Every material Form 8-K Odyssey Therapeutics, Inc. has filed with the SEC since September 08, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Odyssey Therapeutics reported third quarter 2026 results on November 4, 2026, with a GAAP net loss of $53.1 million, up from $35.5 million a year earlier. Research and development expenses rose to $42.1 million from $26.3 million, and the company said it had $387 million in cash, cash equivalents and marketable securities, expected to fund operations into the second half of 2028.
GAAP net loss of $53.1 million for the quarter ended September 30, 2026, versus $35.5 million a year earlier; adjusted net loss (non-GAAP) was $41.9 million
R&D expenses of $42.1 million versus $26.3 million, mainly higher external costs for clinical and preclinical programs; G&A expenses of $11.2 million versus $10.2 million
Cash, cash equivalents and marketable securities of $387 million as of September 30, 2026, expected to fund operations into the second half of 2028
Anthony Opipari, M.D., Ph.D., appointed chief medical officer and Laura Hare appointed chief people officer
Odyssey Therapeutics said the completed induction period of its open-label Phase 2a trial of OD-001 met the primary endpoint, with a mean reduction of 2.4 points in modified Mayo score at Week 12 (p<0.001). The company said the results strengthen the clinical proof of concept and support advancing OD-001 into a placebo-controlled Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab. The data are preliminary, come from a trial without a concurrent placebo control, and remain subject to change until database lock.
Primary endpoint met: mean reduction of 2.4 points in modified Mayo score from baseline at Week 12 (p<0.001) across 56 evaluable patients.
Week 12 clinical remission was 27% at 20 mg BID (n=41) and 20% at 10 mg BID (n=15).
No serious adverse events were reported during the 12-week induction period; three adverse events in the 20 mg BID group were considered drug-related.
Phase 2b monotherapy and Phase 2a combination trials are planned, with topline induction results expected in the second half of 2027.
Odyssey Therapeutics furnished a corporate presentation on Form 8-K, posted to its website on September 8, 2026. The deck covers Phase 2a monotherapy data for its oral RIPK2 inhibitor OD-001 in ulcerative colitis and preclinical data for its SLC15A4 inhibitor OD-002, and states $433 million in cash as of June 30, 2026, with runway into the second half of 2028. The filing contains no financial results, guidance, or new contracts; the presentation is company-prepared and its data are described as ongoing and subject to change.
Balance sheet of $433 million as of June 30, 2026, expected to fund operations into H2 2028
OD-001 Phase 2a monotherapy: 27% clinical remission rate in moderate-to-severe UC patients, with a -2.6 change in MMCS (p < 0.001), per presentation
Next OD-001 data disclosure expected at UEG in October 2026; OD-002 CTA filing expected in H2 2026
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