LLAI Interim Results 2024

LungLife AI, Inc. (the “Company” or “LungLife”) 

 Half-year Report 

 LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for the early detection of lung cancer, announces its unaudited half-year report for the six months ended 30 June 2024.  

 Strong progress with our LungLB® product 

• Successful clinical validation of the Company’s LungLB® test following conclusion of the multi-site validation trial. This completes all of the major milestones set out at the time of the Company’s admission to AIM, including regulatory approval from Clinical Laboratory Improvement Amendments (“CLIA”) / New York State Department of Health (“NYSDOH”), obtaining a reimbursement code, and the securing of a favourable National Medicare price. Collectively, these achievements lay important foundations for commercial readiness. 
• LungLB® test highlighted at the National Cancer Institute’s (“NCI”) Early Detection Research Network meeting, and now included on their list of biomarker tests available in CLIA-approved laboratories. The recognition from the NCI raises the profile of the test nationally to physicians searching for early detection solutions like LungLB®. 
• Initial orders for LungLB® have been placed by physicians through the Early Access Program (“EAP”), and test results have been provided back to them to help with nodule evaluation and patient care. 
• Two abstracts supporting evidence for analytical and clinical validity of LungLB submitted for presentation at the Association for Molecular Pathology annual meeting, to be held in November 2024. 
• A manuscript detailing the analytical validation of LungLB® submitted for peer review. Publication of this validation study will form an important part of our Technical Assessment (“TA”) for LungLB® insurance coverage by public and commercial payors. It provides evidence to physicians that LungLB® is robust and appropriate for everyday clinical use. 
• Post period end, the foundational Local Coverage Determination (“LCD”) for indeterminate lung nodules was published in August 2024. Following this publication, we plan to submit a Technical Assessment for coverage under the LCD in order to receive payment from Medicare. Having the Foundational LCD in place provides an accelerated pathway for this process. This is a key step towards commercialisation for LungLife, having already received a billing code and established a price of $2,030 per LungLB® test. 

 Continued operational delivery :

• Cost control and headcount restructuring following completion of the clinical trial allows the Company to focus on commercialisation activities. 
• Appointed an advisor with expertise in diagnostics and an extensive network to assist with the identification of a suitable strategic partner. 
• Continued the build of the required infrastructure in order to start billing for tests. 
• Created marketing collateral to engage patients, healthcare professionals and insurance companies. 
• Started the process of contacting commercial payors. 
• Fifth internally generated patent application since IPO has entered PCT phase, the path to providing international protection for the latest advancements in the Company’s technology. 

 Financial Highlights: 

• Cash as of 30 June 2024 of $2.62m (31 December 2023: $2.83m) 
• Equity funding in March raising gross proceeds of $2.28m through the issue of 5,172,621 common shares 
• Cash outflow from operating activities of $1.94m (six months to 30 June 2023: $2.70m) 
• EBITDA loss of $1.77m (six months to 30 June 2023: $2.78m) 

Commenting Paul Pagano, Chief Executive Officer of LungLife, said: 

“The successful clinical validation of the LungLB® test and other achievements in this period reflect our commitment to advancing early detection of lung cancer and the team remains dedicated to making a significant impact in this critical area of healthcare. 

We are delighted with the increasing recognition for LungLB® as evidenced by the positive clinician feedback together with the first orders being received under our Early Access Program. Whilst we progress towards commercialisation, we are also actively seeking opportunities for a suitable strategic partner who aligns with our vision and has the capability to accelerate the adoption of LungLB®.” 

Click here to view this as a PDF.