On May 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers provided a corporate update and reported financial results for the first quarter of 2020 (Press release, Agenus, MAY 7, 2020, View Source [SID1234557320]).
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"We accelerated the development of AGEN1181, advanced our plans to file our BLAs and filed two INDs for our allogeneic iNKT cell therapy to treat cancer and COVID-19," said Garo Armen, Ph.D., Chairman and CEO, Agenus. "Our ability to rapidly enroll in our bali and zali trials, in just 2 years, underscores the speed with which we can advance our AGEN1181 +/- bali and our innovative pipeline of products including allogeneic cell therapy programs."
AGEN1181, reveals clinical benefit1 in >70% of response-evaluable patients
Early data suggest that AGEN1181 could be a breakthrough in IO treatment:
Confirmed CR with AGEN1181 (1 mg/kg) in advanced endometrial cancer with a poor prognosis
Confirmed PR (significant tumor reduction) in advanced endometrial cancer with low-dose AGEN1181 + balstilimab
Disease stabilization in the majority of response-evaluable patients
Advisory board endorsed accelerated plans for AGEN1181 development
Balstilimab & zalifrelimab demonstrate ~26% response rates which are durable in an all-comer, non-biomarker selected population
Large cohort analysis (n=55) bali + zali demonstrate ~26% response rates (4 CRs, 10 PRs) in refractory cervical cancer
Responses are durable over 12 months
Allogeneic iNKTs advancing to clinic for the treatment of cancer and COVID-19
COVID-19: iNKTs designed to eliminate COVID-19 virus, dampen harmful inflammation, and promote protection from reinfection (FIM 1H2020)
CANCER: iNKTs designed to promote anti-tumor immunity in cancer & enable optimal combinations with Agenus checkpoint antibodies
Potential best and first in class TIGIT programs advancing to IND filing starting in 4Q2020
Fc enhanced TIGIT antibody (AGEN1327) has outperformed all tested competitor antibodies with superior T cell activation in PD-1 or LAG-3 combos
TIGIT bispecific (AGEN1777) demonstrated potent tumor killing in a difficult to treat colon cancer model where PD-1 antibodies alone are ineffective
Key Upcoming Milestones Expected
BLA filings and pre-commercial activities
IND filings for (2) TIGIT programs in 4Q2020 & 1H2021
Ongoing read-outs from lead clinical trials (AGEN1181, Balstilimab, Zalifrelimab)
Deliver new partnerships
Reduce annualized burn by $50M to mitigate any pandemic related business risk
First Quarter Financial Results
We ended the first quarter of 2020 with a cash balance of $92.3 million as compared to $61.8 million at December 31, 2019.
For the first quarter ended March 31, 2020, we reported a cash burn from our operations of $32 million. Net loss for the quarter was $45 million or $0.31 per share which included non-cash expenses of $16 million. We generated net income for the same period in 2019 of $17 million or $0.14 per share. In the first quarter of 2019 we recognized revenue of $80 million which included revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned. For the same period in 2020 we recorded revenue of $15 million primarily related to non-cash royalties earned.
To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International) and ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or with this link View Source
A replay will be available on the Company’s website approximately one hour after the call and will remain available until July 7, 2020.