The SM 2026 stock competition got me thinking more about Radiopharm Theranostics (ASX:RAD) and some of the other biotechs I have money in.
4DX – market cap $1.9b
Its anyone’s guess where 4DX will be in 5 years time, there will inevitably be a lot of share price volatility however it is pretty clear they are onto a winner with CT:VQ as the share market price (for now) now shows. 4DX has had a number of technical advances over the last 3 years however this time they have tapped into an existing treatment work flow worth about $US1b/year with a superior product to the existing. They have around $200m cash for further CT:VQ commercialisation plus the other developing more niche uses for its software. Maybe a big threat to 4DX in relation to CT:VQ is the current generous reimbursement and the 99% GM. Take that away and the revenue model don’t look so cheery. And the US health regulators now appear a lot smarter, committed and less swayed by vested interests (or maybe a just different vested interests).
Trump and his administration tend to get represented in social and mainstream media as a bunch of stooges. Robert Kenedy as Secretary for Health and Human Services being an extra large target for ridicule. However listen to Marty Markary the new FDA commissioner and you don’t get the impression he is either an amateur or a fool. Amongst other things he appears to have some very clear actions to help reduce that 16% of US GDP disappearing into the health care gurgler. And that’s a big one for America.
Supercharging a New FDA: Marty Makary on Science, Power & Patients - YouTube
Maybe Trump is cunning enough he gets Robert Kennedy’s endorsement and his fraction of a percentage of US voters, and then shoves him in a meaningless role with a big title and gets the likes of Mr Makary to run the show.
Can’t help but think the Botanix (ASX:BOT) clusterF$%k Sofdra launch may be related to the new Administration’s FDA rorts clampdowns. Though CEO, Howie and his old-school pharma gangster mates would be the last people to tell you. Maybe life is getting a lot tougher for some other biotechs looking to the US market.
CU6 market cap $1.3b
Clarity’s (ASX:CU6) lead product is a radiopharmaceutical imaging agent for prostrate cancer that looks far better to anything currently on the market. They have around $150m in funding to get to FDA approval (Clarify and Amplify trials) sometime in late 2027. In 2024 investors got excited and bid the share price up to $9. However what investors seem to have trouble with is stomaching any reward that is more than about 18 months into the future. Too far away and too hard. By the end of this year CU6 will be within a more agreeable 12 months of an FDA approval (all going well) and the market may look at them differently. CEO Alan Taylor is not your typical egg head biotechnician, and you know the wily bastard will fight hard. Maybe a big risk for CU6 is out of the tens of thousands of emerging Chinese biotechs, one comes up with something better. The Chinese can get to speed real quick though still need to go through all the Western hoops if they are going to get sales where the big money is in the US. (The ASX listed biotech Adalta (m/c $15m) has dropped to this and is specifically partnering/financing with Chinese biotechs to get Chinese drugs into high paying western markets. However for their first investment they have chosen a tough one with expensive Car T cell technology).
AYA market cap $500m
Artraya (ASX:AYA) has some impressive heart flow software, two arms of which are FDA approved and they are working on a third approval for their Coronary flow module. They already have a foothold in the south east of the US and if they can execute will give the US incumbent, though still early stage Heartflow Inc (market cap $A3b) a real run. It is not surprising David Paradice (Paradice Funds Management), Phil King (Regal Funds Management) and Geoff Wilson (Wilson LICs) are all substantial because AYA can scale and their analysts are really good at doing primary school level spreadsheets. And David, Phil and Geoff might all be old men but when they get told a hot story combined with some Excel porn they all get a raging woody. Or whatever you get when you are so old your age can only be found by carbon dating.
RAD market cap $80m (3.5b shares at $.023)
Radiopharm Theranostics Limited (ASX:RAD) does not seem to get much love from the market. A child of Paul Hopper and floated in late 2020 at a time when Paul’s name used to attract lots of capital. RAD for a few years became a fringe dwelling deadbeat company that eats up all your capital and then asks for more. However as of late last year RAD appeared to be onto something with their molecule RAD 101. RAD101 a small molecule imaging agent has been shown to pass into the brain and attaches itself to active metastatic brain cancer. Quite a feat and interim Ph IIb studies show a 92% co-relation with an MRI. In addition the RAD 101 PET scan can differentiate between radiation necrosis (dead tissue) and active recurrent metastatic brain cancer. If this can be further proved up, this is a big deal as it should remove the guess work for doctors treating cancers of this type. In other words the conventional external radiation beam treatment would be able to be better directed to the location of the active cancer. Quite an advance that has led to an FDA fast track designation.
Headline Phase 2b (30 patients in 5 centres) data is expected in the middle of this year with the endpoints being the concordance between the MRI and PET scan (which is already showing 92% in the smaller patient readout). RAD claim they have no competitors (in brain cancer metastasis not glioblastoma) directly working on the fatty acid synthase mechanism. Market size for the metastatic brain cancer imaging is estimated to be around $US500m/yr.
RAD in October 25 raised A$40m at $0.03 and has around $59m in the bank (BFG were the lead manager). However with so much going on this will only get them into CY27. This month RAD initiated a $US50m at the market facility allowing it to raise this amount over a 3 year period on market at its discretion. (RAD has a NASDQ listing). Also there are now 1.2b $0.039 options trading as RADOB expiring 31/10/27. So potentially some extra funding and dilution on the way. In addition to RAD101, RAD have three other radio pharmaceuticals in Phase 1 and two other preclinical. RAD are having a red hot go at it and are working on the pre-work for a Ph III (about 150-200 patients).
Paul Hopper was and remains the founding executive chair with his holding falling below substantial with the last capital raise. Lantheus (TLX’s (Illucix) prostrate imaging competitor with Plarify) owns around 15%. The ubiquitous Regal Funds Management, groaning under the weight of cash from the people of the Eastern Suburbs of Sydney who have come upon easy money and want more, has 9%.
The science could fall over or continue to perform. Like all companies as an outsider you never know what is really going on and for biotechs it is a lot worse but sometimes this does not matter too much. If it did the scientists would all be rich. With investors backing out of tech and into gold & commodities maybe biotechs will get some more attention this year. And with 3.5b shares on issue RAD is a member of the disreputable Billionaires Club which is reason for early investors to hate it and more reason to buy it now. If any of the big names at the float like Alex Waislitz, Collette Dinnigan, Frazis Capital Partners and Andrew Banks (Shark Tank) are still there, they have been diluted to the shithouse.
Maybe the overlooked baby RAD doesn’t even have to be too successful from here for investors to make some money -it just need a CEO with a big(er) mouth. Alternatively RAD could do exceptionally well and is my 2026 stock pick.