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It was a rough day at the office for Argenica Therapeutics (ASX: AGN), with shares plunging following the long-awaited release of topline Phase 2 results for its neuroprotective stroke drug, ARG-007. At first glance, the market’s reaction might seem warranted: the trial met its safety endpoint but failed to show an overall efficacy benefit.

However, a deeper look suggests this may be a classic case of shareholders reading the headline, not the footnotes.

What the Market Saw: Safety Yes, Efficacy No

The Phase 2 SEANCON trial enrolled 92 patients across eight Australian hospitals, all of whom suffered an acute ischaemic stroke (AIS) and were treated with endovascular thrombectomy (EVT), the standard-of-care mechanical clot removal procedure.

The primary endpoint was clear-cut: assess whether ARG-007 was safe and well tolerated. Tick. There were no significant differences in adverse events between the treatment and placebo arms. Nor were there any drug-to-drug interactions with thrombolytic agents like alteplase or tenecteplase. Another tick.

But the secondary endpoint - a reduction in infarct (dead brain tissue) volume at 48 hours - showed no statistically significant effect across the entire patient population. And this is likely what spooked investors.

What the Market Missed: The Efficacy Signal Hidden in Plain Sight

Buried beneath the topline numbers is a prespecified subgroup analysis - and it’s here that things start to look more encouraging.

In patients with slow collateral blood flow (a subgroup known to have poorer outcomes under existing treatment regimes), ARG-007 achieved a 15% mean reduction in infarct volume (roughly 5mL). This is meaningful: published literature cites a reduction as small as 0.6mL as clinically important, correlating with improved functional outcomes like the ability to walk, talk and care for oneself post-stroke.

These slow collateral patients represented around 30% of trial participants, and, crucially, they were identified upfront as the group most likely to benefit. This wasn’t a post-hoc fishing expedition - it was a hypothesis baked into the trial design.

Why This Matters: Safety Plus Signal Equals Strategic Optionality

 In the biotech world, passing a safety hurdle in neurology - particularly in a setting as time-sensitive and variable as stroke - is no small feat. Safety de-risks the asset. It’s the foundation upon which all future clinical development is built. Without it, efficacy is irrelevant.

The efficacy signal in the most at-risk group not only supports ARG-007’s mechanism of action - targeting excitotoxicity and oxidative stress in vulnerable but salvageable brain tissue - it also provides a clear strategy for the next phase: a focused, powered study in slow collateral patients.

CEO Dr Liz Dallimore was quick to highlight this path forward:

“We are delighted to have seen an efficacy signal in the most at-risk patients... This information will allow us to target prespecified patient subgroups in later stage clinical trials.”

Funding and Forward Steps

The company reports a cash balance of $7 million, supplemented by an expected R&D tax rebate of up to $4 million, giving Argenica a solid runway to plan its next move. The engagement of Brainomix, a UK-based AI stroke imaging firm, will also bring further clarity to the imaging data and could refine patient selection even further.

Importantly, the lack of interaction with standard clot-busting drugs means ARG-007 can be used flexibly in clinical settings - a logistical advantage that shouldn’t be underestimated in the real-world rollout of stroke therapies.

Investor Takeaway: A Trial Half-Full, Not Half-Empty

The sharp drop in Argenica’s share price suggests that many investors viewed the results as a failure. But the data - and the design - tell a more nuanced story. Phase 2 was always a safety trial first, with efficacy signals sought to inform a targeted Phase 3.

What Argenica has now is:

·       Confirmed safety in a complex clinical setting;

·       A well-defined patient population showing a meaningful efficacy trend;

·       A clear path forward with regulatory and commercial implications;

·       And enough cash to get there.

In the end, this might be less a story of failure and more a lesson in the dangers of reading biotech announcements at face value. Investors with a longer-term lens may want to reconsider whether the recent sell-off was an overreaction - and whether the real value in ARG-007 is only now starting to emerge.

Disclaimer:
This article is for informational purposes only and does not constitute financial product advice, investment advice, or a recommendation to acquire or dispose of any financial product. The content reflects the author’s analysis based on publicly available information and should not be relied upon for investment decisions. Readers should seek independent professional advice before making any financial or investment decisions. The author and TechInvest do not hold any position in Argenica Therapeutics (ASX: AGN) at the time of publication. All care has been taken in preparing this content, but no responsibility is accepted for any errors or omissions.

ASX-listed Biome Australia (ASX: BIO) has taken a major stride in its trans-Tasman ambitions, inking a deal that plugs its flagship Activated Probiotics range into New Zealand’s largest pharmacy network.

Announced to the ASX on Monday, Biome has finalised trading terms with Green Cross Health (NZX: GXH), the healthcare juggernaut behind the Life Pharmacy and UniChem brands. The agreement gives Biome immediate retail access to 328 pharmacies—covering 40% of New Zealand’s prescription volume—beginning in September 2025.

This isn’t just another distribution update—it’s a market entry that vaults Biome into a dominant retail footprint, one that processed over 34 million scripts last year and reaches nearly two million loyalty card holders.

Strategic Stitch-Up

Biome’s Managing Director Blair Norfolk called it “a significant strategic milestone in our international expansion program,” and with good reason. Green Cross Health’s dual-brand model offers a retail one-two punch: Life Pharmacy’s 65 premium sites focus on urban consumers with a wellness bent, while UniChem’s 250-plus community stores cater to locals prioritising clinical advice and accessibility.

Backing it all is Propharma, the EBOS-owned wholesaler already on board since July. Together, the trio forms a tidy supply chain: Propharma pushes stock, Green Cross sells it, and Biome keeps the margins humming.

This integrated approach gives Biome a serious leg-up in a market where distribution, brand trust, and pharmacist endorsement are essential currency.

Tapping the $300m Kiwi Supplement Scene

New Zealand’s natural health market, estimated at NZ$300 million and growing at a clip of 6.5%, is fertile ground. More importantly, pharmacies command about 75% of supplement sales—unlike Australia where supermarkets take a bigger bite.

That means New Zealanders are far more likely to pick up a probiotic bottle from a pharmacist than a grocery aisle, playing directly into Biome’s practitioner-led business model.

Also working in Biome’s favour is New Zealand’s regulatory stance. Probiotics fall under Medsafe’s “functional foods” umbrella, which permits health claims backed by clinical data. This allows Biome to flex its evidence-based credentials—built on a portfolio of double-blind, placebo-controlled trials—without getting tangled in red tape.

Aligning with Vision 27

The announcement ticks a key box under Biome’s Vision 27 strategy, which targets $75 million in cumulative revenue between FY25 and FY27. With the Australian operation gaining traction, New Zealand presents a logical first step in the company’s international scaling effort.

Biome’s Activated Probiotics range is already positioned as one of Australia’s fastest-growing practitioner-only brands, boasting condition-specific formulations targeting everything from cholesterol and eczema to mood and bone health.

More Than Just Pills and Capsules

There’s another angle here that shouldn’t be missed: Green Cross Health doesn’t just run pharmacies. It also operates 65 medical centres with over 416,000 enrolled patients. That opens the door to Biome’s dream scenario—a closed-loop, co-prescription model where doctors recommend its probiotics, patients pick them up in-house, and revenue stays in-network.

Green Cross is already pivoting toward more clinically integrated retail with its “Care & Advice Health Hub” strategy, aiming to rebrand 200 pharmacies under the model by year’s end. It’s a neat dovetail with Biome’s clinical-first messaging.

Bottom Line

Biome’s New Zealand partnership isn’t a toe-dip—it’s a cannonball into a market that rewards professional credibility and regulatory alignment. With a ready-made distribution network, a supportive regulatory regime, and a retail partner focused on health outcomes rather than discounting, Biome’s Trans-Tasman play has the makings of a well-timed growth lever.

As Blair Norfolk succinctly put it, the deal “accelerates our Vision 27 objectives while maintaining our disciplined approach to international expansion.” Whether the company can convert footprint into revenue remains to be seen, but with 328 Kiwi pharmacies on board from day one, the runway looks promising.

ASX-listed dermatology outfit Botanix Pharmaceuticals (ASX:BOT) has added significant clinical and commercial heft to its board, appointing seasoned dermatology expert Dr Patricia Walker as a non-executive director, effective 25 August 2025.

non-executive director, Dr Patricia Walker

For those unfamiliar, Dr Walker isn’t just another white coat in the boardroom. She brings a medley of accolades—over 60 peer-reviewed publications, two dozen academic and professional honours, and a resume stacked with leadership roles in pharmaceutical juggernauts like Allergan, Inamed, and Kythera Biopharmaceuticals.

It’s not her first rodeo with Botanix either. Walker played a pivotal role in the development of Sofdra™ (sofpironium), Botanix’s FDA-approved treatment for primary axillary hyperhidrosis. Her involvement dates back to the molecule’s preclinical days, guiding it through Phase 3 before the company took full ownership.

Executive Chairman Vince Ippolito said the appointment is part of a strategy to fortify the company’s clinical and commercial muscle as it scales up operations. “Dr Walker has a rare and unique skill set including both product development and business acumen that makes her an outstanding addition to the Company’s Board,” he said.

CEO Dr Howie McKibbon echoed the sentiment, noting that Walker’s insights have already been instrumental through her work as Botanix’s Chief Medical Advisor. “With Dr Walker’s experience, from product discovery to global market approvals, she will continue to be instrumental in evaluating potential product acquisitions for Botanix.”

Beyond her stellar biotech pedigree, Dr Walker is also a practising dermatologist—a perspective often underrepresented at board level. She’s well-versed in the practicalities of patient needs and product usability, bridging the often-gaping chasm between lab bench and clinic.

It’s a timely move. Botanix is riding high after the US launch of Sofdra in February 2025, reporting solid uptake in a market historically underserved and worth billions. Backed by a proprietary fulfilment platform and strong early refill rates, the company is now in expansion mode. Plans are in motion to double the US sales force by October and boost gross-to-net returns, with eyes also on licensing and M&A to drive broader growth.

Dr Walker’s appointment isn’t just a box-ticking governance exercise—it reflects a conscious pivot toward scaling, acquiring, and innovating at speed.

In the unforgiving world of biotech, having someone who’s shepherded household names like Botox Cosmetic and Juvéderm from concept to commercialisation is more than cosmetic—it’s strategic gold.

As the company moves deeper into commercialisation and global licensing discussions, having Walker on board could be the differentiator between ‘promising pipeline’ and ‘profitable portfolio’.

It’s still early days, but the message is clear: Botanix isn’t just sweating the small stuff—it’s gearing up for big moves.

Nanoveu (ASX: NVU), the Perth-based purveyor of futuristic screen tech and anti-viral films, is charging into the semiconductor fast lane via its wholly owned subsidiary EMASS. In its latest move, Nanoveu has inked deals with seasoned U.S. semiconductor sales reps to boost adoption of its ultra-low power AI chip, the ECS-DoT SoC - a silicon brain designed for edge computing applications like autonomous drones, smart wearables, and defence robotics.

In short, the Aussies are getting boots - or rather, loafers - on the ground in Silicon Valley, the Midwest, and the U.S. Southwest through partnerships with TAARCOM, IRI, and Haper & Two respectively. Each of these firms brings a Rolodex full of OEM contacts and complementary product portfolios. Critically, none of them are peddling rival AI chips, giving Nanoveu a clean lane to pitch its wares.

“This is about accelerating design-wins and engaging customers early,” said Scott Smyser, EMASS’s VP of Sales and Marketing. “These reps are already trusted by OEMs, and there’s a clear appetite for edge AI. With ECS-DoT, we’re meeting that demand with best-in-class tech.”

Unlike brute-force cloud AI, ECS-DoT is engineered for nimbleness, handling real-time AI inference with miserly power consumption. That’s a game-changer in markets where battery life and speed are non-negotiables - think drone fleets, healthcare monitors, and autonomous machinery.

And timing, as ever, is everything. The expansion coincides with phase two of EMASS’s structured drone evaluation program. Early simulations suggest ECS-DoT could extend drone flight time significantly - an outcome that could turn heads among drone OEMs, especially in defence and industrial sectors.

To make their case, EMASS has trained its AI model on diverse drone flight data—from different altitudes to various weather tantrums. The tech doesn't just cut power usage; it dynamically adapts to changing flight profiles and environmental stress, making it as smart as it is frugal.

Mark Goranson, who leads Nanoveu’s semiconductor division, isn’t shy about the ambition: “With ECS-DoT, we’re not just bringing another chip to market—we’re redefining what’s possible at the edge.”

The goal? Design wins across drones, wearables, IoT, and healthcare. The chip is already fabricated on a 22nm node, and EMASS is laying groundwork for a sleeker 16nm version slated for tape-out in Q4 2025. The reps will also feed back customer insights to guide future iterations.

The sales rep contracts come with standard commercial terms, including defined territories, agent commissions, and termination clauses (60 days in year one, 90 thereafter). They’re locked in for an initial 12-month run, with the possibility of extensions.

On the ground, the ECS-DoT now has a sales army with local know-how and OEM access, allowing Nanoveu to scale without the overhead of building a global direct salesforce. The European front isn’t far behind either, with rep negotiations already in play across Central and Northern Europe.

While it’s too early to slap a revenue target on these arrangements, the strategic significance is clear: this is a well-orchestrated land grab for early design-in wins. As the edge AI market heats up, Nanoveu wants to be in every boardroom where power-efficient chips are on the whiteboard.

Investors might still associate NVU with its EyeFly3D displays and germ-busting Nanoshield films. But with ECS-DoT and EMASS now muscling into the AI chip fray, Nanoveu is angling for a new identity - one measured not just in pixels or polymers, but in nanometres and AI cycles.

It’s not just a new chip. It’s a whole new chip on the shoulder.

It’s been a bumper year for PolyNovo (ASX:PNV), the Melbourne-based biotech redefining wound care with its proprietary NovoSorb technology. For FY25, the company stitched together a compelling financial and operational performance, delivering a 151% increase in net profit after tax to $13.2 million, underpinned by surging global sales and robust clinical momentum.

Commercial product sales reached $118.6 million, up 28.9% year-on-year, thanks in large part to a 28.7% rise in US sales and a 29.6% surge across the rest of the world. It wasn’t just about more sales, but more markets too—PolyNovo added new territories including Malaysia, Peru and the Czech Republic, bringing its reach to 46 countries.

The star of the show was NovoSorb MTX, a thinner and more flexible derivative of PolyNovo’s flagship BTM. MTX brought in $6.7 million in its first full year post-launch in the US, bolstered by expanded regulatory approvals for thicker (up to 6 mm) and more versatile indications. Overall, the US contributed $88.4 million to PolyNovo’s topline—no small feat in a market dominated by entrenched medtech players.

“We’re not just making products; we’re transforming surgical practice,” said acting CEO Dr Robyn Elliott. “FY25 has been a successful year with significant growth in all major indicators: patients treated, units sold, revenue, profit and regulatory approvals.”

The NovoSorb portfolio’s regenerative capabilities have not gone unnoticed. The products are increasingly used not just in burns, but in trauma, limb salvage, and reconstructive surgery—applications that broaden the total addressable market considerably.

Chairman David Williams was equally bullish but pragmatic. “While I am still focused on revenue growth, shareholders will find it refreshing in FY26 to see major capital expenditure coming to an end and increased cash from operations dropping to the bottom line.”

Indeed, PolyNovo is beginning to enjoy the fruits of operational leverage. While revenue rose by nearly 29%, operating expenses climbed a more modest 19.4%. EBITDA more than tripled to $11.2 million, and the company ended the year with a tidy $33.5 million in cash—even after $13.9 million in capital spend and repaying $4.8 million in debt.

From a strategic standpoint, PolyNovo is also prepping for the next phase. Its PMA submission for NovoSorb BTM in full-thickness burns is on track for late CY25, following the 12-month data review from the BARDA-funded pivotal trial. The trial’s outcome could open the door to expanded US indications—and significantly greater reimbursement.

Meanwhile, the pipeline remains fertile. Preclinical results for its hernia mesh prototype have been described as “excellent”, and there’s early promise in a collaboration with Beta Cell Technologies exploring NovoSorb as a delivery platform for pancreatic islets in Type 1 diabetes.

With a refreshed board, a new CEO search underway, and its third manufacturing facility nearing completion, PolyNovo looks well-positioned to maintain momentum.

The only blemish? A 51% share price decline over the past year, from $2.45 to $1.20. But with the fundamentals firming up and the commercialisation path increasingly de-risked, some long-suffering shareholders might finally feel the burn is beginning to heal.