Company Description
Gossamer Bio, Inc. (NASDAQ: GOSS) is a late-stage, clinical biopharmaceutical company focused on the development and commercialization of seralutinib for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH‑ILD). According to the company’s public disclosures, its stated goal is to enhance the lives of patients living with pulmonary hypertension and to be an industry leader in this therapeutic area.
Gossamer Bio is part of the pharmaceutical preparation manufacturing industry within the broader manufacturing sector. The company is based in San Diego, California, and its common stock is listed on the Nasdaq Global Select Market under the ticker symbol GOSS. As a late-stage clinical organization, Gossamer Bio centers its efforts on advancing drug candidates through registrational clinical trials and preparing for potential commercialization, as reflected in its focus on global Phase 3 studies.
Core Therapeutic Focus: Pulmonary Hypertension
The company’s primary product candidate is seralutinib (GB002), described in Gossamer Bio’s communications as an inhaled inhibitor of PDGFR, CSF1R and c‑KIT. Seralutinib is being developed for two main indications:
- Pulmonary arterial hypertension (PAH): Gossamer Bio is conducting the PROSERA Phase 3 Study, a double‑blind, placebo‑controlled, global registrational clinical trial in WHO Functional Class II and III PAH patients. The trial evaluates seralutinib on top of background PAH therapy, with patients randomized between seralutinib and placebo.
- Pulmonary hypertension associated with interstitial lung disease (PH‑ILD): The company is also running the SERANATA Phase 3 Study, a randomized, double‑blind, placebo‑controlled global clinical trial in PH‑ILD patients. The design includes multiple seralutinib dose arms and a placebo arm.
In both Phase 3 programs, Gossamer Bio highlights the six‑minute walk distance (6MWD) as the primary endpoint, comparing change from baseline to placebo at a specified time point. Key secondary endpoints include measures such as time to clinical worsening and, in PH‑ILD, change from baseline in forced vital capacity (FVC). Safety and tolerability are also evaluated as part of these registrational studies.
Scientific and Clinical Evidence Base
Gossamer Bio and its collaborator, the Chiesi Group, have presented multiple seralutinib‑related datasets at scientific meetings, including the European Respiratory Society (ERS) Congress. According to company and partner summaries, these presentations have covered:
- Targeting fibrotic pathways in idiopathic pulmonary fibrosis (IPF) using single‑cell transcriptomics.
- In vitro reduction of vascular inflammatory drivers underlying pulmonary hypertension.
- Anti‑fibrotic effects in patient‑derived models.
- Changes in small pulmonary artery vessel volume and vessel wall remodeling assessed with AI‑driven CT imaging analysis.
- Reductions in endotrophin (PRO‑C6) production, a mediator of fibrosis and inflammation, in an in vitro pulmonary fibrosis model.
These scientific activities illustrate how Gossamer Bio positions seralutinib within pulmonary vascular disease and fibrotic lung biology, and they provide mechanistic and translational context for the ongoing Phase 3 clinical trials.
Pipeline Expansion: Inhaled Vardenafil (RT234)
Beyond seralutinib, Gossamer Bio has entered into an option agreement to acquire Respira Therapeutics, Inc. and its lead product candidate RT234, described as an investigational inhaled vardenafil dry‑powder therapy for pulmonary hypertension, including PAH and PH‑ILD. Public statements from Gossamer Bio and Respira indicate that RT234 is designed for as‑needed (PRN) use to provide rapid, on‑demand relief of exertional symptoms such as breathlessness, on top of chronic background therapies.
Gossamer Bio describes RT234 as potentially complementary to its existing pulmonary hypertension programs and consistent with a plan to build a pulmonary hypertension‑focused commercial enterprise. The option structure involves share issuances rather than upfront cash payments and is intended to allow continued development work on RT234’s chemistry, manufacturing and controls (CMC) and device readiness during the option period.
Collaboration and Corporate Structure
Gossamer Bio reports that it is jointly developing seralutinib with the Chiesi Group under a global collaboration agreement. This collaboration supports clinical development and scientific presentations across pulmonary hypertension and fibrotic lung disease. The company also uses equity‑based incentive plans, such as the 2019 Incentive Award Plan and a 2023 Employment Inducement Incentive Award Plan, to grant stock options to employees as part of its compensation and hiring practices, as reflected in multiple inducement grant announcements.
Corporate governance and compensation matters, including amendments to incentive plans and advisory votes on executive compensation, are documented through stockholder meetings and reported via SEC filings. These filings also describe the terms of the option agreement to acquire Respira Therapeutics, including share issuances and potential milestone‑based payments.
Regulatory and Public Company Reporting
As a Nasdaq‑listed issuer, Gossamer Bio files periodic and current reports with the U.S. Securities and Exchange Commission (SEC). Recent Form 8‑K filings have covered quarterly financial results, stockholder meeting outcomes, and the option agreement with Respira Therapeutics. Through these disclosures, the company provides information on its operating expenses, collaboration revenue, cash resources, and capital structure, as well as material corporate events.
Gossamer Bio characterizes itself as a late‑stage clinical company, emphasizing the progression of seralutinib through Phase 3 programs in PAH and PH‑ILD and its intention to transition toward commercialization if development is successful. Its focus on pulmonary hypertension, use of inhaled therapies, and combination of internal development with external collaboration and option‑based pipeline expansion define the core of its stated business strategy.