Current Report Filing (8-k)
April 20 2021 - 5:28PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
April 18, 2021
Humanigen, Inc.
(Exact name of registrant as specified in its charter)
Delaware
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001-35798
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77-0557236
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(State or other Jurisdiction of
Incorporation)
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(Commission File No.)
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(IRS Employer Identification No.)
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533 Airport Boulevard, Suite 400
Burlingame, CA 94010
(Address of principal executive offices, including
zip code)
(650) 243-3100
(Registrant’s telephone number, including
area code)
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of
the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock
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HGEN
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The Nasdaq Stock Market LLC
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Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule
12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
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Item 1.02.
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Termination of a Material Definitive Agreement.
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On April 19, 2021, Humanigen,
Inc. (the “Company”) issued a press release announcing positive data with lenzilumabTM, the Company’s lead
product candidate, in the ZUMA-19 Phase 1b study evaluating the efficacy and safety of lenzilumab with Yescarta®, the CAR-T therapy
developed by Kite Pharmaceuticals, Inc., a Gilead company (“Kite”), in patients with diffuse large B-cell lymphoma (“DLBCL”).
In addition, the Company announced its plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate
the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL. In connection with its announcement
of its decision to pursue the Phase 2 study, the Company also announced the termination of the Clinical Collaboration Agreement, dated
May 30, 2019, by and between the Company and Kite (the “Collaboration Agreement”). The termination of the Collaboration Agreement
will be effective on May 18, 2021, the 30th day following the Company’s notice of termination. The parties are expected
to collaborate to wind down current study activities related to ZUMA-19.
A copy of the press release
is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form
8-K, including Exhibit 99.1, 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
Humanigen’s plans to initiate a Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available
CD19 CAR-T therapies in DLBCL. These forward-looking statements are subject to a number of risks and uncertainties including, but not
limited to, the risks inherent in Humanigen’s lack of profitability and potential need for additional capital to grow Humanigen’s
business; Humanigen’s dependence on partners to further the development of Humanigen’s product candidates; the uncertainties
inherent in the development, attainment of the requisite regulatory approvals or authorization for emergency or broader patient use for
lenzilumab and launch of lenzilumab; challenges associated with the manufacturing of lenzilumab, and potential changes to the schedule
for such manufacturing efforts; the outcome of pending or future litigation; and the various risks and uncertainties described in the
“Risk Factors” sections and elsewhere in the Humanigen's periodic and other filings with the SEC.
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 filing. Humanigen undertakes no obligation to revise or update any forward-looking statements
made in this filing 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.
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Item 9.01.
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Financial Statements and Exhibits
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SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Humanigen, Inc.
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By:
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/s/ Cameron Durrant
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Name: Cameron Durrant
Title: Chairman of the Board and Chief Executive Officer
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Dated: April 20, 2021
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