EMD presents at US FDA psychedelics hearing and appoints former US Veterans Affairs Secretary as “strategic advisor”

Disclosure: S3 Consortium Pty Ltd (the Company) and Associated Entities own 13,743,293 EMD Shares and 5,822,221 EMD Options and the company’s staff own 138,889 EMD Options at the time of publishing this article. The Company has been engaged by EMD to share our commentary on the progress of our Investment in EMD 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.

Yep... that's our Investment Emyria’s (ASX:EMD) Executive Chairman Greg Hutchinson presenting in front of the US FDA.

At the “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” hearing.

As “one of a limited number of in-person” speaking positions. (source)

It feels like EMD is slowly preparing itself to enter the US psychedelics scene.

That FDA hearing was last Tuesday...

This morning EMD also appointed Dr David Shulkin - the former US Secretary of Veterans Affairs - as a Strategic Advisor.

The second US centric move by EMD in a week.

(source)

(more on why we like the Shulkin appointment in a second)

First, why is an ASX small cap a speaker at a US FDA public hearing?

Because EMD is one of the only companies in the world running fully authorised, legal psychedelic therapy clinics.

EMD got that first mover advantage because the Australian TGA was first in the world to legalise psychedelic therapies back in 2023.

Ever since then EMD has been rolling out psychedelic therapy clinics across Australia.

EMD currently has:

TWO clinics operating in Western Australia, one in Queensland, one in Victoria and one about to open in NSW.

EMD also has a payer deal with Australia’s largest private health insurer, Medibank, plus eligible veterans can have EMD's treatment funded by the Department of Veterans' Affairs (DVA).

Meaning the two organisations pay for their members to receive therapies at EMD’s clinics:

(source)(source)(source)

EMD’s rollout across Australia has taken the business from ~$1.3M in revenues in FY25 to ~$4M in FY26. (source)

EMD is currently capped at $40M with $7.3M cash in the bank at 30 June 2026.

So far so good in Australia and we think those numbers can continue growing...

(Of course it’s a small cap stock we are talking about - no guarantees here)

BUT a big part of why we are Invested in EMD is because we think psychedelic therapies will eventually become more accepted and eventually legalised around the world.

And IF/WHEN it does, EMD will be one of the companies that is able to copy and paste its business model in said country quickly.

Now, the first part of that looks like it might be about to happen.

Five months ago, US President Trump signed an Executive Order with Joe Rogan in the building - hell of a way to give psychedelic therapies free publicity, having the biggest podcaster in the world there for signing):

(source)

That EO was to accelerate access to psychedelic based treatments for patients with serious mental health conditions and said it will "increase clinical trial participation and evidence generation”.

(Exactly what EMD’s been doing for years)

Then... last Tuesday EMD presented that real life evidence at its “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” public hearing:

(here is a link for anyone who wants to watch through the whole thing)

The key takeaway for us after watching through the hearing is that the US regulators seem like they are open to psychedelics in healthcare.

BUT have no idea how psychedelic drugs will be administered to patients effectively.

Right now the FDA doesn’t have anything concrete written into regulations for delivering psychedelic therapies.

BUT on the drug development side there is a lot of interesting things happening right now.

We recently came across this article which highlights two of SpaceX’s directors spending millions to make psychedelics mainstream:

(source)

And then there is the big M&A deal - $1.4 trillion Eli Lilly (the maker of weight loss drug Mounjaro) acquired psychedelic drug developer AtaiBeckley for up to US$3.8BN:

(Eli Lilly isn’t exactly the company that is going to move into a new area for crumbs, they would only be doing it if they think there is a meaningful payoff for them)

(source)

Then there is the Priority Review Voucher (PRV) that were given to three companies developing psychedelic drugs (source).

And right now, the most advanced company developing a drug is $3BN Compass Pathways which expects to commercially launch its psychedelic drug in the “first half of 2027”:

(source)

Baby steps for the industry, but it looks like the first FDA approved psychedelic drug is coming...

Our view is that once a few of these big drugs are FDA approved - the clinical delivery setting will start to get a lot of regulatory (and capital) attention.

And it looks like EMD is getting ready for a big US push

This morning EMD appointed Dr David Shulkin as a Strategic Advisor.

Shulkin used to run the US Department of Veterans Affairs - Barack Obama appointed him Under Secretary for Health in 2015.

Donald Trump then promoted him to Secretary of Veterans Affairs in 2017.

In that role he was responsible for ~1,400 facilities and healthcare for over 9 million US veterans. (source)

Shulkin’s ASX connection came from his time at 4D Medical - where he has been an advisor since April 2023. (source)

Here's what happened with 4D Medical on the US federal side in the ~3 years Shulkin’s been there:

• May 2024 - 4D Medical partners with the West Los Angeles VA Medical Center on a veteran lung imaging study. (source)
  
• January 2025 - 4D Medical signs a US Department of Defense pilot to scan active-duty service members. (source)
  
• July 2026 - a bipartisan bill is introduced in the US Congress directing the VA to set up a US$20M pilot program licensing FDA-cleared 4D functional lung imaging software. (source)

4D Medical shares were trading at ~87c the week Shulkin joined.

Today 4D Medical is capped at ~A$2.6BN - shares last traded at ~$4.31, having traded as high as $7.55 in the past 12 months. (source)

(source)
The past performance of 4DX is not and should not be taken as an indication of EMD's future performance.

Hopefully Shulkin’s involvement at EMD can help emulate that Veteran Affairs success 4D Medical had.

Remember EMD is able to administer the Psychedelic Assisted Psychotherapy funded by the DVA which allowed funding treatment for eligible veterans in Australia from October last year. (source)

Veterans are one of the biggest PTSD demographics anywhere.

The VA's own numbers say 7 in every 100 US veterans will have PTSD in their lifetime - and for those who served in Iraq and Afghanistan it's 29 in 100. (source)

PTSD is exactly what EMD treats with MDMA-assisted therapy - and it's the indication where EMD has already published 12-month real-world remission data (more on that below).

Australia's DVA has roughly 291,000 veterans and spends about A$12.8BN a year. (source)

The US VA has ~9.2 million enrolled veterans and has a budget of US$445BN. (source)

That's ~30x the capacity to spend.

And the US Veterans Affairs is already moving on psychedelics.

In July, the VA and the US Department of Health signed an MoU to work together on psychedelic research and "the responsible deployment" of future FDA-approved therapies for veterans. (source)

The VA currently now has 20 active clinical trials running on psychedelic therapies.

(source)

The connection to EMD actually comes from the MOU committing to training therapists, nurses and doctors to deliver the treatments, building care delivery models, and preparing the VA system so it's ready the day a drug gets approved. (source)

EMD has been answering those exact questions with real patients in Australia for over three years...

We think Shulkin's presence validates what EMD is doing - and positions the company a lot better IF the US VA ever wants to do what the Australian DVA has already done with EMD.

The next big catalysts we are looking out for from EMD

We think the two biggest catalysts going forward for EMD will be related to:

1. How many "payers" emerge for EMD's service - there is already Medibank & the Department of Veterans’ Affairs (a payer is the group funding patient treatments on their behalf)
2. Which indications (specific mental health issues) get legalised for psychedelic treatments - at the moment, EMD can legally treat PTSD and Treatment-Resistant Depression.

On the payer's side we think everything happening in the US could work in EMD’s benefit.

The US Executive Order Trump signed makes it more likely that any company developing a psychedelic drug would become a willing “payer” for EMD’s clinical services...

EMD’s Executive Chair Greg Hutchinson talked to this in a webinar a few months ago saying ~A$3BN NASDAQ listed Compass Pathways was finding it difficult to deliver their drug.

He references an AFR article which mentioned how hard it is to take because of the professionals needed to administer it (which is exactly what EMD specialises in).

Greg hammered that point home saying how EMD is “uniquely positioned to be able to assist” with the delivery of psychedelics to patients.

(skip to 4:30 - also, here is the AFR article he references)

Then there is all of the stuff “Elon Musk’s inner circle” and $1.4 Trillion Eli Lilly - all of those companies will need some sort of delivery partner (if the FDA decides that is the way these drugs get approved and delivered to patients).

(source)(source)

Greg hammered that point home saying how EMD is “uniquely positioned to be able to assist” with the delivery of psychedelics to patients.

On the indications side:

We read the following article in the Australian which said “considering whether to expand access to psilocybin-led therapy to people in end-of-life distress".

(source)

Palliative care alone in Australia means hundreds of thousands of patients per year.

Ultimately, what we want to see is progress on the image below (more of the circles move from scoping into active status):

(source)

We already know EMD's therapy works - and better than expected

Back in February, EMD published real-world data showing that its PTSD treatment program produces durable, lasting recovery.

EMD showed that two thirds of patients were in “remission” - not just at the end of treatment, but over 12 months after treatment ended.

(Remission means a significant decrease in, or disappearance of the signs and symptoms of a disease by a particular treatment).

And that patients were continuing to improve even after EMD’s therapy was complete.

Improvement post therapy is a strong signal because it tells us that EMD’s treatments aren’t just suppressing symptoms temporarily - it's leading to genuine, lasting recovery.

In a cohort of patients with severe, treatment-resistant PTSD who had tried everything else and failed, ~67% no longer met the criteria for a PTSD diagnosis more than a year after EMD's psychedelic-assisted therapy.

~76% showed clinically significant improvement.

(source)

The one case study we found super interesting was of “Kate” - a first responder with cumulative workplace trauma. She was on permanent disability for nearly 5 years, tried every therapy under the sun, and was completely stuck.

Six months after EMD's MDMA-assisted therapy, she returned to work.

More than 12 months after treatment, she remains in remission.

(EMD reported 10/10 patients with work-related PTSD returned to work within 6 months of finishing treatment)

(source)

The ABC report also covers the story of Jess Yugovich who tragically lost her three-year-old daughter. Jess underwent MDMA-assisted psychotherapy at EMD’s Empax clinic, and the results were life saving for her:

(Source)

Ultimately, rolling out these treatments in Australia (and the rest of the world) forms the basis for our EMD Big Bet as follows:

Our EMD Big Bet:

"EMD re-rates to a +$300M market cap by making a breakthrough with one or more of its clinical trial programs (MDMA, psilocybin, ketamine, CBD) while rapidly growing the footprint of its mental health treatment clinics."

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 a lot of work to be done, many risks involved - just some of which we list in our EMD Investment Memo.

Success will require a significant amount of luck. There is no guarantee that our Big Bet will ever come true.

What we want to see next from EMD

EMD execute its national rollout in Australia

We want to see EMD open more clinics around Australia.

Here are the milestones we are tracking:

• ✅ WA, QLD and VIC clinics - operational
• ✅ NSW recruitment completed
• 🔄 NSW clinic opened (expected this month, source)

🔲 Revenue growth from existing clinics

With clinics now running in three states and NSW on the way, we want to see patient throughput and revenue building.

🔲 New payer deals

EMD has both Medibank Private (~$13BN market cap) and DVA (government program) as current “payers” for its treatment protocol.

A big win for EMD would be to get new payers into its network.

We note EMD also has approvals to treat Workcover patients in Australia.

The BIG new one would of course be out of the US.

🔲 Expansion into new indications

We also want to see EMD expand its therapy programs to new indications and drug therapies over time to broaden its addressable market beyond PTSD and treatment-resistant depression.

Here is the image we shared in a recent note which helps visualise the impact this would have on EMD’s business.

What we want to see over the coming months is that more of those circles move from the “scoping” stage into the “active” stage, this is where EMD gets the revenue...

(source)

What are the risks?

Clinic scale ups are not easy to execute, especially across multiple geographic locations.

EMD must replicate its Perth success in multiple states, which involves securing new physical locations, establishing more payer relationships as well as onboarding qualified physicians.

This may not run smoothly by running into unforeseen issues, so until EMD achieves self-sustaining profitability it remains reliant on external market funding to fuel this growth.

Any delays in the scale up could impact the market’s perception of EMD’s ability to execute its strategy and re-rate the company's share price lower.

Scale up risk

Even though EMD can secure funding for Medibank, there is a lot that needs to go right in terms of scale. This includes securing more sites to operate its services as well as securing more MDMA supply to meet the expected demand. Scaling costs money, and EMD needs to reach a level of profitability before it can scale without continuing to tap the market for resources.

Source: “What could go wrong” - EMD Investment Memo 18 June 2025

Other risks

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

With $7.3M in cash as of mid-2026 and an aggressive national rollout underway, EMD runs an ongoing risk of high cash burn. If revenue growth trails scaling expenditure, the company may need to raise further equity capital, leading to potential shareholder dilution.

EMD’s long-term upside hinges heavily on international regulators like the US FDA approving and integrating psychedelic therapies into healthcare systems. Any regulatory setbacks, trial failures, or policy delays in key markets like the US could significantly stall expansion prospects.

Delivering specialised psychedelic-assisted therapy requires a credentialed pool of authorised prescribers and therapists. If EMD encounters recruitment bottlenecks or key talent shortages, clinic throughput and rollout timelines could be constrained.

The financial model relies heavily on third-party payers like Medibank and the Department of Veterans' Affairs funding patient care. Any future changes to reimbursement rates, coverage criteria, or policy frameworks from key partners could negatively impact revenue projections.

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

Our EMD Investment Memo

You can read our EMD Investment Memo in the link below.

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

Our EMD Investment Memo covers:

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