IIQ: Results due within 13 days...?

Disclosure: S3 Consortium Pty Ltd (the Company) and Associated Entities own 1,369,000 IIQ Shares and 575,000 IIQ Options at the time of publishing this article. The Company has been engaged by IIQ to share our commentary on the progress of our Investment in IIQ 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.

Ovarian cancer is one of the deadliest gynecological cancers in the world.

Our $41M capped biotech Investment Inoviq (ASX:IIQ)’s ovarian cancer test detected 100% of early-stage (Stage I and II) ovarian cancers in a 500 sample control study.

With NO missed early-stage diagnoses.

At 99.6% specificity (meaning almost no false alarms).

For a disease that's normally invisible until it's too late, that is a really good outcome.

And now, after over 12 months of further work and tests by IIQ, over the next couple of weeks we should find out:

1. IF IIQ’s ovarian cancer detection test replicates that strong early data over a bigger trial (a 2,000‐sample clinical study has been underway), and
   
2. IF IIQ has a working pre-clinical therapeutic to TREAT ovarian cancer (IIQ has lab data on a therapeutic also coming this month).

Remember IIQ is capped at $41M right now.

Pre-clinical exosome & cell therapy therapeutics products (like what IIQ is working on) have in the past sold for between US$882M to US$1.2BN.

Both of those catalysts are due “this month” (13 days).

Ovarian cancer is deadly and is usually silent and undetectable until it has already spread.

Catch it at Stage 1 and survival rate can be over 90%.

Catch it at Stage 3 or 4 and survival rate drops to around 30%.

So if you can catch it early, it's potentially life-saving.

At the moment there is no approved screening test that healthy women can take to catch ovarian cancer early.

So the big problem is ovarian cancer is usually asymptomatic (no symptoms) in the early stages of the disease, and ~70% of all ovarian cancer is diagnosed as stage 3 or 4 cancer. (source)

Where it's too late and the survival rate has dropped to as low as ~30%.

Meaning that IIQ non-invasively detecting 100% of early-stage (Stage I and II) ovarian cancers With NO missed early-stage diagnoses at 99.6% specificity could be a game changer IF this early data is demonstrated at scale, and it ultimately gets approved for use.

The addressable market for screening ovarian cancer is 243M women every 1 to 2 years:

(source)

IIQ is developing its ovarian cancer test using its “exosome” platform technology.

It's also using that same technology IIQ is using to develop treatments for cancer (more on that in a second).

Exosomes are tiny, microscopic extra-cellular “containers” that carry ‘messages’ between the human body's cells that allows the human body to function.

IIQ is basically trying to use those containers to receive messages (diagnostics) and send messages (therapeutics) (more on the tech later).

IIQ’s lead product right now is a blood test for ovarian cancer based on exosomes.

If it works at scale - and we should know a whole lot more in the coming weeks - it could replace the current ovarian-cancer diagnostic pathway.

(which today involves medical imaging followed by surgical biopsy)

So from this process:

To just a simple blood test like any other, with IIQ’s tech.

(source)

As mentioned earlier, ovarian cancer has one of the worst late-stage survival rates of any major cancer because it's almost always detected too late.

The moonshot for IIQ is if its exosome tech can be applied as therapeutics - targeted treatment for hard to treat cancers.

BUT, at this point, IIQ’s therapeutics program is at a far earlier stage.

What’s been happening to the IIQ share price? Wen news?

IIQ has been fairly quiet over the last ~6-9 months (outside of quarterly reports and one material announcement back in December).

Understandably, the market has slowly sold off the stock, presumably due the lack of newsflow. IIQ’s share price has come down as low as 29.5c per share - well below the last capital raise at 35c per share (our initial entry price is 50c).

The past performance is not and should not be taken as an indication of future performance. Caution should be exercised in assessing past performance. This product, like all other financial products, is subject to market forces and unpredictable events that may adversely affect future performance.

Just because IIQ’s been relatively quiet on the announcements front - it doesn't mean they haven’t been working on anything.

We call this “quiet execution mode” - where a company needs to put their heads down and do the work, meaning a quiet period followed by announcing the results of the work.

IIQ now has two pretty big data readouts coming “this month” (13 days to go...):

1. For its exosome-based blood test for screening ovarian cancer in asymptomatic women - previous testing on ~498 samples showed 100% detection of Stage I-II ovarian cancers, with no missed early-stage diagnoses. Now IIQ is doing the same testing on 2,000 different samples.
   
2. For its therapeutics program (using their exosome tech to target solid cancers) - IIQ has “in-vitro” ovarian cancer-killing data coming.

We think any strong data across either of those could get the market engaged again.

(source)

Now, back to that IIQ share price...

We are not chartists, but it does feel like IIQ has started to build a nice base around the ~30c/share mark - especially with all the director buying in the stock over the last ~6 months:

(source)

The past performance is not and should not be taken as an indication of future performance. Caution should be exercised in assessing past performance. This product, like all other financial products, is subject to market forces and unpredictable events that may adversely affect future performance.

Just yesterday IIQ traded down to 29.5c per share - the lowest price IIQ has traded since ~2018 - that’s two FIFA World Cups ago.

Meaning IIQ’s current market cap is ~$42.5M with $11.9M cash in the bank at March 31 (an ~$29.6M EV).

We think this is one of those situations where the markets are being short termist and not willing to stick around while IIQ does all of the technical work to get its Ovarian Cancer test closer to FDA submissions.

(let alone wait around for the pre-clinical therapeutics program)

We ALSO think IIQ is one of those stocks getting hit hardest by tax-loss selling.

(In Australia, the financial year ends 30 June - so investors sitting on a loss often sell before then to book a capital loss against their gains. It's about tax, not the company.)

If that's what's been pushing IIQ down into its lows...

...then whoever was selling may have already finished - or is almost done “rage selling”.

Which could leave clear air for the share price to run into good news.

And as we have said a few times in this note, two pieces of potential good news (if the data is good) are due in a matter of weeks:

The next two catalysts could revive market interest in IIQ

We are long term investors in IIQ - we came in at 50c per share and added to our position at 35c in the last capital raise.

We think the initial results from IIQ’s first ovarian cancer test study were really strong.

We actually remember reading the announcement and then writing our note covering the results next to a train museum in Sacramento while in the US for some site visit last year.

We sat outside on a park bench waiting for the ASX to open and missed checking out the old town around us...

That first test was across 498 blood samples and detected 100% of early-stage (Stage I and II) ovarian cancers - with no missed early-stage diagnoses.

At 99.6% specificity (meaning almost no false alarms).

For a disease that's normally invisible until it's too late, that is a really good outcome.

Now, IIQ is running an expanded study across ~2,000 blood samples - the kind of larger, tougher test a result needs to survive before anyone takes it to market.

That expanded study's ovarian cancer-control results are on track for completion in June 2026.

And IIQ expects to have the the ovarian cancer test Laboratory Developed Test (LDT) ready by the end of 2026 as of its most recent quarterly:

And there's the SECOND catalyst due this month too.

IIQ is engineering exosomes to carry a tumour-targeting "address label" AND a cancer-killing payload...

...so they hunt down cancer cells and destroy them - without the brutal side effects (and ~US$500k-per-dose price tag) of today's cell therapies.

We think the therapeutics could end up even bigger than the test.

In the lab, IIQ's exosomes have already killed 88% of triple-negative breast cancer and lung cancer cells within 96 hours.

(Source)

In mice, the same approach cut tumour burden by 61.5% and 100% of treated mice survived. (source)

New in vitro (lab) data on its exosome cancer-killing therapy in ovarian cancer is due this month.

If IIQ can show that same cancer-killing effect in ovarian cancer cells this month, it extends the platform to a second tumour type.

Success here could put IIQ into the same conversation as all the other cell therapy/exosome companies that were attracting billion-dollar deals...

The last four on the list below were all working on exosome technologies - all did deals at the pre-clinical stage with total deal values ranging from US$882M to US$1.2BN.

Remember IIQ is currently pre-clinical with its therapeutic and is capped at $41.5M.

(source)

IF IIQ can prove out what could be a more scalable platform tech, then maybe the deal values would be multiples of those in the table above too.

No guarantees of course - this is high risk small cap stock investing, anything can happen.

(Source)

Why we like IIQ’s Ovarian Cancer screening tool

Ovarian cancer is the world’s deadliest gynaecological cancer.

Ovarian cancer is often called the ‘silent killer’ - as it is usually asymptomatic (no symptoms) in the early stages of disease.

Early detection is incredibly important for ovarian cancer.

If a woman is diagnosed at Stage 1 - the survival rates can be over 90%.

If a woman is diagnosed at later stages, then the survival rates drop significantly - only 29% of women survive if the cancer is detected at stages 3/4.

The big problem is that ovarian cancer can be asymptomatic in the early stages - meaning most women will never know they had it until it's too late.

For example, ~70% of all ovarian cancer in Australia is diagnosed as stage 3 or 4 cancer.

At the moment, there is no way of testing for and detecting ovarian cancer EARLY in women.

IIQ is in a position to develop the first ever test that can be used by all women periodically for a routine check.

Currently, no ovarian cancer screening tests are approved by regulators - due to their poor early-stage detection of cancer.

Earlier this year, IIQ released results that showed its ovarian cancer test was almost 100% accurate across ~500 tests.

IIQ’s test accurately detected all early-stage I and II cancer with no missed diagnoses (the earliest stages).

(Source)

Stage 1 and 2 ovarian cancer is usually when patients are asymptomatic (no symptoms).

Currently, ~70% of ovarian cancer is diagnosed in stages 3 and 4.

Those stages are also the periods where early detection can mean the highest survival rates:

With IIQ’s “breakthrough” results, the company has the opportunity to develop and commercialise the first-ever “population screening” tool for ovarian cancer.

(this means anyone can quickly and easily take the screening test)

Now IIQ is focused on getting enough data to achieve regulatory approval for its ovarian cancer screening test, before it can be commercialised.

The world needs an early stage ovarian cancer test that can be used by all women (not just women who are already known to be high risk), and IIQ may have demonstrated they can develop it.

The big opportunity now for IIQ is for its screening test to be used by all healthy women periodically for a routine ovarian cancer check.

Similar to the way men are routinely tested for prostate cancer.

There is currently US$323M spent each year on screening for ovarian cancer - and that's just in high risk patients.

To be able to detect ovarian cancer early, all women need to be tested, not just high risk women, which could make the screening market for ovarian cancer a lot bigger than it is today.

Ovarian cancer affects over 1 million people each year, and is the world’s deadliest gynaecological cancer.

According to the following slide from IIQ’s October 2025 investor presentation, a screening tool could potentially reach ~243M women every 1-2 years only across the 9 major markets globally:

(that is a lot of screening tests...)

(source)

IIQ’s pathway to regulatory approval for its ovarian cancer screening test

There are two paths that IIQ is pursuing to get its screening test being used in practice:

1. Lab Developed Test (smaller commercialisation pathway, faster to get real world data)
2. In Vitro Diagnostic pathway (standard pathway for FDA approval of medical tests)

(more on both those pathways below)

(Source)

Lab Developed Test (LDT) pathway to commercialisation

A Laboratory Developed Test (LDT) is a medical test that’s designed, created, and used inside a single certified lab, rather than being sold as a commercial test kit.

IIQ will be looking for a partner (a physical lab) in the United States to develop a Laboratory Developed Test (LDT).

This will be a central place where patients can come in and undertake IIQ’s test - granting IIQ very valuable “real world data” to advance its regulatory approval.

The LDT is a faster way for IIQ to get its test patients (in a lab setting rather than an off the shelf test) and gather some real world data in anticipation for a larger study.

A company like IIQ developing an ovarian cancer screening test might choose the LDT pathway before, clinical validation study to:

• Prove demand for its product
• Collect more patient data and potentially optimise the algorithm
• Attract partners or investors for a larger clinical validation study.

In Vitro Diagnostics (IVD) pathway to commercialisation

The IVD pathway is the FDA’s formal process for proving test works and then getting permission to sell it as a medical device.

IIQ will first seek “Breakthrough Device Designation”, which will be the first hurdle under this pathway.

Breakthrough Device Designation is a special fast-track pathway for medical devices and diagnostics that could dramatically improve patient care.

Given IIQ’s results so far (where there were no misdiagnoses), we think there is a chance that IIQ could achieve this milestone.

With Breakthrough Device Designation, IIQ will then undertake a much larger clinical validation study (roughly 20,000 patients).

Our IIQ Big Bet

“IIQ re-rates to a +$500M market cap on commercialisation of its breast cancer test, its ovarian cancer test, neurodegenerative disease test and/or its solid tumour (breast cancer) therapy.”

NOTE: our “Big Bet” is what we HOPE the ultimate success scenario looks like for this particular Investment over the long term (3+ years). There is no guarantee that our Big Bet will ever come true. There is a lot of work to be done, many risks involved, including technology risk, scale up risk, regulatory risk and development risk - just some of which we list in our IIQ Investment Memo.

Success will require a significant amount of luck. Past performance is not an indicator of future performance.

How IIQ’s technology actually works

We have spared the science lesson in this note so far, but if you have made it this far in the note, its time.

So IIQ has a proprietary exosome platform with multiple research, diagnostic, and therapeutic applications.

Exosomes are tiny “packages” released by all human cells to help them communicate with each other.

Exosomes are 200 times smaller than a cell.

They work by carrying molecular cargo (like DNA and proteins) that act as cell messages.

These messages can also be used as biomarkers for disease and help humans understand and diagnose whether someone has a particular disease.

The penny dropped for us when we started thinking of exosomes like postal workers delivering the mail to houses.

(communication between cells - mail to houses)

The postal workers (exosomes) are given an address (the cell) and the mail to deliver (communication between cells).

By snooping in on what “messages” individual exosomes are carrying, IIQ can detect diseases at a very early stage (diagnostics), often before the body is showing any physical symptoms.

And because the exosome is carrying messages that contain information about the LOCATION of which cells have a disease.

IIQ can insert treatments for that disease into the exosome, which then proceeds to deliver it to the exact cells with the disease.

Think of it like knowing that a letter is being mailed to the home address of a bad guy...

and inserting a letter bomb.

Wow, our innocent "exosomes are like a mailman” analogy certainly just got pretty dark...

What's next for IIQ

Here is a quick summary of the key catalysts we will be watching out for over the coming months:

Ovarian Cancer Test

• 🔄 Expanded ~2,000-sample ovarian cancer study (analysis started April 2026 - results due THIS MONTH)
• 🔄 Secure a partner / physical lab for clinical validation studies.
• 🔄 Secure breakthrough device designation

Solid Tumour Therapy

• 🔄 First in vitro (lab) ovarian cancer-killing data for the therapy (THIS MONTH)
• 🔄 Triple Negative Breast Cancer therapeutic data (Q3 2026),

We think the following slide from the IIQ investor presentation summarises the key share price catalysts pretty well:

(source)

What could go wrong

The single biggest risk right now is clinical/data risk on the bigger study.

IIQ's standout 100%-early-detection result came from a 498-sample study.

The whole point of the ~2,000-sample study (the one with results due this month) is to stress-test that result across more patients and harder, more "confounding" conditions.

Bigger studies very often produce more modest numbers than the early ones - and if EXO-OC's accuracy slips meaningfully when tested against the harder cohort, the investment case takes a real hit.

Other risks

Like any small-cap biotechnology company, IIQ carries significant risk, here we aim to identify a few more risks.

First, IIQ’s promising therapeutics program is still in its pre-clinical infancy, having only been tested in laboratory environments and mice. Translating successful in-vitro or animal data into human clinical trials is notoriously difficult and carries an incredibly high statistical failure rate.

The company also faces steep regulatory and commercialisation hurdles as it attempts to bring its ovarian cancer diagnostics to market. Securing a reliable US laboratory partner for the LDT pathway or launching a massive 20,000-patient clinical study for formal FDA approval will be operationally complex.

Furthermore, medical development is a highly capital-intensive process. While IIQ currently holds $11.9M in cash, funding global trials and ongoing platform research means a high cash burn rate that could lead to future capital raises and shareholder dilution.

Finally, even a successful regulatory approval does not guarantee commercial victory due to market adoption risks. Overturning entrenched medical habits such as moving doctors away from traditional imaging and surgical biopsies toward a new exosome blood test takes considerable time and sales effort.

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

Our IIQ Investment Memo

Our Investment Memo provides a short, high-level summary of our reasons for Investing.

We use this memo to track the progress of all our Investments over time.

In our IIQ Investment Memo, you can find the following:

• What does IIQ do?
• The macro theme for IIQ
• Our IIQ Big Bet
• What we want to see IIQ achieve
• Why we are Invested in IIQ
• The key risks to our Investment Thesis
• Our Investment Plan