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.
Tetratherix (ASX: TTX) just published its 4C quarterly update.
Quick take…
A very strong quarter.
… and I’m not just saying that cause it was my first Armchair Pick.
This was a genuinely good quarter, solidifying its balance sheet and advancing across all six franchises.
In particular, its nasal spray product for Peptides and GLP-1s
Reminder: What does Tetratherix do?
TTX is founded on the principle of "platform first".
Its technology is an injectable biomaterial that provides tissue with a surface to grow on or space to heal.
Liquid at 25 degrees and hardens at 35-37 degrees in the human body.
There are SIX different applications for TTX's product…
Spacing, bone grafting, healing… and nasal drug delivery of peptides and GLP-1s.
So… what’s the update?
FIRST: Nasal spray for GLP-1s/Peptides to launch this quarter
In March 2026, TTX launched a "precision medicine" franchise, branded STEPP.
Nasal spray for GLP-1s, peptides and hormones.
Now, TTX has cleared a key regulatory requirement for US market entry, with the FDA assigning a unique identifier number (a UNII) to its product.
Commercial launch with partner and compounding pharmacy Superpower Health is scheduled for this quarter.
(Source, TTX Q4 FY26 4C)
Over the next two days, the FDA will hear arguments about the legalisation of several popular peptide products for compounding pharmacies.
IF these black-market peptides become legal, my bet is that compounding pharmacies like Superpower Health (TTX’s partner) will capture a significant share of the peptide market.
Traction is starting to grow here in Australia too…
Here is the Four Corners program that ran last night on peptides and the rise in longevity medicines.
(It was a bit of a hatchet job by the ABC, but it does show that it's going mainstream)
SECOND: Very strong balance sheet
TTX now has $34.4 million in the bank and is generating revenue from its platform products.
(Much earlier than the market anticipated.)
The first US$3M (~A$4.2M) licence fee from Superpower Health for its nasal spray product was received this quarter, meaning the company was actually operating cash flow positive.
Revenue is still lumpy at this stage.
But TTX is being disciplined with its cash burn and tracking spending in line with the expectations under the IPO.
THIRD: Manufacturing facility progressing
As TTX approaches commercialisation, it needs to scale up its manufacturing.
Construction is on track…
(which I've literally never heard of before)
The facility is expected to be certified and operational by the end of the year.
(again, in line with the timelines set at the IPO)
Two months ago I actually visited the site in Alexandria (an inner-Sydney industrial suburb, next to other facilities owned by Tesla and DroneShield):
ALSO, Stage 1 of the Medical Device Single Audit Program has been completed, with the full Stage 2 audit expected in CY2027.
The Medical Device Single Audit Program means a single regulatory audit can satisfy the quality-system requirements of multiple markets (Australia, Canada, US, Japan, Brazil).
So once the facility is accredited, getting approvals across jurisdictions is far more streamlined.
The MDSAP is over the facility, not the device.
FINALLY: Both 510(k) approvals are on track for approval this calendar year
TTX says its bone healing products for both dental and orthopedic applications are still on track for 510(k) approvals this year.
The timeline for 510(k) approval on dental has slipped a quarter, which is likely due to the FDA taking its time for review.
Hopefully that first approval lands any week now.
Let’s dive in…
The Pulse Check
Radiopharm Theranostics (ASX: RAD) meets the primary endpoint in its Phase 2b trial results for RAD101, showing 93% concordance with MRI for brain metastases diagnostics. (RAD)
🪑 RAD was on track with this from the second cohort. The next 10 patients all showed concordance with MRI (now a total of 28/30 patients met the primary endpoint).
RAD will gear up for a Phase 3 clinical trial later this year.
ALSO, Radiopharm Theranostics (ASX: RAD) reports that the first patients in its Phase 1 therapeutic trial of RAD204 showed tumour reductions maintained over four cycles. Early signs of lesion reduction in the second patient. (RAD)
🪑 Genuinely good results and upgrade on the earlier cohorts at lower doses.
ALSO, Radiopharm Theranostics (ASX: RAD) goes into a trading halt for a capital raise. (RAD)
🪑 First Lumos Diagnostics now Radiopharma.
Shame that the company didn’t let the market trade on these results - but it appears that the company is more concerned with bringing the cash in the door.
RAD is a big cash burner - with multiple programs going on at once.
Will be interesting to see the terms of this one.
Optiscan Imaging (ASX: OIL) signs a research agreement with the Mayo Clinic for a US breast cancer imaging study. Recruitment starts now. (OIL)
🪑 Optiscan says it is on track for FDA 510(k) applications by the end of this year.
Big catalyst coming up for the company.
Proteomics International (ASX: PIQ) signs a three-year exclusive national distribution agreement with Healius (ASX: HLS) for its Promarker® portfolio. (PIQ)
🪑 Nice deal. Big tick.
PYC Therapeutics (ASX: PYC) receives approval from the Safety Review Committee to escalate dosing in its Phase 1b trial of PYC-003 for Polycystic Kidney Disease to 2.4 mg/kg. (PYC)
🪑 Milestone ticked!
BLS Pharmaceuticals (ASX: BLS) signs a non-binding agreement with Trexapharm for the Australian commercialisation of a treatment for depression. (BLS)
🪑 I remember speaking to the BLS team a few months ago about the dream to become more than just a GMP manufacturer for cannabis products… but a full-scale GMP manufacturer for all pharmaceutical products.
This deal looks like a step towards that.
Emyria (ASX: EMD) to present at the 'Addressing the Mental Health Crisis' event on Aug 6. (EMD)
REPORT: Psychedelics going mainstream (Financial Times)
Bristol Myers Squibb expands AI footprint with Nvidia, aiming for ‘most powerful AI factory in life sciences’. (Fierce Biotech)
🪑 I love this quote: “The goal isn't speed for its own sake; it's raising the probability that each program we advance is the right one.”
The better the predictive models, the more likely the investment into the trial.
If the investors know that there is a much higher chance of success on the other side, it makes cutting that cheque much easier.
Paradigm Biopharmaceuticals (ASX: PAR) receives a $5.75M boost from R&D tax incentive. (PAR)
Cambium Bio (ASX: CMB) raises A$1.0 million at a 17% premium to existing shareholder Brandon Wu. (CMB)
🪑 I had a good chat with CMB’s CEO Karolis earlier in the year about CMB. A phase 3 ready company that is capped at like ~$11M.
The way that he likes to do these capital raises is: no brokers, negotiates them himself, existing shareholders and done at a premium.
Almost like a private company.
See you all tomorrow,
The Armchair Analyst.
