Ad Hoc Announcements

Important information for immediate release

Formycon also provides ad hoc announcements in compliance with Section 17 of the Regulation (EU) No 596/2014 of the European Parliament and of the Council (Market Abuse Regulation), which requires public companies to publish any company news that could significantly influence share price.

Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announced today that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted.

The approval for FYB201 will be requested directly for a large commercial...

Formycon places Cash Capital Increase of 25.75 Million Euros with Strategic Investor

Munich - The Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) resolved yesterday, with the approval of the Supervisory Board, to increase the company's capital against cash contributions by partially utilizing the approved capital. The Company's share capital of currently EUR...

Formycon informs about the current Status of the BLA Review Process of the Lucentis®Biosimilar Candidate FYB201

Formycon AG and its licensing partner Bioeq announce today, that the U.S. Food and Drug Administration (FDA) has requested additional data as part of the review process of the BLA for the Lucentis® biosimilar candidate FYB201, submitted by Bioeq in December 2019.

Bioeq IP AG Exclusively Licenses US Marketing Rights For FYB201 To Coherus BioSciences, Inc.

Bioeq IP AG, the exclusive owner of the global commercialization rights of Formycon’s FYB201 has signed a license and development agreement with Coherus BioSciences, Inc. The US Biosimilar-specialist, headquartered in California, will exclusively market and distribute Formycon's biosimilar candidate to Lucentis® (FYB201) in the United States of America (US).

Formycon Reports Further Course of Capital Measure

With the agreement dated June 26, 2019, Wendeln & Cie. KG, an asset management company of Mr. Peter Wendeln (anchor shareholder and long-standing member of the Supervisory Board of Formycon AG), acquired all rights from the certificate of subscription as well as the 577,397 shares in Formycon AG from the cash capital increase.

Formycon Reports Latest Status of Capital Increase

As of today, totaling EUR 5,000,000.00, have been paid to the company’s capital increase account. The signatory's debt contribution amounting to EUR 12,264,170.30 is therefore still outstanding. The shares have so far not been delivered due to the as yet unsettled payment.

Formycon Places Cash Capital Increase of EUR 17.3 Million with Institutional Investor

Strategic investor M&H Equity AG subscribes for a cash capital increase of € 17,264,170.30 million in the context of a private placement with an issue price of 29.90 EUR per share. The funds acquired from the capital increase will be used primarily to develop the company’s own biosimilar products, particularly FYB205.

Biosimilar Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study

According to an interim result, the primary endpoint has been achieved in the COLUMBUS-AMD phase III trial, which is intended to demonstrate the efficacy, safety and immunogenicity of FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD).

Formycon and Aristo Pharma are Founding a Joint Venture for the Development of FYB202

Formycon and Aristo Pharma GmbH, a company of the Struengmann-Group, have formed a joint company for the continued development of FYB202, Formycon's biosimilar candidate for Stelara® (ustekinumab).

Formycon signs term sheet for development of FYB202 and executes capital increase

Formycon plans to enter into a co-investment arrangement for its biosimilar candidate FYB202 and aims for a participation of up to 30% in worldwide marketing proceeds.