Spero Therapeutics (SPRO) Corporate Presentation summary

Strategic focus and pipeline overview

• Developing therapies for rare and multi-drug resistant infectious diseases, with a focus on complicated urinary tract infections (CUTI) and non-tuberculous mycobacterial pulmonary disease (NTM-PD).

• Tebipenem HBr positioned as the first and only oral carbapenem for CUTI, with Phase 3 trial stopped early for efficacy and regulatory submission expected in 2H 2025.

• GSK partnership provides global commercial rights (ex-Asia) and strong financial terms, including milestones and royalties.

• SPR720 development for NTM-PD suspended pending further data analysis.

• Strong intellectual property portfolio and financial foundation support ongoing development.

Tebipenem HBr clinical and commercial highlights

• Phase 3 PIVOT-PO trial met primary endpoint, demonstrating non-inferiority to IV imipenem-cilastatin in CUTI, including pyelonephritis.

• No new safety concerns identified; robust safety and efficacy profile supported by over 2,000 subjects in clinical trials and post-marketing surveillance in Japan.

• Tebipenem HBr shows potent in vitro activity against multidrug-resistant Gram-negative pathogens, including ESBL and fluoroquinolone-resistant Enterobacterales.

• Orally bioavailable prodrug with rapid conversion, dose-proportional pharmacokinetics, and low drug-drug interaction potential.

• QIDP and orphan drug designations, with IP protection through 2041.

Market opportunity and competitive landscape

• Approximately 2.9 million annual CUTI treatment episodes in the US, with over $6 billion in healthcare costs.

• Lack of effective oral options leads to increased hospitalizations and healthcare burden.

• Tebipenem HBr is the most advanced oral candidate for CUTI, with competitors in earlier development stages.

• GSK collaboration includes $66M upfront, $9M equity, $30M upon SPA, and up to $400M in additional milestones plus tiered royalties.

• Additional $25M milestone upon NDA submission and up to $225M in sales-related milestones.