Good afternoon,
Sorry for the late send today, I just finished coffee with Cheryl Mayley, the CEO of Starpharma (ASX: SPL)… a great story for next week.
Today, I’m assessing whether the RAT is BACK.
(of course, I’m talking about rapid, point-of-care tests like the RAT tests from the COVID-19 days)
Nexsen (ASX: NXN) is the next company in my Biotech 165 Challenge…
NXN is developing a “lab on a stick” technology for GBS and kidney disease (and potentially more conditions).
The fourth-best-performing healthcare stock last year was Lumos Diagnostics, which also developed a rapid, point-of-care test.
After signing a US$317 million deal in June, Lumos 10-bagged.
So is Nexsen “The Next Lumos”... let’s find out.
But first…
The Pulse Check
Actinogen Medical (ASX: ACW) just got the “go” for its Phase 2 Alziehmers trial. Full Phase 2b/3 results in November. The company is also running a capital raise alongside. (ACW)
🪑Firstly, awesome result; this sets a strong precedent for the biotech industry in 2025.
Second, ACW decided to conduct a capital raise alongside the trial results. Good for investors who can get into the raise, but I’ve never liked that the market doesn’t get a chance to price the results.
More results are expected in November this year, so there are still plenty of interesting developments to come for ACW.
OncoSil Medical (ASX: OSL) reports early clinical data from its OncoSil™ device in combination with chemotherapy for pancreatic cancer, achieving 83% surgical resection success. (OSL)
University of Chicago Medicine has adopted 4DMedical (ASX: 4DX) CT: VQ™ technology. (4DX)
The CEO of Vitura Health (ASX: VIT) has resigned after only 14 months in the role. (VIT)
Atomo Diagnostics (ASX: AT1) secures a $416,000 order for HIV Self-Tests. (AT1)
Substantial shareholder Mark Azzi has disposed of 20 million shares in Nyrada (ASX: NYR), with the next-largest shareholder, Matt Corp, acquiring 14 million shares; the remainder was distributed to other shareholders. (NYR)
🪑I tend to be wary whenever a large, substantial shareholder sells at or near the top. Even if it is due to “urgent personal circumstances”.
The Advance Opportunities Fund continues to sell shares in the market for Osteopore (ASX: OSX). (OSX)
🪑This appears to be a potential momentum killer for the OSX trade. Approximately $15 million in convertible debt remains outstanding, and the Advanced Opportunities Fund has not traded like a long-term shareholder.
Boehringer Ingelheim initiates a Phase 3 trial of apecotrep (BI 764198), a TRPC6-targeted therapy for primary focal segmental glomerulosclerosis. (First World Pharma)
🪑Results from this trial will have a meaningful impact on Nyrada (ASX: NYR). Boehringer is the most advanced company leveraging TRPC6 inhibitor technology for therapeutic uses. If it works, it may validate Nyrada’s entire platform. The trial is expected to be completed in 2029.
The Report Card
Another batch of quarterly reports was released today.
Keep an eye on ones that are announced after market tonight - a big tell that the company is trying to ‘bury’ the result.
Some quick-fire thoughts on a few key quarterlies that I was paying attention to:
4D Medical (ASX: 4DX) currently has over $200 million in cash, but revenues from the CT: VQ product have yet to ramp up. (4DX)
🪑 At a market cap north of $2 billion, shareholders will start to get antsy about when revenues will start to kick in. But with a healthy balance sheet, 4DX has the firepower to get there; it’s all about sales execution now.
Cann Group (ASX: CAN) reports its “first-ever free cash flow positive quarter”. (CAN)
🪑I’m not sure it counts if the R&D credit refund is included in the calculations…
Big cash outflows this quarter from Imugene (ASX: IMU) relative to its balance (spent $13 million and got $14 million remaining). (IMU)
🪑I expect a capital raise soon.
The thinnest cash balance this quarter belongs to Noxopharm (ASX: NOX), down to $100k in the bank, but with a $2.8 million R&D tax grant expected to hit any day now.
🪑The refresh button on the CFO’s keyboard will be getting a strong workout, just waiting for that $2.8 million R&D to drop.
Positive cash flow quarter for Medical Developments (ASX: MVP), Penthrox revenue up $2.3 million, $17 million in the bank.
🪑Solid quarter for MPV trading at a fraction of their all-time lows.
Cash Injection
OncoSil Medical (ASX: OSL) enters a trading halt for a capital raise. (OSL)
Neurizon (ASX: NUZ) secures $6 million R&D tax rebate. (NUZ)
Biotron (ASX: BIT) raises $1.52 million in an entitlement offer. (BIT)
Eikon Therapeutics targets $274M IPO for four clinical-stage oncology candidates (targeting a US$900 valuation. (Feirce Pharma)
Led by BlackRock, Cellares raises a $257M Series D to expand its cell therapy manufacturing platform. (Biospace)
🪑Great news for the CAR-T cell therapy landscape.
M&A, Big Pharma Wants a Wife
Boehringer Ingelheim will pay up to €1.05B deal for the ex-China rights to Simcere's preclinical irritable bowel syndrome antibody. (Fierce Pharma)
Under the Microscope
To assess what macro themes are emerging in the biotech sector, there are two ways:
What is going on in the news
Who were the best-performing stocks in the market?
Last year, we had NYR, a strongly held share register supporting the company's rise off the back of its novel, early-stage platform technology…
We had 4DX and AYA, two medical imaging companies that made genuine progress towards commercial viability in the US...
And not far behind them was LDX, following a US$317 million deal with PHASE Scientific for its rapid, point-of-care diagnostic test.
Today I want to look at LDX and how its 2025 run may have reshaped investor attention on rapid, point-of-care diagnostics… after being one of the hottest macro thematics in 2020/21
We all remember those RAT tests from the COVID-19 years.
(far out, who could forget)
After several years of dormancy, is the RAT BACK, given LDX’s monster share price rise in 2025?
LDX was a true Lazarus story.
Two months after its IPO, the FDA told the company that its COVID-19 RAT test was ‘de-prioritised’ for Emergency Use Authorisation.
12 months later, the FDA rejected the company’s 510(k) application.
The stock went into freefall over the next few months, trading at just 3 cents in 2022, down from its IPO price of around $1.
The FDA finally approved the RAT test in July 2023 after the company narrowed the product's claims… but by then, it was too late.
With the COVID-19 mania winding down, the company pivoted to other conditions, tests for liver issues and women’s health.
In 2024 and early 2025, the company began executing on some goals…
But it wasn't until it signed an exclusive US$317M distribution partnership with PHASE Scientific that the stock market started to notice.
(and it noticed in a big way +1,000% for the year)
Around the same time, a second rapid point-of-care test company started to move.
This time, Atomo Diagnostics (ASX: AT1).
This company was somewhat different: it initially developed a finger-prick rapid point-of-care test for COVID-19 but pivoted to focus on HIV testing.
In July, the company’s share price started to move on the back of the strong news from Lumos.
THEN, in August, the company signed an agreement under which Lumos Diagnostics would purchase Atomo products to help meet projected demand under the PHASE Scientific contract.
Atomo’s share price has been on a strong upward trend ever since.
With that framing, late last year, I was invited to visit Nexsen's (ASX: NXN) laboratories at RMIT.
Nexsen is also developing a rapid, point-of-care technology… “lab on a stick”.
The company had only IPOd two months earlier, so it was incredibly fresh to the ASX.
Given the rapid rise of both Lumos and Atomo in 2025, I wanted to work out whether NXN would be the next rapid, point-of-care company to run.
Stock #11 Biotech 165 series… Nexsen (ASX: NXN)
What’s the story?
NXN is attempting to build a “lab on a stick technology” that aims to diagnose issues with the speed of a RAT test, but with the accuracy of a PCR test.
(still yet to be proven, but that's what clinical trials are for!)
The inventor of the technology, Vipul Bansal, is a top professor at RMIT University, and he was kind enough to invite me to the NXN labs late last year:
It was interesting to see the process of benchtop experimentation, to narrow down the diagnostics to the best and most accurate candidate:
Each test has a slightly different variation…
The strip is a millimetre to the left or to the right; the strip length is slightly shorter or longer… it all makes a difference.
It was interesting to hear how quickly the team could use the platform technology that Vipul had developed to target new and promising indications.
While the first GBS test required ~18 months to develop, the two new kidney tests have taken only 6 months.
GBS is a bacterium that is passed from mother to newborns, which, if not treated, can cause serious illness or death.
But what I was most interested in at the company was kidney disease, given the market size and the potential of the technology.
We’ve all used RAT tests before, and understand how quickly they provide results.
With screening, speed is key.
But speed with accuracy, that’s golden.
NXN IPO’d less than six months ago at 20 cents, and the price has been relatively flat (trading between 13 and 30 cents.
While Lumos and Atomo have run, the market may be waiting for initial clinical validation data from NXN before re-rating the stock.
NXN is currently conducting a clinical validation study for its GBS test and intends to use the 510(k) pathway to obtain market authorisation in the US.
A pre-submission to the FDA was submitted a couple of weeks ago, so we should get a clearer idea of how NXN will approach one-shot registration soon.
The main risks for NXN are…
Will the trial succeed? Has the trial been configured to register it in a single step? What are the company's commercial plans for generating revenue upon registration?
These are questions the company will need to address over the next 12 months, and NXN has only just begun its journey as a listed company.
The idea of a rapid, point-of-care diagnostic test that can be developed quickly (within six months) for new indications is compelling.
The lab on a stick story.
So will NXN be The Next Lumos Diagnostics?
I’m not sure, I’m just the Armchair Analyst.
A big thank you to Vipul and Mark for taking me around the lab and sharing the NXN story.
See you all next week.
The Armchair Analyst
