Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has executed definitive documentation for a secured $5 million loan facility with major shareholders Tenmile Ventures Pty Ltd and Ryder Capital Management Pty Ltd, providing additional financial flexibility as it advances its flagship FebriDx® test towards US regulatory clearance for point-of-care settings.
The facility, first outlined in July under a binding term sheet, replaces an unused tranche of a previous convertible note arrangement and will act as a working capital backstop while Lumos works to secure a Clinical Laboratory Improvement Amendments (CLIA) waiver from the US Food and Drug Administration (FDA).
FebriDx®, a rapid point-of-care test that helps differentiate between bacterial and viral infections, is already FDA-cleared for professional use in clinical laboratories, but a CLIA waiver would extend its reach into frontline health environments such as GP clinics and urgent care, significantly broadening its market potential.
Read more: MST Access lifts Lumos Diagnostics valuation as CLIA waiver bid boosts FebriDx opportunity
Facility terms and equity component
The new loan agreement is structured to allow drawdowns at Lumos’ discretion, depending on its funding needs. In return for establishment and service fees, Tenmile and Ryder will each receive 7.5 million Lumos shares.
As part of the transaction, Lumos has extinguished the second tranche of a $4 million convertible note facility with Lind Global Fund II and SBC Global Investment Fund. That tranche had not been drawn, and the company confirmed there was no cost associated with its termination.
Chief executive Doug Ward said the arrangement reflects the strong backing of Lumos’ cornerstone investors.
“Securing this facility provides Lumos with the flexibility to continue progressing towards CLIA waiver and the broader commercialization of FebriDx®, while minimising equity dilution for our shareholders,” Ward said. “We are grateful for the ongoing commitment of Tenmile and Ryder Capital, whose support has been pivotal in enabling us to execute on our strategy and maintain momentum at this important stage.”
FebriDx® momentum builds
The loan facility comes as Lumos advances multiple initiatives around FebriDx®. The company recently completed a pivotal clinical study, clearing the way for its CLIA waiver application to the FDA. A decision is anticipated in the coming months, with approval expected to open a much larger primary care market for the test.
Alongside the waiver submission, Lumos has secured a six-year US distribution deal with PHASE Scientific valued at up to US$317 million, subject to regulatory clearance and sales milestones. The company is also running a BARDA-backed paediatric study to evaluate FebriDx® in children, further broadening its potential use cases.
Read more: Lumos Diagnostics launches BARDA-backed paediatric study for FebriDx in US CLIA-waived settings
Broader pipeline activity
Beyond FebriDx®, Lumos continues to expand its diagnostic pipeline. Last week it announced a US$1.5 million contract to advance a phenylketonuria (PKU) monitoring device, part of a strategy to leverage its point-of-care technology platform across infectious and inflammatory diseases as well as rare conditions.
Read more: Lumos Diagnostics secures US$1.5M contract to advance PKU monitoring device
With the new facility in place, Lumos says it is well-positioned to maintain its regulatory and commercial momentum through the second half of 2025.