EMD selected to present to the US FDA - meeting on the 14th of September

Our Investment Emyria (ASX: EMD) will be presenting at the US FDA’s “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs‘“ hearing…

On 14 September 2026 (US Time) - so Tuesday next week over here in Australia.

The purpose of the hearing is for the FDA to hear from the people who actually know how psychedelic medicines are being delivered to patients safely and at scale.

(something EMD already does and is one of the first movers in the world in doing)

We highlighted in our last EMD Quick Take (here), EMD’s Chief Scientific Officer Dr Michael Winlo had made a submission to present on behalf of EMD at the hearing.

Here is what Dr Winlow’s submission said:

"Emyria would welcome the opportunity to present this experience at the hearing on 14 September 2026, and would be glad to make our operating protocols, outcome instruments, data dictionary and de-identified aggregate outcomes available to the Agency and its federal partners in whatever form is most useful."

And today, EMD confirmed that the FDA had selected them as “one of a limited number of in-person” speaking positions at the meeting.

(source)

Here is Dr Winlo’s full submission for anyone wanting to get a gist of what EMD will be presenting:

(Check out the full submission here - source)

And here is a link to the FDA hearing, for anyone who wants to tune in live (virtually): registration link here

(source)

We Invested in EMD because we think it can build the leading national network of psychedelic-assisted therapy clinics in Australia, with a clear first mover advantage in this space.

And we think that first mover advantage, not just in Australia but globally, will put EMD in a strong position as the broader psychedelics assisted therapy space develops around the world.

Especially in the US where there is a lot happening in the psychedelics space.

Recently $1.4TN pharmaceuticals giant Eli Lilly moved into the psychedelics space, with the acquisition of psychedelic drug developer AtaiBeckley for up to US$3.8BN:

(source)(source)(source)(source)

Eli Lilly is the company behind weight loss drugs - Zepbound, Mounjaro and more recently Foundayo (with Retatrutide set to be filed for FDA approval this year).

Now Lilly is deploying the billions of dollars they have made there into the psychedelic medicine space which is pretty big news, we covered that here

And there is that Executive Order that US President Trump signed earlier this year to accelerate access to psychedelic based treatments for patients with serious mental health conditions:

(source)

Now, after all of that - EMD is presenting at an FDA hearing talking about how psychedelic medicines could actually be delivered to patients in the US, covering:

• Provider training,
• Patient safety,
• Access, and
• Outcomes data.

It will definitely be interesting to see what sort of press coverage there is around that hearing AND if EMD makes it into any US related press.

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 (~$12BN 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 is already working with Workcover Australia (including the Australian Federal Police's cohort, one of the highest PTSD-burden groups in the country).

The BIG new one would ofcourse 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)