The clinical results presented to SITC show that AGEN1181, as monotherapy and in combination with balstilimab, shows lasting responses in 9 types of cancer, including patients whose cancers have recurred after treatment with PD-1. and several gynecologic cancers Agenus cell therapy subsidiary MiNK Therapeutics (NASDAQ: INKT) launched as a publicly traded company with more than $ 40 million raised to accelerate clinical development AGEN1777, an improved TIGIT bispecific antibody by Fc, entered development phase, triggering milestone payment from Bristol Myers Squibb After successfully reaching clinical milestones and passing FDA inspections, Agenus withdrew its BLA for balstilimab based on guidelines from the FDA; given the clinical benefit demonstrated by balstilimab, Agenus plans to launch an expanded access program in several countries
LEXINGTON, Mass., November 09, 2021 (GLOBE NEWSWIRE) – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad portfolio of checkpoint antibodies, adjuvants and vaccines designed for activating the immune response to cancers and infections, provided a company update today and released financial results for the third quarter of 2021.
âWith over 100 patients treated with our Fc enhanced CTLA-4 antibody, AGEN1181, we are very encouraged by the clinical responses obtained across tumor types. Of note, we are seeing responses in patients who have not responded to all other treatments, including PD-1 inhibitors, âsaid Garo Armen, PhD, Chairman and CEO of Agenus. âWe will be presenting detailed test results at the SITC conference this week. We also successfully completed an initial public offering for MiNK Therapeutics and launched our adjuvant business, SaponiQx. “
AGEN1181 (Fc-enhanced CTLA-4), as monotherapy and in combination with balstilimab (anti PD-1), shows clinical benefit in 9 types of tumors resistant to cold and to treatments; data to be presented to SITC
First presentation of clinical data from more than 100 patients who represent a heavily pretreated population, and who received AGEN1181 as monotherapy or in combination with balstilimab. , melanoma (RA), cervical cancer (RA) and pancreatic cancer (RA), the first three responses occurring in tumors that have not responded to anti-PD-1 therapy. Additional responses in patients treated with AGEN1181 in combination with balstilimab, including in cold and poorly immunogenic tumors. These include: Stable microsatellite colorectal cancer (MSS-CRC): 2 confirmed RA, 2 unconfirmed RA and 7 stable disease (SD) among 17 evaluable patients for a disease control rate of 65% Gynecological malignancies: 2 RA , 3 SD among 6 evaluable patients with ovarian cancer; 1 PR and 1 PR unconfirmed in endometrial cancer MSS Other tumors: 2 unconfirmed responses in visceral angiosarcoma and one unconfirmed response in relapsed / refractory NSCL to PD-1 Majority of responses are durable and continuous , additional data to be presented to SITC in November 12th (Abstract # 479) Monotherapies and combination therapies were well tolerated, with no cases of hypophysitis or pneumonitis. cancers
MiNK Therapeutics launched an IPO; its stock is traded on NASDAQ
MiNK Therapeutics launched a successful IPO, raising more than $ 40 million to support the rapid clinical development of its allogeneic cell therapies. clinical persistence and activity, preclinical anti-tumor activity and tissue distribution, as well as the tumor killing potential of modified iNKT cells generated by taking advantage of a proprietary CAR platform
Launch of SaponiQx to accelerate the development of proven and novel adjuvants, as well as optimized antigen-adjuvant constructs
Respond to the global need for vaccines that deliver sustainable efficacy with secure production, which has been magnified by the current pandemic. with Phyton Biotech and Ginkgo Bioworks to develop and optimize a plant cell culture method for the manufacture of QS-21 and next-generation saponin-based adjuvants for safe and sustainable adjuvant supply
First patients treated in several collaborative programs
First patient to receive AGEN1777, our Fc-enhanced TIGIT bispecific antibody licensed to BMS, triggering a milestone payment of $ 20 million. BMS intends to advance AGEN1777 in high priority indications, such as non-small cell lung cancer. pancreatic cancer
Planning underway to launch extended balstilimab access programs
The BLA for balstilimab in second-line cervical cancer was withdrawn after full approval of pembrolizumab, four months before the FDA deadline, based on data for pembrolizumab plus chemotherapy in First line. Cost reduction As balstilimab met trial endpoints with an ORR of 20% in PD-L1 positive tumors and 8% in PD-L1 negative tumors, Agenus plans to launch an access program expanded in several countries, including the United States, pending regulatory processes Combination of balstilimab and zalifrelimab resulted in a near doubling of responses (33% compared to what was reported with pembrolizumab in patients with PD-L1 + cervical cancer); data was presented at this year’s ESMO conference
Third Quarter 2021 Financial Results
We ended the third quarter of 2021 with a cash and short-term investment balance of $ 262 million, compared to $ 100 million as at December 31, 2020.
For the third quarter ended September 30, 2021, our cash generated from operations was $ 131 million and we reported net income of $ 177 million or $ 0.76 per basic share and 0.72 $ per diluted share. 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 basic and diluted share.
Our cash flow from operations for the nine-month period ended September 30, 2021 was $ 33 million with net income of $ 39 million or $ 0.19 per basic share and 0.18 $ per diluted share, compared to cash flow from 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-month period ended September 30, 2021 were $ 46 million, compared to $ 35 million for the same period of 2020.
We recorded revenue of $ 275 million and $ 57 million for the nine months ended September 30, 2021 and 2020, respectively, which includes revenue related to initial license fees received and milestones earned, non-cash royalties and revenues recognized under our collaboration agreements.
Conference call Tuesday, November 9, 2021 at 8:30 a.m.ET Call numbers: (833) 614-1394 (US) or (914) 987-7115 (International); Conference number: 8585893.
Webcast A live webcast and replay of the conference call will be accessible from the Events and Presentations page of the Company’s website at https://investor.agenusbio.com/events-and-presentations and via https : //edge.media-server .com / mmc / p / mr7ep4vu.
About Agenus Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that mobilize the body’s immune system to fight cancer. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combined approaches that take advantage of a broad repertoire of therapeutic antibodies, adoptive cell therapies (through its subsidiary MiNK Therapeutics), adjuvants and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter account @ agenus â bio. Information that may be important to investors will be posted regularly on our website and on Twitter.
Forward-looking statements This press release contains forward-looking statements that are made in accordance with the safe harbor provisions of federal securities laws, including statements relating to the use of the therapeutic candidates AGEN1181, zalifrelimab, balstilimab AGEN1777 and the therapy cellular iNKT (Agent- 797), for example, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability and safety profile of therapeutic candidates, both alone and in combination with each other and / or with other agents (eg, AGEN1181 in combination with balstilimab); statements relating to future clinical and regulatory development plans for therapeutic candidates alone and in combination with other agents, including AGEN1181 in combination with balstilimab; statements regarding our ability to obtain regulatory approval for our therapeutic candidates, including the timing (including the possibility of expedited review) and scope of such regulatory approval; statements regarding our ability to launch expanded access programs; statements regarding future business plans, including those related to receipt of future milestone payments and collaboration and licensing agreements; statements regarding our ability to develop novel adjuvants and accelerate adjuvant development, as well as statements regarding our ability to develop optimized antigen-adjuvant constructs and to develop and optimize manufacturing methods for QS-21 and other adjuvants; statements of expected savings; ; and any other statement containing the words “may”, “believes”, “expects”, “anticipates”, “hopes”, “intends”, “plans”, “foresees”, “estimates”, “” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described in the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place significant reliance on any forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Agenus assumes no obligation to update or revise any statements, except to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Contact Agenus Inc. Divya Vasudevan, PhD 781-674-4571 [email protected]
Agenus Kimberly Ha Media Relations KKH Advisors 917-291-5744 [email protected]