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Humanigen, Inc.
Humanigen has discovered, developed, and plans to commercialize LENZ® (lenzilumab), a variant-agnostic immunomodulatory antibody, which addresses a significant unmet need in COVID-19.
LENZ® represents a near-term opportunity in COVID-19 with a defined regulatory pathway, a first-line positioning patient segment not addressed by current therapies, and potential for multi-billion dollar annual recurring revenues.
Nasdaq: HGEN
IR Website: https://ir.humanigen.com
Headquarters: Short Hills, NJ
Content provided by Humanigen on 2-22-22.
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Summary
We are a clinical stage biopharmaceutical company, developing our immunology and immuno-oncology portfolio of monoclonal antibodies. We are focusing our efforts on the development of our lead product candidate, lenzilumab, our proprietary Humaneered® (“Humaneered”) anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) monoclonal antibody. Lenzilumab is a monoclonal antibody that has been proven in animal models to neutralize GM-CSF, a cytokine that we believe is of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome (“CRS”) or cytokine storm, associated with COVID-19, chimeric antigen receptor T-cell (“CAR-T”) therapy and acute Graft versus Host Disease (“GvHD”) associated with bone marrow transplants. Lenzilumab binds to and neutralizes GM-CSF.
Humanigen has completed a phase 3 registrational trial with lenzilumab in COVID-19 pneumonia and announced positive topline data in March 2021. This study has led to a filing of an Emergency Use Authorization (“EUA”) application which, if approved, could allow us to begin limited commercialization pursuant to such EUA. Humanigen has also announced positive data in a phase 1b study to reduce CRS and neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”). We are also in the planning stages to conduct a phase 2/3 trial for lenzilumab to treat patients who have undergone allogeneic hematopoietic stem cell therapy (“HSCT”) who are at high risk for acute GvHD. The trial is expected to be conducted by the IMPACT Partnership, a collection of stem cell transplant centers located in the United Kingdom.
Our proprietary and patented Humaneered technology platform is a method for converting existing antibodies (typically murine) into engineered, high-affinity human antibodies designed for therapeutic use, particularly for chronic conditions. We have developed or in-licensed targets or research antibodies, typically from academic institutions, and then applied our Humaneered technology to them. Lenzilumab and our other two product candidates, ifabotuzumab and HGEN005, are Humaneered antibodies. Our Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target but low immunogenicity. We believe our Humaneered antibodies offer additional advantages, such as lower likelihood to induce an inappropriate immune response when used chronically, high potency, and a slow off-rate.
Business Development Fact Sheet
Recent News
Humanigen Reports Year-End 2021 Financial Results
Feb 28, 2022
Humanigen to Present and Participate at Multiple Investor Events in March
Feb 25, 2022
Humanigen to Present at BIO CEO & Investor Conference
Feb 11, 2022
Humanigen Launches Managed Access Program for Lenzilumab
Feb 9, 2022
Humanigen and Cenexi Announce Collaboration to Manufacture Lenzilumab in France
Feb 8, 2022
Humanigen Announces Peer-Reviewed Publication in The Journal of Medical Economics Demonstrating the Clinical and Economic Benefits of Lenzilumab
Jan 18, 2022
Humanigen Aligns with FDA on Potential Registration Phase 3 Study for Lenzilumab with CAR-T
Jan 10, 2022
Management Overview
Cameron Durrant, MD, MBA
Chairman and CEO
• Serial biotech experience as CEO, CFO, Chair, Exec Chair• Merck, GSK, Pharmacia, J+J
• Launched 5 blockbusters during career, including antivirals
Dale Chappell, MD, MBA
Chief Scientific Officer
• Founder, Black Horse Capital Advisors• Decades of biotechnology investment experience
• HHMI Fellow, National Cancer Institute, Rosenberg Lab
• Multiple publications in T-cell therapy, GM-CSF and immunology pathways
Timothy Morris, CPA
Chief Financial Officer & Chief Operating Officer
• Over 36 years of professional finance and accounting experience• Over 22 years as Chief Financial Officer with public biotechnology companies (IOVA, ACRX, VVUS, QCOR)
• Raised over $2 billion in equity and convertible securities for seven companies, completed four offerings for IOVA with over $1 billion in proceeds
• Oversaw increase in market cap of Iovance Biotherapeutics from $550 million to $4.2 billion (7x increase)
• Extensive deal experience with over 75 transactions and combined value in excess of $4 billion
Adrian Kilcoyne, MD, MBA
Chief Medical Officer
• Leadership experience across Medical Affairs, Evidence Generation and R&D• Over 15 years of clinical experience (AstraZeneca, Celgene, Sanofi, Roche, Baxter, Eli Lilly)
• Expertise in COVID-19 and CAR-T
• Directed numerous projects spanning oncology and lymphoma programs
Edward Jordan, MBA
Chief Commercial Officer
• Over 20 years experience building and leading commercial organizations• Broad commercial experience spanning many therapeutic areas
• Biotech builder with biologic experience
• Extensive launch experience and builder of new therapeutic markets
• DBV Technologies, AMAG, TEVA, Schering-Plough
Bob Atwill, MBA
Head of Asia-Pacific Region
• Over 30 years of executive pharma, biotech, cell therapy and healthcare experience• Corporate Officer in listed NYSE, NASDAQ, LSE, ASX and in other organisations for over 23-years
• Expertise in COVID-19, GvHD, virology, I/O and cell & gene therapy
• GSK, Sanofi-Synthélabo, Mesoblast and Benitec Biopharma
• APAC based cross-border M&A and capital service principal with Eaton Square
Risks & Disclosures
This communication is neither an offer to sell nor a solicitation of an offer to buy, nor a recommendation of any securities of the company mentioned herein.
Humanigen Inc. (the “Company”) and its counsel have reviewed the content of this page as well as the accompanying presentation (“Company Presentation”) displayed on this page. To the best of its knowledge, the Company does not believe this content to be misleading or inaccurate in any material respect, nor does it believe there are any material omissions with respect to such content. The Company does not believe the contents of the page or the Company Presentation to contain any non-public material information.
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Information, opinions and estimates contained on this page or in the Company Presentation reflect judgments by the Company as of the original date of publication by the Company and are subject to change without notice. Past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied is made regarding future performance.
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