Gossamer Bio has announced a private placement agreement valued at up to $250m, including $150m of committed capital intended to support the development and potential US Food and Drug Administration (FDA) approval of seralutinib.
Seralutinib is intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The private investment comprises an initial closing, a subsequent closing contingent upon FDA acceptance of a new drug application (NDA) for seralutinib in PAH and warrants exercisable upon FDA approval.
The company plans to submit the NDA by September 2026. The proceeds will help advance seralutinib's clinical development and potential commercialisation, with net funds expected to sustain operations until 2028.
Gossamer recently regained global rights to seralutinib.
The financing involves key institutional investors, including EcoR1 Capital and RA Capital Management. The initial closing will raise approximately $25m through the sale of pre-funded warrants, priced at $0.14 per share minus a nominal exercise price.
A later closing will unlock a further $125m upon NDA acceptance. The terms stipulate that investors must fulfil this commitment if NDA acceptance occurs as planned. The purchase price for the second set of pre-funded warrants will follow the market's five-day volume-weighted average price, less their nominal exercise cost.
Gossamer Bio chairman, co-founder and CEO Faheem Hasnain said: “The committed funding structure aligns capital availability with key regulatory milestones and is expected to support the planned submission and review of our NDA.
“We appreciate the support of this group of leading healthcare investors as we work to bring a potentially important new treatment option to patients with PAH.”
Additionally, investors will receive warrants exercisable upon FDA approval. If these are fully exercised at $0.187 per share, Gossamer Bio could secure up to $100m more. The warrants will expire either 30 days after achieving the FDA approval milestone or five years from their issuance.
Leerink Partners and Cantor are serving as joint placement agents for this financing effort.
In May 2024, Gossamer Bio and Chiesi Farmaceutici (the Chiesi Group) announced a worldwide partnership and licence agreement to develop and market seralutinib for pulmonary hypertension.
