Niki BioSolutions, Inc.

Niki BioSolutions, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of therapeutic assets for diseases with unmet medical needs, specifically in oncology (including orphan oncology indications) and infectious diseases. As of December 31, 2025, and the current date, Niki BioSolutions operates in a single segment, concentrating all its efforts on research and development, and no longer provides any clinical services. The company aims to develop a broad range of novel and repurposed therapeutics and diagnostics technology across various disease and therapeutic areas. Its strategy includes developing innovations across these areas, selectively expanding its portfolio with potential products for orphan drug designation or unmet medical needs, collaborating with academic institutions and Contract Research Organizations (CROs), expanding its in-house pharmaceutical development center, leveraging management expertise and commercial networks, and obtaining government grants for project funding. Niki BioSolutions' lead projects are ALS-4 and SACT-1. ALS-4 is a small drug molecule designed to target products produced by bacterial genes that facilitate bacterial colonization, survival, or cause damage, referred to as "virulence expression." This approach to antimicrobial therapy aims to address antibiotic-resistant bacteria. SACT-1 is a repurposed drug candidate developed under the proprietary Smart-ACT drug discovery platform. Its initial targeted indication is neuroblastoma, a rare cancer classified as an orphan disease, predominantly affecting children aged 5 years and below. In March 2023, Niki BioSolutions completed Pre-IND discussions with the US FDA for ALS-4.