LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that at the Special Meeting held earlier today, both resolutions put to Stockholders were duly passed.
The proxy votes cast in respect of the Resolutions are as follows:
No. | Summary of Resolution | For* | % | Against | % | Withheld** |
1 | To authorise, in accordance with Rule 41 of the AIM Rules for Companies, the cancellation of the admission to trading on AIM of the Common Shares of the Company. | 18,092,184 | 95.2% | 921,240 | 4.8% | 1,969,934 |
2 | To authorise the transaction between the Company and Circulogene Theranostics, Inc. and the related agreements on the terms and conditions and as described in the Circular published by the Company on 29 April 2025. | 20,983,358 | 100% | Nil | 0% | Nil |
* Includes those votes giving the Chairman discretion.
**A vote withheld is not a vote in law and is therefore not counted towards the proportion of votes "for" or "against" the Resolutions
Update on the cancellation of admission of the Common Shares to trading on AIM
As a result of the passing of the Cancellation Resolution, trading in the Company's Common Shares on AIM will be cancelled at 7.00 a.m. on 29 May 2025. Stockholders are therefore reminded that the last day of dealings in the Company's Common Shares on AIM will be 28 May 2025.
Update on Exclusive License and Distribution Agreement with Circulogene Theranostics.
Following the passing of the Agreement Approval Resolution, the Company is proceeding to seek Completion of the Agreement. The Company is working with the relevant stakeholders to satisfy the Required Consents to allow for Completion and at present the Board anticipates that Completion should take place in Q2 2025, although this is expected to be following the date of Cancellation.
Further details of the Agreement and the Cancellation, can be found in the announcement issued by the Company on 29 April 2025 and the Circular which was sent to Stockholders on 29 April 2025 and is available on the Company's website at: https://lunglifeai.com/investors/financial-information-documents-presentations/.
Capitalised terms used in this announcement shall have the meanings given to such terms in the announcement issued by the Company on 29 April 2025 and in the Circular unless otherwise defined herein.
For further information please contact:
LungLife AI, Inc. | www.lunglifeai.com |
Paul Pagano, CEO David Anderson, CFO | via investors@lunglifeai.com |
Allenby Capital Limited Nominated Adviser and Joint Broker Alex Brearley / Lauren Wright - Corporate Finance Matt Butlin / Guy McDougall - Equity Sales & Corporate Broking | Tel: +44 (0)20 3328 5656 info@allenbycapital.com |
Goodbody (Joint Broker) Tom Nicholson / Cameron Duncan | Tel: +44 (0) 20 3841 6202 |
About LungLife
LungLife AI is a developer of clinical diagnostic solutions designed to make a significant impact in the early detection of lung cancer, the deadliest cancer globally. Using a minimally invasive blood draw, the Company's LungLB® test is designed to deliver additional information to clinicians who are evaluating indeterminate lung nodules. For more information visit www.lunglifeai.com.
Our Purpose is to be a driving force in the early detection to lung cancer. And our Vision is to invert the 20:80 ratio such that in years to come at least 80% of lung cancer is detected early.
1. Issuer Details
ISIN
USU5500L1045
Issuer Name
LungLife AI, Inc.
UK or Non-UK Issuer
Non-UK
2. Reason for Notification
An acquisition or disposal of voting rights
3. Details of person subject to the notification obligation
Name
Cable Car Capital LLC
City of registered office (if applicable)
San Francisco
Country of registered office (if applicable)
United States
Name | City of registered office | Country of registered office |
Funicular Funds, LP | San Francisco | United States |
4. Details of the shareholder
Full name of shareholder(s) if different from the person(s) subject to the notification obligation, above
City of registered office (if applicable)
Country of registered office (if applicable)
5. Date on which the threshold was crossed or reached
14-May-2025
6. Date on which Issuer notified
14-May-2025
7. Total positions of person(s) subject to the notification obligation
% of voting rightsattached toshares(total of 8.A) | %ofvotingrights through financial instruments(total of 8.B 1 + 8.B 2) | Totalofboth in % (8.A + 8.B) | Total number ofvotingrights held in issuer | |
Resulting situation on the date on which threshold was crossed or reached | 8.480000 | 0.000000 | 8.480000 | 2600000 |
Position of previous notification (if applicable) | 5.300000 | 0.000000 | 5.300000 |
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached
8A. Voting rights attached to shares
Class/Type of shares ISIN code(ifpossible) | Numberofdirect voting rights (DTR5.1) | Numberofindirect voting rights (DTR5.2.1) | %ofdirectvoting rights (DTR5.1) | %ofindirect votingrights (DTR5.2.1) |
USU5500L1045 | 2600000 | 8.480000 | ||
Sub Total 8.A | 2600000 | 8.480000% |
8B1.FinancialInstrumentsaccordingto(DTR5.3.1R.(1)(a))
Typeoffinancial instrument | Expiration date | Exercise/conversion period | Numberofvotingrightsthatmay be acquired if the instrument is exercised/converted | % of voting rights |
Sub Total 8.B1 |
8B2. Financial Instruments with similar economic effect according to (DTR5.3.1R.(1) (b))
Type of financial instrument | Expiration date | Exercise/conversion period | Physicalorcash settlement | Number of votingrights | %ofvoting rights |
Sub Total 8.B2 |
9. Information in relation to the person subject to the notification obligation
2. Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entities (please add additional rows as necessary)
Ultimate controlling person | Name of controlled undertaking | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold |
Jacob Ma-Weaver | Cable Car Capital, LP | 8.480000 | 8.480000% |
10. In case of proxy voting
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional Information
Cable Car Capital, LP, as the General Partner of Funicular Funds, LP, and Jacob Ma-Weaver, as the Managing Member of Cable Car Capital, LP, may each be deemed the beneficial owner of the shares held by Funicular Funds, LP.
12. Date of Completion
14-May-2025
13. Place Of Completion
San Francisco, CA
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that, further to its previous announcements, the Company will shortly send a circular to Stockholders (the "Circular"), which contains a notice of Special Meeting of Stockholders (the “Special Meeting”) and resolutions (the “Resolutions”) in connection with the proposed cancellation of admission of the Company’s Common Shares to trading on AIM and also to seek the Stockholder approval that is required to allow for Completion of the Company’s Exclusive License and Distribution Agreement (the “Agreement”) with Circulogene Theranostics, Inc. (the “Proposals”).
The purpose of the Circular is to provide information on the background to and reasons for the proposed Cancellation and to explain the consequences of the Cancellation. The purpose of the Circular is also to provide information on the background and reasons for entering into the Agreement; to explain the consequences of the Agreement; and to provide reasons why the Directors unanimously consider both of the Resolutions to be in the best interests of the Company and its Stockholders as a whole and recommend that the Stockholders approve the same.
The Special Meeting is to be convened for 4:00 p.m. UK time on 20 May 2025 at the offices of Allenby Capital Limited at 5th Floor, 5 St Helen's Place, London EC3A 6AB.
Pursuant to Rule 41 of the AIM Rules, the Company through its AIM nominated adviser, Allenby Capital Limited, has notified the London Stock Exchange of the date of the proposed Cancellation which is expected to become effective at 7.00 a.m. on 29 May 2025 if the Cancellation Resolution is passed at the Special Meeting.
Availability of Circular
The Circular will be sent to Stockholders today, 29 April 2025. A copy of this announcement and the Circular will be made available shortly on the Investors section of the Company's website at https://lunglifeai.com/investors/.
Extracts from the Circular are set out, without material amendment, below.
The above summary should be read in conjunction with the full text of this announcement and the Circular, extracts from which are set out in the Appendices below. All capitalised terms used throughout this announcement shall have the meanings given to such terms in the Definitions section in Appendix 3 to this announcement below and as defined in the Circular. References to 'this Document' refer to the Circular. References to numbered 'Parts' below refer to the relevant parts of the Circular.
Unless otherwise defined herein, the capitalised defined terms used in this announcement have the same meaning as those used in the Circular.
For further information please contact:
LungLife AI, Inc. Paul Pagano, CEO David Anderson, CFO | www.lunglifeai.com via investors@lunglifeai.com |
Allenby Capital Limited Nominated Adviser and Joint Broker Alex Brearley / Lauren Wright - Corporate Finance Matt Butlin / Guy McDougall - Equity Sales & Corporate Broking | Tel: +44 (0)20 3328 5656 info@allenbycapital.com |
Goodbody (Joint Broker) Tom Nicholson / Cameron Duncan | Tel: +44 (0) 20 3841 6202 |
About LungLife
LungLife AI is a developer of clinical diagnostic solutions designed to make a significant impact in the early detection of lung cancer, the deadliest cancer globally. Using a minimally invasive blood draw, the Company's LungLB® test is designed to deliver additional information to clinicians who are evaluating indeterminate lung nodules. For more information visit www.lunglifeai.com.
Our Purpose is to be a driving force in the early detection to lung cancer. And our Vision is to invert the 20:80 ratio such that in years to come at least 80% of lung cancer is detected early.
APPENDIX 1: EXTRACTS FROM THE CIRCULAR
PART I - LETTER FROM THE CHAIR
LUNGLIFE AI, INC.
(incorporated in the State of Delaware, USA under the Delaware General Corporation Law with registered file number 4771503)
Directors: Gordon Roy Davis Paul Pagano David Anderson Andrew Norman Boteler Sara Jane Barrington | Registered office: 850 New Burton Road Suite 201, Dover Delaware 19904 USA |
29 April 2025
Dear Stockholder
PROPOSED CANCELLATION OF ADMISSION OF THE COMMON SHARES TO TRADING ON AIM
APPROVAL OF EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT WITH CIRCULOGENE THERANOSTICS, INC.
AND
NOTICE OF SPECIAL MEETING
1. Introduction
On 3 February 2025, the Company announced that the Board intended to seek Stockholder approval for the voluntary cancellation of admission of the Common Shares to trading on AIM (the “Cancellation”). On 29 April 2025, the Company announced that it is seeking Stockholder approval for the Cancellation at the Special Meeting, which has been convened for 4.00 p.m. UK time on 20 May 2025 at the offices of Allenby Capital Limited, 5 St Helen’s Place, London EC3A 6AB.
On 17 April 2025, the Company also announced that it had entered into an Exclusive License and Distribution Agreement with Circulogene Theranostics, Inc (“Circulogene”) (the “Agreement”), a US-based comprehensive liquid biopsy diagnostics company, pursuant to which, if approved by Stockholders and certain other approvals are obtained, inter alia, the Company will receive total advanced payments of $750,000, guaranteed minimum royalty payments of $450,000 and gives an Asset Purchase Option to acquire the LungLB test and related assets for $6,200,000 less payments received by the later of 30 September 2025 or 60 days after Completion (as defined below) of the Agreement.
Completion of the Agreement also requires, among other things, obtaining Stockholder approval to approve the Agreement, which the Company is seeking via the Agreement Approval Resolution. Further details of the Agreement can be found in section 2 of this Part I, below.
If the Cancellation Resolution is passed at the Special Meeting, it is anticipated that the Cancellation will become effective at 7.00 a.m. on 29 May 2025. The Cancellation Resolution is conditional, pursuant to Rule 41 of the AIM Rules, upon the approval of not less than 75 per cent. of the votes cast (whether by Stockholders present in person or by proxy) at the Special Meeting.
In accordance with Rule 41 of the AIM Rules, the Company has notified the London Stock Exchange of the date of the proposed Cancellation, which, subject to Stockholder approval of the Cancellation Resolution, is expected to become effective at 7.00 a.m. on 29 May 2025.
Accordingly, the Board is seeking Stockholder approval for the Cancellation and the Agreement. Further details are set out below.
The purpose of this Document is to provide information on the background to and reasons for the proposed Cancellation; to explain the consequences of the Cancellation; and provide reasons why the Directors unanimously consider the Resolutions to be in the best interests of the Company and its Stockholders as a whole. The purpose of this Document is also to provide information on the background and reasons for entering into the Agreement; to explain the consequences of the Agreement; and provide reasons why the Directors unanimously consider both the Cancellation Resolution and the Agreement Approval Resolution to be in the best interests of the Company and its Stockholders as a whole and recommend that the Stockholders approve the same.
The Notice of the Special Meeting is set out on page 14 of this Document.
2. Background to and reasons for the proposed Resolutions
The Common Shares have been admitted to trading on AIM since the Company’s initial public offering in July 2021. Since the Company’s initial public offering, and subsequent fundraise in March 2024, LungLife has been able to use the funds to advance its LungLB® test, including the successful clinical validation of LungLB® following conclusion of the multi-site validation trial in 2024.
On 3 February 2025, the Company provided an operational and funding update (the “February 2025 Update”), which noted, among other things, that it had become clear to the Board that the most appropriate course of action would be for the Board to seek approval from the Stockholders of the Company to cancel the admission of the Company's Common Shares to trading on AIM in accordance with Rule 41 of the AIM Rules for Companies.
In the February 2025 Update, the Company also stated that the Board proposed to continue to consider potential sources of funding options for the Company but, should none be identified, nor any strategic agreement reached, the Board anticipated the orderly winding up of the business in due course.
On 17 April 2025, the Company announced that Circulogene had continued to perform diligence relating to payor and payment processes and following that due diligence has re-engaged with LungLife in relation to the commercial licencing of the Company’s LungLB® test, which has led to the Company entering into the Agreement.
Licensing Terms
As announced on 17 April 2025, under the Agreement, an advanced payment of $375,000 has been paid to LungLife by Circulogene following signature (the “Advanced Payment”). If LungLife fails to obtain the required consents to allow for completion of the Agreement (“Completion”), including but not limited to, obtaining Stockholder approval and obtaining certain other consents under the Agreement (the “Required Consents”), then LungLife will be required to return the Advanced Payment within thirty days following termination of the Agreement. The Advanced Payment is made pursuant to a promissory note (the “Promissory Note”) provided by LungLife that is secured by certain of LungLife's physical assets.
In order to progress Completion of the Agreement, the Company is seeking Stockholder approval to approve the Agreement, via the Agreement Approval Resolution. As at the date of this Document the Company is working with the relevant stakeholders in order to satisfy the Required Consents.
Following Completion of the Agreement, a further payment of $375,000 is to be received by LungLife and the liability under the Promissory Note, including the security interest in certain of LungLife's physical assets, falls away. From Completion, Circulogene will have the exclusive right and license to improve, further develop, utilise, practice, market, distribute, offer for sale, sell and otherwise commercialise the LungLB® test along with all software and intellectual property which is licensed by the Company in the United States and its territories, along with, among other things, certain of the Company’s equipment which shall be transferred to Circulogene. The Company will work with Circulogene to allow for Circulogene to be able to provide the LungLB® test from its own laboratory as contemplated under the Agreement by 31 August 2025.
LungLife will receive royalty payments equivalent of twenty per cent of the net revenue collected by Circulogene in relation to the LungLB® test for the first year of the Agreement, but with guaranteed minimum royalty payments covering the first three quarters of this year of $450,000, provided that, if the actual royalty payments earned in that period equate to less than $450,000, the shortfall will be offset against future royalty payments due under the Agreement. Following the one year anniversary of the signing of the Agreement, the royalty percentage shall automatically be reduced from twenty per cent. to fifteen per cent.
The initial term of the Agreement is for a period of two years from Completion, after which there is the ability to renew in successive periods for one year, upon the mutual agreement of LungLife and Circulogene, for a maximum of five renewal terms. The initial term is subject to a potential increase to 10 years from Completion in certain circumstances described below.
The Agreement may be terminated by either LungLife or Circulogene in various circumstances, including if the Required Consents, including but not limited to Stockholder approval to approve the Agreement or to allow for the exercise of the Agreement’s asset purchase option (the “Asset Purchase Option”, as described below), are not met within certain specified timeframes.
Asset Purchase Option Terms
In addition to the terms above, from Completion, the Agreement also contains the Asset Purchase Option, whereby Circulogene has the option but not an obligation, by the later of 30 September 2025 or sixty (60) days after Completion (the "Option Window"), to acquire the licensed IP, the leased equipment and all other applicable licenses for a consideration of $6,200,000, less all payments received by LungLife referred to above, but subject to and conditional on, among other things, Stockholder approval of a purchase agreement at the time of exercise and potentially the consent of the Company's Stockholders being given in a meeting pursuant to Rule 15 of the AIM Rules for Companies (as this may be applicable).
Should the Asset Purchase Option be exercised, the Board currently expects that the Company would make a distribution to Stockholders of a portion of the proceeds receivable by LungLife, with the remainder to be used fund the operations of the Company.
If Circulogene exercises the Asset Purchase Option but the transaction is unable to be consummated due to circumstances of LungLife or circumstances outside the reasonable control of Circulogene, such as LungLife's failure to obtain the required Stockholder consent or its breach of the Agreement, then Circulogene has the option to either terminate the Agreement or extend the initial term of the Agreement for a period of ten (10) years from Completion. In that circumstance, the royalty payments would be reduced to ten percent of the net revenue collected by Circulogene in relation to the LungLB® test for the remainder of the term.
Right of First Refusal
If, during the term of the Agreement, LungLife receives an offer to purchase a controlling interest in the Company, to purchase the LungLB® test or related assets, or to exclusively license the LungLB® test outside of the United States and its territories, then, during a certain election period following such offer, Circulogene will have a right of first refusal to itself consummate the proposed transaction on the offered terms or, if LungLife receives the offer within the Option Window, to effectuate the Asset Purchase Option (i.e., purchase the licensed IP, the leased equipment and all other applicable licenses for a consideration of $6,200,000, less all payments received by LungLife referred to above), but subject to and conditional on, among other things, Stockholder approval of a purchase agreement at the time of exercise and potentially the consent of the Company's Stockholders being given in a meeting pursuant to Rule 15 of the AIM Rules for Companies (as this may be applicable).
The Company has not capitalised the research and development expenditure associated with the creation of the LungLB® test and the LungLB® test is therefore recorded as having nil carrying value in the Company’s statement of financial position. The Company’s unaudited statement of financial position as at 30 June 2024, announced in the Company’s half-year report on 22 August 2024, carried an intangible asset value of $5.8 million in relation to a license to access certain de-identified patient records at the Mount Sinai Hospital, which does not form part of the Agreement and will not be subject to the Asset Purchase Option. Approximately $0.5 million of unaudited losses were attributable to the LungLB® test over the year ended 31 December 2024, being the research and development expenditure over that period.
Promissory Note
The Advanced Payment of $375,000 was made pursuant to a Promissory Note under which interest of 7.5% is payable and the amount is secured by a lien in certain tangible assets of the Company. In the event Completion takes place the amount of $375,000 is no longer repayable and the liability under the Promissory Note, including the security interest in certain of LungLife's physical assets, falls away.
About Circulogene
Founded over a decade ago, Circulogene is a US-based liquid biopsy diagnostics company. With multiple clinical laboratories and an extensive testing menu, it supports precision medicine initiatives for patients at risk of cancer and those diagnosed with cancer using proprietary methodologies for tumour analysis, ensuring accurate and timely cancer treatment. As part of a conglomerate of healthcare entities, Circulogene benefits from comprehensive support across the healthcare continuum, including sales, marketing, and revenue cycle management (billing).
Copies of the Agreement and the documents delivered or deliverable thereunder including the Promissory Note and Security Agreement can be requested by Stockholders by emailing: investors@lunglifeai.com.
Operational Update
Since the February 2025 Update, given the constraints of the Company’s cash position and obligations, as outlined in the February 2025 Update, the Company undertook various cost reductions that were envisaged at the time of the February 2025 Update.
On 31 March 2025 the Company had an unaudited cash balance of approximately $850,000 and since the beginning of February 2025 has taken action to reduce expenditure, including the termination of six members of staff. The Agreement will require the re-hiring of a minority of these members of staff, and it is anticipated that the Company’s existing cash balances combined with the minimum funding under the Agreement following Completion will satisfy the Company’s funding needs into 2026.
Should the Agreement Approval Resolution not be approved by Stockholders, or if any of the other Required Consents are not satisfied or if the Agreement were to be terminated, then the Company would be obligated to repay the Advanced Payment pursuant to the Promissory Note, and under these circumstances in the absence of additional financing the Board currently anticipates that the Company would only be able to manage its cash resources to provide a cash runway into Q3 2025, and accordingly in such circumstances the Board would likely revert to a strategy of winding up the Company’s business. Accordingly, the Board considers, among other things, that it is important for Stockholders to vote in favour of Agreement Approval Resolution at the Special Meeting to allow for the proposals under the Agreement to proceed.
Further to the Company’s previous announcements, the Company submitted its application to the relevant Medicare contractor for the technical assessment of LungLB® in Q1 this year.
Proposed Cancellation
Following the Agreement, LungLife is expected to have a limited level of operating activity, with the Company’s activities in the medium-term being expected to principally involve running the LungLB® test and the collection of royalties. Accordingly, the Board believes that LungLife will be best placed as a private company to pursue this and still considers that the most appropriate course of action is for the Company to propose to seek approval from the Stockholders of the Company to cancel the admission of the Company's common shares to trading on AIM in accordance with Rule 41 of the AIM Rules for Companies (the “Cancellation”).
The Board has assessed that the considerable cost of maintaining admission to trading on AIM, including fees payable to its professional advisers, including the nominated adviser and brokers, AIM fees payable to the London Stock Exchange as well as the incremental legal, insurance, accounting and auditing fees, along with the considerable amount of management time associated with maintaining the Company’s admission to trading on AIM are, in the Directors’ opinion, disproportionate to the benefits to the Company given how Lunglife’s operations are likely to proceed under the Agreement.
Following extensive consideration, the Board has unanimously concluded that the proposed Cancellation and the Agreement are in the best interests of the Company and its Stockholders as a whole.
3. Process for, and principal effects of, Cancellation
Stockholders who wish to remain Stockholders of LungLife following Cancellation are welcome to do so. However, the Directors are aware that certain Stockholders may be unable, or unwilling, to hold Common Shares in a private company in the event that the Cancellation is approved and becomes effective. Such Stockholders should consider selling their Common Shares in the market prior to the Cancellation becoming effective, as the shares will be largely illiquid if LungLife is private.
As a private company, there will be no formal market mechanism enabling Stockholders to trade in the Common Shares and the Common Shares (a) will be subject to trade restrictions imposed by US securities laws, and (b) may not be sold, transferred, assigned, pledged, or hypothecated unless an exemption from registration under US securities laws exists, as determined by LungLife, and which may require the holder to deliver to the Company an opinion of counsel regarding the same that is reasonably acceptable to the Company.
It is emphasised that there can be no guarantee that Stockholders will be able to buy or sell Common Shares following Cancellation. Given that there will be no market facility platform in place after Cancellation, Stockholders should be aware of the risks of remaining Stockholders of LungLife following Cancellation.
The Board is not making any recommendation as to whether or not Stockholders should buy or sell their Common Shares.
Rule 41 of the AIM Rules requires any AIM company that wishes the London Stock Exchange to cancel the admission of its shares to trading on AIM to notify stockholders and to separately inform the London Stock Exchange of its preferred cancellation date at least 20 clear Business Days prior to such date.
In accordance with AIM Rule 41, the Directors have notified the London Stock Exchange of the Company’s intention to cancel the Company’s admission of its Ordinary Shares to trading on AIM on 29 May 2025, subject to the Cancellation Resolution being passed at the Special Meeting. Accordingly, if the Cancellation Resolution is passed at the Special Meeting, the Cancellation will become effective at 7.00 a.m. on 29 May 2025.
If the Cancellation becomes effective, Allenby Capital will cease to be the nominated adviser of the Company pursuant to the AIM Rules and the Company will no longer be required to comply with the AIM Rules.
Under the AIM Rules, it is a requirement that the Cancellation must be approved via a general resolution by not less than 75 per cent. of votes cast (by proxy or in person) at the Special Meeting. Accordingly, the Notice of Special Meeting set out at the end of this Document contains the Cancellation Resolution.
The principal effects of the Cancellation will include the following:
Stockholders will no longer be afforded the protections given by the AIM Rules, such as the requirement to appoint an AIM nominated adviser or the requirement for Stockholders to be notified of price sensitive information or certain events and the requirement that the Company seek Stockholder approval for certain corporate actions, where applicable, including substantial transactions, reverse takeovers, related party transactions and fundamental changes in the Company’s business, including certain types of acquisitions and disposals;
the levels of disclosure and corporate governance within the Company will not be as stringent as for a company quoted on AIM. However, the Company intends to continue to communicate information to Stockholders, including via updates on the Company’s website;
The above considerations are not exhaustive, and Stockholders should seek their own independent advice when assessing the likely impact of the Cancellation on them.
4. Transactions in the Common Shares prior to and post Cancellation
Prior to the Cancellation
Stockholders should note that they are able to continue trading in the Common Shares on AIM up to the date of Cancellation. If the requisite Stockholders approve the Cancellation Resolution at the Special Meeting, it is anticipated that the last day of dealings in the Common Shares on AIM will be 28 May 2025. The Board is not making any recommendation as to whether or not Stockholders should buy or sell their Common Shares.
Dealing and settlement arrangements post the Cancellation
In the event that the Cancellation becomes effective, there will be no market facility for dealing in the Common Shares and no price will be publicly quoted for Common Shares as from close of business on 28 May 2025, assuming that the Cancellation Resolution is approved. As such, interests in Common Shares are unlikely thereafter to be readily capable of sale and where a buyer is identified, it may be difficult to place a fair value on any such sale and such sale will require that an exemption from registration of the Common Shares is available under US securities laws. While there can be no guarantee that Stockholders will be able to sell any Common Shares, any Stockholder seeking to do so following the Cancellation should contact the Company in writing by post to the UK registered office of the Company, Heywood House, Westbury, BA13 4NA or by email to: investors@lunglifeai.com. Subject, inter alia, to the trade restrictions imposed by US securities laws, the Company will then be able to advise as to whether the Directors are aware of any prospective buyers for any Common Shares which the holder thereof wishes to sell at that time. It is emphasised that there can be no guarantee that Stockholders will be able to buy or sell Common Shares via the mechanism described above and given that there will be no market facility platform in place after Cancellation, Stockholders should therefore be aware of the risks of remaining Stockholders of LungLife following Cancellation.
If Stockholders wish to buy or sell Common Shares on AIM they must do so prior to the Cancellation becoming effective. As noted above, in the event that Stockholders approve the Cancellation, it is anticipated that the last day of dealings in the Common Shares on AIM will be 28 May 2025 and that the effective date of the Cancellation will be 29 May 2025.
5. Options
The rights of certain individuals who hold options over Common Shares will be unaffected by the proposed Cancellation.
6. Special Meeting
The notice convening the Special Meeting to be held at the offices of Allenby Capital Limited, 5 St Helen’s Place, London EC3A 6AB at 4:00 p.m. UK time on 20 May 2025 is set out at the end of this Document.
7. Action to be taken
Holders of Share Certificates
A Form of Proxy for use at the Special Meeting is enclosed.
Whether or not you intend to attend the Special Meeting, you are requested to return the Form of Proxy duly completed to the Company's registrars, MUFG Corporate Markets at PXS 1, Central Square, 29 Wellington Street, Leeds, LS1 4DL as soon as possible and in any event, so as to be valid, to arrive by 4:00 p.m. on 16 May 2025. As an alternative to completing the hard-copy Proxy Form, Stockholders can also vote via the Investor Centre app or web browser at https://uk.investorcentre.mpms.mufg.com/. Submission of the Proxy vote does not affect your ability to attend the Special Meeting and vote in person, if you wish.
Holders of Depositary Interests
A Form of Direction for use at the Special Meeting is enclosed.
By completing the enclosed Form of Direction, holders of Depositary Interests can instruct the Depositary to vote on their behalf at the Special Meeting, either in person or by proxy. If the Form of Direction is completed without any indications as to how the Depositary should vote, the Depositary Interest holder will be deemed as instructing the Depositary to abstain from voting. If the Depositary Interest holder wishes to instruct the Depositary (other than electronically using CREST or Proxymity), it must lodge the completed Form of Direction with the Depositary at the address stated on the Form of Direction during normal business hours no later than 4:00 p.m. on 15 May 2025.
Alternatively, Depositary Interest holders may instruct the Depositary how to vote by utilising the CREST electronic voting service. To instruct the Depositary how to vote or amend an instruction to vote via the CREST system, the CREST message must be received by the Depositary (CREST ID RA10) no later than 4:00 p.m. on 15 May 2025. For this purpose, the time of receipt will be taken to be the time (as determined by the timestamp applied to the message by the CREST Applications Host) from which the Company's Agent is able to retrieve the message. CREST Personal Members or other CREST sponsored members, and those CREST Members who have appointed a voting service provider, should contact their CREST sponsor or voting service provider for assistance. For further information on CREST procedures, limitations and system timings please refer to the CREST Manual.
If you are an institutional investor you may also be able to submit an instruction electronically via the Proxymity platform, a process which has been agreed by the Company and approved by the Registrar. For further information regarding Proxymity, please go to www.proxymity.io. Your instruction must be lodged by 4:00 p.m. on 15 May 2025 in order to be considered valid or, if the meeting is adjourned, by the time which is 72 hours before the time of the adjourned meeting. Before you can submit an instruction via this process you will need to have agreed to Proxymity’s associated terms and conditions. It is important that you read these carefully as you will be bound by them and they will govern the electronic submission of your instruction. An electronic instruction submitted via the Proxymity platform may be revoked completely by sending an authenticated message via the platform instructing the removal of your submission.
8. Recommendation, irrevocable undertakings and letters of intent
The Board believes that both of the Resolutions are in the best interests of the Company and its Stockholders as a whole and unanimously recommends you to vote in favour of them, as the Directors intend to do in respect of their own beneficial shareholdings, which in aggregate represent 0.39% of the Common Shares currently in issue.
Yours faithfully,
Gordon Roy Davis
Chair
APPENDIX 2: EXPECTED TIMETABLE OF PRINCIPAL EVENTS
2025
Announcement of the proposed Cancellation and approval to enter into the Exclusive License and Distribution Agreement with Circulogene Theranostics, Inc. | 29 April |
Publication and posting of this Document and the Form of Proxy | 29 April |
Latest time for receipt of proxy appointments in respect of the Special Meeting | 4:00 p.m. on 16 May |
Special Meeting | 4:00 p.m. on 20 May |
Announcement of result of Special Meeting | 20 May |
Expected last day of dealings in Common Shares on AIM | 28 May |
Expected time and date of Cancellation | 7:00 a.m. on 29 May |
Notes:
1. Each of the times and dates above is indicative only and is subject to change. If any of the above times and/or dates change, the revised times and/or dates will be notified by the Company to Stockholders by announcement through a Regulatory Information Service.
2. All of the above and below times refer to London time unless otherwise stated.
3. The timetable above assumes that the Resolutions set out in the Notice of Special Meeting will be passed.
4. Events listed in the above timetable following the Special Meeting are conditional on the Resolutions being passed at the Special Meeting without amendment.
APPENDIX 3: DEFINITIONS
The following definitions apply throughout this Document (including the Notice of Special Meeting) and the Form of Proxy unless the context requires otherwise:
:
“Advanced Payment” | Under the Agreement, an advanced payment of $375,000 will shortly be paid to LungLife by Circulogene following signing of the Agreement |
"AIM" | the market of that name operated by the London Stock Exchange |
"AIM Rules" | the AIM Rules for Companies published by the London Stock Exchange from time to time |
“Allenby Capital” | Allenby Capital Limited, the Company’s nominated adviser and joint broker pursuant to the AIM Rules |
“Agreement” | the Exclusive License and Distribution Agreement between the Company and Circulogene Theranostics, Inc, as described in section 2 of Part I of this Document |
“Agreement Approval Resolution” | Resolution 2 set out in the Notice of Special Meeting, to obtain Stockholder approval to approve the Agreement, which is required, among other things, for the Completion of the Agreement |
“Asset Purchase Option” | the Agreement’s asset purchase option, as described in ‘Asset Purchase Option Terms’ in section 2 of Part I of this Document |
"Business Days" | Any day upon which the London Stock Exchange is open for business |
"Bylaws" | the bylaws of the Company, as amended and restated from time to time |
“Cancellation” | the cancellation of admission of the Common Shares to trading on AIM in accordance with Rule 41 of the AIM Rules, subject to passing of the Cancellation Resolution |
“Cancellation Resolution” | Resolution 1 set out in the Notice of Special Meeting, to approve the cancellation of the admission to trading on AIM of the Common Shares in accordance with Rule 41 of the AIM Rules for Companies |
“Circulogene” | Circulogene Theranostics, Inc., a US liquid biopsy diagnostics company |
"Common Shares" or "Shares" | shares of common stock of the Company with a par value per share of $0.0001 per share |
"Company" or "LungLife" | LungLife AI, Inc. a company incorporated in the State of Delaware, United States and having its registered office at 850 New Burton Road, Suite 201, Dover, Delaware 19904 |
"CREST" | the electronic systems for the holding and transfer of shares in dematerialised form operated by Euroclear UK & International Limited |
"Depositary" | MUFG Corporate Markets Trustees (Nominees) Limited, Central Square, 29 Wellington Street, Leeds, LS1 4DL |
"Depositary Interests" or "DIs" | dematerialised depositary interests representing underlying Common Shares that can be settled electronically through and held in CREST, as issued by the Depositary or its nominees who hold the underlying securities on trust |
"Directors" or "Board" | the directors of the Company whose names appear on page 8 of this Document and "Director" shall mean any one of them |
“Disclosure Guidance and Transparency Rules” | the disclosure rules and transparency rules made by the UK Financial Conduct Authority pursuant to section 73A of the Financial Services and Markets Act 2000 |
"Existing Common Shares" | the 30,658,603 Common Shares in issue as of the date of this Document |
"FCA" | the Financial Conduct Authority of the United Kingdom |
“February 2025 Update” | the operational and funding update announced by the Company on 3 February 2025 |
"Form of Direction" | the enclosed Form of Direction for use by Stockholders who hold Depositary Interests in connection with the Special Meeting |
"Form of Proxy" | the enclosed Form of Proxy for use by Stockholders who hold share certificates in connection with the Special Meeting |
"FSMA" | the Financial Services and Markets Act 2000 of the United Kingdom |
"Goodbody" | Goodbody Stockbrokers UC, a company incorporated in Ireland with registered number 54223 and having its registered office at Ballsbridge Park, Ballsbridge, Dublin 4, D04 YW83 Ireland |
"London Stock Exchange" | London Stock Exchange group plc |
"Notice" or "Notice of Special Meeting" | the notice of the Special Meeting set out on page 14 of this Document |
“Promissory Note” | a promissory note provided by LungLife that is secured by certain of LungLife's physical assets, as described in ‘Promissory Note’ in section 2 of Part I of this Document |
“Required Consents” | the required consents to allow for Completion of the Agreement, including but not limited to, obtaining Stockholder approval and obtaining certain other consents under the Agreement |
"Resolutions" | the Resolutions 1 and 2 to be proposed at the Special Meeting as set out in the Notice of Special Meeting, being the Cancellation Resolution and the Agreement Approval Resolution respectively |
"Stockholder" | a holder of Common Shares |
“Special Meeting” | The special meeting of the Company to be held at the offices of Allenby Capital Limited, 5 St Helen’s Place, London EC3A 6AB at 4.00 p.m. on 20 May 2025 |
"UK" | the United Kingdom of Great Britain and Northern Ireland |
"UK MAR" | Regulation (EU) (No 596/2014) of the European Parliament and of the Council of 16 April 2014 on market abuse to the extent that it forms part of the domestic law of the United Kingdom including by virtue of the European Union (Withdrawal) Act 2018 (as amended from time to time) |
"US", "USA" or "United States" | the United States of America, its territories and possessions, any State of the United States, and the District of Columbia |
"£" and "p" | United Kingdom pounds and pence sterling respectively |
"$" and "c" | United States dollars and cents respectively |
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, announces that it has entered into a conditional exclusive license and distribution agreement (the “Agreement”) for the commercial distribution of its LungLB® test (the “LungLB® test”) in the US with Circulogene Theranostics, Inc. a US liquid biopsy diagnostics company (“Circulogene” or the “Strategic Partner”).
As set out in the Operational and Funding Update announced on 3 February 2025, whilst discussions had started with multiple parties in 2024, in January 2025 one particular party became the key focus of these engagements. As noted in the 3 February 2025 announcement, initial conversations regarding a letter of intent resulted in draft documentation being exchanged with draft terms being an upfront fee, along with ongoing royalty payments and an option to buy the relevant IP to operate the LungLB® test for a limited period of time. Since February 2025, Circulogene has continued to perform diligence relating to payor and payment processes and following that due diligence has re-engaged with LungLife in relation to the commercial licencing of the Company’s LungLB® test, which has led to the Company entering into the Agreement.
Licensing Terms
Under the Agreement, an advanced payment of $375,000 will shortly be paid to LungLife by Circulogene following signature (the “Advanced Payment”). If LungLife fails to obtain the required consents to allow for completion of the Agreement (“Completion”), including but not limited to, obtaining shareholder approval and obtaining certain other consents under the Agreement (the “Required Consents”), then LungLife will be required to return the Advanced Payment within thirty days following termination of the Agreement. The Advanced Payment is made pursuant to a promissory note (the “Promissory Note”) provided by LungLife that is secured by certain of LungLife's physical assets.
Following Completion of the Agreement, a further payment of $375,000 is to be received by LungLife and the liability under the Promissory Note, including the security interest in certain of LungLife's physical assets, falls away.
From Completion, Circulogene will have the exclusive right and license to improve, further develop, utilise, practice, market, distribute, offer for sale, sell and otherwise commercialise the LungLB® test along with all software and intellectual property which is licensed by the Company in the United States and its territories, along with, among other things, certain of the Company’s equipment which shall be transferred to Circulogene. The Company will work with Circulogene to allow for Circulogene to be able to provide the LungLB® test from its own laboratory as contemplated under the Agreement by 31 August 2025.
LungLife will receive royalty payments equivalent of twenty per cent of the net revenue collected by Circulogene in relation to the LungLB® test for the first year of the Agreement, but with guaranteed minimum royalty payments covering the first three quarters of this year of $450,000, provided that, if the actual royalty payments earned in that period equate to less than $450,000, the shortfall will be offset against future royalty payments due under the Agreement. Following the one year anniversary of the signing of the Agreement, the royalty percentage shall automatically be reduced from twenty per cent. to fifteen per cent.
The initial term of the Agreement is for a period of two years from Completion, after which there is the ability to renew in successive periods for one year, upon the mutual agreement of LungLife and Circulogene, for a maximum
of five renewal terms. The initial term is subject to a potential increase to 10 years from Completion in certain circumstances described below.
The Agreement may be terminated by either LungLife or Circulogene in various circumstances, including if the Required Consents, including but not limited to shareholder approval to approve the Agreement or to allow for the exercise of the Agreement’s asset purchase option (the “Asset Purchase Option”, as described below), are not met within certain specified timeframes.
Asset Purchase Option Terms
In addition to the terms above, from Completion, the Agreement also contains the Asset Purchase Option, whereby Circulogene has the option but not an obligation, by the later of 30 September 2025 or sixty (60) days after Completion (the "Option Window"), to acquire the licensed IP, the leased equipment and all other applicable licenses for a consideration of $6,200,000, less all payments received by LungLife referred to above, but subject to and conditional on, among other things, shareholder approval of a purchase agreement at the time of exercise and potentially the consent of the Company's shareholders being given in a general meeting pursuant to Rule 15 of the AIM Rules for Companies (as this may be applicable).
Should the Asset Purchase Option be exercised, the Board currently expects that the Company would make a distribution to shareholders of a portion of the proceeds receivable by LungLife, with the remainder to be used fund the operations of the Company.
If Circulogene exercises the Asset Purchase Option but the transaction is unable to be consummated due to circumstances of LungLife or circumstances outside the reasonable control of Circulogene, such as LungLife's failure to obtain the required shareholder consent or its breach of the Agreement, then Circulogene has the option to either terminate the Agreement or extend the initial term of the Agreement for a period of ten (10) years from Completion. In that circumstance, the royalty payments would be reduced to ten percent of the net revenue collected by Circulogene in relation to the LungLB® test for the remainder of the term.
Right of First Refusal
If, during the term of the Agreement, LungLife receives an offer to purchase a controlling interest in the Company, to purchase the LungLB® test or related assets, or to exclusively license the LungLB® test outside of the United States and its territories, then, during a certain election period following such offer, Circulogene will have a right of first refusal to itself consummate the proposed transaction on the offered terms or, if LungLife receives the offer within the Option Window, to effectuate the Asset Purchase Option (i.e., purchase the licensed IP, the leased equipment and all other applicable licenses for a consideration of $6,200,000, less all payments received by LungLife referred to above), but subject to and conditional on, among other things, shareholder approval of a purchase agreement at the time of exercise and potentially the consent of the Company's shareholders being given in a general meeting pursuant to Rule 15 of the AIM Rules for Companies (as this may be applicable).
The Company has not capitalised the research and development expenditure associated with the creation of the LungLB® test and the LungLB® test is therefore recorded as having nil carrying value in the Company’s statement of financial position. The Company’s unaudited statement of financial position as at 30 June 2024, announced in the Company’s half-year report on 22 August 2024, carried an intangible asset value of $5.8 million in relation to a license to access certain de-identified patient records at the Mount Sinai Hospital, which does not form part of the Agreement and will not be subject to the Asset Purchase Option. Approximately $0.5 million of unaudited losses were attributable to the LungLB® test over the year ended 31 December 2024, being the research and development expenditure over that period.
Promissory Note
The Advanced Payment of $375,000 is made pursuant to a Promissory Note under which interest of 7.5% is payable and the amount is secured against certain tangible assets of the Company. In the event Completion takes place the amount of $375,000 is no longer repayable and the liability under the Promissory Note, including the security interest in certain of LungLife's physical assets, falls away.
Operational Update
On 31 March 2025 the Company had an unaudited cash balance of approximately $850,000 and since the beginning of February 2025 has taken action to reduce expenditure, including the termination of six members of staff. The Agreement will require the re-hiring of a minority of these members of staff, and it is anticipated that the Company’s existing cash balances combined with the minimum funding under the Agreement following Completion will satisfy the Company’s funding needs into 2026.
Should the Agreement not be approved by shareholders, including if any of the other Required Consents are not satisfied or if the Agreement were to be terminated, then the Company would be obligated to repay the Advanced Payment secured against the Promissory Note, and under these circumstances the Board would likely revert to a strategy of winding up the Company’s business. Accordingly, the Board considers, among other things, that it is important for shareholders to vote in favour of the resolution to be put to shareholders in due course in relation to shareholder approval to allow for the proposals under the Agreement to proceed.
Further to the Company’s previous announcements, the Company submitted its application to the relevant Medicare contractor for the technical assessment of LungLB® in Q1 this year.
Proposed Cancellation
Following the Agreement, LungLife is expected to have a limited level of operating activity, with the Company’s activities in the medium-term being expected to principally involve running the LungLB® test and the collection of royalties. Accordingly, the Board believes that LungLife will be best placed as a private company to pursue this and still considers that the most appropriate course of action is for the Company to propose to seek approval from the shareholders of the Company to cancel the admission of the Company's common shares to trading on AIM in accordance with Rule 41 of the AIM Rules for Companies (the “Proposed Cancellation”).
A circular convening a general meeting of the Company to obtain shareholder approval for the Proposed Cancellation and also to obtain shareholder approval required to allow for Completion of the Agreement and providing further detail on the next steps will be published in due course and a further announcement will be made at that time.
Paul Pagano, CEO of LungLife, said:
"The search for a strategic partner was a key focus of 2024. We were greatly encouraged by the strong interest shown by a number of parties and we are delighted to have found a commercial partner that shares our vision for the test and are excited to be in a position to move towards accelerating getting LungLB® into the hands of clinicians. We look forward to working with Circulogene as we move towards our vision of enabling 80% of lung cancers to be identified early."
Mike Mullen, CEO of Circulogene, said:
“We are proud to partner with LungLife AI to bring the LungLB® test to clinicians across the U.S. This agreement aligns perfectly with Circulogene’s mission to provide cutting-edge, non-invasive diagnostics that enable earlier detection and more personalized care for cancer patients. We believe LungLB® has the potential to transform lung cancer detection and we are committed to accelerating its adoption to improve outcomes for thousands of patients.”
For further information please contact:
LungLife AI, Inc. Paul Pagano, CEO David Anderson, CFO | www.lunglifeai.com via investors@lunglifeai.com |
Allenby Capital Limited Nominated Adviser and Joint Broker Alex Brearley / Lauren Wright - Corporate Finance Matt Butlin / Guy McDougall - Equity Sales & Corporate Broking | Tel: +44 (0)20 3328 5656 info@allenbycapital.com |
Goodbody (Joint Broker) Tom Nicholson / Cameron Duncan | Tel: +44 (0) 20 3841 6202 |
About LungLife
LungLife AI is a developer of clinical diagnostic solutions designed to make a significant impact in the early detection of lung cancer, the deadliest cancer globally. Using a minimally invasive blood draw, the Company's LungLB® test is designed to deliver additional information to clinicians who are evaluating indeterminate lung nodules. For more information visit www.lunglifeai.com
Our Purpose is to be a driving force in the early detection to lung cancer. And our Vision is to invert the 20:80 ratio such that in years to come at least 80% of lung cancer is detected early.
About the Strategic Partner
Founded over a decade ago, Circulogene is a US-based liquid biopsy diagnostics company. With multiple clinical laboratories and an extensive testing menu, it supports precision medicine initiatives for patients at risk of cancer and those diagnosed with cancer using proprietary methodologies for tumour analysis, ensuring accurate and timely cancer treatment. As part of a conglomerate of healthcare entities, Circulogene benefits from comprehensive support across the healthcare continuum, including sales, marketing, and revenue cycle management (billing).
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, provides the following update.
As set out in the Operational Update on 19 November 2024, the Company had been actively engaged in discussions with several potential strategic partners. These discussions were aimed at identifying a partner that not only shares the Company’s long-term vision but also offers the resources and expertise to help unlock the full commercial potential and accelerate the adoption of LungLB®.
Discussions had started with multiple parties in 2024, however, in January 2025 one particular party became the key focus of these engagements. Initial conversations regarding the entry into a letter of intent resulted in draft documentation being exchanged. The terms presented in the letter of intent anticipated an upfront fee, along with ongoing royalty payments and, longer term, an option to buy the relevant IP to operate the LungLB test. This party continues to perform diligence, but it is the Board’s opinion that they are unlikely to submit a binding proposal in the near term, if at all.
As of 31 December 2024, the Company had a cash balance of $1.31m. The Company has continued to maintain a disciplined approach to costs and maintains a cash runway which is expected to extend into Q2 2025. The Company undertook premarketing work before Christmas and in recent weeks and based on the feedback received, the Board does not consider a further fundraising on the public markets is viable.
The Company proposes 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.
The Board proposes to continue to consider potential sources of funding options for the Company but, should none be identified, nor any strategic agreement reached, the Board anticipates the orderly winding up of the business in due course.
Roy Davis, Chairman of LungLife AI, said
“On behalf of the Board, I would like to express our thanks to Paul and the team as well as our shareholders for their support since IPO and our subsequent funding in March of last year. We successfully took the technology from clinical validation to our first commercial sales. I am proud of the LungLB test that we have created, and we will continue efforts to realize its value for patients within the constraints of our cash position and obligations.”
For further information please contact: LungLife AI, Inc. | www.lunglifeai.com |
Paul Pagano, CEO | via investors@lunglifeai.com |
David Anderson, CFO | |
Investec Bank plc (Nominated Adviser & Broker) | Tel: +44 (0)20 7597 5970 |
Virginia Bull / Lydia Zychowska | |
Goodbody (Joint Broker) | Tel: +44 (0) 20 3841 6202 |
Tom Nicholson / Cameron Duncan |
Strong progress towards commercialisation of LungLB®
LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer, provides an update on its operational progress made since the release of its interim results announcement.
The Company has continued to execute on the commercial proof of concept of LungLB® and to explore opportunities for a suitable strategic partner who aligns with our vision and has the capability to support and accelerate the Company’s next phase of growth.
Positive response to Early Access Program (“EAP”)
Following the launch of our EAP in Q2 of this year, a key step in clinician adoption, the program has made significant progress with highly positive feedback and orders already being received. A number of doctors are evaluating how the test fits into their clinical workflow which should facilitate increased ordering going forward.
This program is allowing us to gain valuable insights and refine our approach to ensure a robust product fit for broader clinical use, including improvements to our mobile phlebotomy process so blood draws occur more smoothly and expediently, and verification of our estimated turn-around-time. By closely observing real-world application and receiving detailed input from early adopters, we are gathering critical data on usability and operational workflow integration which will help ensure the success of the full commercial launch.
From a patient perspective, doctors have used LungLB® as an effective and efficient way to accelerate potential follow-up of surveillance CT scan (from 12 months to 3 months), and to help reassure patients when an invasive procedure for a potential lung cancer is advised, which supports our goal of facilitating early detection. Demonstrating that LungLB® influences clinical care is a key criterion for securing reimbursement and future revenue generation.
Progressing with application for Medicare coverage with MolDx
Additional feedback from physicians in the EAP regarding the importance of insurance coverage supports our rationale for applying for Medicare coverage. The Company has engaged with the Medicare contractor in charge of the MolDx program[1] and has received guidance on specific areas of focus when submitting an application for technical assessment of LungLB®. We continue to anticipate our submission will be completed by the end of this year.
Publications and presentations
As previously announced, two abstracts supporting evidence for analytical and clinical validity of LungLB® were accepted for presentation at the Association for Molecular Pathology annual meeting on 22 November 2024. We look forward to raising awareness of LungLB® in the medical community and connecting with peers and colleagues.
In addition, the Company was delighted to see the publication of data confirming the analytical performance of LungLB® in the journal BMC Pulmonary Medicine in October. Publication in a leading scientific journal is a crucial step in the commercialisation of a new product, as the peer-review process supports the verification of the reliability and credibility of the research, building trust and confidence within the scientific community.
Progressing with discussions with potential strategic partners
The Company is actively engaged in discussions with several potential strategic partners. These discussions are aimed at identifying a partner that not only shares our long-term vision but also offers the resources and expertise to help unlock the full commercial potential and accelerate the adoption of LungLB®. While these discussions are progressing positively, the process is complex and requires careful consideration to ensure alignment on strategy and objectives. We will continue to keep shareholders updated and provide further details at the appropriate time.
Prudent cash management and execution
As at the end of October 2024, the Company had a cash balance of $1.77m. The Company has continued to maintain a disciplined approach to costs and, as a result, reiterates that the current cash runway is expected to extend into Q2 2025. The Company is exploring various additional operational and structural actions to extend the cash runway which would provide further optionality if required.
Paul Pagano, CEO of LungLife, said:
"We have continued to make significant progress with our three primary objectives: evidence generating activities, increasing engagement and awareness, and accelerating the commercial pathway. We are particularly encouraged by the interest shown in the LungLB® technology and look forward to continuing this momentum as we transition towards full commercial launch."
For further information please contact:
LungLife AI, Inc. | www.lunglifeai.com |
Paul Pagano, CEO | via investors@lunglifeai.com |
David Anderson, CFO | |
Investec Bank plc (Nominated Adviser & Broker) | Tel: +44 (0)20 7597 5970 |
Virginia Bull / Lydia Zychowska / Sara Wallace | |
Goodbody (Joint Broker) | Tel: +44 (0) 20 3841 6202 |
Tom Nicholson / Cameron Duncan | |
About LungLife
LungLife AI is a developer of clinical diagnostic solutions designed to make a significant impact in the early detection of lung cancer, the deadliest cancer globally. Using a minimally invasive blood draw, the Company's LungLB® test is designed to deliver additional information to clinicians who are evaluating indeterminate lung nodules. For more information visit www.lunglifeai.com
Our Purpose is to be a driving force in the early detection to lung cancer. And our Vision is to invert the 20:80 ratio such that in years to come at least 80% of lung cancer is detected early.
[1] The Medicare contractor Palmetto GBA evaluates diagnostic tests and determines their suitability for insurance coverage for Medicare patients. The MolDx program was created by Palmetto GBA to streamline the evaluation process by setting standards with unique policies and technical assessments for advanced molecular diagnostics.