Every 8-K that Odyssey Therapeutics, Inc. (ODTX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ODTX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ODTX filings page.
Odyssey Therapeutics, Inc. (ODTX) furnished a new corporate presentation outlining clinical data and pipeline plans across its inflammation and immunology programs. The company reported a balance sheet of $433 million in cash as of June 30, 2026, which it expects to fund operations into the second half of 2028.
Lead program OD-001 (RIPK2 inhibitor) showed Phase 2a proof-of-concept in moderate-to-severe ulcerative colitis, with a 27% clinical remission rate and primary and secondary endpoints reported as met in 49 patients completing 12 weeks. OD-001 was well tolerated at 10 mg and 20 mg BID with no severe (grade ≥3) treatment-emergent adverse events or serious adverse events observed.
The pipeline also includes OD-002 (SLC15A4 inhibitor), targeting B‑cell–driven autoimmune disease with a CTA filing planned in the second half of 2026 and a Phase 1/2 start in the first half of 2027, and OD-003 (TNFR2 agonist) in IND‑enabling studies. The presentation details multiple planned OD-001 Phase 2b and combination readouts in 2027–2028.
Odyssey Therapeutics, Inc. reported results for the quarter ended June 30, 2026, with a GAAP net loss of $52.8 million and adjusted net loss of $38.4 million. Cash, cash equivalents and marketable securities were $433.1 million, expected to fund operations into the second half of 2028.
The company is advancing OD-001, a small molecule RIPK2 scaffolding inhibitor, with Phase 2a expansion treatment complete and data accepted for an oral presentation at UEG Week in October. A Phase 2b monotherapy trial and Phase 2a combination trial with vedolizumab are expected to start in the second half of 2026, with topline induction data from both in the second half of 2027. OD-002, an oral SLC15A4 inhibitor, is expected to complete IND-enabling studies and file a CTA in the second half of 2026, enabling a Phase 1/2a trial in the first half of 2027. Research and development expenses were $36.2 million and general and administrative expenses were $10.5 million for the quarter.
Odyssey Therapeutics furnished a new corporate presentation outlining its immunology and inflammation pipeline and recent clinical data. The deck highlights OD-001, an oral RIPK2 inhibitor, which achieved a 27% clinical remission rate in a 12‑week Phase 2a ulcerative colitis trial in 49 patients, with concordant endoscopic and symptomatic endpoints and a clean safety profile to date. Odyssey also presents OD-002, a small-molecule SLC15A4 inhibitor targeting pathogenic B cells and interferon signaling, and OD-003, a TNFR2 agonist protein designed to expand regulatory T cells in major autoimmune indications. The company reports a cash balance of $464M as of March 31, 2026, pro forma for IPO and private placement, which it believes funds operations into the second half of 2028 while it advances multiple programs toward key Phase 1 and Phase 2 readouts.
Odyssey Therapeutics reported first quarter 2026 results and highlighted key clinical and financing milestones. In a Phase 2a monotherapy trial of OD-001 for moderate to severe ulcerative colitis, 27% of 49 treated patients achieved clinical remission after 12 weeks and 61% achieved clinical response, with OD-001 well tolerated at both doses.
As of March 31, 2026, Odyssey held cash, cash equivalents and marketable securities of $175.7 million, and together with $288.7 million of net proceeds from its initial public offering and concurrent private placement, expects funding to last into the second half of 2028, implying a pro-forma cash position of $464M. The company completed an offering of 15,500,000 shares and a private placement of 1,388,889 shares, with underwriters later purchasing 600,000 additional shares at $18.00 per share.
Research and development expenses were $32.3 million versus $38.8 million a year earlier, general and administrative expenses were $7.4 million versus $8.0 million, and net loss was $38.3 million compared to $38.4 million in the prior-year quarter.