Announcement • Feb 03
LungLife AI, Inc. to Seek Approval from the Shareholders to Cancel the Admission of the Company's Ordinary Shares to Trading on AIM LungLife AI, Inc. proposed to seek to reengage with parties regarding the securing of a strategic partner for LungLife. However, in light of the cash runway available to the Company and the lack of interest in a fundraising, it has now become clear to the Board that the most appropriate course of action is for the Board to seek approval from the shareholders of the Company to cancel the admission of the Company's ordinary shares to trading on AIM in accordance with Rule 41 of the AIM Rules for Companies. A circular convening a general meeting of the Company to approve the proposed cancellation and providing further detail on the next steps will be published in due course and a further announcement will be made at that time. Announcement • Oct 27
LungLife AI, Inc. Announces Resignation of James Mccullough as Non-Executive Director LungLife AI, Inc. announced the resignation of James McCullough, as a non-executive director of the company, with effect from 24 October 2024. James McCullough has taken the decision to step down from the Board to focus on his Executive role at Renalytix plc. Following this resignation, the Board remains confident in its current composition, which continues to reflect a strong balance of skills, experience, and independence. At this time, the Board has no immediate plans to seek a replacement, as it believes the current structure, together with the Scientific Advisory Board, is well-positioned to support the company's ongoing growth and development and does not impact the composition and independence of its committees. New Risk • Aug 23
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$4.3m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (US$29k revenue). Market cap is less than US$10m (UK£3.99m market cap, or US$5.23m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$4.3m). Shareholders have been diluted in the past year (20% increase in shares outstanding). Price Target Changed • Aug 22
Price target decreased by 23% to UK£1.71 Down from UK£2.21, the current price target is provided by 1 analyst. New target price is 1,191% above last closing price of UK£0.13. Stock is down 88% over the past year. The company is forecast to post a net loss per share of US$0.13 next year compared to a net loss per share of US$0.21 last year. Announcement • Aug 16
LungLife AI Announces Medicare Finalises Coverage for Molecular Risk-Stratification Testing of Indeterminate Lung Nodules LungLife AI noted the publication of the finalized Local Coverage Determination (LCD) titled "Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy" (L39654), issued by the Medicare Administrative Contractor (MAC) Noridian Healthcare Solutions, LLC, which has jurisdiction over LungLife's California laboratory. The Medicare coverage criteria are effective for medical insurance claims with dates of service on or after September 22, 2024. This enables LungLife to apply for coverage under the LCD in order to receive payment from Medicare. This is a key step towards commercialisation for LungLife, having already received a billing code and established a price of $2,030 per LungLB® test. The new Medicare coverage policyestablishes criteria for molecular tests that aid in the diagnosis of lung cancer in patients with indeterminate pulmonary (lung) nodules. This is crucial for healthcare providers and patients as setting out the circumstances under which Medicare will pay for these services removes a fundamental barrier to adoption by clinicians. Key points from the LCD include: Coverage for molecular tests to aid in the diagnosis of lung cancer in patients with indeterminate pulmonary (lung) nodules who have a non-diagnostic bronchoscopy, provided the other enumerated coverage criteria of the LCDs are satisfied. LungLife will be eligible to submit a Technical Assessment for LungLB® under this LCD for post-bronchoscopy indications. Almost half1of bronchoscopy biopsies performed are not diagnostic and thus result in a need for follow up activities, accentuating the need for risk stratification testing like LungLB® in the post-bronchoscopy setting governed by the LCD. MolDX is currently considering additional evidence to expand the indications for coverage to pre-bronchoscopy risk stratification. This provides an additional opportunity for LungLife to seek coverage under a potential foundational LCD if they progress with this. Alternatively, LungLife would be in a position to seek an individual coverage determination for this area. Fundamental components for commercialisation: There are three fundamental reimbursement components for commercialisation of LungLB®: securing a designated billing code, establishing a price, and obtaining coverage. The company made strong progress across each of these as follows: A unique billing code allows LungLife to accurately bill for and receive reimbursement from insurance payers, including Medicare and private insurers. LungLife was assigned CPT code 0317U in January 2022. Medicare established a national price of $2,030 per test for LungLB®, effective in January 2023. Obtaining coverage from public and private payers is the next crucial step for LungLife. Following the publication of the LCD, it plan to submit a Technical Assessment for coverage under the LCD in order to receive payment from Medicare. This Foundational LCD provides a clear pathway for LungLife to pursue Medicare coverage with MolDX and is generally less time intensive than obtaining a new test specific LCD. Announcement • Aug 15
LungLife AI, Inc. to Report First Half, 2024 Results on Aug 22, 2024 LungLife AI, Inc. announced that they will report first half, 2024 results on Aug 22, 2024 Board Change • Aug 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Senior Independent Non-Executive Director Andy Boteler was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • May 07
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.97m (US$10.00m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (US$46k revenue). Market cap is less than US$10m (UK£7.97m market cap, or US$10.00m). Minor Risks Share price has been volatile over the past 3 months (7.5% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Announcement • Apr 26
LungLife AI, Inc., Annual General Meeting, Jun 05, 2024 LungLife AI, Inc., Annual General Meeting, Jun 05, 2024, at 15:00 Coordinated Universal Time. Location: Investec Bank plc, 30 Gresham Street, London United Kingdom Reported Earnings • Apr 04
Full year 2023 earnings released: US$0.21 loss per share (vs US$0.30 loss in FY 2022) Full year 2023 results: US$0.21 loss per share (improved from US$0.30 loss in FY 2022). Net loss: US$5.41m (loss narrowed 29% from FY 2022). Revenue is forecast to grow 84% p.a. on average during the next 3 years, compared to a 24% growth forecast for the Biotechs industry in the United Kingdom. Breakeven Date Change • Apr 04
Forecast to breakeven in 2025 The analyst covering LungLife AI expects the company to break even for the first time. New forecast suggests the company will make a profit of US$100.0k in 2025. Average annual earnings growth of 78% is required to achieve expected profit on schedule. Announcement • Mar 27
LungLife AI, Inc. to Report Fiscal Year 2023 Results on Apr 04, 2024 LungLife AI, Inc. announced that they will report fiscal year 2023 results on Apr 04, 2024 Announcement • Mar 24
LungLife AI, Inc. announced that it has received $0.31578 million in funding LungLife AI, Inc. announced that it has received $315,780 in funding on March 22, 2024. The company issued common shares in the transaction. The company issued securities pursuant to exemption provided under Regulation D. The transaction included participation from eight investors. New Risk • Mar 22
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 20% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m (US$37k revenue). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (US$4.2m net loss in 2 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (UK£9.04m market cap, or US$11.4m). New Risk • Feb 25
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m (US$37k revenue). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (US$4.2m net loss in 2 years). Market cap is less than US$100m (UK£11.0m market cap, or US$13.9m). Reported Earnings • Aug 09
First half 2023 earnings released: US$0.11 loss per share (vs US$0.17 loss in 1H 2022) First half 2023 results: US$0.11 loss per share (improved from US$0.17 loss in 1H 2022). Net loss: US$2.81m (loss narrowed 37% from 1H 2022). Revenue is forecast to grow 100% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in the United Kingdom. Announcement • Aug 03
LungLife AI, Inc. to Report First Half, 2023 Results on Aug 08, 2023 LungLife AI, Inc. announced that they will report first half, 2023 results on Aug 08, 2023 New Risk • Jun 11
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.77m (US$9.78m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (US$24k revenue). Market cap is less than US$10m (UK£7.77m market cap, or US$9.78m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$3.9m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Major Estimate Revision • May 24
Consensus revenue estimates increase by 13% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$800.0k to US$900.0k. EPS estimate unchanged from -US$0.26 at last update. Biotechs industry in the United Kingdom expected to see average net income growth of 6.8% next year. Consensus price target of UK£2.26 unchanged from last update. Share price was steady at UK£0.50 over the past week. Reported Earnings • Apr 08
Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2022 results: US$0.003 loss per share. Net loss: US$7.61m (loss widened 2.2% from FY 2021). Revenue missed analyst estimates by 76%. Earnings per share (EPS) exceeded analyst estimates by 2.8%. Revenue is forecast to grow 90% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom. Reported Earnings • Feb 22
Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2022 results: US$0.30 loss per share. Net loss: US$7.61m (loss widened 2.2% from FY 2021). Revenue missed analyst estimates by 76%. Earnings per share (EPS) exceeded analyst estimates by 2.8%. Revenue is forecast to grow 84% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the United Kingdom. Announcement • Feb 08
LungLife AI, Inc. to Report Q4, 2022 Results on Feb 20, 2023 LungLife AI, Inc. announced that they will report Q4, 2022 results on Feb 20, 2023 Price Target Changed • Nov 16
Price target decreased to UK£2.28 Down from UK£2.89, the current price target is provided by 1 analyst. New target price is 103% above last closing price of UK£1.13. Stock is down 42% over the past year. The company is forecast to post a net loss per share of US$0.31 next year compared to a net loss per share of US$0.47 last year. Reported Earnings • Sep 26
First half 2022 earnings released: US$0.17 loss per share (vs US$0.053 loss in 1H 2021) First half 2022 results: US$0.17 loss per share. Net loss: US$4.47m (loss narrowed 2.1% from 1H 2021). Revenue is forecast to grow 105% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the United Kingdom. Announcement • Sep 10
LungLife AI, Inc. to Report First Half, 2022 Results on Sep 26, 2022 LungLife AI, Inc. announced that they will report first half, 2022 results on Sep 26, 2022 Announcement • Sep 02
LungLife AI Receives New York State Approval for Commercial Testing LungLife AI announced 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. Announcement • Apr 08
LungLife AI, Inc., Annual General Meeting, May 11, 2022 LungLife AI, Inc., Annual General Meeting, May 11, 2022, at 13:00 Coordinated Universal Time. Location: Investec Bank plc, 30 Gresham Street London United Kingdom Announcement • Jan 05
LungLife AI, Inc. Announces it Has Been Granted A Cpt® Proprietary Laboratory Analyses Code for Its LungLB® Test by the American Medical Association LungLife AI announced 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.