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

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Odyssey Therapeutics (Nasdaq: ODTX) reported Q1 2026 results and a corporate update.

OD-001 achieved clinical proof-of-concept in Phase 2a ulcerative colitis, with 27% remission and 61% response. An IPO and private placement provided $288.7M net, supporting a pro-forma cash position of $464.4M and runway into 2H 2028.

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Positive

  • OD-001 Phase 2a: 27% remission, 61% clinical response in ulcerative colitis
  • OD-001 well tolerated across both tested doses in Phase 2a
  • Plan to start OD-001 Phase 2b monotherapy and Phase 2a combo trials in 2H 2026
  • OD-002 IND-enabling work targeting CTA filing in 2H 2026
  • IPO and private placement gross proceeds of $314.8M at $18 per share
  • Pro-forma cash of $464.4M expected to fund operations into 2H 2028
  • Research and development expenses fell to $32.3M from $38.8M YoY
  • General and administrative expenses declined to $7.4M from $8.0M YoY

Negative

  • Quarterly net loss of $38.3M, similar to prior-year $38.4M loss
  • Quarterly research and development expenses remain high at $32.3M
  • Company remains pre-revenue and dependent on external financing

News Market Reaction – ODTX

+3.19%
1 alert
+3.19% Session close to close
$935.65M Market Cap
0.1x Rel. Volume

In the Jun 18 session, ODTX gained 3.19%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines Phase 2a proof-of-concept results for OD-001 with an earnings update high...
Analysis

This announcement combines Phase 2a proof-of-concept results for OD-001 with an earnings update highlighting cash, cash equivalents and marketable securities of $175.7M and pro-forma cash of $464.4M. The data show 27% clinical remission and 61% clinical response in 49 patients, while R&D spend was $32.3M and net loss $38.3M. Investors may watch execution on Phase 2b/2a trials and the planned OD-002 CTA as key milestones.

Key Figures

Trial patients: 49 patients Clinical remission rate: 27% Clinical response rate: 61% +5 more
8 metrics
Trial patients 49 patients Completed 12 weeks of OD-001 treatment; eligible for efficacy analysis
Clinical remission rate 27% Phase 2a monotherapy trial of OD-001 in ulcerative colitis
Clinical response rate 61% Phase 2a monotherapy trial of OD-001 in ulcerative colitis
Cash & securities $175.7M Cash, cash equivalents and marketable securities as of March 31, 2026
Net IPO/placement proceeds $288.7M Net proceeds from initial public offering and concurrent private placement
Pro-forma cash $464.4M Pro-forma cash position as of March 31, 2026 after financing events
R&D expenses $32.3M Quarter ended March 31, 2026 (vs. $38.8M in 2025 period)
Net loss $38.3M Quarter ended March 31, 2026 (vs. $38.4M in 2025 period)

Key Terms

phase 2a, monotherapy, ulcerative colitis, ripk2, +4 more
8 terms
phase 2a medical
"Achieved clinical proof-of-concept in a Phase 2a clinical trial of OD-001..."
Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.
monotherapy medical
"Phase 2a monotherapy trial for moderate to severe ulcerative colitis..."
Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.
ulcerative colitis medical
"Phase 2a monotherapy trial for moderate to severe ulcerative colitis..."
A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.
ripk2 medical
"oral RIPK2 scaffolding inhibitor, OD-001, in moderate-to-severe ulcerative colitis..."
RIPK2 is an intracellular enzyme that helps immune cells detect threats and trigger inflammation by relaying signals from pattern-recognition receptors to the cell’s response machinery — like a switchboard operator that turns on defensive alarms. It matters to investors because drugs that block or modulate RIPK2 can dampen harmful inflammation in autoimmune diseases and some cancers, making it a potential therapeutic target, biomarker and licensing opportunity in drug development pipelines.
slc15a4 medical
"small molecule SLC15A4 inhibitor, OD-002, for which we expect to file a CTA..."
SLC15A4 is a gene that makes a protein acting like a specialized courier inside immune cells, moving small building blocks and helping immune sensors send alarm signals. Investors watch it because drugs that block or modulate this courier can calm overactive immune responses in autoimmune and inflammatory diseases, so it’s a potential target for new therapies or a biomarker indicating how well those therapies might work.
investigational new drug regulatory
"Complete investigational new drug (“IND”) enabling studies and file a clinical trial..."
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
clinical trial application regulatory
"file a clinical trial application (“CTA”) in the second half of 2026..."
An application submitted to a regulatory authority requesting formal permission to begin testing a new drug, medical device, or treatment in humans. Like asking for a building permit before construction, it summarizes safety data, plans for how the study will be run, and monitoring procedures; investors watch these filings closely because approval lets a program move from lab research to clinical testing, reducing uncertainty and creating value-driving milestones.
clinical remission medical
"with 27% of patients achieving clinical remission and 61% achieving clinical response."
A state in which a patient’s disease symptoms have largely disappeared or dropped to a level so low they no longer interfere with daily life, as judged by doctors or trial measurements. For investors, reaching clinical remission in a drug trial or treatment program is like flipping a switch that shows the therapy can work — it boosts the odds of regulatory approval, broader use, and future sales, while still not guaranteeing a permanent cure.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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 


FAQ

What clinical results did Odyssey Therapeutics (ODTX) report for OD-001 in Q1 2026?

Odyssey reported Phase 2a proof-of-concept for OD-001 in moderate to severe ulcerative colitis. According to Odyssey, 27% of 49 patients achieved clinical remission and 61% achieved clinical response after 12 weeks, with OD-001 well tolerated at both doses.

What are the next clinical milestones for OD-001 and OD-002 at Odyssey Therapeutics (ODTX)?

Odyssey plans to start an OD-001 Phase 2b monotherapy and a Phase 2a vedolizumab combination trial in 2H 2026. According to Odyssey, topline induction data are expected in 2H 2027, and an OD-002 CTA filing is targeted for 2H 2026.

How much cash runway does Odyssey Therapeutics (ODTX) report after its Q1 2026 IPO financing?

Odyssey expects its cash to fund operations into the second half of 2028. According to Odyssey, Q1 2026 cash of $175.7M plus $288.7M net IPO and private placement proceeds give a pro-forma cash position of $464.4M.

What were Odyssey Therapeutics (ODTX) key Q1 2026 financial results?

Odyssey reported a Q1 2026 net loss of $38.3M. According to Odyssey, research and development expenses were $32.3M, general and administrative expenses were $7.4M, and cash, cash equivalents and marketable securities totaled $175.7M at March 31, 2026.

How large was the Odyssey Therapeutics (ODTX) IPO and at what price?

Odyssey completed an IPO and concurrent private placement totaling $314.8M in gross proceeds. According to Odyssey, 15,500,000 IPO shares and 1,388,889 private placement shares, plus 600,000 overallotment shares, were sold at $18.00 per share under ticker ODTX.

When did Odyssey Therapeutics (ODTX) begin trading on Nasdaq and under which symbol?

Odyssey began trading on the Nasdaq Capital Market on May 8, 2026. According to Odyssey, its common stock trades under the ticker symbol “ODTX”, following completion of its initial public offering and concurrent private placement.