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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
Quarterly
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
the quarterly period ended September 30, 2023
or
☐ |
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: 001-12555
PROTAGENIC
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
06-1390025 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
No.) |
149
Fifth Avenue, Suite 500, New York, New York 10010
(Address
of Principal Executive Office) (Zip Code)
(212)
994-8200
Registrant’s
Telephone Number Including Area Code
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Ticker
symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 |
|
PTIX |
|
Nasdaq
Capital Market |
Common
Stock Purchase Warrant |
|
PTIXW |
|
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 (§ 232.405 of this chapter) 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, smaller reporting company
or 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 126-2 of the Exchange Act).
☐
Yes ☒ No
As
of November 14, 2023 there were 4,435,132 shares of common stock, $0.0001 par value per share, outstanding.
PROTAGENIC
THERAPEUTICS, INC.
Form
10-Q Report
For
the Fiscal Quarter Ended September 30, 2023
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
PROTAGENIC
THERAPEUTICS, INC., AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
| |
| | |
| |
| |
September 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Cash | |
$ | 153,332 | | |
$ | 215,189 | |
Marketable securities | |
| 5,119,252 | | |
| 7,763,517 | |
Prepaid expenses | |
| 104,076 | | |
| 56,939 | |
| |
| | | |
| | |
TOTAL CURRENT ASSETS | |
| 5,376,660 | | |
| 8,035,645 | |
| |
| | | |
| | |
Equipment - net | |
| 55,982 | | |
| 1,775 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 5,432,642 | | |
$ | 8,037,420 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
| |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 524,006 | | |
$ | 669,704 | |
Accounts payable and accrued expenses - related party | |
| 336,337 | | |
| 105,928 | |
Accounts payable and accrued expenses | |
| 336,337 | | |
| 105,928 | |
PIK convertible notes payable, net of debt discount | |
| 220,522 | | |
| 150,591 | |
PIK convertible notes payable, net of debt discount - related parties | |
| 199,241 | | |
| 193,639 | |
PIK convertible notes payable, net of debt discount | |
| 199,241 | | |
| 193,639 | |
TOTAL CURRENT LIABILITIES | |
| 1,280,106 | | |
| 1,119,862 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
$ | 1,280,106 | | |
$ | 1,119,862 | |
| |
| | | |
| | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Preferred stock, $0.000001 par value; 20,000,000 shares authorized; none shares issued and outstanding in the following classes: | |
| | | |
| | |
Preferred stock; par value $0.000001; 2,000,000 shares authorized; none issued and outstanding | |
| - | | |
| - | |
Series B convertible preferred stock, $0.000001 par value; 18,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2023, and December 31, 2022 | |
| - | | |
| - | |
Preferred stock, value | |
| - | | |
| - | |
| |
| | | |
| | |
Common stock, $.0001 par value, 100,000,000 shares authorized, 4,330,959 and 4,321,315 shares issued and outstanding at September 30, 2023, and December 31, 2022 | |
| 434 | | |
| 434 | |
Additional paid-in-capital | |
| 33,871,527 | | |
| 33,371,406 | |
Accumulated deficit | |
| (29,101,688 | ) | |
| (25,777,375 | ) |
Accumulated other comprehensive loss | |
| (617,737 | ) | |
| (676,907 | ) |
| |
| | | |
| | |
TOTAL STOCKHOLDERS’ EQUITY | |
| 4,152,536 | | |
| 6,917,558 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 5,432,642 | | |
$ | 8,037,420 | |
See
accompanying notes to the unaudited consolidated financial statements
PROTAGENIC
THERAPEUTICS, INC., AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| |
| | |
| | |
| | |
| |
| |
For the three months ended September 30, | | |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
OPERATING AND ADMINISTRATIVE EXPENSES | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 1,124,030 | | |
$ | 501,366 | | |
$ | 2,308,440 | | |
$ | 1,331,719 | |
General and administrative | |
| 307,682 | | |
| 422,694 | | |
| 1,006,308 | | |
| 1,570,291 | |
| |
| | | |
| | | |
| | | |
| | |
TOTAL OPERATING AND ADMINISTRATIVE EXPENSES | |
| 1,431,712 | | |
| 924,060 | | |
| 3,314,748 | | |
| 2,902,010 | |
| |
| | | |
| | | |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (1,431,712 | ) | |
| (924,060 | ) | |
| (3,314,748 | ) | |
| (2,902,010 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER (EXPENSE) INCOME | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 69,218 | | |
| 42,496 | | |
| 210,819 | | |
| 93,363 | |
Interest expense | |
| (31,957 | ) | |
| (31,957 | ) | |
| (94,830 | ) | |
| (105,498 | ) |
Realized loss on marketable securities | |
| (23,175 | ) | |
| (11,784 | ) | |
| (146,554 | ) | |
| (39,986 | ) |
Gain on settlement of liabilities | |
| 21,000 | | |
| - | | |
| 21,000 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
TOTAL OTHER INCOME (EXPENSES) | |
| 35,086 | | |
| (1,245 | ) | |
| (9,565 | ) | |
| (52,121 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
INCOME TAX EXPENSE | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (1,396,626 | ) | |
$ | (925,305 | ) | |
$ | (3,324,313 | ) | |
$ | (2,954,131 | ) |
| |
| | | |
| | | |
| | | |
| | |
COMPREHENSIVE LOSS | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Other Comprehensive Loss - net of tax | |
| | | |
| | | |
| | | |
| | |
Net unrealized gain (loss) on marketable securities | |
| (34,463 | ) | |
| (165,913 | ) | |
| 55,503 | | |
| (360,500 | ) |
Foreign exchange translation income (loss) | |
| 3,187 | | |
| 481 | | |
| 3,667 | | |
| (6,262 | ) |
| |
| | | |
| | | |
| | | |
| | |
TOTAL COMPREHENSIVE LOSS | |
$ | (1,427,902 | ) | |
$ | (1,090,737 | ) | |
$ | (3,265,143 | ) | |
$ | (3,320,893 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share - Basic and Diluted | |
$ | (0.32 | ) | |
$ | (0.21 | ) | |
$ | (0.77 | ) | |
$ | (0.68 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares - Basic and Diluted | |
| 4,330,959 | | |
| 4,321,315 | | |
| 4,328,123 | | |
| 4,316,659 | |
See
accompanying notes to the unaudited consolidated financial statements
PROTAGENIC
THERAPEUTICS, INC., AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
For
the Three and Nine Months Ended September 30, 2023 and 2022
(Unaudited)
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Series B
Convertible
Preferred Stock | | |
Common Stock | | |
Additional
Paid-in- | | |
Accumulated | | |
Accumulated
Other
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
(Deficit) | | |
Loss | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE - December 31, 2021 | |
| - | | |
$ | - | | |
| 4,302,403 | | |
$ | 432 | | |
$ | 32,411,742 | | |
$ | (22,221,870 | ) | |
$ | (248,349 | ) | |
$ | 9,941,955 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation gain | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 160 | | |
| 160 | |
Unrealized loss on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (151,170 | ) | |
| (151,170 | ) |
Stock compensation - stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| 215,346 | | |
| - | | |
| - | | |
| 215,346 | |
Stock compensation - warrants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 20,433 | | |
| - | | |
| - | | |
| 20,433 | |
Conversion of notes and interest | |
| - | | |
| - | | |
| 10,917 | | |
| 1 | | |
| 54,967 | | |
| - | | |
| - | | |
| 54,968 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,362,109 | ) | |
| - | | |
| (1,362,109 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE - March 31, 2022 | |
| - | | |
$ | - | | |
| 4,313,320 | | |
$ | 433 | | |
$ | 32,702,488 | | |
$ | (23,583,979 | ) | |
$ | (399,359 | ) | |
$ | 8,719,583 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,903 | ) | |
| (6,903 | ) |
Unrealized loss on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (43,417 | ) | |
| (43,417 | ) |
Stock compensation - stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| 215,535 | | |
| - | | |
| - | | |
| 215,535 | |
Conversion of notes and interest | |
| - | | |
| - | | |
| 7,995 | | |
| 1 | | |
| 40,016 | | |
| - | | |
| - | | |
| 40,017 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (666,717 | ) | |
| - | | |
| (666,717 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE -June 30, 2022 | |
| - | | |
$ | - | | |
| 4,321,315 | | |
$ | 434 | | |
$ | 32,958,039 | | |
$ | (24,250,696 | ) | |
$ | (449,679 | ) | |
$ | 8,258,098 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation gain | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 481 | | |
| 481 | |
Unrealized loss on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (165,913 | ) | |
| (165,913 | ) |
Stock compensation - stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| 214,679 | | |
| - | | |
| - | | |
| 214,679 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (925,305 | ) | |
| - | | |
| (925,305 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE -September 30, 2022 | |
| - | | |
| - | | |
| 4,321,315 | | |
$ | 434 | | |
$ | 33,172,718 | | |
$ | (25,176,001 | ) | |
$ | (615,111 | ) | |
$ | 7,382,040 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE - December 31, 2022 | |
| - | | |
$ | - | | |
| 4,321,315 | | |
$ | 434 | | |
$ | 33,371,406 | | |
$ | (25,777,375 | ) | |
$ | (676,907 | ) | |
$ | 6,917,558 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation gain | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 467 | | |
| 467 | |
Unrealized gain on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 47,677 | | |
| 47,677 | |
Stock compensation - stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| 166,707 | | |
| - | | |
| - | | |
| 166,707 | |
Rounding from reverse split | |
| - | | |
| - | | |
| 9,644 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (718,096 | ) | |
| - | | |
| (718,096 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE - March 31, 2023 | |
| - | | |
$ | - | | |
| 4,330,959 | | |
$ | 434 | | |
$ | 33,538,113 | | |
$ | (26,495,471 | ) | |
$ | (628,763 | ) | |
$ | 6,414,313 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation gain | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 13 | | |
| 13 | |
Unrealized gain on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 42,289 | | |
| 42,289 | |
Stock compensation - stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| 166,707 | | |
| - | | |
| - | | |
| 166,707 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,209,591 | ) | |
| - | | |
| (1,209,591 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE - June 30, 2023 | |
| - | | |
$ | - | | |
| 4,330,959 | | |
$ | 434 | | |
$ | 33,704,820 | | |
$ | (27,705,062 | ) | |
$ | (586,461 | ) | |
$ | 5,413,731 | |
Balance | |
| - | | |
$ | - | | |
| 4,330,959 | | |
$ | 434 | | |
$ | 33,704,820 | | |
$ | (27,705,062 | ) | |
$ | (586,461 | ) | |
$ | 5,413,731 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation gain | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,187 | | |
| 3,187 | |
Foreign currency translation gain (loss) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 3,187 | | |
| 3,187 | |
Unrealized loss on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (34,463 | ) | |
| (34,463 | ) |
Unrealized gain (loss) on marketable securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (34,463 | ) | |
| (34,463 | ) |
Stock compensation - stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| 166,707 | | |
| - | | |
| - | | |
| 166,707 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,396,626 | ) | |
| - | | |
| (1,396,626 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE – September 30, 2023 | |
| - | | |
$ | - | | |
| 4,330,959 | | |
$ | 434 | | |
$ | 33,871,527 | | |
$ | (29,101,688 | ) | |
$ | (617,737 | ) | |
$ | 4,152,536 | |
Balance | |
| - | | |
$ | - | | |
| 4,330,959 | | |
$ | 434 | | |
$ | 33,871,527 | | |
$ | (29,101,688 | ) | |
$ | (617,737 | ) | |
$ | 4,152,536 | |
See
accompanying notes to the unaudited consolidated financial statements
PROTAGENIC
THERAPEUTICS, INC., AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
| |
| | |
| |
| |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net Loss | |
$ | (3,324,313 | ) | |
$ | (2,954,131 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Depreciation expense | |
| 1,600 | | |
| - | |
Stock-based compensation | |
| 500,121 | | |
| 665,993 | |
Realized loss on sale of marketable securities | |
| 146,554 | | |
| 39,986 | |
Amortization of debt discount | |
| 75,533 | | |
| 85,343 | |
Gain on settlement of liabilities | |
| (21,000 | ) | |
| - | |
Changes in operating assets and liabilities | |
| | | |
| | |
Prepaid expenses | |
| (47,137 | ) | |
| 587,084 | |
Accounts payable and accrued expenses | |
| 109,300 | | |
| (237,153 | ) |
| |
| | | |
| | |
NET CASH USED IN OPERATING ACTIVITIES | |
| (2,559,342 | ) | |
| (1,812,878 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES | |
| | | |
| | |
Proceeds from sale of marketable securities | |
| 2,566,192 | | |
| 1,538,567 | |
Purchase of fixed assets | |
| (55,806 | ) | |
| - | |
| |
| | | |
| | |
NET CASH PROVIDED BY INVESTING ACTIVITIES | |
| 2,497,407 | | |
| 1,435,208 | |
| |
| | | |
| | |
Effect of exchange rate changes on cash | |
| 78 | | |
| (5,178 | ) |
| |
| | | |
| | |
NET CHANGE IN CASH | |
| (61,857 | ) | |
| (382,848 | ) |
| |
| | | |
| | |
CASH, BEGINNING OF THE PERIOD | |
| 215,189 | | |
| 541,171 | |
| |
| | | |
| | |
CASH, END OF THE PERIOD | |
$ | 153,322 | | |
$ | 158,323 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION | |
| | | |
| | |
Cash paid for interest expense | |
$ | - | | |
$ | - | |
Cash paid for income taxes | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
NONCASH FINANCING AND INVESTING TRANSACTIONS | |
| | | |
| | |
Shares issued for conversion of notes and interest | |
$ | - | | |
$ | 94,985 | |
Unrealized gain or loss on marketable securities | |
$ | 55,503 | | |
$ | 360,500 | |
See
accompanying notes to the unaudited consolidated financial statements
PROTAGENIC
THERAPEUTICS, INC. & SUBSIDIARY
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
September
30, 2023
NOTE
1 – ORGANIZATION AND NATURE OF BUSINESS
Company
Background
Protagenic
Therapeutics, Inc. (“we,” “our,” “Protagenic” or “the Company”), formerly known as Atrinsic,
Inc., is a Delaware corporation with one subsidiary named Protagenic Therapeutics Canada (2006) Inc. (“PTI Canada”), a corporation
formed in 2006 under the laws of the Province of Ontario, Canada.
We
are a biopharmaceutical company specializing in the discovery and development of therapeutics to treat stress-related neuropsychiatric
and mood disorders.
Reverse
Stock Split
On
March 22, 2023, the Company effectuated a 1 for 4 reverse stock split (the “Reverse Split”). The Company’s stock began
trading on a split-adjusted basis effective on the Nasdaq Stock Market on March 22, 2023. There was no change to the number of authorized
shares of the Company’s common stock. All share and per share information in these financial statements are adjusted to reflect
the Reverse Split.
NOTE
2 – LIQUIDITY AND GOING CONCERN
As
shown in the accompanying consolidated financial statements, the Company has incurred significant recurring losses resulting in an accumulated
deficit. The Company anticipates further losses in the development of its business. The Company also had negative cash flows used in
operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
Based
on its cash resources and positive working capital as of September 30, 2023, the Company does not have sufficient resources to fund
its operations past end of the third quarter of 2024. The positive working capital as of September 30, 2023 was due to funds raised
by the Company from its equity offering during the year ended December 31, 2021. Absent generation of sufficient revenue from the
execution of the Company’s business plan, the Company will need to obtain debt or equity financing by the third quarter of
2024. Because the Company has insufficient resources on hand to fund operations through the next twelve months from the date these
consolidated financial statements are available to be issued, the Company believes that there is substantial doubt in its ability to
continue as a going concern. These financial statements do not include any adjustments to the recoverability
and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to
continue as a going concern.
NOTE 3 – SUMMARY OF
SIGNIFICANT ACCOUNTING POLICIES
Principles
of consolidation
The
consolidated financial statements include the accounts of Protagenic Therapeutics, Inc., and its wholly owned Canadian subsidiary, PTI
Canada. All significant intercompany balances and transactions have been eliminated.
Use
of estimates
The
preparation of the consolidated financial statements in conformity with U.S. 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 consolidated
financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could differ from those
estimates. Significant estimates underlying the consolidated financial statements include valuation of stock options and warrants and
assessment of deferred tax asset valuation allowance.
Concentrations
of Credit Risk
The
Company maintains its cash accounts at financial institutions which are insured by the Federal Deposit Insurance Corporation. At times,
the Company may have deposits in excess of federally insured limits. As of September 30, 2023, the Company does not have bank balances
that exceed the federally insured limits. The Company has not experienced losses on these accounts and management believes, based upon
the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
Funds
held in the Company’s marketable securities are not insured.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.
As of September 30, 2023 and December 31, 2022 the Company did not have any cash equivalents.
Marketable
Securities
The
Company accounts for marketable debt securities, the only type of securities it owns, in accordance with the FASB Accounting Standards
Codification 320, Investments – Debt and Equity Securities (“ASC 320”).
Pursuant
to ASC 320-10-35-1, investments in debt securities that are classified as available for sale shall be measured subsequently at fair value
in the consolidated balance sheets at each balance sheet date. Unrealized holding gains and losses for available-for-sale securities
(including those classified as current assets) shall be excluded from earnings and reported in other comprehensive income until realized.
During
the nine months ended September 30, 2023 the Company purchased $ and sold $2,566,192 in marketable securities with a realized loss
of $146,554 and an unrealized gain of $55,503. As of September 30, 2023 and December 31, 2022, the Company owned marketable securities
with a total value of $5,119,252 and $7,763,517, respectively.
Equipment
Equipment
is stated at cost less accumulated depreciation. Cost includes expenditures for computer equipment. Maintenance and repairs are charged
to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation are removed from
the accounts and any resulting gain or loss is reflected in operations. The cost of equipment is depreciated using the straight-line
method over the estimated useful lives of the related assets which is three years. Depreciation expense was $1,600 and zero for the nine
months ended September 30, 2023 and 2022.
Fair
Value Measurements
ASC
820, “Fair Value Measurements and Disclosure,” defines fair value as the price that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants at the measurement date, not adjusted for transaction
costs. ASC 820 also establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value
into three broad levels giving the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1)
and the lowest priority to unobservable inputs (Level 3).
The
three levels are described below:
Level
1 Inputs – Unadjusted quoted prices in active markets for identical assets or liabilities that is accessible by the Company;
Level
2 Inputs – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable,
either directly or indirectly;
Level
3 Inputs – Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants.
The
carrying amount of the Company’s financial assets and liabilities, such as cash, accounts payable and accrued expenses approximate
their fair value because of the short term maturity of those instruments.
Transactions
involving related parties cannot be presumed to be carried out on an arm’s-length basis, as the requisite conditions of competitive,
free-market dealings may not exist. Representations about transactions with related parties, if made, shall not imply that the related
party transactions were consummated on terms equivalent to those that prevail in arm’s-length transactions unless such representations
can be substantiated.
The
assets or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is
significant to the fair value measurement. The following table provides a summary of financial instruments that are measured at fair
value on a recurring basis as of September 30, 2023.
SCHEDULE OF FAIR VALUE ASSETS AND LIABILITIES MEASURED ON RECURRING BASIC
| |
Carrying | | |
Fair Value Measurement Using | |
| |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Marketable securities | |
$ | 5,119,252 | | |
$ | 5,119,252 | | |
$ | — | | |
$ | — | | |
$ | 5,119,252 | |
The
following table provides a summary of financial instruments that are measured at fair value on a recurring basis as of December 31, 2022.
| |
Carrying | | |
Fair Value Measurement Using | |
| |
Value | | |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Marketable securities | |
$ | 7,763,517 | | |
$ | 7,763,517 | | |
$ | — | | |
$ | — | | |
$ | 7,763,517 | |
Stock-Based
Compensation
The
Company accounts for stock-based compensation costs under the provisions of ASC 718, “Compensation—Stock Compensation”,
which requires the measurement and recognition of compensation expense related to the fair value of stock-based compensation awards that
are ultimately expected to vest. Stock based compensation expense recognized includes the compensation cost for all stock-based payments
granted to employees, officers, non-employees, and directors based on the grant date fair value estimated in accordance with the provisions
of ASC 718. ASC 718 is also applied to awards modified, repurchased, or cancelled during the periods reported.
If
any award granted under the Company’s 2016 Equity Compensation Plan (the “2016 Plan”) payable in shares of common stock
is forfeited, cancelled, or returned for failure to satisfy vesting requirements, otherwise terminates without payment being made, or
if shares of common stock are withheld to cover withholding taxes on options or other awards, the number of shares of common stock as
to which such option or award was forfeited, or which were withheld, will be available for future grants under the 2016 Plan. The Company
recognizes the impact of forfeitures when they occur.
Basic
and Diluted Net (Loss) per Common Share
Basic
(loss) per common share is computed by dividing the net (loss) by the weighted average number of shares of common stock outstanding for
each period. Diluted (loss) per share is computed by dividing the net (loss) by the weighted average number of shares of common stock
outstanding plus the dilutive effect of shares issuable through the common stock equivalents. The effect of dilution on net loss becomes
anti-dilutive and therefore is not reflected on the consolidated statements of operations and comprehensive loss.
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
Potentially Outstanding
Dilutive Common Shares | |
| |
For the
Nine Months Ended
September 30, 2023 | | |
For the
Nine Months Ended
September 30, 2022 | |
| |
| | | |
| | |
Conversion Feature Shares | |
| | | |
| | |
| |
| | | |
| | |
Stock Options | |
| 1,357,466 | | |
| 1,376,215 | |
| |
| | | |
| | |
Warrants | |
| 1,055,066 | | |
| 1,537,158 | |
| |
| | | |
| | |
Convertible Notes | |
| 86,000 | | |
| 86,000 | |
| |
| | | |
| | |
Total potentially outstanding dilutive common shares | |
| 2,498,532 | | |
| 2,999,373 | |
Research
and Development
Research
and development expenses are charged to operations as incurred.
Foreign
Currency Translation
The
Company follows ASC 830, Foreign Currency Matters (“ASC 830”) for foreign currency translation to translate the financial
statements of the foreign subsidiary from the functional currency, generally the local currency, into U.S. Dollars. ASC 830-10-45 sets
out the guidance relating to how a reporting entity determines the functional currency of a foreign entity (including of a foreign entity
in a highly inflationary economy), re-measures the books of record (if necessary), and characterizes transaction gains and losses. Pursuant
to ASC 830-10-45, the assets, liabilities, and operations of a foreign entity shall be measured using the functional currency of that
entity. An entity’s functional currency is the currency of the primary economic environment in which the entity operates; normally,
that is the currency of the environment, or local currency, in which an entity primarily generates and expends cash.
The
functional currency of each foreign subsidiary is determined based on management’s judgment and involves consideration of all relevant
economic facts and circumstances affecting the subsidiary. Generally, the currency in which the subsidiary transacts a majority of its
transactions, including billings, financing, payroll and other expenditures, would be considered the functional currency, but any dependency
upon the parent and the nature of the subsidiary’s operations must also be considered. If a subsidiary’s functional currency
is deemed to be the local currency, then any gain or loss associated with the translation of that subsidiary’s financial statements
is included in accumulated other comprehensive income. However, if the functional currency is deemed to be the U.S. Dollar, then any
gain or loss associated with the re-measurement of these financial statements from the local currency to the functional currency would
be included in the condensed consolidated statements of operations and comprehensive income (loss). If the Company disposes of foreign
subsidiaries, then any cumulative translation gains or losses would be recorded into the condensed consolidated statements of operations
and comprehensive income (loss). If the Company determines that there has been a change in the functional currency of a subsidiary to
the U.S. Dollar, any translation gains or losses arising after the date of change would be included within the condensed consolidated
statements of operations and comprehensive loss.
Based
on an assessment of the factors discussed above, the management of the Company determined its subsidiary’s local currency (i.e.
the Canadian dollar) to be the functional currency for its foreign subsidiary.
Recent
Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326)
Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which requires an entity to utilize a new impairment model known
as the current expected credit loss (CECL) model to estimate its lifetime “expected credit loss” and record an allowance
that, when deducted from the amortized cost basis of the financial assets and certain other instruments. ASU 2016-13 requires a cumulative
effect adjustment to the balance sheet as of the beginning of the first reporting period in which the guidance is effective. In November
2019, the FASB issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and
Leases (Topic 842): Effective Dates, which defers the effective date of ASU 2016-13 to fiscal years beginning after December 15,
2022 for all entities except SEC reporting companies that are not smaller reporting companies. ASU 2016-13 became effective for the Company
beginning January 1, 2023. The adoption of this ASU did not have a material effect on the Company’s financial statements.
In
August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on the issuer’s accounting for convertible debt instruments
by removing the separation models for convertible debt with a cash conversion feature and convertible instruments with a beneficial conversion
feature. As a result, entities will not separately present in equity an embedded conversion feature in such debt and will account for
a convertible debt instrument wholly as debt, unless certain other conditions are met. The elimination of these models will reduce reported
interest expense and increase reported net income for entities that have issued a convertible instrument that is within the scope of
ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share and treasury
stock method will be no longer available. ASU 2020-06 is applicable for fiscal years beginning after December 15, 2022, with early adoption
permitted no earlier than fiscal years beginning after December 15, 2020. The Company does not intend to early adopt, and continues to
evaluate the impact of the provisions of ASU 2020-06 on its consolidated financial statements.
NOTE
4 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consist of the following at:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
| | |
| |
| |
September
30, 2023 | | |
December
31, 2022 | |
| |
| | |
| |
Accounting | |
$ | 36,750 | | |
$ | 36,750 | |
Research and development | |
| 580,069 | | |
| 557,934 | |
Legal | |
| - | | |
| 25,462 | |
Other | |
| 243,524 | | |
| 155,486 | |
Total | |
$ | 860,343 | | |
$ | 775,632 | |
NOTE
5 – NOTE PAYABLE AND CONVERTIBLE NOTE PAYABLE (PIK NOTES)
Convertible
Notes Payable
During
the nine months ended September 30, 2023 and 2022, the Company amortized $69,931 and $79,741 of the debt discount, respectively.
At September 30, 2023 and December 31, 2022, the Company had an unamortized debt discount of $9,478 and $79,409, respectively.
As
of September 30, 2023 and December 31, 2022, the Company owes $230,000 and $230,000 on the outstanding Convertible Notes, respectively.
These convertible notes have a maturity date of November 6, 2023.
Convertible
Notes Payable – Related Parties
During
the nine months ended September 30, 2023 and 2022, the Company amortized $5,602 and $5,602 of the debt discount, respectively. At September
30, 2023 and December 31, 2022, the Company had an unamortized debt discount of $759 and $6,361, respectively.
As
of September 30, 2023 and December 31, 2022, the Company owes $200,000 and $200,000 on the outstanding Convertible Notes, respectively.
These convertible notes have a maturity date of November 6, 2023.
NOTE
6 - STOCKHOLDERS’ DEFICIT
Common
Stock
During
the nine months ended September 30, 2023, the Company issued 9,644 shares of common stock for rounding of shares related to the Reverse
Split.
Stock-Based
Compensation
The
Company adopted an Employee, Director and Consultant Stock Plan on June 17, 2016 (the “2016 Plan”). Pursuant to the 2016
Plan, the Company’s Compensation Committee may grant awards to any employee, officer, director, consultant, advisor or other individual
service provider of the Company or any subsidiary. Due to an annual “evergreen” provision in the 2016 Plan, the number of
shares reserved for future grants was increased by 184,260 and 142,457 in 2022 and 2021, respectively. As a result of these increases,
as of September 30, 2023 and December 31, 2022, the aggregate number of shares of common stock available for awards under the 2016 Plan
was 1,543,872 shares and 1,543,872 shares, respectively. Options issued under the 2016 Plan are exercisable for up to ten years from
the date of issuance.
There
were 1,357,466 options outstanding as of September 30, 2023. During the three and nine months ended September 30, 2023, the Company issued
no options.
The
following is an analysis of the stock option grant activity under the Plan:
SCHEDULE
OF SHARE-BASED COMPENSATION, STOCK OPTIONS, ACTIVITY
| |
Number | | |
Weighted Average
Exercise Price | | |
Weighted Average
Remaining Life | |
Stock Options | |
| | | |
| | | |
| | |
Outstanding December 31, 2022 | |
| 1,357,466 | | |
$ | 7.39 | | |
| 5.41 | |
Granted | |
| - | | |
$ | - | | |
| - | |
Expired | |
| - | | |
$ | - | | |
| - | |
Exercised | |
| - | | |
$ | - | | |
| - | |
Outstanding September 30, 2023 | |
| 1,357,466 | | |
$ | 7.39 | | |
| 4.74 | |
A
summary of the status of the Company’s nonvested options as of September 30, 2023, and changes during the nine months ended September
30, 2023, is presented below:
SCHEDULE
OF SHARE-BASED COMPENSATION NONVESTED SHARES
Nonvested Options | |
Options | | |
Weighted-Average
Exercise Price | |
Nonvested at December 31, 2022 | |
| 118,187 | | |
$ | 13.07 | |
Granted | |
| - | | |
$ | - | |
Vested | |
| 55,073 | | |
$ | 11.51 | |
Forfeited | |
| - | | |
$ | - | |
Nonvested at September 30, 2023 | |
| 63,114 | | |
$ | 14.43 | |
As
of September 30, 2023, the Company had 1,357,466 shares issuable under options outstanding at a weighted average exercise price of $7.39
and an intrinsic value of $0.
The
total number of options granted during the nine months ended September 30, 2023 and 2022 was 0 and 50,000, respectively. The exercise
price for these options was $4.84 per share.
The
Company recognized compensation expense related to options issued of $166,707 and $214,679 for the three months ended September 30, 2023
and 2022, respectively, in which $51,526 and $195,624 is included in general and administrative expenses and $115,181 and $19,055 in
research and development expenses, respectively. For the three months ended September 30, 2023 and 2022, $1,713 and $49,685 of the stock
compensation was related to employees and $164,994 and $164,994 was related to non-employees, respectively.
The
Company recognized compensation expense related to options issued of $500,121 and $645,560 for the nine months ended September 30, 2023
and 2022, respectively, in which $154,578 and $568,198 is included in general and administrative expenses and $345,543 and $77,362 in
research and development expenses, respectively. For the nine months ended September 30, 2023 and 2022, $5,140 and $149,055 of the stock
compensation was related to employees and $494,981 and $496,505 was related to non-employees, respectively.
As
of September 30, 2023, the unamortized stock option expense was $842,837 with $3,712 being related to employees and $839,125 being related
to non-employees. As of September 30, 2023, the weighted average period for the unamortized stock compensation to be recognized is 3.71
years.
Warrants:
A
summary of warrant issuances are as follows:
SUMMARY
OF WARRANT
| |
Number | | |
Weighted Average
Exercise Price | | |
Weighted Average
Remaining Life | |
Warrants | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Outstanding December 31, 2022 | |
| 1,537,158 | | |
$ | 13.49 | | |
| 2.15 | |
Granted | |
| - | | |
| - | | |
| - | |
Expired | |
| (482,092 | ) | |
| 4.00 | | |
| - | |
Exercised | |
| - | | |
| - | | |
| - | |
Outstanding September 30, 2023 | |
| 1,055,066 | | |
$ | 17.82 | | |
| 2.31 | |
As
of September 30, 2023, the Company had 1,055,066 shares issuable under warrants outstanding at a weighted average exercise price of $17.82
and an intrinsic value of $0.
The
Company recognized compensation expense related to warrants issued of $0 and $20,433 during the three months ended September 30, 2023
and 2022, respectively.
The
Company recognized compensation expense related to warrants issued of $0 and $20,433 during the nine months ended September 30, 2023
and 2022, respectively.
NOTE
7 - COLLABORATIVE AGREEMENTS
The
Company and the University of Toronto (the “University”) entered into an agreement effective April 1, 2014 (the “New
Research Agreement”) for the performance of a research project titled “Teneurin C-terminal Associated Peptide (“TCAP”)
mediated stress attenuation in vertebrates: Establishing the role of organismal and intracellular energy and glucose regulation and metabolism”
(the “New Project”). The New Project is to perform research related to work done by Dr. David A. Lovejoy, a professor at
the University and stockholder of the Company, in regard to TCAP mediated stress attenuation in vertebrates: Establishing the role of
organismal and intracellular energy and glucose regulation and metabolism. In addition to the New Research Agreement, Dr. Lovejoy entered
into an agreement with the University in order to commercialize certain technologies. The New Research Agreement expired on March 30,
2016. In February 2017, the New Research Agreement was extended to December 31, 2017. The extension allowed for further development of
the technologies and use of their applications. On April 10, 2018, the agreement was amended and the research agreement has been further
extended to December 31, 2023.
Prior
to January 1, 2016, the University has been granted 6,250 stock options which are fully vested at the exercise price of $4.00 exercisable
over a ten year period which ended on April 1, 2022. As of September 30, 2023, Dr. David Lovejoy of the University has been granted 138,325
stock options, of which 106,346 are fully vested and 31,250 have expired. These have an exercise price of $4.00, $5.00 or $7.00 and are
exercisable over a period ranging from 10 to 13 years.
The
sponsorship research and development expenses pertaining to the Research Agreements were $0 and $27,216 for the three and nine months
ended September 30, 2023 and 2022, respectively.
NOTE 8 - COMMITMENTS AND CONTINGENCIES
Licensing
Agreements
On
July 31, 2005, the Company had entered into a Technology License Agreement (“License Agreement”) with the University pursuant
to which the University agreed to license to the Company patent rights and other intellectual property, among other things (the “Technologies”).
The Technology License Agreement was amended on February 18, 2015 and currently does not provide for an expiration date.
Pursuant
to the License Agreement and its amendment, the Company obtained an exclusive worldwide license to make, have made, use, sell and import
products based upon the Technologies, or to sublicense the Technologies in accordance with the terms of the License Agreement and amendment.
In consideration, the Company agreed to pay to the University a royalty payment of 2.5% of net sales of any product based on the Technologies.
If the Company elects to sublicense any rights under the License Agreement and amendment, the Company agrees to pay to the University
10% of any up-front sub-license fees for any sub-licenses that occurred on or after September 9, 2006, and, on behalf of the sub-licensee,
2.5% of net sales by the sub-licensee of all products based on the Technologies. The Company had no sales revenue for the three and nine
months ended September 30, 2023 and 2022 and therefore was not subject to paying any royalties.
In
the event the Company fails to provide the University with semi-annual reports on the progress or fails to continue to make reasonable
commercial efforts towards obtaining regulatory approval for products based on the Technologies, the University may convert our exclusive
license into a non-exclusive arrangement. Interest on any amounts owed under the License Agreement and amendment will be at 3% per annum.
All intellectual property rights resulting from the Technologies or improvements thereon will remain the property of the other inventors
and/or Dr. Lovejoy, and/or the University, as the case may be. The Company has agreed to pay all out-of-pocket filing, prosecution and
maintenance expenses in connection with any patents relating to the Technologies. In the case of infringement upon any patents relating
to the Technologies, the Company may elect, at its own expense, to bring a cause of action asserting such infringement. In such a case,
after deducting any legal expenses the Company may incur, any settlement proceeds will be subject to the 2.5% royalty payment owed to
the University under the License Agreement and amendment.
The
patent applications were made in the name of Dr. Lovejoy and other inventors, but the Company’s exclusive, worldwide rights to
such patent applications are included in the License Agreement and its amendment with the University. The Company maintains exclusive
licensing agreements and it currently controls the five intellectual patent properties.
Legal
Proceedings
From
time to time we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions,
administrative actions, investigations or claims are pending against us or involve us that, in the opinion of our management, could reasonably
be expected to have a material adverse effect on our business and financial condition.
NOTE
9 – RELATED PARTY TRANSACTIONS
The
Company is provided free office space consisting of a conference room by the Company Executive Chairman, Dr. Armen. The Company does
not pay any rent for the use of this space. This space is used for quarterly board meetings and our annual shareholder meeting.
During
the year ended December 31, 2021, the Company engaged Agenus Inc., a related party, to perform research and development services.
Agenus Inc. is a related party due to the Company’s Director and Chairman of the Board being the CEO and Chairman of the Board
for Agenus Inc. The Company incurred $150,000 and $105,928 in expenses related to these services during the nine months ended
September 30, 2023 and 2022, respectively. As of September 30, 2023 and December 31, 2022, the outstanding balance owed to Agenus
Inc. is $255,928 and $105,928, respectively.
During
the year ended December 31, 2022, the Company engaged CTC North, GmbH (“CTC”) to perform research and development services.
CTC is a related party due to the Company’s Director and Chairman of the Board being the CEO and Chairman of the Board for Agenus
Inc, CTC’s parent company. The total commitment for this agreement is $1.3 million. The Company incurred $106,754 and $105,801
in expenses related to these services during the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023
and December 31, 2022, there is $80,409 and $0 owed to CTC in connection with this agreement, respectively.
NOTE
10 – SUBSEQUENT EVENTS
On November 6, 2023, eight notes with a total principal of $430,000 and accrued interest of $90,866 was converted
into 104,173 shares of common stock.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Forward-Looking Statements
This quarterly report on Form 10-Q contains forward-looking statements
within the meaning of the federal securities laws and the Private Securities Litigation Reform Act of 1995. These forward-looking statements
can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,”
“anticipate,” “estimate,” “believe,” “continue,” “identify” or other similar
words or the negatives thereof. These may include our financial estimates and their underlying assumptions, statements about plans, objectives,
intentions and expectations. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or
will be important factors that could cause actual outcomes or results to differ materially from those indicated in such statements. We
believe these factors include but are not limited to those described under the section entitled “Risk Factors” in our prospectus
and our Annual Report on form 10-K for the year ended December 31, 2022, and any such updated factors included in our periodic filings
with the SEC, which are accessible on the SEC’s website at www.sec.gov. These factors should not be construed as exhaustive and
should be read in conjunction with the other cautionary statements that are included in this document (or our prospectus and other filings).
Except as otherwise required by federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future developments or otherwise.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking”
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the
“Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,”
“expect,” “anticipate,” “estimate,” “target,” “may,” “project,”
“guidance,” “intend,” “plan,” “believe,” “will,” “potential,”
“opportunity,” “future” and other words and terms of similar meaning and expression in connection with any discussion
of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly
to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations.
These statements relate to, among other things, our business strategy, our research and development, our product development efforts,
our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations,
the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results
and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.
We
have included more detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business
that we believe could cause actual results to differ materially from any forward-looking statements in Part II-Item 1A “Risk Factors”
of this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent
in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved.
We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need
to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of
this document, and we undertake no obligation to update or revise these statements.
The
discussion and analysis of our financial condition and results of operations are based on our financial statements, which we have prepared
in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis,
we evaluate such estimates and judgments, including those described in greater detail below. We base these estimates on historical experience
and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
We
expect to continue to incur significant expenses and minimal positive net cash flows from operations or negative net cash flows from
operations for the foreseeable future, and those expenses and losses may fluctuate significantly from quarter-to-quarter and year-to-year.
We anticipate that our expenses will fluctuate substantially as we:
|
● |
continue
our ongoing preclinical studies, clinical trials and our product development activities for our pipeline of product candidates; |
|
|
|
|
● |
seek
regulatory approvals for any product candidates that successfully complete clinical trials; |
|
|
|
|
● |
continue
research and preclinical development and initiate clinical trials of our other product candidates; |
|
|
|
|
● |
seek
to discover and develop additional product candidates either internally or in partnership with other pharmaceutical companies; |
|
|
|
|
● |
adapt
our regulatory compliance efforts to incorporate requirements applicable to marketed products; |
|
|
|
|
● |
maintain,
expand and protect our intellectual property portfolio; and |
|
|
|
|
● |
incur
additional legal, accounting and other expenses in operating as a public company. |
Overview
Our
proprietary, patent-protected, first-in-class lead compound, PT00114, is a synthetic form of Teneurin Carboxy-terminal Associated Peptide
(“TCAP”), an endogenous brain signaling peptide that can dampen overactive stress responses. Our preclinical models have
demonstrated efficacy of PT00114 in animal models of depression, anxiety, substance abuse & addiction, and PTSD.
PT00114
leverages a completely novel mechanism of action. Protagenic owns exclusive, worldwide rights to PT00114 through its license agreement
with the University of Toronto and has an exclusive right to license additional intellectual property generated by Dr. David Lovejoy’s
lab at University of Toronto. Additionally, the company is engaged in the research & development of follow-on compounds in the TCAP
family. Extensive publications in peer-reviewed scientific journals underline the central role stress plays in the onset and proliferation
of neuropsychiatric disorders like depression, anxiety, substance abuse & addiction, and PTSD. The mechanism of action of TCAP suggests
that it counterbalances stress overdrive at the cellular level within the brain’s stress response cascade. TCAP works to alleviate
the harmful behavioral, biochemical, and physiological effects of these disorders, while simultaneously restoring brain health. This
mechanism has been corroborated in preclinical animal models of the psychiatric disorders listed above. Preclinical experiments required
for IND filing have been completed. The Company is in the process of answering regulatory questions in the US and Germany.
On September 26, 2023, we announced the commencement of the Phase I/IIa
clinical trial for PT00114. The trial aims to evaluate the therapeutic potential of PT00114 in treating an array of neuro-psychiatric
conditions, including depression, anxiety, and PTSD. Phase I will recruit 56 subjects, randomized to undergo subcutaneous injections of
either PT00114 or a placebo. The Phase I/IIa study will assess both healthy volunteers and patients diagnosed with Treatment-Resistant
Depression, PTSD, and Generalized Anxiety Disorder. Besides monitoring disease status, the trial will gauge disease response by measuring
biomarkers, such as circulating cortisol levels before and after treatment.
Results
of Operations
We
are a development stage company currently performing clinical trials to obtain Food and Drug Administration (“FDA”) approval
and commercialization of our product.
During
the three months ended September 30, 2023, we incurred a loss from operations of $1,431,712 as compared to $924,060 for the three months
ended September 30, 2022. The increase in the loss is from an increase in research and development expense of $622,664 from $501,366
for the three months ended September 30, 2022 to $1,124,030 for the three months ended September 30, 2023 offset by a decrease in general
and administrative expenses of $115,012 from $422,694 for the three months ended September 30, 2022 to $307,682 for the three months
ended September 30, 2023.
During
the nine months ended September 30, 2023, we incurred a loss from operations of $3,314,748 as compared to $2,902,010 for the nine months
ended September 30, 2022. The increase in the loss is from an increase in research and development expense of $976,721 from $1,331,719
for the nine months ended September 30, 2022 to $2,308,440 for the nine months ended September 30, 2023 offset by a decrease in general
and administrative expenses of $563,983 from $1,570,291 for the nine months ended September 30, 2022 to $1,006,308 for the nine months
ended September 30, 2023.
Liquidity
and Going Concern
We
continually project anticipated cash requirements, predominantly from the ongoing funding requirements of our neuropeptide drug
development program. The majority of these costs relate to paying external vendors such as Contract Research Organizations, peptide
synthesizer companies, and new drug development. As of September 30, 2023, we had cash of $153,332 and working capital of
$4,096,554. We anticipate further losses from the development of our business. Based on its cash resources as of September 30, 2023,
the Company does not have sufficient resources to fund its operations past the end of the third quarter of 2024. Absent generation
of sufficient revenue from the execution of the Company’s business plan, the Company will need to obtain debt or equity
financing by the third quarter of 2024. Because of these factors, the Company believes that there is substantial doubt in the
Company’s ability to continue as a going concern. These financial statements do not include any adjustments to the recoverability and classification of recorded
asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Operating
activities used $2,559,342 and $1,812,878 in cash for the nine months ended September 30, 2023 and 2022, respectively. The use of cash
in operating activities during the nine months ended September 30, 2023, primarily comprised of $3,324,313 net loss, $500,121 in stock
compensation expense, a decrease in prepaid expenses of $47,137, and a $109,300 increase of accounts payable and accrued expenses, which
included payments to legal and accounting professionals, payments to consultants, and other administrative expenses.
Investing
activities provided $2,497,407 and $1,435,208 in cash during the nine months ended September 30, 2023 and 2022, respectively. The cash
provided by investing activities was from $2,566,192 sale of marketable securities, offset by $12,979 used in the purchase of marketable
securities and $55,806 in the purchase of fixed assets during the nine months ended September 30, 2023.
There
was no cash used in or provided by financing activities for the nine months ended September 30, 2023 and 2022.
Item
3. Quantitative and Qualitative Disclosures about Market Risk.
Not
applicable.
Item
4. Controls and Procedures
Disclosure
Controls and Procedures
Evaluation
of disclosure controls and procedures
Under
the supervision and with the participation of our management, including our principal executive officer and principal financial officer,
we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e)
promulgated under the Securities Exchange Act of 1934 (the “Exchange Act), as of September 30, 2023. Based on this evaluation,
we have identified material weaknesses in our internal control over financial reporting. Due to material weaknesses, our principal executive
officer and principal financial officer concluded that our disclosure controls and procedures are not effective to ensure that information
required to be disclosed by us in the reports we file or submit under the Exchange Act, including this Quarterly Report on Form 10-Q,
is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and that our disclosure
and controls are not designed to ensure that information required to be disclosed by us in the reports that we file or submit under the
Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officer, or
persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Material
Weakness in Internal Control Over Financial Reporting
A
material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a
reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented
or detected on a timely basis.
The
material weaknesses we identified are described below:
|
1) |
We
do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and
nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent
possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate
individuals. Management evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls
and procedures and has concluded that the control deficiency that resulted represented a material weakness. |
|
|
|
|
2) |
Limited
level of multiple reviews among those tasked with preparing the financial statements. |
These
material weaknesses could result in a material misstatement to the annual or interim condensed consolidated financial statements that
would not be prevented or detected.
Remediation
Plan
To
address the material weakness described above the Company has engaged an independent third party to enhance our segregation of duties.
Since
we remain a small Company, with limited segregation of duties, the third party has identified certain areas where we can layer in added
controls and procedures. Management intends to implement such controls and procedures in the future.
A
control system, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of
the control system are met. The design of any system of controls is also based in part on certain assumptions regarding the likelihood
of certain events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions. Given these and other inherent limitations of control systems, these are only reasonable assurances that our controls will
succeed in achieving their stated goals under all potential future conditions.
Changes
in Internal Control over Financial Reporting
Other
than as discussed above, there were no changes in our internal controls over financial reporting that occurred during the quarter covered
by this Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part
II: Other Information
Item
1. Legal Proceedings
From
time to time we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions,
administrative actions, investigations or claims are pending against us or involve us that, in the opinion of our management, could reasonably
be expected to have a material adverse effect on our business and financial condition.
Item
1A. Risk Factors
Our business is subject
to substantial risks and uncertainties. Investing in our securities involves a high degree of risk. You should carefully consider the
risk factors in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31,
2023, together with the information contained elsewhere in this report, including Part I, Item 1 “Financial Statements” and
Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our
other SEC filings in evaluating our business. These risks and uncertainties could materially and adversely affect our business, financial
condition, results of operations, prospects for growth, and the value of an investment in our securities.
There were no material changes to the risk factors previously disclosed
in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 31, 2023.
Item
2. Unregistered Sale of Equity Securities and Use of Proceeds
None.
Item
3. Defaults upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
Item
6. Exhibits
The
following is a complete list of exhibits filed as part of this Form 10-Q. Exhibit numbers correspond to the numbers in the Exhibit Table
of Item 601 of Regulation S-K.
(€)
- Filed herewith.
(*)
-Furnished, not filed, in accordance with item 601(32)(ii) of Regulation S-K.
SIGNATURES
Pursuant
to the requirements of Section 12 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.
November
14, 2023 |
Protagenic
Therapeutics, Inc. |
|
|
|
|
By: |
/s/
Alexander K. Arrow |
|
|
Chief
Financial Officer |
Exhibit
31.1
CERTIFICATION
PURSUANT TO RULE 13a-14(a) OF THE
SECURITIES
EXCHANGE ACT OF 1934
I,
Garo H. Armen, PhD, certify that:
|
1. |
I
have reviewed this quarterly report on Form 10-Q of Protagenic Therapeutics, Inc.; |
|
|
|
|
2. |
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; |
|
|
|
|
3. |
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; |
|
|
|
|
4. |
The
registrant’s other certifying officer and I are 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: |
|
(a) |
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; |
|
|
|
|
(b) |
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; |
|
|
|
|
(c) |
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 |
|
|
|
|
(d) |
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 |
|
5. |
The
registrant’s other certifying officer and 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): |
|
(a) |
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 |
|
|
|
|
(b) |
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. |
November
14, 2023 |
|
/s/
Garo H. Armen |
|
Name: |
Garo
H. Armen, Ph.D. |
|
Title: |
Executive
Chairman |
Exhibit
31.2
CERTIFICATION
PURSUANT TO RULE 13a-14(a) OF THE
SECURITIES
EXCHANGE ACT OF 1934
I,
Alexander K. Arrow, MD, certify that:
|
1. |
I
have reviewed this quarterly report on Form 10-Q of Protagenic Therapeutics, Inc.; |
|
|
|
|
2. |
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; |
|
|
|
|
3. |
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; |
|
|
|
|
4. |
The
registrant’s other certifying officer and I are 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: |
|
(a) |
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; |
|
|
|
|
(b) |
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; |
|
|
|
|
(c) |
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 |
|
|
|
|
(d) |
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 |
|
5. |
The
registrant’s other certifying officer and 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): |
|
(a) |
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 |
|
|
|
|
(b) |
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. |
November
14, 2023 |
|
/s/
Alexander K. Arrow |
|
Name: |
Alexander
K. Arrow, MD |
|
Title: |
Chief
Financial Officer |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 906
OF
THE SARBANES OXLEY ACT OF 2002
In
connection with the Quarterly Report of Protagenic Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended September
30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), we, Garo H. Armen, Executive
Chairman, and Alexander K. Arrow, Chief Financial Officer, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes Oxley Act of 2002, that:
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
A
signed original of this certification has been provided to the Company and will be retained by the Company and furnished to the Securities
and Exchange Commission or its staff upon request.
November
14, 2023 |
By: |
/s/
Garo H. Armen |
|
|
Garo
H. Armen, PhD |
|
|
Executive
Chairman |
|
|
(Principal
Executive Officer) |
November
14, 2023 |
By: |
/s/
Alexander K. Arrow |
|
|
Alexander
K. Arrow, MD, CFA |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer) |
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v3.23.3
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
CURRENT ASSETS |
|
|
Cash |
$ 153,332
|
$ 215,189
|
Marketable securities |
5,119,252
|
7,763,517
|
Prepaid expenses |
104,076
|
56,939
|
TOTAL CURRENT ASSETS |
5,376,660
|
8,035,645
|
Equipment - net |
55,982
|
1,775
|
TOTAL ASSETS |
5,432,642
|
8,037,420
|
CURRENT LIABILITIES |
|
|
TOTAL CURRENT LIABILITIES |
1,280,106
|
1,119,862
|
TOTAL LIABILITIES |
1,280,106
|
1,119,862
|
STOCKHOLDERS’ EQUITY |
|
|
Common stock, $.0001 par value, 100,000,000 shares authorized, 4,330,959 and 4,321,315 shares issued and outstanding at September 30, 2023, and December 31, 2022 |
434
|
434
|
Additional paid-in-capital |
33,871,527
|
33,371,406
|
Accumulated deficit |
(29,101,688)
|
(25,777,375)
|
Accumulated other comprehensive loss |
(617,737)
|
(676,907)
|
TOTAL STOCKHOLDERS’ EQUITY |
4,152,536
|
6,917,558
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
5,432,642
|
8,037,420
|
Preferred Stock [Member] |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, value |
|
|
Series B Convertible Preferred Stock [Member] |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Preferred stock, value |
|
|
Nonrelated Party [Member] |
|
|
CURRENT LIABILITIES |
|
|
Accounts payable and accrued expenses |
524,006
|
669,704
|
PIK convertible notes payable, net of debt discount |
220,522
|
150,591
|
Related Party [Member] |
|
|
CURRENT LIABILITIES |
|
|
Accounts payable and accrued expenses |
336,337
|
105,928
|
PIK convertible notes payable, net of debt discount |
$ 199,241
|
$ 193,639
|
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v3.23.3
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value |
$ 0.000001
|
$ 0.000001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
4,330,959
|
4,321,315
|
Common stock, shares outstanding |
4,330,959
|
4,321,315
|
Series B Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.000001
|
$ 0.000001
|
Preferred stock, shares authorized |
18,000,000
|
18,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.000001
|
$ 0.000001
|
Preferred stock, shares authorized |
2,000,000
|
2,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
OPERATING AND ADMINISTRATIVE EXPENSES |
|
|
|
|
Research and development |
$ 1,124,030
|
$ 501,366
|
$ 2,308,440
|
$ 1,331,719
|
General and administrative |
307,682
|
422,694
|
1,006,308
|
1,570,291
|
TOTAL OPERATING AND ADMINISTRATIVE EXPENSES |
1,431,712
|
924,060
|
3,314,748
|
2,902,010
|
LOSS FROM OPERATIONS |
(1,431,712)
|
(924,060)
|
(3,314,748)
|
(2,902,010)
|
OTHER (EXPENSE) INCOME |
|
|
|
|
Interest income |
69,218
|
42,496
|
210,819
|
93,363
|
Interest expense |
(31,957)
|
(31,957)
|
(94,830)
|
(105,498)
|
Realized loss on marketable securities |
(23,175)
|
(11,784)
|
(146,554)
|
(39,986)
|
Gain on settlement of liabilities |
21,000
|
|
21,000
|
|
TOTAL OTHER INCOME (EXPENSES) |
35,086
|
(1,245)
|
(9,565)
|
(52,121)
|
LOSS BEFORE TAX |
(1,396,626)
|
(925,305)
|
(3,324,313)
|
(2,954,131)
|
INCOME TAX EXPENSE |
|
|
|
|
NET LOSS |
(1,396,626)
|
(925,305)
|
(3,324,313)
|
(2,954,131)
|
Other Comprehensive Loss - net of tax |
|
|
|
|
Net unrealized gain (loss) on marketable securities |
(34,463)
|
(165,913)
|
55,503
|
(360,500)
|
Foreign exchange translation income (loss) |
3,187
|
481
|
3,667
|
(6,262)
|
TOTAL COMPREHENSIVE LOSS |
$ (1,427,902)
|
$ (1,090,737)
|
$ (3,265,143)
|
$ (3,320,893)
|
Net loss per common share - Basic |
$ (0.32)
|
$ (0.21)
|
$ (0.77)
|
$ (0.68)
|
Net loss per common share - Diluted |
$ (0.32)
|
$ (0.21)
|
$ (0.77)
|
$ (0.68)
|
Weighted average common shares - Basic |
4,330,959
|
4,321,315
|
4,328,123
|
4,316,659
|
Weighted average common shares - Diluted |
4,330,959
|
4,321,315
|
4,328,123
|
4,316,659
|
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