GT Biopharma Narrows Losses, Equity Turns Positive Amid Cash Burn

TL;DR

**GTBP is burning cash fast, but managed to cut losses and raise capital, making it a speculative bet on future clinical success.**

AI Summary

GT Biopharma, Inc. reported a net loss of $5.3 million for the nine months ended September 30, 2025, a significant improvement from the $9.387 million net loss in the prior year period. The company generated no revenue in either period. Operating expenses decreased, with research and development falling from $3.868 million in 2024 to $2.096 million in 2025, and selling, general and administrative expenses decreasing from $6.733 million to $4.731 million. Cash and cash equivalents decreased from $3.951 million at December 31, 2024, to $2.528 million at September 30, 2025. The company used $8.893 million in cash from operating activities during the nine months ended September 30, 2025, compared to $10.436 million in the same period of 2024. Total stockholders' equity improved from a deficit of $1.670 million to a positive $3.000 million, driven by $6.503 million in proceeds from Series L convertible preferred stock and warrants. The company continues to face substantial doubt about its ability to continue as a going concern due to sustained operating losses and reliance on external financing.

Why It Matters

GT Biopharma's ability to reduce its net loss and achieve positive stockholders' equity is a critical signal for investors, suggesting some success in managing expenses and attracting capital. However, the persistent lack of revenue and significant cash burn from operations, totaling $8.893 million, highlight the ongoing high-risk nature of this clinical-stage biopharmaceutical company. For employees, continued financing is essential for job security and program advancement. Customers (future patients) depend on the company's financial viability to bring its TriKE and Dual Targeting TriKE platforms to market. Competitively, GTBP's financial health and progress in clinical trials will determine its standing against larger, more established biopharmaceutical firms in the immune-oncology space.

Risk Assessment

Risk Level: high — The company reported a net loss of $5.3 million for the nine months ended September 30, 2025, and used $8.893 million in cash from operating activities during the same period. These factors, coupled with the explicit 'Going Concern Analysis' stating 'substantial doubt about the Company's ability to continue as a going concern,' indicate a high financial risk.

Analyst Insight

Investors should approach GTBP with extreme caution, recognizing its high-risk profile as a clinical-stage biopharmaceutical company with no revenue. Monitor future financing activities and clinical trial progress closely, as the company's survival hinges on securing additional capital and advancing its TriKE platform. Consider this a highly speculative investment.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

N/A

total Debt

N/A

net Income

-$5.3M

eps

-$0.83

gross Margin

N/A

cash Position

$2.528M

revenue Growth

N/A

Revenue Breakdown

Key Numbers

• $5.3M — Net Loss (Reduced from $9.387M in prior year, a 43% improvement.)
• $8.893M — Cash Used in Operations (Decreased from $10.436M in prior year, indicating improved cash management.)
• $3.000M — Total Stockholders' Equity (Shifted from a $1.670M deficit, indicating successful capital raises.)
• $2.528M — Cash and Cash Equivalents (Down from $3.951M at year-end 2024, highlighting ongoing cash burn.)
• $2.096M — Research and Development Expenses (Decreased from $3.868M in prior year, a 45.8% reduction.)
• $4.731M — Selling, General and Administrative Expenses (Decreased from $6.733M in prior year, a 29.7% reduction.)
• $6.503M — Proceeds from Series L Convertible Preferred Stock (Key financing activity contributing to positive equity.)
• 0 — Revenue (No revenue generated, typical for a clinical-stage biopharma.)
• $0.8M — Deferred Offering Costs (Capitalized for in-process equity financings, indicating future capital raise efforts.)
• $0.83 — Net Loss Per Share (Q3 2025) (Improved from $1.53 in Q3 2024, despite increased share count.)

Key Players & Entities

• GT Biopharma, Inc. (company) — clinical stage biopharmaceutical company
• Nasdaq Capital Market (regulator) — exchange where common stock is registered
• $5.3 million (dollar_amount) — net loss for nine months ended September 30, 2025
• $8.9 million (dollar_amount) — cash used in operations for nine months ended September 30, 2025
• $3.000 million (dollar_amount) — Total Stockholders' Equity as of September 30, 2025
• $1.670 million (dollar_amount) — Total Stockholders' Deficit as of December 31, 2024
• $2.528 million (dollar_amount) — Cash and cash equivalents as of September 30, 2025
• $3.951 million (dollar_amount) — Cash and cash equivalents as of December 31, 2024
• TriKE (company) — proprietary platform for immune-oncology products
• Dual Targeting TriKE (company) — proprietary platform for immune-oncology products

FAQ

Risk Factors

• Going Concern Uncertainty [high — financial]: The company faces substantial doubt about its ability to continue as a going concern due to sustained operating losses and a history of reliance on external financing. As of September 30, 2025, cash and cash equivalents were $2.528 million, down from $3.951 million at year-end 2024, while operating activities consumed $8.893 million in the first nine months of 2025.
• Dependence on Future Financing [high — financial]: GT Biopharma's ability to fund its operations and development activities is contingent upon its success in raising additional capital. The company has no recurring revenue and has historically relied on equity financings, such as the $6.503 million from Series L convertible preferred stock and warrants, to sustain operations.
• Clinical Trial and Development Risks [high — operational]: As a biopharmaceutical company, GT Biopharma's success is heavily dependent on the outcome of its research and development activities, including the successful progression of its drug candidates through clinical trials. Delays, failures, or unexpected adverse events in clinical trials can significantly impact the company's prospects.
• Regulatory Approval Hurdles [high — regulatory]: The development and commercialization of pharmaceutical products are subject to stringent regulatory review and approval processes by agencies like the FDA. Failure to obtain regulatory approval for its drug candidates would severely impact the company's ability to generate revenue.
• Competition in the Biopharma Sector [medium — market]: The biopharmaceutical industry is highly competitive, with numerous companies developing therapies for similar indications. GT Biopharma faces competition from established pharmaceutical companies and emerging biotech firms, which could affect market penetration and pricing if its products reach commercialization.
• Dilution from Equity Financings [medium — financial]: The company's reliance on equity financing, including the recent Series L preferred stock and warrants, can lead to significant dilution for existing common stockholders. This can impact the value of their holdings and potentially make future capital raises more challenging.

Industry Context

The biopharmaceutical industry is characterized by high R&D costs, long development cycles, and significant regulatory hurdles. Companies like GT Biopharma often operate at a loss for extended periods, relying on external financing until a product gains regulatory approval and market traction. The competitive landscape is intense, with both large pharmaceutical firms and smaller biotech companies vying for market share.

Regulatory Implications

GT Biopharma's operations are subject to rigorous oversight by regulatory bodies such as the FDA. The success of its drug candidates hinges on navigating complex clinical trial requirements and obtaining marketing approval, a process that is lengthy, expensive, and carries a high risk of failure.

What Investors Should Do

1. Monitor cash burn and future financing activities.
2. Evaluate R&D pipeline progress and clinical trial results.
3. Assess the impact of equity financings on dilution.

Key Dates

• 2025-09-30: Nine months ended September 30, 2025 — Reported a net loss of $5.3 million, an improvement from the prior year, with reduced operating expenses and cash burn from operations.
• 2024-12-31: Year-end 2024 — Company had $3.951 million in cash and cash equivalents.
• 2025-09-30: As of September 30, 2025 — Cash and cash equivalents decreased to $2.528 million. Total stockholders' equity improved to a positive $3.000 million from a deficit of $1.670 million.

Glossary

Going Concern

An accounting assumption that a company will continue to operate for the foreseeable future. If substantial doubt exists, it must be disclosed. (GT Biopharma faces substantial doubt about its ability to continue as a going concern due to ongoing losses and cash burn.)

Deferred Offering Costs

Costs incurred in connection with the issuance of equity securities that are capitalized and amortized over the life of the security or expensed upon completion of the offering. (The $0.8M in deferred offering costs indicates capitalizable expenses related to past or ongoing equity financings.)

Convertible Preferred Stock

A class of preferred stock that can be converted into a specified number of shares of common stock. (The Series L convertible preferred stock provided $6.503 million in proceeds, contributing to the improvement in stockholders' equity.)

Operating Expenses

Costs incurred in the normal course of running a business, excluding cost of goods sold. Includes R&D and SG&A. (A significant reduction in both R&D ($2.096M vs $3.868M) and SG&A ($4.731M vs $6.733M) contributed to the reduced net loss.)

Year-Over-Year Comparison

GT Biopharma has significantly reduced its net loss for the nine months ended September 30, 2025, to $5.3 million from $9.387 million in the prior year, a 43% improvement. This was driven by substantial reductions in both R&D expenses (down 45.8% to $2.096 million) and SG&A expenses (down 29.7% to $4.731 million). While cash and cash equivalents have decreased to $2.528 million, the cash used in operations also declined to $8.893 million. A key positive development is the improvement in total stockholders' equity to a positive $3.000 million, largely due to $6.503 million in proceeds from Series L financing, shifting from a deficit position.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share GTBP Nasdaq Ca

Filing Documents

• form10-q.htm (10-Q) — 1076KB
• ex31-1.htm (EX-31.1) — 21KB
• ex31-2.htm (EX-31.2) — 20KB
• ex32-1.htm (EX-32.1) — 7KB
• ex32-2.htm (EX-32.2) — 7KB
• form10-q_001.jpg (GRAPHIC) — 36KB
• form10-q_002.jpg (GRAPHIC) — 66KB
• form10-q_003.jpg (GRAPHIC) — 15KB
• form10-q_004.jpg (GRAPHIC) — 19KB
• form10-q_005.jpg (GRAPHIC) — 15KB
• form10-q_006.jpg (GRAPHIC) — 12KB
• 0001493152-25-023400.txt ( ) — 6372KB
• gtbp-20250930.xsd (EX-101.SCH) — 48KB
• gtbp-20250930_cal.xml (EX-101.CAL) — 38KB
• gtbp-20250930_def.xml (EX-101.DEF) — 228KB
• gtbp-20250930_lab.xml (EX-101.LAB) — 420KB
• gtbp-20250930_pre.xml (EX-101.PRE) — 339KB
• form10-q_htm.xml (XML) — 860KB

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 22 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 30 Item 4.

Controls and Procedures

Controls and Procedures 30

OTHER INFORMATION

PART II OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 31 Item 1A.

Risk Factors

Risk Factors 32 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 32 Item 3. Defaults Upon Senior Securities 32 Item 4. Mine Safety Disclosures 32 Item 5. Other Information 32 Item 6. Exhibits 33

SIGNATURES

SIGNATURES 35 2 GT BIOPHARMA, INC. Condensed Balance Sheets September 30, 2025 December 31, 2024 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 2,528,000 $ 3,951,000 Restricted cash 93,000 93,000 Deferred offering costs 760,000 — Prepaid expenses and other current assets 940,000 188,000 TOTAL ASSETS $ 4,321,000 $ 4,232,000 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities Accounts payable $ 769,000 $ 3,853,000 Accrued expenses 400,000 1,797,000 Dividend payable 144,000 — Warrant liability 8,000 252,000 Total Current Liabilities 1,321,000 5,902,000 Stockholders' Equity (Deficit) Convertible Preferred stock, par value $ 0.01 , 15,000,000 shares authorized: Series C - 96,230 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively 1,000 1,000 Series L - 4,912 and 0 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively — — Preferred stock value - - Common stock, par value $ 0.001 , 250,000,000 shares authorized, 6,051,874 and 2,234,328 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively 6,000 2,000 Additional paid in capital 703,772,000 693,554,000 Accumulated deficit ( 700,779,000 ) ( 695,227,000 ) Total Stockholders' Equity (Deficit) 3,000,000 ( 1,670,000 ) TOTAL LIABILITIES AND STOCKHOLDERS' (EQUITY) DEFICIT $ 4,321,000 $ 4,232,000 The accompanying notes are an integral part of these unaudited condensed financial statements. 3 GT BIOPHARMA, INC. Condensed 2025 2024 2025 2024 The Three Months For the Nine Months Ended September 30, Ended September 30, 2025 2024 2025 2024 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Revenues $ — $ — $ — $ — Operating Expenses: Research and development $ 634,000 $ 1,307,000 $ 2,096,000 $ 3,868,000 Selling, general and administrative (includin

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