Good morning,
Welcome to today’s edition of The Armchair Analyst, a 5-minute daily update on the ASX life-sciences sector.
It was a nervous wait this morning for the results of Amplia’s (ASX: ATX) pancreatic cancer trial.
I’ve been pressing refresh constantly from 8:00 am, hoping not to see the dreaded “suspension” announcement that killed Immutep three weeks ago.
No suspension. No problem.
The results are out, and they are…
Good.
In fact, they are very good.
This was a much-needed result for the biotech sector, reminding investors of the upside case in early-stage drug development.
A median Overall Survival of 11.1 months with no additional toxicity burden.
4 additional patients in the study achieved a complete response (total now 5).
A complete response is the disappearance of all detectable signs of cancer.
Effectively in remission.
So what this tells us is that:
Median Overall Survival: ATX’s product is comparable to the best-in-class therapy (Base Case)
No additional toxicity burden (which makes it better than the best-in-class product). (Upper Base Case)
5 patients with a complete response. This was unexpected. (Bull Case)
So, the product worked very, very well in a small number of people and performed just as well as the best-in-class product, with no additional safety issues in the broader cohort.
This is where it fits in based on our bull/bear/base case scenario we set last Friday:
However, the additional 4 complete responses push these results in the Upper Base / Bull Case scenario:
(Source, The Armchair Analyst, 19th March)
The pathway to a big pharma partnership for this drug is firmly on track.
NEXT, Amplia will conduct a second trial with its drug in combination with a different chemotherapy regimen.
The Amplia team will host a webinar tomorrow at 9:30 am AEDT to run through the results. Register Here.
Well done to Amplia shareholders.
Well done to the biotech sector at large.
We needed a win.
Let’s dive in…
The Pulse Check
Amplia Therapeutics (ASX: ATX) reports five complete responses and a median overall survival rate of 11.1 months in the ACCENT pancreatic cancer trial. (ATX)
🪑Great result.
BlinkLab’s (ASX: BB1) autism diagnostics product has been selected by the Moroccan government for a nationwide autism screening program. (BB1)
🪑 Will be interesting to see if this deal sets a precedent for other countries to leverage BB1’s technology for Autism screening.
Autism is currently the largest line item on the NDIS balance sheet in Australia, and having an objective diagnostic measure like what BB1 is trying to develop will help to alleviate waste, fraud and abuse under the NDIS.
Cyclopharm (ASX: CYC) secures a multi-site agreement with the University of Pennsylvania to install its lung imaging device, Technegas, at 11 clinical locations. (CYC)
🪑This is the benefit of selling into a Healthcare Network. One organisation to negotiate with, but 11 sites secured.
Enlitic (ASX: ENL) secures a US$1.5M contract with Penn Medicine to migrate 71M clinical files into its platform. (ENL)
Nexsen (ASX: NXN) secures FDA feedback and clarity on its regulatory approval pathway for its StrepSure® rapid point-of-care test for GBS diagnostics. (NXN)
🪑While the feedback was “positive”, with this type of FDA meeting, companies will never actually publish what the FDA says (that’s part of their trade secrets for the trial).
What I wanted to know was: Is the trial still on track for 510(k) registration this year? Will the company need to conduct part of its trial in the US to secure FDA approval?
I expect the company to answer both of these questions in due course.
Cleo Diagnostics (ASX: COV) has optimised its ovarian cancer test biomarker panel, expanding from five to eight biomarkers. (COV)
🪑Interesting to make a product improvement so close to the planned FDA 510(k) submission.
The key line from the announcement is that the additional biomarkers “significantly strengthen assay reproducibility and reduce technical risk ahead of the analytical validation and regulatory submission.”
Vitura Health (ASX: VIT), via joint venture Cortexa, has sold most of its first batch of GMP-grade MDMA in Australia (value exceeding A$1.0M). (VIT)
🪑 I learned a lot about GMP-grade psychedelics during my trip to Bioxyne’s facilities last week. Still a very early industry, but these are high-margin, low-volume products.
Bioxyne (ASX: BXN) director Samuel Watson purchased $90,000 of shares on market. (BXN)
🪑 Good signal.
Three announcements in three days for BCAL Diagnostics (ASX: BDX) All on market director purchases from Executive Chair Jayne Shaw. (BDX, BDX, BDX)
🪑 Even better signal.
M&A, Big Pharma Wants a Wife
Novartis agreed to acquire Synnovation Therapeutics’ SNV4818, a pan-mutant-selective PI3Kα inhibitor for US$2B upfront and US$1B in milestones, to strengthen its breast cancer pipeline. (Fierce Biotech)
🪑 Big pharma will pay up for the right cancer asset. This is a monster deal.
Collegium Pharmaceutical acquires the ADHD drug Azstarys from Corium Therapeutics for a US$650M upfront payment. (Fierce Biotech)
🪑 Collegium expects the drug to generate more than US$50M in the second half of 2026. So the drug was essentially acquired at about a 6.5x-7x sales multiple.
See you all tomorrow,
The Armchair Analyst.
