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): May 14, 2019

 

LIQUIDIA TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-38601

 

20-1926605

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

419 Davis Drive, Suite 100, Morrisville, North Carolina

 

27560

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s 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

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

 

Trading Symbol(s)

 

 

Name of each exchange on which registered

Common stock

 

 

LQDA

 

 

Nasdaq Capital Market

 

 

 


 

Item 8.01              Other Events.

 

On May 14, 2019, Liquidia Technologies, Inc., a Delaware corporation (the “Company”), announced that Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division, Professor of Medicine at Tufts University School of Medicine, and INSPIRE Principal Investigator, will present a poster highlighting data from the Company’s Phase 3 INSPIRE trial of LIQ861 for the treatment of pulmonary arterial hypertension at the ATS International Conference in Dallas, Texas. The poster will include data on tolerability of LIQ861 and selected exploratory endpoints at two months of treatment, split by New York Heart Association Functional Class.

 

A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01              Financial Statements and Exhibits.

 

(d)

 

Exhibit
No.

 

Exhibit

 

 

 

99.1

 

Press Release of Liquidia Technologies, Inc., dated May 14, 2019.

 

2


 

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.

 

May 14, 2019

Liquidia Technologies, Inc.

 

 

 

 

 

By:

/s/ Timothy Albury

 

 

Name:

Timothy Albury

 

 

Title:

Interim Chief Financial Officer

 

3


Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

Liquidia Announces Poster Presentation at the

American Thoracic Society (ATS) International Conference 2019

 

To include highlights of the safety and tolerability of LIQ861 at two months of treatment

in the INSPIRE Phase 3 Trial

 

RESEARCH TRIANGLE PARK, NC — May 14, 2019Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company, today announced that Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division, Professor of Medicine at Tufts University School of Medicine, and INSPIRE Principal Investigator, will present a poster highlighting data from Liquidia’s Phase 3 INSPIRE trial of LIQ861 for the treatment of pulmonary arterial hypertension (PAH) at the ATS International Conference in Dallas, Texas. The poster will include data on tolerability of LIQ861 and selected exploratory endpoints at two months of treatment, split by New York Heart Association Functional Class.

 

Presentation details are as follows:

 

Title:

INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH)

 

 

Poster Board Number:

P1155

 

 

Date/Time:

Tuesday, May 21; 11:15 a.m. — 1 p.m. CT

 

 

Location:

Area J (Hall F, Level 2), KBHCCD

 

A copy of the poster will be available on the company’s website following the presentation.

 

About LIQ861

 

Liquidia has developed LIQ861, a dry powder formulation of treprostinil utilizing PRINT® Technology, which is specifically designed to enhance deep-lung delivery and enables QID delivery of treprostinil doses in 1 to 2 breaths per capsule via a convenient, palm-sized dry powder inhaler (DPI). PRINT® Technology results in a treprostinil drug product with particles of a precise, uniform size, shape and composition that are engineered for optimal deposition in the lung following oral inhalation using a DPI. LIQ861 may enhance lung delivery and pharmacodynamic effects of treprostinil in patients diagnosed with PAH.

 

About INSPIRE Clinical Trial

 

Liquidia’s pivotal open-label Phase 3 clinical trial, known as INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, is designed to evaluate patients who have either been under stable treatment with nebulizer-delivered treprostinil for at least three months and are transitioned to LIQ861 under the protocol (Transition) or patients who have been on stable treatment with no more than two non-prostacyclin oral PAH therapies for at least three months and have their treatment regimen supplemented with LIQ861 under the protocol (Add-on). The primary objective of the INSPIRE

 


 

study is to evaluate the long-term safety and tolerability of LIQ861. INSPIRE also includes exploratory endpoints to assess clinical benefits such as 6 Minute Walk Distance (6MWD) and quality of life. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03399604.

 

About Liquidia Technologies

 

Liquidia is a late-stage clinical biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary PRINT® technology to transform the lives of patients. Currently, Liquidia is focused on the development of two product candidates using its PRINT® particle engineering platform: LIQ861 for the treatment of pulmonary arterial hypertension and LIQ865 for the treatment of local post-operative pain. Being evaluated in a Phase 3 clinical trial (INSPIRE), LIQ861 is designed to improve the therapeutic profile of treprostinil by enhancing deep-lung delivery and achieving higher dose levels than current inhaled therapies by using a convenient, palm-sized, disposable dry powder inhaler. LIQ865, for which Liquidia has completed two Phase 1 clinical trials, is designed to deliver sustained-release particles of bupivacaine, a non-opioid anesthetic, to treat local post-operative pain for three to five days through a single administration. For more information visit Liquidia’s website at www.liquidia.com.

 

Forward-Looking Statements

 

This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing of an NDA for LIQ861, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The words “anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “will” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the Securities and Exchange Commission, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contact Information

 

Investors:

Jenny Kobin

IR Advisory Solutions

 


 

919.328.4389

IR@liquidia.com

 

Media:

Christy Curran

Sam Brown Inc.

615.414.8668

media@liquidia.com