KALA News & Events

Red Light Holland and Kala Bio announced that Red Light has engaged Kala Bio's with its Researgency.ai agentic artificial intelligence platform under world wide license from Younet to support the clinical development strategy for PEX010, the patented botanical psilocybin drug candidate originated by Filament Health. The engagement will deploy Kala Bio's purpose-built AI research agents to assist in clinical planning, protocol optimization and scenario modeling as Red Light advances PEX010 through its regulated drug development program. Red Light recently announced a definitive arrangement agreement to acquire Filament's business, including its portfolio of 76 issued patents across 15 patent families, representing one of the largest intellectual property portfolios in botanical psilocybin drug development, as well as its lead drug candidate, PEX010. The engagement of the Kala's Researgency.ai platform represents a key element of Red Light's strategy to integrate advanced AI-driven research capabilities as it expands its regulated psychedelic drug development platform. PEX010 is Filament's patented botanical psilocybin drug candidate and is currently supplied to more than 70 clinical research sites worldwide, making it one of the most widely studied botanical psilocybin drug candidates in regulated clinical research. PEX010 is being studied across multiple indications, including alcohol use disorder, methamphetamine use disorder, treatment-resistant depression, cancer-related anxiety and depression, and cannabis use disorder, at leading research institutions including Johns Hopkins University and Dana-Farber Cancer Institute, among others. The drug candidate has received both Health Canada and FDA authorization for clinical trials and has demonstrated positive Phase 2 clinical data in alcohol use disorder.

Kala Bio announces that it is ready to ship its first commercial AI product in approximately 14 days, transforming the company from a clinical-stage biotech into a dual-engine growth story powered by both a proprietary drug pipeline and a scalable AI platform targeting the $180+ billion AI-in-healthcare market. Kala is building the Palantir for biotech, just as Palantir built a $250+ billion company by helping governments and enterprises make sense of massive data, Kala is doing the same for the biotech and pharmaceutical industry through its Researgency.ai platform, deploying purpose-built AI agents that handle the repetitive, high-stakes jobs that slow drug companies down, faster, cheaper, and with fewer errors than humans. With the full rebrand of Researgency.ai now complete, the platform is live and ready for enterprise clients. Kala's scientists, working alongside Younet's AI engineering team, are building the company's first custom AI agent right now, with delivery expected in approximately 14 days. This is not a rebranding announcement - this is a go-to-market readiness signal.

Kala Bio announced a strategic initiative to build a biotechnology industry dedicated, on-premises artificial intelligence infrastructure platform, designed to be deployed directly within biotech and pharmaceutical client environments, enabling companies across the life sciences sector to unlock additional potential of their proprietary biological data without ever surrendering control of it. The Company also announced that it has entered into a Platform Development and Exclusive License Agreement with 2624465 Ontario, operating as Younet AI, for a proprietary AI research platform, internally designated "Researgency," designed to deploy custom, secure, large language models, or LLMs, purpose-built for biomedical research and data science applications. The Agreement provides KALA with initial platform access during a 12-month initial term and the option, in KALA's sole discretion, to extend the Agreement for successive 12-month renewal terms. The Company's vision is to serve as a dedicated AI infrastructure partner for the biotechnology industry, deploying the Researgency platform directly within each client's own secure environment, on their own servers, under their own control. In this model, KALA would provide the AI platform, the purpose-built biomedical agents, and the ongoing optimization, while the client would retain full ownership and custody of their data at all times. The global AI drug discovery market is projected to grow at a compound annual growth rate approximately 25%, driven by AI's demonstrated ability to compress traditional drug development timelines, which historically average 10 to 15 years and cost up to $2.6B per approved drug, to potentially as little as 12 to 18 months for preclinical candidate nomination, while reducing costs by an estimated 30 to 40 percent. The world's twenty largest pharmaceutical companies collectively invested approximately $167B in research and development in 2024. Researgency is a proprietary biomedical AI research platform licensed to KALA by Younet AI, a specialized artificial intelligence development firm with experience deploying over 100 custom AI agents for enterprise clients across healthcare, technology, and life sciences sectors. The platform is expected to be capable of deploying fully on-premises, secure AI systems that operate independently of any public AI service. The Company expects to report preliminary findings from its internal AI-driven data reassessment during the 12-month initial term, providing investors with tangible evidence of the platform's capabilities prior to external deployment. Under the Agreement, KALA has secured exclusive worldwide license rights to the Researgency platform within the biotechnology field and has received initial platform access to evaluate and demonstrate its capabilities.

Kala Bio files to sell 241.44M shares of common stock for holders