Niagen Bioscience Selects Evotec as CRO to Advance IND-Enabling Development for NB4168 in Ataxia Telangiectasia

• Niagen Bioscience, Inc. (NASDAQ: NAGE) has selected Evotec (NASDAQ: EVO) as a CRO to conduct pharmacokinetic, pharmacodynamic, and bioanalytical method validation studies for NB4168 — its proprietary oral small-molecule candidate for Ataxia Telangiectasia, a rare pediatric genetic disease with no approved treatments — with work to be conducted at Evotec’s Verona, Italy campus through its INDiGO integrated preclinical-to-clinical platform.

• The engagement is designed to generate the pharmacological and bioanalytical evidence package required to advance NB4168 toward an IND submission to the FDA, building on existing nonclinical data showing substantially higher blood exposure for NB4168 compared with NR chloride and on FDA Rare Pediatric Disease and EMA Orphan Medicinal Product designations already secured for the program.

Evotec (NASDAQ: EVO; Frankfurt Prime Standard: EVT), a global life science company and CRO specializing in drug discovery and development, has been selected by Niagen Bioscience, Inc. (NASDAQ: NAGE) to support the preclinical and IND-enabling development of NB4168 — Niagen Bioscience’s proprietary oral small-molecule candidate initially developed for Ataxia Telangiectasia, a rare pediatric genetic disease with no approved therapies. The collaboration was announced on August 3, 2026, from Los Angeles, California, with work to be conducted in collaboration with NAD Pharmaceuticals Corp., Niagen Bioscience’s wholly owned subsidiary focused on rare genetic disease therapeutics.

Under the agreement, Evotec will conduct pharmacokinetic and pharmacodynamic studies and validate bioanalytical methods to further characterize NB4168 and support the generation of the data package required for an IND application submission to the FDA. Studies will be conducted at Evotec’s state-of-the-art campus in Verona, Italy, through its INDiGO platform — an integrated development offering that consolidates the ICH-directed activities required for early-phase clinical evaluation, including active pharmaceutical ingredient development, drug product development, safety studies, ADME, and regulatory and clinical services, under a single, vertically integrated CRO structure designed to accelerate timelines and reduce development risk.

NB4168 is a distinct, proprietary oral small molecule — protected by a composition-of-matter patent — designed to deliver significantly increased systemic exposure to nicotinamide riboside, which enters cells directly and is converted through the NRK pathway into NAD+. NAD+ supports biological processes including DNA repair, mitochondrial function, cellular energy production, and stress response — pathways that are disrupted in Ataxia Telangiectasia, a rare genetic disease caused by mutations in the ATM gene. A-T typically presents in early childhood with progressive loss of motor coordination, impaired immune function, pulmonary complications, and elevated cancer risk, affecting roughly 1 in 40,000 people in the U.S. In nonclinical pharmacokinetic studies conducted to date, NB4168 has demonstrated substantially higher blood exposure compared with NR chloride, supporting its continued advancement as a more bioavailable pharmaceutical candidate.

The Evotec CRO engagement follows NB4168’s receipt of FDA Rare Pediatric Disease Designation and EMA Orphan Medicinal Product Designation — regulatory milestones that provide meaningful development incentives and signal the program’s potential significance for a patient population with no currently approved treatment options. Niagen Bioscience plans to submit an IND application to the FDA in anticipation of initiating human clinical studies, with the pharmacological evidence generated through the Evotec collaboration forming a central component of that regulatory package.

“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. 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.”

Dr. Ashiq Khan, EVP and Chief Commercial Officer, Evotec