On May 6, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported financial results for the first quarter of 2021 (Press release, Agenus, MAY 6, 2021, View Source [SID1234579398]).

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"We have delivered on multiple key initiatives since our last update and expect to achieve additional impactful milestones during the remainder of the second quarter and the rest of 2021," said Garo Armen, PhD, Chief Executive Officer of Agenus. "Among important developments are the continuing clinical responses we are seeing with AGEN1181. We intend to advance AGEN1181 in combination with balstilimab in cancers for which current immunotherapies have shown no activity given AGEN1181’s positive clinical responses in these tumors. Treating these cancers successfully will be of substantial value to patients while potentially representing large commercial opportunities for Agenus."

Balstilimab (anti-PD-1): BLA submitted to U.S. FDA for recurrent/metastatic cervical cancer

A Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for the accelerated approval of balstilimab for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The submission was based on an update to data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 and published in an Oncogene editorial. This updated dataset includes maturation of late patient responses, with the overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months.

Data demonstrating that balstilimab is a potentially differentiated anti-PD-1 antibody will be presented at the 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4 – 8, 2021.

Discussions with the FDA regarding accelerated BLA filing for balstilimab plus zalifrelimab are ongoing; additional guidance and updated response rate data will be provided upon the FDA acceptance of the balstilimab monotherapy BLA.
AGEN1181 (anti-CTLA-4): Data demonstrate continued strong activity, including in tumors unresponsive to immunotherapy, as presented at AACR (Free AACR Whitepaper) 2021

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, a new partial response with AGEN1181 monotherapy was reported in the first and only melanoma patient treated to date, as well as a new conversion to complete response with AGEN1181 plus balstilimab in an ovarian cancer patient.

Continued clinical activity in patients with biomarkers which indicate a poor prognosis with approved immunotherapies, including patients with microsatellite stable (MSS) tumors and melanoma, endometrial, and ovarian cancer with the low-affinity FcyRIIIA allele. No immune-mediated hypophysitis, pneumonitis, or hepatitis were reported.

As of AACR (Free AACR Whitepaper) 2021, a total of seven confirmed objective responses were achieved in a Phase 1/2 trial of AGEN1181 in solid tumors out of 52 evaluable patients: 2 confirmed responses among 21 treated with monotherapy, and 5 confirmed responses among 31 treated with AGEN1181 in combination with balstilimab.

Phase 2 trial in colorectal cancer was initiated; registrational trials are targeted to commence in 2021 with a focus on indications enabling a rapid path to BLA submission. Further data updates expected later this year.
AGEN1777 (anti-TIGIT bispecific): Phase 1 anticipated 2021

IND submission is planned for the current quarter.

Phase 1 study is expected to commence in the third quarter.
Intelligent cell platform: Phase 1 study ongoing with iNKT cell therapy in patients with cancer and ARDS secondary to COVID-19

Phase 1 trial in hematologic cancers was initiated; expansion into solid tumors is expected this year.

Preliminary Phase 1 data for acute respiratory distress syndrome (ARDS) secondary to COVID-19 suggest iNKTs (invariant natural killer T cells) can be dosed without adverse events attributable to the therapy and may demonstrate early signals of activity. Dose escalation is expected to be completed this year with data readouts to be presented at upcoming conferences.
Additional programs and initiatives continue to advance

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

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.
First Quarter Financial Results

We ended our first quarter 2021 with a cash balance of $119 million as compared to $100 million at December 31, 2020.

Cash used in operations for the three months ended March 31, 2021 was $43 million compared to $35 million for the quarter ended March 31, 2020. Net loss for the quarter ended March 31, 2021 was $54 million or $0.27 per share which includes non-cash expenses of $12 million compared to a net loss for the same period in 2020 of $45 million, or $0.31 per share which includes non-cash expenses of $3 million.

We recognized revenue of $12 million and $15 million for the quarters ended March 31, 2021 and 2020, respectively, which includes revenue related to non-cash royalties earned and revenue recognized under our collaboration agreements.