Dr. Garo Armen
Thank you, Nico. Once again, good morning and thank you for joining [Technical difficulty] yesterday for our third quarter update and numbers discussion. It is an exciting time for Agenus and we believe also for the field of immuno-oncology. The Society for Immunotherapy of Cancer otherwise known as SITC Conference starts today in Boston, our home turf, during which we expect to highlight the significant unrealized potential for a new generation of I-O regimens, I-O being immuno-oncology, that potentially would transform the way we treat cancer. We anticipate that one of our most promising clinical assets balstilimab, 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 balstilimab development programs, including our participation at SITC as well as recent initiation of two Phase 2 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 AGEN2373 and provide also a financial update. Let me start with SITC. We will be sharing expanded clinical data from our Phase 1 study of balstilimab across multiple tumor-specific mentioned cohorts of heavily, and this is very important, heavily pretreated consumers, where 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, increase the odds of non-responsiveness and the fact that we have seen responses in that population is the impetus for enthusiasm by experts for balstilimab. So now these data will be presented at an oral plenary session on an expanded patient population whereas we presented the data in colorectal patients at ESMO GI SITC presentation will encompass expanded cancers. And it will be on November 12 at 10:50 AM. The presentation is by Dr. Bree Wilky, the Director of Sarcoma Medical Oncology and Deputy Associate Director for Clinical Research University at the University of Colorado, and it is a plenary session. Agenus will also present translational data from the Phase 1 study. And by the way, again, this is a very large Phase 1 study, not a common Phase 1 study, having already enrolled 250 plus patients, although the data presented will be about half of that number, given the fact that we are presenting data on patients that have had at least one scan to collect data from. And so, Agenus will present translational data from the Phase 1 study and preclinical studies highlighting the mechanisms of underpinning what balstilimab differentiated enhanced anti-tumor immunity as well as new preclinical data demonstrating superior activity than first generation CTLA-4 agents across multiple cold and totally immunogenic tumor models. And as we have communicated, later on November 12, Agenus will host The Road Taken conference let's say Agenus sponsored conference. This R&D event features presentations from key opinion leaders at the forefront of immunotherapy developer including Dr. Michael Adkins, Dr. Alexander Eggermont, Dr. Bree Wilky, 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 under current and future state of I-O treatments as well as the unprecedented data generator to-date in the botensilimab program. The event will take place from 2:00 PM to 5:00 PM Eastern Standard on November 12 at the offices of Ropes & 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 investor section of our Agenus website, although I might indicate that there's a limit in the participation of that as well. Agenus made several important clinical advancements to our both and botensilimab program in the third quarter. Building upon the robust responses of drug in our Phase 1 trial, we have already initiated two randomized worldwide Phase 2 ACTIVATE trials in advanced MSS, that is Microsatellite Stable, or it can be also described as non- MSI-CRC patients as well as melanoma. ACTIVATE-Colorectal trial will evaluate botensilimab monotherapy and in combination with balstilimab our PD-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 pretreated patients that have failed the standard of care in the prior setting. ACTIVATE-Melanoma will evaluate botensilimab monotherapy in patients with refractory to either PD-1 or combine CTLA-4 PD-1 therapy. And this is also a very important trial design because it may achieve the approval of botensilimab as monotherapy in a continuing approval trial. And of course, there are benefits to going after botensilimab monotherapy indication. The primary endpoint of both studies will be overall response rates with durational 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. The Agenus expects to launch, as I said earlier, a third Phase 2 trial in advanced pancreatic cancer by year end. This two will be a randomized trial and it will look at botensilimab in combination with chemo versus chemo alone. Beyond these trials, Agenus continues to enroll patients in its Phase 1 botensilimab study to evaluate expansion cohorts in additional indications. These expansion cohorts will evaluate efficacy signals as well as support those 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 1 trials can be used to accelerate our Phase 2 programs as well as support additional indications for development. And while we have not made a disclosure 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 communications that we've mentioned for the subject of clinical trials this year. Complimenting the progress we've made on botensilimab this quarter, we're advancing additional clinical programs developed from our anti-body engineering and vision platform. This is 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, botensilimab 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 host our very first patient in our Phase 1 study evaluating AGEN1571. This is an ILT2 antagonist anybody and we're doing the Phase 1 trial, first as monotherapy and then it will be in combination with botensilimab and balstilimab in patients with advanced solid tumors. We continued enrollment of our combination study evaluating AGEN2373, which is our CD137 agonist. This is with botensilimab in melanoma patients who are relapsed or refractory to PD-1 therapy. We anticipate enrollment should be completed in the first half of 2023 or sooner. Agenus has a robust track record or value creation through strategic partnerships and this quarter multiple partner assets advanced into new Phase 2 studies. So, they're advancing very nicely. For example, BMS launched a Phase I/II study of BMS now 986442, which is our old TIGIT bispecific license to them, which was discovered by us also known as AGEN1777. 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 has initiated a randomized Phase II study evaluating MK-4830, a candidate ILT4 antagonist also discovered by Agenus. And this is in combination with pembrolizumab, Merck's own PD-1 and chemotherapy in ovarian cancer. Additional Phase 2 studies of MK-4830 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. We are very heightened by the fact that our ILT4 antagonist antibody has indications of activity in all of these very tumors. And lastly, Incyte initiated a randomized Phase 2 study evaluating LAG-3 and TIM-3 antibodies discovered by Agenus in combination with PD-1 in first line squamous cell carcinoma of the head and neck. Additional Phase 2 studies of these four grams are ongoing in melanoma, endometrial cancer and urothelial carcinoma. Finally, our ability to recruit tough talent is critical to the development of our pipeline near-term, more specifically botensilimab into a transformative treatment for patients indeed. To this end, we made some important recent additions to further bolster our clinical and regulatory leadership team. They include Dr. Todd Yancey who was named Senior Global Clinical Development, Medical Affairs & Commercial Advisor. He comes with over 40 years of combined clinical and industry experience, most recently from BeiGene. We also hired Patricia Carlos as our Chief Regulatory, Quality and Safety Officer. Pattie has over 20 years of regulatory affairs experience, leading programs from investigational NDA to commercialization, as she was most recently at Arcus. With that, I will now turn the call over to Christine to cover our financial reporting. Christine?