Ad-Hoc Releases

Formycon announces that the European Medicines Agency published today that the Committee for Medicinal Products for Human Use issued a positive opinion for market approval for FYB203 / AHZANTIVE®/ Baiama®, a biosimilar candidate to Eylea® (Aflibercept).

Formycon AG announces that the U.S. Food and Drug Administration (FDA) today approved FYB202/OtulfiTM (ustekinumab-aauz), a biosimilar to Stelara®.

Formycon AG has today decided, based on the preliminary half-year figures, to raise its guidance for the 2024 fiscal year. This affects the key figures adjusted EBITDA and working capital.

Formycon AG announces that the Committee for Medicinal Products for Human Use of the European Medicines Agencytoday issued a positive opinion for FYB202, a biosimilar candidate to Stelara® (Ustekinumab).

Based on preliminary and unaudited figures for the 2023 financial year, Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Company") expects EBITDA to be around EUR 1.5 million (guidance: EUR -5 million to EUR -15 million)

Based on preliminary and unaudited figures for the 2023 financial year, Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Company") expects EBITDA to be around EUR 1.5 million (guidance: EUR -5 million to EUR -15 million)

Today, the management board of Formycon AG, with the consent of the Company's supervisory board, resolved to increase the Company's share capital against cash contributions by issuing new no par-value bearer shares of the Company, partially utilizing the authorized capital and excluding the shareholders' subscription rights.

Munich – On the basis of the bookbuilding procedure carried out as part of the private placement, the Management Board, with the approval of the Supervisory Board, set a placement price of EUR 77.00 per new share, resulting in gross proceeds from the offering of EUR 70,070,000.00 before commissions and costs. The New Shares correspond to approximately 6.02% of the Company's currently issued share capital.

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon” or “Company") announces that, following strong demand, the Company has decided to upsize their previously announced capital increase from authorized capital from approx. 5% to in total approx. 6% of the outstanding share capital.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) intends to issue approx. 5% of the issued share capital of the Company, representing approx. 750,000 new shares (the "New Shares").

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), today announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”).

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that Klinge Biopharma GmbH, the exclusive owner of the global commercialization rights of FYB203, Formycon’s biosimilar candidate to Eylea® (aflibercept), has entered into a binding term sheet with Coherus BioSciences, Inc. (“Coherus”) for the exclusive commercialization of FYB203 in the United States (U.S.).

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the European Comission (“EC”) today has granted marketing authorization (“MA”) for Ranivisio®, a biosimilar to Lucentis® (ranibizumab-injection) for medical use in the European Union (“EU”).

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).

FYB201 was developed by Bioeq AG, a Joint...

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announce that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") today issued a positive opinion for FYB201, a biosimilar to...

Munich – Today and effective July 1, 2022, the Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon") appointed Dr. Stefan Glombitza, who has led Formycon's operational development activities as Chief Operating Officer (COO) since 2016, as Chief Executive Officer...

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to...

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd ("SCG") today announced that they have entered into a collaboration and license agreement for the development and commercialization of Formycon's proprietary COVID-19 drug FYB207. Under the terms of the agreement,...

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd ("SCG") today announced that they have entered into a collaboration and license agreement for the development and commercialization of Formycon's proprietary COVID-19 drug FYB207. Under the terms of the agreement,...

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis®1, for review and assigned a target action date for the application for August 2022.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG ("Bioeq") announce that the biologics license application (BLA) for FYB201, Formycon's biosimilar candidate to Lucentis(R), has been recently submitted to the U.S. Food and Drug Administration...

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced today that it has received the final notification for a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy in the amount of Euro 12.7 million to support the further development of the COVID-19 drug...

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG announce that the marketing authorization application (MAA) for FYB201, Formycon's biosimilar candidate to Lucentis(R) (ranibizumab), has been submitted to the European Medicines Agency...

Munich - Bioeq AG ("Bioeq"), the exclusive owner of the global commercialization rights of Formycon's biosimilar candidate to Lucentis^(R)1 (ranibizumab), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), that an exclusive strategic partnership for commercialization of FYB201 in...

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...

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 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, 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).

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.

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.

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.

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 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 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.