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25.11.2024

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Rekordbeteiligung bei Science4Life: 142 Start-ups setzen ein Zeichen für Innovation und Pioniergeist

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HBOX Therapies: €600k investment prize from High-Tech Gründerfonds at Stage Two!

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26.10.2022

We are very happy to announce our successful participation at Stage Two in Berlin last weekend. Stage Two is the largest pan-European competition for the best startups spinning out of leading universities. 2 months ago we qualified for the event at the pre-selection of the RWTH Aachen University teams. On Friday morning we were fortunate enough to make it to the finals in an intense pitch battle against amazing teams from all over Europe. In the end, we are very proud to have been awarded one of the two biggest investment prizes of the event: a €600k investment from High-Tech Gründerfonds!

Takeda Enters Collaboration and Licensing Agreement with Zedira and Dr. Falk Pharma to Develop First-in-Class Celiac Disease Therapy

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21.10.2022

Collaboration Provides Takeda an Exclusive License to Develop and Commercialize ZED1227/TAK-227 in the United States and Other Countries Outside of Europe, Canada, Australia and China Agreement Adds Third Investigational Therapy to Takeda’s Pipeline for the Potential Treatment of Celiac Disease Takeda (TSE:4502/NYSE:TAK), Zedira and Dr. Falk Pharma GmbH today announced a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational therapy for the treatment of celiac disease. TAK- 227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage to the small intestine. There are currently no approved therapies for the treatment of celiac disease. “The continued development of TAK-227 in partnership with Zedira and Dr. Falk Pharma has the potential to offer a meaningful benefit to patients with celiac disease who suffer from symptoms and ongoing intestinal injury despite maintaining a gluten-free diet,” said Chinwe Ukomadu, M.D., Ph.D., head, Gastroenterology Therapeutic Area Unit at Takeda. “With three novel programs now in the clinic, Takeda is at the forefront of developing transformative therapies for celiac disease and is advancing multiple therapies for patients living with this challenging lifelong autoimmune condition.” TAK-227 (ZED1227)1 is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the stomach and intestinal tissue. TAK-227 targets the dysregulated transglutaminase to prevent mucosal damage in the small intestine by preventing the body’s immune response to gluten, a disease process mediated by activation of gluten-specific T cells. A Phase 2a proof- of-concept study published in the New England Journal of Medicine previously demonstrated a protective effect of TAK- 227 on the duodenal mucosa and symptoms during a six-week gluten challenge.2 The compound was also found to be safe and well tolerated. “Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life,” said Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma. Martin Hils, Ph.D., CEO at Zedira, added “Takeda’s R&D expertise in gastroenterology, commercial footprint, and its strong commitment to develop therapies to treat celiac disease, make it an ideal partner to help us bring TAK-227 to patients.” Under the terms of the agreement, Takeda and Dr. Falk Pharma will conduct global clinical studies for TAK-227 in celiac disease. Takeda will receive an exclusive license to develop and commercialize TAK-227 in the United States and other territories outside of Europe, Canada, Australia and China. Zedira and Dr. Falk Pharma will receive an upfront payment and are eligible to receive potential development, regulatory and commercial milestones, as well as royalties on net sales. Originally discovered by Zedira, Dr. Falk Pharma licensed the European rights to ZED1227 from Zedira in 2011 and assumed responsibility for preclinical and clinical development of the program. Takeda is advancing a portfolio of investigational therapies for the potential treatment of celiac disease. In addition to TAK-227, Takeda is developing two other investigational celiac disease therapies that recently entered Phase 2 clinical trials. TAK-062 is a potential best-in-class, highly potent glutenase – a protein that degrades ingested gluten – that was computationally engineered to treat celiac disease. TAK-101 is a potential first-in-class, immune-modifying nanoparticle containing gliadin proteins designed to promote immune tolerance to gluten in celiac disease by preventing gliadin- specific T-cell activation. About Celiac Disease Celiac disease is a systemic, immune-mediated disorder characterized by chronic enteropathic inflammation, and precipitated by exposure to dietary gluten in genetically predisposed individuals.3 Global prevalence of celiac disease is ~1%, with highest rates in women, in relatives of individuals with celiac disease, and in those with other immune- mediated disorders; prevalence of celiac disease is increasing worldwide, yet many cases remain undetected or not formally diagnosed.4,5,6 The amount of daily tolerable gluten varies widely among individuals with celiac disease. Although some can tolerate >50 mg/day, others develop mucosal abnormalities with gluten consumption of 10 mg/day, and mucosal damage has been associated with chronic exposures of as little as 1 mg/day.7,8,9 Celiac disease can cause symptoms, including abdominal pain, diarrhea, nausea, and vomiting. Long-term complications of celiac disease may include malnutrition, accelerated osteoporosis, nervous system problems and problems related to reproduction. There is no approved therapy for celiac disease. The only available management option for patients is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins from wheat, barley, and rye, which is not always effective.10 About Takeda Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com. About Zedira GmbH The Darmstadt (Germany) based biotech company has a focus on celiac disease and other transglutaminase-linked conditions in the areas of autoimmunity, fibrotic diseases, and thrombosis. The company develops, produces, and markets specialty reagents and kits for research and development as well as for clinical diagnostics. Zedira established a pipeline of drug candidates adapted to specific indications based on a series of patented synthetic transglutaminase blockers. ZED1227 is the first direct-acting transglutaminase inhibitor in clinical development. Zedira is a portfolio company of the German High-Tech Gründerfonds. About Dr. Falk Pharma GmbH Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre-clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well-being. A family-owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France and Switzerland. Dr. Falk Pharma GmbH employs approximately 990 individuals globally, thereof 218 in Freiburg. Further information on Dr. Falk Pharma can be found online: https://drfalkpharma.com Takeda Media Contacts: Japanese Media Ritsuko Nomura ritsuko.nomura@takeda.com +81 (0) 466-32-4520 U.S. and International Media Chris Stamm chris.stamm@takeda.com +1 617-374-7726 Zedira Media Contact: Ralf Pasternack contact@zedira.com 49 6151-66628-0 Dr. Falk Pharma Media Contact: Roland Greinwald zentrale@drfalkpharma.de +49 761 1514-0 Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. 3 Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec- filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Sources: 1 Büchold C, Hils M, Gerlach U, Weber J, Pelzer C, Heil A, Aeschlimann D, Pasternack R. Features of ZED1227: The First-In-Class Tissue Transglutaminase Inhibitor Undergoing Clinical Evaluation for the Treatment of Celiac Disease. Cells. 2022; 11(10):1667. https://doi.org/10.3390/cells11101667 2 Schuppan D, Mäki M, Lundin KEA, Isola J, Friesing-Sosnik T, Taavela J, Popp A, Koskenpato J, Langhorst J, Hovde Ø, Lähdeaho ML, Fusco S, Schumann M, Török HP, Kupcinskas J, Zopf Y, Lohse AW, Scheinin M, Kull K, Biedermann L, Byrnes V, Stallmach A, Jahnsen J, Zeitz J, Mohrbacher R, Greinwald R; CEC-3 Trial Group. A Randomized Trial of a Transglutaminase 2 Inhibitor for Celiac Disease. N Engl J Med. 2021 Jul 1;385(1):35-45. doi: 10.1056/NEJMoa2032441. PMID: 34192430. 3 Ludvigsson J, Leffler D, Bai J, et al. The Oslo definitions for coeliac disease and related terms. Gut. 2013 Jan;62(1):43-52. 4 Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, Fasano A. Celiac disease: a comprehensive current review. BMC Med. 2019 Jul 23;17(1):142. 5 King J, Jeong J, Underwood F, et al. Incidence of Celiac Disease Is Increasing Over Time: A Systematic Review and Meta-analysis. Am J Gastroenterol. 2020 Apr;115(4):507-525. 6 Al-Toma A, Volta U, Auricchio R, et al. European Society for the Study of Coeliac Disease (ESsCD) guideline for coeliac disease and other gluten-related disorders. United European Gastroenterol J. 2019 Jun;7(5):583-613. 7 Biagi F, Campanella J, Martucci S, Pezzimenti D, Ciclitira PJ, Ellis HJ, Corazza GR. A milligram of gluten a day keeps the mucosal recovery away: a case report. Nutr Rev. 2004 Sep;62(9):360-3. 8 Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796. 9 Akobeng AK, Thomas AG. Systematic review: tolerable amount of gluten for people with coeliac disease. Aliment Pharmacol Ther. 2008 Jun 1;27(11):1044-52 10 Symptoms & Causes of Celiac Disease. National Institute of Diabetes and Digestive and Kidney Diseases. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/celiac-disease/symptoms-causes. Last reviewed: October 2020. Last accessed: June 2022

Lidrotec Receives $1 Million in Investment; Four Additional Companies Secure Follow-on Investments

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21.10.2022

Governor Kathy Hochul today announced Lidrotec as the winner of Round 5 of the Luminate NY optics, photonics, and imaging startup accelerator competition. The Bochum, Germany-based Lidrotec received the “Company of the Year” award at Luminate Finals 2022, which was held live during Optica’s Frontiers in Optics + Laser Science conference in Rochester. The company will receive $1 million in investment from New York State through the Finger Lakes Forward Upstate Revitalization Initiative. As required by the award, all winners of the competition will commit to establishing operations in the region for at least the next 18 months. Through Luminate NY, Lidrotec was introduced to AIM Photonics. This collaboration is helping Lidrotec build the infrastructure for developing the next iteration of its technology and execute on its plans to establish US operations. Luminate NY, which is administered by NextCorps, is the world’s largest business accelerator for emerging companies that have optics, photonics, and imaging enabled technologies. The Finals event marks the completion of the fifth year of the cohort-based program. Earlier this year, Governor Hochul included funding for Luminate NY in the New State budget for four more consecutive years. “New York is on the cutting edge of technological research, as we continue to welcome great talent and opportunities here through our Luminate NY competition,” Governor Hochul said. “We are adding another chapter to the Finger Lakes Region’s unparalleled history in imaging and optics by bringing the most promising companies here to speed the commercialization of groundbreaking technologies. Today’s winners will be able to take advantage of the nation’s most robust, sophisticated, and highly integrated optics, photonics and imaging supply chain that exists here to scale their businesses, leading to their growth as well as New York State’s economy.” Lidrotec’s patent-pending wafer-dicing laser technology for the semiconductor industry enables thinner cuts with a virtually 0% damage rate, providing significant cost savings and productivity increases. Its innovation is in the efficient use of liquids in the laser processing zone, which cool and rinse wafers while the laser cuts out the chips. The resulting benefits include thinner cuts with higher precision, no damages to the material, clean surfaces without debris, and higher processing speeds—all without the need to adapt the production process. Lidrotec CEO Alexander Igelmann said, “Luminate provided us with a new network into the United States, along with contacts to suppliers and clients. These vital connections will help us to meet our development milestones during the next two years, which include market validation for our novel laser technology.” Munich, Germany based Custom Surgical was awarded the Outstanding Graduate Award and $500,000 in follow-on investment. They also received the $10,000 Audience Choice award. The company is modernizing surgery by providing an effective way to record, store, and share medical images and leverage them to diagnose and treat patients. Alertgy from Melbourne, FL secured the Distinguished Graduate award and $250,000 for its technology, which gives diabetics and the world’s 2 billion pre-diabetics a way to non-invasively monitor their blood glucose levels on demand. There was a tie for Honorable Achievement, with MEETOPTICS from Barcelona Spain and SCOUT from Alexandria, VA each receiving $125,000. MEETOPTICS is building an Artificial Intelligence (AI)-driven platform that helps engineers and researchers in the optics and photonics industry quickly access and compare products and technologies from trusted manufacturers online. SCOUT is providing alternatives to the terrestrial sensing paradigm with on-orbit imaging systems and autonomy software for the automated detection, tracking, and characterization of space objects and orbital debris. Videos on all competing startups in the competition are available here. Investments today were presented after a panel of judges from the optics, photonics, and imaging (OPI) industry and venture capitalist community scored the participating companies based on their business pitches and due diligence completed during the six-month accelerator program. Since its inception, Luminate NY has invested $15 million in 53 startups. The companies in the portfolio now share a net worth of more than $400 million. In addition to providing an estimated 1.5 to 2 times return on investment, many of the companies are establishing U.S. operations or some aspect of research and manufacturing in the Rochester region, which has resulted in 150 jobs (100 full-time and 20 contract positions), with an additional 120 projected in the near future from two companies. Last year’s winner, PreAct Technologies, committed to establishing its pilot, high-tech manufacturing in Rochester, which is expected to create 60 jobs. Luminate NY Managing Director Dr. Sujatha Ramanujan said, “This accelerator is providing the critical support that early-stage companies need to bring their technologies to market and expand their businesses in both U.S. and global markets. We are grateful to Governor Hochul for the program’s continuation.” The Luminate NY accelerator is based in Rochester and selects ten promising companies each year to participate in its six-month program. During this time, companies are provided with comprehensive training and resources to advance their technologies and businesses. Applications are now being accepted for Round 6 through January 9, 2023. Teams that can physically locate to Rochester will receive $100,000 in funding upon program start in April 2023. Teams that are unable to come to Rochester due to travel and Visa restrictions will receive $50,000 in funding upon program start and an additional $50,000 that must be used to engage resources in the Finger Lakes region during their time in the accelerator. The Finger Lakes Region is home to an incredibly rich ecosystem of forward-thinking entrepreneurs who are looking to grow their business. Rochester offers the American Institute for Manufacturing Integrated Photonics’ Test, Assembly, and Packaging facility at Eastman Business Park, the University of Rochester’s Institute of Optics, the Rochester Institute of Technology, and more than 150 local OPI companies which employ over 17,000 employees. Empire State Development President, CEO and Commissioner Hope Knight, said, “The Luminate NY competition’s laser focus on accelerating innovation and investment in New York’s world-renowned optics, photonics and imaging industries has further established the Finger Lakes as an OPI hub. Congratulations to all finalists, and in particular Round 5 winner Lidrotec, whose technology complements New York’s strengths in semiconductor manufacturing. We look forward to the growth and impact that these forward-thinking companies will bring to the region.” State Senator Jeremy Cooney said, “Luminate NY continues to bring high-quality jobs to our Greater Rochester region through their accelerator competition, and this round’s winners are no exception. I’m grateful for the advancements in technology, health, wellness, and scientific discovery that these companies will leverage in our area. Thank you to Governor Hochul, Finger Lakes Forward, and Empire State Development for their support of these initiatives.” Assemblymember Harry Bronson said, “The Luminate NY Accelerator Program attracts the most creative and dynamic light technology startups from across the globe. The winners of this competition will advance our optics, photonics and imaging industries across NYS. Congratulations to the team at Lidrotec! We are excited to see you grow your company here in the Finger Lakes Region. Lidrotec’s ingenuity and inventiveness will continue to bring job opportunities and investment to our area. We must meet their vision and successes with equitable workforce development programs that not only support our emerging and expanding industries but also provide career pathways for all members of our community.” Monroe County Executive Adam Bello said, “Congratulations to Lidrotec and all the winners of the Luminate NY program – which continues to inspire innovators and jumpstart the businesses of tomorrow across the Greater Rochester region. “Thank you to Gov. Kathy Hochul and Luminate NY for continuing to foster economic growth in our community – providing quality jobs for our neighbors and strengthening our economy.” Rochester Mayor Malik Evans said, “The Luminate NY accelerator provides our city with an enormous economic boost and expands Rochester’s already dense web of groundbreaking innovators in optics, photonics and imaging. We are thrilled to host the Luminate Finals and wholeheartedly welcome Lidrotec to the region. Congratulations to all of the winners and thanks to Governor Hochul and the Finger Lakes Forward Initiative for making these important investments that benefit our citizens.” Accelerating Finger Lakes Forward Today’s announcement complements “Finger Lakes Forward,” the region’s comprehensive blueprint to generate robust economic growth and community development. The regionally designed plan focuses on investing in key industries including photonics, agriculture and food production, and advanced manufacturing. Now, the region is accelerating Finger Lakes Forward with a $500 million State investment through the Upstate Revitalization Initiative. The State’s $500 million investment will incentivize private business to invest well over $2.5 billion – and the region’s plan, as submitted, projects up to 8,200 new jobs. More information is available here. About Empire State Development Empire State Development (ESD) is New York’s chief economic development agency (www.esd.ny.gov). The mission of ESD is to promote a vigorous and growing economy, encourage the creation of new job and economic opportunities, increase revenues to the State and its municipalities, and achieve stable and diversified local economies. Through the use of loans, grants, tax credits and other forms of financial assistance, ESD strives to enhance private business investment and growth to spur job creation and support prosperous communities across New York State. ESD is also the primary administrative agency overseeing the Regional Economic Development Councils and the marketing of “I LOVE NEW YORK,” the State’s iconic tourism brand. For more information on Regional Councils and Empire State Development, visit www.regionalcouncils.ny.gov and www.esd.ny.gov.

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