Good morning, Armchair Army,
Welcome to today's edition of The Armchair Analyst, a 5-minute daily update on the ASX life-sciences sector.
Investing in drug developers is like the big “swing for the fences” in oil and gas drilling.
Expensive and binary.
Glorious when it hits, brutal when it doesn't.
… particularly for late-stage trials (like Phase 2s and Phase 3s).
The binary event is known as a clinical trial readout.
All the early science in the world doesn’t matter if you can’t prove that it works in a clinic.
A good readout? Company MAKING.
A bad readout? Company BREAKING.
So…
TWO big MAKE-or-BREAK readouts are scheduled in the next six weeks.
The first?
Paradigm (ASX: PAR)
Phase 3 interim analysis for an osteoarthritis pain drug.
The company went into a trading halt on Monday, and into suspension today.
While the company hasn’t said anything definitive…
… it’s not looking good.
(Source: PAR)
The second?
Actinogen (ASX: ACW)
Phase 2b topline results for Alzheimer’s disease.
This morning, the company completed its “last patient visit”.
Topline results still on track for next month.
Big watch…
(Source: ACW)
Two huge readouts that will have big ramifications for the sector.
Negative results?
The market moves to RISK OFF.
It becomes harder for biotech companies to raise money, and investors get scared of binary outcomes.
Positive results?
The market moves to RISK ON.
Glorious for biotech companies. Easier to raise money, and investors start to bet on positive clinical trial results.
We haven’t had much luck from the biotech sector in Australia over the past two years, with notable failures like Immutep and Opthea.
But there have been SOME winners.
Avecho, Amplia, Alterity.
Here are the results (and immediate after-effects) of the last few biotech clinical trial readouts:
In summary…
Too many big, binary drawdowns and not enough wins to balance the ledger.
But things can turn quickly.
A few positive clinical trial results, and it’s back to RISK ON for the industry.
It would also help if the industry didn’t have to fight headwinds from the recent government budget.
eyeroll…
But I know a big lobbying effort is underway.
So…
Let’s hope, with all of our fingers and toes crossed for Paradigm and Actinogen.
(even though Paradigm's trading suspension isn’t promising…)
Let’s dive in…
The Pulse Check
Control Bionics (ASX: CBL) signs a second distribution agreement with Tobii Dynavox to sell CBL’s NeuroNode product in Germany. (CBL, held, Armchair Pick)
🪑 Another very good deal… and it follows the company’s “distribution model” for legacy Assistive Technology products (like the NeuroNode, which helps paralysed people interact with computers).
A capital-light way for CBL to enter the German market while leveraging someone else’s sales force.
Selling starts today at the Rehacare International conference in Düsseldorf, Germany.
Giant trade show, 44,000+ participants.
Earlier this year, CBL secured a reimbursement code in Germany. This unlocked the Tobii partnership in Germany.
Patrys (ASX: PAB) begins dosing participants in the Phase 1a trial of an intravenous quetiapine formulation for delirium. (PAB)
🪑 Milestone ticked. Safety and dose tolerance are key outcomes in this trial.
TrivarX Limited (ASX: TRI) advances pre-clinical work on its MRI brain cancer imaging product. The clinical program will commence early next year. (TRI, held)
🪑 Bit of a “cleanse the market” feel from this announcement.
TruScreen (ASX: TRU) was not selected for multiple UNITAID funding grants for cervical cancer elimination. (TRU)
🪑 Classic case of overpromise and underdeliver.
If you don’t mention the applications (and their value) in the first place, then you don’t have to come back to the market with the tail between your legs when you don’t get them.
A better move is to run these grant applications in the background and surprise to the upside IF they land.
AdAlta Limited (ASX:1AD) schedules a pre-IND meeting with the FDA on its EW-001 CAR-T therapy for product for mesothelioma. (1AD)
🪑 Milestone ticked.
Paradigm Biopharmaceuticals (ASX: PAR) requests a voluntary suspension pending the announcement of interim analysis results for its Phase 3 trial. (PAR)
🪑 🤞🤞
Actinogen Medical (ASX: ACW) confirms the completion of final patient visits in the XanaMIA phase 2b/3 Alzheimer's disease trial, with topline results expected in November. (ACW)
🪑 🍿💪
See you all tomorrow,
The Armchair Analyst
