Preliminary audited results for year ended 31 December 2022

20 February 2023

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

Preliminary audited results for year ended 31 December 2022 

LungLife to report financial results for full-year 2022

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces its audited preliminary results for the year ended 31 December 2022.

Summary and Highlights for the year:

• Cash as of 31 December 2022 of $8.01m (2021: $14.62m)
• Loss before tax of $7.60m (2021: $7.43m)
• Adjusted EBITDA¹ loss of $6.84m (2021: $5.40m)
• Enrolled first participant into multi-centre clinical validation study in February 2022, and on track to complete study enrolment in the next 2-3 months. Total of 14 sites enrolled in the study, including seven from Veterans Affairs Hospitals²
• Centers for Medicare & Medicaid Services (“CMS”) granted a national price of $2,030 per test for the LungLB®, November 2022
• LungLB® test approved and Clinical Laboratory Evaluation Programme (“CLEP”) permit awarded by the New York State Department of Health, allowing the Company to perform clinical utility studies and offer LungLB® commercially in New York state, September 2022
• Selected to participate in the US National Cancer Institute’s Early Detection Research Network (“EDRN”) as part of Boston University-University of California Los Angeles Lung Cancer Biomarker Development Laboratory
• CPT® Proprietary Laboratory Analyses (PLA code), a key component towards reimbursement in the US market, awarded and became effective on 1 April 2022
• Appointment of Dr Drew Moghanaki, an internationally recognised lung cancer specialist, to the Company’s Scientific Advisory Board, March 2022

¹ Earnings before interest, tax, depreciation and amortisation, adjusted to exclude exceptional items, share based payments and other operating income

² Federal government charged with providing life-long healthcare services to eligible veterans

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said: “2022 was a significant year for LungLife and I’m proud of the team for the accomplishments made in fulfilment of our milestones. We initiated our multi-centre validation study in February, expanded the number of participating sites throughout the year and is on track to complete participant enrolment in the next 2-3 months. We ended the year with CMS confirming a price of $2,030 for LungLB® under crosswalk - avoiding a year long process of gapfill price determination and accelerating progress on reimbursement.

“We also received two independent reviews of LungLB® with the New York CLEP permit and selection to participate in the US National Cancer Institute’s Early Detection Research Network. These have provided external evaluation of our technology’s analytical and clinical data and are important steps in increasing awareness of LungLB® and moving towards the Company’s commercialisation plan.

“We remain focused on completing our clinical validation study, commencing our clinical utility study later this year and expanding patient access to LungLB® through implementation of our commercial reimbursement plan. We are very excited by the opportunities ahead and the potential for LungLB® to transform the early detection of lung cancer”.

 For the full report and accounts, click HERE.