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REG - Polarean Imaging PLC - Half-year Report

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RNS Number : 6338L  Polarean Imaging PLC  07 September 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

Half-year Report

 

Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced magnetic resonance imaging ("MRI") of the lungs, announces its
unaudited interim results for the six months ended 30 June 2023.

 

Highlights

·    Secured the first order for a xenon gas blend cylinder for the
production of XENOVIEW™ (xenon Xe 129 hyperpolarised) from Cincinnati
Children's Hospital Medical Center leading to the first clinical scan in North
America, representing a key milestone in the execution of the commercial plan

·    Entered into a collaboration agreement with multinational medical
imaging technology company Philips to advance the field of hyperpolarised
Xenon MRI

·    Submitted a post-marketing commitment plan to the US Food and Drug
Administration ("FDA") to seek approval prior to 30 June 2024 to expand the
minimum current age of XENOVIEW MRI in children from twelve to six years

·    Granted New Chemical Entity designation for XENOVIEW by the FDA, with
a five-year market exclusivity period

·    Selected as one of the featured companies at the American Thoracic
Society's 2023 Respiratory Innovation Summit

·    Appointed Christopher von Jako, Ph.D. as new Chief Executive Officer
and Board Director

·    Net cash of US$9.9m as of 30 June 2023, which based on strategic
decisions, is now expected to fund the Company until the end of Q2 2024

 

Post-period end

·    Upgraded the University of Missouri Health Care polariser system to
a clinical configuration accompanied by the sale of an initial xenon gas blend
cylinder for the production of XENOVIEW

·    Received 510(k) clearance from the FDA for the Company's specialised
MRI chest coil to now include Philips 3.0T MRI scanners for the visualisation
of Xenon 129 nuclei

·    New reimbursement C-code (C9791) from the US Centers for Medicare
& Medicaid Services ("CMS") for the XENOVIEW MRI technology which
corresponds to a payment range of between US$1,201 to US$1,300

·    Requested and granted a formal Type B meeting in October 2023 with
the FDA's Center for Drug Evaluation and Research division to seek guidance on
the clinical plan related to the XENOVIEW indication expansion, which includes
both regional visualisation and quantitative assessment of gas exchange and
microvascular haemodynamics for both pulmonary and cardio-pulmonary diseases

 

Christopher von Jako, Ph.D., CEO of Polarean, commented: "Today marks 80 days
since I joined the dynamic Polarean team, and I am very excited about our
life-altering imaging platform technology and how we can help individuals
suffering from lung disease. Over the past two months, we began revisiting all
our strategic business initiatives with the intent of creating increased focus
on key business drivers. As a result, we have identified five specific growth
initiatives, which include driving utilisation at our newly established
clinical sites, expanding to our highest priority targeted clinical sites,
developing key industry partnerships, establishing reimbursement coverage and
payment, and expanding our current FDA indication to include the even higher
value interstitial lung and pulmonary vascular diseases.

 

"I am also delighted that we received a final determination from CMS that our
new C-code is linked to a new technology APC 1551, which corresponds to a
payment range of between US$1,201 to US$1,300. This reimbursement code should
be helpful as we market XENOVIEW for the evaluation of ventilation, which is
highly useful in obstructive lung diseases like asthma, COPD, and cystic
fibrosis.

 

"Our new focus will also result in reduced operating expenses going forward
which allows us to extend our cash runway until the end of Q2 2024.  All our
initiatives are guided by our belief and desire to revolutionise pulmonary and
cardio-pulmonary medicine."

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018.

 

Enquiries:

 

 Polarean Imaging plc                                        www.polarean.com / www.polarean-ir.com (http://www.polarean-ir.com)
 Christopher von Jako, Ph.D, Chief Executive Officer         Via Walbrook PR
 Charles Osborne, Chief Financial Officer

 Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)                                  +44 (0)20 7710 7600
 Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment
 Banking)
 Nick Adams / Nick Harland (Corporate Broking)

 Walbrook PR         Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
 Anna Dunphy / Phillip Marriage          Mob: +44 (0)7876 741 001 / +44 (0)7867 984 082

 

About Polarean (www.polarean.com)

 

The Company and its wholly owned subsidiary, Polarean, Inc. (together the
"Group") are revenue-generating, medical imaging technology companies
operating in the high-resolution medical imaging space. Polarean aspires to
revolutionise pulmonary medicine by bringing the power and safety of MRI to
the respiratory healthcare community in need of new solutions to evaluate lung
ventilation, diagnose disease, characterise disease progression, and monitor
response to treatment. By researching, developing, and commercialising novel
imaging solutions with a non-invasive and radiation-free functional imaging
platform. Polarean's vision is to help address the global unmet medical needs
of more than 500 million patients worldwide suffering with chronic respiratory
disease. Polarean is a leader in the field of hyperpolarisation science and
has successfully developed the first and only hyperpolarised MRI contrast
agent to be approved in the United States.   The Company also commercialises
systems (such as the HPX hyperpolarisation system), accessories (such as
Xe-specific chest coils and phantoms), and FDA-cleared post-processing
software (to support ventilation defect analysis), to support fully integrated
modern respiratory imaging operations.

 

XENOVIEW IMPORTANT SAFETY INFORMATION

 

Indication

XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized
contrast agent indicated for use with magnetic resonance imaging (MRI) for
evaluation of lung ventilation in adults and pediatric patients aged 12 years
and older.

 

Limitations of Use

XENOVIEW has not been evaluated for use with lung perfusion imaging.

 

CONTRAINDICATIONS

None.

 

Warnings and Precautions

Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen
administered simultaneously with XENOVIEW inhalation can cause degradation of
image quality. For patients on supplemental oxygen, withhold oxygen inhalation
for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation
immediately following the imaging breath hold.

 

Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may
cause transient hypoxemia in susceptible patients. Monitor all patients for
oxygen desaturation and symptoms of hypoxemia and treat as clinically
indicated.

 

 

 

Adverse Reactions

Adverse Reactions in Adult Patients: The adverse reactions (> one patient)
in efficacy trials were oropharyngeal pain, headache, and dizziness.  Adverse
Reactions in Pediatric and Adolescent Patients: In published literature in
pediatric patients aged 6 to 18, transient adverse reactions were reported:
blood oxygen desaturation, heart rate elevation, numbness, tingling,
dizziness, and euphoria. In at least one published study of pediatric patients
aged 6 to 18 years, transient decrease in SpO2% and transient increase in
heart rate was reported following hyperpolarized xenon Xe 129 administration.
XENOVIEW is not approved for use in pediatric patients less than 12 years of
age.

 

Please see full prescribing information at www.xenoview.net

 

 

 

 

CEO Statement

 

Introduction

 

I am excited to have recently joined Polarean, and was initially attracted to
the Company's promising functional imaging technology, the large clinical
unmet need that it addresses, and the business model. I am confident that our
technology will be clinically useful for the pulmonary diseases covered by the
current FDA approval in ventilation, including asthma, COPD, and cystic
fibrosis. In addition, it has even greater potential as we expand into the
high-value areas of interstitial lung and pulmonary vascular disease. The
XENOVIEW MRI technology has the potential to transform the visualisation and
measurement of pulmonary and cardio-pulmonary disease.

 

I have spent the last two months working with the team to understand the
technology and the commercial opportunities. I am very encouraged by the
scientific and medical community's appreciation for the large unmet medical
need in the pulmonary functional imaging space, and we are in the process of
refining our commercialisation strategy to deploy XENOVIEW. My long tenure in
the medical device industry, particularly focused on large capital products,
will be very valuable as we look to ramp up commercial sales.

 

Results overview

 

Polarean received FDA approval in December 2022, which enabled the Company to
start selling its products to the clinical market.  As per US regulations, we
could not start to market the system and services until we received FDA
approval. Our efforts during the first half of 2023 were mainly focused on
preparing our legacy research sites for the conversion to clinical scanning,
obtaining the required state drug licenses, and beginning the commercial
launch process. Whilst we have been encouraged by the successful clinical
conversion of two of our prominent research sites, and the highly positive
response from physicians in both existing and prospective new sites, the
process has gone more slowly than the Company had originally hoped. The
slower-than-expected early commercial sales are primarily due to the hospital
contracting process, which we continue to actively address. From my
perspective, the early results from this type of first-in-class medical
imaging technology launch are not different than in my past experiences.

 

Group revenues for the first half were US$0.1m (H1 2022: US$0.8m), based on
sales of xenon gas blend cylinders and parts and service for polarisers
installed at our customer locations.  Operating expenses for H1 2023
(US$7.7m) increased from H1 2022 (US$7.0m), as we incurred commercialisation
costs to launch our products. In H1 2023, the Company recognised finance
income of US$0.2m (H1 2022: US$nil), due to interest earned on our bank
deposits.  Other gains / (losses) of US$0.1m (H1 2022: US$(0.2m)) were due to
the strengthening of the British pound during the 2023 period versus a
weakening of the British pound during the 2022 period. The overall loss before
tax increased to US$7.4m in H1 2023 (H1 2022: US$6.9m), due to higher
operating expenses, partially offset by the interest income and foreign
exchange gain described above.  As of 30 June 2022, the Company held US$9.9m
in net cash or cash equivalents.

 

Commercialisation plans

 

We are in the market development phase of our novel functional imaging
technology. In order for hospital administrators to embrace our technology, we
need to focus on the most compelling clinical use cases that lead to
meaningful outcomes for patients. We are working with our experienced research
user-base to continue generating case studies, while also equipping them to
utilise the technology in their clinical practice setting. In addition, we are
in conversations with our highest-priority early adopter sites for new
placements, and exploring ways for them to acquire polariser systems that they
can use for both research and clinical uses of our technology. The recent
reimbursement code issuance should aid the market adoption of the polariser
systems.

 

An important part of our strategy will be to seek industry partners, which
includes pharmaceutical and medical device companies as well as specific
disease advocacy organisations to expand the uses of our technology and
provide potential sources of resources and funding. In June 2023, we announced
that we had entered into a collaboration with Philips, a global leader in
health technology. The collaboration was featured at the 2023 International
Society for Magnetic Resonance in Medicine Annual Meeting in Toronto, and
facilitates the sharing of technical data and marketing materials to jointly
advance the field of Xenon MRI into the clinical realm. The collaboration was
shortly followed by Polarean receiving an additional 510(k) from the FDA for
our specialised MRI chest coil to now include Philips 3.0T MRI scanners. This
was an important milestone, not only highlighting the value that Philips sees
in the XENOVIEW MRI technology in furthering pulmonary imaging but also in
growing the number of healthcare systems that are able to utilise XENOVIEW
MRI.

 

Outlook

As I approach my three-month mark as CEO, I strongly believe that the novel
Polarean imaging platform holds the potential to bring significant benefits to
both patients and clinicians. The technology will revolutionise the landscape
of diagnosis and longitudinal monitoring in the fields of pulmonary and
cardio-pulmonary medicine. The recent milestone approval of a new C-code,
which is linked with a new technology APC code featuring a payment range of
US$1,201 to US$1,300, represents another significant achievement by our
Company. This accomplishment establishes a solid foundation for our
reimbursement endeavors within our two targeted fields.

 

In my 30-year career in high-tech medical devices, I have seen the early days
of several minimally invasive disruptive technologies that have since changed
the course of medicine in their respective fields. Each experience has taught
me the importance of focus and cash efficiency while continuing to build
value. In my experience of selling large capital equipment, I have found that
early sales are often irregular and difficult to forecast whilst the
commercialisation process is still evolving.  Therefore, while I am confident
in the demand for our product and its ability to gain commercial traction, we
feel it is sensible to withdraw the previously stated commercial targets at
this time. We will, however, be providing renewed guidance at a suitable time.

 

We are focusing our efforts and expenditures on activities that we believe can
deliver important milestones within our current cash runway. These activities
have led to the identification of specific growth initiatives, which include:

 

1)    Driving utilisation at our newly established clinical sites;

2)    Expanding to our highest-priority targeted clinical sites;

3)    Establishing reimbursement coverage and payment;

4)    Developing key industry partnerships; and

5)    Planning for the expansion of our current FDA labeling to include
visualisation and measurement of gas exchange

 

The Company is funded until the end of Q2 2024, and the continued progress on
the above initiatives will help support future financing at the appropriate
time.

 

I look forward to leading Polarean through this exciting journey and
developing this large potential market for our employees and investors.
Together, we are committed to successfully increasing access to the XENOVIEW
MRI technology because so many people are counting on this technology to
improve patients' lives.

 

 

Christopher von Jako, Ph.D.

Chief Executive Officer

 

7 September 2023

 

 

 

 

POLAREAN IMAGING PLC

Consolidated unaudited statement of comprehensive income

for the six months ended 30 June 2023

 

                                                      Unaudited               Unaudited                Audited
                                                      6 months ended          6 months ended           12 months ended

                                                      30 June 2023            30 June 2022             31 December 2022

                                                      US$                     US$                      US$
                                                Note

 Revenue                                              142,384                 834,087                  1,033,008
 Cost of sales                                        (60,484)                (539,247)                (684,732)
 Gross profit                                         81,900                  294,840                  348,276

 Administrative expenses                              (1,865,084)             (1,480,119)              (2,839,544)
 Research, development and regulatory expenses        (2,460,547)             (2,522,166)              (5,625,222)
 Depreciation                                         (165,509)               (139,058)                (277,461)
 Amortisation                                         (306,126)               (392,739)                (760,780)
 Selling and distribution expenses                    (2,453,477)             (1,738,265)              (3,310,592)
 Share based payment expense                          (433,892)               (701,832)                (1,205.247)
 Total operating expenses                             (7,684,635)93,580)      (6,974,179)984,594)      (14,018,846)
 Loss from operations                                 (7,602,735)0)           (6,679,339)              (13,670,570)

 Finance income                                       192,826                 2,530                    35,045
 Finance expense                                      (8,945)                 (12,944)                 (23,762)

 Other gains/(losses)-net                             67,685                  (228,378)                (246,309)
 Loss on ordinary activities before taxation    3     (7,351,169)             (6,918,131)              (13,905,596)

 Taxation                                             -                       -
 Loss and total other comprehensive expense           (7,351,169)             (6,918,131)              (13,905,596)
 Basic and fully diluted loss per share (US$)   3     (0.035)                 (0.033)                  (0.066)

 

 

 

POLAREAN IMAGING PLC

Consolidated unaudited statement of financial position

at 30 June 2023

                                      Unaudited         Unaudited         Audited
                                      As at             As at             As at

                                      30 June           30 June           31 December 2022

                                      2023              2022              US$

US$
                                      US$
 Assets                         Note
 Non-current assets
 Property, plant and equipment        351,109           504,484           418,498
 Intangible assets                    1,275,465         1,887,717         1,581,591
 Right-of-use asset                   212,373           336,203           274,288
 Trade and other receivables          413,539           5,539             437,539
                                      2,252,486         2,733,943         2,711,916
 Current assets
 Inventories                          2,061,931         1,571,100         1,711,419
 Trade and other receivables          1,505,254         1,958,292         1,659,649
 Cash and cash equivalents            9,879,595         22,690,308        16,454,241
                                      13,446,780        26,219,700        19,825,309
 Total assets                         15,699,266        28,953,643        22,537,225

 Equity
 Share capital                  4     103,861           103,194           103,463
 Share premium                        59,291,496        59,179,376        59,288,383
 Group reorganisation reserve         7,813,337         7,813,337         7,813,337
 Share-based payment reserve          5,299,471         4,362,164         4,865,579
 Accumulated losses                   (60,116,973)      (45,778,339)      (52,765,804)

 Total equity                         12,391,192        25,679,732        19,304,958

 Liabilities
 Non-current liabilities
 Deferred income                      99,596            157,702           128,704
 Lease liability                5     147,667           285,493           216,691
 Trade and other payables             300,000           -                 360,000
 Contingent consideration             316,000           316,000           316,000

                                      863,263           759,195           1,021,395
 Current liabilities
 Trade and other payables             2,169,530         2,179,232         1,979,001
 Lease liability                5     137,827           144,767           142,146
 Deferred income                      137,454           190,717           89,725
                                      2,444,811         2,514,716         2,210,872
 Total equity and liabilities         15,699,266        28,953,643        22,537,225

 

POLAREAN IMAGING PLC

Consolidated unaudited statement of changes in equity

at 30 June 2023

                                                                     Share premium   Group re-organisation

                                                     Share capital                                           Share-based payment reserve   Accumulated losses   Total equity
 Balance as at 31 December 2021 (audited)

                                                     101,642         59,022,919      7,813,337               3,660,332                     (38,860,208)         31,738,022
 Loss and total comprehensive income for the period

                                                     -               -               -                       -                             (6,918,131)          (6,918,131)
 Transactions with owners
 Issue of shares                                     1,552           156,457         -                       -                             -                    158,009
 Share-based payments                                -               -               -                       701,832                       -                    701,832
 Balance as at 30 June 2022 (unaudited)

                                                     103,194         59,179,376      7,813,337               4,362,164                     (45,778,339)         25,679.732
 Comprehensive income
 Loss and total comprehensive income for the period  -               -               -                       -                             (6,987,465)          (6,987,465)
 Transactions with owners
 Issue of shares                                     269             109,007         -                       -                             -                    109,276
 Share-based payments                                -               -               -                       503,415                       -                    503,415
 Balance as at 31 December 2022 (audited)

                                                     103,463         59,288,383      7,813,337               4,865,579                     (52,765,804)         19,304,958
 Loss and total comprehensive income for the period

                                                     -               -               -                       -                             (7,351,169)          (7,351,169)
 Transactions with owners
 Issue of shares                                     398             3,113           -                       -                             -                    3,511
 Share-based payments                                -               -               -                       433,892                       -                    433,892
 Balance as at 30 June 2023 (unaudited)

                                                     103,861         59,291,496      7,813,337               5,299,471                     (60,116,973)         12,391,192

 

POLAREAN IMAGING PLC

Consolidated unaudited cash flow statement

for the six months ended 30 June 2023

                                                              Unaudited       Unaudited       Audited
                                                              6 months ended  6 months ended  12 months ended

                                                              30 June 2023    30 June 2022    31 December 2022

                                                              US$             US$             US$
 Cash flows from operating activities
 Loss for the period before taxation                          (7,351,169)     (6,918,131)     (13,905,596)
 Adjustments for non-cash/non-operating items:
 Depreciation of property, plant and equipment                103,594         139,058         277,461
 Amortisation of intangible and right-of-use assets           368,041         392,739         760,780
 Loss on disposal of property, plant and equipment            -               1,927           2,766
 Share based payment expense                                  433,892         701,832         1,205,247
 Net foreign exchange (gains)/losses                          (67,685)        228,378         246,309
 Finance expense                                              8,945           12,944          23,762
 Finance income                                               (192,826)       (2,530)         (35,045)
                                                              (6,697,208)     (5,443,783)     (11,424,316)
 Changes in working capital:
 Increase in inventories                                      (350,512)       (144,290)       (284,609)
 Decrease/(increase) in trade and other receivables           57,587          (987,325)       (1,120,681)
 Increase in trade and other payables                         227,538         435,439         607,887
 Increase/(decrease) in deferred revenue                      42,421          106,358         (36,312)
 Net cash flows used in operating activities                  (6,720,174)     (6,033,601)     (12,258,031)

 Cash flows from investing activities
 Purchase of property, plant and equipment                    (36,205)        (10,689)        (63,946)
 Interest received                                            192.826         2,530           35,045
 Net cash generated from (used in) investing activities       156,621         (8,159)         (28,901)

 Cash flows from financing activities
 Issue of shares                                              3,511           158,009         267,285
 Interest paid on lease liabilities                           (8,945)         (12,944)        (23,762)
 Principal elements of lease payments                         (73,344)        (59,527)        (130,949)
 Net cash generated from (used in )financing activities       (78,778)        85,538          112,574

 Net decrease in cash and equivalents                         (6,642,331)     (5,956,222)     (12,174,358)

 Cash and equivalents at beginning of period                  16,454,241      28,874,908      28,874,908
 Effect of foreign exchange rate changes on cash
 and cash equivalents                                         67,685          (228,378)       (246,309)

 Cash and equivalents at end of period                        9,879,595       22,690,308      16,454,241

NOTES TO THE INTERIM ACCOUNTS

1. Basis of presentation

 

 

This interim consolidated financial information for the six months ended 30
June 2023 has been prepared in accordance with AIM rule 18, 'Half yearly
reports and accounts'. This interim consolidated financial information is not
the Group's statutory financial statements within the meaning of section 434
of the Companies Act 2006 (and information as required by section 435 of the
Companies Act 2006) and should be read in conjunction with the annual
financial statements for the year ended 31 December 2022, which have been
prepared in accordance with UK-adopted International Accounting Standards (UK
IFRS) and have been delivered to the Registrar of Companies. The auditors have
reported on those accounts; their report was unqualified but drew attention to
a material uncertainty related to going concern. It did not contain statements
under section 498(2) or (3) of the Companies Act 2006.

 

The interim consolidated financial information has been prepared in accordance
with the accounting policies adopted in the Group's most recent annual
financial statements for the year ended 31 December 2022.  A number of
amendments to IFRS accounting standards have become applicable for the current
reporting period. The Group did not have to change its accounting policies or
make retrospective adjustments as a result of adopting these amended
standards.

 

The judgements, estimates and assumptions applied in the interim condensed
consolidated financial information, including the key sources of estimation
uncertainty, were the same as those applied in the Group's last annual
financial statements for the year ended 31 December 2022.

 

The interim consolidated financial information for the six months ended 30
June 2023 is unaudited. In the opinion of the Directors, the interim
consolidated financial information presents fairly the financial position, and
results from operations and cash flows for the period. Comparative numbers for
the six months ended 30 June 2022 are also unaudited.

 

This interim consolidated financial information is presented in US Dollars
(US$).

 

2. Going concern

 

The interim consolidated financial information for the six months ended 30
June 2023 have been prepared on the going concern basis.

 

In considering the appropriateness of this basis of preparation, the Directors
have reviewed the Group's working capital forecasts. It is anticipated that
additional capital will need to be raised by the end of the second quarter of
2024 in order to continue to fund the Group's activities at their planned
levels beyond this date. This represents a material uncertainty that may cast
significant doubt about the Group's and Company's ability to continue as a
going concern. However, the Directors have a reasonable expectation that this
uncertainty can be managed to a successful outcome, and based on that
assessment, the Group has adequate resources to continue for the foreseeable
future. Thus, they continue to adopt the going concern basis of accounting in
preparing these financial statements.

 

3. Loss per share

 

The basic and diluted loss per share for the period ended 30 June 2023 was
US$0.035 (2022: US$0.033) as the warrant and options have an anti-dilutive
effect in the current and prior period. The calculation of loss per share is
based on the loss of US$7,351,169 for the period ended 30 June 2023 (2022:
loss of US$6,918,131) and the weighted average number of shares in issue
during the period for calculating the basic loss per share of 213,052,247
shares (2022: 210,921,193).

 

4. Called up share capital

 

                                    Unaudited         Unaudited         Audited
                                    30 June 2023      30 June 2022      31 December 2022

                                    US$               US$               US$
 Allotted, issued and fully paid
 Ordinary Shares                    103,861           103,194           103,463

 

 

 The number of shares in issue was as follows:  Number of shares
 Balance at 1 January 2022                      209,249,966
 Issued during the period
 Exercised options                              3,190,024
 Balance at 30 June 2022                        212,439,990
 Issued during the period
 Exercised options                              607,519
 Balance at 31 Dec 2022                         213,047,509
 Issued during the period
 Exercised warrants                             852,822
 Balance at 30 June 2023                        213,900,331

 

 

5. Borrowings

                    Unaudited         Unaudited         Audited
                    30 June 2023      30 June 2022      31 December 2022

                    US$               US$               US$
 Non-current
 Lease liability    147,667           285,493           216,691

 Current
 Lease Liability    137,827           144,767           142,146
 Total              285,494           430,260           358,837

6. Share based payments

 

Share Options

The Company grants share options at its discretion to Directors, management
and employees. These are accounted for as equity settled transactions. Should
the options remain unexercised after a period of ten years from the date of
grant the options will expire unless an extension is agreed to by the Board.
Options are exercisable at a price equal to the Company's quoted market price
on the date of grant or an exercise price to be determined by the Board.

 

Details of share options granted, exercised, forfeited and outstanding in the
period ended 30 June 2023 are as follows:

 

                                  Number of share options      Weighted average exercise price

(US$)

 Outstanding at 1 January 2023    19,384,571                   0.51
 Granted during period            5,650,000                    0.37
 Exercised during period          -                            -
 Forfeited during period          (329,166)                    0.87
 Outstanding at 30 June 2023      24,705,405                   0.48
 Exercisable at 30 June 2023      14,740,960                   0.37

 

There were 5,650,000 options granted in the period to 30 June 2023. There were
no options exercised and 329,166 options forfeited in the period to 30 June
2023.

 

The weighted average contractual life of the share options outstanding at the
reporting date is 5 years and 84 days.

 

Share Warrants

The Company grants share warrants at its discretion to Directors, management,
employees, advisors and lenders. These are accounted for as equity settled
transactions. Terms of warrants vary from agreement to agreement.

 

Details of warrants granted, exercised, forfeited and outstanding in the
period ended 30 June 2023 are as follows:

 

                                  Number of            Weighted average exercise price (US$)

share warrants
 Outstanding at 1 January 2023    3,054,129            0.01000
 Exercised during the period      (852,822)            0.00412
 Forfeited during the period      (3,400)              0.18000
 Outstanding at 30 June 2023      2,197,907            0.02000
 Exercisable at 30 June 2023      2,197,907            0.02000

 

There were 852,822 warrants exercised and 3,400 warrants forfeited in the six
months ended 30 June 2023. There were no warrants granted during this period.

 

The weighted average contractual life of the share warrants outstanding at the
reporting date is 1 year and 180 days.

 

 

7. Related party transactions

 

The Company paid US$11,650 of consulting fees to board member Daniel Brague in
the six months ending 30 June 2023.

 

 

8. Events after the reporting period

 

On 4 August 2023, the Company issued a total of 1,948,262 shares upon the
exercise of warrants with an exercise price of US$0.00749 per share for total
proceeds of US$14,583.

 

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.   END  IR BIGDCUDGDGXL

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