Nyrada (ASX:NYR) has confirmed growing clinical momentum, strengthening finances, and expanding scientific validation for its lead candidate, Xolatryp, as the company positions itself for its next phase of development.
During the first half of the financial year, the company completed its Phase 1 clinical trial of Xolatryp, confirming a strong safety profile and predictable pharmacokinetics in humans. No serious adverse events were reported, and observed effects were mild to moderate and occurred across both treatment and placebo groups, reinforcing confidence in the therapy’s tolerability.
Nyrada announced it has shifted focus to a Phase 2a trial targeting patients with ST-Elevation Myocardial Infarction (STEMI) undergoing primary angioplasty. The study aims to test whether Xolatryp can reduce damage that occurs when blood supply returns to the heart after a blockage, a process known as ischemia-reperfusion injury, for which no targeted therapies currently exist.
Approval from the Human Research Ethics Committee was obtained in early 2026, and patient recruitment is expected to begin in March.
The upcoming study will primarily assess safety, but researchers will also monitor cardiac function, biomarker levels such as Troponin I, and arrhythmia rates to gauge early signs of efficacy.
Beyond cardiology, Nyrada said Xolatryp’s potential applications continue to broaden. Collaborative research with the Walter Reed Army Institute of Research and UNSW Sydney has shown the drug may help protect mitochondrial function by regulating calcium levels in brain cells, offering further evidence of its neuroprotective potential. These findings support the underlying mechanism that excessive calcium influx can damage cells in both cardiac and neurological injury.
At the same time, Nyrada has initiated additional preclinical studies to evaluate whether the therapy could also be effective in oncology settings, signalling the company’s ambition to extend the drug’s reach across multiple disease areas.
Financially, Nyrada reported a cash balance of $7.12 million at the end of December 2025, supported by an $8.25 million capital raise completed earlier in the year. The funds are being directed toward the upcoming clinical trial, manufacturing activities, and further research into additional indications. An R&D tax rebate of $2.16 million is also expected.
While the company recorded an operating loss of $3.19 million for the half year, largely reflecting continued investment in research and development, management views the spending as necessary to drive long-term value and advance its clinical pipeline.