Liquidia Corporation Reports Third Quarter 2024 Financial Results and Provides Corporate Update
LQDA 11.13.2024
Drug:treprostinil YUTREPIA
Drug:liposomal treprostinil L606
Diseases:pulmonary arterial hypertension (PAH)
Diseases:pulmonary hypertension associated with interstitial lung disease (PH-ILD)
Diseases:pulmonary hypertension associated with interstitial lung disease (PH-ILD)
- Received tentative approval from the FDA for YUTREPIATM (treprostinil) inhalation powder for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)
U.S. Supreme Court rejected final appeal of ‘793 patent decision, marking victories with respect to three patents originally asserted final and not subject to further appeal- Strengthened balance sheet by raising approximately
$100 million in additional capital
Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “This quarter we achieved our goal of adding pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the indication statement for YUTREPIATM. While the FDA decision to grant three-year exclusivity to TYVASO DPI®, which will expire on
Corporate Updates
Received tentative approval from the FDA for YUTREPIA (treprostinil) inhalation powderIn August, the FDA granted tentative approval for YUTREPIA for the treatment of patients with pulmonary arterial hypertension (PAH) and PH-ILD. At present, final approval of YUTREPIA is delayed until after expiration on
Commenced litigation to challenge regulatory exclusivity blocking final approval of YUTREPIAIn August,
Favorable decisions related to three patents originally asserted against
With the final resolution of the litigation related to the three patents originally asserted against
Strengthened financial position by approximately
Third Quarter 2024 Financial Results
Cash and cash equivalents totaled $204.4 million as of September 30, 2024, compared to
Revenue was
Cost of revenue was
Research and development expenses were
General and administrative expenses were
Total other income, net was
Net loss for the three months ended September 30, 2024, was $23.2 million or $0.30 per basic and diluted share, compared to a net loss of $15.8 million, or $0.24 per basic and diluted share, for the three months ended September 30, 2023.
About YUTREPIATM (treprostinil) Inhalation PowderYUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. In
About L606 (liposomal treprostinil) Inhalation SuspensionL606 is an investigational, sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer. The L606 suspension uses Pharmosa Biopharm’s proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period of time. L606 is currently being evaluated in an open-label study in the United States for treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) with a planned global pivotal placebo-controlled efficacy study for the treatment of PH-ILD.
About Treprostinil InjectionTreprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same strengths, same dosage form and same inactive ingredients as Remodulin®(treprostinil) and is offered to patients and physicians with the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil Injection for the treatment of PAH in the United States in partnership with its commercial partner, Sandoz, who holds the Abbreviated New Drug Application (ANDA) with the FDA.
About Pulmonary Arterial Hypertension (PAH)Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, an estimated 45,000 patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression, and improve quality of life.
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)Pulmonary hypertension (PH) associated with interstitial lung disease (ILD) includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease related ILD, and chronic pulmonary fibrosis with emphysema (CPFE) among others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the United States is greater than 60,000 patients, though actual prevalence in many of these underlying ILD diseases is not yet known due to factors including underdiagnosis and lack of approved treatments until March 2021, when inhaled treprostinil was first approved for this indication.
About Liquidia CorporationLiquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT®Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIATM (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about
Remodulin®and Tyvaso®are registered trademarks of United Therapeutics Corporation.
Cautionary Statements Regarding Forward-Looking StatementsThis 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, 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 submission contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, which may occur after the expiration of the exclusivity period of TYVASO DPI, if at all, the timelines or outcomes related to patent litigation with United Therapeutics in the U.S. District Court for the District of
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| Liquidia CorporationSelect Condensed Consolidated Balance Sheet Data (unaudited)(in thousands) | |||||||
| December 31, | |||||||
| 2024 | 2023 | ||||||
| Cash and cash equivalents | $ | 204,368 | $ | 83,679 | |||
| Total assets | $ | 252,886 | $ | 118,332 | |||
| Total liabilities | $ | 142,368 | $ | 71,039 | |||
| Accumulated deficit | $ | (521,123 | ) | $ | (429,098 | ) | |
| Total stockholders’ equity | $ | 110,518 | $ | 47,293 | |||
| Liquidia CorporationCondensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)(in thousands, except share and per share amounts) | |||||||
| Three Months EndedSeptember, | |||||||
| 2024 | 2023 | ||||||
| Revenue | $ | 4,448 | $ | 3,678 | |||
| Costs and expenses: | |||||||
| Cost of revenue | $ | 1,565 | $ | 570 | |||
| Research and development | $ | 11,890 | $ | 7,440 | |||
| General and administrative | $ | 20,182 | $ | 10,559 | |||
| Total costs and expenses | $ | 33,637 | $ | 18,569 | |||
| Loss from operations | $ | (29,189 | ) | $ | (14,891 | ) | |
| Other income (expense): | |||||||
| Interest income | $ | 1,815 | $ | 862 | |||
| Interest expense | $ | (2,996 | ) | $ | (1,761 | ) | |
| Gain on extinguishment of debt | $ | 7,215 | $ | — | |||
| Total other expense, net | $ | 6,034 | $ | (899 | ) | ||
| Net loss and comprehensive loss | $ | (23,155 | ) | $ | (15,790 | ) | |
| Net loss per common share, basic and diluted | $ | (0.30 | ) | $ | (0.24 | ) | |
| Weighted average common shares outstanding, basic and diluted | $ | 78,316,820 | $ | 64,857,508 | |||
Source: Liquidia Corporation