14 March 2023
LungLife AI, Inc.
(the “Company” or “LungLife”)
Appointment of Joint Broker
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces the appointment of Goodbody as the Company's Joint Broker with immediate effect.
Investec Bank plc remains Nominated Adviser and Joint Broker to the Company.
Click HERE for the full announcement.
13 March 2023
LungLife AI, Inc.
(the “Company” or “LungLife”)
Statement re. Silicon Valley Bank
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, is aware of media reports indicating the closure of Silicon Valley Bank (“SVB”). The Company does not hold any cash at SVB, nor does it have a banking relationship with SVB.
Click HERE for the full announcement.
7 March 2023
LungLife AI, Inc.
(the “Company” or “LungLife”)
Nodule evaluation using LungLB® projected to be cost-effective in US healthcare system
Data strongly support payor coverage of indeterminate lung nodule evaluation using LungLB® in peer-reviewed publication in the Journal of Medical Economics.
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that further to its announcement on 27 February 2023, the final version of the health economics publication is now available. There have been no changes to the results or conclusions, which show LungLB® is projected to be a cost-effective solution for US insurers covering individuals with indeterminate lung nodules.
The publication can now be accessed here: Journal of Medical Economics Vol 26
For the full announcement, click HERE.
27 February 2023
LungLife AI, Inc.
(the “Company” or “LungLife”)
Nodule evaluation using LungLB® projected to be cost-effective in US healthcare system
Data strongly support payor coverage of indeterminate lung nodule evaluation using LungLB® in peer-reviewed publication in the Journal of Medical Economics
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces a draft publication of a cost-effectiveness analysis (“CEA”) model on LungLB® which provides evidence that the test can be utilised as a cost-effective alternative compared to the current diagnostic pathway. Once the final publication as a Version of Record is issued a further announcement will be made.
The principal aim of the research was to explore the incremental cost-effectiveness of LungLB® when added to the current clinical diagnostic pathway for patients with lung nodules, as described in guidelines1. The greater cost savings in the model were demonstrated by a reduction in unnecessary procedures and better patient outcomes from reduced delays in treatment.
Incremental Cost-Effectiveness Ratio (ICER) is a key metric used in the publication to demonstrate cost effectiveness. Integration of LungLB® leads to improvement in outcomes and results in an ICER that was 25% below the willingness to pay (WTP) threshold commonly considered by US commercial payors, suggesting overall savings when LungLB® is priced at $2,300 per test. ICERs remain below WTP thresholds at prices up to $3,647 per test.
1Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and Management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.
Commenting, Paul Pagano, Chief Executive Officer of LungLife, said: “This health economics publication advances our progress towards supporting payor coverage of LungLB®, and is in-line with the pricing of $2,030 recently assigned to the test by the Centers for Medicare and Medicaid Services.”
CEA examines the costs associated with health outcomes when a new intervention is compared to a standard care pathway. Both public and private payors often use CEA to determine how much it would cost to implement the new intervention. The model was developed in collaboration with a third-party, Avalon Health Economics.
For the full announcement, click HERE.
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:
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.
LungLife AI, Inc.
(the “Company” or “LungLife”)
Notice of Results
Investor Presentation
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, will announce its full year results for the year ended 31 December 2022 on Monday 20 February 2023.
Investor presentation
Paul Pagano, Chief Executive Officer, and David Anderson, Chief Financial Officer, will be hosting a live online presentation relating to the full year results via the Investor Meet Company platform at 4.30pm (GMT) on 20 February 2023.
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9am the day before the meeting or at any time during the live presentation.
Investors can sign up to Investor Meet Company for free and register for the presentation here. Investors who already follow LungLife on the Investor Meet Company platform will automatically be invited.
A recording of the presentation and a PDF of the slides used will also be available on the LungLife website: https://investors.lunglifeai.com/media/
For the full announcement, click HERE.
LungLife AI, Inc.
(the “Company” or “LungLife”)
Final Pricing Determination
Medicare Grants Pricing for LungLife’s LungLB® Early Lung Cancer Diagnostic
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that the Centers for Medicare & Medicaid Services (“CMS”) has granted a price at $2,030 per test for the LungLB® early lung cancer detection diagnostic. This final CMS payment determination will be listed in the Calendar Year 2023 Clinical Laboratory Fee Schedule (CLFS) and will apply to all eligible Medicare patients tested by LungLB®.
Medicare, a national health insurance program in the US, covers 63.9 million lives and indeterminate lung nodules are often found in patients of an age typically covered by Medicare. The determination to crosswalk means Medicare beneficiaries will now have a national price for the LungLB® test effective as of January 1, 2023. This represents completion of a key Company milestone as it supports the plan to seek comprehensive reimbursement for the test.
Paul Pagano, CEO for LungLife said:
“This is a major commercial milestone for LungLB® and brings us closer to delivering the test to the people who need it most. We are very pleased to have secured a favourable crosswalk decision which creates added certainty and avoids a year long process of determining price as would be the case under gapfill.”
For the full announcement, click HERE.
LungLife AI, Inc.
(the “Company” or “LungLife”)
Total Voting Rights
The Company’s total issued share capital consists of 25,485,982 Ordinary Shares of US $0.0001 each ("Ordinary Shares") with one voting right per Ordinary Share. There are no Ordinary Shares held in treasury. The total number of voting rights in the Company is therefore 25,485,982. This number may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in the Company under the FCA's Disclosure Guidance and Transparency Rules.
For the full announcement, click HERE.
15 November 2022
LungLife AI, Inc.
("LungLife" or the "Company")
Block Listing Six Monthly Return
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, makes the following six-monthly update on its block listing:
| Name of applicant: | LungLife AI, Inc. | |||
| Name of scheme: |
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| Number and class of securities originally admitted: | 1,356,139 common shares of US $0.0001 each | |||
| Date of admission: | 15 November 2021 | |||
| Period of return: | From: | 15 May 2022 | To: | 15 November 2022 |
| Balance of unallotted securities under scheme(s) from previous return: |
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| Plus: The amount by which the block scheme(s) has been increased since the date of the last return (if any increase has been applied for): |
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| Less: Number of securities issued/allotted under scheme(s) during period (see LR3.5.7G): |
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| Equals: Balance under scheme(s) not yet issued/allotted at end of period: |
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| Name of contact: | David Anderson, Chief Financial Officer |
| Telephone number of contact: | +44 (0)20 7933 8780 or lunglifeai@walbrookpr.com |
For the full announcement, click HERE.