Analyst Conference Summary

Biotechnology

conference date: November 8, 2022 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2022 (Q3, third quarter 2022)

Forward-looking statements

Overview: Initiated Phase 2 trials of botensilimab.

Basic data (GAAP):

Revenue was $23 million, up sequentially from $21 million and down from $253 million year-earlier.

Net income was negative $57 million, down sequentially from negative $49 million, and down from $177 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.19, down sequentially from negative $,0.17 and down from $0.72 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "Botensilimab has demonstrated impressive clinical responses in nine cold, treatment-resistant tumor types with strong durability, and we look forward to presenting expanded data in colorectal, ovarian, lung and sarcoma cohorts at a plenary session at SITC followed by our R&D event this Saturday. In light of these compelling clinical data, we have expanded our leadership team to accelerate the development and seek registration of botensilimab with the aim of delivering this potentially transformative new therapy to patients across multiple tumor types." Believes can continue to generate non-dilutive cash from partnerships.

Next-Gen CTLA-4 agent, botensilimab (AGEN1181) initiated Phase 2 trials for advanced refractory MSS colorectal cancer and for melanoma patients who failed prior PD1 and/or CTLA4 therapy in Q3 2022. A trial in pancreatic cancer will begin in December 2022. Will present more Phase 1 data at SITC on November 12, 2022. In Q2 2022 presented updated data at ESMO showing clinical activity in microsatellite stable colorectal cancer. Combined botensilimab and balstilimab for MSS CRC had a 24% ORR and 73% disease control rate in heavily pretreated MSS CRC (cold tumors, PDL1 negative). Phase 2 studies are now planned in melanoma, colorectal, and pancreatic cancers. Botensilimab is designed to delete T-regs and increase priming. It also overcomes the genetic polymorphism displayed by about 40% of the target cancers (which makes Yervoy unresponsive). Both monotherapy and combination therapy were well-tolerated.

The first patient was dosed with AGEN 1571 in July 2022, alone and then combined with botensilimab and/or balstilimab, in solid cancers. It is an ILT2 inhibitor that targets tumor associated macrophages, which promote resistance to PD-1 and CTLA-4 therapy. Preclinical data was presented at AACR 2022 in April. Another Phase 1 study is planned.

The combination study of AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to PD1 therapy continues to enroll.

AGEN1423 data for pancreatic will be updated at SITC.

In Q3 2023 Bristol Myers launched a Phase I/II study of BMS-986442 (a TIGIT bispecific discovered by Agenus, was AGEN1777) in combination with nivolumab or chemotherapy in patients with advanced solid tumors and non-small cell lung cancer.

In Q3 Merck initiated a Phase II study of MK-4830 (a candidate ILT4 antagonist discovered by Agenus) in combination with pembrolizumab and chemotherapy in ovarian cancer; additional Phase II studies are ongoing in NSCLC, small cell lung cancer, esophageal cancer, MSI-H colorectal cancer, renal cell carcinoma, and melanoma.

In Q3 Incyte initiated a Phase II study of INCAGN02385 (LAG-3) and INCAGN02390 (TIM-3), both discovered by Agenus, in combination with anti-PD-1 in 1L squamous cell carcinoma of the head and neck; additional Phase II studies are ongoing in melanoma, endometrial cancer, and urothelial carcinoma.

Looking for innovative financing and more partnerships while reducing expenses.

Bali/Zali combination will continue to be developed for possible use in ex-US territories.

Incyte therapies licensed from Agenus continue to advance in the clinic.

Shingrix is the most effective shingles vaccine; GSK commercial sales have exceeded projections. Agenus licensed GSK QS-21 Stimulon, a component of Shingrix. Non-cash royalties were $0 million in Q2 2021, down from $8 million year-earlier. 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 now has a PDUFA for May 2, 2023.

The platform includes the capability of identifying patients likely to respond to therapies before those therapies are administered in clinical trials.

Cost of sales was $0 million. Research and development expense was $46 million. General and administrative expense was $18 million. Cost of service revenue $0.3 million. Other income $1 million. Non-cash interest expense of $16 million. Adjustment of fair value $0 million.

Cash and equivalents balance ended at $218 million, down sequentially from $238 million. $33 million cash used in operations. No debt.

Q&A summary:

SITC presentation will include data from more CRC patients. Mature data will be presented in other indications. More data at major conferences in early 2023. We are rapidly acruing expansion cohorts.

AGEN 1571? Patients who don't respond to PD1 or CTLA4 have myeloid cells that produce high levels of ILT2. Our antibody has shown stronger preclinical data than competitors. 1571 is in clinical studies, we could have data later in 2023.

Dose dependent response? We only report confirmed responses. We tried other doses, but most of the SITC data is from 1 mg or 2 mg/kg doses. We are concentrating in the combination cohorts. The clinical activity data is remarkable.

Liver metastasis with CRC? We are seeing responses in both liver and non-liver, but the response rate is higher in non-liver. There are a significant number of patients who do not have liver mets. We think we have clinical benefit across CRC. Myeloid cells defend the liver mets, so we want to add in our 1571 ILT2 agent.

Duration of response? We want to cure cancer. CTLA4 agents can have complete, durable responses. We are seeing strong single-agent activity with botensilimab, including deep, durable responses that are clinically meaningful.

Agenus web site

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