Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the Agenus First Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Dr. Jennifer Buell, President and Chief Operating Officer of Agenus. Dr. Buell, please go ahead.

Thank you. Thank you, Ceanne. 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 statement including statements regarding our clinical development and regulatory plan and timeline, as well as timelines for data release and cash projection. 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, President and Chief Operating Officer of Agenus and joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dhan Chand, Head of Drug Discovery, Dr. [Indiscernible] Lead Scientist for Allogeneic iNKT Cells and Christine Klaskin, our Vice President of Finance. I will now turn the call over to Garo.

Thank you very much, Jen. And a special thank you to all of you for joining us during this time, when the world has turned upsidedown because of the COVID-19 pandemic. I hope you and your families are safe and well. Our team at Agenus has found a productive way to upgrade in this new norm. At the earliest signal of the pandemic, our team reacted swiftly and took proactive measures to protect our employees, their families, and our business. As a result, our operations in Berkeley, Lexington and Cambridge have remained open with a rotating work schedule for safety, and with limited interruption to our key priorities. We operate with approximately one-third of the workforce on site and the remainder working from home. And that has not disrupted any part of our operation so far. And importantly, to the best of our knowledge, none of our employees have been infected with the virus so far, and we’d like to keep it that way. Earlier this year, we projected receipt of approximately $60 million in cash milestone payments for 2020. As we have announced, we’ve already received $15 million based on the sales of Shingrix, which has our QS-21 adjuvant in it. However, given the environment, the remaining $45 million is uncertain, because of the disruptions caused by COVID. And hence, we’ve taken measures to result in annualized cost savings of approximately $50 million. These savings are driven by reductions of both external and internal expenditures, and importantly they will result in slowing down of several programs but, but, we do not expect these steps to affect our near-term or medium-term commercial launch prospects. We also expect that our high-priority clinical development and research programs will proceed as planned. Our proactive measures are designed to deliver our key milestones this year, including plans for our BLA filings, our acceleration of clinical development of our nextgen multipurpose CTLA-4 molecule 1181, about you will hear much more from Dr. Buell, our advancing of iNKT cell therapy to the clinic for the treatment of cancer and COVID-19 patients that you will hear from Dr. [indiscernible] who will also tell you about the advantages of our iNKT cells including for example, substantially reduced costs associated with cell therapy when we practice iNKTs. And also you will hear that we’re advancing important programs like our TIGIT molecules into the clinic. And as you know, we have started this program a number of years ago. And now, we’re ready to take that into the clinic. I will now turn the presentation to Dr. Jen Buell, our President and Chief Operating Officer to provide you with an update on our highest priority programs, starting with AGEN1181, our multipurpose nextgen CTLA-4. Jen?

Thank you very much, Garo, and hello everyone. As Garo mentioned, I’ll start by providing an update on AGEN1181, and there’s a summary of this program on slide 4 that we’ll review today. This molecule is familiar to many of you. As Garo said, it’s our multifunctional T-cell antibody, which also binds to CTLA-4. Now, importantly, this molecule is engineered -- the Fc region of this molecule is engineered. We did this because we knew of some key features this engineering could provide. Those features included increased immunogenicity, increased T-cell activation, beyond which we see with first-generation CTLA-4, superior combination with PD-1, as you see on slide 4 as well as important potential safety benefits such as a reduction in endocrinopathies for patients treated. And we expect to increase or broaden the patient population of responders, patients who will respond or unlikely to respond to a first generation CTLA-4 due to a genetic polymorphism, the impacts about 40% of the population. And what we’re going to talk to you about today, our data from this trial which will show that as the molecule has been designed to benefit patients who harbor this genetic polymorphism, patients are benefiting from AGEN1181. We have also seen no endocrinopathies, none of the safety-related side effects that we see with Yervoy related to hypophysitis or otherwise, a very important feature. Fc engineering is something that we know to be really quite important. We’ve published on this technology and our techniques on our AGEN1181 molecule in Can Cell last year. We’ve also -- as Dhan will speak to you today, we’ve the engineered our TIGIT molecule in order to bring similar enhancements. We’ve shown you data that supports the benefit of this engineering. And we’re also now seeing data from late-stage clinical trials with Fc engineered…

Thank you, Garo and Jen. So, in connection to the T-cells -- for iNKT T-cells have several advantages over other allogeneic approaches in development, including but not limited to their significant expansion capacity, their use in an allogeneic setting without requiring genetic manipulation, and their ability to suppress graft-versus-host disease. I am excited to report that our team filed 2 INDs to advance our iNKT cells to combat cancer and separately COVID-19. iNKT cells are a rare population of lymphocytes. And importantly in late-stage cancer, the frequency and the function of iNKT cells is highly correlated with overall survival. Our modified iNKTs are natural component of the innate immune system and their reduced numbers or function is associated with poor immune response to cancer, and poor prognosis of patients with late-stage disease. You can see on slide 9 some of the notable advantages of iNKT cells. So, first of all, iNKT cells can penetrate into the tissue, which gives them a critical advantage to target solid tumors, there are not certified approved cell therapies. Secondly, iNKT cells can kill cancer without require genetic manipulation. So, employing iNKTs in an unmodified form patients can receive the treatment quickly and at a significantly lower cost. And third, iNKTs are expected to target SARS-CoV-2 and cells infected with the virus. iNKT should be agnostic mutations of the current strain and other coronaviruses. While severe complications of SARS-CoV-2 infection are characterized by life-threatening respiratory disorder and other organ failure, our allogeneic iNKT therapy AGENT-797 is expected to help clear the virus, while controlling harmful inflammation caused by the virus. Preclinical data demonstrates that iNKT activation induces a rapid antiviral response and enhances immunity to respiratory and other infection. Also, iNKTs have been shown to prevent lung injury in preclinical models by reducing the number of inflammatory cells, dampening inflammations and thus preventing or controlling tissue damage. This may be especially important in COVID-19. AGENT-797 could also promote long-term immunity against COVID-19, which would be an important outcome to protect both recovered patients from reinfection and to protect healthy individuals from the disease. So, finally, an important benefit of our allogeneic approach is its scalability. We have demonstrated that iNKT cell from a single donor are manufacturable and scalable. Just based on our early process development work, we have developed a scalable process design to manufacture about a 1,000 doses from a single door. While our near-term clinical trials will help to find the key features of AGENT-797 in cancer and infectious disease, we are ready to quickly design optimal combinations with our cell therapy and checkpoint antibodies. My colleagues will be presenting data at AACR on our utmost combinations with key insights into the criticality of these approaches and significant differentiation that Agenus has in delivering these combinations. Thank you very much. And now, I will turn it over to my colleague, Dhan Chand to discuss our TIGIT program.

Today, I’m excited to discuss two of our TIGIT antibodies, why they’re important and how we believe they will change the treatment paradigm. As Jen mentioned, TIGIT is shaping up as a powerful combination partner with PD-1 antibodies, especially in tumors expressing TIGIT. Our portfolio of TIGIT-targeting antibodies include the Fc enhanced TIGIT monospecific AGEN1327 and our TIGIT bispecific AGEN1777. We believe both molecules have unique advantages over other TIGIT antibodies that are in clinical development. Since TIGIT may be new to many of you, I will describe what TIGIT is, as seen on slide 10. TIGIT is the receptor primarily expressed on T-cells and NK cells. TIGIT attenuates innate and adaptive immune responses by inhibiting the actions of T-cells and NK cells. In addition, it increases the immune suppressive activity on regulatory T-cells. TIGIT is over-expressed in multiple tumors and is known to be a key player in driving resistance to anti-PD-1. And as a result, tumors grow. Locking TIGIT with antibodies like for a monospecific TIGIT antibody AGEN1327 or a TIGIT bispecific AGEN1777 unleashes important immune cells such as T-cells and NK cells to kill many types of cancer. Agenus was the first to discover and report at Cancer Cell and at AACR 2019 that TIGIT antibodies require Fc gamma receptor co-engagement to promote optimal T-cell activity against tumors. Our TIGIT AGEN1327 is engineered with this Fc enhancement and has outperformed all tested competitor antibodies and shown superior T-cell activation when combined with PD-1 or LAG-3 antagonist or OX40, or CD137 agonists. We presented this data at AACR 2019. Our TIGIT is an ideal combination partner for addressing non-resistance mechanism to current checkpoint therapy and with the potential to provide deeper responses. In addition to superior function demonstrated against tested competitors, our molecule is designed to one, maximize…

Thank you, Dhan. We ended the first quarter of 2020 with a cash balance of $92 million, as compared to $62 million at December 31, 2019. For the first quarter ending on March 31, 2020, we reported a cash burn from our operations of $32 million. Net loss for the quarter was $45 million or $0.31 per share, which included non-cash expenses of $16 million. We generated net income for the same period in 2019 of $17 million or $0.14 per share. In the first quarter of 2019, we recognized revenue of $80 million, which included revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned. For the same period in 2020, we recorded revenue of $15 million, primarily related to non-cash royalties earned. I’ll now turn the call back to Garo to close.

Thank you, Christine. And thank you very much to the team who explained our current state of affairs and our prospects very well. Today, we are a company of 260 persons. But, it’s not the number that matters, we have capabilities to innovate, to develop, to manufacture our discoveries and we’re currently building our commercial capabilities to become a fully integrated company. We have stressed all along, speed and innovation are key in our business, particularly a business that has very, very exciting prospects going forward. And Jen Buell talked about the fact that our external advisors have made comments about the fact that, we may be the most innovative, productive company in the field of I-O. Now, we can of course do these things, because we have end-to-end capabilities from novel target discovery to full GMP manufacturing for antibodies. This has been critical to our productivity. We have brought 14 new discoveries to the clinic and launched 6 clinical trials, and we are gearing up to file our first BLA in the third quarter of this year. We’ve developed our clinical operations team and delivered the full target accrual of our clinical trials in the last three years. And these may sound like trivial to some, but we have delivered 11 GMP manufactured batches for our own trials and partnered programs at our manufacturing site at Agenus West. And the team there has done an absolutely terrific job. And as we’ve said before, we’re continuing operations with no interruptions. We have a queue of additional batches to manufacture this year. And as [indiscernible] said, we have launched a cell therapy company AgenTus, which designed a very unique allogeneic cell therapy approach with the kind of advantages that we’re talking about, for example, for COVID-19, it offers potentially the capability of being an anti-viral therapy or anti-inflammation therapy, all in one, and do this with a single cell source, which means it’s an off-the-shelf cell therapy that drives costs down and most importantly, it drives the speed of patient availability up. Now, with all of this, we’ve also talked about in the past that to-date we have generated over $540 million in cash from partnerships, collaborations, transactions with multiple pharmaceutical companies like Gilead, Merck, GSK and Incyte as well as UroGen, and all in the last 4 years plus. And also importantly, we expect additional partnership transactions this year. We are in term sheet discussions with companies already. Now, I think given the fact that my colleagues have done a terrific job of keeping you abreast of everything that is going on, I will stop here and entertain any questions that you may have.

[Operator Instructions] Your first question comes from Matt Phipps with William Blair. Please go ahead.

Hi. This is Hunter [ph] on for Matt. Just a couple of quick questions. I was wondering, if you could provide some color on the unmentioned part of the TIGIT bispecific. I know you did mention specifically what the other part was but maybe sort of the mechanism that you’re targeting there. And then, as just to follow up, I think previously you had mentioned that with the lowest dose of 1181, you had a pending response. And I was just wondering, if that was still pending or a confirmed response. Thank you.

So, let me just make a general comment, and then I’ll turn it over to Dhan and then to Jen to address the 1181 question. But, as some of you may know, we have a very sophisticated competitive intelligence capability at Agenus, and this has been a critical component of our decision-making, our strategy that drives from research strategy onwards. So, I have mentioned that we’ve been working on TIGIT for quite some time, but all along, we have evaluated what is happening with competitors out there in the TIGIT field and what is it that we can add incrementally or leapfrog the other programs, so that we come up with an advantage with a product that offers advantages to our Company of course, but also importantly advantages to the patients. And our TIGIT program has specifically designed to address what is needed, what are the advantages we can provide? So, Dhan will answer your question more specifically on that.

Thank you for the question. The second target in our bispecific, which we have not yet disclosed, is a first-in-class target that is expressed on T-cells and NK cells. What we have discovered is that the best way to target this first-in-class unidentified, which we have not disclosed target is to do so in the form of a bispecific that includes TIGIT. Overall, what we have discovered is that, when we co-target TIGIT and this yet to be identified receptor, we see superior activity as compared to that of monospecific approaches to each of these targets. I would like to emphasize that the second target, which we have not yet disclosed is a first-in-class target.

Regarding 1181, we presented data on two different patients. Both of the responses have been confirmed by independent radiology review.

And also I might add, they have been continuing. I think…

Yes.

One of the hallmarks of immuno-therapy for everybody is the benefit of having responses last for a long time or convert to a curative outcome. And I think, everything that we’re seeing from our first generation products bali and zali to our second generation product so far 1181, are indicative of lasting responses that may convert into a curative outcome. Next question, please?

Your next question comes from Mayank Mamtani from B. Riley. Your line is now live. Please go ahead.

Thanks for taking my question. Congrats team on the progress. And I appreciate the efforts you’re putting in on COVID-19. Just zali bali. On the BLA filings, could you just remind us, it seems like the clinical section is full, like are you just working on the non-clinical side, like what are some of the other things you have to do, if there is an FDA meeting before you’re able to submit the BLA? Could you just remind us on the process?

Sure. Thanks very much, Mayank, for the question. Nice to hear you. Regarding the process, so we’re pursuing rolling submissions, which include meeting with the FDA to discuss different components of the filings. And what I’ll share with you is that for elements like our manufacturing component, the quality, the agency has remarked on the quality of our manufacturing and the completeness of our prior interactions with them for INDs and otherwise. We have already engaged and discussed and are very confident in the completeness of a number of the modules including manufacturing. On the clinical side, we’re continuing to collect data. We completed accrual. And as you know, patients with refractory cervical cancer, if they are to progress, they do so in relatively short amount of time. So, we’ll have a good sense of our complete cohorts very actively, and we’re in the process of analyzing the data and readiness for the submission. So, the interactions -- we’ve had a series of interactions with the agency, because we accelerated this program from a first-in-man study, rapidly to a Phase 2 expansion in refractory cervical cancer, at which point we met with the agency and we discussed our strategy and our trial design. And now, it’s a matter of continuing to engage them to provide updates on each of our molecules, our pharmacology and nonclinical, our manufacturing and clinical, and some of which have been completed, and of course, a couple of which are continuing to proceed until our filing date. And as Garo mentioned, we’ll be filing in the second half of this year.

Great. And then, on 1181 about the recent Advisory Board meeting you had. Could you just talk maybe qualitatively to the stable disease that you’re seeing? Are these in lung and colon cancers that is informing sort of your next choice to go into these bigger indications? Any color there would be great.

So, Mayank, I’ll be thoughtful about my response here, because we are anticipating some upcoming data presentations at major medical conferences. So, what I will share with you are some -- this is a solid tumor study and we have represented cancers that we’ve discussed with the Advisory Board and you see on the slide I presented today including lung and melanoma enrolled in the trial. And we’ve seen activities beyond those indications as well, including other gynecologic cancers, like ovarian for example. And an important case that will be described in much more detail soon is a gynecologic case with very long and durable disease stabilization, nearly a year, which is incredibly unusual for this highly refractory case. So, this is disease stabilization that has not yet met the RECIST criteria for a response, but looks really quite active. We’re seeing some similar trends in other tumor types, disease stabilization in the majority of patients treated. And so, you could -- I’ll leave it at that so that we don’t restrict ourselves to what we can present at some upcoming conferences.

I understand and appreciate the qualitative color. And maybe just one final one on the COVID-19 efforts you have. I mean, it seems like you’re nearing IND acceptance. So, any color on how you’re thinking to develop and any blood institutions [ph] if you may decide to partner with? Obviously, there are certain hotspots that could benefit from having a trial like this. So, any color there?

I think, Mayank, we need to first get signals from the clinic. And the objective of our first trial now is to see -- to look at a whole bunch of blood markers of these patients and see how they respond to therapy in a dose escalation study. And so, bear with us. I think, it’s premature for us to really determine what the next steps are going to be beyond this exploratory clinical trial.

So, to clarify, these are going to be non-severe COVID-19 initially patients?

So, Mayank, first on hotspot, yes, we will be -- the cells will be in the New York population. We have collaborators on New York hospitals, who have been at the frontline of this. The cells we will be exploring because the cells can mitigate the virus and also dampen harmful inflammation which in some cases patients experience after viral clearance. So, there are two very important features. We will first explore the cells in a more severe setting. We will evaluate the persistence of the cells, of course, the activity of the cells and viral clearance as well as in dampening harmful cytotoxic release syndrome, CRS.

Great. And, just last thing on financials. I believe they were 2 different tranches of milestones you were anticipating, one Shingrix related and one progression of I think some pipeline molecules with Gilead. So, in your revised guidance -- any color on what you are seeing that might be addressed for the remainder of the year, Garo, maybe?

Okay. So, as I mentioned, we have received the first tranche of the GSK Shingrix royalty milestone. So, that’s behind us, that’s $15 million. There was a second tranche potentially during the second half of this year. But, even the guidance provided by GSK, which suggested a significant downtick in Shingrix revenues going forward, it’s unlikely that we will meet the revenue milestone, which would have driven the second payment for us. So, that’s one. Now, additionally, there are two sets of milestone payments that we were contemplating from two separate companies. And what we’ve done is have a more conservative posture, and say we have no control over the timing of the clinical trials associated with either one of these situations. So, we’re planning for no milestones. Now that doesn’t mean we’re not going to get them. It just means that we want to be conservative and plan for no additional milestones for the balance of the year, so that we can prudently manage our finances. And as I have mentioned, we have initiated $50 million worth of annualized savings, which are already in place, I might add. And that will of course give us a little bit more comfort. And then, in terms of new potential collaborations, we are in term sheet discussions with two separate parties. And I expect that that will result in upfront cash payments that will help us to manage our cash for the balance of the year and into next year.

I appreciate the color. And looks it will be a wash. Thank you.

Thank you very much. Any other questions? Okay. Well that concludes our call. And I may want to turn this over to Ceanne who will do a stellar job of concluding remarks. Ceanne, would you end the conference?

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