Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.
- Half-year loss rises 74% to US$4.88 million
- Revenues dip 3% to US$6.12 million with contract services down 19%
- FebriDx sales double, supported by US$317 million Phase Scientific deal
- FDA CLIA Waiver decision for FebriDx expected by March 2026
- Secured US$3.31 million loan facility remains undrawn at period end
Financial Performance and Loss Drivers
Lumos Diagnostics Holdings Limited has revealed a widening net loss for the half-year ended 31 December 2025, with losses increasing 74% to US$4.88 million compared to US$2.80 million in the prior corresponding period. This deterioration was primarily driven by higher financing costs linked to a recently established loan facility and a significant rise in share-based payment expenses, both non-cash items.
Revenues for the period slightly declined by 3% to US$6.12 million, reflecting a 19% drop in contract development and manufacturing services to US$4.44 million. This was partially offset by a doubling in sales of Lumos’ own point-of-care diagnostic products, notably FebriDx, which generated US$1.68 million, up from US$0.84 million a year earlier.
Strategic Progress with FebriDx and Regulatory Milestones
FebriDx, Lumos’ flagship rapid test for differentiating viral and bacterial respiratory infections, continues to be a focal point for growth. The company secured a landmark exclusive US distribution and supply agreement with Phase Scientific International Limited valued at up to US$317 million over six years. This deal includes upfront payments and milestone-based purchase orders, underpinning Lumos’ commercial ambitions in the US market.
Regulatory progress remains on track, with Lumos having submitted its application for a CLIA Waiver to the US Food and Drug Administration (FDA) in August 2025. The CLIA Waiver would allow FebriDx to be used in less complex clinical settings, significantly expanding its addressable market. The company expects a decision by the end of March 2026, following positive feedback and supplementary usability assessments requested by the FDA.
Expanding Market Access and Partnerships
In addition to the Phase Scientific deal, Lumos has broadened its distribution footprint by securing a partnership with Interlux for the Baltic region, enhancing access across Lithuania, Estonia, and Latvia. The company also achieved full Medicare reimbursement recognition across all seven US Medicare Administrative Contractor jurisdictions, covering over 100% of the Medicare payment landscape, a critical step for wider adoption.
Lumos is advancing clinical studies to extend FebriDx’s use to paediatric patients aged 2 to 12 years, supported by US government funding from BARDA. This paediatric study, expected to complete enrolment within 12 months, could increase the US market size for FebriDx by up to 20%.
Contract Development and New Product Pipelines
The company continues to develop its contract research and manufacturing services pipeline, including strategic projects with Hologic in women’s health diagnostics and Aptatek Biosciences for in-home monitoring devices. While services revenue declined due to project timeline extensions, these collaborations diversify Lumos’ commercial base beyond infectious diseases.
Lumos is also progressing internal development of women’s sexual health diagnostic tests, with three products now at the technical feasibility stage, reflecting a strategic focus on expanding its product portfolio.
Liquidity and Going Concern Considerations
Despite the loss, Lumos improved its net operating cash inflow to US$0.76 million for the half-year and increased cash reserves to US$2.99 million. The company established a US$3.31 million secured loan facility with major shareholders, providing working capital flexibility, though no drawdowns had been made as of 31 December 2025.
The auditors highlighted material uncertainty regarding Lumos’ ability to continue as a going concern, reflecting the current loss position and cash runway. However, the board remains confident that upcoming milestone payments, regulatory approvals, and revenue growth opportunities will support ongoing operations.
Bottom Line?
Lumos stands at a pivotal juncture, with regulatory and commercial milestones poised to shape its financial trajectory in the coming months.
Questions in the middle?
- Will the FDA grant the CLIA Waiver for FebriDx by the anticipated March 2026 deadline?
- How will the Phase Scientific distribution deal translate into actual sales and cash flow?
- What impact will the paediatric study and expanded reimbursement have on Lumos’ market penetration?