공고 • 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. 공고 • 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 • Oct 01
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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 (€4.23m market cap, or US$4.68m). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$4.3m). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). 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 (€4.70m 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). 공고 • 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. 공고 • 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