Guard Therapeutics Intl (GUARD) investor relations material

Company overview and development focus

• Focuses on kidney diseases, with main candidate RMC035 in late-stage development and a phase 2B study (Pointer) nearing topline data in Q4.

• RMC035 targets acute kidney injury in high-risk open-heart surgery patients, with FDA fast track status and potential for breakthrough designation.

• Market potential estimated at $750 million annually in the US and over $1 billion globally for the initial indication, with no approved competitors.

• Pipeline includes a preclinical program for chronic kidney disease and GTX-peptides for broader indications, but current focus remains on acute settings.

Clinical data and regulatory progress

• Robust phase 2A (Rakita) data showed statistically and clinically significant improvement in kidney function, especially in patients with pre-existing chronic kidney disease.

• Pointer phase 2B study completed recruitment ahead of schedule, with 170 patients enrolled across North America and Europe; primary endpoint is GFR difference at 3 months post-surgery.

• Two independent safety reviews found no safety concerns, supporting continued development.

• Ongoing dialogue with FDA and other regulators, with plans for end-of-phase-2 meetings and breakthrough therapy application if data are positive.

Commercial and strategic outlook

• Actively pursuing business development, with preference for partnering, licensing, or project sale over independent commercialization.

• Interest from pharma companies spans both acute kidney injury and broader indications like sepsis and transplantation, with hospital-focused and large pharma showing different strategic interests.

• GTX-peptides program may be spun out, licensed, or retained, depending on upcoming data and business development discussions.

• Key near-term catalysts include Pointer topline data, potential breakthrough therapy designation, and further business development milestones.