ILA ramping up drug manufacturing to help fight “worst ever” Ebola outbreak

Disclosure: S3 Consortium Pty Ltd (the Company) and Associated Entities own 3,710,339 ILA Shares at the time of publishing this article. The Company has been engaged by ILA to share our commentary on the progress of our Investment in ILA over time. This information is general in nature about a speculative investment and does not constitute personal advice. It does not consider your objectives, financial situation, or needs. Any forward-looking statements are uncertain and not a guaranteed outcome.

The current Ebola outbreak in central Africa has now ticked over to the second worst in history.

But when you measure it by the first 100 days of spread, the current ongoing outbreak is spreading five times faster than the previous two “biggest ever” outbreaks at the same early stage:

(source)

Sadly, it is raging in some of the most challenging conditions imaginable fuelled by poverty, insecurity, displacement and intense population movements.

(sources)

Key takeaway - unfortunately this outbreak is going to get a LOT worse over the coming months.

Because there are NO vaccines or treatments for this particular strain of Ebola.

During the last major Ebola outbreak, US government agencies deployed over US$70M in funding to develop and test a drug called Galidesivir against viral diseases.

Including against Ebola.

Galidesivir ALREADY has Phase 1 safety data (in humans) and effectiveness (in animals) against Ebola, Marburg and 20+ other viral diseases.

Our 2025 Biotech Pick of The Year, Island Pharmaceuticals (ASX:ILA), acquired Galidesivir in 2025.

(after the prior owner shifted strategic focus to other diseases).

ILA decided to develop the drug for the Marburg virus first.

Because Marburg is the only Category A bioterrorism threat (the highest level) with NO current vaccine or FDA-approved treatment.

There is no approved treatment and hence no biodefence treatment stockpile, and approval can be fast-tracked with the FDA

ILA’s animal trials for Marburg are due to start any day now with ILA going for accelerated FDA approvals in Q1 2027 (submissions).

BUT...

Then the major Ebola outbreak happened.

~17 weeks ago: this major Ebola outbreak started.

... and has quickly spread into what looks to become the worst outbreak in history based on the first 100 days of spread.

Six weeks ago: ILA secured full government and regulatory approvals to deploy Galidesivir in infected Ebola patients in Uganda - under a World Health Organization emergency use framework.

(source - Read the ILA announcement)

🚨 THIS MORNING: ILA announced it has commissioned a SECOND manufacturing campaign of GMP-grade Galidesivir to "strengthen active outbreak and biodefence inventory".

In other words - ILA's drug is expected to treat infected humans, in a live outbreak, within the coming months.

Hopefully saving lives and preventing the spread of this currently untreatable strain of Ebola.

And, in parallel, creating the first opportunity to collect HUMAN efficacy, safety and virological data in infected patients.

You can't ethically deliberately infect humans with a deadly disease to test a treatment. Placebo control groups are unethical, and outbreaks to find test patients are rare and unpredictable.

ILA’s Galidesivir has already been proven SAFE for humans to take (Phase 1 trial) - so we are hoping it can actually get onto the field and do some real good for people asap - a low risk but potentially high reward treatment.

With the only cost to ILA being to supply the drug.

A human trial like this would usually cost ~$20M to $30M+.

(and it would be impossible to recruit trial participants - dose of Ebola to see if this drug works? Not very ethical.)

So right now is a rare and precious chance to collect real world HUMAN data on efficacy which is impossible in a non–outbreak scenario.

And most importantly, hopefully proving effective in stopping this horrific virus.

ILA’s SECOND manufacturing run of GMP-grade Galidesivir should mean that by Q4 this year, ILA will have ~700 to 800 treatment courses of Galidesivir made.

"Ready to respond to an active outbreak". (source)

Why further ramp up production of Galidesivir now?

A little bit like a resources exploration company making a discovery and getting more drill rigs on site... a strong sign.

The signal here is that ILA is getting ready to have its drug into the field all over Africa wherever it is most needed.

We remember ILA announcing something similar to today’s news back in early June. (source)

ILA kicked off its FIRST GMP manufacturing run of Galidesivir saying it wanted the ability to "respond to emerging infectious disease threats".

Five weeks later, the Uganda compassionate use approvals were announced.

(source) (source)

The World Health Organisation Director-General is currently saying:

"We must be frank: the epidemic is far from being under control." (source)

And:

“it is not known whether Ervebo (a different Ebola drug being used in the DRC) may be protective against the Bundibugyo virus in humans” (source)

It feels like there is more news to come here...

Maybe ILA’s drug gets put to use in the DRC too, the epicenter of the outbreak and by far the worst affected?

Six hours ago it was reported that 70,000 Ervebo vaccines are being deployed into the outbreak

DESPITE it only being proven effective against the more common Zaire strain of Ebola - it is not known whether Ervebo is protective against the current outbreak strain.

(and rightly so - they should be trying EVERYTHING they can to stop this spread - even long shots like this)

The current Bundibugyo strain of Ebola has no proven vaccines or treatments.

(source)

Given WHO has taken 70,000 vaccines on a safe treatment with unknown effectiveness, we like that ILA has got on the front foot by ramping up its manufacturing to 800 doses.

We think live use during an outbreak has completely transformed what the next 12 months looks like for ILA from a corporate perspective.

Because ILA is now re-running the same playbook that led to another Ebola drug (Ebanga) getting FDA approvals within 12-18 months of in-human use and a US$703M US stockpiling contract.

We think ILA's drug, right now, is where Ebanga was in 2018-19:

(existing animal trials, human safety data and now about to be used in humans to treat Ebola in an outbreak scenario)

(sources - Ebanga - (source)(source)(source)(source)(source)
(sources - Galidesivir - (source)(source)

Ebanga was used on infected patients during the last major Ebola outbreak in 2018-19. (source)

People who took that drug died ~35% of the time, patients who did NOT take it died 49% of the time. (source)

So a ~14% drop in death rate was enough to convince the US FDA to approve the drug in December 2020 only 12-18 months after the human data came in. (source)

And ~three years after THAT, the US government awarded Ebanga's owner a stockpiling contract worth up to US$704M. (source)

(source)

ILA already has animal data showing 100% survival when dosed within 48 hours of infection - versus 0% survival in the placebo group.

And Phase 1 human safety data.

(source)

So IF ILA's drug can show ANY meaningful improvement in survival in the field it could open the door to fast-tracked FDA approvals that potentially comes with:

1. A Priority Review Voucher (PRV) - Ebola was added to the FDA's tropical disease PRV program back in 2014, meaning an approved Ebola drug earns its developer a voucher (source).
   
2. Eligibility for US government stockpiling contracts - the kind Ebanga landed at up to US$704M (source).

PRVs matter because they are TRADEABLE - companies can sell them for cash.

The three most recent PRV sales went for US$180M, US$200M and US$205M. (source, source, source)

ILA is also going for fast-tracked approvals, government stockpiling deals and a PRV for Marburg disease too.

Marburg is the only Category A bioterrorism threat (the highest level) with NO current vaccine or FDA-approved treatment - which also makes it the biggest biowarfare risk.

ILA is about to start animal trials (going for fast-tracked approvals using animal data only) - those should start pretty soon.

🎓 We have covered the Animal Rule process in detail before here: The journey for ILA to get a drug to market in under 12 months

So, ILA will have two cracks at extremely valuable PRV and US stockpiling deals.

Right now ILA is capped at less than the value of a single PRV voucher at ~A$136M...

We think an ILA Ebola drug could be a lot closer to FDA approvals than the market thinks

So that Ebanga Ebola drug went from human data to approvals in ~12-18 months.

We think something similar could happen to ILA - if not quicker (depending on the data obviously).

Why?

Because the current Ebola outbreak is for the “BUNDIBUGYO strain”.

Right now there is NO approved vaccine and NO approved treatment for Bundibugyo Ebola. (source)

The vaccine the DRC is ordering right now is Merck's Ervebo - with 2,000 doses already in the country and another 500,000 requested.

(source)

That drug the DRC is relying on to tackle its Ebola outbreak is approved against the ZAIRE strain of Ebola.

No one knows if that drug does anything against Bundibugyo at all.

This is the same problem with the only other FDA-approved Ebola treatments (Ebanga and Inmazeb) - both are antibody drugs designed for the Zaire strain. (source)

(“Antibody drug” basically means it’s designed for one specific virus)

BUT ILA’s drug isn’t an “antibody” drug - which is why there is data showing ILA’s drug is effective against 20+ other viral diseases (including Ebola and Marburg).

(source)

We think there is a window open for ILA's drug to be deployed not just in Uganda...

... but potentially into somewhere like the DRC - where the outbreak is at its worst, and where the government is desperately looking for treatment options.

(going from 2,000 doses to requesting 500,000 doses is a serious increase)

Hopefully, today’s news - increasing manufacturing capacity is ILA getting itself ready for something like that:

It looks like ILA is getting ready for... something:

(today’s announcement - source)

Remember - last time the world needed an Ebola drug, US government agencies put US$70M+ behind testing ILA's drug against viral diseases... and that money went into ANIMAL trials (source).

The work is already done on animals and there is human safety data now, any positive human efficacy data and we think the transition to a treatment being used could be relatively quick...

We can see a world where things start moving very fast for Ebola - especially with the World Health Organisation having declared Ebola a “PHEIC”.

A PHEIC alarm level is “intended to mobilize international funding, coordination and emergency response efforts”.

Sort of like when COVID started spreading, the WHO declared it a PHEIC and then a global rush of attention and capital began looking for a cure.

(source)

PHEIC status for Ebola could mean we see a COVID style rush to get a vaccine/treatment approved for use in humans ASAP.

And maybe while they are at it ILA’s drug also gets considered for the other ~20 RNA viruses across 9 virus families it's been tested on already... (source)

Interestingly, earlier in the year ILA also signed:

• An R&D contract with the US Army's top biowarfare lab (USAMRIID) and a not-for-profit that manages ~US$383M in research funding across 39 Department of War installations.
• A research collaboration with Australia's Burnet Institute to expand ILA's antiviral pipeline into measles, chikungunya and Ross River virus (all three of which are targeting indications that could also be eligible for government stockpiling deals).

So ILA’s already got things happening in the background across all these other viral diseases.

Putting our Investor hats on, essentially, it’s like a free option for us on the drug working on any one of the 20 viral diseases it has been trialled against.

While we wait for that, the more predictable catalysts for ILA will come from its other program for Marburg disease.

Marburg is the only Category A bioterrorism threat (the highest level) with NO current vaccine or FDA-approved treatment - which also makes it the biggest biowarfare risk.

That also means the US has no stockpiles of any Marburg treatments or vaccines.

Making an FDA-approved Marburg drug a strong candidate for US government stockpile contracts.

For Marburg, ILA is weeks away from starting a dose optimisation study before it runs a second animal trial and goes for accelerated FDA approvals under the “Animal Rule” pathway.

🎓 We have covered the Animal Rule process in detail before here: The journey for ILA to get a drug to market in under 12 months

Over the next 3-9 months, ILA could be running at fast-tracked FDA approvals across TWO different deadly viruses at the same time...

... where EACH approval would be eligible for a PRV (~US$200M based on recent sales) AND US government stockpiling deals (US$100M to US$1.2BN in lifetime sales)...

... while ALSO simultaneously developing an oral version of its drug. (source)

So ILA has at least two shots at getting that PRV and US stockpiling contracts:

1. An FDA approved Marburg drug - animal trials running this year and FDA submissions expected in Q1-2027.
   
2. An FDA approved Ebola treatment - existing animal data, human use in a live outbreak approved and due within months.

Or both...

ILA’s drug is also being advanced for Marburg disease

Until today, ILA’s focus and most advanced indication was Marburg disease.

ILA’s drug has shown 100% survival rates against Marburg in animals 24-48 hours after infection, relative to placebo, where survival rates are 0%.

Overall, ILA’s drug has shown survival rates of up to 94% versus 0% survival in placebo.

(So we already have some idea of when the best times to dose might be - relevant to the first stage of work ILA has to do for approvals):

(Source)

Marburg is the only Category A bioterrorism threat (the highest level) with NO current vaccine or FDA-approved treatment - which also makes it the biggest biowarfare risk.

That also means the US has no stockpiles of any Marburg treatments or vaccines.

Making an FDA-approved Marburg drug a strong candidate for US government stockpile contracts.

Which range between US$100M to US$1.2BN in lifetime sales (source)

The table below shows existing stockpiling deals the US government has done for other Category A bioterror threats:

(source)

The US tries to maintain stockpiles of treatments against all kinds of nasty diseases that can be weaponised.

But it has nothing to counter Marburg disease.

Marburg disease is the only ‘Category A’ bioterror threat gap that remains unfilled.

We Invested in ILA as we think it has a very good chance of filling this gap, and it can be paid handsomely for it.

The US government has already shown it's willing to spend hundreds of billions on a critical military minerals stockpile.

In these times you can imagine how much they could be willing to spend to protect against biological weapons - the threat its own intelligence says is coming from Iran - the country it's currently at war with.

ILA’s Marburg treatment has qualified for the FDA’s Animal Rule - a special “urgency” approval ruling given by the US FDA to bypass human trials that can cut 10 to 15 years off US FDA approval for a drug.

ILA is also eligible for a Priority Review (PRV) voucher.

These PRVs are a tool the FDA uses to incentivise companies to develop treatments for rare paediatric diseases, tropical diseases, or medical countermeasures...

... and these vouchers are tradeable on the open market.

Here are the three most recent sales ranging from US$180M to US$205M:

(source)(source)(source)

IF the FDA approves ILA’s drug it could receive one of these tradeable vouchers.

Which we think is material on its own given ILA’s current market cap is ~A$136M.

(As mentioned earlier - Ebola actually fits into the same category as the Marburg treatment - also potentially PRV/stockpiling eligible)

(source)

ILA’s Marburg drug is approved for an accelerated FDA approvals process

A big part of the reason why we made ILA our Biotech Pick of The Year back in November was because ILA has received confirmation that it is eligible for the Animal Rule pathway.

Animal Rule approvals are typically only available for treatments on diseases that are too deadly to run Phase 1/2/3 clinical trials in humans on.

(skipping the typical 10-15 year Phase 2 and 3 trial process for drugs trying to get to market).

To get approved under the Animal Rule process, ILA now needs to complete the following two step trial process:

• The first stage is an optimisation study - to work out the optimal dose and when to administer that dose
  
• The second pivotal confirmatory study will follow right after - The pivotal study will be when we see how effective ILA’s Marburg drug really is. Fingers crossed it improves on the previous studies, which had survival rates averaging 94%.

Next we want to see ILA execute the following:

1. ✅ 17th November: ILA confirms Animal Rule eligibility for its Marburg drug
   
2. ✅ 4th February: staged approach for FDA approvals confirmed
   
3. 🔄 NEXT: We want to see ILA start “optimisation studies” ahead of a pivotal study later this year.
   
4. 🔄 Ongoing: We want to see ILA sign more agreements with Biosecurity Level 4 (BSL4) facilities that are able to run animal studies - more sites means the studies can be completed quicker.
   
5. 🔲 THEN, we want to see ILA start animal trials (pivotal trial) for Marburg disease. (this is the big one)

Here are the milestones we will be tracking for the animal study:

• 🔲 Clinical trial design completed
• 🔲 Clinical trial starts
• 🔲 Clinical trial completed
• 🔲 Clinical trial results

Assuming the clinical trial results are positive, ILA will then submit to the FDA for a New Drug Application (NDA) of its drug (typically a 6-month review timeframe).

And all of this happens inside the next 12 months. ILA is targeting regulatory submissions in Q1-2027:

(source)

Again... IF APPROVED...

ILA COULD SECURE a Priority Review Voucher, which is a tradeable asset (which have traded at around ~US$200M of late).

(source)

AND/OR, ILA COULD SECURE commercial stockpiling contracts with the US Department of Defense for protection against bioweapons.

As mentioned earlier, some of these can have lifetime deals >US$500M:

(source - stockpiling deals the US government has done for other Category A bioterror threats)

What's next for ILA?

🔄 Ebola (Uganda deployment):

• ✅ Government + regulatory approvals for compassionate use in Uganda
• 🔄 Drug supply / manufacturing scale-up (additional supply commissioned today - source)
• 🔲 First patients dosed (due within CY2026) - (source)
• 🔲 First human efficacy, safety and virological data from the field
• 🔲 Any expansion of deployment beyond Uganda (DRC?)

🔄 Animal rule approvals process for Marburg disease

Here are the two next major milestones for ILA’s Galidesivir drug:

• Stage 1 - Optimisation study - Working out the optimal dose and the best time to administer it.
  
• Stage 2 - Pivotal confirmatory study - The big one - this will determine how effective Galidesivir really is. Fingers crossed it improves on that 94% survival rate.
  

Here are the milestones we are tracking for the trials:

Stage 1 - Optimisation study:

• ✅FDA confirmed Animal Rule eligibility
• ✅FDA confirmed staged approach for approvals
• ✅CRADA (Cooperative Research and Development Agreement) signed with USAMRIID (US Army’s premier infectious disease research institute) and Geneva Foundation (highly influential non-profit that manages nearly US$383M in military medical research funding)
• 🔄Optimisation study (commencing soon)
  

Stage 2 - Pivotal study:

• 🔲 Pivotal study design completed
• 🔲 Pivotal study commences
• 🔲 Pivotal study results
• 🔲 FDA submission (NDA)

Here is an indicative timeline on when to expect all of the above from ILA’s recent presentation:

(source)

What are the risks?

The primary risk for ILA now is “clinical trial risk”.

ILA de-risked its drug from a regulatory perspective, getting approved for the Animal Rule process (for Marburg).

For ebola, there is no guarantee the in human trial data is sufficient enough to get FDA approvals.

ILA may need to run additional clinical trials, which could have significant cost overruns and time delays.

There is also no guarantee that the clinical trials will deliver results strong enough for the FDA to approve ILA’s Marburg Drug.

Negative clinical trial results could hurt the ILA share price.

Source: “What could go wrong” - ILA Investment Memo 21 May 2025

Other risks

Like any early-stage biotechnology company, ILA carries significant risk, here we aim to identify a few more risks.

While Galidesivir has shown promise in animal models, there is no guarantee it will be effective in humans infected with the specific Bundibugyo strain of Ebola. If the drug fails to meaningfully improve survival rates during the live outbreak, the company's path to fast-tracked FDA approval could be completely derailed.

Deploying an experimental drug into active, volatile outbreak zones across Uganda and potentially the Democratic Republic of Congo involves massive logistical and geopolitical challenges. Instability or infrastructure issues in these regions could easily delay patient dosing, disrupt vital data collection, or halt the deployment program entirely.

Even if the clinical data is overwhelmingly positive, ILA relies heavily on the FDA granting a Priority Review Voucher and the US government actually awarding a stockpiling contract. Regulatory frameworks can unexpectedly shift and government defense budgets may change, meaning these highly anticipated financial windfalls are far from guaranteed.

Investors should consider these risks carefully and seek professional advice tailored to their personal circumstances before investing.

Our ILA Investment Memo

You can read our ILA Investment Memo here. We use this memo to track the progress of all our Investments over time.

Our ILA Investment Memo covers:

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