FDA acceptance for the filing of New Drug Application
23 December 2020
Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, provides an update regarding the status of its New Drug Application (“NDA”) with the US Food and Drug Administration (“FDA”) and other corporate developments.
Acceptance of NDA
The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA by the FDA. The FDA has confirmed that the review will follow the standard review time frame with a target Prescription Drug User Fee Act (PDUFA) action date of 5 October 2021. The Company plans to make full use of this time with regards to commercialisation and launch preparation.
Polarean also announces the planned retirement of Mr Ken West, Chief Operating Officer, as an employee of the Company. The Board has approved Ken’s continued involvement with Polarean as a Consultant to the Company and Ken will also transition to Non-Executive Director from Executive Director with immediate effect.
Richard Hullihen, Chief Executive Officer of Polarean said, “FDA acceptance for the filing of Polarean’s NDA represents another important step forward for the Company’s platform. If approved, Polarean’s drug-device technology could provide a new diagnostic option for patients with pulmonary disease.
In addition, the Board would like to thank Ken for his expert and untiring contributions, particularly in managing the NDA submission and its successful acceptance by FDA for review. I look forward to Ken’s continued support at both the Board level and in relation to special projects.”
Grant of Options
Polarean announces that upon the recommendation of the Company's remuneration committee, it has granted options over a total of 900,000 ordinary shares of 0.00037p each in the Company ("Ordinary Shares") to new employees pursuant to the terms of the Company’s existing share option plan (the “New Options”).
The exercise price for the New Options is 73 pence per Ordinary Share and they will vest over a four-year period.
Exercise of Options
Finally, the Company has received notification from certain option holders to exercise options over 1,318,800 Ordinary Shares. The exercise price of the options was 15p and the Company will receive cash proceeds of £197,820 as a result of the options being exercised.
Application has been made for the 1,318,800 new Ordinary Shares (the “New Ordinary Shares”) to be admitted to trading on AIM ("Admission"), which is expected to occur at 8.00 a.m. on or around 30 December 2020. The New Ordinary Shares will rank pari passu with the existing Ordinary Shares. The Company does not hold any Ordinary Shares in treasury.
Following the grant of the New Options and the exercise of the options referred to above, there are 21,012,087 outstanding options and warrants over Polarean's Ordinary Shares, representing 12.9% of the Company's Ordinary Shares and total voting rights on a fully diluted basis.
Total Voting Rights
Following Admission, the total issued share capital of the Company will consist of 163,212,935 Ordinary Shares. This number may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest, or a change to their interest in, the Company under the FCA's Disclosure Guidance and Transparency Rules.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
|Polarean Imaging plc||www.polarean.com / www.polarean-ir.com|
|Richard Hullihen, Chief Executive Officer |
Jonathan Allis, Chairman
|Via Walbrook PR|
|SP Angel Corporate Finance LLP Nomad and Broker||Tel: +44 (0)20 3470 0470|
|David Hignell / Adam Cowl (Corporate Finance)|
|Vadim Alexandre / Rob Rees (Corporate Broking)|
|Stifel Nicolaus Europe Limited (Joint Corporate Broker)||Tel: +44 (0)20 7710 7600|
|Nicholas Moore / Ben Maddison / Samira Essebiyea (Healthcare Investment Banking)|
|Nick Adams / Fred Walsh (Corporate Broking)|
|Walbrook PR||Tel: +44 (0)20 7933 8780 or [email protected]|
|Paul McManus / Anna Dunphy||Mob: +44 (0)7980 541 893 / +44 (0)7876 741 001|
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue generating, medical drug-device combination companies operating in the high resolution medical imaging market.
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 and gas exchange regionally in the smallest airways of the lungs, the tissue barrier between the lung and the bloodstream and in the pulmonary vasculature. Xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.
The Group operates in an area of significant unmet medical need and the Group's technology provides a novel diagnostic approach, offering a non-invasive and radiation-free functional imaging platform which is more accurate and less harmful to the patient than current methods. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.