• PYC-002 increases SHANK3 gene expression in critical brain regions affected by Phelan-McDermid Syndrome (PMS)
• PYC-002 restores SHANK3 gene expression in neurons derived from PMS patients to normal levels
• PYC will progress PYC-002 into Investigational New Drug (IND)-enabling studies prior to human trials in 1H 2026

PYC Therapeutics, a clinical-stage biotechnology company, has announced the nomination of its fourth clinical drug candidate, PYC-002, for the treatment of Phelan-McDermid Syndrome (PMS), a severe neurodevelopmental disorder affecting approximately 1 in 10,000 people. PMS is caused by insufficient expression of the SHANK3 gene in neurons within the brain, leading to impaired communication between neurons. PYC-002 has successfully completed preclinical studies, demonstrating that it can increase SHANK3 gene expression in the critical regions of the brain affected by PMS in animal models. Additionally, the drug candidate was able to restore SHANK3 gene expression in neurons derived from PMS patients back to the levels seen in unaffected individuals. With these positive results, PYC will now progress PYC-002 into an Investigational New Drug (IND)-enabling pathway, with the goal of initiating human trials in the first half of 2026, subject to the risks and uncertainties outlined in the company's previous ASX disclosures.

PYC will now commence the studies required to enable progression of PYC-002 into human trials, with the expectation that First In Human trials of PYC-002 will commence in 1H 2026.