GT Biopharma, Inc. — Cyborg Score 4/10

Challenged
NK cell-based immunotherapy

Strategic Profile

Its lead clinical candidate, GTB-3650, is in a Phase 1 dose-escalation trial for relapsed or refractory CD33-expressing hematologic malignancies, while GTB-5550 targets B7-H3–expressing solid tumors and has reached the IND submission stage. However, in November 2025, the company received a Nasdaq notice that its common stock had closed below $1 per share for 30 consecutive business days, indicating non-compliance with the minimum bid price requirement for continued listing.

Cyborg Score Rationale

GT Biopharma is a pre-revenue clinical-stage biotech with early-phase programs and limited financial resources. The company faces near-term delisting risk from Nasdaq due to low stock price and limited cash runway, which creates significant execution and financing headwinds.

Top Insights

  • Clinical-stage biotech with no approved products; viability entirely dependent on clinical trial outcomes
  • Nasdaq delisting risk as of November 2025 due to stock price falling below $1 minimum bid requirement for 30+ consecutive days
  • Pipeline includes GTB-7550 for CD19-positive lymphoid malignancies and autoimmune diseases, expanding beyond oncology
  • Formerly OXIS International; rebranded and repositioned toward NK cell-based immunotherapy

Named Competitors

  • CAR-NK Cell Therapies — Off-the-shelf engineered NK cell platform
  • CAR-T Cell Therapies — T-cell mediated immunotherapy for hematologic malignancies
  • Immuno-Oncology Immunotherapies — Keytruda and broader immuno-oncology pipeline

Recent Developments

  • (April 2026) Entered into an Investigator Initiated Clinical Trial
  • (Q2 2026) First patient dosed in Phase 1 trial evaluating GTB-5550 for B7-H3-targeted NK cell therapy
  • (Q1 2026) Announced implementation of artificial intelligence-based technologies across drug discovery

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