REG - Polarean Imaging PLC - Final Results
Thu 07:01
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RNS Number : 7780H Polarean Imaging PLC 08 May 2025
Polarean Imaging Plc
("Polarean" or the "Company")
Final Results
Notice of Annual General Meeting
Polarean Imaging plc (AIM: POLX), a commercial-stage medical device leader in
advanced Magnetic Resonance Imaging ("MRI") of lung function, announces its
audited final results for the year ended 31 December 2024.
In addition, Polarean confirms that the Annual Report and Accounts for the
year ended 31 December 2024, the Notice of the Annual General Meeting ("AGM")
and a Form of Proxy are now available on the Company's website
(http://www.polarean-ir.com/content/investors/annual-reports.asp
(http://www.polarean-ir.com/content/investors/annual-reports.asp) ) and will
be posted to shareholders shortly.
The AGM will be held at the Company's office at 2500 Meridian Parkway, Durham,
NC 27713 USA at 2:00 p.m. BST / 9:00 a.m. EDT on Monday, 9 June 2025.
Highlights
· Reported audited revenue for FY24 of US$3.1 million (FY23:
US$891k), exceeding the previously issued guidance of US$2.5 million to US$3.0
million
· Sales of proprietary Xenon gas blend cylinders and other
consumables increased by more than 50% year-on-year, reflecting the growing
number of Xenon MRI scans being performed across clinical and research sites
· Raised gross proceeds of US$12.6 million (£9.9 million), with
strong participation from strategic partners Bracco Imaging S.p.A. and NUKEM
Isotopes GmbH, as well as Directors and members of the management team. The
Company values its close working relationships with both Bracco and NUKEM.
Based on updated plans, this funding is expected to support operations through
to Q2 2026, absent further financing
· Installed a new Xenon MRI system at the University of Alabama at
Birmingham, a leading academic medical centre in the south-eastern United
States ("US") and a de novo site for Polarean
· Completed trade-in system upgrades at Cincinnati Children's, the
University of Virginia Health System, and the University of Kansas Medical
Center, enabling these institutions to replace research-only hyperpolarisers
with clinical-grade systems capable of both research and clinical scanning
· Appointed Dr. Alan Huang as Vice President of Sales and Dr. Chase
Hall as Chief Medical Advisor, strengthening the Company's leadership team
· Submitted a Supplemental New Drug Application to the US Food and
Drug Administration ("FDA") in July 2024 to lower the minimum patient age for
XENOVIEW® from 12 years to six years. Approval would significantly increase
paediatric access to Xenon MRI and expand the Company's total addressable
market
· Continued growth in Xenon MRI visibility with presentations and
posters by the Company, academic researchers, and industry collaborators at
key annual conferences including the Xenon Clinical Trials Consortium,
American Thoracic Society, Radiological Society of North America, CHEST, and
American Society for Radiation Oncology. This ongoing exposure is expanding
awareness and understanding of Xenon MRI across multiple clinical domains
· Granted a key US patent for dynamic cardiopulmonary blood flow
imaging with Xenon MRI, enhancing its application in pulmonary vascular
disease. The Company's portfolio now includes more than 20 active patents,
supporting long-term protection of its core technology
· Net cash of US$12.1 million as of 31 December 2024 (31 December
2023: US$6.2 million)
Post period end highlights
· The Company reaffirmed its revenue guidance for 2025, maintaining
the previously stated range of US$5.0 million to US$6.0 million
· Announced the expansion of a new imaging service model, in
collaboration with VIDA Diagnostics, to support pharma-sponsored research
using Xenon MRI. This announcement coincided with the Company's inclusion of
their clinical trial imaging platform in a sub-study within a global,
multicentre investigational trial for a novel lung therapy, run by a leading
global pharmaceutical company
· Held a Type C meeting with the FDA in March 2025 to discuss the
proposed design of a clinical trial to expand the XENOVIEW® label to include
gas exchange indications, representing a major opportunity to increase the
clinical and commercial value of the platform. Based on FDA feedback and
de-risking from a 230+ subject proof-of-concept study, the Company now expects
the trial to be significantly smaller and completed at an estimated cost of
US$4.0 million to US$4.5 million, down from prior estimates of US$9.0 million
to US$11.0 million
· Entered into a strategic collaboration with SimonMed Imaging, one
of the largest outpatient imaging providers in the US, to expand access to
Polarean's Xenon MRI platform. This collaboration will integrate Polarean's
technology within SimonMed's network, enhancing diagnostic capabilities and
advancing the standard of care for patients with pulmonary diseases
· Announced the issuance of another Chinese patent, covering the
use of the Xenon MRI platform to visualise global and regional pulmonary gas
exchange and microvascular blood flow in real time. This patent strengthens
the Company's intellectual property portfolio in Asia and supports potential
future entry into the Chinese market
· Secured a distribution agreement with Sumtage, a Taiwanese
company, to distribute Polarean's products in Taiwan-marking the Company's
first international commercial partnership. This agreement reflects Polarean's
strategic approach to expand outside the US ("OUS") by engaging like-minded
distributors who will lead local regulatory submissions and manage
installation and servicing, allowing the Company to minimise costs and
maintain its strategic focus on the US market
· Expanded participation in the 2025 Xenon Clinical Trials
Consortium Meeting, which featured presentations from Polarean, academic
researchers, GE Healthcare, Siemens Healthineers, Philips, and representatives
from the pharmaceutical industry. The growing involvement from key
stakeholders across academia, imaging, and pharma underscores increasing
momentum and interest in Xenon MRI
· Presented at the University of Pennsylvania's 2025 International
Workshop on Pulmonary Imaging, with 12 oral presentations focused on Xenon
MRI. Also attended the International Society for Heart and Lung
Transplantation meeting, hosting a session with leading US transplant
physicians to discuss the potential of Xenon MRI for early detection of lung
rejection
· As of the date hereof, the Company has 22 Xenon MRI platform
customers, including seven sites with installed or pending clinical grade
hyperpolariser systems. This represents a net increase of four clinical sites
over the prior year, demonstrating continued commercial momentum
2025 Outlook
The Company has assembled a top-tier commercial team, with the buildout
gaining significant momentum following the hiring of Dr. Alan Huang as Vice
President of Sales in September 2024. As a result, the current US sales force
is effectively a newly formed team, now providing full commercial coverage
across the country. Given the relatively long capital equipment sales cycle in
medical imaging, the expanded sales initiatives are only now beginning to
yield early results. Over the past six months, the team has entered into more
substantive discussions with over 65% of the top academic lung hospitals,
including cancer centres, in the US. The pace and frequency of these
interactions in the last six months is more than what occurred in the prior
two years combined. The Company believes that the foundation is now in place
for meaningful sales acceleration in the second half of 2025.
In addition, Polarean is pursuing distribution partnerships in select OUS
markets. As part of this strategy, the Company is identifying like-minded
distributors who will take responsibility for local regulatory submissions
and, in time, manage customer installation and servicing. This model enables
Polarean to minimise cost and operational complexity while maintaining
strategic focus on the US market. While this international approach offers
long-term commercial potential, the timing of revenue from these OUS
activities remains uncertain.
In the US, Polarean's primary customers are leading academic medical centres,
many of which rely heavily on government research funding to support both
research operations and institutional infrastructure. In early February 2025,
the US National Institutes of Health ("NIH") announced a cap on indirect cost
reimbursements at 15% for all new and existing research grants. This
represents a significant reduction from previously negotiated rates, which
typically ranged from 27% to 28%, with many of Polarean's target institutions
receiving indirect rates exceeding 60%. These indirect costs fund essential
infrastructure, such as administrative support, laboratory maintenance, and
utilities necessary to conduct academic research.
Following this announcement, many academic medical centres began reassessing
internal budgets, with some institutions facing potential losses in the
hundreds of millions of dollars. This reevaluation has introduced sector-wide
uncertainty and led to delays in capital purchasing decisions. As a result,
the Company expects that sales in 2025 will be weighted towards the second
half of the year. However, supported by a robust pipeline of opportunities the
Company has been actively building over the past year, including new site
launches, increased demand for its consumables, clinical trial engagements,
and ongoing partnership discussions-it remains confident in achieving its
previously stated revenue guidance range of US$5.0 million to US$6.0 million.
A key development from recent discussions with the FDA is the refinement of
the Company's planned gas exchange trial. Based on the feedback received, the
anticipated trial size will be significantly smaller than previously
projected. With fewer subjects required, the number of clinical sites can also
be reduced, further lowering the overall cost. Supported by additional
de-risking from a proof-of-concept study involving more than 230 subjects
conducted with one of the Company's leading collaborators, the trial is now
expected to be completed for approximately US$4.0 million to US$4.5 million, a
substantial reduction from the prior estimate of US$9.0 million to US$11.0
million. This streamlined design is expected to accelerate timelines, reduce
capital requirements, and potentially brings the Company closer to
profitability faster than previously anticipated.
In parallel, the Company expects FDA approval and commercial launch of the
expanded paediatric indication for XENOVIEW®-extending access to children as
young as six-in the second half of 2025. This important milestone will
significantly broaden access to Xenon MRI for younger patients. Previously,
only one-third of the paediatric population was eligible; with the expanded
indication, approximately two-thirds of paediatric patients with lung
conditions will become eligible, materially increasing the Company's
addressable market in the US. The importance of radiation-free imaging in
paediatrics has received renewed attention following a study published in the
April 2025 issue of JAMA Internal Medicine,
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832778
(https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2832778) ,
which underscored ongoing concerns related to ionising radiation exposure in
children.
Importantly, the Company enters the year with a healthy backlog comprising
consumables, service agreements, and capital equipment orders. This reflects
sustained customer engagement and commercial activity, although the timing of
revenue recognition remains uncertain in light of broader funding pressures.
In response to this evolving environment, the Company is taking several
strategic actions:
· Pursuing new commercial and strategic partnerships, including
both revenue-generating collaborations and potential funding opportunities.
· Strengthening supply chain resilience, with Polarean's Xenon-129
supplier, NUKEM Isotopes, having relocated a significant volume of gas to the
US. This move enables the Company to blend gas domestically and avoid tariffs
for at least the next two years.
· Evaluating cost reduction opportunities to maximise operational
efficiency and extend the current cash runway.
Based on current planning and disciplined cost management, the Company now
believes its existing cash reserves are sufficient to fund operations through
the end of Q2 2026, representing an extension from the previously anticipated
runway through Q1 2026.
Christopher von Jako, Ph.D., CEO of Polarean, commented: "While the current
funding environment for our academic customers presents near-term challenges,
I am encouraged by the momentum we are seeing across our commercial, clinical,
and strategic initiatives. We have assembled a strong sales team, expanded our
footprint through key collaborations, and continue to strengthen our
foundation for long-term growth. The anticipated approval of our expanded
paediatric indication later this year represents a meaningful opportunity to
broaden access to our Xenon MRI platform and deliver on our mission to
transform pulmonary medicine. The financing we completed in June 2024 gave us
the ability to enhance our team by attracting some top sales and medical
talent, and fine tune our strategy to build on further key aspects of our
five-pillar commercial strategy which we originally highlighted to the market
in February 2024
(https://irtools.co.uk/62/story/ad7a67d8-1556-465f-9ffa-98dc8cbe96b8) . We
remain focussed on delivering on this plan and we continue to make commercial
traction globally with our recent collaborations with Sumtage and SimonMed.
"I am proud of the team's execution and remain confident in our ability to
navigate the headwinds and build value for patients, clinicians, and
shareholders."
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 (NOMAD and Sole Corporate Broker) +44 (0)20 7710 7600
Nicholas Moore / Nick Harland / Brough Ransom / Ben Good
Walbrook PR Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
(mailto:polarean@walbrookpr.com)
Anna Dunphy / Paul McManus Mob: +44 (0)7876 741 001 / +44 (0)7980 541 893
About Polarean
Polarean is a revenue-generating medical imaging technology company
revolutionising pulmonary medicine through direct visualisation of lung
function by introducing the power and safety of MRI to the respiratory
healthcare community. This community is in desperate need of modern solutions
to accurately assess lung function. The Company strives to optimise lung
health and prevent avoidable loss by illuminating hidden disease, addressing
the global unmet medical needs of more than 500 million patients worldwide
suffering from chronic respiratory disease. Polarean is a leader in the field
of hyperpolarisation science and has successfully developed the first and only
hyperpolarised Xenon MRI inhaled contrast agent, XENOVIEW®, which is now
FDA-approved in the United States. Polarean is dedicated to researching,
developing, and commercialising innovative imaging solutions with its
non-invasive and radiation-free pulmonary functional MRI platform. This
comprehensive drug-device platform encompasses the proprietary Xenon gas
blend, gas hyperpolarisation system, as well as software and accessories,
facilitating fully integrated modern respiratory imaging operations. Founded
in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is
committed to increasing global awareness of and broad access to its XENOVIEW
MRI technology platform. For the latest news and information about Polarean,
please visit www.polarean.com (http://www.polarean.com) .
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
Chairman's Statement
2024 was the first full year for the Company's current Chief Executive
Officer, Dr. Christopher von Jako. Chris has brought a great deal of energy
and focus to the Company. The Board is very pleased with the progress he has
made in developing a focused commercial strategy, securing financing to
implement the strategy, and executing the commercial strategy once the
financing was secured.
In a difficult financing environment for AIM listed companies, the Company
closed a US$12.6 million (gross proceeds) in June 2024. The financing was
enabled by the continued support from our strategic partners NUKEM Isotopes
GmbH ("NUKEM") and Bracco Imaging S.p.A ("Bracco"). With the financing
secured, the Company was able to recruit top-tier medical and sales talent to
drive the commercial strategy of the Company forward.
The Company made good progress in all areas of its five-pillar growth strategy
(Drive Utilisation, Grow User Base, Broaden Reimbursement, New
Indications/Geography, Partnerships to Accelerate Growth). There were several
key additions to the sales team during 2024 and early 2025, and the expanded
sales force is beginning to have tangible results. The Company exceeded the
top end of its revenue guidance for 2024, and pipeline is building nicely for
2025.
I am particularly excited about the progress in partnering with medical
imaging companies and pharmaceutical companies, as I believe that partnerships
are critical to the future success of the Company. The Company has a
co-marketing deal with Philips that it signed in 2023 and has excellent
relationships with GE HealthCare ("GE") and Siemens Healthineers ("Siemens").
We recently announced our first collaboration with a global pharmaceutical
company to participate in a multi-site global drug clinical trial, along with
our partner VIDA Diagnostics ("VIDA"). We believe this opens a very important
new business vertical for the Company and further enhances the Company's value
proposition for academic sites to build Xenon magnetic resonance imaging
("MRI") programmes. Partnerships for sales and for market expansion will be a
significant driver for future growth, and we are seeing the first successes of
these efforts.
In light of the challenging market environment recently and resulting impact
on the Company's share price, we have increased our investor relations efforts
and continue to explore other ways to support and grow our share price. We
believe that continued execution of the Company's strategy will ultimately be
recognised by the markets.
The momentum for functional lung imaging with the Xenon MRI platform has never
been stronger. The annual Xenon MRI Clinical Consortium meeting in January
2025 was the largest ever, and included clinicians, scientists, and MRI and
pharmaceutical companies. Academic research users of Xenon MRI platform
continue to publish papers and present at conferences demonstrating how Xenon
MRI could potentially revolutionise pulmonary and cardiopulmonary diagnostics.
Reimbursement for our clinical uses is healthy and growing. With an expanded
sales team and commercial partnerships in place and growing, we are excited
for the future.
As Chris discusses in detail in his statement, the Company is facing some
headwinds from the United States ("US") macroeconomic environment. The Board
and management are monitoring the situation closely and will continue to adapt
the company strategy to the changing environment.
On behalf of the Board, I would once again like to thank all our stakeholders
for their continued support as we continue to commercialise this important
technology for the benefit of patients.
Kenneth West
Non-Executive Chairman
7 May 2025
Chief Executive Officer's Statement
2024 - Strategy Refinement, Financing and Commercial Execution
My more than 30 years of medical technology experience have been invaluable as
I have led Polarean along the path to commercialising our innovative pulmonary
imaging technology. The year 2024 was my first full year with the Company, and
it was one of significant progress and execution.
We achieved three major milestones during the year:
1. A comprehensive refinement of our commercialisation strategy
2. Securing financing to support the execution of that strategy
3. Recruiting top-tier medical and commercial talent to sell new
systems and drive adoption
In addition to these strategic achievements, I am pleased to report that we
exceeded our 2024 revenue guidance of US$2-3 million, reflecting growing
clinical interest and commercial momentum in the market.
Strategy Development and Implementation
We have made solid progress across all fronts in executing our five-pillar
strategy:
• Drive utilisation: The Polarean team has been consistently
visiting our current and prospective clinical sites to educate referring
physicians-such as pulmonologists, thoracic surgeons, radiation oncologists,
and haematologist-oncologists-as well as imaging professionals, including
radiologists, imaging scientists, magnetic resonance ("MR") technologists, and
administrative staff. These engagements focus on demonstrating the clinical
and research applications of our Xenon MRI platform utilising our US Food and
Drug Administration ("FDA") approved XENOVIEW®inhaled MRI contrast agent. The
addition of Dr. Chase Hall, a practising pulmonologist, as our Chief Medical
Advisor during 2024 has brought valuable clinical insight to support our
utilisation efforts. Interest in our technology-and the number of scans being
performed across both clinical and research settings-has continued to grow.
• Grow user base: In September 2024, we appointed Dr. Alan
Huang, as our Vice President of Global Sales and built a high-performing sales
team, which is now comprised of six individuals. Alan previously served as
General Manager of Philips' MRI business in the US and brings extensive
leadership and commercial experience in MRI to Polarean. He also holds a PhD
from the Johns Hopkins University School of Medicine, where he focused on
applications of MRI-adding deep scientific expertise to his commercial acumen.
Since joining, he has been instrumental in introducing structure and tools to
our young sales process. The team made strong progress during the year, and
the Company exceeded its 2024 revenue guidance. Given the relatively long
sales cycle for capital equipment in imaging, the expanded sales efforts we
began in 2024 are beginning to show results and we expect more rapid growth
later in the year. In parallel, we are pursuing a disciplined and highly
selective international expansion strategy. We have identified our first
international partner in Taiwan, who will collaborate with us on the necessary
regulatory and commercial planning. The Company is prioritising international
markets where we can work with trusted distribution partners-organisations
with strong local presence, a proven track record, and a shared commitment to
introducing innovative technologies that advance lung health. At the same
time, we are maintaining a focus on cost discipline to ensure that
international growth remains aligned with our long-term strategic goals and
delivers maximum impact and efficiency.
• Broaden reimbursement coverage: The Company has been working
closely with its clinical sites to support their efforts in securing
reimbursement for clinical Xenon MRI scans. We have received encouraging
feedback that sites have successfully obtained reimbursement from both public
and select private payers. In parallel, the Company continues to work with
external consultants and engage with relevant medical societies to broaden
reimbursement coverage for non-hospital settings and to advocate for wider
adoption by additional private US health insurers.
• Expand total addressable market: In July 2024, the Company
submitted a New Drug Application to the FDA to extend the use of our inhaled
MRI contrast agent, XENOVIEW, to paediatric patients aged six years and
older-down from the current label restriction of 12 years and older. Since
that submission, we have been in regular communication with the FDA and
anticipate approval in mid-2025, based on usual FDA approval timeframes,
though no guarantees can be provided at this stage. This expanded indication
would increase the US total addressable market (TAM) by approximately one
million patients. Additionally, the Company held a Type C meeting with the FDA
in March 2025 to discuss the proposed design of a clinical trial to expand the
XENOVIEW®label to include gas exchange indications. Based on FDA feedback and
de-risking from a 230+ subject proof-of-concept study, the Company now expects
the trial to be significantly smaller and completed at an estimated cost of
US$4.0 million to US$4.5 million, down from prior estimates of US$9.0 million
to US$11.0 million.
• Further develop partnerships: The Company's existing strategic
partnerships with Philips and VIDA continue to play an important role in
expanding our reach. Philips is actively supporting efforts to raise awareness
of Polarean among potential Xenon MRI platform customers for both clinical and
research use in the US and internationally, and we work closely with them in
these efforts. We also work closely with VIDA, who is introducing Polarean and
our Xenon MRI platform to its extensive network of pharmaceutical partners to
support drug development efforts. As interest in using Xenon MRI biomarkers to
assess pulmonary treatment effects continues to grow, there remains a
significant unmet need for a harmonised imaging platform to support drug
development. This includes standardised image acquisition and processing
protocols, quality control, and analytical tools to enable efficient
multicentre trials-potentially reducing patient numbers or accelerating
timelines. Polarean's partnership with VIDA, a leader in lung imaging
intelligence, has enabled the creation of an imaging services platform to meet
this need and expand a new revenue-generating business vertical for the
Company. The Company was selected, in collaboration with VIDA, to support a
multinational pharmaceutical partner's global clinical trial-an important
milestone that further validates the role of Xenon MRI in therapeutic
development. The trial is expected to begin in late 2025 at selected sites in
the US and Canada equipped with Xenon MRI systems. Together with VIDA,
Polarean will provide site qualification and training, image harmonisation,
and biomarker analysis for the Xenon MRI sub-study. We continue to explore
additional opportunities to expand this model with other pharmaceutical
companies.
Financials
Sales for 2024 exceeded our original expectations. We began the year with
revenue guidance of US$2.0 million to US$3.0 million and subsequently raised
the lower end of that range to US$2.5 million as commercial momentum built. We
ultimately surpassed the top end of our guidance, delivering revenue of US$3.1
million for the year.
We maintained a disciplined approach to spending, reducing cash operating
expenses to US$8.5 million in 2024-down significantly from US$11.1 million in
2023. In June 2024, we completed a financing that generated gross proceeds of
US$12.6 million. The Company ended the year with a cash balance of US$12.1
million.
2025 and Beyond
As outlined above, we continue to focus on executing our five-pillar growth
strategy. We are pleased with the progress we made in 2024 and the investments
we made in the last half of 2024 and early 2025 are actively building a strong
commercial and clinical pipeline for the remainder of 2025 and
beyond.Macroeconomic conditions, including spending reductions by the US
government and volatility related to US trade policies, have created headwinds
for our academic hospital customers, many of whom rely heavily on US
government grant funding. These conditions have introduced sector-wide
uncertainty and led to delays in capital purchasing decisions. As a result,
the Company expects that sales in 2025 will be weighted toward the second half
of the year. However, supported by a robust pipeline of opportunities the
Company has been actively building over the past year it remains confident in
achieving its previously stated revenue guidance range of US$5.0 million to
US$6.0 million.
In light of ongoing macroeconomic challenges, we are taking decisive action to
strengthen our position. This includes pursuing new commercial and strategic
partnerships to expand market access and accelerate growth. We are also
proactively mitigating tariff-related supply chain risks through NUKEM's
relocation of a significant volume of raw Xenon-129 gas-used in our gas blend
cylinders-to the US. In parallel, we are maintaining strict cost discipline to
preserve capital. As a result of these actions, we now project our existing
cash resources will support operations through the second quarter of
2026-extending beyond our prior guidance of the first quarter of 2026.
We are encouraged with our continued progress towards our mission of
revolutionising pulmonary medicine through direct visualisation of lung
function. Our team remains focused and energised by the growing awareness and
clinical adoption of the Xenon MRI technology platform, and our partners help
us leverage our resources with their critical market access and technical
expertise.
I would like to express my gratitude to the investors who supported us in our
2024 financing, particularly our long-term strategic partners, NUKEM and
Bracco. I am also deeply appreciative of our exceptional team of employees,
consultants, and advisers, whose dedication and expertise continue to drive
the Company forward and contribute to improving the lives of patients.
We look forward to a productive and impactful 2025.
Christopher von Jako, Ph.D.
Chief Executive Officer
7 May 2025
Consolidated Statement of Comprehensive Income
2024 2023
Notes US$ US$
Revenue 4 3,089,957 890,933
Cost of sales (1,666,667) (555,450)
Gross profit 1,423,290 335,483
Administrative expenses (3,102,331) (3,337,836)
Research, development and regulatory expenses (3,440,590) (4,194,006)
Depreciation 11 (254,993) (208,786)
Amortisation 12 (710,058) (728,411)
Selling and distribution expenses (1,950,755) (3,562,412)
Share-based payment expense 19 (713,895) (860,195)
Total operating costs (10,172,622) (12,891,646)
Operating loss 6 (8,749,332) (12,556,163)
Finance income 7 274,838 298,899
Finance expense 7 (16,178) (15,990)
Other (losses)/gains - net 7 (49,300) 388,451
Loss before tax (8,539,972) (11,884,803)
Taxation 10 - -
Loss for the year and total other comprehensive expense (8,539,972) (11,884,803)
Consolidated Statement of Financial Position
2024 2023
Notes US$ US$
ASSETS
Non-current assets
Property, plant and equipment 11 231,268 288,627
Intangible assets 12 373,822 969,339
Right-of-use assets 23 464,752 158,129
Trade and other receivables 14 339,961 387,961
1,409,803 1,804,056
Current assets
Inventories 15 1,428,633 2,221,823
Trade and other receivables 14 842,162 685,117
Cash and cash equivalents 16 12,111,708 6,171,636
14,382,503 9,078,576
TOTAL ASSETS 15,792,306 10,882,632
EQUITY AND LIABILITIES
Equity attributable to holders of the parent
Share capital 17 570,336 104,780
Share premium 17 70,509,842 59,305,160
Group re-organisation reserve 18 7,813,337 7,813,337
Share-based payment reserve 19 6,439,669 5,725,774
Accumulated losses 18 (73,190,579) (64,650,607)
12,142,605 8,298,444
Non-current liabilities
Contract liabilities 20 56,771 67,032
Trade and other payables 21 120,000 240,000
Lease liability 23 374,265 74,846
551,036 381,878
Current liabilities
Trade and other payables 21 2,702,879 1,831,587
Lease liability 23 129,521 141,845
Contract liabilities 20 266,265 228,878
3,098,665 2,202,310
TOTAL EQUITY AND LIABILITIES 15,792,306 10,882,632
Consolidated Statement of Changes in Equity
Share capital Share premium Group Share-based payment reserve Accumulated losses Total equity
US$
US$
US$
US$
re-organisation reserve US$
US$
As at 1 January 2023 103,463 59,288,383 7,813,337 4,865,579 (52,765,804) 19,304,958
Comprehensive income
Loss for the year - - - - (11,884,803) (11,884,803)
Transactions with owners
Issue of shares 1,317 16,777 - - - 18,094
Share-based payment expense - - - 860,195 - 860,195
As at 31 December 2023 104,780 59,305,160 7,813,337 5,725,774 (64,650,607) 8,298,444
Comprehensive income
Loss for the year - - - - (8,539,972) (8,539,972)
Transactions with owners
Issue of shares 465,556 11,204,682 - - - 11,670,238
Share-based payment expense - - - 713,895 - 713,895
As at 31 December 2024 570,336 70,509,842 7,813,337 6,439,669 (73,190,579) 12,142,605
Consolidated Statement of Cash Flows
2024 2023
US$
US$
Cash flows from operating activities
Loss before tax (8,539,972) (11,884,803)
Adjustments for non-cash/non-operating items:
Depreciation of property, plant and equipment 254,993 208,786
Amortisation of intangible assets and right-of use-assets 710,058 728,411
Share-based payment expense 713,895 860,195
Net foreign exchange losses/(gains) 49,300 (72,451)
Writeback of contingent consideration - (316,000)
Finance expense 16,178 15,990
Finance income (274,838) (298,899)
Operating cash outflows before movements in working capital (7,070,386) (10,758,771)
Decrease/(increase) in inventories 793,189 (510,404)
(Increase)/decrease in trade and other receivables (109,044) 1,024,108
Increase/(decrease) in trade and other payables 751,292 (267,413)
Increase in contract liabilities 27,126 77,482
Net cash used in operations (5,607,823) (10,434,998)
Cash flows from investing activities
Purchase of property, plant and equipment (197,634) (78,915)
Dividend and interest received 274,838 298,899
Net cash generated by investing activities 77,204 219,984
Cash flows from financing activities
Issue of shares 12,578,433 18,094
Share issue costs (908,195) -
Interest paid on lease liabilities (16,178) (15,990)
Principal elements of lease payments (134,069) (142,146)
Net cash generated by/(used in) financing activities 11,519,991 (140,042)
Net increase/(decrease) in cash and cash equivalents 5,989,372 (10,355,056)
Cash and cash equivalents at the beginning of year 6,171,636 16,454,241
Effect of foreign exchange rate changes on cash and cash equivalents (49,300) 72,451
Cash and cash equivalents at end of year 12,111,708 6,171,636
For the full notes on these tables, please see here
(https://www.polarean-ir.com/content/investors/annual-reports) .
.
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