Spero Therapeutics Provides Corporate Update and 2024 Outlook

In 2H 2024, expect to provide Phase 2a topline proof-of-concept data from our wholly-owned lead program SPR720 in NTM-PD patients

Initiated dosing in PIVOT-PO Phase 3 trial for tebipenem HBr in cUTI patients. Entitled to receive $95 million in development milestones, payable over two years, as part of the GSK license agreement

Updated preliminary cash balance and cash runway guidance into late 2025

CAMBRIDGE, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset, clinical-stage, biopharmaceutical company, focused on identifying and developing novel therapies for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need, today provided a corporate update highlighting its recent accomplishments and anticipated milestones for 2024.

“We look forward to another productive year for Spero in 2024, having achieved important clinical and regulatory milestones over the past twelve months,” said Sath Shukla, President, and CEO of Spero Therapeutics. "We are very pleased to move forward with the PIVOT-PO clinical trial, evaluating tebipenem HBr in complicated urinary tract infections, as we recently began dosing patients. Our Phase 2a trial of SPR720 in nontuberculous mycobacterial pulmonary disease is on track, and we look forward to reporting topline data, which is expected in the second half of 2024. Additionally, we ended 2023 with a strong cash balance, and believe our cash and cash equivalents, together with milestone payments from our tebipenem HBr commercial partner, GSK, will provide runway into late 2025.”

2023 Pipeline Updates and 2024 Anticipated Milestones

SPR720 for Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)

• In 2H 2024, the company expects to share topline data from the ongoing Phase 2a clinical trial of SPR720, which is being developed as a novel first-line oral treatment for non-tuberculous mycobacterial pulmonary disease (NTM-PD).
• The trial is expected to enroll up to 35 treatment-naïve or treatment-experienced non-refractory participants with NTM-PD, due to Mycobacterium avium complex. For more information on the trial, see ClinicalTrials.gov identifier NCT05496374.

Tebipenem HBr for complicated urinary tract infections (cUTI), including acute pyelonephritis (AP)