Key Highlights

  • Four hospitals are activated and screening in the PROTECT-MI Phase IIa trial, with three patients dosed.
  • FDA pre-IND feedback raised no major issues, supporting an IND submission for Xolatryp in 1H CY2027.
  • Cash was AU$13.72 million at 30 September 2026, and a AU$12.0 million placement is committed.
  • Final patient dosing in PROTECT-MI is estimated for mid-2027, with preliminary results anticipated in Q3 or Q4 CY2027.

Nyrada Inc. (ASX:NYR), a clinical-stage biotechnology company developing TRPC ion channel inhibitors, released its Quarterly Activities Report and Appendix 4C for the three months ending 30 September 2026 on 19 October 2026. The report covered the PROTECT-MI trial, regulatory feedback, preclinical oncology work and funding.

PROTECT-MI Phase IIa trial

PROTECT-MI is assessing the safety and preliminary efficacy of Xolatryp in reducing cardiac reperfusion injury in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention. During the quarter the trial moved from start-up into active recruitment, with the network growing from one hospital to four: Nepean Hospital, Sir Charles Gairdner Hospital, Northern Hospital and Royal Perth Hospital. Three patients have been recruited across two sites. Nyrada expects two further sites by the end of October 2026 and two more by the end of November 2026, giving eight, and is assessing sites in Australia, New Zealand, Singapore and Hong Kong.

Nyrada is working with sites to extend screening hours because potentially eligible patients are presenting outside the core hours of 8:00am to 4:30pm on weekdays. Safety Review Committee meetings will follow dosing of 8, 30, 60 and 90 patients. As the trial is randomised, double-blind and placebo-controlled, efficacy data will only be available once it is complete and unblinded.

Timeline and regulatory feedback

Nyrada estimates the final patient will be dosed in mid-2027. After a 30-day follow-up and about 90 days for data cleaning and review, it anticipates preliminary results in Q3 or Q4 CY2027. After quarter end, the FDA gave feedback on the pre-IND submission across chemistry, manufacturing and controls, non-clinical, clinical and regulatory aspects with no major issues raised. This supports an IND application for Xolatryp in the first half of CY2027. A US composition of matter patent over Xolatryp was also granted.

Oncology and other programs

In a five-week rodent study of doxorubicin-induced cardiomyopathy, with 12 animals per group, Xolatryp protected cardiac function across four echocardiographic measures, with protection comparable in magnitude to dexrazoxane. Myocardial injury was reduced from moderate to mild focal injury. Cardiac troponin I was about 19% lower at week five and collagen content was numerically lower at 13.2% against 17.4%, although neither difference reached statistical significance. Design of a Phase Ib oncology trial and of a preclinical stroke study is in progress.

Funding

Cash was AU$13.72 million at 30 September 2026. Nyrada has AU$12.0 million before costs committed under a placement, comprising AU$6.875 million received during the quarter and AU$5.125 million committed by directors, which is subject to CDI holder approval. A Securities Purchase Plan to raise up to a further AU$2.0 million before costs is to be conducted in October 2026.