GT Biopharma Reports Full Year 2025 Financial Results

Rhea-AI Summary

GT Biopharma (NASDAQ: GTBP) reported full year 2025 results and operational updates on March 2, 2026. The company had $7M cash as of Dec 31, 2025 and an unaudited proforma cash balance of $9M as of Jan 31, 2026, anticipated to fund operations through Q4 2026.

GTBP is enrolling a Phase 1 dose‑escalation trial of GTB-3650 and plans to initiate a Phase 1 basket trial of GTB-5550 mid‑2026; next pipeline update expected in Q3 2026.

Positive

• Unaudited proforma cash of $9M as of Jan 31, 2026 expected to fund through Q4 2026
• IND clearances for GTB-3650 (2024) and GTB-5550 (Jan 2026) enabling clinical programs
• Phase 1 enrollment ongoing for GTB-3650 with Cohort 5 dosing planned in Q2 2026

Negative

• Net loss widened to $28.4M for 2025, up $15.2M year over year
• Cash balance only $7M at Dec 31, 2025, implying limited runway without additional financing
• Loss from operations of $12.4M for 2025

Key Figures

Cash balance: $7 million Proforma cash: $9 million R&D expenses: $3.5 million +5 more

8 metrics

Cash balance $7 million Cash and equivalents as of Dec 31, 2025

Proforma cash $9 million Unaudited proforma cash as of Jan 31, 2026

R&D expenses $3.5 million Year ended Dec 31, 2025

SG&A expenses $8.5 million Year ended Dec 31, 2025 (ex-stock comp)

Loss from operations $12.4 million Year ended Dec 31, 2025

Net loss $28.4 million Year ended Dec 31, 2025

Planned patients 14 patients GTB-3650 Phase 1 dose escalation (2 per cohort, up to 7 cohorts)

Dose levels 6 dose levels GTB-5550 Phase 1a dose escalation to identify MTD

Market Reality Check

Price: $0.4780 Vol: Volume 767,521 is below t...

low vol

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Volume Volume 767,521 is below the 20-day average of 1,449,925 (relative volume 0.53x). low

Technical Shares at 0.478 are trading below the 200-day MA 1.29 and 87.58% under the 52-week high.

Peers on Argus

GTBP was up 1.92% pre‑news while momentum scanner flagged only one peer (SPRC) m...

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GTBP was up 1.92% pre‑news while momentum scanner flagged only one peer (SPRC) moving down 6.04%, suggesting stock-specific factors rather than a coordinated sector move.

Previous Earnings Reports

5 past events · Latest: Nov 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 14	Q3 2025 earnings	Positive	+26.1%	Reported Q3 2025 results with GTB‑3650 trial progress and runway into Q1 2026.
Aug 14	Q2 2025 earnings	Positive	-7.6%	Q2 2025 results showed lower net loss and R&D/SG&A cuts with GTB‑3650 progress.
Nov 14	Q3 2024 earnings	Negative	-3.0%	Q3 2024 results showed higher net loss and SG&A despite cash into Q2 2025.
Aug 14	Q2 2024 earnings	Neutral	+3.5%	Q2 2024 update outlined TriKE pipeline timelines and a <b>$9.2M</b> cash position.
May 15	Q1 2024 earnings	Neutral	+7.2%	Q1 2024 results with <b>$9.81M</b> cash and plans for GTB‑3650 and GTB‑5550 INDs.

Pattern Detected

Earnings releases have produced mixed reactions, with an average absolute move around 5.25% and a blend of sharp gains and notable selloffs.

Recent Company History

Over recent earnings cycles, GT Biopharma has consistently paired financial updates with progress on its TriKE® pipeline. Prior quarters highlighted advancing GTB‑3650 from trial planning to active Phase 1 enrollment, while GTB‑5550 moved from planned IND to submission timing. Cash balances ranged from $6.5M to $9.81M, generally projected to fund operations into future periods. Against this backdrop, the new 2025 results and updated runway through Q4 2026 extend the narrative of tight but managed financing alongside steady clinical advancement.

Historical Comparison

+5.3% avg move · Past earnings headlines moved GTBP by an average of 5.25%, with both strong rallies and sharp pullba...

earnings

+5.3%

Average Historical Move earnings

Past earnings headlines moved GTBP by an average of 5.25%, with both strong rallies and sharp pullbacks, framing today’s full-year 2025 report within a historically volatile reaction pattern.

Earnings updates have tracked GTB‑3650 from pre‑IND to ongoing Phase 1 dosing and GTB‑5550 from early planning to IND submission and clearance, while cash runway has generally extended by several quarters each update.

Market Pulse Summary

This announcement outlines full-year 2025 results alongside clinical progress for GTB‑3650 and GTB‑5...

Analysis

This announcement outlines full-year 2025 results alongside clinical progress for GTB‑3650 and GTB‑5550. Management reported cash of about $7 million at year-end and proforma $9 million as of January 31, 2026, guiding runway through Q4 2026. The update also details an expanding Phase 1 program and a planned basket trial in multiple solid tumors. Investors may track future cash balances, net loss trends, and milestone timing against prior regulatory filings noting going-concern and Nasdaq compliance risks.

Key Terms

phase 1, phase 2, basket trial, investigational new drug (ind), +3 more

7 terms

phase 1 medical

"Phase 1 trial evaluating GTB-3650 TriKE® continues to actively enroll..."

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

phase 2 medical

"After the dose escalation phase, the Phase 2 expansion component of the trial..."

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

basket trial medical

"Phase 1 basket trial evaluating GTB-5550 TriKE® in multiple solid tumor types..."

A basket trial is a type of clinical study that tests one treatment across multiple diseases or patient groups that share a common biological feature, like a genetic marker. Think of it as trying one key in several different locks that use the same mechanism; positive results can speed development and expand a drug’s potential market, while mixed results can raise uncertainty about which patient groups will benefit and how regulators will view approvals.

investigational new drug (ind) regulatory

"received clearance from the Food and Drug Administration with respect to its Investigational New Drug (“IND”) application..."

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

maximum tolerated dose (mtd) medical

"will test up to 6 dose levels to identify the maximum tolerated dose (MTD)."

Maximum tolerated dose (MTD) is the highest dose of an experimental drug that can be given to patients in early clinical testing without causing unacceptable or dangerous side effects. Investors watch the MTD because it frames whether a drug can reach effective levels safely, affects later trial design and approval chances, and influences expected development costs and market potential—like finding the fastest safe speed for a new vehicle before mass production.

progression free survival (pfs) medical

"Patients are followed for 12 months to determine progression free survival (PFS)..."

Progression free survival (PFS) is the amount of time after a treatment starts during which a patient’s disease does not get worse. Investors watch PFS because it’s a commonly reported measure in clinical trials that can indicate a drug’s effectiveness earlier than overall survival, much like measuring how long a dam holds before leaks reappear; stronger PFS results can speed regulatory decisions and affect a drug’s commercial prospects.

overall survival (os) medical

"Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS)."

Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.

AI-generated analysis. Not financial advice.

Phase 1 trial evaluating GTB-3650 TriKE^® continues to actively enroll, with the next update anticipated in Q3 2026 following completion of enrollment in dose Cohort 5

Phase 1 basket trial evaluating GTB-5550 TriKE^® in multiple solid tumor types known to express B7-H3 remains on track to initiate mid-2026

Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to provide sufficient cash runway through Q4 2026

SAN FRANCISCO, CALIFORNIA, March 02, 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 full year 2025 financial results for the period ended December 31, 2025.

“2026 looks to bring more significant milestones for the company, as we plan to initiate the first clinical trial with GTB-5550,” said Michael Breen, Executive Chairman and Chief Executive Officer. “Advancing our third TriKE candidate into the clinic underscores the continued momentum of our pipeline. GTB-3650 has shown an excellent safety profile thus far, and the higher dose cohorts will be more reflective of surpassing a potential efficacy threshold. With sufficient cash runway through Q4 2026, we look forward to providing the next update in the third quarter 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 in Cohort 4 (10 µg/kg/day) is ongoing, and the Company expects to initiate dosing in Cohort 5 (25 µg/kg/day) in Q2 2026. The Company anticipates providing the next update in the third quarter of 2026, which would include longer term follow-up on the six patients in Cohort 1 through 3 as well as initial observations from patients in Cohort 4 and Cohort 5. 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 Phase 1 basket trial with GTB-5550 will be the first dual nanobody TriKE^® tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will test up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 2 expansion component of the trial will then confirm the MTD identified in the Phase 1a trial in up to seven different possible metastatic disease cohorts (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. The Company remains well on track to initiate the trial in mid-2026.

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. 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).

Year Ended December 31, 2025 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $7 million as of December 31, 2025, and an unaudited proforma cash balance as of January 31, 2026 of approximately $9 million, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2025 were approximately $3.5 million compared to $5.8 million for the prior year. The $2.3 million decrease was primarily due to a reduction in production and material costs. R&D expenses primarily relate to the Company’s continued licensing, development and production of its most advanced TriKE^® product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates. In late June 2024, the Company received clearance from the Food and Drug Administration with respect to its Investigational New Drug (“IND”) application in relation to its next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and the Company has advanced into the clinic, enrolling patients, and performing tests for data collection throughout the year. In late January 2026, the Company received clearance from the FDA with respect to its IND Application in relation to GTB-5550, with a Phase 1 dose escalation basket trial expected to initiate mid-2026.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the year ended December 31, 2025 were relatively flat compared to the prior year, amounting to approximately $8.5 million compared to $8.3 million, respectively.

Loss from Operations: The Company reported a loss from operations of approximately $12.4 million for the year ended December 31, 2025, compared to $14.4 million for the prior year. The $2 million decrease consisted primarily of significant decreases in R&D expenses (as described above).

Net Loss: The Company reported a net loss of approximately $28.4 million for the year ended December 31, 2025, compared to $13.2 million for the prior year. The $15.2 million increase consisted almost entirely of a non-cash expense resulting from the change in fair value of additional investment rights connected to the Company’s Series L Preferred Stock during the year.

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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FAQ

What cash runway does GT Biopharma (GTBP) report for 2026?

GT Biopharma reports an unaudited proforma cash balance of approximately $9 million as of January 31, 2026. According to the company, that level is anticipated to provide sufficient cash runway through Q4 2026, absent material changes.

When will GT Biopharma (GTBP) provide the next clinical update for GTB-3650?

GT Biopharma expects the next update in Q3 2026 with longer follow-up and initial observations. According to the company, updates will include data from Cohorts 1–4 and planned Cohort 5 dosing.

What is the timing for the GTB-5550 Phase 1 basket trial for GTBP?

GT Biopharma plans to initiate the GTB-5550 Phase 1 basket trial in mid-2026. According to the company, the trial will use subcutaneous dosing and include a Phase 1a dose escalation followed by Phase 2 expansion cohorts.

How did GT Biopharma's (GTBP) R&D spending change in 2025?

R&D expenses fell to approximately $3.5 million in 2025 from $5.8 million the prior year. According to the company, the $2.3 million decrease was mainly due to reduced production and material costs.

Why did GT Biopharma (GTBP) report a larger net loss in 2025?

The net loss increased to about $28.4 million in 2025, driven largely by a non-cash change in fair value tied to Series L preferred stock rights. According to the company, this non-cash expense accounted for most of the increase.

What are the near-term clinical milestones investors should watch for GTBP?

Investors should watch for Cohort 5 dosing of GTB-3650 in Q2 2026 and a first update in Q3 2026. According to the company, GTB-5550 trial initiation mid-2026 is another key milestone.