Current Report Filing (8-k)
June 01 2020 - 7:07AM
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): June 1, 2020
Altimmune, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-32587
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20-2726770
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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910 Clopper Road Suite 201S
Gaithersburg, Maryland
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20878
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (240)
654-1450
Not Applicable
(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:
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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:
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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, par value $0.0001 per share
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ALT
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The NASDAQ Global Market
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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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 7.01.
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Regulation FD Disclosure.
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On June 1, 2020, Altimmune, Inc. (the Company) issued a press release announcing that the U.S. Food and Drug Administration
(the FDA) had cleared the Companys Investigational New Drug application (IND) to proceed with a Phase 1/2 clinical trial of T-COVID, the Companys investigational agent for
the treatment of early COVID-19 (T-COVID).
The information in this Item 7.01, including Exhibit 99.1 attached hereto, 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 in any filing under the Securities Act of 1933, as amended, except as
expressly set forth by specific reference in such a filing.
On June 1, 2020, the Company announced FDA clearance of the IND for T-COVID. The Company expects
to initiate a placebo-controlled Phase 1/2 double-blind clinical trial to evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19
in June 2020 and expects a data read out in the fourth quarter of 2020.
Forward-Looking Statement
The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of
historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, the timing of key milestones for our clinical assets, the development of our T-COVID product candidate, initiation of a Phase 1/2 clinical trial for T-COVID and corresponding data read out in the fourth quarter of 2020. In some cases, forward-looking
statements can be identified by terminology such as may, could, should, anticipate, believe, estimate, expect, intend, plan,
predict and similar expressions and their variants or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The Company cautions that these forward-looking
statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical
experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global economy the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Companys product
candidates; funding delays, reductions in or elimination of U.S. government funding and/or non-renewal of expiring funding under the Companys agreement with Biomedical Advanced Research and Development
Authority (BARDA), or the Companys contract with the National Institutes of Allergy and Infectious Diseases (NIAID); the Companys ability to satisfy certain technical milestones under the Companys contracts
with BARDA and NIAID that would entitle the Company to receive additional funding over the period of the agreement; delays caused by third parties challenging government contracts awarded to the Company; the receipt of future potential payments
under government contracts or grants; the Companys ability to identify potential future government contracts or grant awards; the Companys ability to obtain potential regulatory approvals on the timelines anticipated, or at all; the
Companys ability to obtain additional patents or extend existing patents on the timelines anticipated, or at all; the Companys ability to identify and consummate potential future strategic partnerships or business combinations; the
Companys ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Companys ability to commercialize its products; the Companys anticipated
financial or operational results; the Companys ability to obtain additional capital resources; unforeseen safety and efficacy issues; breaches of data privacy, or disruptions in the Companys information technology systems; and the
Companys ability to continue to satisfy the listing requirements of the NASDAQ Global Market. Further information on the factors and risks that could affect the Companys business, financial conditions and results of operations are
contained in the Companys filings with the U.S. Securities and Exchange Commission, including under the heading Risk Factors in the Companys annual report on Form 10-K for the fiscal
year ended December 31, 2019 and our quarterly report on Form 10-Q for the quarter ended March 31, 2020, which are available at www.sec.gov. Except as required by law, the Company disclaims any
intention or responsibility for updating or revising any forward-looking statements contained in this Current Report on Form 8-K in the event of new information, future developments or otherwise. These
forward-looking statements speak only as of the date hereof.
Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
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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Date: June 1, 2020
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ALTIMMUNE, INC.
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By:
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/s/ William Brown
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William Brown
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Chief Financial Officer
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