Spero Therapeutics Provides Business Update and Announces Interim Leadership Changes

Tebipenem HBr Development - Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), with the potential to reduce hospitalizations or shorten in-patient therapy [1] - The Phase 3 PIVOT-PO trial for Tebipenem HBr, a global randomized, double-blind study comparing its efficacy with intravenous imipenem cilastatin, began enrolling patients in January 2024 and aims to enroll approximately 2,648 participants, with full enrollment expected by the second half of 2025 [5][14] - As of December 31, 2024, over 60% of the enrollment target for the PIVOT-PO trial has been achieved [14] SPR720 and SPR206 Programs - SPR720 is an oral prodrug converted to SPR719, targeting the ATPase site of DNA gyrase B in mycobacteria, offering a distinct mechanism for treating Non-Tuberculous Mycobacterial-Pulmonary Disease (NTM-PD) [2] - A Phase 2a proof-of-concept trial for SPR720 concluded enrollment in July 2024 with 25 patients, but interim analysis indicated it did not meet its primary endpoint, and safety data highlighted potential dose-limiting issues [14] - SPR206, an investigational intravenous polymyxin, has shown activity against multidrug-resistant (MDR) Gram-negative pathogens and received FDA clearance for a Phase 2 trial in hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), contingent on non-dilutive funding [8] Leadership and Corporate Updates - Esther Rajavelu was appointed Interim President and CEO, and Frank Thomas was named Chairman of the Board, following leadership changes in response to a Wells Notice from the SEC related to 2022 disclosures [9][10] - The company maintains that its disclosures were appropriate and is cooperating with the SEC, intending to vigorously defend against the matter [4][10] - The Board expressed confidence in the interim leadership and the company's strategy to advance its pipeline, including the Tebipenem HBr program [7] Financial and Operational Guidance - As of December 31, 2024, the company had $52.9 million in cash and cash equivalents, with a cash runway extending into mid-2026, supported by non-dilutive funding commitments and milestone payments from GSK [13] - The company remains focused on advancing its Tebipenem HBr clinical program and other ongoing activities, leveraging its financial resources to maintain operational momentum [7][13] Research and Development Support - Select studies for Tebipenem HBr and SPR206 have received funding from federal agencies, including the Department of Health and Human Services and the Department of Defense, highlighting the strategic importance of these programs [6][16][22]