8-K

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): October 2, 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))

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

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 7.01Regulation FD Disclosure.

On October 2, 2019, Liquidia Technologies, Inc. (the “Company”) provided an update on the Phase 3 development program for LIQ861, an investigational treatment for pulmonary arterial hypertension (“PAH”), and updated its company overview (the “Company Overview”). 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 Company’s website at www.liquidia.com.

The clinical program for LIQ861 has been completed and the Company is proceeding with plans for submission of the new drug application (the “NDA”) for the treatment of adults with PAH.

The Company has recently conducted a pre-NDA meeting with the U.S. Food and Drug Administration (the “FDA”) with respect to the chemistry, manufacturing and controls (“CMC”) aspects of the LIQ861 NDA and received no new CMC requirements from the FDA for NDA submission. Moreover, the supplemental healthy volunteer pharmacokinetics study showed minimized subject variability and the Company believes it has established comparative bioavailability to the reference listed drug.

The Company has also requested a pre-NDA meeting with the FDA focused on clinical and nonclinical contents of the NDA. The date of this meeting has not yet been confirmed but the Company anticipates that the meeting will likely occur in November, 2019. While the Company continues to focus its efforts on submitting the NDA as expeditiously as possible, without clear timing of its clinical and nonclinical pre-NDA meeting and potential follow-on FDA requirements, if any, the Company is now anticipating an early first quarter 2020 NDA submission for LIQ861.

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 9.01Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Exhibit
99.1	Liquidia Technologies, Inc. October 2019 Company Overview.

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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.

October 2, 2019	Liquidia Technologies, Inc.
	By:	/s/ Richard D. Katz, M.D.
		Name:	Richard D. Katz, M.D.
		Title:	Chief Financial Officer

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EX-99.1

Exhibit 99.1

2019 Cantor Fitzgerald Global Healthcare Conference October 2, 2019 New York City

Forward-Looking Statements This presentation includes, and our response to various questions may include, forward-looking statements. All statements contained in this presentation 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. 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, 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, are subject to a number of risks, 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 and trends discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the date of this presentation to conform these statements to actual results or revised expectations, except as required by law. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. This presentation includes long-term goals that are forward-looking, are subject to significant business, economic, regulatory and competitive uncertainties and contingencies, many of which are beyond the control of us and our management, and are based upon assumptions with respect to future decisions, which are subject to change. Actual results will vary and those variations may be material. Nothing in this presentation should be regarded as a representation by any person that these goals will be achieved and we undertake no duty to update our goals.

Novel products via precise control of drug particles Late-stage clinical biopharmaceutical company focused on transforming the lives of patients Pulmonary Arterial Hypertension (PAH): New Drug Application (NDA); Decision Resources Group, Landscape & Forecast, PAH, Nov 2018 Preparing NDA LIQ861: inhaled dry powder targeting segment of PAH market ($3.7B U.S.) Completed clinical program and preparing NDA submission Pipeline Growth LIQ865: to manage local, post-operative pain for 3-5 days (Phase 1) Poised to expand PRINT Technology advantages into future products Proprietary Technology Broadly applicable across therapeutic areas, modalities and routes of delivery Fully scaled PRINT® platform offers multiple product advantages LIQ861

LIQ861 for PAH PRINT® treprostinil, dry powder inhalation

Continually released by lungs to bind local receptors Vasodilates the pulmonary arteries Relaxes smooth muscle Inhibits platelet aggregation PAH is a rare, progressive disease that results in right heart failure Sources: Farber Eur Respir Rev 2016; Lang Eur Respir Rev 2014; Channik Advances in Pulmonary Hypertension Spring, 2002, DRG, PH Disease Landscape, Nov 2016; Yen-Chun Lai et al. Circ Res. 2014;115:115-130; Decision Resources Group, Landscape & Forecast, PAH, Nov 2018. Prostacyclin is essential to normal lung function $1.4B of $3.7B market in prostacyclin pathway in 2017 Abnormal changes in arteries of the lungs increase pressure in pulmonary arteries Prostacyclin Deficiency Prostacyclin Analogs PAH Patient PAH Treatment Parenteral infusion Inhaled Oral, analog Oral, IP agonist ERAs PDE-5 inhibitors sGC stimulators Prost. IP agonist, Oral Prostacyclin, Oral Prostacyclin, Inhaled Prostacyclin, iv/sc

Goal of prostacyclin therapy is to maximize exposure to highest tolerable level Local delivery generates fewer off-tissue effects Source: Decision Resources, Pulmonary Hypertension Disease landscape & Forecast, November 2018. Current prostacyclin products have clear tradeoffs Oral = Convenient, but with systemic toxicities and minimal symptom relief Increases side effects in GI, Nervous and Vascular systems Requires up-titration that can be challenging given side effects Nebulized = Targeted, but provides limited dose range Limits max dose due to throat irritation, adverse events Requires water, power, supplies, cleaning and time to dose Infusion = Effective, but systemic toxicities & site pain, limits on lifestyle Delivers continuously via i.v. or s.c. line, 24 hours a day Poses potential for infection risk

Treprostinil = Proven efficacy Proven compound with FDA approvals for i.v., s.c., inhaled and oral routes PRINT® = Deep-lung delivery Delivers higher dose levels than approved inhaled formulations Device = Simple, Disposable Compact, easy inhaler with established commercial track record LIQ861 combines Effective + Targeted + Convenient into one product RS00 Model 8 (DMF # 18418) Disposable & long track record Precise, Uniform, Trefoil Trusted prostacyclin-analog RS00 Model 8 (DMF # 18418)

After consulting FDA, initiated Phase 3 INSPIRE pursuant to 505(b)(2) Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil Sources: https://clinicaltrials.gov/ct2/show/NCT03399604; PGI – prostacyclin; TEAEs – treatment-emergent adverse events; SAEs – serious adverse events; Quote from Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine and INSPIRE Principal Investigator. 1. Adjusting dose levels to comparable Tyvaso® emitted dose Design Open-label, U.S. multicenter Population At least 100 WHO Group I (PAH) patients; NYHA Class II, III and IV Criteria On stable dose of Tyvaso® for >3 months (or) taking <2 approved non-PGI oral PAH therapies Primary endpoint Incidence of TEAEs and SAEs at 2 months Exploratory endpoints 6 minute walk distance (6MWD) Sustained treatment transition (Tyvaso® transitions) NYHA functional class improvement Quality of life using Minnesota Living with Heart Failure Questionnaire (MLHFQ) PK Sub-Study1 Transitions from Tyvaso® in a one-directional crossover to compare bioavailability and PK Data collection Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 30 months We will continue to treat patients and collect data in a roll-over safety study

LIQ861 met primary endpoint at Month 2 in pivotal INSPIRE study TEAEs observed are consistent with inhaled prostacyclins 1. Preliminary data from INSPIRE at Month 2; Serious Adverse Events (SAEs); Treatment Emergent Adverse Events (TEAEs) deemed related to LIQ861; Maximum Tolerated Dose (MTD) ^LIQ861 capsule strength doses 125 mcg and 150 mcg are two capsules but if approved, they could be developed as single capsules. 93% of patients completed 2 months* No SAEs related to LIQ861 at Month 2 TEAEs > 4% patients all mild to moderate Most observed during first 2-weeks Have not yet reached an MTD At Month 2, dosed up to 150mcg capsule strength^ TEAEs at Month 2* in > 4% of Patients Receiving LIQ861 LIQ861 (tresprostinil) Transitions (n=44) Add-ons (n=65) All Treated (n=109) Cough 13.6% 46.2% 33.0% Headache 20.5% 16.9% 18.3% Throat irritation 9.1% 16.9% 13.8% Dizziness 9.1% 10.8% 10.1% Diarrhea 4.5% 10.8% 8.3% Oropharyngeal pain 2.3% 7.7% 5.5% Nausea 4.5% 6.2% 5.5% Dyspnea 6.8% 4.6% 5.5% Flushing 2.3% 7.7% 5.5% Chest discomfort 2.3% 6.2% 4.6%

Transitioning to LIQ861 may build on known benefits of inhaled treprostinil Exploratory endpoints presented at ISHLT 2019 and ATS 2019 *Preliminary data from INSPIRE at Month 2; Minnesota Living with Heart Failure Questionnaire (MLHFQ); 6 Minute Walk Distance (6MWD); Quality of Life (QoL) ISHLT 2019 Presentation: Hill N. S., et al. INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH) ATS 2019 Poster: Hill N. S., et al. INSPIRE: A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH) Median 6MWD meters Median MLHFQ QOL score Tyvaso Transitions NYHA Class II NYHA Class III Physical Activity 6MWD Maintained Increased Quality of Life MLHFQ Improved Maintained A five (5) point change in score is the minimal clinically important difference 444 450 0 200 400 600 Transition FC II Baseline n=36 Transition FC II Month 2 n=30 342 421 0 200 400 600 Transition FC III Baseline n=8 Transition FC III Month 2 n=7 30 19 0 10 20 30 40 Transitions FC II Day 0 n=36 Transition FC II Month 2 n=33 33 34 0 10 20 30 40 Transitions FC III Day 0 n=8 Transition FC III Month 2 n=7

Adding LIQ861 as first prostacyclin earlier in disease may be a viable option Exploratory endpoints presented at ISHLT 2019 and ATS 2019 *Preliminary data from INSPIRE at Month 2; Minnesota Living with Heart Failure Questionnaire (MLHFQ); 6 Minute Walk Distance (6MWD); Quality of Life (QoL) ISHLT 2019 Presentation: Hill N. S., et al. INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH) ATS 2019 Poster: Hill N. S., et al. INSPIRE: A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in Pulmonary Arterial Hypertension (PAH) Median MLHFQ QOL score Add-on patients NYHA Class II NYHA Class III Physical Activity 6MWD Increased Maintained Quality of Life MLHFQ Improved Maintained A five (5) point change in score is the minimal clinically important difference Median 6MWD meters 34 24 0 10 20 30 40 Add-on FC II Day 0 n=36 Add-on FCII Month 2 n=35 37 34 0 10 20 30 40 Add-on FC III Day 0 n=29 Add-on FC III Month 2 n=24 424 450 0 200 400 600 Add-on FC II Baseline n=36 Add-on FC II Month 2 n=35 360 358 0 200 400 600 Add-on FC III Baseline n=29 Add-on FC III Month 2 n=22

LIQ865 for Local Post-Operative Pain PRINT® bupivacaine, sustained-release injectable

LIQ865 offers the potential for an optimal product profile Target 3 to 5 days duration of action Supported by PK & PD data from Ph 1 studies Simple, uniform particles of a single active Easy reconstitution from a powder Flexible application at the surgical site Adjustable concentration range to deliver the dose Enables instillation or injection around incision Limited potential for dose dumping Compatible with co-administration of instant-release local anesthetics LIQ865: Bupivacaine + PLGA blend

Ph1a, healthy volunteers in Denmark Single, ascending dose No dose-limiting toxicities All adverse events were mild to moderate Cmax well below reported thresholds for neurotoxicity and cardiotoxicity QST demonstrated pharmacodynamic effect for up to 5 days LIQ865 was well-tolerated at all doses with dose proportional PK in Ph1 Sources: Randomized, double-blind, controlled, single ascending dose, safety, PK ,PD trial of two different formulations of LIQ865 in 28 healthy male volunteers; Quantitative Sensory Testing (QST) Initiated Phase 2-enabling tox studies in March 2019 with Phase 2 trials planned for 2020 1 10 100 1000 0 24 48 72 96 120 Bupivacaine (ng/mL) Time (h) LIQ865A Log Linear Mean Concentration Over Time (N=16) 150 mg (n=3) 225 mg (n=3) 300 mg (n=3) 450 mg (n=6) 600 mg (n=1)

PRINT® Technology

Compatible with nearly any material, payload and route of delivery Examples, not exhaustive PLGA Porous Hydrogel Nucleic Acid PLGA/DC-Chol Crystalline API Formulated Protein PEG Hydrogel PLGA/RNA Albumin/Lactose PLGA-Steroid Monoclonal Antibody 100 % Cyclosporine

PRINT® production has been scaled for clinical and commercial demands Lab Line 2 (2008) Highly agile platform enabling process experimentation Ideal for early stage process development Lab Line 3 (non-cGMP 2015; cGMP 2017) Capable of larger batches with increased process control We believe Lab Line 3 is fully cGMP compliant to support product launch Commercial Line 1 (expected 2019) Optimized drug substance production process Designed for continued market supply and scale Preclinical and R&D Highly versatile, flexible cGMP Process Development Optimization, scale-up cGMP Production Repeatable and deployable

Conclusion

2019 Milestones Milestone Anticipated Timing Report LIQ861 Ph 3 two-week safety data from INSPIRE trial 1Q:2019 Report LIQ861 Ph 3 primary endpoint from INSPIRE trial 1Q:2019 Initiate LIQ865 Ph 2-enabling tox studies 1Q:2019 Conduct pre-NDA CMC meeting with FDA 3Q:2019 Report LIQ861 final PK results from healthy volunteer study 4Q:2019 Conduct pre-NDA Clinical/Non-Clinical meeting with FDA 4Q:2019 Target NDA submission to the FDA for LIQ861 Early 1Q:2020

Thank You