Centessa Pharmaceuticals (CNTA) TD Cowen 46th Annual Health Care Conference summary

Progress and strategic vision

• ORX750 has advanced to patient studies, with registrational studies for rare hypersomnias planned to start this quarter.

• The platform aims to deliver first-in-class treatments for NT2 and idiopathic hypersomnia, leveraging potent and selective orexin agonists.

• Expansion into multiple neuropsych and neurodegenerative indications is planned, utilizing follow-up assets ORX142 and ORX489.

• The company is transitioning toward a pre-commercial phase, preparing to hire a commercial team and enhance physician education.

• A robust communication strategy is being developed to support upcoming registrational studies and commercial readiness.

Clinical data and development updates

• November data showed best-in-class efficacy at low doses, with significant improvements in MWT and ESS, and strong cataplexy control.

• Dose escalation has continued to explore maximum tolerated doses, aiming for optimal efficacy and tolerability.

• Phase II updates in Q1 will focus on top-end efficacy and may include multiple indications, with registrational program design details.

• Open label extension data show sustained efficacy with no degradation from two to four weeks, and high patient uptake.

• No adverse events have limited the therapeutic index; insomnia is considered a marker for maximum tolerated dose.

Differentiation and competitive positioning

• ORX750 is designed for once-daily dosing with linear PK, rapid onset, and flexibility for split dosing to enhance patient control.

• Differentiation is driven by prolonged duration of action, normalization of wakefulness, and strong efficacy in both EDS and cataplexy.

• Visual disturbances observed were mild, transient, and not dose-dependent; titration may further improve tolerability.

• The company maintains strong alignment with FDA and regulatory bodies for its registration program.

• Phase III design will incorporate creative features to fully explore the therapeutic index and maintain first-in-class positioning.