Formycon receives approval for early action for COVID-19 drug FYB207 as part of a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi)

DGAP-News: Formycon AG / Key word(s): Financing/Study
27.04.2021 / 07:00
The issuer is solely responsible for the content of this announcement.

Press Release // April 27, 2021

Formycon receives approval for early action for COVID-19 drug FYB207 as part of a grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi)

- Consideration of FYB207 in the funding call "BayTherapie2020"

- Funded project includes development activities of FYB207 through to completion of Phase IIa clinical trials

- Requested funding amount of approximately Euro 11 million

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.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
Phone: +49 (0) 89 - 86 46 67 149
Fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

27.04.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de