Good morning, Armchair Army,
Welcome to today's edition of The Armchair Analyst, a 5-minute daily update on the ASX life-sciences sector.
Disclosure: Armchair Analyst Media Pty Ltd owns 18,750 escrowed TTX shares. TTX has also engaged Armchair Analyst for investor awareness services.
This information is general in nature and does not constitute personal financial advice.
We’re just 10 days away…
The FDA advisory committee will meet to decide whether compounding pharmacies can sell a range of popular peptides that were previously banned in the US.
(Source: FDA)
Positive discussions here could unlock sales of several peptide products in the US, including BPC-157, TB-500, and others.
Right now, many peptide products are sold on the black market in the US…
(It’s a well-documented issue that has been blowing up over the past year or so)
But soon there could be a legal pathway to give patients access to them.
Through compounding pharmacies.
Tetratherix (ASX: TTX), my first-ever Armchair Analyst Pick, launched a nasal spray for peptides, GLP-1s, and hormones with a compounding pharmacy earlier this year.
Its partner?
Superpower Health.
A compounding pharmacy that just secured Giannis Antetokounmpo as its first brand ambassador:
IF these black-market peptides become legal, what happens next?
My bet is that compounding pharmacies like Superpower Health will capture a significant share of the peptide market.
In the middle of it all?
TTX and its nasal spray product.
A key differentiator for better delivery when compared to injections.
… We’ll find out how this regulatory catalyst is tracking in 10 days.
For TTX, the nasal spray peptide product is just one of six different applications of its medical device.
Its medical device is an injectable polymer that is liquid at room temperature and goes solid in the body.
It's safe. It’s modular.
Several major catalysts sit on the horizon for TTX with this technology, with TWO 510(k) approvals set for this calendar year.
FIRST, for bone healing in dental applications.
TTX already has a deal with Henry Schein, the #1 global distributor of dental products.
This one was scheduled for the last quarter, but it appears that the FDA has taken a bit longer than expected.
… could drop any day now.
SECOND, for bone healing in orthopedic applications.
TTX is still negotiating to find a go-to-market partner, which could land unexpectedly at any time.
If you include the regulatory catalyst driven by the FDA meeting on peptides, that is a THIRD big piece of news on the horizon for Tetratherix in a short amount of time.
The company recently raised $15.6 million at $6.00 through a capital raise and SPP, which is now closed.
Stock’s held up well…
Last traded at $6.60.
A big few months coming for TTX.
Watch this space…
The Pulse Check
Neurotech International (ASX: NTI) secures a US IND for its cannabinoid product NTI164. (NTI, not held)
🪑 This milestone cannot be understated.
NTI was an old client of mine at Next Investors, and I’ve followed the story for about four years now - this is a huge milestone for the company, and about 2.5 years in the making.
Many didn’t think that they would ever get an IND because their cannabis product is botanical (plant-based), making getting an IND much harder.
But it's secured now. Well done to the NTI team. Massive de-risking event.
BlinkLab (ASX: BB1) expands its clinical study portfolio beyond its FDA autism program, with ten exploratory studies set for readouts in 2026-2027. (BB1, not held)
🪑Some interesting studies using the BlinkLabs technology. One that stood out to me was “early dementia detection”.
Each of these studies is generally run in collaboration with a research institute, and they are very much exploratory (to see what other conditions BB1’s technology can be used for), beyond Paediatric Autism (which is its most advanced).
Mesoblast (ASX: MSB) completes enrollment of 300 patients in its pivotal Phase 3 trial to treat chronic low back pain. (MSB, not held)
🪑 Looking forward to this readout.
Aroa Biosurgery (ASX: ARX) announces that the CMS will maintain its US$127.14 rate for skin substitute products in 2027. (ARX)
HeraMED (ASX: HMD) completes Phase 1 pilot with Lee Health for the HeraCARE remote patient monitoring for prenatal care. (HMD)
🪑 100% likelihood to recommend was the number that stood out to me (from 44 patients)
Biotron (ASX: BIT) secures EMA feedback on its regulatory pathway, the first milestone in its acquisition of Sedarex, a next-generation anesthetic. (BIT)
Pacific Edge (ASX: PEB) reports a 12.9% rise in Q1 27 commercial test volumes for its Cxbladder test (on pcp), while US test volumes show a small decline due to a reduction in sales teams. (PEB)
Very much a “holding pattern” quarter for PEB, as the company looks to get its CMS code returned.
Recce Pharmaceuticals (ASX: RCE) secures a Vietnamese patent for RECCE® anti-infectives. (RCE)
Paradigm Biopharmaceuticals (ASX: PAR) draws US$3M of a US$27M facility to fund its Phase 3 trial of iPPS for knee osteoarthritis. (PAR)
The US FDA has finalised guidance on psychedelics and plans a broader industry hearing for September. (Endpoints)
🪑 Some really interesting takeaways.
One thing that stood out was that patients who experience the euphoric effects of psychedelics would be considered an “adverse event”.
This is not the final recommendation, with an industry hearing scheduled in September.
A key pillar of that hearing will be the care and reimbursement models. What does it look like and how should it be shaped?
(Two questions that ASX-listed Emyria (ASX: EMD | Held) is very well placed to answer.)
Report: Biotech companies issue warning over Labour changes to R&D tax incentives. (AFR)
🪑 Good lobbying for the biotech industry.
My thoughts on the tax changes in the announced budget are well known, and I’ve made my own submission to the treasurer.
See you all tomorrow,
The Armchair Analyst
