Agenus Inc.

Good morning. My name is Audra, and I will be your conference operator today. At this time, I would like to welcome everyone to the Agilent Inc. fourth quarter and full year 2023 results conference call. Today's conference is being recorded. 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 would like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 1 again. At this time, I would like to turn the conference over to Zach Arman, Head of Investor Relations. Please go ahead.

Thank you, Audra, 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, among other updates. These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Garrow Arman, Chairman and Chief Executive Officer, Dr. Steven O'Day, Chief Medical Officer, and Christine Klaskin, Vice President of Finance. Dr. Robin Taylor, Chief Commercial Officer, and Dr. Todd Yancey, Chief Strategic Advisor, will be participating in the Q&A session. Now, I'd like to turn the call over to Gero to highlight our progress in 2023 and to speak to our outlook for 2024. Gero. Thank you very much.

Ladies and gentlemen, today it is with great enthusiasm that we gather to share the remarkable strides Genesis made over the past year. Our journey has been marked by significant achievements. pivotal milestones, and a steadfast commitment to innovation in the field of oncology. In 2023, Agenis reached crucial milestones, particularly with our But-Mal program, a cornerstone of our operational focus. But-Mal therapy has undergone rigorous testing in over 900 patients, demonstrating promising activity in cancers that represent significant unmet medical needs, notably colon cancer, where we are poised for potential first approval. The impressive response rates, sustained durability, and overall clinical efficacy observed across multiple challenging cancer types have garnered attention and excitement from leading experts in the field. It is essential to note that the patients enrolled in our trials have exhausted available standard treatments, making clinical responses achieved all the more meaningful. Our achievements in the past year underscored the immune potential, immense potential of botansilumab, both as a standalone therapy and in combination with botansilumab and or chemotherapy. All of these trials are currently ongoing. The presentation of our data at six prestigious scientific forums and publication in five peer-reviewed journals is a testament to the robustness and significance of our findings. Dr. Odey will delve into the clinical data shortly, providing more detailed insights during this call. The resounding feedback from over 1,000 physicians we engaged with over the past year underscores the transformative impact of our work and the impact it could have on patient care. Furthermore, the fast-track designation granted by the FDA acknowledges the urgent need for new treatments in our lead indications, which is refractory, MSS-CRC, in non-liver metastatic patients. As we stand on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval filing. Our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards. In 2024, our primary objective is to pursue a global regulatory strategy for buck bowel in our fast track indication. Following alignment with the FDA, we intend to initiate the submission of our biologics license application, otherwise known as a BLA, for potential accelerated approval. Subsequently, pending feedback from scientific and regulatory advice in Europe, we plan to submit to the European Medicines Agency, known as the EMA, in 2025. To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory authorities with a comprehensive data package that demonstrates the safety, efficacy, and Clinical Pharmacology of Butt-Bell in Refractory MSS-CRC. Our Phase II study, completed in October 2023, or I should say completed enrollment in 2023, was meticulously designed to evaluate Butt-Bell's dosage and the contribution of its components. Additionally, by the end of 2024, we anticipate initiating a Phase III study in the patient population of our proposed indication. Our commitment to transparency and stakeholder engagement remains unwavering as we progress towards delivering these potentially life-altering treatments to patients. Looking ahead, our mission to enhance the lives of cancer patients to the power of the immune system remains steadfast. That's been our mission from day one, 30 years ago. Of course, today we're leading the charge in our dynamic portfolio of agents. To expedite this transformative journey, we are actively exploring strategic partnerships. Our ongoing collaborations have already yielded significant returns, exemplified, for example, by the recent $25 million milestone payment from BMS, triggered by the commencement of a phase two study with BMS 986442, this is a tiget by specific antibody discovered and the early development was done by a genus and it was licensed to BMS. We have received a total of $250 million from this collaboration thus far. Moreover, we are progressing our efforts to monetize non-core assets and explore royalty financing and project funding opportunities, with the potential to generate an additional $100 to $200 million in the relatively near term. Furthermore, we're engaged in discussions with several prospective pharmaceutical partners, exploring avenues for co-marketing and co-development agreements, specifically for Bad-Bao. Dr. Odey will now provide an overview of our latest clinical findings, further illuminating the groundbreaking progress we've made so far. Thank you for your continued support and confidence in Agenis. Together, we are pioneering a new era in cancer treatment, one that offers hope and healing to patients worldwide. Dr. Odey.