Corporate News

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 2024.

Highlights

• Group revenues for H1 2024 of US$1.1m (H1 2023: US$0.1m), reflecting increased commercial traction
• Operating expenses for H1 2024 of US$4.6m (H1 2023 US$7.7m), reflecting the focus of expenditures in the highest value areas
• Successfully raised gross proceeds of US$12.6m (£9.9m), including the participation of existing strategic partners NUKEM Isotopes GmbH and Bracco Imaging S.p.A., and certain Directors and management of the Company, extending cash runway until at least Q1 2026
• Received de novo Xenon MRI System order from the University of Alabama at Birmingham (“UAB”) Hospital, a top-tier academic medical hospital in the southeastern region of the U.S.
• Received and installed Cincinnati Children’s trade-in agreement order, which exchanged their existing research hyperpolariser for a new clinical-grade Xenon MRI hyperpolariser system, thereby providing them additional flexibility for both research and clinical Xenon MRI scanning
• A significant U.S. patent was granted for dynamic cardiopulmonary blood flow imaging with Xenon MRI, expanding its utility in the diagnosis and monitoring of diseases of the pulmonary vasculature

Post period end

• With the H1 2024 revenue and orders received to date, the Company is raising its revenue guidance for 2024 to a range of $2.5m to $3.0m
• The Company now has 21 sites that have either installed or ordered hyperpolariser systems and five dedicated salespeople who will continue to drive sales for the remainder of 2024 and secure orders for 2025
• Received a trade-in agreement order to exchange the University of Virginia Health System’s (“UVA Health”) existing two research hyperpolarisers for two new clinical-grade Xenon MRI hyperpolariser systems
• Received a trade-in agreement order to exchange the University of Kansas Medical Center’s (“KUMC”) existing research hyperpolariser for a new clinical-grade Xenon MRI hyperpolariser system
• Appointed Alan Huang, Ph.D., as Vice President of Sales
• Appointed Chase Hall, M.D., as Chief Medical Advisor
• Submitted a New Drug Application ("NDA") supplement to the US Food and Drug Administration ("FDA"), to allow the administration of XENOVIEW™ to paediatric patients aged six years and older

Christopher von Jako, Ph.D., CEO of Polarean, commented: “We are very pleased with the results for the first half of 2024. The revenue is tangible proof that our five-pillar growth strategy to revolutionise pulmonary medicine is starting to produce results. The installation of the new hyperpolariser system at Cincinnati Children’s and the receipt of the de novo order from UAB Hospital, expected to be installed later this year, are important milestones for the Company toward achieving the revenue targets laid out in our February 2024 strategy update. Additionally, the orders from UVA Health and KUMC in July 2024 further our progress toward converting legacy research sites to performing both research and clinical scans, and this continues to highlight the growing interest in this important technology from pulmonary clinicians.

“The first half of 2024 was marked by our efforts to successfully raise capital for the commercialisation of our pulmonary functional Xenon MRI platform. With gross proceeds of US$12.6m received in June 2024, we are now well-positioned to expand our sales team, as evidenced by the addition of Dr. Huang as our new VP of Sales, to help broaden our discussions with prospective sites. Additionally, we continue to advance the clinical applications of our technology. If our NDA supplement, filed at the end of July 2024, is approved by the FDA, it would significantly broaden our XENOVIEW label to include patients as young as six years old, greatly enhancing our clinical utility in the critical paediatric population.

“I would like to extend my gratitude to the Polarean team, our customers and investors who are helping us bring this important technology to patients suffering from chronic lung conditions.”

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:

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

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

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CEO Statement

Introduction

Upon joining Polarean fifteen months ago, my top priorities were clear: craft a strategy for the successful commercialisation of our innovative pulmonary functional Xenon MRI platform technology, align our cost structure with the Company's market development stage, and secure the necessary financing to support our commercialisation efforts. I am pleased to report that we have achieved all three objectives, through the support of our shareholders and employees, as evidenced by our results in the first half of 2024.

Results overview 

The results for the first half of 2024 show that we are successfully driving sales, while strictly controlling costs and focusing on the highest-value opportunities.

Group revenues for H1 2024 (US$1.1m) were significantly higher than for H1 2023 (US$0.1m), due to the completion of the Cincinnati Children’s sale, sales of clinical and research Xenon gas blend cylinders, and parts and services for our installed customers.

Operating expenses for H1 2024 (US$4.6m) decreased significantly from H1 2023 (US$7.7m), as we closely controlled costs throughout the organisation. Research, development, and regulatory expenses for H1 2024 (US$1.8m) decreased from H1 2023 (US$2.5m) as the 2023 expense included significant FDA post-approval activities that were completed during 2023. Selling and distribution expenses for H1 2024 (US$0.8m) also decreased significantly from H1 2023 (US$2.5m) as the latter included large launch-related expenses that were not incurred during H1 2024. Share-based expense was a contra-expense of US$0.1m in H1 2024 versus an expense of US$0.4m in H1 2023 due to the forfeiture of a large number of stock options in H1 2024.

Finance income in H1 2024 (US$0.1m) was lower than H1 2023 (US$0.2m) due to lower bank balances during H1 2024.

The overall loss before tax decreased to US$4.0m from US$7.4m in H1 2023, due to the higher revenue and lower operating expenses. With the proceeds from the June 2024 financing, the Company held US$15.2m in net cash or cash equivalents as of 30 June 2024.

Commercial progress

During the first half of the year, we achieved significant sales growth compared to H1 2023, driven by the sale and completed installation of a new Xenon MRI hyperpolariser system to Cincinnati Children’s and increased Xenon gas blend cylinder sales. We have been particularly pleased with our progress in advancing prospects through the sales pipeline, successfully securing sales in both the clinical and research markets, with a de novo order received from the UAB Hospital, and two trade-in agreement orders with current research sites upgrading them to hyperpolarisation systems approved for clinical scans. The trade-in agreements will result in lower gross margin in H2 2024, but are an important step towards activating more clinical sites. We now have 21 sites that have either installed or ordered hyperpolariser systems.  Following the successful completion of our funding round in June 2024, we now have five dedicated salespeople and will continue to drive sales for the remainder of 2024 and secure orders for 2025.

We now feel confident to raise the previously disclosed lower range for our 2024 revenue target of US$2.0m to US$2.5m, and we are now also actively working on securing the orders that will allow us to achieve our targets for 2025. Dr. Huang’s extensive experience in medical device sales, particularly with MRI systems and related devices, coupled with his strategic insights into the radiology market, will be instrumental in driving our commercial efforts forward. As he begins to engage with our team and strategy, his leadership is expected to be critical in helping us expand our market reach and deepen relationships with key stakeholders.

An important part of our growth strategy involves collaboration with industry partners in both the MedTech and the pharmaceutical sectors. Our ongoing partnership with Philips continues to evolve, offering valuable cross-selling opportunities. We also continue to have productive dialogues with both GE HealthCare and Siemens. Additionally, we are in active discussions with several pharmaceutical companies to integrate our Xenon MRI platform technology into their clinical trials. These partnerships not only enhance awareness of our technology but also allow us to engage with a broader audience of potential customers, all while maintaining a lean commercial team.

To efficiently execute our strategy, we are leveraging external consultants to bring in specialised expertise. We recently appointed Dr. Chase Hall as our Chief Medical Advisor on a consultancy basis, and Dr. Bastiaan Driehuys moved to a consultancy basis to serve his role as Chief Scientific Officer. Dr. Hall’s extensive background in pulmonary medicine and clinical research with the Xenon MRI platform technology will be invaluable as we continue to identify and validate high-value clinical use cases for our technology. In addition, Dr. Driehuys, with his rich history in Xenon MRI and his clinical research work at Duke University Hospital, provides us with access to valuable intellectual property through our exclusive license with Duke Health.

Outlook

As we look to the future, I am very pleased with our progress in 2024 as we continue to execute our five-pillar growth strategy, which includes driving utilisation, expanding our user base, enhancing reimbursement coverage and payment, expanding our total addressable market, and continuing to develop key industry partnerships.

The sales traction we have achieved so far has been very encouraging, particularly given my experience with companies pioneering novel imaging technologies and our limited resources during the first half of the year. With the recent financing, we are confident in our ability to build an expanded team that will drive the commercialisation of our innovative pulmonary functional Xenon MRI platform technology and improve outcomes for even more patients with chronic lung disease.

We look forward to providing additional updates on our progress as we achieve future milestones.

Christopher von Jako, Ph.D.
Chief Executive Officer

4 September 2024

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POLAREAN IMAGING PLC
Unaudited consolidated statement of comprehensive income
for the six months ended 30 June 2024

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POLAREAN IMAGING PLC
Unaudited consolidated statement of financial position
at 30 June 2024

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POLAREAN IMAGING PLC
Unaudited consolidated statement of changes in equity
at 30 June 2024

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POLAREAN IMAGING PLC
Unaudited consolidated cash flow statement
for the six months ended 30 June 2024

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