Agenus Webcast January 2026 | Access to Acceleration: BOT+BAL Global Momentum Entering 2026

Thank you very much, Stephanie, and thank you everyone for joining us today. We've had patients and families, physicians, researchers, partners, and shareholders—of course, all of them are our stakeholders. We appreciate your time and your continued engagement with Agenus, because Agenus is on a very important mission, and we'll be talking about the details of that during the course of our session today. As we enter 2026, we're doing so with greater clarity. Clarity means lack of uncertainty, certainly some of the uncertainty that we experienced in the second half of last year with the delayed closing of one of our important transactions. With the recent closing of our collaboration transaction, which involved the sale of our facility in Emeryville as well as our sale of equity at a significant premium to market price with Zidus Life Sciences, Agenus has strengthened our ability to go about our business. This collaboration secures long-term US-based biologics manufacturing capacity for us, because it's the facility that we built and it's the team that helped build that facility and operationalize some of the wonderful capabilities of that facility, that will allow us to supply clinical and authorized access programs and support future commercialization, all with the same expert team. And just as importantly, it provides the capital that we need in order to be able to have a level of resilience to be able to execute our strategy with a high level of discipline and focus, and we've already started doing that in the first weeks of this year. As you know, we've talked about this, and I don't think the constituency that looks at us understands the full power of our accelerating momentum for patient access. This started in last September with the surprise to the world of France's reimbursed AAC program. This is a program where every French citizen who is eligible for access to botbal can have access to it, with the French government providing full reimbursement for it. And what began with colorectal cancer in this program has now, in the last few weeks, expanded to include sarcoma and ovarian cancer. Even though colorectal cancer is the largest indication, sarcoma and ovarian cancer patients who have exhausted other means have a very significant potential benefit from botbal. We've of course published and presented this data at a major setting at ESMO in Berlin. It was an important plenary session presented by Michael Gordon, who was one of the participants in our previous webcast program. These decisions, namely patient access, reflect more than regulatory flexibility. They reflect urgency and a recognition that innovation must reach patients who are in need while the confirmatory trials continue. They're a very important consideration because, as you know, confirmatory trials can take a long time, and while we're pursuing those as well, access to patients before based on the data that we have generated, significant data for that matter, is very important. So the urgency that we feel, the urgency that patients feel, is well-founded. When we speak about historically resistant cancers, we're talking about very specifically microsatellite stable tumors. And microsatellite stable tumors are in the form of many different types of cancers, and they represent more than 80% of all solid tumors and importantly, more than approximately 95% of colorectal cancers. I just want to note that, for example, with colorectal cancer, you may have heard in the headlines that there are products such as PD-1s and PD-L1s that have shown some very impressive activity in colorectal cancer patients, but remember, those are less than 5% of the patients. The other 95% of patients targeted by our botbal are the kinds of cancers that don't respond to these other currently approved products. So at the same time, the societal burden of colorectal cancer is accelerating. Just last week, many of you may have heard that the American Cancer Society and Journal of the American Medical Association, JAMA, reported that CRC, unfortunately, is now the leading cause of cancer-related deaths in people under 50. We were expecting this to happen by 2030, but unfortunately for patients and for the overall population, reaching this milestone is now four years ahead of expectations. This is not just a medical challenge. It's a societal crisis, and some countries including France are recognizing both the urgency and the potential value of immunotherapy in responding to it. And lastly, we have the BATMAN randomized trial. It's an important trial for us, of course, and this is a trial that is going to be launched very soon. It is a trial rigorously designed for a global phase three study in the MSS metastatic colorectal cancer, a population as we talked about long considered beyond the reach of currently approved immunotherapies. Of course, the level of engagement we're seeing from investigators and cooperative groups reflects a shared understanding that we're very hopeful about the quick enrollment of the randomized trial. The early efficacy from a large phase one and phase two trials is driving this. When I talk about large phase one and phase two trials, we're talking about close to 500 patients worth of data that has been generated. And now this will be tested in a randomized setting, which is next on the roster for us. Now looking ahead, taken together, these developments shape our priorities for 2026: expanding appropriate patient access through authorized pathways, a very important initiative. You're going to hear a lot more about that during the course of this session and beyond. Preparing for global regulatory filings informed by both clinical trials and real-world evidence. Now, previously, as you know, we've had our challenges with the US FDA in terms of filing for accelerated approval in the US. Well, there are also changes in the regulatory environment in the US. So, we're going to diligently pursue filing in the US for accelerated approval once again. And in Europe, things have been a bit more optimistic, of course, with the progressive way of thinking in Europe. We've had meetings with the European regulators and they have been a lot more receptive for conditional approval possibility than historically what we have faced in the US. Advancing BATMAN with urgency and rigor is a very, very important priority as well. And to be able to accomplish all of this, we're scaling up as we speak our medical affairs capabilities. And this is going to support growing physician and patient interest and responsibility. Our medical affairs team is represented by Dr. Jose Galacias today, and you're going to hear from him both during the webcast session as well as during our Q&A. So unquestionably the role of immunotherapy is expanding. There's no question about it because chemotherapy and some of the other toxic therapies are archaic treatments, and we're confident that they will be either displaced completely by the new generation of treatments like immunotherapies, or they're going to be used as adjunctive treatments to immunotherapy in the future, which is fine. And our responsibility to patients must expand with the expanding immunotherapy usage. And with that, let's begin.

Well, this is an occasion that will allow us to have definition on the next steps for our company, our treatment, our partners. And as you know, transactions take a long time. People don't realize that. They think that we come to an agreement, shake hands, the agreements are drafted and here we go. It doesn't happen that way. Of course, there's excessive negotiation, and as you said, with Zidus, we really started negotiating well over a year ago, and then we came to a point of announcement last June. And of course, our expectation was that after the announcement would come to an expeditious closure. Usually, transactions between two companies are governed by Hart-Scott-Rodino Act, which is an antitrust regulatory act. In this particular case, it was added to that with a national defense clarity that needed to be explored, and regrettably, that took about six months more.

Their needs and our needs had to really match up. This is a company that has a culture. It has the absolute right intentions for the people that they're serving, which includes, of course, their patients and their employees. Zidus is basically a company that has made its fortune in the generics business. It's a 10 billion dollar company in terms of market value. A lot of their operations on the generic side of things is in the US, but they didn't have a manufacturing facility in the US, no biologics manufacturing. And as you know, a number of high value-added biologics, particularly in the oncology field, are coming of age now in the biosimilar area, meaning a number of very high value-added biologics are going to be introduced as biosimilars in the US, of course, and to do that you need to have a US manufacturing facility. So this is what it provides Zidus. With our pipeline is of course driven by biologics, and in our case, our lead programs, botbal, are two antibodies that we aspire to manufacture in our west coast facilities.

You want to make sure that you don't find yourself of not having appropriate supplies of the product that is the cornerstone of this treatment. And I've learned this lesson from many years ago with my affiliation with Imunix, when for a wonderful arthritis product that was introduced, they couldn't produce enough and so they had to put patients on a waiting list. So that has been impregnated into my head, and so many years ago I thought that we wouldn't really want to find ourselves in such a predicament should our product be approved quickly and the demand for it should skyrocket, and that's why we want to have our own manufacturing facility. And so the Emeryville, which is a commercial facility, fulfills that dream for us. Everything is underway. And so with this transaction, we'll be able to meet our needs and meet the demand down the road with a partner who has the same vision that we do. There are honorable people that are in the business of serving the patients, and they have retained our entire team. This is a superstar team. They were key in designing the facility, bring the facility up to where it is today, and they will be continuing with the leadership of our chief manufacturing officer, Al Dudson, who will now be a Zidus executive serving both Zidus and Agenus. So it meets our capital requirements and our operational manufacturing requirements. So it's the best of all worlds, really.

These are critically important questions, and we foresaw those things many years ago, because as you said, we had drug substance being produced in Seattle. It was being shipped to Wuppertal, Germany, and then being shipped back to the US and then back to a warehouse. Every time this happens, it affects costs. There are risks associated with it, and it also affects timelines. Imagine our product visiting multiple continents if it can be made in one location efficiently, and that was the reason, fundamental reason, why we built the Emeryville facility.

You mentioned they have hospitals. In fact, they have oncology hospitals as well. In fact, they have a hospital that also provides patients with free treatment. And so, this is a very noble company. It's a very noble company, and we're delighted that they have these capabilities in India that you spoke about, hospital capabilities as well as clinical research organizations that can streamline the development of a product or generation of clinical data. We visited with their facilities, we visited with their hospitals, several hospitals, and we also visited with the company. Over a dozen physicians, oncologists, came from all over India to Ahmedabad to meet with us. Things got done in one and a half days without any bureaucracy, and this is what we need to implement in our country.

Over my career I had always heard about Hart-Scott-Rodino, HSR, and that's very well known. Of course, the government is in the business of making sure that there's no monopoly, and that clearance for us took literally 30 days because there was no issue. I had never heard of CFIUS, but CFIUS has been in existence for a long time. It's a government agency that is sort of supervised, overseen by the Department of Treasury, Department of Defense, now it's Department of War, and also the Department of Commerce. And its express purpose is to make sure that when a transaction takes place between a US company and a foreign company, that that transaction doesn't pose a national security threat, a very important consideration, but the government is not really a specialist in healthcare per se. And so when this review got started, similar to Hart-Scott-Rodino, we thought it was going to be a relatively straightforward thing.

It was a perfect storm. So we had CFIUS officials, very good people, doing their due diligence, and it's a back and forth educational process, of course, because you don't expect these officials to know much about Agenus or much about Zidus. So there's an education that goes on about both companies. But to the credit of CFIUS officials, these people worked through Thanksgiving, through some of the shutdown, through Christmas, and through New Year's. All of this resulted in an expedited closure. And expedited closure meaning it could have extended more. So wonderful news that the closure came, and now we're able to move forward with many of the plans that we had set out for 2026.

It's not a secret, Stephanie, that we came through a six-month period where our financials were very challenging. No question about it. Very challenging. In spite of the fact that we have a treatment like no other in our industry. I'm a CEO that has worked for no cash compensation for an extended period of time. It is done because of a high sense of responsibility to the patients. Now we have more financial means to attend to our priorities. Given the data that we've generated, data that has been presented at major conferences, it's been published amongst the most prestigious journals. Priorities for 2026 are very clear. Number one, we've seen a growing interest, and I must say substantially growing interest, in our nation programs, namely the paid nation, France, and outside of France. It is our moral responsibility to make sure that that demand is met honorably and with compliance. Number two, priority of the company in the next 6 to 12 months is to make sure that we're on a path to file both in the US and in Europe for the registration of our product, even though the old FDA oncology division has not been helpful in endorsing an accelerated approval filing. We just heard from another company today that they are revisiting this and they're going to go ahead and file for approval even though the FDA, the previous FDA oncology, did not. And the third priority, of course, is to do our randomized trial.

Thank you very much, Stephanie.