- GSK Plc GSK has entered into an exclusive license agreement for Spero Therapeutics Inc's SPRO late-stage antibiotic asset, tebipenem HBr.
- Tebipenem HBr is being developed as the first oral carbapenem antibiotic for complicated urinary tract infections (cUTI).
- Spero expects to start a new phase 3 trial in 2023, following encouraging FDA regulatory feedback on the proposed trial design.
- Spero received an FDA Complete Response Letter in June 2022, citing data from Spero's initial Phase 3 cUTI trial, ADAPT-PO, which were insufficient to support approval.
- GSK will receive exclusive rights to the antibiotic in all territories except Japan and certain other Asian countries, which Spero partner, Meiji Seika, will retain.
- Spero will be responsible for the execution and costs of the follow-up Phase 3 trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional development, including Phase 3 regulatory filing and commercialization activities.
- Spero will receive an upfront payment of $66 million and milestone payments of $225 million.
- GSK has also agreed to take an equity stake in Spero, purchasing 7.45 million shares at approximately $1.20805 per share, not to exceed 19.99% ownership of Spero by GSK.
- As of June 30, Spero had a cash balance of $45.4 million. The company believes its current cash runway will be sufficient to fund it beyond 2024.
- Price Action: SPRO shares are up 154.30% at $2.09 during the premarket session on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Posted In: BiotechLarge CapNewsPenny StocksHealth CareFinancingContractsPre-Market OutlookMoversTrading IdeasGeneralBriefswhy it's moving
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in