Analyst Conference Summary

Biotechnology

conference date: August 3, 2017 @ 8:00 AM Pacific Time
for quarter ending: June 30, 2017 (Q2, second quarter 2017)

Forward-looking statements

Overview: Many milestones expected in 2H. Has 4 antibodies in clinical trials.

Basic data (GAAP):

Revenue was $4.2 million, down sequentially from $27.0 million and up from $6.6 million year-earlier.

Net income was negative $31.8 million, down sequentially from negative $17.1 million, and down from negative $28.4 million year-earlier.

Earnings per share (EPS) were negative $0.32, up sequentially from negative $0.18, and down from negative $0.33 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "In the second quarter, we advanced our anti-CTLA-4 and anti-PD-1 antibodies in preparation for initiating combination trials in the second half of this year. We also produced GMP grade product in our facilities in Berkeley and selected a commercial supplier for our lead antibodies. In addition, our partnering efforts are maturing and we expect to close on several transactions in the second half of this year." "Speed of development in critical today" because approvals have sped up from average of 8 years to 4 years. Experts believe IO combinations will be the driver for therapies going forward. Agenus combines a variety of immuno-oncology platforms under one roof.

Agenus is in multiple discussions to license or partner its antibodies.

Potential milestones for the second half: AGEN1884 (anti-CTLA-4) Phase 1 trial to complete dose-escalation and compile safety and pharmacodynamic data; AGEN2034 (anti-PD-1) Phase 1/2 trial to complete dose-escalation for monotherapy, define optimal combination dose, get receptor occupancy data and recruit patients with second line cervical cancer; AGEN1884+AGEN2034 Phase 1b trial: commencement; AutoSynVax™ (neoantigen vaccine) immunological readouts expected in advanced malignancies; advance cell therapy spin off efforts; secure substantial funds from existing agreements and future transactions.

Good data would set up Agenus to begin clinical trials in 2018.

Incyte (INCY) is collaborating with Agenus to develop GITR and OX40 antibodies (they are immune checkpoint modulators). Renamed to INCAGN1876 & INCAGN1949. There should be data released in the next 6 months.

AGEN1884 partial data released at ASCO showed a partial response in angiosarcoma, and since then that patient experienced a complete response. The patient had failed 9 prior lines of therapy. This CTLA-4 antibody is differentiated from the AstraZeneca (AZN) one that failed its trial last week. It is meant to be developed in a combination therapy. If successful 1884 would be the second CTLA-4 approved after Yervoy.

GSK's Shingrix vaccine, containing Agenus QS-21 Stimulon, is anticipated to receive a U.S. approval in Q4. 97% efficacy "effectively shuts down any contender in this market."

The Basel, Switzerland facility will be closed down in 2017, functions moved to Cambridge, UK.

The Phase 1 trial for its PD-1 antagonist AGEN2034 in second line cervical cancer continued.

1884 + 2034 combination will commence a Phase 1b trial in before the end of 2017.

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

AGEN2041, a distinct CTLA-4 antibody, will start clinical studies in 2017.

AutoSynVax for cancers initiated a Phase 1 trial in April and already closed accrual. The ASV program targets cancer neoantigens with an autologous synthetic vaccine approach. Readouts should be available before the end of 2017. Is used with QS-21 adjuvant.

GSK's malaria vaccine containing QS-21 expects to begin distribution in Africa.

Manufacturing capability has been successfully tested with AGEN2034.

Working with Amgen on research collaboration on phosphopeptide program..

A portfolio of undisclosed checkpoint modulators is being advanced in the lab. Neoantigen vaccines continue to be developed. Animal models have shown synergy between CPMs and vaccines. Agenus is identifying mutated proteins from cancers that could serve as a basis for vaccines.

Cost of sales was $0 million. Research and development expense was $25.8 million. General and administrative expense was $8.1 million. Contingent fair-value adjustment of negative $0.9 million. Leaving operating income at negative $28.9 million. Other expense was $3 million.

Cash and equivalents balance ended at $96.8 million, down $27 million sequentially from $124 million. No debt.

Cash burn has been reduced, so cash now should last until new cash from strategic transactions comes in.

Agenus is talking to potential partners about collaborations or licensing of its potential therapies.

Q&A:

AutoSynVax, what metrics will be used? We accrue all the patients almost immediately. It is mainly to test for safety, but also looking at efficacy. And we expect to see that, with tests for immune response. Combination trial should begin towards the end of this year.

2034 competitiveness? Several paths forward, like selecting a different set of patients.

1884, 2034, and AutoSynVax combination possibility? 1884 + 2034 could begin first part of 2018.

CTLA-4 + PD1 dosing color? We have good data. No reason not to use the dosing schedule already approved for other indications.

Phase 1b dosing? Prudent and conventional dose escalation exercise. Anti PD1 at full dose, CTLA-4 at low dose to ensure patient safety.

We are not selling rights in the coming deals, we are allowing them to use our drugs in combination trials. Our concentration is on North American markets. For ex-U.S. we are discussing licensing with third parties.

LAG3 plans? We licensed LAG3 to Incyte, so it is up to them to comment on their plans.

1884 trials, have you taken biopsies to determine mechanism of action? No. We have the functional equivalent of Yervoy.

Tigit program? No timeline disclosure, but we are advancing it quite aggressively. It is a priority program.

Agenus web site

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