Odyssey Therapeutics (ODTX) investor relations material

Strategy and pipeline

• Portfolio targets upstream inflammatory signaling and includes oral RIPK2 inhibitor OD-001, oral SLC15A4 inhibitor OD-002, and protein TNFR2 agonist OD-003.

• Programs address IBD, B-cell-mediated diseases, and autoimmune and inflammatory diseases; OD-004 targets TSLP/IL-33 for COPD and asthma.

• Strategy emphasizes first-in-class targets, validated pathways, modality flexibility, and lean execution; average program initiation-to-development-candidate time is 1–1.5 years.

OD-001 clinical proof of concept

• Phase 2a in moderately to severely active UC met its primary endpoint in both parts and overall; consolidated mMS change was -2.4, p<0.001. Results remain preliminary pending database lock.

• Efficacy, biomarker, and transcriptomic findings support 20 mg BID as the projected therapeutic dose; activity was reported in both advanced-therapy-naïve and experienced patients.

• No SAEs, serious infections, or drug-related TEAE discontinuations were reported; safety data are ongoing and subject to change before the CSR.

• OD-001 reduced inflammatory biomarkers and inflammatory and fibrotic gene-expression signatures; transcriptomic responses overlapped with anti-IL-23 response and affected additional inflammatory pathways.

• Phase 2b monotherapy and Phase 2a vedolizumab-combination induction readouts are expected in H2 2027; first maintenance readout is expected in H1 2028.

OD-002 and OD-003

• OD-002 is a selective oral SLC15A4 inhibitor; reported in-vitro potency is ≤10 nM, selectivity is >1,000x, and projected once-daily human dose is 18 mg.

• Preclinical studies showed inhibition of RNA- and DNA-driven signaling and reduced pathogenic B cells and anti-dsDNA antibodies in lupus-prone mice, while sparing B cells in healthy mice.

• CTA filing for OD-002 is planned for H2 2026; Phase 1/2a initiation is expected in H1 2027, with Phase 2a readouts across multiple indications expected in H2 2028.

• OD-003 is a TNFR2 agonist in IND-enabling studies, with completion projected in Q1 2027.