TIDMLLAI
RNS Number : 5416E
LungLife AI, INC
08 July 2021
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This announcement is not and does not constitute or form part
of, and should not be construed as, an offer of securities for
subscription or sale in any jurisdiction nor a solicitation of any
offer to buy or subscribe for, any securities in any jurisdiction,
including in or into any Restricted Jurisdiction, nor shall it or
any part of it, or the fact of its distribution, form the basis of,
or be relied on in connection with, any contract or commitment
whatsoever. This announcement is not an admission document or
prospectus and does not constitute a recommendation regarding any
securities. Terms capitalised in this announcement but not defined
herein shall have the meaning given to them in the admission
document published by the Company on 2 July 2021 (the "Admission
Document").
LungLife AI, Inc.
(the "Company" or "LungLife")
Admission to trading on AIM
& First Day of Dealings
LONDON, UK. AND THOUSAND OAKS, C ALIFORNIA, US (8 July 2021).
LungLife AI (AIM: LLAI), a developer of clinical diagnostic
solutions for lung cancer enhanced by artificial intelligence,
announces that admission to trading on AIM ("Admission") will take
place and dealings will commence at 8.00 a.m. today under the
ticker LLAI and ISIN USU5500L1045.
Summary and Highlights:
-- Successful Fundraising for gross proceeds of GBP17 million
-- Issue price of 176 pence per share
-- Market capitalisation of approximately GBP45 million on Admission
-- 25,480,790 Common Shares in issue on admission, free float of approximately 50.6 per cent.
-- Investec acted as Sole Bookrunner in relation to the
Fundraising and is acting as the Company's Nominated Adviser and
Corporate Broker from Admission
About LungLife
LungLife is a developer of clinical diagnostic solutions for
lung cancer enhanced by artificial intelligence. The Company's
diagnostic solutions are designed to make a significant impact in
the early detection of lung cancer.
The Company's technology is a combination of the recovery of
rare cells and blood-based biomarkers shown to be altered in lung
cancer. The Company employs machine learning to improve biomarker
detection, and intends to build a deep, novel pool of lung
cancer-related data for AI-enabled applications designed to improve
its diagnostic solutions over time.
The Company's core technologies are integrated in the LungLB(R)
test, which is intended to be used as a tool to provide physicians
with additional information to help in the decision-making process
for people with indeterminate lung nodules that may be lung cancer
following a CT scan. There are estimated to be over 1.5 million
individuals with indeterminate lung nodules diagnosed each year in
the United States. The LungLB(R) test may have additional
utilities, the most significant of which is likely to be in
monitoring individuals for recurrence following surgical removal of
cancerous lung nodules.
The Company has completed a 149 subject pilot study to evaluate
the LungLB(R) test, which showed a well-balanced performance and a
Positive Predictive Value of 89 per cent. The Company is now
gearing up to proceed to a larger, multi-centre validation study to
garner regulatory and reimbursement support and facilitate
commercialisation.
To support development of the LungLB(R) technology, the Company
has entered into various agreements with the Icahn School of
Medicine at Mount Sinai ("Mount Sinai"), which is an international
leader in medical and scientific training and biomedical research
and is part of the Mount Sinai Health System. Mount Sinai is
committed to building a world-renowned lung cancer programme with
expertise in screening, early detection and biomarker research and
has recently established its Center of Excellence for Thoracic
Oncology programme.
Use of proceeds and reasons for Admission
The Directors and Proposed Directors believe that raising money
in a public market context provides a signal of quality to
prospective partners and customers, raises the profile of the
business and its diagnostic tests and provides a supportive
platform from which to grow the business further through its
clinical development and commercialisation plans, as well as
supporting in-licensing of additional technologies or selective
acquisitions as may be appropriate in the future.
The Directors and Proposed Directors anticipate that the net
proceeds of the Fundraising will be sufficient to:
-- complete the validation study and commence the utility study
of the LungLB(R) test for indeterminate lung nodules, each of which
are required in the context of seeking FDA authorisation and
gathering support for reimbursement;
-- commence the post-surgical monitoring validation study for the LungLB(R) test;
-- obtain a code and commence pricing and coverage for Medicare
reimbursement for the LungLB(R) test;
-- further develop the Company's AI algorithms;
-- fund the cash payments due under the Mount Sinai Licence Agreement and Mount Sinai SRA;
-- cover general corporate overheads, including marketing and
business development, other planned capital expenditure and for
general working capital purposes; and
-- pay Admission and Fundraising related fees and expenses.
Paul Pagano, Chief Executive Officer of LungLife, said : "We are
delighted with the strong support shown by new institutional
investors for our fundraise and we are very proud to complete our
admission to AIM, which is a key milestone in the advancement of
our AI-enabled LungLB(R) test for early lung cancer detection.
" Lung cancer accounts for nearly a quarter of all
cancer-related deaths in the US because in many cases it's
diagnosed too late. Early detection is key and we believe our
simple blood test enhanced by artificial intelligence will give
physicians the additional information needed to identify this
disease earlier and reduce its impact.
" Our focus now is to proceed to a larger multi-centre pivotal
validation study and secure regulatory authorisation and
reimbursement support. We look forward to updating investors as we
hit these milestones."
For further information please contact:
LungLife AI, Inc. www.lunglifeai.com
Paul Pagano, CEO Via Walbrook PR
David Anderson, CFO
Investec Bank plc (Nominated Adviser Tel: +44 (0)20 7597 5970
& Broker)
Daniel Adams / Virginia Bull / Cameron
MacRitchie
Walbrook PR Limited Tel: +44 (0)20 7933 8780 or LungLifeAI@walbrookpr.com
Paul McManus / Alice Woodings Mob: 07980 541 893 / 07407 804 654
Background to the Company
Business overview
A significantly underserved medical need
The Directors and Proposed Directors believe that the early
detection of lung cancer is a significantly unmet medical need.
According to the World Health Organisation, over 2.2 million new
cases of lung cancer were diagnosed in 2020 and approximately 1.8
million deaths from lung cancer were recorded in 2020 globally.
Nearly 80 per cent. of all lung cancers in the United States are
diagnosed in later stages when survival rates are low because the
options for curative treatment are then limited. This is in part
due to the lack of effective early detection solutions and the fact
that lung cancer largely develops asymptomatically.
A computed tomography ("CT") scan is the standard method for the
early detection of lung cancer and multiple studies including The
National Lung Screening Trial in the US showed a significant
reduction in lung cancer-specific mortality with CT screening as
these cancers were found at an earlier stage when they are more
treatable. While the CT scan is highly sensitive (meaning that it
is successful in detecting an indeterminate lung nodule), it
suffers from low specificity (meaning that many of those
indeterminate nodules will be benign or not harmful) and,
accordingly, a high rate of false positives (where an indeterminate
lung nodule is not lung cancer).
The methods available to physicians to diagnose cancer from an
indeterminate nodule are inadequate and potentially result in harm
to the patient and significant costs to the healthcare system. The
Directors and Proposed Directors believe that the LungLB(R) test
will provide significant benefit when added to the clinical care
pathway by reducing the number of unnecessary invasive procedures
and reducing delays in treatment that may otherwise afford
cure.
LungLB(R) test
The Company expects to launch LungLB(R) in 2023. LungLB(R) is an
AI-enhanced, blood-based test that uses circulating tumour cells
("CTC") to stratify cancerous and benign lung nodules identified by
CT scan, which is intended to support the physician's decision to
biopsy or to monitor non-invasively using additional imaging. The
Company intends that the LungLB(R) test will undergo a multi-centre
clinical validation study to support a submission for FDA
authorisation, as well as a clinical utility study programme to
measure the LungLB(R) test's short and long-term impacts on patient
health and healthcare costs.
While the price has not yet been determined for the LungLB(R)
test, the Directors and Proposed Directors believe that it will be
less than one tenth of the cost of a lung biopsy (the average cost
of which is $14,587) and that is before taking into account the
additional cost of care of dealing with any adverse event from a
biopsy (the average cost of which is $37,745).
AI, machine learning
The Company is in the process of developing the LungLB(R) test
to utilise machine learning in order to more accurately identify
and count CTCs with the aim of reducing operator hands-on time and
increasing test performance. Achieving optimal machine learning
performance requires access to large and specific sets of data
inputs. The Directors and the Proposed Directors believe that the
quality and quantity of cells derived from the Company's pilot
study will provide the necessary breadth of sufficiently detailed
data to allow its machine learning algorithms to be developed,
validated and improved in a timely and cost-effective manner.
The Company intends to deploy machine learning and deep learning
and is working with Persistent Systems Limited ("Persistent
Systems") to develop secure, cloud-based data integration software
architecture, and secure, high-performance algorithms for its
diagnostic tests.
Collaboration with Mount Sinai
The Company has entered into various agreements with Mount
Sinai, which is an international leader in medical and scientific
training and biomedical research and is part of the Mount Sinai
Health System, a large integrated healthcare provider in the US.
The Mount Sinai Health System has approximately 6,600 associated
physicians, eight hospitals, more than 300 community locations
throughout the New York metropolitan area and receives
approximately 4 million out-patient visits per year. Mount Sinai is
committed to building a world-renowned lung cancer programme with
expertise in screening, early detection and biomarker research and
has recently established its Center of Excellence for Thoracic
Oncology programme.
Further details of the agreements entered into between the
Company and Mount Sinai are set out in the Admission Document.
Mount Sinai will hold 9.7 per cent. of the share capital of the
Company on Admission.
History of the Company
The Company was incorporated on 30 December 2009 as Cynvenio
Biosystems, Inc. and founded on technology licensed from the
University of California, Santa Barbara.
From 2010 to 2014 the Company deployed the technology for CTC
enrichment and detection for cancer diagnostics with input and
funding from pharmaceutical companies and built the LiquidBiopsy(R)
platform. The Company also built a CLIA-certified diagnostics
laboratory and offered testing services to physicians with its
first products focused on breast and prostate cancers using next
generation DNA sequencing.
In 2015 and 2016, the Company evaluated technology from MD
Anderson Cancer Center for the early detection of lung cancer, and
on 29 June 2017 the Company signed an exclusive licence agreement
for the technology, which is the basis of the LungLB(R) test. Since
2019, the Company made the strategic decision to focus on LungLB(R)
test development and since then completed a 149 subject pilot study
with subjects with indeterminate lung nodules, reduced reagent and
labour costs, and filed multiple patent applications with a view to
protecting additional aspects of the LungLB(R) test.
IMPORTANT NOTICE
Investec, which is authorised by the Prudential Regulation
Authority and regulated in the United Kingdom by the FCA and the
Prudential Regulation Authority, is acting exclusively as nominated
adviser, sole bookrunner and sole broker to the Company in
connection with the Placing and Admission and will not be acting
for any other person (including a recipient of this announcement)
or otherwise be responsible to any person for providing the
protections afforded to clients of Investec or for advising any
other person in respect of the Placing and Admission or any
transaction, matter or arrangement referred to in this
announcement. Investec's responsibilities as the Company's
nominated adviser and broker under the AIM Rules for Nominated
Advisers are owed solely to London Stock Exchange and are not owed
to the Company or to any Director or to any other person in respect
of his decision to acquire shares in the Company in reliance on any
part of this announcement. Apart from the responsibilities and
liabilities, if any, which may be imposed on Investec by FSMA or
the regulatory regime established thereunder, Investec does not
accept any responsibility whatsoever for the contents of this
announcement, including its accuracy, completeness or verification
or for any other statement made or purported to be made by it, or
on its behalf, in connection with the Company, the Common Shares or
the Placing and Admission. Investec accordingly disclaims all and
any liability whether arising in tort, contract or otherwise (save
as referred to above) in respect of this announcement or any such
statement.
This announcement is not for publication or distribution, in
whole or in part, directly or indirectly, in or into any Restricted
Jurisdiction. The distribution of this announcement may be
restricted by law in certain jurisdictions and persons into whose
possession any document or other information referred to herein
comes should inform themselves about and observe any such
restriction. Any failure to comply with these restrictions may
constitute a violation of the securities laws of any such
jurisdiction.
This announcement does not contain or constitute an offer of, or
the solicitation of an offer to buy or subscribe for, the
securities referred to herein to any person in any Restricted
Jurisdiction. The securities referred to herein may not be offered
or sold, transferred or delivered directly or indirectly, in the
United States unless registered under the Securities Act or offered
in a transaction exempt from, or not subject to, the registration
requirements of the Securities Act or any other applicable
securities laws of the United States and in accordance with any
applicable securities laws of any state or other jurisdiction of
the United States. There is no intention to register any securities
referred to herein in the United States or to make a public
offering of the securities in the United States.
The securities referred to herein have not been and will not be
registered under the Securities Act or under the applicable
securities laws of Australia, Canada, Japan, New Zealand or the
Republic of South Africa. There will be no public offer of the
Common Shares in the United States, Australia, Canada, Japan, New
Zealand or the Republic of South Africa. Subject to certain
exceptions, the Common Shares referred to herein may not be offered
or sold in Australia, Canada, Japan, New Zealand or the Republic of
South Africa or to, or for the account or benefit of, any national,
resident or citizen of Australia, Canada, Japan, New Zealand or the
Republic of South Africa.
The price of shares and any income expected from them may go
down as well as up and investors may not get back the full amount
invested upon disposal of the shares. Past performance is no guide
to future performance, and persons needing advice should consult an
independent financial adviser.
Neither the content of the Company's website nor any website
accessible by hyperlinks on the Company's website is incorporated
in, or forms part of, this announcement.
Certain figures in this announcement, including financial
information, have been subject to rounding adjustments.
Accordingly, in certain instances, the sum or percentage change of
the numbers contained in this announcement may not conform exactly
with the total figure given. This announcement contains statements
that are, or may be deemed to be, "forward-looking statements". In
some cases, these forward-looking statements can be identified by
the use of forward-looking terminology, including, without
limitation, the terms "anticipate", "believes", "could", "would",
"envisage", "estimate", "expect", "aim", "intend", "may", "plan",
"project", "target", "should", "will" or, in each case, their
negative or other variations or comparable terminology. These
forward-looking statements relate to matters that are not
historical facts. They appear in a number of places throughout this
announcement and include statements regarding the intentions,
beliefs and current expectations of the Company, the Directors or
the Proposed Directors concerning, amongst other things, the
results of operations, financial condition, liquidity, prospects,
growth, objectives and strategies of the Company and the industry
in which the Company operates. By their nature, forward-looking
statements involve risks and uncertainties because they relate to
events and depend on circumstances that may or may not occur in the
future. Forward-looking statements are not guarantees of future
performance. The actual results, performance or achievements of the
Company or developments in the industry in which the Company
operates may differ materially from the future results, performance
or achievements or industry developments expressed or implied by
the forward-looking statements contained in this announcement. The
forward-looking statements contained in this announcement speak
only as at the date of this announcement. The Company expressly
disclaims any undertaking or obligation to update or revise
publicly the forward-looking statements contained in this
announcement to reflect any change in expectations or to reflect
events or circumstances occurring or arising after the date of this
announcement, except as required in order to comply with its legal
and regulatory obligations (including under the AIM Rules for
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