Odyssey Therapeutics, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 17 June 2026: press release. The quarter’s numbers.

Key takeaways

OD-001 reached clinical proof-of-concept: The company reported that its Phase 2a trial of OD-001 in moderate to severe ulcerative colitis achieved clinical proof-of-concept, with 49 patients completing 12 weeks of treatment. Source
Activity seen after advanced therapies: Management said OD-001 was well tolerated at both doses tested and showed efficacy in patients who were naive or experienced to advanced therapies. Remission and response rates are given in the sector figures. Source
Two OD-001 trials to start: Management expects to start a Phase 2b monotherapy trial and a Phase 2a vedolizumab combination trial in the second half of 2026, with topline induction data from both in the second half of 2027. Source
Net loss nearly unchanged: The company reported a net loss of $38.3 million for the quarter, compared with $38.4 million in the same period of 2025. Source
IPO raised $314.8M gross: The IPO and concurrent private placement closed at $18.00 per share, with gross proceeds of $314.8 million. Underwriters partly exercised their option for 600,000 additional shares. Source
Pro-forma cash of $464.4M: After the net financing proceeds, pro-forma cash as of March 31, 2026 is $464.4 million, which management expects to fund operations into the second half of 2028. Source
OD-001 late-stage plans: The CEO said the company looks forward to advancing OD-001 into late-stage development and a series of combination trials with standard of care therapies, aiming to break the therapeutic ceiling in inflammatory bowel disease. Source

“During the quarter, we continued to build meaningful momentum and made significant progress across our portfolio, including delivering clinical proof-of-concept for our oral, small molecule, RIPK2 scaffolding inhibitor, OD-001, in moderate-to-severe ulcerative colitis”
Gary D. Glick, Ph.D., President and Chief Executive Officer

Guidance

Area	Period	Figure
OD-001 trial initiation Source	second half of 2026	second half of 2026
OD-001 topline data Source	second half of 2027	second half of 2027
OD-002 regulatory filing Source	second half of 2026	second half of 2026
OD-002 clinical start Source	first half of 2027	first half of 2027
Cash runway Source	into the second half of 2028	second half of 2028

What changed from last quarter

New: The company closed an initial public offering and a concurrent private placement at $18.00 per share, and began trading on Nasdaq on May 8, 2026. Source

Clinical results in ulcerative colitis

OD-001 reached clinical proof-of-concept: The company reported that its Phase 2a trial of OD-001 in moderate to severe ulcerative colitis achieved clinical proof-of-concept, with 49 patients completing 12 weeks of treatment. Source
Activity seen after advanced therapies: Management said OD-001 was well tolerated at both doses tested and showed efficacy in patients who were naive or experienced to advanced therapies. Remission and response rates are given in the sector figures. Source

Pipeline timing for OD-001 and OD-002

Two OD-001 trials to start: Management expects to start a Phase 2b monotherapy trial and a Phase 2a vedolizumab combination trial in the second half of 2026, with topline induction data from both in the second half of 2027. Source
OD-002 filing precedes first trial: OD-002, an SLC15A4 inhibitor, is expected to reach a CTA filing in the second half of 2026. The company said this would enable a Phase 1/2a trial to start in the first half of 2027. Source

“We look forward to rapidly advancing OD-001 into late-stage development and a series of combination trials with standard of care therapies”
Gary D. Glick, Ph.D., President and Chief Executive Officer

Operating expenses in the quarter

R&D lower after prior-year charge: Research and development expense declined from the prior-year quarter. Management said the change primarily reflected a non-cash lease impairment charge recorded in the prior-year period. Source
G&A slightly lower year over year: General and administrative expenses were $7.4 million for the quarter, compared with $8.0 million in the same period of 2025. Source
Net loss nearly unchanged: The company reported a net loss of $38.3 million for the quarter, compared with $38.4 million in the same period of 2025. Source

Financing and cash position

IPO raised $314.8M gross: The IPO and concurrent private placement closed at $18.00 per share, with gross proceeds of $314.8 million. Underwriters partly exercised their option for 600,000 additional shares. Source
Cash of $175.7M at quarter end: Cash, cash equivalents and marketable securities were $175.7 million at March 31, 2026, before the $288.7 million of net IPO and private placement proceeds. Source
Pro-forma cash of $464.4M: After the net financing proceeds, pro-forma cash as of March 31, 2026 is $464.4 million, which management expects to fund operations into the second half of 2028. Source

“we expect to use the net financing proceeds to support advancement of our broader portfolio”
Gary D. Glick, Ph.D., President and Chief Executive Officer

Strategy and portfolio focus

OD-001 late-stage plans: The CEO said the company looks forward to advancing OD-001 into late-stage development and a series of combination trials with standard of care therapies, aiming to break the therapeutic ceiling in inflammatory bowel disease. Source
Proceeds to fund broader pipeline: Management said the net financing proceeds are expected to support the broader portfolio, including the OD-002 SLC15A4 inhibitor. Source
Portfolio built from internal discovery: The company describes its portfolio as internally discovered and developed medicines, with its first program advancing through multiple clinical milestones. Source

Listing and leadership

Nasdaq listing began in May: Shares began trading on the Nasdaq Capital Market under the ticker ODTX on May 8, 2026. Source
CEO gave quarter remarks: Gary D. Glick, Ph.D., President and Chief Executive Officer, gave the company's remarks on the quarter in the release. Source

Coming up, as management said on 17 June 2026

OD-001 trial starts in second half: The company plans to initiate a Phase 2b monotherapy trial and a Phase 2a vedolizumab combination trial in the second half of 2026. Source
OD-002 clinical trial application: Management expects to file a CTA for OD-002 in the second half of 2026. Source

Figures management reported

Figure	Reported
Patients completing 12 weeks of OD-001 treatment Source	49
Clinical remission rate, OD-001 Phase 2a Source	27%
Clinical response rate, OD-001 Phase 2a Source	61%
Research and development expense, quarter Source	$32.3 million

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Odyssey Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

Reported positive clinical proof-of-concept data for OD-001, our first-in-class, oral RIPK2 scaffolding inhibitor, in a Phase 2a monotherapy trial for moderate to severe ulcerative colitis

Cash on hand as of March 31, 2026, together with net proceeds from the IPO, and concurrent private placement, of $464M expected to fund operations into the second half of 2028

BOSTON, June 17, 2026 (GLOBE NEWSWIRE) - Odyssey Therapeutics, Inc. (Nasdaq: ODTX) (“Odyssey” or the “Company”), a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that precisely target disease pathology, today reported financial results for the first quarter ended March 31, 2026 and highlighted progress across its clinical and preclinical portfolio.

“During the quarter, we continued to build meaningful momentum and made significant progress across our portfolio, including delivering clinical proof-of-concept for our oral, small molecule, RIPK2 scaffolding inhibitor, OD-001, in moderate-to-severe ulcerative colitis” said Gary D. Glick, Ph.D., President and Chief Executive Officer of Odyssey. “We look forward to rapidly advancing OD-001 into late-stage development and a series of combination trials with standard of care therapies to deliver on our aim of breaking the therapeutic ceiling in inflammatory bowel disease and providing a safe, oral medicine for long-term disease management. In addition, we expect to use the net financing proceeds to support advancement of our broader portfolio, including our small molecule SLC15A4 inhibitor, OD-002, for which we expect to file a CTA in the second half of 2026.”

First Quarter Business Highlights and Recent Developments

Pipeline Highlights

OD-001: Small molecule RIPK2 scaffolding inhibitor

Achieved clinical proof-of-concept in a Phase 2a clinical trial of OD-001 in moderate to severe ulcerative colitis. 49 patients completed 12 weeks of treatment with OD-001 and were eligible for efficacy analysis. OD-001 was well tolerated at both doses tested and observed to be efficacious in patients naïve, or experienced, to advanced therapies, with 27% of patients achieving clinical remission and 61% achieving clinical response.

Odyssey is continuing to advance OD-001 and expects to initiate both 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 trials expected in the second half of 2027.

Corporate Highlights

Closed initial public offering and concurrent private placement, resulting in gross proceeds of $314.8M

Closed an initial public offering of 15,500,000 shares of common stock and a concurrent private placement of 1,388,889 shares of common stock at the initial public offering price of $18.00 per share. Following the closing of the Company’s initial public offering, the underwriters partially exercised their option to purchase 600,000 additional shares of common stock at $18.00 per share. All the shares of common stock sold in these transactions were offered by Odyssey with gross proceeds, before deducting underwriting discounts and commissions, placement agent fees, and other offering expenses, of $314.8M. Odyssey began trading on the Nasdaq Capital Market under the ticker symbol “ODTX” on May 8, 2026.

Anticipated Key Clinical Milestones

OD-001 (RIPK2 scaffolding inhibitor): Initiate a Phase 2b monotherapy trial and a Phase 2a combination trial with vedolizumab in the second half of 2026, with results from both studies expected in the second half of 2027. Results from the signal-seeking Phase 2a monotherapy trial, for which topline induction data were released in April 2026, will be presented in the second half of 2026.

OD-002 (SLC15A4 inhibitor): Complete investigational new drug (“IND”) enabling studies and file a clinical trial application (“CTA”) in the second half of 2026, which would enable the initiation of a Phase 1/2a clinical trial with healthy participants and patients in the first half of 2027.

First Quarter 2026 Financial Results

As of March 31, 2026, Odyssey had cash, cash equivalents and marketable securities of $175.7 million, which, together with the $288.7 million of net proceeds raised as part of its initial public offering, and concurrent private placement, are expected to fund Odyssey’s operations into the second half of 2028. Odyssey’s pro-forma cash position as of March 31, 2026, after giving effect to the net proceeds from these financing events, is $464.4M.

Research and development expenses were $32.3 million for the quarter ended March 31, 2026, compared to $38.8 million for the same period in 2025. The change primarily reflected a non-cash lease impairment charge recorded in the corresponding period from the prior year. General and administrative expenses were $7.4 million for the quarter ended March 31, 2026, compared to $8.0 million for the same period in 2025. Net loss was $38.3 million for the quarter ended March 31, 2026, compared to a net loss of $38.4 million for the same period in 2025.

Additional financial information is available in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed today with the U.S. Securities and Exchange Commission and accessible at www.sec.gov and through the “Investors” section of the Company’s website at investors.odysseytx.com.

About Odyssey Therapeutics

Odyssey Therapeutics is a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that are designed to precisely target disease pathology. Since its founding in 2021, Odyssey has built a portfolio of internally discovered and developed medicines with its first program advancing through multiple clinical milestones. The portfolio leverages the scientific expertise of its team of experienced drug hunters and a comprehensive suite of tools to efficiently advance product candidates that the Company believes have the potential to induce deep and durable remission for patients across several inflammatory diseases with unmet need.

For more information, please visit www.odysseytx.com and follow Odyssey on LinkedIn.

Forward-Looking Statements

Forward-looking statements notice

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: Odyssey’s expectations regarding the development of OD-001, OD-002, OD-003, OD-004 and its other product candidates; the timing, design, initiation, enrollment, conduct and results of preclinical studies and clinical trials, including the ongoing Phase 2a trial of OD-001 in ulcerative colitis and Odyssey’s anticipated future clinical trials for this program; anticipated corporate and development milestones and the expected timing thereof; the timing and forums for announcing data from Odyssey’s ongoing and future preclinical studies and clinical trials, and the content of any such presentation; the sufficiency of the Company’s cash, cash equivalents and marketable securities to fund planned operations for any specified time period; the timing of regulatory filings and receipt of regulatory authorizations; the therapeutic potential of Odyssey’s product candidates; and Odyssey’s strategy, business plans, financial performance, financial position, and focus. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “intend,” “goal,” “may,” “plan,” “potential,” “will,” “would” and variations of these words or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are based on Odyssey’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties related to: the Company’s limited operating history and history of net losses; its need for additional capital and unanticipated costs and expenses impacting the Company’s cash runway; the unpredictable nature of preclinical and clinical development, including risks that clinical trials may not be initiated, enrolled, conducted, or completed on the timelines the Company expects, or at all, and that interim results or results from earlier studies may not be predictive of final or later results; the potential for varying interpretation of the results of clinical trials and analyses, reliance on third parties, including contract research and manufacturing organizations; competition; the Company’s ability to leverage its team’s scientific expertise and suite of tools to enable more informed drug research and development; intellectual property; legal and regulatory developments; and the other risks and uncertainties described under “Risk Factors” in the Company’s most recently filed Quarterly Report on Form 10-Q and the Company’s other filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Odyssey undertakes no duty to update such information except as required under applicable law.

Contacts
Collin Todd
SVP, Strategy and Business Development investors@odysseytx.com