REG - LungLife AI, INC - Operational update

LungLife AIAnnouncement

19/11/2024 07:00

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RNS Number : 6728M  LungLife AI, INC  19 November 2024

LungLife AI, Inc.

(the "Company" or "LungLife")

 

Operational update

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  (#_ftn1) 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 (https://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
(http://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  (#_ftnref1) 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.

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