[PART I. FINANCIAL INFORMATION](index=9&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed financial statements, management's financial analysis, and disclosures on market risk and internal controls [Item 1. Condensed Financial Statements (unaudited)](index=9&type=section&id=Item%201.%20Condensed%20Financial%20Statements) Liquidia Corporation's unaudited condensed financial statements reveal an increased net loss and a 'going concern' uncertainty due to recurring losses and future funding requirements [Condensed Consolidated Balance Sheets](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Liquidia's balance sheet shows a decrease in cash and equity, with total assets slightly down and total liabilities significantly up due to increased long-term debt Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $169,758 | $176,479 | | Total current assets | $177,205 | $185,105 | | Total assets | $227,429 | $230,313 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $60,518 | $41,781 | | Long-term debt, noncurrent | $103,182 | $95,268 | | Total liabilities | $177,716 | $150,935 | | Total stockholders' equity | $49,713 | $79,378 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations show a widened net loss of **$38.4 million** for Q1 2025, primarily driven by increased general and administrative expenses despite stable revenue Statement of Operations Summary (in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $3,120 | $2,972 | | Cost of Revenue | $1,517 | $1,467 | | Research and development | $6,966 | $10,057 | | General and administrative | $30,062 | $20,249 | | Loss from operations | ($35,425) | ($28,801) | | Net loss | ($38,367) | ($30,083) | | Net loss per share, basic and diluted | ($0.45) | ($0.40) | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements indicate a net decrease in cash of **$6.7 million** in Q1 2025, with increased cash used in operations and reduced financing activities compared to the prior year Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($30,679) | ($24,866) | | Net cash used in investing activities | ($330) | ($624) | | Net cash provided by financing activities | $24,288 | $99,669 | | **Net (decrease) increase in cash** | **($6,721)** | **$74,179** | [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical details on Liquidia's product development, 'going concern' uncertainty, significant long-term debt, and ongoing legal disputes with United Therapeutics - The company is focused on developing and commercializing products for rare cardiopulmonary diseases like PAH and PH-ILD. Its lead product candidate, YUTREPIA, has a PDUFA goal date of May 24, 2025, for final FDA approval[24](index=24&type=chunk)[27](index=27&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern for the next year due to recurring operating losses, an accumulated deficit of **$595.8 million**, and the need for additional capital to fund operations and meet debt covenants[33](index=33&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) - The company capitalized **$16.6 million** of prelaunch inventory for YUTREPIA as of March 31, 2025, based on the assessment that regulatory approval and commercialization are probable[51](index=51&type=chunk)[76](index=76&type=chunk) - The company has significant long-term debt under an agreement with HealthCare Royalty Partners (HCR), with **$140.8 million** outstanding as of March 31, 2025. The agreement includes a covenant to maintain a minimum cash balance of **$15.0 million**[114](index=114&type=chunk)[121](index=121&type=chunk)[126](index=126&type=chunk) - Liquidia is involved in multiple legal proceedings with United Therapeutics concerning patent infringement and trade secrets related to YUTREPIA[142](index=142&type=chunk)[147](index=147&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=55&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion analyzes the increased net loss, reiterates the 'going concern' warning, and details critical accounting estimates related to YUTREPIA's commercialization and debt financing [Results of Operations](index=61&type=section&id=Results%20of%20Operations) A comparison of Q1 2025 to Q1 2024 shows a **28%** increase in net loss to **$38.4 million**, primarily due to a **48%** rise in General & Administrative expenses for YUTREPIA launch preparations Comparison of Operations (in thousands) | Item | Q1 2025 | Q1 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $3,120 | $2,972 | $148 | 5% | | Research and development | $6,966 | $10,057 | ($3,091) | (31)% | | General and administrative | $30,062 | $20,249 | $9,813 | 48% | | Loss from operations | ($35,425) | ($28,801) | ($6,624) | 23% | | Net loss | ($38,367) | ($30,083) | ($8,284) | 28% | - The **$3.1 million** decrease in R&D expenses was mainly due to a **$3.6 million** reduction in personnel costs as focus shifted to commercialization preparation for YUTREPIA[186](index=186&type=chunk) - The **$9.9 million** increase in G&A expenses was primarily due to an **$8.1 million** rise in personnel costs (including stock-based compensation) driven by higher headcount for the potential YUTREPIA launch[187](index=187&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity and capital resources highlight **$169.8 million** in cash, but management expresses substantial doubt about the company's ability to continue as a going concern without additional financing or YUTREPIA revenue - The company had cash and cash equivalents of **$169.8 million** as of March 31, 2025[189](index=189&type=chunk) - In Q1 2025, the company received **$25.0 million** in net proceeds from its HCR debt agreement. In Q1 2024, it received **$74.9 million** from a private placement and **$25.0 million** from the HCR agreement[205](index=205&type=chunk) - Management concluded there is substantial doubt about the ability to continue as a going concern, as existing cash is insufficient to fund operations and meet a **$15.0 million** minimum cash covenant for the next twelve months without YUTREPIA revenue or new financing[198](index=198&type=chunk)[171](index=171&type=chunk) [Critical Accounting Estimates](index=70&type=section&id=Critical%20Accounting%20Estimates) Critical accounting estimates include accrued Research and Development expenses, long-term debt under the HCR agreement, and the capitalization of prelaunch inventory for YUTREPIA, which carries a risk of write-off - Key estimates include accrued R&D expenses, which are based on the estimated level of service performed by vendors like CROs and CMOs[220](index=220&type=chunk) - The accounting for long-term debt from the HCR Agreement is critical, requiring accretion under the effective interest method based on contractual future payments[224](index=224&type=chunk) - Capitalization of prelaunch inventory (**$16.6 million** as of March 31, 2025) is a critical estimate based on the probability of YUTREPIA's regulatory approval and commercial success. Failure to achieve this could lead to a write-off[225](index=225&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=74&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is deemed not applicable as the company qualifies as a smaller reporting company - The company has determined that quantitative and qualitative disclosures about market risk are not applicable[230](index=230&type=chunk) [Item 4. Controls and Procedures](index=74&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[232](index=232&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[233](index=233&type=chunk) [PART II. OTHER INFORMATION](index=75&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section details the company's significant legal proceedings, comprehensive risk factors, and other required disclosures including exhibits [Item 1. Legal Proceedings](index=75&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in significant ongoing legal proceedings, primarily patent infringement and trade secret disputes with United Therapeutics, which could impact YUTREPIA's commercialization - For details on legal proceedings, the report refers to Note 14 of the financial statements[234](index=234&type=chunk) - Key litigation includes the 'New Hatch-Waxman Litigation' where United Therapeutics alleges YUTREPIA infringes its '327 Patent. A motion for a preliminary injunction by United Therapeutics was denied, and trial is set for June 2025[144](index=144&type=chunk) - United Therapeutics has also filed two trade secret lawsuits, alleging misappropriation of trade secrets and seeking ownership of certain Liquidia intellectual property[147](index=147&type=chunk)[148](index=148&type=chunk) - Liquidia has filed its own patent infringement lawsuit against United Therapeutics concerning its Tyvaso DPI product and Liquidia's '494 Patent[149](index=149&type=chunk) [Item 1A. Risk Factors](index=75&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including a 'going concern' warning, heavy dependence on YUTREPIA's success amid litigation, supply chain vulnerabilities, and restrictive debt covenants - The company has a history of losses and its financial statements raise substantial doubt about its ability to continue as a going concern without additional funding[241](index=241&type=chunk) - The company is heavily dependent on the success of YUTREPIA, which faces multiple lawsuits from United Therapeutics that could delay or block its commercial launch and limit its approved indications[236](index=236&type=chunk)[273](index=273&type=chunk) - The HCR debt facility contains restrictive covenants, including maintaining a **$15.0 million** minimum cash balance, and is collateralized by all company assets[247](index=247&type=chunk) - The company relies on single-source suppliers for critical components of YUTREPIA (active ingredient, device, encapsulation) and L606, posing a significant supply chain risk[425](index=425&type=chunk)[426](index=426&type=chunk) - Sales of Treprostinil Injection are constrained by the limited availability of the CADD-MS 3 infusion pump, which is no longer manufactured or supported[236](index=236&type=chunk)[269](index=269&type=chunk) [Item 5. Other Information](index=168&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted or terminated by directors or executive officers during the first quarter of 2025 - No new Rule 10b5-1 trading plans were adopted or terminated by directors or executive officers during the three months ended March 31, 2025[517](index=517&type=chunk) [Item 6. Exhibits](index=169&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL financial data files - The exhibits filed with the report include certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act[521](index=521&type=chunk) - Inline XBRL (eXtensible Business Reporting Language) documents are also included as exhibits, providing interactive data for financial statements[521](index=521&type=chunk)

[Company Overview and Q1 2025 Highlights](index=1&type=section&id=1.%20Company%20Overview%20and%20Q1%202025%20Highlights) Liquidia Corporation reported Q1 2025 financial results, emphasizing YUTREPIA's regulatory progress, legal outcome, and financial strengthening [Introduction and CEO Statement](index=1&type=section&id=1.1%20Introduction%20and%20CEO%20Statement) Liquidia Corporation reported its first quarter 2025 financial results, with CEO Dr. Roger Jeffs emphasizing the company's focus on preparing YUTREPIA for commercial availability pending FDA approval, believing it has the potential to be the prostacyclin of first choice for PAH and PH-ILD patients - Liquidia Corporation reported **Q1 2025 financial results** and provided a corporate update[2](index=2&type=chunk) - CEO Dr. Roger Jeffs highlighted the upcoming FDA PDUFA goal date for YUTREPIA NDA (**May 24, 2025**) and the company's readiness for commercial launch upon full approval[3](index=3&type=chunk) - YUTREPIA is believed to have the potential to be the prostacyclin of first choice for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)[3](index=3&type=chunk) [Corporate Updates](index=1&type=section&id=1.2%20Corporate%20Updates) Liquidia provided several key corporate updates, including significant progress on YUTREPIA's regulatory pathway with the FDA, a favorable legal outcome against United Therapeutics, and a strengthened financial position through an amended financing agreement [YUTREPIA Regulatory and Clinical Progress](index=1&type=section&id=1.2.1%20YUTREPIA%20Regulatory%20and%20Clinical%20Progress) This section details YUTREPIA's regulatory progress, including FDA NDA resubmission, PDUFA goal date, and positive interim data from the ASCENT study - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA (treprostinil) inhalation powder for PAH and PH-ILD as a complete Class 1 response[4](index=4&type=chunk) - The FDA has set a PDUFA goal date of **May 24, 2025**, for YUTREPIA, coinciding with the day after regulatory exclusivity expires for Tyvaso DPI®[4](index=4&type=chunk) - Liquidia completed enrollment of Cohort A of the open-label ASCENT study for YUTREPIA in PH-ILD patients, with **over 50 patients enrolled**[6](index=6&type=chunk) - Interim data from the first 20 patients in ASCENT Cohort A showed tolerability consistent with the INSPIRE study and positive trends on exploratory efficacy measures, including 6-minute walk distance, with patients titrating to doses **three-times higher** than nebulized Tyvaso's target dose[6](index=6&type=chunk) [Legal Developments](index=1&type=section&id=1.2.2%20Legal%20Developments) The U.S. District Court dismissed United Therapeutics' cross-claim challenging Liquidia's YUTREPIA NDA amendment for the PH-ILD indication - The U.S. District Court for the District of Columbia **dismissed, without prejudice**, a cross-claim filed by United Therapeutics (UTHR) challenging Liquidia's amendment to its YUTREPIA NDA to add the PH-ILD indication[5](index=5&type=chunk) - The District Court ruled that UTHR's claim was **unripe** and that UTHR **failed to plausibly allege standing**, though UTHR retains the right to appeal[5](index=5&type=chunk) [Financial Strengthening](index=2&type=section&id=1.2.3%20Financial%20Strengthening) Liquidia strengthened its financial position by amending the HCR agreement to secure up to an additional **$100 million** in financing - Liquidia entered into a sixth amendment to its agreement with HealthCare Royalty (HCR Agreement) to provide for **up to an additional $100 million** of financing in three tranches[8](index=8&type=chunk) - The proceeds are intended to fund ongoing commercial development of YUTREPIA, continued development of YUTREPIA in other clinical trials (including pediatric and further PAH/PH-ILD trials), clinical development of L606, and general corporate purposes[8](index=8&type=chunk) - Key updates include awaiting FDA action on YUTREPIA™ NDA with a PDUFA goal date of **May 24, 2025**[7](index=7&type=chunk) - The District Court dismissed a cross-claim filed by United Therapeutics challenging the PH-ILD amendment to the YUTREPIA NDA[7](index=7&type=chunk) - Cohort A of the ASCENT study in patients with PH-ILD has been **fully enrolled**[7](index=7&type=chunk) - Liquidia further strengthened its financial position by accessing **up to an additional $100 million** from an existing financing agreement with HealthCare Royalty[7](index=7&type=chunk)[8](index=8&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=2.%20First%20Quarter%202025%20Financial%20Results) Liquidia's Q1 2025 financial results are presented, detailing balance sheet highlights and income statement analysis [Balance Sheet Highlights](index=2&type=section&id=2.1%20Balance%20Sheet%20Highlights) As of March 31, 2025, Liquidia's cash and cash equivalents decreased slightly from the end of 2024, while total liabilities increased and total stockholders' equity decreased | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $169,758 | $176,479 | | Total assets | $227,429 | $230,313 | | Total liabilities | $177,716 | $150,935 | | Accumulated deficit | $(595,756) | $(557,389) | | Total stockholders' equity| $49,713 | $79,378 | [Income Statement Analysis](index=2&type=section&id=2.2%20Income%20Statement%20Analysis) For Q1 2025, Liquidia reported a slight increase in revenue, a 31% decrease in R&D expenses due to a shift towards commercialization, and a 48% increase in G&A expenses driven by higher headcount and commercialization preparation. The net loss widened to $38.4 million | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Revenue | $3,120 | $2,972 | **+$148 (+5.0%)** | | Cost of revenue | $1,517 | $1,467 | +$50 (+3.4%) | | Research and development | $6,966 | $10,057 | **-$3,091 (-30.7%)** | | General and administrative | $30,062 | $20,249 | **+$9,813 (+48.5%)** | | Total costs and expenses | $38,545 | $31,773 | +$6,772 (+21.3%) | | Loss from operations | $(35,425) | $(28,801) | -$(6,624) (-23.0%) | | Total other expense, net | $(2,942) | $(1,282) | -$(1,660) (-129.5%) | | Net loss and comprehensive loss | $(38,367) | $(30,083) | **-$(8,284) (-27.5%)** | | Net loss per common share, basic and diluted | $(0.45) | $(0.40) | -$(0.05) (-12.5%) | - The $0.1 million increase in revenue was primarily due to the impact of unfavorable gross-to-net returns adjustments recorded in the prior year offset by lower sales volumes in the current year, related to the promotion agreement with Sandoz, Inc. for Treprostinil Injection[10](index=10&type=chunk) - The decrease in R&D expenses was primarily due to a **$3.6 million decrease** in personnel expenses as activities shifted from R&D to preparation for YUTREPIA's potential commercialization, partially offset by a **$1.7 million increase** in clinical expenses for the L606 program[12](index=12&type=chunk) - The increase in G&A expenses was primarily due to an **$8.1 million increase** in personnel expenses (higher headcount and shift from R&D to commercialization prep), a **$0.6 million increase** in legal fees for YUTREPIA-related litigation, and a **$0.6 million increase** in facilities and infrastructure expenses[13](index=13&type=chunk) - The increase in total other expense, net, was primarily driven by a **$1.5 million increase in interest expense** attributable to higher borrowings under the HCR Agreement[14](index=14&type=chunk) [Product Portfolio and Disease Information](index=3&type=section&id=3.%20Product%20Portfolio%20and%20Disease%20Information) Liquidia's product portfolio, including YUTREPIA and L606, is outlined alongside overviews of PAH and PH-ILD [Key Product Candidates](index=3&type=section&id=3.1%20Key%20Product%20Candidates) Liquidia's product pipeline includes YUTREPIA, an investigational inhaled dry-powder treprostinil with tentative FDA approval, L606, an investigational sustained-release liposomal treprostinil, and the commercially available generic Treprostinil Injection [YUTREPIA™ (treprostinil) Inhalation Powder](index=3&type=section&id=3.1.1%20YUTREPIA%E2%84%A2%20%28treprostinil%29%20Inhalation%20Powder) YUTREPIA is an investigational, inhaled dry-powder treprostinil formulation with tentative FDA approval, designed using PRINT® technology for enhanced lung deposition - YUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device[16](index=16&type=chunk) - It received **tentative FDA approval in August 2024** for PAH and PH-ILD indications[16](index=16&type=chunk) - YUTREPIA was designed using Liquidia's PRINT® technology for precise and uniform drug particles, engineered for enhanced lung deposition[16](index=16&type=chunk) - Clinical studies include INSPIRE (Phase 3 for PAH) and ASCENT (Open-Label for PH-ILD safety and tolerability)[16](index=16&type=chunk) [L606 (liposomal treprostinil) Inhalation Suspension](index=3&type=section&id=3.1.2%20L606%20%28liposomal%20treprostinil%29%20Inhalation%20Suspension) L606 is an investigational, sustained-release liposomal treprostinil formulation administered twice-daily, currently in an open-label study for PAH and PH-ILD - L606 is an investigational, sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer[17](index=17&type=chunk) - It uses Pharmosa Biopharm's proprietary liposomal formulation to encapsulate treprostinil for slow, controlled release and extended drug exposure in the lung[17](index=17&type=chunk) - L606 is currently being evaluated in an open-label study in the US for PAH and PH-ILD, with a planned global pivotal placebo-controlled efficacy study for PH-ILD[17](index=17&type=chunk) [Treprostinil Injection (Generic)](index=3&type=section&id=3.1.3%20Treprostinil%20Injection%20%28Generic%29) Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration, promoted in partnership with Sandoz - Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration[18](index=18&type=chunk) - It contains the same active ingredient, strengths, dosage form, and inactive ingredients as Remodulin (treprostinil) and is offered at a lower price[18](index=18&type=chunk) - Liquidia PAH promotes its use in the US in partnership with Sandoz, who holds the Abbreviated New Drug Application (ANDA) with the FDA[18](index=18&type=chunk) [Disease Overviews](index=3&type=section&id=3.2%20Disease%20Overviews) This section provides an overview of Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD), detailing their characteristics, prevalence, and current treatment landscape [Pulmonary Arterial Hypertension (PAH)](index=3&type=section&id=3.2.1%20Pulmonary%20Arterial%20Hypertension%20%28PAH%29) PAH is a rare, chronic, progressive disease affecting pulmonary arteries, with an estimated **45,000 patients** in the US, lacking a cure but managed with symptom-alleviating treatments - PAH is a rare, chronic, progressive disease caused by hardening and narrowing of pulmonary arteries, leading to right heart failure and potentially death[19](index=19&type=chunk) - An **estimated 45,000 patients** are diagnosed and treated in the United States[19](index=19&type=chunk) - There is no cure for PAH; existing treatments aim to alleviate symptoms, improve functional class, delay disease progression, and enhance quality of life[19](index=19&type=chunk) [Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)](index=4&type=section&id=3.2.2%20Pulmonary%20Hypertension%20Associated%20with%20Interstitial%20Lung%20Disease%20%28PH-ILD%29) PH-ILD encompasses diverse pulmonary diseases, significantly impacting survival, with an estimated prevalence exceeding **60,000 patients** in the US - PH-ILD encompasses a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis and chronic hypersensitivity pneumonitis[20](index=20&type=chunk) - Any level of PH in ILD patients is associated with **poor 3-year survival**[20](index=20&type=chunk) - Current estimates place PH-ILD prevalence in the United States at **greater than 60,000 patients**, though actual prevalence may be higher due to underdiagnosis and historical lack of approved treatments[20](index=20&type=chunk) [Additional Information](index=4&type=section&id=4.%20Additional%20Information) Liquidia Corporation details, forward-looking statements, financial revision, and contact information are provided [About Liquidia Corporation](index=4&type=section&id=4.1%20About%20Liquidia%20Corporation) Liquidia Corporation is a biopharmaceutical company focused on developing and commercializing innovative therapies for rare cardiopulmonary diseases, leveraging its proprietary PRINT Technology for products like YUTREPIA and L606, and marketing generic Treprostinil Injection - Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease[21](index=21&type=chunk) - The company's focus includes developing and commercializing products in pulmonary hypertension and other applications of its proprietary PRINT Technology[21](index=21&type=chunk) - Its lead candidate is YUTREPIA™ (treprostinil) inhalation powder, and it is also developing L606 and markets generic Treprostinil Injection[21](index=21&type=chunk) [Cautionary Statements Regarding Forward-Looking Statements](index=4&type=section&id=4.2%20Cautionary%20Statements%20Regarding%20Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, highlighting that actual results may differ materially due to significant risks and uncertainties inherent in the competitive and rapidly changing biopharmaceutical industry, and the company undertakes no duty to update these statements - The press release includes forward-looking statements regarding future results, financial position, strategic initiatives, business strategy, and operational objectives[23](index=23&type=chunk) - These statements involve significant risks and uncertainties, and actual results could differ materially from those expressed or implied[23](index=23&type=chunk) - The company operates in a competitive and rapidly changing environment with inherent industry risks, and new risks may emerge[23](index=23&type=chunk) - Liquidia undertakes no duty to update its goals or any forward-looking statements[23](index=23&type=chunk) [Financial Statement Revision](index=5&type=section&id=4.3%20Financial%20Statement%20Revision) Liquidia voluntarily revised its previously issued 2024 annual consolidated financial statements to correct immaterial errors related to the accounting treatment of the fourth and fifth amendments to the HCR Agreement, resulting in adjustments to interest expense, long-term debt, and accumulated deficit - Liquidia identified **immaterial errors** in its accounting treatment of the fourth and fifth amendments to the HCR Agreement during Q1 2025[24](index=24&type=chunk) - The company **voluntarily revised** its previously issued 2024 annual consolidated financial statements to correct these errors[24](index=24&type=chunk) - The revision **eliminated a loss on extinguishment** and recorded an adjustment to interest expense, with corresponding adjustments to long-term debt and accumulated deficit accounts[24](index=24&type=chunk) [Contact Information](index=5&type=section&id=4.4%20Contact%20Information) Contact details for investor relations and media inquiries are provided, including names, titles, and contact numbers for Jason Adair (Chief Business Officer) and Patrick Wallace (Director, Corporate Communications) - Investors can contact Jason Adair, Chief Business Officer, at 919.328.4350 or Jason.adair@liquidia.com[25](index=25&type=chunk) - Media can contact Patrick Wallace, Director, Corporate Communications, at 919.328.4383 or patrick.wallace@liquidia.com[25](index=25&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=5.%20Condensed%20Consolidated%20Financial%20Statements) Liquidia Corporation's unaudited condensed consolidated financial statements, including balance sheet and income statement data, are presented [Select Condensed Consolidated Balance Sheet Data](index=6&type=section&id=5.1%20Select%20Condensed%20Consolidated%20Balance%20Sheet%20Data) This section presents the unaudited condensed consolidated balance sheet data for Liquidia Corporation as of March 31, 2025, and December 31, 2024, showing key financial positions | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $169,758 | $176,479 | | Total assets | $227,429 | $230,313 | | Total liabilities | $177,716 | $150,935 | | Accumulated deficit | $(595,756) | $(557,389) | | Total stockholders' equity| $49,713 | $79,378 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=5.2%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section provides the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025, and March 31, 2024, detailing revenue, expenses, and net loss | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $3,120 | $2,972 | | Costs and expenses: | | | | Cost of revenue | $1,517 | $1,467 | | Research and development | $6,966 | $10,057 | | General and administrative | $30,062 | $20,249 | | Total costs and expenses | $38,545 | $31,773 | | Loss from operations | $(35,425) | $(28,801) | | Other income (expense): | | | | Interest income | $1,728 | $1,880 | | Interest expense | $(4,670) | $(3,162) |\ | Total other expense, net | $(2,942) | $(1,282) | | Net loss and comprehensive loss | $(38,367) | $(30,083) | | Net loss per common share, basic and diluted | $(0.45) | $(0.40) | | Weighted average common shares outstanding, basic and diluted | 85,172,696 | 75,393,907 |

Core Viewpoint - Liquidia Corporation is focused on the potential commercialization of YUTREPIA, an inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), with an FDA decision expected by May 24, 2025 [2][3][8]. Corporate Updates - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA, setting a PDUFA goal date of May 24, 2025, coinciding with the expiration of regulatory exclusivity for Tyvaso DPI [3][8]. - A U.S. District Court dismissed a cross-claim from United Therapeutics challenging the NDA amendment for YUTREPIA, allowing Liquidia to proceed without legal hindrance [4][8]. - Liquidia completed enrollment of Cohort A in the ASCENT study, with over 50 patients, showing promising results in dosing and tolerability [5][8]. Financial Position - Liquidia entered into a sixth amendment with HealthCare Royalty, allowing for up to an additional $100 million in financing to support the development of YUTREPIA and other clinical trials [6][8]. - As of March 31, 2025, cash and cash equivalents were $169.8 million, a decrease from $176.5 million at the end of 2024 [7][8]. - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily from a promotion agreement with Sandoz [9][8]. Expenses and Losses - Research and development expenses decreased by 31% to $7.0 million in Q1 2025, down from $10.1 million in Q1 2024, due to a shift in focus towards commercialization [11][8]. - General and administrative expenses rose by 48% to $30.1 million in Q1 2025, attributed to increased personnel costs and legal fees [12][8]. - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [14][8].

MORRISVILLE, N.C., May 06, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that the company's Chief Financial Officer and Chief Operating Officer, Michael Kaseta, and Chief Medical Officer, Rajeev Saggar, will provide a business update during a fireside chat at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025, beginning at 1:40 p.m. PT / 4:40 p.m. ...

Core Insights - The article discusses potential investment opportunities in LQDA, indicating a possible long position may be initiated within the next 72 hours [1]. Group 1 - The analyst has no current stock, option, or similar derivative position in any of the companies mentioned [1]. - The article expresses the author's own opinions and is not receiving compensation from any company mentioned [1]. - There is an indication of a potential beneficial long position through stock or call options in LQDA [1].

Company Overview - Liquidia Technologies, Inc. (LQDA) shares increased by 13.2% to close at $15.83, with notable trading volume compared to typical sessions, following a 1.1% loss over the past four weeks [1][2] Recent Developments - The U.S. District Court for the District of Columbia dismissed a cross-claim by United Therapeutics challenging Liquidia's amendment to its new drug application for Yutrepia, which now includes treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2] Financial Expectations - Liquidia is expected to report a quarterly loss of $0.42 per share, reflecting a year-over-year increase of 22.2%, with revenues projected at $3.31 million, up 11.4% from the previous year [3] - The consensus EPS estimate for Liquidia has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Liquidia Technologies operates within the Zacks Medical - Biomedical and Genetics industry, where CRISPR Therapeutics AG (CRSP) also competes, having closed 1.4% higher at $38.25 and showing a 15.5% return over the past month [4]

Core Viewpoint - Liquidia Corporation has received a favorable ruling from the U.S. District Court, which dismissed United Therapeutics' cross-claim against its New Drug Application (NDA) for YUTREPIA, allowing the company to proceed with its plans for the drug's approval [1][2]. Group 1: Legal Developments - The U.S. District Court dismissed United Therapeutics' cross-claim regarding Liquidia's amendment to its NDA for YUTREPIA, determining that the claim was unripe and lacked standing [1][2]. - United Therapeutics retains the right to appeal the court's decision [2]. Group 2: Product Development and Approval Timeline - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the YUTREPIA NDA on May 24, 2025, following the expiration of regulatory exclusivity on May 23, 2025 [3][6]. - Liquidia aims for YUTREPIA to become the preferred treatment for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2][4]. Group 3: Company Overview - Liquidia Corporation focuses on developing innovative therapies for rare cardiopulmonary diseases, with a particular emphasis on pulmonary hypertension [4]. - The company is also working on L606, a sustained-release formulation of treprostinil, and markets a generic version of Treprostinil Injection for PAH treatment [4].

Core Points - Liquidia Corporation will report its first quarter 2025 financial results on May 8, 2025, and will host a webcast at 8:30 a.m. Eastern Time to discuss these results and provide a corporate update [1][2] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for patients with rare cardiopulmonary diseases [3] - The company's primary focus includes the development and commercialization of products for pulmonary hypertension, utilizing its proprietary PRINT Technology [3] - Liquidia's lead candidate is YUTREPIA™ (treprostinil) inhalation powder, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3] - The company is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [3]

Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for patients with rare cardiopulmonary diseases [3] - The company is currently developing and commercializing products for pulmonary hypertension and other applications using its proprietary PRINT Technology [3] Product Development - Liquidia's lead candidate is YUTREPIA™ (treprostinil) inhalation powder, which is an investigational drug aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3] - The company is also working on L606, an investigational sustained-release formulation of treprostinil that is administered twice daily with a next-generation nebulizer [3] - Additionally, Liquidia markets a generic version of Treprostinil Injection for the treatment of PAH [3] Upcoming Events - Liquidia will present an overview of its business at the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025, at 8:45 a.m. ET [1] - Access to a webcast of the presentation will be available on the "Investors" page of Liquidia's website, with an archived version accessible for at least 30 days post-event [2]

Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for patients with rare cardiopulmonary diseases [3] - The company is currently developing and commercializing products for pulmonary hypertension and other applications using its proprietary PRINT Technology [3] - Liquidia's lead candidate is YUTREPIA™ (treprostinil) inhalation powder, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3] - The company is also working on L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [3] Upcoming Events - Liquidia will present an overview of its business at the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025, at 8:45 a.m. ET [1] - Access to a webcast of the presentation will be available on the "Investors" page of Liquidia's website, with an archived version accessible for at least 30 days post-event [2]