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Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) yesterday received the Pharma Trend Image & Innovation "Most Innovative Product(R)" Award in the category of Leap Innovations for its COVID-19 drug development FYB207.

For what is now the 22nd time, the Pharma Trend Image & Innovation Awards, also known in the industry as the Pharma Oscars, were presented in various categories at a celebratory awards ceremony under the patronage of Bavarian Health Minister Klaus Holetschek, MdL.

Pharma Trend is the benchmark study on innovation and sustainability which has been conducted on behalf of PharmaBarometer magazine since 2000 and which, through a survey of more than 1,000 physicians, pharmacists and patients, serves as the basis for the awards. For the first time this year, "Most Innovative Product(R)" was awarded in the category of Leap Innovations in cooperation with BioM, a network organization of the biotechnology industry in Munich and Bavaria acting on behalf of the Bavarian Ministry of Economic Affairs. Companies that will receive funding from the German Federal Ministry of Education and Research (BMBF) or the Free State of Bavaria for the development of COVID-19 therapies in 2021 were eligible to apply. In July 2021, Formycon received a commitment from the Bavarian State Ministry of Economic Affairs, Regional Development and Energy (StMWi) of up to EUR 12.7 million to support the further development of the COVID-19 drug FYB207.

FYB207 is a long-acting ACE2 immunoglobulin fusion protein. SARS-CoV-2 and other coronaviruses use the ACE2 protein 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 portion of human immunoglobulin to create an innovative COVID-19 agent (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. The basic scientific work on this is being funded by the Bavarian Research Foundation.

Laboratory studies conducted by Formycon in collaboration with its academic partners Prof. Ulrike Protzer, Chair of Virology, and Prof. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich (TUM) show that Formycon's ACE2 fusion protein, in addition to efficiently neutralizing the coronavirus variants alpha (B.1.17) and beta (B.1.351) in the picomolar range, also exhibits 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 for the rapidly spreading SARS-CoV-2 variants-of-concern.

"Receiving the prestigious Pharma Trend Image & Innovation 'Most Innovative Product(R)' Award for Leap Innovations is a great pleasure and encourages us in our innovative COVID-19 drug development. We would like to thank the jury for this award as well as our academic partners at the Technical University of Munich and our entire team for their excellent scientific work. We would like to express our gratitude to the Bavarian Research Foundation and the Free State of Bavaria for their extensive financial support. We believe that SARS-CoV-2 will remain a long-term threat to the health of many people. With FYB207, we are working on a tailor-made COVID-19 drug that also protects against viral mutations and thus should also contribute to the prevention of future coronaviruses," commented Dr. Carsten Brockmeyer, CEO of Formycon AG.

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."

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today presented the sales and earnings figures for the first quarter of 2021, demonstrating a positive start to the financial year.

Consolidated sales including other income increased by around EUR 2.2 million to a total of EUR 9.4 million as of March 31, 2021, compared with the same period of the previous year (EUR 7.2 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -1.7 million (Q1/previous year: EUR 0.4 million), the operating result (EBIT) amounted to EUR -1.9 million (Q1/previous year: EUR 0.2 million) and therefore was in line with expectations. The quarterly result totaled EUR -2.0 million (Q1/previous year: EUR 0.2 million). In line with its growth strategy, Formycon will continue to invest in the development of its own as-yet unpartnered pipeline programs in 2021 and, in addition to the COVID-19 drug FYB207, will also advance the as-yet unpublished biosimilar candidate FYB206 on the development side. The forecast Group sales for 2021 will be higher than in the previous year (EUR 34.2 million).

In the current phase of the company, Formycon is focusing on the research and development activities of its own and out-licensed biosimilar projects or projects developed in partnership, which are providing the current revenues. After successful approval of the biosimilar candidates, Formycon will also participate in the marketing revenues.

The liquidity ratios of the Formycon Group also developed as planned by the end of the first quarter: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 35.3 million at the end of March. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 10.7 million, the Formycon Group held liquid assets totaling EUR 46.0 million on the day of reporting (Q1/previous year: EUR 25.8 million).

In the first three months of the year, Formycon AG as the company's actual operational unit achieved a turnover of EUR 5.1 million (Q1/previous year: EUR 5.3 million). The company's three-month result was EUR -2.1 million (Q1/previous year: EUR 0.1 million).

Commenting on the first quarter, Chief Financial Officer Dr. Nicolas Combé said: "We are very pleased with the start to the new fiscal year. We are on track with our biosimilar candidates as communicated and the development of our COVID-19 drug (FYB207) is also progressing. Our strengthened liquidity base allows further investments in FYB207 beyond the currently ongoing preclinical phase and we also continue to advance the still unpartnered biosimilar project FYB206 according to our plans. For the full year 2021, we expect consolidated revenues to be above the prior year."

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.