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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 (TUM), today announced the publication of new in vitro data on the development of the COVID-19 drug FYB207 following peer review in the journal Antiviral Research.

The study, titled "Picomolar inhibition of SARS-CoV-2 variants of concern by an engineered ACE2-IgG4-Fc fusion protein" (https://doi.org/10.1016/j.antiviral.2021.105197), which builds on previously published data (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443), describes optimized ACE2-IgG4-Fc fusion constructs that exhibit broad neutralizing activity against SARS-CoV-2 viruses, retain ACE2 enzyme activity, and show promising pharmaceutical properties. The ACE2-IgG4-Fc fusion proteins neutralize the original SARS-CoV, the January and April 2020 SARS-CoV-2, and the rapidly spreading alpha, beta and delta variants. Importantly, the neutralizing effect is maintained even with the SARS-CoV-2 delta variant at picomolar concentrations, demonstrating that the lead candidate ACE2-IgG4-Fc (FYB207), unlike vaccines and neutralizing antibodies, retains its full antiviral potential even with the SARS-CoV-2 variants of concern currently circulating worldwide.

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 (Fc) of human immunoglobulin G (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro. The fusion with the Fc moiety stabilizes ACE2 and prolongs its in vivo efficacy. ACE2 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all other coronaviruses that utilize ACE2 as a portal of entry.

As part of the ongoing in vivo preclinical studies, pharmacokinetics data are being collected in two different models and efficacy data on different variants of the ACE2-Fc fusion proteins are being collected in another model to select the most appropriate candidate for clinical testing. The clinical trial is scheduled to begin in the first half of 2022.

"New variants of concern, such as the omicron variant, demonstrate once again that vaccines and antibodies alone are not sufficient in the SARS-CoV-2 pandemic. Because ACE2 is the entry point for cell infection, SARS-CoV-2 cannot escape the ACE2-Fc fusion proteins. Our ACE2-Fc fusion proteins show consistently strong neutralization in cell cultures of all SARS-CoV-2 viral variants tested to date. Testing of omicron is underway, and we expect high efficacy here as well. Thus, with FYB207, we are developing a highly potent, long-lasting COVID-19 drug directed against all variants. Our ongoing preclinical program is designed to select the best FYB207 drug candidate and thus increase the probability of success for clinical testing," states Dr. Carsten Brockmeyer, CEO of Formycon AG.

"ACE2-IgG4-Fc is a promising antiviral drug candidate for COVID-19 that retains its full antiviral potential against the rapidly spreading SARS-CoV-2 variants. Against the background of further emerging variants of concern, there is a great need for a broadly acting SARS-CoV-2 antiviral agent", says Prof. Dr. Ulrike Protzer, Director of the Institute of Virology at the Technical University of Munich and Helmholtz Center Munich and senior author of the study.

Formycon, together with its academic research partners, receives funding from the Bavarian Research Foundation for the basic research of this project. In July 2021, Formycon also received a commitment from the Bavarian State Ministry of Economic Affairs, Regional Development and Energy (StMWi) of up to €12.7 million to support further development of the COVID-19 drug FYB207.

In October 2021, Formycon and SCG Cell Therapy Pte Ltd ("SCG") entered into a collaboration and license agreement to develop and commercialize Formycon's COVID-19 drug FYB207 in the Asia Pacific (APAC) region, excluding Japan.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine month of the 2021 fiscal year.

The key financial figures of the Formycon Group also developed as expected at the end of the third quarter. 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 29.1 million in the first nine months of 2021 (same period last year: Euro 23.5 million). For the full year of 2021, Formycon now expects revenues of approximately Euro 40.0 million 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 the biosimilar projects, as well as for the COVID-19 drug (FYB207). The current revenues 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 -10.0 million (same period of the previous year: Euro -2.0 million), the operating result (EBIT) and the consolidated net profit for the period were around Euro -10.6 million and Euro -10.7 million as of September 30, 2021, compared with Euro -2.7 million in the previous year period.

The changes compared to the previous year period continue to be mainly due to investments in the 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. The key figures include income of Euro 1.5 million from the approved grant of up to Euro 12.7 million from the Free State of Bavaria for the SARS-CoV-2 blocker FYB207 as part of the Bavarian Therapeutic Strategy to combat the COVID-19 pandemic.

The Formycon Group's stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 26.3 million as of September 30, 2021. Including short-term receivables from deliveries and services, as well as other assets worth around Euro 7.4 million, the Formycon Group held liquid assets totaling Euro 33.7 million on the day of reporting (same period last year: Euro 23.5 million).

In the first nine months of the year, Formycon AG, as the company's actual operational unit, achieved a turnover of Euro 20.4 million (same period last year: Euro 18.0 million). The company's nine-month result was Euro -10.7 million compared to Euro -2.8 million last year.

"We are very satisfied with the course of the fiscal year so far. Important milestones were achieved on all development projects and major operational progress was made. A special highlight in the past quarter was the submission of the biologics license application for our Lucentis(R)1 biosimilar candidate FYB201 to the U.S. Food and Drug Administration (FDA) and the submission of the marketing authorization application to the European Medicines Agency (EMA), by our licensee. This was a key step in the transformation to a company that generates cash flows from product commercialization in addition to revenues from development activities. With the scheduled investments in the pipeline projects, particularly in FYB206, we are systematically implementing our growth strategy and are convinced that this will create sustainable value for our company. We will continue on this path", comments Chief Financial Officer Dr Nicolas Combé.

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

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd (“SCG”) 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 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.

“We are very glad about the collaboration with SCG which allows us to accelerate the development and commercialization of our COVID-19 drug FYB207 in the most populated region of the world”, says Dr. Carsten Brockmeyer, CEO of Formycon, and continues: “We believe SCG with its outstanding scientific base and network in Singapore, China and Germany is an excellent partner. SCG will be responsible for the development and manufacturing of FYB207 in Asia, and if approved, bring this innovative COVID-19 drug to patients and healthcare providers in the Asia-Pacific region.”

“FYB207 is a promising antiviral drug candidate for COVID-19, and it retains its full antiviral potential even against the rapidly spreading SARS-CoV-2 variants-of-concern”, says Prof. Dr. Ulrike Protzer, Director of the Institute of Virology of the Technical University of Munich and the Helmholtz Center Munich, and Scientific Founder of SCG. “We are excited with the encouraging results from FYB207 and we are pleased to collaborate with Formycon to accelerate the development of this promising antiviral to bring it to patients in need in the Asia-Pacific region and combat COVID-19”, says Frank Wang, CEO of SCG, and adds further: “Formycon focuses on developing high-quality biopharmaceutical medicines and we look forward to combining our presence in Asia with Formycon to provide effective and affordable treatment options to patients.”

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/.

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.

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.

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."