SAN DIEGO, Calif. & PARMA, Italy - Gossamer Bio, Inc. (NASDAQ:GOSS), a clinical-stage biopharmaceutical company, and Chiesi Farmaceutici S.p.A, a research-focused biopharmaceutical group, have announced a global collaboration for the development and commercialization of seralutinib, a treatment for pulmonary hypertension (PH). Under the agreement, Gossamer will receive a $160 million development reimbursement from Chiesi and could receive up to $146 million in regulatory milestones and $180 million in sales milestones.
The partnership is designed to leverage the strengths of both companies to promote seralutinib as a potential treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Gossamer will lead the US commercialization activities for PAH and PH-ILD and will book sales in the US. The two companies will share commercial profits and development costs in the US equally. Chiesi will have exclusive rights to commercialize seralutinib outside the US and will pay Gossamer mid-to-high teens royalties on net sales.
A Phase 3 trial of seralutinib in PH-ILD is planned to begin in mid-2025. This study follows the positive results from the Phase 2 TORREY Study in PAH patients and the initiation of the Phase 3 PROSERA Study in 2023. Seralutinib is an inhaled therapy designed to be delivered via dry powder inhaler and is an inhibitor of PDGFRα/β, CSF1R, and c-KIT.
The collaboration is expected to expand the reach of seralutinib to patients worldwide, addressing high unmet medical needs in the treatment of PH. PAH affects an estimated 30,000 to 50,000 people in the US, with similar prevalence in Europe, while PH-ILD is estimated to affect approximately 60,000-100,000 patients in the US.
Chiesi, with its expertise in global respiratory and rare disease drug development, and Gossamer, with its specialized PAH and PH-ILD development teams, aim to accelerate the development of seralutinib. The companies are committed to innovation in healthcare and improving patient outcomes in the pulmonary hypertension space.
The information in this article is based on a press release statement from Gossamer Bio, Inc.
InvestingPro Insights
In light of the recent collaboration between Gossamer Bio, Inc. (NASDAQ:GOSS) and Chiesi Farmaceutici, investors are closely monitoring the financial health and market performance of Gossamer. According to InvestingPro data, Gossamer Bio holds a market capitalization of $167.4 million. The company's stock price has experienced significant volatility, with a 6.28% increase over the past week, but a notable decline of 28.16% over the past month. Year-to-date, the stock has decreased by 18.9%.
InvestingPro Tips for Gossamer Bio suggest a mixed financial landscape. The company is noted for holding more cash than debt, which could provide financial flexibility in pursuing its development strategies. Additionally, two analysts have revised their earnings upwards for the upcoming period, possibly indicating a positive outlook on the company's revenue potential. However, it's important to note that analysts do not expect the company to be profitable this year, and it has been rapidly burning through cash. Gossamer Bio has not been profitable over the last twelve months, which could be a concern for investors looking for immediate returns.
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