Context

Humanigen is a US-based clinical-stage biopharmaceutical company, developing an immunology and immuno-oncology portfolio of monoclonal antibodies. Its immediate focus is to prevent or minimize cytokine release syndrome, which precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia.

On 29 March 2021, Humanigen reported positive Phase 3 topline results demonstrating that its Lenzilumab™ improves survival without need for mechanical ventilation in hospitalized patients with COVID-19.

Despite a massive vaccination campaign initiated at the end of 2020 for COVID-19, the US and Europe are still facing severe cases with respiratory distress. FDA approval for Lenzilumab™, which would be Humanigen’s first product to be approved, would make it possible to treat those cases.

Humanigen is also working to create next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity.

The capital raise aims to finance manufacturing and commercial preparation in the event of FDA Emergency Use Authorization for Lenzilumab™ in hospitalized COVID-19 patients.

About Humanigen

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen’s immediate focus is to prevent or minimize cytokine release syndrome that precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia. Humanigen is also working to create next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of Lenzilumab™ as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T-cell-engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat Graft versus Host Disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating Lenzilumab™ in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration.

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Pierre Kiecolt-Wahl

Equity Capital Markets

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Hervé Ronin

Investment Banking

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Olga SMOLENTSEVA

Equity Research

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Pierre Sertour

Equity Capital Markets

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