Agenus Inc. Chardan's 10th Annual Healthcare Conference

Okay. I don't think it's on.

Okay, now it's on. Fantastic.

Thank you. Thank you, Andreas.

Thanks, Andreas, and thank you, Dr. Schlechter, for being here as well. We made the decision during the July financing discussions to move to the phase III ROBIN trial as our sole registration-enabling trial focus. As Dr. Schlechter pointed out, there is a significant need in the late line metastatic setting, and the company continues to believe wholeheartedly in that need. We have pursued multiple regulatory pathways and other pre-marketing authorization pathways to ensure that patients have access to the drug. We have a compassionate access program where patients have access to the drug in 30-odd different countries. We have our program in France, which is through the AAC program, where the therapy is being reimbursed by the French government for patients in late-line refractory MSS colon and rectal cancer, sarcoma, and ovarian cancers.

As Andreas just mentioned, we just got our first marketing authorization in Armenia for the advanced metastatic MSS colorectal cancer setting. We are doing everything we can from a patient access perspective to ensure that patients who want access to the therapy have ways that they can access it in multiple different countries. We did enroll over 1,000 patients now across late-line metastatic settings. Dr. Schlechter and his team at Dana-Farber were a big part of many of those trials. We have a plethora of data that supports the value proposition of this therapy across major late-line tumor settings, and we hope that that will become part of future sponsored work. It may become part of the way that oncologists decide to prescribe the drug, even if we do not have yet a label there. That is a completely separate commercial topic, which I will not get into.

As far as the company's focus, and our strategic decisioning around moving to the ROBIN trial in the neoadjuvant setting, there were many factors. One, it was a bandwidth and resource consideration. It is really hard to go stand up a global phase III trial for any small or mid-size biotech company. The idea of doing two of those at the same time was a concern around bandwidth and resources. Of course, capital resources being something that are an important consideration in our industry and needing to focus those capital resources on the Stage II/III colon cancer setting, was a decision that we came to. As Dr. Schlechter pointed out very clearly and elegantly, this is the area where we can make the most profound impact on patients.

You talk about the ability to deescalate the use of chemotherapy in the case of rectal cancer, to deescalate the use of radiation along with mutilating surgeries and preserving the organ, in the case of patients who have to receive an ostomy procedure, and then just the ability to drive higher event-free survival. These patients who have been treated with BOT/BAL in both NEST and UNICORN, those patients had a very short treatment course of BOT/BAL, and they all are remaining treatment-free now for multiple years in the case of NEST, and we plan to have updates to UNICORN as well in the coming weeks and months. This is an exciting setting for us and for many oncologists around the world, and we are really focusing all of our time and energy on getting the trial ready to begin enrollment.