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

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for the early detection of lung cancer, provides an update on the Company’s clinical validation study for its LungLB® test.

As stated in the Company’s half-year report on 8 August 2023, LungLife is currently focussed on preparing data from the clinical validation study for detailed analysis, which was expected to be concluded by the end of September 2023. Due to delays in the provision of data from study sites, full database lock, and the consequent knock-on impact on ability to analyse the data we now expect this to be concluded in Q4 2023.

Click HERE for the full announcement.

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

Director share purchases

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for the early detection of lung cancer, announces that it has received notification of the following transactions in the Company’s common shares of US $0.0001 each (“Common Shares”) undertaken by directors.

On 14 August 2023, Paul Pagano, Chief Executive Officer, purchased 7,123 Common Shares at a price of 69.84 pence per share. Following this purchase, Paul Pagano now holds 12,123 Common Shares, representing approximately 0.047% of the outstanding share capital of the Company.

In addition, on 14 August 2023, David Anderson, Chief Financial Officer, purchased 7,123 Common Shares at a price of 69.84 pence per share. Following this purchase, David Anderson now holds 12,123 Common Shares, representing approximately 0.047% of the outstanding share capital of the Company.

Click HERE for the full announcement.

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 2023.

Operational Highlights:

• Completed enrolment of the Company’s 425-participant pivotal clinical validation study in May, in line with expectations.
• Health economics study highlighting the cost-effectiveness of LungLB® when added to the clinical care pathway for indeterminate lung nodule management peer-reviewed and published in the Journal of Medical Economics.
• Peer-reviewed publication of LungLB® study in the Nature-Springer journal BMC Pulmonary Medicine demonstrating high test performance, successfully detecting lung cancer in its earliest stages when it is most curable.

Financial Highlights:

• Cash as of 30 June 2023 of $5.36m (30 June 2022: $10.63m, 31 December 2022: $8.01m)
• Cash outflow from operating activities $2.70m (six months to 30 June 2022: $3.26m)
• Loss before tax of $2.81m (six months to 30 June 2022: $4.47m) and EBITDA loss of $2.78m (six months to 30 June 2022: $4.31m)

Commenting Paul Pagano, Chief Executive Officer of LungLife, said: “This has been an important six months for the Company as we continue to meet our milestones. We have concluded participation in our clinical validation study and published two important reports that will assist with the commercialisation of LungLB®. Our present focus is the analysis of the results of our clinical validation study which we continue to expect to report on by the end of September.”

Click HERE for the full report.

3 August 2023

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

Notice of Results
Investor Presentation

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for the early detection of lung cancer, will announce its unaudited half-year report for the six months ended 30 June 2023 on Tuesday 8 August 2023.

Investor presentation

Paul Pagano, Chief Executive Officer, and David Anderson, Chief Financial Officer, will be hosting a live online presentation relating to the half-year report via the Investor Meet Company platform at 4.30pm (BST) on Tuesday 8 August 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://lunglifeai.com/media/

Click HERE for the full announcement.

6 June 2023

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

LungLB® study demonstrating high performance published in peer-reviewed journal

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces the publication of successful performance results for the Company’s blood-based LungLB® test from a multi-site prospective study in patients with indeterminate pulmonary nodules. The study was performed in collaboration with MD Anderson Cancer Center (Houston, TX) and Icahn School of Medicine at Mount Sinai (New York, NY) and appears in the journal BMC Pulmonary Medicine.

The primary objective of the study was to compare the LungLB® test result with a lung biopsy diagnosis and assess performance in a patient cohort where commonly used nodule evaluation tools were not informative.

Key points from the study include:

• 151 study participants scheduled for CT-guided lung biopsy, 70% of whom were found to have “intermediate risk” nodules that represent the most challenging diagnostic subtype
• The LungLB® test outperformed commonly used evaluation tools, including the Mayo Clinic risk model and PET scan
• The test demonstrated robust performance in smaller nodules (<2 cm in diameter) and in early-stage cancer
• The LungLB® biomarker was found to be the strongest independent predictor of cancer in this study, exceeding commonly known strong predictors such as nodule size and smoking status
• The LungLB® test performed equally well in current, former, and never smokers
• The data support potential clinical utility of LungLB® in reducing delays in treatment, in which positive LungLB® test results were available months ahead of lung cancer diagnosis in three highlighted cases

LungLB® is a blood-based liquid biopsy assay that uses fluorescence in situ hybridisation (“FISH”) and image analysis to identify circulating genetically abnormal cells (“CGAC”), which include circulating tumour cells (“CTCs”). The technique incorporates an AI-derived image analysis strategy to identify unique cell populations reflective of the disease state under interrogation.

The current publication is an independent validation in the US population and informed the design of LungLife’s larger, pivotal validation study that started in February 2022. The pivotal validation study results are expected later this year and are not included in this publication.

The publication can be found here: https://doi.org/10.1186/s12890-023-02433-4.

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said: “Having the results of our study peer-reviewed is not only an independent confirmation of the scientific validity of our approach, but is also an important part of our strategic effort to build evidence for efficacy and utility in our efforts to increase access of our testing to those who need it most.

“We were excited to see that the LungLB® performance remained strong in people who never smoked, because evidence has shown that the incidence of lung cancer in never smokers is increasing, and it is important new technologies address this expanding group. Additionally, LungLB® was able to detect cancer in its earliest stages, which can be the most challenging to diagnose for doctors and most beneficial for patients.”

Click HERE for the full announcement.

23 May 2023

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

Enrolment completed for pivotal validation study of LungLB®

Company to work with clinical sites to ensure data quality ahead of analysis and readout

 LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces the completion of enrolment for its prospective, pivotal validation study of LungLB®. Since February 2022, 425 study participants have been enrolled from seventeen sites across the United States from leading academic medical centres and Veterans Affairs hospitals.

The Company is now focused on preparing the data for detailed analysis, including working with each clinical site to finalise monitoring of study data before it is unblinded. Monitoring ensures complete, accurate, and high-quality information will be received for all participants in the study prior to final analyses and results interpretation. In line with expectations, the Company estimates this process will take between 3-4 months, at which point the study results are expected to be known. Following this, the Company will seek to publish the study findings in a peer-reviewed medical journal.

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said: “Completing enrolment is a considerable milestone along the path to commercialisation, and we are pleased that we continue to remain on-track with the timeline set out at IPO. We would like to thank our clinical investigators and their teams, and importantly the study participants, for taking part in our trial and for their continued support with study close-out.”

Click HERE for the full announcement.

15 May 2023

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 pursuant to AIM Rule 29 and Schedule 6 of the AIM Rules for Companies:

Name of applicant:		LungLife AI, Inc.
Name of scheme:		1.       2010 Stock Incentive Plan 2.       2020 Stock Incentive Plan 3.       2021 Omnibus Long-Term Incentive Plan
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 November 2022	To:	15 May 2023
Balance of unallotted securities under scheme(s) from previous return:		1.       475,583 2.       201,374 3.       673,990
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):		1.       NIL 2.       NIL 3.       NIL
Less: Number of securities issued/allotted under scheme(s) during period (see LR3.5.7G):		1.       NIL 2.       NIL 3.       NIL
Equals: Balance under scheme(s) not yet issued/allotted at end of period:		1.       475,583 2.       201,374 3.       673,990
Total number of securities in issue at the end of the period		25,485,982

 

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.

4 May 2023

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

Result of Annual General Meeting

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that at its Annual General Meeting, held at earlier today, all 10 resolutions put to members were passed on a poll.

The number of votes lodged by proxy for and against each of the resolutions proposed, and the number of votes withheld was as follows:

 

Resolution	Votes for	%	Votes against	%	Votes withheld
Resolution 1 (Common) TO receive the Annual Report and Accounts of the Company for the year ended 31 December 2022 together with the directors’ and auditor’s reports thereon.	13,016,289	100.00	0	0.00	0
Resolution 2 (Common) TO approve the Directors’ Remuneration Policy.	9,997,926	76.81	3,018,363	23.19	0
Resolution 3 (Common) TO receive the Directors’ Remuneration Report for the year ended 31 December 2022.	13,016,289	100.00	0	0.00	0
Resolution 4 (Common) THAT Roy Davis be, and hereby is, re-elected as a director of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0
Resolution 5 (Common) THAT Paul Pagano be, and hereby is, re-elected as a director of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0
Resolution 6 (Common) THAT David Anderson be, and hereby is, re-elected as a director of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0
Resolution 7 (Common) THAT Andrew Boteler be, and hereby is, re-elected as a director of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0
Resolution 8 (Common) THAT Sara Barrington be, and hereby is, re-elected as a director of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0
Resolution 9 (Common) THAT James McCullough be, and hereby is, re-elected as a director of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0
Resolution 10 (Common) THAT Crowe UK LLP be, and hereby is, reappointed as auditor of the Company to hold office until the conclusion of the next Annual General Meeting of the Company.	13,016,289	100.00	0	0.00	0

 

The Company notes that, whilst Resolution 2 was passed with the required majority, there was a sizable vote against it representing 23% of shareholders who voted. The Company acknowledges these votes and will engage with shareholders to understand further the reasons behind this vote. The Board will provide an update on this engagement and any actions taken will be published within six months of the AGM.

As at 4 May 2023, there were 25,485,982 common shares in issue. Stockholders are entitled to one vote per common share. Votes withheld are not votes in law and so have not been included in the calculation of the proportion of votes for and against a resolution.

 

Click HERE for the full announcement.

2 May 2023

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

Confirmation of AGM

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, confirms that its Annual General Meeting ("AGM") will be held at 3:00 P.M. (BST) on Thursday 4 May 2023, at Investec Bank plc, 30 Gresham Street, London, EC2V 7QP.

For those shareholders who would like to dial into the meeting, please register by emailing LungLifeAI@walbrookpr.com or calling +44 (0)20 7933 8780 and the dial in link will be sent by email.

The Notice of AGM, Form of Direction and associated Form of Proxy are available on the Company’s website and have already been posted to those shareholders who have opted out of electronic communications. The resolutions to be proposed at the AGM are summarised in the Notice of AGM. All documents are available here: https://lunglifeai.com/

The results of voting on the resolutions will be announced via a regulatory information service and posted on the Company’s website as soon as practicable after the AGM.

Click HERE for the full announcement.

06 April 2023

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

Publication of Annual Report and Accounts & Notice of AGM

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that the Annual Report and Accounts, Notice of Annual General Meeting ("AGM"), Form of Direction and associated Form of Proxy are now available on the Company’s website and have been posted to those shareholders who have opted out of electronic communications.

The documents are available here: https://lunglifeai.com/

The Company's AGM will be held at 3:00 P.M. (BST) on 4 May 2023, at Investec Bank plc, 30 Gresham Street, London, EC2V 7QP. The Board will make arrangements for shareholders to listen to proceedings remotely should they wish to do so. The Company will announce details of how to listen to the meeting remotely and any other significant changes to the meeting arrangements via RNS and on LungLife’s website at https://lunglifeai.com/

Shareholders are strongly encouraged to vote by proxy, whether or not they plan to attend the Company’s AGM in person. Shareholders may register their votes on the resolutions of the AGM by completing and returning the Form of Proxy that accompanies the Notice of AGM in accordance with the instructions printed on the Form of Proxy.

Where shareholders hold Common Shares by way of dematerialised depository interests representing underlying Common Shares (“Depository Interests”), they can vote through the CREST system or by returning a Form of Direction to the Company’s agent, Link Group. Further instructions are set out in the Notes to the Notice of AGM.

The resolutions to be proposed at the AGM are summarised in the Notice of AGM.

The results of voting on the resolutions will be announced via a regulatory information service and posted on the Company’s website as soon as practicable possible after the AGM.

 For the full announcement, click HERE.