Block Listing Six Monthly Return

16 May 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 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 2021 To: 15 May 2022
Balance of unallotted securities under scheme(s) from previous return: 1.       480,775

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.       480,775

2.       201,374

3.       673,990
Total number of securities in issue at the end of the period 25,480,790

 

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.

Result of Annual General Meeting

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 the Annual General Meeting, held at Investec Bank PLC, 30 Gresham St, London, EC2V 7QP earlier today, all 8 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 2021 together with the directors’ and auditor’s reports thereon.

 14,321,090 100 0 0 0
Resolution 2 (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.

 14,321,090 100 0 0 0
Resolution 3 (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.

 14,321,090 100 0 0 0
Resolution 4 (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.

 14,321,090 100 0 0 0
Resolution 5 (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.

 14,321,090 100 0 0 0
Resolution 6 (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.

 14,321,090 100 0 0 0
Resolution 7 (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.

 14,321,090 100 0 0 0
Resolution 8 (Common)

THAT Crowe 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.

 14,321,090 100 0 0 0

 

As at 11 May 2022, there were 25,480,270 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.

 

For the full announcement click HERE

AGM dial in details (09.05.22)

The Annual General Meeting of LungLife AI,Inc. the “Company”) to be held at 2:00 p.m. BST on 11 May 2022 at Investec Bank plc, 30 Gresham Street, London, EC2V 7QP, United Kingdom (including any adjournment or postponement thereof, the “AGM”).

Stockholders will be able to listen live to the AGM by accessing the below Microsoft Teams invite on the day of the AGM. Access to the AGM via the Microsoft Teams will be available from 2:00p.m. (BST) on Wednesday, 11 May 2022.

Microsoft Teams meeting

Join on your computer or mobile app

Click here to join the meeting

Join with a video conferencing device

investec@m.webex.com

Video Conference ID: 123 532 422 3

Alternate VTC instructions

Or call in (audio only)

+44 20 7660 8292,,245342891#   United Kingdom, London

Phone Conference ID: 245 342 891#

Find a local number | Reset PIN

Learn More | Meeting options

This link can be accessed online on a stockholder's device (whether by smart phone, tablet or computer). It is highly recommended that stockholders check their system capabilities in advance of the day of the AGM.

Stockholders using the above webcast facilities should please note that it will not be possible to vote or ask questions using these facilities, and attendees will be placed on mute. As stated in the Notice of AGM, dated 1 April 2022, the business of the AGM will be conducted on a poll to ensure that the votes of all stockholders unable to attend in person are taken into consideration.

Read the full notice HERE. 

 

Publication of Annual Report and Accounts & Notice of AGM

8 April 2022

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://investors.lunglifeai.com/

The Company's AGM will be held at 2:00 P.M. (BST) on 11 May 2022, at Investec Bank plc, 30 Gresham Street, London, EC2V 7QP.

Following the easing of coronavirus (COVID-19) restrictions in the UK, the Board has made arrangements to enable shareholders to attend the Annual General Meeting in person. However, in light of the uncertainty as to any further COVID-19 measures that may be put in place by the UK Government and bearing in mind the inherent risk of large gatherings, the Company encourages shareholders to consider submitting their voting instructions in advance by appointing the Chairman of the meeting as their proxy, rather than attending and voting on the day. This will ensure that votes are registered in accordance with shareholders’ wishes regardless of any restrictions or disruption around the Annual General Meeting and will also help protect the health and safety of shareholders, directors and other necessary attendees. Depending on the public health situation, we may impose additional procedures or limitations on attendees beyond any described in this Notice of the Annual General Meeting. The Board will make arrangements for shareholders to listen to proceedings remotely should they wish to do so. We will announce details of how to listen to the meeting remotely and any other significant changes to the meeting arrangements via RNS and on our website at https://investors.lunglifeai.com/

We strongly encourage you to vote by proxy, whether or not you plan to attend the Company’s Annual General Meeting in person. Alternatively, you may register your votes on the resolutions of the Annual General Meeting by completing and returning the proxy form that accompanies the Notice in accordance with the instructions printed on the proxy form. Or by using the link www.signalshares.com and selecting LUNGLIFE AI, INC (You will need to log into your Signal Shares account or register if you have not previously done so. To register you will need your Investor Code, this is detailed on your share certificate or available from our Registrar, Link Group).

If your holding of Common Shares is by way of dematerialised depository interests representing underlying Common Shares (“Depository Interests”), you can vote through the CREST system or by returning a Form of Direction to the Depositary. Further instructions are set out in the Notes to the Notice of Annual General Meeting, available on the Company website.

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.

 

Please click HERE to view the full announcement.

LungLife AI (AIM: LLAI) - Preliminary Results

28 March 2022

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

Preliminary results

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces its maiden audited preliminary results for the year ended 31 December 2021, following admission to trading on AIM on 8 July 2021.

Summary and Highlights for the year:

Post-period end:

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said: “Since IPO, we have achieved several milestones which has kept us on track with our strategic vision. During the year, we laid the groundwork towards commencing our multi-centre validation study, and post-period end we enrolled our first participants. Our clinical laboratory in Thousand Oaks also achieved CAP accreditation in November 2021, confirming that we are maintaining the highest standards of excellence in laboratory testing for patients.

“Throughout the rest of the year we will continue with our validation study which we expect to complete in Q1 2023, as well as work towards regulatory authorisation and commercial reimbursement, which we made our first step towards post-period end when we were granted a CPT® PLA code. We remain focused on bringing early detection solutions to those who need them most, which will lead to better outcomes for people with lung cancer.”

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

Please click HERE to view the full announcement.

LungLife AI (AIM: LLAI) - Veterans Affairs (VA) sites added to validation study with first Veteran enroled

17 March 2022

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

Veterans Affairs (VA) sites added to validation study with first Veteran enroled
Key lung cancer specialist, Dr Drew Moghanaki, appointed to Scientific Advisory Board

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces its pivotal clinical study to evaluate the LungLB® test will now include multiple VA medical centres, of which the first participant has been enroled from the Bay Pines VA in Florida. 

The VA has the United States’ largest integrated health care system, providing care at nearly 1,300 facilities and serving 9 million veterans each year. Lung cancer is the leading cause of cancer-related deaths among US veterans, and it is believed that veterans are at higher risk in part due to environmental exposures during military service. An estimated 900,000 US veterans are at-risk for lung cancer, and VA hospitals diagnose around 7,700 new lung cancer cases each year. 

The Company also announces the appointment of Dr Drew Moghanaki, MD, MPH, to its Scientific Advisory Board, who is an internationally recognised lung cancer specialist. He is Professor and Chief of Thoracic Oncology at the UCLA Department of Radiation Oncology. Dr Moghanaki brings extensive leadership to the Scientific Advisory Board as the Director of the VA Partnership to increase Access to Lung Cancer Screening programme (VA-PALS), and the co-chair of the VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR) Phase III study, investigating treatment options for stage I lung cancer. Dr Moghanaki is also Staff Physician at the Greater Los Angeles VA Healthcare System. 

Dr Drew Moghanaki, MD, MPH, Scientific Advisory Board member at LungLife, said: “Blood-based testing to facilitate early detection of lung cancer would be a welcomed advance as the majority of lung cancers continue to be diagnosed in later stages. I am pleased to be joining LungLife’s Scientific Advisory Board and look forward to working with them to unlock the full potential of the LungLB® test.” 

Paul Pagano, Chief Executive Officer of LungLife, said: “I am delighted that we will have representation from the VA Healthcare System in our study, as this marks an important step on our journey towards the successful deployment of the LungLB® test. Dr Moghanaki brings with him significant experience in early detection and treatment of lung cancer which will further strengthen our Scientific Advisory Board.” 

Please click HERE to view the full announcement.

LungLife AI, Inc. - Notice of Results

8 March 2022

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 2021 on Monday 28 March 2022.

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 Tuesday 29 March 2022. The presentation is open to all existing and potential shareholders.

 

Investors can sign up to Investor Meet Company for free and register for the presentation here:

https://www.investormeetcompany.com/lunglife-ai-inc/register-investor 

 

Investors who already follow LungLife on the Investor Meet Company platform will automatically be invited.

 

Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the "Ask a Question" function.  Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation, a PDF of the slides used, and responses to the Q&A session will be available on the Investor Meet Company platform afterwards. 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 - First patient enrolment for LungLB® validation study

2 February 2022

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

First patient enrolment for LungLB® validation study

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer announces it has enrolled its first patient in its pivotal clinical study to evaluate the LungLB® test in subjects presenting with indeterminate lung nodules.

The multi-centre clinical study will be used to validate the LungLB® test performance, looking to repeat the high performance already observed in the pilot study completed earlier in the year. The study will enrol 425 participants across multiple US sites, including MD Anderson Cancer Center and Mount Sinai Hospital in New York City, involving participants who present with indeterminate lung nodules that would otherwise be scheduled for needle biopsy.

It is estimated over 5m chest CT scans are performed in the US each year with over 1.5m of them showing indeterminate lung nodules, requiring further imaging or potentially unnecessary and risky biopsy to determine whether they are cancerous.

This first patient enrolment confirms that the Company is on track to enrol patients over the next 14 months, with study completion expected in Q1 2023 and in-line with expectations. Study completion is key to offering the test commercially through LungLife AI’s CLIA-certified laboratory, in addition to supporting the Company’s desire to pursue FDA submission.

Paul Pagano, Chief Executive Officer of LungLife, said: “I am delighted that we remain on track with this key validation study and first patient enrolment. This is an important milestone on our journey towards the successful commercial roll-out of our blood-based diagnostic test, which we believe is set to become a driving force in the early detection of lung cancer.”

LungLB® is an AI-enhanced, blood-based test to stratify cancerous and benign lung nodules identified by CT scan, and is designed to support a physician’s decision to biopsy or to monitor non-invasively using additional imaging. The test utilises well-established FISH (Fluorescence in situ hybridization) techniques to identify rare target cells isolated from whole blood.

Please click HERE to view the full announcement.

LungLife AI, Inc. - CPT® Code granted by American Medical Association

4 January 2022

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

 

CPT® Code granted by American Medical Association

Successful grant marks first step facilitating commercial reimbursement

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer announces it has been granted a CPT® Proprietary Laboratory Analyses (PLA) code for its LungLB® test by the American Medical Association (AMA). The new code has been approved and published by the AMA Editorial Panel and is scheduled to become effective on 1 April 2022.

 

Reimbursement in the US is comprised of three components: code, price, and coverage. CPT® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT® code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers. The successful granting of a CPT® code marks the first step on the path for commercial reimbursement.

 

Paul Pagano, Chief Executive Officer, LungLife AI said: “A CPT® code is fundamental in the commercialisation of the LungLB® test. We were delighted with the AMA’s decision as this will facilitate access to LungLB® for patients with indeterminate pulmonary nodules who are at-risk for lung cancer.”

 

For the full announcement please click HERE.

LungLife AI Clinical Laboratory achieves CAP accreditation

19 November 2021

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

 

LungLife AI Clinical Laboratory achieves CAP accreditation

Independent inspection confirms highest standard of care for laboratory patients

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that its clinical laboratory in Thousand Oaks, California has been awarded accreditation by the College of American Pathologists (CAP). The Company, whose clinical laboratory is already CLIA certified, voluntarily sought the accreditation as part of its on-going commitment to maintaining best in class quality systems.

 

The Company’s laboratory processes have been independently assessed by the CAP, the world’s largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes, during a recent on-site inspection designed to ensure the highest standard of care for all laboratory patients.

 

As part of this process, the inspectors examine a laboratory’s records and quality control procedures, as well as laboratory staff qualifications, equipment, facilities, safety programme and overall management. The U.S. federal government recognises the CAP Laboratory Accreditation Program as being equal-to or more-stringent than the government’s own inspection programme, and the Centers for Medicare and Medicaid Services (CMS) have granted the CAP Laboratory Accreditation Program “deeming authority,” which allows for CAP accreditation in lieu of a CMS inspection.

 

Lara Baden, VP Clinical Operations, LungLife AI, commented: “We are proud of the recognition of our quality by the College of American Pathologists through receiving this accreditation, which reflects our commitment to maintaining the highest standards of excellence in laboratory testing for patients and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide ordering physicians and patients a further degree of confidence in the results they are receiving for our LungLB® test as well as for future products.”

For the full announcement, please click here.