ILA signs deal with research facility while it waits for further feedback from the FDA - due in “early January 2026”

Our 2025 biotech Pick Of The Year Island Pharmaceuticals (ASX: ILA) just signed a deal with a Biomedical research facility in the USA.

ILA signed a Master Service Agreement (MSA) with Texas Biomedical Research Institute - one of only four facilities in the US capable of conducting certain preclinical infectious disease research trials in non-human primates.

(ILA is looking to develop an infectious disease drug using animal studies - so today’s deal is very relevant to ILA’s drug development process).

Here is a picture included in today’s announcement that shows Texas Biomedical Research Institute’s facility.

(source)

So after today’s announcement, ILA is in a position to start animal studies for its Marburg drug as soon as FDA feedback is received on ILA’s trial design.

A few weeks ago ILA received approval from the FDA to utilise the animal rule pathway to go for approvals for its Marburg drug.

(Read more about the animal rule here: How can ILA fast track approvals through the “Animal Rule”?)

This allows ILA to effectively skip a 15+ year, expensive process of human phase 2 & 3 clinical trials.

ILA is currently waiting for another round of feedback from the FDA before it kicks off animal studies.

ILA expects to hear back in early January, specifically prior to January 2nd (US time) from a prior announcement. (source) and reaffirmed with “early January” today.

ILA’s Marburg drug and why we think its important

ILA is looking to develop Galidesivir as an antiviral drug aimed at treating Marburg disease.

Marburg virus is classified as a Category A bioterrorism threat (the highest level threat) by the US government (source).

Marburg is the only Category A biothreat with no current vaccine or FDA approved treatment…

It's also one of the most deadly with a fatality rate up to 88%.

It’s classified as a biothreat because it can be weaponised (and it was part of the soviet bioweapons program in the 80’s,(source, source).

ILA is going for approvals on the drug via a fast tracked “Animal Rule” approvals pathway - which is basically where biotech’s can seek FDA approvals for really deadly diseases on animal trials alone.

(Cutting out the 10-15 years of human trials needed for most drugs).

We are Invested in ILA to see it go through the animal rule process - get its drug FDA approved (fingers crossed).

Approvals for ILA (potentially inside the next 12-18 months) could unlock:

• A Priority Review Voucher (PRV) that comes in if ILA’s Galidesivir is FDA approved - these can be worth on average ~US$150M.
• US Government national stockpiling deals - these can be worth anything between US$100M to US$1.2BN ANNUALLY

We covered all of this in our most recent note here: ILA: Our Biotech Pick of the Year

What’s next for ILA in the next ~6 months

Mid November: ILA confirmed Animal Rule eligibility for its Marburg drug ✅

NEXT: FDA provides feedback on ILA’s animal trial design.

NEXT: ILA confirms it will be using the animal rule FDA approval process for its Margurg disease drug.

NEXT: Commence animal trial for deadly Marburg disease. Here are the milestones we will be tracking for the animal study:

• ✅ Deal signed with clinical trial research facility.
• 🔲 Clinical trial design completed
• 🔲 Clinical trial starts
• 🔲 Clinical trial completed
• 🔲 Clinical trial results

NEXT: (Assuming results are good) Submit to FDA for commercial approval and access to Priority Review Voucher