Biosimilars Training Course: Prepare for the Biosimilar Market Growth As Some of the World’s Best-known Biologics Face Patent Expiration in the Coming Years (Online Event: Mar 16th – Mar 17th, 2026) – ResearchAndMarkets.com




Biosimilars Training Course: Prepare for the Biosimilar Market Growth As Some of the World’s Best-known Biologics Face Patent Expiration in the Coming Years (Online Event: Mar 16th – Mar 17th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Biosimilars Training Course (Mar 16th – Mar 17th, 2026)” training has been added to ResearchAndMarkets.com’s offering.

In today’s pharmaceutical landscape, the rise of biosimilars presents a pivotal shift in therapeutic options, offering more affordable alternatives to biologics whose patents are expiring. With major biologics facing patent expiration in the near future, the biosimilars market is poised for substantial growth, driving increased interest and investment in this sector.

This seminar delves into the critical distinctions between biosimilars and their reference biologics, addressing the complex regulatory pathways and challenges in both the EU and US markets.

Participants will gain insights into essential dossier requirements specific to biotech products compared to pharma products, alongside strategies for successful biosimilar development. Moreover, the course emphasises key biological considerations and the concept of totality in biological reviews, discussing unique aspects of biosimilars compared to small molecule generics.

This course will equip attendees with comprehensive knowledge essential for navigating the evolving biosimilar landscape.

Benefits of attending

• Discuss global considerations and definitions of biotech/biosimilar products
• Gain an invaluable overview of the regulatory pathways for biosimilars in the EU and US
• Understand the key Module 3 dossier requirements for biotech products versus pharmaceutical products
• Learn how to develop effective strategies for development of biosimilar products

Who Should Attend:

This course is perfect for pharmaceutical professionals working in regulation, quality assurance, pharmaceutical development, and R&D, including:

• Regulatory affairs professionals
• Medical affairs professionals
• Clinical development managers
• Quality assurance personnel
• Legal and compliance officers

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Key Topics Covered:

Day 1

Biologics introduction

• Technical and legal definitions
• Examples of biologics
• The complexity of biologicals
• The challenges with the development of biologics

Biosimilars vs generics

• How the process is the product
• A simple excursive to be reminded of the difference between biosimilars and generics
• Creating a copy with limited and imperfect tools

The (e)CTD

• International Council of harmonization (ICH)
• The common technical document
• CMC explained (incl. quality by design, specifications)
• Why the CMC section for biologics is more extensive (as compared to small molecules)

The (e)CTD continued

Day 2

The registration process

• A review of EMA and FDA biosimilar guidelines
• Biosimilar development as a step-wise approach
  • Quality
  • Non-clinical
  • Clinical
• Non-comparable biologics
• Other regulatory topics
  • Interchangeability
  • Naming
  • Labelling
  • Pharmacovigilance

Module 3 for biosimilars – section by section

• In-depth review of module 3 documentation with special remarks regarding biologics and biosimilars specifically

Challenges for biosimilar sponsors

• Global development
• Costs
• Uncertainty

Main players in the biosimilar field

• A review of the current situation

Strategic considerations

• A summary of key points to consider when (starting to) develop biosimilars

Case study

Speakers:

Andrew Willis

Consultant

Independent

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs.

He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.

He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.

For more information about this training visit https://www.researchandmarkets.com/r/kvxsfr

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

ImmunityBio Founder Dr. Patrick Soon-Shiong Recognized as One of “100 Most Influential People in Oncology in 2025”




ImmunityBio Founder Dr. Patrick Soon-Shiong Recognized as One of “100 Most Influential People in Oncology in 2025”

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that OncoDaily has recognized Dr. Patrick Soon-Shiong as being one of “The 100 Most Influential People in Oncology in 2025.” Soon-Shiong is the company’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and is a global thought leader in advancing the goal of a cancer-free society.

On its website announcing the honor, OncoDaily highlighted Soon-Shiong’s extensive scientific and research accomplishments, noting that The 100 Most Influential People in Oncology in 2025 recognizes changemakers in cancer care who have helped shape current oncology practice and continue to drive innovation across research, patient outcomes, advocacy, philanthropy, leadership, and education.

OncoDaily, the “Voice of Oncology,” is a respected global source of news and information about developments in oncology, whose editorial staff and advisory board is comprised of leading academics, researchers and physicians specializing in cancer. Its annual Influential People list highlights individuals whose work is shaping oncology through clinical leadership, scientific innovation, education, advocacy, and philanthropy.

“Dr. Soon-Shiong has earned this honor in recognition of his lifelong commitment to science, medicine, and patient care, a commitment that inspires our team and our partners every day,” said Richard Adcock, President and CEO of ImmunityBio. “His ideas and leadership are a driving force powering our mission to bring transformative therapies to people living with cancer and other serious diseases.”

About ImmunityBio

ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements, if any, regarding the potential implications of the recognition of Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. by OncoDaily as one of the most influential people in oncology in 2025. Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual outcomes or results to differ materially from those expressed or implied by these statements. These risks and uncertainties include, but are not limited to, changes in business, regulatory, scientific, or market conditions. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company’s Form 10-Q filed with the SEC on November 5, 2025 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

Contacts

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media

Sarah Singleton

ImmunityBio, Inc.

+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

CEL-SCI Reports Fiscal 2025 Results




CEL-SCI Reports Fiscal 2025 Results

• Filed for Breakthrough Designation for Multikine in Saudi Arabia
• A 212-patient Confirmatory Registration Study for Multikine in PD-L1 low newly diagnosed head and neck cancer patients is currently in final stage of preparations – enrollment expected to begin Spring 2026
• Plans to seek early approval in U.S. based on pre-surgical response rate upon full enrollment

VIENNA, Va.–(BUSINESS WIRE)–$CVM #Multikine–CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2025, as well as key clinical and corporate developments.

“During fiscal 2025, our regulatory advancements accelerated driven by new opportunities for Multikine in Saudi Arabia and the green light we have received for our Confirmatory Registration trial in the U.S.,” stated CEL-SCI CEO, Geert Kersten. “The Confirmatory Registration study required by the FDA is designed to confirm data from our prior Phase 3 study by evaluating Multikine in only those patients who showed the best type of tumor responses and survival in that study in a highly statistically significant manner. The long-term survival with our drug of 73% vs. only 45% without our drug, a huge improvement demonstrated in our prior Phase 3 study, significantly decreases risk associated with the development of Multikine as a cancer therapy. Preparations for this final registration study are ongoing, and we expect to commence enrollment in Spring 2026.”

Clinical and Corporate Developments:

• CEL-SCI is in final preparations to start enrollment of its 212-patient U.S. Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028.

• An application was submitted for Breakthrough Medicine Designation for Multikine in the treatment of head and neck cancer in Saudi Arabia as recommended by the Saudi Food and Drug Authority (SFDA). This was done in combination with a Saudi company, also as recommended by the SFDA. CEL-SCI believes it has addressed all of the scientific questions posed by the SFDA. In response to an additional request, CEL-SCI also submitted a blueprint for its strategy to support and become a part of the Saudi Arabia’s ambitious Vision 2030 goals to further advance the Kingdom’s global leadership in biotechnology.

• CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was validated and manufacturing of Multikine for the confirmatory Registration Study was completed, a significant milestone towards starting enrollment. Should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on the Breakthrough Medicine Designation, CEL-SCI is ready to manufacture and ship doses to Saudi Arabia from its U.S. facility while diversifying its geographic manufacturing base with support from Saudi counterparts.

• CEL-SCI is working closely with Ergomed, a clinical research organization (CRO) with a strong track record of fast enrolment and high-quality study delivery, to complete the final preparations for its confirmatory Registration Study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study.

• A new study supports CEL-SCI’s strategy to seek early approval in the U.S. The third-party study recently published in Cancer Cell titled “Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies” provides support for CEL-SCI’s approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The data give further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.

• More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June 2025, the FDA approved Merck’s KEYTRUDA® (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine. Importantly, while Keytruda confers benefit in patients with a high levels of PD-L1, Multikine has been shown to significantly extend life in patients with low to zero levels of PD-L1. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival.

Financial Results

During the fiscal year ended September 30, 2025, research and development expenses were $15.9 million, which decreased by approximately $2.3 million, or 13%, compared to the year ended September 30, 2024. General and administrative expenses in fiscal 2025 were $8.9 million, which increased by approximately $0.7 million, or 9%, compared to the year ended September 30, 2024. Net loss available to common shareholders decreased by $2.2 million to approximately $25.4 million for the twelve months ended September 30, 2025 from $27.6 million in fiscal 2024. The operating cash expenditures for the year were approximately $17.1 million. CEL-SCI’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to CEL-SCI’s ability to continue as a going concern. CEL-SCI raised gross proceeds of approximately $28.3 million in fiscal 2025 through the sale of common stock.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system “target” the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words “intends,” “believes,” “anticipated,” “plans” and “expects,” and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2025. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

Contacts

COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

1 Day Essential Overview of the Pharmaceutical and Biotech Industries Training Course (ONLINE EVENT: March 12, 2026) – ResearchAndMarkets.com




1 Day Essential Overview of the Pharmaceutical and Biotech Industries Training Course (ONLINE EVENT: March 12, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–“An Essential Overview of the Pharmaceutical and Biotech Industries Training Course (Mar 12, 2026)” has been added to ResearchAndMarkets.com’s offering.

The pharmaceutical and biotechnology industries are both complex and developing at a rapid pace.

This intensive one-day course will give you an invaluable overview, refresher and update on all the important aspects from discovery of the molecule through development to marketing. The interactive programme will provide a step-by-step understanding of the main areas of drug development and will discuss the roles and responsibilities of key departments and how they work and interact together.

There will be interactive discussion sessions throughout the day, led by our expert course leader, and you will come away with a good knowledge of the structure and function of these industries.

Who Should Attend:

This event will be of interest to all those looking to develop their knowledge of how the pharmaceutical and biotechnology industries work. It will be particularly helpful for those wanting to understand what other departments do, for new staff working in the industry and for non-scientific and administrative personnel.

Why you should attend

• Increase your understanding of the pharma/biotech industries
• Develop your knowledge of the stages of drug development from drug discovery through to marketing
• Get to grips with the phases of clinical trials, regulatory processes and pharmacovigilance requirements
• Understand the roles and responsibilities of key departments and how they work together
• Demystify the technical terminology and jargon

Certification:

• CPD: 6 hours for your records
• Certificate of completion

Key Topics Covered:

How the Pharma/Biotech Industries Develop Medicines

• Overview of drug development
• Framework of the industry – research, development and manufacture of pharma products on an international level
• Difference between pharma and biotech drug development
• Drug discovery
• Non-clinical/pre-clinical – the importance of examining safety
• Technologies and innovations across the industry

Demystifying the Jargon and Terminology

Roles and Responsibilities of the People in the Pharma/Biotech Industries

Clinical Trials

• Phases of clinical research – phase 1 to Phase IV and range of clinical trials
• Setting up and running of clinical trials
• Quality of the data – monitoring, auditing and compliance with GCP innovations in running clinical trials

Pharmacovigilance

• Understanding safety reporting and signal detection
• Definitions and periodic and drug safety update reports

Regulatory Processes

• Overview of regulatory submissions and approval procedures for pharma/biotech products including EU and FDA procedures
• The importance of ICH including the electronic Common Technical Document (eCTD)
• The EU Clinical Trial Regulation

Commercial Considerations for How Medicines are Marketed and Sold

• Marketing terminology and activities

Speakers:

Laura Brown

Pharmaceutical QA and Training Consultant

University of Cardiff

Dr Laura Brown MBA, BSc, PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International.

She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.

For more information about this training visit https://www.researchandmarkets.com/r/ltwv29

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Omeros Announces New Date for YARTEMLEA® Approval Conference Call




Omeros Announces New Date for YARTEMLEA® Approval Conference Call

— Omeros to Host Conference Call Wednesday, January 7, 2026 at 4:30 p.m. ET —

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced a revised date for its conference call to discuss the recent FDA approval of YARTEMLEA^® (narsoplimab-wuug), the first and only therapy indicated for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

To ensure broad participation following this significant milestone — and to accommodate shareholders’ and investors’ holiday schedules — the call will now take place on Wednesday, January 7, 2026 at 4:30 p.m. Eastern Time. Details for the webcast and registration remain unchanged and are provided below.

We are excited to kick off the new year by sharing more about this landmark approval and our January 2, 2026 U.S. market launch of YARTEMLEA.

Conference Call and Webcast

Wednesday, January 7, 2026 at 4:30 p.m. Eastern Time

Live webcast: Access the live webcast at https://investor.omeros.com/upcoming-events.

Conference call (phone): To join by phone, participants must register at https://register-conf.media-server.com/register/BI860d4c7c1e5d4bb1a77988a530e78171 to receive a unique PIN. After registering, you may either:

1. dial in using the conference line and PIN provided at the registration site; or
2. select the “Call Me” option to receive an automated call to the phone number that you provide.

If you lose your PIN or registration confirmation email, please re-register to receive a new PIN.

Replay: A replay will be made available at https://investor.omeros.com/archived-events.

About YARTEMLEA^®

YARTEMLEA^® (narsoplimab-wuug), a fully human monoclonal antibody, is the first and only approved inhibitor of the lectin pathway of complement. YARTEMLEA inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway. In hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation. By selectively blocking activation of the lectin pathway, YARTEMLEA preserves classical and alternative pathway activity, including functions essential to the adaptive immune response.

YARTEMLEA is approved by the U.S. FDA for the treatment of TA-TMA in adults and in children ages two years and older. A marketing authorization application for YARTEMLEA for TA-TMA is under review by the European Medicines Agency (EMA) with a decision expected in mid-2026.

YARTEMLEA has received breakthrough therapy and orphan drug designations from the FDA for TA-TMA, and the EMA has granted it orphan drug designation in hematopoietic stem-cell transplantation.

YARTEMLEA is the first and only approved therapy for TA-TMA.

About Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children. TA-TMA is driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors, with activation of the lectin pathway of complement playing a central role in disease pathogenesis.

TA-TMA can occur following both autologous and allogeneic transplant, with higher prevalence after allogeneic procedures. Approximately 30,000 allogeneic transplants are performed annually in the U.S. and Europe. Recent studies estimate that TA-TMA develops in up to 56 percent of allogeneic transplant recipients. Mortality in severe TA-TMA can exceed 90 percent, and survivors frequently face long-term renal complications, including dialysis dependence.

YARTEMLEA^® is the only approved treatment for TA-TMA.

About Omeros Corporation

Omeros is an innovative biotechnology company that discovers, develops, and commercializes first-in-class small-molecule and protein therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead lectin pathway inhibitor YARTEMLEA^®, which inhibits the pathway’s effector enzyme MASP-2, is FDA-approved for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients ages two years and older, with a planned U.S. launch in January 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by the European Medicines Agency, with a decision expected in mid-2026. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), a MASP-3 inhibitor in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder and fully funded by the National Institute on Drug Abuse, as well as a growing portfolio of novel molecular and cellular oncology programs. For more information about Omeros and its programs, visit www.omeros.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the marketing authorization application for YARTEMLEA^® in Europe, prospects for obtaining EMA approval of YARTEMLEA in any indication, plans and expectations regarding the commercial launch of YARTEMLEA in the U.S., and in the EU following any EMA approval, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA, plans for development of zaltenibart or other products under the asset purchase and license agreement, and the potential therapeutic benefits of zaltenibart and its commercial prospects, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in the YARTEMLEA MAA, inability to respond satisfactorily to information requests during regulatory review of the YARTEMLEA MAA, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether the EMA determines the registry used in our statistical analysis is sufficiently representative of TA-TMA patients, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties, and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2025 and in subsequently filed Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

Contacts

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

CareDx Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




CareDx Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA), — The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the award of inducement grants.

On December 19, 2025, as an inducement material to acceptance of employment with CareDx, 39 new employees were awarded restricted stock units (RSUs) for an aggregate of 80,425 shares of common stock.

The RSU awards were made pursuant to the Company’s 2025 Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over four years, with 25% of the RSUs vesting on the first anniversary of each employee’s vesting commencement date, and 1/16th of the RSUs vesting on each date that is three (3) months thereafter subject to each employee’s continued service through each vesting date.

CareDx is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

Contacts

CareDx

Media Contacts

Natasha Moshirian Wagner

nwagner@caredx.com

Investor Relations

Caroline Corner

investor@caredx.com

Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd – Mar 3rd, 2026) – ResearchAndMarkets.com




Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd – Mar 3rd, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course (Mar 2nd – Mar 3rd, 2026)” training has been added to ResearchAndMarkets.com’s offering.

Understand the regulatory frameworks governing drug/device and device/drug combinations in the European Union and the USA.

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing.

At the same time, cell therapy and tissue-engineered products are being combined with both pharmaceuticals and medical devices. This course will address the European and FDA regulatory requirements, help you define the regulatory route for your product and offer practical guidance on Notified Body expectations, clinical trial considerations and post-market surveillance of borderline products.

Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.

By the end of the course, participants will have the knowledge and skills needed to navigate the complex regulatory landscape for drug/device and device/drug combinations in the EU and the USA effectively. They will be equipped to ensure compliance with the regulatory requirements and facilitate the successful development and commercialisation of these innovative products.

PRE-SEMINAR READING – It is recommended that you have read the EU Medical Device Regulation, particularly, Article 120 and the General Safety & Performance Requirements (Annex I) and Technical Documentation (Annexes II and III). For the US, review FDA’s Office of Combination Products website prior to attending this seminar.

Benefits of attending

• Understand the European regulatory guidance
• Know what your competent authority expects
• Gain an insight into notified bodies’ considerations on drug/device products
• Learn how to define the approval route for your product
• Clarify the major differences in documentation and approval routes
• Consider quality systems requirements for combination products
• Discover the FDA’s regulatory approach to combination products
• Hear how to deal with human tissue-engineered products
• Stay up-to-date on post-market surveillance for combination products

Who Should Attend:

Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who need to understand the complex requirements applicable to medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Key Topics Covered:

Day 1

Introductory overview

• Regulatory agencies in the EU and the USA
• Impact of the revision to the MDD
• Transitional period from the MDD to the MDR
• EU regulatory reform proposals
• EMA’s viewpoint management
• Evolving regulatory landscape
• Emerging trends

European regulatory guidance: drug/device and device/drug combination products

• European regulatory framework for drug/device and device/drug combinations
• Legal EU definitions of a drug/device and device/drug combination
• Article 117: EU requirements for integral drug/device combinations
• ‘In exclusive use with’
• Other combinations – AI systems etc.

European regulatory guidance continued

• Risk management and compliance strategies
• Interactions with regulatory agencies and stakeholders
• Best practices for navigating the regulatory landscape

Defining the regulatory approval pathway for your product

• Product classification
• Differences between devices containing ancillary medicinal substances and medicinal products
• Responsibilities of regulatory affairs professionals in product development commercialisation

Medical device CE certification – notified body expectations

• CE marking process for medical devices
• Devices containing ancillary medicinal substances
• Post CE marking expectations and changes
• Notified Body Opinion (NBOp)

MDR’s impact on the medicinal product directive

• Article 117

Documentation requirements

• Preparing regulatory submissions for drug/device and device/drug combinations
• General Safety and Performance Requirements (GSPR) checklist

Day 2

Clinical trial considerations

• How the regulatory pathway for the final marketed product determines the clinical trial regulation to be followed
• Clinical Trials Directive 2001/20/EC – medicines
• Requirements for clinical development of medical devices
• Clinical data requirements and post-marketing surveillance

Product information

• Labelling requirements under the MDR
• Labelling for combination products
• Electronic Product Information (ePI)

Companion diagnostics

• Regulatory considerations

UK post-Brexit

• UK IRP: International Recognition Procedure

Pharmacovigilance for combination products: vigilance or pharmacovigilance

• Understanding the differences between medical device vigilance and pharmacovigilance
• How to handle the challenges posed by combination products
• Pharmacovigilance reporting
• Device vigilance reporting

FDA’s approach to combination products

• Background and legal framework
• Definitions of drug, biologics and medical device
• “Borderline” issues and products (v. combination products)
• Types of combination products
• Primary mode of action and FDA’s assignment algorithm
• Jurisdiction and designation process

FDA’s approach to combination products (continued)

• Submission and regulatory pathways
• Current GMP and quality system requirements
• Post-market safety reporting requirements
• Strategies for development and summary points

For more information about this training visit https://www.researchandmarkets.com/r/3gcfku

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Softgel Capsules Market Outlook Report 2025-2032: Increasing Adoption of Plant-Based Gelling Agents in Softgel Production to Meet Vegan and Clean Label Consumer Demand – ResearchAndMarkets.com




Softgel Capsules Market Outlook Report 2025-2032: Increasing Adoption of Plant-Based Gelling Agents in Softgel Production to Meet Vegan and Clean Label Consumer Demand – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Softgel Capsules Market – Global Forecast 2025-2032” has been added to ResearchAndMarkets.com’s offering.

Senior executives face a rapidly evolving softgel capsules market shaped by new technologies, regulatory demands, and sustainability considerations. Informed, agile strategy is essential to capture value and manage emerging industry risks.

Market Snapshot: Growth Trajectory of the Softgel Capsules Market

The global softgel capsules market expanded from USD 4.48 billion in 2024 to USD 4.84 billion in 2025 and is projected to maintain a CAGR of 7.98%, reaching USD 8.28 billion by 2032. This growth reflects widespread adoption across healthcare, wellness, and consumer-facing industries. Adoption is driven by rising demand for plant-based options, regulatory evolution, and advancements in formulation technologies. The sector’s momentum is underpinned by robust application in pharmaceuticals, nutraceuticals, animal health, and cosmetics, with both producer and consumer priorities reinforcing the positive industry outlook.

Scope & Segmentation of the Softgel Capsules Market

This market research report provides a detailed analysis of the softgel capsules market, focusing on key value segments, technological developments, and changing regional dynamics. Each segment is designed to equip decision-makers with actionable intelligence relevant to sourcing, production, and product differentiation.

• Ingredient Types: Coverage includes traditional sources like bovine, fish, and porcine gelatin, as well as vegetarian alternatives such as carrageenan, pullulan, and starch-addressing trends in regulatory compliance, ethical preferences, and sustainability.
• Product Types: Profiles coated, liquid-filled, multi-layer, and standard softgel formats, each tailored for unique stability, formulation, and regulatory requirements across end uses.
• Applications: Utilization is explored in animal health, cosmetics (hair care, skin care, makeup), dietary supplements (multivitamins, omega-3s, probiotics), and the pharmaceutical sector, demonstrating a broad and diverse field of application.
• End Users: Analyzes strategies targeting adults, elderly populations, and pediatric segments, where precise delivery formats and formulation adaptation are crucial for product success.
• Regions Covered: Provides insights into mature and emerging markets including the Americas (North and Latin America), Europe, Middle East & Africa, and Asia-Pacific, considering region-specific regulations and growth factors.
• Key Industry Players: Highlights Catalent, Lonza, Evonik, BASF, Thermo Fisher Scientific, Jubilant Life Sciences, Suheung, Siegfried, Aenova, and Soft Gel Technologies, giving context for competitive benchmarking and partnership development.

Key Takeaways for Senior Decision-Makers

• Softgel capsules enhance bioavailability and patient adherence, providing diversified solutions for healthcare, wellness, and consumer segments.
• The adoption of new encapsulation technologies and alternative ingredients fosters more sustainable pathways, enabling companies to meet shifting consumer and regulatory demands effectively.
• Supply-side adaptation, with manufacturers prioritizing cleaner-label and responsibly sourced ingredients, elevates compliance and market acceptance.
• Digital controls and advanced automation technologies support batch consistency, efficient process workflows, and reduced production losses, thereby optimizing operational effectiveness.
• Geographically localized production and supply chain collaboration build greater resilience, especially in regions sensitive to regulatory or logistical shifts.
• Targeted segmentation facilitates precise product differentiation, allowing businesses to create value for specific end-user groups within the expanding application landscape.

Why This Report Matters for B2B Strategy

• Equips leaders to anticipate emerging regulatory, technology, and sourcing trends that will shape product pipeline development and market positioning within the softgel capsules market.
• Offers a region-specific assessment of growth drivers and competitor dynamics, facilitating well-informed resource allocation and collaboration decisions.
• Enables organizations to proactively recognize market risks and opportunities, informing entry, investment, and expansion strategies aligned with long-term objectives.

Conclusion

Leveraging informed intelligence positions organizations to achieve sustainable growth, establish robust supplier relationships, and maintain compliance in an increasingly regulated and complex softgel capsules market.

Insights stem from direct interviews with R&D specialists, procurement leaders, and industry consultants. The analysis is supported by reviewing peer-reviewed research, technical publications, and updated regulatory filings. Stringent validation protocols are applied to deliver actionable and dependable data for strategic planning.

Key Attributes

Market Insights

• Incorporation of advanced encapsulation techniques using spray congealing and extrusion spheronization for enhanced bioavailability in softgel capsules
• Increasing adoption of plant-based gelling agents such as agar and carrageenan in softgel production to meet vegan and clean label consumer demand
• Integration of digital supply chain tracking and serialization technologies for real-time quality assurance in softgel manufacturing processes
• Development of multifunctional softgel capsules combining omega fatty acids with probiotics and botanical extracts for holistic health support
• Rising investment in continuous manufacturing platforms to reduce production costs and accelerate time to market for softgel products
• Collaboration between nutraceutical companies and biopolymer researchers to create biodegradable softgel shells with reduced environmental impact
• Application of AI-driven formulation optimization to design next-generation softgel capsules with targeted release profiles and minimal excipients

The companies profiled in this Softgel Capsules market report include:

• Catalent, Inc.
• Lonza Group AG
• Evonik Industries AG
• BASF SE
• Thermo Fisher Scientific Inc.
• Jubilant Life Sciences Ltd.
• Suheung Co., Ltd.
• Siegfried Holding AG
• Aenova GmbH
• Soft Gel Technologies, LLC

For more information about this report visit https://www.researchandmarkets.com/r/w1chp4

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Kerecis Fish-Skin Platform Broadens Coverage as CMS Withdraws Proposed Skin Substitute LCDs




Kerecis Fish-Skin Platform Broadens Coverage as CMS Withdraws Proposed Skin Substitute LCDs

Legacy coverage remains in place as Kerecis continues to lead under evolving Medicare payment models

ARLINGTON, Va. & REYKJAVIK, Iceland–(BUSINESS WIRE)–#kerecis–Kerecis, the company pioneering the use of sustainably sourced fish skin in cellular therapy and tissue regeneration, today reaffirmed the strength of its fish-skin platform following the December 24, 2025 announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) that its A/B Medicare Administrative Contractors (MACs) have withdrawn the proposed Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products in the outpatient setting.

The withdrawn LCDs, that were just recently updated on December 15^th and scheduled to take effect on January 1, 2026, would have introduced coverage limitations to certain products and certain wound types. The withdrawn LCDs covered diabetic foot ulcers and venous leg ulcers but would not have covered other wound types. Their withdrawal reverts coverage back to the existing MAC LCDs, commonly referred to as the Legacy Policies.

Under the current framework:

• Legacy LCDs across MACs such as CGS, Novitas, and FCSO continue unchanged. Palmetto, NGS, WPS, and Noridian remain without an active LCD.
• The previously announced $127/cm² fixed payment rate will still take effect on January 1, 2026.
• Coverage for additional wound types, including pressure ulcers and surgical wounds that have failed 30 days of conservative care, remains available.
• The maximum application frequency remains 10 applications, rather than the reduced limit proposed in the withdrawn LCDs.

Kerecis has built its outpatient Medicare business operating under the Legacy Policies, establishing a strong and defensible market position. With an average outpatient Medicare price of approximately $110/cm², Kerecis’ fish-skin grafts are well aligned with the upcoming fixed payment structure, reinforcing the company’s ability to compete effectively as reimbursement models evolve. Kerecis strong body of evidence makes it ready for any new coverage rules that might emerge from this.

“We have built Kerecis to win in the real-world clinical and reimbursement environment,” said Fertram Sigurjonsson, Coloplast EVP of Wound & Tissue Repair and CEO of Kerecis. “While others scramble to restructure their pricing or fight coverage: our fish-skin technology, pricing discipline, and broad coverage position make us a safe harbor for providers today and a strong competitor as the market continues to change.”

Kerecis remains focused on expanding access, supporting clinicians, and advancing tissue regeneration through its fish-skin platform.

About Kerecis

Kerecis, founded by Fertram Sigurjonsson, develops intact fish tissue derived products for cellular therapy, tissue regeneration, and protection. When grafted onto damaged human tissue or implanted, the patented material supports the body’s own processes to heal and regenerate. Because no viral or prion transfer risk exists between Atlantic cod and humans, Kerecis products are only gently processed and retain their similarity to human tissue. The gentle processing preserves the material’s original three-dimensional structure, maintaining its inherent natural strength, complexity, and molecules (such as fatty acids). Clinical studies show that Kerecis products heal wounds faster than competitors. Kerecis is the only global manufacturer of medical devices containing intact fish-tissue and is the fastest growing company in the U.S. xenograft biologics skin market. Products include SurgiBind®/SurgiClose®, GraftGuide®, MariGen®, and Shield™ for various medical applications. Committed to the UN Sustainable Development Goals, Kerecis uses sustainably sourced Icelandic fish processed with renewable energy. Kerecis is a part of Coloplast, a leading supplier of intimate healthcare products. For more information about Kerecis and its clinical research, visit www.kerecis.com.

Trademarks and registered trademarks are the property of their respective owners.

Contacts

Media Relations Agency

(952) 697 5220

Adicet Bio Announces Reverse Stock Split




Adicet Bio Announces Reverse Stock Split

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that its board of directors has determined to effect a one-for-16 reverse stock split of Adicet’s common stock, par value $0.0001 per share.

The reverse stock split ratio approved by the board of directors is within the previously disclosed range of ratios for a reverse stock split authorized by the stockholders of the company at the 2025 Special Meeting of Stockholders of Adicet held on December 19, 2025. The reverse stock split will take effect at 12:01 a.m. Eastern Time on December 30, 2025, and Adicet’s common stock will begin trading on a split-adjusted basis on The Nasdaq Capital Market as of the opening of trading on December 30, 2025. The CUSIP number of 007002207 will be assigned to Adicet’s common stock when the reverse stock split becomes effective.

When the reverse stock split becomes effective, every sixteen (16) of Adicet’s issued shares of common stock will be combined into one issued share of common stock, without any change to the par value per share. This will reduce the number of outstanding shares of common stock from approximately 153.3 million shares to approximately 9.6 million shares. The reverse stock split will not affect the absolute number of Adicet’s authorized shares of common stock, which will remain at 300,000,000, but the total number of shares of Adicet’s common stock available for future issuance will increase.

Proportional adjustments will also be made to the number of shares of common stock awarded and available for issuance under Adicet’s equity incentive plans, as well as the exercise price and the number of shares issuable upon the exercise or conversion of Adicet’s outstanding stock options and other equity securities under Adicet’s equity incentive plans. All outstanding pre-funded warrants will also be adjusted in accordance with their terms, which will result in proportionate adjustments being made to the number of shares issuable upon exercise of such warrants and to the exercise prices of such warrants, as applicable.

No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise be entitled to receive fractional shares will automatically be entitled to receive cash in lieu of such fractional share.

Stockholders with shares held in book-entry form or through a bank, broker, or other nominee are not required to take any action and will see the consequence of the reverse stock split reflected in their accounts on or after December 30, 2025. Such beneficial holders may contact their bank, broker, or nominee for more information.

The reverse stock split is intended to enable Adicet to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

About Adicet Bio, Inc.

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the timing and completion of the reverse stock split, the intended effects of the reverse stock split and trading of Adicet’s common stock on a split-adjusted basis, and the effect the reverse stock split will have on Adicet’s ability to regain compliance with the Nasdaq listing standards.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, quarterly reports on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.

Contacts

Adicet Bio, Inc.
Investor and Media Contacts
Anne Bowdidge

abowdidge@adicetbio.com

Penelope Belnap
Precision AQ
212-362-1200

Penelope.belnap@precisionaq.com