TETRA BIO-PHARMA

Global Leaders in Cannabinoid-Based Drug Discovery and Development

Value Creating Milestones

December 30, 2020

Value Creating Milestones

2020 - Milestone Status

ARDS-003

  • Completion of intravenous finished drug product for human trials.
    • Completed; NR dated August 18th.
  • Completion of clinical batch IND-enabling toxicology with no safety issues for proceeding to humans.
    • Completed; Nov 16th & Dec 2nd NR.
  • File CTA/IND of Phase 1 trial.
    • Initiated regulatory process.

QIXLEEF

  • Initiate PLENITUDE (Phase II) in advanced cancer patients with uncontrolled pain in USA.
    • Trial launched; NR dated Sept 2nd.
  • File EU Phase 3 Plenitude trial in cancer pain.
    • Trial implementation; NR dated Nov 16th.

Ophthalmic

  • File CTA/IND of Phase 1 trial
    • Initiated regulatory process.

CAUMZ

  • Initiate Phase 3 enabling toxicology.
    • Studies initiated.
  • File IND THC-CBD interactions trials required for NDA.
    • Initiated regulatory process.
  • File IND for Reborn trial.
    • Refer to Nov. 16th NR.
  • File IND for trial in advanced cancer patients.
    Initiated regulatory process.

QIXLEEF & CAUMZ:

  • Complete mapping of cannabinoid metabolites
    • Completed; Nov 16th NR.

Dronabinol NDS filing

  • New Drug Submission filing to Health Canada
    • Completed; Dec 30th NR.

Corporate Presentation I

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Tetra Bio-Pharma Inc. published this content on 30 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 January 2021 15:51:07 UTC