Item 8.01. Other Events

Humanigen, Inc. (the "Company") provides the following regulatory updates on lenzilumab™:





Lenzilumab in COVID-19

On June 30, 2022, the Company issued a press release confirming that the Company had received notice from the National Institute of Allergy and Infectious Diseases ("NIAID") that it has completed database lock for its Big Effect Trial of lenzilumab ("BET-B") being conducted in collaboration with the National Institutes of Health ("NIH") public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines-5 ("ACTIV-5"). The Company expects to receive topline results from NIH/NIAID in July.

Lenzilumab in chimeric antigen receptor T-cell ("CAR-T")

The Company's study to evaluate the efficacy and safety of lenzilumab combined with two FDA-approved CAR-T therapies in non-Hodgkin lymphomas, known as SHIELD, is now expected to dose its first patient in the third quarter of 2022. SHIELD will study lenzilumab for the prevention of CAR-T therapy-related toxicities including immune effector cell associated neurotoxicity ("ICANS") and cytokine release syndrome ("CRS").

Lenzilumab in Acute Graft versus Host Disease ("aGvHD")

The study of lenzilumab as a companion to allogeneic hematopoietic stem cell therapy ("HSCT") for patients with hematological cancers to prevent/treat aGvHD conducted by the IMPACT Partnership in the United Kingdom, known as the RATinG study, is now expected to dose its first patient in the third quarter of 2022.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K 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 anticipated time for release of topline data from the ACTIV-5/BET-B study; and statements regarding the expected timing of the first patient dosed in the RATinG and SHIELD studies; and other statements regarding our plans relating to lenzilumab.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the Company's lack of profitability and need for additional capital to grow its business; the Company's dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration; and the various risks and uncertainties described in the "Risk Factors" sections of the Company's latest annual and quarterly reports and other filings with the SEC.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The Company undertakes no obligation to revise or update any forward-looking statements made in this Current Report on Form 8-K to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

Item 9.01. Financial Statements and Exhibits






(d)    Exhibits





Exhibit No.      Exhibit Description

104              Cover Page Interactive Data File (embedded within the Inline XBRL
                 document)

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