Investor Porn (10/3/26)

WORK SAFE: 5min video from Investor Stream was emailed to me for those interested:

https://www.youtube.com/watch?v=-n1bb6SaS94&feature=youtu.be

Dr Tillett owns 5.67% of the company per the previous annual report, founder and CEO of Nucleics, CEO and MD of Racura Oncology… so not some random!

Disc: I own RL+SM

Anitviral pipeline expansion (9/3/26) - Antiviral-pipeline-expansion-through-strategic-collaboration.pdf

Island is using a low-cost, grant-supported collaboration to turn ISLA‑101 and Galidesivir into multi-indication, stockpile-aligned antivirals, increasing strategic value and partnership options without material dilution. Announcement summary:

·        Island Pharma announces a non-dilutive R&D collaboration with Burnet Institute to broaden ISLA-101 and Galidesivir into measles, chikungunya and Ross River virus.

·        The program leverages existing clinical and preclinical data, so no new assets or major capex are required.​

·        Target indications are chosen to fit national stockpile, biodefence and public health funding frameworks.

·        Burnet’s Dr Johanna Fraser, co‑inventor of ISLA-101 and arbovirus specialist, will run in vitro and translational work to define antiviral activity and inform development paths.

She has secured a >A$780k three‑year NHMRC grant that de-risks and co-funds ISLA‑101 research alongside Island’s Phase 2/3 plans.

·        Management frames this as an IP- and data-building exercise that expands commercial and partnering optionality and aligns the portfolio with preparedness-driven, broad-spectrum antiviral demand.

Summaried by AI (Perplexity), reviewed by GAI (Generally Average Intelligence, aka me)

Disc: I own RL

CRADA (4/3/26)

To provide some context to todays Cooperative Research and Development Agreement (CRADA) with USAMRIID and Geneva Foundation to seek FDA approval for Galidesivir:

• Island acquired Galidesivir from BioCryst and prioritised it as a Marburg countermeasure, leveraging strong historical NHP data showing 94% survival in Marburg‑infected primates vs 0% in controls.
• In late 2025, the FDA confirmed that the Animal Rule is an appropriate pathway for Galidesivir in Marburg and that, if approved, it would qualify for a Tropical Disease Priority Review Voucher, materially de‑risking the regulatory/commercial case.
• The company has framed its goal as needing only one pivotal, GLP‑compliant Non-Human Primate (NHP) Marburg study under FDA‑agreed protocols to support an NDA, contingent on alignment around the animal model and challenge design.
• On 4 February 2026, the FDA provided detailed alignment on the Angola Marburg strain, cynomolgus macaque model and challenge dose, and endorsed a two‑stage development sequence (dose‑optimisation/PK followed by pivotal NHP efficacy), further clarifying the path to approval.
• Island moved to secure execution capacity via advanced engagement with BSL‑4 partners such as Texas Biomed and other specialist facilities to run the required animal studies.
• The company also raised about US$9m via a placement to fund Galidesivir through Animal Rule development and NDA submission, signalling a funding runway specifically earmarked for Marburg development and potential US stockpile positioning.
• The new CRADA with USAMRIID and The Geneva Foundation now slots into this pre‑defined FDA‑aligned plan as the operational vehicle to design and execute the NHP studies needed to deliver the pivotal Marburg dataset for NDA.

In effect, their first and biggest customer are in an agreement to help conduct the NHP study which under the Animal Rule will be sufficient for FDA approval (ie receiving an NDA).

Disc: I own RL