Annexin Pharmaceuticals (ANNX) investor relations material

Scientific and clinical focus

• Focused on ophthalmology, particularly retinal vein occlusion (RVO) and diabetic retinopathy, using a novel protein-based therapy, Annex V, derived from Annexin A5.

• Therapy aims to be first-in-class, targeting upstream mechanisms to potentially eliminate the need for current anti-VEGF treatments.

• Demonstrated disease-modifying potential, aiming to stop chronic progression of eye diseases.

• Phase 2A data shows rapid, durable effects and positive safety signals in RVO patients.

• Visual acuity improvements and fluid reduction in the retina were observed, with durable patient responses.

Differentiation and mechanism of action

• Annex V targets a phospholipid exposed on stressed or dying cells, blocking inflammation and coagulation triggers.

• Unlike anti-VEGF therapies, which require frequent injections, the new approach may reduce or eliminate this need.

• Phase 2A study reduced anti-VEGF injections from five to a maximum of one over four months in most patients.

• Blood flow in the retina improved significantly after treatment, a mechanistic differentiator in ophthalmology.

• Key opinion leaders in the US view the results as a significant advance, calling it a "holy grail" outcome.

Clinical development and strategy

• Preparing for a phase 2B trial, pending funding and FDA feedback, with a strong US-based advisory board.

• Advisory board provides expertise in trial design, regulatory endpoints, and FDA engagement.

• Strategic partnerships are sought to finance and potentially co-run the next trial phase.

• US market is prioritized due to regulatory clarity and market size, with Europe and Asia as future steps.

• Regulatory advice and FDA feedback are considered critical for advancing development and partnerships.