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Munich, Germany – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that the Company’s Supervisory Board has appointed Mr. Enno Spillner to the Company’s Executive Board as Chief Financial Officer (CFO) effective April 1, 2023.

Mr. Spillner has more than 23 years of experience and outstanding expertise in the biotechnology industry. In his latest position he has been serving from 2016 to 2023 as CFO and member of the Management Board of Evotec SE, an international science company for the discovery, development and production of highly effective medicines.

In his role as CFO at Evotec SE, which is listed on MDAX, TecDAX as well as NASDAQ, the 52-year-old business graduate was responsible, inter alia, for the company’s successful capital market positioning and various successful financial and M&A transactions, and led the company to the US technology exchange NASDAQ in 2021. Most importantly, he helped ensure Evotec SE’s very dynamic international growth. Previously, Mr. Spillner worked for more than ten years (2005-2016) at the publicly listed 4SC AG, an innovative biopharmaceutical company, where he held the position as Chief Financial Officer and later additionally as Chief Executive Officer. Prior to that, Mr. Spillner had worked at Bioᴹ AG since 1999, initially as Head of Finance & Controlling. Later on, he gained additional responsibility for significant parts of the Bioᴹ investment business and in 2021 also took over the management of the BioM VC Fund as a partner. In this context, he held interim positions as CFO or CEO in portfolio companies.

Mr. Spillner currently holds supervisory board mandates at Nanobiotix SA, Paris and Leon-Nanodrugs GmbH, Munich.

In his role as Formycon CFO, he will be operationally responsible for the areas Finance/Controlling, Communications & Investor Relations, Human Resources, Legal/Compliance and IT and will, together with his colleagues on the Executive Board Dr. Stefan Glombitza (CEO), Nicola Mikulcik (CBO) and Dr. Andreas Seidl (CSO), drive the company’s further development into a globally operating and fully integrated pharmaceutical company with a focus on biosimilars.

Enno Spillner succeeds Dr. Nicolas Combé, whose appointment ended as scheduled on June 30, 2022. Since then, the co-founder of Formycon AG accompanied the company in an advisory capacity as interim CFO.

“I am very much looking forward to my new role of supporting Formycon with full verve in implementing its further growth strategy. The company has established a very promising position as a developer of high-quality biosimilars with a substantial portfolio. Formycon has extraordinary potential and I will work intensively with my new colleagues and the entire team to develop Formycon into one of the leading players in one of the large growth segments in the pharmaceutical industry. In particular, my wide-ranging experiences from the years at Evotec as well as my network can help to consistently implement the upcoming organizational and strategic steps. I would like to thank the Supervisory Board for the trust they have placed in me,” said Enno Spillner.

“With Enno Spillner, we are gaining an experienced and outstanding manager who has worked extremely successfully for many years as Chief Financial Officer at internationally operating listed biotechnology companies. We are convinced that he will shape the company with his expertise and help to continue Formycon’s success story.

I would like to express my special thanks to Dr. Combé, who, as founder and CFO, was jointly responsible for the establishment and development of our company for more than ten years and played a decisive role in driving it forward. On behalf of the entire Supervisory Board, we wish Nicolas all the best and are pleased that he will remain closely associated with the company,” commented Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG.

“Building Formycon from a start-up to a publicly listed company has been a fantastic and intense experience with many great moments. I have been very fortunate to be able to contribute to this success story, and I am very grateful for the support of so many special people over the years. In particular, I would like to thank my employees for their exceptional commitment, loyalty and willingness to perform, as well as my colleagues and the Supervisory Board for their ever-trusting cooperation and high personal appreciation. I am convinced that Enno Spillner as the new CFO is the ideal solution for Formycon and wish him and the entire Formycon family only the best for the future,” adds Dr. Nicolas Combé.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea^®.

The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea^® in patients with neovascular age-related macular degeneration (nAMD).

The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity.

Following the approval and market launch of the ophthalmological biosimilar for Lucentis® (FYB201 marketed as Ongavia®² (UK), Ranivisio®³ (EU), and Cimerli^TM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area.

Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050.[i]

Eylea® is currently the top-selling drug in the field of age-related eye disease and in 2021 achieved revenues of around US$ 9 billion. Recently, Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights of FYB203, had entered into a binding term sheet for the exclusive commercialization of FYB203 in the United States of America with Coherus BioSciences, Inc.

Formycon’s CSO, Dr. Andreas Seidl, comments on the successful phase III study as follows: “We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development.”

[i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077. Last accessed in January 2023.

¹Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
³Ranivisio® is a registered trademark of Bioeq AG
⁴Cimerli^TM is a trademark of Coherus BioSciences, Inc

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara^® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.

Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.

Fresenius Kabi is a global healthcare company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions. In the field of biosimilars, Fresenius Kabi focuses on the development and marketing of biosimilars in the area of autoimmune diseases and oncology.

In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. The randomized, double-blind multi-centric phase III study achieved the primary endpoint, demonstrating comparable efficacy of FYB202 and the reference medicine Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.

FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis with a global sales volume of more than USD 9.5 billion in 2022.

“We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar after approval. The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients,” says Nicola Mikulcik, Chief Business Officer at Formycon AG.

“We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization. With the commercialization of the Ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option. In line with our Vision 2026, this is yet another key milestone for Fresenius Kabi in delivering on our strategic priority of providing access to biosimilars for patients worldwide,” says Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board.

¹⁾ Stelara^® is a registered trademark of Johnson & Johnson
²⁾ Middle East and North Africa

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine months of the 2022 fiscal year. On the Group level, reporting is performed in accordance with IFRS (International Financial Reporting Standards).

At the end of the third quarter, the Formycon Group’s financial figures were as expected. The turnover of the Group, which, alongside Formycon AG, comprises the fully consolidated subsidiary companies Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH as well as a 50% stake in Bioeq AG, which is consolidated at equity, totaled Euro 28.2 million in the first nine months of the year 2022 (prior-year period IFRS: Euro 27.4 million). Formycon is forecasting revenues at Group level of around Euro 40 million for the whole year.

The Formycon Group focuses on research and development for its own, or out-licensed biosimilars projects as well as its own COVID-19 drug (FYB207). A large part of the revenue results from the development services for the out-licensed (FYB203) and partnered project (FYB201).

In July 2022 the commercialization of FYB201 in Great Britain started, through the distribution partner Teva Pharmaceutical Industries Ltd. (“Teva”) and in October, in the US, through Coherus BioSciences Inc. Additionally, in November, FYB201 was introduced onto the market in Germany by Teva. The nine-month figures included the first commercialization revenues from Great Britain since the introduction of FYB201 onto the market at the start of July. For the full year 2022, sales and earnings contributions from the marketing revenues in the additional territories are expected.

The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.9 million (prior-year period IFRS: Euro -10.0 million), the operating result (EBIT) was Euro -12.1 million as of September 30, 2022, compared with -10.9 million in the prior-year period. The Group net period result amounted to Euro 61.1 million (prior-year period IFRS: Euro -11.1 million).

The period result is further affected by a one-off effect that influenced the result but not the liquidity. This resulted from the sale of the minority stake (24.9%) in FYB 202 in the course of the transaction with ATHOS KG (“ATHOS”). In the course of this, Formycon AG withdrew as a partner of FYB 202 GmbH & Co. KG. In parallel with this, the acquisition of 100% of the shares of FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, took place.

After the acquisition of FYB202, as part of the transaction with ATHOS, the 50% stake ATHOS held in FYB201, a biosimilar for Lucentis®¹, was also taken over, among others. For both financial assets (FYB201 and FYB202) there is a conditional liability (conditional purchase price components) towards ATHOS, the amount of which depends on the project-specific and actual realization of proceeds. The compounding of this liability, which must be adapted periodically, also influences the result but not liquidity and runs counter to the previously described effect.

The Formycon Group’s stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 12.1 million as of September 30, 2022. Including short-term receivables from deliveries and services, as well as other assets, the Formycon Group held liquid assets totaling Euro 22.6 million on the day of reporting (prior year: Euro 33.7 million).

In the first nine months of the year, Formycon AG, as the Group’s central development and operational unit, continues to report according to the regulations of the Handelsgesetzbuch (HGB – German Commercial Code) and achieved a turnover of Euro 21.8 million (prior-year period: Euro 20.4 million). The company’s nine-month result was Euro 73.7 million compared to Euro -10.7 million last year.

“The nine-month result reflects our expectations. The global introduction onto the market of FYB201 under the trade name Ongavia®² (UK) or Ranivisio®³ (EU) and Cimerli^TM4 (US) by our partners and the revenues anticipated due to this are an important milestone in our transformation to a commercial-stage company. At the same time, we continue our growth strategy with planned investments into our pipeline, in order to create sustainable value, explains Dr. Stefan Glombitza, CEO of Formycon AG.

¹Lucentis® is a registered trademark of Genentech Inc.
²Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
³Ranivisio® is a registered trademark of Bioeq AG
⁴Cimerli^TM is a trademark of Coherus BioSciences, Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published preclinical in vivo results for the development of their COVID-19 drug FYB207.

In the course  of preclinical in vivo studies, data on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein were collected in two different models, in order to select the most appropriate candidate for the human clinical trial.

The proprietary modifications of the molecular structure of the FYB207 lead candidate led to the desired effects and resulted in a significant extension of the half-life. By corresponding glyco optimizations and sequence modifications in the antibody part (Fc part), the lead candidate ACE2-IgG1-Fc (FYB207) achieved a half-life of more than 14 days, which is the order of magnitude of antibodies. As a result, FYB207 may not only have a broader application spectra for prophylaxis and treatment of COVID-19 but also in other indication areas.

Due to the high sialylation achieved within the context of glyco optimization, binding affinity to relevant receptors in the liver is reduced, which significantly slows down the elimination of the active substance and increases the bioavailability in the organism. In addition, sequence modifications have been introduced in the binding region of the antibody portion to the neonatal-receptor, enabling FYB207 to bind better to this receptor, thereby improving the recycling of the fusion protein in the body.

In the efficacy study, the in vivo preclinical models showed a significant reduction in viral load in the lungs, demonstrating the neutralizing effect of FYB207 also against the SARS-CoV-2 Delta variant in the organism. Thus, the FYB207 lead candidate, unlike vaccines and neutralizing antibodies, retains its full antiviral potential against SARS-CoV-2 variants of concern.

SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Biotechnologically produced ACE2 may compete for binding of the virus and thus prevent cell infection. Formycon has fused the human ACE2 protein to the constant part of human immunoglobulin G1 (IgG1) using computational structural design and thereby created FYB207, a highly effective SARS-CoV-2 blocker. By fusion with the optimized Fc part, ACE2 was stabilized and bioavailability significantly prolonged. ACE2 also has inherent enzymatic activity that may provide patients with additional protection for their lungs and cardiovascular system. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.

The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute (“PEI”) and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. Another PEI meeting to align the clinical program is scheduled this year.

The GMP production of the study medication currently takes place for the start of the clinical trials. A toxicity study with the optimized molecular construct will be conducted at the beginning of next year. Entry into clinical trials is planned for 2023.

“The performed pre-clinical studies and the available data from the lead candidates form an important milestone in the development of our COVID-19 drug. The expanded in vivo study confirmed the intended objective – extending half-life – and showed that with FYB207 we are on track to develop a highly effective and long-lasting COVID-19 medication that is directed against all variants. In terms of efficacy, the study also showed the desired successes by demonstrating that viral load in the lungs of living organisms is significantly reduced,” explains Dr. Andreas Seidl, CSO of Formycon AG.

“The threat of viral mutations will continue in the future. With each successful mutation, SARS-CoV-2 evades vaccines and therapeutic antibodies a little bit more. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19,” adds Dr. Stefan Glombitza, CEO of Formycon AG.

Formycon will present the results of the completed in vivo preclinical studies at the Festival of Biologics in Basel (Switzerland) on November 4, 2022 and the Drug Discovery Summit in Madrid (Spain) on November 16/17, 2022.