Spero Therapeutics is reshaping its strategy by shifting its focus from antibiotics to immune and inflammatory diseases through a licensing agreement with Innovent Biologics that could be worth as much as $1.1 billion.
As part of the deal, Spero has secured exclusive rights to research, create, and market SP001 outside China. The therapy, previously known as IBI355, will earn Innovent a combination of upfront compensation, milestone payments, and tiered royalties based on future sales, although the companies did not disclose the financial breakdown.
CD40L is a protein expressed on activated T cells that plays an important role in regulating vascular inflammation, cell survival, and anti-tumor immune responses. Innovent has already evaluated the antibody in two Phase 1 studies involving healthy volunteers, along with a Phase 1b trial in patients with Sjögren’s disease, an autoimmune disorder that damages the tear and salivary glands, causing persistent dry eyes and dry mouth.
Spero plans to move SP001 into a Phase 2 study targeting IgG4-related disease, a rare autoimmune disorder marked by inflammatory lesions and tissue fibrosis.
Spero Chief Executive Officer Esther Rajavelu said the agreement lays the groundwork for the company’s new development pipeline, adding that targeting the CD40L pathway could create opportunities across a range of immune and inflammatory disorders. She also said that after successfully bringing a treatment for serious infectious diseases through development, Spero intends to apply the same disciplined approach to therapies for immune-mediated conditions.
Spero’s new direction will be supported by a $105 million financing agreement with Healthcare Royalty (HCRx), which is providing the funding in exchange for a share of future royalty income generated by Utebzi. The oral antibiotic, approved by the FDA last month and marketed by GSK, is indicated for complicated urinary tract infections.
Under the financing arrangement, HCRx will receive quarterly payments covering principal and interest from the royalties GSK pays Spero on Utebzi sales until the loan has been repaid. After that point, HCRx will be entitled to as much as 65% of the profits generated by the drug.
In a separate statement, Rajavelu said monetizing part of the future milestone and royalty revenue from Utebzi provides Spero with immediate capital to advance the clinical development of SP001 while continuing to build a differentiated pipeline focused on immune-mediated diseases, which is a win-win situation.
The company’s move into immune and inflammatory diseases follows the long and difficult path taken by Utebzi. The FDA initially rejected the therapy in 2022, when it was still known as tebipenem pivoxil hydrobromide, after concluding that the Phase 3 data were insufficient to support approval. GSK later partnered with Spero in a $66 million agreement to continue development and conduct another pivotal study.
Following the FDA’s initial rejection, Spero let go of three quarters of its workforce. The company announced another round of layoffs in 2024, cutting an additional 39% of employees after an oral therapy for nontuberculous mycobacterial pulmonary disease failed to outperform placebo and raised safety concerns because of signs of toxicity.
Strategic Benefits for Spero
The collaboration provides with access to an innovative biologic candidate while allowing the company to expand its presence in the rapidly growing immunology market. In addition to strengthening its pipeline, Spero may benefit from future commercial opportunities if the therapy successfully progresses through clinical trials and regulatory review.
The agreement also highlights Spero’s strategy of combining internal research with external innovation to accelerate product development.
Growing Interest in Autoimmune Therapies
The autoimmune treatment market continues to attract significant investment as biotechnology and pharmaceutical companies pursue next-generation antibody therapies. Spero joins a growing list of organizations investing heavily in precision immunology to improve outcomes for patients with chronic inflammatory diseases.

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