Preliminary audited results for year ended 31 December 2023

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

Preliminary audited results for year ended 31 December 2023

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces its audited preliminary results for the year ended 31 December 2023.

Summary and Highlights for the year and post-period end:

• Cash as of 31 December 2023 of $2.83m (2022: $8.01m).
• Loss before tax of $5.41m (2022: $7.60m).
• Adjusted EBITDA1 loss of $5.19m (2022: $6.84m).
• Effective 1 January 2023, LungLB PLA code 0317U was added to Medicare’s Clinical Laboratory Fee Schedule (“CLFS”) at a National price of $2,030 per test.
• LungLife’s cost effectiveness analysis was published in the Journal of Medical Economics, providing evidence that LungLB is cost effective when used to evaluate indeterminate lung nodules when integrated into the current clinical care pathway. This is a key publication for payors, including Medicare, when considering coverage for LungLB.
• The Company’s lead-in multi-site validation of LungLB was published in Nature-Springer's BMC Pulmonary Medicine, demonstrating high performance in smaller lung nodules and outperforming PET scan and Mayo Nodule Calculator tools, and indicating the potential to reduce delays in treatment from earlier detection using LungLB.
• Successful clinical validation of the Company’s LungLB test following conclusion of the multi-site validation trial with a positive predictive value (“PPV”) of 81% for those indeterminate nodules less than 15mm in size and outperformed PET scan and Mayo Nodule Calculator tools, replicated the findings from the lead-in validation study.
• In March 2024, the Company raised gross proceeds of $2.28m (GBP1.81m) from the issue of 5,172,621 shares at 35 pence.

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said:“2023 was a year of considerable achievement culminating in the conclusion of our multi-site clinical validation study, which was the primary objective at our IPO. A positive predictive value of over 80% in smaller indeterminate nodules is significant. This is where physicians consistently indicate the greatest unmet need and where currently available tools fall short.

“In March 2024 we concluded our fund raising to commence the commercialisation of our test. This enables us to initiate our Early Access Program, submit forms to MolDX for technical assessment for Medicare coverage consideration, and continue other matters necessary for commercialisation. We have also started the process of considering all strategic options to get the LungLB test into the hands of patients who need it most.

“Our revised cash runway to April 2025 has required significant cost reductions, the largest being to headcount and salaries for the executive team. We are now a smaller team focussed on the key commercialisation activities. Those who have left the Company played an important role in delivering our achievements to date and on behalf of the whole Board, I would like to thank them for their efforts.”

To see the full results statement, click HERE.