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 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.
This morning, my very first Armchair Analyst pick, Tetratherix (ASX: TTX), shipped a commercial batch of its GLP-1 nasal spray to the US.
(Source: TTX)
We are now “officially” off to the races.
Tetratherix’s commercialisation partner, Superpower Health, will now embark on a “targeted and deliberate trial period” to get this product into the hands of real customers.
… and, importantly, collect valuable data on the product.
This is how the product works:
Last week, Tetratherix CEO Will Knox spoke at my Armchair After Market event, where he shared the history of the precision medicine franchise.
Originally, it was designed to transport mRNA vaccines through the nose.
This was during COVID when every healthcare company was looking to position for a quick go-to-market solution.
The company had a Research & Development deal with one of the world’s largest vaccine manufacturers, Sanofi, to create a nasal spray version of their products.
But, the world changed.
… and quickly.
After COVID, the vaccine landscape cooled, especially as the Trump administration took office with a “Make America Healthy Again” agenda.
But Tetratherix had done all of this amazing work to successfully deliver small, fragile molecules through the nose.
Can’t let that go to waste!
So it pivoted from mRNA to peptides, GLP-1s and hormones.
The company quickly realised it had a potential blockbuster when two big pharma companies were immediately interested.
Tetratherix seriously considered it…
But big pharma isn't known for speed.
So rather than sit in R&D purgatory…
Tetratherix wanted to see their nasal spray product in the market, and in the hands of customers quickly.
As Will said at the event.
“Nothing makes big pharma move quicker than real-world evidence.”
So it partnered with a compounding pharmacy, Superpower Health, to sell its product via its platform in the US.
But Armchair… the nasal spray product hasn’t gone through a clinical trial yet…
How can it be sold in the US?
Let me tell you about something called the compounding pharmacy.
What is a Compounding Pharmacy?
Compounding pharmacies make customised medicines for individual patients whose needs cannot be met by an existing FDA-approved product.
A child needing a liquid instead of a tablet…
A patient allergic to a particular ingredient…
A patient needing a dosage strength that is not commercially available…
Under Section 503A, pharmacies can prepare patient-specific medicines with novel delivery mechanisms without the usual FDA approval process.
Provided that the compounding rules are met:
The ingredients must be eligible for compounding
The prescription must be patient-specific
The product cannot be an “essential copy” of an approved drug already commercially available.
… so it’s not a complete free-for-all, but provides much broader access to products.
This is the model used by platforms such as Hims & Hers.
Hims is not technically a compounding pharmacy itself, but it owns and works with affiliated 503A pharmacies that prepare personalised medications prescribed through its platform.
When GLP-1 shortages hit the US, compounding pharmacies helped fill the gap by producing versions of drugs patients struggled to access.
This set the tone for how Compounding Pharamcies could provide access to personalised medicines, peptides and other longevity treatments.
The pathway was set.
… and potentially expanded when the FDA gave the green light for seven popular peptides to be sold under the compounding pharmacy regulations:
(Source: Reuters)
This is how Tetratherix is launching its nasal spray product.
NOT the traditional big pharma model, with years of trials and products stuck in development.
But immediate, real-world evidence in a growing sector of the market - Longevity medicines.
This nasal spray is also not a “copy” of any product on the market.
… even though it may use FDA-approved GLP-1s.
It is a genuinely different delivery mechanism for an existing, FDA-approved product.
This means Tetratherix has a path to market without running a traditional clinical-development program.
It is still small-scale for now, and the larger play I think is an eventual registered product for Tetratherix.
(Where it can sell through traditional pharma channels… Particularly in an indication like insulin where there is lots of money to be made)
But in the meantime…
Tetratherix will look to generate early revenue (and importantly data) to put pressure on big pharma companies with a genuinely differentiated approach to delivering the biggest blockbuster pharmaceutical product in the last 100 years…
GLP-1s.
Let’s dive in…
The Pulse Check
Emyria (ASX: EMD) director Michael Winlow spoke to a friend of the newsletter, Emily Casey, from What the Health about all things psychedelics.
Tetratherix Limited (ASX: TTX) exports its first commercial shipment of Tetramatrix™ polymer to the US. (TTX, held, Armchair Pick)
🪑We’re off to the races.
Avecho Biotechnology (ASX: AVE) recommences recruitment for its Phase III insomnia trial, targeting 320 additional participants. (AVE)
🪑As these sites start up, we’ll get a clearer picture of the timeline to full study results.
Island Pharmaceuticals (ASX: ILA) is approved to use Marburg-Angola non-human primate natural history data in its eventual FDA submission. (ILA)
🪑Regulatory milestone ticked, but starting the primate trial is still the most important milestone ahead.
Ceretas Limited (ASX: CTS) secures Ethics Committee approval for additional sites in its Phase 2 CERE-CALM trial for Alzheimer's disease treatment. (CTS)
🪑Milestone ticked.
EMVision Medical Devices (ASX: EMV) surpasses 200 patient enrolments in its emu™ Pivotal Trial for its brain scanner for stroke diagnosis. (EMV)
🪑Two-thirds of the way to full recruitment. Full enrolment expected by early 2027.
Genetic Signatures (ASX: GSS) announces board changes with Mike Aicher assuming Chair role following Caroline Waldron's resignation. (GSS)
🪑More moves afoot.
Report: The Consumer Wearables market is set to Generate More Than $1 trillion in Cumulative Revenue Between 2026 and 2032. (Counterpoint)
A growing consumer and health market that Control Bionics (ASX: CBL) has just entered with its NeuroStrip device.
Revolution Medicines’ pancreatic cancer drug should quickly become a blockbuster, with a ~US$40,000 per month list price. (BioPharma Dive)
Sword Health will acquire digital mental health company Headspace for up to US$300M, down from a US$3B valuation in October 2021. (Axios)
The Report Card
Visionflex (ASX: VFX) reports FY26 revenue of $4.2 million (down 10%) but a reduction in net loss to $54K. (VFX)
🪑While revenue fell, costs fell too. Indicating good cost control and a reset for the company.
Monash IVF Group (ASX: MVF) reports FY26 revenue of $269.5M, down 0.9%, and Underlying NPAT of $16.1M. (MVF)
Cash Injection
Alterity Therapeutics (ASX: ATH) enters into an underwriting agreement with MST Financial to raise A$4.2 million. (ATH)
🪑Last close at 52 cents, options exercisable at 50 cents, so they managed to underwrite about half the outstanding options. Good result.
Big Pharma company Moderna is offering US$2B in convertible notes to fund its cancer vaccine business. (Yahoo Finance)
See you all tomorrow,
The Armchair Analyst
