Current Report Filing (8-k)
March 29 2021 - 09:19AM
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):
March 29, 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 7.01.
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Regulation FD Disclosure
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On March 29, 2021, Humanigen,
Inc. (the “Company”) issued a press release announcing top-line data from its pivotal Phase 3 trial of lenzilumabTM
in patients hospitalized with COVID-19. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On March 29, 2021, the Company hosted a conference call for investors
and other interested stakeholders to discuss the top-line data from the Phase 3 lenzilumab trial. A copy of the presentation materials
discussed on the conference call is furnished as Exhibit 99.2 to this report. A copy of the presentation is also available on the
Company's website, www.humanigen.com.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on
Form 8-K, including Exhibit 99.1 and Exhibit 99.2, 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 Company’s
expectations regarding the timeline to file for and potential to obtain emergency use authorization (EUA) and a Biologics License
Application (BLA) for lenzilumab as a COVID-19 therapy. These 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 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 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
filing. The Company 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.
Certain Information
The information in this Item
7.01, including Exhibit 99.1 and Exhibit 99.2, is being furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended,
except to the extent expressly set forth by specific reference in such a filing.
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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: March 29, 2021
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