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Munich - Bioeq AG ("Bioeq"), the exclusive owner of the global commercialization rights of FYB201, Formycon's biosimilar candidate to Lucentis(R) (ranibizumab), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), that an exclusive strategic partnership for commercialization of FYB201 in Europe, Canada, Israel and New Zealand has been concluded with Teva Pharmaceutical Industries Ltd. ("Teva").

Teva Pharmaceutical Industries Ltd. is a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Teva maintains an established presence in generics and also conducts significant innovative research to support its growing portfolio of specialty and biopharmaceutical products.

By the end of 2019, Bioeq had already entered into a license and development agreement with the US Biosimilar-specialist Coherus BioSciences, Inc., which will exclusively distribute FYB201 in the United States of America (US). With today's partnership between Bioeq and Teva, FYB201's distribution is now complemented by another strong partner. After successful approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Formycon will participate in the marketing revenues.

"With the selection of the two commercialization partners Coherus BioSciences, Inc. and Teva Pharmaceutical Industries Ltd. by Bioeq AG we are optimistically looking forward to the marketing launch of FYB201, which is scheduled for the coming year. We are delighted that two powerful companies will commercialize our product in the territories of the US, Europe, Canada, Israel and New Zealand and are convinced of the quality and potential of our biosimilar candidate to Lucentis(R) (ranibizumab)" says Dr. Carsten Brockmeyer, CEO of Formycon AG.

¹⁾ Lucentis(R) is a registered trademark of Genentech Inc.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its financial performance indicators for 2020 and has recorded a solid financial year.

On the day of reporting, December 31, 2020, the Formycon Group's commercial figures had developed as forecast. Consolidated group sales which, in addition to the AG, include the two subsidiaries Formycon 201 Project GmbH and Formycon 203 Project GmbH as well as the 24.9 percent share in the FYB 202 GmbH & Co. KG joint venture, amounted, as forecast, to a total of Euro 34.2 million (previous year: Euro 33.2 million).

Group earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to Euro -4.8 million (previous year: Euro -1.4 million) on the day of reporting. The operating result (EBIT) totaled Euro -5.7 million (previous year: Euro -2.3 million). At Euro -5.9 million (previous year Euro -2.3 million), the result for the year was in line with expectations. In line with its growth strategy, Formycon had invested in the development of its own or young pipeline in the 2020 financial year, resulting in a slightly higher negative annual result compared to previous years. In addition to the COVID-19 drug (FYB207), the main development focus was on the as yet unpublished and unpartnered biosimilar candidate FYB206. Formycon was also able to recruit further qualified specialists last year in line with the needs of the development projects and employed 131 people at the end of the reporting period (+16% compared to the previous year).

Current assets consist largely of liquidity and near-liquid assets. As of December 31, 2020, the Formycon Group had a solid capital base, which, including the cash capital increase of around Euro 25.8 million completed in the fourth quarter of 2020, totaled Euro 42.2 million (previous year: Euro 22.4 million) in cash and cash equivalents (cash on hand, checks, bank balances, and securities). Including short-term receivables and other assets worth a further Euro 7.0 million, the Formycon Group holds liquid assets of Euro 49.2 million in total (previous year Euro 27.6 million) and therefore has flexible room for maneuver for the further development of its own or as yet unpartnered projects. In the current phase of the company, Formycon is focusing on the research and development activities of its own and out-licensed biosimilar projects, which are providing the current revenues. After successful approval of the biosimilar candidates, Formycon will also participate in the marketing revenues.

The Group's balance sheet total rose by 41% to around Euro 75.6 million (previous year: Euro 53.6 million) with an equity ratio of 90 percent, unchanged from the previous year. The company has no financial liabilities.

Formycon AG, as the Group's actual operational unit, achieved a turnover of Euro 25.1 million (previous year: Euro 21.0 million) and recorded an EBITDA of Euro -4.7 million (previous year: Euro -1.3 million). Accordingly, this resulted in an EBIT amounting to Euro -5.6 million (previous year: Euro -2.2 million) and an annual result of a rounded Euro -5.7 million (previous year: Euro -2.2 million).

Dr. Nicolas Combé, CFO of Formycon AG, looks back on the past financial year as follows: "Due to the prevailing Corona pandemic, 2020 was a year full of challenges. We are proud of what we have achieved and, in addition to our aspirational biosimilar projects, we have added another asset to the product pipeline with the development of our COVID-19 drug (FYB207). The good liquidity base allows us to operate from a stable position and, in addition to investments in FYB207, also enabled us to intensively further develop the early-stage and as yet unpartnered biosimilar candidate FYB206. Through our well-positioned development organization, we are able to develop up to five projects in parallel, creating further value for Formycon."

The full 2020 annual financial statements / annual report can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the approval of early action for its COVID-19 drug (FYB207) by the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi). The requested grant is expected to support the further development of FYB207 until the completion of clinical phase IIa and has an anticipated volume of approximately Euro 11 million. The total amount of funding will be determined upon receipt of the formal notice of approval.

The early start of the project enables Formycon to implement the preclinical development activities as planned and to manufacture the test product under GMP conditions before the final approval is granted. FYB207 is expected to move into Phase I/IIa clinical testing in the fourth quarter of 2021.

As part of the Bavarian therapy strategy to combat the COVID-19 pandemic, the Free State of Bavaria has created the conditions for funding development and innovation projects aimed at opening up new therapy options for treating the infectious disease induced by the SARS-CoV-2 coronavirus with the funding call "BayTherapie 2020" and the provision of a total of up to Euro 50 million.

SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design and created FYB207, a highly effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.

Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against viral escape by mutation. The risk of infection amplification by vaccines and IgG1 antibodies described for coronaviruses is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide patients with additional lung and cardiovascular protection. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.

Recently, Formycon AG, together with its academic partners Prof. Ulrike Protzer, Chair of Virology, and Prof. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, published new results on the in vitro neutralization of SARS-CoV-2 variants by Formycon's COVID-19 drug FYB207. These showed that FYB207 had an even stronger effect against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants.

"We are pleased that the Bavarian State Ministry of Economic Affairs, Regional Development and Energy has granted an early start to our funding application. Our project prevailed in a highly competitive process and, in addition to the associated scientific and technological recognition of our development approach by renowned reviewers, the support of public funding is a key component of project financing. We want FYB207 to be an important treatment option for COVID-19 patients that saves lives. At the same time, we also want to contribute to the prevention of outbreaks of new coronaviruses in the future," comments Formycon CFO Dr. Nicolas Combé.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich, today announced new results on the in vitro neutralization of SARS-CoV-2 variants by Formycon's COVID-19 drug FYB207. These show that FYB207 is even more efficient against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants.

The study, which builds on previous published data (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443) will be presented today at the "30^th Annual Meeting of the Society for Virology" and is titled "Singular ACE2-IgG4-Fc fusion protein efficiently inhibits SARS-CoV-2 entry". The presentation will be available soon on our website https://www.formycon.com/en/pipeline/fyb207/.

In the current study, a series of SARS-CoV-2 variants with increasing infectivity were tested: (I) SARS-CoV-2-Jan, isolated from a COVID-19 patient from the earliest documented COVID-19 outbreak in Germany in January 2020, which was directly related to the first outbreak in Wuhan, China, (II) SARS-CoV-2-April, which was isolated when the virus first spread massively in Europe in April 2020, and (III) SARS-CoV-2 variant B.1.1.7, which was first detected in the United Kingdom in September 2020, is associated with increased infectivity and mortality, and soon became the predominant SARS-CoV-2 variant in Europe.

The FYB207 concentration required for 50% inhibition in vitro (IC50 value) is in the low nanomolar range and decreased with each variant: (I) 4.7 nM, (II) 1.3 nM, (III) 0.6 nM, clearly showing that the neutralizing activity of FYB207 increased the more infectious and harmful the SARS-CoV-2 variant was. The IC50 values for FYB207 suggest a high neutralizing activity against SARS-CoV-2 B.1.1.7. The in vitro neutralization assay is considered a surrogate for potential therapeutic efficacy in SARS-CoV-2 infected patients.

"Health authorities around the world are increasingly concerned that neutralizing antibodies or vaccines may lose their activity against emerging SARS-CoV-2 mutants. While studies with neutralizing antibodies and sera from vaccinated individuals in vitro have indicated a reduction in neutralizing activity against B.1.1.7 and further SARS-CoV-2 mutants, our new in vitro data show that FYB207 neutralizes SARS-CoV-2 mutant B.1.1.7 even more. These results support our strategy to develop FYB207 as a treatment option for COVID-19 patients, but also to contribute to the preparedness for the outbreak of new coronavirus mutants", says Dr. Carsten Brockmeyer, CEO of Formycon AG.

SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory tract infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.

Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against escape of the virus by mutation. The risk of infection amplification by vaccines and IgG1 antibodies, described for coronaviruses, is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all coronaviruses that use ACE2 as a portal of entry.

The preclinical activities as well as the preparations for the entry into clinical trials with FYB207 are proceeding according to plan. In addition, Formycon had a successful Scientific Advice Meeting with the Paul-Ehrlich-Institute and has already secured GMP manufacturing capacity for FYB207.

Formycon, together with its academic research partners, is receiving funding from the Bavarian Research Foundation for the initial development steps of this project.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") confirm the planned timeline for resubmission of the Biologics License Application ("BLA") for their Lucentis(R) biosimilar candidate FYB201 following a successful pre-BLA interaction with the U.S. Food and Drug Administration (FDA).

As announced in November 2020, the initial submission strategy of the Lucentis(R) biosimilar candidate FYB201 has been adjusted as part of a simplification of the approval procedure. With the optimization of the commercial supply chain, the approval for FYB201 will directly occur in a large commercial scale. In the context of the interaction with the FDA, the data requested by the authorities have been reviewed and the further procedure has been aligned. The BLA-submission is expected to be filed with the U.S. Food and Drug Administration on schedule during the first half of 2021. Submission to the European Medicines Agency (EMA) is expected to follow-up.

In addition to the approval in the United States of America and the countries of the European Union, Formycon and Bioeq are seeking approval of the biosimilar candidate to Lucentis(R) (ranibizumab) in other highly regulated territories such as Canada, Australia, the United Kingdom and Switzerland.

* Lucentis(R) is a registered Trademark of Genentech Inc.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received the consent from the Paul-Ehrlich-Institute (PEI) regarding the proposed development concept for its innovative SARS-CoV-2 blocker FYB207. As result of the Scientific Advice, the Federal Institute for Vaccines and Biomedicines supports Formycon's approach in the further development of FYB207. In particular, analytics, process development, manufacturing (so-called CMC-part: Chemistry-Manufacturing and Control), the preclinical development as well as the clinical concept of phases I and II, including the associated bioanalytical strategy, have been aligned. The review of the applications for the clinical trials is expected to be conducted in an accelerated process. All preclinical activities as well as preparations for entering clinical trials with FYB207 are progressing according to plan. In addition, Formycon is preparing a Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) and has assured GMP manufacturing capacity for FYB207 with an experienced German manufacturer.

With FYB207, Formycon, together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, is developing an efficient antiviral SARS-CoV-2 blocker based on a long-acting ACE2-immunoglobulin fusion protein. SARS-CoV-2 and other corona viruses use ACE2 on the surface of human cells as an entry point for respiratory tract infections. Formycon has therefore fused the human ACE2 protein to the constant part of human Immunoglobulin G4 (IgG4) by using computer-aided structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.

The risk of infection enhancement by vaccines and antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has a natural enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. Because ACE2 is the human receptor for the spike protein of SARS-CoV-2, FYB207 is protected against virus escape by mutation. In addition, FYB207 can potentially be used for all corona viruses that use ACE2 as an entry portal.

"We are delighted about the positive feedback from the Paul-Ehrlich-Institute and feel confirmed in the development approach of FYB207. Especially in terms of virus mutations, an effective drug becomes an indispensable cornerstone in the fight against the corona pandemic. With FYB207, we are developing an important treatment option for COVID-19 patients while also contributing to the prevention of outbreaks of future corona viruses", says Dr. Carsten Brockmeyer, CEO of Formycon AG.

Dr. Stefan Glombitza, COO of Formycon AG adds: "The consultation with the Paul-Ehrlich-Institute has provided us with clarity for our approach in the development of FYB207. The speed with which we are advancing this program from initial laboratory studies to entry into clinical trials reflects the high level of commitment of all parties involved. People infected with SARS-CoV-2 and at risk of severe illness or even death urgently need effective medicines."

Munich - Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that its academic partners of the Technical University of Munich, present results on Formycon's COVID-19 drug (FYB207).

The results of the publication (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443) were approved for an E-Poster presentation at the international "Keystone Symposia - Antibodies and Vaccines as Drugs for COVID-19" on today's date titled "Highly efficient inhibition of SARS-CoV-2 entry by a biologically unique ACE2-IgG4-Fc fusion protein with a stabilized hinge region." The poster will be available soon on our website: https://www.formycon.com/en/pipeline/fyb207.

Formycon's innovative SARS-CoV-2-Blocker completely prevents in-vitro infection of cells. Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against virus escape by mutation. The risk of infection enhancement by vaccines and IgG1 antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. In addition, FYB207 can potentially be used for treatment of all corona viruses that use ACE2 as an entry portal.

Formycon is currently preparing documents for a Scientific Advice at the Paul-Ehrlich-Institute on the preclinical and clinical studies for FYB207, which is planned to be conducted within the next weeks. The clinical trial is expected to start during the second half of 2021.