GT Biopharma, Inc. issued the following announcement on Mar. 28.
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 fourth quarter and full-year 2021 results for the period ended December 31, 2021.
"We're excited for GTB-3650's prospects in the new year as we advance the Company's second-generation Tri-specific NK cell engager (TriKE®) technology into an IND-enabling study. The development of GTB-3650, our lead-asset second generation nanobody TriKE® has been significantly de-risked, propelled by GTB-3550 predecessor data published in 2021 including: positive first-in-human Phase 1 data; and in-vivo animal model data, conducted in combination with a bispecific killer cell engager asset," said Michael Breen, Executive Chairman and Interim Chief Executive Officer. "Our optimism continues to rise as these proof-of-concept data demonstrate a well-tolerated safety profile and strong NK cell activation against a broad range of tumors. In total, the Company's TriKE® nanobody platform, a rich platform technology, has demonstrated broad utility. We are confident in our ability to develop these assets as a monotherapy, as a combination therapy with conventional chemotherapy, or in combination with other potential joint commercialization technologies."
Quarterly Highlights
- The Company presented pre-clinical TriKE® data in an oral poster-presentation both virtually and in-person at ESMO Targeted Anticancer Therapies (TAT) Congress, March 7–8, 2022.
- The pre-clinical evidence suggests, despite the difference in circulating immune cells of Stage IVB NSCLC patients, mesothelin-targeted TriKE® can work alongside current standard of care and provide benefit even in the hypoxic environment of a solid tumor.
- Dr. Jeffrey Miller, GT Biopharma consultant Chief Scientific Officer, also participated in an oral poster-presentation session at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress, December 8–11, 2021.
- The presentation highlighted the broad activity of GTB-5550, which harbors wild-type IL-15 in combination with TriKE® against B7-H3-expressing tumors.
- GT Biopharma will participate in poster-presentation sessions at the following upcoming medical conferences:
- EBMT Abstract AS_EBMT-2022-00508, "A Tri-specific Killer Engager (TriKE®) against B7-H3 enhances NK cell mediated killing of multiple myeloma"
- AACR Abstract 3435, "GTB-5550 (cam16-IL15-camB7H3) Tri-specific Killer Engager (TriKE®) drives natural killer cell activation and antibody dependent cellular cytotoxicity against head and neck squamous cell carcinomas"
Cash Position: The Company had total cash, cash equivalents and short-term investments of $32.0 million as of December 31, 2021, compared to $5.3 million as of December 30, 2020. This is expected to provide ample runway to fund operations into 2023 including Phase 1 clinical development of its lead products GTB-3650 and GTB-5550.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were $6.3 million compared to $233,000 in the same quarter a year ago. R&D expenses for the year-ending December 31, 2021, were $9.6 million compared to $485,000 in the year ended December 31, 2020. Research and development expenses increased primarily due to the admittance of additional patients into the Phase 1 GTB-3550 clinical trial and the continued development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2021 were $11.8 million compared to $2.0 million in the same quarter a year-ago. G&A expenses for the year ending December 31, 2021, were $47.9 million compared to $6.3 million for the year ending December 31, 2020. The increase in general and administrative expenses was primarily attributable to the increase in stock-based compensation and expenses incurred in support of our planned growth and new public company compliance initiatives. For the year ended December 31, 2021, we incurred $33.9 million of stock-based compensation expense as compared to $269,000 in stock-based compensation expense for the year ended December 31, 2020.
Net Loss: For the fourth quarter of 2021, the Company reported a net loss of $18.0 million, compared to a net loss of $6.3 million in the same quarter a year ago. For the year ended December 31, 2021, the Company reported a net loss of $58.0 million compared to a net loss of $28.3 million for the year ending December 31, 2020.
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