- Seralutinib demonstrated a placebo-adjusted improvement in Six-Minute Walk Distance (6MWD) of +13.3 meters at Week 24 (p = 0.0320), missing the prespecified alpha threshold of 0.025 -

- At week 24, patients receiving seralutinib had a median change of +28.2 meters from baseline, while patients receiving placebo had a median change from baseline of +13.5 meters -

- Consistent with the TORREY Study, prespecified intermediate and high-risk subgroup (n = 234) showed a +20.0 meter placebo-adjusted 6MWD improvement (p = 0.0207), with 3 of 4 key secondary endpoints achieving p < 0.0125 -

- Overall treatment effect was most pronounced in North America (n = 75), with a +25.9m placebo-adjusted improvement in 6MWD (p = 0.0573) -

- Generally well tolerated - safety consistent with prior experience -

- Gossamer plans to meet with the U.S. FDA to discuss the path forward -

- Gossamer to host a conference call today, Monday, February 23rd at 8:30am EST -

Gossamer Bio, Inc. (NASDAQ:GOSS) a 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 topline results for the PROSERA Phase 3 Study of seralutinib in patients with PAH. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement.

At Week 24, patients receiving seralutinib had a median change of +28.2 meters in 6MWD from baseline, while patients receiving placebo had a median change from baseline in 6MWD of +13.5 meters. The estimated Hodges‑Lehmann treatment effect was +13.3 meters, with a p‑value of 0.0320, which did not meet the prespecified threshold on the primary endpoint (α = 0.025); therefore, p‑values for the key secondary endpoints cannot be evaluated for statistical significance. All p‑values herein are nominal. All four key secondary endpoints favored seralutinib versus placebo in the overall population.

Consistent with the Phase 2 TORREY Study, seralutinib delivered a compelling signal in the prespecified intermediate‑ and high‑risk subgroup (n = 234), as defined by the REVEAL 2 Lite Risk Score ≥ 6 at screening, with a +20.0m placebo‑adjusted improvement in 6MWD (p = 0.0207). Three of four key secondary endpoints also demonstrated a p-value below 0.0125, underscoring seralutinib's activity in patients with higher risk.

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