Analyst Conference Summary

Biotechnology

conference date: March 14, 2024 @ 5:30 AM Pacific Time
for quarter ending: December 30, 2023 (Q4, fourth quarter 2023)

Forward-looking statements

Overview: First FDA submission for approval could come in mid 2024.

Basic data (GAAP):

Revenue was $83.8 million, up 249% sequentially from $24 million and up 195% from $28.4 million year-earlier.

Net income was negative $48.6 million, up sequentially from negative $65 million, and up from negative $74.1 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.13, up sequentially from negative $0.16 and up from negative $0.24 year-earlier.

Guidance:

Cash should last until beginning of 2025.

Conference Highlights:

CEO Garo Armen stated: "In 2023, Agenus made significant advances across our BOT/BAL development program. Our first target indication is metastatic, refractory colorectal cancer that is not MSI-H/dMMR, for which we are focused on pursuing accelerated approval. We are also pursuing multiple strategies to capitalize the company through this important path in our efforts to bring BOT and BOT/BAL to the forefront of solid tumor cancer treatment. Our vision is to maximize BOT's utility to benefit patients in combination with other immune therapies as well as current standards of care for patients with both early and late-stage tumors." Bot/Bal has now been tested in over 900 patients in multiple challenging cancer types, with good results. In 2024 primary objective is to align with FDA in our Fast Track indication. Agenus is actively pursuing strategic partnerships.

Agenus is pursuing immediate prospects for additional cash infusions, but not stock issuance. 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.

The bot/bal combo received FDA Fast Track designation for patients with metastatic colorectal cancer that is not MSI-H/dMMR and who do not have liver metastases, and who were previously treated with standard combination chemotherapy, anti-VEGF and anti-EGFR if RAS wild type (refractory MSS mCRC NLM). The Phase 2 trial completed enrollment in October 2023. Strong Phase 1 clinical data reported, but detailed Phase 2 data will not be reported until after an FDA meeting in May. Data was also presented in neoadjuvant CRC in January 2024.

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. 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 began in November 2023, which resulted in a milestone payment for Agenus of $25 million in January 2024.

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.

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 $30 million R&D; $53 million non-cash royalty (QS-21); $0.5 million other.

Cost of sales was $0 million. Research and development expense was $67 million. General and administrative expense was $21 million. Cost of service revenue $0.3 million. Other income $0.2 million. Non-cash interest expense of $45 million. Fair value adjustment $0.2 million.

Cash and equivalents balance ended at $76 million, down sequentially from $106 million. In January 2024 received a $25 million milestone payment from Bristol. No debt.

Q&A selective summary:

Extension of the independent investigator MSS adjuvant study will allow for a follow up longer period. The new data is very exciting. Prior MS stable immunotherapy had not been effective, so only allowed 4 weeks before surgery. Our results convinced that a longer therapeutic window should be tested. We expect further deepening of resonses. Will also look for surgical outcomes.

Phase 3 colon cancer launch timeline? Completed Phase 2 enrollment in October. Typically 80% of patients respond within 6 months of first dose. So detailed data will be available in next few months, likely in May. Will first share with FDA, at a midyear meeting, then will make detailed data public and a BLA timeline. Phase 3 would likely start by end of 2024, with a potential PDUFA date by end of 2025.

Discussions with prospective partners for Bot/Bal have developed as data came in. Believes will show broader activity than Yervoy in melanoma. Looking for partner upon first BLA, then want financial support for a broad clinical program across 9 or more cancer types. The partner should be selected in th next several months. We have a number of active discussions right now, but they can take a long time.

Pancreatic patient numbers? Randomized Phase 3 trial, 30 patients in each arm, currently accruing. Has reserved remarkable activity in some relapsed patients in Phase 2. All patients saw a reduction in tumor size, but not all shrinkage was enough to be considered a response. Believes could be generating data that the FDA would grant an accelerated approval for.

The trial was not designed to be statistically powered. We are waiting for data to mature to the point where we have a compelling data set, which could be midyear. Then FDA meeting midyear.

In NSCLC we have seen profound reductions in tumor size and high response rates, but need to do a larger trial to confirm.

Neoadjuvant MSS and surgery? At least one patient with a complete response refused to have surgery. But currently a physician cannot recommend that. Would require appropriate regulatory guidance.

In lung cancer we are looking for subsets of patients with best responses, by biomarkers, before we proceed. But that should happen quickly.

Agenus web site

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