Gossamer Bio secures US$250M to advance seralutinib toward FDA review
Seralutinib is an investigational treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
GERMANY— Gossamer Bio has entered into a private placement agreement to raise up to US$250 million, including US$150 million in committed capital, to support the development and potential US Food and Drug Administration (FDA) approval of seralutinib.
Seralutinib is an investigational treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The company plans to use proceeds from the financing to fund the drug’s clinical development, regulatory activities, and potential commercialization.
Funding linked to regulatory milestones
The financing will take place in stages. An initial closing is expected to generate approximately US$25 million through the sale of pre-funded warrants at US$0.14 per share, less a nominal exercise price.
A second closing could provide another US$125 million if the FDA accepts Gossamer Bio’s new drug application (NDA) for seralutinib in PAH.
Under the agreement, participating investors will be required to complete the additional investment if the FDA accepts the NDA as anticipated.
The purchase price for the second tranche of pre-funded warrants will be based on the company’s five-day volume-weighted average share price, less the nominal exercise price. Gossamer Bio expects to submit the NDA by September 2026.
The company said the net proceeds from the financing are expected to provide sufficient funding to support operations through 2028, while advancing seralutinib towards potential regulatory approval and commercialisation.
Additional financing through warrants
In addition to the committed investment, participating investors will receive warrants that become exercisable upon FDA approval of seralutinib.
If investors fully exercise these warrants at US$0.187 per share, Gossamer Bio could receive up to a further US$100 million.
The warrants will expire 30 days after the FDA approval milestone is achieved or five years after their issuance, whichever terms apply under the agreement.
Gossamer Bio chairman, co-founder and chief executive officer Faheem Hasnain said the financing structure links the company’s access to capital with key regulatory milestones and will support the planned NDA submission and review.
“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,” Hasnain said.
Institutional investor support
The private placement includes institutional investors such as EcoR1 Capital and RA Capital Management. Leerink Partners and Cantor are acting as joint placement agents for the transaction.
The financing follows Gossamer Bio’s recent reacquisition of global rights to seralutinib, strengthening the company’s control over the programme as it advances towards regulatory submission.
In May 2024, Gossamer Bio and Chiesi Farmaceutici, part of the Chiesi Group, announced a worldwide partnership and licence agreement to develop and commercialise seralutinib for pulmonary hypertension.
The agreement formed part of efforts to advance the investigational therapy for patients with serious pulmonary vascular diseases.
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