Spero Therapeutics Stock More Than Doubles On GSK Pact For Its Lead Antibiotic

  • 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.
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