Nyrada Inc. Posts $2.46M Loss as NYR-BI03 Advances to First Human Trial

Financial Results Reflect Heavy R&D Investment

Nyrada Inc., the ASX-listed biotechnology company focused on small-molecule therapies targeting TRPC ion channels, reported a substantial loss of $2.46 million for the half-year ended 31 December 2024. This marks a sharp reversal from a modest profit of $136,359 in the prior corresponding period. Revenues fell 64% to $884,584, reflecting the company's strategic pivot towards intensive research and development activities.

The loss was primarily driven by a near doubling of R&D expenditure to $1.81 million, alongside increased corporate and administrative costs. Despite the financial setback, Nyrada's cash reserves remain healthy at $5.71 million, bolstered by a $1.24 million R&D tax incentive refund and $3.38 million raised through capital placements during the period.

Advancing NYR-BI03: From Preclinical Promise to Human Trials

Nyrada's lead drug candidate, NYR-BI03, continues to demonstrate compelling preclinical efficacy. Earlier in 2024, the company announced that NYR-BI03 achieved a statistically significant 42% neuroprotective effect in a stroke model, rescuing brain tissue in the critical penumbra region. Further preclinical studies revealed an impressive 86% cardioprotective effect following myocardial ischemic-reperfusion injury, a major cause of heart tissue damage.

These promising results underpin NYR-BI03's potential to address significant unmet medical needs, particularly as no FDA-approved drugs currently target secondary brain injury or ischemia-reperfusion injury. The company successfully completed Good Laboratory Practice safety studies, confirming a favorable safety profile that enabled submission to the Human Research Ethics Committee (HREC) for a first-in-human Phase Ia clinical trial.

Subsequent to the reporting period, Nyrada received HREC approval to initiate this double-blind, randomized, placebo-controlled, dose-escalating study in healthy volunteers. The trial will assess safety, tolerability, and pharmacokinetics, with results expected in the third quarter of calendar year 2025.

Strategic Intellectual Property and Collaborations

During the half-year, Nyrada filed composition of matter patent applications across key jurisdictions including Australia, Europe, and North America to protect its TRPC channel blocking assets. These patents, if granted, will secure exclusivity for 20 years from the priority date in November 2024, reinforcing the company's competitive moat.

Additionally, Nyrada is collaborating with the Walter Reed Army Institute of Research and UNSW Sydney on a traumatic brain injury study using a rodent model that mimics military head injuries. Results from this study are anticipated imminently and could further validate NYR-BI03’s neuroprotective capabilities.

Outlook: Clinical Progress and Broader Therapeutic Potential

Looking ahead, Nyrada is focused on executing its Phase Ia trial and exploring additional therapeutic applications for NYR-BI03, leveraging its broad potential in neuro- and cardioprotection. The company plans to provide regular updates as clinical milestones are achieved.

While the current financial loss underscores the high costs inherent in drug development, the successful transition of NYR-BI03 into human trials marks a critical inflection point that could unlock significant value for shareholders if clinical outcomes prove favorable.