GT Biopharma, Inc.
For the period ended Dec 31, 2025. Filed Mar 2, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 2, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-02-21.
0001493152-25-007908
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-02.
0001493152-26-008443
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 48 previous paragraphs and 54 current paragraphs.
31 unchanged; 14 reworded; 9 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Warrant Liability
Current report
Interest expense of $127,000 for the year ended December 31, 2025, consists of straight line amortization of the pre-funded warrants underlying an aggregate of 300,000 shares of common stock issued in connection with the Committed Equity Facility.
Current report
Loss on Initial Recognition and Change in Fair Value of Greenshoe Rights Liability
Current report
The Greenshoe Rights connected to the Series L Preferred Stock issued in the May 2025 equity offering required classification as a liability and marked to market at each reporting date as required under GAAP. The Company recognized other income (expense) for the change in the fair value of the Greenshoe Rights liability at each reporting date. The Greenshoe Rights liability was extinguished and reclassified to equity as of the date of the redemption rights waiver of the Series L 10% Convertible Preferred Stock effective in September 2025 (see Note 10 of the accompanying financial statements).
Current report
Gain on Settlement of Vendor Payable
Current report
In June 2025, a legal services firm currently engaged by the Company agreed to reduce the Company’s prior year unpaid fees by approximately $1 million..
Current report
Other
Current report
In May 2025 the Company issued warrants underlying 24,390 shares of common stock exercisable at $2.24 per share with a fair value of approximately $44,000 in exchange for the waiver of a variable rate transaction (“VRT”). The Company classified this transaction as other expense. The Company also recorded other income of $200,000 in June 2025 due to the extinguishment of an accrual of consulting fees recorded in prior years.
Current report
Net cash provided by financing activities was approximately $16 million for the year ended December 31, 2025, and resulted from net proceeds from the issuance of Series L Preferred Stock and warrants, and net proceeds from the exercise of warrants for cash and inducement warrants.
Removed paragraphs (3)
Previous report
Interest expense decreased by $213,000 for the year ended December 31, 2024 compared to the prior year as financing costs incurred associated with warrants accounted as warrant liability were incurred in the prior year but not in the current year.
Previous report
Gain on Extinguishment of Debt
Previous report
Gain on extinguishment of debt decreased by $547,000 for the year ended December 31, 2024 compared to the prior year as the gain on extinguishment of debt that resulted from share settlements of a greater amount of vendor accounts payable than the fair value of the shares on the date of settlement occurred in the prior year but not in the current year.
Reworded paragraphs (14)
Previous wording
Some of the statements in this Annual Report on Form 10-K are “forward-looking statements” within the meaning of the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our current beliefs, goals and expectations about matters such as our expected financial position and operating results, our business strategy and our financing plans. The forward-looking statements in this report are not based on historical facts, but rather reflect the current expectations of our management concerning future results and events. The forward-looking statements generally can be identified by the use of terms such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “foresee,” “may,” “guidance,” “estimate,” “potential,” “outlook,” “target,” “forecast,” “likely” or other similar words or phrases. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be different from any future results, performance and achievements expressed or implied by these statements. We cannot guarantee that our forward-looking statements will turn out to be correct or that our beliefs and goals will not change. Our actual results could be very different from and worse than our expectations for various reasons. You should carefully review all information, including the discussion of risk factors under “Part I. Item 1A: Risk Factors” and elsewhere in this annual report. Any forward-looking statements in the Form 10-K are made only as of the date hereof and, except as may be required by law, we do not have any obligation to publicly update any forward-looking statements contained in this Form 10-K to reflect subsequent events or circumstances.
Current wording
Some of the statements in this Annual Report on Form 10-K are “forward-looking statements” within the meaning of the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our current beliefs, goals and expectations about matters such as our expected financial position and operating results, our business strategy and our financing plans. The forward-looking statements in this report are not based on historical facts, but rather reflect the current expectations of our management concerning future results and events. The forward-looking statements generally can be identified by the use of terms such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “foresee,” “may,” “guidance,” “estimate,” “potential,” “outlook,” “target,” “forecast,” “likely” or other similar words or phrases. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be different from any future results, performance and achievements expressed or implied by these statements. We cannot guarantee that our forward-looking statements will turn out to be correct or that our beliefs and goals will not change. Our actual results could be very different from and worse than our expectations for various reasons. You should carefully review all information, including the discussion of risk factors under “Part I. Item 1A: Risk Factors” and elsewhere in this annual report. Any forward-looking statements in this Form 10-K are made only as of the date hereof and, except as may be required by law, we do not have any obligation to publicly update any forward-looking statements contained in this Form 10-K to reflect subsequent events or circumstances.
Previous wording
The preparation of our financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. When making these estimates and assumptions, we consider our historical experience, our knowledge of economic and market factors and various other factors that we believe to be reasonable under the circumstances. Actual results may differ under different estimates and assumptions. The accounting estimates and assumptions discussed in this section are those that we consider to be the most critical to gain an understanding of our financial statements because they inherently involve significant judgments and uncertainties.
Current wording
The preparation of our financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. When making these estimates and assumptions, we consider our historical experience, our knowledge of economic and market factors and various other factors that we believe to be reasonable under the circumstances. Actual results may differ under different estimates and assumptions. The accounting estimates and assumptions discussed in this section are those that we consider to be the most critical to gain an understanding of our financial statements because they inherently involve significant judgments and uncertainties.
Previous wording
Research and development expenses decreased by $668,000 for the year ended December 31, 2024 compared to the prior year, primarily due to a decrease in project materials costs, partially offset by an increase in scientific research costs.
Current wording
Research and development expenses decreased by approximately $2.3 million for the year ended December 31, 2025, compared to the prior year, primarily due to a decrease in production and materials costs.
Previous wording
Research and development expenses relate to our continued development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with the progression on other promising candidates. 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. We anticipate our direct clinical and preclinical expenses to increase in 2025 as our next generation GTB-3650 camelid nanobody product is in the clinic. We also plan to complete the product development of GTB-5550 in 2025. We do not, however, anticipate an increase in related R&D licensing and administrative costs.
Current wording
Research and development expenses relate to our continued licensing, development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with the progression on other promising candidates. In late June 2024, we received clearance from the FDA with respect to our IND Application in relation to our next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and we have advanced into the clinic, enrolling patients, and performing tests for data collection throughout the year. In late January 2026, we received clearance from the FDA with respect to our IND Application in relation to GTB-5550, with a Phase 1 dose escalation basket trial that is expected to initiate mid-2026.
Previous wording
Selling, general, and administrative expenses increased by approximately $3.4 million for the year ended December 31, 2024 compared to the prior year, primarily due to an increase in legal fees and settlement expenses.
Current wording
Selling, general, and administrative expenses remained relatively flat, increasing by only $182,000 for the year ended December 31, 2025, compared to the prior year.
Previous wording
Interest income decreased by $378,000 for the year ended December 31, 2024 compared to the prior year primarily due to lower short-term investment balances.
Current wording
Interest income decreased by $279,000 for the year ended December 31, 2025, compared to the prior year primarily due to lower highly liquid and short-term investment balances.
Previous wording
The change in fair value of warrant liability decreased by approximately $4.0 million for the year ended December 31, 2024 compared to the prior year, primarily due to the decline in the Company’s stock price at December 31, 2024, as compared to the prior year.
Current wording
The change in fair value of warrant liability decreased by $559,000 for the year ended December 31, 2025, compared to the prior year, primarily due to the decline in the Company’s stock price at December 31, 2025, as compared to the prior year.
Previous wording
Net loss increased $5,565,000 for the year ended December 31, 2024, primarily due to the decrease in the change in fair value of warrant liability, and an increase in legal fees, and was partially offset by a decrease in stock compensation and research and development expenses, all as described above.
Current wording
Net loss increased approximately $15.2 million for the year ended December 31, 2025, primarily due to the change in fair value of greenshoe rights liability, slightly offset by a decrease in research and development expenses, as described above.
Previous wording
The accompanying financial statements have been prepared assuming that we will continue as a going concern. We do not have any product candidates approved for sale and have not generated any revenue from our product sales. We have sustained operating losses since inception, and we expect such losses to continue into the foreseeable future. Historically, we have financed our operations through public and private sales of common stock, issuance of preferred and common stock, issuance of convertible debt instruments, and strategic collaborations. For the year ended December 31, 2024, we recorded a net loss of approximately $13.2 million and used cash in operations of approximately $12.9 million. These factors raise substantial doubt about our ability to continue as a going concern within one year of the date that the financial statements are issued.
Current wording
The accompanying financial statements have been prepared assuming that we will continue as a going concern. We do not have any product candidates approved for sale and have not generated any revenue from our product sales. We have sustained operating losses since inception, and we expect such losses to continue into the foreseeable future. Historically, we have financed our operations through public and private sales of common stock, the issuance of preferred and common stock, the issuance of convertible debt instruments, and strategic collaborations. For the year ended December 31, 2025, we recorded a net loss of approximately $28.4 million and used cash in operations of approximately $12.9 million. These factors raise substantial doubt about our ability to continue as a going concern within one year of the date that the financial statements are issued. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s December 31, 2025 financial statements, raised substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Previous wording
We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised substantial doubt about our ability to continue as a going concern. While it is very difficult to estimate our future liquidity requirements we believe if we are unable to obtain additional financing, existing cash resources will not be sufficient to enable us to fund the anticipated level of operations through one year from the date the accompanying financial statements are issued. There can be no assurances that we will be able to secure additional financing on acceptable terms. In the event that we do not secure additional financing, we will be forced to delay, reduce, or eliminate some or all of our discretionary spending, which could adversely affect our business prospects, ability to meet long-term liquidity needs and ability to continue operations.
Current wording
We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised substantial doubt about our ability to continue as a going concern. While it is very difficult to estimate our future liquidity requirements we will need to obtain additional financing. If we are unable to obtain additional financing, we believe existing cash resources will not be sufficient to enable us to fund the anticipated level of operations through one year from the date the accompanying financial statements are issued. There can be no assurances that we will be able to secure additional financing on acceptable terms. In the event that we do not secure additional financing, we will be forced to delay, reduce, or eliminate some or all of our discretionary spending, which could adversely affect our business prospects, ability to meet long-term liquidity needs and the ability to continue operations.
Previous wording
Net cash used in operating activities was approximately $12.9 million for the year ended December 31, 2024, and was primarily due to a net loss of approximately $13.2 million, and a decrease in the fair value of warrant liability of $0.8 million.
Current wording
Net cash used in operating activities was approximately $12.9 million for the year ended December 31, 2025, and was primarily due to a net loss of approximately $28.4 million and a decrease in accounts payable and accrued expenses of $2.6 million, offset by the reclassification the Greenshoe Right liability to equity amounting to approximately $17.3 million.
Previous wording
Net cash used in operating activities was approximately $8.9 million for the year ended December 31, 2023, and was primarily due to a net loss of approximately $7.6 million, a decrease in the fair value of warrant liability of $4.8 million, and partially offset by stock compensation of $2.2 million and an increase in accounts payable and accrued expenses of approximately $2.0 million.
Current wording
Net cash used in operating activities was approximately $12.9 million for the year ended December 31, 2024, and was primarily due to a net loss of approximately $13.2 million, a decrease in the fair value of warrant liability of $800,000, and partially offset an increase in accounts payable and accrued expenses of approximately $900,000.
Previous wording
Net cash provided (used) in financing activities for the years ended December 31, 2024 and 2023, resulted primarily from proceeds from the sale, or (purchase), of short-term investments.
Current wording
Net cash provided by financing activities for the year ended December 31, 2024, resulted primarily from proceeds from the sale of short-term investments.
Previous wording
Net cash provided by financing activities for the years ended December 31, 2024 and 2023, resulted from proceeds from the issuance of common stock and warrants.
Current wording
Net cash provided by financing activities approximately $3.0 million for the year ended December 31, 2024, and resulted from net proceeds from issuance of common stock and warrants.