ASX Quarterly Health Wrap: Blinklab starts key FDA study, Mach 7 set to meet FY25 guidance

During Q2 FY25 Blinklab initiated an FDA registrational study of its Dx 1 platform as an aid in autism diagnosis, plus more biotech quarterlies.

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• During Q2 FY25 Blinklab initiated an FDA registrational study of its Dx 1 platform

• Mach7 on track to meet FY25 guidance with CARR of $31.8 million in Q2 FY25

• Lumos unaudited revenue of US$2.9m for the quarter, up 71% on pcp

Quarterly season is nearing its end, triggering a rush from small caps to hit the month-end reporting deadline.

Here, we wrap up report highlights from standout stocks in the ASX health sector.

Blinklab (ASX:BB1)

• During Q2 FY25 Blinklab initiated an FDA registrational study of its Dx 1 platform as an aid in autism diagnosis
• Final results are expected by the end of CY25 and will be used for the 510(k) FDA approval

The highlight for the quarter for Blinklab was initiation an FDA registrational study of its Dx 1 platform as an aid in the diagnosis of autism.

The company said the initial phase would recruit up to 100 participants (children aged between 2-11 years old), with the main study recruiting up to 1000 subjects.

Blinklab said four clinical sites have been selected, with six additional sites to be added with sites spread across the US to ensure diversity of  population.

Blinklab said final results are expected by the end of CY25 and will be used for the 510(k) FDA approval. The company reported positive feedback from a pre-submission meeting with the FDA regarding the regulatory pathway for Dx 1.

In November Blinklab posted positive final results from the pivotal autism study, which has bolstered its confidence that Dx 1 will surpass the accuracy parameters that are required for regulatory approval in the upcoming FDA registration trial.

BlinkLab and Monash University announced a partnership during the quarter on the large-scale Monash Autism-ADHD Genetics and Neurodevelopment (MAGNET) study, which aims to conduct deep phenotyping in children on the autism spectrum, with ADHD, or both.

The study will also work towards further improvements to BlinkLab’s machine learning algorithm to better distinguish between autism and ADHD-specific clinical features.

Blinklab ended the quarter with a cash balance of $4.4m.

Mach7 Technologies (ASX:M7T)

• Mach7 on track to meet FY25 guidance with CARR of $31.8 million in Q2
• Company to undertake an on-market share buy-back of up to $5m
• Customer demand expected to continue in North America, APAC and Middle East

The medical imaging software solutions provider said it was on track to meet FY25 guidance after delivering "a solid result" with new signed contracts with existing customers, demonstrating the importance of its strategic focus on "customer intimacy" and success of its "land and expand" model.

Mach7 reported contracted annual recurring revenue (CARR) of $31.8m in Q2 FY24, up  15.6% on Q1 FY24, while the annual recurring revenue run rate of $25.1m at December 31, 2024 was, up 14.1% on the previous quarter end.

The company said sales orders for Q2 were $14m (total contract value). The majority of sales orders received were for ARR-type sales.

Mach7 reaffirmed FY25 guidance for 15-25% growth in CARR and revenue on pcp and closed the quarter with cash of $23.6m, up 4% on pcp.

Mach7 expects to see continued demand and volume growth from both new and existing customers across North America, APAC and the Middle East.

The company yesterday announced an on-market share buy-back of up to $5m. Mach7 said the board considered the buy-back to be an efficient use of capital given the strength of its balance sheet and strong cash inflows to date.

Race Oncology (ASX:RAC)

• Race reports significant progress made towards first patient treatment in phase I trial of RC220 in combination with doxorubicin during quarter
• Board renewal continued with the appointment of Dr Megan Baldwin as an independent non-executive director
• R&D Tax Incentive payment of $5.25m received, increasing cash held to $18.78m

Race said the quarter saw continued transformation of its board with Dr Megan Baldwin, founder and chief innovation officer of Opthea (ASX:OPT), appointed as independent non-executive director.

During the quarter Race also welcomed two new senior scientists to the team, Drs Kirsten Curnow and Sumit Shani.

The company said it made significant progress towards first patient treatment in a phase 1 trial of lead drug candidate RC220 in combination with doxorubicin in patients with advanced solid tumours, via submission of the ethics and regulatory package to Bellberry Human Research Ethics Committee (HREC) in December 2024.

Subject to final ethics approval and governance approval, site activation and first patient recruitment is expected in the March quarter.

In November, Race announced it had successfully completed an FTO-targeted drug discovery program at Monash University’s Fragment Platform.

Race’s ended the quarter with cash and cash equivalents of $18.78m, with more than two thirds of spending in the quarter directed toward R&D and drug manufacturing activities.

The cash and cash equivalent position was $4.2m higher than Q1, underpinned by receipt of an R&D Tax Incentive payment of $5.25m and conversion of $870,000 in options during the quarter.

Lumos Diagnostics (ASX:LDX)

• Lumos unaudited revenue of US$2.9m for the quarter, up 71% on pcp
• Completed a strongly supported $6.9 million retail entitlement offer
• Starts FebriDx CLIA waiver trial in the US with first patient tested in December

The developer of rapid point-of-care diagnostic technologies reported unaudited revenue of US$2.9m for the quarter, up 71% on the prior corresponding period (PCP).

Lumos said product revenue was up 200% on pcp while services revenue rose 53% on pcp.

During the quarter Lumos successfully completed a $6.9m retail entitlement component of a $10m capital raise, which the company said was strongly supported by new and existing shareholders, Tenmile and Ryder Capital.

The company also signed a partnership agreement with Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response.

The deal will see BARDA provide ~US$3m in non-dilutive funding to support FebriDx CLIA waiver trial in the US, with funding options to expand to US$8.3m.

The CLIA waiver study has kicked off with the first patient successfully tested on December 19, 2024.

FebriDx is a unique, rapid point-of-care (POC) test that uses a fingerstick blood sample to aid in the differentiation between bacterial and non-bacterial acute respiratory infections.

During the quarter a CPT PLA procedure code was approved for FebriDx in the US with a reimbursement rate of US$41.38 per test.

Lumos ended the quarter with a cash balance of US$6.4 million, which includes milestone payment from BARDA.

Optiscan (ASX:OIL)

• Optiscan signs collaborative research deal with University of Minnesota College of Veterinary Medicine
• Inks deal with Monash University to develop AI technology solutions for gastroenterology imaging
• Clinical flexible endomicroscope prototype completed and delivered to University Mainz Hospital for evaluation

Optiscan has continued to make progress with its product development and clinical pipeline achievements over the quarter including signing a collaborative research agreement with the University of Minnesota College of Veterinary Medicine.

The company said development of a dedicated veterinary imaging product had started, with planned for unveiling in early FY26. The device will integrate Optiscan’s high-resolution imaging technology for real-time diagnostic applications in veterinary medicine.

During the quarter Optiscan also signed of an agreement with Monash University to develop AI technology solutions for gastroenterology imaging.

Optiscan said in a key equipment deliverable during the quarter a clinical flexible endomicroscope prototype was completed and delivered to University Mainz Hospital for evaluation.  Testing with Professor Ralf Kiesslich’s team in Germany will begin in Q3 FY25.

The company said substantial progress had been made on the InVue product development, with delivery on track to support
clinical evidence generation programs at the Royal Melbourne Hospital and Mayo Clinic in the US

Optiscan delivered a ViewnVivo system to its China-based distribution partner and said it had "pulled out all stops to bolster market awareness of Optiscan’s expanding medtech offering".

During the quarter Optiscan said it had finalised sterilisation methodologies for its devices, addressing a variety of clinical settings and operational needs.

Substantial enhancements to Optiscan’s pathology laboratory device, a groundbreaking alternative to frozen section biopsy, were finalised in Q2 FY25. The device’s unveiling is scheduled for Q3 FY25, with Optiscan targeting applications in the lucrative diagnostic tissue pathology market.

Optiscan also announced it had received its R&D tax refund for FY24 amounting to $1,775,733. The company said the amount was significantly higher than the FY23 amount of $672,320 due to its successful Advance and Overseas Finding application, which allows companies to claim eligible overseas R&D costs.

At Stockhead, we tell it like it is. While Blinklab, Race Oncology, Lumos Diagnostics and Optiscan are Stockhead advertisers, they did not sponsor this article.

Disclosure: The author held shares in Mach 7 at the time of writing this article.

Originally published as ASX Quarterly Health Wrap: Blinklab starts key FDA study, Mach 7 set to meet FY25 guidance