9 September 2021

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 enhanced by artificial intelligence, announces its maiden unaudited half-year report for the six months ended 30 June 2021 following admission to trading on AIM on 8 July 2021.

LungLife, based in California, USA, is a developer of clinical diagnostic solutions for the early detection of lung cancer from a simple blood draw, enhanced by artificial intelligence (“AI”). Lung cancer is one of the most lethal cancers, accounting for nearly a quarter of all cancer-related deaths in the US, and its global incidence has increased by 37% from 2007-2017.

Summary and Highlights:

• H1 2021 Revenues of $107k which entirely relates to resale of FISH probes to the licensee of the LungLB technology in China
• Loss before tax of $4.57m, after charging IPO costs of $2.1m. Adjusted EBITDA¹ loss of $2.23m.
• Admission to AIM & successful £17m (gross) fundraising at an issue price of 176p on 8 July 2021
• Net proceeds to be used to complete its multi-centre pivotal validation studies and support progress towards regulatory authorisation and reimbursement
• Since IPO:
  • CRO for clinical studies has been engaged
  • Actively seeking our first new hires: Directors of R&D and Quality and a Clinical Laboratory Scientist
  • On track for PLA code application
• Targeting commercialisation of LungLB® in 2023

Commenting on outlook, Paul Pagano, Chief Executive Officer of LungLife, said: “Early detection is absolutely key to ensure better outcomes for people with lung cancer and we believe our LungLB® test will give physicians the additional information needed to identify this disease earlier and reduce its impact.

“The funding provided through our AIM IPO allows us to proceed to a larger multi-centre pivotal validation study and secure regulatory authorisation and reimbursement support.  We are now laying the groundwork for successful implementation of our clinical programmes.”

 Notes:

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

 Please click here to view the full announcement. 

3 September 2021

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 enhanced by artificial intelligence, announces that its maiden unaudited half-year report for the six months ended 30 June 2021 will be announced on Thursday 9 September 2021.

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 Thursday 9 September 2021. 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.

Click here to read the full announcement.

LungLife AI plc - TR-1 (28.07.21)

8 July 2021

LungLife AI, Inc.
("LungLife" or the "Company") 

Director/PDMR Notification

LungLife  (AIM: LLAI), the developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that it has been notified of the following transaction in the Company's common shares of US $0.0001 each (“Common Shares”) undertaken by directors.

The transactions were made in connection with the placing of new Common Shares in the capital of the Company as part of the Company’s admission to trading on AIM.

Roy Davis, Non-Executive Chair, has today purchased 14,204 Common Shares at the placing price of 176.0 pence per share. Following this purchase, Mr Davis now holds 14,204 Common Shares, representing approximately 0.06% of the outstanding share capital of the Company.

In addition, Andrew Boteler, Non-Executive Director, has today purchased 5,681 Common Shares at the placing price of 176.0 pence per share. Following this purchase, Mr Boteler now holds 5,681 Common Shares, representing approximately 0.02% of the outstanding share capital of the Company.

The following disclosures are made in accordance with the requirements of the UK Market Abuse Regulation.

Click Here to Read the Full Announcement

8 July 2021

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO OR FROM THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO MIGHT CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION (EACH A “RESTRICTED JURISDICTION”).

This announcement is not and does not constitute or form part of, and should not be construed as, an offer of securities for subscription or sale in any jurisdiction nor a solicitation of any offer to buy or subscribe for, any securities in any jurisdiction, including in or into any Restricted Jurisdiction, nor shall it or any part of it, or the fact of its distribution, form the basis of, or be relied on in connection with, any contract or commitment whatsoever. This announcement is not an admission document or prospectus and does not constitute a recommendation regarding any securities. Terms capitalised in this announcement but not defined herein shall have the meaning given to them in the admission document published by the Company on 2 July 2021 (the "Admission Document"). 

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

Admission to trading on AIM
& First Day of Dealings

LONDON, UK. AND THOUSAND OAKS, CALIFORNIA, US (8 July 2021). LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that admission to trading on AIM (“Admission”) will take place and dealings will commence at 8.00 a.m. today under the ticker LLAI and ISIN USU5500L1045.

Summary and Highlights:

• Successful Fundraising for gross proceeds of £17 million
• Issue price of 176 pence per share
• Market capitalisation of approximately £45 million on Admission
• 25,480,790 Common Shares in issue on admission, free float of approximately 50.6 per cent.
• Investec acted as Sole Bookrunner in relation to the Fundraising and is acting as the Company’s Nominated Adviser and Corporate Broker from Admission

Click Here to Read the Full Announcement

 2 July 2021 

 NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO OR FROM THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO MIGHT CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION (EACH A “RESTRICTED JURISDICTION”). 

This announcement is not and does not constitute or form part of, and should not be construed as, an offer of securities for subscription or sale in any jurisdiction nor a solicitation of any offer to buy or subscribe for, any securities in any jurisdiction, including in or into any Restricted Jurisdiction, nor shall it or any part of it, or the fact of its distribution, form the basis of, or be relied on in connection with, any contract or commitment whatsoever. This announcement is not an admission document or prospectus and does not constitute a recommendation regarding any securities. Investors should not subscribe for or purchase any securities referred to in this announcement except in compliance with applicable securities laws and regulation and on the basis of the information in the final admission document (“Admission Document”) to be published by the Company, and any supplement thereto, in connection with the placing of the existing common shares of $0.0001 each in the capital of the Company (“Common Shares”) and the proposed admission of the Common Shares to trading on the AIM market of London Stock Exchange plc (“Admission”). The Admission Document will be published today and will be available for viewing on the Company’s website at www.lunglifeai.com. Terms capitalised in this announcement but not defined herein shall have the meaning given to them in the Admission Document. 

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

Confirmation of Issue Price for Placing & Subscription 

Fundraising of 9,659,091 Common Shares at 176 pence per share 

and 

Admission to trading on AIM 

LONDON, UK. AND THOUSAND OAKS, CALIFORNIA, US (2 July 2021). LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that it has raised approximately £17 million by way of a Placing and Subscription (the “Fundraising”) at the Issue Price of 176 pence per share. 

On Admission, LungLife will have 25,480,790 Common Shares in issue, all of which will be admitted to trading on AIM, and a free float of approximately 50.6 per cent. It is expected that Admission will become effective and that dealings will commence in the Common Shares on AIM at 8.00 a.m. on 8 July 2021 under the ticker LLAI. The Company’s ISIN is USU5500L1045 and its SEDOL is BLPJ4G2. 

The market capitalisation of the Company at the Issue Price will be approximately £44.85 million immediately following Admission. 

Investec Bank plc is acting as Nominated Adviser, Sole Bookrunner and Sole Broker. 

Key Highlights 

• LungLife is a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence. The Company’s diagnostic solutions are designed to make a significant impact in the early detection of lung cancer. 

• The Company’s technology is a combination of the recovery of rare cells and blood-based biomarkers shown to be altered in lung cancer. The Company employs machine learning to improve biomarker detection, and 

• intends to build a deep, novel pool of lung cancer-related data for AI-enabled applications designed to improve its diagnostic solutions over time. 

• The Company’s core technologies are integrated in the LungLB® test, which is intended to be used as a tool to provide physicians with additional information to help in the decision-making process for people with indeterminate lung nodules that may be lung cancer following a CT scan. There are estimated to be over 1.5 million indeterminate lung nodules diagnosed each year in the United States. The LungLB® test may have additional utilities, the most significant of which is likely to be in monitoring individuals for recurrence following surgical removal of cancerous lung nodules. 

• The Company has completed a 149 subject pilot study to evaluate the LungLB® test, which showed a well-balanced performance and a Positive Predictive Value of 89 per cent. The Company is now gearing up to proceed to a larger, multi-centre validation study to garner regulatory and reimbursement support and facilitate commercialisation. 

• To support development of the LungLB® technology, the Company has entered into various agreements with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”), which is an international leader in medical and scientific training and biomedical research and is part of the Mount Sinai Health System. Mount Sinai is committed to building a world-renowned lung cancer programme with expertise in screening, early detection and biomarker research and has recently established its Center of Excellence for Thoracic Oncology programme. 

Click Here to read the Full Announcement

Thousand Oaks, CA – October 1, 2020 – LungLife AI, a leader in liquid biopsy technology for cancer diagnosis and management, announced today that clinical data from a research collaboration in early lung cancer detection will be presented at the International Association for the Study of Lung Cancer (IASLC) Hot Topic Meeting taking place on October 2nd and 3rd. The data highlight the Company’s progress in developing the LungLB® test which discriminates benign from malignant lesions in individuals with indeterminate lung nodules who are at-risk for lung cancer.

The study is being completed with collaborators from Mount Sinai Hospital in New York and MD Anderson Cancer Center in Houston, and demonstrates the potential of circulating tumor cells (CTC) for early lung cancer detection. LungLife AI is also presenting on the use of artificial intelligence in accurate CTC identification developed in partnership with Persistent Systems.

“Lung cancer spreads early and by using CTCs we are best positioned to find malignancy at the earliest possible stage,” says Paul Pagano, PhD, CEO at LungLife AI. “The majority of cancerous nodules in our study were diagnosed at Stage I, when the possibility for cure is greatest. We are delighted to have the opportunity to share results of our pilot study with scientists, physicians, and advocates.”

The following are the details for the two presentations:

Title:  Pilot study of a novel liquid biopsy test to discriminate benign vs malignant processes in subjects with indeterminate pulmonary nodules
Abstract Number: 034
Type: Oral Poster Presentation
Presenters: Joshua D Kuban1, Shahram Tahvilian2, Lara Baden2, Claudia I Henschke3, David F Yankelevitz3, Daniel Leventon2, Rebecca Reed2, Ashley Brown2, Allison Muldoon2, Michael J Donovan4, Paul C Pagano2

1.     Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX

2.     LungLife AI, Inc, Thousand Oaks, CA

3.     Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY

4.     Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY 

Title:  Use of an artificial intelligence-derived algorithm for accurate FISH probe detection in a liquid biopsy test for lung cancer

Abstract Number:   039
Type: Poster Presentation
Presenters: Shahram Tahvilian1, Chinmay Savadikar2, Lara Baden1, Daniel Leventon1, Rebecca Reed1, Ashley Brown1, Michael J Donovan3, Bhushan Garware2, Paul C Pagano1

1.     LungLife AI, Inc, Thousand Oaks, CA

2.     Persistent Systems, Ltd, Pune, India

3.     Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY. 

About LungLife AI, Inc.

LungLife AI is a cancer diagnostics company focused on transforming cancer diagnosis and management through artificial intelligence (AI) enabled molecular analysis of cancer biomarkers in blood.

LungLife AI is focused upon lung cancer diagnostic solutions recognizing the need to substantially improve patient outcomes. The company's testing methodology is designed to deliver actionable information to clinicians via a minimally invasive blood draw.

LungLife AI is based in Thousand Oaks, California. For more information, please visit https://www.lunglifeAI.com/.

LungLife AI the developer of an Artificial Intelligence (AI) enabled non-invasive liquid biopsy test for the early detection of lung cancer, announced today that the Company has received certification from the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under the “deemed status” provision of the US Department of Health and Human Services (HHS) Center for Medicare and Medicaid Services (CMS), the state of California has granted the company’s initial CLIA clinical laboratory license.

“Today’s CLIA certification marks a pivotal step towards the commercialization of leading cancer diagnostics for early-stage lung cancer. Our LungLB test will provide a significant impact on patient outcomes and to clinical decision making.  This CLIA certification is the natural next stage in becoming a lung cancer diagnostic leader.” said CEO, Sara Barrington.

ABOUT LUNGLIFE AI

LungLife AI is a cancer diagnostics company focused on transforming cancer diagnosis and management through artificial intelligence (AI) enabled the molecular analysis of cancer biomarkers in blood.

LungLife AI is focused upon lung cancer diagnostic solutions recognizing the need to substantially improve patient outcomes. The company's testing methodology is designed to deliver actionable information to clinicians via a minimally invasive blood draw. Our tests span all stages of lung cancer, from aid in diagnosis for patients with suspicious lung nodules as well as treatment stratification and monitoring in late-stage lung cancer.

The CLIA regulations include federal standards applicable to all US facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CMS regulates this testing in the United States through the CLIA. The Centers for Disease Control and Prevention (CDC), in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.

WESTLAKE VILLAGE, CA – March 18, 2019 – LungLife AI, a leader in liquid biopsy technology for cancer diagnosis and management, announced today that James McCullough has been appointed as Board member.

Mr. McCullough has leadership experience building emerging technology companies in both the public and private sectors with specific expertise in the life-sciences industry. His focus is on equity and debt capital formation, strategic development and partnerships. James is currently the CEO of Renalytix AI, PLC, an AIM listed company (AIM: RENX), which develops Artificial Intelligence enabled In-Vitro Diagnostics for kidney disease.  James’ was most recently chief executive officer of Exosome Diagnostics, a venture backed personalized medicine company developing non-invasive liquid biopsy diagnostics in cancer, sold to Bio-Techne (NASDAQ: TECH).  James is also a managing partner of Renwick Capital, LLC (“Renwick”), a management consulting firm specializing in assisting emerging healthcare technology companies with strategic planning and business execution and a co-founder of PAIGE.AI, a computational pathology spin-out from the Memorial Sloan Kettering Cancer Center.

 “The Board is pleased to welcome James and we strongly believe that his experience in both the private and public funding markets will assist LungLife AI into its next stage of development,” said Simon Raab, Chairman of LungLife AI’s Board of Directors. “The company’s Artificial Intelligence (AI) enabled diagnostic solutions are poised to transform liquid biopsy-based technologies and James’ experience in this area will be invaluable.”

About LungLife AI, Inc.

LungLife AI is focused on the development of cancer diagnostic solutions, particularly in lung disease, recognizing the need to substantially improve patient outcomes. The company’s tests span all stages of cancer and are designed to deliver actionable information to clinicians via minimally invasive blood draw. LungLife AI is based in Thousand Oaks, California. For more information, please visit https://www.lunglifeAI.com/.

LiquidBiopsy® is a registered trademark of LungLife AI, Inc.