Good day, ladies and gentlemen. And welcome to the Agenus Third Quarter 2019 Financial Results and Business Update Conference Call. As a reminder, today's conference is being recorded. Now, I would like to turn the conference over to Dr. Jennifer Buell, Chief Operating Officer of Agenus. Please go ahead, Dr. Buell.

Thank you, operator. Today's call is being webcast and will be available on our website with our accompanying slide material for replay. Just a reminder, the slides are now live on our webcast and accessed through computer, you will be able to view them manually. Before we start, we would like to remind you that this call will include forward-looking statements, including statements regarding our clinical development and regulatory plans and timelines as well as timelines for data release and partnership opportunities. 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. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Anna Wijatyk, Head of Clinical Development and Operations; and Craig Klaskin, our Vice President of Finance. I’m going to start this call today by saying first asking our Garo to provide you with the reality of Agenus operationally and in the marketplace. I expect these facts, as they are and what we have achieved, will be eye-opening to you all. Garo?

Thank you, Jenn. During our last quarterly call, I shared a visual with you. That's the very first slide that you have in your possession. This one speaks to our R&D productivity, and the fact that over the last four years in the IND filings, we have outpaced other immuno-oncology companies, large and small. Also important is the fact that all the INDs that we have filed, all 13 of them so far, represent inventions of Agenus. During this call, we will update you on the progress we've made with our most advanced programs: Our CTLA-4 antibody; Zalifrelimab and our PD-1 antibody, Balstilimab. I know these are mouthfuls, and I'm just getting used to using them myself. We are targeting commercializing both agents in the first half of 2021, which means we will be filing our BLA or BLAs in 2020. Our first indication will be second line cervical cancer. But, and importantly, we are developing these two antibodies because they are critically important agents to be used in combination with many of our own next generation antibodies including bispecifics, in combination with our allogeneic cell therapy for which our first IND is on track to be filed this year. And also in combination with our cancer vaccines which include our off-the-shelf phosphorylated antigen vaccine where we have a highly proprietary position. As you can see from our IND chart, we have generated 13 immuno-oncology agents, which are all in clinical development trajectory. We expect that some of the next generation agents in our pipeline can help expand the market opportunity for our PD-1 and our CTLA-4 antibodies. For example, to the extent that the combination of our NexGen CTLA-4 antibody plus our PD-1 antibody performs better than those in the market today, we believe our PD-1 commercial opportunity could…

Thank you very much, Garo. As Garo mentioned, this is indeed a very exciting time for us. While the transformation of the Company occurred within the last four years, we are operating with the integration, agility and flexibility of a team that’s been together for decades. This is largely due to our shared passion to deliver high-impact therapies and small, fast clinical trials designed for a rapid regulatory and commercial success with products that are acceptable to our patients who need them. We share commitment to transform the experience that diagnosis of cancer means for patients. And I'm very excited to have Dr. Anna Wijatyk share details about the progress we're making in the clinic. Before doing so, I want to summarize a few highlights of our progress in 2019 with details on some of our critical catalysts. This year, we’ve made remarkable progress on our trials, which includes the completion of accrual into one trial and approaching completion of accrual into our second. The interim analyses, which were preplanned, based on independent core lab reviews are underway. To-date, our available investigator reported data underscore the clinical benefits of our PD-1, AGEN2034, Zalifrelimab as a monotherapy for patients with refractory cervical cancer, and furthermore, the benefit of the addition of CTLA-4, which is our AGEN1884 Balstilimab to PD-1 in combination with PD-1 to expand response rate and potentially the durability of these responses, and I will tell you more about these programs shortly. We advanced four novel discoveries to IND this year. And these discoveries are now advancing in the clinic, generating validating data on the differentiated proof of mechanism of our potentially first or best-in-class agents. These discoveries include our next generation CTLA-4, AGEN1181; our differentiated CD137 AGEN2373; our first-in-class Treg depleting bispecific antibody AGEN1223; and of course, GS-1423,…

Thank you, Jenn and Garo. This year has indeed been very productive and exciting, as Jenn and Garo descried. I have had a pleasure to work with an extraordinary team to deliver real breakthrough outcomes and timing to complete enrollment in our trials designed to support BLA as well as in parallel, advance four novel molecules to the clinic this year with the same accelerated pace. As a matter of fact, similar to our accelerated pace shared in discovery and manufacturing, our clinical operations team is innovating to do the same in the clinic. In that regard, we have advanced from IND clearance to first-in-man trial in a matter of weeks and exactly 69 days to first patient in after the IND clear. As Jenn and Garo already mentioned, the progress on our lead molecules is very important to enable us to start the combination with our next generation molecules. The first combinations with our next generation CTLA-4 AGEN1181 is expected to start this month and our PK and PD data that we are acquiring in an ongoing manner are informing optimal dosing in the study. Now, our lead programs. Our proprietary CTLA-4 and PD-1 antibodies, Zalifrelimab and Balstilimab are advancing towards the planned BLA filing in 2020. At the upcoming Society of Immunotherapy and Cancer Conference this year, we will present clinical data from our Phase 1 dose escalation and expansion cohort showing that Balstilimab is well-tolerated and reveals immunologic as clinical activity in recurrent ovarian cancer, which is more impressive than what was previously reported in this population with other PD-1 antibodies. As Garo and Jenn reminded, we are pursuing Balstilimab as a monotherapy and in combination with Zalifrelimab in patients with relapsed/refractory category cervical cancer. In the combination trial, we have completed our accrual requirement for a…

Thank you very much, Anna and your team for moving our clinical programs at such a record pace. As I mentioned in our strategy -- as 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. Earlier I indicated that we expect to generate meaningful clinical data in the next 12 months and a significant number of both, partnered and wholly-owned programs. This, we expect to help our efforts to monetize on our ex-U.S. rights with significant value considering. This strategy will be tested with our second generation CTLA-4 antibody, currently in clinical development as Jenn and Anna talked about with prospects of generating early but potentially meaningful clinical data in the next months. Our ability to control key components of immuno-oncology combinations under one roof, specifically checkpoint antibodies, cell therapy, neoantigen vaccines and our QS-21 adjuvant, we believe is a key advantage in our ability to develop the right combination drugs, and in our ability to price them affordably, all for the purpose of benefiting patients. Before turning the call over to Christine for recapping our quarterly financial report, I wanted to summarize a few key points. We have an outstanding pipeline of novel and second generation immuno-oncology designed to deliver substantial benefit to patients with cancer. We expect to become a commercial-stage company with our PD-1 and CTLA-4 antibodies, first in cervical cancer with strategies to rapidly expand to other cancers, particularly with our combination agents. We are emphasizing smaller focused trials to achieve high-response rates specifically targeted patients who are not being effectively served by today's first generation immuno-oncology agents. In addition to the clinical readouts, which I outlined earlier, targeted for the year 2020, it is what we expect to accomplish by year's end 2019 and into 2020. One, complete our monotherapy, as we talked about, PD-1 trial accrual and conduct our planned interim analysis for this trial for a BLA filing. Both are monotherapy and combination trials designed to lead to BLA filings for accelerated approvals. Two, complete dose escalation and commence combination trials for our second generation CTLA-4 with our proprietary PD-1 molecule. Three, as I mentioned earlier, advance our differentiated best-in-class molecules into clinic, including advancing and generating clinical readouts with our differentiated CD137 molecule, AGEN2373 and our selected Treg depleting bispecific AGEN1223. Advanced additional breakthrough discoveries and file at least two additional INDs in 2020. Advance our allogeneic cell therapy program and have AgenTus funded independently, as Jenn mentioned. And importantly, we expect to complete additional business development transactions in 2019 and in 2020. Now, I will turn it over to Christine Klaskin to provide financial highlights. Christine?

Thank you, Garo. We ended the third quarter of 2019 with a cash balance of $93 million as compared to $53 million at December 31, 2018. Our cash used in operations for the quarter ended September 2019 was $28 million, compared to $25 million for the same period in 2018. Cash provided by operations for the nine months ended September 2019 was $13 million, which compared to cash used in operations of $95 million for the same period in 2018. For the third quarter ended September 30, 2019, we reported net loss of $46 million or $0.33 per share compared to a net loss for the same period in 2018 of $34 million or $0.29 per share. For the nine months ended September 30, 2019, we reported a net loss of $81 million or $0.58 per share compared to a net loss for the same period in 2018 of $113 million or $1.04 per share. During the nine months ended September 2019, we recognized revenue of $116 million, which includes revenue from our transaction with Gilead and non-cash royalties earned. This compares to revenue of $30 million for the nine months ended September 2018. Through the third quarter of 2019, we also recorded $30 million of non-cash interest expense due to our transaction with Healthcare Royalty related to the sale of future royalties. I now turn the call back Garo.

Thank you, all. Thank you, Jenn, Christine and Anna. And thank you all for your attention. Now, I will turn the call over to Chuck to field questions.

[Operator Instructions] And our first question will come from Biren Amin of Jefferies. Please go ahead.

Yes. Hi, guys. Thanks for taking my questions. Garo, can you just maybe talk about the 2034 monotherapy and combo trial with 1884? I think, that trial has arm 1, which has monetary component and arm 2, which is a combo component. Which of these was interim analysis conducted for? And can you just talk about the thresholds that you would need to hit in order to start the study on enrollment for each arm?

Okay. Biren, just a reminder, I did mention during my talk, the one that we conducted an interim analysis for is the combination trial. And, I must also emphasize that these are planned interim analyses. So, they are preplanned into the trial. The other preplanned interim analysis for the monotherapy trial will happen soon. And, we will also of course make that available to our DSMB. With regard to our regulatory strategy, I will turn it over to my colleagues here, Jenn and Anna to comment on that.

So, just to be very clear, these trials are being conducted as two single arm trials to support BLA approval, both of them pre-discussed with the agency and otherwise. Now, the monotherapy trial with PD-1 is in relapsed/refractory cervical cancer, and that trial accrual is ongoing, planned to be completed by end of year. To support accelerated approval, which is our regulatory strategy with this particular product in this indication, we effectively need to demonstrate what pembro has done comparable to pembro, which is as you know, between 12% and 14% response rates. We have not completed the interim analysis yet, the planned interim analysis for the monotherapy trial, but we are on track to do so, before year-end. For the combination trial where we believe that we are going to deliver expanded response rate and durability of response, given the mechanism of action of the addition of CTLA-4 to an indication that is largely based in a virally-induced tumor such as cervical. And just comparably, we’ve seen that addition of CTLA-4 in a number of different cancer types has done this, in RCC, in some data presented at ESMO in cervical cancer and otherwise. We believe that we will do the same with our own combination program. Similarly, combination CTLA-4 and PD-1 is being pursued as a single arm trial to forward accelerated approval in second line cervical cancer with accrual completed and the planned interim analysis also completed. While we would very much like the opportunity to share the data publicly, in our most recent discussions with our regulatory advisors, the agency and our scientific advisors, it’s likely in the best interest of the Company and the integrity of the trials not to do as at this time. However, we do plan to provide you with a good clinical review, and Anna will do so at the Investor Day where you’ll have sense of how the activity of the monotherapy and the combination of our agents are working in cervical cancer and in number of other different cancer types. Anna, do you want to add anything to that?

No. I fully agree with what you said, Jenn. I think, on the way of completing enrollment for the monotherapy study, we completed the combination therapy, and the durability obviously requires more time to be followed on. And so, I think, we’ll just push through and will stay on track for our filing in 2020.

Fantastic. Thanks, Anna. And I'll make one more point, Biren. We will continue to ascertain data from these agents in total for a number of the different reasons for our own pipeline development as well as for some of the collaborative -- in clinical collaborations that we're contemplating. And so, what you will see is that the accrual will be open. And to our discretion, we’ve completed our obligation to meet that trial enrollment but we have the discretion and opportunity to continue to accumulate data in these indications. So, I don't there to be any confusion.

So, let me, if could, ask some follow-ups on your comments. On the combination arm for the interim, do you believe you’ve hit the necessary threshold that you needed to hit on that analysis? I'm going to assume ORR was the primary endpoint that you’ve done for that analysis. And second, I guess, as it relates to dosing on the combination arms, can you just review that for us? And then, I guess, third question is for the combination cohort. Were these specifically PD-1 positive patients at baseline that you’ve enrolled in the study?

So, maybe, Anna, if we might do this in a bit of a different order, we’ll start with dosing, we’ll talk about the endpoints, and PD-L1, the patient selectivity, and then impression of where we are with the data. Anna?

So, in terms of both studies, actually, we have enrolled patients, regardless of the PD-L1 status. So, they are not selected specifically. We obviously are assessing this PD-L1 efficient status, but the selection has not happened at the study enrollment. In terms of availability and the promise of the data from the interim analysis, as you know very well, interim analyses are slated on a small number of patients and they only give you a preliminary glimpse of what the totality of the data will look like. They are slated mostly for the assessment of that futility and then the early safety signals that as such this has been evaluated by our data safety monitoring board. And as Garo mentioned the committee recommended to continue the study without modification. So, at this point, I don't think we can disclose any more data, based on the recommendation from regulators and advisors and the importance of keeping the data integrity for the filing.

Dosage used? There was a question about which dosage we’ve used?

So, in terms of the combination therapy, the dosage we used for the CTLA-4 is 1 milligram per kilogram every six weeks. So, it's a much lower dose than in the monotherapy settings for this agent. So, that also gives you potential good safety profile and that is on top of the PD-1 agent used every two weeks, 1 milligram per kilogram -- sorry 2 milligrams per kilogram in this population.

And Biren, I'm going to add a couple of points here. On the dosing, we have the opportunity and have done the comparability to have flexibility in how we want to dose these products. So, the trial is designed to interrogate, as Anna mentioned, biweekly dosing PD-1 AGEN2034 at 3 mgs per K and AGEN1884 at 1 mg per K. And none of the patients agents have come off due to interoperability. And that was the reason for selection to get the real value of CTLA-4 dosing, we want to ensure proper exposure. Additionally, the PD-1 selection biomarker. Now, as you can imagine, we know that pembro is approved in a selected population patients who are positive for PD-L1. And we are pursuing, while we’ll analyze these data, we believe that when you add CTLA-4 on top of PD-1, it may be able to bring the benefit regardless of this particular biomarker selection. And that's an important point, and our data supports our hypothesis in this regard. With respect to the outcomes, as Anna mentioned, and we're very thoughtful and conservative about the presentation of these data, but I'll say that based on the preponderance of evidence that you're seeing in this indication with the combination, we're very confident in the results that we're seeing as of now.

And our next question will come from Matt Phipps of William Blair. Please go ahead.

So, I was just wondering if you could maybe firm up the timeline for a little bit for the second line cervical filings, now that you've completed enrollment in one and soon to complete enrollment in the other. And I assume response rate with a certain duration of therapy is what will be needed. Is it is six months duration that you have to report on for auxiliary approval or can give any clarification there?

So, Matt, very big questions. With respect to the timing, while we have advanced these programs, and Anna and her exceptional team, we are certainly ahead of our earlier projections. But, what I will say is that we have not -- we will certainly -- we feel very strongly that we will hit our BLA filing in 2020. We believe that we are earlier than prior projections, but we have not yet given an actual time line for that filing. So, if you will just bare with us, we will continue to keep you informed as much as we can as we advance through this process. We are in the process of now building out the submission package. So, on the last point, or follow-up right now, as you know with these patients, the disease is really uniformly [indiscernible]. There are no highly beneficial products for these patients. And they progress very quickly. They progress in 8 to 12 weeks. So, that would be the minimum amount of time that we would be following these patients. And ideally, with the extension or with activity, we can see responses and continue to follow patients beyond 6 and ideally to 12 and longer -- months and longer. But, we will now in a few months after dosing starts, what the activity looks like. I hope that helps.

Good, thanks. And then, do these have to be filed together or can they be filed separately, just...

They filed it through independent BLA path. So, they don't need to be filed together.

Okay. And then, as far as the 1181 development strategy, just curious if you think you can maybe go after some kind of an accelerated initial pathway and melanoma patients who don't have that high affinity CD16 allele or you try to go after other tumor types where maybe CTLA-4 hasn’t been as effective? Just kind of curious what your current thoughts are on the next steps for that program.

Matt, thank you very much. I'll tell you we just are coming off of a -- a couple of days go, we held an advisory board meeting with our key scientific advisors who are incredibly experienced in this space, and many of their names will be known to you. We’ve spoken about this opportunity. And based on the data available to us to-date, we are perusing development pathways that will leverage accelerated approvals via the U.S. FDA. We do think that there is a large unmet need in some of these tumors, such as melanoma, as you’ve mentioned, as well as other tumors where first generation CTLA-4s are proved, and this next generation may actually expand the benefit to the patients as you’ve mentioned. We will be -- and Anna can speak to this collecting data, particularly on this biomarker selected population as well. But, right now, we’ve opened the trials to a broad group, because our NexGen CTLA-4 covers the gamut. It should address all of the mechanisms for first generation CTLA-4 plus the added benefit in those patients with the polymorphism. Anna?

Yes. And to answer that, I think, it’s still early in the development as we think that we are planning to open combination cohorts as well as we are perusing data gathering for different dosage for the dose escalation phases. We are contemplating opening dose expansion cohorts in a number of indications that could be of interest such as refractory, melanoma indication. So, that's definitively in our plans.

Okay. And lastly on AgenTus, so just -- this has been something that's been kind of around in the background for a while and talked about spinning off into an entity and getting its own funding. I mean, how confident are you that you can make that happen now? And I think there's definitely some interest from investors, and I'm trying to reduce the burn rate a little bit, and maybe this is one way where that can happen I guess?

Yes. Matt, let me -- I mean, you make some very good points here. There are several drivers. One is that after the acquisitions of two high profiles of high companies, the interest in the field sort of cooled down, and that has had a slightly negative effect in our timelines of funding it independently. However, AgenTus has been spun out. It is a separate company in terms of legal, financial, and other considerations. We are getting closer to filing an IND, which I think will be a very important value inflection point for us. We’re slated for that IND filing this month. Whereas, previously we were pursuing both autologous and allogeneic formats, now, there is focus on the allogeneic format. So, we will no longer be pursuing autologous format, which is -- puts us in a much more focused strategy. And so, once we file our IND and the operations become clarified for the investors, we feel very confident that we will be able to fund this company separately in the next few months.

Our next question will come from Harshita Polishetty, an investor. Please go ahead.

Hi. Good morning. Congrats on the quarter, and thank you for providing the updates this morning. Just one question on my end. With regard to the Gilead collaboration, I noticed that they filed to offer up to 11.1 million of Agenus shares on October 25th. This is the entire Gilead stake in Agenus, if I remember correctly. So, I was hoping you could provide some color on what's happening there, and perhaps a brief update on how the collaboration is ongoing?

Sure. As you know, Harshita, we have fulfilled all of our 2019 milestone obligations with Gilead. And our collaboration is proceeding on a very, very positive path. And so, our additional opportunities in coming years in terms of additional milestone payments, and so on that we're very hopeful, will materialize, including in 2020. With regard to the filing that you're referencing, unfortunately because of legal requirements, sometimes disclosures are misleading. I mean, you'd expect that the SEC and the legal profession would make this language disclosures that would be crystal clear. But, that's not the case unfortunately. And so, this filing of 11 million shares is simply a registration statement. So, as per contractual obligation, and we've done this previously with other companies where there's a share exchange, we are obligated to register the shares. It has nothing to do whatsoever with Gilead's interest to sell shares. In fact, to the best of our knowledge, Gilead has absolutely no plans to sell any of the shares as we have seen no such sales from our previous partnerships. So, it's a combination of language that unfortunately is that as clear as it should be and perhaps investors not indulging in reading beyond the first paragraph.

Great. That's really helpful. Thank you so much for the color, Garo.

It's our pleasure.

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Garo Armen for any closing remarks. Please go ahead.

Thank you very much, Chuck. Harshita's question has sort of evoked other sort of misperceptions. One misperception is that we have a significant amount of debt on our balance sheet. And once again, this is an accounting mishap in the way things are disclosed. So, we have no substantial debt on our balance sheet. What that is, is representative of the royalty arrangement that we did with HCR about a couple of years ago or less, which obligates us to put a number on our balance sheet that has nothing to do with our debt obligation. In fact, under no circumstances that debt obligation could be triggered. And, in fact, as Jenn mentioned earlier, our only debt obligation, which was $27.5 million, has already been extinguished because of the success of Shingrix. Shingrix' sales have exceeded a certain amount, which is $1 billion in net revenues that extinguishes that obligation. And moreover, if you look at the publicly disclosed Shingrix revenues and annualize that number, we will meet the next two milestones in the course of 2020 for payment of additional $40 million to Agenus. So, next year, we expect to have reasonable milestones, including this one that will augment our cash position. And when we make a public disclosure in our financial statements that we have enough cash into the second quarter of next year, it does not include all of these additional milestones that are due to us. So, just bear with us, we'll make things a lot more clearer going forward. And at the expense of simplicity, we will add simple comments that make these disclosures more digestible and less confusing. So, thank you very much for your attention. We look forward to keeping you abreast of additional progress. And we're heading into a very exciting 2020 in terms of both data and other accomplishments, and we look forward to communicating all of that to you. Thank you.

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