IXICO assists FDA clearance of new Alzheimer’s blood-based diagnostic
One of the advantages of investing in IPR-rich life science firms with best-in-class products, operating in expanding therapeutic areas, is that new potential 'use cases' crop up from time to time, increasing the total addressable market.
This is exactly the case for (mrkcap £10.2m), an AI-powered medical imaging analytics expert. It is already the world's #1 player in interpreting brain scans for Huntington's, and has expanded into Alzheimer's (AD), Parkinson's, and other neurodegenerative conditions.
Today, the company announced that its 'gold standard' analysis of PET scans had helped one of its clients, Fujirebio, obtain FDA approval for its breakthrough new blood test for AD - thus further extending 's neuroimaging biomarker capabilities beyond clinical trials to the analysis and validation of diagnostic biomarkers.
Moreover, given there is billions of dollars being ploughed into diagnostics to help identify and treat neurodegenerative disease (eg longitudinal testing of existing drugs eg Leqembi and Kisunla), then this could be a significant future money spinner.
What's more, later this year, two potentially blockbuster new Alzheimer's treatments are hopefully moving into Phase 3 clinical trials - namely Bristol Myers Squibb’s Cobenfy and Roche’s trontinemab. Here, advanced digital imaging is also the quickest, cheapest, safest and most effective way to understand, monitor and treat brain disorders, alongside playing a vital role in obtaining FDA approval and conducting post-marketing surveillance.
In terms of the numbers, the Board is aiming to increase turnover to £10m over the next few years, compared to forecast Sept FY25 turnover, EBITDA and net cash of £6.0m, -£1.4m and £3m respectively - underpinned by near 100% revenue cover for H2. Breakeven sales are estimated to be around £8.5m, whilst house broker Cavendish has a 24p/share price target versus today's 11p, equivalent to a modest 1.2x EV/revs.
CEO Bram Goorden commenting: "This is a major milestone in AD biomarker development and will provide a significant boost to biomarker use in clinical diagnosis and clinical trials. As a first-line screening tool, the blood-based biomarker allows to efficiently funnel those subjects to a gold-standard PET assessment that require confirmation of amyloid positivity or that resulted in an indeterminate blood-based biomarker assessment. Multimodal use of complementary biomarkers can increase screening throughput, a key requirement when targeting pre-symptomatic populations."
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