GT Biopharma Reports Second Quarter Fiscal 2022 Financial Results and Business Update

GT Biopharma Reports Second Quarter Fiscal 2022 Financial Results and Business Update




GT Biopharma Reports Second Quarter Fiscal 2022 Financial Results and Business Update

  • 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