GT Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update
GT Biopharma (NASDAQ: GTBP) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024, with initial clinical data in 1H 2025.
2. GTB-5550 TriKE® IND submission for B7H3 positive solid tumors expected in 1H 2025, with Phase 1 trial initiation in 2025.
3. GTB-7550 TriKE® in preclinical development for autoimmune indications.
4. Cash position of $9.2 million as of June 30, 2024, expected to fund operations into 2025.
5. Q2 2024 financial results: R&D expenses decreased to $1.8 million, SG&A expenses increased to $2.1 million, and net loss increased to $3.7 million compared to Q2 2023.
GT Biopharma (NASDAQ: GTBP) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. GTB-3650 TriKE® l'inizio della sperimentazione di fase 1 è previsto nella seconda metà del 2024, con i dati clinici iniziali attesi nella prima metà del 2025.
2. GTB-5550 TriKE® la presentazione dell'IND per i tumori solidi positivi per B7H3 è attesa nella prima metà del 2025, con l'inizio della sperimentazione di fase 1 previsto per il 2025.
3. GTB-7550 TriKE® è in sviluppo preclinico per indicazioni autoimmuni.
4. Posizione di liquidità di 9,2 milioni di dollari al 30 giugno 2024, prevista per finanziare le operazioni fino al 2025.
5. Risultati finanziari del secondo trimestre del 2024: le spese per R&D sono diminuite a 1,8 milioni di dollari, le spese SG&A sono aumentate a 2,1 milioni di dollari e la perdita netta è aumentata a 3,7 milioni di dollari rispetto al secondo trimestre del 2023.
GT Biopharma (NASDAQ: GTBP) informó sobre sus resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los puntos destacados incluyen:
1. GTB-3650 TriKE® se espera que la iniciación del ensayo de fase 1 ocurra en la segunda mitad de 2024, con datos clínicos iniciales en la primera mitad de 2025.
2. GTB-5550 TriKE® se espera la presentación del IND para tumores sólidos positivos para B7H3 en la primera mitad de 2025, con la iniciación del ensayo de fase 1 también prevista para 2025.
3. GTB-7550 TriKE® se encuentra en desarrollo preclínico para indicaciones autoinmunes.
4. Posición de efectivo de 9,2 millones de dólares al 30 de junio de 2024, que se espera financie las operaciones hasta 2025.
5. Resultados financieros del segundo trimestre de 2024: los gastos de I+D disminuyeron a 1,8 millones de dólares, los gastos de SG&A aumentaron a 2,1 millones de dólares y la pérdida neta aumentó a 3,7 millones de dólares en comparación con el segundo trimestre de 2023.
GT Biopharma (NASDAQ: GTBP)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. GTB-3650 TriKE® 1상 시험 시작은 2024년 하반기로 예상되며, 초기 임상 데이터는 2025년 상반기에 제공될 예정입니다.
2. GTB-5550 TriKE® B7H3 양성 고형 종양에 대한 IND 제출은 2025년 상반기로 예상되며, 2025년에 1상 시험이 시작될 예정입니다.
3. GTB-7550 TriKE®는 자가면역 질환에 대한 전임상 개발 중입니다.
4. 2024년 6월 30일 기준 920만 달러의 현금 보유액이며, 이는 2025년까지 운영 자금을 지원할 것으로 예상됩니다.
5. 2024년 2분기 재무 결과: 연구개발비는 180만 달러로 감소하였고, SG&A 비용은 210만 달러로 증가하였으며, 순손실은 370만 달러로 2023년 2분기 대비 증가하였습니다.
GT Biopharma (NASDAQ: GTBP) a annoncé ses résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les principaux points à retenir incluent :
1. GTB-3650 TriKE® le lancement de l'essai de phase 1 est prévu pour la seconde moitié de 2024, avec les premières données cliniques attendues dans la première moitié de 2025.
2. GTB-5550 TriKE® la soumission de l'IND pour les tumeurs solides positives pour B7H3 est attendue dans la première moitié de 2025, avec le début de l'essai de phase 1 prévu pour 2025.
3. GTB-7550 TriKE® est en développement préclinique pour des indications auto-immunes.
4. Position de liquidités de 9,2 millions de dollars au 30 juin 2024, qui devrait financer les opérations jusqu'en 2025.
5. Résultats financiers du deuxième trimestre 2024 : les dépenses en R&D ont diminué à 1,8 million de dollars, les dépenses SG&A ont augmenté à 2,1 millions de dollars et la perte nette a augmenté à 3,7 millions de dollars par rapport au deuxième trimestre 2023.
GT Biopharma (NASDAQ: GTBP) hat die Finanz Ergebnisse für das 2. Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Die wichtigsten Punkte sind:
1. GTB-3650 TriKE® der Beginn der Phase 1 Studie wird in der zweiten Hälfte 2024 erwartet, mit ersten klinischen Daten in der ersten Hälfte 2025.
2. GTB-5550 TriKE® IND-Einreichung für B7H3-positive solide Tumoren wird in der ersten Hälfte 2025 erwartet, mit Beginn der Phase 1 Studie im Jahr 2025.
3. GTB-7550 TriKE® befindet sich in der präklinischen Entwicklung für Autoimmunindikationen.
4. Die Liquiditätsposition beträgt zum 30. Juni 2024 9,2 Millionen Dollar und wird voraussichtlich die Betriebstätigkeiten bis 2025 finanzieren.
5. Finanzielle Ergebnisse des 2. Quartals 2024: Die F&E-Ausgaben sanken auf 1,8 Millionen Dollar, die SG&A-Ausgaben stiegen auf 2,1 Millionen Dollar und der Nettoverlust stieg auf 3,7 Millionen Dollar im Vergleich zum 2. Quartal 2023.
- GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024
- GTB-5550 TriKE® IND submission for solid tumors expected in 1H 2025
- Cash position of $9.2 million expected to fund operations into 2025
- FDA clearance received for GTB-3650 IND Application in June 2024
- R&D expenses decreased by $300,000 compared to Q2 2023
- Net loss increased to $3.7 million in Q2 2024 from $2.0 million in Q2 2023
- SG&A expenses increased by $600,000 compared to Q2 2023
- Other income decreased by $1.4 million primarily due to reduction in non-cash change in fair value of warrant liability
Insights
GT Biopharma's Q2 2024 results reveal a mixed financial picture. The company's cash position of
R&D expenses decreased slightly, which is unusual for a biotech advancing clinical programs. This could indicate efficient resource management or potential delays in development. The anticipated increase in clinical expenses for GTB-3650 and GTB-5550 in 2024 may pressure the cash runway, potentially necessitating additional funding before 2025.
GT Biopharma's pipeline progress is promising, with GTB-3650 entering Phase 1 trials in 2H 2024 and initial data expected in 1H 2025. This TriKE® platform targeting CD33+ hematologic malignancies could address significant unmet needs in AML and MDS. The planned IND submission for GTB-5550 in 1H 2025 is particularly intriguing, as it targets B7H3+ solid tumors across six types, potentially broadening the company's market reach.
The exploration of NK cell engagers in autoimmune diseases with GTB-7550 demonstrates the platform's versatility. However, investors should note that success in hematological cancers doesn't guarantee efficacy in solid tumors or autoimmune conditions, areas with historically challenging drug development landscapes.
- GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024; initial clinical data expected in 1H 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 six solid tumor types, including prostate, breast, head and neck, ovarian, lung, and GI
- GTB-7550 TriKE® is in preclinical development for autoimmune indications and targets CD19
- Cash of approximately
$9.2 million as of June 30, 2024, anticipated to be sufficient to fund operations into 2025
SAN FRANCISCO, CALIFORNIA, Aug. 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 second quarter 2024 financial results for the period ended June 30, 2024.
“We are thrilled to be in a position to initiate a Phase 1 trial evaluating GTB-3650 in cancer patients in the second half of this year. Initial data from the dose escalation phase of this trial is anticipated in the first half of 2025. We also expect to submit a second IND, for GTB-5550, in the first half of 2025, which has much broader potential in multiple solid tumors and could fuel our future success as a company specializing in NK cell engagers”, said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma.
The Phase 1 dose escalation study will evaluate GTB-3650 in up to six cohorts (two patients per cohort) in adults with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 will be dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.
“We also remain active in exploring additional opportunities where our TriKE platform technology may have therapeutic utility, especially for autoimmune indications, which are quickly becoming recognized as an intriguing new area for immune-related therapies. Another area of continued interest and work is thoroughly assessing the potential to combine our engagers with NK cellular therapies,” said Michael Breen. “There are compelling reasons to explore combination approaches in this rapidly emerging field, including the potential for synergistic clinical effects. Our patented platform technology can be leveraged across multiple NK cell engager constructs with new targets and for additional diseases, including GTB-7550 which targets CD19 for autoimmune indications. GTB-3650 and GTB-5550 are the frontrunners to further validate our platform, which has already yielded a portfolio of multiple pipeline development candidates. We look forward to advancing all the opportunities in our deep pipeline as the science continues to emerge.”
Second 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 second quarter ended March 31, 2024 were
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter ended June 30, 2024 were
Other Income: Other income for the second quarter ended June 30, 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 different types of antibodies compared to those naturally made in humans. Human conventional antibodies have recognition domains made up of heavy chains and light chains. 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
| June 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 9,249,000 | $ | 1,079,000 | ||||
| Short-term investments | — | 12,893,000 | ||||||
| Prepaid expenses and other current assets | 18,000 | 84,000 | ||||||
| Total Current Assets | 9,267,000 | 14,056,000 | ||||||
| Operating lease right-of-use asset | - | 53,000 | ||||||
| TOTAL ASSETS | $ | 9,267,000 | $ | 14,109,000 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,717,000 | $ | 4,328,000 | ||||
| Accrued expenses | 1,765,000 | 1,195,000 | ||||||
| Current operating lease liability | — | 58,000 | ||||||
| Warrant liability | 277,000 | 1,052,000 | ||||||
| Total Current Liabilities | 3,759,000 | 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 | (688,041,000 | ) | (682,065,000 | ) | ||||
| Total Stockholders’ Equity | 5,508,000 | 7,476,000 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 9,267,000 | $ | 14,109,000 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
| For The Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 1,784,000 | $ | 2,095,000 | $ | 2,561,000 | $ | 3,745,000 | ||||||||
| Selling, general and administrative (including | 2,122,000 | 1,526,000 | 4,436,000 | 3,541,000 | ||||||||||||
| Loss from Operations | (3,906,000 | ) | (3,621,000 | ) | (6,997,000 | ) | (7,286,000 | ) | ||||||||
| Other Income (Expense) | ||||||||||||||||
| Interest income | 105,000 | 220,000 | 247,000 | 384,000 | ||||||||||||
| Interest expense | — | (1,000 | ) | — | (213,000 | ) | ||||||||||
| Change in fair value of warrant liability | 117,000 | 1,387,000 | 775,000 | 4,311,000 | ||||||||||||
| Gain on extinguishment of debt | — | 14,000 | — | 547,000 | ||||||||||||
| Unrealized gain (loss) on marketable securities | 1,000 | 9,000 | (1,000 | ) | 38,000 | |||||||||||
| Other | (27,000 | ) | — | — | — | |||||||||||
| Total Other Income | 196,000 | 1,629,000 | 1,021,000 | 5,067,000 | ||||||||||||
| Net Loss | $ | (3,710,000 | ) | $ | (1,992,000 | ) | $ | (5,976,000 | ) | $ | (2,219,000 | ) | ||||
| Net Loss Per Share - Basic and Diluted | $ | (2.17 | ) | $ | (1.49 | ) | $ | (3.86 | ) | $ | (1.68 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 1,711,955 | 1,339,087 | 1,546,294 | 1,321,069 | ||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
GT BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
| For The Six Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (5,976,000 | ) | $ | (2,219,000 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock based compensation - services | - | 315,000 | ||||||
| Stock based compensation - officers, directors, and employees | 222,000 | 905,000 | ||||||
| Change in fair value of warrant liability | (775,000 | ) | (4,311,000 | ) | ||||
| Gain on extinguishment of share settled debt | - | (547,000 | ) | |||||
| Change in operating lease right-of-use assets | 53,000 | 51,000 | ||||||
| Unrealized loss (gain) on marketable securities | (1,000 | ) | (38,000 | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Decrease in prepaid expenses | 67,000 | 5,000 | ||||||
| Increase (Decrease) in accounts payable and accrued expenses | (1,231,000 | ) | 1,052,000 | |||||
| (Decrease) in operating lease liability | (58,000 | ) | (54,000 | ) | ||||
| Net Cash Used in Operating Activities | (7,699,000 | ) | (4,841,000 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Sale (purchase) of investments | 12,893,000 | (4,332,000 | ) | |||||
| Net Cash Provided by (Used in) Investing Activities | 12,893,000 | (4,332,000 | ) | |||||
| 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 | 8,170,000 | (2,905,000 | ) | |||||
| Cash at Beginning of Period | 1,079,000 | 5,672,000 | ||||||
| Cash at End of Period | $ | 9,249,000 | $ | 2,767,000 | ||||
| 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 | $ | 591,000 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
FAQ
When is GT Biopharma (GTBP) expecting to initiate the Phase 1 trial for GTB-3650?
What is GT Biopharma's (GTBP) cash position as of June 30, 2024?
What was GT Biopharma's (GTBP) net loss for Q2 2024?
When does GT Biopharma (GTBP) expect to submit the IND for GTB-5550?
