Analyst Conference Summary

Biotechnology

conference date: August 9, 2021 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2021 (Q2, second quarter 2021)

Forward-looking statements

Overview: Made FDA submission of balstilimab in Q2.

Basic data (GAAP):

Revenue was $10.7 million, down sequentially from $11.7 million and down from $26.9 million year-earlier.

Net income was negative $84.0 million, down sequentially from negative $54.4 million, and down from negative $48.2 million year-earlier.

Earnings per share (EPS) were negative $0.37, down sequentially from negative $0.27, and up from negative $0.28 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "In the first half of this year, we announced a collaboration with BMS and advanced our flagship clinical candidate AGEN1181 to an important data inflection point. In the second half, we will disclose this data at a key cancer conference and be ready with our commercial platform in preparation for a balstilimab launch." Also increasing antibody manufacturing capabilities.

Bristol Myers Squibb deal: in Q2 2021 licensed AGEN1777 Fc-enhanced anti-TIGIT for $200 million upfront, possible $1.36 billion milestones, and tiered double-digit royalties.

Agenus is preparing for commercial launch for second line cervical cancer, should balstilimab receive FDA approval.

Jennifer Buell, President and COO said research and development has delivered 17 new products to the clinic. Already preparing infrastructure for launch of AGEN1181, building it to take into account future launches too. Retained ability to combine AGEN1777 with other Agenus antibodies.

The PDUFA date for balstilimab is December 16, 2021. It is eligible for priority review. Target is second-line cervical cancer. Updated data at ASCO was monotherapy had response rates of 20% in PD-L1 positive tumors and 15% in PD-L1 positive and negative tumors combined. That is superior to approved competitors pembrolizumab (Keytruda) and nivolumab (Opdivo).

Zalifrelimab as monotherapy showed active responses in PD-1 refractory tumors, with 1 complete response and 3 partial responses, so a Phase 2 expansion trial of multiple tumor types was launched in Q3 2020, with additional cancers to follow. In Q1 2021 Agenus entered into a clinical collaboration with Nelum Pharmaceuticals for zalifrelimab in combination with NLM-001, Nelum's small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer.

Discussions with the FDA regarding accelerated BLA filing for balstilimab plus zalifrelimab are ongoing. Balstilimab + zalifrelimab Phase 2 trial in second line cervical cancer achieved response rates of 27% in PD-L1 positive tumors with 22% in all tumors (PD-L1 positive and negative) with a median duration of response not yet reached, per data presented at ESMO 2020. Responses continue to improve as data matures. More data will be released in 2H 2021.

Next-Gen CTLA-4, AGEN1181, as of AACR 2021 report, had seven confirmed objective clinical responses in Phase 1/2. More data will be released in H2 2021. A registrational trial is expected to begin before year-end 2021. In Q2 2021 a Phase 2 trial in colorectal cancer was initiated. 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). Also testing cohorts of second-line NSCLC, endometrial cancer and melanoma.

Agenus plans to file for an IND in 2021 for the Fc enhanced TIGIT antibody AGEN1327. Has outperformed all tested competitor antibodies with superior T cell activation in PD-1 or LAG-3 combos.

An IPO is planned for MiNK Therapeutics (formerly Agentus) is planned. A Phase 1 trial of AGENT-797 in hematologic cancers completed dosing, with data later in 2021. An expansion trial, Phase 1/2, in acute respiratory distress syndrome is underway as of Q2 2021.

A data update on a Phase 1 trial of AGEN2373 (a CD137 agonist antibody) will be presented at the 2021 ASCO Annual Meeting in June.

Singled out AGEN2373, a CD137 antibody for solid tumors, as a value generator based on Phase 1 data. Combination trials are planned.

Shingrix is the most effective shingles vaccine; GSK commercial sales have exceeded projections, reached over $2 billion in 2019. Agenus licensed GSK QS-21 Stimulon, a component of Shingrix. A large-scale trial with GSK's Mosquirix vaccine, containing QS-21, against malaria, continued in Africa.

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

First-in-class bispecific, AGEN1223, continues development. In Phase 1 achieved durable SD in ovarian, lung cancer, sarcoma, without liver toxicity. It is being advanced into a combination trial with balstilimab. Data on AGEN1223, a novel bispecific, will be presented at a future scientific conferences.

Prophage for newly diagnosed GBM (glioblastoma, a brain cancer) program continues.

Incyte-partnered checkpoint inhibitors from Agenus continue to be advanced in preclinical or clinical trials. INCAGN1876 (GITR) is in Phase 2; INCAGN1949 (OX40) completed dose escalation. For both development is expected to focus on combination therapy. INCAGN2385 (LAG-3) and INCAGN2390 (TIM-3)are in Phase 1 trials.

Cost of sales was $0 million. Research and development expense was $46 million. General and administrative expense was $17 million. Cost of service reenue $1 million. Other expense $1 million. Non-cash interest expense of $16 million. Contingent consideration (non-cash) $14 million.

Cash and equivalents balance ended at $74 million, down sequentially from $119 million. Subsequent to end of Q2 rerceived $200 million form Bristol. $56 million cash used in operations. No debt.

Q&A summary:

Market strategy for bali as monotherapy? IO combinations generally achieve better results than monotherapy. Particularly improved duration of response. There are regulatory hurdles to beginning with a combination for regulatory approval. We are taking an appropriate path forward. As to the monotherapy launch, we are building relationships with that community, which will also help us with subsequent launches.

Bali Zali combo data at ESMO? Very exciting data, cannot release in advance.

1181 update expectations? Excited about 1181. Now have over 100 patients treated as monotherapy or in combination. Hope to present data by end of year at a major conference. It is performing as a second-generation CTLA-4 agent, with responses not seen in prior agents. We are rapidly expanding the colorectal cohort.

No prediction on whether there will be an Advisory Committee FDA meeting on balstilimab.

Capital spend? We have always been careful with cash. Bristol transaction provides a jump. Expect additional jumps in 2H 2021 from milestones and funding of subsidiaries with outside capital, including QS-21 subsidiary. We expect to be left with a substantial cash cushon at the end of each period.

1327 TIGIT plans? 1777 bispecific has advantages, but 1327 could be an important combination agent, so we will continue to advance it to an IND filing.

We will continue to develop monospecific antibodies, though they may be used in combinations.

Agenus web site

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