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Gossamer Bio (GOSS)

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Earnings summaries and quarterly performance for Gossamer Bio.

Recent press releases and 8-K filings for GOSS.

Gossamer Provides Update on Seralutinib Phase 3 Data, Commercial Strategy, and Pipeline Expansion
GOSS
Guidance Update
New Projects/Investments
Product Launch
  • Gossamer anticipates top-line results from the Prosera Phase 3 study for seralutinib in February 2026, with an expected 20-25 meter increase in six-minute walk distance. The last patient, last visit for this study is expected by the end of November 2025.
  • Regulatory approval and launch of seralutinib are projected for the late second quarter of 2027, positioning it as the first third-line agent in PAH.
  • The company has initiated the Seronata PH-ILD study, with the first patient expected to enroll before the end of 2025, and views PH-ILD as a multi-billion dollar revenue opportunity.
  • Gossamer's cash runway extends until May 2027, which is sufficient to cover the Prosera readout and the launch of the PH-ILD study.
Nov 11, 2025, 3:00 PM
Gossamer Provides Update on Saralutinib Phase III Data Readout, PHILD Expansion, and Pipeline Development
GOSS
New Projects/Investments
Guidance Update
Product Launch
  • Gossamer expects top-line results from its Phase III PROCERRA study for saralutinib in pulmonary arterial hypertension (PAH) in February 2025, guiding for a 20 to 25 meter increase in six-minute walk distance. Regulatory approval and launch are anticipated in 2027.
  • The company has initiated a Phase III Serenata study for saralutinib in pulmonary hypertension associated with interstitial lung disease (PHILD), a market with twice the patient population of PAH and limited competition, with first patient enrollment expected by year-end. Gossamer estimates saralutinib could be a $2.0-2.5 billion revenue opportunity in PAH globally, with PHILD potentially being a multiple of that.
  • Gossamer has secured an option to acquire an inhaled version of Vardenafil for PRN use in PAH and PHILD, which could generate $500-750 million in annual revenue in the US alone.
  • The company's cash runway extends until May 2027, providing sufficient capital to achieve the PROCERRA readout and advance the PHILD study.
Nov 11, 2025, 3:00 PM
Gossamer Bio Announces Q3 2025 Financial Results and Business Updates
GOSS
Earnings
Guidance Update
New Projects/Investments
  • Gossamer Bio reported a net loss of $48.2 million, or $0.21 basic net loss per share, for the third quarter ended September 30, 2025.
  • As of September 30, 2025, the company held $180.2 million in cash, cash equivalents, and marketable securities, which is expected to fund operating and capital expenditures into 2027.
  • Topline results from the Phase 3 PROSERA Study for seralutinib in pulmonary arterial hypertension (PAH) are anticipated in February 2026.
  • The first clinical site was activated for the registrational Phase 3 SERANATA Study in pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Nov 5, 2025, 10:23 PM
Gossamer Bio Announces Q3 2025 Financial Results and Business Updates
GOSS
Earnings
New Projects/Investments
Guidance Update
  • Gossamer Bio reported a net loss of $48.2 million (or $0.21 basic net loss per share) for the third quarter ended September 30, 2025.
  • As of September 30, 2025, the company held $180.2 million in cash, cash equivalents, and marketable securities, which is expected to fund operating and capital expenditures into 2027.
  • The company anticipates announcing topline results from the PROSERA Phase 3 Study for pulmonary arterial hypertension (PAH) in February 2026.
  • The first clinical site for the global, registrational Phase 3 SERANATA Study in pulmonary hypertension associated with interstitial lung disease (PH-ILD) was activated in the fourth quarter of 2025.
  • Gossamer Bio entered a strategic option agreement on September 24th to acquire Respira Therapeutics Inc., with the option exercise involving 1.5 million shares of Gossamer Bio common stock.
Nov 5, 2025, 9:01 PM
Gossamer Bio Updates on Seralutinib Clinical Trials and Market Expansion; Regen BioPharma Nears Phase 1 Funding
GOSS
New Projects/Investments
Guidance Update
  • Gossamer Bio (GOSS) anticipates top-line data from the ProSera phase 3 study for seralutinib in pulmonary arterial hypertension (PAH) in February of next year (2026).
  • Gossamer Bio also plans to commence a phase 3 study for seralutinib in pulmonary hypertension associated with interstitial lung disease (PAH-ILD) by the end of this year (2025), targeting a market potentially two to three times larger than the $7 billion PAH market.
  • Regen BioPharma, Inc. (RGBP) has raised approximately $95,000 through a Reg A offering, approaching its $105,000 goal to initiate clinical phase 1.
  • Regen BioPharma anticipates an FDA response within 90 days regarding its orphan drug status application.
Oct 23, 2025, 7:40 PM
Gossamer Bio Awaits Seralutinib Phase 3 Readout; Regen BioPharma Nears Phase 1 Funding
GOSS
New Projects/Investments
Guidance Update
  • Gossamer Bio (GOSS) anticipates the Phase 3 readout for its PROSERA study of seralutinib in pulmonary arterial hypertension (PAH) in February of next year. The company expects this to be a significant catalyst for becoming a market leader in the $7 billion PAH marketplace.
  • GOSS plans to commence a Phase 3 study for seralutinib in pulmonary hypertension associated with interstitial lung disease (PH-ILD) by the end of this year, targeting a market two to three times larger than the PAH market with limited competition. The company also highlighted seralutinib's best-in-class safety profile as a key differentiator and potential reimbursement advantage.
  • Regen BioPharma Inc (RGBP) has raised approximately $95,000 through a Reg A offering, nearing its $105,000 goal to initiate clinical Phase 1 for HemaAccelerate. The company is also awaiting a response from the FDA within 90 days regarding its Orphan Drug status application.
Oct 23, 2025, 7:40 PM
Gossamer Bio Enters Option Agreement to Acquire Respira Therapeutics
GOSS
M&A
New Projects/Investments
  • Gossamer Bio has entered into an option agreement to acquire Respira Therapeutics, including its lead product candidate RT234, an investigational inhaled dry-powder therapy designed for on-demand treatment of pulmonary hypertension.
  • The deal includes an initial issuance of 2.5 million shares of Gossamer common stock upon signing, with an additional 1.5 million shares upon exercising the acquisition option, along with milestone payments and high single-digit royalties on potential net sales of RT234.
  • During an anticipated two-year option period, Gossamer will fund specific development activities to advance RT234's readiness for clinical trials.
  • This acquisition is expected to expand Gossamer’s pulmonary hypertension portfolio, complementing its existing product Seralutinib, despite Gossamer’s current financial challenges including negative margins.
Sep 25, 2025, 1:30 PM
Gossamer Bio Enters Agreement for Option to Acquire Respira Therapeutics
GOSS
M&A
New Projects/Investments
Takeover Bid
  • Gossamer Bio has entered into an agreement with Respira Therapeutics, Inc., granting Gossamer an option to acquire the company.
  • The transaction is designed to accelerate the development of RT234, an investigational first-in-class, as-needed treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • In connection with the signing, Gossamer is issuing 2.5 million shares of common stock, and will issue an additional 1.5 million shares upon exercise of the acquisition option.
  • The acquisition agreement also provides for success-based clinical, regulatory, and commercial milestone payments, and a royalty on potential net sales of RT234.
Sep 25, 2025, 11:41 AM
Gossamer Bio Prepares for Seralutinib Commercialization and Key Data Readouts
GOSS
Product Launch
New Projects/Investments
  • Gossamer Bio is transitioning into a commercialization company, preparing for the launch of seralutinib for Pulmonary Arterial Hypertension (PAH) in the first half of 2027, with commercial approval anticipated between March and May 2027.
  • The company expects a significant Phase 3 data readout for the ProSera study of seralutinib in PAH in February 2026, targeting a clinically meaningful 20 to 25 meter improvement in the six-minute walk test.
  • Gossamer Bio plans to deploy approximately 60 sales representatives for the U.S. launch of seralutinib, with the company booking sales domestically and receiving mid to high teens royalties from ex-U.S. sales by a partner.
  • A second Phase 3 study, Serenata, for seralutinib in PH-ILD is expected to enroll its first patient by the end of 2025, leveraging significant operational synergies with the ProSera study, including 60% site overlap.
Sep 3, 2025, 2:22 PM