31 August 2022
Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product for magnetic resonance imaging (MRI), announces its unaudited interim results for the six months ended 30 June 2022.
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- United States Food and Drug Administration (“FDA”) acceptance of resubmission of Polarean’s New Drug Application (“NDA”) following the Complete Response Letter (“CRL”) received in October 2021, with an established user fee goal date of 30 September 2022
- The Company is responding to FDA questions and requests as FDA reviews the resubmitted NDA
- Research system placements at McMaster University in Ontario, Canada and Cincinnati Children’s Medical Center
- Continued preparation for potential commercial launch of the Company’s product in the U.S.
- Ongoing planning for a new clinical trial to seek FDA approval for label expansion into the high-value gas exchange applications of Polarean’s technology
- Appointment of Frank Schulkes, Dan Brague and Marcella Ruddy, MD to the Board as Non-Executive Directors
- Appointment of Ken West as Non-Executive Chairman, following the retirement of Jonathan Allis
- Net cash of US$22.7m as of 30 June 2022, which, based on strategic decisions, could finance the Company into 2024
- Research collaboration with Oxford University Hospitals NHS Trust for long-COVID
- New publications by top-tier academic researchers exploring the applications of Xenon MRI in Asthma, COPD, cardiopulmonary disease, endobronchial valve placement, and long-COVID
- Selection of Polarean as one of the featured companies surrounding novel developments in interstitial lung disease at the 2022 ATS Respiratory Innovation Summit
- Numerous presentations of new findings in various clinical scenarios presented by researchers using Polarean’s Xenon Hyperpolarisation systems at the high-profile scientific conferences American Thoracic Society (“ATS”), International Society for Magnetic Resonance in Medicine (“ISMRM”), and Pulmonary Vascular Research Institute (“PVRI”)
Richard Hullihen, CEO of Polarean, commented: “During the first half of this year, we have focused on the approval process of our NDA, and addressing the findings related to the CRL. The FDA processes are proceeding with question and answer and other interactions with the FDA as we approach our goal action date of 30 September 2022. We have also made appropriate progress on our commercialisation planning activities, which include medical engagement of pulmonology and radiology thought-leaders at scientific conferences, profiling of our target top-tier academic institutions, and reimbursement code investigation and applications. We are excited to welcome our latest new researchers and sites, while renewing the capabilities of existing users, which continue to increase clinical research momentum.”
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.
|Polarean Imaging plc||www.polarean.com / www.polarean-ir.com|
|Richard Hullihen, Chief Executive Officer||Via Walbrook PR|
|Ken West, Chairman|
|Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)||+44 (0)20 7710 7600|
|Nicholas Moore / Samira Essebiyea / William Palmer-Brown (Healthcare Investment Banking)|
|Nick Adams / Fred Walsh / Nick Harland (Corporate Broking)|
|Walbrook PR||Tel: +44 (0)20 7933 8780 or [email protected]|
|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, investigational drug-device combination companies operating in the high-resolution medical imaging research space.
The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised xenon gas (129Xe) as an imaging agent to visualise ventilation. 129Xe gas is currently being studied for visualisation of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue membrane, and into the pulmonary bloodstream.
In October 2020, the Group submitted a New Drug Application (“NDA”) to the FDA for hyperpolarised 129Xe used to evaluate pulmonary function and to visualise the lung using MRI. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a goal action date of 30 September 2022.
The Group operates in an area of significant unmet medical need and the Group's technology provides a novel investigational diagnostic approach, offering a non-invasive and radiation-free functional imaging platform.
During the six month period ending 30 June 2022, Polarean’s activities were largely focused on resubmitting the NDA for the Company’s drug-device combination. The NDA resubmission was completed in March 2022 and the Company has received a goal action date of 30 September 2022. Post resubmission, the Company, its suppliers and providers are responding to questions and requests from the FDA.
The Company continued to strengthen its Board of Directors, with the addition of three independent Directors with significant industry experience. Frank Schulkes joined the Board as a Non-Executive Director and Chairman of the Audit Committee in April 2022. Daniel Brague joined the Board as a Non-Executive Director and Chairman of the Remuneration Committee in May 2022. On 25 August 2022, Marcella Ruddy, MD was appointed Non-Executive Director to the Board. Also in May 2022, Jonathan Allis retired from the Board and the Remuneration Committee. Kenneth West was appointed Chairman.
During the six month period ending 30 June 2022, we continued to sell our polariser systems for research purposes. We completed installations at McMaster University in Ontario, Canada and Cincinnati Children’s Medical Center.
Increasing Awareness of Company’s Technology
Polarean’s technology was highlighted at the ATS and the ISMRM conferences during May 2022 with numerous abstracts related to the research use of hyperpolarised 129Xe accepted for presentation at the two conferences. The academic research user base of our polarisers continues to expand and document the research applications of our technology across the spectrum of pulmonary disease.
In May 2022, the Company, and Oxford University Hospitals NHS Foundation Trust ("OUH") announced that they have entered into a research collaboration to study the long-term effects of COVID-19 in patients who are still experiencing difficulty breathing months after the virus infection is gone, as part of the upcoming EXPLAIN study. Under the terms of the collaboration, Polarean will provide its investigational xenon polariser system to OUH for their research. In turn, OUH will work with Polarean to optimise the imaging workflow and analyse the datasets coming from the newly enrolling EXPLAIN study. Through novel analyses of gas-exchange images, Polarean and OUH hope to better characterise long COVID and improve patient care.
Group revenues for the first half were US$0.8m (2021: US$0.6m), largely derived from the sale of polariser systems to McMaster University in Ontario, Canada and Cincinnati Children’s Medical Center. We continue to sell our polariser systems on a research-use-only basis to academic institutions in the US, Canada and Europe. Operating expenses for H1 2022 (US$7.0m) increased from H1 2021 (US$5.5m), as regulatory costs increased to support the resubmission of the NDA and administrative costs increased as we built infrastructure to support the launch of our product, and non-cash share-based costs increased due to the expense related to stock options issued in H2 2021 and H1 2022. During H1 2022, the Company recognised Finance Expense of US$0.2m due to the weakening of the British pound during the period versus Finance Income of $0.4m in H1 2021 due to the strengthening of the British pound during that period. Our overall loss before tax increased from US$4.9m to US$6.9m in the same comparable period, due to the higher operating expenses and weakening of the British pound described above. As of 30 June 2022, we held US$22.7m in net cash or cash equivalents.
Post-period end events
FDA review of NDA
We, and our suppliers and providers, continue to interact with the FDA as they review our NDA and we move through the process toward our goal action date of 30 September 2022.
Preparation for launch and future indications
We continue to prepare for the potential launch of our drug device combination post FDA approval. In addition, we have begun clinical trial preparation for the study most likely to be required for approval of future high-value gas exchange indications to expand the clinical applications of our technology.
Publications and planning for conference exhibitions
As the research use of our technology continues to grow, there have been new publications by top-tier academic researchers exploring the applications of Xenon MRI in long-COVID and fibrotic lung disease.
We plan to utilise conference exhibitions to increase the awareness of Polarean’s technology with exhibitions planned at the American College of Chest Physicians (“CHEST”) conference in October 2022 and the Radiologic Society of North America (“RSNA”) conference in November 2022.
We continue to believe that Polarean's technology has the potential to be of tremendous benefit to patients and clinicians for discovering and characterising treatable traits in pulmonary medicine. In addition, our latest new techniques lead us into the field of research for cardiology and pulmonary vascular disease which is one example of the further potential of our technology. We also look forward to evaluating new uses of our technology in pharmaceutical drug development.
The burden of pulmonary disease in the USA is approximately US$150bn and is widespread and growing, affecting nearly 40 million Americans and 500 million worldwide, with post COVID patients comprising a new segment approaching the scale of asthma. Given the limitations of existing methods of diagnosis and lung disease monitoring, we estimate that there is a significant unmet need for safe, non-invasive, quantitative, and cost-effective image-based diagnosis technology. We believe that our unique medical drug-device combination utilising 129Xe offers the ideal solution for improving pulmonary disease diagnosis.
As we enter the final stages of the NDA review process, we look towards a potential commercial launch before the end of 2022.
Chief Executive Officer
30 August 2022
POLAREAN IMAGING PLC
Consolidated unaudited statement of comprehensive income
for the six months ended 30 June 2022
|6 months ended |
30 June 2022
|6 months ended |
30 June 2021
|12 months ended |
31 December 2021
|Cost of sales||(539,247)||(323,185)||(677,402)|
|Research, development and regulatory expenses||(2,522,166)||[1,691,052]||(3,493,273)|
|Selling and distribution expenses||(1,738,265)||(1,799,324)||(5,557,829)|
|Share based payment expense||(701,832)||(367,397)||(1,814,882)|
|Total operating expenses||(6,974,179)||(5,539,116)||(14,824,472)|
|Loss from operations||(6,679,339)||(5,240,427)||(14,316,447)|
|Loss on ordinary activities before taxation||3||(6,918,131)||(4,855,296)||(14,016,004)|
|Loss and total other comprehensive expense||(6,918,131)||(4,855,296)||(14,016,004)|
|Basic and fully diluted loss per share (US$)||3||(0.033)||(0.026)||(0.071)|