GMP Manufacturing (4/6/26)

Island has started Good Manufacturing Practices (GMP) manufacturing of Galidesivir with global CRDMO PI Health Sciences to supply its pivotal Marburg study under the FDA Animal Rule pathway. The newly manufactured GMP material is earmarked for the pivotal efficacy study expected to underpin a future FDA submission.

Existing Galidesivir stock will be used for dose‑optimisation work which didn’t require the scale or compliance of a GMP manufacturing facility so was cheaper for volume needed for this testing. The newly manufactured GMP material is earmarked for the pivotal efficacy study expected to underpin a future FDA submission.

Island note that the new manufacturing arrangements will allow it to respond quickly to biodefence and outbreak opportunities, including the current Bundibugyo Ebola outbreak. Effectively, once up and running it will be able to generate significantly greater quantities of dosses in time and able to address an outbreak if needed, ie commercial supply will be possible.

Overall a good and important step, but one that needed to be taken and didn’t have risk around it so I don’t expect any significant or lasting price uplift. That will come once the animal studies are underway with read outs and results critical points.

Disc: I own RL+SM

4C Update (27/4/26)

Island finished the quarter with A$14.2m cash which is around 10 quarters at normal burn rates excluding the planned Marburg animal testing trials that need completing. This follows the A$9m capital raise in the quarter which has resulted in 4m options being issued to Taurus Capital for assisting ($0.60 exercise price). The announcement to that capital raise on 4 February stated “Capital extends Island’s cash runway and fully fund Galidesivir through its two stage FDA Animal Rule development pathway and NDA submission in Marburg”

Based on the timeline provided in the February investor presentation the clinical study requirements are planned for this calendar year. So I think the cash runway is more likely to be 4-5 quarters once Galidesivir study costs are included.

The announcement is a summary of a packed quarter for Island, in terms of new information beyond cash there isn’t much but some change in emphasis and conviction:

• The company is now setting expectations for the PRV value at US$200m, having moved from US$100-155m last quarter and flagging recent sales at US$200m in more recent communications.
• Confidence of the pathway to approval with the FDA letter dated 30 Jan 2026 sets a defined two‑stage clinical pathway and CRADA formally executed with USAMRIID and The Geneva Foundation to run the non‑human primate studies required for Marburg NDA under the Animal Rule.
• US filoviridae patent now disclosed with full detail: US Patent No. 12,508,266, protection to October 2031, broad therapeutic claims across Marburg and Ebola.
• The only near-term additional funds are the R&D Tax Incentive refund of ~A$143k for FY25 received, tied to ISLA‑101, was received after quarter end.

We are a third into what should be a very interesting year for Island Pharmaceuticals.

Disc: I own RL+SM

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