Ad-hoc notification in accordance with Sec. 17 of the MAR

Drägerwerk AG & Co. KGaA: Preliminary figures 2024: Net sales just below and earnings just above expectations –Forecast 2025

Lübeck, January 15, 2025 – Based on preliminary calculations, Dräger’s net sales in fiscal year 2024 increased by 0.6 percent (net of currency effects; nominal: 0.0 percent). Net sales were thus just below the last forecast, according to which Dräger had expected an increase in net sales in the range of 1.0 to 3.0 percent (net of currency effects). At around EUR 3,373 million, net sales nevertheless came close to the high figure of the prior year (2023: EUR 3,373.5 million), in which Dräger had benefited from strong catch-up effects as a result of the noticeable improvement in delivery capability and the surge in demand for ventilators in China. As expected, these two effects were absent in 2024.

The safety division continued its growth in the 2024 fiscal year and recorded an increase in net sales of 5.1 percent (net of currency effects; nominal: 4.7 percent) to around EUR 1,473 million (2023: EUR 1,407.3 million). The medical division saw a decline of 2.6 percent (net of currency effects; nominal: -3.4 percent) to around EUR 1,900 million (2023: EUR 1,966.2 million), which is attributable in particular to the aforementioned base effects in the prior year and the current difficult market conditions in China. The Group’s gross margin rose to around 45.0 percent (2023: 43.3 percent).

Earnings before interest and taxes (EBIT) increased significantly by around 19 percent to around EUR 197 million (2023: EUR 166.4 million). In addition to the operating business performance, several one-time effects with an impact on earnings amounting to around EUR 22 million had a positive effect on EBIT. At 5.8 percent (2023: 4.9 percent), the EBIT margin was just above the last annual forecast (range of 4.0 to 5.5 percent).

At around EUR 3,381 million, Dräger’s order intake was up 3.4 percent (net of currency effects; nominal: 2.7 percent) on the high prior-year figure (2023: EUR 3,290.0 million). Both divisions contributed to this positive development: order intake in safety rose by 6.5 percent (net of currency effects; nominal: 6.1 percent) to around EUR 1,457 million (2023: EUR 1,373.8 million), while order intake in medical increased by 1.2 percent (net of currency effects; nominal: 0.4 percent) to around EUR 1,923 million (2023: EUR 1,916.2 million) following a decline in the prior year.

Dividend proposal
In line with the existing dividend policy, Dräger intends to distribute around 30 percent of the group net profit to its shareholders. The final dividend proposal will be made with the final business figures for 2024.

Forecast for 2025
For the current fiscal year, Dräger expects an increase in net sales of 1.0 to 5.0 percent (net of currency effects) and an EBIT margin of 3.5 to 6.5 percent. The expected EBIT margin is therefore in line with our goal of increasing the EBIT margin by an average of one percentage point each year.

The full 2024 Annual Report will be published on April 3, 2025.

Drägerwerk AG & Co. KGaA
Moislinger Allee 53–55
23558 Lübeck, Germany
www.draeger.com

Investor Relations:
Thomas Fischler
Tel. +49 451 882-2685
thomas.fischler@draeger.com

Corporate Communications:
Melanie Kamann
Tel. +49 451 882-3998
melanie.kamann@draeger.com

Disclaimer
This ad hoc report contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to date. They were compiled to the best of the company’s knowledge. Dräger does not provide any warranty nor assume any responsibility for the future developments and results described above. These are dependent on a number of factors. They entail various risks and contingencies outside of the company’s influence and are based on assumptions which could prove to be incorrect. Dräger does not assume any responsibility for updating the forward-looking statements contained in this report. This does not infringe any legal stipulations on the adjustment of forecasts. Please go to Investor Relations / Definitions of financial indicators at www.draeger.com for information on alternative performance measures used.

Annual Report 2023/24: BRAIN Biotech AG acts from a strong cash position and is confident about its growth prospects

• Group cash and cash equivalents improved to € 27.2 million
• Successfully closed two milestone transactions with Royalty Pharma and Akribion Therapeutics
• Management sees a strong start to the new financial year
• Updated mid-term targets at the CMD 2024 and well-founded optimism for new business year 2024/25

ZWINGENBERG, Germany, January 15, 2025 – BRAIN Biotech AG, a leading provider of specialty enzymes and innovative biosolutions for industry, has published the BRAIN Biotech Group´s financial figures for the fiscal year 2023/24. The Group’s cash position has been built up during the year to a strong € 27.2 million.

The company successfully closed two milestone transactions in the last financial year: first, a royalty monetization with Royalty Pharma with potential proceeds from milestone payments of up to € 128.88 million; second, an exclusive pharma licensing deal with Akribion Therapeutics for up to € 92.3 million in milestones plus royalties on net sales. Consolidated revenue in the 2023/24 financial year was roughly flat at € 54.6 million.

CEO Adriaan Moelker says: “With two closed benchmark transactions from our BioIncubator pipeline we were able to develop the Group significantly from a strategic perspective while our revenue growth has taken a breather during the last financial year. I am very confident about the growth prospects for the current year and our mid-term target to reach € 100 million revenues in the BRAINBiocatalysts segment within the next five years. We have a good and solid foundation on which to build, our markets are large and attractive, and we have the tools to succeed.”

BRAIN Biotech reported an adjusted EBITDA of € – 0.4 million compared to € +0.4 million last year despite macroeconomic headwinds and high investments in the Group’s BioIncubator projects. CFO Michael Schneiders states: “During a year full of economic challenges we have managed to keep our adjusted EBITDA close to breakeven. With a strong focus on the successful execution of strategic initiatives we have been able to bring our group cash position to a very comfortable level of € 27.2 million and to reduce our cost base significantly for the running financial year. We have laid excellent foundations for success in the years to come. Hence, we forecast a clearly positive adjusted EBITDA for 2024/25.”

Development of the segments

In the reporting period, BRAIN Biotech’s business activities were structured into the operating segments BioProducts, BioScience and BioIncubator.

The BioProducts segment mainly consists of its industrially scalable products business focusing on specialized enzymes and proteins. Revenue development in this segment was nearly flat at € 42.6 million versus € 42.5 million in the previous financial year. While some sub-segments have been growing very dynamically other business activities within the segment performed below expectations. This was particularly due to the slower than expected ramp curve of the second large-scale fermenter. The fermenter has now been successfully commissioned. The segment’s total operating performance retracted slightly from € 42.8 million in the previous year to € 42.6 million. The segment’s adjusted EBITDA was at € 5.3 million versus € 5.5 million last financial year. This slight decline is mainly attributable to adverse product mix changes and the costs associated with the ramp of the second large scale fermenter.

The BioScience segment includes the research and development business with industrial partners. In this segment, revenue decreased by 13.1 % from € 12.3 million to € 10.7 million. This is attributable to the generally weak economic environment and corresponding postponements in the project business. Total operating performance decreased by € 2.2 million to € 11.2 million. The segment’s adjusted EBITDA stood at – € 0.2 million after € 0.8 million in the previous financial year.

The BioIncubator segment includes the external R&D project pipeline and the company’s own R&D projects offering high value-creation potential. The segment generated revenue of € 1.7 million, which was strongly up from € 0.6 million in the previous reporting period. This revenue was generated primarily by milestone and license income from pharma-related projects. The segment’s negative adjusted EBITDA is mainly driven by high investments in genome editing and amounted to € -2.1 million in the financial year (previous € -2.7 million). Gross investments into the Akribion Genomics platform were € 3.0 million versus € 3.3 million in the previous year.

Key financials from Financial Year 2023/24:

1 Revenues + change in inventories + other income including R&D grants

2 The reconciliation from adjusted to unadjusted EBITDA can be found in the Annual report 2023/24

Outlook for 2025

For the financial year 2024/25 BRAIN Biotech expects to accelerate its revenue growth path in-line with the projected mid-term growth forecast. Adjusted EBITDA growth is expected to be above sales growth. In line with its communicated strategy the company will continue to explore bolt-on acquisitions that can add product expertise and accelerate growth further.

The full quantitative guidance for the financial year 2024/25 will be issued with the 3M reporting on February 26, 2025.

The company had recently updated its mid-term guidance during the 2024 Capital Markets Day. BRAIN Biotech will further sharpen its focus on profitable growth and now targets for its growth segment BRAINBiocatalysts € 100 million revenues and an adjusted EBITDA margin of 15 % within the next five years. In addition, the company intends to continuously harvest high value opportunities from its BioIncubator pipeline.
 

Link to BRAIN Biotech AG Annual Report 2023/24:

https://reports.brain-biotech-group.com/report-2024/en/

+++

BRAIN Biotech Group

The BRAIN Biotech Group is a leading company in the research, development and production of specialty enzymes with a focus on the food and life science industries. In addition, the Group develops microbial production organisms and scalable bioprocesses for the economic production of specialty enzymes and other proteins. Customized innovative biological solutions for more sustainable products and processes round off the portfolio.

The parent company of the BRAIN Biotech Group is BRAIN Biotech AG. The business activities of the integrated company are divided into the two segments BRAINBiocatalysts (development, production and distribution of specialty enzymes, microorganisms, ingredients) and BRAINBioIncubator (research-intensive development projects, pharmaceuticals). For production, the Group operates fermentation plants in the UK as well as production facilities in continental Europe and the USA.

BRAIN Biotech has been listed on the Frankfurt Stock Exchange since February 9, 2016 (Ticker: BNN; ISIN DE0005203947 / WKN 520394). The company employs around 325 people at several locations and generated revenues of EUR 54.6 million in the 2023/24 financial year. Further information can be found at: www.brain-biotech-group.com.

Contact Investor Relations

Martina Schuster
Investor Relations
Phone: +49 6251 9331-69
Email: ms@brain-biotech.com

Contact Media

Dr. Stephanie Konle
PR & Corporate Communications
Phone: +49 6251 9331-70
Email: stk@brain-biotech.com

The BRAIN Biotech Group on social media and on the internet:

BRAIN Biotech Group

Web: www.brain-biotech-group.com

LinkedIn: https://www.linkedin.com/company/brainbiotech

Threads: https://www.threads.net/@brainbiotechag

Bluesky: https://bsky.app/profile/brain-biotech-group.com

X: https://x.com/BRAINbiotech

Youtube: https://www.youtube.com/channel/UCS33HJqku674X22UQ8QIsyg

Biocatalysts Ltd (Production, Sales)

LinkedIn:

Biocatalysts Ltd on LinkedIn

Biocatalysts Baking on LinkedIn

BRAIN-Biocatalysts Life Science Solutions on LinkedIn

BRAIN Biotech Zwingenberg (Research & Development)

Web: www.brain-biotech.com

AnalyticonDiscovery (Research & Development)

Web: https://ac-discovery.com/

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN Biotech AG, and are based on information currently available to the management.

Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors.

BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.

Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Australia, Canada or Japan or any other jurisdiction in which such release, publication or distribution would be unlawful. The important notes at the end of this announcement need to be observed.
 

Legalization of cannabis brings strong growth: Cantourage Group SE increases its sales by 118% to EUR 51.4 million in full year 2024

Berlin, January 15, 2025 – Cantourage Group SE (hereafter “Cantourage,” ISIN: DE000A3DSV01, www.cantourage.com), Europe’s leading publicly listed cannabis company, posted sales of EUR 51.4 million in the full year 2024. This exceeded the most recently raised sales forecast for 2024 (EUR 46 million to EUR 50 million). The growth in sales in 2024 represents an increase of 118% compared to the previous year (2023: EUR 23.6 million) and demonstrates the exceptional scalability and performance of Cantourage’s business model.

On a monthly and quarterly basis, Cantourage continued to see strong growth in sales throughout 2024. At the end of the year, Cantourage once again set new sales records at both the monthly and quarterly level:

• Sales in December 2024: EUR 8.5 million (previous record: EUR 7.2 million; November 2024)
• Sales in Q4 2024: EUR 21.2 million (previous record: EUR 13.2 million; Q3 2024)

The main driver of this positive business performance was the continuously growing demand for Cantourage’s cannabis flowers, especially in Germany and the UK. By significantly expanding its own processing capacities, the company was increasingly able to meet the sustained increase in demand for cannabis-based pharmaceuticals in its various markets over the course of 2024.

“2024 was a very eventful year for cannabis in Germany. Over the course of the year, it became clear that the partial legalization in April is giving more and more people access to medical cannabis – and bringing enormous economic potential for the entire industry. We are pleased to be able to meet the growing demand for high-quality, safe cannabis flowers together with our strong partner network. Despite all the macroeconomic challenges, we have now exceeded the EUR 50 million sales mark only five and a half years after our company was founded. We have thus increased our sales revenues of around EUR 500,000 in 2020, when we launched our first product, by more than a hundredfold,” said Philip Schetter, CEO of Cantourage.

“For 2025, we have already launched new growth drivers such as our recent very successful market entry in Poland or the relaunch of our telemedicine platform www.telecan.de,” emphasizes Philip Schetter. “By doing so, we want to support even more people on their way to cannabis therapy and expand our leading position in the dynamic European market environment – while continuing to grow profitably as a company. With the help of our asset-light business model, we will be able to realize this growth using our own resources. Overall, we will place a strong emphasis on continuously improving our efficiency, making even better use of economies of scale and significantly increasing our profitability even further.”
 

About Cantourage

Cantourage is a leading European producer and distributor of cannabis flowers and cannabis-based medicinal preparations and drugs. The Berlin-based company was founded in 2019 by industry pioneers Norman Ruchholtz, Dr. Florian Holzapfel and Patrick Hoffmann. With an experienced management team and its “Fast Track Access” platform, Cantourage enables producers from around the world to become part of the growing European medical cannabis market faster, easier and more cost-effectively by processing and distributing their cannabis raw materials and extracts. In this context, Cantourage ensures compliance with the highest European pharmaceutical quality standards at all times. The company offers pharmaceutical-grade products in all relevant market segments: dried flower, extracts, dronabinol and cannabidiol. Cantourage was listed on the Frankfurt Stock Exchange on 11 November 2022 and is listed under ticker symbol “HIGH.”

Further information: www.cantourage.com
 

This announcement does not constitute a public offer or an advertisement for a public offer to sell securities, in particular not within the meaning of Regulation (EU) 2017/1129 (Prospectus Regulation).
 

Press contact at Cantourage:

Frederick Steudemann
Tel. +49 (0)30 4701 350 – 50
steudemann@cantourage.com

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.