Argenica Therapeutics (AGN) Investor update summary

Clinical development progress

• All FDA-requested assays for xaranetide (ARG-007) have been completed, addressing clinical hold requirements and showing a clean safety profile.

• Post hoc analysis and phase II data show statistically significant improvements in functional outcomes for moderate to severe stroke patients, especially those with larger infarct cores.

• Phase II-B trial will focus on patients with ASPECTS scores of 3–8, using AI-assisted imaging for accurate severity assessment and validated endpoints.

• Manufacturing scale-up is underway to ensure sufficient drug supply for upcoming trials, with completion and drug availability targeted by late 2024 or early 2025.

• IND submission, protocol finalization, and regulatory approvals are key near-term priorities, with a comprehensive clinical hold response to be submitted to the FDA within weeks.

Financial and operational status

• Cash reserves were AUD 8 million (or $8M) at March quarter, expected to be over AUD 6 million by end of June.

• Current market cap is around AUD 15 million ($15M) as of April 2026.

• R&D tax credit and grant applications are being pursued to support trial funding, with non-dilutive funding targeted for the TBI trial.

• 128.5M shares on issue, with 37% held by top 20 shareholders.

Phase II-B trial design and endpoints

• The trial will be randomized, placebo-controlled, and test both current and lower doses.

• Primary endpoint is functional outcome (mRS), with interim analysis planned at 50% enrollment (160 patients), which may allow dose arm adjustment and will be a key value inflection point.

• Estimated enrollment is 350–400 patients, with sites in Australia and the U.S.