Good morning, Armchair Army,
Welcome to today's edition of The Armchair Analyst, a 5-minute daily update on the ASX life-sciences sector.
This morning the US psychedelics industry moved one step closer to the first approved product.
Compass Pathways (NASDAQ: CMPS) announced 26-week data from its Pivotal Phase 3 study using psilocybin for treatment-resistant depression.
(Source: Compass Pathways)
Here is what the data looked like:
What the data showed was strong durability of psilocybin on treatment-resistant depression across six months.
This data rounds out the company’s pivotal program and sets the stage for the first US approvals for psychedelic therapy early next year.
The FDA have already knocked back one approval of psychedelics (Lykos in 2024).
But it is likely that Compass (and other players in the space) have learned from the FDA Complete Response letter to Lykos and adjusted their pivotal trials accordingly.
Compass has over 800 patients in TWO pivotal Phase 3 studies.
Six-month data.
Addressed the functional unblinding issue.
Holds a Priority Review Voucher granted by the Trump Administration.
… and is the best shot so far for the industry to get a psychedelic medicine approved in the US.
There are no guarantees here (but I’m quietly confident).
Even in the UK, one NHS hospital is trialling psychedelic medicines and seeing benefits:
(Source, Financial Times)
Once approved, the industry will have another challenge.
How the hell do you deliver it at scale?
In 2023 Australia did something quite unprecedented and downscheduled psilocybin and MDMA so that (provided you had an ‘authorised prescriber’) you could commercially deliver psychedelic-assisted therapy.
Over the past few years, ASX-listed Emyria (ASX: EMD) has built its care model for delivering psychedelic-assisted therapy across Australia.
Physical clinics, trained staff, real revenues.
It has the largest global workforce of trained therapists for psychedelic-assisted therapy and the care protocols.
Two years of building valuable insights and data that could potentially be transferred to any US-based psychedelics company.
The care model matters.
The commercial launch of J&J’s Ketamine nasal spray is a perfect demonstration of this.
My deep dive here: Spray and Pray: How J&J grew a US$2.3b drug from a three-year bad trip
I remember speaking to one of the Emyria directors last year who was sitting on a panel at the largest psychedelics conference in the US, where the speakers were speculating on the care model.
One dose or two? How do we train staff? How do we onboard patients? What’s the reimbursement model look like? Etc.. Etc..
He just put his hand up and said: “Well, at Emyria, we’ve been doing this for 18 months now”.
… and that stuck with me.
Emyria has at least a two-year head start in this game; let’s see how they take advantage of it.
Disclosure: Armchair Analyst Media Pty Ltd owns 1,000,000 escrowed EMD shares. I have also personally bought an additional 1,000,000 EMD shares over the previous 12 months. EMD has engaged Armchair Analyst Media for investor awareness services.
This information is general in nature and does not constitute personal financial advice.
Let’s dive in…
The Pulse Check
Opthea (ASX: OPT) has updated its name and stock ticker to Ceryvyn Therapeutics (ASX: CYV). (OPT, not held)
🪑 New era.
PYC Therapeutics (ASX: PYC) secures three US composition-of-matter patent grants for its RNA therapies, extending patent life for PYC-003 to 2044, PYC-001 to 2043, and VP-001 to 2043. (PYC, not held)
🪑 “Composition of matter” patents provide the best level of protection.
ResMed (ASX: RMD) sells its MatrixCare business to Frazier Healthcare Partners for US$490M. (RMD, not held)
Proteomics International (ASX: PIQ) secures a US patent for its PromarkerEndo diagnostic blood test for endometriosis. (PIQ, not held)
🪑 Nice, by far their most promising/interesting test.
Argent BioPharma (ASX: RGT) was up over 100% yesterday on a US$5.5 million deal with a NYSE-listed company for its CannEpil. (RGT, not held)
🪑 The company used the word “Upfront” to describe the $5.5 million, but a close look at the deal terms showed that it was anything but…
Here is my post on LinkedIn:
Cash Injection
Vitrafy Life Sciences (ASX: VFY) had applications for A$9.4M in its SPP, exceeding its A$2M cap. (VFY, not held)
🪑 Good demand signal when the SPP is this oversubscribed.
CurveBeam AI (ASX: CVB) secures $5.0M in commitments for a placement at $0.02 per share (a premium to the last traded price), plus a $2M loan from shareholder Arun Singh and announces a $1M SPP. (CVB, not held)
🪑 Always good when you close a raise at a premium to the last traded price.
M&A, Big Pharma Wants a Wife
Vertex Pharmaceuticals acquires Crinetics Pharmaceuticals for US$10B in largest-ever deal, expanding into endocrine diseases. (Endpoints)
Report Card
Cogstate (ASX: CGS) reports record FY26 net sales contracts of $89.0M, up 116%, with $48.3M in contracted revenue expected for FY27, marking a 54% increase. (CGS, not held)
See you all tomorrow,
The Armchair Analyst
