Latest news with #PH-ILD
Business Wire
4 days ago
- Business
- Business Wire
Halo Biosciences Announces Thorax Publication of Phase 2a SATURN Study Results in PH-ILD
PALO ALTO, Calif.--(BUSINESS WIRE)--Halo Biosciences ('Halo'), a clinical-stage biotechnology company developing extracellular matrix-targeted therapies, today announced publication of results from the Phase 2a SATURN study in Thorax. The study, conducted at Stanford University, evaluated 4-methylumbelliferone (4-MU) in patients with pulmonary hypertension, a highly progressive disease with significant unmet needs. The SATURN study, a Phase 2a randomized, double-blind, placebo-controlled trial, enrolled 16 patients with pulmonary hypertension. 4-MU was safe and well-tolerated throughout the 24-week treatment period. The primary hemodynamic measurement of change in pulmonary vascular resistance was not statistically significant. Among patients with PH-ILD, prespecified exploratory efficacy signals showed a mean improvement of 66 meters in six-minute walk distance and enhanced quality-of-life scores. These findings support further clinical evaluation of 4-MU as a potential disease-modifying therapy for inflammatory and fibrotic lung diseases. 'These clinical data reinforce the scientific rationale for targeting hyaluronan in fibrotic and inflammatory lung disease and highlight 4-MU's potential as a first-in-class, disease-modifying ECM-modulator for patients with serious conditions like PH-ILD,' said Paul Bollyky, M.D., professor of medicine at Stanford University and scientific co-founder of Halo Biosciences. 'This represents a meaningful step forward for individuals living with PH-ILD, a condition with limited treatment options and a high burden of disease.' HB-1614, Halo's lead investigational therapy, is a proprietary, oral formulation of 4-MU optimized for improved bioavailability and long-term use in patients with chronic lung conditions such as PH-ILD. By inhibiting hyaluronan synthesis, HB-1614 targets a key driver of extracellular matrix (ECM) remodeling involved in inflammation and fibrosis—processes central to disease progression in several debilitating diseases, including PH-ILD. 'We are proud to see the SATURN study featured in Thorax, validating our translational approach and marking a key milestone in our development of HB-1614,' said Anissa Kalinowski, chief executive officer of Halo Biosciences. 'We are thankful to Stanford University and sponsor investigators Roham Zamanian, M.D., and Vinicio de Jesus Perez, M.D., for their leadership of the SATURN trial, unlocking the potential of this new mechanism of action.' Halo Biosciences is progressing clinical development of HB-1614 and exploring partnership opportunities to accelerate its work in PH-ILD and other fibrotic conditions. The company holds exclusive intellectual property for its formulation and is positioned to optimize drug delivery, bioavailability and regulatory strategy. The full manuscript is now available online. To access the paper, visit: ABOUT HB-1614 HB-1614 is Halo Biosciences' lead investigational therapy, a proprietary formulation of 4-methylumbelliferone (4-MU) designed to inhibit hyaluronan synthesis, a key driver of inflammation and fibrosis in the ECM. By targeting this dysregulated pathway, HB-1614 offers a novel, disease-modifying approach for conditions like pulmonary hypertension associated with interstitial lung disease (PH-ILD). ABOUT PULMONARY HYPERTENSION Pulmonary hypertension (PH) is a progressive condition caused by elevated blood pressure in the arteries of the lungs, leading to reduced oxygen exchange, right heart strain, and eventual heart failure. i Symptoms include breathlessness, fatigue, and dizziness ii. PH diagnosis is often delayed and accompanied by comorbidities, with most patients diagnosed between the ages of 60 and 70 iii. When PH is associated with interstitial lung disease (PH-ILD), the course of disease is often more accelerated, with these patients facing a median survival of just 2 to 5 years. iv Currently, there is only one FDA-approved therapy for PH-ILD, iv leaving a significant unmet need for therapies that target the underlying mechanisms of disease progression. New approaches are urgently needed to improve outcomes and quality of life for this vulnerable patient population. ABOUT HALO BIOSCIENCES Halo Biosciences is a clinical-stage biopharmaceutical company targeting the extracellular matrix (ECM) to transform the treatment of diseases characterized by inflammation and fibrosis. It is headquartered in Palo Alto, CA. For more information, visit i Pulmonary Fibrosis Foundation. Pulmonary Hypertension Related to Interstitial Lung Disease (for Patients). Retrieved from ii Pulmonary Hypertension Association. Diagnosing Pulmonary Hypertensio n. Accessed on June 3, 2025 from iii Mount Sinai Health System. (n.d.). Idiopathic pulmonary fibrosis. Mount Sinai Health Library. Retrieved June 3, 2025, from iv Nathan, S. D., Stinchon, M. R., Atcheson, S., Simone, L., & Nelson, M. (2025). Shining a spotlight on pulmonary hypertension associated with interstitial lung disease care: The latest advances in diagnosis and treatment. Journal of Managed Care & Specialty Pharmacy, 31(1-a Suppl), S2–S29.
Yahoo
24-05-2025
- Business
- Yahoo
FDA Approves Liquidia Corporation (LQDA)'s YUTREPIA Amid Patent Dispute
Liquidia Corporation (NASDAQ:LQDA) announced today that the U.S. Food and Drug Administration (FDA) has approved YUTREPIA (treprostinil) inhalation powder for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). A healthcare professional working on a computer terminal with a patient in the background. YUTREPIA, enabled by Liquidia Corporation (NASDAQ:LQDA)'s proprietary PRINT technology, is the first and only prostacyclin dry-powder formulation designed for deep-lung delivery using a low-effort, portable inhalation device. The approval is based on results from the Phase 3 INSPIRE trial, which showed YUTREPIA to be safe and well-tolerated, offering a new treatment option for over 105,000 U.S. patients suffering from PAH and PH-ILD. Liquidia Corporation (NASDAQ:LQDA)'s commercial team is preparing to launch YUTREPIA, aiming to improve exercise ability and quality of life for patients. However, United Therapeutics Corporation has filed a patent infringement lawsuit and is seeking a court order to block YUTREPIA's commercial launch, with a decision on the injunction still pending. While we acknowledge the potential of LQDA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than LQDA and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
Business Insider
24-05-2025
- Business
- Business Insider
Liquidia announces FDA approval of Yutrepia
Liquidia (LQDA) announced that the U.S. Food and Drug Administration has approved Yutrepia inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, to improve exercise ability. 'Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia's proprietary PRINT technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort,' the company stated. Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: 'Today, we celebrate for the patients and physicians who will now have access to a potential best-in-class dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability. Thank you to the clinical investigation team, our steering committee, and the members of the pulmonary hypertension patient communities who helped make this day a reality. With today's milestone, our commercial team is prepared to launch Yutrepia and bring meaningful change to the lives of patients in need, and we look forward to speaking with physicians and patients about the unique benefits of Yutrepia in the days and weeks ahead.' As previously disclosed, United Therapeutics (UTHR) filed a complaint on May 9, in the U.S. District Court for the Middle District of North Carolina against Liquidia alleging infringement of U.S. Patent No. 11,357,782 and seeks to enjoin Liquidia from commercializing Yutrepia to treat PAH and PH-ILD. United Therapeutics has filed a motion for temporary restraining order and preliminary injunction to block Liquidia from commercially launching Yutrepia. Oral argument on the motion was held on May 20. The motion remains pending with the Court.
Yahoo
23-05-2025
- Business
- Yahoo
U.S. FDA Approves Liquidia's YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
FDA's approval of YUTREPIA paves the way for prescribers to add a new treatment option for patients with PAH and PH-ILD YUTREPIA is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort Demonstrated tolerability and titratability in the pivotal INSPIRE study Liquidia will host a webcast Tuesday, May 27, 2025 at 8:30 a.m. ET to provide an update on commercial launch preparations MORRISVILLE, N.C., May 23, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced today that the U.S. Food and Drug Administration (FDA) has approved YUTREPIA™ (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. YUTREPIA is the first and only prostacyclin dry-powder formulation enabled by Liquidia's proprietary PRINT™ technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort. Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: 'Today, we celebrate for the patients and physicians who will now have access to a potential best-in-class dry-powder form of treprostinil with exceptional portability, tolerability, titratability and durability. Thank you to the clinical investigation team, our steering committee, and the members of the pulmonary hypertension patient communities who helped make this day a reality. With today's milestone, our commercial team is prepared to launch YUTREPIA and bring meaningful change to the lives of patients in need, and we look forward to speaking with physicians and patients about the unique benefits of YUTREPIA in the days and weeks ahead.' The approval of YUTREPIA is based on findings from the Phase 3 INSPIRE trial which evaluated patients who were naïve to treprostinil, as well as those transitioning to YUTREPIA from nebulized treprostinil. YUTREPIA was shown to be safe and well-tolerated regardless of a patient's previous exposure to treprostinil. Results from the INSPIRE study were published in the Pulmonary Circulation Journal in 2022 and the Vascular Pharmacology Journal in 2021. Please see the 'Selected Safety Information' in the section entitled 'About YUTREPIA™ (treprostinil) Inhalation Powder.' Dr. Nicholas Hill, Chief Pulmonary, Critical Care & Sleep Division, Professor of Medicine at Tufts University School of Medicine and Principal Investigator on the Phase 3 INSPIRE study, said: 'I am so pleased that patients with PAH and PH-ILD now have this newly introduced option for inhaled treprostinil. Having treated patients for more than six years in Liquidia's INSPIRE and extension studies, I am confident in the safety, tolerability and dosing that YUTREPIA offers. The low-effort inhalation device used to deliver YUTREPIA may make it easier to start and maintain patients on treatment, especially those with limited inspiratory flows or lung capacity.' Matt Granato, President and Chief Executive Officer of the Pulmonary Hypertension Association, said: 'PAH and PH-ILD impact more than 105,000 patients in the U.S. alone. These patient communities and the physicians who serve them need therapies that can lead to the improvement of quality of life. We are always glad to see industry research leading to development of drugs that expand options for the patient community.' As previously disclosed, United Therapeutics Corporation (UTHR) filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00368) against Liquidia alleging infringement of U.S. Patent No. 11,357,782 (the '782 patent) and seeks to enjoin Liquidia from commercializing YUTREPIA to treat PAH and PH-ILD. UTHR has filed a motion for temporary restraining order and preliminary injunction to block Liquidia from commercially launching YUTREPIA. Oral argument on the motion was held on May 20, 2025. The motion remains pending with the Court. Webcast InformationLiquidia will provide an update on YUTREPIA commercial launch preparations via a live webcast on Tuesday, May 27, 2025, at 8:30 a.m. ET. Access to the webcast will be available on the 'Investors' page of Liquidia's website at A replay and transcript of the webcast will be archived on the company's website for at least 30 days. About Pulmonary Arterial Hypertension (PAH) Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused by narrowing, thickening or stiffening 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 200 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 population size 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 YUTREPIA™ (treprostinil) Inhalation PowderYUTREPIA is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. YUTREPIA was designed using Liquidia's PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has completed the INSPIRE trial (NCT03399604), or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are naïve to inhaled treprostinil or who are transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial (NCT06129240), or An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH, with the objective of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861 in investigational YUTREPIA (treprostinil) inhalation powder is a prostacyclin analog indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). SELECTED SAFETY INFORMATION: WARNINGS AND PRECAUTIONS Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Treprostinil may produce symptomatic hypotension. Treprostinil inhibits platelet aggregation and increases the risk of bleeding. Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness. Like other inhaled prostaglandins, YUTREPIA may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment. Most common adverse reactions with YUTREPIA (≥10%) are cough, headache, throat irritation and dizziness. Prescribing Information and Instructions for Use for YUTREPIA (treprostinil) inhalation powder are available at About Liquidia Corporation Liquidia 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 YUTREPIA™ (treprostinil) inhalation powder, a drug that has been approved for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD). 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 Liquidia, please visit Tyvaso® is a registered trademark 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; our ability to successfully commercialize our products, including YUTREPIA, for which we obtain FDA or other regulatory authority approval; the acceptance by the market of our products, including YUTREPIA, and their potential pricing and/or reimbursement by third-party payors, if approved (in the case of our product candidates) and whether such acceptance is sufficient to support continued commercialization or development of our products; the successful development or commercialization of our products, including YUTREPIA; our revenue from product sales and whether or not we may become profitable in the near term, or at all; future competitive or other market factors that may adversely affect the commercial potential for YUTREPIA; 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. Despite the approval of YUTREPIA by the FDA, it is possible that commercialization of YUTREPIA may be blocked or delayed in connection with legal proceedings that have been initiated or that may in the future be initiated, or we may be required to pay damages, including royalties, in connection with our commercial launch, as a result of these legal proceedings. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would,' 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 SEC, 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 919.328.4350 Media: Patrick Wallace 919.328.4383 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-05-2025
- Business
- Yahoo
Gossamer Bio Announces First Quarter 2025 Financial Results and Provides Business Update, Including Closure of New Patient Screening in Phase 3 PROSERA Study
- Enrollment Completion for Ongoing Registrational PROSERA Phase 3 Study in PAH Expected in Early June; New Patient Screening Closed - - Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 - - To Date, Blinded Baseline Characteristics Align with Intended Study Population - - First Site Activations for Planned Registrational Phase 3 SERANATA Study in PH-ILD Expected in the Fourth Quarter of 2025 - - Cash, cash equivalents and marketable securities totaled $258 million as of March 31, 2025 - SAN DIEGO, May 15, 2025--(BUSINESS WIRE)--Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), today announced its financial results for the first quarter ended March 31, 2025, and announced the closure of new patient screening for the ongoing registrational Phase 3 PROSERA Study in PAH patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. "I am incredibly proud to announce that, following the recent closing of new patient screening, we are just weeks away from fully enrolling the PROSERA Phase 3 Study in PAH," said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer Bio. "This achievement is the result of our team's unwavering dedication, tireless effort, and steadfast commitment to our mission. We expect to publicly announce topline data from this pivotal study in February of 2026. Enrolling the appropriate patients for this study was of paramount importance, and the baseline characteristics of those who have been randomized to date demonstrate that our diligence and focus on study quality has paid off. This reinforces our optimism for meaningful results and brings us one step closer to the potential of having a new, first-in-class therapy for patients with PAH." Chief Medical Officer Dr. Richard Aranda added, "We are also delighted to unveil the clinical trial design for the Phase 3 SERANATA Study in PH-ILD, a landmark moment in our pursuit to address unmet patient need. A product of close collaboration and alignment with global regulatory authorities, including the FDA and EMA, this study represents a groundbreaking effort to offer new hope to patients with PH-ILD." Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor On May 14th, we closed new patient screening for the ongoing PROSERA Study in Functional Class II and III PAH patients. To date, 343 patients have been enrolled or are scheduled to randomize into the PROSERA Study. With the additional patients currently in screening, we expect to complete enrollment with over 350 PAH patients in early June. The Phase 3 PROSERA Study is a double-blind, placebo-controlled, global registrational clinical trial evaluating seralutinib in PAH patients, on top of background PAH therapy. Patients are assigned 1:1 to either the seralutinib or placebo arms. Patients receive blinded treatment for up to 48 weeks. The primary endpoint of the PROSERA Study is change in six-minute walk distance (6MWD) from baseline as compared to placebo at week 24. Included in the key secondary endpoints is time to clinical worsening, as compared to placebo, up to week 48. In addition to other secondary and exploratory endpoints, safety and tolerability will be evaluated. The patient population enrolled in PROSERA aligns with the target demographic, as evidenced by available baseline characteristics. The PROSERA Study utilizes enrichment criteria, including the REVEAL Lite 2 Risk Score and other criteria, to identify patients more likely to show a greater magnitude of effect on 6MWD at week 24, as informed by the Phase 2 TORREY study. Seralutinib Clinical Trial Baseline Characteristics: Phase 3 PROSERA Study* v. Phase 2 TORREY Study PROSERA Phase 3* TORREY Phase 2 Study Participants n = 324 (target: 350) n = 86 Mean 6MWD 376 meters 408 meters Mean NT-proBNP 986 ng/L 628 ng/L Functional Class III Patients 239 (74%) 36 (42%) Geographic Distribution North America: 61 (19%) Rest of World: 263 (81%) North America: 59 (69%) Rest of World: 27 (31%) *Characteristics shown are for the first 324 patients enrolled in the PROSERA Study, and all PROSERA Study percentages are out of 324. Given the patients scheduled to randomize and those still in screening, we expect to complete full enrollment in early June. Final baseline characteristics for the PROSERA Study are subject to change. We expect to announce topline results from the ongoing Phase 3 PROSERA Study in February 2026. We expect to activate clinical sites for the global, registrational Phase 3 SERANATA Study in PH-ILD patients in the fourth quarter of 2025. Achieved alignment on study design and endpoints with global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The planned SERANATA Study will be a 24-week, randomized, double-blind, placebo-controlled, global clinical trial in PH-ILD patients. Approximately 480 patients will be randomized 1:1:1 to receive either 90mg seralutinib twice-daily, 120mg seralutinib twice-daily or placebo. The primary endpoint of the SERANATA Study is change in 6MWD from baseline as compared to placebo at week 24. Key secondary endpoints will include time to clinical worsening and change from baseline in forced vital capacity (FVC). One poster related to seralutinib will be presented at the American Thoracic Society (ATS) 2025 International Conference, taking place from May 16th through 21st, in San Francisco, California. Poster Presentation Title: Seralutinib in Pulmonary Arterial Hypertension: Exploring Mechanisms of Reverse Remodeling Versus Vasodilation Poster Number: P920 Session: A76 Finger on the Pulse: Cardiopulmonary Dysfunction in Lung Disease Date: Sunday, May 18th Time: 11:30am – 1:15pm PDT Location: Area G, Hall F (North Building, Exhibition Level), Moscone Center Following its presentation at the ATS 2025 International Conference, the poster will also be made available on the "Posters & Publications" section of the Gossamer Bio website at Financial Results for Quarter Ended March 31, 2025 Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2025, were $257.9 million. We expect the combination of current cash, cash equivalents and marketable securities will be sufficient to fund our operating and capital expenditures into the first half of 2027. Revenue from Sale of Licenses and from Contracts with Collaborators: For the quarter ended March 31, 2025, revenue associated with our collaboration with Chiesi was $9.9 million, including $6.6 million of cost reimbursement revenue. Research and Development (R&D) Expenses: For the quarter ended March 31, 2025, R&D expenses were $38.0 million, compared to $32.4 million for the same period in 2024. General and Administrative (G&A) Expenses: For the quarter ended March 31, 2025, G&A expenses were $8.7 million, compared to $9.6 million for the same period in 2024. Net Loss: Net loss for the quarter ended March 31, 2025, was $36.6 million, or $0.16 basic net loss per share, compared to a net loss of $41.9 million, or $0.19 basic net loss per share, for the same period in 2024. Conference Call and Webcast Gossamer's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, May 15th, to discuss its first quarter 2025 financial results and business update. The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company's website at Alternatively, the conference call may be accessed through the following: Domestic Dial-in Number: (800) 285-6670International Dial-in Number: (713) 481-0091Live Webcast: A replay of the audio webcast will be available for 30 days on the "Investors" section of the Company's website, About Gossamer Bio Gossamer Bio is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension. Forward-Looking Statements Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing of enrollment completion and a data readout from our Phase 3 PROSERA Study; the potential or likelihood for a meaningful data readout from our PROSERA Study; the development potential of seralutinib; the anticipated timing on commencing a Phase 3 clinical trial in PH-ILD; and the expected timeframe for funding our operating plan with current cash, cash equivalents and marketable securities. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from unexpected events, including clinical trial delays; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer's clinical trials and preclinical studies for seralutinib; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of seralutinib that may limit its development, regulatory approval and/or commercialization, or may result in clinical holds, recalls or product liability claims; Gossamer's ability to obtain and maintain intellectual property protection for seralutinib; Gossamer's ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may adversely affect our business and financial condition and the broader economy and biotechnology industry; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Gossamer Bio Statement of Operations Condensed Consolidated Statement of Operations (in thousands, except share and per share amounts) (unaudited) Three months ended March 31, 2025 2024 Revenue: Revenue from contracts with collaborators $ 9,889 $ — Total revenue 9,889 — Operating expenses: Research and development 38,041 32,392 General and administrative 8,658 9,567 Total operating expenses 46,699 41,959 Loss from operations (36,810 ) (41,959 ) Other income (expense) Interest income 294 344 Interest expense (2,746 ) (3,129 ) Other income, net 2,624 2,816 Total other income, net 172 31 Net loss $ (36,638 ) $ (41,928 ) Net loss per share, basic and diluted $ (0.16 ) $ (0.19 ) Weighted average common shares outstanding, basic and diluted 226,818,051 225,735,236 Condensed Consolidated Balance Sheet (in thousands) BALANCE SHEET DATA: March 31, 2025 December 31, 2024 (unaudited) Cash, cash equivalents, and marketable securities $ 257,934 $ 294,518 Working capital 227,252 264,878 Total assets 280,589 315,292 Total liabilities 286,839 285,800 Accumulated deficit (1,305,206 ) (1,268,568 ) Total stockholders' equity (deficit) (6,250 ) 29,492 View source version on Contacts For Investors and Media: Bryan Giraudo, Chief Financial Officer & Chief Operating OfficerGossamer Bio Investor Relationsir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
