Turn Therapeutics (TTRX) investor relations material

Company background and innovation

• Originated from the founder's personal experience as a chronic wound patient, leading to the development of a novel polymer-based ointment using a patented PermaFusion process.

• The active pharmaceutical ingredient (API) is a new chemical entity with NCE status in the U.S., offering high bioavailability and a unique mechanism of action.

• Extensive safety data from human use and FDA clearance in wound care, with no reported adverse events in over 53 patients during phase I studies.

• The company operates with a low burn rate, has raised $21 million, and holds 17 issued patents with protection extending into the late 2040s.

• Leadership and advisory board include experienced industry professionals and regulatory experts.

Clinical pipeline and trial updates

• Lead asset targets moderate to severe eczema, acting as the first IL-36 and IL-31 inhibitor of its kind, with a novel non-steroidal, non-systemic profile.

• Ongoing phase II trial in the U.S. with 114–120 patients, using an adaptive design; interim and top-line data expected in Q2 2026.

• Primary endpoint is EASI (Eczema Area and Severity Index) change versus vehicle, with secondary endpoints including IGA and itch score.

• Interim assessment will occur after 50–60 patients, with the trial designed to ensure statistical precision and compliance.

• The product is positioned as a potential first-line treatment for eczema due to its safety and efficacy profile.

Scientific rationale and mechanism of action

• The product inhibits IL-36 and IL-31, key cytokines in the inflammatory cascade of eczema and other skin diseases.

• Preclinical studies showed a 57% reduction in Investigator Global Assessment in an IL-36-driven eczema model.

• The ointment also reduces staph bioburden and addresses skin barrier dysfunction, potentially working from both sides of the disease process.

• The mechanism is supported by in vivo and cytokine analysis, confirming inhibition of IL-36-alpha, IL-36-gamma, IL-31, and IL-4.