Lumos Diagnostics shares soar 155% after $487m deal
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The news: Lumos Diagnostics' shares more than doubled in value in afternoon trade after the biotech announced a USD317 million ($487 million) deal for the distribution of its rapid blood sample testing devices.
The numbers: The small-cap diagnostic device producer’s share price had skyrocketed by 155.2% to $0.07 at 1:57pm AEST.
Lumos Diagnostics announced to the exchange on Wednesday that it had signed an exclusive US distribution and supply agreement for its FebriDx product with PHASE Scientific International.
The agreement includes a USD1 million exclusivity payment on signing and an additional USD7.5 million in prepaid purchase orders that will be paid in three phases.
Lumos expects the total value of the deal to be USD317 million if the payment milestones above and minimum order quantities over the next six years are met by PHASE.
The context: Lumos still needs to obtain a Clinical Laboratory Improvements Amendments (CLIA) waiver for its FebriDx product from the US Food and Drugs Administration.
This would enable the use of the diagnostic device in physicians' offices, urgent care clinics and other outpatient clinics not operating under moderate-complexity laboratory certification.
The CLIA waiver application is expected to be lodged within the next three months. As of 9 July, Lumos had enrolled 105 of the 120 patients in the FebridDx CLIA waiver study being undertaken with the US Biomedical Advanced Research and Development Authority.
PHASE is a Hong-Kong headquartered biotech that also has offices in Southern California.
What they said: “This distribution agreement reflects a pivotal moment in Lumos’ evolution. We look forward to working with the PHASE Scientific team to ensure that FebriDx secures adoption in the US Market, delivering tangible clinical and financial value to the broader healthcare system,” Lumos chief executive Doug Ward said.
“This agreement validates the value of the FebriDx technology and provides a clear pathway to the US market, which we expect will accelerate rapidly, should we secure the CLIA waiver classification from the FDA.”
The source: ASX
