NEW YORK, Aug. 26, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Liquidia Corporation ("Liquidia" or the "Company") (NASDAQ: LQDA). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Liquidia and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On August 19, 2024 ...

Core Viewpoint - Liquidia Corporation has filed litigation against the FDA's decision to grant 3-year new clinical investigation exclusivity to Tyvaso DPI®, which delays the final approval of Liquidia's YUTREPIA™ inhalation powder for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease [1][2] Group 1: Company Actions and Legal Proceedings - Liquidia Corporation has initiated litigation in the U.S. District Court of the District of Columbia to challenge the FDA's exclusivity decision, which it believes stifles competition and patient access to alternative treatments [1][2] - The FDA granted tentative approval for YUTREPIA™ on August 16, 2024, but the exclusivity awarded to Tyvaso DPI delays its final approval until May 23, 2025 [1] - United Therapeutics voluntarily dismissed its complaint against the FDA regarding Liquidia's amended NDA for YUTREPIA, allowing the FDA to proceed with the review [3] Group 2: Product Information - YUTREPIA™ is an inhaled dry-powder formulation of treprostinil designed for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [7][9] - The product utilizes Liquidia's PRINT® technology, which allows for precise and uniform drug particle development, enhancing lung deposition [7] - Liquidia is conducting ongoing clinical studies, including the ASCENT trial, to evaluate the safety and tolerability of YUTREPIA in patients with PH-ILD [8] Group 3: Market Context - Pulmonary arterial hypertension (PAH) affects an estimated 45,000 patients in the U.S., with no current cure, making symptom management and quality of life improvement critical [5] - Pulmonary hypertension associated with interstitial lung disease (PH-ILD) has a prevalence of over 60,000 patients in the U.S., with many underlying conditions underdiagnosed [6]

Core Points - Liquidia Corporation (LQDA) shares fell nearly 31% after the FDA delayed full approval for its Yutrepia inhalation powder for lung disorders [1] - The FDA granted tentative approval for Yutrepia for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and previously for pulmonary arterial hypertension (PAH) in 2021 [1][2] - Final approval for Yutrepia may be delayed until after the three-year regulatory exclusivity for United Therapeutics' Tyvaso Dry Powder Inhaler (DPI) expires on May 23, 2025 [2] - Liquidia plans to challenge the three-year exclusivity to expedite patient access to Yutrepia [3] - Liquidia's stock has decreased 18.6% year-to-date, compared to a 1.7% decline in the industry [3] - Ongoing patent litigation exists between Liquidia and United Therapeutics regarding Yutrepia [4] - The tentative approval is based on data from the phase III INSPIRE study, which indicated Yutrepia is safe and well-tolerated [5] Industry Context - United Therapeutics' stock rose 8.6% following the FDA's announcement regarding Yutrepia [2] - Liquidia currently holds a Zacks Rank 3 (Hold), while Arcturus Therapeutics and Fulcrum Therapeutics have better rankings of 1 (Strong Buy) [6] - Arcturus Therapeutics has seen improvements in loss per share estimates for 2024 and 2025, despite a year-to-date stock decline of 32.1% [7] - Fulcrum Therapeutics has improved loss per share estimates for 2024 and 2025, with a year-to-date stock increase of 38.4% [8]

BOSTON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Liquidia Corp. (Nasdaq: LQDA) for potential securities law violations. Investors who have lost money in their Liquidia Corp. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/lqda. What is this all about? Liquidia shares have dropped 35% today following an announcement that the FDA has postponed final approval of Liquidia's Yutrepia drug ...

U.S. stock futures were slightly higher this morning, with the S&P 500 futures gaining around 0.1% on Monday. Shares of Liquidia Corporation LQDA fell sharply in today's pre-market trading. The company announced that the FDA granted tentative approval of YUTREPIA inhalation powder to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Liquidia shares dipped 36.3% to $8.98 in pre-market trading. Here are some big stocks recording losses in t ...

MORRISVILLE, N.C., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), announced today the company will present nine encore thematic posters at the PHA 2024 International PH Conference and Scientific Sessions taking place August 15 to August 18, 2024 in Indianapolis, Indiana. The company's posters, which will be presented on Friday, August 16, 2024 from 8:00 a.m. – 5:30 p.m. EDT and Saturday, August 17, 2024 from 9:00 a.m. – 1:00 p.m. EDT, focus on the company's investigational products, ...

Liquidia Technologies, Inc. (LQDA) came out with a quarterly loss of $0.37 per share versus the Zacks Consensus Estimate of a loss of $0.35. This compares to loss of $0.36 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -5.71%. A quarter ago, it was expected that this company would post a loss of $0.32 per share when it actually produced a loss of $0.54, delivering a surprise of -68.75%. Over the last four quarters, the compa ...

Financial Performance - Revenue for Q2 2024 was $3.659 million, a decrease from $4.786 million in Q2 2023[16] - Net loss for Q2 2024 was $27.942 million, compared to $23.517 million in Q2 2023[16] - Net loss for the six months ended June 30, 2024 was $68.9 million[20] - Accumulated deficit as of June 30, 2024 was $497.968 million, compared to $429.098 million as of December 31, 2023[17] - Accumulated deficit as of June 30, 2024 was $498.0 million[30] - Total stockholders' equity as of June 30, 2024 was $62.722 million, down from $47.293 million as of December 31, 2023[17] Expenses and Costs - Research and development expenses for Q2 2024 were $9.420 million, down from $17.695 million in Q2 2023[16] - General and administrative expenses for Q2 2024 were $19.943 million, up from $9.245 million in Q2 2023[16] - Total costs and expenses for Q2 2024 were $30.856 million, compared to $27.611 million in Q2 2023[16] - Stock-based compensation for the six months ended June 30, 2024 was $8.9 million[20] - Total stock-based compensation expense for the six months ended June 30, 2024 was $8,896, compared to $5,051 for the same period in 2023[81] Cash and Liquidity - Cash and cash equivalents at the end of June 30, 2024 were $133.1 million[20] - Net cash used in operating activities for the six months ended June 30, 2024 was $47.5 million[20] - Proceeds from sale of common stock, net of issuance costs, were $74.9 million for the six months ended June 30, 2024[20] - The company must maintain minimum cash covenants of $7.5 million in 2024 and $15.0 million thereafter[31] - Substantial doubt exists about the company's ability to continue as a going concern beyond one year[33] Revenue and Accounts Receivable - Accounts receivable from one customer accounted for 95% and 99% of total accounts receivable as of June 30, 2024 and December 31, 2023, respectively[42] - Approximately 97% of revenue during the six months ended June 30, 2024 was generated from the Promotion Agreement with Sandoz[90] - Revenue is recognized in accordance with ASC 606, which involves a five-step process to identify contracts, performance obligations, transaction price, and revenue recognition timing[48] Research and Development - L606 is being evaluated in an open-label study for PAH and PH-ILD treatment[26] - Research and development costs are expensed as incurred and include facility-related costs, third-party direct costs, and employee-related expenses[52] - The company estimates accrued research and development expenses based on services performed and associated costs, with adjustments made as necessary[53] Stock and Compensation - Weighted average common shares outstanding for Q2 2024 were 76,435,831, up from 64,788,482 in Q2 2023[16] - As of June 30, 2024, 639,155 shares of common stock were reserved for issuance under the Employee Stock Purchase Plan (ESPP)[80] - The number of shares available for issuance under the ESPP increased by 150,000 shares on January 1, 2024[80] - 67,982 shares were issued under the ESPP during the six months ended June 30, 2024, down from 81,281 shares in the same period of 2023[80] - As of June 30, 2024, 3,193,741 restricted stock units (RSUs) were unvested, with a weighted average grant-date fair value of $10.48 per RSU[89] - The aggregate intrinsic value of stock options outstanding as of June 30, 2024 was $67,980[87] - The weighted average fair value for options granted during the six months ended June 30, 2024 was $9.84 per share, up from $5.09 per share in 2023[84] Fair Value and Assets - Fair value measurements are classified into three levels based on the availability of observable inputs, with Level 1 being the most reliable[57] - Money market funds (cash equivalents) valued at $127,294 as of June 30, 2024, classified within Level 1 of the fair value hierarchy[58] - Money market funds (cash equivalents) valued at $79,912 as of December 31, 2023, classified within Level 1 of the fair value hierarchy[60] - Inventory valued at $7,212 as of June 30, 2024, including raw materials and work in process[62] - Total property, plant, and equipment valued at $21,981 as of June 30, 2024, with net value of $6,387[64] - Contract acquisition costs and intangible asset net carrying amounts of $7,621 and $3,300 respectively as of June 30, 2024[65] - Litigation finance payable and indemnification asset classified as long-term assets and liabilities as of June 30, 2024[70] Agreements and Contracts - The company entered into a Revenue Interest Financing Agreement (RIFA) with HCR for up to $100 million, with $42.5 million funded as of June 30, 2024[96][97] - Quarterly fixed payments to HCR are $4.2 million as of June 30, 2024, potentially increasing to $5.8 million in Q3 2025 if the Third Investment Amount is not funded[98] - The company recorded a loss on extinguishment of $11.5 million during Q1 2024 due to the Fourth Amendment to the RIFA[104] - The effective annual interest rate for the RIFA is estimated at 12.3% as of June 30, 2024[105] - Expected annual payments on the RIFA payable as of June 30, 2024 total $114.8 million, with $37.5 million due in 2025 and $23.2 million annually from 2026 to 2028[108] - The company entered into a License Agreement with Pharmosa for L606, paying an upfront fee of $10 million and potential milestone payments up to $215 million[109][110] - The company is obligated to pay UNC royalties equal to a low single-digit percentage of net sales for products using licensed technology[113] - The company has agreements with Chasm Technologies for manufacturing consulting services, with future contingent milestones and royalties totaling up to $1.5 million[114] - Company entered into a 5-year Amended and Restated Commercial Manufacturing Services and Supply Agreement with Lonza Tampa LLC for YUTREPIA encapsulation and packaging services[117] - Company must provide Lonza with quarterly forecasts for 24-month production requirements, with the first 12 months as binding orders[118] - Company has a multi-year supply agreement with LGM Pharma, LLC with an annual minimum purchase commitment of $2.7 million[119] - Non-cancelable commitments for product manufacturing and supply costs as of June 30, 2024, total approximately $3.5 million[119] Litigation and Legal Matters - FDA approval for YUTREPIA is delayed until at least 2027 due to patent litigation involving the '793 Patent[124] - Company filed a motion to set aside the injunction on YUTREPIA FDA approval, which was granted in March 2024[127] - United Therapeutics filed a second patent infringement lawsuit in September 2023, asserting infringement of the '793 and '327 Patents[128] - Judge Andrews denied United Therapeutics' motion for a preliminary injunction against YUTREPIA for PH-ILD treatment in May 2024[130] - United Therapeutics filed a complaint against the FDA in February 2024, challenging the FDA's acceptance of the amended NDA for YUTREPIA[131] - Company filed a motion to dismiss all claims in a trade secret litigation filed by United Therapeutics in July 2024[133] - United Therapeutics was granted partial summary judgment on antitrust and unfair competition claims, while Sandoz was granted partial summary judgment on the breach of contract claim[137] - A trial to determine damages from United Therapeutics to Sandoz for the breach of contract claim was held from late April to early May 2024[137] - Proceeds from the litigation will be divided evenly between Sandoz and Liquidia PAH under the Promotion Agreement[138] - Net proceeds received by Liquidia PAH from the RareGen Litigation will be divided between Henderson and PBM[138] Product Development and Approvals - YUTREPIA received tentative FDA approval for PAH treatment in November 2021[25] - L606 is being evaluated in an open-label study for PAH and PH-ILD treatment[26] - The company capitalized $7.2 million of prelaunch inventory as of June 30, 2024, compared to none as of December 31, 2023[43] - Capitalized costs of $7.2 million associated with the manufacture of YUTREPIA during the six months ended June 30, 2024[63] Internal Controls and Procedures - The Company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2024[195] - No changes in internal control over financial reporting during the quarter ended June 30, 2024 materially affected the company's internal control[196] Leases and Commitments - The weighted average remaining lease term for operating leases as of June 30, 2024 was 2.3 years[94] - The weighted average discount rate for finance leases as of June 30, 2024 was 6.5%[94] - Future minimum lease payments as of June 30, 2024 total $3,297 million, with $719 million due in 2024, $1,420 million in 2025, and $1,158 million in 2026[95] Other Financial Information - Interest income for Q2 2024 was $1.855 million, up from $734,000 in Q2 2023[16] - Interest expense for Q2 2024 was $2.600 million, compared to $1.426 million in Q2 2023[16] - Total stock options, restricted stock units, and warrants amounted to 12,959,258 as of June 30, 2024[59] - Total accrued expenses and other current liabilities amounted to $13,100 as of June 30, 2024[72] - The company completed its annual goodwill impairment test as of July 1, 2024 and concluded that no impairments had occurred[46] - The company recognized a liability related to amounts received in January 2023, July 2023, and January 2024 pursuant to the RIFA[47] - Stock-based compensation expense is estimated based on the grant date fair value of awards and amortized over the vesting period, with adjustments for forfeiture rates[55] - Basic and diluted net loss per share are calculated by dividing net loss by weighted average shares outstanding, excluding anti-dilutive common stock equivalents[56] - Sandoz and Liquidia PAH received a payment of $4.25 million evenly split between the parties[136] - Smiths Medical granted Liquidia PAH and Sandoz a non-exclusive, royalty-free license in the United States for patents and copyrights associated with the CADD-MS 3 Cartridge[136] - Smiths Medical agreed to provide information and assistance for FDA clearance of the RG 3ml Medication Cartridge until January 1, 2025[136]

Financial Performance - Revenue was $3.7 million for Q2 2024, a decrease of $1.1 million (23%) compared to $4.8 million in Q2 2023[6] - Revenue for Q2 2024 decreased to $3.659 million from $4.786 million in Q2 2023, a decline of 23.5%[19] - Net loss for Q2 2024 was $27.9 million or $0.37 per share, compared to a net loss of $23.5 million or $0.36 per share in Q2 2023[10] - Net loss increased to $27.942 million in Q2 2024 from $23.517 million in Q2 2023, a rise of 18.8%[19] - Net loss per common share remained relatively stable at $0.37 in Q2 2024 compared to $0.36 in Q2 2023[19] - Weighted average common shares outstanding increased to 76,435,831 in Q2 2024 from 64,788,482 in Q2 2023, a rise of 18.0%[19] Expenses - Research and development expenses decreased by $8.3 million (47%) to $9.4 million in Q2 2024 compared to $17.7 million in Q2 2023[7] - General and administrative expenses increased by $10.8 million (116%) to $20.0 million in Q2 2024 compared to $9.2 million in Q2 2023[8] - Cost of revenue increased to $1.493 million in Q2 2024 from $0.671 million in Q2 2023, a rise of 122.5%[19] - Research and development expenses decreased to $9.420 million in Q2 2024 from $17.695 million in Q2 2023, a reduction of 46.8%[19] - General and administrative expenses increased to $19.943 million in Q2 2024 from $9.245 million in Q2 2023, a rise of 115.7%[19] - Total costs and expenses increased to $30.856 million in Q2 2024 from $27.611 million in Q2 2023, a rise of 11.7%[19] Cash and Assets - Cash and cash equivalents totaled $133.1 million as of June 30, 2024, compared to $83.7 million as of December 31, 2023[6][18] - Total assets increased to $177.4 million as of June 30, 2024, compared to $118.3 million as of December 31, 2023[18] Product Development and FDA Approval - YUTREPIA is progressing towards FDA approval for PAH and PH-ILD, with no legal impediments currently[2][3] - L606 is in Phase 3 clinical trials for PAH and PH-ILD, with a planned global pivotal placebo-controlled efficacy study for PH-ILD[5][12] - The company has a clear legal path for FDA approval of YUTREPIA following court rulings in its favor[2][3] Presentations and Conferences - Liquidia presented new data on YUTREPIA and L606 at the World Symposia on Pulmonary Hypertension and the American Thoracic Society 2024 International Conference[4][5]

MORRISVILLE, N.C., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today reported financial results for the second quarter ended June 30, 2024. The company will host a webcast at 8:30 a.m. ET on August 7, 2024 to discuss the financial results and provide a corporate update. Dr. Roger Jeffs, Liquidia's Chief Executive Officer, said: "We continue to face no legal impediments for t ...