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Humanigen Announces ZUMA-19 Abstract Accepted for Presentation at American Society of Hematology 2020 Annual Meeting

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Humanigen, Inc., (Nasdaq:HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF) with its lead therapeutic candidate lenzilumab™, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, today announced the acceptance of an abstract describing the ongoing ZUMA-19 study for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, to be held virtually from December 5-8, 2020.

"The rationale for GM-CSF neutralization with CAR-T cell therapy is appealing and well-understood and we look forward to discussing this ongoing trial at ASH in collaboration with our research partners," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.

ZUMA-19 is a joint Humanigen/Kite, a Gilead Company, clinical study that is being conducted as part of a clinical collaboration in the US. The ongoing ZUMA-19 Phase 1b/2 multicenter study is evaluating lenzilumab in adults with relapsed/refractory large B-cell lymphoma (R/R LBCL) who are receiving CAR-T cell therapy with axicabtagene ciloleucel.

The abstract, titled "ZUMA-19: A Phase 1/2 Multicenter Study of Lenzilumab Use with Axicabtagene Ciloleucel (Axi Cel) in Patients (Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL)," will be presented as a Trials-in-Progress poster (Abstract #2103) on Sunday, December 6 at 10:00 a.m. ET.

About Humanigen, Inc.

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. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating 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, the company 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. The company 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 axicabtagene ciloleucel in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the potential for lenzilumab to be used to prevent or treat COVID-19, GvHD and, as sequenced therapy with Kite’s axicabtagene ciloleucel, in CAR-T therapies. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability; our dependence on partners to further the development of our product candidates; the costs and the uncertainties inherent in the development, attainment of requisite regulatory approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201104005710/en/


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Solebury Trout