Good day and thank you for standing by. Welcome to the Agenus Third Quarter 2021 Financial Results Conference Call. [Operator Instructions] I would now like to hand the conference over to Divya Vasudevan. Thank you. Please go ahead.

Thank you, Timya and thank you all for joining us today. Today’s call is being webcast and will be available on our website for replay. I’d like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial 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 another reminder, this call is being recorded for audio broadcast. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Jennifer Buell, Chief Executive Officer of MiNK Therapeutics; Dr. Steven O’Day, Chief Medical Officer of Agenus; and Christine Klaskin, Vice President of Finance. Now, I will turn the call over to Garo to highlight the progress we have made to-date this year. Garo?

Thank you very much, Divya and thank you all for your participation and your interest in Agenus as well as MiNK Therapeutics. As we have shared previously, our business model is comprised of four pillars. Now for today’s discussion, I will redefine what those four pillars are. And we will primarily talk about pillar number one, two and three. I’ll make some broad comments about pillar number four. The first pillar is what we describe as our significant value creators. We believe these compounds and opportunities could be significant. And they represent certainly our next generation compounds in one primary example of that, which we will talk about in some detail today is our next generation CTLA-4inhibitor, AGEN1181. The second pillar is represented by our partner programs and recently launched affiliated businesses, including MiNK Therapeutics and SaponiQx. The third pillar we describe as supportive programs, such as balstilimab and zalifrelimab. And I will define what we mean by supportive programs in just a bit. And our fourth pillar, which is a silent component of our business, we don’t talk very much about it, but a very important component, because without it, we wouldn’t be able to accomplish the kind of things, innovations and advancements as we have. And that is represented by our vertically integrated structures comprised of key operational capabilities for the company, including our commercial manufacturing, including our vision technology, which is our response prediction platform designed to facilitate the development of our pipeline by targeting patients who are likely to respond to therapy. Now, I would like to begin the call by addressing the first pillar, which is driven by our flagship program, AGEN1181. Now, as you know, we have a SITC presentation coming up. This morning, we announced the SITC publication of an abstract summarizing data…

Thank you very much, Dr. O’Day and congratulations on those results. This will be an exciting conference for us at Agenus as well as at MiNK, which I am going to highlight some of the data that’s coming out now, of course, our abstracts have been released, but the data updates will be presented more fully in the upcoming posters. So, turning to MiNK, I want to just remind you of our goals and in launching MiNK Therapeutics as a separate public entity enabled us a way to create two patient-focused companies with independent financing, streamlines operations, and focus teams to accelerate the development of their collective and independent innovative pipelines. So as Garo mentioned, we launched the IPO and to-date we actually raised $46 million at point, which includes our initial public offering of $40 million and then the green shoe which was also executed most recently and with those proceeds will be rapidly advancing our clinical stage portfolio. Now, we believe that invariant natural killer T-cells or iNKTs represent a potential best-in-class allogeneic cell therapy approach. iNKT is naturally home to the size of the tumor or infection. And we believe that this ability to penetrate solid tumors is a critical advantage compared to T-cells or NK cells and also the capability of the cells to naturally proliferate enables us to expand upon that benefit and the functions of these cells. What we have observed to-date is that other cell therapy approaches have shown limited durable efficacy and solid tumors. And we have also of course observed some more recent toxicity challenges. And what I can tell you that we have publicly informed is that the iNKT cells can be dosed to a billion cells with no neurotoxicity and no cytokine release syndrome observed to-date, very important clinical…

Thank you, Jen. We ended the third quarter of 2021 with a cash and short-term investment balance of $262 million as compared to $100 million at December 31, 2020. For the third quarter ended September 2021, our cash provided by operations was $131 million and we reported a net income of $177 million or $0.76 per share basic and $0.72 per share diluted. This compares to cash used in operations for the same period in 2020 of $32 million and a net loss of $52 million or $0.28 per share basic and diluted. Our cash provided by operations for the 9 months ended September 2021 was $33 million, with net income of $39 million or $0.19 per share basic and $0.18 per share diluted. This compares to cash used in operations of $104 million and a net loss for the same period last year of $145 million or $0.87 per share basic and diluted. Non-cash operating expenses for the 9 months ended September 2021 were $46 million compared to $35 million for the same period of 2020. We recognized revenue of $275 million through September 2021 and $57 million for the 9 months ended September 2020. Revenue includes upfront license fees received, milestones earned, non-cash royalties, and revenue recognized under our collaboration agreements. I would now like to turn the call back to Garo.

I would like to thank my colleagues for their statements during this call and also thank you all for your interest in Agenus and MiNK Therapeutics and joining us this morning. Looking into the current quarter and beyond into 2022, we expect to achieve value driving events with our clinical and preclinical pipeline. And when we talk about preclinical pipeline, we do expect to take a number of our own discoveries into the clinic over the next months. Firstly, accelerating the development of AGEN1181 and balstilimab by launching our Phase 2/3 trials in colorectal cancer, in ovarian cancer and endometrial cancers is something that we are very much focused on. And of course we are very encouraged with the responses that we have seen which we have disclosed some of it this morning. And you will see additional details this Friday at SITC, but even beyond that as Dr. Steven already mentioned, these responses are of a certain cutoff rate – date. We do expect responses to develop beyond that cutoff date, which will not be released at this meeting this week. Secondly, initiating a combination study or AGEN1181 with our conditionally active CD137 agonist in melanoma this year. Third, advancing our TIGIT bispecific to Phase 1 studies in collaboration with BMS, and this is a very exciting program, as we have mentioned. First, several patients are convinced already. Fourthly, advancing clinical development of our allogeneic iNKT cell therapies, as Jen mentioned, in cancer and immune mediated diseases through MiNK Therapeutics with a data update at SITC this week. And we will have appropriate updates beyond that. Building a sustainable supply of saponin-based adjuvants, proprietary adjuvants that include our QS-21 Stimulon through SaponiQx. Launching a standard access programs for balstilimab and providing an update regarding the strategy for balstilimab, zalifrelimab combination in second line cervical cancer. Now, this is a very important program that we undertake seriously, because we have had a number of requests, including from our physicians, who have been engaged in our trials. And it is our moral responsibility to make sure that we provide access to the products that are active on terms that are going to make the patient treatment streamlined. Continuing to advance novel programs to IND as I have just mentioned, with our next IND filings planned in early 2022. And of course, integration of our VISION intelligence platform to support discovery of rational drug combinations, selection of new targets, and addictive biomarkers beyond what is commonly practiced today. And lastly, progressing construction of our facility, fully integrated facility for commercial manufacturing in Emeryville, California. And this is a very important undertaking for us, because it will make Agenus self reliant in its ability to deliver products without dependence on third-parties, which is particularly important in today’s environment with significant capacity constraints and supply chain issues. And once again, thank you very much for your attention. We will open it up now for questions.

[Operator Instructions] Your first question comes from the line of Mayank Mamtani with B. Riley Securities.

Good morning team. Congrats on the progress on multiple fronts. And thanks for taking our questions. So, maybe if I can start with the 1181 data abstract at SITC, just a couple of quick questions I have. So, on the 24% ORR we are seeing on MSS CRC here? Could you just give an update on where we are in terms of median follow-up with these patients, just trying to understand the durability and depth of response that you are seeing? And then also on the unconfirmed PR, we have in PD-1 refractory non-small cell lung cancer, just it would be helpful to understand the baseline patient characteristics and also how many lung cancer patients you have already in the cohort enrolled?

Okay. So, let me answer the question broadly. And then of course, we are going to ask Dr. O’Day to provide more color. I would caution against assigning response rates, even though we are very pleased with the responses we are seeing in such a trial, where we have gone through a dose escalation process. In the beginning certainly, the doses used were not necessarily optimized doses. So, to take the denominator and the numerator and mixing and matching this probably is not an accurate depiction of the response rates in this trial. Now, in addition to that, of course, in terms of certain cohorts, because of the high science that we are engaged in here at Agenus, we really dissect the patient profiles based on a whole bunch of predictive and other biomarkers. And so patient selection criteria is going to be much more precise going forward into our Phase 2 and 3 trials. So with that Steven, if you could address Mayank’s question? Steven O’Day: Yes. Thank you, Garo. Thank you for the question. I think what we can say is obviously that the cutoff for this abstract that we are discussing, sorry, was in July and the cutoff for the poster, which will be delivered on Friday of September. And we will be updating the follow-up and the unconfirmed to confirmed responses on the Friday poster. So, I think we should wait and share with you the data. But I think you will see both the development of the further follow-up on the patients and obviously further follow-up in terms of the confirmation of responses.

I understood. And then my second bucket of question was around, what sort of work you are doing with Nelum. And sort of thinking broadly about, two aspects focused on pancreatic cancer franchise given the first gen CTLA-4 has a signal with a hedgehog, but also you are seeing PR with next gen CTLA-4 here. But I am also broadly curious to hear your thoughts Garo, as you know, you look at other agents targeted our IO that bigger pharma companies have, and you try to prosecute 1181 in certain indications where maybe a backbone therapy might not be within Agenus portfolio. So, how should we think about that?

So, if you can repeat the point that you are trying to make, the last point, Mayank, because when you say a how should we think about it in the context of large companies portfolio? What do you mean by that?

Yes. For instance, OBGYN is a big priority for you. I am just making this up, having an access to a part, or another targeted therapy could kind of make sense to become combining with a CTLA-4, for instance. So, how you might be thinking of partnering up with a bigger player here, given the bigger player will also value the importance of 1181 from an IO standpoint?

Right. So, very good. Now, it’s clear. So, in terms of a couple of points here, one is, in comparing what we can do to large companies, we have several advantages here. Number one, we have a very expensive armamentarium of immunooncology agents at our disposal, these are our inventions. So, mixing and matching and combining them is relatively straightforward for us. That’s number one. Number two, we have a technology such as VISION, which is a very important tool for us, in terms of its ability to be predictive of responses and patient selection. Now, what does all that mean, it means that we could be striving as VISION advances to identifying biomarkers or patient markers that are going to be agnostic to specific indications, okay. That’s not quite there yet now, but I think we are heading in that direction. So, we can envision for example, selecting patients and therapies matching them it regardless of indication, similar to what they have done at big companies, such as Merck, but they have done it in a very crude fashion. We would like to do that much more specifically. Having said that, to address your last question, what is in our partnering strategy, how do we go about thinking about the future now? While we have said in the past is that because of our resource constraints and when I talk about resource constraints, we are not talking about just money, we are talking about overall capabilities and global reach. Because of that, we opted to license things such as AGEN1777 globally. Now, going forward, we have made statements about AGEN1181 saying that a logical path forward for us would be the geographic segregation of the rights. So for example, U.S. rights, we will keep and ex-U.S. rights, we will license that. Now in the context of an appropriate development program, it’s very, very plausible that we may do a global co-development with a prospective collaborator or a partner with these geographies carved out for commercial launch of a product. So and then of course, as we put into place substantial resources over the coming years earned with the performance of our products and commercial launches, I would see us even venturing into taking a bigger share of the global reach for our future collaboration deals. Does that answer your question?

Yes, very helpful, Garo. Thank you. And if I can squeeze in another one before I pass it on to my colleagues. Remind us of the pro forma ownership in iNKT. And then how should we think of SaponiQx, given the experience you have had iNKT, but also the considerations that are different in terms of partnerships and scale up and capital needs might be very different than what was with iNKT?

Sure, I will ask Dr. Buell address the iNKT question, and then I will come back to SaponiQx.

Sure. So Mayank, we have what you now have access to is that the Agenus ownership of the MiNK iNKT is just under 80%, its 79%.

Okay. Now, as far as SaponiQx is concerned. SaponiQx, you could assume to follow pretty much the footsteps of iNKT, our main therapeutics. So, we formed SaponiQx recently, based on the needs that I articulated for an effective vaccine that has long-term long-lasting protection. And as I have said earlier, one of the limitations of current vaccines, even though they are highly efficacious, we don’t know for example, how efficacious they will be to potential new variants, we hope that they will be highly efficacious. But one thing we know for sure is that their efficacy wanes after three months, six months, that is for sure. And of course, the prospects of a booster shot every three months, six months forever is not an appropriate way of strategizing for vaccine. So, having longer lasting immunity is critically important. And the only limitation of QS-21 Stimulon right now is not that it cannot offer that long-lasting limitation, it can, I mean, protection, it can, of course. But we are quantity limited. And hence, the right thing to do for us – the morally appropriate thing to do is to collaborate with governments and potential with other companies to sprint towards being able to manufacture QS-21 Stimulon and other adjuvants data pipe that have very important nasal immunity, mucosal immunity characteristics at a high speed so that we can offer the benefit of QS-21 beyond the number of – limited number of patients that are or I should say, healthy individuals that are benefiting in the context of SHINGRIX. We need to get what we have shown scientifically to be possible with this process. It’s an engineering challenge that could take us to billions of doses of production of QS-21 Stimulon.

Very helpful. Thanks again for taking our questions.

Thank you.

Your next question comes from the line of Kelly Shi with Jefferies.

Hi, good morning. This is Jason Bouvier on for Kelly Shi. Thank you for taking our call and congratulations again on the 1181 data. Just one question on the Bal/Za combo in cervical, you mentioned on a previous call, you need to discuss a possible path forward with the FDA. Can you provide any – do you have any higher resolution on the timing of that conversation? And maybe when we can expect to learn about the outcome of the meeting? And then what do you anticipate that path looking like going forward? Thanks a lot.

Okay. So it’s not clear entirely yet. But we will have some additional data points that will inform us what the next steps will be, whether there will be next steps by the end of this year.

Okay, great. Thank you.

Your next question comes from the line of Matt Phipps with William Blair.

Good morning. Thanks for taking my questions. Congrats on the update. Dr. O’Day, I was wondering if you could – I realized probably for Friday for a lot of disclosure, but anymore comments on any colitis seen with this combination, 1181, one thing we have kind of been looking at based on the update last year. And then as we were thinking about these Phase 2/3 trials, I wondered if I guess one, any thoughts on the endometrial landscape. We have had two approvals this year for therapy regimens one in the dMMR setting for monotherapy and then [indiscernible] MSS setting. So, I am just kind of curious if you can give us any insight on where you are thinking of going endometrial, assuming that’s one of the gynecological cancers. And then you mentioned Phase 2 or Phase 2/3, any of these potentially accelerated pathways?

Matt, thank you for these questions. Let me just guide you broadly and then, of course, Dr. O’Day will answer. So, we have made a strategic decision not to discuss the competitive – our next moves with regard to details of our clinical trials design, because of competitive reasons. I mean what happened with Bal monotherapy approval process, of course, highlights how important competitive issues are and timelines are and of course, how important FDA consideration is for reviewing one company’s product versus another company’s products. And so that’s why we are going to be a little bit guarded in terms of how much detail we will provide. But we have discussed this internally. And Steven, feel free to indulge in any kind of detail that we have determined to be publicly disclosed at this point. Steven O’Day: Yes. Thanks, Matt. In terms of the development, I think Garo had spoken about it. Obviously, we are very excited about launching these trials in GYN malignancies and ovarian and endometrial and more to come on that, we have to disclose further. But needless to say, we have KOLs and leadership around these trials that are very excited about the data to-date and a rational plan forward. In terms of the toxicity, I think obviously, what is really remarkable to-date is the lack of hepatitis, pneumonitis or clinically relevant, high grade hepatitis, which as you know are potentially life threatening and are chronic toxicities of first generation CTLA-4. So, we see this really as different with over 100 patients treated. In terms of colitis, I will refer you to the abstract right now. There will be further safety follow-up on Friday with updated patients and follow-up. But certainly we are confident that the colitis is certainly getting, it’s difficult with cross-trial comparisons of first generation agents. But we feel very good about the colitis in the sense that it appears to be comparable or in the same range as first generation. And we have strategies in our Phase 2 programs to mitigate that further, which we are very excited about. So, more to come with a follow-up safety data, but that’s what I can say about flyers to-date.

Okay. Thank you.

At this time, there are no further questions. I would like to turn the call back over to management for closing remarks.

Thank you very much for everybody. I think we have had a quite an extensive cold and we look forward to your engagement, additional questions. Please feel free to connect with us. Thank you again.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.