Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced a Start-Up Agreement with Mass General Brigham (MGB) to begin detailed planning for what is envisioned to be the largest and most comprehensive clinical trial of Niagen (patented nicotinamide riboside or NR) to date.

“This agreement reflects the next stage of responsible NAD+ science,” said Rob Fried, CEO of Niagen Bioscience. “As NAD+ continues to gain mainstream attention, a larger, longer, well-designed trial is needed to study the preventative, long term benefits of this remarkable ingredient, Niagen. The established products such as multivitamins, fish oil, and vitamin D have earned trust through large, long-term trials. We believe it is time for Niagen to earn similar status and adoption.”

As an investigator-led study, MGB is developing the proposed trial in collaboration with the Niagen Research Program, the Company’s external research program supporting independent and collaborative research on food-grade and pharmaceutical-grade Niagen and other precursors. The prospective, randomized, placebo-controlled clinical trial is designed to evaluate Niagen’s short- and long-term effects on major clinical and healthy aging outcomes and related biomarkers in a large number of apparently healthy adults aged 50 and older.

In addition to the two founding collaborators, MGB and Niagen Bioscience, the initiative seeks interest from other academic, nonprofit, philanthropic, and industry organizations aligned with the project’s scientific goals and willing to contribute meaningful expertise or resources to support trial planning and execution.

“Large-scale prevention trials are essential to understanding how nutrition interventions definitively impact clinically meaningful outcomes over time,” said Howard Sesso, ScD, MPH, Associate Director, Division of Preventive Medicine, Brigham and Women’s Hospital and Associate Professor of Medicine, Harvard Medical School. “Our unique hybrid randomized trial design will allow us to evaluate Niagen supplementation that combines clinical, functional, and wellness outcomes with novel biomarker measures and other innovative assessments relevant to aging biology and mechanisms of effect in subsets of participants.”

Outcomes under consideration include major morbidity and mortality; functional measures of Intrinsic Capacity (IC), such as physical activity, cognition, and fatigue; wellness outcomes such as energy and sleep; and biomarker-based measures related to biological aging, inflammation, and NAD+ status. Final trial design elements such as sample size, supplemental dose, duration, clinical endpoints, regulatory review, and logistics remain subject to ongoing planning, budgeting, and final agreements.

The proposed trial will build on prior large-scale nutrition and prevention research and clinical trials spearheaded by Dr. Sesso and colleagues at the Brigham and Women’s Hospital Division of Preventive Medicine while incorporating advances in biomarker science and innovative assessments of healthy aging. This trial design is expected to maximize the investment’s scientific value by enabling researchers to evaluate multiple relevant endpoints within one integrated trial framework.

Through the Niagen Research Program, independent investigators from world-renowned institutions have historically requested Niagen for pre-clinical and clinical research on NAD+ biology. The program provides oral food-grade and pharmaceutical-grade Niagen research materials, scientific collaboration, and technical support. To date, more than 45 peer-reviewed clinical studies have been published on Niagen, and the program supports more than 175 ongoing and developing research studies.

Niagen stands out in the NAD+ category for its extensive human clinical research, patented nicotinamide riboside technology, rigorous quality protocols, and established scientific standards. Earlier this year, nicotinamide riboside chloride, the patented form of NR in Niagen, became the first among NR, NMN, and NAD+ to receive a published United States Pharmacopeia dietary supplement ingredient monograph, establishing an independent quality benchmark for NRCl.

Interested collaborators can contact Dr. Andrew Shao (andrew.shao@niagenbio.com) and Dr. Howard Sesso (hsesso@bwh.harvard.edu) for information on how to get involved.

For additional information on Niagen, visit www.niagenbioscience.com.

About Niagen Bioscience:

Niagen Bioscience, Inc. (NASDAQ: NAGE) is the global authority in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.

The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.

Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.

At the heart of its clinically proven product portfolio is Niagen® (patented nicotinamide riboside, or NR), the most efficient, well-researched, and high-quality NAD+ booster available. Niagen powers the Company’s consumer supplement, Tru Niagen®, the number one NAD+ boosting oral supplement in the United States† (available at www.truniagen.com), and Niagen™ Plus, featuring pharmaceutical-grade intravenous (IV) and injectable Niagen products (www.niagenplus.com). Pharmaceutical-grade Niagen IV and injections are compounded and distributed by U.S. FDA-registered 503B outsourcing facilities and are available exclusively at clinics with a prescription.

Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.

†Based on revenue per largest U.S. e-commerce marketplace (Jan. 2025 – Dec. 2025)

Forward Looking Statements:

This 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. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects,” “anticipates,” “intends” “estimates,” “plans,” “potential,” “possible,” “probable,” “believes” “seeks,” “may,” “will,” “should,” “could,” “predicts,” “projects,” “continue,” “would” or the negative of such terms or other similar expressions.

Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those described. These risks and uncertainties include, but are not limited to, inflationary conditions and adverse economic conditions; our history of operating losses; the growth and profitability of our product sales; our ability to maintain and grow sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; risks of conducting business in China; including unanticipated developments in and risks related to the Company’s ability to secure adequate quantities of pharmaceutical-grade Niagen in a timely manner; the Company’s ability to obtain appropriate contracts and arrangements with U.S. FDA-registered 503B outsourcing facilities required to compound and distribute pharmaceutical-grade Niagen to clinics; the Company’s ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company’s ability to maintain and enforce the Company’s existing intellectual property and obtain new patents; whether the potential benefits of NRC can be further supported; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities, including with respect to products seeking to compete in our market; mislabeling or other misleading marketing practices by competitors; economic and market instability, including as a result of tariffs or trade conflicts; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and Niagen Bioscience undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

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