SEC Filing | Odyssey Therapeutics, Inc

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8-K

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): June 17, 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 June 17, 2026, Odyssey Therapeutics, Inc. (the "Company") announced its financial results for the three months ended March 31, 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 June 17, 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:	June 17, 2026	By:	/s/ Jason Haas
			Jason Haas Chief Financial Officer

EX-99.1

Exhibit 99.1

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

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

Investor Relations

Collin Todd

SVP, Strategy and Business Development

investors@odysseytx.com