GT Biopharma, Inc.
GTBP evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for GTBP—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · GTBP
GT Biopharma, Inc. is a clinical-stage biotechnology company focused on developing TriKE® natural killer cell engagers for oncology, with lead candidates GTB-3650 and GTB-5550 in clinical development and no approved products or revenue.
Key risk: Going concern risk
BioSniper Score
Based on 5 of 6 signals
Market Cap
$13.5M
Cash Runway
3.7 moLead Asset
gtb-3650 (Phase 1)
Next Catalyst
Phase3_Topline · Jan 23, 2031Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 35 clinical trials · 1 catalyst for GT Biopharma, Inc..
GT Biopharma, Inc. is a clinical-stage biotechnology company focused on developing TriKE® natural killer cell engagers for oncology, with lead candidates GTB-3650 and GTB-5550 in clinical development and no approved products or revenue.
- GT Biopharma is developing TriKE® (tri-specific killer engager) product candidates GTB-3650 and GTB-5550 for hematologic malignancies [sec_mda · as of 2025-02-21].
- The company has no product candidates approved for sale and has not generated any revenue from product sales [sec_mda · as of 2025-11-14].
- As of June 30, 2026, GT Biopharma reported cash and equivalents of $5.1 million, a net loss of $4.5 million for the quarter, and shareholders' equity of $5.8 million [sec].
- The company has sustained operating losses since inception and expects losses to continue, raising substantial doubt about its ability to continue as a going concern [sec_mda · as of 2025-11-14].
- GTB-3650 received FDA IND clearance in late June 2024, and study enrollment for relapsed/refractory AML and high-grade MDS began on January 21, 2025 [sec_mda · as of 2025-02-21].
What works
- GT Biopharma has a proprietary TriKE® platform that may offer a differentiated approach to NK cell engagement for oncology [sec_mda · as of 2025-02-21].
- The company has advanced GTB-3650 into the clinic with FDA IND clearance and ongoing enrollment, indicating regulatory and operational progress [sec_mda · as of 2025-02-21].
- GT Biopharma has historically financed operations through multiple channels including public/private stock sales, convertible debt, and strategic collaborations, demonstrating some access to capital [sec_mda · as of 2025-11-14].
What to weigh
- GT Biopharma has no approved products, no revenue from product sales, and has sustained operating losses since inception [sec_mda · as of 2025-11-14].
- The company's financial statements include a going concern qualification, indicating substantial doubt about its ability to continue operations [sec_mda · as of 2025-11-14].
- GT Biopharma expects to need substantial additional capital to develop and commercialize any product candidates, and financing may not be available on acceptable terms [sec · filed 2026-04-30].
- Research and development expenses have fluctuated, with decreases in some periods due to lower production and material costs, which may signal variability in development activity [sec_mda · as of 2025-11-14].
From the filings
Quoted directly from source documents.
The company has no approved products and no product revenue.
“We do not have any product candidates approved for sale and have not generated any revenue from our product sales.”
SEC MD&A · November 14, 2025
GTB-3650 IND clearance and enrollment start.
“In late June 2024, we received clearance from the FDA with respect to our IND Application in relation to GTB 3650, and we started study enrollment targeting patients with relapsed/refractory AML and high grade MDS on January 21, 2025.”
SEC MD&A · February 21, 2025
Going concern and need for additional capital.
“We have sustained operating losses since inception, and we expect such losses to continue into the foreseeable future.”
SEC MD&A · November 14, 2025
Catalyst timeline
- 2031-01-23 · Phase3_Topline — Phase 3 Topline: A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizu — This is a long-dated catalyst; watch for any updates or changes to the timeline for the Phase 3 extension study of rozanolixizumab.
Risks & what to watch (4)›
Key risks
- Going concern risk — Substantial doubt about ability to continue as a going concern due to sustained losses and no revenue [sec_mda · as of 2025-11-14].
- Capital needs — Expects to need substantial additional capital; financing may not be available on acceptable terms [sec · filed 2026-04-30].
- No approved products — No product candidates approved for sale; no revenue from product sales [sec_mda · as of 2025-11-14].
- Dilution risk — Additional equity financing could result in significant dilution to stockholders [sec · filed 2026-04-30].
What to watch
- Progress of GTB-3650 Phase 1/2 clinical trial enrollment and any topline data [sec_mda · as of 2025-02-21].
- GTB-5550 product development completion and potential IND filing [sec_mda · as of 2025-02-21].
- Ability to secure additional financing or strategic partnerships to extend cash runway [sec · filed 2026-04-30].
- Any updates on the going concern status and cash position in future SEC filings [sec_mda · as of 2025-11-14].
Sources: SEC filings · SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
3.7 months
OCF -$4M · Net income -$5M
Lead: Phase 1
1 candidate
1 upcoming, next in ~1607d
No insider transactions in the last 180 days
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
36
Total value held
$715K
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 903,750 | $369K |
| geode capital management, llc | 294,459 | $120K |
| vanguard fiduciary trust co | 225,938 | $92K |
| citadel advisors llc | 66,165 | $27K |
| two sigma securities, llc | 31,796 | $13K |
| osaic holdings, inc. | 21,000 | $9K |
| cerity partners llc | 20,023 | $8K |
| integrated wealth concepts llc | 20,006 | $8K |
| private wealth management group, llc | 20,000 | $8K |
| morgan stanley | 16,599 | $7K |
Showing top 10 of 36 institutional holders of GT Biopharma, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 21, 2026- % of float
- 1.7%
- Days to cover
- 1.0
- Shares short
- 604,557
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
GTBP short interestGovernance
Frequently asked questions
What is the AI investment thesis for GT Biopharma, Inc.?
GT Biopharma, Inc. is a clinical-stage biotechnology company focused on developing TriKE® natural killer cell engagers for oncology, with lead candidates GTB-3650 and GTB-5550 in clinical development and no approved products or revenue.
What is GT Biopharma, Inc.'s lead drug candidate?
GT Biopharma, Inc.'s most advanced tracked candidate is gtb-3650 (Phase 1) for Relapsed/refractory AML and high-risk MDS.
What is GT Biopharma, Inc.'s next catalyst?
GT Biopharma, Inc.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizu" — expected January 23, 2031.
Who is the CEO of GT Biopharma, Inc.?
Mr. Michael Martin Breen L.L.B. is the chief executive officer of GT Biopharma, Inc. (GTBP).
Where is GT Biopharma, Inc. headquartered?
GT Biopharma, Inc. (GTBP) is headquartered in San Francisco, CA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.