Odyssey Therapeutics, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 4 August 2026: press release. Guidance figures: 4 kept. The quarter’s numbers.

Key takeaways

Net loss rose to $52.8 million: The company reported a net loss of $52.8 million for the quarter, against $41.2 million a year earlier. The Q1 2026 net loss was $38.3 million. Source
R&D spend rose on external costs: R&D expenses were $36.2 million, against $30.2 million a year earlier. Management attributed the increase mainly to external costs for clinical and preclinical programs. Q1 2026 R&D was $32.3 million. Source
Phase 2a expansion cohort dosing complete: Treatment in the Phase 2a expansion cohort of OD-001 is complete. Data analyses are ongoing. Source
Full induction data due at UEG: Updated safety and efficacy results from the full Phase 2a induction dataset, including the expansion cohort, and exploratory endpoints are to be presented at UEG Week in October. Source
Two OD-001 trials start 2H 2026: The company continues to expect the next stage of the RIPK2 program to begin in the second half of 2026, with a Phase 2b monotherapy trial and a Phase 2a vedolizumab combination trial. Source
OD-002 CTA planned by year-end: The company plans to complete IND-enabling studies and file a CTA for OD-002 in the second half of 2026. Source
Cash covers operations into 2H 2028: Cash, cash equivalents and marketable securities were $433.1 million at June 30, 2026, which the company expects to fund operations into the second half of 2028. Source

““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

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	From June 30, 2026 cash position	into the second half of 2028	Kept
OD-001 Phase 2b monotherapy and Phase 2a vedolizumab combination trials Source	Second half of 2026	second half of 2026	Kept
OD-001 topline induction data from both trials Source	Second half of 2027	second half of 2027	Kept
OD-002 Phase 1/2a trial start Source	First half of 2027	first half of 2027	Kept

What changed from last quarter

New: Treatment in the Phase 2a expansion cohort of OD-001 is complete, with data analyses ongoing. The Q1 release did not mention an expansion cohort. Source
New: The Q2 release names UEG Week in October as the venue and month for the oral presentation of Phase 2a induction data. The Q1 release said only second half of 2026. Source

Financial results and expenses

Net loss rose to $52.8 million: The company reported a net loss of $52.8 million for the quarter, against $41.2 million a year earlier. The Q1 2026 net loss was $38.3 million. Source
R&D spend rose on external costs: R&D expenses were $36.2 million, against $30.2 million a year earlier. Management attributed the increase mainly to external costs for clinical and preclinical programs. Q1 2026 R&D was $32.3 million. Source
G&A fell on lower legal fees: G&A expenses were $10.5 million, against $13.2 million a year earlier. The decrease reflected lower legal and accounting professional fees than in the prior-year period. Q1 2026 G&A was $7.4 million. Source
Adjusted net loss excludes two items: Adjusted net loss (non-GAAP) was $38.4 million, excluding an $8.7 million non-cash charge tied to contingent consideration and $5.7 million of stock-based compensation. The prior-year period showed $38.1 million. Source

OD-001 clinical progress

Phase 2a expansion cohort dosing complete: Treatment in the Phase 2a expansion cohort of OD-001 is complete. Data analyses are ongoing. Source
Full induction data due at UEG: Updated safety and efficacy results from the full Phase 2a induction dataset, including the expansion cohort, and exploratory endpoints are to be presented at UEG Week in October. Source
Q1 efficacy figures not restated: The Q1 release reported that 49 patients completed 12 weeks of treatment and were eligible for efficacy analysis, with 27% achieving clinical remission and 61% achieving clinical response. The Q2 release does not restate these figures.

“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.”
Gary D. Glick, Ph.D., President and Chief Executive Officer

OD-001 next-stage trials

Two OD-001 trials start 2H 2026: The company continues to expect the next stage of the RIPK2 program to begin in the second half of 2026, with a Phase 2b monotherapy trial and a Phase 2a vedolizumab combination trial. Source
Trial details to follow in 2026: Additional details on both OD-001 studies are expected to be shared in the second half of 2026. Source
Topline induction data in 2H 2027: Topline induction data from both OD-001 trials are expected in the second half of 2027. Source

OD-002 pipeline progress

OD-002 CTA planned by year-end: The company plans to complete IND-enabling studies and file a CTA for OD-002 in the second half of 2026. Source
OD-002 Phase 1/2a start 1H 2027: Initiation of a Phase 1/2a trial in healthy participants is expected in the first half of 2027, followed by patient cohorts in several diseases. Source
OD-002 aimed at B cell populations: The company describes OD-002 as an oral SLC15A4 inhibitor designed to selectively modulate pathogenic B cell populations to treat autoimmune disease. Source

Cash position and runway

Cash covers operations into 2H 2028: Cash, cash equivalents and marketable securities were $433.1 million at June 30, 2026, which the company expects to fund operations into the second half of 2028. Source
Q1 pro-forma cash included IPO proceeds: The Q1 release reported cash of $175.7 million at March 31, 2026, and a pro-forma figure of $464.4 million after net proceeds from the IPO and concurrent private placement.

Company focus and strategy

Focus on autoimmune and inflammatory disease: The company describes its aim as transforming the standard of care for autoimmune and inflammatory diseases through medicines designed to precisely target disease pathology. Source
Founded 2021, first program advancing: The company was founded in 2021, and its first program has advanced through multiple clinical milestones, according to the release. Source
Drug hunters and tools drive portfolio: The company says its portfolio uses the expertise of experienced drug hunters and a comprehensive suite of tools to advance product candidates efficiently. Source

Coming up, as management said on 4 August 2026

Oral data presentation at UEG Week: Updated Phase 2a induction data, including the expansion cohort, are to be presented at UEG Week in October 2026. Source
Trial details to be shared later in 2026: The company expects to share additional details on the Phase 2b and combination trials in the second half of 2026. Source

Figures management reported

Figure	Reported
R&D expense, quarter ended June 30, 2026 Source	$36.2 million
OD-001 Phase 2a expansion cohort Source	Treatment complete; data analyses ongoing
OD-001 Phase 2a data presentation Source	UEG Week, October 2026
OD-001 topline induction data Source	Expected second half of 2027

Earlier plans management reported on

Not stated: Management reiterated its expectation for the next stage of OD-001 development in the second half of 2026. Source
Not stated: The release lists the OD-002 CTA filing as a milestone for the second half of 2026. Source

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 Second Quarter 2026 Financial Results and Provides Corporate Update

Data from the Phase 2a monotherapy trial of OD-001 accepted for oral presentation at United European Gastroenterology Week in October

Phase 2a combination trial of OD-001 with vedolizumab and Phase 2b monotherapy trial of OD-001 expected to initiate in 2H 2026

Cash on hand as of June 30, 2026 of $433.1M expected to fund operations into the second half of 2028

BOSTON, August 4, 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 second quarter ended June 30, 2026 and provided an update on recent progress and anticipated milestones.

“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,” said 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.”

Second Quarter Business Highlights and Recent Developments

Pipeline Highlights

OD-001: Small molecule RIPK2 scaffolding inhibitor

Treatment with OD-001 in the Phase 2a expansion cohort is now complete, with data analyses ongoing. Updated safety and efficacy results from the full Phase 2a induction dataset, including expansion cohort, as well as assessments of exploratory endpoints, are expected to be presented in an oral presentation at the United European Gastroenterology (UEG) Week in October.

Odyssey continues to expect the RIPK2 program to enter its next stage of clinical development, with initiation of a Phase 2b monotherapy trial and Phase 2a combination trial with vedolizumab expected in the second half of 2026. Additional details on both studies are expected to be shared in the second half of 2026.

Anticipated Key Clinical Milestones

OD-001 (RIPK2 scaffolding inhibitor): Initiate a Phase 2b monotherapy trial and 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 (SLC15A4 inhibitor): Complete investigational new drug (“IND”)-enabling studies and file a clinical trial application (“CTA”) in the second half of 2026, enabling initiation of a Phase 1/2a clinical trial in the first half of 2027 in healthy participants, followed by patient cohorts across a number of diseases, including cutaneous lupus erythematosus and additional autoimmune diseases.

Second Quarter 2026 Financial Results

As of June 30, 2026, Odyssey had cash, cash equivalents and marketable securities of $433.1 million, which are expected to fund Odyssey’s operations into the second half of 2028.

Research and development expenses were $36.2 million for the quarter ended June 30, 2026, compared to $30.2 million for the same period in 2025. The change primarily reflected an increase in external research and development costs associated with advancing the Company’s clinical and preclinical programs. General and administrative expenses were $10.5 million for the quarter ended June 30, 2026, compared to $13.2 million for the same period in 2025. The decrease primarily reflected lower legal and accounting professional fees than were recorded in the corresponding period for the prior year.

Net loss was $52.8 million for the quarter ended June 30, 2026, compared to a net loss of $41.2 million for the same period in 2025. Adjusted net loss (non-GAAP) was $38.4 million for the quarter ended June 30, 2026, after excluding $8.7 million of non-cash charges related to the change in the fair value of contingent consideration and $5.7 million of stock-based compensation expense. See “Non-GAAP Financial Measures” below for additional information and a reconciliation to the most directly comparable GAAP financial measure.

Additional financial information will be available in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, to be filed with the U.S. Securities and Exchange Commission and will be accessible at www.sec.gov and through the “Investors” section of the Company’s website at investors.odysseytx.com.

Non-GAAP Financial Measures

This press release includes adjusted net loss, a financial measure that is not prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). Adjusted net loss is defined as GAAP net loss excluding non-cash changes in the fair value of contingent consideration and stock-based compensation expense.

Management believes adjusted net loss provides investors with useful supplemental information regarding the Company's operating performance. Management uses adjusted net loss, together with GAAP financial measures, to evaluate the Company's operating performance and facilitate comparisons across reporting periods.

Adjusted net loss should not be considered in isolation or as a substitute for GAAP net loss. Because other companies may calculate similarly titled non-GAAP financial measures differently, adjusted net loss may not be comparable to similarly titled measures reported by other companies.

The following table reconciles GAAP net loss to adjusted net loss:

	Three Months Ended June 30,
	2026	2025
	(in millions)
GAAP Net Loss	$(52.8)	$(41.2)
Change in fair value of contingent consideration	8.7	(0.6)
Stock-based compensation expense	5.7	3.7
Adjusted Net Loss (Non-GAAP)	$(38.4)	$(38.1)

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. Odyssey’s 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 https://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, and its other product candidates; the timing, design, initiation, enrollment, conduct and results of preclinical studies and clinical trials, including the anticipated Phase 2b trial of OD-001 as a monotherapy and Phase 2a combination trial with vedolizumab in ulcerative colitis and the Phase 1/2a trial of OD-002; 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
Investor Relations Collin Todd SVP, Strategy and Business Development investors@odysseytx.com