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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ |
Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
the quarterly period ended June 30, 2023.
☐ |
Transition
report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
the transition period from __________ to ____________.
Commission
File Number 001-40023
GT
BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
94-1620407 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
Number) |
8000
Marina Blvd, Suite 100
Brisbane, CA 94005
(Address of principal executive offices and zip code)
415-919-4040
(Registrant’s telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol |
|
Name
of exchange on which registered |
Common
Stock, $0.001 par value per share |
|
GTBP |
|
Nasdaq Capital Market |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
Emerging
growth company ☐ |
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark
whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 7, 2023, the registrant had 40,639,688 shares of common stock outstanding.
GT
BIOPHARMA, INC. AND SUBSIDIARIES
FORM 10-Q
For the Six Months Ended June 30, 2023
Table
of Contents
GT
BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except shares and par value)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 2,767 | | |
$ | 5,672 | |
Short-term investments | |
| 15,206 | | |
| 10,836 | |
Prepaid expenses and other current assets | |
| 48 | | |
| 54 | |
Total Current Assets | |
| 18,021 | | |
| 16,562 | |
| |
| | | |
| | |
Operating lease right-of-use asset | |
| 114 | | |
| 165 | |
Deposits | |
| 9 | | |
| 9 | |
TOTAL ASSETS | |
$ | 18,144 | | |
$ | 16,736 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 3,501 | | |
$ | 3,140 | |
Accrued expenses | |
| 1,222 | | |
| 1,669 | |
Current operating lease liability | |
| 120 | | |
| 110 | |
Total Current Liabilities | |
| 4,843 | | |
| 4,919 | |
| |
| | | |
| | |
Non-current operating lease liability | |
| - | | |
| 64 | |
Warrant liability | |
| 1,538 | | |
| 19 | |
Total Liabilities | |
$ | 6,381 | | |
$ | 5,002 | |
| |
| | | |
| | |
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, 2023 and December 31, 2022, respectively | |
| 1 | | |
| 1 | |
Common stock, par value $0.001, 250,000,000
shares authorized, 40,639,688
shares and 32,722,452 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 41 | | |
| 33 | |
Additional paid in capital | |
| 688,408 | | |
| 686,168 | |
Accumulated deficit | |
| (676,687 | ) | |
| (674,468 | ) |
Total Stockholders’ Equity | |
| 11,763 | | |
| 11,734 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 18,144 | | |
$ | 16,736 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
GT
BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands, except per share data)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For The Three Months
Ended June 30, | | |
For the Six Months
Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | |
Revenues | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Operating Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,095 | | |
| 1,139 | | |
| 3,745 | | |
| 3,226 | |
| |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative (including $398 and $463 from stock compensation granted to officers, directors and employees for the three months ended June 30, 2023 and 2022, respectively, and $905 and $910 for the six months ended June 30, 2023 and 2022, respectively) | |
| 1,526 | | |
| 1,875 | | |
| 3,541 | | |
| 5,230 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from Operations | |
| 3,621 | | |
| 3,014 | | |
| 7,286 | | |
| 8,456 | |
| |
| | | |
| | | |
| | | |
| | |
Other (Income) Expense | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| (220 | ) | |
| (36 | ) | |
| (384 | ) | |
| (44 | ) |
Interest expense | |
| 1 | | |
| - | | |
| 213 | | |
| - | |
Change in fair value of warrant liability | |
| (1,387 | ) | |
| (5 | ) | |
| (4,311 | ) | |
| (23 | ) |
Gain on extinguishment of debt | |
| (14 | ) | |
| - | | |
| (547 | ) | |
| - | |
Unrealized (gain) loss on marketable securities | |
| (9 | ) | |
| 6 | | |
| (38 | ) | |
| 30 | |
Total Other (Income), net | |
| (1,629 | ) | |
| (35 | ) | |
| (5,067 | ) | |
| (37 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (1,992 | ) | |
$ | (2,979 | ) | |
$ | (2,219 | ) | |
$ | (8,419 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss Per Share - Basic and Diluted | |
$ | (0.05 | ) | |
$ | (0.10 | ) | |
$ | (0.06 | ) | |
$ | (0.26 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Common Shares Outstanding - Basic and Diluted | |
| 40,172,599 | | |
| 31,237,560 | | |
| 39,632,060 | | |
| 31,865,425 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
GT
BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in
thousands)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | |
| |
Capital | | |
Deficit | | |
Total | |
For The Three Months Ended June 30, 2023 (Unaudited) | |
| | |
| |
| |
| | |
| | |
| |
| |
Preferred Shares | | |
Common Shares | |
| |
Additional Paid in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | |
| |
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| |
| |
| | |
| | |
| |
Balance, March 31, 2023 | |
| 96 | | |
$ | 1 | | |
| 36,883 | | |
$ | 37 | |
- | |
$ | 687,710 | | |
$ | (674,695 | ) | |
$ | 13,053 | |
Cancellation of common stock
upon settlement with former officer | |
| | | |
| | | |
| - | | |
| | |
| |
| | | |
| | | |
| | |
Cancellation of common stock | |
| | | |
| | | |
| - | | |
| | |
| |
| | | |
| | | |
| | |
Equity compensation to officers,
employees, and board of directors | |
| | | |
| | | |
| - | | |
| | |
| |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Fair value of vested stock options | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| 398 | | |
| - | | |
| 398 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Issuance of common shares for services | |
| | | |
| | | |
| - | | |
| | |
| |
| | | |
| | | |
| | |
Issuance of common stock for exercise of Prefunded Warrants | |
| - | | |
| - | | |
| 2,900 | | |
| 3 | |
- | |
| (3 | ) | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Issuance of common shares in settlement of vendors payable | |
| - | | |
| - | | |
| 857 | | |
| 1 | |
| |
| 303 | | |
| - | | |
| 304 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| - | | |
| (1,992 | ) | |
| (1,992 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Balance, June 30, 2023 | |
| 96 | | |
$ | 1 | | |
| 40,640 | | |
$ | 41 | |
- | |
$ | 688,408 | | |
$ | (676,687 | ) | |
$ | 11,763 | |
For The Six Months Ended June 30, 2023 (Unaudited) | |
| | |
| |
|
|
| | |
| | |
| |
| |
Preferred Shares | | |
Common Shares | |
|
|
Additional Paid in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | |
|
|
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| |
|
|
| | |
| | |
| |
Balance, December 31, 2022 | |
| 96 | | |
$ | 1 | | |
| 32,723 | | |
$ | 33 | |
- |
|
$ | 686,168 | | |
$ | (674,468 | ) | |
$ | 11,734 | |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Private placement of common stock | |
| - | | |
| - | | |
| 3,600 | | |
| 4 | |
|
|
| 6,264 | | |
| - | | |
| 6,268 | |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Initial recognition of fair value of warrant liability | |
| - | | |
| - | | |
| - | | |
| - | |
|
|
| (5,831 | ) | |
| - | | |
| (5,831 | ) |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Fair value of vested stock options | |
| - | | |
| - | | |
| - | | |
| | |
|
|
| 905 | | |
| - | | |
| 905 | |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Issuance of common shares for services | |
| - | | |
| - | | |
| 73 | | |
| - | |
- |
|
| 315 | | |
| - | | |
| 315 | |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Issuance of common stock for exercise of Prefunded Warrants | |
| - | | |
| - | | |
| 2,900 | | |
| 3 | |
|
|
| (3 | ) | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Issuance of common shares in settlement of vendors payable | |
| - | | |
| - | | |
| 1,344 | | |
| 1 | |
|
|
| 590 | | |
| - | | |
| 591 | |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | |
|
|
| - | | |
| (2,219 | ) | |
| (2,219 | ) |
| |
| | | |
| | | |
| | | |
| | |
|
|
| | | |
| | | |
| | |
Balance, June 30, 2023 | |
| 96 | | |
$ | 1 | | |
| 40,640 | | |
$ | 41 | |
- |
|
$ | 688,408 | | |
$ | (676,687 | ) | |
$ | 11,763 | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
For The Three Months Ended June 30, 2022 (Unaudited) | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Preferred Shares | | |
Common Shares | | |
Common Shares Issuable | | |
Additional Paid in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, March 31, 2022 | |
| 96 | | |
$ | 1 | | |
| 32,346 | | |
$ | 32 | | |
| - | | |
$ | - | | |
$ | 676,780 | | |
$ | (659,024 | ) | |
$ | 17,789 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Cancellation of common stock upon settlement with former officer | |
| - | | |
| - | | |
| (1,845 | ) | |
| (1 | ) | |
| - | | |
| - | | |
| (222 | ) | |
| - | | |
| (223 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Equity compensation to officers, employees, and board of directors | |
| - | | |
| - | | |
| 79 | | |
| - | | |
| - | | |
| - | | |
| 463 | | |
| - | | |
| 463 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common shares for services | |
| - | | |
| - | | |
| 114 | | |
| - | | |
| - | | |
| - | | |
| 390 | | |
| - | | |
| 390 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,979 | ) | |
| (2,979 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2022 | |
| 96 | | |
$ | 1 | | |
| 30,694 | | |
$ | 31 | | |
| - | | |
$ | - | | |
$ | 677,411 | | |
$ | (662,003 | ) | |
$ | 15,440 | |
For The Six Months Ended June 30, 2022 (Unaudited) | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Preferred Shares | | |
Common Shares | | |
Common Shares Issuable | | |
Additional Paid in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, December 31, 2021 | |
| 96 | | |
$ | 1 | | |
| 32,062 | | |
$ | 32 | | |
| 327 | | |
$ | 1,113 | | |
$ | 674,348 | | |
$ | (653,584 | ) | |
$ | 21,910 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Cancellation of common stock upon settlement with former officer | |
| - | | |
| - | | |
| (1,845 | ) | |
| (1 | ) | |
| - | | |
| - | | |
| (222 | ) | |
| - | | |
| (223 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Cancellation of common stock | |
| - | | |
| - | | |
| (291 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common shares issued upon conversion of notes payable | |
| - | | |
| - | | |
| 327 | | |
| | | |
| (327 | ) | |
| (1,113 | ) | |
| 1,113 | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Equity compensation to officers, employees, and board of directors | |
| - | | |
| - | | |
| 164 | | |
| - | | |
| - | | |
| - | | |
| 910 | | |
| - | | |
| 910 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common shares for services | |
| - | | |
| - | | |
| 277 | | |
| - | | |
| - | | |
| - | | |
| 1,262 | | |
| - | | |
| 1,262 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (8,419 | ) | |
| (8,419 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2022 | |
| 96 | | |
$ | 1 | | |
| 30,694 | | |
$ | 31 | | |
| - | | |
$ | - | | |
$ | 677,411 | | |
$ | (662,003 | ) | |
$ | 15,440 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
GT
BIOPHARMA, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands)
| |
2023 | | |
2022 | |
| |
For The Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
(Unaudited) | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (2,219 | ) | |
$ | (8,419 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock based compensation - services | |
| 315 | | |
| 1,262 | |
Stock based compensation - officers, employees and board of directors | |
| 905 | | |
| 910 | |
Change in fair value of warrant liability | |
| (4,311 | ) | |
| (23 | ) |
Gain on extinguishment in settlement of vendor payable | |
| (547 | ) | |
| - | |
Change in operating lease right-of-use assets | |
| 51 | | |
| 46 | |
Unrealized (gain) loss on marketable securities | |
| (38 | ) | |
| 30 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
(Increase) decrease in prepaid expenses | |
| 5 | | |
| (32 | ) |
Increase in deposits | |
| - | | |
| (9 | ) |
Increase (decrease) in accounts payable and accrued expenses | |
| 1,052 | | |
| (1,729 | ) |
(Decrease) in operating lease liability | |
| (54 | ) | |
| (37 | ) |
Net Cash Used in Operating Activities | |
| (4,841 | ) | |
| (8,001 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES | |
| | | |
| | |
Sale (purchase) of investments | |
| (4,332 | ) | |
| 4,614 | |
Net Cash Provided by (Used in) Investing Activities | |
| (4,332 | ) | |
| 4,614 | |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES | |
| | | |
| | |
Proceeds from issuance of common stock and prefunded warrants | |
| 6,268 | | |
| - | |
Cancellation of common stock upon settlement with former officer | |
| - | | |
| (223 | ) |
Net Cash Provided by (Used in) Financing
Activities | |
| 6,268 | | |
| (223 | ) |
| |
| | | |
| | |
Net Decrease in Cash | |
| (2,905 | ) | |
| (3,610 | ) |
Cash at Beginning of Period | |
| 5,672 | | |
| 8,968 | |
Cash at End of Period | |
$ | 2,767 | | |
$ | 5,358 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid during the year for: | |
| | | |
| | |
Interest | |
$ | - | | |
$ | - | |
Income taxes paid | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES | |
| | | |
| | |
Right-of-use assets exchanged for lease liabilities | |
$ | - | | |
$ | 260 | |
Initial recognition of fair value of warrant liability | |
$ | 5,831 | | |
$ | - | |
Fair value of common stock issued to a vendor to settle accounts payable | |
$ | 591 | | |
$ | - | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
GT
BIOPHARMA, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June
30, 2023 and 2022
(Unaudited, in thousands, except shares data)
Note
1 – Organization and Operations
In
1965, the corporate predecessor of GT Biopharma, Inc. (Company), Diagnostic Data, Inc. was incorporated in the State of California. Diagnostic
Data changed its incorporation to the State of Delaware in 1972 and changed its name to DDI Pharmaceuticals, Inc. in 1985. In 1994, DDI
Pharmaceuticals merged with International BioClinical, Inc. and Bioxytech S.A. and changed its name to OXIS International, Inc. In July
2017, the Company changed its name to GT Biopharma, Inc.
The
Company is a clinical stage biopharmaceutical company focused on the development and commercialization of novel immune-oncology products
based on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®) platforms.
The Company’s TriKE® and Dual Targeting TriKE® platforms generate proprietary therapeutics designed to harness and enhance
the cancer killing abilities of a patient’s own natural killer cells (NK cells).
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation and Principles of Consolidation
The
consolidated condensed financial statements include the accounts of the Company and its wholly-owned subsidiaries, Oxis Biotech, Inc.
and Georgetown Translational Pharmaceuticals, Inc. All intercompany transactions and balances have been eliminated in consolidation.
The
accompanying condensed consolidated financial statements are unaudited. These interim condensed consolidated financial statements have
been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable
rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information
and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant
to such rules and regulations. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with
the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, filed with the SEC on March 30, 2023 (the “2022 Annual Report”). The consolidated balance sheets
as of December 31, 2022 included herein, was derived from the audited consolidated financial statements as of that date.
In
the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to
fairly present the Company’s financial position and its results of operations for the interim periods reflected. Except as noted,
all adjustments contained herein are of a normal recurring nature. Results of operations for the fiscal periods presented herein are
not necessarily indicative of fiscal year-end results.
Liquidity
The
accompanying consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern.
Such assumptions contemplate the realization of assets and satisfaction of liabilities in the normal course of business. For the six
months ended June 30, 2023, the Company recorded a net loss of $2.2 million and used cash in operations of $4.8 million. As of June 30,
2023, the Company had a cash and short-term investments balance of $18.0 million, working capital of $13.2 million, and stockholders’
equity of $11.8 million. Management anticipates that the $18.0 million of cash and cash equivalents, and short-term investments are adequate
to satisfy the liquidity needs of the Company for at least one year from the date the Company’s condensed consolidated financial
statements for the six-month period ended June 30, 2023 were issued.
Historically,
the Company has financed its operations through public and private sales of common stock, issuance of preferred and common stock, issuance
of convertible debt instruments, and strategic collaborations. There can be no assurances that the Company will be able to secure additional
financing on acceptable terms. In the event the Company does not generate sufficient cash flows from investing and financing activities,
the Company will be forced to delay, reduce, or eliminate some or all of its discretionary spending, which could adversely affect the
Company’s business prospects, ability to meet long-term liquidity needs or ability to continue its operations.
COVID-19
The
global COVID-19 pandemic continues to present uncertainty and unforeseeable risks to our operations and business plans. The Company has
closely monitored recent developments, including the lifting of COVID-19 safety measures, the spread of new strains or variants of the
coronavirus (such as the Delta and Omicron variants), and supply chain, raw materials and labor shortages. Thus, the full impact of the
COVID-19 pandemic on the business and operations remains uncertain and will vary depending on the pandemic’s future impact on the
third parties with whom the Company does business, as well as any legal or regulatory consequences resulting therefrom. The Company has
been following the recommendations of health authorities to minimize exposure risk for its team members and may take further actions
that alter our operations, including any required by federal, state or local authorities, or that it determines are in the best interests
of its employees and other third parties with whom GT Biopharma does business.
Accounting
Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant
estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation
of equity instruments issued for services and realization of deferred tax assets. Actual results could differ from those estimates.
Cash
Equivalents and Short-Term Investments
The
Company considers highly liquid investments with maturities of three months or less at the date of acquisition as cash equivalents in
the accompanying condensed consolidated financial statements. Total cash equivalents, which consist of money market funds, totaled approximately
$2.4 million and $5.5 million at June 30, 2023 and December 31, 2022, respectively.
The
Company also invested its excess cash in commercial paper and corporate notes and bonds. Management generally determines the appropriate
classification of its investments at the time of purchase. We classify these investments as short-term investments as part of current
assets, based upon our ability and intent to use any and all of these investments as necessary to satisfy liquidity requirements that
may arise from our business. Investments are carried at fair value with the unrealized holding gains and losses reported in the accompanying
condensed consolidated statements of operations. Total short-term investments totaled approximately $15.2 million and $10.8 million at
June 30, 2023 and December 31, 2022, respectively.
Fair
Value of Financial Instruments
Financial
Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820-10 requires entities to disclose
the fair value of financial instruments, both assets and liabilities recognized and not recognized on the balance sheet for which it
is practicable to estimate fair value. ASC 820-10 defines the fair value of a financial instrument as the amount at which the instrument
could be exchanged in a current transaction between willing parties.
The
three levels of the fair value hierarchy are as follows:
|
Level
1 |
Valuations
based on unadjusted quoted prices in active markets for identical assets or liabilities that the entity has the ability to access. |
|
|
|
|
Level
2 |
Valuations
based on quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are
observable or can be corroborated by observable data for substantially the full term of the assets or liabilities. |
|
|
|
|
Level
3 |
Valuations
based on inputs that are unobservable, supported by little or no market activity and that are significant to the fair value of the
assets or liabilities. |
The
carrying amount of the Company’s warrant liability of $1.5 million and $19 at June 30, 2023 and December 31, 2022, respectively,
was based on Level 3 measurements.
The
carrying amounts of the Company’s other financial assets and liabilities such as cash, other current assets, accounts payable and
accrued expenses approximate their fair values because of the short maturity of these instruments.
Derivatives
and Liability-Classified Instruments
The
Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of
the specific terms of the warrants and the guidance provided by the FASB in ASC 480, Distinguishing Liabilities from Equity (ASC
480) and ASC 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants are freestanding
financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and meet all of the requirements
for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own stock and whether the
holders of the warrants could potentially require net cash settlement in a circumstance outside of the Company’s control,
among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at
the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. The fair value
of the warrant liability is determined using a Binomial valuation method at inception and on
subsequent valuation dates.
Stock-Based
Compensation
The
Company accounts for share-based awards to employees, nonemployees, and consultants in accordance with the provisions of ASC 718, Compensation-Stock
Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense
over the requisite service or vesting period.
The
Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the
Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free
interest rate. The Company estimates volatility using its own historical stock price volatility. The expected term of the instrument
is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published
federal funds rates.
Research
and Development Costs
Costs
incurred for research and development are expensed as incurred. The salaries, benefits, and overhead costs of personnel conducting research
and development of the Company’s products are included in research and development costs. Purchased materials that do not have
an alternative future use are also expensed.
Leases
The
Company accounts for its leases in accordance with the guidance of ASC 842, Leases. The Company determines whether a contract is, or
contains, a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term,
and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and
lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease
term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present
value of unpaid lease payments (see Note 8 – Operating Leases for the Company’s lease disclosures).
Net
Loss Per Share
Basic
loss per share is computed using the weighted-average number of common shares outstanding during the period. Common stock issuable is
included in our calculation as of the date of the underlying agreement. Diluted loss per share is computed using the weighted-average
number of common shares and the dilutive effect of contingent shares outstanding during the period. Potentially dilutive contingent shares,
which primarily consist of stock issuable for the exercise of stock options and warrants, have been excluded from the diluted loss per
share calculation because their effect is anti-dilutive.
These
following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive:
Schedule
of Anti-dilutive Securities
| |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | |
Options to purchase common stock | |
| 3,737,952 | | |
| 302,500 | |
Warrants to purchase common stock | |
| 9,148,880 | | |
| 2,337,274 | |
Unvested restricted common stock | |
| - | | |
| 488,429 | |
Total anti-dilutive securities | |
| 12,886,832 | | |
| 3,128,203 | |
Concentration
Cash
is deposited in one financial institution. The balances held at this financial institution at times may be in excess of Federal Deposit
Insurance Corporation (“FDIC”) insurance limits of up to $250.
From time to time, however, the Company may be exposed to risk for the amounts of funds held in bank accounts in excess of the FDIC limit.
To minimize the risk, the Company’s policy is to maintain cash balances with high quality financial institutions.
The
Company has a significant concentration of expenses incurred and accounts payable from a single vendor (see Note 4 – Accounts Payable for further information).
Segments
The
Company determined its reporting units in accordance with ASC 280, “Segment Reporting” (“ASC 280”). Management
evaluates a reporting unit by first identifying its’ operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated.
Management
has determined that the Company has one consolidated operating segment. The Company’s reporting segment reflects the manner in
which its chief operating decision maker reviews results and allocates resources. The Company’s reporting segment meets the definition
of an operating segment and does not include the aggregation of multiple operating segments.
Recent
Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Credit Losses – Measurement of Credit
Losses on Financial Instruments (“ASC 326”). ASU 2016-13 requires entities to use a forward-looking approach based on
current expected credit losses (“CECL”) to estimate credit losses on certain types of financial instruments, including trade
receivables. This may result in the earlier recognition of allowances for losses. ASU 2016-13 is effective for the Company beginning
January 1, 2023, and early adoption is permitted. The Company adopted this standard effective January 1, 2023 and there was no material impact of adopting this standard
on the Company’s financial statements and related disclosures.
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock
Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU 2021-04 provides clarification
and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options
(such as warrants) that remain equity classified after modification or exchange. An issuer measures the effect of a modification or exchange
as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification
or exchange. ASU 2021-04 introduces a recognition model that comprises four categories of transactions and the corresponding accounting
treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and
debt origination or modification). ASU 2021-04 was effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years, applied prospectively to modifications or exchanges occurring on or after the effective date. Effective January
1, 2022, we adopted ASU 2021-04 using a prospective approach. It did not have a material impact on the Company’s financial statements
or disclosures.
Other
recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public
Accountants, and the SEC did not or are not believed by management to have a material impact on the Company’s present or future
consolidated financial statements.
Note
3 – Fair Value of Financial Instruments
The
estimated fair values of financial instruments outstanding were as follow:
Schedule
of Estimated Fair Value of Financial Instrument
| |
June 30, 2023 (Unaudited) | |
| |
| | |
Unrealized | | |
Unrealized | | |
Fair | |
| |
Cost | | |
Gains | | |
Losses | | |
Value | |
Short-term investments | |
$ | 15,168 | | |
$ | 38 | | |
$ | — | | |
$ | 15,206 | |
Total | |
$ | 15,168 | | |
$ | 38 | | |
$ | — | | |
$ | 15,206 | |
| |
December 31, 2022 | |
| |
| | |
Unrealized | | |
Unrealized | | |
Fair | |
| |
Cost | | |
Gains | | |
Losses | | |
Value | |
Short-term investments | |
$ | 10,866 | | |
$ | — | | |
$ | (30 | ) | |
$ | 10,836 | |
Total | |
$ | 10,866 | | |
$ | — | | |
$ | (30 | ) | |
$ | 10,836 | |
The
following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments):
Schedule of Fair Value Hierarchy Financial Assets
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2023 (Unaudited) | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Money market funds | |
$ | 2,364 | | |
$ | 2,364 | | |
$ | — | | |
$ | — | |
Corporate notes and commercial paper | |
| 15,206 | | |
| 15,206 | | |
| — | | |
| — | |
Total financial assets | |
$ | 17,570 | | |
$ | 17,570 | | |
$ | — | | |
$ | — | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2022 | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Money market funds | |
$ | 5,505 | | |
$ | 5,505 | | |
$ | — | | |
$ | — | |
Corporate notes and commercial paper | |
| 10,836 | | |
| 10,836 | | |
| — | | |
| — | |
Total financial assets | |
$ | 16,341 | | |
$ | 16,341 | | |
$ | — | | |
$ | — | |
As
of June 30, 2023, the fair value of the warrant liability amounted to $1,492. The details of warrant liability transactions for the
three and six months ended June 30, 2023 and 2022, are as follows:
Schedule of Derivative Liability Transactions
| |
June 30, 2023 | | |
June 30, 2022 | | |
June 30, 2023 | | |
June 30, 2022 | |
| |
Three Months Ending | | |
Six Months Ending | |
| |
June 30, 2023 | | |
June 30, 2022 | | |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | |
Beginning balance | |
$ | 2,925 | | |
$ | 120 | | |
$ | 19 | | |
$ | 138 | |
Fair value upon issuance of warrants | |
| — | | |
| — | | |
| 5,830 | | |
| — | |
Change in fair value | |
$ | (1,433 | ) | |
$ | (5 | ) | |
$ | (4,357 | ) | |
$ | (23 | ) |
Ending balance | |
$ | 1,492 | | |
$ | 115 | | |
$ | 1,492 | | |
$ | 115 | |
Note
4 – Accounts Payable
Accounts
payable consisted of the following:
Schedule of Accounts Payable
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
Accounts payable to a third-party manufacturer | |
$ | 2,910 | | |
$ | 2,283 | |
Other accounts payable | |
| 591 | | |
| 857 | |
Total accounts payable | |
$ | 3,501 | | |
$ | 3,140 | |
The
Company relies on a third-party contract manufacturing operation to produce and/or test our compounds used in our potential product candidates.
In
October 2020, the Company entered into a Master Services Agreement with a third-party product manufacturer to perform biologic development
and manufacturing services on behalf of the Company. Associated with this, the Company has subsequently executed a number of Statements
of Work for the research and development of products for use in clinical trials.
On
August 24, 2022, existing agreements with the third-party product manufacturer were amended. As part of the amendment, the third-party
manufacturer agreed that services to be rendered in future periods, will be paid or settled at the Company’s discretion, in a combination
of cash and issuance of the Company’s common stock. The amendment also eliminated future financial commitments of the Company.
The outstanding balance payable to the third-party product manufacturer
totaled $2.9 million and $2.3 million at June 30, 2023 and December 31, 2022, respectively.
The
Company recorded $2.1 million and $3.7 million in research and development expenses to account for services rendered by the third-party
product manufacturer for the three months and six months ended June 30, 2023, as compared to $1.1 million and $3.2 million for the same
comparable periods in 2022. In addition, the Company paid cash of $1.1 million and issued 1.3 million shares of its common stock with
a fair value of $591 in settlement of accounts payable of $1.1 million, which resulted in a gain of on settlement of $547, during
the six months ended June 30, 2023.
The
outstanding accounts payable balance due to the third-party product manufacturer totaled $2.9 million and $2.3 million as of June 30,
2023 and December 31, 2022, respectively.
Note
5 – Warrant Liability
2023
Warrants
On
January 4, 2023, as part of the private placement offering, the Company issued common stock, warrants to purchase up to an aggregate
of 6,500,000
shares of the Company’s common stock (the “Common Warrants”), and placement agent warrants to purchase up to 390,000
shares of the Company’s common stock (the “Placement Agents Warrants”) see Note 6 – Stockholders’
Equity.
The
Purchase Warrant provides for a value calculation for the Purchase Warrant using the Black Scholes model in the event of certain fundamental
transactions. The fair value calculation provides for a floor on the volatility amount utilized in the value calculation at 100%
or greater. The Company has determined this provision introduces leverage to the holders of the Purchase Warrant that could result in
a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Therefore,
pursuant to ASC 815, the Company has classified the Purchase Warrant as a liability in its consolidated balance sheet. The classification
of the Purchase Warrant, including whether the Purchase Warrant should be recorded as liability or as equity, is evaluated at the end
of each reporting period with changes in the fair value reported in other income (expense) in the consolidated statements of operations
and comprehensive loss. The Purchase Warrant was initially recorded at a fair value at $5.8
million at the grant date and is re-valued at
each reporting date. Upon the closing of placement, the fair value of the Purchase Warrant liability was recorded as a cost of capital.
As of June 30, 2023, the fair value of the warrant liability was $1.5 million.
All
changes in the fair value of the warrant liabilities are recognized as a change in fair value of warrant liability in the Company’s
condensed consolidated statements of operations until they are either exercised or expire.
The
warrant liabilities for the Common Warrants and the Placement Agents Warrants were valued using a Binomial pricing model with the following
weighted average assumptions:
Schedule of Derivative Liabilities Assumptions
| |
Common Warrants and Placement
Agents Warrants | |
| |
June 30, 2023 | | |
At Inception | |
| |
(Unaudited) | | |
(Unaudited) | |
Stock price | |
$ | 0.31 | | |
$ | 1.20 | |
Risk-free interest rate | |
| 4.13 | % | |
| 3.60 | % |
Expected volatility | |
| 119.7 | % | |
| 121.5 | % |
Expected life (in years) | |
| 5.0
– 4.5 | | |
| 5.0 | |
Expected dividend yield | |
| - | | |
| - | |
Fair value of warrants (in thousands) | |
$ | 1,535 | | |
$ | 5,831 | |
2020
Warrants
The
Company issued certain warrants during the year ended December 31, 2020 that contained a fundamental transaction provision that could
give rise to an obligation to pay cash to the warrant holder upon occurrence of certain change in control type events. In accordance
with ASC 480, the fair value of these warrants is classified as a liability in the Condensed Consolidated Balance Sheets and will be
re-measured at the end of every reporting period with the change in value reported in the Condensed Consolidated Statements of Operations.
The
warrant liabilities for the 2020 Warrants were valued using a Binomial pricing model with the following assumptions:
Schedule of Derivative Liabilities Assumptions
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
Stock price | |
$ | 0.31 | | |
$ | 0.89 | |
Risk-free interest rate | |
| 4.87 | % | |
| 4.22 | % |
Expected volatility | |
| 91 | % | |
| 109 | % |
Expected life (in years) | |
| 2.1 | | |
| 2.6 | |
Expected dividend yield | |
| - | | |
| - | |
| |
| | | |
| | |
Fair value of warrants | |
$ | 3 | | |
$ | 19 | |
During
the three months and six months ended June 30, 2023, the Company recognized a gain of $1.4 million and $4.4 million to account for the
change in fair value of the warrant liability between the reporting periods in accordance with ASC 842. During the three months and
six months ended June 30, 2022, the Company recognized a gain of $5 and $23 to account for the change in the fair value of the
warrant liability.
The
risk-free interest rate was based on rates established by the Federal Reserve Bank. The Company uses the historical volatility of its
common stock to estimate the future volatility for its common stock. The expected life of the warrant securities was determined by
the remaining contractual life of the warrant instrument. For derivative instruments that already matured, the Company used the estimated
life. The expected dividend yield was based on the fact that the Company has not paid dividends to its common stockholders in the past
and does not expect to pay dividends to its common stockholders in the future.
Note
6 – Stockholders’ Equity
The
Company’s authorized capital as of June 30, 2023 was 250,000,000 shares of common stock, par value $0.001 per share, and 15,000,000
shares of preferred stock, par value $0.01 per share.
Common
Stock
Private
Placement of Common Stock
On
January 4, 2023, GT Biopharma received gross proceeds of $6.5 million, before deducting placement agent fees and other offering expenses
of $232 in relation to a purchase agreement (the “Purchase Agreement”) signed on December 30, 2022, between the Company
and an institutional investor (the “Purchaser”) for the issuance and sale, in a registered direct offering (the “Offering”),
of 3,600,000 shares of the Company’s common stock, par value $0.001 per share (the “Shares”), pre-funded warrants to
purchase up to 2,900,000 shares of the Company’s common stock (the “Pre-Funded Warrants”), warrants to purchase up
to an aggregate of 6,500,000 shares of the Company’s common stock (the “Common Warrants”) and placement agent warrants
to purchase up to 390,000 of the Company’s common stock (the “Placement Agents Warrants”). The Common Warrants have
an exercise price equal to $1.00, will be exercisable commencing six months following issuance, and will have a term of exercise equal
to five years following the initial exercise date. The Pre-Funded Warrants have an exercise price of $0.0001 per Share, are immediately
exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in full. The
Placement Agents Warrants have an exercise price equal to $1.25, will be exercisable commencing six months following issuance, and will
have a term of exercise equal to five years following the initial exercise date. The Shares and Common Warrants were sold at an offering
price of $1.00 per Share and accompanying Common Warrant and the Pre-Funded Warrants and Common Warrants were sold at an offering price
of $0.9999 per Pre-Funded Warrant and accompanying Common Warrant.
The
Common Warrants and the Placement Agents Warrants contained a clause not considered to be within the Company’s control. The Company
determined that the provision represented a variable that is not an input to the fair value of a “fixed-for-fixed” option
as defined under ASC 815-40, and thus the Common Warrants and the Placement Agent Warrants are not considered indexed to the Company’s
own stock and not eligible for an exception from derivative accounting. Accordingly, the Common Warrants and the Placement Agent Warrants
were classified as a warrant liability, and $5.8 million of the initial common stock offering was classified as a warrant liability (see
Note 5 – Warrant Liability).
During
the three months ended June 30, 2023, the 2,900,000 Pre-Funded Warrants were exercised. The Company received cash consideration of $0.290
and issued 2,900,000 shares of common stock in exchange for the exercise price of $0.0001 per share.
Common
Stock Issuable
On
February 16, 2021, because of the mandatory conversion of the notes payable and accrued interest in the aggregate amount of $38.8 million,
the Company issued a total of 11,413,322 shares of common stock to the respective noteholders, of which 11,086,024 were already issued
as of December 31, 2021. The remaining 327,298 common shares issuable at December 31, 2021 valued at $1.1 million, were issued during
the three months ended March 31, 2022.
Cancellation
of Common Stock
The
Company cancelled 290,999 previously issued shares of common stock during the three months ended March 31, 2022.
Common
Stock Issued for Services
During
the three and six months ended June 30, 2023, and pursuant to the vesting term of a 2021 agreement, the Company issued 0 and 73,454 shares
of common stock with a fair value of $0 and $315, respectively to members of the Board of Directors, employees and consultants. The
shares were valued at the respective date of the agreements.
Common Stock Issued for Vendor Payable
During the six months ended June 30, 2023,
the Company issued a total of 1,343,783
shares of common stock with a fair value of $591
to settle a vendor payable of $1.1
million. As a result, the Company recorded a gain of $577
to account the difference between the fair value of the common stock issued and the account payable settled. The common stock issued
were valued at the respective date of their issuance.
Preferred
Stock
Series
C Preferred Stock
At
June 30, 2023 and December 31, 2022, there were 96,230 shares of series C preferred stock, par value $0.01 per share (the “Series
C Preferred Stock”) issued and outstanding.
As
a result of reverse stock splits in previous years and the agreement terms for adjusting the rights of the related shares, the 96,230
shares of Series C Preferred Stock are not currently convertible, have no voting rights, and in the event of liquidation, the holders
of the Series C Preferred Stock would not participate in any distribution of the assets or surplus funds of the Company. The holders
of Series C Preferred Stock also are not currently entitled to any dividends if and when declared by the Company’s board of directors
(the “Board”). No dividends to holders of the Series C Preferred Stock were issued or unpaid through June 30, 2023 and 2022,
respectively.
Series
K Preferred Stock
On
February 16, 2021, the Board designated 115,000 shares of Series K preferred stock, par value $.01. (the “Series K Preferred Stock”).
Shares
of the Series K Preferred Stock are convertible at any time, at the option of the holders, into shares of the Company’s common
stock at an effective conversion rate of 100 shares of common stock for each share of Series K Preferred. Shares of the Series K Preferred
Stock have the same voting rights as the shares of the Company’s common stock, with the holders of the Series K Preferred Stock
entitled to vote on an as-converted-to-common stock basis, subject to the beneficial ownership limitation, together with the holders
of the Company’s common stock on all matters presented to the Company’s stockholders. The Series K Preferred Stock are not
entitled to any dividends (unless specifically declared by the Board) but will participate on an as-converted-to-common-stock basis in
any dividends to the holders of the Company’s common stock. In the event of the Company’s dissolution, liquidation or winding
up, the holders of the Series K Preferred Stock will be on parity with the holders of the Company’s common stock and will participate,
on an as-converted-to-common stock basis, in any distribution to holders of the Company’s common stock.
As
of June 30, 2023 and December 31, 2022, there were no shares of Series K Preferred stock issued and outstanding.
Warrants
and Options
Common
Stock Warrants
Common
stock warrant transactions for the six months ended June 30, 2023 were as follows:
Schedule of Warrant Activity
| |
Number of | | |
Weighted Average | |
| |
Warrants | | |
Exercise Price | |
Warrant outstanding at December 31, 2022: | |
| 2,337,274 | | |
$ | 5.30 | |
Granted | |
| 9,790,000 | | |
| 0.71 | |
Forfeited/canceled | |
| (78,394 | ) | |
| 3.40 | |
Exercised | |
| (2,900,000 | ) | |
| 0.0001 | |
Warrants outstanding at June 30, 2023 | |
| 9,148,880 | | |
$ | 2.11 | |
Warrants exercisable at June 30, 2023 | |
| 2,258,880 | | |
$ | 5.45 | |
The
warrants had an exercise price greater than the market price, which resulted in no intrinsic value.
Warrants
outstanding as of June 30, 2023 are exercisable as follows:
Schedule
of Warrants Outstanding
| | | |
| Warrants Outstanding | | |
| Warrants Exercisable | |
| Range of Exercise Price | | |
| Number Outstanding | | |
| Weighted Average Remaining Contractual Life (Years) | | |
| Weighted Average Exercise Price | | |
| Number Exercisable | | |
| Weighted Average Exercise Price | |
| $1.00 – 1.25 | | |
| 6,890,000 | | |
| 5.0 | | |
$ | 1.01 | | |
| - | | |
$ | - | |
| 3.40 – 5.50 | | |
| 2,258,880 | | |
| 2.6 | | |
| 5.45 | | |
| 2,258,880 | | |
| 5.45 | |
| | | |
| 9,148,880 | | |
| | | |
| | | |
| 2,258,880 | | |
| | |
Common
Stock Options
Common
stock option transactions for the six months ended June 30, 2023 were as follows:
Schedule
of Options Activity
| |
Number of | | |
Weighted Average | |
| |
Options | | |
Exercise Price | |
Options outstanding at December 31, 2022 | |
| 1,630,452 | | |
$ | 2.57 | |
Granted | |
| 2,500,000 | | |
| 0.75 | |
Forfeited/canceled | |
| (392,500 | ) | |
| 2.81 | |
Exercised | |
| - | | |
| - | |
Options outstanding at June 30, 2023 | |
| 3,737,952 | | |
$ | 1.32 | |
Options vested and exercisable at June 30, 2023 | |
| 2,177,891 | | |
$ | 1.71 | |
The
Company recognized the corresponding stock compensation expense for options granted to certain consultants, employees, officers and directors
based upon their vesting term.
On
January 27, 2023, the Company granted stock options to employees and members of its board of directors to purchase an aggregate of 2.0
million shares of common stock at an
exercise price of $0.85 per
share. The stock options expire in 10 years,
vest over twelve months and had a fair value of $1.4 million
at the date of grant determined using the Black-Scholes Option Pricing model with the following weighted average
assumptions.
On
May 15, 2023, the Company granted stock options to a member of its board of directors to purchase 500,000
shares of common stock at an exercise price of $0.35
per share. The stock options expire in 10
years, vest over twelve months and had a fair value of $150
on at the date of grant determined using the Black-Scholes Option Pricing model.
The
Company used the following weighted average assumptions in the Black-Scholes Option Pricing model to compute the fair value of the stock options granted during the period
ended June 30 ,2023.
Schedule
of Stock Granted Assumptions
Stock price | |
$ | $0.35 - $0.85 | |
Risk-free interest rate | |
| 3.62% - 3.99 | % |
Expected volatility | |
| 120.81% - 123.61 | % |
Expected life (in years) | |
| 5.3 | |
Expected dividend yield | |
| - | |
For
the three months and six months ended June 30, 2023, the Company recognized stock compensation expense relating to the vesting of options
granted in 2023 and prior years of $398 and $905, respectively.
Options
outstanding as of June 30, 2023 are exercisable as follows:
Schedule
of Options Outstanding
| | | |
| Options Outstanding | | |
| Options Exercisable |
| Range of Exercise Price | | |
| Number Outstanding | | |
| Weighted Average Remaining Contractual Life (Years) | | |
| Weighted Average Exercise Price | | |
| Number Exercisable | | |
| Weighted Average Exercise Price | |
$ | 2.48 | | |
| 1,237,952 | | |
| 9.0 | | |
$ | 2.48 | | |
| 1,154,081 | | |
$ | 2.48 | |
| 0.85 | | |
| 2,000,000 | | |
| 9.6 | | |
| 0.85 | | |
| 1,000,000 | | |
| 0.85 | |
| 0.35 | | |
| 500,000 | | |
| 9.9 | | |
| 0.35 | | |
| 23,810 | | |
| 0.35 | |
| | | |
| 3,737,952 | | |
| | | |
| | | |
| 2,177,891 | | |
| | |
At
June 30, 2023, fair value of unvested options totaled $1.1
million, which will be recognized as stock compensation
expense in future periods based upon the remaining vesting term of the applicable grants.
There
was no intrinsic value of the outstanding options as of June 30, 2023 as the exercise price of these options was greater than the market
price.
Note
7 – Commitments and Contingencies
Litigation
The
Company is involved in certain legal proceedings that arise from time to time in the ordinary course of our business. Except for income
tax contingencies, we record accruals for contingencies to the extent that our management concludes that the occurrence is probable and
that the related amounts of loss can be reasonably estimated. Legal expenses associated with the contingency are expensed as incurred.
There is no current or pending litigation of any significance with the exception of the matters that have arisen under, and are being
handled in, the normal course of business.
On
May 11, 2023, our former interim Chief Executive Officer, Dr. Greg Berk, filed a complaint with the Occupational Safety and Health Administration
alleging retaliation against him during his tenure at the Company for raising concerns related to the public disclosure of certain product
timelines. The Company is vigorously defending this matter and believe it to be without merit. At this early stage in the proceedings,
the Company is not able to determine the probability of the outcome of this matter or a range of reasonably expected losses, if any.
On
May 13, 2022, the Company made a claim against Michael Handelman, its former Chief Financial Officer, asserting that he misappropriated
Company funds and shares of common stock, and failed to file the required SEC reports on Form 3 and Form 4 regarding each acquisition
and disposition of the Company’s common stock. The Company seeks monetary damages estimated at $370; the return of shares of
our common stock received without authorization and the disgorgement of any profits earned from the sale of those shares; a full accounting
for all sums charged on the Company’s debit card, with payment to the Company for any charges that cannot be demonstrated to have
a corporate purpose; an order directing Mr. Handelman to make all filings required by Section 16(a) of the 1934 Act; an award of all
sums and shares improperly issued to members of Mr. Handelman’s family; and an award of the Company’s attorneys’ fees
and any forum and arbitration fees. As a component of Mr. Handelman’s contract with the Company, disputes shall be fully addressed
and finally resolved by binding arbitration conducted by the American Arbitration Association (AAA) in New York City, New York, in accordance
with its National Employment Dispute Resolution rules. In connection with any such arbitration, the Company shall bear all costs not
otherwise borne by a plaintiff in a court proceeding. The Company agrees that any decisions of the arbitration panel will be binding
and enforceable in any state in which the Company conducts the operation of its business. In accordance with California Labor Laws, the
Company has designated Los Angeles, California as the venue for this arbitration. The claims are pending before an arbitrator in Los
Angeles and the hearing is scheduled to begin on October 26, 2023. Mr. Handelman has not asserted counterclaims against the Company.
On
May 24, 2023, TWF Global, LLC (“TWF”) filed a Complaint in the California Superior Court for the County of Los Angeles naming
the Company as defendant. The Complaint alleges that TWF is the holder of two convertible notes and that the Company did not deliver
shares of common stock due on conversion in February 2021. TWF is seeking per diem liquidated damages based on the terms of alleged
convertible notes. The Company filed a motion to dismiss for improper forum on July 14, 2023 because the convertible notes
require disputes to be filed in New York state and federal courts. The Company believes that TWF’s claims are without merit
and will continue to defend vigorously against these claims.
Significant
Agreements
Research
and Development Agreements
In
June 2017, we entered into a co-development partnership agreement with Altor BioScience Corporation in which we will collaborate exclusively
in the clinical development of a novel 161533 (GTB-3550) TriKE® fusion protein for cancer therapies using our TriKE®
technology. The GTB-3550 Phase 1 clinical trial for treatment of patients with CD33-expressing, high risk myelodysplastic syndromes
and refractory/relapsed acute myeloid leukemia opened for patient enrollment September 2019 and completed enrollment in September 2021.
The results of our first generation GTB-3550 Phase 1 clinical trial support our plans to advance the next generation camelid nanobody
into the clinic, and as such, no further clinical development will ensue with GTB-3550.
The
Company is a party to a scientific research agreement with the Regents of the University of Minnesota, effective June 16, 2021. This
scientific research agreement aims to work with the Company with three major goals in mind: (1) support the Company’s TriKE®
product development and GMP manufacturing efforts; (2) TriKE® pharmacokinetics optimization in humans; and (3) investigation
of the patient’s native NK cell population based on insights obtained from the analysis of the human data generated during our
GTB-3550 clinical trial. The major deliverables proposed here are: (1) creation of IND enabling data for TriKE® constructs
in support of our product development and GMP manufacturing efforts; (2) TriKE® platform drug delivery changes to allow
transition to alternative drug delivery means and extended PK in humans; and (3) gain an increased understanding of changes in the patient’s
native NK cell population as a result of TriKE® therapy. Most studies will use TriKE® DNA/amino acid sequences
created by us under current UMN/GTB licensing terms. This agreement expired on June 30, 2023. The University of Minnesota shall use reasonable
efforts to complete the project for a fixed sum of $2.1 million.
For
the three months and six months ended June 30, 2023 and June 30, 2022, the Company recorded an expense of $192 and
$383,
respectively, for each respective period. The Company has recorded expense in the aggregate of $2.1 million
as of June 30, 2023 pursuant to this agreement.
Patent
and License Agreements
2016
Exclusive Patent License Agreement
The
Company is party to an exclusive worldwide license agreement with the Regents of the University of Minnesota, (“UofMN”),
to further develop and commercialize cancer therapies using TriKE® technology developed by researchers at the UofMN to
target NK cells to cancer. Under the terms of the 2016 agreement, the Company receives exclusive rights to conduct research and to develop,
make, use, sell, and import TriKE® technology worldwide for the treatment of any disease, state, or condition in humans.
The Company is responsible for obtaining all permits, licenses, authorizations, registrations, and regulatory approvals required or granted
by any governmental authority anywhere in the world that is responsible for the regulation of products such as the TriKE®
technology, including without limitation the FDA and the European Agency for the Evaluation of Medicinal Products in the European Union.
Under the agreement, the UofMN received an upfront payment of $200, and an annual License Maintenance fee of $100 beginning in
2021. The agreement also includes 4% royalty fees, not to exceed 6% under subsequence license agreements or amendments to this agreement
or minimum annual royalty payments ranging from $250 to $5.0 million. The agreement also includes certain performance milestone payments
totaling $3.1 million, and one-time sales milestone payments of $1.0 million upon reaching $250 million in gross sales, and $5.0 million
upon reaching $500 million dollars in cumulative gross sales of Licensed Products.
The
Company did not incur any research and development expense relating to the 2016 Exclusive Patent License Agreement for the three months
and six months ended June 30, 2023.
2021
Patent License Agreement
On
March 26, 2021, the Company signed an agreement specific to the B7H3 targeted TriKE®. Under the agreement, the UofMN received
an upfront license fee of $20,000 and will receive an annual License Maintenance fee of $5 beginning in 2022, 2.5% to 5% royalty
fees, or minimum annual royalty payments of $250 beginning in the year after the first commercial sales of Licensed Product, and
$2.0 million beginning in the fifth year after the first commercial sale of such Licensed Product. The agreement also includes certain
performance milestone payments totaling $3.1 million, and one-time sales milestone payments of $1.0 million upon reaching $250 million
in gross sales, and $5.0 million upon reaching $500 million dollars in cumulative gross sales of Licensed Products. There is no double
payment intended; if one of the milestone payments has been paid under the 2016 agreement no further payment is due for the corresponding
milestone above.
The
Company did not incur any research and development expense relating to the 2021 Patent License Agreement for the three months and six
months ended June 30, 2023.
Note
8 – Operating Leases
On
November 19, 2021, the Company entered into a sublease with a third party for 4,500 square feet of office space located in Brisbane,
California, with a commencement date of January 1, 2022 and maturing on June 30, 2024. Leases with an initial term of 12 months or less
are not recorded on the balance sheet. The Company accounts for the lease and non-lease components of its leases as a single lease component.
Rent expense is recognized on a straight-line basis over the lease term. As a result of this agreement, the Company recognized right-of-use
(“ROU”) asset and liability of $247 pursuant to ASC 842, Leases. Operating lease ROU assets and liabilities are recognized
at the lease commencement date based on the present value of lease payments over the lease term. ROU assets represent the Company’s
right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments
arising from the lease. Generally, the implicit rate of interest in arrangements is not readily determinable and the Company utilizes
its incremental borrowing rate in determining the present value of lease payments. The Company’s incremental borrowing rate is
a hypothetical collateralized borrowing rate based on its understanding of what its credit rating would be. The operating lease ROU asset
includes any lease payments made and excludes lease incentives.
On
February 8, 2022, the Company entered into a copier lease which will end on February 7, 2025. As a result, the Company recognized
additional ROU asset and liability of $13.
As
a result of these lease agreements, the Company recognized ROU asset and liability in the aggregate of $260.
Rent
expense related to these leases reflected on the Company’s Condensed Consolidated Statements of Operations totaled $29 and
$58 for the three months and six months ended June 2023. Rent expense totaled $29 and $58 for the three months and six months
ended June 2022.
Other
information related to leases and future minimum lease payments under non-cancellable operating leases were as follows:
Schedule of Other Information Related Leases Under Non-Cancellable
| |
June 30, 2023
| | |
June 30, 2022
| |
| |
(Unaudited) | | |
(Unaudited) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 30 | | |
$ | 49 | |
Right-of-use assets obtained in exchange for lease liabilities: | |
| | | |
| | |
Operating leases | |
$ | 114 | | |
$ | 165 | |
Weighted-average remaining lease term (in years): | |
| | | |
| | |
Operating leases | |
| 1.25 | | |
| 2.25 | |
Weighted-average discount rate: | |
| | | |
| | |
Operating leases | |
| 10 | % | |
| 10 | % |
Future
minimum lease payments under non-cancellable operating leases were as follows:
Schedule of Future Minimum Lease Payments
| |
June 30, 2023
| |
| |
(Unaudited) | |
Within one year | |
$ | 153 | |
After one year and within two years | |
| 3 | |
Thereafter | |
| - | |
Total future minimum lease payments | |
$ | 156 | |
Less – discount | |
| (36 | ) |
Lease liability | |
$ | 120 | |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. CAUTIONARY NOTICE REGARDING FORWARD-LOOKING
STATEMENTS
Some
of the statements in this Quarterly Report on Form 10-Q are “forward-looking statements” within the meaning of the safe harbor
from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding
our current beliefs, goals and expectations about matters such as our expected financial position and operating results, our business
strategy and our financing plans. The forward-looking statements in this report are not based on historical facts, but rather reflect
the current expectations of our management concerning future results and events. The forward-looking statements generally can be identified
by the use of terms such as “believe,” “expect,” “anticipate,” “intend,” “plan,”
“foresee,” “may,” “guidance,” “estimate,” “potential,” “outlook,”
“target,” “forecast,” “likely” or other similar words or phrases. Similarly, statements that describe
our objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause our actual results, performance or achievements to be different from any future results,
performance and achievements expressed or implied by these statements. We cannot guarantee that our forward-looking statements will turn
out to be correct or that our beliefs and goals will not change. Our actual results could be very different from and worse than our expectations
for various reasons. You should review carefully all information, including the discussion of risk factors under “Part I. Item
1A: Risk Factors” and “Part II. Item 7: Management’s Discussion and Analysis of Financial Condition and Results of
Operations” of the Form 10-K for the year ended December 31, 2022. Any forward-looking statements in the Form 10-Q are made only
as of the date hereof and, except as may be required by law, we do not have any obligation to publicly update any forward-looking statements
contained in this Form 10-Q to reflect subsequent events or circumstances.
Throughout
this Quarterly Report on Form 10-Q, the terms “GTBP,” “we,” “us,” “our,” “the Company”
and “our Company” refer to GT Biopharma, Inc., a Delaware corporation, formerly known as Oxis International, Inc., DDI Pharmaceuticals,
Inc. and Diagnostic Data, Inc., together with our subsidiaries.
Overview
We
are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based
on our proprietary Tri-specific Killer Engager (“TriKE®”) fusion protein immune cell engager technology platform.
Our TriKE® platform generates proprietary therapeutics designed to harness and enhance the cancer killing abilities of
a patient’s own natural killer cells (“NK cells”). Once bound to an NK cell, our moieties are designed to enhance the
NK cell, through induction of NK cell expansion and priming via the cytokine portion, and precisely direct it to one or more specifically
targeted proteins expressed on a specific type of cancer cell or virus infected cell, ultimately resulting in the targeted cell’s
death. TriKE® can be designed to target any number of tumor antigens on hematologic malignancies or solid tumors and do
not require patient-specific customization.
We
are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic
malignancies and solid tumors. The platform is scalable, and we are putting processes in place to be able to produce investigational
new drug (IND) ready moieties in a timely manner after a specific TriKE® conceptual design. Specific drug candidates can
then be advanced into the clinic on our own or through potential collaborations with partnering companies. We believe our TriKE®
may have the ability, if approved for marketing, to be used as both a monotherapy and in combination with other standard-of-care
therapies including combinations with off-the-shelf NK cell infusions.
Our
initial work has been conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by
Dr. Jeffrey Miller, the Deputy Director. Dr. Miller is a recognized key opinion leader in the field of NK cell and IL-15 biology and
their therapeutic potential. We have exclusive rights to the TriKE® platform and are generating additional intellectual
property for specific moieties.
GTB-3550
GTB-3550
was our first TriKE® product candidate. It reflected our first-generation TriKE® platform. It is a single-chain, tri-specific
scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies
and a modified form of IL-15. We studied this anti-CD16-IL-15-anti-CD33 TriKE® in CD33 positive leukemias, a marker expressed on
tumor cells in acute myelogenous leukemia, or AML, and myelodysplastic syndrome, or MDS. CD33 is primarily a myeloid differentiation
antigen with endocytic properties broadly expressed on AML blasts and, possibly, some leukemic stem cells. CD33 or Siglec-3 (sialic acid
binding immunoglobulig-like lectin 3) is a transmembrane receptor expressed on cells of myeloid lineage. It is usually considered myeloid-specific,
but it can also be found on some lymphoid cells. The anti-CD33 antibody fragment used for these studies was derived from the M195 humanized
anti-CD33 scFv and has been used in multiple human clinical studies. It has been exploited as a target for therapeutic antibodies for
many years. The approval of the CD33 antibody-drug conjugate gemtuzumab validates this targeted approach.
GTB-3550
is being replaced by a more potent next-generation camelid nanobody TriKE®, GTB-3650, targeting relapsed/refractory Acute Myeloid
Leukemia (AML) and high-risk Myelodysplastic Syndromes (MDS).
GTB-3650
GTB-3650
is a CD33 targeted TriKE® which targets CD33 on the surface of myeloid leukemias and an agonistic camelid engager to the potent activating
receptor on NK cells, CD16. Use of this engager enhances the activity of wild type IL-15 included in GTB-3650, no longer needing the
mutant IL-15 included in GTB-3550. We are advancing GTB-3650 through preclinical studies and anticipate filing an Investigational New
Drug (IND) application in the 2nd half of 2023. The only curative therapy for AML and MDS is transplant, and relapse still
occurs in many patients that undergo transplants so novel immunotherapeutic approaches that can be leveraged in this setting are highly
desirable. It is also important to note that elderly frail patients cannot receive transplants and thus alternative approaches are needed.
The TriKE® approach provides a novel way to specifically target these tumors by leveraging NK cells, which have been shown to mediate
relapse protection in this setting, in an anti-CD33-targeted fashion. We are moving GTB-3650 clinically based on pre-clinical data showing
a marked increase in potency compared to GTB-3550, which we anticipate could lead to an enhanced efficacy signal in these diseases.
GTB-5550
GTB-5550
is a B7-H3 targeted TriKE® which targets B7-H3 on the surface of advanced solid tumors. We are advancing GTB-5550 through preclinical
studies and have initiated a GMP manufacturing campaign in anticipation of filing an IND and starting a study targeting patients with
B7-H3 positive solid tumors thereafter. B7-H3 expression is expressed in a number of solid tumor settings as well as in multiple myeloma
and is not expressed on normal tissues, making it an exciting pan-cancer tumor target. Expression of B7-H3 is also associated with disease
progression and bad outcomes in many cancers. Due to these characteristics several clinical trials are ongoing leveraging targeting of
B7-H3 in solid tumor. GTB-5550 would be the first modality to target B7-H3 through NK cell immunotherapy and a unique single domain camelid
B7-H3. The initial study will be designed as a basket trial, targeting solid tumor malignancies with high expression of B7-H3, including
prostate cancer, ovarian cancer, head and neck cancer, lung cancer, and breast cancer.
Economic
Disruption
While
we make our strategic planning decisions based on the assumption that the markets we are targeting will grow in the long term, our business
is dependent, in large part on, and directly affected by, business cycles and other factors affecting the economy generally. Our industry
depends on general economic conditions and other factors, including consumer spending and preferences, changes in inflation rates, supply
chain issues and impediments should they arise for us, as the U.S. and various other major economies are now experiencing, consumer confidence,
fuel costs, fuel availability, environmental impact, governmental incentives and regulatory requirements, and political volatility, especially
in cybersecurity growth markets.
In
addition, the outbreak of hostilities between Russia and Ukraine and global reactions thereto have increased U.S. domestic and global
energy prices. Oil supply disruptions related to the Russia-Ukraine conflict, and sanctions and other measures taken by the U.S. and
its allies, could lead to higher costs for gas, food, and goods in the U.S. and other geographies and exacerbate the inflationary pressures
on the worldwide economy, with potentially adverse impacts on our business, results of operations and financial condition.
Results
of Operations
Comparison
of the Three Months and Six Months Ended June 30, 2023 and 2022
Research
and Development Expenses (“R&D”)
We
recorded $2.1 million and $1.1 million in research and development expense (“R&D”) for the three months ended June 30,
2023 and 2022, an increase of $1.0 million over the prior year comparable period. We recorded $3.7 million and $3.2 million in R&D
for the six months ended June 30, 2023 and 2022, an increase of $0.5 million over the prior year comparable period. R&D expenses
relate to our continued development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with
the progression on other promising candidates.
Selling, General and Administrative Expenses
(“S,G&A”)
We
recorded $1.5 million and $1.9 million in selling, general and administrative expense (“SG&A”) for the three months
ended June 30, 2023 and 2022, a decrease of $0.4 million over the prior year comparable period. We recorded $3.5 million and $5.2
million in SG&A for the six months ended June 30, 2023 and 2022, a decrease of $1.7 million over the prior year comparable
period. The decrease in SG&A is primarily attributable to decreases in advisory board fees, investor relations expense, legal and
professional fees, and payroll expense.
Interest
Income
We
recorded interest income of $220 and $36 for the three months ended June 30, 2023 and 2022, and $384 and $44 for the
six months ended June 30, 2023 and 2022, respectively. The increase in interest income is due to higher interest rates offered by financial
institutions in the three months and six months ended June 30, 2023 as compared to the same comparable periods of 2022.
Interest
Expense
We
recorded interest expense of $1 and $0 for the three months ended June 30, 2023 and 2022, and $213 and $0 for the six months
ended June 30, 2023 and 2022, respectively. The increase in interest expense is due to the financing costs incurred associated with warrants
accounted as warrant liability sold during the current year, with no comparable costs in the prior year.
Change in Fair Value of Warrant Liability
We
recorded a gain of $1.4 million and $5 for the three months ended June 30, 2023 and 2022, and $4.4 million and $23 for the six
months ended June 30, 2023 and 2022, respectively. The gain was recorded as a result of a change in fair value of warrant liability for
the three months and six months ended June 30, 2023 as compared to the same comparable periods of 2022.
Gain on Extinguishment of Debt
We
recorded $14 and $0 gain on extinguishment of debt for the three months ended June 30, 2023 and 2022, respectively, and a gain of
$547 and $0 for the six months ended June 30, 2023 and 2022, respectively. The gain in the six months ended June 30, 2023 was as
a result of share settlement of a greater amount of vendor accounts payable than the fair value of the shares on the date of
settlement.
Unrealized Gain or Loss on Marketable Securities
We
recorded unrealized gains on marketable securities of $9 and $38 for the three months and six months ended June 30, 2023,
respectively, compared to unrealized losses of $6 and $30 for the three and six months ended June 30, 2022, respectively. This
resulted from an improved mix of investments combined with higher interest rates for the three months and six months ended June 30,
2023 as compared to prior year comparable periods of 2022.
As
a result of the above increases to other income, the Company recorded a net loss of $2.0 million and $2.2 million for the three
months and six months ended June 30, 2023, as compared to a net loss of $3.0 million and $8.4 million for the same comparable
periods in 2022.
Liquidity
and Capital Resources
The
Company’s current operations have focused on business planning, raising capital, establishing an intellectual property
portfolio, hiring, and conducting preclinical studies. On January 4, 2023, the Company raised $6.5 million from an institutional
investor by selling 3.6 million shares of common stock, and pre-funded warrants to purchase up to 2.9 million shares of common
stock. The Company does not have any product candidates approved for sale and has not generated any revenue from its product sales.
The Company has sustained operating losses since inception and expects such losses to continue into the foreseeable future. We
anticipate that cash utilized in the twelve months following this filing date for selling, general and administrative expenses will
range between $3.0 million and $4.0 million, and research and development expenses will range between $10.0 million and $12.0
million.
The
Company reported cash and cash equivalents of $2.8 million and short-term investments of $15.2 million as of June 30, 2023. Management
believes that the Company has sufficient cash and cash equivalents, and short-term investments to funds its operations for more than
twelve months from the date of this filing.
Management
is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include but are
not limited to: public offerings of equity and/or debt securities, payments from potential strategic research and development, licensing
and/or marketing arrangements with pharmaceutical companies.
Critical
Accounting Policies
We
consider the following accounting policies to be critical given they involve estimates and judgments made by management and are important
for our investors’ understanding of our operating results and financial condition.
Basis
of Presentation and Principles of Consolidation
The
accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“GAAP”). These condensed consolidated financial statements include the accounts of the Company and
its wholly owned subsidiaries, Oxis Biotech, Inc. and Georgetown Translational Pharmaceuticals, Inc. Intercompany transactions and
balances have been eliminated in consolidation.
Accounting
Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those
estimates. Significant estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant
liabilities, valuation of equity instruments issued for services, and valuation of deferred tax assets. Actual results could differ
from those estimates.
Stock-Based
Compensation
The
Company accounts for share-based awards to employees, nonemployees, and consultants in accordance with the provisions of ASC 718, Compensation-Stock
Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense
over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and
accounts for forfeitures when they occur. Use of the Black-Scholes option pricing model requires the input of subjective assumptions
including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using its own historical
stock price volatility. The expected term of the instrument is estimated by using the simplified method to estimate expected term. The
risk-free interest rate is estimated using comparable published federal funds rates.
Inflation
We
believe that inflation has not had a material adverse impact on our business or operating results during the periods presented other
than the impact of inflation on the general economy. However, there is a risk that the Company’s operating costs could become subject
to inflationary pressures in the future, which would have the effect of increasing the Company’s operating costs, and which would
put additional stress on the Company’s working capital resources.
Off-balance
Sheet Arrangements
We
have no off-balance sheet arrangements as of June 30, 2023.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Our Company qualifies as a smaller reporting company, as defined in 17 C.F.R. §229.10(f)(1) and is not required to provide information
for this Item.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer evaluated the effectiveness of our “disclosure
controls and procedures” (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the United States Securities Exchange Act
of 1934, as amended), as of June 30, 2023. Based on that evaluation, we have concluded that our disclosure controls and procedures were
effective as of June 30, 2023.
Management’s
Report on Internal Control Over Financial Reporting
Management
is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting
is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by,
or under the supervision of, a company’s principal executive and principal accounting officers and effected by a company’s
board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles
and includes those policies and procedures that:
|
● |
Pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets
of the Company |
|
|
|
|
● |
Provide
reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance
with authorizations of management and directors of the company; and |
|
|
|
|
● |
Provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s
assets that could have a material effect on the consolidated financial statements. |
All
internal control systems, no matter how well designed, have inherent limitations and can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our
company have been detected. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect
to financial statement preparation and presentation.
As
of June 30, 2023, our management, including our interim Chief Executive Officer and Chief Financial Officer conducted an assessment of
the effectiveness of the Company’s internal control over financial reporting. In making this assessment, we used the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission in internal control integrated framework. Based upon our
evaluation, we concluded that our internal controls over financial reporting were operating effectively with a significant level of precision
as of June 30, 2023.
Changes
in Internal Control Over Financial Reporting
Except
for the ongoing remediation of previously disclosed material weaknesses in internal controls over financial reporting, no changes in our internal
control over financial reporting were made during our most recent fiscal quarter that has materially affected, or is reasonably likely
to materially affect, our internal control over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
On May 11, 2023, our former interim Chief Executive
Officer, Dr. Greg Berk, filed a complaint with the Occupational Safety and Health Administration alleging retaliation against him during
his tenure at the Company for raising concerns related to the public disclosure of certain product timelines. The Company is vigorously
defending this matter and believe it to be without merit. At this early stage in the proceedings, the Company is not able to determine
the probability of the outcome of this matter or a range of reasonably expected losses, if any.
On
May 13, 2022, the Company made a claim against Michael Handelman, its former Chief Financial Officer, asserting that he misappropriated
Company funds and shares of common stock, and failed to file the required SEC reports on Form 3 and Form 4 regarding each acquisition
and disposition of the Company’s common stock. The Company seeks monetary damages estimated at $370; the return of shares of
our common stock received without authorization and the disgorgement of any profits earned from the sale of those shares; a full accounting
for all sums charged on the Company’s debit card, with payment to the Company for any charges that cannot be demonstrated to have
a corporate purpose; an order directing Mr. Handelman to make all filings required by Section 16(a) of the 1934 Act; an award of all
sums and shares improperly issued to members of Mr. Handelman’s family; and an award of the Company’s attorneys’ fees
and any forum and arbitration fees. As a component of Mr. Handelman’s contract with the Company, disputes shall be fully addressed
and finally resolved by binding arbitration conducted by the American Arbitration Association (AAA) in New York City, New York, in accordance
with its National Employment Dispute Resolution rules. In connection with any such arbitration, the Company shall bear all costs not
otherwise borne by a plaintiff in a court proceeding. The Company agrees that any decisions of the arbitration panel will be binding
and enforceable in any state in which the Company conducts the operation of its business. In accordance with California Labor Laws, the
Company has designated Los Angeles, California as the venue for this arbitration. The claims are pending before an arbitrator in Los
Angeles and the hearing is scheduled to begin on October 26, 2023. Mr. Handelman has not asserted counterclaims against the Company.
On
May 24, 2023, TWF Global, LLC (“TWF”) filed a Complaint in the California Superior Court for the County of Los Angeles
naming the Company as defendant. The Complaint alleges that TWF is the holder of two convertible notes and that the Company did
not deliver shares of common stock due on conversion in February 2021. TWF is seeking per diem liquidated damages based on the
terms of alleged convertible notes. The Company filed a motion to dismiss for improper
forum on July 14, 2023 because the convertible notes require disputes to be filed in New York state and federal courts. The
Company believes that TWF’s claims are without merit and will continue to defend vigorously against these claims.
Item
6. Exhibits
Exhibit |
|
Description |
|
Filed
Herewith |
|
Form |
|
Number |
|
SEC
File No. |
|
Filing
Date |
|
|
|
|
|
|
|
|
|
|
|
|
|
3.1 |
|
Restated Certificate of Incorporation as filed in Delaware September 10, 1996 and as thereafter amended through March 1, 2002 |
|
|
|
10-KSB |
|
3.A |
|
000-08092 |
|
4/1/2002 |
3.2 |
|
Certificate of Amendment to the Restated Certificate of Incorporation of GT Biopharma, Inc., dated February 9, 2011 |
|
|
|
10-K |
|
3.2 |
|
000-08092 |
|
3/31/2011 |
3.3 |
|
Certificate of Amendment to the Restated Certificate of Incorporation of GT Biopharma, Inc., effective as of July 19, 2017 |
|
|
|
8-K/A |
|
3.1 |
|
000-08092 |
|
3/15/2018 |
3.4 |
|
Certificate of Amendment to the Restated Certificate of Incorporation of GT Biopharma, Inc., effective as of February 10, 2021 |
|
|
|
8-K |
|
3.1 |
|
001-40023 |
|
2/11/2021 |
3.5 |
|
Certificate of Amendment to Restated Certificate of Incorporation of the Registrant effective June 13, 2022 |
|
|
|
10-K |
|
3.5 |
|
001-40023 |
|
3/30/2023 |
3.6 |
|
Amended and Restated Bylaws of GT Biopharma, Inc. effective November 3, 2022. |
|
|
|
8-K |
|
3.1 |
|
01-40023 |
|
11/09/2022 |
4.1 |
|
Certificate
of Designation of Preferences, Rights and Limitations of Series J-1 Preferred Stock of GT Biopharma, Inc. dated April 3, 2019 |
|
|
|
8-K |
|
3.1 |
|
000-08092 |
|
04/04/2019 |
4.2 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series K Preferred Stock of GT Biopharma, Inc., dated April 3, 2019 |
|
|
|
10-K |
|
4.2 |
|
001-40023 |
|
4/16/2021 |
31.1 |
|
Certification of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended. |
|
X |
|
|
|
|
|
|
|
|
31.2 |
|
Certification of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended. |
|
X |
|
|
|
|
|
|
|
|
32.1 |
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002. |
|
X |
|
|
|
|
|
|
|
|
32.2 |
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002. |
|
X |
|
|
|
|
|
|
|
|
101.INS |
|
Inline
XBRL Instance Document. |
|
X |
|
|
|
|
|
|
|
|
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document. |
|
X |
|
|
|
|
|
|
|
|
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase |
|
X |
|
|
|
|
|
|
|
|
101.DEF
|
|
Inline
XBRL Taxonomy Extension Definition Linkbase |
|
X |
|
|
|
|
|
|
|
|
101.LAB
|
|
Inline
XBRL Taxonomy Extension Label Linkbase Document. |
|
X |
|
|
|
|
|
|
|
|
101.PRE
|
|
Inline
XBRL Taxonomy Extension Presentation Linkbase |
|
X |
|
|
|
|
|
|
|
|
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
|
X |
|
|
|
|
|
|
|
|
* |
This
certification shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the
liability of that Section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act or the
Exchange Act. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
GT
Biopharma, Inc. |
|
|
|
Dated:
August 7, 2023 |
By: |
/s/
Manu Ohri |
|
|
Manu
Ohri |
|
|
Chief Financial Officer and Secretary
(Principal Financial and Accounting Officer) |
Exhibit 31.1
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY
ACT
I, Michael Breen, certify that:
|
a. |
I have reviewed this report on Form 10-Q of GT Biopharma, Inc.; |
|
|
|
|
b. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
|
|
c. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
|
|
d. |
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
|
|
i) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
|
|
ii) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
|
|
iii) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
|
|
iv) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
e. |
I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
|
i) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
|
|
ii) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 7, 2023 |
By: |
/s/ Michael Breen |
|
Name: |
Michael Breen |
|
Title: |
Interim Chief Executive Officer, |
|
|
Chairman of the Board
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY
ACT
I, Manu Ohri, certify that:
|
a. |
I have reviewed this report on Form 10-Q of GT Biopharma, Inc.; |
|
|
|
|
b. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
|
|
c. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
|
|
d. |
I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
|
|
i) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
|
|
ii) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
|
|
iii) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
|
|
iv) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
e. |
I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
|
i) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
|
|
ii) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 7, 2023 |
By: |
/s/ Manu Ohri |
|
Name: |
Manu Ohri |
|
Title: |
Chief Financial Officer and Secretary
(Principal Financial Officer)
|
Exhibit 32.1
CERTIFICATION TO SECTION 906 OF THE SARBANES-OXLEY
ACT OF 2002
Pursuant to 18 U.S.C. § 1350, as created by Section
906 of the Sarbanes-Oxley Act of 2002, I, Michael Breen, Interim Chief Executive Officer of GT Biopharma, Inc. (the “Company”),
hereby certify that, to the best of my knowledge:
(i) the Quarterly Report on Form
10-Q of the Company for the fiscal quarter ended June 30, 2023 (the “Report”) fully complies with the requirements of Section
13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained
in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.
Date: August 7, 2023 |
By: |
/s/ Michael Breen |
|
Name: |
Michael Breen |
|
Title: |
Interim Chief Executive Officer, |
|
|
Chairman of the Board
(Principal Executive Officer)
|
Exhibit 32.2
CERTIFICATION TO SECTION 906 OF THE SARBANES-OXLEY
ACT OF 2002
Pursuant to 18 U.S.C. § 1350, as created by Section
906 of the Sarbanes-Oxley Act of 2002, I, Manu Ohri, Chief Financial Officer and Principal Accounting Officer of GT Biopharma, Inc. (the
“Company”), hereby certify that, to the best of my knowledge:
(i) the Quarterly Report on Form
10-Q of the Company for the fiscal quarter ended June 30, 2023 (the “Report”) fully complies with the requirements of Section
13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained
in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.
Date: August 7, 2023 |
By: |
/s/ Manu Ohri |
|
Name: |
Manu Ohri |
|
Title: |
Chief Financial Officer and Secretary
(Principal Financial Officer)
|
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 07, 2023 |
Cover [Abstract] |
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Document Type |
10-Q
|
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Amendment Flag |
false
|
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Document Quarterly Report |
true
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Document Transition Report |
false
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Document Period End Date |
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|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-40023
|
|
Entity Registrant Name |
GT
BIOPHARMA, INC.
|
|
Entity Central Index Key |
0000109657
|
|
Entity Tax Identification Number |
94-1620407
|
|
Entity Incorporation, State or Country Code |
DE
|
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Entity Address, Address Line One |
8000
Marina Blvd
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Entity Address, Address Line Two |
Suite 100
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Entity Address, City or Town |
Brisbane
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Entity Address, State or Province |
CA
|
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Entity Address, Postal Zip Code |
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City Area Code |
415
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Local Phone Number |
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|
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Title of 12(b) Security |
Common
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|
|
Trading Symbol |
GTBP
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Security Exchange Name |
NASDAQ
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Entity Current Reporting Status |
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v3.23.2
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash and cash equivalents |
$ 2,767
|
$ 5,672
|
Short-term investments |
15,206
|
10,836
|
Prepaid expenses and other current assets |
48
|
54
|
Total Current Assets |
18,021
|
16,562
|
Operating lease right-of-use asset |
114
|
165
|
Deposits |
9
|
9
|
TOTAL ASSETS |
18,144
|
16,736
|
Current liabilities |
|
|
Accounts payable |
3,501
|
3,140
|
Accrued expenses |
1,222
|
1,669
|
Current operating lease liability |
120
|
110
|
Total Current Liabilities |
4,843
|
4,919
|
Non-current operating lease liability |
|
64
|
Warrant liability |
1,538
|
19
|
Total Liabilities |
6,381
|
5,002
|
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, 2023 and December 31, 2022, respectively |
1
|
1
|
Common stock, par value $0.001, 250,000,000 shares authorized, 40,639,688 shares and 32,722,452 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
41
|
33
|
Additional paid in capital |
688,408
|
686,168
|
Accumulated deficit |
(676,687)
|
(674,468)
|
Total Stockholders’ Equity |
11,763
|
11,734
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 18,144
|
$ 16,736
|
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v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
15,000,000
|
15,000,000
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
250,000,000
|
250,000,000
|
Common stock, shares issued |
40,639,688
|
32,722,452
|
Common stock, shares outstanding |
40,639,688
|
32,722,452
|
Series C Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares issued |
96,230
|
96,230
|
Preferred stock, shares outstanding |
96,230
|
96,230
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
|
|
|
Operating Expenses: |
|
|
|
|
Research and development |
2,095
|
1,139
|
3,745
|
3,226
|
Selling, general and administrative (including $398 and $463 from stock compensation granted to officers, directors and employees for the three months ended June 30, 2023 and 2022, respectively, and $905 and $910 for the six months ended June 30, 2023 and 2022, respectively) |
1,526
|
1,875
|
3,541
|
5,230
|
Loss from Operations |
3,621
|
3,014
|
7,286
|
8,456
|
Other (Income) Expense |
|
|
|
|
Interest income |
(220)
|
(36)
|
(384)
|
(44)
|
Interest expense |
1
|
|
213
|
|
Change in fair value of warrant liability |
(1,387)
|
(5)
|
(4,311)
|
(23)
|
Gain on extinguishment of debt |
(14)
|
|
(547)
|
|
Unrealized (gain) loss on marketable securities |
(9)
|
6
|
(38)
|
30
|
Total Other (Income), net |
(1,629)
|
(35)
|
(5,067)
|
(37)
|
Net Loss |
$ (1,992)
|
$ (2,979)
|
$ (2,219)
|
$ (8,419)
|
Net Loss Per Share - Basic |
$ (0.05)
|
$ (0.10)
|
$ (0.06)
|
$ (0.26)
|
Net Loss Per Share - Diluted |
$ (0.05)
|
$ (0.10)
|
$ (0.06)
|
$ (0.26)
|
Weighted average common shares outstanding - basic |
40,172,599
|
31,237,560
|
39,632,060
|
31,865,425
|
Weighted average common shares outstanding - diluted |
40,172,599
|
31,237,560
|
39,632,060
|
31,865,425
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member] |
Common Stock [Member] |
Common Shares Issuable [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 1
|
$ 32
|
$ 1,113
|
$ 674,348
|
$ (653,584)
|
$ 21,910
|
Beginning balance, shares at Dec. 31, 2021 |
96,000
|
32,062,000
|
327,000
|
|
|
|
Ending balance, value at Mar. 31, 2022 |
$ 1
|
$ 32
|
|
676,780
|
(659,024)
|
17,789
|
Ending balance, shares at Mar. 31, 2022 |
96,000
|
32,346,000
|
|
|
|
|
Beginning balance, value at Dec. 31, 2021 |
$ 1
|
$ 32
|
$ 1,113
|
674,348
|
(653,584)
|
21,910
|
Beginning balance, shares at Dec. 31, 2021 |
96,000
|
32,062,000
|
327,000
|
|
|
|
Cancellation of common stock upon settlement with former officer |
|
$ (1)
|
|
(222)
|
|
(223)
|
Cancellation of common stock upon settlement with former officer, shares |
|
(1,845,000)
|
|
|
|
|
Cancellation of common stock |
|
|
|
|
|
|
Cancellation of common stock, shares |
|
(291,000)
|
|
|
|
|
Equity compensation to officers, employees, and board of directors |
|
|
|
910
|
|
910
|
Equity compensation to officers, employees, and board of directors, shares |
|
164,000
|
|
|
|
|
Issuance of common shares for services |
|
|
|
1,262
|
|
1,262
|
Issuance of common shares for services, shares |
|
277,000
|
|
|
|
|
Net loss |
|
|
|
|
(8,419)
|
(8,419)
|
Common shares issued upon conversion of notes payable |
|
|
$ (1,113)
|
1,113
|
|
|
Common shares issued upon conversion of notes payable, shares |
|
327,000
|
(327,000)
|
|
|
|
Ending balance, value at Jun. 30, 2022 |
$ 1
|
$ 31
|
|
677,411
|
(662,003)
|
15,440
|
Ending balance, shares at Jun. 30, 2022 |
96,000
|
30,694,000
|
|
|
|
|
Beginning balance, value at Mar. 31, 2022 |
$ 1
|
$ 32
|
|
676,780
|
(659,024)
|
17,789
|
Beginning balance, shares at Mar. 31, 2022 |
96,000
|
32,346,000
|
|
|
|
|
Cancellation of common stock upon settlement with former officer |
|
$ (1)
|
|
(222)
|
|
(223)
|
Cancellation of common stock upon settlement with former officer, shares |
|
(1,845,000)
|
|
|
|
|
Equity compensation to officers, employees, and board of directors |
|
|
|
463
|
|
463
|
Equity compensation to officers, employees, and board of directors, shares |
|
79,000
|
|
|
|
|
Issuance of common shares for services |
|
|
|
390
|
|
390
|
Issuance of common shares for services, shares |
|
114,000
|
|
|
|
|
Net loss |
|
|
|
|
(2,979)
|
(2,979)
|
Ending balance, value at Jun. 30, 2022 |
$ 1
|
$ 31
|
|
677,411
|
(662,003)
|
15,440
|
Ending balance, shares at Jun. 30, 2022 |
96,000
|
30,694,000
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 1
|
$ 33
|
|
686,168
|
(674,468)
|
11,734
|
Beginning balance, shares at Dec. 31, 2022 |
96,000
|
32,723,000
|
|
|
|
|
Fair value of vested stock options |
|
|
|
905
|
|
905
|
Issuance of common shares for services |
|
|
|
315
|
|
315
|
Issuance of common shares for services, shares |
|
73,000
|
|
|
|
|
Issuance of common stock for exercise of Prefunded Warrants |
|
$ 3
|
|
(3)
|
|
|
Issuance of common stock for exercise of Prefunded Warrants, shares |
|
2,900,000
|
|
|
|
|
Issuance of common shares in settlement of vendors payable |
|
$ 1
|
|
590
|
|
$ 591
|
Issuance of common shares in settlement of vendors payable, shares |
|
1,344,000
|
|
|
|
1,343,783
|
Net loss |
|
|
|
|
(2,219)
|
$ (2,219)
|
Private placement of common stock |
|
$ 4
|
|
6,264
|
|
6,268
|
Private placement of common stock, shares |
|
3,600,000
|
|
|
|
|
Initial recognition of fair value of warrant liability |
|
|
|
(5,831)
|
|
(5,831)
|
Ending balance, value at Jun. 30, 2023 |
$ 1
|
$ 41
|
|
688,408
|
(676,687)
|
11,763
|
Ending balance, shares at Jun. 30, 2023 |
96,000
|
40,640,000
|
|
|
|
|
Beginning balance, value at Mar. 31, 2023 |
$ 1
|
$ 37
|
|
687,710
|
(674,695)
|
13,053
|
Beginning balance, shares at Mar. 31, 2023 |
96,000
|
36,883,000
|
|
|
|
|
Cancellation of common stock upon settlement with former officer, shares |
|
|
|
|
|
|
Cancellation of common stock, shares |
|
|
|
|
|
|
Equity compensation to officers, employees, and board of directors, shares |
|
|
|
|
|
|
Fair value of vested stock options |
|
|
|
398
|
|
398
|
Issuance of common shares for services, shares |
|
|
|
|
|
|
Issuance of common stock for exercise of Prefunded Warrants |
|
$ 3
|
|
(3)
|
|
|
Issuance of common stock for exercise of Prefunded Warrants, shares |
|
2,900,000
|
|
|
|
|
Issuance of common shares in settlement of vendors payable |
|
$ 1
|
|
303
|
|
304
|
Issuance of common shares in settlement of vendors payable, shares |
|
857,000
|
|
|
|
|
Net loss |
|
|
|
|
(1,992)
|
(1,992)
|
Ending balance, value at Jun. 30, 2023 |
$ 1
|
$ 41
|
|
$ 688,408
|
$ (676,687)
|
$ 11,763
|
Ending balance, shares at Jun. 30, 2023 |
96,000
|
40,640,000
|
|
|
|
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
Net loss |
$ (1,992)
|
$ (2,979)
|
$ (2,219)
|
$ (8,419)
|
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
Stock based compensation - services |
|
|
315
|
1,262
|
|
Stock based compensation - officers, employees and board of directors |
|
|
905
|
910
|
|
Change in fair value of warrant liability |
(1,387)
|
(5)
|
(4,311)
|
(23)
|
|
Gain on extinguishment in settlement of vendor payable |
(14)
|
|
(547)
|
|
|
Change in operating lease right-of-use assets |
|
|
51
|
46
|
|
Unrealized (gain) loss on marketable securities |
|
|
(38)
|
30
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
(Increase) decrease in prepaid expenses |
|
|
5
|
(32)
|
|
Increase in deposits |
|
|
|
(9)
|
|
Increase (decrease) in accounts payable and accrued expenses |
|
|
1,052
|
(1,729)
|
|
(Decrease) in operating lease liability |
|
|
(54)
|
(37)
|
|
Net Cash Used in Operating Activities |
|
|
(4,841)
|
(8,001)
|
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
Sale (purchase) of investments |
|
|
(4,332)
|
4,614
|
|
Net Cash Provided by (Used in) Investing Activities |
|
|
(4,332)
|
4,614
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
Proceeds from issuance of common stock and prefunded warrants |
|
|
6,268
|
|
|
Cancellation of common stock upon settlement with former officer |
|
|
|
(223)
|
|
Net Cash Provided by (Used in) Financing Activities |
|
|
6,268
|
(223)
|
|
Net Decrease in Cash |
|
|
(2,905)
|
(3,610)
|
|
Cash at Beginning of Period |
|
|
5,672
|
8,968
|
$ 8,968
|
Cash at End of Period |
$ 2,767
|
$ 5,358
|
2,767
|
5,358
|
$ 5,672
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: |
|
|
|
|
|
Interest |
|
|
|
|
|
Income taxes paid |
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES |
|
|
|
|
|
Right-of-use assets exchanged for lease liabilities |
|
|
|
260
|
|
Initial recognition of fair value of warrant liability |
|
|
5,831
|
|
|
Fair value of common stock issued to a vendor to settle accounts payable |
|
|
$ 591
|
|
|
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v3.23.2
Organization and Operations
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Operations |
Note
1 – Organization and Operations
In
1965, the corporate predecessor of GT Biopharma, Inc. (Company), Diagnostic Data, Inc. was incorporated in the State of California. Diagnostic
Data changed its incorporation to the State of Delaware in 1972 and changed its name to DDI Pharmaceuticals, Inc. in 1985. In 1994, DDI
Pharmaceuticals merged with International BioClinical, Inc. and Bioxytech S.A. and changed its name to OXIS International, Inc. In July
2017, the Company changed its name to GT Biopharma, Inc.
The
Company is a clinical stage biopharmaceutical company focused on the development and commercialization of novel immune-oncology products
based on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®) platforms.
The Company’s TriKE® and Dual Targeting TriKE® platforms generate proprietary therapeutics designed to harness and enhance
the cancer killing abilities of a patient’s own natural killer cells (NK cells).
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v3.23.2
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation and Principles of Consolidation
The
consolidated condensed financial statements include the accounts of the Company and its wholly-owned subsidiaries, Oxis Biotech, Inc.
and Georgetown Translational Pharmaceuticals, Inc. All intercompany transactions and balances have been eliminated in consolidation.
The
accompanying condensed consolidated financial statements are unaudited. These interim condensed consolidated financial statements have
been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable
rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information
and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant
to such rules and regulations. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with
the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, filed with the SEC on March 30, 2023 (the “2022 Annual Report”). The consolidated balance sheets
as of December 31, 2022 included herein, was derived from the audited consolidated financial statements as of that date.
In
the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to
fairly present the Company’s financial position and its results of operations for the interim periods reflected. Except as noted,
all adjustments contained herein are of a normal recurring nature. Results of operations for the fiscal periods presented herein are
not necessarily indicative of fiscal year-end results.
Liquidity
The
accompanying consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern.
Such assumptions contemplate the realization of assets and satisfaction of liabilities in the normal course of business. For the six
months ended June 30, 2023, the Company recorded a net loss of $2.2 million and used cash in operations of $4.8 million. As of June 30,
2023, the Company had a cash and short-term investments balance of $18.0 million, working capital of $13.2 million, and stockholders’
equity of $11.8 million. Management anticipates that the $18.0 million of cash and cash equivalents, and short-term investments are adequate
to satisfy the liquidity needs of the Company for at least one year from the date the Company’s condensed consolidated financial
statements for the six-month period ended June 30, 2023 were issued.
Historically,
the Company has financed its operations through public and private sales of common stock, issuance of preferred and common stock, issuance
of convertible debt instruments, and strategic collaborations. There can be no assurances that the Company will be able to secure additional
financing on acceptable terms. In the event the Company does not generate sufficient cash flows from investing and financing activities,
the Company will be forced to delay, reduce, or eliminate some or all of its discretionary spending, which could adversely affect the
Company’s business prospects, ability to meet long-term liquidity needs or ability to continue its operations.
COVID-19
The
global COVID-19 pandemic continues to present uncertainty and unforeseeable risks to our operations and business plans. The Company has
closely monitored recent developments, including the lifting of COVID-19 safety measures, the spread of new strains or variants of the
coronavirus (such as the Delta and Omicron variants), and supply chain, raw materials and labor shortages. Thus, the full impact of the
COVID-19 pandemic on the business and operations remains uncertain and will vary depending on the pandemic’s future impact on the
third parties with whom the Company does business, as well as any legal or regulatory consequences resulting therefrom. The Company has
been following the recommendations of health authorities to minimize exposure risk for its team members and may take further actions
that alter our operations, including any required by federal, state or local authorities, or that it determines are in the best interests
of its employees and other third parties with whom GT Biopharma does business.
Accounting
Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant
estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation
of equity instruments issued for services and realization of deferred tax assets. Actual results could differ from those estimates.
Cash
Equivalents and Short-Term Investments
The
Company considers highly liquid investments with maturities of three months or less at the date of acquisition as cash equivalents in
the accompanying condensed consolidated financial statements. Total cash equivalents, which consist of money market funds, totaled approximately
$2.4 million and $5.5 million at June 30, 2023 and December 31, 2022, respectively.
The
Company also invested its excess cash in commercial paper and corporate notes and bonds. Management generally determines the appropriate
classification of its investments at the time of purchase. We classify these investments as short-term investments as part of current
assets, based upon our ability and intent to use any and all of these investments as necessary to satisfy liquidity requirements that
may arise from our business. Investments are carried at fair value with the unrealized holding gains and losses reported in the accompanying
condensed consolidated statements of operations. Total short-term investments totaled approximately $15.2 million and $10.8 million at
June 30, 2023 and December 31, 2022, respectively.
Fair
Value of Financial Instruments
Financial
Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820-10 requires entities to disclose
the fair value of financial instruments, both assets and liabilities recognized and not recognized on the balance sheet for which it
is practicable to estimate fair value. ASC 820-10 defines the fair value of a financial instrument as the amount at which the instrument
could be exchanged in a current transaction between willing parties.
The
three levels of the fair value hierarchy are as follows:
|
Level
1 |
Valuations
based on unadjusted quoted prices in active markets for identical assets or liabilities that the entity has the ability to access. |
|
|
|
|
Level
2 |
Valuations
based on quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are
observable or can be corroborated by observable data for substantially the full term of the assets or liabilities. |
|
|
|
|
Level
3 |
Valuations
based on inputs that are unobservable, supported by little or no market activity and that are significant to the fair value of the
assets or liabilities. |
The
carrying amount of the Company’s warrant liability of $1.5 million and $19 at June 30, 2023 and December 31, 2022, respectively,
was based on Level 3 measurements.
The
carrying amounts of the Company’s other financial assets and liabilities such as cash, other current assets, accounts payable and
accrued expenses approximate their fair values because of the short maturity of these instruments.
Derivatives
and Liability-Classified Instruments
The
Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of
the specific terms of the warrants and the guidance provided by the FASB in ASC 480, Distinguishing Liabilities from Equity (ASC
480) and ASC 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants are freestanding
financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and meet all of the requirements
for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own stock and whether the
holders of the warrants could potentially require net cash settlement in a circumstance outside of the Company’s control,
among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at
the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. The fair value
of the warrant liability is determined using a Binomial valuation method at inception and on
subsequent valuation dates.
Stock-Based
Compensation
The
Company accounts for share-based awards to employees, nonemployees, and consultants in accordance with the provisions of ASC 718, Compensation-Stock
Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense
over the requisite service or vesting period.
The
Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the
Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free
interest rate. The Company estimates volatility using its own historical stock price volatility. The expected term of the instrument
is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published
federal funds rates.
Research
and Development Costs
Costs
incurred for research and development are expensed as incurred. The salaries, benefits, and overhead costs of personnel conducting research
and development of the Company’s products are included in research and development costs. Purchased materials that do not have
an alternative future use are also expensed.
Leases
The
Company accounts for its leases in accordance with the guidance of ASC 842, Leases. The Company determines whether a contract is, or
contains, a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term,
and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and
lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease
term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present
value of unpaid lease payments (see Note 8 – Operating Leases for the Company’s lease disclosures).
Net
Loss Per Share
Basic
loss per share is computed using the weighted-average number of common shares outstanding during the period. Common stock issuable is
included in our calculation as of the date of the underlying agreement. Diluted loss per share is computed using the weighted-average
number of common shares and the dilutive effect of contingent shares outstanding during the period. Potentially dilutive contingent shares,
which primarily consist of stock issuable for the exercise of stock options and warrants, have been excluded from the diluted loss per
share calculation because their effect is anti-dilutive.
These
following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive:
Schedule
of Anti-dilutive Securities
| |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | |
Options to purchase common stock | |
| 3,737,952 | | |
| 302,500 | |
Warrants to purchase common stock | |
| 9,148,880 | | |
| 2,337,274 | |
Unvested restricted common stock | |
| - | | |
| 488,429 | |
Total anti-dilutive securities | |
| 12,886,832 | | |
| 3,128,203 | |
Concentration
Cash
is deposited in one financial institution. The balances held at this financial institution at times may be in excess of Federal Deposit
Insurance Corporation (“FDIC”) insurance limits of up to $250.
From time to time, however, the Company may be exposed to risk for the amounts of funds held in bank accounts in excess of the FDIC limit.
To minimize the risk, the Company’s policy is to maintain cash balances with high quality financial institutions.
The
Company has a significant concentration of expenses incurred and accounts payable from a single vendor (see Note 4 – Accounts Payable for further information).
Segments
The
Company determined its reporting units in accordance with ASC 280, “Segment Reporting” (“ASC 280”). Management
evaluates a reporting unit by first identifying its’ operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated.
Management
has determined that the Company has one consolidated operating segment. The Company’s reporting segment reflects the manner in
which its chief operating decision maker reviews results and allocates resources. The Company’s reporting segment meets the definition
of an operating segment and does not include the aggregation of multiple operating segments.
Recent
Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Credit Losses – Measurement of Credit
Losses on Financial Instruments (“ASC 326”). ASU 2016-13 requires entities to use a forward-looking approach based on
current expected credit losses (“CECL”) to estimate credit losses on certain types of financial instruments, including trade
receivables. This may result in the earlier recognition of allowances for losses. ASU 2016-13 is effective for the Company beginning
January 1, 2023, and early adoption is permitted. The Company adopted this standard effective January 1, 2023 and there was no material impact of adopting this standard
on the Company’s financial statements and related disclosures.
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock
Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU 2021-04 provides clarification
and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options
(such as warrants) that remain equity classified after modification or exchange. An issuer measures the effect of a modification or exchange
as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification
or exchange. ASU 2021-04 introduces a recognition model that comprises four categories of transactions and the corresponding accounting
treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and
debt origination or modification). ASU 2021-04 was effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years, applied prospectively to modifications or exchanges occurring on or after the effective date. Effective January
1, 2022, we adopted ASU 2021-04 using a prospective approach. It did not have a material impact on the Company’s financial statements
or disclosures.
Other
recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public
Accountants, and the SEC did not or are not believed by management to have a material impact on the Company’s present or future
consolidated financial statements.
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v3.23.2
Fair Value of Financial Instruments
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value of Financial Instruments |
Note
3 – Fair Value of Financial Instruments
The
estimated fair values of financial instruments outstanding were as follow:
Schedule
of Estimated Fair Value of Financial Instrument
| |
June 30, 2023 (Unaudited) | |
| |
| | |
Unrealized | | |
Unrealized | | |
Fair | |
| |
Cost | | |
Gains | | |
Losses | | |
Value | |
Short-term investments | |
$ | 15,168 | | |
$ | 38 | | |
$ | — | | |
$ | 15,206 | |
Total | |
$ | 15,168 | | |
$ | 38 | | |
$ | — | | |
$ | 15,206 | |
| |
December 31, 2022 | |
| |
| | |
Unrealized | | |
Unrealized | | |
Fair | |
| |
Cost | | |
Gains | | |
Losses | | |
Value | |
Short-term investments | |
$ | 10,866 | | |
$ | — | | |
$ | (30 | ) | |
$ | 10,836 | |
Total | |
$ | 10,866 | | |
$ | — | | |
$ | (30 | ) | |
$ | 10,836 | |
The
following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments):
Schedule of Fair Value Hierarchy Financial Assets
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2023 (Unaudited) | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Money market funds | |
$ | 2,364 | | |
$ | 2,364 | | |
$ | — | | |
$ | — | |
Corporate notes and commercial paper | |
| 15,206 | | |
| 15,206 | | |
| — | | |
| — | |
Total financial assets | |
$ | 17,570 | | |
$ | 17,570 | | |
$ | — | | |
$ | — | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2022 | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Money market funds | |
$ | 5,505 | | |
$ | 5,505 | | |
$ | — | | |
$ | — | |
Corporate notes and commercial paper | |
| 10,836 | | |
| 10,836 | | |
| — | | |
| — | |
Total financial assets | |
$ | 16,341 | | |
$ | 16,341 | | |
$ | — | | |
$ | — | |
As
of June 30, 2023, the fair value of the warrant liability amounted to $1,492. The details of warrant liability transactions for the
three and six months ended June 30, 2023 and 2022, are as follows:
Schedule of Derivative Liability Transactions
| |
June 30, 2023 | | |
June 30, 2022 | | |
June 30, 2023 | | |
June 30, 2022 | |
| |
Three Months Ending | | |
Six Months Ending | |
| |
June 30, 2023 | | |
June 30, 2022 | | |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | |
Beginning balance | |
$ | 2,925 | | |
$ | 120 | | |
$ | 19 | | |
$ | 138 | |
Fair value upon issuance of warrants | |
| — | | |
| — | | |
| 5,830 | | |
| — | |
Change in fair value | |
$ | (1,433 | ) | |
$ | (5 | ) | |
$ | (4,357 | ) | |
$ | (23 | ) |
Ending balance | |
$ | 1,492 | | |
$ | 115 | | |
$ | 1,492 | | |
$ | 115 | |
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v3.23.2
Accounts Payable
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accounts Payable |
Note
4 – Accounts Payable
Accounts
payable consisted of the following:
Schedule of Accounts Payable
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
Accounts payable to a third-party manufacturer | |
$ | 2,910 | | |
$ | 2,283 | |
Other accounts payable | |
| 591 | | |
| 857 | |
Total accounts payable | |
$ | 3,501 | | |
$ | 3,140 | |
The
Company relies on a third-party contract manufacturing operation to produce and/or test our compounds used in our potential product candidates.
In
October 2020, the Company entered into a Master Services Agreement with a third-party product manufacturer to perform biologic development
and manufacturing services on behalf of the Company. Associated with this, the Company has subsequently executed a number of Statements
of Work for the research and development of products for use in clinical trials.
On
August 24, 2022, existing agreements with the third-party product manufacturer were amended. As part of the amendment, the third-party
manufacturer agreed that services to be rendered in future periods, will be paid or settled at the Company’s discretion, in a combination
of cash and issuance of the Company’s common stock. The amendment also eliminated future financial commitments of the Company.
The outstanding balance payable to the third-party product manufacturer
totaled $2.9 million and $2.3 million at June 30, 2023 and December 31, 2022, respectively.
The
Company recorded $2.1 million and $3.7 million in research and development expenses to account for services rendered by the third-party
product manufacturer for the three months and six months ended June 30, 2023, as compared to $1.1 million and $3.2 million for the same
comparable periods in 2022. In addition, the Company paid cash of $1.1 million and issued 1.3 million shares of its common stock with
a fair value of $591 in settlement of accounts payable of $1.1 million, which resulted in a gain of on settlement of $547, during
the six months ended June 30, 2023.
The
outstanding accounts payable balance due to the third-party product manufacturer totaled $2.9 million and $2.3 million as of June 30,
2023 and December 31, 2022, respectively.
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.2
Warrant Liability
|
6 Months Ended |
Jun. 30, 2023 |
Warrant Liability |
|
Warrant Liability |
Note
5 – Warrant Liability
2023
Warrants
On
January 4, 2023, as part of the private placement offering, the Company issued common stock, warrants to purchase up to an aggregate
of 6,500,000
shares of the Company’s common stock (the “Common Warrants”), and placement agent warrants to purchase up to 390,000
shares of the Company’s common stock (the “Placement Agents Warrants”) see Note 6 – Stockholders’
Equity.
The
Purchase Warrant provides for a value calculation for the Purchase Warrant using the Black Scholes model in the event of certain fundamental
transactions. The fair value calculation provides for a floor on the volatility amount utilized in the value calculation at 100%
or greater. The Company has determined this provision introduces leverage to the holders of the Purchase Warrant that could result in
a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Therefore,
pursuant to ASC 815, the Company has classified the Purchase Warrant as a liability in its consolidated balance sheet. The classification
of the Purchase Warrant, including whether the Purchase Warrant should be recorded as liability or as equity, is evaluated at the end
of each reporting period with changes in the fair value reported in other income (expense) in the consolidated statements of operations
and comprehensive loss. The Purchase Warrant was initially recorded at a fair value at $5.8
million at the grant date and is re-valued at
each reporting date. Upon the closing of placement, the fair value of the Purchase Warrant liability was recorded as a cost of capital.
As of June 30, 2023, the fair value of the warrant liability was $1.5 million.
All
changes in the fair value of the warrant liabilities are recognized as a change in fair value of warrant liability in the Company’s
condensed consolidated statements of operations until they are either exercised or expire.
The
warrant liabilities for the Common Warrants and the Placement Agents Warrants were valued using a Binomial pricing model with the following
weighted average assumptions:
Schedule of Derivative Liabilities Assumptions
| |
Common Warrants and Placement
Agents Warrants | |
| |
June 30, 2023 | | |
At Inception | |
| |
(Unaudited) | | |
(Unaudited) | |
Stock price | |
$ | 0.31 | | |
$ | 1.20 | |
Risk-free interest rate | |
| 4.13 | % | |
| 3.60 | % |
Expected volatility | |
| 119.7 | % | |
| 121.5 | % |
Expected life (in years) | |
| 5.0
– 4.5 | | |
| 5.0 | |
Expected dividend yield | |
| - | | |
| - | |
Fair value of warrants (in thousands) | |
$ | 1,535 | | |
$ | 5,831 | |
2020
Warrants
The
Company issued certain warrants during the year ended December 31, 2020 that contained a fundamental transaction provision that could
give rise to an obligation to pay cash to the warrant holder upon occurrence of certain change in control type events. In accordance
with ASC 480, the fair value of these warrants is classified as a liability in the Condensed Consolidated Balance Sheets and will be
re-measured at the end of every reporting period with the change in value reported in the Condensed Consolidated Statements of Operations.
The
warrant liabilities for the 2020 Warrants were valued using a Binomial pricing model with the following assumptions:
Schedule of Derivative Liabilities Assumptions
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
Stock price | |
$ | 0.31 | | |
$ | 0.89 | |
Risk-free interest rate | |
| 4.87 | % | |
| 4.22 | % |
Expected volatility | |
| 91 | % | |
| 109 | % |
Expected life (in years) | |
| 2.1 | | |
| 2.6 | |
Expected dividend yield | |
| - | | |
| - | |
| |
| | | |
| | |
Fair value of warrants | |
$ | 3 | | |
$ | 19 | |
During
the three months and six months ended June 30, 2023, the Company recognized a gain of $1.4 million and $4.4 million to account for the
change in fair value of the warrant liability between the reporting periods in accordance with ASC 842. During the three months and
six months ended June 30, 2022, the Company recognized a gain of $5 and $23 to account for the change in the fair value of the
warrant liability.
The
risk-free interest rate was based on rates established by the Federal Reserve Bank. The Company uses the historical volatility of its
common stock to estimate the future volatility for its common stock. The expected life of the warrant securities was determined by
the remaining contractual life of the warrant instrument. For derivative instruments that already matured, the Company used the estimated
life. The expected dividend yield was based on the fact that the Company has not paid dividends to its common stockholders in the past
and does not expect to pay dividends to its common stockholders in the future.
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
6 – Stockholders’ Equity
The
Company’s authorized capital as of June 30, 2023 was 250,000,000 shares of common stock, par value $0.001 per share, and 15,000,000
shares of preferred stock, par value $0.01 per share.
Common
Stock
Private
Placement of Common Stock
On
January 4, 2023, GT Biopharma received gross proceeds of $6.5 million, before deducting placement agent fees and other offering expenses
of $232 in relation to a purchase agreement (the “Purchase Agreement”) signed on December 30, 2022, between the Company
and an institutional investor (the “Purchaser”) for the issuance and sale, in a registered direct offering (the “Offering”),
of 3,600,000 shares of the Company’s common stock, par value $0.001 per share (the “Shares”), pre-funded warrants to
purchase up to 2,900,000 shares of the Company’s common stock (the “Pre-Funded Warrants”), warrants to purchase up
to an aggregate of 6,500,000 shares of the Company’s common stock (the “Common Warrants”) and placement agent warrants
to purchase up to 390,000 of the Company’s common stock (the “Placement Agents Warrants”). The Common Warrants have
an exercise price equal to $1.00, will be exercisable commencing six months following issuance, and will have a term of exercise equal
to five years following the initial exercise date. The Pre-Funded Warrants have an exercise price of $0.0001 per Share, are immediately
exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in full. The
Placement Agents Warrants have an exercise price equal to $1.25, will be exercisable commencing six months following issuance, and will
have a term of exercise equal to five years following the initial exercise date. The Shares and Common Warrants were sold at an offering
price of $1.00 per Share and accompanying Common Warrant and the Pre-Funded Warrants and Common Warrants were sold at an offering price
of $0.9999 per Pre-Funded Warrant and accompanying Common Warrant.
The
Common Warrants and the Placement Agents Warrants contained a clause not considered to be within the Company’s control. The Company
determined that the provision represented a variable that is not an input to the fair value of a “fixed-for-fixed” option
as defined under ASC 815-40, and thus the Common Warrants and the Placement Agent Warrants are not considered indexed to the Company’s
own stock and not eligible for an exception from derivative accounting. Accordingly, the Common Warrants and the Placement Agent Warrants
were classified as a warrant liability, and $5.8 million of the initial common stock offering was classified as a warrant liability (see
Note 5 – Warrant Liability).
During
the three months ended June 30, 2023, the 2,900,000 Pre-Funded Warrants were exercised. The Company received cash consideration of $0.290
and issued 2,900,000 shares of common stock in exchange for the exercise price of $0.0001 per share.
Common
Stock Issuable
On
February 16, 2021, because of the mandatory conversion of the notes payable and accrued interest in the aggregate amount of $38.8 million,
the Company issued a total of 11,413,322 shares of common stock to the respective noteholders, of which 11,086,024 were already issued
as of December 31, 2021. The remaining 327,298 common shares issuable at December 31, 2021 valued at $1.1 million, were issued during
the three months ended March 31, 2022.
Cancellation
of Common Stock
The
Company cancelled 290,999 previously issued shares of common stock during the three months ended March 31, 2022.
Common
Stock Issued for Services
During
the three and six months ended June 30, 2023, and pursuant to the vesting term of a 2021 agreement, the Company issued 0 and 73,454 shares
of common stock with a fair value of $0 and $315, respectively to members of the Board of Directors, employees and consultants. The
shares were valued at the respective date of the agreements.
Common Stock Issued for Vendor Payable
During the six months ended June 30, 2023,
the Company issued a total of 1,343,783
shares of common stock with a fair value of $591
to settle a vendor payable of $1.1
million. As a result, the Company recorded a gain of $577
to account the difference between the fair value of the common stock issued and the account payable settled. The common stock issued
were valued at the respective date of their issuance.
Preferred
Stock
Series
C Preferred Stock
At
June 30, 2023 and December 31, 2022, there were 96,230 shares of series C preferred stock, par value $0.01 per share (the “Series
C Preferred Stock”) issued and outstanding.
As
a result of reverse stock splits in previous years and the agreement terms for adjusting the rights of the related shares, the 96,230
shares of Series C Preferred Stock are not currently convertible, have no voting rights, and in the event of liquidation, the holders
of the Series C Preferred Stock would not participate in any distribution of the assets or surplus funds of the Company. The holders
of Series C Preferred Stock also are not currently entitled to any dividends if and when declared by the Company’s board of directors
(the “Board”). No dividends to holders of the Series C Preferred Stock were issued or unpaid through June 30, 2023 and 2022,
respectively.
Series
K Preferred Stock
On
February 16, 2021, the Board designated 115,000 shares of Series K preferred stock, par value $.01. (the “Series K Preferred Stock”).
Shares
of the Series K Preferred Stock are convertible at any time, at the option of the holders, into shares of the Company’s common
stock at an effective conversion rate of 100 shares of common stock for each share of Series K Preferred. Shares of the Series K Preferred
Stock have the same voting rights as the shares of the Company’s common stock, with the holders of the Series K Preferred Stock
entitled to vote on an as-converted-to-common stock basis, subject to the beneficial ownership limitation, together with the holders
of the Company’s common stock on all matters presented to the Company’s stockholders. The Series K Preferred Stock are not
entitled to any dividends (unless specifically declared by the Board) but will participate on an as-converted-to-common-stock basis in
any dividends to the holders of the Company’s common stock. In the event of the Company’s dissolution, liquidation or winding
up, the holders of the Series K Preferred Stock will be on parity with the holders of the Company’s common stock and will participate,
on an as-converted-to-common stock basis, in any distribution to holders of the Company’s common stock.
As
of June 30, 2023 and December 31, 2022, there were no shares of Series K Preferred stock issued and outstanding.
Warrants
and Options
Common
Stock Warrants
Common
stock warrant transactions for the six months ended June 30, 2023 were as follows:
Schedule of Warrant Activity
| |
Number of | | |
Weighted Average | |
| |
Warrants | | |
Exercise Price | |
Warrant outstanding at December 31, 2022: | |
| 2,337,274 | | |
$ | 5.30 | |
Granted | |
| 9,790,000 | | |
| 0.71 | |
Forfeited/canceled | |
| (78,394 | ) | |
| 3.40 | |
Exercised | |
| (2,900,000 | ) | |
| 0.0001 | |
Warrants outstanding at June 30, 2023 | |
| 9,148,880 | | |
$ | 2.11 | |
Warrants exercisable at June 30, 2023 | |
| 2,258,880 | | |
$ | 5.45 | |
The
warrants had an exercise price greater than the market price, which resulted in no intrinsic value.
Warrants
outstanding as of June 30, 2023 are exercisable as follows:
Schedule
of Warrants Outstanding
| | | |
| Warrants Outstanding | | |
| Warrants Exercisable | |
| Range of Exercise Price | | |
| Number Outstanding | | |
| Weighted Average Remaining Contractual Life (Years) | | |
| Weighted Average Exercise Price | | |
| Number Exercisable | | |
| Weighted Average Exercise Price | |
| $1.00 – 1.25 | | |
| 6,890,000 | | |
| 5.0 | | |
$ | 1.01 | | |
| - | | |
$ | - | |
| 3.40 – 5.50 | | |
| 2,258,880 | | |
| 2.6 | | |
| 5.45 | | |
| 2,258,880 | | |
| 5.45 | |
| | | |
| 9,148,880 | | |
| | | |
| | | |
| 2,258,880 | | |
| | |
Common
Stock Options
Common
stock option transactions for the six months ended June 30, 2023 were as follows:
Schedule
of Options Activity
| |
Number of | | |
Weighted Average | |
| |
Options | | |
Exercise Price | |
Options outstanding at December 31, 2022 | |
| 1,630,452 | | |
$ | 2.57 | |
Granted | |
| 2,500,000 | | |
| 0.75 | |
Forfeited/canceled | |
| (392,500 | ) | |
| 2.81 | |
Exercised | |
| - | | |
| - | |
Options outstanding at June 30, 2023 | |
| 3,737,952 | | |
$ | 1.32 | |
Options vested and exercisable at June 30, 2023 | |
| 2,177,891 | | |
$ | 1.71 | |
The
Company recognized the corresponding stock compensation expense for options granted to certain consultants, employees, officers and directors
based upon their vesting term.
On
January 27, 2023, the Company granted stock options to employees and members of its board of directors to purchase an aggregate of 2.0
million shares of common stock at an
exercise price of $0.85 per
share. The stock options expire in 10 years,
vest over twelve months and had a fair value of $1.4 million
at the date of grant determined using the Black-Scholes Option Pricing model with the following weighted average
assumptions.
On
May 15, 2023, the Company granted stock options to a member of its board of directors to purchase 500,000
shares of common stock at an exercise price of $0.35
per share. The stock options expire in 10
years, vest over twelve months and had a fair value of $150
on at the date of grant determined using the Black-Scholes Option Pricing model.
The
Company used the following weighted average assumptions in the Black-Scholes Option Pricing model to compute the fair value of the stock options granted during the period
ended June 30 ,2023.
Schedule
of Stock Granted Assumptions
Stock price | |
$ | $0.35 - $0.85 | |
Risk-free interest rate | |
| 3.62% - 3.99 | % |
Expected volatility | |
| 120.81% - 123.61 | % |
Expected life (in years) | |
| 5.3 | |
Expected dividend yield | |
| - | |
For
the three months and six months ended June 30, 2023, the Company recognized stock compensation expense relating to the vesting of options
granted in 2023 and prior years of $398 and $905, respectively.
Options
outstanding as of June 30, 2023 are exercisable as follows:
Schedule
of Options Outstanding
| | | |
| Options Outstanding | | |
| Options Exercisable |
| Range of Exercise Price | | |
| Number Outstanding | | |
| Weighted Average Remaining Contractual Life (Years) | | |
| Weighted Average Exercise Price | | |
| Number Exercisable | | |
| Weighted Average Exercise Price | |
$ | 2.48 | | |
| 1,237,952 | | |
| 9.0 | | |
$ | 2.48 | | |
| 1,154,081 | | |
$ | 2.48 | |
| 0.85 | | |
| 2,000,000 | | |
| 9.6 | | |
| 0.85 | | |
| 1,000,000 | | |
| 0.85 | |
| 0.35 | | |
| 500,000 | | |
| 9.9 | | |
| 0.35 | | |
| 23,810 | | |
| 0.35 | |
| | | |
| 3,737,952 | | |
| | | |
| | | |
| 2,177,891 | | |
| | |
At
June 30, 2023, fair value of unvested options totaled $1.1
million, which will be recognized as stock compensation
expense in future periods based upon the remaining vesting term of the applicable grants.
There
was no intrinsic value of the outstanding options as of June 30, 2023 as the exercise price of these options was greater than the market
price.
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note
7 – Commitments and Contingencies
Litigation
The
Company is involved in certain legal proceedings that arise from time to time in the ordinary course of our business. Except for income
tax contingencies, we record accruals for contingencies to the extent that our management concludes that the occurrence is probable and
that the related amounts of loss can be reasonably estimated. Legal expenses associated with the contingency are expensed as incurred.
There is no current or pending litigation of any significance with the exception of the matters that have arisen under, and are being
handled in, the normal course of business.
On
May 11, 2023, our former interim Chief Executive Officer, Dr. Greg Berk, filed a complaint with the Occupational Safety and Health Administration
alleging retaliation against him during his tenure at the Company for raising concerns related to the public disclosure of certain product
timelines. The Company is vigorously defending this matter and believe it to be without merit. At this early stage in the proceedings,
the Company is not able to determine the probability of the outcome of this matter or a range of reasonably expected losses, if any.
On
May 13, 2022, the Company made a claim against Michael Handelman, its former Chief Financial Officer, asserting that he misappropriated
Company funds and shares of common stock, and failed to file the required SEC reports on Form 3 and Form 4 regarding each acquisition
and disposition of the Company’s common stock. The Company seeks monetary damages estimated at $370; the return of shares of
our common stock received without authorization and the disgorgement of any profits earned from the sale of those shares; a full accounting
for all sums charged on the Company’s debit card, with payment to the Company for any charges that cannot be demonstrated to have
a corporate purpose; an order directing Mr. Handelman to make all filings required by Section 16(a) of the 1934 Act; an award of all
sums and shares improperly issued to members of Mr. Handelman’s family; and an award of the Company’s attorneys’ fees
and any forum and arbitration fees. As a component of Mr. Handelman’s contract with the Company, disputes shall be fully addressed
and finally resolved by binding arbitration conducted by the American Arbitration Association (AAA) in New York City, New York, in accordance
with its National Employment Dispute Resolution rules. In connection with any such arbitration, the Company shall bear all costs not
otherwise borne by a plaintiff in a court proceeding. The Company agrees that any decisions of the arbitration panel will be binding
and enforceable in any state in which the Company conducts the operation of its business. In accordance with California Labor Laws, the
Company has designated Los Angeles, California as the venue for this arbitration. The claims are pending before an arbitrator in Los
Angeles and the hearing is scheduled to begin on October 26, 2023. Mr. Handelman has not asserted counterclaims against the Company.
On
May 24, 2023, TWF Global, LLC (“TWF”) filed a Complaint in the California Superior Court for the County of Los Angeles naming
the Company as defendant. The Complaint alleges that TWF is the holder of two convertible notes and that the Company did not deliver
shares of common stock due on conversion in February 2021. TWF is seeking per diem liquidated damages based on the terms of alleged
convertible notes. The Company filed a motion to dismiss for improper forum on July 14, 2023 because the convertible notes
require disputes to be filed in New York state and federal courts. The Company believes that TWF’s claims are without merit
and will continue to defend vigorously against these claims.
Significant
Agreements
Research
and Development Agreements
In
June 2017, we entered into a co-development partnership agreement with Altor BioScience Corporation in which we will collaborate exclusively
in the clinical development of a novel 161533 (GTB-3550) TriKE® fusion protein for cancer therapies using our TriKE®
technology. The GTB-3550 Phase 1 clinical trial for treatment of patients with CD33-expressing, high risk myelodysplastic syndromes
and refractory/relapsed acute myeloid leukemia opened for patient enrollment September 2019 and completed enrollment in September 2021.
The results of our first generation GTB-3550 Phase 1 clinical trial support our plans to advance the next generation camelid nanobody
into the clinic, and as such, no further clinical development will ensue with GTB-3550.
The
Company is a party to a scientific research agreement with the Regents of the University of Minnesota, effective June 16, 2021. This
scientific research agreement aims to work with the Company with three major goals in mind: (1) support the Company’s TriKE®
product development and GMP manufacturing efforts; (2) TriKE® pharmacokinetics optimization in humans; and (3) investigation
of the patient’s native NK cell population based on insights obtained from the analysis of the human data generated during our
GTB-3550 clinical trial. The major deliverables proposed here are: (1) creation of IND enabling data for TriKE® constructs
in support of our product development and GMP manufacturing efforts; (2) TriKE® platform drug delivery changes to allow
transition to alternative drug delivery means and extended PK in humans; and (3) gain an increased understanding of changes in the patient’s
native NK cell population as a result of TriKE® therapy. Most studies will use TriKE® DNA/amino acid sequences
created by us under current UMN/GTB licensing terms. This agreement expired on June 30, 2023. The University of Minnesota shall use reasonable
efforts to complete the project for a fixed sum of $2.1 million.
For
the three months and six months ended June 30, 2023 and June 30, 2022, the Company recorded an expense of $192 and
$383,
respectively, for each respective period. The Company has recorded expense in the aggregate of $2.1 million
as of June 30, 2023 pursuant to this agreement.
Patent
and License Agreements
2016
Exclusive Patent License Agreement
The
Company is party to an exclusive worldwide license agreement with the Regents of the University of Minnesota, (“UofMN”),
to further develop and commercialize cancer therapies using TriKE® technology developed by researchers at the UofMN to
target NK cells to cancer. Under the terms of the 2016 agreement, the Company receives exclusive rights to conduct research and to develop,
make, use, sell, and import TriKE® technology worldwide for the treatment of any disease, state, or condition in humans.
The Company is responsible for obtaining all permits, licenses, authorizations, registrations, and regulatory approvals required or granted
by any governmental authority anywhere in the world that is responsible for the regulation of products such as the TriKE®
technology, including without limitation the FDA and the European Agency for the Evaluation of Medicinal Products in the European Union.
Under the agreement, the UofMN received an upfront payment of $200, and an annual License Maintenance fee of $100 beginning in
2021. The agreement also includes 4% royalty fees, not to exceed 6% under subsequence license agreements or amendments to this agreement
or minimum annual royalty payments ranging from $250 to $5.0 million. The agreement also includes certain performance milestone payments
totaling $3.1 million, and one-time sales milestone payments of $1.0 million upon reaching $250 million in gross sales, and $5.0 million
upon reaching $500 million dollars in cumulative gross sales of Licensed Products.
The
Company did not incur any research and development expense relating to the 2016 Exclusive Patent License Agreement for the three months
and six months ended June 30, 2023.
2021
Patent License Agreement
On
March 26, 2021, the Company signed an agreement specific to the B7H3 targeted TriKE®. Under the agreement, the UofMN received
an upfront license fee of $20,000 and will receive an annual License Maintenance fee of $5 beginning in 2022, 2.5% to 5% royalty
fees, or minimum annual royalty payments of $250 beginning in the year after the first commercial sales of Licensed Product, and
$2.0 million beginning in the fifth year after the first commercial sale of such Licensed Product. The agreement also includes certain
performance milestone payments totaling $3.1 million, and one-time sales milestone payments of $1.0 million upon reaching $250 million
in gross sales, and $5.0 million upon reaching $500 million dollars in cumulative gross sales of Licensed Products. There is no double
payment intended; if one of the milestone payments has been paid under the 2016 agreement no further payment is due for the corresponding
milestone above.
The
Company did not incur any research and development expense relating to the 2021 Patent License Agreement for the three months and six
months ended June 30, 2023.
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v3.23.2
Operating Leases
|
6 Months Ended |
Jun. 30, 2023 |
Operating Leases |
|
Operating Leases |
Note
8 – Operating Leases
On
November 19, 2021, the Company entered into a sublease with a third party for 4,500 square feet of office space located in Brisbane,
California, with a commencement date of January 1, 2022 and maturing on June 30, 2024. Leases with an initial term of 12 months or less
are not recorded on the balance sheet. The Company accounts for the lease and non-lease components of its leases as a single lease component.
Rent expense is recognized on a straight-line basis over the lease term. As a result of this agreement, the Company recognized right-of-use
(“ROU”) asset and liability of $247 pursuant to ASC 842, Leases. Operating lease ROU assets and liabilities are recognized
at the lease commencement date based on the present value of lease payments over the lease term. ROU assets represent the Company’s
right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments
arising from the lease. Generally, the implicit rate of interest in arrangements is not readily determinable and the Company utilizes
its incremental borrowing rate in determining the present value of lease payments. The Company’s incremental borrowing rate is
a hypothetical collateralized borrowing rate based on its understanding of what its credit rating would be. The operating lease ROU asset
includes any lease payments made and excludes lease incentives.
On
February 8, 2022, the Company entered into a copier lease which will end on February 7, 2025. As a result, the Company recognized
additional ROU asset and liability of $13.
As
a result of these lease agreements, the Company recognized ROU asset and liability in the aggregate of $260.
Rent
expense related to these leases reflected on the Company’s Condensed Consolidated Statements of Operations totaled $29 and
$58 for the three months and six months ended June 2023. Rent expense totaled $29 and $58 for the three months and six months
ended June 2022.
Other
information related to leases and future minimum lease payments under non-cancellable operating leases were as follows:
Schedule of Other Information Related Leases Under Non-Cancellable
| |
June 30, 2023
| | |
June 30, 2022
| |
| |
(Unaudited) | | |
(Unaudited) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 30 | | |
$ | 49 | |
Right-of-use assets obtained in exchange for lease liabilities: | |
| | | |
| | |
Operating leases | |
$ | 114 | | |
$ | 165 | |
Weighted-average remaining lease term (in years): | |
| | | |
| | |
Operating leases | |
| 1.25 | | |
| 2.25 | |
Weighted-average discount rate: | |
| | | |
| | |
Operating leases | |
| 10 | % | |
| 10 | % |
Future
minimum lease payments under non-cancellable operating leases were as follows:
Schedule of Future Minimum Lease Payments
| |
June 30, 2023
| |
| |
(Unaudited) | |
Within one year | |
$ | 153 | |
After one year and within two years | |
| 3 | |
Thereafter | |
| - | |
Total future minimum lease payments | |
$ | 156 | |
Less – discount | |
| (36 | ) |
Lease liability | |
$ | 120 | |
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v3.23.2
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation and Principles of Consolidation |
Basis
of Presentation and Principles of Consolidation
The
consolidated condensed financial statements include the accounts of the Company and its wholly-owned subsidiaries, Oxis Biotech, Inc.
and Georgetown Translational Pharmaceuticals, Inc. All intercompany transactions and balances have been eliminated in consolidation.
The
accompanying condensed consolidated financial statements are unaudited. These interim condensed consolidated financial statements have
been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable
rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information
and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant
to such rules and regulations. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with
the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, filed with the SEC on March 30, 2023 (the “2022 Annual Report”). The consolidated balance sheets
as of December 31, 2022 included herein, was derived from the audited consolidated financial statements as of that date.
In
the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary to
fairly present the Company’s financial position and its results of operations for the interim periods reflected. Except as noted,
all adjustments contained herein are of a normal recurring nature. Results of operations for the fiscal periods presented herein are
not necessarily indicative of fiscal year-end results.
|
Liquidity |
Liquidity
The
accompanying consolidated financial statements have been prepared under the assumption that the Company will continue as a going concern.
Such assumptions contemplate the realization of assets and satisfaction of liabilities in the normal course of business. For the six
months ended June 30, 2023, the Company recorded a net loss of $2.2 million and used cash in operations of $4.8 million. As of June 30,
2023, the Company had a cash and short-term investments balance of $18.0 million, working capital of $13.2 million, and stockholders’
equity of $11.8 million. Management anticipates that the $18.0 million of cash and cash equivalents, and short-term investments are adequate
to satisfy the liquidity needs of the Company for at least one year from the date the Company’s condensed consolidated financial
statements for the six-month period ended June 30, 2023 were issued.
Historically,
the Company has financed its operations through public and private sales of common stock, issuance of preferred and common stock, issuance
of convertible debt instruments, and strategic collaborations. There can be no assurances that the Company will be able to secure additional
financing on acceptable terms. In the event the Company does not generate sufficient cash flows from investing and financing activities,
the Company will be forced to delay, reduce, or eliminate some or all of its discretionary spending, which could adversely affect the
Company’s business prospects, ability to meet long-term liquidity needs or ability to continue its operations.
|
COVID-19 |
COVID-19
The
global COVID-19 pandemic continues to present uncertainty and unforeseeable risks to our operations and business plans. The Company has
closely monitored recent developments, including the lifting of COVID-19 safety measures, the spread of new strains or variants of the
coronavirus (such as the Delta and Omicron variants), and supply chain, raw materials and labor shortages. Thus, the full impact of the
COVID-19 pandemic on the business and operations remains uncertain and will vary depending on the pandemic’s future impact on the
third parties with whom the Company does business, as well as any legal or regulatory consequences resulting therefrom. The Company has
been following the recommendations of health authorities to minimize exposure risk for its team members and may take further actions
that alter our operations, including any required by federal, state or local authorities, or that it determines are in the best interests
of its employees and other third parties with whom GT Biopharma does business.
|
Accounting Estimates |
Accounting
Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant
estimates include accruals for potential liabilities, assumptions used in deriving the fair value of warrant liabilities, valuation
of equity instruments issued for services and realization of deferred tax assets. Actual results could differ from those estimates.
|
Cash Equivalents and Short-Term Investments |
Cash
Equivalents and Short-Term Investments
The
Company considers highly liquid investments with maturities of three months or less at the date of acquisition as cash equivalents in
the accompanying condensed consolidated financial statements. Total cash equivalents, which consist of money market funds, totaled approximately
$2.4 million and $5.5 million at June 30, 2023 and December 31, 2022, respectively.
The
Company also invested its excess cash in commercial paper and corporate notes and bonds. Management generally determines the appropriate
classification of its investments at the time of purchase. We classify these investments as short-term investments as part of current
assets, based upon our ability and intent to use any and all of these investments as necessary to satisfy liquidity requirements that
may arise from our business. Investments are carried at fair value with the unrealized holding gains and losses reported in the accompanying
condensed consolidated statements of operations. Total short-term investments totaled approximately $15.2 million and $10.8 million at
June 30, 2023 and December 31, 2022, respectively.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
Financial
Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820-10 requires entities to disclose
the fair value of financial instruments, both assets and liabilities recognized and not recognized on the balance sheet for which it
is practicable to estimate fair value. ASC 820-10 defines the fair value of a financial instrument as the amount at which the instrument
could be exchanged in a current transaction between willing parties.
The
three levels of the fair value hierarchy are as follows:
|
Level
1 |
Valuations
based on unadjusted quoted prices in active markets for identical assets or liabilities that the entity has the ability to access. |
|
|
|
|
Level
2 |
Valuations
based on quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are
observable or can be corroborated by observable data for substantially the full term of the assets or liabilities. |
|
|
|
|
Level
3 |
Valuations
based on inputs that are unobservable, supported by little or no market activity and that are significant to the fair value of the
assets or liabilities. |
The
carrying amount of the Company’s warrant liability of $1.5 million and $19 at June 30, 2023 and December 31, 2022, respectively,
was based on Level 3 measurements.
The
carrying amounts of the Company’s other financial assets and liabilities such as cash, other current assets, accounts payable and
accrued expenses approximate their fair values because of the short maturity of these instruments.
|
Derivatives and Liability-Classified Instruments |
Derivatives
and Liability-Classified Instruments
The
Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of
the specific terms of the warrants and the guidance provided by the FASB in ASC 480, Distinguishing Liabilities from Equity (ASC
480) and ASC 815, Derivatives and Hedging (ASC 815). The assessment considers whether the warrants are freestanding
financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and meet all of the requirements
for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own stock and whether the
holders of the warrants could potentially require net cash settlement in a circumstance outside of the Company’s control,
among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at
the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. The fair value
of the warrant liability is determined using a Binomial valuation method at inception and on
subsequent valuation dates.
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company accounts for share-based awards to employees, nonemployees, and consultants in accordance with the provisions of ASC 718, Compensation-Stock
Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense
over the requisite service or vesting period.
The
Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the
Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free
interest rate. The Company estimates volatility using its own historical stock price volatility. The expected term of the instrument
is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published
federal funds rates.
|
Research and Development Costs |
Research
and Development Costs
Costs
incurred for research and development are expensed as incurred. The salaries, benefits, and overhead costs of personnel conducting research
and development of the Company’s products are included in research and development costs. Purchased materials that do not have
an alternative future use are also expensed.
|
Leases |
Leases
The
Company accounts for its leases in accordance with the guidance of ASC 842, Leases. The Company determines whether a contract is, or
contains, a lease at inception. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term,
and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and
lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease
term. The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present
value of unpaid lease payments (see Note 8 – Operating Leases for the Company’s lease disclosures).
|
Net Loss Per Share |
Net
Loss Per Share
Basic
loss per share is computed using the weighted-average number of common shares outstanding during the period. Common stock issuable is
included in our calculation as of the date of the underlying agreement. Diluted loss per share is computed using the weighted-average
number of common shares and the dilutive effect of contingent shares outstanding during the period. Potentially dilutive contingent shares,
which primarily consist of stock issuable for the exercise of stock options and warrants, have been excluded from the diluted loss per
share calculation because their effect is anti-dilutive.
These
following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive:
Schedule
of Anti-dilutive Securities
| |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | |
Options to purchase common stock | |
| 3,737,952 | | |
| 302,500 | |
Warrants to purchase common stock | |
| 9,148,880 | | |
| 2,337,274 | |
Unvested restricted common stock | |
| - | | |
| 488,429 | |
Total anti-dilutive securities | |
| 12,886,832 | | |
| 3,128,203 | |
|
Concentration |
Concentration
Cash
is deposited in one financial institution. The balances held at this financial institution at times may be in excess of Federal Deposit
Insurance Corporation (“FDIC”) insurance limits of up to $250.
From time to time, however, the Company may be exposed to risk for the amounts of funds held in bank accounts in excess of the FDIC limit.
To minimize the risk, the Company’s policy is to maintain cash balances with high quality financial institutions.
The
Company has a significant concentration of expenses incurred and accounts payable from a single vendor (see Note 4 – Accounts Payable for further information).
|
Segments |
Segments
The
Company determined its reporting units in accordance with ASC 280, “Segment Reporting” (“ASC 280”). Management
evaluates a reporting unit by first identifying its’ operating segments under ASC 280. The Company then evaluates each operating
segment to determine if it includes one or more components that constitute a business. If there are components within an operating segment
that meet the definition of a business, the Company evaluates those components to determine if they must be aggregated into one or more
reporting units. If applicable, when determining if it is appropriate to aggregate different operating segments, the Company determines
if the segments are economically similar and, if so, the operating segments are aggregated.
Management
has determined that the Company has one consolidated operating segment. The Company’s reporting segment reflects the manner in
which its chief operating decision maker reviews results and allocates resources. The Company’s reporting segment meets the definition
of an operating segment and does not include the aggregation of multiple operating segments.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Credit Losses – Measurement of Credit
Losses on Financial Instruments (“ASC 326”). ASU 2016-13 requires entities to use a forward-looking approach based on
current expected credit losses (“CECL”) to estimate credit losses on certain types of financial instruments, including trade
receivables. This may result in the earlier recognition of allowances for losses. ASU 2016-13 is effective for the Company beginning
January 1, 2023, and early adoption is permitted. The Company adopted this standard effective January 1, 2023 and there was no material impact of adopting this standard
on the Company’s financial statements and related disclosures.
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock
Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. ASU 2021-04 provides clarification
and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options
(such as warrants) that remain equity classified after modification or exchange. An issuer measures the effect of a modification or exchange
as the difference between the fair value of the modified or exchanged warrant and the fair value of that warrant immediately before modification
or exchange. ASU 2021-04 introduces a recognition model that comprises four categories of transactions and the corresponding accounting
treatment for each category (equity issuance, debt origination, debt modification, and modifications unrelated to equity issuance and
debt origination or modification). ASU 2021-04 was effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years, applied prospectively to modifications or exchanges occurring on or after the effective date. Effective January
1, 2022, we adopted ASU 2021-04 using a prospective approach. It did not have a material impact on the Company’s financial statements
or disclosures.
Other
recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public
Accountants, and the SEC did not or are not believed by management to have a material impact on the Company’s present or future
consolidated financial statements.
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v3.23.2
Summary of Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Anti-dilutive Securities |
These
following common stock equivalents were excluded in the computation of the net loss per share because their effect is anti-dilutive:
Schedule
of Anti-dilutive Securities
| |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | |
Options to purchase common stock | |
| 3,737,952 | | |
| 302,500 | |
Warrants to purchase common stock | |
| 9,148,880 | | |
| 2,337,274 | |
Unvested restricted common stock | |
| - | | |
| 488,429 | |
Total anti-dilutive securities | |
| 12,886,832 | | |
| 3,128,203 | |
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v3.23.2
Fair Value of Financial Instruments (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Estimated Fair Value of Financial Instrument |
The
estimated fair values of financial instruments outstanding were as follow:
Schedule
of Estimated Fair Value of Financial Instrument
| |
June 30, 2023 (Unaudited) | |
| |
| | |
Unrealized | | |
Unrealized | | |
Fair | |
| |
Cost | | |
Gains | | |
Losses | | |
Value | |
Short-term investments | |
$ | 15,168 | | |
$ | 38 | | |
$ | — | | |
$ | 15,206 | |
Total | |
$ | 15,168 | | |
$ | 38 | | |
$ | — | | |
$ | 15,206 | |
| |
December 31, 2022 | |
| |
| | |
Unrealized | | |
Unrealized | | |
Fair | |
| |
Cost | | |
Gains | | |
Losses | | |
Value | |
Short-term investments | |
$ | 10,866 | | |
$ | — | | |
$ | (30 | ) | |
$ | 10,836 | |
Total | |
$ | 10,866 | | |
$ | — | | |
$ | (30 | ) | |
$ | 10,836 | |
|
Schedule of Fair Value Hierarchy Financial Assets |
The
following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments):
Schedule of Fair Value Hierarchy Financial Assets
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
June 30, 2023 (Unaudited) | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Money market funds | |
$ | 2,364 | | |
$ | 2,364 | | |
$ | — | | |
$ | — | |
Corporate notes and commercial paper | |
| 15,206 | | |
| 15,206 | | |
| — | | |
| — | |
Total financial assets | |
$ | 17,570 | | |
$ | 17,570 | | |
$ | — | | |
$ | — | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
December 31, 2022 | |
| |
Fair Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
Money market funds | |
$ | 5,505 | | |
$ | 5,505 | | |
$ | — | | |
$ | — | |
Corporate notes and commercial paper | |
| 10,836 | | |
| 10,836 | | |
| — | | |
| — | |
Total financial assets | |
$ | 16,341 | | |
$ | 16,341 | | |
$ | — | | |
$ | — | |
|
Schedule of Derivative Liability Transactions |
Schedule of Derivative Liability Transactions
| |
June 30, 2023 | | |
June 30, 2022 | | |
June 30, 2023 | | |
June 30, 2022 | |
| |
Three Months Ending | | |
Six Months Ending | |
| |
June 30, 2023 | | |
June 30, 2022 | | |
June 30, 2023 | | |
June 30, 2022 | |
| |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | | |
(Unaudited) | |
Beginning balance | |
$ | 2,925 | | |
$ | 120 | | |
$ | 19 | | |
$ | 138 | |
Fair value upon issuance of warrants | |
| — | | |
| — | | |
| 5,830 | | |
| — | |
Change in fair value | |
$ | (1,433 | ) | |
$ | (5 | ) | |
$ | (4,357 | ) | |
$ | (23 | ) |
Ending balance | |
$ | 1,492 | | |
$ | 115 | | |
$ | 1,492 | | |
$ | 115 | |
|
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v3.23.2
Accounts Payable (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accounts Payable |
Accounts
payable consisted of the following:
Schedule of Accounts Payable
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
Accounts payable to a third-party manufacturer | |
$ | 2,910 | | |
$ | 2,283 | |
Other accounts payable | |
| 591 | | |
| 857 | |
Total accounts payable | |
$ | 3,501 | | |
$ | 3,140 | |
|
X |
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v3.23.2
Warrant Liability (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Short-Term Debt [Line Items] |
|
Schedule of Derivative Liabilities Assumptions |
Schedule
of Stock Granted Assumptions
Stock price | |
$ | $0.35 - $0.85 | |
Risk-free interest rate | |
| 3.62% - 3.99 | % |
Expected volatility | |
| 120.81% - 123.61 | % |
Expected life (in years) | |
| 5.3 | |
Expected dividend yield | |
| - | |
|
2023 Warrants [Member] |
|
Short-Term Debt [Line Items] |
|
Schedule of Derivative Liabilities Assumptions |
The
warrant liabilities for the Common Warrants and the Placement Agents Warrants were valued using a Binomial pricing model with the following
weighted average assumptions:
Schedule of Derivative Liabilities Assumptions
| |
Common Warrants and Placement
Agents Warrants | |
| |
June 30, 2023 | | |
At Inception | |
| |
(Unaudited) | | |
(Unaudited) | |
Stock price | |
$ | 0.31 | | |
$ | 1.20 | |
Risk-free interest rate | |
| 4.13 | % | |
| 3.60 | % |
Expected volatility | |
| 119.7 | % | |
| 121.5 | % |
Expected life (in years) | |
| 5.0
– 4.5 | | |
| 5.0 | |
Expected dividend yield | |
| - | | |
| - | |
Fair value of warrants (in thousands) | |
$ | 1,535 | | |
$ | 5,831 | |
|
2020 Warrants [Member] |
|
Short-Term Debt [Line Items] |
|
Schedule of Derivative Liabilities Assumptions |
The
warrant liabilities for the 2020 Warrants were valued using a Binomial pricing model with the following assumptions:
Schedule of Derivative Liabilities Assumptions
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
Stock price | |
$ | 0.31 | | |
$ | 0.89 | |
Risk-free interest rate | |
| 4.87 | % | |
| 4.22 | % |
Expected volatility | |
| 91 | % | |
| 109 | % |
Expected life (in years) | |
| 2.1 | | |
| 2.6 | |
Expected dividend yield | |
| - | | |
| - | |
| |
| | | |
| | |
Fair value of warrants | |
$ | 3 | | |
$ | 19 | |
|
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v3.23.2
Stockholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Class of Warrant or Right [Line Items] |
|
Schedule of Warrants Outstanding |
Common
stock warrant transactions for the six months ended June 30, 2023 were as follows:
Schedule of Warrant Activity
| |
Number of | | |
Weighted Average | |
| |
Warrants | | |
Exercise Price | |
Warrant outstanding at December 31, 2022: | |
| 2,337,274 | | |
$ | 5.30 | |
Granted | |
| 9,790,000 | | |
| 0.71 | |
Forfeited/canceled | |
| (78,394 | ) | |
| 3.40 | |
Exercised | |
| (2,900,000 | ) | |
| 0.0001 | |
Warrants outstanding at June 30, 2023 | |
| 9,148,880 | | |
$ | 2.11 | |
Warrants exercisable at June 30, 2023 | |
| 2,258,880 | | |
$ | 5.45 | |
|
Schedule of Options Activity |
Common
stock option transactions for the six months ended June 30, 2023 were as follows:
Schedule
of Options Activity
| |
Number of | | |
Weighted Average | |
| |
Options | | |
Exercise Price | |
Options outstanding at December 31, 2022 | |
| 1,630,452 | | |
$ | 2.57 | |
Granted | |
| 2,500,000 | | |
| 0.75 | |
Forfeited/canceled | |
| (392,500 | ) | |
| 2.81 | |
Exercised | |
| - | | |
| - | |
Options outstanding at June 30, 2023 | |
| 3,737,952 | | |
$ | 1.32 | |
Options vested and exercisable at June 30, 2023 | |
| 2,177,891 | | |
$ | 1.71 | |
|
Schedule of Stock Granted Assumptions |
Schedule
of Stock Granted Assumptions
Stock price | |
$ | $0.35 - $0.85 | |
Risk-free interest rate | |
| 3.62% - 3.99 | % |
Expected volatility | |
| 120.81% - 123.61 | % |
Expected life (in years) | |
| 5.3 | |
Expected dividend yield | |
| - | |
|
Schedule of Options Outstanding |
Options
outstanding as of June 30, 2023 are exercisable as follows:
Schedule
of Options Outstanding
| | | |
| Options Outstanding | | |
| Options Exercisable |
| Range of Exercise Price | | |
| Number Outstanding | | |
| Weighted Average Remaining Contractual Life (Years) | | |
| Weighted Average Exercise Price | | |
| Number Exercisable | | |
| Weighted Average Exercise Price | |
$ | 2.48 | | |
| 1,237,952 | | |
| 9.0 | | |
$ | 2.48 | | |
| 1,154,081 | | |
$ | 2.48 | |
| 0.85 | | |
| 2,000,000 | | |
| 9.6 | | |
| 0.85 | | |
| 1,000,000 | | |
| 0.85 | |
| 0.35 | | |
| 500,000 | | |
| 9.9 | | |
| 0.35 | | |
| 23,810 | | |
| 0.35 | |
| | | |
| 3,737,952 | | |
| | | |
| | | |
| 2,177,891 | | |
| | |
|
Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Schedule of Warrants Outstanding |
Warrants
outstanding as of June 30, 2023 are exercisable as follows:
Schedule
of Warrants Outstanding
| | | |
| Warrants Outstanding | | |
| Warrants Exercisable | |
| Range of Exercise Price | | |
| Number Outstanding | | |
| Weighted Average Remaining Contractual Life (Years) | | |
| Weighted Average Exercise Price | | |
| Number Exercisable | | |
| Weighted Average Exercise Price | |
| $1.00 – 1.25 | | |
| 6,890,000 | | |
| 5.0 | | |
$ | 1.01 | | |
| - | | |
$ | - | |
| 3.40 – 5.50 | | |
| 2,258,880 | | |
| 2.6 | | |
| 5.45 | | |
| 2,258,880 | | |
| 5.45 | |
| | | |
| 9,148,880 | | |
| | | |
| | | |
| 2,258,880 | | |
| | |
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v3.23.2
Operating Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Operating Leases |
|
Schedule of Other Information Related Leases Under Non-Cancellable |
Other
information related to leases and future minimum lease payments under non-cancellable operating leases were as follows:
Schedule of Other Information Related Leases Under Non-Cancellable
| |
June 30, 2023
| | |
June 30, 2022
| |
| |
(Unaudited) | | |
(Unaudited) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 30 | | |
$ | 49 | |
Right-of-use assets obtained in exchange for lease liabilities: | |
| | | |
| | |
Operating leases | |
$ | 114 | | |
$ | 165 | |
Weighted-average remaining lease term (in years): | |
| | | |
| | |
Operating leases | |
| 1.25 | | |
| 2.25 | |
Weighted-average discount rate: | |
| | | |
| | |
Operating leases | |
| 10 | % | |
| 10 | % |
|
Schedule of Future Minimum Lease Payments |
Future
minimum lease payments under non-cancellable operating leases were as follows:
Schedule of Future Minimum Lease Payments
| |
June 30, 2023
| |
| |
(Unaudited) | |
Within one year | |
$ | 153 | |
After one year and within two years | |
| 3 | |
Thereafter | |
| - | |
Total future minimum lease payments | |
$ | 156 | |
Less – discount | |
| (36 | ) |
Lease liability | |
$ | 120 | |
|
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v3.23.2
Schedule of Anti-dilutive Securities (Details) - shares
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive securities |
12,886,832
|
3,128,203
|
Equity Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive securities |
3,737,952
|
302,500
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive securities |
9,148,880
|
2,337,274
|
Unvested Restricted Common Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive securities |
|
488,429
|
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v3.23.2
Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
|
|
|
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Mar. 31, 2022 |
Dec. 31, 2021 |
Accounting Policies [Abstract] |
|
|
|
|
|
|
|
|
Net loss |
$ 1,992
|
$ 2,979
|
$ 2,219
|
$ 8,419
|
|
|
|
|
Cash used in operating activities |
|
|
4,841
|
8,001
|
|
|
|
|
Cash on hand and short term investment |
18,000
|
|
18,000
|
|
|
|
|
|
Working capital |
13,200
|
|
13,200
|
|
|
|
|
|
Stockholders' equity |
11,763
|
$ 15,440
|
11,763
|
$ 15,440
|
$ 13,053
|
$ 11,734
|
$ 17,789
|
$ 21,910
|
Cash and cash equivalents, and short-term investments |
18,000
|
|
18,000
|
|
|
|
|
|
Cash equivalents |
2,400
|
|
2,400
|
|
|
5,500
|
|
|
Short-term investments |
15,206
|
|
15,206
|
|
|
10,836
|
|
|
Derivative liability |
1,500
|
|
1,500
|
|
|
$ 19
|
|
|
Cash, FDIC Insured Amount |
$ 250
|
|
$ 250
|
|
|
|
|
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Schedule of Estimated Fair Value of Financial Instrument (Details) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Cost |
$ 15,168
|
$ 10,866
|
Unrealized gains |
38
|
|
Unrealized losses |
|
(30)
|
Fair value |
15,206
|
10,836
|
Short-Term Investments [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Cost |
15,168
|
10,866
|
Unrealized gains |
38
|
|
Unrealized losses |
|
(30)
|
Fair value |
$ 15,206
|
$ 10,836
|
X |
- DefinitionAmortized cost of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).
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v3.23.2
Schedule of Fair Value Hierarchy Financial Assets (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
$ 17,570
|
$ 16,341
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
17,570
|
16,341
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
2,364
|
5,505
|
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
2,364
|
5,505
|
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
Corporate Notes and Commercial Paper [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
15,206
|
10,836
|
Corporate Notes and Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
15,206
|
10,836
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
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Schedule of Derivative Liability Transactions (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Fair Value Disclosures [Abstract] |
|
|
|
|
Beginning balance |
$ 2,925
|
$ 120
|
$ 19
|
$ 138
|
Fair value upon issuance of warrants |
|
|
5,830
|
|
Change in fair value |
(1,433)
|
(5)
|
(4,357)
|
(23)
|
Ending balance |
$ 1,492
|
$ 115
|
$ 1,492
|
$ 115
|
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v3.23.2
Schedule of Accounts Payable (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
Accounts payable to a third-party manufacturer |
$ 3,501
|
$ 3,140
|
Other accounts payable |
591
|
857
|
Total accounts payable |
3,501
|
3,140
|
Third Party [Member] |
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
Accounts payable to a third-party manufacturer |
2,910
|
2,283
|
Total accounts payable |
$ 2,910
|
$ 2,283
|
X |
- DefinitionCarrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).
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Accounts Payable (Details Narrative) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Reserach and development expenses |
$ 2,095
|
$ 1,139
|
$ 3,745
|
$ 3,226
|
|
Stock Issued During Period, Value, New Issues |
|
|
6,268
|
|
|
Accounts Payable, Current |
3,501
|
|
3,501
|
|
$ 3,140
|
Common Stock [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Accounts Payable |
1,100
|
|
$ 1,100
|
|
|
Stock Issued During Period, Shares, New Issues |
|
|
3,600
|
|
|
Stock Issued During Period, Value, New Issues |
|
|
$ 4
|
|
|
Service Agreement [Member] | Third Party Manufacturer [Member] | Common Stock [Member] |
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
Accounts Payable |
2,900
|
|
2,900
|
|
$ 2,300
|
Reserach and development expenses |
2,100
|
$ 1,100
|
3,700
|
$ 3,200
|
|
Cash received |
1,100
|
|
$ 1,100
|
|
|
Stock Issued During Period, Shares, New Issues |
|
|
1,300
|
|
|
Stock Issued During Period, Value, New Issues |
|
|
$ 591
|
|
|
Accounts Payable, Current |
$ 1,100
|
|
1,100
|
|
|
Gain (Loss) Related to Litigation Settlement |
|
|
$ 547
|
|
|
X |
- DefinitionCarrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).
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v3.23.2
Schedule of Derivative Liabilities Assumptions (Details) $ in Thousands |
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jan. 04, 2023
USD ($)
$ / shares
|
Jun. 30, 2023
USD ($)
$ / shares
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
$ / shares
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
$ / shares
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Fair value of warrants |
|
$ (1,387)
|
$ (5)
|
$ (4,311)
|
$ (23)
|
|
Minimum [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
3.62
|
|
3.62
|
|
|
Maximum [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
3.99
|
|
3.99
|
|
|
2023 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Fair value of warrants |
$ 5,831
|
|
|
$ 1,535
|
|
|
2020 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Fair value of warrants |
|
|
|
$ 3
|
|
$ 19
|
Measurement Input, Share Price [Member] | 2023 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield | $ / shares |
1.20
|
0.31
|
|
0.31
|
|
|
Measurement Input, Share Price [Member] | 2020 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield | $ / shares |
|
0.31
|
|
0.31
|
|
0.89
|
Measurement Input, Risk Free Interest Rate [Member] | 2023 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
3.60
|
4.13
|
|
4.13
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | 2020 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
4.87
|
|
4.87
|
|
4.22
|
Measurement Input, Price Volatility [Member] | Minimum [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
120.81
|
|
120.81
|
|
|
Measurement Input, Price Volatility [Member] | Maximum [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
123.61
|
|
123.61
|
|
|
Measurement Input, Price Volatility [Member] | 2023 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
121.5
|
119.7
|
|
119.7
|
|
|
Measurement Input, Price Volatility [Member] | 2020 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
91
|
|
91
|
|
109
|
Measurement Input, Expected Term [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected life (in years) |
|
|
|
5 years 3 months 18 days
|
|
|
Measurement Input, Expected Term [Member] | 2023 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected life (in years) |
5 years
|
|
|
|
|
|
Measurement Input, Expected Term [Member] | 2023 Warrants [Member] | Minimum [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected life (in years) |
|
|
|
5 years
|
|
|
Measurement Input, Expected Term [Member] | 2023 Warrants [Member] | Maximum [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected life (in years) |
|
|
|
4 years 6 months
|
|
|
Measurement Input, Expected Term [Member] | 2020 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected life (in years) |
|
|
|
2 years 1 month 6 days
|
|
2 years 7 months 6 days
|
Measurement Input, Expected Dividend Rate [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
|
|
|
|
|
Measurement Input, Expected Dividend Rate [Member] | 2023 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
|
|
|
|
|
Measurement Input, Expected Dividend Rate [Member] | 2020 Warrants [Member] |
|
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
|
Expected dividend yield |
|
|
|
|
|
|
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v3.23.2
Warrant Liability (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
|
|
|
|
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 31, 2023 |
Jan. 04, 2023 |
Dec. 31, 2022 |
Mar. 31, 2022 |
Dec. 31, 2021 |
Fair Value Adjustment of Warrants |
$ (1,387)
|
$ (5)
|
$ (4,311)
|
$ (23)
|
|
|
|
|
|
Derivative liability |
1,492
|
115
|
1,492
|
115
|
$ 2,925
|
|
$ 19
|
$ 120
|
$ 138
|
Account change in fair value of derivative liability |
1,400
|
$ 5
|
$ 4,400
|
$ 23
|
|
|
|
|
|
Common Warrants [Member] | Pre Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
Placement agent warrants to purchase up |
|
|
|
|
|
6,500,000
|
|
|
|
Placement Agent Warrant [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Placement agent warrants to purchase up |
|
|
|
|
|
390,000
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate |
|
|
100.00%
|
|
|
|
|
|
|
Fair Value Adjustment of Warrants |
|
|
$ 5,800
|
|
|
|
|
|
|
Derivative liability |
$ 1,500
|
|
$ 1,500
|
|
|
|
|
|
|
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v3.23.2
Schedule of Warrant Activity (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Equity [Abstract] |
|
Warrants outstanding, beginning balance | shares |
2,337,274
|
Weighted average exercise price, beginning balance | $ / shares |
$ 5.30
|
Number of warrants, granted | shares |
9,790,000
|
Weighted average exercise price, granted | $ / shares |
$ 0.71
|
Number of warrants, forfeited | shares |
(78,394)
|
Weighted average exercise price, forfeited | $ / shares |
$ 3.40
|
Number of warrants, exercised | shares |
(2,900,000)
|
Weighted average exercise price, exercised | $ / shares |
$ 0.0001
|
Warrants outstanding, beginning balance | shares |
9,148,880
|
Weighted average exercise price, beginning balance | $ / shares |
$ 2.11
|
Warrants exercisable, ending balance | shares |
2,258,880
|
Exercisable, ending balance | $ / shares |
$ 5.45
|
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v3.23.2
Schedule of Warrants Outstanding (Details) - $ / shares
|
|
|
6 Months Ended |
|
May 15, 2023 |
Jan. 27, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Class of Warrant or Right [Line Items] |
|
|
|
|
Warrants outstanding |
|
|
9,148,880
|
2,337,274
|
Remaining contractual life years |
10 years
|
10 years
|
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 2.11
|
$ 5.30
|
Warrants exercisable |
150,000
|
1,400,000
|
2,177,891
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 5.45
|
|
Range One [Member] |
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
Range of lower excercise price, per share |
|
|
$ 2.48
|
|
Remaining contractual life years |
|
|
9 years
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 2.48
|
|
Warrants exercisable |
|
|
1,154,081
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 2.48
|
|
Range Two [Member] |
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
Range of lower excercise price, per share |
|
|
$ 0.85
|
|
Remaining contractual life years |
|
|
9 years 7 months 6 days
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 0.85
|
|
Warrants exercisable |
|
|
1,000,000
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 0.85
|
|
Warrants [Member] |
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
Warrants outstanding |
|
|
9,148,880
|
|
Warrants exercisable |
|
|
2,258,880
|
|
Warrants [Member] | Range One [Member] |
|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
Range of lower excercise price, per share |
|
|
$ 1.00
|
|
Range of lower excercise price, per share |
|
|
$ 1.25
|
|
Warrants outstanding |
|
|
6,890,000
|
|
Remaining contractual life years |
|
|
5 years
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 1.01
|
|
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|
|
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
|
|
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|
|
|
|
Class of Warrant or Right [Line Items] |
|
|
|
|
Range of lower excercise price, per share |
|
|
3.40
|
|
Range of lower excercise price, per share |
|
|
$ 5.50
|
|
Warrants outstanding |
|
|
2,258,880
|
|
Remaining contractual life years |
|
|
2 years 7 months 6 days
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 5.45
|
|
Warrants exercisable |
|
|
2,258,880
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 5.45
|
|
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v3.23.2
Schedule of Options Activity (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Equity [Abstract] |
|
Number of options outstanding, beginning | shares |
1,630,452
|
Weighted-Average Exercise Price, Beginning | $ / shares |
$ 2.57
|
Number of options, Granted | shares |
2,500,000
|
Weighted-Average Exercise Price, Granted | $ / shares |
$ 0.75
|
Number of options, Forfeited | shares |
(392,500)
|
Weighted-Average Exercise Price, Forfeited | $ / shares |
$ 2.81
|
Number of options, Exercised | shares |
|
Weighted-Average Exercise Price, Exercised | $ / shares |
|
Number of options outstanding, ending | shares |
3,737,952
|
Weighted-Average Exercise Price, Beginning | $ / shares |
$ 1.32
|
Number of options outstanding vested and exercisable | shares |
2,177,891
|
Weighted-Average Exercise Price, Ending | $ / shares |
$ 1.71
|
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v3.23.2
Schedule of Options Outstanding (Details) - $ / shares
|
|
|
6 Months Ended |
|
May 15, 2023 |
Jan. 27, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Options outstanding |
|
|
3,737,952
|
1,630,452
|
Options outstanding remaining contractual life years |
10 years
|
10 years
|
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 2.11
|
$ 5.30
|
Warrants exercisable |
150,000
|
1,400,000
|
2,177,891
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 5.45
|
|
Range One [Member] |
|
|
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Range of upper excercise price, per share |
|
|
$ 2.48
|
|
Options outstanding |
|
|
1,237,952
|
|
Options outstanding remaining contractual life years |
|
|
9 years
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 2.48
|
|
Warrants exercisable |
|
|
1,154,081
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 2.48
|
|
Range Two [Member] |
|
|
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Range of upper excercise price, per share |
|
|
$ 0.85
|
|
Options outstanding |
|
|
2,000,000
|
|
Options outstanding remaining contractual life years |
|
|
9 years 7 months 6 days
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 0.85
|
|
Warrants exercisable |
|
|
1,000,000
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 0.85
|
|
Range Three [Member] |
|
|
|
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
|
Range of upper excercise price, per share |
|
|
$ 0.35
|
|
Options outstanding |
|
|
500,000
|
|
Options outstanding remaining contractual life years |
|
|
9 years 10 months 24 days
|
|
Share Based Compensation Arrangements By Share Based Payment Award Non Options Outstanding Weighted Average Exercise Price |
|
|
$ 0.35
|
|
Warrants exercisable |
|
|
23,810
|
|
Share Based Compensation Arrangement By ShareBased Payment Award Non Options Exercisable Weighted Average Exercise Price |
|
|
$ 0.35
|
|
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v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
May 15, 2023 |
Jan. 27, 2023 |
Jan. 04, 2023 |
Feb. 16, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2021 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
250,000,000
|
|
|
250,000,000
|
|
|
250,000,000
|
Common stock, par value |
|
|
|
|
$ 0.001
|
|
|
$ 0.001
|
|
|
$ 0.001
|
Preferred stock, shares authorized |
|
|
|
|
15,000,000
|
|
|
15,000,000
|
|
|
15,000,000
|
Preferred stock, par value |
|
|
|
|
$ 0.01
|
|
|
$ 0.01
|
|
|
$ 0.01
|
Cash Acquired from Acquisition |
|
|
$ 6,500,000
|
|
|
|
|
|
|
|
|
Direct offering |
|
|
|
|
40,639,688
|
|
|
40,639,688
|
|
|
32,722,452
|
Change in fair value of warrant liability |
|
|
|
|
$ (1,387,000)
|
$ (5,000)
|
|
$ (4,311,000)
|
$ (23,000)
|
|
|
Shares issued, value |
|
|
|
|
|
|
|
6,268,000
|
|
|
|
Number of shares cancelled in common stock |
|
|
|
|
|
|
290,999
|
|
|
|
|
Shares issued, value |
|
|
|
|
|
$ 390,000
|
|
$ 315,000
|
$ 1,262,000
|
|
|
Common stock issued |
|
|
|
|
|
|
|
1,343,783
|
|
|
|
Fair value to settle a vendor payable |
|
|
|
|
|
|
|
$ 591,000
|
|
|
|
Gain on fair value of debt |
|
|
|
|
|
|
|
$ 577,000
|
|
|
|
Shares granted |
$ 500,000
|
$ 2,000,000.0
|
|
|
|
|
|
|
|
|
|
Price per share |
$ 0.35
|
$ 0.85
|
|
|
|
|
|
|
|
|
|
Expiry period |
10 years
|
10 years
|
|
|
|
|
|
|
|
|
|
Share vested value |
150,000
|
1,400,000
|
|
|
2,177,891
|
|
|
2,177,891
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To unvest Outstanding Aggregate Intrinsic Value |
|
|
|
|
$ 1,100,000
|
|
|
$ 1,100,000
|
|
|
|
Equity Option [Member] | Share-Based Payment Arrangement, Tranche Three [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Options granted |
|
|
|
|
$ 398,000
|
|
|
$ 905,000
|
|
|
|
Series C Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
|
|
$ 0.01
|
|
|
$ 0.01
|
|
|
$ 0.01
|
Preferred stock, shares outstanding |
|
|
|
|
96,230
|
|
|
96,230
|
|
|
96,230
|
Preferred stock, shares issued |
|
|
|
|
96,230
|
|
|
96,230
|
|
|
96,230
|
Series K Preferred Stocks [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
|
$ 0.01
|
|
|
|
|
|
|
|
Preferred stock shares designated |
|
|
|
115,000
|
|
|
|
|
|
|
|
Convertible shares issuable |
|
|
|
100
|
|
|
|
|
|
|
|
Series K Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
0
|
|
|
0
|
|
|
0
|
Board Of Directors Employees And Consultants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares issued |
|
|
|
|
0
|
|
|
73,454
|
|
|
|
Shares issued, value |
|
|
|
|
$ 0
|
|
|
$ 315,000
|
|
|
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Other offering expenses |
|
|
$ 232,000
|
|
|
|
|
|
|
|
|
Purchase Agreement [Member] | Pre Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercise price of warrant |
|
|
$ 0.9999
|
|
$ 0.0001
|
|
|
$ 0.0001
|
|
|
|
Purchase Agreement [Member] | Institutional Investor [Member] | Pre Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercise price of warrant |
|
|
0.0001
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
250,000,000
|
|
|
250,000,000
|
|
|
|
Preferred stock shares designated |
|
|
|
|
|
|
|
3,600,000
|
|
|
|
Debt converted amount |
|
|
|
$ 38,800,000
|
|
|
|
|
|
|
|
Converted conversion of common stock |
|
|
|
11,413,322
|
|
|
|
|
|
11,086,024
|
|
Shares issued, value |
|
|
|
|
|
|
|
$ 4,000
|
|
|
|
Shares issued |
|
|
|
|
|
114,000
|
|
73,000
|
277,000
|
|
|
Shares issued, value |
|
|
|
|
|
|
|
|
|
|
|
Common stock issued |
|
|
|
|
857,000
|
|
|
1,344,000
|
|
|
|
Accounts payable |
|
|
|
|
$ 1,100,000
|
|
|
$ 1,100,000
|
|
|
|
Common Stock [Member] | Pre Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercise price of warrant |
|
|
$ 1.00
|
|
|
|
|
|
|
|
|
Warrants exercised |
|
|
|
|
2,900,000
|
|
|
2,900,000
|
|
|
|
Cash consideration |
|
|
|
|
|
|
|
$ 290,000
|
|
|
|
Stock option exercised |
|
|
|
|
|
|
|
2,900,000
|
|
|
|
Common Stock [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Direct offering |
|
|
3,600,000
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 0.001
|
|
|
|
|
|
|
|
|
Preferred stock shares designated |
|
|
6,500,000
|
|
|
|
|
|
|
|
|
Exercise price of warrant |
|
|
$ 1.25
|
|
|
|
|
|
|
|
|
Prefunded Warrant [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
|
|
2,900,000
|
|
|
|
|
|
|
|
|
Placement Agent Warrant [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock shares designated |
|
|
390,000
|
|
|
|
|
|
|
|
|
Common Warrants [Member] | Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 1.00
|
|
|
|
|
|
|
|
|
Common Warrant and Placement Agent Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability |
|
|
$ 5,800,000
|
|
|
|
|
|
|
|
|
Common Stock Issuable [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock shares designated |
|
|
|
|
|
|
|
|
|
327,298
|
|
Shares issued, value |
|
|
|
|
|
|
$ 1,100,000
|
|
|
|
|
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v3.23.2
Commitments and Contingencies (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
6 Months Ended |
May 13, 2022 |
Mar. 26, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Monetary damages estimated amount |
$ 370,000
|
|
|
|
|
|
Project fees |
|
|
|
|
$ 2,100,000
|
|
Research and development expense |
|
|
$ 2,095,000
|
$ 1,139,000
|
3,745,000
|
$ 3,226,000
|
Research and Development Expense (Excluding Acquired in Process Cost) |
|
|
|
|
2,100,000
|
|
Scientific Research Agreement [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Research and development expense |
|
|
192,000
|
$ 383,000
|
192,000
|
$ 383,000
|
2016 Patent Exclusive License Agreement [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Research and development expense |
|
|
|
|
0
|
|
Proceeds from upfront amount |
|
|
$ 200,000
|
|
200,000
|
|
Maintenance fee |
|
|
|
|
100,000
|
|
Performance milestone payments |
|
|
|
|
3,100,000
|
|
Sales milestone payments |
|
|
|
|
1,000,000.0
|
|
Gross sales |
|
|
|
|
250,000,000
|
|
Sales revenue |
|
|
|
|
5,000,000.0
|
|
Cumulative gross sales |
|
|
|
|
$ 500,000,000
|
|
2016 Patent Exclusive License Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Net sales percentage |
|
|
|
|
4.00%
|
|
Annual royalty payments |
|
|
|
|
$ 250,000
|
|
2016 Patent Exclusive License Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Net sales percentage |
|
|
|
|
6.00%
|
|
Annual royalty payments |
|
|
|
|
$ 5,000,000.0
|
|
2021 Patent License Agreement [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Research and development expense |
|
|
|
|
$ 0
|
|
Maintenance fee |
|
$ 2,000,000.0
|
|
|
|
|
Annual royalty payments |
|
250
|
|
|
|
|
Performance milestone payments |
|
3,100,000
|
|
|
|
|
Sales milestone payments |
|
1,000,000.0
|
|
|
|
|
Gross sales |
|
250,000,000
|
|
|
|
|
Sales revenue |
|
5,000,000.0
|
|
|
|
|
Cumulative gross sales |
|
500,000,000
|
|
|
|
|
Upfront license fee |
|
20,000,000
|
|
|
|
|
License maintenance fee, receivable |
|
$ 5,000
|
|
|
|
|
2021 Patent License Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Net sales percentage |
|
2.50%
|
|
|
|
|
2021 Patent License Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Net sales percentage |
|
5.00%
|
|
|
|
|
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v3.23.2
Operating Leases (Details Narrative) $ in Thousands |
|
3 Months Ended |
6 Months Ended |
|
|
Nov. 19, 2021
USD ($)
ft²
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Feb. 08, 2022
USD ($)
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Right of use asset |
|
$ 114
|
|
$ 114
|
|
$ 165
|
|
Right of use liability |
|
156
|
|
156
|
|
|
|
Rent expense |
|
29
|
$ 29
|
58
|
$ 58
|
|
|
Lease Agreements [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Area of land | ft² |
4,500
|
|
|
|
|
|
|
Commencement date |
commencement date of January 1, 2022 and maturing on June 30, 2024
|
|
|
|
|
|
|
Right of use asset |
$ 247
|
260
|
|
260
|
|
|
$ 13
|
Right of use liability |
|
$ 260
|
|
$ 260
|
|
|
$ 13
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