LungLife AI (LLAI) is making great strides commercialising its next-generation early-stage lung cancer test LungLB.
Tragically, approximately 125,000 Americans (and 1.8 million people worldwide) die each year from lung cancer, often due to direct or passive smoking. This high mortality rate is largely because most patients are diagnosed only after the disease has spread or become metastatic.
The LungLB test can flip this around, in turn tapping into an addressable market potentially worth more than $2bn pa, based on 1.5m indeterminate nodules being detected each year in the US, which are both small and relate to patients who would otherwise have a tissue biopsy.
Today, the company confirmed that its Early Access Program (EAP) was already generating "very positive" feedback from doctors, and providing "valuable insights" with regards to operational improvements (eg mobile blood draw units), which together "should facilitate increased ordering going forward".
Better still, the business is on track to submit its Technical Assessment application (to MolDx) for Medicare coverage by the end of 2024 (re reimbursement price of $2,030/test) that once approved should enable first revenues to realised.
Medicare is the US government's healthcare insurance program for the disabled and elderly (>65 years old), representing 18.7% of the population or 67.3m people.
Strategically, LungLife AI is in active discussions with several industry partners to help unlock the full potential of LungLB and accelerate its adoption - which if concluded would be transformational.
CEO Paul Pagano commenting: "We have continued to make significant progress with our three primary objectives: evidence generating activities, increasing engagement and awareness, and accelerating the commercial pathway. We are particularly encouraged by the interest shown in the LungLB technology and look forward to continuing this momentum as we transition towards full commercial launch."
Here, LungLB has already successfully passed a pivotal 425-person, 17-site, validation study with flying colours under 'real-world' conditions. LungLB achieved a 81% Positive Predictive Value (PPV) in patients with smaller nodules (<15mm) vs 60% and 67% respectively for CT (current standard of care) and PET scans.
Lastly, in terms of the balance sheet, the business had net funds of $1.77m as at the end of Oct'24, and reiterated its cash runway guidance to Q2'25 - with several other levers to pull later if required. House broker Investec has a 171p/share target price.
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