Niagen Bioscience Selects Global Drug Development Pioneer Evotec to Advance Preclinical Development for NB4168

Collaboration will support pharmacokinetic, pharmacodynamic, and bioanalytical studies for Niagen Bioscience’s lead investigational candidate for rare pediatric diseases

Evotec brings deep drug development expertise, serving leading pharmaceutical and biotechnology companies across the life sciences industry

LOS ANGELES--(BUSINESS WIRE)--$NAGE #Biotech--Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that it has selected Evotec (NASDAQ: EVO; Frankfurt Prime Standard: EVT), a global life science company specializing in drug discovery and development, as a contract research organization to support the advancement of NB4168. The work will be conducted in collaboration with NAD Pharmaceuticals Corp., Niagen Bioscience’s wholly owned subsidiary focused on developing therapies for accelerated aging and rare genetic diseases.

Under the collaboration, Evotec will conduct pharmacokinetic and pharmacodynamic studies and validate bioanalytical methods to further characterize NB4168 and support Niagen Bioscience’s preclinical and Investigational New Drug (IND)-enabling development activities. NB4168 is Niagen Bioscience’s proprietary oral small-molecule candidate initially developed for Ataxia Telangiectasia (A-T), a rare pediatric genetic disease with no approved treatments.

The studies will take place at Evotec’s state-of-the-art campus in Verona, Italy, which provides a streamlined path to the clinic through Evotec’s INDiGO platform. It integrates the ICH-directed activities required for early-phase clinical evaluation—including active pharmaceutical ingredient development, drug product development, safety, absorption, distribution, metabolism, and excretion, and regulatory and clinical services. This vertically integrated model is designed to accelerate timelines, reduce development risk and improve cost efficiency.

“Selecting Evotec adds streamlined drug development capabilities and executional scale to the NB4168 program,” said Ozan Pamir, Chief Financial Officer of Niagen Bioscience. “This collaboration is an important step in building the pharmacological and bioanalytical evidence required to advance NB4168 toward clinical evaluation in patients with A-T.”

In nonclinical pharmacokinetic studies conducted to date, NB4168 has demonstrated substantially higher blood exposure compared with NR chloride, supporting its continued development as a more bioavailable pharmaceutical candidate. Existing NR research in A-T, including two independent open-label clinical studies and several preclinical studies of NR chloride, reported improvements in neurological measures and related biomarkers (Presterud et al., 2023; Veenhuis et al., 2021; Yang et al., 2021; Fang et al., 2016).

“Our collaboration with Niagen Bioscience demonstrates the value of Evotec’s integrated development offering in supporting innovative companies as they advance assets toward the clinic,” said Dr. Ashiq Khan, EVP, Chief Commercial Officer of Evotec. “NB4168 is a promising program, supported by a defined biological rationale and a focused preclinical development plan. We look forward to helping generate the data needed to inform the next stage of development for this investigational candidate.”

About NB4168

NB4168 is a distinct, proprietary small molecule designed for oral pharmaceutical development. It is not commercially available as a supplement or approved drug and is protected by Niagen Bioscience’s patent portfolio, including a composition-of-matter patent. After oral administration, NB4168 is designed to deliver significantly increased exposure to NR, which enters cells directly and is converted through the nicotinamide riboside kinase (NRK) pathway into NAD+. NAD+ supports biological processes including DNA repair, mitochondrial function, cellular energy production and stress responses—pathways that are disrupted in A-T.

Niagen Bioscience has received U.S. Food and Drug Administration Rare Pediatric Disease Designation and European Medicines Agency Orphan Medicinal Product Designation for NB4168 for the treatment of A-T. The Company is advancing preclinical development activities and plans to submit an IND application to the FDA in anticipation of initiating human clinical studies.

About Ataxia Telangiectasia (A-T)

A-T is a rare genetic disease caused by mutations in the ATM gene. The disease typically presents in early childhood and is characterized by progressive loss of motor coordination, impaired immune function, increased susceptibility to infections, pulmonary complications, and a substantially elevated risk of cancer. Children living with A-T often experience worsening neurological disability over time, with many requiring wheelchair assistance as the disease progresses. There are currently no FDA-approved therapies for A-T, and treatment is largely limited to supportive care. A-T impacts roughly 1 in 40,000 people in the U.S. (Riboldi et al., 2023; Teive et al., 2015) and 1 in 150,000 people in Europe (Bhatt et al., 2015).

For additional information on Niagen Bioscience’s pharmaceutical program and NB4168, visit www.niagenbioscience.com/nad-pharmaceuticals.

About Niagen Bioscience

Niagen Bioscience, Inc. (NASDAQ: NAGE) is the global authority in healthy aging and NAD+ (nicotinamide adenine dinucleotide) science. 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. NAD Pharmaceuticals Corp., the Company’s wholly owned subsidiary focused on developing therapies for accelerated aging and rare genetic diseases, is conducting research on NB4168, a differentiated molecule.

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, statements regarding Niagen Bioscience's NB4168 pharmaceutical development program; planned preclinical, IND-enabling and clinical development activities; the potential timing of an IND submission or first-in-human study; the potential bioavailability, exposure, safety, tolerability, efficacy, pharmacodynamic or clinical profile of NB4168; and the Company's ability to translate its NAD+ platform into pharmaceutical products; 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.

Niagen Bioscience Media Contact:
Kendall Knysch, Senior Director of Media Relations & Partnerships
310.405.5227
kendall.knysch@niagenbio.com

Niagen Bioscience Investor Relations Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
212.896.1254
Niagen@kcsa.com