New Biotic

Executive Summary

New Biotic is a San Diego-based biotechnology company pioneering the development of novel therapeutics derived from the human microbiome to treat neurological diseases. The company leverages the gut-brain axis to address complex pathologies, with a primary focus on Amyotrophic Lateral Sclerosis (ALS). Its lead candidate, RaphaLX™, is a biotherapeutic that has received Orphan Drug Designation from the FDA. New Biotic’s approach targets muscle atrophy and glutamate excitotoxicity, two key drivers of ALS progression, offering a differentiated mechanism compared to existing therapies. The company is currently advancing RaphaLX through preclinical and early clinical stages, aiming to address the high unmet need in ALS, where few disease-modifying treatments exist. With a strong scientific foundation in microbiome research and a clear focus on neurological indications, New Biotic is positioned to contribute to the emerging field of microbiome-based neurotherapeutics. New Biotic’s strategy centers on translating microbiome insights into tangible treatments. The company’s lead asset, RaphaLX, is being developed for ALS, a rapidly progressive neurodegenerative disease with limited options. Preclinical data suggests RaphaLX modulates the gut microbiome to reduce neuroinflammation and excitotoxicity. The company is expected to initiate Phase 1/2 trials in the near term, with potential clinical data readouts anticipated in 2026. Additionally, New Biotic is exploring pipeline expansion into other neurodegenerative conditions such as Alzheimer's disease. The company’s orphan designation provides regulatory advantages, including market exclusivity upon approval. With a seasoned management team and strategic partnerships, New Biotic represents a compelling opportunity in the microbiome therapeutics space, though it remains at an early stage with inherent development risks.

Upcoming Catalysts (preview)

• Q3 2026Initiation of Phase 1/2 trial for RaphaLX in ALS65% success
• Q4 2026Presentation of preclinical data for Alzheimer's disease program70% success
• Q2 2027Strategic partnership or licensing deal for RaphaLX50% success