Press Release // January 15, 2025

Formycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi^® (ustekinumab), a biosimilar to Stelara^®

• Otulfi^® received MHRA approval for both subcutaneous and intravenous formulations, to treat serious inflammatory diseases
• UK approval follows the series of successful approvals by the FDA, the European Commission and Health Canada for FYB202/Otulfi^® submissions
• The earliest date for commercialization of Otulfi^® in the UK is defined in a confidential settlement agreement between Formycon, Fresenius Kabi and Johnson & Johnson signed in March 2024

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi^®1 (ustekinumab), a biosimilar to Stelara^®2, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The U.S. Food and Drug Administration (FDA) as well as the European Commission had already granted marketing authorization for FYB202 in September 2024, followed by Health Canada’s approval end of December 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “For millions of people around the world, chronic inflammatory diseases have a massive impact on the quality of life. There is a clear demand to help those patients, who are suffering severely from the symptoms of their disease. Each approval is important and brings us a step ahead in our mission to offer a highly effective and cost-efficient treatment option to as many patients as possible across multiple geographies.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the UK.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

————————————————————————————-

¹⁾ Otulfi^® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe and Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG, headquartered in Munich, is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: https://www.formycon.com/

About Fresenius Kabi:
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com. For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

Berlin, 14 January 2025. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) today signed a licence agreement with Qi Kang Medical, Ltd (QKM), a joint venture between Eckert & Ziegler and the Chinese company DC Pharma, for the cyclotron technology used by Eckert & Ziegler to manufacture Ac-225. The contract guarantees Eckert & Ziegler a one-time payment of EUR 10 million and additional royalties on Ac-225 sales.

For Eckert & Ziegler the licence and collaboration agreement is an important step towards establishing the company as a major supplier of Ac-225 for the radiopharmaceutical industry. Eckert & Ziegler is already supplying Ac-225 and will be able to provide the market with significantly increased quantities of Ac-225 in GMP quality from 2025.

Currently, Ac-225-based radiopharmaceuticals are under clinical investigation for various cancers, including prostate tumors, colorectal cancer, and leukemia. A substantial increase in the demand for Ac-225 is projected over the next decade, driven by its expanding clinical applications and the promising results seen in ongoing trials. Despite its therapeutic promise, sufficient quantities of Ac-225 remain scarce.

Contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

EXTON, Pa., / January 13, 2025 / – Frontage Holdings Corporation (SEHK stock code: 1521) announced on January 6 2025 that Dr. Abdul Mutlib has decided to step aside from his current role as CEO of the company to facilitate the Company’s leadership succession planning and that Chief Strategy Officer Dr. Wentao Zhang and President Dr. John Lin have been promoted to Co-CEOs of the company effective today. Going forward, Dr. Mutlib will assume an advisory role as the Chief Scientific and Strategy Officer, ensuring a smooth transition and business continuity. Dr. Mutlib will remain committed to Frontage for at least a year, advising and supporting the Frontage leadership team, contribute to Frontage’s growth plans across various business units, and participate in business development, especially in early drug discovery and development.

Dr. Zhang has been a valued Frontage executive for nearly 4 years, following Frontage’s acquisition of Quintara Discovery, which Dr. Zhang founded in 2012. Likewise, Dr. Lin has been a core member of Frontage’s executive team for over 17 years, most recently serving as President of Frontage Laboratories, Inc.

In announcing the promotions, Dr. Song Li, Executive Chairman on the Board, said, “Since its founding over 20 years ago, Frontage has been a remarkable and dynamic organization. We have continued to enjoy impressive growth in many areas during Abdul’s successful tenure as CEO and we are grateful for his vision and leadership over the past two years. I believe he has guided the company through a period that has presented some challenges to the CRO industry and, through his steady stewardship, has positioned us for ongoing success.”

Dr. Li continued, “Wentao and John are incredibly talented leaders – each of them have proven track records of delivering impressive results for Frontage, while inspiring their colleagues at Frontage and our partners throughout the industry. They both have many years of executive-level experience and have been working closely with Abdul in preparation for assuming their new responsibilities as Co-CEOs. I respect Abdul’s decision to step aside from his role as CEO and I am thankful that he will be remaining with the organization as Chief Scientific and Strategy Officer – a role in which he will offer support to Wentao and John, while also offering guidance to the company in strategic and corporate development initiatives. As Co-CEOs, Wentao and John will have clearly delineated roles and responsibilities, and I believe their history of effective collaboration presents a unique leadership opportunity for Frontage. On behalf of the board of directors, it is my privilege to announce their elevation to their new roles.”

In announcing his decision to step aside as CEO, Dr. Mutlib said, “As I approach my 65th birthday, the time is right for me to transition from day-to-day duties of actively managing the Frontage organization. Serving our clients, employees, and stockholders as CEO for the past 2 years has been an honor and privilege. The support of Frontage’s Board of Directors and Frontage’s extraordinary employees has helped us navigate through a challenging environment while delivering the impressive results that our clients have come to expect from us. I am looking forward to continuing to serve Frontage in my role as Chief Scientific and Strategy Officer, a role in which I will offer my full support to Wentao and John. I have complete confidence in their ability to lead Frontage into the future, and I congratulate them as my successors.”

Dr. Zhang said, “I am honored to succeed Abdul as Frontage’s Co-CEO. He has demonstrated remarkable leadership for the company over the last 2 years. I am fortunate to continue to work with Abdul in my new role and am humbled by the confidence that Abdul, Song, the Frontage board of directors, and our dedicated employees have placed in me. My Co-CEO John and I have worked together for many years, and it is the honor of my business career to collaborate with him in leading our company.”

Dr. Lin said, “I would like to express my thanks to Song and the board of directors for the opportunity to lead this outstanding organization with Wentao as Co-CEOs. Abdul has set an impressive example in leadership over the past two years, and I am grateful for the opportunity to continue to work with him. Wentao is a remarkable colleague, and we will endeavor to jointly lead Frontage with humility, integrity and care, as we maintain our focus on serving our customers, enhancing profitability and creating long-term value for all of our stakeholders.”

About Frontage ( www.frontagelab.com )

Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiaries including Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) that provides integrated, science-driven, product development services from drug discovery to late-phase clinical process to enable biopharmaceutical companies to achieve their development goals.Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safetyand toxicology assessment, and early-phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. For more details visit www.frontagelab.com.

Berlin, Germany and Sydney, Australia, 13. January 2025. Eckert & Ziegler (ISIN DE0005659700, SDAX) and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specialising in developing antibody radiopharmaceuticals for solid tumors, today announced the expansion of their existing Lutetium-177 based collaboration with a global supply agreement for Actinium-225 (Ac-225). Eckert & Ziegler will provide high-quality Ac-225 to support GlyTherix’s clinical research and development activities on innovative alpha radiotherapeutics.

In December 2024 Eckert & Ziegler announced the start of their Ac-225 production as part of the collaboration with the Nuclear Physics Institute of the Czech Academy of Sciences (ÚJF). The establishment of Ac-225 manufacturing in GMP quality is ongoing and expected to be finalized in the first half of 2025, enabling new possibilities for pharmaceutical companies developing alpha-emitting drugs.

GlyTherix’s radiotherapy approach combines a radionuclide with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer. GlyTherix plans to use 177Lu-DOTA-Miltuximab in its planned Australian Phase Ib in early 2025, followed by US Phase II trials in 2026. GlyTherix has commenced its Ac-225-based research and development activities at the Australian ARC Research Hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR) at the University of Queensland.

“We are happy to extend our collaboration with GlyTherix to fully support the planned development activities also for Actinium-225-based radiopharmaceuticals,” said Dr. Harald Hasselmann, CEO of Eckert & Ziegler. ”Increasing the availability of Ac-225 is our key objective as it will accelerate both progress in clinical research and commercial applications, which will ultimately result in the improved access to cancer therapies for patients globally.”

Dr. Brad Walsh, GlyTherix Chief Executive Officer commented, “We are pleased to be able to rely on Eckert & Ziegler also for the supply of Actinium-225. Alongside with Lutetium-177, Actinium-225 will become an important part of our clinical program later this year. It is therefore vital securing a reliable network for global supply of the alpha emitter to consistently support our upcoming trials.”

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

About GlyTherix
GlyTherix Ltd is an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumours. Miltuximab specifically targets Glypican-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue. The company has a strong proprietary and Intellectual Property position covering both Miltuximab and the antigen Glypican-1. This provides robust and long-term protection for the commercialization of important new treatments to people with little hope.
GlyTherix has completed a ‘First-in-Human’ trial of 12 patients using Miltuximab with no drug-related adverse events. Miltuximab will be used in a Phase Ib trial as an antibody theranostic. GlyTherix is interested in partnerships or collaborations with larger biotech and pharmaceutical partners.

Contact
Eckert & Ziegler SE
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Jan Schöpflin, Marketing / Karolin Riehle, Investor Relations
jan.schoepflin@ezag.de / karolin.riehle@ezag.de
Tel.: +49 (0) 30 / 94 10 84-138; www.ezag.com

GlyTherix
Dr Brad Walsh, CEO
+61 413 231 296
Brad.Walsh@glytherix.com

PRESS RELEASE

Heidelberg Pharma Progresses into Cohort 7 in a Phase I/IIa Study with BCMA ATAC Candidate HDP-101 Targeting Multiple Myeloma

• HDP-101 is well tolerated to date, with no signs of dose-limiting toxicities
• Complete remission observed in one patient from Cohort 5
• Proprietary novel payload with a unique mode of action, representing new treatment options for patients with relapsed or refractory multiple myeloma

Ladenburg, Germany, 13 January 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that it is advancing into Cohort 7 in a Phase I/IIa dose escalation study with lead ATAC candidate HDP-101 for the treatment of relapsed or refractory multiple myeloma.

Previously, in Cohort 6, dose optimization regimens were introduced with three different settings. These included premedication or different dose distribution to ameliorate the short-term reduction in platelet count that was observed with the prior dosing regimen. HDP-101 was well tolerated across all 10 patients in Cohort 6 dosed with 90 µg/kg, with no dose-limiting toxicities (DLTs) detected in any of the three parallel treatment arms. The Safety Review Committee (SRC) recommended to progress into Cohort 7 with an escalated dose above 100 µg/kg, in two parallel treatment arms with different split dosing. One arm will include additional premedication. First patients of Cohort 7 have already been dosed.

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “Our lead ATAC candidate, HDP-101, is demonstrating promising data as it advances into Cohort 7. The adapted dosing strategies showed a positive effect by limiting the platelet count reduction seen in prior cohorts. Using these new dosing regimens allows us to escalate the dose further. HDP-101 was well tolerated in Cohort 6, and we are looking forward to publishing first efficacy and additional safety data of this patient group at forthcoming scientific conferences in 2025.”

Heidelberg Pharma’s Phase I/IIa clinical study is an ongoing, non-randomised, open label study that is actively enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA (B-cell maturation antigen). The study is currently assessing the safety, tolerability, pharmacokinetics, and efficacy of HDP-101 in patients with multiple myeloma.

Clinical data from Cohort 5 demonstrated complete remission in one patient who had been heavily pre-treated across nine prior lines of therapy, including another BCMA-targeting agent. This patient showed an objective improvement (“partial response”) in the 2nd cycle of treatment, with complete remission observed after the 11th cycle and continues sustaining response for more than a year. In addition, several other patients showed biological activity and objective responses demonstrating the potential of HDP-101 as a promising treatment option for patients with the disease.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

Presse Release // January 13, 2025
 

Teva becomes strategic commercialization partner for Formycon’s biosimilar candidate FYB203 (Eylea®/ aflibercept) in major parts of Europe and Israel

Planegg-Martinsried, Germany – Klinge Biopharma GmbH (Klinge), the licensee and exclusive global commercialization rights holder for FYB203, Formycon’s biosimilar candidate to Eylea^®1 (Aflibercept), informed Formycon AG (FSE: FYB) about the signing of a licensing agreement with Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (Teva) for the semi-exclusive commercialization of FYB203 in major parts of Europe and Israel. In parallel Formycon has signed an agreement with Teva under which Formycon will supply the finished product.

The collaboration combines Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries with Teva’s deep commercial experience in biosimilars and its extensive distribution network and -broad sales and marketing reach across Europe.

Teva is a global pharmaceutical leader harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine.

Under the licensing agreement, Teva will obtain semi-exclusive commercialization rights for major parts of Europe, excluding Italy, as well as for Israel for FYB203, Formycon’s biosimilar candidate to Eylea^®, to be marketed under the brand name AHZANTIVE^®2 subject to regulatory approval. In return, Klinge will receive milestone payments and royalties on net sales.

Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from this agreement. Furthermore, Formycon will receive payments for organizing the commercial market supply of AHZANTIVE^® on behalf of Klinge.

“With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio^®3/ Ongavia^®4) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product,” commented Nicola Mikulcik, CBO of Formycon AG.

Commenting on the agreement, Richard Daniell, Executive Vice President European Commercial of Teva, says: “We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio^®3 / Ongavia^®4) for Lucentis^®5 in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve.”

In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE^® / Baiama^®6. The European Commission’s decision on approval is expected in the second half of January 2025.

Eylea^® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® achieved global sales of approximately USD 9 billion[i], including USD 2.9 billion[ii] in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector.
 

1. Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
2. AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
3. Ranivisio^® is a registered trademark of Bioeq AG
4. Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.
5. Lucentis^® is a registered trademark of Genentech Inc.
6. Baiama^® is a registered trademark of Klinge Biopharma GmbH

1. https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/
2. IQVIA sales data

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon shares are listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and are part of the selection index SDAX and TecDAX. Further information can be found at: https://www.formycon.com/

About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Mail: Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

The European industrial hemp and cannabis group SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) is planning further strategically important acquisitions and investments for 2025. The aim is to further expand the value chain from cultivation to production and retail, increase sales and achieve a consolidated profit.

“We want to fully utilise the potential of the industrial hemp and cannabis sector in order to provide our investors and shareholders with the best return opportunities,” explains Daniel Kruse, CEO of SYNBIOTIC.

Under the leadership of Daniel Kruse, SYNBIOTIC has realised four further investments for the group of companies:

• Ilesol Pharmaceuticals, with one of the leading European production facilities for the manufacture of cannabinoid extracts and isolates
• WEECO Pharma, an importer and wholesaler with an international network of medical cannabis producers, including some of the world’s leading EU GMP producers
• greensby, a universal platform for the entire hemp and cannabis industry and one of the largest comparison portals for medical cannabis in Europe
• GOC NEXUS OPERATIONS, a company for the microbiological decontamination of cannabis GACP raw materials into EU GMP medicinal products

Legalisation of cannabis 2024

The year 2024 was a milestone for SYNBIOTIC and the entire industrial hemp and cannabis industry. The legalisation of cannabis and its removal from the Narcotics Act have revolutionised the market in Germany. For the industry, the past twelve months have been characterised by regulatory progress on the one hand, but also by political uncertainty on the other. The traffic light coalition has broken up, but has brought about important reforms such as legalisation and the planned liberalisation of industrial hemp. A recent success is the rejection of the “intoxication clause” in the Bundesrat, a step towards promoting the competitiveness of the German hemp industry.

Background: cancellation of the intoxication clause

In Section 1 No. 9a of the Consumer Cannabis Act, the so-called intoxication clause is to be deleted by the industrial hemp liberalisation initiative. This clause is considered the biggest obstacle to the industrial use of hemp, as it severely hinders the cultivation and processing of industrial hemp. The removal of this clause would simplify cultivation and utilisation and reduce the bureaucratic burden.

Industrial hemp and cannabis 2025 – quo vadis?

However, the exact timing of implementation in the Bundestag remains questionable due to political instability. In general, SYNBIOTIC is looking to the coming year with great confidence. “This possible regulatory change harbours incredible growth potential for the entire industrial hemp sector and therefore, of course, for the companies in the SYNBIOTIC Group operating in this area,” says CEO Daniel Kruse. Also particularly regarding medicinal cannabis SYNBIOTIC is looking to 2025 and the future with great confidence. The increasing acceptance of cannabis and cannabis products as medicine promises great potential for the sector.

“Our investors and shareholders can rest assured that SYNBIOTIC’s management is well prepared for this potential with its investments!”, concludes Daniel Kruse.

SYNBIOTIC will continue to focus on innovation, efficient supply chains and distribution channels, accompanied by strategic buy-and-build expansion. Politically, it will be crucial to complete the reforms that have been initiated in order to minimise legal uncertainties and ensure the sustainable development of the industry. The industry associations EIHA, of which Daniel Kruse is President, and BvCW, of which SYNBIOTIC is a member, will continue to campaign for this.

Current note: Impending risk of confusion

In December 2024, the SYNBIOTIC SE share (ISIN DE000A3E5A59 | WKN A3E5A5) fell through no fault of its own. The trigger for the setback was, based on all available information, a negative announcement from Symbotic Inc. (ISIN US87151X1019 | WKN A3DK1X). The identical spelling except for two letters led to otherwise unfounded large sell orders. We would like to point out that there are no connections between SYNBIOTIC SE and Symbotic Inc.

Publisher
SYNBIOTIC SE
Daniel Kruse
CEO
Münsterstrasse 336
40470 Düsseldorf
Germany
www.synbiotic.com

Media contact
Rüdiger Tillmann
SYNBIOTIC Public Relations Manager
e-mail ruediger.tillmann@synbiotic.com
Mobile +49 170 9651451
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a listed group of companies in the hemp and cannabis sector with a buy-and-build investment strategy focussed on Europe. The group covers the entire value chain from cultivation to production and retail – from the field to the shelf. The subsidiaries’ core businesses are the research and development, production and commercialisation of hemp, CBD and cannabis products.
SYNBIOTIC is pursuing a clear pan-European strategy of further expanding its business areas in order to cover the relevant growth markets while minimising risks and increasing opportunities for investors through diversification.

Press Release // January 9, 2025
 

Formycon included in TecDAX Index of Deutsche Börse

• Formycon to join the ranks of the 30 leading listed technology companies
• Uplisting to the Prime Standard, inclusion in the SDAX, and robust business development further enhance the stock’s appeal
• Entry into the TecDAX becomes effective as of January 13, 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) will officially be included in the TecDAX of Deutsche Börse on January 13, 2025. This decision was announced today as part of an unscheduled index adjustment by Deutsche Börse. With its inclusion in the TecDAX, Formycon is now ranked among the 30 largest publicly traded technology companies in Germany, based on free-float market capitalization and trading volume.

“We are extremely pleased that, just three weeks after joining the SDAX, Formycon will now also be included in the TecDAX. This milestone strengthens our position in the capital markets and increases our visibility as one of Germany’s important technology stocks. Being part of these important stock indices underscores the success of our capital market strategy. Moreover, it serves as further recognition of the outstanding performance of the entire Formycon team as part of our successful growth strategy as a leading ‘pure-play’ biosimilar developer,” said Enno Spillner, CFO of Formycon AG.

Since its initial listing in 2010, Formycon has consistently aligned itself with the demands of the capital markets, thereby laying the foundation for its exceptionally positive business development in recent years. This strategic focus also paved the way for the successful uplisting to the Prime Standard of Deutsche Börse in November 2024.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe and Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and has been part of the selection index SDAX since December 2024. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.
 

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Mail: Sabrina.Mueller@formycon.com

 
Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

PRESS RELEASE

Important milestone for Biotest: Biologics License Application for Fibrinogen submitted to the US Food and Drug Administration (FDA)

• Biotest’s fibrinogen aims to fulfill a high unmet medical need for additional fibrinogen to treat acquired fibrinogen deficiency
• US submission follows EU application for marketing authorization submitted in October 2024
• Subject to FDA approval, new treatment would bring significant improvement in sales, EBIT and cash flow

Dreieich, Germany, January 9, 2025. The Biologics License Application (BLA) for Biotest’s Fibrinogen has been submitted to the US Food and Drug Administration. Fibrinogen is the second product developed and manufactured by Biotest in Dreieich, Germany, for which a BLA has been submitted to the FDA.

The new application covers both supplementation in patients with acquired fibrinogen deficiency and treatment and prophylaxis of acute bleeding episodes in all patients with congenital fibrinogen deficiency.

The application is now under evaluation by the FDA, with a decision anticipated by the end of 2025. This submission follows Biotest’s earlier application for marketing authorization in selected European markets filed in October 2024.

“Clinical data demonstrates efficacy and safety of Biotest’s Fibrinogen in various bleeding conditions,” said Dr. Christina Erb, Head of Scientific Operations and Innovation. “Fibrinogen deficiency can lead to uncontrolled blood loss potentially resulting in patient’s death. Biotest’s Fibrinogen can be stored at room temperature and is designed to be more convenient and faster to prepare than alternatives for the treatment of fibrinogen deficiency associated with severe blood loss. As such, it will provide an effective and safe option for the management of bleeding in patients with serious and potentially life-threatening conditions”.

In many regions of the world, the use of cryoprecipitate or fresh frozen plasma as a fibrinogen substitute is the standard of care for the management of major surgical bleeding. However, these treatments contain not only fibrinogen, but also additional proteins and components that may exhibit undesired effects for the patient. In addition, they are not subject to the same rigorous pathogen safety protocols as Fibrinogen. Fibrinogen also offers the significant advantages of being readily available and allowing for faster administration, ensuring timely and targeted treatment.

As a member of the Grifols Group, Biotest is committed to playing a leading role in expanding access to this therapy to a broader patient population.

About Biotest’s Fibrinogen

The newly developed manufacturing process for fibrinogen results in high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility.

About AdFIrst trial no. 995

The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of Fibrinogen (BT524) in patients with acquired fibrinogen deficiency. Patients experiencing high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen (BT524) or fresh frozen plasma (FFP)/cryoprecipitate. To evaluate the efficacy of BT524, blood loss was compared between the two treatment options. For more information on the trial design and outcomes, please visit www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20). Full trial results are expected to be published in a medical journal later in 2025.

About fibrinogen and fibrinogen deficiency

Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood’s ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. The Fibrinogen alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to administration. The defined amount of fibrinogen in the fibrinogen developed by Biotest will allow a tailor-made, patient specific and highly effective treatment.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology, and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

 Newron and Myung In Pharm announce license agreement
for evenamide in South Korea

• Myung In Pharm to develop, manufacture and commercialize evenamide in South Korea
• Myung In Pharm to contribute 10% of patients to Newron’s pivotal Phase III trial for evenamide, and share global development costs
• Newron will receive upfront payment, development and regulatory milestones, and royalties on net sales
• Newron expects to begin pivotal Phase III trial in H1 2025

Milan, Italy; Morristown, NJ, USA; and Seoul, Republic of Korea – January 9, 2025 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for diseases of the central and peripheral nervous system, and Myung In Pharm Co. Ltd. (“Myung In Pharm”), South Korea’s leading CNS specialist pharmaceutical company, today announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, an add-on therapy for treatment-resistant schizophrenia (TRS) and poorly responding patients with schizophrenia, in South Korea. 

Under the terms of the license agreement, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming pivotal Phase III trial and cover the costs related to this population. Myung In Pharm’s involvement leverages its established clinical infrastructure and expertise in the central nervous system (CNS) field. Furthermore, the company will bear a percentage of eligible global development costs and will also be responsible for all regulatory, registration, marketing, and commercialization costs for evenamide in South Korea. In return, Newron will receive an upfront payment, milestone payments for development and regulatory achievements, and royalties on net sales. Further details were not disclosed by the parties. 

The Phase III randomized, double-blind, one-year trial is expected to begin in H1 2025 and will compare evenamide to placebo as an add-on treatment in at least 600 patients with TRS. It will be coordinated by Newron, who will oversee the trial design, execution, and data analysis. Myung In Pharm will be responsible for enrolling patients in South Korea through its extensive network of clinical sites, as well as providing support with monitoring and data collection. Newron continues to pursue further development opportunities for evenamide in other territories. On December 13, 2024, Newron and EA Pharma (a subsidiary of Eisai Co., Ltd.) announced a license agreement for evenamide in Japan and other Asian territories.

“We are thrilled to partner with Myung In Pharm in this important clinical trial and to grant them the rights to develop, manufacture and commercialize evenamide in South Korea,” said Stefan Weber, CEO of Newron. “Their strong expertise in CNS therapies and their clinical infrastructure will be instrumental in advancing the development of evenamide. This collaboration underscores our shared commitment to transforming the treatment landscape for patients with unmet needs.”

Hang Myung LEE, Chairman of Myung In Pharm, commented: “Newron’s innovative approach aligns with our commitment to improving patient outcomes in the CNS area, and we believe our participation will make a significant contribution to the success of the study. Furthermore, we are honored to have received the license to commercialize evenamide in South Korea. This partnership presents a valuable opportunity for us to bring a new treatment option to patients in South Korea, a key market for Myung In Pharm. We look forward to working closely with the Newron team to bring this promising therapeutic to the forefront of clinical development and expand its impact in South Korea.”

Jefferies International Limited (“Jefferies”) acted as the exclusive financial advisor to Newron. Orrick Herrington & Sutcliffe LLP advised as legal counsel to Newron.

Cosmo Group Inc. of USA acted as the advisor to Myung In Pharm.

About schizophrenia

Approximately 25 million people worldwide are affected by schizophrenia, including more than 210,000 in South Korea as reported in 2022 by HIRA (Health Insurance Review & Assessment Service, Government agency). Despite more than 60 different types of atypical and typical antipsychotics used for schizophrenia globally, a considerable number of patients remain severely ill or resistant to treatment. Overall, 30-50% of patients do not respond to the available medications and are defined treatment resistant. In addition to the patients with treatment-resistant schizophrenia (TRS), another 20-30% are described as “poor responders to anti-psychotic medication,” even if not meeting the criteria for TRS. New findings indicate that patients with TRS have abnormalities in the glutamatergic system, but not in dopaminergic transmission, so there is a huge unmet medical need for a glutamatergic mechanism of action, efficacious both in TRS patients and in those who are poor responders to the current treatments.

About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial, as an add-on treatment to second generation anti-psychotics including clozapine, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS)¹, and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit” on the outcome variables. Evenamide was extremely well tolerated, without any of the usual side effects of available anti-psychotics.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago^®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

About Myung In Pharm

Myung In Pharm is a fully integrated pharmaceutical company established in 1985, based in Seoul, Republic of Korea. The company specializes in the manufacturing, processing, and distribution of pharmaceutical drugs, with a strong focus on central nervous system (CNS) therapies. Ranked number one in South Korea in the CNS field, Myung-In Pharm operates state-of-the-art manufacturing facilities that meet cGMP standards. With a robust network of over 1,200 neurologists and relationships with 98% of domestic neurology hospital departments, Myung In Pharm is dedicated to improving patient care and advancing the field of neuroscience. http://myunginph.co.kr/main/en/

References:

[1] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

For more information, please contact:

Newron

Stefan Weber – CEO, +39 02 6103 46 26, pr@newron.com

UK/Europe

Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting, +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland

Valentin Handschin, IRF, +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe

Anne Hennecke / Maximilian Schur, MC Services, +49 211 52925227, newron@mc-services.eu

USA

Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

Myung In Pharm:

Jung Uk Lee – Executive Director, +82 2 3465 9640, julee@myunginph.co.kr

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.