Current Report Filing (8-k)
January 05 2022 - 5:05AM
Edgar (US Regulatory)
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2022-01-05
2022-01-05
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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): January 5, 2022
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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¨
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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. ¨
Item 8.01. Other
Events
Humanigen, Inc. (the “Company”)
provides the following regulatory update on lenzilumab™ for the treatment of COVID-19 in the United States, United Kingdom,
and the European Union:
United States
The Company met with senior
staff representatives of the United States Food and Drug Administration (“FDA”) in a Type B meeting as part of the follow-up
to FDA’s response to the Company’s Emergency Use Authorization (“EUA”) submission. Based on the FDA’s written
responses to the Company’s pre-meeting briefing materials and verbal comments in the meeting, the Company intends to include the
results from the ACTIV-5/BET-B study, if positive and confirmatory of the results generated by the Company’s LIVE-AIR study, in
an amendment to the previously filed submission for EUA. ACTIV-5/BET-B has met its target enrollment and topline data from the study is
expected in late first quarter or early second quarter 2022.
United Kingdom
The Company received a written
response from the Medicines and Healthcare products Regulatory Agency (MHRA) to the Company’s submission of lenzilumab for marketing
authorization and held a series of clarifying discussions with MHRA representatives. The MHRA response included several requests for further
information related to clinical, manufacturing and quality processes. The Company believes it can respond to a majority of the requests
in the first quarter of 2022. Certain performance process qualification (“PPQ”) drug product batches have to be manufactured
and the analytical data from these batches would need to be submitted to MHRA unless waived. This work is expected to be completed in
the second quarter of 2022. The Company also plans on including the results from ACTIV-5/BET-B, if positive and confirmatory, in the responsive
MHRA submission.
European Union
As a result of feedback received
from representatives of the European Medicines Agency (“EMA”), the Company intends to submit a Conditional Marketing Authorization
(“CMA”) for lenzilumab with an Accelerated Approval request. The Company believes EMA’s requirements will be similar
to MHRA and anticipates including in the CMA the same information submitted to MHRA. The Company also plans to include the results from
ACTIV-5/BET-B in the CMA.
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, if favorable, submitting an amended EUA request; statements
regarding our anticipated time to complete certain work required in connection with our response to MHRA and make our submission for CMA;
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; 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.
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Item 9.01.
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Financial Statements and Exhibits
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(d) Exhibits
Exhibit No.
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Exhibit Description
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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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: January 5, 2022
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