Biofrontera reports third quarter and first nine months 2020 results - Seite 3

At the same time, the new BF-RhodoLED XL lamp is being completed, which enables the application of Ameluz on larger areas. Due to delays in the supply of parts for the first manufacturing batch caused by the coronavirus crisis, the dossier for marketing approval will now be submitted to the FDA in the first quarter of 2021.

Despite the difficult conditions, Biofrontera is working intensively to maintain all ongoing clinical studies and to meet the communicated timelines as far as possible. The already slow patient recruitment of the Phase III study of Ameluz in the US for the treatment of basal cell carcinoma also continues as planned.

Litigation

Since September, the company has been engaged in a process of mediation with the Deutsche Balaton Group by order of the US District Court for the Southern District of New York. Within the framework of the ongoing process of mediation, an experienced and renowned mediator has been engaged to resolve ongoing (legal) disputes. In order to have sufficient time for the complex negotiations, the parties mutually agreed to extend the original deadline of November 11, 2020 until the end of February 2021.

In its ruling of September 22, 2020, the German Federal Supreme Court overturned a ruling of the Cologne Higher Regional Court of November 15, 2018, which had been directed against the Company. The reversed judgment of the Cologne Higher Regional Court concerned an action for rescission and nullity by the shareholder Deutsche Balaton AG, which is directed against resolutions of the Annual General Meeting on May 24, 2017. The matter has now been referred back to the Cologne Higher Regional Court for retrial and decision. In its reasons for the decision, the Cologne Higher Regional Court assumed that the Management Board had violated the requirement of equal treatment of shareholders in connection with a capital increase carried out in October/November 2016 in a severe and unequivocal manner. The German Federal Supreme Court has now determined that the violation of law assumed by the Cologne Higher Regional Court has not at all occurred. Among other things, the Annual General Meeting on May 24, 2017, had resolved to create new authorized capital.