Pic via Getty Images
Health & Biotech
Actinogen Medical (ASX:ACW) reports that its well-anticipated Alzheimer’s disease clinical trial is on track, with an interim analysis expected by mid next year.
At the company’s AGM chairman today, Geoff Brooke said patient and recruitment was “ramping up” for the phase 2b/3 trial, with four US sites now active in addition to the 15 local sites.
“A further six US sites will be activated before the end of the year and we expect enrolment to accelerate in the coming months as a result,” he said.
Dubbed Xanamia, the double-blinded, placebo-controlled trial aims to enrol 220 patients with mild to moderate but progressive Alzheimer’s, as determined by elevated levels of a protein biomarker called pTau181.
A novel therapy, Xanamem aims to control the level of cortisol in the brain by inhibiting an enzyme called 11-beta-HSD1.
Elevated cortisol levels are closely related to Alzheimer’s, but no-one has been able to crack the solution.
Initial results from an interim analysis of the first 100 participants are anticipated in mid 2025 and final results by mid 2026.
Earlier this year, a phase 2a, 167-patient Alzheimer’s-related depression trial recruited 167 patients in 16 months – but failed to meet its primary endpoint of improved cognition owing to an “unexpectedly high” placebo effect.
Yep, the sham worked better than expected – but the company is undeterred.
“In the targeted secondary endpoint, we were very pleased to see positive benefits on depression, providing further evidence to support Xanamem as an effective cortisol control mechanism,” Brooke says.
He adds that Actinogen’s improved valuation has been supported by “gradually improving” conditions in the biotech market from the start of 2024.
This has been reflected in increased licensing and M&A activity “signalling a change in sentiment from the very challenging market headwinds of 2023, particularly in the small-cap biotech sector.”
Courtesy of capital raisings, options conversions and R&D tax rebates, the company is funded until “at least” mid 2026 with $24.5 million of cash in the bank.
Actinogen shares have gained 20% over the year and this morning were steady at 2.4 cents.
With radiopharmacy house Telix Pharmaceuticals (ASX:TLX) deriving most of its revenues from the US, it’s apt that the company is accessible to US investors by way of a Nasdaq listing.
The $7.8 billion market cap Telix this morning said its shares had commenced trading on the Nasdaq Global Select Market, under the ticker TLX (the same as its code for the ASX, which will remain its primary listing).
Each American Depository Share (ADS) – that is, Nasdaq share – will represent one fully paid ordinary Telix share.
Earlier this year Telix pulled a planned Nasdaq listing and $300 million capital raising, because investors demanded an unacceptably steep discount.
Instead, the company raised $650 million in convertible bonds, which are listed on the Singapore exchange. So there!
“Listing on Nasdaq is an important milestone and one that will facilitate streamlined access to Telix shares for a significant portion of our workforce and US and global investors,” says Telix CEO Dr Chris Behrenbruch.
“It is an appropriate step given the growth trajectory of company, leadership position in radiopharmaceuticals and expanding footprint in North America.”
In October Telix reported September quarter revenue of $201 million, up 55% and almost wholly attributable to US sales of its prostate cancer imaging product Illuccix.
Telix also reaffirmed 2024 full year guidance of $745 million to $776 million.
It will be interesting to see if the Nasdaq listing prompts an immediate re-rating of Telix shares when they trade in earnest tonight.
Most other ASX life sciences plays migrating to the Nasdaq have not enjoyed the expected instant valuation uplift.
“There has been no trading at this time since existing investors need to convert their holdings to ADSs first,” a Telix spokesperson says.
“We anticipate a gradual ramp-up period as first conversions are made.”
Telix’s local shares don’t exactly lack support, having bounded 146% over the last year and hitting a record $23.99 on Tuesday.
So, it’s more a case of tapping a broader investor base in the longer term and ensuring employees – most of whom are in the US – can access their shares.
Telix shares eased 0.6% to $22.84 this morning.
Psychedelic therapies house Tryptamine Therapeutics (ASX:TYP) has had a bolter of a share run – up 165% in the last month and 30% over the last week.
With no announcements to explain the most recent leg-up we can only assume that – as per our report on Emyria (ASX:EMD) yesterday – the company is benefiting from the Trump effect.
The other likely factor is the company’s recent strong capital raising (see below).
The Trump effect refers to expectations the new administration will liberalise psychedelics research and the path to drug approval.
Presumptive health czar Robert F Kennedy Junior is not only a vaccine denier but a certified fan of these treatments which include psylocibin (magic mushrooms), MDMA (‘Molly’ or ecstasy), ketamine and LSD.
In fact, RFK Jr. even went so far as to allege the US Food & Drug Administration has engaged in “aggressive suppression” of psychedelics.
For its part, Tryptamine has two phase 2a synthetic psylocibin efficacy trials underway in the US, for fibromyalgia pain (University of Michigan) and irritable bowel syndrome (Massachusetts General Hospital/Harvard University).
A binge eating disorder trial at the University of Florida previously reported a median 80% improvement in the condition.
While these trials use oral psylocibin, the company is pioneering an intravenous delivery for more precise drug blood levels.
The share bump has bought early reward for the backers of a $6 million placement, notably the Merchant Biotech Fund and Dr Daniel Tillett, who leads the drug repurposer Race Oncology (ASX:RAC).
Tillett chipped in $1 million – 50 million shares at 2 cents apiece.
Given the shares also come with free options one-for-one a basis exercisable at 4 cents within two years, Tillett is flying high (substance-free of course).
Tryptamine shares this morning eased 2% to 5.3 cents.
At Stockhead, we tell it as it is. While Tryptamine Therapeutics is a Stockhead advertiser, it did not sponsor this article
Health & Biotech
Health & Biotech
Health & Biotech
