FDA invites Emyria (ASX: EMD) to speak in Washington

Good morning, Armchair Army,

Welcome to today's edition of The Armchair Analyst, a 5-minute daily update on the ASX life-sciences sector.

For nearly 40 years, mental health treatment has followed the same story.

A daily pill.

Therapy.

More therapy.

Then another pill when the first one stops working.

SSRIs (like Prozac and other antidepressants) changed how mental health was treated.

But they manage symptoms rather than fix the problem.

Psychedelics promise something different.

Long-term, durable results.

There is now a race to get the first psychedelic medicine approved in the US.

(Even Eli Lilly has entered the race)

But when it’s approved… what happens next?

How do you actually get the drug to patients safely?

Emyria (ASX: EMD | MC: $36 million | Cash: $7 million) has spent the past three years figuring out how to scale delivery.

Who delivers the drug?

Where do patients go?

Who trains the therapists?

Who pays?

And how do you prove the treatment works over a long period of time?

To answer these questions, and more…

The FDA has personally invited Emyria to Washington to be a part of an upcoming hearing on psychedelic medicine delivery.

… and the whole industry will be watching.

EMD provides mental health services through psychedelic-assisted therapies for people with PTSD and treatment-resistant depression in Australia.

In February 2023, the Therapeutic Goods Administration rescheduled MDMA and psilocybin from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines).

This allowed organisations like Emyria to actually deliver psychedelic-assisted therapies in a commercial setting.

Emyria is by far the biggest company in Australia doing this.

With over 130 trained therapists and 5 sites across WA, Victoria, NSW, and Queensland.

It is essentially three years ahead of the game in delivering care.

Next week, it will present in front of the FDA and help to shape the care regulations for psychedelics in the US. 

All the big psychedelic companies will be watching.

Compass Pathways.

Definium.

Eli Lilly.

Johnson & Johnson.

Part of my investment thesis for Emyria, and part of the reason I selected it as my Second Armchair Analyst Pick for 2026, was…

IF psychedelics get approved in the US

THEN one of the first phone calls these companies will make will be to Emyria to support.

Emyria has spent three years solving a big problem.

… how to scale care.

Because it's all well and good to get the drug approved.

But if no one is there to deliver it, then no money comes into the drug companies.

This is what I’d call the Emyria “Playbook”.

All the systems and processes it has built to scale care in Australia, potentially licensed or franchised into the US.

This hearing is the first step towards that future.

… and every single company that will benefit from this playbook will be watching.

But first…

Trey Burke Racing becomes the first motorsports athlete to pilot Control Bionics (ASX: CBL) NeuroStrip Device. (CBL, held, Armchair Pick)

🪑 With over 50 pilot trials across multiple sports and rehab clinics, CBL’s product is getting into the hands of the right customers.

A really good write-up by the Trey Burke Racing team, and a good video of them using the device too:

The AFR reports a possible three-way merger between BCAL (ASX: BDX), Genetic Signatures (ASX: GSS), and Microba (ASX: MAP). (AFR)

🪑 I’ve been covering this story for a couple of weeks now, with updates here and here.

There are a few updates in this AFR article that we didn’t know before, with quotes from some major shareholders:

As mentioned, it’s the SHAREHOLDERS of Genetic Signatures that get to decide what happens.

… and BCAL is the largest, with an 18.50% stake.

More to play out.

Cleo Diagnostics (ASX: COV) has selected Asuragen as its CLIA-certified lab for the clinical validation of its Pre-Surgical Ovarian Cancer Test. (COV)

🪑 Milestone ticked.

Optiscan Imaging Ltd (ASX: OIL) has reached over 80 cases using its InForm™ platform in collaboration with Australian Clinical Lab. (OIL)

🪑 Earlier this week, I was lucky enough to visit the Optiscan facility in Mulgrave and get a full demo of the product.

Very cool tech.

Right now, the psychedelic industry is at a key inflection point in the US.

The first psychedelic medicine for mental health could be approved within the next six months.

Compass Pathways is already completing its rolling FDA application for COMP360, with a US launch expected in the first half of 2027.

(Subject to approval, of course)

Even Elon Musk’s inner circle is coming to the party, pouring millions of dollars into psychedelic research and companies pursuing approval for MDMA-assisted therapy:

Ever since Trump signed the psychedelics executive order in April (with Jo Rogan in the background no less), it’s felt like the industry has had a major rocket strapped to it.

Here is a timeline…

APRIL: President Trump signs an executive order directing US agencies to accelerate psychedelic research, access and regulatory review for serious mental illness.

APRIL: The FDA awards Commissioner’s National Priority Vouchers to psychedelic programs from Compass Pathways, Usona Institute and Otsuka.

JUNE: Definium Therapeutics reports positive Phase 3 results for its LSD-based treatment for major depressive disorder.

JULY: Compass Pathways reports six-month Phase 3 data for COMP360, its synthetic psilocybin treatment for treatment-resistant depression.

JULY: Eli Lilly agrees to acquire AtaiBeckley for US$2.8 billion upfront, with another US$1 billion tied to clinical and regulatory milestones.

JULY: The FDA finalises its guidance for companies running clinical trials of psychedelic drugs.

THIS WEEK: Notable psychedelic drug researcher Dr Michael Davis is named the permanent director of the FDA’s CDER.

NEXT WEEK: The FDA hosts a landmark public hearing on how psychedelic medicines could actually be delivered in supervised and supportive settings.

Emyria has been selected for one of the limited in-person speaking positions.

What does this mean?

Next week, the FDA will bring regulators, clinicians, researchers, patients and industry representatives together at its White Oak campus in Maryland.

Topics to cover?

Provider training and credentialing.

Patient safety.

Access and reimbursement.

Data collection and standardisation.

Where Emyria has been working in Australia over the last three years.

Domestically, Emyria is kicking goals.

Only in June last year did the company sign an agreement with Australia’s largest private health insurer, Medibank, to fund treatment for eligible members.

Earlier this week, the company held its full-year webinar to go through its FY26 results.

To highlight the company’s growth over the past year, here are some of the key numbers presented:

Let’s quickly run through the business model.

EMD provides mental health services through psychedelic-assisted therapies for people with PTSD and treatment-resistant depression in Australia.

Each treatment room generates roughly A$10,000 in revenue per dosing day.

(with costs paid to lease the rooms, pay for the drug and pay therapists).

Each room hosts one psychedelic dosing session, which lasts for about eight hours.

At full capacity, with all clinics up and running, Emyria can complete about 90 dosing days per week.

Right now, the company is running at a fraction of that capacity.

Demand is not the issue.

… it’s all about supply.

More therapists.

More nurses.

More Authorised Prescribers.

More trained staff.

I like to think about it as getting cars off a freeway.

The more lanes Emyria opens, the more patients it can treat.

Each clinic also has a ramp-up period before it reaches break-even.

This is the time it takes for Emyria to train the new batch of staff and get the systems and processes in place to set up the clinic.

It takes about 9 to 12 months per clinic.

The Perth clinic has already reached clinic-level profitability.

Now the company needs to repeat that across the network.

Earlier this week, Emyria confirmed that its Sydney clinic remains on track to open this quarter.

The new clinic will add four treatment rooms and take Emyria’s national network to five sites across four states.

As Emyria comes off a very strong FY26 and moves into FY27, there are a few things I’m looking out for.

This means more trained staff, more authorised prescribers, and higher patient throughput in the clinic.

Right now, Emyria has a strong relationship with Avive Health.

Rather than spending millions building standalone clinics, Emyria licenses clinical space inside Avive’s existing private hospitals.

Avive provides the infrastructure, and Emyria brings the clinicians, protocols and patients.

It is a capital-light model that avoids a large upfront investment in bricks and mortar.

Emyria also holds expansion rights across Avive’s existing and future hospital network.

I want to see the company add a few more clinics over the next financial year.

I haven’t talked about this much, but it is important.

This is effectively EMD’s CRO-style services business.

CRO = Organisation that runs clinical trials.

Emyria has one of the largest specialised workforces of trained psychedelic therapists.

That makes it an attractive partner for US drug developers looking to run clinical trials through an established delivery network.

Emyria already has one customer through the program.

North American psychedelic company Psyence Group is using Emyria as a clinical-trial site for its Phase 2b study.

… I want to see it get more.

(and I suspect that the hearing next week will help with this pipeline)

Today’s news is absolutely the first step in this direction.

I want to see Emyria position itself as best it can for the incoming wave of attention and capital flowing into the US psychedelic sector.

The FDA invitation puts Emyria in pole position to take advantage.

I’m making a big bet on the psychedelic industry.

… and when it comes to delivering care, Emyria is at least three years ahead of the game.

Championing the company is Executive Chairman Greg Hutchinson, who led Sonic HealthPlus for 15 years and knows how to scale clinical services.

The pieces are starting to fall into place.

This invitation by the FDA is further validation of Emyria’s position as a global leader in psychedelic care delivery.

My big blue-sky bet is that one day, Emyria’s EMPAX clinics will be franchised around the world… 

Delivering essential mental-health care to the people who need it.

We are only at the start of that journey.

But Emyria has proven it can execute.

And there is still so much room to expand and grow.

Next week, Emyria will be centre stage with the whole industry watching.

You bet I will be up early to tune in.

See you all tomorrow,

The Armchair Analyst