Gossamer Bio to Present Clinical and Preclinical Data at the Pulmonary Vascular Research Institute 2025 Annual Congress

Rhea-AI Summary

Gossamer Bio (NASDAQ: GOSS) announced presentations of clinical and preclinical data for seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress in Rio de Janeiro. The company will showcase one oral and three poster presentations highlighting seralutinib's potential in treating pulmonary arterial hypertension (PAH).

Key highlights include preclinical evidence demonstrating synergistic effects when combining seralutinib with sotatercept, a recently approved PAH therapy. The company's ongoing global Phase 3 PROSERA Study allows for patient enrollment on stable sotatercept background treatment and permits other enrolled patients to add sotatercept after 24 weeks where approved.

The presentations will feature data from preclinical models, post-hoc analysis of the TORREY open-label extension, and sustained effects on circulating biomarkers, building upon positive Phase 2 TORREY Study results where most patients were on triple background PAH therapy.

Positive

• Preclinical data shows synergistic treatment effects when combining seralutinib with approved PAH therapy sotatercept
• Phase 3 PROSERA study design allows for first-in-human combination experience with sotatercept
• Positive Phase 2 TORREY Study results demonstrated efficacy in patients on triple background therapy

Negative

• None.

- Gossamer to Present Preclinical Evidence of Synergistic Treatment Effect from Combination Seralutinib & Sotatercept in Models of PAH -

SAN DIEGO--(BUSINESS WIRE)-- Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage 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 one oral and three poster presentations related to seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress taking place January 29^th through February 1^st in Rio de Janeiro, Brazil.

“Gossamer is committed to generating and presenting data that reflect the rapidly evolving pulmonary hypertension treatment landscape to best address the needs of patients. To that end, we are immensely proud to be able to present data from preclinical models that provide evidence of a synergistic treatment effect from the combination of seralutinib and sotatercept, a recently approved therapy for the treatment of PAH,” said Faheem Hasnain, Co-Founder, CEO, and Chairman of Gossamer Bio.

“These data underscore seralutinib’s potential to transform the PAH treatment paradigm, if approved, and they highlight the potential promise of these complementary mechanisms of action when utilized in combination. PAH is a progressive disease in which polypharmacy is the standard of care, and these preclinical results further build upon the positive PAH patient data generated in the Phase 2 TORREY Study, in which a majority of patients were on triple background PAH therapy.”

“Furthermore, our ongoing global registrational Phase 3 PROSERA Study in PAH allows for the enrollment of a small number of patients on stable background treatment with sotatercept, provided they meet study entry criteria. All other patients who are enrolled in PROSERA may add sotatercept after 24 weeks, where approved and as appropriate. These study design elements will provide a limited, first-in-human combination experience with seralutinib and sotatercept, and importantly, they have been welcomed by patients and investigators, alike,” added Mr. Hasnain.

Presentations related to Seralutinib, an Inhaled PDGFR, CSF1R and c-KIT Inhibitor:

Preclinical Models Support the Synergistic Potential of Seralutinib and Sotatercept in Treating Pulmonary Arterial Hypertension

Oral presentation
Session: Risk stratification & treatment in the new era of PH therapeutics
Date: Thursday, January 30^th
Time: 3:07pm – 3:15pm BRT
Location: Windsor Oceanico, Asia, 3^rd floor
Presenter: Ravikumar Sitapara, MS, PhD

Poster presentation
Date: Friday, January 31^st
Time: 4:30pm – 6:00pm BRT
Location: Windsor Oceanico, Asia, 3^rd floor

Sustained Benefit with Seralutinib Treatment: A Post-Hoc Analysis of the TORREY Open-Label Extension

Poster presentation
Date: Friday, January 31^st
Time: 4:30pm – 6:00pm BRT
Location: Windsor Oceanico, Asia, 3^rd floor

Sustained Effect of Seralutinib on Circulating Biomarkers in the TORREY Phase 2 Open-Label Extension Study

Poster presentation
Date: Friday, January 31^st
Time: 4:30pm – 6:00pm BRT
Location: Windsor Oceanico, Asia, 3^rd floor

About Gossamer Bio

Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. 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 ability to generate relevant seralutinib clinical data for the evolving PAH treatment landscape and the development and market potential of seralutinib. 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 a pandemic, 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, including Chiesi, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250128621305/en/

For Investors and Media:

Bryan Giraudo, Chief Operating Officer and Chief Financial Officer

Gossamer Bio Investor Relations

ir@gossamerbio.com

Source: Gossamer Bio, Inc.

FAQ

What are the key findings of Gossamer Bio's (GOSS) seralutinib preclinical studies?

The preclinical studies demonstrated synergistic treatment effects when combining seralutinib with sotatercept in PAH models, suggesting potential enhanced efficacy in treating pulmonary arterial hypertension.

How is Gossamer Bio (GOSS) structuring the Phase 3 PROSERA trial for seralutinib?

The PROSERA trial allows for enrollment of patients on stable sotatercept background treatment, with other enrolled patients permitted to add sotatercept after 24 weeks where approved.

What were the results from Gossamer Bio's (GOSS) Phase 2 TORREY Study?

The Phase 2 TORREY Study showed positive results with seralutinib, particularly in patients on triple background PAH therapy, demonstrating sustained benefits in the open-label extension.

What presentations will Gossamer Bio (GOSS) deliver at PVRI 2025?

Gossamer Bio will present one oral and three poster presentations at PVRI 2025, covering preclinical evidence, TORREY Study post-hoc analysis, and biomarker data for seralutinib.