Gossesam organization announces financial results in the fourth quarter and the year in 2024 and offers business updates

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– Registration Phase 3 in PH -GLD is expected to start in the second half of 2025 – –

– Seralutinib receives a pampering drug name for PAH in Japan –

– Cash, cash equivalents and marketable securities amounted to $ 295 million at the end of 2024 –

San Diego- (Business Wire)-$ Goss–Gossamer organic, Inc. (NASDAQ: GOSD), a clinical biopharmaceutical company in the late stage that focuses on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension in connection with interstitial-letters (pH-GLT).

“While we close the book over 2024 and included the promise of 2025, I am both humble and remarkable advances that gossamer has made in his mission to improve the life of pulmonary high blood pressure patients,” said Faheem Hasnain, chairman, co -founder and CEO of gossam organic organic.

“Rationally developed in order to aim at paths of abnormal cellular proliferation, inflammation and fibrosis with pulmonary hypertension, we believe that seralutinib, which is currently being examined in the registration prossera study in PAH, has the potential to form the treatment paradigm.”

“Our confidence in Seralutinib is that in the second half of this year we activate clinical bodies in the second half of this year for our second state phase 3 study at PH-Glinden. And beyond PAH and PH-Bild, there is additional indications of a high, uncovered need that we believe that seralutinib has the potential to improve the life of patients. Despite the possibilities that are in front of Seralutinib, the Gossesam team continues to focus on the execution of the Prosera study to ensure the topline results by the end of the year. ”

Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-kit inhibitor

• Registration will take place in the ProSersa study, a global clinical study of registration phase 3 in patients with WHO functional classes II and III PAH. The primary endpoint is the change in the six-minute span (6 MWD) compared to the starting value in week 24. Topline results of the ProSera study are expected in the fourth quarter of 2025.
• We assume that we will activate clinical bodies for a registrative phase-3-pH-GLD-Clinical study in the second half of 2025. The planned phase 3 study will be a randomized, double-blind, placebo-controlled, global clinical study in pH body patients.
• On January 31, the Japanese Ministry of Health, Work and Welfare (MHLW) granted a seralutinib orphan medication for the treatment of PAH. Previously, the Japan (PMDA) of the pharmaceutical and medical devices enabled the current phase -3 professional study to the inclusion of Japanese clinical studies. Subject to the final clinical study results, Prosera could form the basis for a marketing application in Japan.
• An oral presentation and three posters related to seralutinib were presented at the annual congress of Pulmonal Vascular Research Institute (PVRI) in 2025, which took place on January 29 to February 1st in Rio de Janeiro. The posters linked below:
  • Preclinical models support the synergistic potential of seralutinib and sotatercept in the treatment of pulmonary arterial hypertension | Link:
  • Sustainable benefits with seralutinib treatment: a post-hoc analysis of the open label extension of Torrey | Link:
  • Persistent effect of seralutinib on circulating biomarkers in the Torrey Phase 2 Open label extension study | Link:

Financial results for quarter and overall year ended on December 31, 2024

• Cash, cash equivalents and marketable securities: Cash, cash equivalent and marketable securities as of December 31, 2024, $ 294.5 million. As a result, we expect our current cash, cash equivalents and marketable securities to be sufficient to finance the operating and investment expenditure in the first half of 2027.
• Research and development costs (F&E): For the quarter that ended on December 31, 2024, the F&E expenditure was $ 36.1 million compared to F&E costs of $ 30.0 million for the same period in 2023. Million USD.
• General and administrative (G&A) expenses: For the quarter ending on December 31, 2024, G&A expenditure was $ 9.1 million compared to $ 9.1 million in 2023.
• Net: The net loss for the three months on December 31, 2024 was $ 33.0 million or $ 0.15 per share compared to a net loss of $ 48.1 million or 0.21 USD per share for the same period of 2023. $ 0.25 for the share of $ 0.25 or a share of $ 0.25 for a share of $ 0.25. 31, 2023.

About Gossamer Bio

Gossesam organic is a clinical biopharmaceutical company in the late stage that focuses on the development and marketing of seralutinib for the treatment of pulmonary arterial hypertension and pulmonary hypertension in connection with interstitial lung diseases. His goal is to be the industry leader in lung high pressure and to improve the life of patients.

Predicted statements

Gossamer warns her that statements contained in this press release, in relation to matters that are not historical facts, are future -oriented statements. These statements are based on the current beliefs and expectations of the company. These future-oriented statements include statements: the expected time of a data takeover from our phase-3-prospera study; the development and market potential of seralutinib; the expected time at the beginning of a clinical phase 3 study in the PH-Gld; Expectations of the development of seralutinib for additional indications; the ability to set a commercial marketing application in Japan until clinical data; And the expected time frame for the financing of our company plan with ongoing cash, cash equivalents and marketable securities. The inclusion of future -oriented statements should not be seen as a representation of gossamer that one of his plans is achieved. The actual results can differ from the risks and uncertainties given in this press release that are inherent in the business of gossamer, including, without restriction: possible delays at the beginning, enrollment and conclusion of clinical studies; Disruption of our operations through unexpected events, including delays in clinical studies; the dependence of the company on third parties in connection with product production, research as well as preclinical and clinical tests; The results of preclinical studies and early clinical studies will not necessarily predict future results. The success of Gosamer's clinical studies and preclinical studies for seralutinib; regulatory developments in the USA and abroad; Unexpected adverse side effects or insufficient effectiveness of seralutinib, which can limit its development, regulatory approval and/or marketing or lead to clinical attitudes, recall or product liability claims; Gossamer's ability to maintain and maintain the protection of intellectual property for seralutinib; Gosamer's ability to comply with his obligations in collaboration agreements with third parties or the agreements according to which IT rights licensed by third parties; Unstable market and economic conditions as well as negative developments in relation to financial institutions and the associated liquidity risk can have a disadvantage on our business and financial situation as well as the broader economic and biotechnology industry. Gossamer can use his capital resources earlier than expected. And other risks described in the company's earlier press releases and the submissions of the company at the Securities and Exchange Commission (SEC), including the heading “Risk Factors” in the company's annual report on form 10-K and subsequent submissions at Sec. You are pointed out that you do not rely on these future -oriented statements that only speak here on the date, and gossamer assumes no obligation to update such statements in order to reflect events or circumstances that exist on the date. All future -oriented statements are qualified in this warning decision, which is made according to the provisions of the Safe Harbor of the Reform Act for private securities from 1995.

Contacts

For investors and media:
Bryan Giraudo, Chief Financial Officer and Chief Operating Officer
Gossam Bio Investor Relations
ir@gossamerbio.com