Syn2Bio S.A. Anticipates Interim Analysis Results for Phase III Cardiotracer Study in Q4 2026
Syn2Bio S.A. has announced that the Phase III clinical trials for its innovative cardiotracer, SYN2, are progressing on schedule across European centers. The company expects to receive interim analysis results in the fourth quarter of 2026. The cardiotracer, a radiopharmaceutical designed for heart disease diagnosis using PET/CT imaging, is being tested on a projected cohort of 200–220 patients, with final numbers to be confirmed after interim evaluations.
Patient recruitment in European centers has reached a level sufficient for the planned interim analysis. Meanwhile, preparations are underway in the United States to initiate clinical sites, including technology transfer for SYN2 production and quality assurance procedures. Patient recruitment in the U.S. is contingent on the FDA assigning an IND (Investigational New Drug) number.
Syn2Bio reported that its primary expenditures in Q2 2026, totaling approximately PLN 11 million, were allocated to intensified research and development activities. As of June 30, 2026, the company held cash reserves of nearly PLN 19 million, sufficient to fund research for an estimated 10–11 months. Additional funding may be sought through grants, subsidies, and development support programs targeted at small and medium-sized enterprises (SMEs), a status that Syn2Bio holds.
Syn2Bio reiterated that it does not anticipate generating revenue until the commercialization of SYN2, in line with its business model.
Relevance to Syn2Bio S.A.: This update highlights Syn2Bio's progress in advancing its flagship cardiotracer project, a core component of its business strategy, and underscores its financial planning and resource allocation to support ongoing clinical trials and eventual commercialization.