West LA Times

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.

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