2020

28.02.2020 – COSMO Pharmaceuticals N.V.

Cosmo announces Australian regulatory approval of GI GENIUS™

Cosmo announces Australian regulatory approval of GI GENIUS™

Dublin, Ireland – February 28, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) (“Cosmo”) today announced that GI Genius™ has received regulatory approval in Australia.

GI Genius™ is the first system using artificial intelligence to detect colorectal polyps and is already available in Europe.

Cosmo recently announced very positive results of the first investigator initiated prospective clinical study of its GI Genius™ artificial intelligence endoscopy device. In this trial the system increased adenoma detection rate by an absolute value of 16% from 40.9% in the control arm to 56.9% in the GI Genius™ group.

The trial required for the registration of GI Genius™ in the U.S. has commenced and is expected to last approximately 4-6 months.

Alessandro Della Chà (CEO of Cosmo) commented: “This is another positive development in relation to the commercialization of GI Geniusworldwide.”

For more information regarding the GI Genius™ investigator initiated trial please visit: https://www.cosmopharma.com/news-and-media/press-releases-and-company-news/2020/200220

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ it’s artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee of ByFavo™(remimazolam) for the U.S. for procedural sedation, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com

Calendar

Credit Suisse Global Healthcare Conference, London

March 3-4, 2020

Jefferies Equity Linked Conference 2020

March 26, 2020

Full Year Results 2019, Zurich

April 3, 2020

Swiss Biotech Conference, Basel

April 21, 2020

Annual General Meeting, Amsterdam

May 28, 2020

Jefferies Healthcare Conference, London

June 2-4, 2020

Contact:

Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70

ndonnelly@cosmopharma.com

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

This press release does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union (the "Prospectus Directive") of the securities referred to in it (the "Securities") in any member state of the European Economic Area (the "EEA"). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.


close