Completed Registrational Studies of LIQ861 to Include in New Drug Application (NDA)
Targeting Submission of NDA for LIQ861 in 1Q 2020
Management to Host Webcast and Conference Call Today at 8:00 a.m. ET
RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia” or the “Company”), a late-stage clinical biopharmaceutical company, today reported financial results for the quarter ended September 30, 2019, and provided a corporate update.
“We continue to deliver on our key objectives by completing the clinical program for LIQ861 and driving towards our first NDA submission,” stated Neal Fowler, Liquidia’s Chief Executive Officer. "We are engaged in pre-NDA meetings with the U.S. Food and Drug Administration (FDA) in preparation for the NDA submission. In parallel, we are executing concurrent clinical studies to supplement the medical information available upon the potential approval of LIQ861.
“We also strengthened our Board of Directors with the appointments of Dr. Joanna Horobin and Katie Rielly-Gauvin, both accomplished pharmaceutical industry executives, to provide advice and guidance as we mature into a commercial-stage biopharmaceutical company. We are fortunate to have the benefit of their experience and broad therapeutic area expertise as we plan for the future.
“Given our need for additional capital prior to a potential commercial launch of LIQ861, and interest to maximize value for our stockholders, we are exploring all funding options, including potential partnerships with companies offering strategic and commercial synergies. We are pleased to be working with our long-time financial advisor Jefferies LLC in this effort,” Mr. Fowler concluded.
Recent 2019 Corporate Updates
Anticipated Upcoming Milestones
Third Quarter 2019 Financial Highlights
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: 8390077. A live and archived webcast of the call will be available on the Events & Presentations page of Liquidia’s website.
About Liquidia
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. Having been 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.
* Tyvaso® is a registered trademark of United Therapeutics Corporation.
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 strategic and financial initiatives, including the potential licensing of LIQ861, 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 and our ability to execute on our strategic or financial initiatives, 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:
Jason Adair
Vice President, Corporate Development and Strategy
919.328.4400
jason.adair@liquidia.com
Media:
Christy Curran
Sam Brown Inc.
615.414.8668
media@liquidia.com
-Financial Tables Follow-
Liquidia Technologies, Inc.
Balance Sheets (Unaudited)
September 30, 2019 | September 30, 2018 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 39,304,564 | $ | 39,534,985 | |||
Accounts receivable – trade and other | 945,662 | 272,557 | |||||
Prepaid expenses and other current assets | 486,471 | 219,057 | |||||
Total current assets | 40,736,697 | 40,026,599 | |||||
Property, plant and equipment, net | 8,090,272 | 8,130,708 | |||||
Operating lease right-of-use assets, net | 2,836,829 | — | |||||
Prepaid expenses and other assets | 574,857 | 1,260,951 | |||||
Total assets | $ | 52,238,655 | $ | 49,418,258 | |||
Liabilities and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,543,940 | $ | 3,235,949 | |||
Accrued expenses | 1,531,133 | 1,459,182 | |||||
Accrued compensation | 2,263,083 | 2,515,519 | |||||
Deferred rent | — | 268,599 | |||||
Current portion of operating lease liabilities | 543,677 | — | |||||
Current portion of finance lease liabilities | 1,020,546 | 452,703 | |||||
Current portion of long-term debt | 4,293,611 | 316,906 | |||||
Total current liabilities | 14,195,990 | 8,248,858 | |||||
Long-term operating lease liabilities | 5,822,244 | — | |||||
Long-term finance lease liabilities | 1,106,083 | 376,082 | |||||
Long-term deferred rent | — | 2,406,084 | |||||
Long-term deferred revenue | — | 8,071,920 | |||||
Long-term debt | 11,565,636 | 11,627,643 | |||||
Total liabilities | 32,689,953 | 30,730,587 | |||||
Stockholders’ equity: | |||||||
Preferred stock — 10,000,000 shares authorized as of September 30, 2019 and December 31, 2018, 0 and 0 issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | — | — | |||||
Common stock — $0.001 par value, 40,000,000 shares authorized as of June 30, 2019 and December 31, 2018, 18,656,686 and 15,519,469 issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 18,656 | 15,520 | |||||
Additional paid-in capital | 220,277,054 | 185,726,048 | |||||
Accumulated deficit | (200,747,008 | ) | (167,053,897 | ) | |||
Total stockholders’ equity | 19,548,702 | 18,687,671 | |||||
Total liabilities and stockholders’ equity | $ | 52,238,655 | $ | 49,418,258 | |||
Liquidia Technologies, Inc.
Statements of Operations and Comprehensive Loss (Unaudited)
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||
Revenues | $ | — | $ | 169,730 | $ | 8,072,120 | $ | 2,138,579 | ||||
Costs and expenses: | ||||||||||||
Cost of sales | — | — | 807,192 | 121,391 | ||||||||
Research and development | 10,942,561 | 7,156,618 | 32,330,454 | 20,701,022 | ||||||||
General and administrative | 2,377,687 | 2,283,936 | 7,807,920 | 6,424,892 | ||||||||
Total costs and expenses | 13,320,248 | 9,440,554 | 40,945,566 | 27,247,305 | ||||||||
Loss from operations | (13,320,248 | ) | (9,270,824 | ) | (32,873,446 | ) | (25,108,726 | ) | ||||
Other income (expense): | ||||||||||||
Interest income | 162,207 | 128,120 | 519,861 | 139,965 | ||||||||
Interest expense | (265,018 | ) | (636,573 | ) | (737,429 | ) | (18,759,078 | ) | ||||
Derivative and warrant fair value adjustments | — | 106,265 | — | 277,715 | ||||||||
Total other income (expense), net | (102,811 | ) | (402,188 | ) | (217,568 | ) | (18,341,398 | ) | ||||
Net loss | (13,423,059 | ) | (9,673,012 | ) | (33,091,014 | ) | (43,450,124 | ) | ||||
Other comprehensive loss | — | — | — | — | ||||||||
Comprehensive loss | $ | (13,423,059 | ) | $ | (9,673,012 | ) | $ | (33,091,014 | ) | $ | (43,450,124 | ) |
Net loss per common share: | ||||||||||||
Basic | $ | (0.72 | ) | $ | (0.83 | ) | $ | (1.85 | ) | $ | (10.16 | ) |
Diluted | (0.72 | ) | (0.84 | ) | (1.87 | ) | (10.27 | ) | ||||
Weighted average common shares outstanding: | ||||||||||||
Basic | 18,757,166 | 11,606,489 | 17,856,826 | 4,277,554 | ||||||||
Diluted | 18,650,892 | 11,464,459 | 17,737,737 | 4,229,691 |