U.S. markets closed
  • S&P 500

    3,693.23
    -64.76 (-1.72%)
     
  • Dow 30

    29,590.41
    -486.27 (-1.62%)
     
  • Nasdaq

    10,867.93
    -198.88 (-1.80%)
     
  • Russell 2000

    1,679.59
    -42.72 (-2.48%)
     
  • Crude Oil

    79.43
    -4.06 (-4.86%)
     
  • Gold

    1,651.70
    -29.40 (-1.75%)
     
  • Silver

    18.83
    -0.78 (-3.99%)
     
  • EUR/USD

    0.9693
    -0.0145 (-1.47%)
     
  • 10-Yr Bond

    3.6970
    -0.0110 (-0.30%)
     
  • GBP/USD

    1.0857
    -0.0398 (-3.54%)
     
  • USD/JPY

    143.3300
    +0.9950 (+0.70%)
     
  • BTC-USD

    19,093.82
    -43.60 (-0.23%)
     
  • CMC Crypto 200

    434.61
    -9.92 (-2.23%)
     
  • FTSE 100

    7,018.60
    -140.92 (-1.97%)
     
  • Nikkei 225

    27,153.83
    -159.30 (-0.58%)
     

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

·9 min read
GT Biopharma, Inc.
GT Biopharma, Inc.
  • 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