AGEN Agenus Inc.

3.71
-0.08  -2%
Previous Close 3.79
Open 3.82
52 Week Low 1.82
52 Week High 4.785
Market Cap $680,572,243
Shares 183,442,653
Float 176,612,720
Enterprise Value $611,216,844
Volume 1,380,088
Av. Daily Volume 2,548,641
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Upcoming Catalysts

Drug Stage Catalyst Date
Balstilimab (AGEN2034) anti-PD-1
Cervical cancer
BLA Filing
BLA Filing
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Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4)
Solid tumors
BLA Filing
BLA Filing
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Drug Pipeline

Drug Stage Notes
Zalifrelimab - AGEN1884 (anti-CTLA-4)
Solid cancers
Phase 1/2
Phase 1/2
Phase 3 expansion trial underway - noted August 6, 2020.
AGEN1181 - 2nd gen CTLA
Advanced cancer
Phase 1
Phase 1
Phase 1 data presented at Investor Day February 20, 2020.
Shingrix
Shingles
Approved
Approved
Approval announced October 20, 2017.

Latest News

  1. LEXINGTON, Mass., Aug. 6, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today provided an R&D and business update and reported financial results for the second quarter of 2020.

    • Balstilimab BLA filing to be initiated in current quarter
      • Balstilimab granted FTD and eligible for priority review
      • Combo trial with zali completes accrual & required follow-up; BLA planning underway
    • Zalifrelimab actives responses in PD-1 refractory tumors (1CR, 3PRs)
      • Ph2 expansion trial in angiosarcoma underway; additional cancers to follow
    • AGEN1181 combo w bali achieves CR with both primary and metastatic tumors confirmed by PET scan
      • Updated Ph1 achieves a total of 2 CRs & clinical benefit (CR/PR/SD) in ~65% patients
      • Expansion cohorts in NSCLC, MSS tumors, melanoma, and RCC launched
    • AGEN2373 achieves durable SD in ovarian, lung, sarcoma
      • No liver toxicity observed
      • AGEN2373 advancing to combo with balstilimab
    • Production of QS-21 from a renewable source achieved and equivalence to QS-21 Saponin demonstrated
      • High-yield process development underway
      • Bioequivalence to first-generation demonstrated
      • Enhanced antibody responses achieved in SARS-CoV-2 models
    • Completed partnership with Betta Pharmaceuticals; $15M upfront, $20M equity investment, $100M in milestones & royalties
      • Rights to balstilimab and zalifrelimab for Greater China
      • Clinical development in major cancers being planned

    First Quarter Financial Results

    We ended the second quarter of 2020 with a cash balance of $79 million as compared to $62 million at December 31, 2019. Subsequent to the quarter end we received $35 million related to our Betta partnership.  With this and other anticipated cash inflows, based on our current plans and projections our cash position will be sufficient to support our operations into the third quarter of 2021.

    For the second quarter ended June 30, 2020, our cash used in operations was $37 million and we reported a net loss of $48 million or $0.28 per share.  This compares to cash used in operations for the same period in 2019 of $36 million and a net loss of $52 million or $0.38 per share. 

    Our cash used in operations for the six months ended June 30, 2020 was $72 million with a net loss of $94 million or $0.59 per share compared to cash provided by operations of $41 million and a net loss for the same period in 2019 of $34 million or $0.24 per share.

    For the six-month period ended June 30, 2020, we recognized revenue of $42 million which includes revenue related to the upfront license fee from our transaction with Betta in addition to non-cash royalties earned.  For the same period in 2019 we recorded revenue of $96 million which includes revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned.

    Select Financial Information









    (in thousands, except per share data)









    (unaudited)











































    June 30, 2020



    December 31, 2019

































    Cash and cash equivalents





    $       79,171



    $               61,808



































































    Three months ended June 30,



    Six months ended June 30,











    2020



    2019



    2020



    2019

























    Revenues, research and development



    $       18,068



    $                 4,399



    $  19,996



    $  75,271

    Revenues, non-cash royalty





    7,846



    9,263



    21,002



    17,869

    Revenues, other







    1,031



    2,053



    1,075



    2,468

      Total Revenue







    26,945



    15,715



    42,073



    95,608

















































    Research and development expenses



    38,550



    45,243



    74,913



    85,374

    General and administrative expenses



    14,195



    11,405



    24,809



    22,211

    Cost of service revenue





    634



    -



    634



    -

    Other expense (income)





    623



    540



    1,865



    (115)

    Non-cash interest expense





    14,347



    10,181



    28,191



    19,609

    Loss on modification of debt





    -



    -



    2,720



    -

    Non-cash contingent consideration fair value adjustment

    6,840



    213



    2,456



    2,961

    Net loss









    $      (48,244)



    $              (51,867)



    $ (93,515)



    $ (34,432)

























    Net loss per share attributable to Agenus Inc. common stockholders

    $         (0.28)



    $                  (0.38)



    $    (0.59)



    $    (0.24)

























    Cash (used in) provided by operations



    $      (37,375)



    $              (35,704)



    $ (71,880)



    $  40,883

    Call Access

    To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International) and ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company's website at http://investor.agenusbio.com/presentation-webcasts or via https://www.webcaster4.com/Webcast/Page/1556/35715. A replay will be available approximately two hours after the call and will remain available until November 7, 2020.

    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 AgenTus 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 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 and anticipated corporate milestones. 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.

    Investor Contact:

    Jennifer S. Buell, PhD

    781-674-4420

      

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/agenus-provides-rd-update--second-quarter-financial-report-301107311.html

    SOURCE Agenus Inc.

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  2. LEXINGTON, Mass., Aug. 4, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, announced today that Dr. Jennifer Buell, President and COO of Agenus will present on Targeting Myeloid Cells in the Tumor Microenvironment at the upcoming William Blair Biotech Focus Conference 2020.

    Date: Tuesday, August 4, 2020

    Webcast Info: http://wsw.com/webcast/blair57/p1/

    Title: Targeting Myeloid Cells in Tumor Microenvironment

    Time: 11:00AM12:00 PM

    Keynote Speaker:

    Miriam Merad, M.D., Ph.D., - Chair Professor in Cancer Immunology and Director of the Precision Immunology Institute Mount Sinai School of Medicine

    Presentations:

    Agenus Inc.

    Jennifer Buell, Ph.D. – President and Chief Operating Officer

    Codiak Biosciences

    Douglas Williams, Ph.D. - President and Chief Executive Officer

    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 and infections. 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 AgenTus 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 twitter.

    Contact:

    Agenus Inc. 

    Jennifer Buell, PhD

    781-674-4420 

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/agenus-to-present-on-targeting-myeloid-cells-in-tumor-microenvironment-at-the-william-blair-biotech-focus-2020-conference-301105604.html

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  3. LEXINGTON, Mass., July 29, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced it will provide an update on programs and plans and release its second quarter 2020 financial results before the market opens on Thursday, August 6, 2020. Agenus executives and thought leaders will host a video conference call and webcast at 8:30 a.m. ET.

    Topics to be discussed:

    • Registration plans and strategy for balstilimab +/- zalifrelimab
    • Agenus & Betta Pharmaceuticals partnership progress for China
    • Clinical status/next steps for AGEN1181 (NextGen CTLA-4) +/- balstilimab (anti-PD-1)
    • Allogeneic iNKT cells potential breakthrough for COVID-19 and cancer based on efficacy and cost
    • Cell therapy and antibody combinations preclinically show curative potential
    • AGEN1223 & AGEN2373 clinical update and plans for bali +/- zali combos
    • Myeloid immune response modifiers (TIGIT bispecific & other novel targets)

    Live Call:  Dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International)

    Webcast:  The call will be accessible from the Company's website at http://investor.agenusbio.com/presentation-webcasts or via https://www.webcaster4.com/Webcast/Page/1556/35715.  A replay will be available approximately two hours after the call and will remain available until November 7, 2020.

    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 AgenTus 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.

    Contact

    Agenus Inc. 

    Jennifer Buell, PhD

    781-674-4420

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/agenus-rd-update--second-quarter-earnings-report-301102427.html

    SOURCE Agenus Inc.

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  4. LEXINGTON, Mass., July 28, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology (I-O) company with an extensive pipeline of agents designed to activate immune response to cancers, today announced the closing of a $20 million equity investment, at $4.03 per share, by Betta Pharmaceuticals (SZ300558) bringing the total received to $35M. Betta is a top Chinese pharmaceutical company focusing on the development of innovative oncology therapies.  The equity investment by Betta Pharmaceuticals is part of the broader immuno-oncology (I-O) partnership that Agenus and Betta Pharmaceuticals announced last month.

    Under the partnership Agenus is also eligible to receive up to $100 million in potential milestones plus royalties on net sales.  In exchange Betta received exclusive rights for the development and commercialization of balstilimab and zalifrelimab, as both monotherapies and combination therapies, excluding intravesical delivery, in greater China, including Mainland China, Hong Kong, Macau and Taiwan.

    Agenus' balstilimab (anti-PD-1) is planned for a BLA filing this year.  Trials for balstilimab alone and in combination with zalifrelimab (anti-CTLA-4) have already completed accrual and follow up of all patients. The US FDA granted Fast Track designation for balstilimab alone and in combination with zalifrelimab in this indication and the molecules are eligible for US FDA Priority Review.

    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, proprietary cancer vaccine platforms, and adoptive cell therapies (through its AgenTus Therapeutics subsidiary). 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 early phase 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.

    About Betta Pharmaceuticals

    Betta Pharmaceuticals Co., Ltd. (SZ300558), established in 2003 in Hangzhou, China, is one of the leading Chinese pharmaceutical companies dedicated to develop and commercialize innovative oncology products to meet high unmet medical needs. With over 1,300 employees in Hangzhou and Beijing, Betta's development capabilities range from small-molecule to biologics discovery, clinical development, manufacturing, sales and marketing. Betta's leading product – icotinib (Conmana®), the first innovative oncology product developed and commercially launched by a Chinese pharmaceutical company – is one of the top selling targeted therapies treating non-small cell lung cancer patients in China, having achieved 1.55 billion RMB annual sales in 2019. Betta currently has two programs under NDA review by the NMPA, two programs under late-stage clinical development, eight programs under proof-of-concept clinical development, and multiple small-molecule and biologics programs under pre-clinical discovery. Throughout the years, Betta has set up strategic partnerships with Amgen Inc., Xcovery LLC., Beijing Mabworks Biotech Co., Ltd., Tyrogenex Inc., InventisBio lnc., and Merus N.V.. For additional information, please visit http://bettapharma.com/en.php

    Agenus 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 the anticipated benefits of the collaboration, the receipt of potential milestones and royalties, as well as timing for planned BLA filings. 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.

    Agenus Contact:

    Jennifer Buell, PhD

    781-674-4420

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/agenus-receives-35m-in-immuno-oncology-transaction-with-betta-pharmaceuticals-301101340.html

    SOURCE Agenus Inc.

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  5. LEXINGTON, Mass., July 21, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies and cancer vaccines, announced today that Dr. Jennifer Buell, President and COO of Agenus, and Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/New York Presbyterian Hospital, will discuss AgenTus Therapeutics, Inc.'s (a subsidiary of Agenus) allogeneic iNKT cell therapy approach for infectious diseases at the B. Riley Virtual Infectious Disease Summit – Therapeutics Day on a Panel entitled Pursuing Curative Cell Therapy Approaches.

    LEXINGTON, Mass., July 21, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies and cancer vaccines, announced today that Dr. Jennifer Buell, President and COO of Agenus, and Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/New York Presbyterian Hospital, will discuss AgenTus Therapeutics, Inc.'s (a subsidiary of Agenus) allogeneic iNKT cell therapy approach for infectious diseases at the B. Riley Virtual Infectious Disease Summit – Therapeutics Day on a Panel entitled Pursuing Curative Cell Therapy Approaches.

    Date: Tuesday, July 21, 2020

    Time: 3:00 PM4:00 PM ET

    Title: Pursuing Curative Cell Therapy Approaches – Cell Therapy has become a fast-changing field after becoming a powerful clinical therapy for late line cancer patients with the approval of the first generation CD19+ CAR T cell treatments (Yescarta and Kymriah). Participants in the panel include AgenTus Therapeutics, a biotech company and subsidiary of Agenus Inc. developing new cancer treatments, including AGENT-797, an early unmodified allogeneic iNKTcell therapy, Magenta Therapeutics, a cell therapy company developing novel cell therapies including MGTA-456, a stem -cell production therapy, and SQZ Biotechnologies Company, a biotech company developing oncology drugs including APC HPV, an autologous based therapy for several types of cancer.

    Agenus Inc.

    Jennifer Buell, Ph.D. – President and Chief Operating Officer

    Manuel Hidalgo, M.D. –Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/New York Presbyterian

    Excision BioTherapeutics

    Daniel Dornbusch - Chief Executive Officer

    Pluristem Therapeutics (PSTI)

    Racheli Ofir – Vice President of Research & IP

    About AgenTus Therapeutics, Inc. 

    AgenTus Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of breakthrough allogeneic iNKT cells in the unmodified and modified with engineered receptors, such as T cell receptors (TCRs) and Chimeric Antigen Receptors (CARs), designed to supercharge the human immune system cells to seek and destroy cancer.  AgenTus also aims to advance adoptive cell therapy formats which would enable off-the-shelf living drugs.  AgenTus has locations in Lexington, MA and Cambridge, UK.  For more information, please visit www.agentustherapeutics.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 and infections. 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 AgenTus 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 twitter.

    Contact:

    Agenus Inc. 

    Jennifer Buell, PhD

    781-674-4420 

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/agenus-to-participate-in-a-panel-on-cell-therapy-for-infectious-diseases-at-the-b-riley-virtual-infectious-disease-summit-301097296.html

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