GT Biopharma Reports First Quarter 2024 Financial Results and Provides Corporate Update
GT Biopharma (NASDAQ: GTBP) reported its Q1 2024 financial results and provided a corporate update. Key highlights include the anticipated IND clearance for GTB-3650, a nanobody TriKE® for CD33+ leukemia in Q2 2024, and Phase 1 trial initiation in 2H 2024. The company also expects to submit an IND for GTB-5550 in Q4 2024, targeting B7H3-positive solid tumors, with a Phase 1 trial planned for early 2025. GT Biopharma reported $9.81 million in cash as of March 31, 2024, enough to fund operations into 2025. R&D expenses decreased significantly to $777,000 from $1.65 million YoY, while SG&A expenses rose to $2.31 million from $2.02 million YoY. Net loss widened to $2.27 million from $227,000 in Q1 2023.
- Cash position of $9.81 million as of March 31, 2024, sufficient to fund operations into 2025.
- Anticipated IND clearance for GTB-3650 in Q2 2024.
- Phase 1 trial for GTB-3650 expected in 2H 2024.
- Planned IND submission for GTB-5550 targeting B7H3-positive solid tumors in Q4 2024.
- Planned Phase 1 trial for GTB-5550 in early 2025.
- Net loss of $2.27 million for Q1 2024, significantly higher than the $227,000 loss in Q1 2023.
- Cash position decreased from $13.97 million on December 31, 2023, to $9.81 million on March 31, 2024.
- R&D expenses decreased from $1.65 million to $777,000, potentially indicating reduced research activity.
- SG&A expenses increased from $2.02 million to $2.31 million YoY.
- Other income net of expenses decreased from $3.44 million to $825,000 YoY.
Insights
GT Biopharma's first quarter 2024 financial results show a significant increase in net loss, from
The cash position, though reduced, is still sufficient to fund operations into 2025. However, investors should keep an eye on the company's ability to secure additional funding or revenue streams, as the current cash might not cover future operational needs if R&D expenses rise as anticipated.
Overall, while the short-term financials indicate a need for caution, long-term potential exists if the company's TriKE® platforms achieve clinical success.
GT Biopharma’s update on their INDs and clinical trials for GTB-3650 and GTB-5550 is promising in the context of advancing cancer therapeutics. The focus on CD33+ leukemia and B7H3 positive solid tumors suggests targeting areas with significant unmet clinical needs. The initiation of Phase 1 trials for GTB-3650 in the latter half of 2024 could provide important early data on the treatment’s efficacy and safety.
From a research perspective, the company’s strategic move to target multiple solid tumors with GTB-5550 via a basket trial can expedite the evaluation process across different cancer types, potentially accelerating time-to-market if results are positive.
Investors should be aware that early-stage trials come with high risks. Failure in these stages could impact the stock negatively, but successful results could lead to substantial gains, considering the innovative nature of the TriKE® platform.
GT Biopharma’s TriKE® platform, being a novel therapeutic approach, holds substantial market potential if it proves effective in its clinical trials. The company's ability to clear INDs and initiate trials in a timely manner will be critical. Targeting both hematologic cancers and solid tumors widens the market scope, making their pipeline attractive for future licensing or partnerships.
However, the market also demands clear evidence of clinical success and eventual regulatory approval. The anticipated trials and subsequent data readouts over the next 18 months will be pivotal in establishing GT Biopharma's market position.
Retail investors should watch for milestones such as IND clearances, trial initiations and preliminary data releases. These events will likely drive short-term stock movements and provide indicators for long-term potential.
- IND clearance for GTB-3650, a 2nd generation nanobody TriKE® for treatment of CD33+ leukemia expected in Q2 2024
- Phase 1 trial initiation with GTB-3650 expected in 2H 2024
- Anticipate IND submission for GTB-5550 TriKE® for treatment of B7H3 positive solid tumors in Q4 2024
- Plan to initiate a Phase 1 dose escalation basket trial evaluating GTB-5550 in six solid tumor cancers – prostate, breast, head and neck, ovarian, lung, and GI
- Cash of approximately
$9.81 million as of March 31, 2024, provides sufficient runway to fund operations into 2025
BRISBANE, CALIFORNIA, May 15, 2024 (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 first quarter 2024 financial results for the period ended March 31, 2024.
“As we continue to work towards FDA clearance of the IND for GTB-3650, we look forward to submitting a second IND later this year for GTB-5550. By targeting B7H3, GTB-5550’s potential target market within solid tumors increases multifold”, said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma. “We expect the next 18 months to be an eventful period for the Company with substantial clinical activity followed by data readouts. Our Phase 1 trial evaluating GTB-3650 in AML patients is anticipated to start this year, followed by a basket trial with GTB-5550 for multiple solid tumors in early 2025. We also remain active in exploring additional opportunities where our TriKE’s may have therapeutic utility, including autoimmune indications.”
First Quarter 2024 Financial Summary
Cash Position: The Company had cash, cash equivalents and short-term investments of
Research and Development (R&D) Expenses: R&D expenses for the first quarter ended March 31, 2024 were
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter ended March 31, 2024 were
Other Income and expense: Other income net of other expenses, for the first quarter ended March 31, 2024 was
Net Loss: The Company reported a net loss of
About Camelid Antibodies
Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce two main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of two heavy chains and two light chains. They also produce another type of antibody that is made up of only two heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.
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 "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 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 those 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
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(in thousands, except shares and par value)
| March 31, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 1,950 | $ | 1,079 | ||||
| Short-term investments | 7,857 | 12,893 | ||||||
| Prepaid expenses and other current assets | 78 | 84 | ||||||
| Total Current Assets | 9,885 | 14,056 | ||||||
| Operating lease right-of-use asset | 27 | 53 | ||||||
| TOTAL ASSETS | $ | 9,912 | $ | 14,109 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,213 | $ | 4,328 | ||||
| Accrued expenses | 963 | 1,195 | ||||||
| Current operating lease liability | 30 | 58 | ||||||
| Warrant liability | 394 | 1,052 | ||||||
| Total Current Liabilities | 4,600 | 6,633 | ||||||
| Total Liabilities | $ | 4,600 | $ | 6,633 | ||||
| Stockholders’ Equity | ||||||||
| Convertible Preferred stock, par value | 1 | 1 | ||||||
| Common stock, par value | 1 | 1 | ||||||
| Additional paid in capital | 689,641 | 689,539 | ||||||
| Accumulated deficit | (684,331 | ) | (682,065 | ) | ||||
| Total Stockholders’ Equity | 5,312 | 7,476 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 9,912 | $ | 14,109 | ||||
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
| For The Three Months Ended | |||||||||||||
| March 31, | |||||||||||||
| 2024 | 2023 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||
| Revenues | $ | - | $ | - | |||||||||
| Operating Expenses: | |||||||||||||
| Research and development | 777 | 1,650 | |||||||||||
| Selling, general and administrative (including | 2,314 | 2,015 | |||||||||||
| Loss from Operations | 3,091 | 3,665 | |||||||||||
| Other (Income) Expense | |||||||||||||
| Interest income | (142 | ) | (164 | ) | |||||||||
| Interest expense | - | 212 | |||||||||||
| Change in fair value of warrant liability | (658 | ) | (2,924 | ) | |||||||||
| Gain on extinguishment of debt | - | (533 | ) | ||||||||||
| Unrealized loss (gain) on marketable securities | 2 | (29 | ) | ||||||||||
| Other | (27 | ) | - | ||||||||||
| Total Other (Income) Expense | (825 | ) | (3,438 | ) | |||||||||
| Net Loss | $ | (2,266 | ) | $ | (227 | ) | |||||||
| Net Loss Per Share - Basic and Diluted | $ | (1.64 | ) | $ | (0.21 | ) | |||||||
| Weighted average common shares outstanding - basic and diluted | 1,380,633 | 1,082,871 | |||||||||||
GT BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
| For The Three Months Ended March 31, 2024 (Unaudited) | ||||||||||||||||||||||||||||
| Preferred Shares | Common Shares | Additional Paid in | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance, December 31, 2023 | 96 | $ | 1 | 1,381 | $ | 1 | $ | 689,539 | $ | (682,065 | ) | $ | 7,476 | |||||||||||||||
| Fair value of vested stock options | - | - | - | - | 102 | - | 102 | |||||||||||||||||||||
| Net loss | - | - | - | - | - | (2,266 | ) | (2,266 | ) | |||||||||||||||||||
| Balance, March 31, 2024 | 96 | $ | 1 | 1,381 | $ | 1 | $ | 689,641 | $ | (684,331 | ) | $ | 5,312 | |||||||||||||||
| For The Three Months Ended March 31, 2023 (Unaudited) | ||||||||||||||||||||||||||||
| Preferred Shares | Common Shares | Additional Paid in | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance, December 31, 2022 | 96 | $ | 1 | 1,091 | $ | 1 | $ | 686,200 | $ | (674,468 | ) | $ | 11,734 | |||||||||||||||
| Private placement of common stock | - | - | 120 | - | 6,268 | - | 6,268 | |||||||||||||||||||||
| Initial recognition of fair value of warrant liability | - | - | - | - | (5,831 | ) | - | (5,831 | ) | |||||||||||||||||||
| Fair value of vested stock options | - | - | - | - | 507 | - | 507 | |||||||||||||||||||||
| Issuance of common shares for services | - | - | 2 | - | 315 | - | 315 | |||||||||||||||||||||
| Issuance of common shares in settlement of vendors payable | - | - | 16 | - | 287 | - | 287 | |||||||||||||||||||||
| Net loss | - | - | - | - | - | (227 | ) | (227 | ) | |||||||||||||||||||
| Balance, March 31, 2023 | 96 | $ | 1 | 1,229 | $ | 1 | $ | 687,746 | $ | (674,695 | ) | $ | 13,053 | |||||||||||||||
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(in thousands)
| For The Three Months Ended | |||||||||||||
| March 31, | |||||||||||||
| 2024 | 2023 | ||||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||||
| Net loss | $ | (2,266 | ) | $ | (227 | ) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||
| Stock based compensation - services | - | 176 | |||||||||||
| Stock based compensation - officers, employees and board of directors | 102 | 646 | |||||||||||
| Change in fair value of warrant liability | (658 | ) | (2,924 | ) | |||||||||
| Gain on extinguishment of share settled debt | - | (533 | ) | ||||||||||
| Change in operating lease right-of-use assets | 26 | 25 | |||||||||||
| Unrealized loss (gain) on marketable securities | 2 | (29 | ) | ||||||||||
| Changes in operating assets and liabilities: | |||||||||||||
| Decrease in prepaid expenses | 6 | 16 | |||||||||||
| (Decrease) in accounts payable and accrued expenses | (1,347 | ) | (29 | ) | |||||||||
| (Decrease) in operating lease liability | (28 | ) | (27 | ) | |||||||||
| Net Cash Used in Operating Activities | (4,163 | ) | (2,906 | ) | |||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||||
| Sale (purchase) of investments | 5,034 | (6,989 | ) | ||||||||||
| Net Cash Provided by (Used in) Investing Activities | 5,034 | (6,989 | ) | ||||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||||
| Proceeds from issuance of common stock and prefunded warrants | - | 6,268 | |||||||||||
| Net Cash Provided by Financing Activities | - | 6,268 | |||||||||||
| Net Increase (Decrease) in Cash | 871 | (3,627 | ) | ||||||||||
| Cash at Beginning of Period | 1,079 | 5,672 | |||||||||||
| Cash at End of Period | $ | 1,950 | $ | 2,045 | |||||||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||||||||||||
| Cash paid during the year for: | |||||||||||||
| Interest | $ | - | $ | - | |||||||||
| Income taxes | $ | - | $ | - | |||||||||
| SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES | |||||||||||||
| Initial recognition of fair value of warrant liability | $ | - | $ | 5,831 | |||||||||
| Fair value of common stock issued to a vendor to settle accounts payable | $ | - | $ | 287 | |||||||||
FAQ
What is GT Biopharma's cash position as of Q1 2024?
When is the IND clearance for GTB-3650 expected?
When will the Phase 1 trial for GTB-3650 begin?
What are the plans for GTB-5550?
What was GT Biopharma's net loss in Q1 2024?
How did GT Biopharma's R&D expenses change in Q1 2024?
How did GT Biopharma's SG&A expenses change in Q1 2024?
How did GT Biopharma's other income net of expenses change in Q1 2024?
