Healthcare Quarterly Wrap: Acquisitions, product launches and clinical progress

• Dimerix doubles cash position, expands drug pipeline with acquisition and progresses Phase III kidney trial
• Lumos advances US rollout of flagship POC test FebriDx to differentiate between bacterial or viral respiratory illness 
• TrivarX progresses Stabl-lm toward planned Phase I trial as Optiscan advances regulatory and clinical programs 

Despite ongoing economic pressures and uncertainty across markets it has been business as usual for several ASX small-cap healthcare companies with the September quarter delivering a series of clinical, regulatory and commercial milestones.

Companies reported progress across clinical programs and regulatory pathways, acquisitions of new drug assets to expand pipelines, commercial launches and accelerating product rollouts, alongside new partnerships and deals as they made a strong start to FY27.

Dimerix (ASX:DXB)

• Dimerix doubles cash position after $14.1 million upfront payment from licensing deal and $17m drawdown on funding facility
• Expands pipeline with acquisition of Phase II ready asset DMX-652, with first indication acute kidney injury
• ACTION3 Phase III trial fully recruited with first 100 patients completing treatment period and progressing through follow-up

DXB’s cash position more than doubled to $34.8 million at September 30, 2026, after a $14.1m upfront payment from Everest Medicines and a first $17m drawdown on a $34m non-dilutive facility.

Everest is DXB’s fifth regional licensing deal for DMX-200, its lead drug candidate for the rare kidney disease focal segmental glomerulosclerosis (FSGS). The deal covers Greater China, South Korea and several other key South East Asian markets.

DXB says it has enough funding to complete the pivotal ACTION3 Phase III trial of DMX-200 in FSG and keep the Phase II trial of new asset DMX-652 in acute kidney injury (AKI) progressing.

During the quarter DXB announced the acquisition of Phase II-ready DMX-652 and took over sponsorship of its US Food and Drug Administration (FDA) investigational new drug application.

This acquisition broadens the company’s pipeline beyond rare kidney disease exposure to the significantly larger acute kidney injury market, where there are currently no approved therapies.

DXB’s ACTION3 Phase III trial continued to advance, with the first 100 patients completing their treatment period and progressing through follow-up.

The trial is fully recruited in the adult cohort, with 333 patients dosed across 219 sites in 21 countries, and the final proteinuria endpoint is due in H1 CY28.

The first patient also completed the Open Label Extension study, representing four years of continuous participation in the DMX-200 clinical program.

Expanded patient access to DMX-200 is being offered through post-trial access pathways, supporting continuity of treatment for eligible patients

The company has secured composition-of-matter patents for DMX-200, including in the US.

On the corporate front, Hugh Alsop was appointed interim chair following the planned retirement of Mark Diamond.

CEO Dr Nina Webster also received a 2026 Governor of Victoria Export Award, recognising her leadership in taking Australian innovation to global markets.

“With a strengthened balance sheet, two differentiated renal assets in development, global commercial partners and multiple near-term catalysts ahead, Dimerix remains well positioned to continue building potential long-term value for both patients and shareholders,” Webster said.

Lumos Diagnostics (ASX:LDX)

• Lumos advances US commercialisation of FebriDx with 265 healthcare sites now ordering and using the test
• Thirteen of the top 100 US urgent care groups using or evaluating POC test to distinguish bacterial from viral respiratory infections
• Lumos posted Q1 FY27 revenue of US$2 million, with FebriDx sales rising 224% to US$564,000

During Q1 FY27 LDX continued to progress the US commercialisation of FebriDx, its rapid point-of-care (POC) finger-prick blood test, to distinguish whether an acute respiratory infection (ARI) is bacterial or viral.

As of October 11 there were 265 healthcare sites across 29 US states actively ordering and using FebriDx, up from 215 sites in 26 states on September 15 and 170 sites in 24 states on July 26.

Evaluations are underway across 485 sites, up from 405 sites on September 1.

The company said 13 of the top 100 urgent care groups in the US were either using or evaluating FebriDx.

Three of the groups are appraising FebriDx across 50 sites, which treat a combined 250,000 respiratory patients annually.

The FDA cleared FebriDx in 2023 and in March this year the commercial opportunity expanded significantly with granting of a Clinical Laboratory Improvement Amendments (CLIA) waiver.

This waiver allows FebriDx to be deployed across more than 300,000 US healthcare settings, including GPs and urgent care clinics, retail health and pharmacy clinics.

LDX is also undertaking a CLIA-waiver study with Biomedical Advanced Research and Development Authority (BARDA) for paediatric patients aged 2-12, further expanding the market opportunity for FebriDx.

The company said ~400 patients had been enrolled to date in the paediatric CLIA waiver with total enrolment and bacterial positive cases lower than expected. Three hospital emergency departments are being added in Q2 FY27 to help boost numbers.

LDX and the Biomedical Advanced Research and Development Authority (BARDA), which is supporting the study, are also working closely to monitor the study’s progress.

The company said this included engaging with the FDA to see whether the trial parameters could be adjusted to address the bacterial-positive presentation rate encountered to date.

LDX reported Q1 FY27 revenue of US$2m, with FebriDx sales rising 224% to US$564,000.

The company recorded operating cash outflows of US$4.7m, including US$1m spent building FebriDX inventory ahead of the US flu season.

It said development and contract manufacturing work continued across 12 projects during the quarter, including for Hologic, Micro-Pak, TeleMedVet and Aptatek Biosciences.

TrivarX (ASX:TRI)

• Stabl-lm development milestones achieved with technical, procedural and operational activities progressing toward planned Phase I trial 
• Formal site and principal investigator selection underway with specialist clinical trial manager selected 
• First participant enrolment targeted for Q1 CY27 with initial clinical study results anticipated during Q2 CY27 

TRI made further progress towards clinical evaluation of its Stabl-Im technology during the quarter, completing key technical and operational milestones ahead of its planned Phase 1 clinical study.

Stabl-Im is designed to provide biologically meaningful information on tumour activity, cell proliferation and treatment response using stable isotopes and existing MRI infrastructure, without the need for radioactive tracers.

During the quarter, TRI completed the design requirements for its initial healthy-volunteer study, started pre-clinical animal studies along with securing and receiving investigational product supply.

TRI also started formal selection of a clinical site and principal investigator, with a clinical trial manager added to the development team to support study start-up and execution. Discussions with a preferred specialist analytical vendor also advanced.

The planned initial clinical study will evaluate the safety, tolerability and pharmacokinetics of controlled deuterium enrichment in healthy volunteers. It aims to generate foundational data to inform further development of Stabl-lm and its potential oncology applications.

TRI secured and received the investigational product supply required for the study, progressing preparations for clinical administration in accordance with Therapeutic Goods Administration requirements. Subsequent to quarter-end, it appointed Australian pharmaceutical manufacturing specialist Syntro Health to undertake product preparation and quality testing.

The company is targeting first participant enrolment in Q1 CY27, with initial clinical study results expected in Q2 CY27, subject to remaining regulatory, ethics and operational requirements.

Alongside the clinical preparations, TrivarX also started additional non-clinical investigations to assess broader potential applications for the Stabl-Im platform.

Initial results from these investigations and the pre-clinical program are anticipated in the current quarter.

TRI held $1.96m in cash at September 30, which the company said provided financial flexibility to advance pending clinical development of Stabl-lm.

The company continues to maintain its existing mental health technology portfolio, with expenditure focused primarily on IP maintenance while it explores potential partnering and licensing opportunities.

“During the September quarter, TRI completed essential steps towards clinical evaluation of Stabl-Im,” CEO Dr Danielle Meyrick said.

“We finalised the initial study design requirement, commenced pre-clinical studies and secured and received the investigational product needed for the planned healthy volunteer study,” she said.

Optiscan (ASX:OIL)

• Lodged US FDA 510(k) submissions for InForm digital pathology and InVue precision surgery devices following substantial testing, validation and regulatory work
• Signed two research deals with Mayo Clinic, started breast cancer and head and neck cancer studies in US evaluating both devices in integrated surgical-pathology workflows
• Officially launched InSpecta device in the US veterinary market at the American Veterinary Medical Association Convention

OIL made significant regulatory and clinical progress during the September quarter, moving its two lead human-use imaging devices closer to potential US market entry.

Following extensive technical, clinical, testing and regulatory work during the period, OIL lodged a 510(k) submission with the FDA for its InForm digital pathology device on October 1 and its InVue precision surgery device on October 5.

InForm is designed to provide real-time, slide-free microscopic imaging of fresh or fixed tissue within pathology workflows, while InVue gives surgeons cellular-level imaging capabilities during operations.

“These submissions are among the most significant milestones in Optiscan’s recent history,” CEO Dr Camile Farah said.

During the quarter OIL also expanded its clinical collaboration with the Mayo Clinic in Rochester, Minnesota, signing two research deals covering breast cancer and head and neck cancer imaging studies.

Each study aims to enrol up to 35 US patients and will evaluate both devices in integrated surgical-pathology workflows. Recruitment started during the quarter for the head and neck study.

In Australia, the breast cancer study at Royal Melbourne Hospital had completed 40 of its planned 50 cases, while the head and neck study at St John of God Murdoch Hospital in Perth had enrolled 13 of the 50 patients.

Progress on an anatomical pathology study with Australian Clinical Labs continued to build momentum generating 84 data sets as at September 30 across a broad range of tissue types and pathology.

Preparation and site initiation activities progressed for the observational gastrointestinal imaging study at the University Medical Centre Mainz in Germany. 

On the commercial front, OIL officially launched its InSpecta device into the US veterinary market at the American Veterinary Medical Association Convention in California in July.

The company also engaged a US-based outsourced business development team to identify prospective customers and develop its sales pipeline, while strengthening manufacturing capabilities through the appointment of two additional precision technicians.

“This has been a defining quarter for Optiscan, and I am incredibly proud of what our team has achieved,” Farah said.

This story does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

At Stockhead we tell it like it is. While Dimerix, Lumos Diagnostics, TrivarX and Optiscan are Stockhead advertisers, the companies did not sponsor this article. 

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