Second Quarter 2026
Filed Aug 4, 2026Odyssey Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
The company reported higher research and development expense and a wider GAAP net loss, while adjusted net loss was nearly unchanged from the prior-year period. Cash, cash equivalents and marketable securities of $433.1 million are expected to fund operations into the second half of 2028, alongside multiple clinical and regulatory milestones planned for the second half of 2026.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Research and development expensesGAAP | $36.2 million | – | – |
| General and administrative expensesGAAP | $10.5 million | – | – |
| Net lossGAAP | $52.8 million | – | – |
| Change in fair value of contingent considerationGAAP | $8.7 million | – | – |
| Stock-based compensation expenseGAAP | $5.7 million | – | – |
| Adjusted net lossnon-GAAP | $38.4 million | – | – |
Second half of 2026 and beyond outlook
- NoteCash, cash equivalents and marketable securities of $433.1 million are expected to fund Odyssey’s operations into the second half of 2028.
- NoteInitiate a Phase 2b monotherapy trial and Phase 2a combination trial with vedolizumab for OD-001 in the second half of 2026.
- NoteTopline induction data from both OD-001 studies expected in the second half of 2027.
- NoteComplete IND-enabling studies and file a CTA for OD-002 in the second half of 2026.
- NoteInitiate a Phase 1/2a clinical trial of OD-002 in the first half of 2027.
- NoteUpdated safety and efficacy results from the full Phase 2a induction dataset for OD-001 are expected to be presented at UEG Week in October.
What drove it
- Research and development expense increased primarily because of higher external research and development costs associated with advancing clinical and preclinical programs.
- General and administrative expense decreased primarily because of lower legal and accounting professional fees than in the corresponding prior-year period.
- Treatment with OD-001 in the Phase 2a expansion cohort is complete, with data analyses ongoing.
- The company plans to advance OD-001 through a Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab.
- Odyssey plans to complete IND-enabling studies and file a CTA for OD-002 in the second half of 2026.
Concerns
- GAAP net loss was $52.8 million, compared to a net loss of $41.2 million for the same period in 2025.
- The GAAP loss included $8.7 million of non-cash charges related to the change in the fair value of contingent consideration.
- The company identifies risks relating to its limited operating history and history of net losses, need for additional capital, unanticipated costs and expenses, and uncertainties in clinical development.
- Clinical trial timelines, initiation, enrollment, conduct and results may differ from expectations, and interim or earlier study results may not predict final or later results.
What to watch
- Oral presentation of updated safety and efficacy results from the full OD-001 Phase 2a induction dataset at UEG Week in October.
- Initiation and additional study details for the OD-001 Phase 2b monotherapy trial and Phase 2a vedolizumab combination trial in the second half of 2026.
- Completion of OD-002 IND-enabling studies and CTA filing in the second half of 2026.
- Initiation of the OD-002 Phase 1/2a clinical trial in the first half of 2027.
- Topline induction data from the two OD-001 studies expected in the second half of 2027.
- Progress against the stated cash runway into the second half of 2028.
Balance sheet and cash flow
- Cash, cash equivalents and marketable securities as of June 30, 2026: $433.1 million.
- Cash, cash equivalents and marketable securities are expected to fund operations into the second half of 2028.
Analysis
Odyssey reported a GAAP net loss of $52.8 million for the quarter ended June 30, 2026, compared with a GAAP net loss of $41.2 million for the same period in 2025. Adjusted net loss was $38.4 million, compared with $38.1 million in the prior-year period. The difference between the GAAP and adjusted result reflects the exclusion of $8.7 million of non-cash charges related to the change in fair value of contingent consideration and $5.7 million of stock-based compensation expense.
Operating spending remained centered on pipeline advancement. Research and development expenses were $36.2 million, compared with $30.2 million for the same period in 2025, primarily reflecting increased external research and development costs for clinical and preclinical programs. General and administrative expenses were $10.5 million, compared with $13.2 million in the prior-year period, primarily due to lower legal and accounting professional fees.
Liquidity is the central financial support for the clinical plan. Odyssey had cash, cash equivalents and marketable securities of $433.1 million as of June 30, 2026, and stated that this balance is expected to fund operations into the second half of 2028. The release did not report revenue, gross margin, operating income, EPS, operating cash flow, free cash flow, debt, share repurchases or dividends.
The principal operational focus is OD-001. Treatment in the Phase 2a expansion cohort has been completed and data analyses are ongoing. Updated safety and efficacy results from the full Phase 2a induction dataset, including the expansion cohort and exploratory endpoint assessments, are expected in an oral presentation at UEG Week in October. Odyssey expects to initiate a Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab in the second half of 2026, with topline induction data from both studies expected in the second half of 2027.
OD-002 is the next pipeline catalyst. The company expects to complete IND-enabling studies and file a CTA in the second half of 2026, enabling a Phase 1/2a study in healthy participants in the first half of 2027, followed by patient cohorts. The key execution items are the planned OD-001 study starts, the October data presentation, the OD-002 CTA filing, and management’s ability to maintain its stated funding runway while advancing these programs.
Management, verbatim
Positive clinical proof-of-concept data for OD-001 marked an important milestone for Odyssey and we look forward to sharing additional, supportive data from this trial in October.
Gary D. Glick, Ph.D., President and Chief Executive Officer of Odyssey
We are focused on continuing to build momentum for this program as we prepare to initiate the next monotherapy trial and the first combination trial for OD-001 later this year. In addition, we plan to file a CTA for our second clinical program, OD-002, an oral SLC15A4 inhibitor designed to selectively modulate pathogenic B cell populations to treat autoimmune disease, by the end of this year.
Gary D. Glick, Ph.D., President and Chief Executive Officer of Odyssey
Not in the filing
stated, not guessed- Total revenue
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- Gross profit and gross margin
- Operating income or loss
- GAAP and non-GAAP EPS
- Operating cash flow
- Free cash flow
- Debt
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- Dividends
- Prior-quarter comparisons for reported operating expenses and losses
- Percentage year-over-year and quarter-over-quarter changes for reported metrics
- Prior outlook for comparison with actual results
- Financial revenue, margin, operating expense, or tax-rate guidance
AlphAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.