Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured $20 million in a strongly supported institutional placement, with the fresh capital to be used to scale manufacturing and commercial operations for its flagship point-of-care test — the FebriDx respiratory infection test — in the United States.
The raise was announced at the same time as the US FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for FebriDx®.
The placement was priced at 22.5 cents per share and attracted support from existing and new institutional investors. Lumos is also targeting a further $2 million through a share purchase plan (SPP), giving eligible shareholders in Australia and New Zealand the opportunity to buy shares at the same price.
In addition, existing shareholders Tenmile and Ryder Capital have committed to exercise at least 43.9 million options, which is expected to bring in a further $3.1 million.
Funds to support manufacturing, sales and loan repayment
The capital will be directed primarily towards expanding manufacturing capacity for FebriDx at its Carlsbad, California, facility and building out its US sales, marketing and medical implementation teams as commercial activity ramps up.
Managing director Doug Ward said the additional funding strengthened the company’s balance sheet and positioned it to support wider commercialisation of FebriDx through increased manufacturing and frontline commercial capability.
“This additional capital strengthens Lumos’ balance sheet to scale up our manufacturing, sales and marketing capacity to commence the broader commercialisation of FebriDx® in the United States. We are grateful for the commitment of these new investors and our existing shareholders, whose support is pivotal in enabling us to execute on our strategy and maintain momentum at this important inflection point.
"The granting of a CLIA waiver for FebriDx® by the US FDA marks a transformative moment for the management of acute respiratory infections in the US healthcare system. This approval allows Lumos to access a vastly larger market — allowing healthcare professionals in outpatient clinics to deliver rapid and accurate results at the time of the consultation to deliver more effective patient outcomes.”
The company will also use proceeds to assess additional proprietary product opportunities, repay amounts drawn under its loan facility and cover offer costs and general working capital.
The raising follows recent FDA CLIA waiver clearance for FebriDx, which Lumos sees as a key step in broadening access to the test across the US market.