Agenus Inc.

Welcome to the Janus first quarter 2022 financial results conference call. My name is James, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the Q&A session, if you have a question, please press 01 on your touchtone phone. And I'd now like to turn the call over to Ethan Lovell, Chief External Affairs and Communications Officer. Mr. Lovell, you may begin.

Thank you, James, 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 contain 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 on the call are Dr. Gero Arman, Chairman and Chief Executive Officer, Dr. Steven O'Day, Chief Medical Officer, Dr. Dan Chand, Head of Drug Discovery, Christine Klaskin, Vice President of Finance, and Dr. Jennifer Buell, Chief Executive Officer of Mink Therapeutics. Now I'd like to turn the call over to Gero to highlight our progress and speak to our outlook for the remainder of the year. Gero?

Thank you, Ethan. And thank you all for being with us today. As we all have witnessed, the biotech sentiment is the most negative we've seen in decades. Given the current climate, I'd like to begin today's call by indicating that we are aware of this reality and are putting on hold all programs which are not critical for near-term value generation. Wireless, and importantly, We are marching ahead with programs which we believe have the prospects of generating significant near-term value. Overall, we expect these steps will result in significant cost reduction for the balance of this year. Ironically, despite recent trends, scientific and medical innovation is at an all-time peak. It appears that irrational exuberance coupled with recent regulatory uncertainty, I'm mumbling my words here by even talking about regulatory uncertainty, but particularly this is happening in the U.S., of course, has made it more difficult for investors to differentiate between the good, the bad, and the ugly. Still, some companies will continue to innovate and achieve success. Several like us have already started restructuring their operations and curtailing their ambitions to adjust to current realities. While this shifting environment has led to a discouraging financial climate for biotech, we believe companies like Agenis with integrated capabilities and importantly platforms which can drive continuous innovation will emerge at the forefront. A few will be able to build significant value while advancing profoundly effective treatments and cures. At Agenis, we expect that our portfolio of innovative discoveries and our steadfast commitment will trump all hurdles and deliver life-changing medicines to patients while creating significant value for all stakeholders. Thus, Agenis' strategy is to continue to drive innovation in today's shifting environment. Now I will outline our highest priority programs, starting with Potencilumab, our most advanced fully-owned program represents the highest potential in our portfolio. This is, by the way, based on the fact that the compound, Potencilumab, is the most advanced in the clinic among the novel compounds that we have in our portfolio. Our expectations of Potencilumab as a potential blockbuster I.O. agent are supported with additional clinical data, which we expect to present at an upcoming cancer conference. Botansilumab is an activator of both innate and adaptive arms of the immune system. Data from our proprietary vision platform continues to support its broad and unique activity, including responses in patients with so-called cold tumors, which typically do not respond to immune therapy. We have expanded patient enrollment in our existing clinical trials in specific cohorts of patients, which will form the basis of our Phase II studies in colorectal cancer, melanoma, and pancreatic cancer. Our efforts to initiate these studies are currently in high gear. Our clinical development strategy of Potencilumab is to demonstrate clear superiority to existing checkpoint immunotherapies and or other standards of care. This is based on strong signals we have observed in our Phase I study in patients who were heavily pretreated. These observations led to our prioritization of relapsed refractory melanoma, MSS colorectal cancer, and pancreatic cancer as our target indications for potential approval. Now, for a minute, for context, colorectal cancer is the third leading cause of cancer-related deaths in the United States, with over 50,000 Americans dying each year. Immunotherapy treatments in colorectal cancer have been largely unsuccessful, partly because Most colorectal cancers are cold tumors. And for those with metastatic disease, five-year survival rates are in the low teens. Also for context, current standards of care for patients which are represented in our trials deliver approximately a 2% response rate with significant side effects and minor improvement in survival. In contrast, botansilumab in combination with our anti-PD-1 bolstilumab has delivered significantly higher response rates, which will be discussed soon. Botansilumab also holds significant potential in melanoma, where despite treatment advances, there remains few effective therapies for those who fail frontline regimens, particularly with immunotherapies as well. In addition to these indications, we presented data at last year's CITSE, demonstrating that rotencilumab benefits in several other cold tumors, including endometrial, cervical, and pancreatic cancers. Over 50% of patients treated with botansilumab had received at least three prior lines of therapy. Botansilumab produced objective responses in these difficult-to-treat patient settings. Hence, we're preliminarily exploring development strategies across these indications to bring therapy options to patients who have limited or no options today. The unique attributes of Potencilimab have been the result of the deliberate efforts of our team, who engineered this molecule based on their understanding of tumor biology and the immune system. These translated into a unique mechanism of action, which results in the activity of Potencilimab across a variety of tumors. We presented botansilumab's activity in nine different tumors. While this botansilumab binds to CTLA-4, it has a much broader activity by targeting both the adaptive and the innate immune arms of the system. We're working closely with scientific and regulatory experts to advance potencylamide in hard-to-treat cancers, which I mentioned, include cancers characterized by cold tumor types. We're hopeful that the unique attributes of this molecule will lead to life-changing outcomes for underserved patients, including potential treatments for pediatric cancers. While advancing our portfolio with our high priority programs, we're also pursuing our business development plans with potential collaborators. In addition, we're actively looking at innovative financing mechanisms, which we have excelled in delivering previously. Adopting our business model in consideration of the current industry landscape is for us a critical extension of our innovation. and strategic thinking. Agenis has had an impressive track record of VD transactions and innovative financings with more than $800 million raised in just the past six years and potential to realize significant milestone in royalty payments from six different companies involving eight product candidates currently in clinical development. As Agenis moves with speed and innovation to execute our scientific discovery and clinical research, we're committed to taking the steps which will ensure our medical advances will be widely available to patients all over the world. Investing in integrated discovery development and manufacturing capabilities and emphasizing on international approaches to clinical development and commercialization are critical to achieving our objectives in this regard. We're putting these strategies into practice. For example, with Balzac, as we strive to make this combination available in ex-U.S. territories and as we continue to prioritize industry partnerships, which allow Agenis to retain elements of independence and control over the development of our molecules. It is also noteworthy to mention that Agenis' science has already advanced 16 discoveries into clinical development, and with a very exciting cell therapy company, represented today by the CEO, Dr. Jennifer Bew. that's Mink Therapeutics, created as a separate company, and another, Saponix, potentially in the making. Our ability to discover and innovate best-in-class molecules and treatments has been the basis for a significant number of productive industry partnerships. Our company values and the high worth we place on science has been instrumental in industry breakthrough therapies, such as GSK's Shingrix vaccine, with current analyst estimates of approaching $3 billion in annualized revenues this year. As I mentioned earlier, we're also sharpening our focus around expense management. to extend our runway to continue with our discoveries uninterrupted. Every aspect of this process matters to us. We have initiated a comprehensive review to eliminate non-discretionary spending and implement highly efficient practices. While we believe Agenis is in a strong financial position with over $260 million in cash, Our view is to exercise a conservative fiscal policy, particularly in times of uncertainty in financial markets and drug regulation. Our focus also includes our technology advancements, which drive efficiencies in product discovery and innovation. This is highlighted by our unique discovery platform, Vision, which has led to, among others, to our emerging work on myeloid checkpoint targets. At AACR in April, we presented data on our anti-ILT2 anybody, agent 1571, which represents our first fully-owned clinical stage myeloid targeting agent. In preclinical studies, agent 1571 has already demonstrated several important advantages. We expect to enroll patients in our phase one studies of agent 1571 shortly. Our plans are to evaluate this agent both as monotherapy and in combination guided by readouts from our vision platform. Last month, We also announced the receipt of a $5 million milestone payment from our partner, Gilead Sciences. While this is a tiny amount, it denotes the advancement of agent 2373, RCD137 agonist, which has unique advantages over other molecules. CD137 is an important pathway for anti-tumor immunity due to its ability to enhance T cell and NK cell proliferation, cytokine secretion, and cellular cytotoxicity. Importantly, Agen 2373 was designed to mitigate the liver toxicity that has limited the advancement of a first-generation molecule. Gilead retains an exclusive option to license Agen 2373, while Agenis has the ability to opt in for a 50-50 profit share and U.S. commercialization rights. Agenis stands to receive up to $570 million in future potential option fields and milestones from this product candidate alone. And that would be, of course, additional royalty payments, depending on the magnitude of a product like this upon successful launch. Development of AGEN-1777, our FC-enhanced digit by specific antibody partnered with BMS, is also advancing in the clinic. We continue to believe One-triple-seven represents a best-in-class antibody with an increasing body of evidence suggesting, indicating that FC enhancement is required to achieve optimal results with a digit-targeting approach. The programs I highlighted today signify Agenis' unique ability to advance our own pipeline with our own combinations. which is also enabled by information and knowledge we gather from our proprietary vision platform. Among others, vision informs upstream target prioritization and downstream biomarker identification as well as trial design. It is this ability to work rapidly with independence and integrity driven by science that positions Agenis to be a leader in biotech's currently shifting environment. So thank you very much, and I now turn it over to Christine, and I'll come back shortly after that.