Liquidia Technologies Reports Third Quarter 2018 Financial Results and Provides Corporate Update
- Completed enrollment of the safety portion of our Ph3 LIQ861 (INSPIRE) clinical trial
- Two-week safety Ph3 LIQ861 data readout anticipated in the first quarter of 2019
Stephen Blochappointed as Chairman of the Board
- Management to host webcast and conference call today at
8 a.m. ET
“We have made significant progress in the second half of 2018 with the closing of our IPO in July and the recent completion of enrollment for the safety portion of our pivotal Phase 3 clinical trial, INSPIRE, evaluating LIQ861 for the treatment of pulmonary arterial hypertension. Based on feedback from the U.S.
“With today’s news, we also announced the appointment of Dr. Bloch as Chairman of the Board. Dr. Bloch has been on the board of
- Completed enrollment of the safety portion of our single, open-label Phase 3 clinical trial (INSPIRE) evaluating LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of pulmonary arterial hypertension (PAH). As of
October 24, 2018, 109 patients have enrolled in our INSPIRE trial and Liquidiahas completed enrollment for the safety portion of the trial. We are currently focusing our efforts on completing patient enrollment in our one-directional crossover sub-study to compare bioavailability and pharmacokinetics (PK) of treprostinil as the patients transition from Tyvaso® to LIQ861. The primary objective of the INSPIRE study is to evaluate the long-term safety and tolerability of LIQ861. Of the total enrolled patient population, as of October 24, 2018, 104 patients have received at least two weeks of LIQ861. We expect to report two-week safety data in the first quarter of 2019 followed by PK results anticipated in the second quarter of 2019. We are targeting a new drug application (NDA) submission to the U.S. Food and Drug Administration( FDA) in late 2019.
- Completed initial public offering. In July and August,
Liquidiaclosed an initial public offering (IPO) of 4,833,099 shares of common stock at a public offering price of $11.00per share, including 287,644 shares sold pursuant to the partial exercise of the underwriters’ over-allotment option to purchase additional shares. Liquidiareceived $49.4 millionin net proceeds, which included underwriting discounts and commissions, but prior to the payment of other offering expenses.
- Closed on new credit facility and repaid certain existing debt. On
October 26, 2018, Liquidiaand Pacific Western Bank(PWB) entered into an Amended and Restated Loan and Security Agreement (the “A&R LSA”) that resulted in the extinguishment of Liquidia’s $8.0 millionin outstanding indebtedness under the Loan and Security Agreement with PWB and the repayment in full of the promissory note issued to the University of North Carolina at Chapel Hillin the amount of $1.8 million. The A&R LSA provides for an initial tranche of $11.0 millionreceived by Liquidiaat closing and a second tranche of up to $5.0 millionavailable to be drawn through June 30, 2019, subject to the achievement of certain clinical milestones. The A&R LSA provides for interest-only payments through December 31, 2019, bears interest at the greater of the prime rate or 5% and has a four-year term.
- Appointed Dr.
Stephen Blochas Chairman of the Board. Dr. Bloch has been appointed Chairman of the Board, effective immediately, following Dr. Seth Rudnick’srequest to step down as Chairman of the Board. Dr. Rudnick will continue to serve as a member of the Board.
Anticipated Upcoming Milestones
- Present Phase 1a safety, PK and pharmacodynamic results in healthy volunteers for our second product candidate, LIQ865, at the
American Society of Regional Anesthesia and Pain Medicine, being held November 15-17in San Antonio, TX
- Initiate Phase 2-enabling toxicology studies for LIQ865, currently being evaluated for the treatment of local post-operative pain, in the fourth quarter of 2018
- Report LIQ861 Phase 3 two-week safety data from the INSPIRE study in the first quarter of 2019
- Enroll the first patient in the first quarter of 2019 in an additional clinical trial that explores the effects of LIQ861 on acute and chronic hemodynamic measurements and right heart function in PAH patients; this clinical trial is not required by the
- Report LIQ861 Phase 3 PK results from our one-directional crossover sub-study in the second quarter of 2019
- NDA submission to the
FDAfor LIQ861 in late 2019
Third Quarter 2018 Financial Highlights
- Revenues: Revenues for the third quarter of 2018 were
$0.2 million, compared to $1.8 millionfor the third quarter of 2017. Currently, our revenue is primarily derived from collaborating and licensing our proprietary PRINT® technology to pharmaceutical companies. The decrease primarily reflects lower research and development services performed as we prioritize developing our own pharmaceutical products.
- Research and Development (R&D): R&D expenses for the third quarter of 2018 were
$7.2 million, compared to $6.5 millionfor the third quarter of 2017. The increase in R&D expenses was primarily due to our ongoing Phase 3 clinical trial of LIQ861 (INSPIRE), which commenced in late December 2017.
- General and Administrative (G&A): G&A expenses for the third quarter of 2018 were
$2.3 million, compared to $3.0 millionfor the third quarter of 2017. The decrease in G&A expenses was primarily due to costs of an abandoned equity offering being expensed during the third quarter of 2017.
- Net Loss: A net loss of
$9.7 millionfor the third quarter of 2018 was reported, compared to $19.2 millionfor the third quarter of 2017. The decrease was due to several factors including the decrease in G&A expenses, the decrease in interest expense of $3.5 million, and the decrease in derivative and warrant fair value adjustments (expense) of $7.4 million, partially offset by the decrease in revenues and the increase in R&D expenses.
- Cash Position: As of
September 30, 2018, we had $47.5 millionin cash.
Webcast and Conference Call
Liquidia’s management team will host a webcast and conference call at
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 (including the funding therefor, anticipated patient enrollment, safety 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
Director, Investor Relations & Corporate Communications
|Liquidia Technologies, Inc.|
|Statements of Operations|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Costs and expenses:|
|Cost of sales||—||79,940||121,391||239,819|
|Research and development||7,156,618||6,532,940||20,701,022||17,966,244|
|General and administrative||2,283,936||3,004,612||6,424,892||8,079,304|
|Total costs and expenses||9,440,554||9,617,492||27,247,305||26,285,367|
|Loss from operations||(9,270,824||)||(7,796,644||)||(25,108,726||)||(20,843,347||)|
|Other income (expense):|
|Derivative and warrant fair value adjustments||106,265||(7,284,256||)||277,715||(8,197,356||)|
|Total other income (expense), net||(402,188||)||(11,439,970||)||(18,341,398||)||(16,521,012||)|
|Other comprehensive loss||—||—||—||—|
|Net loss per common share:|
|Weighted average common shares outstanding:|
|Liquidia Technologics, Inc.|
|Balance Sheet Data|
|September 30, 2018||December 31, 2017|
|Long-term debt and capital leases||$||11,975,705||$||22,145,554|
|Total stockholders' equity (deficit)||$||27,855,536||$||(33,692,236||)|
Source: Liquidia Technologies, Inc.