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): February 26, 2019

LIQUIDIA TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

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

Item 2.02                                           Results of Operations and Financial Condition.

On February 26, 2019, Liquidia Technologies, Inc., a Delaware corporation, issued a press release announcing its financial results for the three months and year ended December 31, 2018. A copy of the press release is furnished herewith as Exhibit 99.1.*

Item 9.01                                           Financial Statements and Exhibits.

(d) Exhibits.

* The information in Item 2.02 of this Form 8-K shall not be deemed “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 it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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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.

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Exhibit 99.1

Liquidia Technologies Reports Fourth Quarter and Full-Year 2018
Financial Results and Provides Corporate Update

·             Reported positive interim LIQ861 safety data from its pivotal Phase 3 INSPIRE clinical trial

·             Accepted by FDA into Emerging Technology Program to support review of PRINT® technology

·             Management to host webcast and conference call today at 8:00 a.m. ET

RESEARCH TRIANGLE PARK, NC — February 26, 2019 — Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT® technology to transform the lives of patients, today reports its financial results for the fourth quarter and full-year ended December 31, 2018 and provides a corporate update.

“We have made meaningful progress across our clinical programs, as highlighted by our recent announcement of two-week safety data from our pivotal, open-label Phase 3 clinical trial (INSPIRE) in pulmonary arterial hypertension (PAH). With patients remaining on drug, we continue to accumulate longitudinal data related to the long-term safety and tolerability of LIQ861 and intend to report that in advance of the New Drug Application (NDA) filing expected late this year,” stated Neal Fowler, Chief Executive Officer of Liquidia.

“In addition to recent and planned presentations on LIQ861, we recently presented Phase 1 data on LIQ865, our non-opioid, sustained-release formulation of bupivacaine for the management of local post-operative pain, at the American Society of Regional Anesthesia and Pain Medicine (ASRA) Annual Pain Medicine Meeting. Our continued progress in advancing our pipeline demonstrates the versatility of our PRINT® technology platform and our ability to develop potential therapeutic treatments to transform the lives of patients,” concluded Mr. Fowler.

Recent Corporate Highlights

·                  Reported positive interim safety data from our pivotal, open-label Phase 3 clinical trial (INSPIRE) evaluating LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of PAH. LIQ861 was observed to be well-tolerated in PAH patients (n=109) at the two-week timepoint, the period which addresses the U.S. Food and Drug Administration’s (FDA) request for data inclusion in an NDA submission. LIQ861 was evaluated at doses up to 125 mcg treprostinil capsule strength with no study-drug related serious adverse events or dose-limiting toxicities observed. Patients have continued to receive treatment beyond two weeks with the first patient dosed in March 2018. Liquidia anticipates submitting the full NDA for LIQ861 to the FDA in late 2019.

·                  Accepted by the FDA into the Center for Drug Evaluation and Research (CDER) Emerging Technology Program. The Emerging Technology Program was created to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing technologies likely to improve product safety, identity, strength, quality, and purity.  It supports innovation by providing a forum for sponsors to engage FDA early in development and ensures consistency, continuity, and predictability in review and inspection. The program will allow Liquidia to meet with Emerging Technology Team members to discuss its novel PRINT® technology prior to filing a regulatory submission.

·                  Presented Phase 1 results for LIQ865 at ASRA’s 17th Annual Pain Medicine Meeting. Our second product candidate, LIQ865 is an injectable, non-opioid, sustained-release formulation of bupivacaine for the management of local post-operative pain. The Phase 1 study measured the safety, pharmacokinetics (PK) and pharmacodynamics of LIQ865 in healthy volunteers.

Anticipated Upcoming Milestones

·                  Initiate Phase 2-enabling toxicology studies for LIQ865 in March 2019;

·                  Report LIQ861 bioavailability and PK of treprostinil in the second quarter of 2019;

·                  Initiate an additional clinical trial in Europe that explores the effects of LIQ861 on acute and chronic hemodynamic measurements and right heart function in PAH patients to help inform the medical community and support clinical development; and

·                  Submit an NDA to the FDA for LIQ861 in late 2019.

Fourth Quarter and Full Year 2018 Financial Highlights

·                  Revenues: Revenues were $0.6 million and $2.7 million for the quarter and year ended December 31, 2018, respectively, compared to $1.8 million and $7.3 million for the comparable prior year quarter and year ended December 31, 2017, respectively. Our revenue is primarily derived from collaborating and licensing our proprietary PRINT® technology to pharmaceutical companies. The decrease results primarily from lower research and development services performed for other pharmaceutical companies as we prioritize the development of our own pharmaceutical products.

·                  Research and Development (R&D): R&D expenses were $8.0 million and $28.7 million for the quarter and year ended December 31, 2018, respectively, compared to $6.8 million and $24.8 million for the comparable prior year quarter and year ended December 31, 2017, respectively. The increase in R&D expenses was primarily due to our ongoing Phase 3 clinical trial for LIQ861 (INSPIRE), which commenced in December 2017.

·                  General and Administrative (G&A): G&A expenses were $2.3 million and $8.8 million for the quarter and year ended December 31, 2018, respectively, compared to $2.1 million and $10.2 million for the comparable prior year quarter and year ended December 31, 2017, respectively. The full-year decrease in G&A expenses was primarily due to costs of an abandoned equity offering being expensed during the year ended December 31, 2017.

·                  Net Loss: A net loss of $9.7 million and $53.1 million for the quarter and year ended December 31, 2018, respectively, compared to net income of $8.2 million and a net loss of $29.2 million for the comparable prior year quarter and year ended December 31, 2017, respectively. The change from a profit to a net loss for the fourth quarter was primarily related to $20.1 million of positive derivative fair market value adjustments (FMV) related to convertible instruments and warrants in 2017 that were settled in 2018.  The increase in net loss for the full-year was primarily due to a decrease in revenues and increases in R&D, interest and derivative FMV adjustment expenses, partially offset by a decrease in G&A expenses during the year ended December 31, 2018 as compared to the year ended December 31, 2017.

·                  Cash Position: Cash totaled $39.5 million as of December 31, 2018.

·                  Shares Outstanding: There were 15,519,469 shares of common stock outstanding as of December 31, 2018.

Webcast and Conference Call

Liquidia’s management team will host a webcast and conference call at 8:00 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-877-707-8711 (domestic) and 1-857-270-6219 (international) and entering the conference code: 5960248. A live and archived webcast of the call will be available on the Events & Presentations page of Liquidia’s website.

About Liquidia Technologies

Liquidia Technologies is a late-stage clinical biopharmaceutical company focused on the development and commercialization of human 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.

-Financial Tables Follow-

Liquidia Technologies, Inc.

Balance Sheets

Liquidia Technologies, Inc.

Statements of Operations and Comprehensive Loss

Liquidia Technologies, Inc.

Statements of Cash Flows