Innovative SARS-CoV-2 Blocker from Formycon Completely Prevents Infection of Cells

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, have published results on Formycon's COVID-19-drug (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443).

Based on Formycon's clinically validated experience with antibodies and antibody fusion proteins, the Company initiated the development of an ACE2 antibody fusion protein (FYB207) in March 2020, shortly after the COVID-19 pandemic broke out in Europe.

SARS-CoV-2 and other corona viruses use ACE2 on the surface of human cells as an entry point for respiratory tract infections. Formycon has therefore combined the human ACE2 protein to the constant part of human antibodies by using computer-aided structural design, creating a very effective SARS-CoV-2 blocker called ACE2-IgG-Fc. Different variants of the virus blocker were investigated in laboratory scale for manufacturability, stability and virus inhibition. In vitro tests with isolates of SARS-CoV-2 as well as the original SARS-CoV from 2003 show that Formycon's ACE2 antibody fusion protein effectively binds to SARS corona viruses and completely prevents infection of the cells.

Compared to vaccines and therapeutic antibodies, the ACE2 antibody fusion protein is maximally protected against virus escape by mutation. The risk of infection enhancement by vaccines and IgG1 antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. In addition, FYB207 can potentially be used in all corona viruses that use ACE2 as an entry portal.

"Vaccines and antibodies alone will not be sufficient in the SARS-CoV-2 pandemic. Infected people need medication, especially if they are at risk of becoming more seriously ill or even dying. For symptomatic COVID-19 patients, there is currently no sufficiently effective drug available. As SARS-CoV-2 mutates, the virus may become resistant to vaccines and drugs. FYB207 has excellent protection against mutation and shows in vitro complete neutralization of different SARS-CoV-2 and SARS-CoV variants. With FYB207, we are thus creating a treatment option for COVID-19 patients, but also contributing to the prevention of outbreaks of new corona viruses," says Dr. Carsten Brockmeyer, CEO of Formycon AG.

Dr. Stefan Glombitza (COO) adds: "We are very pleased with the encouraging results from our compound. Based on the results of our laboratory studies, we expect FYB207 to have advantages in efficacy, safety and convenience compared to antibodies and chemical active ingredients. The implementation of this innovative project will have no impact on our ongoing biosimilar programs."

Formycon, together with its research partners, will receive 290,000 euros in funding from the Bavarian Research Foundation for this project. In order to accelerate further development and clinical trials, Formycon is considering options for financial and strategic partnerships. It is planned to spin off the project into a separate subsidiary. The aim is to achieve rapid approval of the COVID-19 drug for emergency use. In the search for partners, Formycon is supported by the independent corporate finance firm goetzpartners.


Chief Operating Officer Dr. Stefan Glombitza appointed to Formycon AG's Management Board for another Four Years

Munich - The Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has extended the appointment of Management Board member Dr. Stefan Glombitza as Chief Operating Officer (COO) until December 31, 2024. With this decision, the supervisory committee is honoring the Formycon manager's successful work over recent years, and providing the continuity needed at the head of the company.

Since October 1, 2016, Dr. Glombitza has been the COO of Formycon AG in charge of operational development activities and has since then played a leading role in the progress of Formycon AG's development projects. The initiatives for operational excellence, which were also initiated and successfully implemented under his responsibility, were and continue to be central building blocks of organizational development, making Formycon an outstanding and scalable development organization.

"In light of his outstanding achievements for the company, we are particularly pleased to extend Stefan Glombitza's appointment to the Management Board until the end of 2024. Thanks to his comprehensive expertise and his particular commitment, Mr. Glombitza has successfully advanced the further development of the individual biosimilar projects as well as the entire development organization in recent years. We are convinced that with Dr. Brockmeyer (CEO), Dr. Combé (CFO) and Dr. Glombitza (COO) we have established a strong leadership team at Formycon and look forward to continuing to work together," commented Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG.


Formycon Reports its Nine-month Figures for 2020



  • Group turnover and other earnings total EUR 23.5 million
  • EBITDA is EUR -2.0 million and corresponds to expectations
  • Group revenues for 2020 remain forecast to be EUR 35.0 to 40.0 million

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its figures for the first nine months of the 2020 fiscal year.

Sales and other income of the Formycon Group totaled EUR 23.5 million as of September 30 of this year (prior year period: EUR 26.8 million). Earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to EUR -2.0 million (previous year: balanced at EUR 0.0 million). The operating result (EBIT) as well as the net result amounted to a rounded EUR -2.7 million (previous year: EUR -0.7 million each) and were thus in line with the forecasts. Formycon is consistently working on building and developing its own pipeline and is investing in organizational development, such as the expansion of internal capacities and far-reaching measures to further digitalize processes.

The reported sales revenues result from reimbursements for development work in the licensed-out projects or projects developed in partnership (FYB201, FYB202 and FYB203). For the 2020 fiscal year, revenues of between EUR 35.0 and 40.0 million are still anticipated at Group level.

The Formycon Group's stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 19.2 million as of September 30, 2020. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 4.3 million, the Formycon Group held liquid assets totaling EUR 23.6 million on the day of reporting. The cash capital increase announced in October 2020 with gross proceeds of EUR 25.75 million, which was fully subscribed by the strategic investor the Active Ownership Group, has now been fully implemented. The company's liquid assets have increased accordingly to almost EUR 50 million.

In the first nine months of the year, Formycon AG - as the company's actual operational unit - achieved a turnover of EUR 18.0 million (same period last year: EUR 16.2 million). The company's nine-month result was EUR -2.8 million compared to EUR -0.8 million in the previous year.

"The figures for the first nine months meet our expectations. By consistently developing our pipeline and our organization, we believe we are well positioned for the future. In addition, with the Active Ownership Group, we have been able to gain a strategic and long-term oriented investor and at the same time strengthen our liquidity base for the further projects and the development of our company," comments CFO Dr. Nicolas Combé.


Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab)



  • Vespucci study examines comparable efficacy, safety and immunogenicity of FYB202 and the reference product Stelara(R) in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)
  • Successful transfer of the third (late-stage) biosimilar candidate into a Phase III clinical trial

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH announced the dosage of the first patient in the Phase III clinical trial (first-patient-in). The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris. This is the most common form of psoriasis, accounting for 80 to 90 percent of its occurrence, and is also known as plaque psoriasis. Due to this systemic disease affecting the entire body or organism, affected patients also have an increased risk of developing psoriatic arthritis and chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara(R) has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were expanded to treat Crohn's disease and in 2019 it was also approved for the treatment of ulcerative colitis. Both of these conditions are chronic inflammatory bowel diseases. The drug is also used to treat psoriatic arthritis. In 2019, the reference market for Stelara(R) was over USD 6 billion worldwide.

FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).

Formycon's COO Dr. Stefan Glombitza is pleased: "With the start of what is now our third clinical Phase III study, we have reached another milestone in the development of our (late-stage) biosimilar candidates. With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. We would also like to thank our partners for their constructive cooperation and look forward to further joint steps towards the approval of our high-quality Stelara(R) biosimilar."

* Stelara(R) is a registered Trademark of Johnson & Johnson


Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announced today that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted.

The approval for FYB201 will be requested directly for a large commercial scale. Formycon and Bioeq are in close coordination with the U.S. Food and Drug Administration (FDA). Through the revised submission strategy, Formycon and Bioeq expect a simplification of the approval procedure. The modified submission dossier is expected to be filed with the FDA in the first half of 2021. The adjustment of the regulatory strategy in the course of optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and European Union countries.

* Lucentis(R) is a registered Trademark of Genentech Inc.

End of Ad Hoc Announcement


Formycon Announces Virtual Annual General Meeting for December 10, 2020

Munich - Against the background of the COVID-19 pandemic, which is set to continue for the foreseeable future, the rules of conduct adopted by the Free State of Bavaria which are still in force, and the objective of avoiding health risks, the Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has, with the approval of the company's Supervisory Board on the basis of Article 2 of the law intended to mitigate the consequences of the COVID-19 pandemic in civil, insolvency and criminal proceedings of March 27, 2020, and for the benefit of the health of shareholders, decided to hold the Annual General Meeting (AGM) in a virtual format. The AGM will be broadcast in sound and vision over the Internet, via the company's AGM portal, for formally registered shareholders of Formycon AG and their proxies.

The notice convening the AGM was published today in the electronic Federal Gazette (Bundesanzeiger) in accordance with normal statutory deadlines. All further information regarding the company's virtual AGM can be found on the website at https://www.formycon.com/en/investor-relations/annual-general-meeting/.


Formycon Receives Funding for COVID-19 Drug Research from the Bavarian Research Foundation

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received a grant from the Bavarian Research Foundation for the project "Characterization of ACE2-lgG constructs" amounting to Euro 290,000.

SARS-CoV-2 requires the binding of the virus spike protein to the membrane angiotensin converting enzyme 2 (ACE2) for entry into the human host cell. The aim of the project is to develop therapeutic fusion proteins that interrupt this bond. Through sequence model development, the fusion proteins will be characterized structurally and functionally in order to identify the characteristics that are important for a therapeutic application. Formycon's project partners are Prof. Dr. Ulrike Protzer, Chair of Virology, Technical University Munich and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University Munich.

"We are very pleased about the positive assessment of our project by the Bavarian Research Foundation, which took place in an overly competitive environment. The funding by the Bavarian Research Foundation and the very good cooperation with top researchers at the Technical University of Munich make us confident to achieve our goal to contribute significantly to the solution of the worldwide COVID-19 pandemic with a highly effective and safe drug", commented Dr. Carsten Brockmeyer, CEO of Formycon AG.


Strategic Investor Active Ownership Group Subscribes for Cash Capital Increase of EUR 25.75 million



  • Increase of the share capital by 1,000,000 shares at an issue price of EUR 25.75 per share
  • Use of cash inflow mainly for expansion and further development of own pipeline projects
  • Capital measure supports consistent implementation of the company’s growth strategy

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the subscription of a cash capital increase by the Active Ownership Group in a private placement. Based on the resolutions of the Management Board and the Supervisory Board, the Company's share capital will be increased by partially utilizing the approved capital from currently EUR 10,000,000.00 by EUR 1,000,000.00 to a total of EUR 11,000,000.00 by issuing 1,000,000 new no-par value bearer shares, each with a notional value of EUR 1.00 of the share capital, against cash contribution.

The total inflow of funds amounts to EUR 25,750,000.00 and corresponds to an issue price per share of EUR 25.75. The Active Ownership Group (AOC) is an independent, owner-managed investment company that acquires significant shares in medium-sized, listed companies in the DACH region and Scandinavia. As a committed co-owner, AOC is actively committed to increasing shareholder value by implementing operational, strategic and structural improvements. Together with the management, AOC defines value-creating strategies and measures for this purpose. AOC supports the implementation of these strategies and measures by serving on supervisory and advisory boards as well as by providing new growth capital. The company was founded in 2015 by Florian Schuhbauer and Klaus Roehrig. In its category, the Active Ownership Fund 2019 was awarded by the analysis house Preqin as the best fund with a European focus in the period 2017-2019.

The funds raised from the capital increase will be used primarily for the expansion and further development of the Company's own product pipeline. Strategically, the development of biosimilars remains the company's focus. The additional liquidity provides Formycon with the opportunity to develop the projects into late stages of development and thus tap significant value creation potential. With FYB206, the company has a promising preclinical biosimilar project in which important milestones have already been reached and value-generating intellectual property (IP) has been built up. In addition, Formycon is pursuing a promising approach in the development of novel antibody-based COVID-19 medicines. The transfer of this project into clinical trials is planned for next year.

Klaus Roehrig, founding partner of AOC, comments on the entry as follows: "We see significant potential in Formycon and have great confidence in the management team. By subscribing to the capital increase and the associated provision of growth capital, we are expressing this. Formycon is on its way to becoming a key global player in the rapidly growing, multi-billion dollar global biosimilar market. The upcoming launch of FYB201 (biosimilar candidate for ranibizumab), combined with the advanced development of biosimilars for ustekinumab (FYB202) and aflibercept (FYB203), underscores the current value of the company. At the same time, the existing pipeline of late-stage projects demonstrates the company's ability to select the right reference products and successfully advance their development all the way to market approval. Formycon thus fits perfectly with our investment focus on well-positioned and future-oriented companies. We look forward to supporting the company's growth strategy over the long term."

Dr. Nicolas Combé, CFO of Formycon AG adds: "We are very pleased about the entry of the Active Ownership Group and their long-term commitment to support the consistent implementation of our growth strategy. We will invest the capital provided in the further development of our pipeline. The FYB206 project is extremely promising and with the additional liquidity we are able to move this and other projects into later development phases while retaining exclusive rights for as long as possible. This is the core of our growth strategy and we are confident that it will further optimize the commercialization potential of our projects. In addition to the development and expansion of our biosimilar pipeline, we want to advance our project in the field of COVID-19 therapies and see considerable opportunities here as well. Formycon is a strong development company with exceptional growth potential and together with AOC, it is our goal to successfully continue on the path we have taken so far. We are looking forward to a long-term and trusting cooperation."


Formycon places Cash Capital Increase of 25.75 Million Euros with Strategic Investor

Munich - The Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) resolved yesterday, with the approval of the Supervisory Board, to increase the company's capital against cash contributions by partially utilizing the approved capital. The Company's share capital of currently EUR 10,000,000.00 will be increased by EUR 1,000,000.00 to a total of EUR 11,000,000.00 by issuing 1,000,000 new no-par value bearer shares with a notional value of EUR 1.00 each in the share capital against cash contribution.

The issue price of the new shares was set at EUR 25.75 per share, resulting in gross issue proceeds of EUR 25,750,000.00. Shareholders' subscription rights for the new shares were excluded in accordance with § 4 (3) of the Articles of Association. The subscription was made in a private placement by the Active Ownership Group, an independent, owner-managed investment company that acquires significant shares in medium-sized, listed companies in the DACH region and Scandinavia.

The funds raised from the capital increase will be used primarily for the expansion and further development of the Company's own product pipeline. Strategically, the development of biosimilars remains the company's focus. The additional liquidity provides Formycon with the opportunity to develop the projects into late stages of development and thus tap significant value creation potential. With FYB206, the company has a promising preclinical biosimilar project in which important milestones have already been reached and value-generating intellectual property (IP) has been built up. In addition, Formycon is pursuing a promising approach in the development of novel antibody-based COVID-19 medicines. The transfer of this project into clinical trials is planned for next year.

The new shares will shortly be approved for trading in the "Scale" segment of OTC trading at the Frankfurt Stock Exchange and will be entitled to a share of profits from the start of the financial year, for which the Annual General Meeting had not yet passed a resolution regarding the use of the balance sheet profits at the time that the shares were issued.

End of Ad Hoc Announcement


Formycon Announces Half-Year Results for 2020



  • Group turnover of Euro 16.5 million corresponds to forecasts
  • EBITDA of Euro -0.9 million and half-year result of Euro -1.35 million in line with expectations
  • Significant progress in late-stage projects, the expansion and further development of the company’s own pipeline and in organizational development



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2020.

On the day of reporting, June 30, 2020, the Formycon Group's commercial figures developed as forecasted. The Group's turnover which, in addition to the joint-stock company also includes the 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, totaled Euro 16.5 million in the first six month of 2020 (H1/2019: Euro 17.2 million).

During the company's current phase, the Formycon Group continues to focus on research and development activities for its own and out-licensed biosimilar projects as well as its own COVID-19 project. The development services for the out-licensed or partnered projects are also the source of the current revenue returns. Following the successful approval of these products, Formycon also participates in the subsequent marketing revenues.

Consolidated earnings before interest, tax, depreciation and amortization (EBITDA) amounted to Euro-0.9 million (H1/2019: Euro -0.2 million), the operating result (EBIT) totaled around Euro -1.4 million (H1/2019: Euro -0.7 million). As of June 30, 2020, the Group period result was Euro -1.4 million compared to Euro -0.7 million in the same period last year.

For the full year 2020, Formycon expects revenues at the group level to be between EUR 35 and 40 million. As in previous years, the Group's financial position is solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 20.2 million on the day of reporting. Including short-term receivables and other assets worth Euro 6.0 million, the Formycon Group held liquid assets of around Euro 26.2 million in total.

Formycon AG, as the company's central development and operational unit, achieved a turnover of Euro 12.0 million during the first half of 2020 (H1/2019: Euro 11.3 million). The earnings for this period totaled Euro -1.3 million (H1/2019: Euro -0.7 million).

"The half-year figures are in line with our expectations. We have made good progress in the out-licensed and partnered projects. At the same time, we are working intensively on building and developing our own pipeline and are convinced that we will create sustainable value. In addition, we are investing in organizational development, which includes expanding our capacities as well as extensive measures to further digitalize our processes," comments Dr. Nicolas Combé, CFO of Formycon AG.

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