Spero Therapeutics, Inc.

Spero Therapeutics, Inc. announced it will report its financial results for the second quarter ended June 30, 2026, on Wednesday, August 12, 2026, after market close. Following the release, management will host a conference call and live audio webcast at 5:00 pm EDT to discuss the results and provide a business and pipeline update. The webcast will be available on the company's investor relations page.

Spero Therapeutics entered an exclusive license agreement with Innovent Biologics for SP001, a Phase 2-ready anti-CD40L antibody, gaining worldwide rights (excluding Greater China) for its development and commercialization. Spero will pay Innovent a $35 million upfront fee and up to $1.05 billion in milestones, with plans to initiate a Phase 2 trial for SP001 in IgG4-related disease in Q2 2027. Concurrently, Spero secured a $105 million non-recourse non-dilutive financing from Healthcare Royalty, backed by future Utebzi milestones and royalties, extending its cash runway into the second half of 2029 to fund SP001's development.

Spero Therapeutics announced a $105 million non-recourse non-dilutive royalty financing transaction with Healthcare Royalty (HCRx), a KKR business. This funding will primarily advance SP001, Spero's first immunology drug candidate, into Phase 2 development. The deal unlocks immediate value from future Utebzi milestones and royalties, significantly strengthening Spero's balance sheet and extending its cash runway into the second half of 2029. This strategic move positions the company for its immunology-focused growth strategy, following the recent U.S. approval of Utebzi.

Spero Therapeutics and Innovent Biologics announced an exclusive license agreement for SP001 (IBI355), a third-generation Fc-silent anti-CD40L antibody. Under the terms, Spero gains exclusive global rights, excluding Greater China, to develop, research, manufacture, and commercialize SP001. Innovent will receive an upfront payment and is eligible for development, regulatory, and commercial milestone payments totaling approximately US$1.1 billion, plus tiered royalties on net sales. Spero plans to initiate a Phase 2 trial for SP001 in IgG4-related disease in Q2 2027, while Innovent plans a Phase 2 trial in China for Sjögren’s disease by early 2027.

Spero Therapeutics' stockholders approved an amendment to the company's Certificate of Incorporation, doubling the authorized common stock from 120 million to 240 million shares. Additionally, the 2026 Stock Incentive Plan, allowing for the issuance of up to 12,895,866 shares, was approved. These actions took place at the Annual Meeting on June 23, 2026, where stockholders also re-elected two directors, ratified the independent auditor, and approved executive compensation.

Spero Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted approval for Utebzi (tebipenem pivoxil), an oral antibiotic. Utebzi is approved for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adult patients with limited or no alternative oral treatment options. This marks the first and only oral carbapenem antibiotic approved for these patients, stemming from a development and licensing agreement with GSK. The approval was based on positive results from the PIVOT-PO phase III trial, and the drug is expected to be available in the US by the end of 2026.

Spero Therapeutics, Inc. and GSK plc announced that the US FDA has approved Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections (cUTIs) who have limited or no alternative oral treatment options. The approval, based on the PIVOT-PO trial, marks a significant advancement in treating infections caused by resistant pathogens. Utebzi is expected to be available by the end of 2026, offering an oral alternative to intravenous carbapenems and potentially reducing reliance on hospital care.

Spero Therapeutics reported a significantly reduced net loss of $7.2 million for Q1 2026, down from $13.9 million in Q1 2025, and achieved positive operating cash flow of $15.9 million. The company has ceased development of its SPR206 and SPR720 programs, focusing resources on the tebipenem HBr program, for which GSK submitted an NDA with a PDUFA date of June 18, 2026. Despite a decrease in total revenue, operating expenses were substantially lower due to the strategic reprioritization.

Spero Therapeutics announced its first quarter 2026 financial results, reporting a net loss of $7.2 million, an improvement from $13.9 million in the prior year. Total revenue for the quarter significantly decreased to $0.3 million from $5.9 million year-over-year. The company also provided a business update, confirming the FDA's PDUFA date for the tebipenem HBr New Drug Application (NDA) is set for June 18, 2026. Spero Therapeutics reiterated its cash runway guidance, extending into 2028.

Spero Therapeutics, Inc. will hold its 2026 annual meeting of stockholders virtually on June 23, 2026. Stockholders will vote on several key proposals, including the election of two directors, ratification of the independent auditor, and an advisory vote on executive compensation. Most notably, the company seeks approval to double its authorized common stock from 120 million to 240 million shares and to adopt a new 2026 Stock Incentive Plan.