GT Biopharma Reports First Quarter 2026 Financial Results
Rhea-AI Summary
GT Biopharma (NASDAQ:GTBP) reported results for the quarter ended March 31, 2026 and provided pipeline updates. Cash and equivalents were about $9 million, expected to fund operations through Q4 2026.
Phase 1 trials of GTB-3650 for CD33+ leukemias and GTB-5550 for B7-H3+ solid tumors are ongoing, with additional data updates anticipated in 2H 2026.
For the comparable 2025 period, R&D expenses declined to about $0.4 million from $1.1 million, while SG&A (ex-stock comp) rose to about $2.4 million from $0.8 million. Net loss increased to approximately $2.8 million from $0.8 million.
Positive
- Cash balance of about $9 million expected to fund operations through Q4 2026
- Three TriKE candidates reportedly advanced into clinical development
- Ongoing Phase 1 trial of GTB-3650 with up to 7 planned cohorts and detailed dosing regimen
- Initiation of Phase 1 basket trial of GTB-5550 in May 2026 with subcutaneous dosing
- R&D expenses decreased to about $0.4 million from $1.1 million year over year
Negative
- SG&A expenses (ex-stock comp) increased to about $2.4 million from $0.8 million
- Loss from operations rose to approximately $2.8 million from $1.9 million
- Net loss widened to about $2.8 million from $0.8 million year over year
- Decrease of about $1.1 million in non-recurring other income versus the prior-year period
News Market Reaction – GTBP
In the May 15 session, GTBP declined 10.25%, reflecting a significant negative market reaction. Argus tracked a peak move of +15.0% during that session. Argus tracked a trough of -5.3% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. Trading volume was elevated at 2.5x the daily average, suggesting increased selling activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 02 | Annual 2025 results | Positive | -2.3% | Reported 2025 results, cash of $7M–$9M and updates on GTB-3650 and GTB-5550. |
| Nov 14 | Q3 2025 results | Positive | +26.1% | Q3 2025 update with $2.6M cash, lower R&D, and GTB-3650 advancing to Cohort 4. |
| Aug 14 | Q2 2025 results | Positive | -7.6% | Q2 2025 results showing $5.3M cash, reduced loss, and GTB-3650 trial progress. |
| Nov 14 | Q3 2024 results | Negative | -3.0% | Q3 2024 results with higher net loss, limited cash and increased SG&A expenses. |
| Aug 14 | Q2 2024 results | Positive | +3.5% | Q2 2024 earnings with $9.2M cash and plans to advance GTB-3650 and GTB-5550. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings releases have produced modest but inconsistent reactions, with both rallies and selloffs and an average move of 3.35% around prior financial updates.
Over the past two years, GT Biopharma’s earnings releases have consistently paired limited cash resources with updates on its TriKE® pipeline. Cash ranged from $2.6M in Q3 2025 to $9.2M in Q2 2024, generally extending runway only a few quarters. During this time, GTB-3650 progressed from planned initiation to active Phase 1 enrollment, while GTB-5550 advanced from IND planning to clearance and now clinical development. Today’s Q1 2026 results continue this pattern of small-company financing strain alongside clinical advancement.
Key Terms
phase 1 medical
basket trial medical
hematologic malignancies medical
subcutaneous medical
maximum tolerated dose medical
progression free survival medical
overall survival medical
pharmacokinetics medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Phase 1 trial evaluating GTB-3650 TriKE® remains ongoing, with additional updates anticipated in 2H 2026
Phase 1 basket trial evaluating GTB-5550 TriKE® in multiple solid tumor types known to express B7-H3 initiated May 2026 with updates anticipated in 2H 2026 as enrollment progresses through dose escalation cohorts
Cash balance as of March 31, 2026 of approximately
SAN FRANCISCO, CALIFORNIA, May 15, 2026 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced first quarter 2026 financial results for the period ended March 31, 2026.
"With the initiation of our GTB-5550 Phase 1 trial, we have now advanced three TriKE® candidates into the clinic, a significant milestone that underscores the continued momentum of our pipeline," said Michael Breen, Executive Chairman and Chief Executive Officer. "GTB-3650 has demonstrated an excellent safety profile thus far, and we look forward to continuing enrollment progress. With sufficient cash runway through Q4 2026, we look forward to providing updates on both programs in the second half of 2026."
GTB-3650 TriKE for CD33 positive leukemias
The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment is ongoing, with Cohort 4 enrollment now complete and a total of 8 patients treated across the first four cohorts; the Company expects to provide continued progress updates throughout 2026. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.
GTB-5550 TriKE for B7H3 positive solid tumor cancers
The ongoing Phase 1 trial with GTB-5550 is the first nanobody TriKE® tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial is focused primarily on enrolling prostate cancer patients and will evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.
GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573.
First Quarter Ended March 31, 2026 Financial Summary
Cash Position: The Company had cash and cash equivalents of approximately
Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were approximately
Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the second quarter of 2026 were approximately
Loss from Operations: The Company reported a loss from operations for the second quarter of 2026 of approximately
Net Loss: The Company reported a net loss of approximately
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward- looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as “aims,” "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that the use of these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include (i) the Company’s ability to continue as a going concern; (ii) the risk that if the Company experiences delays or difficulties in the enrollment of patients in clinical trials, those clinical trials could take longer than expected to complete and the Company’s receipt of necessary regulatory approvals could be delayed or prevented; (iii) the risk that the Company will need additional capital to conduct its operations and develop its products, and the Company’s ability to obtain the necessary funding is uncertain; (iv) the risk that the Company’s common stock may be delisted in the future if the Company is unable to maintain compliance with continued listing requirements; (v) the risk that the Company’s products may fail to achieve necessary safety and efficacy endpoints during clinical trials, which may limit the company’s ability to general revenues from therapeutic products and (vi) those other factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission.
TriKE® is a registered trademark owned by GT Biopharma, Inc.
Investor Relations Contact:
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
212-915-2577
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