GT Biopharma Reports Third Quarter 2024 Financial Results
GT Biopharma (NASDAQ: GTBP) reported Q3 2024 financial results with a net loss of $3.4 million, compared to $2.4 million in Q3 2023. The company maintains $6.5 million in cash, expected to fund operations into Q2 2025. R&D expenses remained flat at $1.3 million, while SG&A expenses increased to $2.3 million from $1.2 million year-over-year.
The company expects to dose its first patient in the GTB-3650 Phase 1 trial in Q4 2024, with initial clinical data expected in Q2 2025. Additionally, GTB-5550 IND submission for B7H3 positive solid tumors is planned for 1H 2025, with phase 1 trials expected to begin in 2025.
GT Biopharma (NASDAQ: GTBP) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di 3.4 milioni di dollari, rispetto ai 2.4 milioni di dollari del terzo trimestre 2023. L'azienda mantiene 6.5 milioni di dollari in contante, che si prevede finanzieranno le operazioni fino al secondo trimestre 2025. Le spese per R&S sono rimaste stabili a 1.3 milioni di dollari, mentre le spese SG&A sono aumentate a 2.3 milioni di dollari, rispetto all'1.2 milioni dell'anno precedente.
L'azienda prevede di somministrare il primo trattamento al paziente nel trial di fase 1 GTB-3650 nel quarto trimestre 2024, con dati clinici iniziali attesi nel secondo trimestre 2025. Inoltre, è prevista la presentazione dell'IND per GTB-5550 per tumori solidi positivi per B7H3 nel primo semestre del 2025, con l'inizio dei trial di fase 1 previsto per il 2025.
GT Biopharma (NASDAQ: GTBP) reportó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 3.4 millones de dólares, en comparación con 2.4 millones de dólares en el tercer trimestre de 2023. La compañía mantiene 6.5 millones de dólares en efectivo, que se espera financien operaciones hasta el segundo trimestre de 2025. Los gastos en I+D se mantuvieron estables en 1.3 millones de dólares, mientras que los gastos SG&A aumentaron a 2.3 millones de dólares desde 1.2 millones año tras año.
La compañía espera administrar la primera dosis a su paciente en el ensayo de fase 1 GTB-3650 en el cuarto trimestre de 2024, con los datos clínicos iniciales esperados para el segundo trimestre de 2025. Además, se planea la presentación del IND para GTB-5550 para tumores sólidos positivos por B7H3 en el primer semestre de 2025, con ensayos de fase 1 esperados para comenzar en 2025.
GT Biopharma (NASDAQ: GTBP)는 2024년 3분기 재무 결과를 보고했으며, 순손실은 340만 달러로, 2023년 3분기의 240만 달러와 비교됩니다. 회사는 650만 달러의 현금을 보유하고 있으며, 이는 2025년 2분기까지 운영을 지원할 것으로 예상됩니다. 연구개발 비용은 130만 달러로 유지되었고, SG&A 비용은 전년 대비 120만 달러에서 230만 달러로 증가했습니다.
회사는 2024년 4분기에 GTB-3650 1상 시험에서 첫 환자에게 투여할 예정이며, 초기 임상 데이터는 2025년 2분기에 예상됩니다. 또한, B7H3 양성 고형 종양을 위한 GTB-5550 IND 제출이 2025년 상반기에 계획되어 있으며, 2025년에는 1상 시험이 시작될 것으로 예상됩니다.
GT Biopharma (NASDAQ: GTBP) a annoncé ses résultats financiers pour le troisième trimestre 2024, faisant état d'une perte nette de 3.4 millions de dollars, contre 2.4 millions de dollars au troisième trimestre 2023. L'entreprise maintient 6.5 millions de dollars en liquidités, qui devraient financer ses opérations jusqu'au deuxième trimestre 2025. Les dépenses en R&D sont restées stables à 1.3 million de dollars, tandis que les dépenses SG&A ont augmenté à 2.3 millions de dollars, contre 1.2 million de dollars l'année précédente.
L'entreprise prévoit de traiter son premier patient dans le essai de phase 1 GTB-3650 au quatrième trimestre 2024, avec des données cliniques initiales attendues pour le deuxième trimestre 2025. De plus, la soumission de l'IND pour GTB-5550 ciblant les tumeurs solides positives pour B7H3 est prévue pour le premier semestre 2025, avec un début des essais de phase 1 anticipé pour 2025.
GT Biopharma (NASDAQ: GTBP) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 mit einem Nettoverlust von 3.4 Millionen Dollar, verglichen mit 2.4 Millionen Dollar im dritten Quartal 2023. Das Unternehmen hält 6.5 Millionen Dollar in Bar, was voraussichtlich ausreicht, um die Geschäfte bis zum zweiten Quartal 2025 zu finanzieren. Die Forschungs- und Entwicklungskosten blieben mit 1.3 Millionen Dollar stabil, während die SG&A-Kosten von 1.2 Millionen Dollar im Vorjahr auf 2.3 Millionen Dollar anstiegen.
Das Unternehmen plant, im GTB-3650 Phase 1 Versuch im vierten Quartal 2024 seinen ersten Patienten zu behandeln, wobei die ersten klinischen Daten im zweiten Quartal 2025 erwartet werden. Darüber hinaus ist die IND-Einreichung für GTB-5550 bei B7H3-positiven soliden Tumoren für das 1. Halbjahr 2025 geplant, wobei die Phase-1-Studien 2025 beginnen sollen.
- First patient dosing in GTB-3650 Phase 1 trial expected in Q4 2024
- Initial clinical data for GTB-3650 expected in Q2 2025
- R&D expenses remained stable at $1.3 million
- Net loss increased to $3.4 million from $2.4 million year-over-year
- SG&A expenses nearly doubled to $2.3 million from $1.2 million
- Cash runway only extends into Q2 2025, suggesting potential need for additional funding
Insights
The Q3 results reveal concerning financial metrics for GT Biopharma. With a cash position of
The flat R&D spending of
The clinical development timeline for GTB-3650 shows promise, with first patient dosing expected in Q4 2024 and initial data readout in Q2 2025. The Phase 1 trial design targeting CD33-expressing hematologic malignancies is well-structured with 12 patients across 6 cohorts. The expansion into autoimmune indications with GTB-7550 (CD19-targeted) and solid tumors with GTB-5550 demonstrates platform versatility.
However, the compressed timeline between first patient dosing and data readout (~6 months) for a dose-escalation study raises feasibility concerns, especially for safety evaluation in refractory patient populations. Competition in NK cell therapeutics is intensifying, making timely execution crucial.
- GTB-3650 TriKE® Phase 1 trial first patient dosed expected in Q4 2024; initial clinical data expected in Q2 2025
- GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025
- GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating multiple solid tumor types, including prostate, breast, head and neck, ovarian, lung, liver, and GI
- GTB-7550 TriKE® targets CD19 and is in preclinical development for the treatment of Lupus and other autoimmune indications
- Cash of approximately
$6.5 million as of September 30, 2024, anticipated to be sufficient to fund operations into Q2 2025
SAN FRANCISCO, CALIFORNIA, Nov. 14, 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 third quarter 2024 financial results for the period ended September 30, 2024.
“We are pleased to be progressing towards dosing the first patient in our Phase 1 trial evaluating GTB-3650 in cancer patients in the fourth quarter of this year. This dose escalation study will evaluate GTB-3650 in 12 patients (six cohorts) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). We believe that NK cell engagers, like GTB-3650, have the potential to offer patients with a safer alternative to current treatments, like CAR-T therapy”, said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma.
This past October, the company held a virtual KOL event featuring Jeffrey Miller, MD1 and Mark Juckett, MD from the University of Minnesota Medical School2 who spoke to the value of NK cells within the broader therapeutic landscape as well as the potential for GT Biopharma’s NK cell engager pipeline, and specifically GTB-7550 which targets CD19 for autoimmune indications. “As a company, we are especially excited to continue exploring opportunities where our TriKE platform technology may have therapeutic utility, especially for autoimmune indications and in combination with NK cell therapies”, said Michael Breen. “In this rapidly emerging field, combination approaches may offer us the opportunity to leverage our patented platform technology across multiple NK cell engager constructs with new targets and for additional diseases.
- Dr. Miller is the Consulting Senior Medical Director at GT Biopharma and holds stock and options in GTBP.
- The University of Minnesota, pursuant to its license agreement with GT Biopharma, is entitled to receive royalties should commercial sales of GTB-3650 be realized. This interest has been reviewed and managed by the University of Minnesota in accordance with its conflict of interest policies.
Third Quarter 2024 Financial Summary
Cash Position: The Company had cash and cash equivalents of approximately
Research and Development (R&D) Expenses: R&D expenses for the third quarter ended September 30, 2024 were
Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the third quarter ended September 30, 2024 were
Other Income: Other income for the third quarter ended September 30, 2024 was
Net Loss: The Company reported a net loss of
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
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 6,418,000 | $ | 1,079,000 | ||||
| Restricted cash | 93,000 | — | ||||||
| Short-term investments | — | 12,893,000 | ||||||
| Prepaid expenses and other current assets | 248,000 | 84,000 | ||||||
| Total Current Assets | 6,759,000 | 14,056,000 | ||||||
| Operating lease right-of-use asset | — | 53,000 | ||||||
| TOTAL ASSETS | $ | 6,759,000 | $ | 14,109,000 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,612,000 | $ | 4,328,000 | ||||
| Accrued expenses | 1,868,000 | 1,195,000 | ||||||
| Current operating lease liability | — | 58,000 | ||||||
| Warrant liability | 182,000 | 1,052,000 | ||||||
| Total Current Liabilities | 4,662,000 | 6,633,000 | ||||||
| Stockholders’ Equity | ||||||||
| Convertible Preferred stock, par value | 1,000 | 1,000 | ||||||
| Common stock, par value | 2,000 | 1,000 | ||||||
| Additional paid in capital | 693,546,000 | 689,539,000 | ||||||
| Accumulated deficit | (691,452,000 | ) | (682,065,000 | ) | ||||
| Total Stockholders’ Equity | 2,097,000 | 7,476,000 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 6,759,000 | $ | 14,109,000 | ||||
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
| For The Three Months Ended | For the Nine Months Ended | ||||||||||||||||||||
| September 30, | September 30, | ||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||||
| Operating Expenses: | |||||||||||||||||||||
| Research and development | $ | 1,307,000 | $ | 1,364,000 | $ | 3,868,000 | $ | 5,109,000 | |||||||||||||
| Selling, general and administrative (including | 2,297,000 | 1,758,000 | 6,733,000 | 5,299,000 | |||||||||||||||||
| Loss from Operations | (3,604,000 | ) | (3,122,000 | ) | (10,601,000 | ) | (10,408,000 | ) | |||||||||||||
| Other Income (Expense) | |||||||||||||||||||||
| Interest income | 96,000 | 216,000 | 343,000 | 600,000 | |||||||||||||||||
| Interest expense | — | — | — | (213,000 | ) | ||||||||||||||||
| Change in fair value of warrant liability | 95,000 | 485,000 | 870,000 | 4,796,000 | |||||||||||||||||
| Gain on extinguishment of debt | — | — | — | 547,000 | |||||||||||||||||
| Unrealized gain on marketable securities | 2,000 | 5,000 | 1,000 | 43,000 | |||||||||||||||||
| Total Other Income, Net | 193,000 | 706,000 | 1,214,000 | 5,773,000 | |||||||||||||||||
| Net Loss | $ | (3,411,000 | ) | $ | (2,416,000 | ) | $ | (9,387,000 | ) | $ | (4,635,000 | ) | |||||||||
| Net Loss Per Share - Basic and Diluted | $ | (1.53 | ) | $ | (1.77 | ) | $ | (5.28 | ) | $ | (3.47 | ) | |||||||||
| Weighted average common shares outstanding - basic and diluted | 2,234,328 | 1,367,206 | 1,777,313 | 1,336,532 | |||||||||||||||||
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
| For The Nine Months Ended | ||||||||||||
| September 30, | ||||||||||||
| 2024 | 2023 | |||||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||
| Net loss | $ | (9,387,000 | ) | $ | (4,635,000 | ) | ||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Stock based compensation – services | — | 430,000 | ||||||||||
| Stock based compensation - officers, directors, and employees | 222,000 | 1,337,000 | ||||||||||
| Change in fair value of warrant liability | (870,000 | ) | (4,796,000 | ) | ||||||||
| Gain on extinguishment of share settled debt | — | (547,000 | ) | |||||||||
| Change in operating lease right-of-use assets | 53,000 | 78,000 | ||||||||||
| Unrealized loss (gain) on marketable securities | 1,000 | (43,000 | ) | |||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Decrease in prepaid expenses | (164,000 | ) | 16,000 | |||||||||
| Increase (Decrease) in accounts payable and accrued expenses | (233,000 | ) | 1,437,000 | |||||||||
| (Decrease) in operating lease liability | (58,000 | ) | (82,000 | ) | ||||||||
| Net Cash Used in Operating Activities | (10,436,000 | ) | (6,805,000 | ) | ||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||||||
| Sale (Purchase) of investments | 12,892,000 | (2,487,000 | ) | |||||||||
| Net Cash Provided by (Used in) Investing Activities | 12,892,000 | (2,487,000 | ) | |||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||
| Proceeds from issuance of common stock and warrants, net | 2,976,000 | 6,268,000 | ||||||||||
| Net Cash Provided by Financing Activities | 2,976,000 | 6,268,000 | ||||||||||
| Net Increase (Decrease) in Cash and Cash Equivalents and Restricted Cash | 5,432,000 | (3,024,000 | ) | |||||||||
| Cash and Cash Equivalents and Restricted Cash at Beginning of Period | 1,079,000 | 5,672,000 | ||||||||||
| Cash and Cash Equivalents and Restricted Cash at End of Period | $ | 6,511,000 | $ | 2,648,000 | ||||||||
| 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 | $ | — | $ | 5,831,000 | ||||||||
| Fair value of common stock issued to a vendor to settle accounts payable | $ | 810,000 | $ | 700,000 | ||||||||
FAQ
When will GT Biopharma (GTBP) begin dosing patients in the GTB-3650 Phase 1 trial?
What was GT Biopharma's (GTBP) net loss in Q3 2024?
When will GT Biopharma (GTBP) submit the IND for GTB-5550?
How much cash does GT Biopharma (GTBP) have as of Q3 2024?
