On November 9, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today provided a corporate update and reported financial results for the third quarter of 2021 (Press release, Agenus, NOV 9, 2021, View Source [SID1234594867]).
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"With more than 100 patients treated with our Fc-enhanced CTLA-4 antibody, AGEN1181, we are very encouraged by the clinical responses achieved across tumor types. Of note, we are seeing responses in patients who have failed to respond to all other treatment, including PD-1 inhibitors," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "We will be presenting detailed trial results at the SITC (Free SITC Whitepaper) conference this week. We have also successfully completed an initial public offering for MiNK Therapeutics, and have launched our adjuvant business, SaponiQx."
AGEN1181 (Fc-enhanced CTLA-4), as a monotherapy and in combination with balstilimab (anti PD-1), shows clinical benefit in 9 cold and treatment-resistant tumor types; data to be presented at SITC (Free SITC Whitepaper)
First presentation of clinical data from 100+ patients who represent a heavily pre-treated population, and were administered AGEN1181 as a monotherapy or in combination with balstilimab
Evidence of AGEN1181 monotherapy activity with multiple confirmed responses: microsatellite stable (MSS) – endometrial cancer (CR), melanoma (PR), cervical cancer (PR), and pancreatic cancer (PR), with the former three responses occurring in tumors which failed to respond to anti-PD-1 therapy
Additional responses in patients treated with AGEN1181 in combination with balstilimab, including in cold, poorly immunogenic tumors. These include:
Microsatellite stable colorectal cancer (MSS-CRC): 2 confirmed PRs, 2 unconfirmed PRs, and 7 stable disease (SD) among 17 evaluable patients for a disease control rate of 65%
Gynecological malignancies: 2 PRs, 3 SDs among 6 evaluable ovarian cancer patients; 1 PR and 1 unconfirmed PR in MSS-endometrial cancer
Other tumors: 2 unconfirmed responses in visceral angiosarcoma, and one unconfirmed response in PD-1-relapsed/refractory NSCLC
Majority of responses are durable and ongoing, with additional data to be presented at SITC (Free SITC Whitepaper) on November 12th (Abstract # 479)
Both monotherapy and combination therapy were well tolerated, with no cases of hypophysitis or pneumonitis
Based on these data, Agenus will commence Phase 2/3 trials evaluating AGEN1181, as a monotherapy and in combination with balstilimab, in colorectal and gynecological cancers
MiNK Therapeutics launched an IPO; its stock is trading on NASDAQ
MiNK Therapeutics launched a successful IPO, raising >$40M to support the rapid clinical development of its allogeneic cell therapies
MiNK has three presentations planned at SITC (Free SITC Whitepaper), which will showcase data on clinical-stage, allogeneic, iNKT cell therapy (AgenT-797), including clinical persistence and activity, preclinical anti-tumor activity and tissue distribution, as well as the tumor killing potential of engineered iNKT cells generated by leveraging a proprietary CAR platform
SaponiQx launch to accelerate development of proven and novel adjuvants, as well as optimized antigen-adjuvant constructs
Will address global need for vaccines offering long-lasting efficacy with secure production, which has been amplified by the current pandemic
QS-21 Stimulon adjuvant is proven to drive durable immunity – SHINGRIX (GSK zoster vaccine, recombinant) offers protection of >9 years
Collaborating with Phyton Biotech and Ginkgo Bioworks to develop and optimize a plant cell culture method of manufacturing QS-21 and next-generation saponin- based adjuvants for a secure and sustainable adjuvant supply
First patients dosed in multiple collaborator programs
First patient dosed with AGEN1777, our Fc-enhanced TIGIT bispecific antibody licensed to BMS, triggering a $20 million milestone payment. BMS intends to advance AGEN1777 in high-priority indications, such as non-small cell lung cancer
First patient dosed in clinical collaboration with Nelum, evaluating our first-generation CTLA-4, zalifrelimab, in combination with Nelum’s hedgehog inhibitor and chemotherapy in first-line pancreatic cancer
Planning underway to launch expanded access programs for balstilimab
BLA for balstilimab in second-line cervical cancer was withdrawn after full approval of pembrolizumab, four months ahead of the FDA goal date, based on data for pembrolizumab plus chemotherapy in first-line setting
Agenus will discontinue the confirmatory trial, resulting in a >$100M expense reduction
As balstilimab met trial endpoints with ORR of 20% in PD-L1 positive tumors and 8% in PD-L1 negative tumors, Agenus plans to launch an expanded access program in several countries, including the US, pending regulatory processes
Combination of balstilimab and zalifrelimab resulted in a near doubling of responses (33% vs. what has been reported with pembrolizumab in PD-L1+ cervical cancer patients); data was presented at this year’s ESMO (Free ESMO Whitepaper) Conference
Third Quarter 2021 Financial Results
We ended the third quarter of 2021 with a cash and short-term investment balance of $262 million as compared to $100 million at December 31, 2020.
For the third quarter ended September 30, 2021, our cash provided by operations was $131 million and we reported a net income of $177 million or $0.76 per share basic and $0.72 per share diluted. This compares to cash used in operations for the same period in 2020 of $32 million and a net loss of $52 million or $0.28 per share basic and diluted.
Our cash provided by operations for the nine-months ended September 30, 2021 was $33 million with net income of $39 million or $0.19 per share basic and $0.18 per share diluted, compared to cash used in operations of $104 million and a net loss for the same period in 2020 of $145 million or $0.87 per share, basic and diluted. Non-cash operating expenses for the nine-months ended September 30, 2021 were $46 million compared to $35 million for the same period of 2020.
We recognized revenue of $275 million and $57 million for the nine-months ended September 30, 2021 and 2020, respectively, which includes revenue related to upfront license fees received and milestones earned, non-cash royalties, and revenue recognized under our collaboration agreements.
Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source