Syn2bio sums up the third quarter of the financial year: Trials of the SYN2 cardiotracer in Europe according to schedule, preparations to launch trials in the US

Syn2bio, which debuted on the Warsaw Stock Exchange in mid-April due to the spinoff from Synektik of R&D activity, including the SYN2 cardiotracer project, has summed up the results and events in the third quarter of its financial year, covering the period of 1 April – 30 June 2026.

In the past quarter Syn2bio continued its phase 3 clinical trials of the SYN2 cardiotracer, an innovative radiopharmaceutical for diagnosis of heart disease using the PET/CT method. The research, conducted using the adaptive trial design at centres in Europe and the United States, is intended to assess the diagnostic efficacy of SYN2 compared to reference angiographic methods, on an anticipated group totalling about 200–220 patients (this number is to be confirmed or adjusted following analysis of the interim stages).

The trials at the European institutions are proceeding according to the projected timetable. The number of recruited patients has achieved the level enabling the planned interim analysis to be conducted, the results of which the company expects to receive in the 4^th quarter of 2026.

In the United States, preparations are underway to launch clinical centres which include inter alia transfer of the SYN2 production technology and implementation of quality assurance procedures. The start of recruitment of patients depends on assignment by the US Food and Drug Administration of an Investigational New Drug (IND) number.

“The third quarter of the current financial year was primarily about further consistent implementation of the clinical trials programme for the SYN2 cardiotracer,” said Cezary Kozanecki, CEO of Syn2bio. “The current stage of development of this project is one of the most time-consuming and costly. In Europe we are approaching the major stage of interim analysis of the results, while in the United States we are finalizing the work necessary to begin recruiting patients.”

In line with the adopted projections and business model of Syn2bio, during the period in question the company did not generate sales revenue, and will not do so until commercialization of the SYN2 cardiotracer. The main cost item was expenditures on development work connected with the conduct of clinical trials, which during the period amounted to about PLN 11 million. They were higher than the average quarterly spending level, reflecting the intensification of research work prior to the summer holiday season.

As of 30 June 2026 Syn2bio held cash of nearly PLN 19 million, which in the management board’s assessment will ensure financing of research on the cardiotracer for a period of about 10–11 months following the balance sheet date. Additional sources of financing may include grants, subsidies, and funds from R&D support programmes earmarked for SMEs. Syn2bio intends to take advantage of these programmes as it holds the status of an SME, which Synektik, as a large enterprise, did not have.

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