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Odyssey Therapeutics (Nasdaq: ODTX) details Q2 loss and $433.1M cash runway

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

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.

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Filing Explained

This Form 8-K furnishes the company’s June 30, 2026 results release under Item 2.02; the release is not treated as filed or incorporated by reference unless a later filing specifically says so.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and marketable securities $433.1 million As of June 30, 2026, expected to fund operations into the second half of 2028
Research and development expenses $36.2 million Quarter ended June 30, 2026
Research and development expenses prior-year period $30.2 million Quarter ended June 30, 2025
General and administrative expenses $10.5 million Quarter ended June 30, 2026
General and administrative expenses prior-year period $13.2 million Quarter ended June 30, 2025
GAAP net loss $52.8 million Quarter ended June 30, 2026
Adjusted net loss (non-GAAP) $38.4 million Quarter ended June 30, 2026
Change in fair value of contingent consideration $8.7 million Added back in reconciliation from GAAP to adjusted net loss for Q2 2026
RIPK2 scaffolding inhibitor medical
"OD-001: Small molecule RIPK2 scaffolding inhibitor"
A RIPK2 scaffolding inhibitor is a drug that blocks the non-enzymatic role of the RIPK2 protein, preventing it from acting as a molecular “connector” that brings together other proteins in innate immune signaling pathways. Unlike traditional kinase inhibitors that target enzyme activity, scaffolding inhibitors disrupt protein–protein interactions, which can change immune responses in inflammatory or autoimmune diseases; this mechanism can affect clinical outcomes, development timelines, and valuation considerations for drug candidates.
SLC15A4 inhibitor medical
"OD-002, an oral SLC15A4 inhibitor designed to selectively modulate"
contingent consideration financial
"excluding non-cash changes in the fair value of contingent consideration"
Contingent consideration is an additional payment agreed when one company buys another that will be paid later only if specific future targets are met, such as revenue, profit, or regulatory milestones. It matters to investors because it shifts risk between buyer and seller and affects the acquiring company's future cash flow and reported value — like promising a bonus after results are proven.
stock-based compensation expense financial
"excluding non-cash changes in the fair value of contingent consideration and stock-based compensation expense"
Stock-based compensation expense is the value that a company records when it gives employees or executives shares or options to buy shares as part of their pay. It matters because it shows the true cost of paying employees this way, which can affect the company's profits and how investors see its financial health.
non-GAAP financial measures financial
"This press release includes adjusted net loss, a financial measure that is not prepared in accordance with U.S. GAAP"
Non-GAAP financial measures are numbers companies use to show their financial performance that exclude certain expenses or income. They help investors see how the company might perform without one-time costs or other unusual items, giving a different perspective from official reports. However, since they can be adjusted, they don’t always tell the full story and should be looked at alongside standard financial figures.
GAAP net loss $52.8 million vs $41.2 million for the three months ended June 30, 2025
Adjusted net loss (non-GAAP) $38.4 million vs $38.1 million for the three months ended June 30, 2025
Research and development expenses $36.2 million vs $30.2 million for the three months ended June 30, 2025
General and administrative expenses $10.5 million vs $13.2 million for the three months ended June 30, 2025

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FAQ

What were Odyssey Therapeutics' (ODTX) key financial results for Q2 2026?
Odyssey reported a GAAP net loss of $52.8 million and an adjusted net loss of $38.4 million for the quarter, with R&D expenses of $36.2 million and G&A expenses of $10.5 million, compared with the same period in 2025.

How much cash does Odyssey Therapeutics (ODTX) have and what is its cash runway?
As of June 30, 2026, Odyssey had $433.1 million in cash, cash equivalents and marketable securities, which the company expects will fund operations into the second half of 2028, supporting ongoing and planned clinical development activities.

What is the current status of Odyssey Therapeutics' (ODTX) OD-001 clinical program?
OD-001, a RIPK2 scaffolding inhibitor, has completed treatment in its Phase 2a expansion cohort, with updated data to be presented 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.

What are Odyssey Therapeutics' (ODTX) development plans for OD-002?
OD-002, an oral SLC15A4 inhibitor, is expected to complete IND-enabling studies and file a clinical trial application in the second half of 2026, enabling initiation of a Phase 1/2a trial in the first half of 2027 in healthy participants and autoimmune disease patients.

How does Odyssey Therapeutics (ODTX) define adjusted net loss?
Odyssey defines adjusted net loss as GAAP net loss excluding non-cash changes in the fair value of contingent consideration and stock-based compensation expense. Management uses this non-GAAP measure alongside GAAP results to evaluate operating performance across reporting periods.

What upcoming milestones did Odyssey Therapeutics (ODTX) highlight?
Key milestones include an oral presentation of OD-001 Phase 2a data at UEG Week in October, initiation of Phase 2b and Phase 2a OD-001 trials in the second half of 2026, and a planned Phase 1/2a trial of OD-002 starting in the first half of 2027.
false000188278200018827822026-08-042026-08-04

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 04, 2026

 

 

ODYSSEY THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-43270

86-3384382

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

51 Sleeper Street, Suite 800

 

Boston, Massachusetts

 

02210

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (617) 865-9628

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

ODTX

 

The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Item 2.02 Results of Operations and Financial Condition.

On August 4, 2026, Odyssey Therapeutics, Inc. (the "Company") announced its financial results for the three months ended June 30, 2026. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed "filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit

Number

 

Description

99.1

 

Press Release, dated August 4, 2026

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Odyssey Therapeutics, Inc.

 

 

 

 

Date:

August 4, 2026

By:

/s/ Jason Haas

 

 

 

Jason Haas
Chief Financial Officer

 

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
o
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.
o
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

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

Source: View Original Filing on SEC EDGAR

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