On 27 March 2026, Lumos was delighted to announce that the US Food and Drug Administration (FDA) had granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for its flagship point-of-care test, FebriDx®, following its 510(k) clearance [K260787].
A transformative moment for Lumos, the 510(k) clearance and granting of the CLIA waiver triggered milestone payments of US$5.5 million under agreements with a US$5.0 million pre-paid purchase order from distribution partner PHASE Scientific and US$0.5 million from the Biomedical Advanced Research and Development Authority (BARDA) for achieving CLIA waiver. The clearance and granting of CLIA waiver expands the applicability of FebriDx to over 80 million US patients, per annum and a total market opportunity of US$1.0+ billion, representing a 15-fold increase on the market opportunity, prior to CLIA waiver.
In tandem with this announcement, Lumos announced it had completed an A$20 million Placement to existing and new institutional investors, to provide funding for commercialisation of FebriDx in the US, and that it would offer eligible shareholders an opportunity to participate under a Share Purchase Plan.
Lumos Diagnostics (ASX: LDX) has launched a Share Purchase Plan (SPP) that gives Eligible Shareholders the opportunity to acquire up to A$30,000 of new fully paid ordinary shares in Lumos, at an Issue Price of A$0.225 per SPP Share, with one free option provided for every two SPP Shares subscribed for. The options have an exercise price of A$0.34 per share, are unquoted and expire on 31 December 2027. No brokerage or transaction costs will be incurred by shareholders for securities subscribed for under the SPP Offer.
| Prospectus or SPP Offer enquiries | For enquiries relating to the Prospectus or the SPP Offer, please contact the Company Secretary by email via [email protected] or by phone, on +61 3 9087 1598. |
| Registry related matters | For any other registry related matters, please contact the Share Registry on 1300 850 505 (within Australia) or +61 3 9415 4000 (outside Australia). |
The funds raised from the Offer will be used to:
The Prospectus is primarily being issued for the offer of up to 8,888,889 Shares at an issue price of A$0.225 per Share and 4,444,444 New Options to Eligible Shareholders, on the basis of one (1) free-attaching New Option for every two (2) Shares subscribed for and issued under the SPP, to raise up to A$2,000,000 (before costs) (SPP Offer).
This Prospectus is also being issued for the Placement Options Offer described in this Prospectus.
| Event* | Date |
|---|---|
| Record Date (7.00pm AEDT) for entitlement to participate in SPP Offer | 26 March 2026 |
| Opening Date of Offers | 10 April 2026 |
| Closing Date of Offers (5.00pm AEST) | 24 April 2026 |
| Announcement of results of the SPP Offer and issue of Securities under the Offers | 1 May 2026 |
| Anticipated date of Official Quotation of Shares issued under the SPP Offer | 4 May 2026 |
* The dates and times noted above are indicative only and subject to change. Any material changes will be notified by the Company to ASX. The Company reserves the right to amend any or all of these dates and times, including amending the Closing Date of the Offers, without prior notice subject to the Corporations Act, the Listing Rules and other applicable laws. Accordingly, Applicants are encouraged to submit their Application Form as early as possible.
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