Definium Therapeutics, Inc.

Definium Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing psychedelic-based medicines for brain health disorders. The company’s lead program is DT120 ODT, which it is advancing through Phase 3 trials in generalized anxiety disorder (GAD) and major depressive disorder (MDD).

6.29

6.29

— Definium Therapeutics, Inc.
%
Lead clinical candidate0% DT120 ODT is the company’s lead oral disintegrating tablet program being advanced in late-stage trials.
Pipeline product candidates0% Additional psychedelic or neuropsychiatric candidates under research and development.
Clinical development services0% Internal and external trial design, execution, and data generation for regulatory approval.
Manufacturing and supply0% cGMP production, packaging, and supply of investigational product for trials and launch readiness.
Commercialization preparation0% Market access, medical affairs, and launch planning for any approved product.

The company does not yet sell approved products, so its current “customers” are primarily clinical trial sites,...

  • Clinical trial ecosystemprimary

    Research sites, investigators, and CRO-like partners that execute studies and generate data for approval.

  • Regulatory stakeholdersprimary

    FDA and other regulators that determine whether product candidates can advance to market.

  • Psychiatry prescriberssecondary

    Psychiatrists and other physicians who would prescribe DT120 ODT if approved for GAD or MDD.

  • Patients with brain health disorderssecondary

    Adults with anxiety or depression who may use the therapy if it reaches commercialization.

  • Controlled-substance distributors and pharmaciessecondary

    DEA-registered supply chain participants needed to distribute any scheduled product.

Definium is headquartered in New York, with a Canadian corporate base in British Columbia and a U.S...

  • •Headquartered in New York, United States
  • •Canadian parent company incorporated in British Columbia
  • •Wholly owned U.S. subsidiary in Delaware
  • •Offices in San Diego, Durham, and Madison
  • •No disclosed revenue geography because the company has no product sales

The company’s strategy is to advance psychedelic-based psychiatry with scientific rigor, centered on completing Phase 3...

01
Advance DT120 ODT through Phase 3short-term

Late-stage data is the main value driver and the key step toward approval.

02
Prepare for regulatory and commercial executionmedium-term

Approval would require manufacturing, distribution, and market access readiness.

03
Maintain financing flexibilityshort-term

The company has no product revenue and depends on external capital to fund R&D.

Definium is a pre-revenue clinical-stage company, so its value depends on successful trial outcomes, regulatory...

critical

Clinical development failure

The company’s lead value driver depends on positive Phase 3 results in GAD and MDD.

Scope
DT120 ODT and other pipeline candidates
Materiality
high
high

Capital dependence

The company has operating losses, no product revenue, and ongoing R&D cash burn.

Scope
Equity markets, debt facilities, and future dilution
Materiality
high
high

Regulatory and controlled-substance restrictions

Approval, scheduling, DEA registration, and state monitoring rules can slow uptake.

Scope
U.S. distribution and prescribing
Materiality
high
high

Product liability and professional indemnity

Any adverse events in trials or post-approval could trigger claims and reputational damage.

Scope
Clinical trials and future commercial use
Materiality
medium
medium

Public perception of psychedelics

Negative publicity may reduce physician willingness to prescribe and patient acceptance.

Scope
Market adoption in psychiatry
Materiality
medium
Research and development expense timing
Affects operating loss comparability and cash burn analysis
Stock-based compensation
Inflates non-cash operating expense and reduces comparability
Debt and warrant accounting
Can affect net loss, leverage presentation, and dilution analysis
Contingent liabilities and product liability reserves
May change reported liabilities and earnings if estimates shift

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: 28.4.2026