Odyssey Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $387 million as of September 30, 2026, expected to fund operations into the second half of 2028.
• Research and development expenses were $42.1 million for the quarter ended September 30, 2026, an increase from $26.3 million in the same period in 2025, driven by higher external R&D costs.
• General and administrative expenses were $11.2 million for the quarter ended September 30, 2026, compared to $10.2 million in the same period in 2025, primarily due to higher personnel-related expenses including stock-based compensation.
• Net loss was $53.1 million for the quarter ended September 30, 2026, compared to a net loss of $35.5 million in the same period in 2025.
• Adjusted net loss (non-GAAP) was $41.9 million for the quarter ended September 30, 2026, compared to $28.7 million in the same period in 2025.
• Stock-based compensation expense was $7.9 million for the quarter ended September 30, 2026, compared to $4.9 million in the same period in 2025.
• Change in fair value of contingent consideration was $3.3 million for the quarter ended September 30, 2026, compared to $1.9 million in the same period in 2025.

Guidance and Future Outlook:

• Topline induction results for the Phase 2b monotherapy trial and Phase 2a combination trial with vedolizumab for OD-001 are expected in the second half of 2027.
• Odyssey expects to initiate a Phase 1/2a clinical trial for OD-002 in the first half of 2027, initially enrolling healthy participants followed by patient cohorts.
• Healthy participant data for OD-002, including results from an ex vivo stimulation assay, is expected to be reported in the second half of 2027.

Business Segments and Product Lines:

• OD-001 (RIPK2 scaffolding inhibitor): Additional analyses from the Phase 2a induction period involving 56 efficacy-evaluable patients with moderate-to-severe ulcerative colitis strengthened clinical proof of concept, supported by concordant findings in clinical outcomes, inflammatory biomarkers, mucosal transcriptomics, and histologic improvement.
• OD-002 (SLC15A4 inhibitor): IND-enabling studies were completed for this first-in-class oral inhibitor designed to modulate innate immune pathways including TLR7/8/9-mediated responses.
• OD-003 (TNFR2 agonist): Preclinical data demonstrating expansion of regulatory T cells with enhanced stability and suppressive function will be presented at ACR Convergence 2026; the program is advancing through IND-enabling studies.
• OD-004 (TSLP/IL-33 bispecific antagonist): A development candidate was nominated with potency comparable or superior to approved and investigational monospecific agents; the program is advancing into IND-enabling studies.

Market and Competitive Landscape:

• The company positions its pipeline to address autoimmune and inflammatory diseases with unmet need, aiming to induce deep and durable remission.
• OD-002 targets a convergence point of TLR7, TLR8, and TLR9 signaling to broadly modulate disease-driving innate immune pathways while preserving normal host defense functions.
• OD-004 is described as a potentially best-in-class TSLP/IL-33 bispecific antagonist.

Risks and Challenges:

• Forward-looking statements involve risks including inherent limitations of open-label trials without concurrent placebo controls, uncertainties associated with exploratory transcriptomic findings, and the possibility of different outcomes in future trials.
• Risks also include clinical, regulatory, competitive, and third-party risks, as well as factors described in the company's most recent Form 10-Q and other SEC filings.

Management Commentary and Tone:

• CEO Gary D. Glick, Ph.D., stated that the company made meaningful progress across its entire pipeline, highlighting the reinforcement of clinical proof of concept for OD-001 and the completion of IND-enabling studies for OD-002.
• Management emphasized that an enhanced executive leadership team and strong financial foundation position the company to execute its clinical development strategy.

Other Key Points:

• Anthony Opipari, M.D., Ph.D., was appointed chief medical officer, having previously overseen the Phase 2a OD-001 monotherapy trial in ulcerative colitis.
• Laura Hare was appointed chief people officer, bringing over 20 years of experience in organizational strategy and operations from biotechnology and technology-driven companies.
• The company plans to present additional Phase 2a induction findings for OD-001 at United European Gastroenterology (UEG) Week in October.
• Full financial details will be available in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.