Spero Therapeutics Inc

Spero Therapeutics reported a net loss of $9.6 million for the second quarter of 2026, compared to a net loss of $1.7 million in the same period last year, while highlighting the FDA approval of its antibiotic Utebzi. The company recorded no revenue in the quarter, down from $14.2 million a year earlier, as prior collaboration revenue from Pfizer and GSK was fully realized. Research and development expenses fell to $3.4 million from $10.7 million due to reduced clinical activity, while general and administrative expenses rose to $6.5 million from $5.9 million. Spero also announced it closed a $105 million non-dilutive, non-recourse royalty financing with Healthcare Royalty, extending its cash runway into the second half of 2029. The company said the FDA approved Utebzi on June 17, 2026, for complicated urinary tract infections, making it the first oral carbapenem approved in the US, with GSK holding exclusive commercialization rights worldwide excluding certain Asian territories.

Spero Therapeutics has appointed Debra Jeske Zack as Chief Medical Officer. The clinical-stage biopharmaceutical company said the move strengthens its clinical leadership team as it advances SP001, a Phase 2-ready third-generation anti-CD40L antibody being developed for IgG4-related disease and other immune-mediated conditions. Zack brings more than 25 years of experience in developing therapies for immune-mediated diseases, most recently serving as Chief Medical Officer of Exagen Inc. and previously holding clinical leadership roles at Xencor Inc. and Novartis' Biotherapeutics Development Unit. Spero Therapeutics shares were up nearly 2% in pre-market trading after closing at $1.19.

Innovent Biologics has entered an exclusive licensing agreement with Spero Therapeutics for IBI355, a third-generation Fc-silent anti-CD40L antibody for autoimmune diseases, in a deal worth up to about $1.1 billion. Innovent will receive an upfront payment and is eligible for development, regulatory and commercial milestone payments, plus tiered royalties on net sales in Spero's licensed territories. Spero gains exclusive worldwide rights to develop, manufacture and commercialize IBI355 outside Greater China, while Innovent retains rights in Greater China. IBI355 has been evaluated in two Phase 1 studies in healthy volunteers and a Phase 1b study in patients with Sjögren's disease. Spero expects to start a Phase 2 trial in IgG4-related disease in the second quarter of 2027, and Innovent plans to begin a Phase 2 study in China for Sjögren's disease by early 2027.

Spero Therapeutics announced a $105 million non-recourse non-dilutive royalty financing transaction with affiliates of Healthcare Royalty, a royalty acquisition company majority owned by KKR & Co. Inc. The proceeds will primarily support advancement of Spero's immunology drug candidate SP001. Healthcare Royalty will provide the $105 million payment at closing, net of original issue discount and applicable fees, in exchange for rights to a portion of future milestone and royalty payments from sales of Utebzi owed by GSK. Healthcare Royalty will receive quarterly principal and interest payments derived solely from those GSK payments until the loan balance is repaid, after which Spero will retain 35% of subsequent GSK payments related to Utebzi sales. Following the transaction, Spero updated its cash runway guidance into the second half of 2029. In pre-market trading on NasdaqGS, Spero shares fell 6.79 percent to $2.03.

Spero Therapeutics has secured $105 million in non-recourse, non-dilutive financing from affiliates of Healthcare Royalty, a business of KKR. The proceeds will primarily fund the Phase 2 development of SP001, Spero's lead immunology candidate, a third-generation anti-CD40L monoclonal antibody in-licensed from Innovent Biologics. The transaction strengthens Spero's balance sheet and extends its expected cash runway into the second half of 2029. The stock price declined about 9% on Tuesday pre-market.

GSK and Spero Therapeutics received U.S. FDA approval for Utebzi, a first-in-class oral carbapenem antibiotic for complicated urinary tract infections, while GSK's momelotinib gained Orphan Drug Designation for VEXAS syndrome. Utebzi offers an oral treatment option for multidrug-resistant infections, addressing a market with over 3 million U.S. cases annually and high treatment failure rates. The Orphan Drug Designation for momelotinib adds a rare disease asset to GSK's portfolio, potentially providing regulatory support and market exclusivity. These milestones highlight GSK's focus on specialty medicines and infectious diseases, though financial impact will depend on clinical adoption and commercialization.

The U.S. Food and Drug Administration has approved Utebzi, the first oral carbapenem antibiotic for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options. GSK plc and Spero Therapeutics, Inc. announced the approval on Wednesday, noting that complicated UTIs affect more than 3 million people annually in the U.S., with treatment failure occurring in as many as 34% of patients and multidrug-resistant infections contributing over $6 billion in annual healthcare costs. The decision was supported by Phase 3 PIVOT-PO trial data showing tebipenem pivoxil was non-inferior to intravenous imipenem-cilastatin, with overall success rates of 58.5% versus 60.2% and an adjusted treatment difference of minus 1.3%. GSK expects Utebzi to be available to patients in the U.S. by the end of 2026, and the development received partial federal funding from the Biomedical Advanced Research and Development Authority.

The biotech sector saw FDA approvals, study halts, layoffs, and deals this week. Spero Therapeutics and GSK won FDA approval for Utebzi, the first oral carbapenem for complicated urinary tract infections, while AbbVie's Allergan Aesthetics unit received expanded approval for SKINVIVE by JUVÉDERM to treat neck lines. Neumora Therapeutics halted its Phase 3 KOASTAL studies of Navacaprant in major depressive disorder after the drug failed to beat placebo and announced plans to lay off about 35% of its workforce. Biogen agreed to acquire RayThera in a deal valued at up to $1 billion to expand its immunology portfolio, with closing expected in the third quarter of 2026.