Current Report Filing (8-k)
January 07 2019 - 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):
January 7, 2019
LIQUIDIA TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware
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001-38601
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20-1926605
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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419 Davis Drive, Suite 100, Morrisville, North Carolina
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27560
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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:
(919) 328-4400
(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. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in 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
x
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.
x
Item 7.01
Regulation FD Disclosure.
Liquidia Technologies, Inc. (the Company) has updated its company overview (the Company Overview) and a copy of the slides comprising the Company Overview is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Company Overview may also be accessed under the Investors tab on the Companys website at www.liquidia.com.
In accordance with General Instruction B.2 on Form 8-K, the information set forth in this Item 7.01 and the Company Overview slides, attached to this report as Exhibit 99.1, are furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Please refer to Exhibit 99.1 for a discussion of certain forward-looking statements included therein and the risk and uncertainties related thereto.
Item 8.01
Other Events.
On January 7, 2019, the Company issued a press release reporting positive interim safety data from its open-label, multicenter Phase 3 clinical trial (INSPIRE) evaluating LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of pulmonary arterial hypertension. The safety data at the two-week timepoint addresses the U.S. Food and Drug Administrations (the FDA) data request for inclusion in a New Drug Application (NDA) submission. The Company anticipates submitting the full NDA for LIQ861 to the FDA in late 2019.
The full text of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
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SIGNATURE
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.
January 7, 2019
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Liquidia Technologies, Inc.
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By:
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/s/ Kevin Gordon
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Name:
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Kevin Gordon
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Title:
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President and Chief Financial Officer
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