Spero reports Q2 2026 results, highlights Utebzi approval and Innovent license for SP001
Spero says FDA approval of Utebzi, a $105 million royalty financing, and an exclusive license for SP001 extend its cash runway into the second half of 2029.
Spero Therapeutics reported second quarter 2026 results and a business update on August 12, 2026. In July 2026, the company entered into an exclusive license agreement with Innovent Biologics, Inc. for SP001, gaining exclusive rights to develop, research, manufacture, and commercialize the drug worldwide, excluding Greater China, where Innovent retains rights.1 SP001 is a third-generation, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L, an upstream immune activation signal involved in T-cell, B-cell, antigen-presenting cell, and platelet biology.1 Innovent had already completed two healthy volunteer Phase 1 trials, a single ascending dose study and a multiple ascending dose study, as well as a Phase 1b MAD study in patients with primary Sjögren's disease.1 Spero said it plans to advance SP001 into a Phase 2 study in IgG4-related disease.1
On the regulatory side, in June 2026 Spero and GSK announced FDA approval of Utebzi (tebipenem pivoxil) for complicated urinary tract infections including pyelonephritis in adults with limited or no oral alternatives, making it the first and only oral carbapenem antibiotic approved for these patients.1 GSK is expected to make the product available to U.S. patients by the end of 2026, and holds commercialization rights in the U.S. and Europe.1
To fund SP001's advancement, Spero in July 2026 closed a non-recourse, non-dilutive royalty financing with affiliates of HealthCare Royalty Partners, a business of KKR, for $105 million in gross proceeds tied to a portion of anticipated Utebzi sales payments from GSK.1 The company also appointed Debra Jeske Zack, M.D., Ph.D., a board-certified rheumatologist with a Ph.D. in immunology and more than 25 years of leadership in immune-mediated disease therapeutics, as Chief Medical Officer in July 2026.1
As of June 30, 2026, cash and cash equivalents were $50.8 million, not reflecting the July 2026 royalty financing proceeds.1 The company said its cash together with the financing proceeds is expected to fund operations into the second half of 2029.1
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