Formycon Concludes Collaboration and License Agreement with SCG Cell Therapy for its COVID-19 Drug FYB207 for the Asia Pacific Region

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, SCG, a biotechnology company established and headquartered in Singapore with a strong footprint and scientific network in Singapore, China and Germany, has access to Formycon's ACE2 fusion protein technology and has acquired an exclusive license to develop, manufacture and commercialize FYB207 in the Asia-Pacific (APAC) region (except Japan). Formycon is eligible to receive potential development, regulatory and sales-related milestone payments of up to € 63.5 million as well as royalties on net sales in the low double-digit percentage range. The APAC region is home to about 60% of the world's population and is the world's second largest healthcare market.

Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis® (ranibizumab) by the U.S. Food and Drug Administration (FDA)

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. Bioeq submitted the BLA to the FDA in August 2021.

Bioeq is a Swiss biopharmaceutical joint venture between the Struengmann Group and the Polpharma Biologics Group which develops, licenses and commercializes biosimilars.

Subject to regulatory approval, FYB201 (also known as BQ201 and CHS-201) will be commercialized in the United States of America by Coherus BioSciences, Inc. (“Coherus”), a US pharmaceutical company with an expertise in biosimilar development and commercialization. Formycon will participate economically in U.S. product sales through its interest in royalties paid by Coherus to Bioeq.

Lucentis® is used in the treatment of neovascular (wet) macular degeneration. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. This leads to progressive loss of vision and is one of the major causes of age-related blindness. The total market for ophthalmic drugs in anti-VEGF therapy is over $11 billion per year and, according to analysts, will continue to grow significantly.

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


Formycon Reports on Virtual Annual General Meeting 2021



  • Shareholders approve all items on the agenda
  • Management Board reports in detail on ongoing development projects
  • Supervisory Board and Management Board ratified by a large majority



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on September 27, 2021 - for the protection of all persons involved - in virtual form.

The shareholders were able to follow the virtual Annual General Meeting live in picture and sound via the Company's AGM portal. They followed the proposals of the Management Board and Supervisory Board and approved all the resolutions proposed by the management with large majorities. Both the members of the Management Board and the Supervisory Board were given a vote of confidence with majorities of more than 98 percent each. In its presentation, the Management Board informed the shareholders in detail about the current biosimilar projects as well as about the development of the COVID-19 drug and answered all the questions received in advance.

Voting rights could be executed before and during the virtual Annual General Meeting by postal vote or by authorizing the Company's proxies. A total of around 6.1 million no-par value shares were submitted to the vote, corresponding to 55.36 % of the share capital.

Detailed voting results and further information on the 2021 virtual Annual General Meeting can be found at https://www.formycon.com/en/investor-relations/annual-general-meeting/.


Formycon Publishes Half-Year Results for 2021



  • Group turnover above H1 half-year level at Euro 20.3 million
  • EBITDA of Euro -9.7 million and half-year results of Euro -10.2 million in line with plans
  • Result due to investments in the non-partnered projects FYB206 and FYB207
  • Significant progress in the biosimilar projects and the COVID-19 drug



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2021.

On the day of reporting, June 30, 2021, the Formycon Group's financial figures were as forecast. Turnover within the Group which, alongside the joint-stock company also includes two fully consolidated subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, as well as the shareholding in FYB 202 GmbH & Co. KG which is not consolidated, stood at a total of Euro 20.3 million in the first six months of 2021 (H1/2020: Euro 16.5 million). For the full year of 2021, Formycon forecasts revenues above last year's level for the entire Group (2020: Euro 34.2 million).

During the company's current phase, the Formycon Group is focusing on research and development activities for its own and licensed biosimilar projects, as well as its own COVID-19 drug (FYB207). The current revenues also result from the development services for the out-licensed or partnered projects. Following the successful approval of these products, Formycon will also take a share of subsequent commercialization revenues.

The Group's earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -9.7 million (H1/2020: Euro -0.9 million), the operating result (EBIT) and the consolidated net profit for the period were around Euro -10.2 million as of June 30, 2021, compared with Euro -1.4 million in the prior-year period.

The changes compared to the prior-year period are mainly due to investments in our own pipeline. Significant progress was made in the development of the pre-clinical biosimilar candidate FYB206 and the development of the innovative SARS-CoV-2 drug FYB207 was advanced at a fast pace. In collaboration with experienced European manufacturers, Formycon has accelerated the development of the production process for FYB207 and has already produced material at a pilot scale for pre-clinical in vivo studies and begun scale-up to a large GMP scale for clinical trial supply. At the same time, the entire infrastructure for conducting the pre-clinical in vivo studies and starting clinical development was established together with experienced contract companies. The key figures do not yet include income from the approved funding of up to Euro 12.7 million from the Free State of Bavaria as part of the Bavarian Therapy Strategy to combat the COVID 19 pandemic, as a first tranche of Euro 1.5 million was not disbursed until after the reporting date.

As in previous years, the Group's financial position appears to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 33.6 million on the day of reporting. Including short-term receivables and other assets worth around Euro 9.6 million, the Formycon Group held liquid assets of around Euro 42.2 million in total (H1/2020: Euro 26.2 million).

Formycon AG, as the company's central development and operational unit, achieved a turnover of approx. Euro 12.4 million during the first half of 2021 (H1/2020: Euro 12.0 million). The result for this period was Euro -10.1 (H1/2020: Euro -1.3 million).

Dr. Nicolas Combé, CFO of Formycon AG, gave the following statement with regard to the half-year results: "The progress of our development activities, both in biosimilar candidates and in our innovative COVID-19 drug, is reflected in the half-year figures. The submission of the marketing authorization application for our Lucentis(R)1 biosimilar candidate FYB201 to the FDA and EMA by our licensee also paved the way towards future commercialization revenues. At the same time, we have invested heavily in our own development projects to create sustainable value and thus generate further growth."

The full half-year report can be found on the Internet athttps://www.formycon.com/en/investor-relations/financial-reports/

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


Formycon's COVID-19 drug FYB207 Wins Prestigious Pharma Trend Image & Innovation Award 2021

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.


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."


Formycon and Bioeq announce submission of the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the U.S. Food and Drug Administration (FDA)

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 (FDA).

Lucentis(R) is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

If approved, Coherus BioSciences, Inc. ("Coherus") will commercialize FYB201 (also known as CHS-201) in the United States of America per the terms of the November 2019 license and development agreement between Bioeq and Coherus. Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group and develops, licenses and commercializes biosimilars. Coherus is a U.S. pharmaceutical company with an expertise in biosimilar development and commercialization.

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


Formycon receives Euro 12.7 million grant for further development of COVID-19 drug FYB207 as part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic

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 FYB207.

The funding will support the currently ongoing preclinical development, the production of the investigational product under GMP conditions, and the clinical testing of FYB207 in a phase I/IIa trial, which is scheduled to start in the fourth quarter of 2021.

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 to the constant part of human immunoglobulin G4 (IgG4) using computer-aided structural design and created FYB207, a very effective SARS-CoV-2 blocker that has shown in vitro to completely prevent cells from infection.

As part of the Bavarian Therapy Strategy to combat the COVID-19 pandemic, the Free State of Bavaria had created the opportunity to support development and innovation projects that aim to open up new therapy options for the treatment of 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.


Formycon Reports Financial Results for the First Quarter of 2021



  • Sales and other earnings total EUR 9.4 million
  • EBITDA is EUR -1.7 million
  • EBIT and net result in line with expectations at around EUR -2.0 million each



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."


Formycon and Bioeq announce submission of the marketing authorization application for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the European Medicines Agency (EMA)

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 (EMA).

Lucentis(R) is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The commercialization of FYB201 in Europe will be performed by Teva Pharmaceutical Industries Ltd., which has acquired the distribution rights under an exclusive strategic partnership from Bioeq AG.

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