Spero Therapeutics (SPRO) TD Cowen 45th Annual Healthcare Conference summary

Corporate overview and strategy

• Focuses on rare and multi-drug-resistant infectious diseases with a diversified mid to late-stage clinical portfolio.

• All assets have QIDP designation, with some also holding Orphan and Fast Track status.

• Strong IP position and financial runway into mid-2026, supported by pharma and government partnerships.

• Lead asset tebi HBr is in a global phase III trial for complicated urinary tract infections (cUTI), with enrollment completion targeted for the second half of the year.

• Additional assets include SPR-206 (phase II ready for hospital-acquired pneumonia) and SPR-720 (phase IIa for NTM-PD, currently paused for safety analysis).

Clinical development and pipeline progress

• Over 60% enrollment achieved in the tebi phase III trial in 2024, aiming for 2,650 patients globally.

• Tebi is positioned to be the first oral carbapenem for cUTI, addressing a high unmet need in patients resistant to current oral therapies.

• The phase III trial is a randomized, double-blind, non-inferiority study with a 10% margin, using imipenem-cilastatin as the IV comparator.

• SPR-206 development is contingent on securing non-dilutive funding, with NIAID as a key partner.

• SPR-720 oral program suspended due to dose-limiting toxicities; further data analysis and potential reformulation (e.g., inhaled) are under consideration.

Partnerships and financial outlook

• GSK partnership for tebi includes $200 million received to date, with up to $400 million in future milestones and tiered royalties.

• $47.5 million in committed milestones remain, with a $25 million milestone expected upon NDA submission by GSK at year-end.

• Meiji and Pfizer hold regional rights for other assets, and government collaborations provide non-dilutive capital.

• No further enrollment updates planned for tebi until completion; data expected in the second half of the year.

• Tebi label expansion into other indications possible, but future development beyond cUTI would be GSK's responsibility.