Odyssey Therapeutics (ODTX) investor relations material

Company strategy and pipeline overview

• Focus on developing transformative therapies for autoimmune and inflammatory diseases using small molecules and protein therapeutics, aiming for first or second market entry.

• All programs are internally developed since 2021, leveraging validated modalities.

Lead program: RIPK2 inhibitor in IBD

• RIPK2 scaffolding inhibition targets a key pathway in IBD, with genetic rationale supported by CARD9 and ATG16L1 mutations.

• Phase IIA trial in ulcerative colitis tested 10mg and 20mg BID doses, showing robust inhibition of inflammatory cytokines and clinical activity in both treatment-naive and anti-TNF-experienced patients.

• Centralized, blinded endoscopy and rigorous patient selection increased confidence in trial results.

• 25% clinical remission rate in anti-TNF-experienced patients, a group with typically low placebo response.

• Additional data, including biomarker analysis and expanded lower-dose cohort, to be presented at UEGW.

Future clinical plans for RIPK2

• Two new trials planned for the second half of the year: a Phase IIA combination study with vedolizumab and a Phase IIB monotherapy trial.

• Combination approach aims to break the therapeutic ceiling in IBD, leveraging vedolizumab's established safety and complementary mechanism.

• Trial design details for the combination study to be shared at ACG; monotherapy Phase IIB design to be released later.