The financial report presents the financial statements of the company for the fiscal year ended December 31, 2024, as well as the six months ended June 30, 2024, and the year ended December 31, 2023. The company reported total revenues of $X million and total expenses of $Y million, resulting in a net income of $Z million. The company’s balance sheet as of December 31, 2024, shows total assets of $W million, total liabilities of $V million, and total equity of $U million. The company’s cash and cash equivalents increased by $X million during the year, and its short-term investments increased by $Y million. The company’s fair value of its investments in money market funds and U.S. Treasury securities was $Z million as of December 31, 2024. The company’s research and development expenses were $X million and $Y million for the years ended December 31, 2024, and December 31, 2023, respectively. The company’s selling, general, and administrative expenses were $X million and $Y million for the years ended December 31, 2024, and December 31, 2023, respectively.
Overview
GT Biopharma is a clinical-stage biopharmaceutical company focused on developing and commercializing novel immuno-oncology products based on its proprietary Tri-specific Killer Engager (TriKE®) technology platform. The TriKE® platform generates therapeutics designed to harness and enhance the cancer-killing abilities of a patient’s natural killer (NK) cells. These moieties are designed to bind to NK cells and precisely direct them to target and kill specific types of cancer or virus-infected cells.
Critical Accounting Policies
GT Biopharma’s financial statements are prepared in accordance with generally accepted accounting principles (GAAP) in the United States. This requires the company to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosures. The most critical accounting policies involve significant judgments and uncertainties, including the use of estimates, warrant liability accounting, and stock-based compensation.
Results of Operations
Comparison of the Years Ended December 31, 2024 and 2023
Operating Expenses
Expense Category | 2024 | 2023 | $ Change | % Change |
---|---|---|---|---|
Research and development | $5,798,000 | $6,466,000 | $(668,000) | (10)% |
Selling, general and administrative | $8,336,000 | $4,890,000 | $3,446,000 | 70% |
Stock compensation | $230,000 | $2,220,000 | $(1,990,000) | (90)% |
Total Operating Expenses | $14,364,000 | $13,576,000 | $788,000 | 6% |
Research and development expenses decreased by $668,000 in 2024 due to lower project material costs, partially offset by increased scientific research. The company expects R&D expenses to increase in 2025 as its next-generation TriKE® product candidate GTB-3650 advances into the clinic.
Selling, general, and administrative expenses increased by $3.4 million in 2024, primarily due to higher legal fees and settlement expenses.
Other Income (Expense)
Other Income (Expense) | 2024 | 2023 | $ Change | % Change |
---|---|---|---|---|
Interest income | $402,000 | $780,000 | $(378,000) | (48)% |
Interest expense | $- | $(213,000) | $213,000 | (100)% |
Change in fair value of warrant liability | $800,000 | $4,797,000 | $(3,997,000) | (83)% |
Gain on extinguishment of debt | $- | $547,000 | $(547,000) | (100)% |
Unrealized gain (loss) on marketable securities | $- | $48,000 | $(48,000) | (100)% |
Other | $- | $20,000 | $(20,000) | (100)% |
Total Other Income (Expense) | $1,202,000 | $5,979,000 | $(4,777,000) | (80)% |
The decrease in other income was primarily due to a $4.0 million decline in the change in fair value of warrant liability, as well as lower interest income and the absence of gains on debt extinguishment and unrealized gains on securities compared to the prior year.
Net Loss
Metric | 2024 | 2023 | $ Change | % Change |
---|---|---|---|---|
Net Loss | $(13,162,000) | $(7,597,000) | $(5,565,000) | 73% |
The net loss increased by $5.6 million in 2024, primarily due to the decrease in the change in fair value of warrant liability, higher legal fees, and settlement expenses, partially offset by decreases in stock compensation and R&D expenses.
Liquidity and Capital Resources
GT Biopharma has sustained operating losses since inception and expects to continue incurring losses in the foreseeable future. The company has historically financed operations through public and private stock offerings, debt, and strategic collaborations. As of December 31, 2024, the company had $4.0 million in cash and cash equivalents, but a working capital deficit of $1.7 million.
The company’s auditors have expressed substantial doubt about its ability to continue as a going concern within one year of the financial statement issuance date. GT Biopharma will need to obtain additional financing to fund its operations and development programs. There can be no assurance the company will be able to secure such financing on acceptable terms. If additional funding is not obtained, the company may be forced to delay, reduce, or eliminate discretionary spending, which could adversely impact its business and ability to continue operations.
Cash Flows
Cash Flow Metric | 2024 | 2023 |
---|---|---|
Net cash used in operating activities | $(12,904,000) | $(8,852,000) |
Net cash provided by (used in) investing activities | $12,893,000 | $(2,009,000) |
Net cash provided by financing activities | $2,976,000 | $6,268,000 |
Net increase (decrease) in cash and cash equivalents and restricted cash | $2,965,000 | $(4,593,000) |
Cash used in operations increased to $12.9 million in 2024 from $8.9 million in 2023, primarily due to the higher net loss. Investing activities provided $12.9 million in 2024 from the sale of short-term investments, compared to $2.0 million used in 2023 for investment purchases. Financing activities provided $3.0 million in 2024 from stock and warrant issuances, down from $6.3 million in 2023.
Outlook
GT Biopharma faces significant liquidity challenges and will need to secure additional financing to fund its operations and development programs. The company’s ability to continue as a going concern is in substantial doubt without access to new capital. If the company is unable to raise sufficient funds, it may be forced to delay, reduce, or eliminate key initiatives, which could severely impact its business prospects and long-term viability.
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