Agenus Inc.

Thank you for holding, and welcome everyone to the Adgenis 3rd Quarter 2022 Financial Results Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you'd like to withdraw your question, again press star 1. Thank you. I'll now turn the call over to Nico Freelich from Investor Relations. Mr. Frelick, please go ahead.

Thank you, Jack, 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. Joining me today are Dr. Garrow Arman, Chairman and Chief Executive Officer, and Christine Klaskin, Vice President of Finance. Our Chief Medical Officer, Dr. Stephen O'Day, will be joining us for Q&A. Now, I'd like to turn the call over to Garrow to highlight our progress and speak to our outlook for the remainder of the year.

Garrow. Thank you, Nicole. Once again, good morning, and thank you for joining us today for our third quarter update and numbers discussion. It is an exciting time for agenists, and we believe also for the field of immuno-oncology. The Society for Immunotherapy of Cancer, otherwise known as FITC Conference, starts today in Boston, our home turf, during which we expect to highlight the significant unrealized potential for a new generation of IO regimens, IO being Immune Oncology, that potentially would transform the way we treat cancer. We anticipate that one of our most promising clinical assets Botansilamab, a novel adaptive innate immune activator, in addition to being a CTLA-4 binder, can provide important future therapeutic options for patients with tumors that are particularly resistant to current therapies, including, very importantly, immunotherapies. On today's call, we will provide an update on both Hansel and Matt development programs, including our participation at 60, as well as recent initiation of two Phase II ACTIVATE trials in advanced colorectal cancer for one and in melanoma for two, to be followed by trial in pancreatic cancer before the end of the year. It's important to point out that all of these trials are randomized trials. We will also highlight progress on several of our earlier stage clinical programs, including our ILT2 antagonist, AGEN1571, and our CD137 agonist, agent 2373, and provide also a financial update. Let me start with CITI. We will be sharing expanded clinical data from our phase one study on botanism map across multiple tumor-specific expansion cohorts, of heavily, and this is very important, heavily pretreated cold tumors. When we presented the data in colorectal cancer several months ago at ESMO GI in Barcelona, the experts at that time scrutinized the heavily pretreated nature of these patients, and it was the consensus that the data presented was unique in that it was both in heavily pretreated patients as well as in cold colorectal tumors. Both of them, by the way, increased the odds of non-responsiveness. And the fact that we've seen responses in that population is the impetus for enthusiasm by experts on botanical meth. Now, these data will be presented at an oral plenary session on an expended patient population, whereas we presented the data in colorectal patients at ESMO-GI, cystic presentation will encompass expended cancers. And it will be on November 12th at 10.50 a.m., The presentation is by Dr. Brie Wilkie, the Director of Sarcoma Medical Oncology and Deputy Associate Director of Clinical Research at the University of Colorado. And it is a plenary session. Agenis will also present translational data from the Phase I study. And by the way, again, this is a very large Phase I study, not a common Phase I study. Having already enrolled 250-plus patients, although the data presented will be about half of that number, given the fact that we're presenting data on patients that have had at least one scan collect data from. And so Agenis will present translational data from the phase one study and preclinical studies highlighting the mechanisms of underpinning botansilumab's differentiated enhanced anti-tumor immunity, as well as new preclinical data demonstrating superior activity in than first-generation CTLA-4 agents across multiple cold and totally immunogenic tumor models. And as we have communicated, later on November 12th, Janice will host the Road Taken conference. That's a Janice-sponsored conference. This R&D event features presentations from key opinion leaders at the forefront of immunotherapy development, including Dr. Michael Atkins, Dr. Alexander Eggermont, Dr. Brie Wilkie, the presenter of the plenary session that morning, and Dr. Larry Norton, as well as multiple presentations from our own leadership team. The agenda will center on the current and future state of I.O. treatments, as well as the unprecedented data generated to date in the Botancilla MAP program. The event will take place from 2 p.m. to 5 p.m. Eastern Standard on November 12th at the offices of Roxanne Gray in Boston. While in-person attendance is now closed due to space restrictions, institutional investors, analysts, and members of the medical community are invited to attend the live webcast of the event that can be accessed on the Investors section of our Agenis website. although I might indicate that there's a limit in the participation of that as well. Agenis made several important clinical advancements to our Botancillomab program in the third quarter. Building upon the robust responses observed in our phase one trial, we have already initiated two randomized worldwide phase two activate trials. in advanced MSS, that is microsatellite stable, or it can be also described as non-MS high CRC patients, as well as melanoma. Activate colorectal trial will evaluate botansilumab monotherapy, and in combination with bolsilimab, RPD-1 antibody, It is randomized to current standards of care in patients that have received at least one prior chemotherapy regimen. So again, these are pre-treated patients that have failed the standard of care in the prior setting. Activate melanoma will evaluate botansilumab monotherapy in patients refractory to either PD-1 or combined CTLA-4 PD-1 therapy. And this is also a very important trial design because it may achieve the approval of botansilumab as monotherapy in a continuing approvable trial. And, of course, there are benefits to going after botansilumab monotherapy indications. The primary endpoints of both studies will be overall response rates with duration of response, progression-free survival, and overall survival as primary and secondary endpoints. This is also important because all of these endpoints are considered the gold standard in clinical trial conduct. Agenis expects to launch, as I said earlier, a third phase two trial in advanced pancreatic cancer by year-end. This, too, will be a randomized trial, and it will look at botancillin map in combination with chemo versus chemo alone. Beyond these trials, Agenis continues to enroll patients in its phase one botancillin map study to evaluate expansion cohorts in additional indications. These expansion cohorts will evaluate efficacy signals as well as support dose optimization and contribution of components for the PD-1 combinations. These larger and richer data sets that will be obtained from the expansion of our Phase I trials can be used to accelerate our Phase II programs as well as support additional indications for development. And while we have not made disclosures on what additional indications we will be going after, we have a clear vision of what they are, and they include some very difficult cancers as well as some very large cancer opportunities. beyond the three indications that we've mentioned for the subject of clinical trials this year. Complementing the progress we've made on Potencilumab this quarter, we're advancing additional clinical programs developed from our antibody engineering and vision platform. It's very important also to mention that every product, other than our first-generation CTLA-4 and our PD-1, has been specifically engineered with attributes in mind. And of course, propancilumab is a clear example of that attribute, which has been designed into the molecule, which has been proven to be validated in preclinical models, and now we're seeing that to be validated in clinical trials. So getting back to our other agents, we dosed our very first patient in our phase one study, evaluating agent 1571. This is an ILT2 antagonist antibody. And we're doing the phase one trial first as monotherapy, and then it will be in combination with odansilumab and balsilumab in patients with advanced solid tumors. We continued enrollment. of our combination study evaluating agent 2373, which is our CD137 agonist. This is with potencylamab in melanoma patients who are relapsed or refractory to PD-1 therapy. We anticipate enrollment to be completed in the first half of 2023 or sooner. Agenis has a robust track record of value creation through strategic partnerships. And this quarter, multiple partner assets advance into new phase two studies. So they're advancing very nicely. For example, BMS launched a Phase 1-2 study of BMS now 986442, which is our old TIGIT by specific license to them, which was discovered by us, also known as ASIAN-1777. BMS 986442 is being evaluated in combination with Nivolumab, their own PD-1, and chemotherapy in patients with advanced solid tumors and non-small cell lung cancer. Second, Merck initiated a randomized phase two study evaluating MK4830, a candidate ILT4 antagonist also discovered by Agenis. And this is in combination with pembrolizumab, Merck's own PD-1, and chemotherapy in ovarian cancer. Additional Phase II studies of MK4830 are also ongoing in non-small cell lung cancer. Small cell lung cancer, in addition, esophageal cancer, MS high colorectal cancer, Renal cell carcinoma and melanoma were very heartened by the fact that our ILT4 antagonist antibody has indications of activity in all of these varied tumors. And lastly, INSIGHT initiated a randomized Phase II study evaluating LAG3 and TIM3 antibodies discovered by agenists in combination with PD-1 in first-line squamous cell carcinoma of the head and neck. Additional Phase II studies of these programs are ongoing in melanoma, endometrial cancer, and urothelial carcinoma. Finally, our ability to recruit top talent is critical to the development of our pipeline near-term, more specifically Botancilla Lab, into a transformative treatment for patients in need. To this end, we made some important recent additions to further bolster our clinical and regulatory leadership team. They include Dr. Todd Yancy, who was named Senior Global Clinical Development, Medical Affairs, and Commercial Advisor. He comes to us with over 40 years of combined clinical and industry experience, most recently from Beijing. We also hired Patricia Carlos as our Chief Regulatory Quality and Safety Officer. Patty has over 20 years of regulatory affairs experience, leading programs from investigational NDA to commercialization, and she was most recently at ARCIS. With that, I will now turn the call over to Christine to cover our financial reporting. Christine?