AGEN Agenus Inc.

6.03
+0.22  (+4%)
Previous Close 5.81
Open 5.86
52 Week Low 2.5
52 Week High 6.79
Market Cap $1,405,681,309
Shares 233,114,645
Float 231,178,523
Enterprise Value $1,340,035,233
Volume 2,442,961
Av. Daily Volume 3,560,812
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Upcoming Catalysts

Drug Stage Catalyst Date
Balstilimab
Cervical cancer
PDUFA priority review
PDUFA priority review
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AGEN1181 and balstilimab (anti-CTLA-4)
Various cancers
Phase 1/2
Phase 1/2
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agenT-797 (iNKT)
Multiple myeloma
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Balstilimab (anti-PD-1) and Zalifrelimab - AGEN1884 (anti-CTLA-4)
Cervical cancer
Phase 2
Phase 2
Phase 2 data showed in 125 patients, the objective response rate (ORR) was 26%, with 9% of patients achieving a complete response (CR), and 17% of patients achieving a partial response (PR), noted September 17, 2021.
AGEN1777
Solid tumors
Phase 1
Phase 1
Phase 1 trial to be initiated 3Q 2021.
agenT-797
COVID-19 / Acute respiratory distress syndrome (ARDS)
Phase 1/2
Phase 1/2
Phase 1 initial data released February 4, 2021. 3/4 patients were extubated and released after treatment. Phase 1/2 expansion trials underway.
AGEN2373
Solid tumors
Phase 1
Phase 1
Phase 1 initial data presented at ASCO June 4, 2021. 5/22 patients showed stable disease.
Zalifrelimab - AGEN1884 (anti-CTLA-4)
Solid cancers
Phase 1/2
Phase 1/2
Phase 3 expansion trial underway - noted August 6, 2020.
MK-4830
Non-small cell lung cancer
Phase 2
Phase 2
Phase 2 trial ongoing.

Latest News

    • Objective response rate of 33% and median duration of response not reached with 19.4 months median follow-up in PD-L1+ tumors; expands benefit of anti-PD-1 alone
    • Improved responses seen across all histology subgroups including populations of patients unresponsive to other therapies
    • Dr. David O'Malley to present data in an oral presentation on Sept. 19th

    LEXINGTON, Mass., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Agenus (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, today presented final results from the Bal/Zal combination study at the European Society for Medical Oncology (ESMO) Virtual Conference 2021…

    • Objective response rate of 33% and median duration of response not reached with 19.4 months median follow-up in PD-L1+ tumors; expands benefit of anti-PD-1 alone
    • Improved responses seen across all histology subgroups including populations of patients unresponsive to other therapies
    • Dr. David O'Malley to present data in an oral presentation on Sept. 19th

    LEXINGTON, Mass., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Agenus (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, today presented final results from the Bal/Zal combination study at the European Society for Medical Oncology (ESMO) Virtual Conference 2021 in an abstract titled Balstilimab (anti-PD-1) in combination with zalifrelimab (anti-CTLA-4): final results from a Phase 2 study in patients (pts) with recurrent/metastatic (R/M) cervical cancer (CC).

    The data are being presented by lead investigator Dr. David O'Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

    "With a median follow-up of almost 2 years, the Bal/Zal combination showed high response rates, durable clinical activity, and promising overall survival results", said Steven O'Day, MD, Chief Medical Officer of Agenus. "Furthermore, later this year we expect to present new data on our next-generation CTLA-4 inhibitor AGEN1181, which we expect to further define the positive role this combination strategy could have in addressing unmet needs for cancer patients."

    The Phase 2 trial was conducted in 155 patients with recurrent/metastatic cervical cancer (R/M CC) which has limited effective treatment options and disproportionately affects younger women. In the 125 evaluable patients, the objective response rate (ORR) in all patients was 26%, with 9% of patients achieving a complete response, and 17% of patients achieving a partial response. The median duration of response (DoR) was not reached after a 19.4-month median follow-up. Notably, responses were also observed in the PD-L1 negative and adenocarcinoma populations, with 9% of both patient groups achieving an ORR. Based on these observations, we predict more than half of the patients to be alive beyond 12 months*.

    The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified.

    Detailed results from this trial will be presented in a Mini Oral Session on September 19th from 11:35 – 11:40am ET by David O'Malley, MD. In addition, in a Trials in Progress abstract, Agenus presented the RaPiDS trial design for balstilimab alone or in combination with zalifrelimab as second-line treatment for patients with previously treated R/M CC.

    "This trial represents the largest study evaluating PD-1 + CTLA-4 inhibition in relapsed cervical cancer to date and shows that the combination could represent a meaningful new option for patients in this setting," said Dr. O'Malley. "Efficacy outcomes continued to improve over time, and the combination likewise continued to show a positive safety profile."

    * Updated data to be presented during September 19th Mini Oral session.

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its MiNK Therapeutics subsidiary), 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 handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding potential therapeutic benefit and future clinical development plans for balstilimab, zalifrelimab, and AGEN1181 alone and in combination with other agents. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under 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 considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact

    Agenus Investor Relations

    Jan Medina, CFA

    Agenus

    781-674-4490

    Jan.Medina@agenusbio.com

    Agenus Media Relations

    Kimberly Ha

    KKH Advisors

    917-291-5744

    kimberly.ha@kkhadvisors.com



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  1. LEXINGTON, Mass. and BOSTON, Sept. 10, 2021 (GLOBE NEWSWIRE) -- Agenus (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 today announced the launch of SaponiQx, a subsidiary of Agenus, dedicated to driving innovation in novel adjuvant discovery and vaccine design, and its partnership with Ginkgo Bioworks, Inc. ("Ginkgo"), the leading horizontal platform for cell programming. Ginkgo, which recently announced a business combination with Soaring Eagle Acquisition Corp. (NASDAQ:SRNG), is enabling customers across industries to improve products and manufacturing processes, and to increase efficiency…

    LEXINGTON, Mass. and BOSTON, Sept. 10, 2021 (GLOBE NEWSWIRE) -- Agenus (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 today announced the launch of SaponiQx, a subsidiary of Agenus, dedicated to driving innovation in novel adjuvant discovery and vaccine design, and its partnership with Ginkgo Bioworks, Inc. ("Ginkgo"), the leading horizontal platform for cell programming. Ginkgo, which recently announced a business combination with Soaring Eagle Acquisition Corp. (NASDAQ:SRNG), is enabling customers across industries to improve products and manufacturing processes, and to increase efficiency and sustainability, by making biology easier to engineer.

    SaponiQx is building an innovative adjuvant platform to deliver both sustainable manufacturing approaches and a secure supply of known adjuvants, as well as discover novel adjuvants and develop new, more effective vaccines utilizing optimized antigen-adjuvant pairings. Adjuvants are substances known to enhance the body's immune response and are a key component of many existing vaccines. Ginkgo's experience in metabolic engineering, enzymatic diversification, and process optimization can be applied to discover novel adjuvants and improve current manufacturing processes that can then be applied toward developing better-integrated vaccines.

    "Vaccines are one of the most powerful tools we have to fight pandemics, but ensuring widespread access to efficacious vaccines continues to be a major challenge worldwide," says Jason Kelly, CEO of Ginkgo Bioworks. "We're proud that our platform is being used by companies across the vaccine supply chain to develop and manufacture the materials necessary for life-saving vaccines."

    "Agenus is pleased for SaponiQx to collaborate with Ginkgo Bioworks to develop its novel saponin products from sustainably sourced raw materials, with a goal to meet the current demands placed on the vaccine industry for pandemic vaccines," says Garo Armen, CEO and Chairman of Agenus and Executive Chairman of SaponiQx. "QS21 Stimulon™ has shown long term efficacy and long-term protection in both commercially launched and experimental vaccines."

    About SaponiQx

    SaponiQx plans to be a global, integrated immune-education medicine company which is planning to develop safe and effective immunomodulators to protect the world's population from health threats. Its pipeline is led by the best-in-class QS21 Stimulon™ adjuvant already used in GSK's Shingrix™ vaccine and is expected to include a wide-ranging portfolio of saponin-based adjuvants and vaccines, including AutoSynVax™, PhosphoSynVax™, and Prophage™. SaponiQx is headquartered in Lexington, MA. For more information, please visit www.saponiQx.com and our Twitter handle, @saponiQx.

    Contact:

    SaponiQx Investor Relations

    investor@saponiqx.com

    SaponiQx Media Relations

    media@saponiqx.com

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its MiNK Therapeutics subsidiary), 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 handle, @agenus_bio. Information that may be important to investors will be routinely posted on our website and on Twitter.

    Contact

    Agenus Investor Relations

    Jan Medina, CFA

    Agenus

    781-674-4490

    Jan.Medina@agenusbio.com

    Agenus Media Relations

    Kimberly Ha

    KKH Advisors

    917-291-5744

    kimberly.ha@kkhadvisors.com

    About Ginkgo Bioworks

    Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. In May 2021, Ginkgo announced a business combination with Soaring Eagle Acquisition Corp. (NASDAQ:SRNG), which, if completed, will result in Ginkgo, through a parent entity, Ginkgo Bioworks Holdings, Inc., becoming a public company. The extraordinary general meeting of Soaring Eagle's shareholders in connection with the transaction has been scheduled for September 14, 2021 and the transaction is expected to close shortly thereafter, subject to customary closing conditions. For more information, visit www.ginkgobioworks.com.

    MEDIA CONTACT:

    press@ginkgobioworks.com

    INVESTOR CONTACT:

    investors@ginkgobioworks.com

    ADDITIONAL LEGAL INFORMATION

    Forward-Looking Statements Legend

    This document contains certain forward-looking statements within the meaning of the federal securities laws with respect to the proposed transaction between Ginkgo and Soaring Eagle, including statements regarding the anticipated timing of the transaction, the services offered by Ginkgo and the markets in which it operates, and Ginkgo's projected future results. These forward-looking statements generally are identified by the words "believe," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of Soaring Eagle's securities, (ii) the risk that the transaction may not be completed by Soaring Eagle's business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by Soaring Eagle, (iii) the failure to satisfy the conditions to the consummation of the transaction, including the adoption of the agreement and plan of merger by the shareholders of Soaring Eagle and Ginkgo, the satisfaction of the minimum trust account amount following redemptions by Soaring Eagle's public shareholders and the receipt of certain governmental and regulatory approvals, (iv) the lack of a third party valuation in determining whether or not to pursue the proposed transaction, (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement and plan of merger, (vi) the effect of the announcement or pendency of the transaction on Ginkgo business relationships, performance, and business generally, (vii) risks that the proposed transaction disrupts current plans of Ginkgo and potential difficulties in Ginkgo employee retention as a result of the proposed transaction, (viii) the outcome of any legal proceedings that may be instituted against Ginkgo or against Soaring Eagle related to the agreement and plan of merger or the proposed transaction, (ix) the ability to maintain the listing of Soaring Eagle's securities on Nasdaq, (x) volatility in the price of Soaring Eagle's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (xi) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities, and (xii) the risk of downturns in demand for products using synthetic biology. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors'' section of Soaring Eagle's proxy statement/prospectus relating to the transaction (the "Proxy Statement"), and in Soaring Eagle's other filings with the SEC. Soaring Eagle and Ginkgo caution that the foregoing list of factors is not exclusive. Soaring Eagle and Ginkgo caution readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Neither Soaring Eagle nor Ginkgo undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

    Additional Information and Where to Find It

    This document relates to a proposed transaction between Ginkgo and Soaring Eagle. This document does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. In connection with the proposed transaction, Soaring Eagle filed a Proxy Statement on August 13, 2021. The Proxy Statement has been sent to all Soaring Eagle shareholders as of the record date of August 10, 2021. Soaring Eagle also will file other documents regarding the proposed transaction with the SEC. Before making any voting decision, investors and security holders of Soaring Eagle and Ginkgo are urged to read the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction.

    Investors and security holders may obtain free copies of the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Soaring Eagle through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by Soaring Eagle may be obtained free of charge by written request to Soaring Eagle at 955 Fifth Avenue, New York, NY, 10075, Attention: Eli Baker, Chief Financial Officer, (310) 209-7280.

    Participants in Solicitation

    Soaring Eagle and Ginkgo and their respective directors and officers may be deemed to be participants in the solicitation of proxies from Soaring Eagle's shareholders in connection with the proposed transaction. Information about Soaring Eagle's directors and executive officers and their ownership of Soaring Eagle's securities is set forth in Soaring Eagle's filings with the SEC. To the extent that holdings of Soaring Eagle's securities have changed since the amounts printed in Soaring Eagle's proxy statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the proxy statement/prospectus regarding the proposed transaction when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph.

    Agenus/SaponiQx Forward Looking Statements:

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding SaponiQx's business plans, including its collaboration with Ginkgo and its ability to successfully develop its technology, including its ability to build an adjuvant platform, create and deliver sustainable and improved manufacturing approaches, create a secure supply of known adjuvants, and generate novel or optimized adjuvants and vaccine candidates.. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under 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 considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

     



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  2. LEXINGTON, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Agenus (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, today announced that Jennifer Buell, PhD, President and COO of Agenus, will participate in the following upcoming conferences:

    • H.C. Wainwright 23rd Annual Global Investment Conference presentation will be available on-demand from Monday, September 13, 2021, starting at 7:00 a.m. ET.
    • Baird 2021 Global Healthcare Conference presentation on Wednesday, September 15, 2021 from 4:20 p.m. to 4:50 p.m. ET.

    A webcast and replay for the Baird 2021 Global Healthcare Conference may be accessed on the…

    LEXINGTON, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Agenus (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, today announced that Jennifer Buell, PhD, President and COO of Agenus, will participate in the following upcoming conferences:

    • H.C. Wainwright 23rd Annual Global Investment Conference presentation will be available on-demand from Monday, September 13, 2021, starting at 7:00 a.m. ET.
    • Baird 2021 Global Healthcare Conference presentation on Wednesday, September 15, 2021 from 4:20 p.m. to 4:50 p.m. ET.

    A webcast and replay for the Baird 2021 Global Healthcare Conference may be accessed on the company's website at https://investor.agenusbio.com/events-and-presentations.

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its MiNK Therapeutics subsidiary), 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 handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Contact

    Agenus Investor Relations

    Jan Medina, CFA

    Agenus

    781-674-4490

    Jan.Medina@agenusbio.com

    Agenus Media Relations

    Kimberly Ha

    KKH Advisors

    917-291-5744

    kimberly.ha@kkhadvisors.com



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    • Objective response rate of 20% and median duration of response not reached with 14.6 month median follow-up in PD-L1+ tumors
    • Responses seen across all histology subgroups including populations of patients unresponsive to other therapies

    LEXINGTON, Mass., Aug. 26, 2021 (GLOBE NEWSWIRE) -- 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, today announced that results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer were published online in the international peer reviewed journal Gynecologic Oncology (https://doi.org/10.1016/j.ygyno.2021.08.018

    • Objective response rate of 20% and median duration of response not reached with 14.6 month median follow-up in PD-L1+ tumors
    • Responses seen across all histology subgroups including populations of patients unresponsive to other therapies

    LEXINGTON, Mass., Aug. 26, 2021 (GLOBE NEWSWIRE) -- 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, today announced that results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer were published online in the international peer reviewed journal Gynecologic Oncology (https://doi.org/10.1016/j.ygyno.2021.08.018).

    "Publication of these data marks another significant achievement toward our objective to provide effective therapeutic options to those battling cancer," said Steven O'Day, MD, Chief Medical Officer of Agenus. "These data are drawn from the largest Phase 2 study to date evaluating PD-1 inhibition in advanced cervical cancer patients who have progressed on or after first-line chemotherapy; the results indicate balstilimab's potential as an effective new therapy."

    In the 140 evaluable patients, the objective response rate (ORR) in patients with PD-L1 positive tumors was 20.0% and included 3 patients (3/85, 3.5%) with a complete response and 14 patients (14/85, 16.5%) with a partial response. The median duration of response (DoR) was not reached after a 14.6-month median follow-up. Responses were also observed in the PD-L1 negative population with an ORR of 7.9%. The confirmed ORR for both PD-L1 positive and negative tumors was 15.0% and included 5 patients (3.6%) with a complete response and 16 patients (11.4%) with a partial response. The median DoR was 15.4 months and the disease control rate was ~50%. Notably, responses were observed across histologies, with responses in the squamous cell histology (ORR 17.6%) and in the more difficult to treat adenocarcinoma histology (ORR 12.5%). The safety profile was manageable and consistent with that of currently approved anti-PD-1 antibodies; it also compared favorably to the safety profiles of chemotherapies used in this population. Data from this trial continue to mature.

    As discussed in the publication, these data suggest that balstilimab may be a differentiated anti-PD-1 antibody as compared to currently approved PD-1 inhibitors. In the KEYNOTE-158 trial of pembrolizumab, an anti-PD-1 antibody, in the same setting, an ORR of 14.6% was observed in the PD-L1 positive population and no responses were observed in the PD-L1 negative population. In addition, the noted 12.5% response rate of balstilimab in patients with cervical adenocarcinoma is significant as this subpopulation typically does not respond to immunotherapy and represents a growing proportion of advanced cervical cancer cases. Balstilimab thus provides the potential for therapeutic benefit to patient populations that do not typically respond to currently-available immunotherapy, both alone and in combination with other therapies, such as Agenus' anti-CTLA-4 antibodies zalifrelimab and AGEN1181. Final results from a Phase 2 trial of balstilimab in combination with zalifrelimab in advanced cervical cancer will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) Congress 2021 on September 19 from 11:35 – 11:40am ET by David O'Malley, MD.

    "The efficacy and safety of balstilimab provides additional evidence of the importance of immune checkpoint blockade in the treatment of recurrent, advanced cervical cancer patients," said David O'Malley, MD, Professor, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine; Director, Division of Gynecologic Oncology, OSUCCC – James; and lead author on the publication. "Furthermore, responses to balstilimab were seen in patients who were PD-L1 positive, PD-L1-negative, bevacizumab pre-treated, and squamous cell and adenocarcinoma histologies. Balstilimab clearly provides clinical benefit in a broad range of cervical cancer patients."

    Study Design (NCT03104699)

    This was an open-label, single-arm, global Phase 2 clinical trial conducted at 60 sites throughout the United States, Europe, South America, and Australia. Patients were enrolled from November 20, 2017, to April 16, 2020, and received intravenous balstilimab at a dose of 3 mg/kg once every two weeks, given as a 60-minute infusion. Treatment was permitted for up to 24 months, or until disease progression, intolerable toxicity, or investigator/patient decision.

    About Balstilimab Monotherapy

    Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Agenus announced it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on April 19, 2021, for use in patients with recurrent or metastatic cervical cancer, and the application is under priority review with a target action date of December 16, 2021.

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its MiNK Therapeutics subsidiary), 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 handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding potential therapeutic benefit and future clinical development plans for balstilimab, zalifrelimab, and AGEN1181 alone and in combination with other agents. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under 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 considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact

    Agenus Investor Relations

    Jan Medina, CFA

    Agenus

    781-674-4490

    Jan.Medina@agenusbio.com

    Agenus Media Relations

    Kimberly Ha

    KKH Advisors

    917-291-5744

    kimberly.ha@kkhadvisors.com



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    • $200M received from BMS for anti-TIGIT bispecific antibody collaboration
    • FDA cleared IND for AGEN1777 clinical enrollment
    • AGEN1181 rapidly advancing in the clinic; data to be presented in 2H 2021
    • Cell therapy subsidiary MiNK Therapeutics filed confidential S-1 for planned IPO
    • FDA accepted balstilimab BLA for Priority Review with December PDUFA date

    LEXINGTON, Mass., Aug. 09, 2021 (GLOBE NEWSWIRE) -- 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, today provided a corporate update and reported financial results for the second quarter of 2021.

    "In the first half of this year, we announced…

    • $200M received from BMS for anti-TIGIT bispecific antibody collaboration

    • FDA cleared IND for AGEN1777 clinical enrollment
    • AGEN1181 rapidly advancing in the clinic; data to be presented in 2H 2021
    • Cell therapy subsidiary MiNK Therapeutics filed confidential S-1 for planned IPO
    • FDA accepted balstilimab BLA for Priority Review with December PDUFA date

    LEXINGTON, Mass., Aug. 09, 2021 (GLOBE NEWSWIRE) -- 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, today provided a corporate update and reported financial results for the second quarter of 2021.

    "In the first half of this year, we announced a collaboration with BMS and advanced our flagship clinical candidate AGEN1181 to an important data inflection point," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "In the second half, we will disclose this data at a key cancer conference and be ready with our commercial platform in preparation for a balstilimab launch."

    AGEN1181 (Fc-enhanced anti-CTLA-4): Clinical data support superior activity in difficult-to-treat cancers

    • Updated clinical data for AGEN1181 alone and in combination with balstilimab will be presented at an upcoming conference.



    • Clinical responses seen in patients refractory to 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 (typically seen with first generation anti-CTLA-4s) were reported.



    • Registrational trials targeted to commence by year-end 2021 with a focus on rapid path to Biologics License Application (BLA) submission.

    MiNK Therapeutics: Allogeneic iNKT cell therapy company advances towards IPO

    • MiNK Therapeutics (currently an Agenus company) filed a confidential S-1 to support a planned Initial Public Offering (IPO).



    • Phase 1 trial of AGENT-797 in hematologic cancers dose cohorts completed with data readouts planned in the second half of 2021; Phase 1/2 expansion trials in viral acute respiratory distress syndrome (ARDS) are underway.

    AGEN1777 (Fc-enhanced anti-TIGIT bispecific): Collaboration with BMS provides additional cash resources to advance Agenus' high value drivers

    • Global exclusive license with Bristol Myers Squibb for AGEN1777 provides $200 million upfront cash. In addition, Agenus to receive up to $1.36 billion in development, regulatory, and commercial milestones, and tiered double-digit royalties upon product sales.



    • FDA cleared Investigational New Drug (IND) application; Phase 1 dosing with AGEN1777 alone and in combination with an anti-PD-1 in advanced solid tumors planned to begin this quarter.

    Balstilimab (anti-PD-1): BLA accepted for Priority Review by U.S. FDA; data updates presented at ASCO

    • Balstilimab BLA accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2021.



    • Commercial preparation underway for a highly efficient, targeted launch to provide broad product access to physicians and patients while laying the foundation for future Agenus products.



    • Clinical data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting:



      • Phase 2 data for balstilimab showed a response rate of 20% in PD-L1 positive tumors, overall response rate of 15%, and median duration of response of 15.4 months.
      • Balstilimab showed superior tumor killing compared to approved anti-PD-1s such as pembrolizumab and nivolumab.



    • Results from a Phase 2 trial of balstilimab plus zalifrelimab combination in recurrent or metastatic cervical cancer to be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) Congress 2021 on September 19 from 11:35 – 11:40am ET.

    Additional programs

    • Phase 1 data for AGEN2373, a CD137 agonist antibody, in patients with advanced solid tumors were presented at ASCO 2021.



      • No dose limiting toxicities were seen at doses up to 3 mg/kg, including no liver toxicity. Combination trials are in planning.



    • Process for scale up of QS-21 manufacturing continues to advance.



    • VISION platform knowledge base expanding to support AGEN1181 response prediction and combination discovery.

    Management appointments

    • Steven O'Day, MD appointed to Chief Medical Officer.



    • Andy Hurley appointed to Chief Commercial Officer.



    • Marc Wiles, PhD appointed to Vice President of Regulatory Affairs.



    • Julie DeSander promoted to Chief Business Officer.



    • Joseph Grossman, MD, appointed to Vice President of Exploratory Medicine.



    • Jason Paragas appointed to Vice President of Data Sciences.



    • Jennifer Buell, PhD, appointed to Chief Executive Officer of MiNK Therapeutics. Dr. Buell will continue as a member of the Agenus Executive Committee.

    Second Quarter Financial Results

    We ended the second quarter of 2021 with a cash balance of $74 million as compared to $100 million at December 31, 2020. Subsequent to the quarter end we received $200 million related to our BMS partnership.

    For the second quarter ended June 30, 2021, our cash used in operations was $56 million and we reported a net loss of $84 million or $0.37 per share which included a number of non-cash items. This compares to cash used in operations for the same period in 2020 of $37 million and a net loss of $48 million or $0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021 were $30 million compared to $18 million for the second quarter of 2020.

    Our cash used in operations for the six months ended June 30, 2021 was $98 million with a net loss of $138 million or $0.65 per share compared to cash used in operations of $72 million and a net loss for the same period in 2020 of $94 million or $0.59 per share.

    We recognized revenue of $22 million and $42 million for the six-months ended June 30, 2021 and 2020, respectively, which includes revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and in 2020, $14 million from an upfront license fee received.



    Select Financial Information
    (in thousands, except per share data)
    (unaudited)
             
      June 30, 2021 December 31, 2020   
             
    Cash and cash equivalents $73,543 *$99,871     
             
    *Excludes $200 million received in July 2021 from BMS       
             
      Three months ended June 30, Six months ended June 30,
       2021   2020   2021   2020 
             
    Revenues, research and development $1,708  $18,068  $3,279  $19,996 
    Revenues, non-cash royalty  7,826   7,846   16,310   21,002 
    Revenues, other  1,196   1,031   2,860   1,075 
    Total Revenue  10,730   26,945   22,449   42,073 
             
             
    Research and development expenses  45,508   38,550   82,184   74,913 
    General and administrative expenses  16,650   14,195   33,003   24,809 
    Cost of service revenue  667   634   1,772   634 
    Other expense (income)  1,210   623   (1,369)  1,865 
    Non-cash interest expense  16,386   14,347   31,997   28,191 
    Loss on modification of debt  -       -       -       2,720 
    Non-cash contingent consideration fair value adjustment 14,300   6,840   13,256   2,456 
    Net loss $(83,991) $(48,244) $(138,394) $(93,515)
             
    Net loss per share attributable to Agenus Inc. common stockholders$(0.37) $(0.28) $(0.65) $(0.59)
             
    Cash used in operations $ (55,557) $ (37,375) $ (98,301) $ (71,880)
    Non-cash operating expenses $30,171  $17,685  $41,984  $20,806 
             

    Conference Call

    Monday August 9, 2021, 8:30am ET

    Dial-in numbers: (833) 614-1394 (US) or (914) 987-7115 (International).

    Conference ID number: 3686849.

    Webcast

    A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company's website at https://investor.agenusbio.com/events-and-presentations and via https://edge.media-server.com/mmc/p/gsbikqz2.

    About Agenus

    Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its MiNK Therapeutics subsidiary), 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 handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding clinical development and regulatory plans and timelines, anticipated corporate milestones, new clinical data and program updates to be presented, and the anticipated commercial launch of balstilimab. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under 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 considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

    Contact

    Agenus Investor Relations

    Jan Medina, CFA

    Agenus

    781-674-4490

    Jan.Medina@agenusbio.com

    Agenus Media Relations

    Kimberly Ha

    KKH Advisors

    917-291-5744

    kimberly.ha@kkhadvisors.com



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