Odyssey Therapeutics Files for Nasdaq IPO with Focus on Inflammation and Immune Disorders

PharmaCircleLearned: Previously in 2025Year1Mid to late month, established in2021Year'sOdyssey TherapeuticsSubmit the prospectus, prepare for listing on Nasdaq, code“ODTX”。Before the submission of the prospectus, Odyssey Therapeutics had completed multiple rounds of financing. In 2021, 2022, and 2023, it completed Series A, B, and C financings respectively, with a total financing amount reaching $487 million.

Moxie Medicine Database: Financing Information

In this IPO, Odyssey Therapeutics plans to raise 100 million US dollars to support the advancement of its R&D pipeline and the company's operational development. Before the IPO, the company's shareholder structure was relatively dispersed. Among them, SR One Capital Management holds 16.2%, OrbiMed Private Investments VIII holds 14.3%, FMR holds 6.7%, Foresite Capital holds 6%; Logos Opportunities Fund III holds 5.3%, General Catalyst Group holds 5%, Gary D. Glick holds 5.4%, and Jeffrey M. Leiden holds 1.2%.

Current therapies for inflammatory diseases primarily focus on the adaptive immune response, particularly the inhibition of cytokines. Despite targeting different cytokines, these approaches have fundamental limitations. Since cytokines possess redundant functions, blocking any single cytokine will not prevent other cytokines from activating the adaptive immune response. By concentrating on upstream immune responses, Odyssey Therapeutics' pipeline has the potential to address the issue of downstream cytokine redundancy and mitigate direct damage caused by innate immune responses, while also reducing the risk of immunosuppression.

Odyssey TherapeuticsStrategically adopting both small molecule and protein therapeutic modalities with the goal of developing innovative drugs that represent a significant advancement over standard therapies.

The company's most advanced pipeline isOD-07656，This is aRIPK2Inhibitor，Being studied for the treatment ofUC(Ulcerative Colitis, InflammatoryA type of enteropathy).RIPK2 is a key signaling protein in the innate immune system that responds to bacterial byproducts in the digestive tract and is considered an initiating factor for IBD (inflammatory bowel disease) as well as a mechanism of resistance to standard therapies such as tumor necrosis factor (TNF) and integrin blockade. Based on observations of increased RIPK2 activation in IBD patients, the association between RIPK2-related gene expression and disease severity, and the alleviation of disease following RIPK2 gene knockout or inhibition in preclinical models, the company believes that blocking RIPK2 has the potential to address the core pathological issues of IBD. Inhibiting RIPK2 can block the response of multiple cytokines to bacterial byproducts, many of which are effective targets for IBD treatment, including TNF, TL1A, and IL-23. By blocking these cytokines, the adaptive immune response can be reduced. It is also inferred that blocking RIPK2 may prevent direct damage to the intestinal epithelial lining caused by the activation of innate immune cells.

Whether used as a monotherapy or in combination with existing therapies,OD-07656All are possible to breakIBDThe Ceiling of Treatment.

Study Design of Phase 2a Clinical Trials for OD-07656 Program

Expected2025The first quarter of the year beginsOD-07656Clinical Trials2aPhase Research, EvaluationOD-07656As a monotherapyUCThe patient's outcome, and in2026Preliminary induction results announced in the first half of the year; in2026The second clinical trial began in the first half of the year.2aPhase Research, EvaluationOD-07656In combination with standard therapy integrin blockade vedolizumab, and is expected to2027Top-line results of the combination induction to be announced mid-year.After completing the aforementioned clinical trials, Odyssey Therapeutics may also initiate further studies in other diseases suitable for RIPK2 inhibition, including Crohn's disease and spondyloarthritis.

Another oral small molecule on the agendaIRAK4InhibitorAiming to block the inflammatory signaling of myosin, a protein complex present in various tissue cells. IRAK4 inhibitors are expected to be used in the treatment of multiple inflammatory diseases, including AD, purulent tonsillitis, and osteoarthritis.Once selectedIRAK4Candidate development drugs will be subsequently launched.INDAdaptive Toxicology Research, IfINDThe results of the adaptive toxicology study are acceptable and expected.2026Submitted in Australia in the first half of the yearCTAApplication.

Clinical trials conducted in healthy volunteers1The research period is expected to includeSADAndMADIn two parts, to evaluate safety, pharmacokinetics, and pharmacodynamics. Currently expected to2026The trial will begin in the first half of the year, pendingTGAApproval, and in2026The trial results will be announced in the second half of the year.The above is the clinical trial Phase 1 study design for the IRAK4 inhibitor program.

OD-00910Is a monospecific tetravalentV-shaped body, designed to selectively activate TNFR2 on Tregs. TNFR2 is a receptor highly expressed on Tregs and has relatively limited expression on other cells. Activating TNFR2 on Tregs can reduce inflammation by increasing the number of Tregs, improve the immunosuppressive function and tissue homing of Tregs, and maintain Tregs in a stable immunosuppressive phenotype.

OD-00910Expected2025To be submitted in Australia by the end of the yearCTAApplication. Clinical Trial1aThe phase trial is expected to include healthy volunteers.SADPart, followed by implementation in inflammation patientsMADThe purpose of the trial and research is to evaluate safety, pharmacokinetics, and pharmacodynamics. It is expected that2026In the first half of the yearSADPart of the trial, pendingTGAApproval, and in2026Clinical trial results announced in the second half of the year1aResults of the study.

Other early pipeline developments also includeTSLP/IL-33Bispecific antagonist,NLRP1Small molecule inhibitors andMDA5Small molecule inhibitors.In addition, Odyssey Therapeutics also collaborates withCollaboration with Janssen Pharmaceuticals, a Johnson & Johnson company, leveraging the company's artificial intelligence and machine learning capabilities to develop molecules targeting multiple therapeutic sites; andPfizerCollaborate to identify candidate products targeting transcription factors using the company's natural products; additionally, collaborate withTerray TherapeuticsCollaborate to discover and develop an immunological transcription factor of mutual interest.--Inhibitor of interferon regulatory factor 5 (IRF5) for the treatment of systemic lupus erythematosus.

Odyssey Therapeutics had no revenue in 2022, and its revenue in 2023 was $1.037 million.

2024Before the YearQ3 CompanyRevenue is270"Million USD,"Increased compared to the same period last year.262%; R&D expenses are8110Million US dollars, decreased compared to the same period last year.540Million USD; General and administrative expenses are1970Million US dollars, increased compared to the same period last year.280"Million US dollars;"Operating Loss9950Million USD, net loss of9340"Million USD."Deadline2024Year12Month31The cash and cash equivalents as of the date are approximately1.294Billion USD.

Reference:

NMPA/CDE；

Moxie Pharma Database, https://pharma.bcpmdata.com/;

FDA/EMA/PMDA；

Relevant companies' public disclosures (unless otherwise noted, images in the main text are from the companies' official websites);

https://odysseytx.com/；

https://www.sec.gov/cgi-bin/browse-edgar?company=Odyssey+Therapeutics&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany；

https://www.biospace.com/business/sionna-odyssey-join-growing-2025-ipo-class-as-analysts-forecast-muted-market; etc.