On May 9, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided corporate updates and reported financial results for the first quarter of 2019 (Press release, Agenus, MAY 9, 2019, View Source [SID1234536002]).
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"2019 is off to a strong start. We have made significant progress towards our efforts to bring transformative treatments to cancer patients." said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In the first quarter of this year, we have strengthened our balance sheet, accelerated enrollment in our BLA path trials, and started a new clinical trial with our second generation CTLA4."
Achievements
Strengthened balance sheet
Closed on our collaboration with Gilead, which included $120M upfront, $30M equity investment and up to $1.7B in potential additional fees and milestone payments plus royalties
Received $7.5 million from Gilead as milestone payment for IND acceptance of AGEN1423 (now GS-1423), by the FDA
Enrollment in lead trials progressing; On track for BLA in 2020
Ongoing trials in cervical cancer are designed to support BLA via accelerated pathway
We plan to expand PD-1 development in additional indications through novel funding mechanisms
Enrollment proceeding in next-gen CTLA-4 trial
Started first-in-human trial with our next-gen CTLA4.
Enrollment advancing, and combinations and data expected this year
Advanced new discoveries, towards the clinic
First-in-class bispecific licensed to Gilead, GS-1423 IND accepted by the FDA
On track to file an IND for a CD137 agonist and an off-the shelf phosphorylated neoantigen vaccine
QS-21 Updates
Sales of Shingrix, containing our QS-21 Stimulon, continue to increase; GSK projects 2019 sales will exceed $1.3Bn and pledged $100M investment to expand production of its adjuvant system
A large-scale trial with QS-21 containing Mosquirix vaccine against malaria, began in Africa
AgenTus Cell Therapy Business:
2019 INDs are on track
Partnership and private financing discussions are underway
First Quarter 2019 Financial Results
We ended the first quarter of 2019 with a cash balance of $158 million as compared to $53 million at December 31, 2018.
For the first quarter ended March 31, 2019, we reported net income of $17 million or $0.14 per share compared to a net loss for same period in 2018 of $54 million, or $0.53 per share. In the first quarter we recognized revenue of $80 million which includes revenue from our transaction with Gilead and non-cash royalties earned.
Conference Call, Webcast and Prepared Statement Information
Date: Thursday, May 9, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 682-6100
International Dial-in Number: (862) 298-0702
Conference ID: Agenus
Live Webcast: 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 two hours after the call and will remain available for 90 days.