PYC Therapeutics (PYC) Investor update summary

Strategic Focus and Development Approach

• Strong operational progress with a clear focus on execution and achieving near-term human proof of concept readouts for multiple drug candidates, prioritizing data-driven milestones to attract investor support.

• Strategy is set with assets in clinical development, targeting PKD, PMS, ADOA, and RP11, with combined market potential exceeding $18bn annually.

• Registrational strategy aligns with business objectives, focusing on compelling early clinical data to secure funding for later-stage trials.

• U.S. capital markets are increasingly important, with plans to deepen engagement and consider a Nasdaq listing.

• Board expansion and late-stage development capabilities are being actively pursued to support growth.

Clinical Development and Program Updates

• PKD program is progressing through single and multiple ascending dose studies, aiming for clinical proof of concept on total kidney volume with a 12-month readout and leveraging an accelerated approval pathway.

• PMS program will initiate clinical trials in an observational context this year, transitioning to interventional studies in 2025, with immediate focus on completing GLP toxicology studies and leveraging CNS delivery modalities.

• ADOA program is progressing through Phase 1/2/3 trials, targeting early human safety and efficacy data to establish clinical proof of concept.

• RP11 program is defining the path to NDA, with ongoing open-label extension studies and regulatory engagement to support long-term safety and efficacy.

• Safety profile across all programs remains strong, with no treatment-related serious adverse events reported.

Market Opportunity and Investor Engagement

• PKD and PMS markets are potentially larger than previously estimated, with conservative assumptions used for prevalence and pricing.

• New institutional investors are supporting operational execution, especially in the U.S., but not altering strategic direction.

• U.S. investor base and research coverage are being actively cultivated to close the gap between enterprise and intrinsic value.

• Recent M&A activity in the sector highlights the importance of strong phase I/II data for valuation and potential partnerships or acquisitions.