formats in our industry, and perhaps, in other industries going forward. It is a novel idea. It is in incubation, so to speak. And we will be in the forefront when the time is right. But suffice it to say, that we do plan on completing a BEST-based or a product-based financing by year-end for PD-1, and perhaps, for CTLA-4 as well.

The second question is about AgenTus. When will the independent financing for AgenTus be put into place. So we have been going back and forth on this possibility. And we have decided that since we're so close to entering the clinic and the value inflection for a company once it enters a clinic with an IND filing, goes up significantly, we will slow down the process in order for us to benefit from that value inflection. So the timing of that, I anticipate, will be in the next few months and probably be coincident with our entering the clinic.

Now the third and very important question, by the way, and thank you for this, is an issue that is nobody's fault on one hand, but it is very frustrating for us. And it is also very tragic for cancer patients. In the last few months alone, several patients that have come to my attention that have lost their battle for cancer. And even though I am the CEO of Agenus, and we have access to many, many reagents. The bureaucracy of the system. And I don't mean the FDA by bureaucracy of the system. I'm talking about the bureaucracy of the entire medical establishment impedes the speed with which some novel therapies that could be life-saving to reach patients. I lost a 26-year old brilliant Colombia law student to gastric cancer a few months ago. And just about 2 weeks ago, we lost a mother of 3 in her 30s, to breast cancer. And the frustration is that we knew about these cases, they've come to my attention, personally appealed to me, and somehow this system prevented us to get some of the novel medicines to them in time to potentially save their lives. So that's a sad reality today. We're working very hard to change it. But specifically, your question about right-to-try, which is a very important consideration. The FDA has allowed the industry to make some progress, not all the progress that we'd like to make, but some progress in this regard.

But Jen, maybe you can provide some details on that

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Jennifer Buell, Agenus Inc. - COO [14]

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Thanks for your question, Brian. Right-to-try is legislation, for those of you who aren't aware, that enables patients who have life-threatening diseases with really nothing available for them that's approved, they can enable access to these treatments. There's a now legislation that will support this access. However, as Garo mentioned, there are many steps in the process that are independent of regulations and of the FDA, and that requires willingness of a treating clinician to treat the patient, to take the time to actually submit the required documentation that's required to enable the product to ship to that patient. And the institutions, these hospitals, to support physicians and enabling access. So giving time to clinicians to prepare the documentation that's required. This has no impact on Agenus and the reason for that, the right-to-try itself, is we have -- since our inception, we've been committed to enabling access for the individual patients who need access to our therapies. So when patients require access or request access, and they have a treating clinician who's supported by their institution to enable access, we, without question, will support that initiative and enable access to our products. So nothing has changed from our end. We are hopeful and optimistic that perhaps the regulations and legislations will remove some of the challenges in the process, but we still need to have treating clinicians who are -- who have the time and interest and willingness to support access and hospitals and institutions to enable that access. And that's still a hurdle right now for patients and their families.

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Operator [15]

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Our next question comes from [Zachary Ralston] with [Retail].

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Unidentified Analyst, [16]

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Yes. My question is in regards to Shingrix. It's selling faster than anticipated. And I wonder if there is any time lines to paying off Agenus' debt associated with the development of that?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [17]

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Sorry. Can you paraphrase that question clearly so we know what it is?

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Unidentified Analyst, [18]

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Okay. So there's debt associated with the development of Shingrix, and the vaccine is selling faster than anticipated. So I'm wondering if you guys have a time frame from when Agenus' debt will be paid off with that vaccine?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [19]

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Okay. So this is a big confusion, and I apologize for this. It has to do with accounting standards rather than anything else, that's something because of the unknown nature for the accounting system of this particular royalty monetization transaction. It is recorded as debt on our balance sheet, which it isn't, it categorically isn't. So we show on an entry in the balance sheet of a debt upwards of $150 million plus and the reality is, we have 0, and I underline, 0 exposure associated with that accounting entry. So we have 0 debt with our royalty monetization process, what happens is that as the royalties are paid off for the company that we sold royalties to, that balance sheet entry gets extinguished. But under no circumstances, would that translate to a debt for us.

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Unidentified Analyst, [20]

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Okay. So is there a time line on when that balance sheet entry will be fully extinguished?

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [21]

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It is to be fully extinguished. But remember, it is not debt that will be fully extinguished. It's the entry that will be fully extinguished. So Agenus has no debt associated with the balance -- with the royalty monetizations.

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Operator [22]

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This concludes our question-and-answer session. I would like to turn the conference back over to Garo Armen for any closing remarks.

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Garo H. Armen, Agenus Inc. - Founder, Executive Chairman & CEO [23]

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Thank you very much, Brandon. Just in closing, I know that in the past, we have been advised to restrict questions from nonqualified institutions and analysts, that policy will change. I have decided to change that policy so that every single investor -- retail investor, has an opportunity to ask questions. Of course, we ask your questions to be well thought through, and so that we don't waste people's times on the call. But we welcome your questions going forward. And if you have any additional questions post this call that you'd like to submit to us, to our Investor Relations portal, feel free to do that as well. But as you know, we are improving our communications with all constituencies. Very importantly, communications with the investment community, analysts, and that process is ongoing. We have a newsletter, gets published every 2 weeks. That is both an Agenus-centric piece as well as it will be increasingly an educational piece for the industry on the subject of immuno-oncology, so that is very complexed, scientific and medical field becomes clearer to people that follow us, invest in us, and for people that do this for other companies as well. And so that is our mission, and we will continue with that. Of course, every time we do something novel, there's misunderstandings and confusions and other things that happen. And so bear with us, and we will clarify those misunderstandings and confusions. And please be proactive in conveying your ideas to us so that we address them going forward.

But thank you very much for your time. And we look forward to your being a part of the Agenus family going forward.

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Operator [24]

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The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.