Liquidia Technologies Reports First Quarter 2019 Financial Results and Provides Corporate Update
Recent Phase 3 Data Highlight Clinical Relevance of LIQ861 in Treating Pulmonary Arterial Hypertension
On Track for Planned New Drug Application (NDA) Submission for LIQ861 in Late 2019
Continued Pipeline Progress Leveraging Proprietary Print® Technology
Management to Host Webcast and Conference Call Today at
“Liquidia has started the year strong, delivering on our clinical timelines and driving towards an NDA submission for LIQ861, our lead program to treat patients with pulmonary arterial hypertension (PAH),” stated
“Based on this data and our interactions with clinicians and patients, we believe LIQ861 is safe, well-tolerated and has utility as a first-line prostacyclin in PAH. If approved, LIQ861 will be the first-to-market inhaled dry powder treprostinil that can be delivered using a convenient, palm-sized device, with the potential to maximize the therapeutic benefits of treprostinil by safely delivering higher doses into the lungs,” concluded Mr. Fowler.
Recent Corporate Highlights
- Met the primary endpoint of the INSPIRE study by demonstrating safety and tolerability of ‘861 at the two-month timepoint. LIQ861 was observed to be well-tolerated in 109 patients, 60% of whom were naïve to prostacyclin therapy (Add-Ons) and 40% of whom transitioned from Tyvaso. Both patient groups remained on therapy with 93% of patients completing at least two months of treatment, thereby meeting the study’s primary endpoint. LIQ861 was evaluated at doses exceeding 150 mcg capsule strength with no study-drug related serious adverse events. Most treatment-related adverse events were mild to moderate, consistent with prostacyclin therapy, and observed in the first two weeks of treatment.
Liquidiaanticipates submitting the NDA for LIQ861 to the U.S. Food and Drug Administration( FDA) in late 2019.
- Presented data on LIQ861 from the INSPIRE trial highlighting safety and tolerability along with preliminary data on functional and patient outcomes. The presentation at the 39th
International Society for Heart & Lung Transplantation (ISHLT) Meetingin April 2019provided detailed results by patient group on the adverse event profile, duration of treatment and two of the exploratory endpoints. Specifically, at the two-month timepoint, the functional measure of median “six-minute walk distance” was maintained or improved in both the Add-On and Tyvaso transition groups. Additionally, patients in both groups reported physical and emotional improvements in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire.
- Initiated Phase 2-enabling toxicology studies for LIQ865 in the first quarter of 2019. Our second product candidate, LIQ865, is an injectable, non-opioid, sustained-release formulation of bupivacaine for the management of local post-operative pain.
$34.5 millionin additional capital through a public offering in the first quarter of 2019. We completed an offering of 3,000,000 shares of our common stock for gross proceeds of $34.5 million, or approximately $31.7 million, net of underwriting discounts, commissions and offering expenses.
Anticipated Upcoming Milestones
- Report LIQ861 bioavailability and pharmacokinetic properties of treprostinil in the second quarter of 2019;
- Initiate an additional clinical trial in
Europethat 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;
- Submit an NDA to the
FDAfor LIQ861 in late 2019;
- Present longitudinal data on LIQ861 at key medical conferences, including at the
American Thoracic Society International Conference May 17-22, Dallas, TX; and
- Complete toxicology studies that support LIQ865 as a Phase 2-ready program by the end of the year.
First Quarter 2019 Financial Highlights
- Revenues: We reported no revenue for the quarter ended
March 31, 2019, compared to $0.9 millionfor the quarter ended March 31, 2018. Our revenue has been primarily derived from collaborating and licensing our proprietary PRINT® technology to pharmaceutical companies. There were no research and development services performed for other pharmaceutical companies during the quarter ended March 31, 2019as we prioritize the development of our own pharmaceutical products.
- Research and Development (R&D): R&D expenses were
$10.7 millionfor the quarter ended March 31, 2019, compared to $7.6 millionfor the quarter ended March 31, 2018. The increase in R&D expenses was primarily due to our ongoing INSPIRE Phase 3 clinical trial for LIQ861, which commenced in December 2017.
- General and Administrative (G&A): G&A expenses were
$3.0 millionfor the quarter ended March 31, 2019, compared to $2.1 millionfor the quarter ended March 31, 2018. The increase was primarily due to employee-related expenditures, including stock-based compensation, and public company costs, partially offset by a decrease in professional fees.
- Interest Expense: Interest expense was
$0.2 millionfor the three months ended March 31, 2019, compared to $17.9 millionfor the three months ended March 31, 2018. The decrease was primarily due to lower levels of debt during the three months ended March 31, 2019as a result of the conversion of convertible notes into shares of Series D preferred stock in February 2018.
- Net Loss: The net loss for the first quarter of 2019 was
$13.8 million, compared to $27.5 millionfor the quarter ended March 31, 2018. The change was primarily due to a decrease in revenues and an increase in R&D and G&A expenses, offset by lower interest expense.
- Cash Position: Cash totaled
$60.8 millionas of March 31, 2019.
- Shares Outstanding: There were 18,637,012 shares of common stock outstanding as of
March 31, 2019.
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, 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
IR Advisory Solutions
Sam Brown Inc.
-Financial Tables Follow-
|March 31, 2019||December 31, 2018|
|Prepaid expenses and other current assets||302,945||219,057|
|Total current assets||61,123,210||40,026,599|
|Property, plant and equipment, net||7,525,450||8,130,708|
|Operating lease right-of-use assets, net||3,909,054||—|
|Prepaid expenses and other assets||1,162,199||1,260,951|
|Liabilities and stockholders’ equity (deficit)|
|Current portion of operating lease liabilities||477,008||—|
|Current portion of finance lease liabilities||899,512||452,703|
|Current portion of long-term debt||924,505||316,906|
|Total current liabilities||10,982,542||8,248,858|
|Long-term operating lease liabilities||6,102,448||—|
|Long-term finance lease liabilities||1,349,180||376,082|
|Long-term deferred rent||—||2,406,084|
|Long-term deferred revenue||8,071,920||8,071,920|
|Stockholders’ equity (deficit):|
|Common stock — $0.001 par value, 40,000,000 and 40,000,000 shares authorized as of March 31, 2019 and December 31, 2018, respectively, 18,637,012 and 15,519,469 issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||18,637||15,520|
|Additional paid-in capital||218,721,394||185,726,048|
|Total stockholders’ equity (deficit)||37,317,247||18,687,671|
|Total liabilities and stockholders’ equity (deficit)||$||73,719,913||$||49,418,258|
Statements of Operations and Comprehensive Loss
|Three Months Ended|
|Costs and expenses:|
|Cost of sales||—||27,049|
|Research and development||10,664,302||7,626,701|
|General and administrative||3,021,581||2,149,725|
|Total costs and expenses||13,685,883||9,803,475|
|Loss from operations||(13,685,883||)||(8,877,505||)|
|Other income (expense):|
|Derivative and warrant fair value adjustments||—||(753,887||)|
|Total other income (expense), net||(80,906||)||(18,630,682||)|
|Other comprehensive loss||—||—|
|Net loss per common share:|
|Weighted average common shares outstanding:|
Statements of Cash Flows
|Three Months Ended March 31,|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Depreciation and amortization||609,034||324,854|
|Amortization of discount on long-term debt and convertible notes||—||17,550,541|
|Non-cash interest expense||16,559||227,186|
|Warrant fair value adjustment||—||753,887|
|Non-cash rent (income) expense||—||(51,465||)|
|Changes in operating assets and liabilities:|
|Prepaid expenses and other current assets||(83,888||)||(178,326||)|
|Other non-current assets||481,177||(5,433||)|
|Net cash used in operating activities||(10,108,355||)||(10,000,261||)|
|Purchases of property, plant and equipment||(245,319||)||(257,067||)|
|Net cash used in investing activities||(245,319||)||(257,067||)|
|Principal payments on finance leases||(220,933||)||(151,430||)|
|Refund of principal payments on long-term debt||—||588,889|
|Principal payments on long-term debt||—||(912,011||)|
|Payments for debt issuance costs||—||(392,000||)|
|Proceeds from issuance of Series D preferred stock, net of issuance costs||—||25,206,742|
|Proceeds from public offering of common stock, net of underwriting fees and commissions||32,047,576||—|
|Payments for deferred offering costs||(262,077||)||(58,734||)|
|Proceeds from exercise of stock options and warrants||63,902||150,689|
|Net cash provided by (used in) financing activities||31,628,468||24,432,145|
|Net increase (decrease) in cash||21,274,794||14,174,817|
|Cash, beginning of period||39,534,985||3,418,979|
|Cash, end of period||$||60,809,779||$||17,593,796|
Source: Liquidia Technologies, Inc.