Analyst Conference Summary

Biotechnology

conference date: 6:00 AM Pacific Time, November 7, 2023
for quarter ending: September 30, 2023 (Q3, third quarter 2023)

Forward-looking statements

Overview: Updated cancer therapies data in October. First FDA submission for approval could come in mid 2024.

Basic data (GAAP):

Revenue was $24 million, down 4% sequentially from $25 million and up 5% from $23 million year-earlier.

Net income was negative $65 million, up sequentially from negative $73 million, and down from negative $57 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.16, up sequentially from negative $0.20 and down from negative $0.19 year-earlier.

Guidance:

With expected deals cash should last into 2025.

Conference Highlights:

CEO Garo Armen stated: "The botensilimab franchise, after treating more than 750 patients, has demonstrated consistent tumor responses across a diverse range of nine tumor types, showcasing its potential for significant impact in oncology. The emerging data indicating the efficacy of botensilimab in earlier stages of cancer marks a notable shift towards less invasive treatment options. Agenus is forging ahead with a focus on our regulatory filing in CRC, advancing our robust clinical pipeline, and committing to deliver substantial outcomes for patients and create value for our shareholders."

Agenus is pursuing immediate prospects for additional cash infusions, but not stock issuance, including a milestone payment from a partnered programs, expected by the end of 2023. Agenus is in the process of selling two non-strategic assets plus the partial sale of other milestones and royalties due to Agenus from partnered programs. These three sales are expected to close by the end of the first half of 2024. This should provide funding through the end of 2024, into 2025. In addition Agenus is in advanced discussions for a potential structured financing for BOT/BAL as well as a potential corporate collaboration with a large pharma or biotech company.

Next-Gen CTLA-4 agent, botensilimab (AGEN1181) reported updated data at with or without balstilimab (BAL), is broadly effective in treating five advanced solid tumors: colorectal, pancreatic, lung, melanoma, and sarcoma.Over the past 12 months, clinical data on BOT/BAL has been featured in six oral or plenary sessions at major cancer conferences and published in peer-reviewed medical and scientific journals.Considering the poor treatment alternatives for patients with advanced colorectal cancer (CRC) and the promising, long-lasting benefits of BOT/BAL, a Biologics License Application (BLA) is anticipated for submission to the FDA for microsatellite stable (MSS) metastatic CRC in mid-2024. Enrollment for the ACTIVATE-CRC Phase 2 Trial is complete; data readouts for the ACTIVATE-Pancreatic, ACTIVATE-Melanoma, and the Phase 1b trial in non-small cell lung cancer (NSCLC) are expected throughout 2024.

Bristol Myers Squibb's BMS-986442,(was AGEN1777), is a bispecific antagonist targeting TIGIT and CD96. It is designed to augment tumor-reactive T cell activity through its Fc-enhanced region. Following the licensing agreement in 2021, the phase 1 study in solid tumors concluded successfully. A phase 2 dose expansion study is underway, assessing BMS-986442 in combination with nivolumab, with or without chemotherapy. Dosing of the first phase 2 patient is scheduled for November 2023, which will result in a milestone payment for Agenus.

The combination study of AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to PD1 therapy continues to enroll. Monotherapy results for Phase 1 was presented on June 3, 2023 at ASCO. Responses in metastatic prostate cancer, ampullary carcinoma, and vulvar squamous cell carcinoma were reported. Data from the combination portion of the study will be presented later in 2023.

In second line pancreatic cancer, a Phase 2 random study update is expected in 1H 2024, with a possible sBLA filing in 2025.

There has also been positive indicators in the trials for neoadjuvant CRC, refractory melanoma, NSCLC, and advanced sarcomas.

Shingrix is the most effective shingles vaccine; GSK commercial sales have exceeded projections. Agenus licensed GSK QS-21 Stimulon, a component of Shingrix. It is also a component of GSK's Mosquirix vaccine, against malaria, which has received regulatory approval in Africa. SaponiQx subsidiary was launched to provide SQ-21 and next-generation agents, collaborating with Phyton Biotech and Ginkgo Bioworks. Will use a plant-cell based technology. SQ-21 Stimulon is also a component of the GSK RSV vaccine that was approved by the FDA in May 2023.

Revenue consisted of $3.4 million R&D; $20.4 million non-cash royalty (QS-21); $0.5 million other.

Cost of sales was $0 million. Research and development expense was $51 million. General and administrative expense was $19 million. Cost of service revenue $0.3 million. Other expense $1 million. Non-cash interest expense of $19 million. Fair value adjustment $ million.

Cash and equivalents balance ended at $106 million, down sequentially from $158 million. $ million cash used in operations. No debt.

Q&A selective summary:

The data that has been disclosed in the Phase 2 studies indicates we should have an improving respnse rate as the data matures. It is a regulatory decision as to when to disclose it and to make the BLA decision.

Neoadjuvant plans? These tend to be large studies and lengthy. But we may be able to look at a high morbidity with standard of care subset, and compared to that have a shorter study. Standard of care currently often requires colestomy bags. So hope is to start a trial in the first half of next year.

Fully enrolled randomized CRC study bar? 5 arms, one is standard of care. Randomized. 4 arms with bot, 2 with bal. Seeing a substantial benefit in the combination. Standard of care response is 3%. Bot/bal is showing 24%. We only need to show it is better than standard of care. We believe adding bal should at least double the response. Note there are 1 and 2 milligram/kilogram dose cohorts.

OR at time of BLA? We would have evidence trends. We know from Phase 1 responses are translating to durable response and substantial overall survival. After submission we can present updated data. So far the longer the study goes, the better the survival.

Cash guidance details? $40 million Q4 burn. Milestone payment due by year end. Sale of 2 nonstrategic assets by mid 2024. Then the third party transaction for royalties. Total $200 million or so cash. Should take us well beyond the end of 2024.

2nd line CRC approval confirmatory study? Two choices: first line setting, or 2/3 line. Only talked with FDA about 2/3 line so far, waiting for more data. We want to accelerate access for a broader patient population, but is data dependent and needs FDA and EU alignment.

Pancreatic cancer number of patients? Enthusiasm about data, so expanding to another 60 randomized patients in coming months.

We are seeing single agent activity in melanoma, including in CTLA-4 and PD1 refractory patients, should have data in 2024.

We are discussing a global collaboration for all indications, and possibly segregating by indications. A good deal would be driven by the appropriateness of the partner, their ability to see the value of bot. We see an enourmous need for our product, so the partner must have high conviction, including in the commercial potential. We want a partner who will suppport rapid development.

CRC with liver mets? Liver mets are a black box right now, patients don't respond well to therapies. Liver has special immuno suppressions. Some of our pancreatic cancer patients had liver met responses, so we are looking at a plan of action. Would start with a small trial. If we move to a first line cRC Phase 3 trial we would treat all comers.

Agenus web site

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