GT Biopharma Inc
For the period ended Dec 31, 2024. Filed Feb 21, 2025.
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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.
FY2024 · Filed Feb 21, 2025
GTBP$4.42-2.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-26.
0001493152-24-011332
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 67 previous paragraphs and 48 current paragraphs.
14 unchanged; 5 reworded; 29 added; 48 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 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 (29)
Current report
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 report
Use of Estimates
Current report
We evaluate our financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC Topic 815, “Derivatives and Hedging”. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations.
Current report
Our use of derivative financial instruments is generally limited to warrants issued by us that do not meet the criteria for equity treatment and are recorded as liabilities. We do not use financial instruments or derivatives for any trading purposes.
Current report
We periodically issue stock-based compensation to officers, directors, employees, and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.
Current report
Stock-based payments made to officers, directors, employees, and consultants in exchange for goods and services, including grants of employee stock options, are recognized in the financial statements based on their grant date fair values in accordance with ASC 718,Compensation-Stock Compensation. Stock based payments to officers, directors, employees, and consultants, which are generally time vested, are measured at the grant date fair value and depending on the conditions associated with the vesting of the award, compensation cost is recognized on a straight-line or graded basis over the vesting period. Recognition of compensation expense for non-employees is in the same period and manner as if we had paid cash for the services. The fair value of stock options granted is estimated using the Black-Scholes option-pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life, and future dividends. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods.
Current report
Operating Expenses
Current report
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 report
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 report
Interest Income
Current report
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 report
Interest Expense
Current 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.
Current report
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 report
Gain on Extinguishment of Debt
Current report
Net Loss
Current report
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 report
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 report
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 report
Cash Flows
Current report
Operating Activities
Current report
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 report
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 report
Investing Activities
Current report
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 report
Financing Activities
Current report
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 report
Working Capital (Deficit)
Current report
The following table summarizes total current assets, liabilities, and working capital (deficit) for the years ended December 31, 2024 and 2023:
Removed paragraphs (48)
Previous report
As shown in the accompanying consolidated financial statements, the Company has an accumulated deficit of $682.1 million as of December 31, 2023. On a consolidated basis, the Company had cash and cash equivalents of $1.1 million and short-term investments of $12.9 million at December 31, 2023. We anticipate we will have to raise additional capital to fund our selling, general and administrative, and research and development expenses until we have a marketable product. There are no assurances that we will be able to raise the funds necessary to maintain our operations or to implement our business plan. The consolidated financial statements included in this Annual Report on Form 10-K do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be necessary in the event we cannot continue our operations.
Previous report
COVID-19
Previous report
In March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, has adversely affected workforces, customers, economies, and financial markets globally. It has also disrupted the normal operations of many businesses. This outbreak could decrease spending, adversely affect demand for the Company’s products, and harm the Company’s business and results of operations.
Previous report
During the year ended December 31, 2023, the Company believes the COVID-19 pandemic did impact its operating results. However, the Company has not observed any impairments of its assets or a significant change in the fair value of its assets due to the COVID-19 pandemic. At this time, it is not possible for the Company to predict the duration or magnitude of the adverse results of the outbreak and its effects on the Company’s business or results of operations, financial condition, or liquidity.
Previous report
The Company has been following the recommendations of health authorities to minimize exposure risk for its team members, including the temporary closure of its corporate office and having team members work remotely. Most vendors have transitioned to electronic submission of invoices and payments.
Previous report
Corporate Developments
Previous report
On May 1, 2023, Charles Casamento joined as a member of the Company’s Board of Directors.
Previous report
Reverse Stock Split
Previous report
On February 1, 2024, the Company announced a reverse stock-split of its common stock, par value $0.001 per share, at a ratio of 1 for 30. The reverse stock-split became effective on February 2, 2024. The Company’s common stock began trading on a reverse stock-split-adjusted basis on The Nasdaq Capital Market on February 5, 2024, under our existing trading symbol “GTBP.”
Previous report
As a result of the reverse stock-split, every thirty (30) shares of issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock, without any change in the par value per share. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive fractional shares of common stock will be entitled to receive their pro-rata portion of the net proceeds obtained from the aggregation and sale by the exchange agent of the fractional shares resulting from the reverse stock-split (reduced by any customary brokerage fees, commission and other expenses).
Previous report
Proportionate adjustments were made to the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding stock options for the Company’s common stock and to the number of shares of common stock reserved for future issuance pursuant to the GT Biopharma, Inc. 2022 Omnibus Incentive Plan.
Previous report
All share and per share information has been adjusted to retroactively reflect the reverse stock-split as of the earlies period presented.
Previous report
Private Placement of Common Stock
Previous report
On January 4, 2023, GT Biopharma received gross proceeds of $6.5 million, before deducting placement agent fees and other offering expenses of $232,000 in relation to a purchase agreement (the “Purchase Agreement”) signed on December 30, 2022, between the Company and an institutional investor (the “Purchaser”) for the issuance and sale, in a registered direct offering (the “Offering”), of 120,000 shares of the Company’s common stock, par value $0.001 per share (the “Shares”), pre-funded warrants to purchase up to 96,667 shares of the Company’s common stock (the “Pre-Funded Warrants”), warrants to purchase up to an aggregate of 216,667 shares of the Company’s common stock (the “Common Warrants”) and placement agent warrants to purchase up to 13,000 of the Company’s common stock (the “Placement Agents Warrants”). The Common Warrants have an exercise price equal to $30.00, became exercisable commencing six months following issuance, and shall have a term of exercise equal to five years following the initial exercise date. The Pre-Funded Warrants had an exercise price of $0.003 per Share, were immediately exercisable and could be exercised at any time after their original issuance until such Pre-Funded Warrants were exercised in full. The Placement Agents Warrants have an exercise price equal to $37.50, became exercisable commencing six months following issuance, and shall have a term of exercise equal to five years following the initial exercise date. The Shares and Common Warrants were sold at an offering price of $30.00 per Share and accompanying Common Warrant and the Pre-Funded Warrants and Common Warrants were sold at an offering price of $29.997 per Pre-Funded Warrant and accompanying Common Warrant.
Previous report
Issuance of Common Stock in Public Offering
Previous report
On February 16, 2021, the Company completed a public offering of 164,834 shares of common stock to investors for net proceeds of $24.7 million, after deducting underwriting discounts, commissions and other direct offering expenses. As part of the offering, the Company also granted to these investors, warrants to purchase 173,075 shares of common stock. The warrants are fully vested, exercisable at $165.00 per share and will expire in five years.
Previous report
As a result of the completion of the public offering and the successful listing of the Company’s shares of common stock on the Nasdaq Capital Market, convertible notes and accrued interest totaling $38.8 million, were mandatorily converted into 380,444 shares of the Company’s common stock at its stated conversion rate of $102.00 per share. The Company issued 369,534 shares of common stock to the note holders while the remaining 10,910 common shares, valued at $1.1 million, were issuable at December 31, 2021.
Previous report
During the year ended December 31, 2022, the Company issued the remaining 10,910 common shares. In addition, the Company also issued an additional 347 shares of commons stock with a fair value of $35,000 as settlement to a noteholder.
Previous report
Significant Agreements
Previous report
TriKE®Agreement
Previous report
In June 2017, we entered into a co-development partnership agreement with Altor BioScience Corporation in which we agreed to collaborate exclusively in the clinical development of a novel 161533 (GTB-3550) TriKE® fusion protein for cancer therapies using our TriKE®technology. The GTB-3550 Phase 1 clinical trial for treatment of patients with CD33-expressing, high risk myelodysplastic syndromes and refractory/relapsed acute myeloid leukemia opened for patient enrollment in September 2019 and completed enrollment in September 2021. The results of our first generation GTB-3550 Phase 1 clinical trial support our plans to advance the next generation camelid nanobody into the clinic, and as such, no further clinical development will ensue with GTB-3550.
Previous report
University of Minnesota Scientific Research Agreement
Previous report
We are a party to a scientific research agreement with the Regents of the University of Minnesota (“UofMN”), effective June 16, 2021. This scientific research agreement aims to work with the Company with three major goals in mind: (1) support the Company’s TriKE®product development and GMP manufacturing efforts; (2) TriKE® pharmacokinetics optimization in humans; and (3) investigation of the patient’s native NK cell population based on insights obtained from the analysis of the human data generated during our GTB-3550 clinical trial. The major deliverables proposed here are: (1) creation of IND enabling data for TriKE®constructs in support of our product development and GMP manufacturing efforts; (2) TriKE® platform drug delivery changes to allow transition to alternative drug delivery means and extended PK in humans; and (3) gain an increased understanding of changes in the patient’s native NK cell population as a result of TriKE®therapy. Most studies will use TriKE®DNA/amino acid sequences created by us under current UMN/GTB licensing terms. This agreement expired on June 30, 2023. The Company and UofMN are negotiating the terms of a new scientific research agreement and expect to finalize it in the first half of 2024.
Previous report
For the years ended December 31, 2023 and 2022, we recorded an expense of $383,000 and $766,000 pursuant to the scientific research agreement for each respective period. We have recorded an expense in the aggregate of $2.1 million as of December 31, 2023 pursuant to this agreement.
Previous report
Subcontract Manufacturing Agreement
Previous report
On October 5, 2020, we entered into a Master Services Agreement with a third-party product manufacturer to perform biologic development and manufacturing services on behalf of the Company. Associated with this, we have subsequently signed five Statements of Work (“SOWs”) for the research and development of products for use in clinical trials. On August 24, 2022, we entered into a revised agreement with this third-party manufacturer and issued 40,743 shares of common stock with a fair value of $3.2 million as part of a payment arrangement. The shares were valued at $79.80 per share based on the closing price of the Company’s common stock on the date of the agreement. As part of the revised agreement, we paid to this third-party manufacturer $3.3 million in cash on specified dates. In addition, the Company and the third-party manufacturer agreed that services to be rendered in future periods, as specified in the agreement, will be paid or settled at the Company’s discretion, in a combination of cash and issuance of the Company’s common stock. The agreement also amended certain agreements executed in prior years which eliminated future financial commitments of the Company.
Previous report
The SOWs agreements totaled approximately $13.0 million, of which $7.5 million was incurred at that date and an additional $5.5 million is in process. The Company was indebted $3.5 million to this third- party manufacturer as of December 31, 2023.
Previous report
Clinical Trial Agreement
Previous report
In September 2019, we executed clinical trial agreement with the Regents of the University of Minnesota, to commence enrollment in its first-in-human GTB-3550 TriKE® (CD16/IL-15/CD33) Phase 1, open-label, dose escalation clinical trial for the treatment of CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The clinical trial was conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick and Dr. Mark Juckett. The primary objective of the trial was to determine safety and tolerability as well as the maximum tolerated dose of GTB-3550 TriKE®. The hypothesis was that GTB-3550 TriKE®would induce natural killer cell function by targeting malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to tumor induced immunosuppression. Because CD16 is a potent activating receptor on NK cells, this single agent GTB-3550 investigational agent may induce a targeted anti-CD33+ tumor response. The phase 1 trial was completed in September 2021.
Previous report
License Agreements
Previous report
See discussion of Patents and Licenses above under Item 1: Business
Previous report
During the years ended December 31, 2023 and 2022, we incurred $7.1 million and $12.4 million of selling, general and administrative expenses (S,G&A), respectively. The decrease in S,G&A of $5.3 million as compared to 2022 was primarily attributable to a reduction of $1.7 million in stock compensation expenses for officers, employees and Board of Directors and $1.9 million for outside consultants, reduction of $1.3 million in consulting advisory board fees, and reduction of $500,000 in patents and insurance costs for the year ended December 31, 2023. S,G&A decreased due to better managing and use of consultants and advisors, and overall reductions in other general and administrative expenses in 2023.
Previous report
Other income net of other expenses, was $6.0 million and $373,000 for the years ended December 31, 2023 and 2022, respectively. Other income and expenses consisted of interest income, interest expense, change in the fair value of warrant lability, gain on extinguishment of debt, and unrealized gain and loss on marketable securities.
Previous report
We recorded interest income of $780,000 and $292,000 for the years ended December 31, 2023 and 2022, respectively. Interest income increased primarily due to the interest earned on short-term investments due to higher interest rates during the year 2023.
Previous report
We recorded interest expense of $213,000 and $8,000 for the years ended December 31, 2023 and 2022, respectively. The increase in interest expensewas due to the financing costs incurred associated with the issuance of warrants accounted as warrant liability during 2023, with no such comparable costs in 2022.
Previous report
We recorded $48,000 of unrealized gain on marketable securities for the year ended December 31, 2023 as compared to unrealized loss on marketable securities for the year ended December 31, 2022 as a result of fair value remeasurement of our marketable securities.
Previous report
We recorded other income of $20,000 related to subletting our premises during the year ended December 31, 2023 compared to $0 for the year ended December 31, 2022.
Previous report
The Company’s current operations have focused on business planning, raising capital, establishing an intellectual property portfolio, hiring, and conducting preclinical studies and clinical trials. The Company does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company has sustained operating losses since inception and expects such losses to continue over the foreseeable future. On January 4, 2023, the Company raised $6.5 million from an institutional investor by selling 120,000 shares of common stock, and pre-funded warrants to purchase up to 96,667 shares of common stock. During 2021, the Company had raised $24.7 million through issuance of common stock, had raised $16.4 million through the exercise of warrants and raised $1.2 million from a series of issuances of convertible notes. The Company reported $14.0 million of cash and short-term investments at December 31, 2023. We anticipate that we will need cash of approximately $10.0 million for the next twelve months for research and development and selling, general and administrative expenses. We expect the cash and short-term investments totaling $14.0 million will be sufficient to fund operations for the following 12 months, and anticipate raising additional funds as needed to fund our continued clinical trials.
Previous report
The Company has incurred substantial losses since inception to December 31, 2023. The Company anticipates incurring additional losses until such time, it can generate significant sales or revenue from out-licensing of its products currently in development. Substantial additional financing will be needed by the Company to fund its operations and to commercially develop its product candidates.
Previous report
Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include but are not limited to public offerings of equity and/or debt securities; and payments from potential strategic research and development, licensing and/or marketing arrangements with other pharmaceutical companies.
Showing the first 40 of 48 passages. Open the source sections for the rest.
Reworded paragraphs (5)
Previous wording
The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include accruals for potential liabilities, assumptions used in deriving the fair value of derivative liabilities, share-based compensation and valuation of deferred tax assets. Actual results could differ from those estimates.
Current wording
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation of equity instruments issued for services, and valuation of deferred tax assets. Actual results could differ from those estimates.
Previous wording
During the years ended December 31, 2023 and 2022, we incurred $6.5 million and $8.8 million of research and development expenses (R&D), respectively. The $2.3 million reduction in R&D was primarily due to a $3.6 million reduction in licensing and administrative costs, offset by an increase of $1.3 million in R&D costs related 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 product candidates. The reduction of $3.6 million in licensing and administrative costs over the previous year was primarily due to better management of R&D expenses with consultants and reduction in stock compensation to employees. We anticipate our direct clinical and preclinical expenses to continue to increase in 2024 as we plan to advance our next generation GTB-3650 camelid nanobody product into the clinic and enroll patients, perform tests for data collection, complete the product development of GTB 5550 and anticipate submission of IND application for GTB 5550 in the fourth quarter of 2024. 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 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.
Previous wording
The change in fair value of warrant liability was due to fair value remeasurement which resulted in a gain of $4.8 million and $119,000 for the years ended December 31, 2023 and 2022, respectively.
Current wording
Change in Fair Value of Warrant Liability
Previous wording
We recorded a gain on extinguishment of debt of $547,000 and $0 for the years ended December 31, 2023 and 2022, respectively. The gain resulted due to share settlement of a greater amount of vendor accounts payable than the fair value of the shares on the date of settlement.
Current wording
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.
Previous wording
The consolidated financial statements of the Company have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, the financial statements do not include any adjustments that might be necessary should the Company be unable to continue in existence.
Current wording
The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern. Accordingly, the financial statements have been prepared on a basis that assumes we will continue as a going concern, and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.