On March 15, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported financial results for fourth quarter and full year 2017 (Press release, Agenus, MAR 15, 2018, View Source [SID1234524804]).

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"Innovation and speed are key drivers of success in I-O. With our current capabilities and our extensive portfolio of novel I-O approaches, we have positioned Agenus to develop combination treatments for more patients and more cancers. Our ability to rapidly advance clinical trials with our CTLA-4 (AGEN1884) and Keytruda as well as trials using our own proprietary combinations with AGEN1884 and PD-1 (AGEN2034) could lead to our BLA filing as soon as the end of 2019. We recently produced commercial grade CTLA-4 to assure our commercial readiness," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "This year, we will also file several INDs for our novel I-O antibodies including first/best-in-class bispecific tumor microenvironment conditioning agents."

Milestones Achieved:

Clinical Trials

o Launched phase 2 trial with the combination of AGEN1884 with Keytruda in patients with 1L NSCLC and over 50% PD-L1 expression

o Completed dose escalation trials for AGEN1884 (anti-CTLA-4) and AGEN2034 (anti-PD-1)

o Launched a phase 2 trial with the combination of our proprietary CTLA-4 (AGEN1884) and PD-1 (AGEN2034), identified optimal dose, and expanded trial into relapsed/refractory cervical cancer

o Reported initial safety and immunogenicity of our neoantigen vaccine AutoSynVax; combination trials with our checkpoint antibodies are planned.

· Pipeline – first and/or best-in-class monospecific and bispecific antibodies

o Developed our novel next generation CTLA-4 – IND filing expected in 2018.

o Developed molecules and initiated IND preparations for our first/best in class bispecific antibodies designed to condition the tumor microenvironment through regulatory T cell depletion and other undisclosed mechanisms; IND filings expected in 2018

·Launched AgenTus Therapeutics, our cell therapy subsidiary

oAppointed Bruno Lucidi as CEO of AgenTus, advanced our pipeline including our proprietary allogeneic format and our proprietary phosphorylated targets.

·Completed non-dilutive financial transaction

oCompleted a $230 million non-dilutive royalty transaction with HealthCare Royalty Partners on sales of GlaxoSmithKline’s QS-21 containing vaccines and eliminated liabilities associated with Oberland notes. Net proceeds to Agenus from this transaction were approximately $28 million.

2018 MILESTONES

·Efficacy data for AGEN 1884 plus Keytruda in 1L NSCLC and planning for BLA filing

·Efficacy data from AGEN1884 (anti-CTLA-4) and AGEN2034 (anti-PD-1) trials

·Formalize regulatory engagements for the above combos for BLA filing

·IND filing for next generation CTLA-4 and two undisclosed bispecific antibodies

·Start combination trial with our CTLA-4 and PD1 with AGEN neoantigen vaccine AutoSynVax

·Complete IND enabling studies for AgenTus Therapeutics lead adoptive cell therapy program

Update on GMP manufacturing

·Expanded and upgraded antibody manufacturing capabilities

·Produced GMP grade CTLA-4 and PD1 antibodies for our clinical trials and acquired commercial grade AGEN1884 (anti-CTLA-4) and expecting commercial grade AGEN2034 (anti-PD-1) by mid-year.

Fourth Quarter and Full Year 2017 Financial Results

Cash, and cash equivalents were $60.2 million at December 31, 2017. Subsequent to the end of the year, Agenus received net proceeds of approximately $28.1 million from our royalty bond restructuring.

For the fourth quarter, Agenus’ cash used in operating activities was approximately $25.8 million compared to approximately $26.2 million during the third quarter while our reported net loss for the quarter was $35.0 million or $0.35 per share, compared with a net loss for the fourth quarter of 2016 of $26.1 million, or $0.30 per share.

Cash used in operating activities for the year ended December 31, 2017 was $94.2 million compared to $80.0 million for the year ended 2016. The Company incurred a net loss of $120.7 million or $1.23 per share, for the year ended December 31, 2017 compared with a net loss of $127.0 million, or $1.46 per share, in the same period in 2016.