NetraMark Holdings (AIAI) H.C. Wainwright 28th Annual Global Investment Conference summary

Industry challenges and technology overview

• Clinical trial success rates are below 12%, with phase III failure rates reaching up to 65% depending on the therapeutic area.

• Traditional data analysis methods struggle to identify key variables causing trial failures.

• NetraAI technology analyzes clinical trial data to identify subgroups impacting drug response, placebo effects, and adverse events.

• The technology is purpose-built for small, noisy clinical trial datasets and is not based on large language models.

• Case studies show NetraAI can reveal subgroups that improve trial design and increase the likelihood of phase III success.

Commercialization and validation

• Commercialization relies on institutional collaborations, FDA engagement, and peer-reviewed validation.

• Collaborations include NIMH, Mayo Clinic, CAMH, and FMP, with published work in Nature and npj Digital Medicine.

• Achieved a Critical Path Innovation Meeting with the FDA, confirming the technology's novelty and pathway for use in clinical trials.

• Peer-reviewed publications validate the technology across psychiatry, oncology, and CNS fields.

• Competitive moat includes unique FDA engagement, proprietary mathematical paradigm, and scientific validation.

Market opportunity and business model

• Addressable market estimated at CAD 10 billion, based on over 34,000 phase II and III trials globally and average project fees of CAD 300,000–400,000.

• Pricing power could double the addressable market if project fees increase.

• Dual commercialization strategy: direct-to-sponsor and channel partners (CROs), with over 50 active opportunities and 10 repeat contracts with a NASDAQ-listed client.

• Strategic partnership with Worldwide Clinical Trials, a major CRO operating in 70 countries, to expand market reach.

• Leadership team includes experienced executives from technology and pharmaceutical sectors, with strong regulatory and scientific backgrounds.