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:		2010 Stock Incentive Plan 2020 Stock Incentive Plan 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 May 2022	To:	15 November 2022
Balance of unallotted securities under scheme(s) from previous return:		480,775 201,374 673,990
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):		NIL NIL NIL
Less: Number of securities issued/allotted under scheme(s) during period (see LR3.5.7G):		5,192 NIL NIL
Equals: Balance under scheme(s) not yet issued/allotted at end of period:		475,583 201,374 673,990

 

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.

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

Director share purchases

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for 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 2 November 2022, Paul Pagano, Chief Executive Officer, purchased 5,000 Common Shares at a price of 130 pence per share. Following this purchase, Paul Pagano now holds 5,000 Common Shares, representing approximately 0.02% of the outstanding share capital of the Company.

In addition, on 2 November 2022, David Anderson, Chief Financial Officer, purchased 5,000 Common Shares at a price of 130 pence per share. Following this purchase, David Anderson now holds 5,000 Common Shares, representing approximately 0.02% of the outstanding share capital of the Company.

For the full announcement, click HERE. 

Notification of transactions by Directors, Persons Discharging Managerial Responsibilities ("PDMRs") and persons closely associated with them.

1.	Details of the person discharging managerial responsibilities / person closely associated
a)	Name	Paul Pagano
2.	Reason for the Notification
a)	Position/status	Chief Executive Officer
b)	Initial notification/amendment	Initial notification
3.	Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a)	Name	LungLife AI, Inc
b)	LEI	549300VBVDIF0Y3OVI38
4.	Details of the transaction(s):section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv)each place where transactions have been conducted
a)	Description of the Financial instrument, type of instrument, identification code	Common shares of $0.0001 each in the capital of the Company ISIN: USU5500L1045
b)	Nature of the Transaction	Purchase of Common Shares
c)	Price(s) and volume(s)	Price Volume 130 pence 5,000
d)	Aggregated information -     Aggregated volume -     Price	As above
e)	Date of the transaction	2/11/2022
f)	Place of the transaction	London Stock Exchange

 

Notification of transactions by Directors, Persons Discharging Managerial Responsibilities ("PDMRs") and persons closely associated with them.

1.	Details of the person discharging managerial responsibilities / person closely associated
a)	Name	David Anderson
2.	Reason for the Notification
a)	Position/status	Chief Financial Officer
b)	Initial notification/amendment	Initial notification
3.	Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a)	Name	LungLife AI, Inc
b)	LEI	549300VBVDIF0Y3OVI38
4.	Details of the transaction(s):section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv)each place where transactions have been conducted
a)	Description of the Financial instrument, type of instrument, identification code	Common shares of $0.0001 each in the capital of the Company ISIN: USU5500L1045
b)	Nature of the Transaction	Purchase of Common Shares
c)	Price(s) and volume(s)	Price Volume 130 pence 5,000
d)	Aggregated information -     Aggregated volume -     Price	As above
e)	Date of the transaction	2/11/2022
f)	Place of the transaction	London Stock Exchange

 

 

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

 LungLife to participate in the US National Cancer Institute’s Early Detection Research Network

 LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that based on the strength of its technology it will be one of two industry partners to participate in the Boston University (“BU”) -University of California Los Angeles (“UCLA”) Lung Cancer Biomarker Development Laboratory of the US National Cancer Institute’s Early Detection Research Network (“EDRN”).

The EDRN is a division of the US National Cancer Institute, the federal government’s principal agency for cancer research and training. The EDRN’s mission is to discover, develop, and validate new biomarkers and medical imaging technologies to detect early-stage cancers, and to translate them into clinical tests. It is comprised of over 300 investigators from academic institutions and industry partners working collaboratively to bring new diagnostic biomarkers to clinical use.

LungLife’s clinical laboratory will operate as a Biomarker Reference Laboratory, processing blood samples from the participating academic centres at UCLA and BU where the LungLB® test will be combined with imaging to assist their early detection research, as well as validate combined test performance in patients with indeterminate lung nodules. It is expected the blood samples will be collected over a number of years with progress and results presented to EDRN members at annual meetings, representing the first independent study of LungLB®. These activities are independent of LungLife’s ongoing pivotal validation study and do not impact on the progress of this study.

The work of the EDRN closely aligns with LungLife’s mission to increase the early detection of lung cancer and will provide further clinical evidence for the LungLB® technology as well as widen awareness of our technology with leading US investigators. It also affords LungLife the potential to offer novel cell-based diagnostic biomarkers discovered at UCLA and BU to physicians from its clinical laboratory, thereby potentially expanding its lung cancer testing capabilities.

Paul Pagano, CEO for LungLife said: “We are excited that LungLife will participate in such a prestigious national programme aimed at bringing early detection technology to the clinic, and we are delighted to work with UCLA and BU, two leading medical research institutions with teams that have been pushing the field forward to make important biomarkers available to patients.”

 Denise Aberle, MD, Professor of Radiology and Bioengineering, Vice Chair for Research, Department of Radiological Sciences at UCLA, EDRN Investigator said: “Lung cancer remains the deadliest cancer because most people are diagnosed in later stages after developing symptoms – the ability to detect lung cancer in early stages could have a profound effect on patients’ outcomes. Cell-based biomarkers have considerable potential for early cancer detection. When combined with imaging markers using artificial intelligence/radiomics analysis of computed tomography, combined imaging and cell-based approaches could substantially shift the diagnosis of lung cancer to early stages when it is most curable. 

 “We look forward to collaborating on this grant to evaluate novel imaging and cell-based biomarkers in patients with intermediate-risk indeterminate lung nodules, which are the most diagnostically challenging nodules to evaluate and represent a critical unmet need in early lung cancer detection.”

BU’s press release can be found at: https://www.bumc.bu.edu/busm/news-events/

For the full announcement click HERE. 

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 2022.

Summary and Highlights (including post-period end):

• Cash as of 30 June 2022 of $10.63m
• Loss before tax of $4.47m and EBITDA loss of $4.31m
• Six sites participating in the Company’s LungLB® validation study, up from three at time of preliminary results in March, with more in the pipeline
• New York Clinical Laboratory Evaluation Programme (“CLEP”) permit awarded
• 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
• With the existing sites participating in the validation study and the additional sites already in the pipeline, there is a continued expectation that we will complete enrolment of our validation study by end of March 2023 and initial commercialisation with nominal revenues of LungLB® later in 2023

 Commenting on outlook, Paul Pagano, Chief Executive Officer of LungLife, said: “I am proud of the progress that the team has made over this six-month period. Our validation study is well underway, having enrolled our first participant in February, and we are where we expected to be at this time point to be able to complete enrolment by the end of Q1 2023.

“Beyond the continued enrolment of participants into the LungLB® validation study, over the remainder of the year we are focused on progressing towards commercial reimbursement. Following the grant of a CPT® PLA code in January, we now look ahead to the processes of pricing and coverage for the LungLB® test.”

Please click HERE for the full report.

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 interim results for the six months ended 30 June 2022 on Monday 26 September 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 Monday 26 September 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, Inc.
(the “Company” or “LungLife”)

 

New York State approves LungLB® for commercial testing

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that the New York State Department of Health (“NYSDOH”) has awarded LungLife a Clinical Laboratory Evaluation Program (“CLEP”) permit following their recent on-site audit, during which there were no deficiencies found.

 

The CLEP permit allows LungLife to perform clinical utility studies and offer the LungLB® test commercially in New York state, in addition to 46 other states permitted by the Company’s existing Clinical Laboratory Improvement Amendments (“CLIA”) certification.

 

This is an important step in LungLife’s commercialisation plan, given its relationship with the Icahn School of Medicine at Mount Sinai in New York, a key site in the ongoing pivotal validation trial, and from which the Company is now able to accept study participants in future utility studies. Securing a CLEP permit is a requirement to consider participants from New York state in the utility studies planned for 2023, from which the Company expects first nominal revenues.

 

The audit was performed to ensure that the premises, laboratory practice, equipment, personnel, and record-keeping methods meet state requirements. Issuance of the CLEP permit follows a rigorous, independent scientific review of both analytical and clinical data for LungLB®, as well as evaluation of adherence to the Company’s quality management system.

 

Lara Baden, VP of Clinical Operations for LungLife said: “We are pleased to have received a CLEP permit from the NYSDOH. Not only does this provide further validation of our best-in-class quality system, but also approval of the LungLB® test means that LungLife can offer this service to physicians in New York state who evaluate indeterminate lung nodules for early cancer detection.”

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.

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