Analyst Conference Summary

Biotechnology

conference date: November 9, 2021 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (Q3, third quarter 2021)

Forward-looking statements

Overview: Getting ready for Phase 2/3 trials of AGEN1181, after balstilimab disappointment. Spike in revenue was due to milestones and license fees.

Basic data (GAAP):

Revenue was $252 million, up sequentially from $10.7 million and up from $15 million year-earlier.

Net income was $177 million, up sequentially from negative $84.0 million, and up from negative $52 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.72, up sequentially from negative $0.37, and up from negative $0.28 year-earlier.

Guidance:

Year-end cash around $250 million.

Conference Highlights:

Agenus had announced in October that it had to withdraw the Balstilimab application to the FDA, despite the good data, because of loss of accelerated approval following full approval of another PD1 agent in its indication. The PDUFA date for balstilimab had been December 16, 2021. Filing now would have required a confirmatory trial in cervical cancer, costing over $100 million. Instead will launch an expanded access program. The program of combining it with AGEN1181 will continue.

CEO Garo Armen stated: "With more than 100 patients treated with our Fc-enhanced CTLA-4 antibody, AGEN1181, we are very encouraged by the clinical responses achieved across tumor types. Of note, we are seeing responses in patients who have failed to respond to all other treatment, including PD-1 inhibitors. We will be presenting detailed trial results at the SITC conference this week. " Four pillars of value are: (1) specific therapies like 1181, (2) partnered programs and MiNK, (3) supportive programs like balstilimab, and (4) key operational capabilities including Vision technology.

Next-Gen CTLA-4 agent, AGEN1181, will present data at SITC showing durable responses in 9 cancer types in over 100 heavily pretreated patients. A registrational trial is expected to begin before year-end 2021 in colorectal and gynecological cancers. Could be a best-in-class combination agent, works for cold tumors. AGEN1181 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. Data to date could support filing for regulatory approval.

In Q3 2021 an IPO is planned for MiNK Therapeutics (formerly Agentus) was launched, raising $40 million. A Phase 1 trial of AGENT-797 in hematologic cancers completed dosing. An expansion trial, Phase 1/2, in acute respiratory distress syndrome is underway as of Q2 2021. Data will be revealed at SITC.

Jennifer Buell, CEO of MiNK, "[IPO] Enabled us to create 2 patient focussed companies with streamlined operations and focus." Total funds raised were $46 million. Ready to rapidly advance the portfolio of therapies. SITC posters will show ability to home in on tumors and show anti-tumor activity. MiNK also has a CAR development platform to combine with INKT regimens.

In Q3 2021 Bristol-Myer dosed the first patient with AGEN1777, triggering a $20 million milestone. BMS plans to use it in high-priority indications like non-small cell lung cancer.

Zalifrelimab had its first patient doesd in collaboration with Nelum's hedgehog inhibitor in first line pancreatic cancer. [WM: but due to the bali delay and success of 1181, Zali looks to be de-emphasized.]

AGEN2373, a CD137 agent, showed good results at ASCO 2021. Will combine in trial with 1181 for melanoma in Q4 2021.

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, containing QS-21, against malaria, which has received regulatory approval in Africa. SaponiQx was launched to provide SQ-21 and next-generation agents, collaborating with Phyton Biotech and Ginkgo Bioworks. Will use a plant-cell based technology.

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 $43 million. General and administrative expense was $21 million. Cost of service reenue $1 million. Other expense $0 million. Non-cash interest expense of $16 million. Gain related to debt $6 million.

Cash and equivalents balance ended at $262 million, up sequentially from $74 million. Received $200 million form Bristol. $131 million cash from operations. No debt.

Q&A summary:

1181 at SITC, MSSCRC follow up? Two few people to assign response rates. Doses varied during the trial. Each patient is checked for many biomarkers, so selection criteria will be much more precise going into Phase 2. Data cutoff was July, but Friday posters will have some updated data.

Nelum pancreatic cancer?

Could you partner 1181 with a bigger player? We have some advantages over large companies. We have many agents to mix and match. We have Vision, which is predictive. We could partner 1181 by licensing out ex-US rights, or global co-development.

MiNK ownership? Agenus owns 79%.

SaponiQx could follow the footsteps of MiNK. The goal is to keep immune efficacy from waining. We know it works, it is currently quantity limited.

We are not yet giving details or plans for new trials for 1181. KOLs are excited about data to date. The high safety vs. first generation products is particularly attractive.

Agenus web site

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