- Presented preclinical data demonstration second-generation CD19 targeting Tri-specific Killer Engager (TRIKE®) driving robust NK cell function against B cell malignancies at EHA 2022 Congress.
- GTB-5550 (B7-H3) abstract poster presentation accepted at upcoming ESMO 2022 Congress.
- $23.7 million in cash, cash equivalents and short-term investments as of June 30, 2022, is expected to provide runway to fund operations into 2023.
BRISBANE, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (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 fiscal 2022 results for the period ended June 30, 2022.
“As we move GTB-3650, our second-generation lead Camelid TriKE®, forward into the clinic, we are maintaining momentum across the larger breadth of promising oncology indications in GT Biopharma’s pipeline. We expect to file an Investigational New Drug (IND) application for GTB-3650 in the first half of 2023, subsequently followed by an IND application for GTB-5550. We are building a strong portfolio of knowledge across GT Biopharma’s TriKE® product candidates through investigation of preclinical solid tumor and hematological cancers models. As we continue to produce additional validating preclinical data across our pipeline, we believe we will be able to fulfill the critical need for novel and targeted therapeutic interventions for the treatment of patients in our pipeline cancer indications,” said Michael Breen, Executive Chairman and Interim CEO of GT Biopharma.
Quarterly Highlights
- Presented preclinical data demonstration second-generation CD19 targeting Tri-specific Killer Engager (TRIKE®) driving robust NK cell function against B cell malignancies at EHA 2022 Congress.
- Abstract poster presentation accepted at upcoming European Society for Medical Oncology (ESMO) Congress 2022: “B7-H3 Targeted Tri-specific Killer Engagers deliver IL-15 to NK cells but not T cells, and specifically targets solid tumors as a pan-tumor antigen strategy mediated through NK cells.”
- Mr. Alan Urban a member of the Board of Directors has assumed the role of financial expert of the Audit Committee. Mr. Urban has over 30 years of experience in corporate finance and accounting. He previously served as Chief Financial Officer for several publicly traded companies.
Second Quarter Fiscal 2022 Financial Summary
Cash Position: The Company had total cash, cash equivalents and short-term investments of $23.7 million as of June 30, 2022, compared to $32.0 million as of December 31, 2021. This is expected to provide ample runway to fund operations into 2023.
Research and Development (R&D) Expenses: We recorded R&D expenses of $1.1 million and $0.6 million for the three months ended June 30, 2022 and 2021, respectively, an increase of $0.5 million over prior year comparable period. We recorded R&D expenses $3.2 million and $2.3 million for the six months ended June 30, 2022 and 2021, respectively, an increase of $0.9 million over prior year comparable period. R&D expenses increased primarily due to hiring of additional employees and professionals in 2022 and costs associated with the continued development and manufacturing of our most advanced TriKE® product candidates GTB-3650 and GTB-5550.
Selling, General and Administrative (S,G&A) Expenses: We recorded S,G&A expenses of $1.9 million and $3.7 million for the three months ended June 30, 2022 and 2021, respectively, a decrease of $1.8 million over prior year comparable period. We recorded G&A expenses of $5.2 million and $31.1 million for the six months ended June 30, 2022 and 2021, respectively, a decrease of $25.9 million over the prior year comparable period. The decrease in S,G&A resulted primarily due to a decrease in stock-based compensation to consultants, officers and directors. We recorded additional expenses during the three months and six months ended June 30, 2021 that consisted of legal, finance, consulting and professional fees in support of our planned growth and new public company compliance initiatives.
Net Loss: We recorded net loss of $3.0 million or $0.10 per share and $8.4 million or $0.26 per share for the three months ended June 30, 2022 and 2021, respectively. We recorded net loss of $4.9 million or $0.15 per share and $34.6 million or $1.39 per share for the six months ended June 30, 2022 and 2021, respectively. The decrease in net loss resulted primarily due to increase in R&D expenses and reduction in S,G&A expenses for the three months and six months ended June 30, 2022 as compared to the same comparable periods in 2021.
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 Contacts:
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)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 5,358 | $ | 8,968 | ||||
| Short-term investments | 18,367 | 23,011 | ||||||
| Prepaid expenses and other current assets | 222 | 190 | ||||||
| Total current assets | 23,947 | 32,169 | ||||||
| Operating lease right-of-use asset | 214 | - | ||||||
| Deposits | 9 | - | ||||||
| TOTAL ASSETS | $ | 24,170 | $ | 32,169 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 7,263 | $ | 8,220 | ||||
| Accrued expenses | 1,129 | 1,901 | ||||||
| Current operating lease liability | 103 | - | ||||||
| Derivative liability | 115 | 138 | ||||||
| Total current liabilities | 8,610 | 10,259 | ||||||
| Non-current operating lease liability | 120 | - | ||||||
| Total liabilities | 8,730 | 10,259 | ||||||
| Stockholders’ equity | ||||||||
| Convertible Preferred stock, par value $0.01, 15,000,000 shares authorized | ||||||||
| Series C – 96,230 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1 | 1 | ||||||
| Common stock, par value $0.001, 750,000,000 shares authorized, 30,693,558 shares and 32,061,989 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 31 | 32 | ||||||
| Common stock issuable 0 shares and 327,298 shares at June 30, 2022 and December 31, 2021, respectively | - | 1,113 | ||||||
| Additional paid in capital | 677,411 | 674,348 | ||||||
| Accumulated deficit | (662,003 | ) | (653,584 | ) | ||||
| Total stockholders’ equity | 15,440 | 21,910 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 24,170 | $ | 32,169 | ||||
GT BIOPHARMA, INC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
| For the three months ended | For the six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 1,139 | 639 | 3,226 | 2,279 | ||||||||||||
| Selling, general and administrative (including $463 and $577 expense from stock compensation granted to officers and directors during the three months ended June 30, 2022 and 2021, and $910 and $14,873 for the six months ended June 30, 2022 and 2021, respectively) | 1,875 | 3,742 | 5,230 | 31,104 | ||||||||||||
| Loss from Operations | 3,014 | 4,381 | 8,456 | 33,383 | ||||||||||||
| Other (Income) Expense | ||||||||||||||||
| Interest income | (36 | ) | - | (44 | ) | - | ||||||||||
| Interest expense | - | - | - | 696 | ||||||||||||
| Change in fair value of derivative liability | (5 | ) | 480 | (23 | ) | 459 | ||||||||||
| Unrealized loss on marketable securities | 6 | - | 30 | - | ||||||||||||
| Total Other (Income) Expense | (35 | ) | 480 | (37 | ) | 1,155 | ||||||||||
| Net Loss | $ | (2,979 | ) | $ | (4,861 | ) | $ | (8,419 | ) | $ | (34,538 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.10 | ) | $ | (0.15 | ) | $ | (0.26 | ) | $ | (1.39 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 31,237,560 | 33,516,428 | 31,865,425 | 24,925,908 | ||||||||||||
GT BIOPHARMA, INC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
| For the six months ended | ||||||||
| June 30, | ||||||||
| 2022 | 2021 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net loss | $ | (8,419 | ) | $ | (34,538 | ) | ||
| Adjustments to reconcile net loss to net cash (used in) operating activities: | ||||||||
| Stock based compensation – consultants and research and development | 1,262 | 10,134 | ||||||
| Stock based compensation - officers, employees and board of directors | 910 | 14,873 | ||||||
| Convertible notes payable issued for consulting services | - | 720 | ||||||
| Change in fair value of derivative liability | (23 | ) | 459 | |||||
| Change in operating lease right-of-use assets | 46 | - | ||||||
| Unrealized loss on marketable securities | 30 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| (Increase) decrease in prepaid expenses | (32 | ) | 302 | |||||
| (Increase) in deposits | (9 | ) | - | |||||
| (Decrease) in accounts payable and accrued expenses | (1,729 | ) | (611 | ) | ||||
| (Decrease) in operating lease liability | (37 | ) | - | |||||
| Increase in accrued interest | - | 689 | ||||||
| Net Cash (Used in) Operating Activities | (8,001 | ) | (7,972 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
| Sales of short term investments | 4,614 | - | ||||||
| Net Cash Provided By Investing Activities | 4,614 | - | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Proceeds from issuance of common stock | - | 24,679 | ||||||
| Cancellation of common stock upon settlement with former officer | (223 | ) | - | |||||
| Proceeds from exercise of warrants | - | 16,296 | ||||||
| Proceeds from issuance of notes payable | - | 1,205 | ||||||
| Net Cash (Used in) Provided by Financing Activities | (223 | ) | 42,180 | |||||
| Net (Decrease) Increase in Cash | (3,610 | ) | 34,208 | |||||
| Cash at Beginning of Period | 8,968 | 5,297 | ||||||
| Cash at End of Period | $ | 5,358 | $ | 39,505 | ||||
| SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
| Cash paid during the period for: | ||||||||
| Interest | $ | - | $ | - | ||||
| Income taxes | $ | - | $ | - | ||||
| SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES | ||||||||
| Recognition of operating lease right-of-use assets and related lease liabilities | $ | 260 | $ | - | ||||
| Extinguishment of unamortized debt discount and adjustment to accumulated deficit upon adoption of ASU 2020-06 | $ | - | $ | 4,745 | ||||
| Common stock issued upon conversion of notes payable and accrued interest | $ | - | $ | 38,799 | ||||
| Convertible notes payable issued for accrued expenses | $ | - | $ | 1,525 | ||||
