DGAP-News: Formycon reports on the status of FYB207 development

Press Release // August 11, 2021

Formycon reports on the status of FYB207 development

- Efficient neutralization of SARS-CoV-2 variants-of-concern

- Production for preclinical and clinical product established at fast track

- Expansion of preclinical efficacy testing planned

- Phase I/IIa clinical trial expected to start first half of 2022

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today provided an update on the development status of its COVID-19 drug FYB207.

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 with the constant part of human immunoglobulin to create an innovative COVID-19 drug (FYB207) that is protected against viral mutations, completely prevents cell infection in vitro, and can potentially be used against all coronaviruses that use ACE2 as a portal of entry for cell infection.

A recently published study on the neutralization of SARS-CoV-2 variants-of-concern Alpha (B.1.17) and Beta (B.1.351) by Formycon's ACE2 fusion protein FYB207, performed by Formycon together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich (TUM) (Research Square Preprint: https://www.researchsquare.com/article/rs-459941/v1), shows efficient in vitro neutralization of the coronavirus variants in the picomolar range. The study was conducted with two drug candidates (FYB207a, FYB207b) of the ACE2 fusion protein and builds on previously published data of four FYB207 drug candidates published by Formycon in collaboration with the TUM scientists (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443). Recent studies with FYB207a show that Formycon's ACE2 fusion protein also has strong binding to the viral spike protein of the SARS-CoV-2 Delta variant (B.1.617.2). In summary, these laboratory data demonstrate that FYB207 retains its full antiviral potential even in the rapidly spreading SARS-CoV-2 variants-of-concern.

In parallel to the laboratory studies, Formycon has been working with experienced European manufacturers at a rapid pace to develop the manufacturing process for FYB207 and has already produced material at a pilot scale for preclinical in vivo studies, as well as advancing the scale-up to a large scale GMP manufacturing for clinical trial supply. At the same time, the entire infrastructure for conducting the preclinical in vivo studies and the Phase I/IIa clinical trial has been set up together with experienced contract companies.

In the ongoing in vivo preclinical studies, pharmacokinetics data are being collected in two different models and efficacy data are being generated in another model for FYB207a and FYB207b. In all studies conducted, the administration of the study drug was safe without apparent side effects. While the analysis of the study results is ongoing and expected to be completed in November, further efficacy data are required to select the appropriate FYB207 drug candidate prior to initiation of clinical trials. Due to the expansion of preclinical testing, clinical development is expected to start in the first half of 2022.

"We believe SARS-CoV-2 will be a lasting threat to the health of many people. Herd immunity seems unrealistic given waning vaccine and antibody efficacy and the increasing number of SARS-CoV-2 variants-of-concern, as well as other factors. The patient situation motivates us to pursue the development of our COVID-19 drug with great speed and care. Formycon's FYB207 fusion proteins show consistent neutralization of SARS-CoV-2 variants-of-concerns in vitro. With FYB207 we aim to develop a highly effective COVID-19 drug protected against viral mutations, for the current SARS-CoV-2 coronavirus and as preventive measure for future coronaviruses. The expansion of the preclinical program serves to select the best FYB207 drug candidate and thus increase the probability of success for clinical testing" commented Dr. Carsten Brockmeyer, CEO of Formycon AG.

Dr. Stefan Glombitza (COO): "In parallel to the significant progress in our biosimilar projects, we are pleased that we have already been able to establish important elements in the production process and infrastructure for the preclinical and clinical studies in FYB207 within a short period of time thanks to our commitment and biotechnological expertise. Our high level of motivation in all programs is focused on the goal of providing access to high-quality medicines for as many patients as possible."

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
[email protected] // 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.