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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
Or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period ended:
QSAM
Biosciences, Inc.
(Exact
name of Registrant as specified in its Charter)
Delaware |
|
001-41337 |
|
20-1602779 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
9442
Capital of Texas Hwy N, Plaza 1, Suite 500
Austin,
TX 78759
(Address
of Principal Executive Offices)
(512)
343-4558
(Registrant’s
Telephone Number, including area code)
(Former
name or former address, if changed since last report.)
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.0001
Indicate
by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No ☒
Indicate
by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted 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 and post such files). Yes ☒ No ☐
Indicate
by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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.
(1)
Yes ☒ No ☐; (2) 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:
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 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 ☒
Indicate
the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date:
As
of August 11, 2023, the registrant had 3,287,941
common shares outstanding.
Documents
incorporated by reference: None.
QSAM
BIOSCIENCES, INC.
FORM
10-Q
TABLE
OF CONTENTS
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q (“Report”), including this “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” contains forward-looking statements, within the meaning of the Private Securities Litigation
Reform Act of 1995, regarding future events and the future results of the Company that are based on current expectations, estimates,
forecasts, and projections about the industry in which the Company operates and the beliefs and assumptions of the management of the
Company. Words such as “expects,” “anticipates,” “targets,” “goals,”
“projects,” “intends,” “plans,” “believes,” “seeks,”
“estimates,” “may”, “could” and variations of such words, and similar expressions
are intended to identify such forward-looking statements. These forward-looking statements are only predictions and are subject to risks,
uncertainties and assumptions that are difficult to predict. In particular, as discussed in greater detail below, our financial condition
and results could be materially adversely affected by the continued impacts and disruptions caused by the novel coronavirus (COVID-19)
global pandemic and governmental responses thereto. Forward-looking statements are based on certain assumptions, discuss future expectations,
describe future plans and strategies, contain financial and operating projections or state other forward-looking information. Our ability
to predict results or the actual effect of future events, actions, plans or strategies is inherently uncertain. Although we believe that
the expectations reflected in our forward-looking statements are based on reasonable assumptions, our actual results and performance
could differ materially from those set forth or anticipated in our forward-looking statements. Therefore, actual results may differ materially
and adversely from those expressed in any forward-looking statements. Factors that might cause or contribute to such differences include,
but are not limited to, those discussed elsewhere in this Report, including under “Risk Factors”, and in other reports the
Company files with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report
on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023 (under the heading “Risk Factors”
and in other parts of that report).
Exchange
Act Reporting Requirements
Section
14(a) of the Exchange Act requires all companies with securities registered pursuant to Section 12(g) of the Exchange Act like we are
to comply with the rules and regulations of the SEC regarding proxy solicitations, as outlined in Regulation 14A. Matters submitted to
shareholders at a special or annual meeting thereof or pursuant to a written consent will require us to provide our shareholders with
the information outlined in Schedules 14A (where proxies are solicited) or 14C (where consents in writing to the action have already
been received or anticipated to be received) of Regulation 14, as applicable; and preliminary copies of this information must be submitted
to the SEC at least 10 days prior to the date that definitive copies of this information are forwarded to our shareholders. We are also
required to file annual reports on Form 10-K and quarterly reports on Form 10-Q with the SEC on a regular basis, and will be required
to timely disclose certain material events (e.g., changes in corporate control; acquisitions or dispositions of a significant amount
of assets other than in the ordinary course of business; and bankruptcy) in a Current Report on Form 8-K. All public filing made with
the SEC are available via the SEC’s website on EDGAR at www.sec.gov.
PART
I – FINANCIAL INFORMATION
Item
1: Financial StatementS
QSAM
BIOSCIENCES, INC.
CONSOLIDATED
BALANCE SHEETS
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
| |
(Unaudited) | | |
| |
| |
| | |
| |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
Cash | |
$ | 389,690 | | |
$ | 225,276 | |
Prepaid expenses and other current assets | |
| 72,922 | | |
| 139,345 | |
TOTAL CURRENT ASSETS | |
| 462,612 | | |
| 364,621 | |
| |
| | | |
| | |
TOTAL ASSETS | |
$ | 462,612 | | |
$ | 364,621 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 911,744 | | |
$ | 745,011 | |
Accrued payroll and related expenses | |
| 79,166 | | |
| 79,166 | |
Accrued Series B preferred stock dividends | |
| 379,480 | | |
| 304,653 | |
Convertible notes payable, net of discount | |
| - | | |
| 443,700 | |
Notes payable - related parties | |
| 7,500 | | |
| 7,500 | |
TOTAL CURRENT LIABILITIES | |
| 1,377,890 | | |
| 1,580,030 | |
| |
| | | |
| | |
TOTAL LIABILITIES | |
| 1,377,890 | | |
| 1,580,030 | |
| |
| | | |
| | |
Redeemable convertible preferred stock - Series A; $0.0001 par value, 1,500 authorized, 480 shares issued and outstanding (liquidation preference of $735,600 and $721,200) as of June 30, 2023 and December 31, 2022, respectively | |
| 735,600 | | |
| 721,200 | |
| |
| | | |
| | |
STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Preferred stock, Series B, $0.001 par value; 2,500 shares authorized, 1,509 shares issued and outstanding (liquidation preference of $1,850,814 and $1,813,607) as of June 30, 2023 and December 31, 2022 | |
| 2 | | |
| 2 | |
Preferred stock, Series E-1, $0.0001 par value; 8,500 shares authorized, 0 shares issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| - | | |
| - | |
Preferred stock, value | |
| - | | |
| - | |
| |
| | | |
| | |
Common stock, $0.0001 par value, 300,000,000 shares authorized, 3,241,941 and 2,279,019 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 324 | | |
| 228 | |
Unearned deferred compensation | |
| (1,459,884 | ) | |
| (187,329 | ) |
Additional paid-in capital | |
| 38,278,618 | | |
| 33,428,115 | |
Accumulated deficit | |
| (38,469,938 | ) | |
| (35,177,625 | ) |
TOTAL STOCKHOLDERS’ DEFICIT | |
| (1,650,878 | ) | |
| (1,936,609 | ) |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
$ | 462,612 | | |
$ | 364,621 | |
See
notes to the unaudited consolidated financial statements.
QSAM
BIOSCIENCES, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended | | |
For the six months ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
REVENUES | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
Payroll and related expenses | |
| 274,066 | | |
| 791,721 | | |
| 606,382 | | |
| 1,548,120 | |
Professional fees | |
| 449,365 | | |
| 218,006 | | |
| 908,499 | | |
| 857,411 | |
General and administrative | |
| 66,083 | | |
| 49,300 | | |
| 134,081 | | |
| 168,768 | |
Research and development expenses | |
| 448,256 | | |
| 204,216 | | |
| 654,795 | | |
| 459,053 | |
Total Operating Expenses | |
| 1,237,770 | | |
| 1,263,243 | | |
| 2,303,757 | | |
| 3,033,352 | |
| |
| | | |
| | | |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (1,237,770 | ) | |
| (1,263,243 | ) | |
| (2,303,757 | ) | |
| (3,033,352 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER INCOME (EXPENSE) | |
| | | |
| | | |
| | | |
| | |
Financing costs including interest | |
| (112 | ) | |
| (20,203 | ) | |
| (43,230 | ) | |
| (38,340 | ) |
Inducement interest | |
| - | | |
| - | | |
| (397,937 | ) | |
| - | |
Total Other Expense, net | |
| (112 | ) | |
| (20,203 | ) | |
| (441,167 | ) | |
| (38,340 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
INCOME TAXES | |
| - | | |
| - | | |
| - | | |
| - | |
NET LOSS | |
| (1,237,882 | ) | |
| (1,283,446 | ) | |
| (2,744,924 | ) | |
| (3,071,692 | ) |
| |
| | | |
| | | |
| | | |
| | |
PREFERRED STOCK | |
| | | |
| | | |
| | | |
| | |
Series A preferred contractual dividends | |
| (7,200 | ) | |
| (6,018 | ) | |
| (14,400 | ) | |
| (13,220 | ) |
Series B preferred contractual dividends | |
| (37,620 | ) | |
| (38,035 | ) | |
| (74,827 | ) | |
| (75,241 | ) |
Deemed dividend on warrant modification | |
| - | | |
| - | | |
| - | | |
| (41,225 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | |
$ | (1,282,702 | ) | |
$ | (1,327,499 | ) | |
$ | (2,834,151 | ) | |
$ | (3,201,378 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC AND DILUTED: | |
$ | (0.43 | ) | |
$ | (0.79 | ) | |
$ | (1.07 | ) | |
$ | (1.91 | ) |
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC | |
$ | (0.48 | ) | |
$ | (0.79 | ) | |
$ | (1.07 | ) | |
$ | (1.91 | ) |
| |
| | | |
| | | |
| | | |
| | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED | |
| 2,968,078 | | |
| 1,677,681 | | |
| 2,652,518 | | |
| 1,677,681 | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC | |
| 2,652,518 | | |
| 1,677,681 | | |
| 2,968,078 | | |
| 1,677,681 | |
See
notes to the unaudited consolidated financial statements.
QSAM
BIOSCIENCES, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
FOR
THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022
(UNAUDITED)
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Series B Preferred Stock | | |
Series E-1 Preferred Stock | | |
Common Stock | | |
Deferred | | |
Additional | | |
| | |
Total Stockholders’ | |
| |
Shares | | |
Par Value | | |
Shares | | |
Par Value | | |
Shares | | |
Par Value | | |
Stock-based Compensation | | |
Paid-In Capital | | |
Accumulated Deficit | | |
Equity (Deficit) | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, December 31, 2021 | |
| 1,509 | | |
$ | 2 | | |
| - | | |
$ | - | | |
| 1,652,102 | | |
$ | 165 | | |
$ | (900,742 | ) | |
$ | 29,765,585 | | |
$ | (29,281,674 | ) | |
$ | (416,664 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued for services, including a director | |
| - | | |
| - | | |
| - | | |
| - | | |
| 28,750 | | |
| 3 | | |
| - | | |
| 254,748 | | |
| - | | |
| 254,751 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Conversion of debentures | |
| - | | |
| - | | |
| - | | |
| - | | |
| 5,469 | | |
| 1 | | |
| - | | |
| 34,999 | | |
| - | | |
| 35,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Incremental value from warrant modifications | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 41,225 | | |
| (41,225 | ) | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series A, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,202 | ) | |
| - | | |
| (7,202 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
40:1 Reverse Split Fractional Shares Adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| 266 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series B, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (37,206 | ) | |
| - | | |
| (37,206 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Accretion of stock-based compensation to employees and directors | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 213,041 | | |
| 107,312 | | |
| - | | |
| 320,353 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss period for the three months ended March 31, 2022 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,788,246 | ) | |
| (1,788,246 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, March 31, 2022 | |
| 1,509 | | |
| 2 | | |
| - | | |
| - | | |
| 1,686,587 | | |
| 169 | | |
| (687,701 | ) | |
| 30,159,461 | | |
| (31,111,145 | ) | |
| (1,639,214 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series A, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,018 | ) | |
| - | | |
| (6,018 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series B, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (38,035 | ) | |
| - | | |
| (38,035 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Accretion of stock-based compensation to employees and directors | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 215,409 | | |
| 212,175 | | |
| - | | |
| 427,584 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss period for the three months ended June 30, 2022 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,283,446 | ) | |
| (1,283,446 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2022 | |
| 1509 | | |
| - | | |
| - | | |
| - | | |
| 1,686,587 | | |
| 169 | | |
| (472,292 | ) | |
| 30,327,583 | | |
| (32,394,591 | ) | |
| (2,539,129 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2022 | |
| 1,509 | | |
$ | 2 | | |
| - | | |
$ | - | | |
| 2,279,019 | | |
$ | 228 | | |
$ | (187,329 | ) | |
$ | 33,428,115 | | |
$ | (35,177,625 | ) | |
$ | (1,936,609 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued for services | |
| - | | |
| - | | |
| - | | |
| - | | |
| 16,500 | | |
| 2 | | |
| 115,090 | | |
| 141,477 | | |
| - | | |
| 256,569 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Incremental value from warrant modifications | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 282,309 | | |
| (282,309 | ) | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Deemed dividend from Series A conversion price adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 96,245 | | |
| (96,245 | ) | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Deemed dividend from Series B conversion price adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 168,835 | | |
| (168,835 | ) | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series A, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,200 | ) | |
| - | | |
| (7,200 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series B, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (37,207 | ) | |
| - | | |
| (37,207 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Accretion of stock-based compensation to employees and directors | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 36,740 | | |
| 132,593 | | |
| - | | |
| 169,333 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock for cash | |
| - | | |
| - | | |
| - | | |
| - | | |
| 69,834 | | |
| 7 | | |
| - | | |
| 314,239 | | |
| - | | |
| 314,246 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of warrants for cash to common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| 365,001 | | |
| 37 | | |
| - | | |
| 1,094,965 | | |
| - | | |
| 1,095,001 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Conversion of convertible debt to common stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| 164,446 | | |
| 16 | | |
| - | | |
| 519,696 | | |
| - | | |
| 519,712 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Inducement for conversion of convertible debt | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 397,937 | | |
| - | | |
| 397,937 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss period for the three months ended March 31, 2023 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,507,042 | ) | |
| (1,507,042 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, March 31, 2023 | |
| 1,509 | | |
$ | 2 | | |
| - | | |
$ | - | | |
| 2,894,800 | | |
$ | 290 | | |
$ | (35,499 | ) | |
$ | 36,532,003 | | |
$ | (37,232,056 | ) | |
$ | (735,260 | ) |
Balance | |
| 1,509 | | |
$ | 2 | | |
| - | | |
$ | - | | |
| 2,894,800 | | |
$ | 290 | | |
$ | (35,499 | ) | |
$ | 36,532,003 | | |
$ | (37,232,056 | ) | |
$ | (735,260 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Common stock issued for services | |
| - | | |
| - | | |
| - | | |
| - | | |
| 76,000 | | |
| 7 | | |
| (78,875 | ) | |
| 323,482 | | |
| - | | |
| 244,614 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series A, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,200 | ) | |
| - | | |
| (7,200 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Series B, preferred stock contractual dividends | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (37,620 | ) | |
| - | | |
| (37,620 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Accretion of stock-based compensation to employees and directors | |
| - | | |
| - | | |
| - | | |
| - | | |
| 271,141 | | |
| 27 | | |
| (1,345,510 | ) | |
| 1,467,953 | | |
| - | | |
| 122,470 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss period for the three months ended June 30, 2023 | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,237,882 | ) | |
| (1,237,882 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2023 | |
| 1,509 | | |
$ | 2 | | |
| - | | |
$ | - | | |
| 3,241,941 | | |
$ | 324 | | |
$ | (1,459,884 | ) | |
$ | 38,278,618 | | |
$ | (38,469,938 | ) | |
$ | (1,650,878 | ) |
Balance | |
| 1,509 | | |
$ | 2 | | |
| - | | |
$ | - | | |
| 3,241,941 | | |
$ | 324 | | |
$ | (1,459,884 | ) | |
$ | 38,278,618 | | |
$ | (38,469,938 | ) | |
$ | (1,650,878 | ) |
See
notes to the unaudited consolidated financial statements.
QSAM
BIOSCIENCES, INC.
CONSOLIDATED
STATEMENT OF CASH FLOWS
(UNAUDITED)
| |
2023 | | |
2022 | |
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net Loss | |
$ | (2,744,924 | ) | |
$ | (3,071,692 | ) |
Adjustments to reconcile net loss to net cash used in operations: | |
| | | |
| | |
Common stock issued for services | |
| 501,183 | | |
| 254,751 | |
Stock-based compensation to employees and directors | |
| 291,803 | | |
| 747,937 | |
Amortization of debt discount | |
| 36,300 | | |
| 18150 | |
Inducement expense | |
| 397,937 | | |
| - | |
Changes in operating assets and liabilities | |
| | | |
| | |
Decrease in prepaid expenses and other current assets | |
| 66,423 | | |
| 26,793 | |
Increase in accounts payable and accrued expenses | |
| 199,515 | | |
| 425,143 | |
Increase in accrued payroll and related expenses | |
| - | | |
| 493,405 | |
Increase in accrued interest – related parties | |
| 6,930 | | |
| - | |
Net cash used in operating activities | |
| (1,244,833 | ) | |
| (1,105,513 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES | |
| | | |
| | |
Deferred offering costs | |
| - | | |
| 35,000 | |
Proceeds from warrant exercise | |
| 1,095,001 | | |
| - | |
Proceeds from sale of common stock and warrants | |
| 314,246 | | |
| - | |
Net cash provided by financing activities | |
| 1,409,247 | | |
| 35,000 | |
| |
| | | |
| | |
NET INCREASE (DECREASE) IN CASH | |
| 164,414 | | |
| (1,070,513 | ) |
| |
| | | |
| | |
CASH - Beginning of period | |
| 225,276 | | |
| 1,499,866 | |
CASH - End of period | |
$ | 389,690 | | |
$ | 429,353 | |
| |
| | | |
| | |
SUPPLEMENTAL CASH FLOW DISCLOSURES: | |
| | | |
| | |
Payment of interest in cash | |
$ | - | | |
$ | - | |
Payment of income taxes | |
$ | - | | |
$ | - | |
| |
| | | |
| | |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | |
| | | |
| | |
Accrual of contractual dividends on Series A convertible preferred stock | |
$ | 14,400 | | |
$ | 13,220 | |
Accrual of contractual dividends on Series B convertible preferred stock | |
$ | 74,827 | | |
$ | 75,241 | |
Deemed dividend on warrant modifications | |
$ | 282,309 | | |
$ | 41,225 | |
Incremental value of Series A conversion modifications | |
$ | 96,245 | | |
$ | - | |
Incremental value of Series B conversion modifications | |
$ | 168,835 | | |
$ | - | |
Deferred Compensation for Employees and Consultants | |
$ | 1,459,884 | | |
$ | - | |
Conversion of notes payable to common stock | |
$ | 519,712 | | |
$ | - | |
See
notes to the unaudited consolidated financial statements
QSAM
BIOSCIENCES INC.
NOTES
TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – ORGANIZATION AND DESCRIPTION OF BUSINESS
QSAM
Biosciences Inc. (hereinafter the “Company”, “we”, “our”, “us”), incorporated in Delaware
on August 26, 2004, is currently engaged in the business of developing a novel radiopharmaceutical drug candidate for the treatment of
bone cancer. This business line commenced in earnest in the fourth fiscal quarter of 2020 as a result of the separation and transfer
pursuant to an Omnibus Separation Agreement dated November 6, 2020 (the “Separation Agreement”) of the Company’s prior
business in a separate sector (the “Legacy Business”) through an unconsolidated investee entity called Earth Property Holdings
LLC, a Delaware limited liability company (“EPH”). Pursuant to the Separation Agreement, the Company transferred to EPH all
assets and related liabilities in connection with the Legacy Business in return for a forgiveness of debt. The Company sold its entire
equity interest in EPH to a third party in the first quarter of 2021 for $100,000, and currently holds no ownership in EPH.
In
April 2020, the Company established QSAM Therapeutics Inc. (“QSAM”) as a wholly-owned subsidiary incorporated in the state
of Texas, and through QSAM, executed a Patent and Technology License Agreement and Trademark Assignment (the “License Agreement”)
with IGL Pharma, Inc. (“IGL”). The License Agreement provides QSAM with exclusive, worldwide and sub-licensable rights to
all of IGL’s patents, product data and knowhow with respect to Samaium-153 DOTMP aka CycloSam® (the “Technology”),
a clinical stage novel radiopharmaceutical meant to treat different types of bone cancer and other diseases.
In
connection with the transition to the life sciences sector, the Company changed its name to QSAM Biosciences Inc. on September 4, 2020,
and subsequently changed its stock symbol to QSAM, to better reflect its business moving forward.
On
March 4, 2022, the Company completed a 40:1 reverse stock split of its common shares. All shares and share prices set forth in this report
have been adjusted retroactively to present this reverse stock split as if it had occurred at the beginning of the period presented in
these consolidated financial statements.
NOTE
2 – BASIS OF PRESENTATION AND GOING CONCERN
The
accompanying unaudited financial statements are prepared in accordance with Rule 8-01 of Regulation S-X of the Securities Exchange Commission
(“SEC”). Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance
with generally accepted accounting principles in the United States of America (“US GAAP”) have been condensed or omitted
pursuant to such rules and regulations. However, the Company believes that the disclosures included in these unaudited consolidated financial
statements are adequate to make the information presented not misleading. The unaudited consolidated financial statements included in
this document have been prepared on the same basis as the annual financial statements, and in our opinion reflect all adjustments, which
include normal recurring adjustments necessary for a fair presentation in accordance with US GAAP and SEC regulations for interim financial
statements. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that the Company
will have for any subsequent period or for the calendar year ended December 31, 2023. These unaudited consolidated financial statements
should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31,
2022 which was filed with the SEC on March 30, 2023.
For
the six months ended June 30, 2023, the Company used net cash in operating activities for its operations of $1,244,833 and incurred a loss
from its operations of $. As of June 30, 2023, the Company has negative working capital of $915,278 and cash of $389,690, and
the Company’s accumulated deficit is $38,469,938. These conditions raise substantial doubt about the Company’s ability to
continue as a going concern for one year from the issuance of these financial statements.
The
Company has supported operations through the issuance of common stock, preferred stock and debt over the last 12 months. This includes
a common stock and warrant offering which closed March 31, 2023, of which a total of $2.85 million was raised, inclusive of $342,667
in subscriptions receivables existing at the end of the quarter which were received in April 2023.
Management
expects expenses to increase in 2023 as our drug technology continues through clinical trials, and as a result, we will need to raise
additional capital to support these operations. Management believes that it can do so through equity or debt raises in the second half
of 2023. If the Company is not successful in raising additional capital, it may need to delay clinical trials, reduce overhead, or in
the most extreme scenario, shut down operations.
There
is no guarantee whether the Company will be able to generate revenue and/or raise capital sufficient to support its continuing operations.
The ability of the Company to continue as a going concern is dependent on management’s plans which include implementation of its
business model to develop and commercialize its drug candidate, seek strategic partnerships to advance clinical trials and other research
endeavors which could provide additional capital to the Company, and continue to raise funds for the Company through equity or debt offerings.
There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that
it will be available on terms acceptable to the Company. The unaudited consolidated financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
NOTE
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation
The
unaudited consolidated financial statements include the accounts of QSAM Biosciences Inc. and its wholly-owned subsidiaries (the “Subsidiaries”)
QSAM Therapeutics Inc. and Q2Power Corp. (currently inactive). All significant inter-company transactions and balances have been eliminated
in consolidation. References herein to the Company include the Company and its Subsidiaries unless the context otherwise requires.
Cash
and Cash Equivalents
The
Company considers cash, short-term deposits, and other investments with original maturities of no more than ninety days when acquired
to be cash and cash equivalents for the purposes of the statement of cash flows. The Company maintains cash balances at one national
financial institution and has experienced no losses with respect to amounts on deposit. Any loss incurred or a lack of access to such
funds above the FDIC limit could have a significant adverse impact on the Company’s financial condition, results of operations
and cash flows. The Company held no cash equivalents as of June 30, 2023 and December 31, 2022.
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers (“ASC 606”) and
all the related amendments.
The
core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers
in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC
606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required
within the revenue recognition process than previously required under U.S. GAAP, including identifying performance obligations in the
contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to
each separate performance obligation.
The
Company had no revenue in 2023 and 2022.
Stock
Based Compensation
The
Company applies the fair value method of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification
(“ASC”) 718, “Share Based Payment”, in accounting for its stock-based compensation with employees and
non-employees. This standard states that compensation cost is measured at the grant date based on the fair value of the award and is
recognized over the service period, which is usually the vesting period. The Company values stock-based compensation at the market price
for the Company’s common stock and other pertinent factors at the grant date.
The
Black-Scholes option pricing valuation method is used to determine fair value of stock options consistent with ASC 718, “Share
Based Payment”. Use of this method requires that the Company make assumptions regarding stock volatility, dividend yields,
expected term of the awards and risk-free interest rates.
Research
and Development
Research
and development costs are expensed as incurred. Research and development costs were $654,795 for the six months ended June 30, 2023,
and are a result of the Company’s clinical trials of its drug Technology. Research and development costs were $459,053 for the
six months ended June 30, 2022, and are also a result of the clinical trials and fees owed under its License Agreement (see Note 8 –
Commitments and Contingencies).
Income
Taxes
Income
taxes are accounted for under the asset and liability method as stipulated by FASB ASC 740, “Income Taxes” (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit
carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities
or a change in tax rate is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced to estimated
amounts to be realized by the use of a valuation allowance. A valuation allowance is applied when in management’s view it is more
likely than not (50%) that such deferred tax will not be utilized.
In
the event that an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there
is a probability that the uncertain tax position taken would be sustained upon examination by the taxing authorities. Reserves for uncertain
tax positions would be recorded if the Company determined it is probable that a position would not be sustained upon examination or if
payment would have to be made to a taxing authority and the amount is reasonably estimated. As of June 30, 2023 and December 31, 2022,
the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authorities.
Interest and penalties related to any unrecognized tax benefits is recognized in the unaudited consolidated financial statements as a
component of income taxes.
Basic
and Diluted Loss Per Share
Net
loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders
by the weighted average number of common shares outstanding during the period plus any potentially dilutive shares related to the issuance
of stock options, shares from the issuance of stock warrants, shares issued from the conversion of convertible preferred stock and shares
issued for the conversion of convertible debt.
As
of June 30, 2023, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
SCHEDULE
OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 50,000 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 244,144 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 348,420 | |
| |
| 820,379 | |
As
of June 30, 2022, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 37,083 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 110,437 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 271,490 | |
| |
| 675,409 | |
Significant
Estimates
U.S.
Generally Accepted Accounting Principles (“GAAP”) requires the Company to make judgments, estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited
financial statements, the reported amounts of revenues and expenses, cash flows and the related footnote disclosures during the period.
On an on-going basis, the Company reviews and evaluates its estimates and assumptions, including, but not limited to, those that relate
to the fair value of stock-based compensation, and a valuation allowance on deferred tax assets. Actual results could differ from these
estimates.
Recent
Accounting Pronouncements
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06,
Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s
Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify accounting for certain financial instruments. ASU 2020-06 eliminates
the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies
the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard
also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s
own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for
all convertible instruments. ASU 2020-06 is effective January 1, 2022 for public business entities that are not smaller reporting companies
and for all other entities, fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The standard
should be applied on a full or modified retrospective basis, with early adoption permitted beginning on January 1, 2021. Effective January
1, 2021, the Company adopted ASU 2020-06 and noted no material impact to the consolidated financial statements.
Management
does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect
on its unaudited financial statements.
Concentration
of Risk
The
Company expects cash to be the asset most likely to subject the Company to concentrations of credit risk. The Company’s bank deposits
may at times exceed federally insured limits. The Company’s policy is to maintain its cash with high credit quality financial institutions
to limit its risk of loss exposure. The Company’s cash balance as of June 30, 2023, is in excess of FDIC limits in the amount of
approximately $139,690.
The
Company is subject to a number of risks similar to those of other companies at a clinical-stage for radiopharmaceutical drug candidates,
including dependence on key individuals; the need to develop commercially viable therapeutics; competition from other companies, many
of which are larger and better capitalized; intellectual property risks; and the need to obtain adequate additional financing to fund
the development of its products. The Company currently depends on third-party suppliers for key materials and services used in its research
and development manufacturing process, and is subject to certain risks related to the loss of these third-party suppliers or their inability
to supply the Company with adequate materials and services. The Company’s primary Technology is licensed from one party and is
subject to general risks related to contractual relationships and the performance of the parties under the contract.
Fair
Value of Financial Instruments
In
accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information
about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that
value. Cash is carried fair value.
Other
financial instruments, including accounts payable, accrued liabilities and short-term debt, are carried at cost, which approximates fair
value given their short-term nature.
Deferred
Offering Cost
Costs
incurred prior to an equity offering are capitalized until the offering occurs. Upon the equity offering, all accumulated costs are charged
against proceeds. If the Company determines that the equity offering will not occur, the accumulated costs are charged to operations.
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
views its operations and manages its business as one segment.
NOTE
4 – RELATED PARTY TRANSACTIONS
The
Company has a License Agreement with IGL Pharma, Inc. (“IGL”), an entity in which the Company’s Executive Chairman
serves as President, holds options to purchase less than a 1% non-controlling equity interest and receives a $500 per month fee. Effective
November 17, 2021, the Company amended the License Agreement with IGL which adjusted milestone payment amounts during the course of the
agreement term. Under the License Agreement, the Company incurred research and development related expenses of $0 and $9,355 during the
three-month period ending June 30, 2023 and June 30, 2022, respectively. As of June 30, 2023 and December 31, 2022, amounts outstanding
due IGL for their services amounted to $11,658 and $13,900, respectively.
During
the year ended December 31, 2020, the Company received $45,500 of proceeds from short-term notes payable with officers and directors
of the Company bearing interest at 10%. As of June 30, 2023 and December 31, 2022, $7,500 of principal remains outstanding on certain
of these short-term notes payable.
During 2022, the Company started
accuring compensation for the Board of Directors. Each board member receives an annual retainer of $30,000. Additionally, directors receive
annual fees of $20,000, $15,000 and $10,000 for serving as Chair of the Audit Committee, Compensation
Committee, and Nominating & Governance Committee, respectively; and annual fees of $7,500, $5,000 and $3,500 for serving as members
of the Audit Committee, Compensation Committee and Nominating & Governance Committee, respectively. As of June 30, 2023 and
December 31, 2022, the Company accrued director fees of $157,622 and $101,991, respectively.
NOTE
5 –CONVERTIBLE PROMISSORY NOTES
Convertible
Notes Payable
In
the fourth quarter of 2021, the Company issued a total of $605,000 in convertible notes payable, the total principal and accrued interest
of which was converted into a total of 186,601 shares of common stock as of June 30, 2023. The convertible notes were to mature on December
31, 2023, and included a 6% simple interest rate per annum payable upon maturity. In addition to the notes payable, each holder received
a warrant for the purchase of shares of common stock with a purchase price of $24.00, which expired in 2022. In accordance with accounting
standards, the warrants were valued using a Black Scholes Model and the relative fair value of the warrant was applied against the convertible
note for a debt discount of $72,600.
In
the fourth quarter of 2022, two note holders converted $132,932 of principal and interest on their notes into 22,155 shares of common
stock, at a reduced conversion price approved by the Board of $6.00. In the first quarter of 2023, the remaining holders converted $519,712
of principal and interest on their notes into 148,621 shares of common stock, at a reduced conversion price approved by the Board of
$3.50, and the two holders who converted in 2022 received an additional 15,825 shares to “make whole” their prior conversion
at a higher price. Due to the inducement to the reduced conversion price, the Company recorded $397,937 of inducement interest expense
to other income and expenses. The fair value of the shares issued for the conversion as of March 31, 2023 was $594,484 based on the stock
price of $4.00 as of March 31, 2023.
During
the six-month periods ended June 30, 2023 and 2022, the Company recorded interest expense related to the amortization of the discount
of $36,300 and $9,075, respectively. As of June 30, 2023 and December 31, 2022, unamortized debt discount was $0 and $36,300, respectively.
NOTE
6 – TEMPORARY EQUITY, PREFERRED STOCK, COMMON STOCK, AND WARRANTS
Series
A Redeemable Convertible Preferred Stock (“Series A Stock”)
As
of June 30, 2023 and December 31, 2022, the Company has 480 shares of Series A Stock issued and outstanding. The Series A Stock has no
voting rights until converted to common stock and has a liquidation preference equal to the aggregate purchase price of $480,000 plus
accrued dividends. Pursuant to a modification agreement effective as of March 31, 2023, the two Series A Stockholders have agreed to
change the redemption date on their Series A Stock to December 31, 2023 and waive any prior defaults by the Company.
The
Series A Stock carries a 6% per annum dividend calculated on the stated value of the stock and is cumulative and payable quarterly beginning
July 1, 2016. These dividends are accrued at each reporting period and are added to the redemption value of the stock; however, since
the Company has an accumulated deficit, the charge has been recognized in additional paid-in capital. The accrued dividends are $255,600
and $241,200 as of June 30, 2023 and December 31, 2022, respectively. As of June 30, 2023 and December 31, 2022, the stated value of
the Series A Stock and the accrued dividends was $735,600 and $721,200, respectively, which has been presented as mezzanine equity on
the consolidated balance sheets, which resides between liabilities and stockholders’ deficit.
The
outstanding principal and accrued dividends on the shares of Series A Stock as of June 30, 2023 are convertible into the Company’s
common stock at $3.00 (the “Conversion Price”), which was reduced in 2023 pursuant to a price protection provision included
in the Series A Stock Certificate of Designation (“Series A Designation”), as the Company offered an inducement to holders
of warrants to convert their warrants at such lower conversion price. The Series A Designation requires an adjustment to the Conversion
Price if a subsequent equity sale occurs at a price below the conversion rate. The Company recorded a deemed dividend within stockholders’
deficit associated with the reduction in Conversion Price from $3.33 to $3.00 of $96,245 based on the incremental value to the Series
A Stockholders due to the Conversion Price reduction. This incremental value has also been presented on the consolidated statement of
operations as an addition to the net loss available to common stockholders. The incremental value was determined by computing the additional
shares the Series A Stockholders would receive based on the Conversion Price reduction multiplied by the estimated fair value of common
stock of $4.00.
Prior
to the recent Conversion Price adjustment, the outstanding shares of Series A Stock as of December 31, 2022 were convertible at $3.33
per share of the Company’s common stock, which was reduced in 2022 pursuant to the Series A Designation as the Company sold a common
stock and warrant unit in an offering at $4.50, the fair value of which was determined to be $3.33. The Company recorded a deemed dividend
within stockholders’ equity associated with the reduction in Conversion Price from $6.40 to $3.33 of $342,497 based on the incremental
value to the Series A Stockholders due to the Conversion Price reduction. This incremental value has also been presented on the consolidated
statement of operations as an addition to the net loss available to common stockholders. The incremental value was determined by computing
the additional shares the Series A Stockholders would receive based on the Conversion Price reduction multiplied by the estimated fair
value of common stock of $.
Management
has determined that the Series A Stock is more akin to a debt security than equity primarily because it contains a mandatory 2-year redemption
at the option of the holder (which pursuant to a June 30, 2023 modification signed by both Series A Stockholders, was changed to December
31, 2023), which only occurs if the Series A Stock is not converted to common stock. Therefore, management has presented the Series A
Stock outside of permanent equity as mezzanine equity, which resides between liabilities and equity.
Series
B Convertible Preferred Stock (“Series B Stock”)
In
December 2020, the Company filed an amendment to its Articles of Incorporation to authorize the issuance of up to 2,500 shares of Series
B Stock, par value $0.001 per share, pursuant to a Certificate of Designation (“Series B Designation”). The Series B Stock
provides the holders a 10% annual paid-in-kind dividend, a liquidation preference equal to the purchase price of the shares ($1,000 per
share) followed by the right to participate with the common stockholders in the instance of a liquidation or other exit event, and provide
the holders the right to vote along with the common holders based on the common conversion amount of their holdings. In January 2021,
the Company closed a private offering of its Series B Stock for $1,000 per share, raising a total of $2,500,000, inclusive of $156,000
in prior debt conversion and $23,000 of notes payable with directors converted to shares of Series B Stock and warrants. Between July
27 and August 24, 2021, 15 holders of an aggregate of 991 shares of Series B Stock converted their preferred shares into 163,134 shares
of common stock, which included $53,061 of accrued dividends. As of June 30, 2023 and December 31, 2022, 1,509 shares of Series B Stock
were issued and outstanding. The accrued dividends are $379,480 and $304,653, as of June 30, 2023 and December 31, 2022, respectively,
which are presented on the consolidated balance sheets.
The
Series B Stock was originally convertible into common stock at a ratio of $6.40 per share, subject to anti-dilution protections in the
case of certain issuances of securities below that conversion price, and as a result of this price protection, the ratio was reduced
in the fourth quarter of 2022 to $6.19 per share based on the Series B Designation which defines the adjustment to the conversion ratio
and incremental shares when the Company issues common stock at a price below the conversion ratio. For the year ended December 31, 2022,
the Company recorded a deemed dividend within stockholders’ equity associated with the reduction in conversion price from $6.40
to $6.19 of $30,938 based on the incremental value to the Series B Stockholders due to the conversion price reduction. This incremental
value has also been presented on the consolidated statement of operations as an addition to the net loss available to common stockholders.
For
the three-month period ended March 31, 2023, the anti-dilution protections were triggered as a result of additional common stock issuances
and the warrant conversion repricing, and the conversion ratio was reduced to $5.42. The Company recorded a deemed dividend within stockholders’
equity associated with the reduction in conversion price from $6.19 to $5.42 of $168,835 based on the incremental value to the Series
B Stockholders due to the conversion price reduction. This incremental value has also been presented on the consolidated statement of
operations as an addition to the net loss available to common stockholders.
Series
E-1 Preferred Stock (“Series E-1 Stock”)
On
December 3, 2020, the Company filed an amendment to its Articles of Incorporation to authorize the issuance of up to 8,500 shares of
Series E-1 Stock pursuant to a Certificate of Designation. As discussed below, no shares of Series E-1 Stock are currently outstanding.
The
shares of Series E-1 Stock were incentive-based, vesting and forfeitable securities that were issued to the Company’s executives
and one director. The Series E-1 Stock also provided the holders the right in the aggregate to receive an “earnout” equal
to 20% of the total consideration received by the Company in the instance of a sale or sub-license of its core licensed radiopharmaceutical
Technology, or sale or merger of the Company, which was to be paid on a priority, senior basis, as well as other conversion and voting
rights.
On
December 6, 2021, the Company entered into an Exchange Agreement and Plan of Reorganization (the “Exchange Agreement”) with
all Series E-1 Stockholders pursuant to which all shares of Series E-1 Stock were exchanged into an aggregate of 720,986 shares of common
stock of the Company. The fair value of the Series E-1 Stock was determined to be approximately $8.65 million at the time of exchange,
and was based upon a valuation report provided to the Board by an independent third party expert, and approved for fairness by the independent
chairman of the Compensation Committee. The common stock issued in the exchange was based on a value of $12.00 per share using a 30-day
weighted average closing price calculation, and was issued proportionately to each holder based on their individual holdings of Series
E-1 Stock. All shares of common stock issued to the shareholders are subject to the same vesting schedules as was originally provided
in each shareholder’s Series E-1 Stock issuance agreement, meaning that such shares of common stock are forfeitable if certain
conditions of employment are not met by the holders. As of June 30, 2023, all 720,986 common shares are fully vested and there are no
remaining common shares that are unvested.
For
the six-month periods ending June 30, 2023 and 2022, the Company recognized stock-based compensation to employees and directors totaling
$0 and $428,450, respectively, related to the Series E-1 Stock, which is included in compensation and related expenses on the consolidated
statements of operations. As of June 30, 2023, there is no unrecognized compensation remaining.
Common
Stock
In
2022, the Company effected a 40:1 reverse stock split and all share numbers herein have been adjusted for that change.
During
the six-month periods ended June 30, 2023 and 2022, the Company issued shares of common stock as follows:
SCHEDULE
OF ISSUED SHARES OF COMMON STOCK
| |
2023 | | |
2022 | |
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
Conversion of debentures and accrued interest | |
| - | | |
| 5,469 | |
Exercise of common stock warrants to common stock | |
| 365,001 | | |
| - | |
Stock based compensation to employees and directors | |
| 271,141 | | |
| - | |
Stock based compensation for services performed by one prior director | |
| - | | |
| 10,000 | |
Conversion of convertible debt to common stock, including “make whole” issuances | |
| 164,446 | | |
| - | |
Issuance of common stock for cash | |
| 69,834 | | |
| - | |
Stock based compensation for services | |
| 92,500 | | |
| 18,750 | |
Total common shares issued | |
| 962,922 | | |
| 34,219 | |
During
the six-month period ended June 30, 2023, the Company issued 69,834 shares
of common stock for $314,251 in
its common stock and warrant unit offering. Additionally, the Company converted outstanding convertible debt of $480,000 plus
interest totaling $519,712 into 164,446 shares
of common stock at a conversion price of $3.50.
The Company also received exercises of 365,001 warrants
into 365,001 shares
of common stock at an exercise price of $3.00,
for a total of $1,144,501,
which included $49,500 that
offset fees owed for services, and which also included $342,669 in
subscription receivables related to conversion notices that were executed prior to March 31, 2023 and funds that were received in
April 2023.
Additionally
during the six-month period ended June 30, 2023, the Company issued 269,102 shares
to board members and employees for their annual bonus as deferred compensation until vested. The awards are subject to
vesting and forfeiture conditions including satisfaction of certain performance-based milestones, as follows: (1)
209,102 shares were issued as incentive compensation vesting 50% upon the Company’s uplisting to Nasdaq if within three years,
with the balance vesting in eight quarterly installments commencing on the sooner of such Nasdaq uplisting or 12 months after
issuance; provided all shares shall vest upon the sale, merger or other “exit” event for the Company and its
shareholders; and (2) 60,000 shares were issued to compensate four members of the management team for acceptance of a significant
reduction in their base salaries in 2023 to help the Company conserve cash resources, and vest upon the completion of the
Company’s next funding in the amount of at least $5
million or Company exit. The awards scheduled to vest upon the occurrence of the vesting conditions will not vest in accordance with those
vesting conditions if the recipient of the award is no longer providing services to the Company at the time of vesting. The award recipient’s
status will end on the day the notice of terminiation is provided (whether by the Company or by the Participant upon resignation) and
will not be extended by any notice eriod that may be required contractually or under applicable local law.
Further, the Company issued 2,040 immediately
vested unregistered shares of common stock to its Chief Financial Officer in lieu of deferred cash compensation of approximately $10,200.
In connection
with these awards, the Board of Directors approved for 2023 an increase in the total number of shares authorized under the 2016 Omnibus
Equity Incentive Plan (the “2016 Plan”) by 350,000 additional shares, in accordance with the terms and conditions of the
shareholder-approved equity plan. As of the date of this report, there are approximately 106,000 shares available for future issuance
under the 2016 Plan.
During
the six-month period ended June 30, 2022, $35,000 of debentures and accrued interest were converted into 5,469 shares of common stock
at a price of $6.40 per share. Additionally, the Company issued 18,750 shares of common stock for services, and 10,000 shares of common
stock for services provided by one director who resigned from the Board in the same period.
Warrants
During
the six-month period ended June 30, 2023, the Company issued 69,834 warrants in connection with the common stock and warrant unit offering
(the “Common Stock Warrants”), and 50,000 warrants to a service provider totaling $91,979 in consulting services expense.
The Company did not issue any warrants in the same period in 2022.
A
summary of warrant activity and related information for the period ending June 30, 2023 is as follows:
SCHEDULE
OF ALL OUTSTANDING COMMON STOCK WARRANTS
| | |
Warrants | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | | |
| 323,543 | | |
$ | 6.15 | | |
$ | - | |
Issued | | |
| 119,832 | | |
| 4.25 | | |
| - | |
Exercised | | |
| 381,500 | | |
| 3.00 | | |
| - | |
Expired | | |
| 11,875 | | |
| 10.00 | | |
| - | |
Outstanding as of June 30, 2023 | | |
| 50,000 | | |
$ | 6.00 | | |
$ | - | |
The
aggregate intrinsic value of the warrants is the difference between the fair market value of the Company’s closing price of its
common stock at each reporting date, less the exercise price multiplied by the number of warrants outstanding, which was $0 at June 30,
2023 and December 31, 2022, respectively.
The
following is a summary of the outstanding common stock warrants as of June 30, 2023:
SCHEDULE
OF STOCKHOLDERS’ EQUITY NOTE WARRANTS OR RIGHTS
| |
Number of Warrants | | |
Exercise price per share | | |
Expiration Date |
Warrants issued in connection services agreement | |
| 50,000 | | |
$ | 6.00 | | |
January 15, 2025 |
Total outstanding as of June 30, 2023 | |
| 50,000 | | |
| | | |
|
NOTE
7 – STOCK OPTIONS
In
2016 to compensate officers, directors and other key service providers with equity grants, the Board approved the 2016 Omnibus Equity
Incentive Plan (“2016 Plan”), which initially allowed for 4,000 shares of common stock, stock options, stock rights (restricted
stock units), or stock appreciation rights to be granted by the Board in its discretion. This authorized amount was increased multiple
times by Board resolution, most recently to 550,000 shares on May 23, 2023. As of June 30, 2023, there are 105,898 shares available under
the 2016 Plan for future issuance; however, the Board may increase the authorized shares under the 2016 Plan each year to an amount equal
to 5% of the total issued and outstanding common shares of the Company or such other amount in its reasonable discretion.
The
Company has not issued any stock options during the three and six-month period ended June 30, 2023; however, it did issue 269,102 shares
of restricted stock under the 2016 Plan in May 2023 (see “Common Stock” above).
A
summary of stock option activity and related information during the six-month period ended June 30, 2023 is as follows:
SUMMARY
OF STOCK OPTION ACTIVITY
| | |
Options | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | | |
| 177,815 | | |
$ | 12.57 | | |
| 8.8 | | |
$ | - | |
Granted | | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding as of June 30, 2023 | | |
| 177,815 | | |
$ | 12.57 | | |
| 8.56 | | |
$ | - | |
The
Company recorded $281,605 and $319,487 of stock-based compensation expense which is included in compensation and related expenses for
the six-month period ending June 30, 2023 and June 30, 2022, respectively, on the consolidated statement of operations.
The
aggregate intrinsic value of options is the difference between the fair market value of the Company’s closing price of its common
stock at each reporting date, less the exercise price multiplied by the number of options granted, which was $0 at June 30, 2023.
As
of June 30, 2023, there was unrecognized stock-based compensation of $393,375 which is expected to be expensed through March 2026 based
on the option vesting requirements.
We
estimate the fair value of stock-based awards on the date of grant using the Black-Scholes option pricing model using the fair market
value of our common stock on the date of grant and a number of other assumptions. These assumptions include estimates regarding the expected
term of the awards, estimates of the stock volatility over a duration that approximates the expected term of the awards, estimates of
the risk-free rate, and estimates of expected dividend rates.
NOTE
8 – COMMITMENTS AND CONTINGENCIES
Employment
Agreements
The
employment agreements as amended for the Company’s Executive Chairman and CEO each contain termination provisions whereby if they
are terminated without cause or following a material change, as defined therein, they will receive salary through the date of termination
plus an additional 24 months, bonus that would be earned during the full year when the termination became effective (or a lump sum of
50% of the full target bonus), all stock options shall vest and healthcare benefits will continue for 24 months. The Company’s
General Counsel’s employment agreement, as amended, contains an 18-month severance payment in the instance of a termination without
cause or following a material change, as defined therein. In June 2023, the Company’s General Counsel was provided the additional
title of Executive Vice President – Corporate Development.
Pursuant
to amendments dated November 14, 2022 to the three employment agreements of the Company’s Executive Chairman, CEO and EVP/General
Counsel, as well as an amendment to the employment agreement for the Company’s VP Operations (the “2022 Amendments”),
each of these four employees have agreed to accept reduced salaries until the Company is successful in raising additional funds. Specifically,
when the Company raises at least $7.5 million in a single offering, each employee’s salary will be increased to the full contracted
rate; and prior to that time, the reduced salaries will be gradually increased as the Company raises $2 million and then $5 million.
During this time, the difference between the reduced salaries and the full contracted salaries will not accrue as liabilities for the
Company. As of June 30, 2023 and December 31, 2022, the accrued salary for the management team was $79,166.
Pursuant
to the 2022 Amendments, $758,748 of accrued salaries were settled with shares of common stock with an estimated fair value of $606,998
and cash payments of $151,750, of which $79,166 remains unpaid and has been accrued as of June 30, 2023. The Company issued 168,611 shares
of common stock on December 31, 2022 in connection with conversion of management salaries. The salary was converted at a price of $3.55
per share.
The
shares of common stock issued pursuant to the 2022 Amendments are restricted and shall be subject to forfeiture as follows: until such
time that the Company successfully closes $5 million in a single fundraising (the “Trigger Event”), which may be completed
in one or more closings over a period of 90 days, the shares of common stock may not be sold, transferred or otherwise disposed of by
the holder. Upon the occurrence of the Trigger Event, the shares shall be fully vested. If the Trigger Event does not occur within 36
months of November 2022, the shares of common stock shall be forfeited and returned to the Company. The shares issued with the 2022 Amendments
have been presented as issued and outstanding on the statement of stockholders’ deficit as of June 30, 2023.
The
employment agreements, as amended, for the Company’s Executive Chairman and CEO each contain a transaction bonus in the instance
any of the Company’s assets are sold or sublicensed or if the Company or its subsidiary is acquired, equal to 1.75% of the consideration
received by the Company. The employment agreement, as amended, for the Company’s EVP/General Counsel and for its VP Operations
each contain a similar transaction bonus equal to 1.0% of consideration received by the Company, pursuant to a Board consent authorized
and approved as of July 26, 2023 (see Note 9 – Subsequent Events).
Board
of Director Agreements
In
January 2022, Adriann Sax was appointed as a Director to the Board and awarded an annual retainer of $30,000 per year with an additional
$7,500 for serving as an Audit Committee member and an additional $10,000 for serving as the Nominating & Governance Committee Chair.
Ms. Sax has agreed to defer compensation for serving as a Director until the completion of the next fundraising round. As such, the Company
has accrued the director compensation for Ms. Sax monthly with a total accrued balance of $72,339 and $43,542 as of June 30, 2023 and
December 31, 2022, respectively.
In
February 2022, Charles J. Link, Jr. was appointed as a Director to the Board and awarded an annual retainer of $30,000 per year with
an additional $7,500 for serving as an Audit Committee member and an additional $15,000 for serving as the Compensation Committee Chair,
and $3,500 for serving as a member of the Nominating Committee. Dr. Link has agreed to defer compensation for serving as a Director until
the completion of the next fundraising round. As such, the Company has accrued the director compensation for Dr. Link monthly with a
total accrued balance of $85,283 and $51,333 as of June 30, 2023 and December 31, 2022, respectively.
In
May 2023, each of Ms. Sax and Dr. Link received 10,455 shares of restricted common stock as bonuses in lieu of cash. These shares vest
50% upon a Nasdaq listing of the Company’s stock if completed within three years, and 50% in eight quarterly installments upon
the sooner of the Nasdaq listing or 12 months from issuance. All shares will vest upon the sale, merger or other “exit” event
of the Company.
License
Agreement
The
License Agreement for the Technology, as amended, between the Company’s wholly-owned subsidiary QSAM Therapeutics and IGL is for
20 years or until the expiration of the multiple patents covered under the license and requires multiple milestone-based payments including:
up to $410,000 as CycloSam® advances through Phase 3 of clinical trials, and $2 million upon commercialization. IGL has
also received 12,500 shares of the Company’s common stock as additional compensation. Upon commercialization, IGL will receive
an on-going royalty equal to 4.5% of Net Sales, as defined in the License Agreement, and 5% of any consideration we receive pursuant
to a sublicense, sale of the asset, or sale of the QSAM subsidiary. The Company will also pay for ongoing patent filing and maintenance
fees, and has certain requirements to defend the patents against infringement claims.
In
connection with the License Agreement, QSAM signed a two-year Consulting and Confidentiality Agreement (the “Consulting Agreement”)
with IGL, which provided IGL with payments of $8,500 per month starting 60 days after signing through April 2022. The Consulting Agreement
provided QSAM with additional consulting and advisory services from the Technology’s founders to assist in the clinical development
of CycloSam. During the period ending March 31, 2023, the Company paid $56,854 in expense reimbursements required under the agreement.
The drug development costs to IGL which has been reflected as research and development expense on the consolidated statements of operations
was $0 and $95,988 for the period ending June 30, 2023 and June 30, 2022, respectively.
As
of June 30, 2023, $48,978 of these costs remained outstanding and included in accounts payable and accrued expenses on the consolidated
balance sheets.
On
July 1, 2022, QSAM signed a new work order under the Master Services Agreement dated August 31, 2020 with IsoTherapeutics Group, Inc.
(“ISO”), a company that has common ownership control with IGL. The new work order with ISO is a $8,500 per month consulting
contract to utilize the knowledge and expertise of Drs. Keith Frank and Jim Simon, primary scientists and owners in ISO and IGL, and
to provide scientific and manufacturing consulting support with the clinical trials as they progress through each phase. The work order
is a two year term with a 15 day cancellation notice and the Company is only obligated for fees incurred for services performed to date.
NOTE
9 – SUBSEQUENT EVENTS
On
July 26, 2023, the Board approved amendments to the employment agreements of the Company’s EVP/General Counsel and its VP-Operations,
to increase the contingent compensation Transaction Bonus for both employees to 1% of the Net Proceeds received by the Company from a
Major Transaction, as such terms are defined in their respective agreements.
On
July 27, 2023, the Company issued 16,000 shares to a service provider as the second tranche of compensation pursuant to an agreement
signed in April 2023. On August 11, 2023, the Company issued 30,000 shares to a second service provider pursuant to an agreement signed
in April 2023.
Item
2: MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS
FORWARD
LOOKING STATEMENTS
This
document contains certain forward-looking statements that are subject to various risks and uncertainties. Forward-looking statements
are generally identifiable by use of forward-looking terminology such as “may,” “will,” “should,”
“potential,” “intend,” “expect,” “outlook,” “seek,” “anticipate,”
“estimate,” “approximately,” “believe,” “could,” “project,” “predict,”
or other similar words or expressions. Forward-looking statements are based on certain assumptions, discuss future expectations, describe
future plans and strategies, contain financial and operating projections or state other forward-looking information. Our ability to predict
results or the actual effect of future events, actions, plans or strategies is inherently uncertain. Although we believe that the expectations
reflected in our forward-looking statements are based on reasonable assumptions, our actual results and performance could differ materially
from those set forth or anticipated in our forward-looking statements. Factors that could have a material adverse effect on our forward-
looking statements and upon our business, results of operations, financial condition, funds derived from operations, cash available for
dividends, cash flows, liquidity and prospects include, but are not limited to, the factors referenced in this document, including those
set forth below, and more fully set forth in the risk factors described in our annual report on Form 10-K for the year ended December
31, 2022 or in this report:
|
● |
our lack
of an operating history; |
|
● |
the net losses
that we expect to incur as we develop our business; |
|
● |
obtaining
FDA or other regulatory approvals or clearances for our technology; |
|
● |
implementing
and achieving successful outcomes for clinical trials of our products; |
|
● |
convincing
physicians, hospitals and patients of the benefits of our technology and to convert from current standard of care; |
|
● |
the ability
of users of our products (when and as developed) to obtain third-party reimbursement; |
|
● |
any failure
to comply with rigorous FDA and other government regulations; and |
|
● |
securing,
maintaining and defending patent or other intellectual property protections for our technology. |
When
considering forward-looking statements, you should keep in mind the risk factors and other cautionary statements in this document. Readers
are cautioned not to place undue reliance on any of these forward-looking statements, which reflect our views as of the date of this
document. The matters summarized below and elsewhere in this document could cause our actual results and performance to differ materially
from those set forth or anticipated in forward-looking statements. Accordingly, we cannot guarantee future results or performance. Furthermore,
except as required by law, we are under no duty to, and we do not intend to, update any of our forward-looking statements after the date
of this document, whether as a result of new information, future events or otherwise.
A.
Plan of Operation
We
are developing next-generation nuclear medicines for the treatment of cancer and other diseases. Our initial technology is Samarium-153
DOTMP, a/k/a CycloSam® (“CycloSam®” or the “Technology”), a clinical-stage bone
targeting therapeutic radiopharmaceutical. CycloSam® features a patented, low specific activity form of Samarium-153,
a beta-emitting radioisotope with a short 46-hour half-life, and the chelating agent DOTMP, which selectively targets sites of high bone
mineral turnover and reduces off-site migration of the tumor-killing radiation. We believe improvements in formulation and manufacturing
from a prior FDA-approved drug (Quadramet®) utilizing the same radioisotope has resulted in our drug candidate demonstrating
significantly less impurities, lower costs and more frequent availability. Samarium-153 and DOTMP form a highly stable complex, which
we believe, when used in multi-dose regimens either as a monotherapy or in combination with other more widely used treatments such as
external beam radiation, may demonstrate meaningful disease modifying results in primary and metastatic bone cancer. Ultimately, we may
seek to further develop and commercialize CycloSam® for one or more market indications or license or sell the Technology
to a larger pharmaceutical partner.
In
August 2021, the Food & Drug Administration (FDA) cleared our Investigational New Drug (IND) application to commence Phase 1 clinical
trials for CycloSam® as a treatment for cancer that has metastasized to the bone from the breast, lung, prostate, and
other organs. We initiated this trial at our first site (Houston, TX) in November 2021, and dosed our first patient in this open-label,
dose escalating study in April 2022. As of August 11, 2023, we have dosed a total of four patients, which includes completion of the
first cohort grouping in this study. This phase of our clinical trials is expected to conclude in early 2024, subject to timely funding, at which
time we expect to seek approval from the FDA to commence Phase 2 efficacy trials of CycloSam®.
Also
in August 2021, the FDA granted Orphan Drug Designation for the use of CycloSam® to treat a primary bone cancer
called osteosarcoma, a devastating disease that mostly affects children and young adults, and in January 2022, the FDA granted us
Rare Pediatric Disease Designation for that indication. Although patients with osteosarcoma or Ewing’s sarcoma are eligible to
participate in our initial Phase 1 trials, we anticipate filing separate indication-specific protocol(s) to our IND in the future,
subject to funding, to commence clinical trials specifically for these primary, pediatric bone cancers. In March 2020,
CycloSam® was also utilized in a Single Patient Investigational New Drug for Emergency Use at the Cleveland Clinic.
We believe the study we conducted at the Cleveland Clinic showed promising safety results in connection with a bone marrow ablation
procedure, including patient tolerability at high dosages. We are also looking at how CycloSam® can be used to treat
the debilitating pain from cancer that has metastasized to the bone and may seek to initiate a separate study for that important
indication in the near future.
Clinical
trials, the drug approval process, and the marketing of drugs are intensively regulated in the United States and in all major foreign
countries. In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and related
regulations. Drugs are also subject to other federal, state, and local statutes and regulations. Failure to comply with the applicable
U.S. regulatory requirements at any time during the product development process, approval process or after approval may subject an applicant
to administrative or judicial sanctions. These sanctions could include the imposition by the FDA Institutional Review Board (“IRB”)
of a clinical hold on trials, the FDA’s refusal to approve pending applications or supplements, withdrawal of an approval, warning
letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties
or criminal prosecution. Any agency or judicial enforcement action could have a material adverse effect on us.
What
is CycloSam®
CycloSam®
is a targeted, bone seeking radiopharmaceutical that combines the beta-emitting radioisotope Samarium-153 (153Sm) with a chelating
agent, DOTMP (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetramethylenephosphonic acid). Samarium-153 is acquired from a nuclear reactor
from a third party and the chelating agent is supplied in the form of kits. Chelating agents are organic compounds capable of linking
together metal ions to form complex ring-like structures. This combination forms a stable complex which delivers a radioactive dose to
sites of rapid bone mineral turnover such as those that form around bone cancers and tumors. CycloSam® has a physical
half-life of 46 hours (radiation decreases by half in 46 hours) and emits both medium-energy beta particles that produce the therapeutic
effect, and gamma photons that make it possible to take images of the skeleton and locate and characterize the size and nature of tumors.
The use of radioisotopes to both diagnose and treat disease is called “theragnostics” and is a rapidly growing area of medical
discovery.
License
Agreement
Through
our wholly-owned subsidiary, QSAM Therapeutics, we entered into an exclusive worldwide patent and technology license agreement (the “License
Agreement”) with IGL Pharma, Inc. (“IGL”) on April 20, 2020 with respect to the innovative work of Jim Simone, PhD
and R. Keith Frank, PhD, at IsoTherapeutics on Samarium-153 DOTMP. IGL is an affiliated company with IsoTherapeutics, and the President
of IGL also serves as our Executive Chairman.
Our
License Agreement with IGL, as amended in November 2021, is for 20 years or until the expiration of the multiple patents covered under
the license, and requires multiple milestone-based payments up to $410,000 as CycloSam® advances through multiple stages
of clinical trials, and $2 million upon commercialization. IGL also received 12,500 shares of common stock of the Company. Upon commercialization,
IGL will receive an on-going royalty equal to 4.5% of Net Sales, as defined in the License Agreement, and will receive 5% of any consideration
we receive pursuant to a sublicense, sale of the asset, or sale of the QSAM subsidiary. We will also pay for ongoing patent filing and
maintenance fees, and we have certain requirements to defend the patents against infringement claims. The parties have agreed to mutual
indemnification.
Either
party may terminate the License Agreement 30 days after notice in the event of an uncured breach, or immediately in the case of bankruptcy
or insolvency of the other party. We may terminate for any reason upon 30 days’ notice. In the case IGL terminates due to an uncured
breach, IGL will repay to us 25% of our direct clinical costs to assume ownership of data and other information gained in that process.
Strategic
Plan
We
are actively advancing the development of our Technology through clinical trials. We believe that we can complete the current Phase 1
safety trial of approximately 17 patients in early 2024, if we have adequate funding in a timely manner. Management estimates that an
additional $3 million to $4 million will be required to complete this phase of our study, which would represent an important near-term
milestone that may provide a material value inflection point for the Company.
The
next step in our clinical trial program, if cleared by the FDA, is expected to be a study designed to show both safety and efficacy in
the treatment of bone tumors utilizing a multi-dose regimen of CycloSam®. Significant and compelling data from prior clinical
studies suggest that Samarium-153, when used multiple times over a six to nine month period, can have a material beneficial effect on
metastatic bone tumors. [Sinzinger H, Palumbo B, Ozker K. The Vienna protocol and perspectives in radionuclide therapy. The Quarterly
Journal of Nuclear Medicine and Molecular Imaging: Official Publication of the Italian Association of Nuclear Medicine (AIMN) [and] the
International Association of Radiopharmacology (IAR), [and] Section of the Society of... 2011 Aug;55(4):420-430.] Replication of
certain portions of this study utilizing our new, patented formulation of CycloSam® could provide data that allow the
Company to seek approval from the FDA to commence pivotal trials, or possibly attract a partnership with a much larger pharmaceutical
entity. Management estimates that an additional $12 million to $14 million will be required to complete the first portion of this critical
phase of our study over the next 24 to 30 months.
Beyond
our current focus of studying CycloSam® in the treatment of metastatic bone cancer, if funding and resources allow, management
will seek to advance other potential indications for our Technology, including the treatment of pediatric osteosarcoma and Ewing’s
sarcoma, and the use of CycloSam® to perform bone marrow ablation procedures prior to stem cell transplants. Additionally,
we believe there may be an opportunity for CycloSam® to be used to treat the debilitating pain from cancer that has metastasized
to the bone, and we may seek to initiate a separate study for that important indication in the near future. Advancement of current and
future plans for our Technology will require additional funding, which will result in the issuance of more common stock, preferred stock
or debt in subsequent raises. There is no guaranty that we will be successful in raising such funding on terms acceptable to our shareholders,
if at all, and if we are not successful, we may be required to slow down or cease our clinical trials.
B.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
COVID-19
In
March 2020, the World Health Organization declared COVID-19 a global pandemic and recommended containment and mitigation measures worldwide.
Although our operations are not currently affected by the Covid outbreak, Covid previously had a direct but temporary impact on the commencement
of our clinical trials. General conditions around Covid have also created supply chain delays with certain of our manufacturers and distributors.
Lastly, there remains a risk with the rise of Covid cases in the US could delay enrollment of patients into our clinical trials, interrupt
treatment, or cause a patient to withdraw due to prolonged effects of infection. To mitigate these risks, we have worked with our vendors
and suppliers to designate and train additional staff to support our project, and we have ordered sufficient supplies to support our
entire Phase I trial. We are also securing secondary suppliers to ensure supply chain resilience. Additionally, we are working with our
clinical trial site to screen more patients in order to have a sufficient volume of qualified patients waiting to enroll.
Results
of Operations for the three-month periods ended June 30, 2023 and 2022
For
the three-month periods ended June 30, 2023 and 2022, we recorded no revenue from operations.
For
the three-month period ended June 30, 2023, we recorded a net loss from operations of $1,237,882, a decrease of $45,564 (3.6%) from our
net loss from operations of $1,283,446 for the same period in 2022. Basic and diluted net loss per share was $0.48 and $0.95 for the
three-month periods ended June 30, 2023 and 2022, respectively. The primary reasons for the decrease in the net loss for 2023 over 2022
were as follows:
(1)
FY Q2 2023 decrease in compensation and related expenses of $517,653 is driven by a decrease in employee stock option expense of $315,314,
a decrease in accrual of wages of $221,000 due to reduced salaries for management per their amended employment agreements, offset by
an increase in 2023 for Board of Directors fees.
(2)
FY Q2 2023 increase in General & Administrative costs of $16,782 is driven primarily by an increase in patient marketing of $12,000,
an increase of $2,921 of D&O insurance, and an increase in travel expenses.
(3)
FY Q2 2023 decrease in Other Expenses of $20,091 is driven primarily by a decrease in interest expense of $11,042 and a decrease of $9,050
in loan interest due to the conversion and retirement of all of the Company’s convertible notes in Q1 2023.
(4)
FY Q2 2023 increase in Professional Fees of $231,348 is primarily driven by an increase in consulting stock expense for services of $244,615,
an increase in legal fees of $101,195, offset by a decrease in consulting fees of $91,559, and a decrease of investor relations fees of
$21,460.
(5)
FY Q2 2023 increase in Research and Development of $244,050 is driven by an increase in vendor expenses related to the timing of dosing
patients in the clinical trial.
Results
of Operations for the six-month periods ended June 30, 2023 and 2022
For
the six-month periods ended June 30, 2023 and 2022, we recorded no revenue from operations.
For
the six-month period ended June 30, 2023, we recorded a net loss from operations of $2,744,924, a decrease of $729,593 (24.0%) from our
net loss from operations of $3,071,692 for the same period in 2022. Basic and diluted net loss per share was $0.95 and $1.91 for the
six-month periods ended June 30, 2023 and 2022, respectively. The primary reasons for the decrease in the net loss for 2023 over 2022
were as follows:
(1)
FY Q2 2023 decrease in compensation and related expenses of $941,738 is driven by a decrease in employee stock option expense of $466,333,
a decrease in accrual of wages of $442,990 due to reduced salaries for management per their amended employment agreements, and a decrease
in payroll tax expenses of $22,364.
(2)
FY Q2 2023 decrease in General & Administrative costs of $34,687 is driven primarily by a decrease in SEC filing fees.
(3)
FY Q2 2023 increase in Other Expenses of $402,818 is driven primarily by inducement expense of $397,937 for conversion of convertible
notes in the 2023 period, and an increase in financing costs including interest of $4,890.
(4)
FY Q2 2023 increase in Professional Fees of $51,088 is primarily driven by a decrease in legal fees.
(5)
FY Q2 2023 increase in Research and Development of $195,742 is driven by a increase in vendor expenses related to the timing of dosing
patients in the clinical trial.
Net
Loss Attributable to Common Stockholders
Net
loss attributable to common stockholders for the three months ended June 30, 2023 was $1,282,702 as compared to $1,327,499 for the three
months ended June 30, 2022. The net loss attributed to common stockholders for the three months ended June 30, 2023 and 2022 includes
Series A and Series B preferred contractual dividends and deemed dividends. The net loss attributable to common stockholders, basic and
diluted, for the three months ended June 30, 2023 was a loss of $0.48 per share as compared to a loss of $0.79 per share for the 2022
period.
Net
loss attributable to common stockholders for the six months ended June 30, 2023 was $2,834,144 as compared to $3,201,378 for the six
months ended June 30, 2022. The net loss attributed to common stockholders for the six months ended June 30, 2023 and 2022 includes Series
A and Series B preferred contractual dividends and deemed dividends. The net loss attributable to common stockholders, basic and diluted,
for the six months ended June 30, 2023 was a loss of $0.95 per share as compared to a loss of $1.91 per share for the 2022 period.
Financial
Condition, Liquidity and Capital Resources
Net
cash used in operating activities was $1,244,833 for the six months ended June 30, 2023, which reflected our net loss during the period
of $2,744,924, non-cash adjustments of $1,227,223, and a net increase in operating assets and a net increase in assets of $625,729. The
non-cash adjustments are comprised of stock-based compensation and inducement expense.
Net
cash used in operating activities was $1,105,513 for the six months ended June 30, 2022, which reflected our net loss during the period
of $3,071,692, non-cash adjustments of $1,020,838, and a net increase in operating assets and a net decrease in liabilities of $980,341.
The non-cash adjustments are comprised of stock-based compensation.
There
was no cash provided by or used in investing activities during the six months ended June 30, 2023 and 2022.
Net
cash provided by financing activities during the six months ended June 30, 2023 was $1,066,578 due to the issuance of common stock for
cash of $254,246 and exercise of warrants for cash of $812,332. Net cash used by financing activities during the six months ended June
30, 2022 was $35,000 due to deferred offering costs.
As
of June 30, 2023, we had cash of $389,690. Our cash is currently held at large U.S. banks.
Based
on our current strategy and operating plan, we will need to raise additional funds in 2023. This process is ongoing and there is substantial
doubt about our ability to operate as a going concern. See “Note 2 – Basis of Presentation and Going Concern” in our
consolidated financial statements.
As
the Company advances its clinical trials, management expects expenses to increase. These expenses include dosing and monitoring of patients
who participate in our clinical trials, manufacturing expenses, payment of fees to our CRO and other service providers, and other general
overhead expenses including additional public company costs. We anticipate that we have under $100,000 in commitments to contractors
and third-parties, not including employees, that we must pay even if we do not advance the clinical trials. We anticipate that we will
be able to continue the clinical trials without material interruption or delay through the third quarter of 2023, but we must raise additional
funds through future offerings to maintain this plan. There is no guarantee, however, that we can complete any future offerings on terms
suitable to the Company and its shareholders if at all.
We
have raised capital through equity and debt fundings over the last two years to advance the development of the Technology. Most recently,
on March 31, 2023, we closed a total of $2.86 million in a common stock and warrant unit offering, which consisted of 381,500 shares
of common stock at $4.50 and 381,500 two-year common stock warrants (the “Warrants”) which were all exercised. The Warrants
originally had an exercise price of $6.00 per share, but on March 31, 2023, our Board approved a reduction of the price to $3.00 as an
inducement to immediate exercise of the Warrants. All Warrant holders exercised at this reduced price, which raised an additional $1.14
million for the Company, inclusive of $342,669 in subscription receivables which were received in April 2023.
In
the fourth quarter of 2021, we entered into convertible note purchase agreements with eight accredited investors, pursuant to which we
issued an aggregate of $605,000 of 6% annual interest, unsecured convertible notes (the “Notes”). The Notes were due to mature
on December 31, 2023 and were originally convertible into shares of common stock of the Company at a conversion price of $8.00 per share.
On March 31, 2023, our Board approved a reduction of the conversion price from $8.00 to $3.50 as an inducement to immediate conversion.
All outstanding Notes were converted into 164,446 shares of common stock. As of June 30, 2023, we had no Notes outstanding.
As
of June 30, 2023, the Company had $389,690 in cash and no debt from convertible notes.
We
have limited operations and are not currently generating any revenues from our business operations. Our independent registered public
accounting firm has issued a going concern opinion for the year ended December 31, 2022. This means that our auditors believe there is
substantial doubt that we can continue as an on-going business for the next 12 months. The unaudited financial statements do not include
any adjustments that might result from the outcome of these uncertainties. The ability of the Company to continue as a going concern
is dependent on management’s plans. The Company has supported operations through the issuance of common stock, preferred stock
and debt over the last 12 months. This includes the recent common stock and warrant offering, the Series B Preferred Stock offering in
the first quarter of 2021, the exercise of warrants issued in connection with the Series B offering, and also the convertible debt offering
conducted in the fourth quarter of 2021 which was recently converted to common stock. Management expects expenses to increase in 2023
as our drug technology advances through clinical trials, and as a result, we will need to raise additional capital to support these operations.
There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that
it will be available on terms acceptable to the Company. Management believes that is has cash to support operations into the third quarter
of 2023. We currently have accounts payable and accrued expenses that are greater than our cash on hand, and to extend our ability to
operate under these conditions, management has deferred a large part of their salaries and we are working with vendors to delay payments
until we are able to raise additional capital. Management understands that such efforts cannot be sustained indefinitely. If we are not
successful in raising additional capital, we may need to delay clinical trials, reduce overhead, or in the most extreme scenario, shut
down operations.
Prior
Financings
Series
B Financing. In January 2021, the Company closed a Series B Convertible Preferred Stock private placement (the “Series
B Offering”) and issued a total of 2,500 shares at a price of $1,000 per share, raising an aggregate amount of $2.5 million, inclusive
of $156,000 in debt conversion. The Series B Offering, which commenced in 2020, was led by Checkmate Capital Group, LLC, a California
based investment firm focused on biotechnology and other technology investments. The Company completed the offering primarily to advance
its new business of drug development including funding the Company’s clinical trials for its drug candidate CycloSam, as well as
for general working capital and overhead. There are currently 1,509 shares of Series B Stock outstanding, and as a result of the current
common stock private placement, the conversion price of the Series B Stock has been reset to $5.42 per share multiplied by the issuance
price.
Warrant
Conversion. In connection with this Series B Offering closing, we issued in 2021 approximately 150,000 common stock warrants,
which were originally exercisable prior to July 8, 2021 at an exercise price of $14.00 per share, and later modified by our Board to
expire on October 15, 2021 and be exercisable at $10.00 per share. As of October 15, 2021, seven holders of the Series B warrants exercised
those warrants and received a total of 46,786 common shares for total consideration to the Company of $467,858. Also in 2021, our lead
investor in the Series B Offering earned a warrant for 11,875 shares exercisable at $18.00 per share, which warrant was to expire January
15, 2022, but modified in January 2022 to expire January 15, 2023 and be exercisable at $10.00 per share. These warrants expired in January
2023.
Series
A Preferred Stock Financing. The Company raised $600,000 in a Series A 6% Convertible Preferred Stock (the “Series A Stock”)
from two separate accredited investors in November 2015 and January 2016, respectively. The Series A Stock bears a 6% dividend per annum,
calculable and payable per quarter in cash or additional shares of common stock as determined in the Certificate of Designation. The
Series A Stock was originally convertible at $6.50 per share at the discretion of the holders and contains price protection provisions
in the instance that we issue shares at a lower price, subject to certain exemptions. The price has been reset several times since the
issuance of the Series A Stock. Most currently, as a result of the current private placement offering and warrant exercise inducement,
the conversion price was reset to $3.00 per share. Series A Stockholders also received other rights and protections including piggy-back
registration rights, rights of first refusal to invest in subsequent offerings, security over our assets (secondary to our debt holders),
and certain negative covenant guaranties that we will not incur non-ordinary debt, enter into variable pricing security sales, redeem
or repurchase stock or make distributions, and other similar warranties. The Series A Stock is redeemable on December 31, 2023, pursuant
to a March 31, 2023 modification agreement signed by both Series A Stockholders. The Series A Stock has no voting rights until converted
to common stock.
Attempted
Underwritten Offering and NASDAQ Uplisting. In December 2021, the Company filed a registration statement on Form S-1 with the
SEC to raise up to $20 million through a common stock offering underwritten by an investment bank based in New York. Concurrently, the
Company submitted an application with the NASDAQ Stock Market LLC to list its common shares on that national exchange. Due to market
conditions, in May 2022, the Company terminated this offering; however, management plans to pursue a NASDAQ uplisting in the future.
Cash
and Working Capital
We
have incurred negative cash flows from operations since inception. As of June 30, 2023, we had an accumulated deficit of $38,469,938
and working capital deficit of $915,278.
Critical
Accounting Policies
Our
management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which
have been prepared in accordance with accounting principles generally accepted in the United States. 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 revenue and expenses incurred during the
reported periods. On an ongoing basis, we evaluate our estimates and judgments. We base our 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 apparent from other sources. Changes in estimates are reflected in reported
results for the period in which they become known.
Accrued
Research and Development Expenses
We
make estimates of our accrued expenses as of each balance sheet date in our financial statements based on the facts and circumstances
known to us at that time. Our expense accruals for contract research, contract manufacturing and other contract services are based on
estimates of the fees associated with services provided by the contracting organizations. Payments under some of the contracts we have
with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones.
In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in
each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be
required to estimate these services based on other information available to us. If we underestimate or overestimate the activity or fees
associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future
periods. Subsequent changes in estimates may result in a material change in our accruals.
Stock-Based
Compensation
We
recognize stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under our Incentive
Plan to employees, nonemployees and nonemployee members of our board of directors based on the grant-date fair value of those awards.
The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period.
In addition, in the past we have granted performance-based stock option awards and restricted stock grants, which vest based upon our
satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options
will be recognized only if, and when, we estimate that these options will vest, which is based on whether we consider the options’
performance conditions to be probable of attainment. Our estimates of the number of performance-based options that will vest will be
revised, if necessary, in subsequent periods.
We
use the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based
on assumptions with respect to (i) expected volatility of our common stock price, (ii) the periods of time over which employees and members
of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected dividend yield on the
common stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time
of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if
actual forfeitures differ from those estimates.
Our
financial statements are prepared in conformity with U.S. generally accepted accounting principles (GAAP). Disclosures regarding our
Critical Accounting Policies are provided in Note 3 – Summary of Significant Accounting Policies of the footnotes to our consolidated
financial statements.
Off-Balance
Sheet Arrangements
The
Company did not engage in any “off-balance sheet arrangements” (as that term is defined in Item 303(a)(4)(ii) of Regulation
S-K) as of June 30, 2023.
ITEM
3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
required for smaller reporting companies.
ITEM
4: CONTROLS AND PROCEDURES
In
connection with the preparation of this Quarterly Report, management, under the supervision and with the participation of the Company’s
Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures,
as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”),
as of the end of the period covered by this Quarterly Report. Disclosure controls and procedures are designed to ensure that information
required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within
the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to management,
including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures. Management
concluded that, as of June 30, 2023, the Company’s disclosure controls and procedure were not effective based on the criteria in
Internal Control – Integrated Framework issued by the COSO, version 2013 as discussed below.
Management’s
Quarterly Report on Internal Control Over Financial Reporting
The
Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such
term is defined in Securities Exchange Act Rule 13a-15(f). The Company carried out an evaluation under the supervision and with the participation
of the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, of the effectiveness
of the Company’s internal control over financial reporting. The Company’s management used the framework in Internal Control-Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations (COSO) to perform this evaluation. As a result of this assessment,
management identified a material weaknesses in internal control over financial reporting. A material weakness is a control deficiency,
or a 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 identified
material weakness is disclosed below:
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● |
Due to the
size of the Company and available resources, there are limited personnel to assist with the accounting and financial reporting function,
which results in a lack of segregation of duties. |
As
a result of the material weakness in internal control over financial reporting described above, management concluded that, as of June
30, 2023, the Company’s internal control over financial reporting was not effective based on the criteria in Internal Control
– Integrated Framework issued by the COSO. Management notes that upon subsequent funding, the Company expects to have the available
resources in order to hire additional personnel to expand the finance and accounting department in order to mitigate the material weakness
noted above.
This
quarterly report does not include an attestation report of our independent registered public accounting firm regarding internal control
over financial reporting. We were not required to have, nor have we, engaged our independent registered public accounting firm to perform
an audit of internal control over financial reporting pursuant to the rules of the Securities and Exchange Commission that permit us
to provide only management’s report in this annual report.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting in connection with the evaluation required by Rule 13a-15(d) of the
Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q 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
We
are not a party to any pending legal proceeding and, to the knowledge of our management, no federal, state or local governmental agency
is presently contemplating any proceeding against us. No director, executive officer, affiliate of ours, or owner of record or beneficially
of more than five percent of our common stock is a party adverse to the Company or has a material interest adverse to us in any proceeding.
ITEM
1A: RISK FACTORS
We
face risks and uncertainties related to our business, many of which are beyond our control. In particular, risks associated with our
business include:
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Drug development
is a long and inherently uncertain process with a high risk of failure at every stage of development. |
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The future
of our business and operations depends on the success of our development and commercialization programs. |
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If we do
not obtain regulatory approval for our product candidates or if the terms of any approval impose significant restrictions or limitations
on use, our business, results of operations and financial condition will be adversely affected. |
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Our business
is highly dependent on our lead product candidate, CycloSam®, and a failure to obtain regulatory approval or successfully
commercialize our product could adversely affect our financial condition and results of operations. |
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We must design
and conduct successful clinical trials for our product candidates to obtain regulatory approval. We rely on third parties to conduct
our clinical trials, which reduces our control over their timing, conduct and expense and may expose us to conflicts of interest.
Clinical trial results may be unfavorable or inconclusive, and often take longer and cost more than expected. |
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A pandemic,
epidemic or outbreak of an infectious disease, such as COVID-19, or coronavirus, may materially and adversely affect our business
and our financial results. |
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Even if our
product candidates obtain regulatory approval, our ability to generate revenue will depend upon public perception of radiopharmaceuticals
and will be diminished if our products are not accepted in the marketplace, or if we select pricing strategies for our products that
are less competitive than those of our competitors, or fail to obtain acceptable prices or an adequate level of reimbursement for
products from third-party payers or government agencies. |
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We are subject
to extensive and ongoing regulation, which can be costly and time consuming, may interfere with regulatory approval for our product
candidates, and can subject us to unanticipated limitations, restrictions, delays and fines. |
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Our products
may face regulatory, legal or commercial challenges even after regulatory approval. |
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We are increasingly
dependent on information technology, and potential cyberattacks, security problems, or other disruption and expanding social media
vehicles present new risks. |
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We have a
limited operating history and are operating at a loss, and there is no guaranty that we will become profitable. |
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Because our
history is limited and we are subject to intense competition, any investment in us would be inherently risky. |
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There is
substantial doubt as to our ability to continue as a going concern. |
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We have limited
funds and we will require additional financing. |
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Our success
will be dependent on our management, and the continued service of key employees. |
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We are dependent
upon third parties for a variety of functions. These arrangements may not provide us with the benefits we expect. |
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Manufacturing
resources could limit or adversely affect our ability to commercialize products. |
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● |
Failure of
any manufacturer of our various product candidates to comply with applicable regulatory requirements could subject us to penalties
and have a material adverse effect on supplies of our product candidates. |
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● |
If the use
of hazardous and biological materials by us or third parties, such as CROs or CMOs, in a manner that causes injury or violates applicable
law, we may be liable for damages. |
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Unexpected
disruptions could seriously harm our future revenue and financial condition and increase our expenditures. |
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The validity,
enforceability and commercial value of our patents and other intellectual property rights are highly uncertain. |
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● |
We depend
on intellectual property licensed from third parties and unpatented technology, trade secrets and confidential information. If we
lose any of these rights, including by failing to achieve milestone requirements or to satisfy other conditions, our business, results
of operations and financial condition could be harmed. |
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If we infringe
third-party patent or other intellectual property rights, we may need to alter or terminate a product development program. |
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We may be
involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming
and unsuccessful. |
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Liquidity
risks associated with our common stock. |
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The price
of our common stock may fluctuate significantly, which could lead to losses for stockholders. |
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The application
of the “penny stock” rules could adversely affect the market price of our common stock and increase your transaction
costs to sell those shares. |
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We do not
intend to pay dividends. |
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● |
The stock
ownership of our management and a few other shareholders represents a significant concentration of stock ownership and control over
the Company. |
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The Company
has Preferred Stock with additional priority rights. |
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We are a
smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies
will make our common stock less attractive to investors. |
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● |
If we fail
to comply with the rules and regulations under the Sarbanes-Oxley Act, our operating results, our ability to operate our business
and investors’ views of us may be harmed. |
|
● |
We have historically
identified certain material weaknesses in our internal control over financial reporting and if our remediation of such material weaknesses
is not effective, or if we fail to develop and maintain an effective system of disclosure controls and internal control over financial
reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be
impaired. |
|
|
|
|
● |
Our financial
statements may be materially affected if our estimates prove to be inaccurate as a result of our limited experience in making critical
accounting estimates. |
These
summary risk factors are qualified in their entirety by the Risk Factors provided in the Company’s Form 10-K for the year ended
December 31, 2022.
ITEM
2: Unregistered Sales of Equity Securities and Use of Proceeds
Unregistered
Sales of Equity Securities
During
the quarter ended June 30, 2023, and through the date of this filing, the Company made the following sales of unregistered securities.
Purpose
/ Holder |
|
Number
of
Shares |
|
|
Total
Price/Amount |
|
Common stock issued
under three service agreements (1) |
|
|
92,000 |
|
|
$ |
395,168 |
|
Common stock issued to employees and
board of directors (2) |
|
|
271,142 |
|
|
$ |
1,345,510 |
|
(1) |
Issued in
April 2023 to Redstone Communications (30,000 shares) and Force Family Office (16,000 shares), for investor relations and other similar
services, and issued in June 2023 to GSB Holdings (30,000 shares) for general consulting and advisory services. Per the
agreement with Force, an additional 16,000 shares were issued in July 2023. |
(2) |
Issued in
June 2023 to Richard Piazza, Executive Chairman (72,276 shares); Douglas Baum, CEO (72,276 shares); Christopher Nelson, EVP and General
Counsel (46,365 shares); Adam King, CFO (22,950 shares); Namrata Chand, VP (36,365 shares), Adriann Sax, Director (10,455 shares),
and Charles Link Jr., Director (10,455 shares), for employee compensation and annual bonuses in lieu of cash, and board
of director bonuses in lieu of cash. |
Purchases
of Equity Securities by the Issuer and Affiliated Purchasers
None.
ITEM
3: DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4: MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5: OTHER INFORMATION
|
(a) |
There was
no information required to be disclosed in a report on Form 8-K during the period that the Company failed to report. |
|
|
|
|
(b) |
None, not
applicable. |
ITEM
6: EXHIBITS
Exhibit |
|
|
Number
|
|
Description |
|
|
|
31.1 |
|
302 Certification of Douglas Baum, Chief Executive Officer |
|
|
|
31.2 |
|
302 Certification of Adam King, Chief Financial Officer |
|
|
|
32 |
|
906 Certification |
|
|
|
101 |
|
The following
financial information from QSAM’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, formatted in Inline XBRL
(eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii)
the Consolidated Statements of Stockholders Deficit, (iv) the Consolidated Statements of Cash Flows, and (vi) the Notes to Consolidated
Financial Statements |
|
|
|
101.INS |
|
Inline
XBRL Instance Document |
|
|
|
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) 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.
|
QSAM BIOSCIENCES INC. |
|
|
|
Date: August 14, 2023 |
By: |
/s/
Douglas Baum |
|
|
Chief Executive Officer |
|
|
|
Date: August 14, 2023 |
By: |
/s/
Adam King |
|
|
Chief Financial Officer |
Exhibit 31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
RULE 13a-14(a)/15d-14(a)
CERTIFICATIONS
I, Douglas
Baum, certify that:
1. I have reviewed
this quarterly report on Form 10-Q of QSAM Biosciences, Inc. for the period ending June 30, 2023;
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 quarterly report;
3. Based on
my knowledge, the financial statements, and other financial information included in this quarterly 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
quarterly 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 controls 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 quarterly 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;
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
that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
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
function):
a) all significant deficiencies and material
weaknesses in the design or operation of internal controls 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 controls over financial reporting.
Date: August 14, 2023 |
|
|
|
|
By: |
/s/ Douglas Baum |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
Exhibit 31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
RULE 13a-14(a)/15d-14(a)
CERTIFICATIONS
I, Adam King,
certify that:
1. I have reviewed
this quarterly report on Form 10-Q of QSAM Biosciences, Inc. for the period ending June 30, 2023;
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 quarterly report;
3. Based on
my knowledge, the financial statements, and other financial information included in this quarterly 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
quarterly 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 controls 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 quarterly 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;
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
that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
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
function):
a) all significant deficiencies and material
weaknesses in the design or operation of internal controls 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 controls over financial reporting.
Date: August 14, 2023 |
|
|
|
|
By: |
/s/ Adam King |
|
|
Chief Financial Officer |
|
Exhibit 32
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER AND
PRINCIPAL
FINANCIAL OFFICER
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 on Form 10-Q for QSAM Biosciences, Inc., (the “Company”) for the period ended June 30, 2023, as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), Douglas Baum, Chief Executive Officer
and Adam King, Chief Financial Officer, of the Company certify pursuant to 18 U.S.C. section 1350 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; and
(2) The information
contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 14, 2023 |
|
|
|
|
By: |
/s/ Douglas Baum |
|
|
Chief Executive Officer |
|
|
|
|
By: |
/s/ Adam King |
|
|
Chief Financial Officer |
|
A signed original
of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature
that appears in typed form within the electronic version of this written statement 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.
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 11, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-41337
|
|
Entity Registrant Name |
QSAM
Biosciences, Inc.
|
|
Entity Central Index Key |
0001310527
|
|
Entity Tax Identification Number |
20-1602779
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
9442
Capital of Texas Hwy N
|
|
Entity Address, Address Line Two |
Plaza 1
|
|
Entity Address, Address Line Three |
Suite 500
|
|
Entity Address, City or Town |
Austin
|
|
Entity Address, State or Province |
TX
|
|
Entity Address, Postal Zip Code |
78759
|
|
City Area Code |
(512)
|
|
Local Phone Number |
343-4558
|
|
Title of 12(g) Security |
Common Stock, par value $0.0001
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
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|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
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|
|
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|
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v3.23.2
Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
CURRENT ASSETS |
|
|
Cash |
$ 389,690
|
$ 225,276
|
Prepaid expenses and other current assets |
72,922
|
139,345
|
TOTAL CURRENT ASSETS |
462,612
|
364,621
|
TOTAL ASSETS |
462,612
|
364,621
|
CURRENT LIABILITIES |
|
|
Accounts payable and accrued expenses |
911,744
|
745,011
|
Accrued payroll and related expenses |
79,166
|
79,166
|
Accrued Series B preferred stock dividends |
379,480
|
304,653
|
Convertible notes payable, net of discount |
|
443,700
|
TOTAL CURRENT LIABILITIES |
1,377,890
|
1,580,030
|
TOTAL LIABILITIES |
1,377,890
|
1,580,030
|
Redeemable convertible preferred stock - Series A; $0.0001 par value, 1,500 authorized, 480 shares issued and outstanding (liquidation preference of $735,600 and $721,200) as of June 30, 2023 and December 31, 2022, respectively |
735,600
|
721,200
|
STOCKHOLDERS’ DEFICIT |
|
|
Preferred stock, value |
|
|
Common stock, $0.0001 par value, 300,000,000 shares authorized, 3,241,941 and 2,279,019 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
324
|
228
|
Unearned deferred compensation |
(1,459,884)
|
(187,329)
|
Additional paid-in capital |
38,278,618
|
33,428,115
|
Accumulated deficit |
(38,469,938)
|
(35,177,625)
|
TOTAL STOCKHOLDERS’ DEFICIT |
(1,650,878)
|
(1,936,609)
|
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
462,612
|
364,621
|
Series B Preferred Stock [Member] |
|
|
STOCKHOLDERS’ DEFICIT |
|
|
Preferred stock, value |
2
|
2
|
Series E-1 Preferred Stock [Member] |
|
|
STOCKHOLDERS’ DEFICIT |
|
|
Preferred stock, value |
|
|
Related Party [Member] |
|
|
CURRENT LIABILITIES |
|
|
Notes payable - related parties |
$ 7,500
|
$ 7,500
|
X |
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v3.23.2
Consolidated Balance Sheets (Parenthetical) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Temporary equity, par or stated value per share |
$ 0.0001
|
$ 0.0001
|
Temporary equity, shares authorized |
1,500
|
1,500
|
Temporary equity, shares issued |
480
|
480
|
Temporary equity, shares outstanding |
480
|
480
|
Temporary equity, liquidation preference |
$ 735,600
|
$ 721,200
|
Common stock, par or stated value per share |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
300,000,000
|
300,000,000
|
Common stock, shares issued |
3,241,941
|
2,279,019
|
Common stock, shares outstanding |
3,241,941
|
2,279,019
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, par or stated value per share |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
2,500
|
2,500
|
Preferred stock, shares issued |
1,509
|
1,509
|
Preferred stock, shares outstanding |
1,509
|
1,509
|
Preferred stock, liquidation preference, value |
$ 1,850,814
|
$ 1,813,607
|
Series E-1 Preferred Stock [Member] |
|
|
Preferred stock, par or stated value per share |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
8,500
|
8,500
|
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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v3.23.2
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
REVENUES |
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
Payroll and related expenses |
274,066
|
791,721
|
606,382
|
1,548,120
|
Professional fees |
449,365
|
218,006
|
908,499
|
857,411
|
General and administrative |
66,083
|
49,300
|
134,081
|
168,768
|
Research and development expenses |
448,256
|
204,216
|
654,795
|
459,053
|
Total Operating Expenses |
1,237,770
|
1,263,243
|
2,303,757
|
3,033,352
|
LOSS FROM OPERATIONS |
(1,237,770)
|
(1,263,243)
|
(2,303,757)
|
(3,033,352)
|
OTHER INCOME (EXPENSE) |
|
|
|
|
Financing costs including interest |
(112)
|
(20,203)
|
(43,230)
|
(38,340)
|
Inducement interest |
|
|
(397,937)
|
|
Total Other Expense, net |
(112)
|
(20,203)
|
(441,167)
|
(38,340)
|
Loss from operations before income taxes |
(1,237,882)
|
(1,283,446)
|
(2,744,924)
|
(3,071,692)
|
INCOME TAXES |
|
|
|
|
NET LOSS |
(1,237,882)
|
(1,283,446)
|
(2,744,924)
|
(3,071,692)
|
PREFERRED STOCK |
|
|
|
|
Series A preferred contractual dividends |
(7,200)
|
(6,018)
|
(14,400)
|
(13,220)
|
Series B preferred contractual dividends |
(37,620)
|
(38,035)
|
(74,827)
|
(75,241)
|
Deemed dividend on warrant modification |
|
|
|
(41,225)
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ (1,282,702)
|
$ (1,327,499)
|
$ (2,834,151)
|
$ (3,201,378)
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC AND DILUTED: |
$ (0.43)
|
$ (0.79)
|
$ (1.07)
|
$ (1.91)
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS: BASIC |
$ (0.48)
|
$ (0.79)
|
$ (1.07)
|
$ (1.91)
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED |
2,968,078
|
1,677,681
|
2,652,518
|
1,677,681
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC |
2,652,518
|
1,677,681
|
2,968,078
|
1,677,681
|
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v3.23.2
Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Preferred Stock [Member]
Series B Preferred Stock [Member]
|
Preferred Stock [Member]
Series E-1 Preferred Stock [Member]
|
Common Stock [Member] |
Deferred Stock Based Compensation [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
$ 2
|
|
$ 165
|
$ (900,742)
|
$ 29,765,585
|
$ (29,281,674)
|
$ (416,664)
|
Balance, shares at Dec. 31, 2021 |
1,509
|
|
1,652,102
|
|
|
|
|
Common stock issued for services |
|
|
$ 3
|
|
254,748
|
|
254,751
|
Common stock issused for services, shares |
|
|
28,750
|
|
|
|
|
Conversion of debentures |
|
|
$ 1
|
|
34,999
|
|
35,000
|
Conversion of debentures, shares |
|
|
5,469
|
|
|
|
|
Incremental value from warrant modifications |
|
|
|
|
41,225
|
(41,225)
|
|
Series A, preferred stock contractual dividends |
|
|
|
|
(7,202)
|
|
(7,202)
|
40:1 Reverse Split Fractional Shares Adjustment |
|
|
|
|
|
|
|
40:1 Reverse Split Fractional Shares Adjustment, shares |
|
|
266
|
|
|
|
|
Series B, preferred stock contractual dividends |
|
|
|
|
(37,206)
|
|
(37,206)
|
Accretion of stock-based compensation to employees and directors |
|
|
|
213,041
|
107,312
|
|
320,353
|
Accretion of stock-based compensation to employees and directors, shares |
|
|
|
|
|
|
|
Net loss period |
|
|
|
|
|
(1,788,246)
|
(1,788,246)
|
Balance at Mar. 31, 2022 |
$ 2
|
|
$ 169
|
(687,701)
|
30,159,461
|
(31,111,145)
|
(1,639,214)
|
Balance, shares at Mar. 31, 2022 |
1,509
|
|
1,686,587
|
|
|
|
|
Balance at Dec. 31, 2021 |
$ 2
|
|
$ 165
|
(900,742)
|
29,765,585
|
(29,281,674)
|
(416,664)
|
Balance, shares at Dec. 31, 2021 |
1,509
|
|
1,652,102
|
|
|
|
|
Net loss period |
|
|
|
|
|
|
$ (3,071,692)
|
Issuance of common stock for cash, shares |
|
|
|
|
|
|
34,219
|
Balance at Jun. 30, 2022 |
|
|
$ 169
|
(472,292)
|
30,327,583
|
(32,394,591)
|
$ (2,539,129)
|
Balance, shares at Jun. 30, 2022 |
1,509
|
|
1,686,587
|
|
|
|
|
Balance at Mar. 31, 2022 |
$ 2
|
|
$ 169
|
(687,701)
|
30,159,461
|
(31,111,145)
|
(1,639,214)
|
Balance, shares at Mar. 31, 2022 |
1,509
|
|
1,686,587
|
|
|
|
|
Series A, preferred stock contractual dividends |
|
|
|
|
(6,018)
|
|
(6,018)
|
Series B, preferred stock contractual dividends |
|
|
|
|
(38,035)
|
|
(38,035)
|
Accretion of stock-based compensation to employees and directors |
|
|
|
215,409
|
212,175
|
|
427,584
|
Net loss period |
|
|
|
|
|
(1,283,446)
|
(1,283,446)
|
Balance at Jun. 30, 2022 |
|
|
$ 169
|
(472,292)
|
30,327,583
|
(32,394,591)
|
(2,539,129)
|
Balance, shares at Jun. 30, 2022 |
1,509
|
|
1,686,587
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 2
|
|
$ 228
|
(187,329)
|
33,428,115
|
(35,177,625)
|
(1,936,609)
|
Balance, shares at Dec. 31, 2022 |
1,509
|
|
2,279,019
|
|
|
|
|
Common stock issued for services |
|
|
$ 2
|
115,090
|
141,477
|
|
256,569
|
Common stock issused for services, shares |
|
|
16,500
|
|
|
|
|
Incremental value from warrant modifications |
|
|
|
|
282,309
|
(282,309)
|
|
Series A, preferred stock contractual dividends |
|
|
|
|
(7,200)
|
|
(7,200)
|
Series B, preferred stock contractual dividends |
|
|
|
|
(37,207)
|
|
(37,207)
|
Accretion of stock-based compensation to employees and directors |
|
|
|
36,740
|
132,593
|
|
169,333
|
Net loss period |
|
|
|
|
|
(1,507,042)
|
(1,507,042)
|
Deemed dividend from Series A conversion price adjustment |
|
|
|
|
96,245
|
(96,245)
|
|
Deemed dividend from Series B conversion price adjustment |
|
|
|
|
168,835
|
(168,835)
|
|
Issuance of common stock for cash |
|
|
$ 7
|
|
314,239
|
|
314,246
|
Issuance of common stock for cash, shares |
|
|
69,834
|
|
|
|
|
Exercise of warrants for cash to common stock |
|
|
$ 37
|
|
1,094,965
|
|
1,095,001
|
Exercise of warrants for cash to common stock, shares |
|
|
365,001
|
|
|
|
|
Conversion of convertible debt to common stock |
|
|
$ 16
|
|
519,696
|
|
519,712
|
Conversion of convertible debt to common stock, shares |
|
|
164,446
|
|
|
|
|
Inducement for conversion of convertible debt |
|
|
|
|
397,937
|
|
397,937
|
Balance at Mar. 31, 2023 |
$ 2
|
|
$ 290
|
(35,499)
|
36,532,003
|
(37,232,056)
|
(735,260)
|
Balance, shares at Mar. 31, 2023 |
1,509
|
|
2,894,800
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 2
|
|
$ 228
|
(187,329)
|
33,428,115
|
(35,177,625)
|
(1,936,609)
|
Balance, shares at Dec. 31, 2022 |
1,509
|
|
2,279,019
|
|
|
|
|
Net loss period |
|
|
|
|
|
|
$ (2,744,924)
|
Issuance of common stock for cash, shares |
|
|
|
|
|
|
962,922
|
Balance at Jun. 30, 2023 |
$ 2
|
|
$ 324
|
(1,459,884)
|
38,278,618
|
(38,469,938)
|
$ (1,650,878)
|
Balance, shares at Jun. 30, 2023 |
1,509
|
|
3,241,941
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 2
|
|
$ 290
|
(35,499)
|
36,532,003
|
(37,232,056)
|
(735,260)
|
Balance, shares at Mar. 31, 2023 |
1,509
|
|
2,894,800
|
|
|
|
|
Common stock issued for services |
|
|
$ 7
|
(78,875)
|
323,482
|
|
244,614
|
Common stock issused for services, shares |
|
|
76,000
|
|
|
|
|
Series A, preferred stock contractual dividends |
|
|
|
|
(7,200)
|
|
(7,200)
|
Series B, preferred stock contractual dividends |
|
|
|
|
(37,620)
|
|
(37,620)
|
Accretion of stock-based compensation to employees and directors |
|
|
$ 27
|
(1,345,510)
|
1,467,953
|
|
122,470
|
Accretion of stock-based compensation to employees and directors, shares |
|
|
271,141
|
|
|
|
|
Net loss period |
|
|
|
|
|
(1,237,882)
|
(1,237,882)
|
Balance at Jun. 30, 2023 |
$ 2
|
|
$ 324
|
$ (1,459,884)
|
$ 38,278,618
|
$ (38,469,938)
|
$ (1,650,878)
|
Balance, shares at Jun. 30, 2023 |
1,509
|
|
3,241,941
|
|
|
|
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|
|
|
3 Months Ended |
Mar. 09, 2022 |
Mar. 04, 2022 |
Mar. 31, 2022 |
Statement of Stockholders' Equity [Abstract] |
|
|
|
Reverse stock split |
all shares adjusted to reflect a 40:1 reverse stock split
|
the Company completed a 40:1 reverse stock split of its common shares.
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Consolidated Statement of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net Loss |
$ (2,744,924)
|
$ (3,071,692)
|
Adjustments to reconcile net loss to net cash used in operations: |
|
|
Common stock issued for services |
501,183
|
254,751
|
Stock-based compensation to employees and directors |
291,803
|
747,937
|
Amortization of debt discount |
36,300
|
18,150
|
Inducement expense |
397,937
|
|
Changes in operating assets and liabilities |
|
|
Decrease in prepaid expenses and other current assets |
66,423
|
26,793
|
Increase in accounts payable and accrued expenses |
199,515
|
425,143
|
Increase in accrued payroll and related expenses |
|
493,405
|
Increase in accrued interest – related parties |
6,930
|
|
Net cash used in operating activities |
(1,244,833)
|
(1,105,513)
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
Deferred offering costs |
|
35,000
|
Proceeds from warrant exercise |
1,095,001
|
|
Proceeds from sale of common stock and warrants |
314,246
|
|
Net cash provided by financing activities |
1,409,247
|
35,000
|
NET INCREASE (DECREASE) IN CASH |
164,414
|
(1,070,513)
|
CASH - Beginning of period |
225,276
|
1,499,866
|
CASH - End of period |
389,690
|
429,353
|
SUPPLEMENTAL CASH FLOW DISCLOSURES: |
|
|
Payment of interest in cash |
|
|
Payment of income taxes |
|
|
NON-CASH INVESTING AND FINANCING ACTIVITIES: |
|
|
Accrual of contractual dividends on Series A convertible preferred stock |
14,400
|
13,220
|
Accrual of contractual dividends on Series B convertible preferred stock |
74,827
|
75,241
|
Deemed dividend on warrant modifications |
282,309
|
41,225
|
Incremental value of Series A conversion modifications |
96,245
|
|
Incremental value of Series B conversion modifications |
168,835
|
|
Deferred Compensation for Employees and Consultants |
1,459,884
|
|
Conversion of notes payable to common stock |
$ 519,712
|
|
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v3.23.2
ORGANIZATION AND DESCRIPTION OF BUSINESS
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
ORGANIZATION AND DESCRIPTION OF BUSINESS |
NOTE
1 – ORGANIZATION AND DESCRIPTION OF BUSINESS
QSAM
Biosciences Inc. (hereinafter the “Company”, “we”, “our”, “us”), incorporated in Delaware
on August 26, 2004, is currently engaged in the business of developing a novel radiopharmaceutical drug candidate for the treatment of
bone cancer. This business line commenced in earnest in the fourth fiscal quarter of 2020 as a result of the separation and transfer
pursuant to an Omnibus Separation Agreement dated November 6, 2020 (the “Separation Agreement”) of the Company’s prior
business in a separate sector (the “Legacy Business”) through an unconsolidated investee entity called Earth Property Holdings
LLC, a Delaware limited liability company (“EPH”). Pursuant to the Separation Agreement, the Company transferred to EPH all
assets and related liabilities in connection with the Legacy Business in return for a forgiveness of debt. The Company sold its entire
equity interest in EPH to a third party in the first quarter of 2021 for $100,000, and currently holds no ownership in EPH.
In
April 2020, the Company established QSAM Therapeutics Inc. (“QSAM”) as a wholly-owned subsidiary incorporated in the state
of Texas, and through QSAM, executed a Patent and Technology License Agreement and Trademark Assignment (the “License Agreement”)
with IGL Pharma, Inc. (“IGL”). The License Agreement provides QSAM with exclusive, worldwide and sub-licensable rights to
all of IGL’s patents, product data and knowhow with respect to Samaium-153 DOTMP aka CycloSam® (the “Technology”),
a clinical stage novel radiopharmaceutical meant to treat different types of bone cancer and other diseases.
In
connection with the transition to the life sciences sector, the Company changed its name to QSAM Biosciences Inc. on September 4, 2020,
and subsequently changed its stock symbol to QSAM, to better reflect its business moving forward.
On
March 4, 2022, the Company completed a 40:1 reverse stock split of its common shares. All shares and share prices set forth in this report
have been adjusted retroactively to present this reverse stock split as if it had occurred at the beginning of the period presented in
these consolidated financial statements.
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v3.23.2
BASIS OF PRESENTATION AND GOING CONCERN
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PRESENTATION AND GOING CONCERN |
NOTE
2 – BASIS OF PRESENTATION AND GOING CONCERN
The
accompanying unaudited financial statements are prepared in accordance with Rule 8-01 of Regulation S-X of the Securities Exchange Commission
(“SEC”). Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance
with generally accepted accounting principles in the United States of America (“US GAAP”) have been condensed or omitted
pursuant to such rules and regulations. However, the Company believes that the disclosures included in these unaudited consolidated financial
statements are adequate to make the information presented not misleading. The unaudited consolidated financial statements included in
this document have been prepared on the same basis as the annual financial statements, and in our opinion reflect all adjustments, which
include normal recurring adjustments necessary for a fair presentation in accordance with US GAAP and SEC regulations for interim financial
statements. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that the Company
will have for any subsequent period or for the calendar year ended December 31, 2023. These unaudited consolidated financial statements
should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31,
2022 which was filed with the SEC on March 30, 2023.
For
the six months ended June 30, 2023, the Company used net cash in operating activities for its operations of $1,244,833 and incurred a loss
from its operations of $. As of June 30, 2023, the Company has negative working capital of $915,278 and cash of $389,690, and
the Company’s accumulated deficit is $38,469,938. These conditions raise substantial doubt about the Company’s ability to
continue as a going concern for one year from the issuance of these financial statements.
The
Company has supported operations through the issuance of common stock, preferred stock and debt over the last 12 months. This includes
a common stock and warrant offering which closed March 31, 2023, of which a total of $2.85 million was raised, inclusive of $342,667
in subscriptions receivables existing at the end of the quarter which were received in April 2023.
Management
expects expenses to increase in 2023 as our drug technology continues through clinical trials, and as a result, we will need to raise
additional capital to support these operations. Management believes that it can do so through equity or debt raises in the second half
of 2023. If the Company is not successful in raising additional capital, it may need to delay clinical trials, reduce overhead, or in
the most extreme scenario, shut down operations.
There
is no guarantee whether the Company will be able to generate revenue and/or raise capital sufficient to support its continuing operations.
The ability of the Company to continue as a going concern is dependent on management’s plans which include implementation of its
business model to develop and commercialize its drug candidate, seek strategic partnerships to advance clinical trials and other research
endeavors which could provide additional capital to the Company, and continue to raise funds for the Company through equity or debt offerings.
There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that
it will be available on terms acceptable to the Company. The unaudited consolidated financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
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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
3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles
of Consolidation
The
unaudited consolidated financial statements include the accounts of QSAM Biosciences Inc. and its wholly-owned subsidiaries (the “Subsidiaries”)
QSAM Therapeutics Inc. and Q2Power Corp. (currently inactive). All significant inter-company transactions and balances have been eliminated
in consolidation. References herein to the Company include the Company and its Subsidiaries unless the context otherwise requires.
Cash
and Cash Equivalents
The
Company considers cash, short-term deposits, and other investments with original maturities of no more than ninety days when acquired
to be cash and cash equivalents for the purposes of the statement of cash flows. The Company maintains cash balances at one national
financial institution and has experienced no losses with respect to amounts on deposit. Any loss incurred or a lack of access to such
funds above the FDIC limit could have a significant adverse impact on the Company’s financial condition, results of operations
and cash flows. The Company held no cash equivalents as of June 30, 2023 and December 31, 2022.
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers (“ASC 606”) and
all the related amendments.
The
core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers
in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC
606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required
within the revenue recognition process than previously required under U.S. GAAP, including identifying performance obligations in the
contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to
each separate performance obligation.
The
Company had no revenue in 2023 and 2022.
Stock
Based Compensation
The
Company applies the fair value method of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification
(“ASC”) 718, “Share Based Payment”, in accounting for its stock-based compensation with employees and
non-employees. This standard states that compensation cost is measured at the grant date based on the fair value of the award and is
recognized over the service period, which is usually the vesting period. The Company values stock-based compensation at the market price
for the Company’s common stock and other pertinent factors at the grant date.
The
Black-Scholes option pricing valuation method is used to determine fair value of stock options consistent with ASC 718, “Share
Based Payment”. Use of this method requires that the Company make assumptions regarding stock volatility, dividend yields,
expected term of the awards and risk-free interest rates.
Research
and Development
Research
and development costs are expensed as incurred. Research and development costs were $654,795 for the six months ended June 30, 2023,
and are a result of the Company’s clinical trials of its drug Technology. Research and development costs were $459,053 for the
six months ended June 30, 2022, and are also a result of the clinical trials and fees owed under its License Agreement (see Note 8 –
Commitments and Contingencies).
Income
Taxes
Income
taxes are accounted for under the asset and liability method as stipulated by FASB ASC 740, “Income Taxes” (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit
carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities
or a change in tax rate is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced to estimated
amounts to be realized by the use of a valuation allowance. A valuation allowance is applied when in management’s view it is more
likely than not (50%) that such deferred tax will not be utilized.
In
the event that an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there
is a probability that the uncertain tax position taken would be sustained upon examination by the taxing authorities. Reserves for uncertain
tax positions would be recorded if the Company determined it is probable that a position would not be sustained upon examination or if
payment would have to be made to a taxing authority and the amount is reasonably estimated. As of June 30, 2023 and December 31, 2022,
the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authorities.
Interest and penalties related to any unrecognized tax benefits is recognized in the unaudited consolidated financial statements as a
component of income taxes.
Basic
and Diluted Loss Per Share
Net
loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders
by the weighted average number of common shares outstanding during the period plus any potentially dilutive shares related to the issuance
of stock options, shares from the issuance of stock warrants, shares issued from the conversion of convertible preferred stock and shares
issued for the conversion of convertible debt.
As
of June 30, 2023, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
SCHEDULE
OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 50,000 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 244,144 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 348,420 | |
| |
| 820,379 | |
As
of June 30, 2022, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 37,083 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 110,437 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 271,490 | |
| |
| 675,409 | |
Significant
Estimates
U.S.
Generally Accepted Accounting Principles (“GAAP”) requires the Company to make judgments, estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited
financial statements, the reported amounts of revenues and expenses, cash flows and the related footnote disclosures during the period.
On an on-going basis, the Company reviews and evaluates its estimates and assumptions, including, but not limited to, those that relate
to the fair value of stock-based compensation, and a valuation allowance on deferred tax assets. Actual results could differ from these
estimates.
Recent
Accounting Pronouncements
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06,
Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s
Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify accounting for certain financial instruments. ASU 2020-06 eliminates
the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies
the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard
also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s
own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for
all convertible instruments. ASU 2020-06 is effective January 1, 2022 for public business entities that are not smaller reporting companies
and for all other entities, fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The standard
should be applied on a full or modified retrospective basis, with early adoption permitted beginning on January 1, 2021. Effective January
1, 2021, the Company adopted ASU 2020-06 and noted no material impact to the consolidated financial statements.
Management
does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect
on its unaudited financial statements.
Concentration
of Risk
The
Company expects cash to be the asset most likely to subject the Company to concentrations of credit risk. The Company’s bank deposits
may at times exceed federally insured limits. The Company’s policy is to maintain its cash with high credit quality financial institutions
to limit its risk of loss exposure. The Company’s cash balance as of June 30, 2023, is in excess of FDIC limits in the amount of
approximately $139,690.
The
Company is subject to a number of risks similar to those of other companies at a clinical-stage for radiopharmaceutical drug candidates,
including dependence on key individuals; the need to develop commercially viable therapeutics; competition from other companies, many
of which are larger and better capitalized; intellectual property risks; and the need to obtain adequate additional financing to fund
the development of its products. The Company currently depends on third-party suppliers for key materials and services used in its research
and development manufacturing process, and is subject to certain risks related to the loss of these third-party suppliers or their inability
to supply the Company with adequate materials and services. The Company’s primary Technology is licensed from one party and is
subject to general risks related to contractual relationships and the performance of the parties under the contract.
Fair
Value of Financial Instruments
In
accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information
about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that
value. Cash is carried fair value.
Other
financial instruments, including accounts payable, accrued liabilities and short-term debt, are carried at cost, which approximates fair
value given their short-term nature.
Deferred
Offering Cost
Costs
incurred prior to an equity offering are capitalized until the offering occurs. Upon the equity offering, all accumulated costs are charged
against proceeds. If the Company determines that the equity offering will not occur, the accumulated costs are charged to operations.
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
views its operations and manages its business as one segment.
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v3.23.2
RELATED PARTY TRANSACTIONS
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
NOTE
4 – RELATED PARTY TRANSACTIONS
The
Company has a License Agreement with IGL Pharma, Inc. (“IGL”), an entity in which the Company’s Executive Chairman
serves as President, holds options to purchase less than a 1% non-controlling equity interest and receives a $500 per month fee. Effective
November 17, 2021, the Company amended the License Agreement with IGL which adjusted milestone payment amounts during the course of the
agreement term. Under the License Agreement, the Company incurred research and development related expenses of $0 and $9,355 during the
three-month period ending June 30, 2023 and June 30, 2022, respectively. As of June 30, 2023 and December 31, 2022, amounts outstanding
due IGL for their services amounted to $11,658 and $13,900, respectively.
During
the year ended December 31, 2020, the Company received $45,500 of proceeds from short-term notes payable with officers and directors
of the Company bearing interest at 10%. As of June 30, 2023 and December 31, 2022, $7,500 of principal remains outstanding on certain
of these short-term notes payable.
During 2022, the Company started
accuring compensation for the Board of Directors. Each board member receives an annual retainer of $30,000. Additionally, directors receive
annual fees of $20,000, $15,000 and $10,000 for serving as Chair of the Audit Committee, Compensation
Committee, and Nominating & Governance Committee, respectively; and annual fees of $7,500, $5,000 and $3,500 for serving as members
of the Audit Committee, Compensation Committee and Nominating & Governance Committee, respectively. As of June 30, 2023 and
December 31, 2022, the Company accrued director fees of $157,622 and $101,991, respectively.
|
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
CONVERTIBLE PROMISSORY NOTES
|
6 Months Ended |
Jun. 30, 2023 |
Convertible Promissory Notes |
|
CONVERTIBLE PROMISSORY NOTES |
NOTE
5 –CONVERTIBLE PROMISSORY NOTES
Convertible
Notes Payable
In
the fourth quarter of 2021, the Company issued a total of $605,000 in convertible notes payable, the total principal and accrued interest
of which was converted into a total of 186,601 shares of common stock as of June 30, 2023. The convertible notes were to mature on December
31, 2023, and included a 6% simple interest rate per annum payable upon maturity. In addition to the notes payable, each holder received
a warrant for the purchase of shares of common stock with a purchase price of $24.00, which expired in 2022. In accordance with accounting
standards, the warrants were valued using a Black Scholes Model and the relative fair value of the warrant was applied against the convertible
note for a debt discount of $72,600.
In
the fourth quarter of 2022, two note holders converted $132,932 of principal and interest on their notes into 22,155 shares of common
stock, at a reduced conversion price approved by the Board of $6.00. In the first quarter of 2023, the remaining holders converted $519,712
of principal and interest on their notes into 148,621 shares of common stock, at a reduced conversion price approved by the Board of
$3.50, and the two holders who converted in 2022 received an additional 15,825 shares to “make whole” their prior conversion
at a higher price. Due to the inducement to the reduced conversion price, the Company recorded $397,937 of inducement interest expense
to other income and expenses. The fair value of the shares issued for the conversion as of March 31, 2023 was $594,484 based on the stock
price of $4.00 as of March 31, 2023.
During
the six-month periods ended June 30, 2023 and 2022, the Company recorded interest expense related to the amortization of the discount
of $36,300 and $9,075, respectively. As of June 30, 2023 and December 31, 2022, unamortized debt discount was $0 and $36,300, respectively.
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v3.23.2
TEMPORARY EQUITY, PREFERRED STOCK, COMMON STOCK, AND WARRANTS
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
TEMPORARY EQUITY, PREFERRED STOCK, COMMON STOCK, AND WARRANTS |
NOTE
6 – TEMPORARY EQUITY, PREFERRED STOCK, COMMON STOCK, AND WARRANTS
Series
A Redeemable Convertible Preferred Stock (“Series A Stock”)
As
of June 30, 2023 and December 31, 2022, the Company has 480 shares of Series A Stock issued and outstanding. The Series A Stock has no
voting rights until converted to common stock and has a liquidation preference equal to the aggregate purchase price of $480,000 plus
accrued dividends. Pursuant to a modification agreement effective as of March 31, 2023, the two Series A Stockholders have agreed to
change the redemption date on their Series A Stock to December 31, 2023 and waive any prior defaults by the Company.
The
Series A Stock carries a 6% per annum dividend calculated on the stated value of the stock and is cumulative and payable quarterly beginning
July 1, 2016. These dividends are accrued at each reporting period and are added to the redemption value of the stock; however, since
the Company has an accumulated deficit, the charge has been recognized in additional paid-in capital. The accrued dividends are $255,600
and $241,200 as of June 30, 2023 and December 31, 2022, respectively. As of June 30, 2023 and December 31, 2022, the stated value of
the Series A Stock and the accrued dividends was $735,600 and $721,200, respectively, which has been presented as mezzanine equity on
the consolidated balance sheets, which resides between liabilities and stockholders’ deficit.
The
outstanding principal and accrued dividends on the shares of Series A Stock as of June 30, 2023 are convertible into the Company’s
common stock at $3.00 (the “Conversion Price”), which was reduced in 2023 pursuant to a price protection provision included
in the Series A Stock Certificate of Designation (“Series A Designation”), as the Company offered an inducement to holders
of warrants to convert their warrants at such lower conversion price. The Series A Designation requires an adjustment to the Conversion
Price if a subsequent equity sale occurs at a price below the conversion rate. The Company recorded a deemed dividend within stockholders’
deficit associated with the reduction in Conversion Price from $3.33 to $3.00 of $96,245 based on the incremental value to the Series
A Stockholders due to the Conversion Price reduction. This incremental value has also been presented on the consolidated statement of
operations as an addition to the net loss available to common stockholders. The incremental value was determined by computing the additional
shares the Series A Stockholders would receive based on the Conversion Price reduction multiplied by the estimated fair value of common
stock of $4.00.
Prior
to the recent Conversion Price adjustment, the outstanding shares of Series A Stock as of December 31, 2022 were convertible at $3.33
per share of the Company’s common stock, which was reduced in 2022 pursuant to the Series A Designation as the Company sold a common
stock and warrant unit in an offering at $4.50, the fair value of which was determined to be $3.33. The Company recorded a deemed dividend
within stockholders’ equity associated with the reduction in Conversion Price from $6.40 to $3.33 of $342,497 based on the incremental
value to the Series A Stockholders due to the Conversion Price reduction. This incremental value has also been presented on the consolidated
statement of operations as an addition to the net loss available to common stockholders. The incremental value was determined by computing
the additional shares the Series A Stockholders would receive based on the Conversion Price reduction multiplied by the estimated fair
value of common stock of $.
Management
has determined that the Series A Stock is more akin to a debt security than equity primarily because it contains a mandatory 2-year redemption
at the option of the holder (which pursuant to a June 30, 2023 modification signed by both Series A Stockholders, was changed to December
31, 2023), which only occurs if the Series A Stock is not converted to common stock. Therefore, management has presented the Series A
Stock outside of permanent equity as mezzanine equity, which resides between liabilities and equity.
Series
B Convertible Preferred Stock (“Series B Stock”)
In
December 2020, the Company filed an amendment to its Articles of Incorporation to authorize the issuance of up to 2,500 shares of Series
B Stock, par value $0.001 per share, pursuant to a Certificate of Designation (“Series B Designation”). The Series B Stock
provides the holders a 10% annual paid-in-kind dividend, a liquidation preference equal to the purchase price of the shares ($1,000 per
share) followed by the right to participate with the common stockholders in the instance of a liquidation or other exit event, and provide
the holders the right to vote along with the common holders based on the common conversion amount of their holdings. In January 2021,
the Company closed a private offering of its Series B Stock for $1,000 per share, raising a total of $2,500,000, inclusive of $156,000
in prior debt conversion and $23,000 of notes payable with directors converted to shares of Series B Stock and warrants. Between July
27 and August 24, 2021, 15 holders of an aggregate of 991 shares of Series B Stock converted their preferred shares into 163,134 shares
of common stock, which included $53,061 of accrued dividends. As of June 30, 2023 and December 31, 2022, 1,509 shares of Series B Stock
were issued and outstanding. The accrued dividends are $379,480 and $304,653, as of June 30, 2023 and December 31, 2022, respectively,
which are presented on the consolidated balance sheets.
The
Series B Stock was originally convertible into common stock at a ratio of $6.40 per share, subject to anti-dilution protections in the
case of certain issuances of securities below that conversion price, and as a result of this price protection, the ratio was reduced
in the fourth quarter of 2022 to $6.19 per share based on the Series B Designation which defines the adjustment to the conversion ratio
and incremental shares when the Company issues common stock at a price below the conversion ratio. For the year ended December 31, 2022,
the Company recorded a deemed dividend within stockholders’ equity associated with the reduction in conversion price from $6.40
to $6.19 of $30,938 based on the incremental value to the Series B Stockholders due to the conversion price reduction. This incremental
value has also been presented on the consolidated statement of operations as an addition to the net loss available to common stockholders.
For
the three-month period ended March 31, 2023, the anti-dilution protections were triggered as a result of additional common stock issuances
and the warrant conversion repricing, and the conversion ratio was reduced to $5.42. The Company recorded a deemed dividend within stockholders’
equity associated with the reduction in conversion price from $6.19 to $5.42 of $168,835 based on the incremental value to the Series
B Stockholders due to the conversion price reduction. This incremental value has also been presented on the consolidated statement of
operations as an addition to the net loss available to common stockholders.
Series
E-1 Preferred Stock (“Series E-1 Stock”)
On
December 3, 2020, the Company filed an amendment to its Articles of Incorporation to authorize the issuance of up to 8,500 shares of
Series E-1 Stock pursuant to a Certificate of Designation. As discussed below, no shares of Series E-1 Stock are currently outstanding.
The
shares of Series E-1 Stock were incentive-based, vesting and forfeitable securities that were issued to the Company’s executives
and one director. The Series E-1 Stock also provided the holders the right in the aggregate to receive an “earnout” equal
to 20% of the total consideration received by the Company in the instance of a sale or sub-license of its core licensed radiopharmaceutical
Technology, or sale or merger of the Company, which was to be paid on a priority, senior basis, as well as other conversion and voting
rights.
On
December 6, 2021, the Company entered into an Exchange Agreement and Plan of Reorganization (the “Exchange Agreement”) with
all Series E-1 Stockholders pursuant to which all shares of Series E-1 Stock were exchanged into an aggregate of 720,986 shares of common
stock of the Company. The fair value of the Series E-1 Stock was determined to be approximately $8.65 million at the time of exchange,
and was based upon a valuation report provided to the Board by an independent third party expert, and approved for fairness by the independent
chairman of the Compensation Committee. The common stock issued in the exchange was based on a value of $12.00 per share using a 30-day
weighted average closing price calculation, and was issued proportionately to each holder based on their individual holdings of Series
E-1 Stock. All shares of common stock issued to the shareholders are subject to the same vesting schedules as was originally provided
in each shareholder’s Series E-1 Stock issuance agreement, meaning that such shares of common stock are forfeitable if certain
conditions of employment are not met by the holders. As of June 30, 2023, all 720,986 common shares are fully vested and there are no
remaining common shares that are unvested.
For
the six-month periods ending June 30, 2023 and 2022, the Company recognized stock-based compensation to employees and directors totaling
$0 and $428,450, respectively, related to the Series E-1 Stock, which is included in compensation and related expenses on the consolidated
statements of operations. As of June 30, 2023, there is no unrecognized compensation remaining.
Common
Stock
In
2022, the Company effected a 40:1 reverse stock split and all share numbers herein have been adjusted for that change.
During
the six-month periods ended June 30, 2023 and 2022, the Company issued shares of common stock as follows:
SCHEDULE
OF ISSUED SHARES OF COMMON STOCK
| |
2023 | | |
2022 | |
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
Conversion of debentures and accrued interest | |
| - | | |
| 5,469 | |
Exercise of common stock warrants to common stock | |
| 365,001 | | |
| - | |
Stock based compensation to employees and directors | |
| 271,141 | | |
| - | |
Stock based compensation for services performed by one prior director | |
| - | | |
| 10,000 | |
Conversion of convertible debt to common stock, including “make whole” issuances | |
| 164,446 | | |
| - | |
Issuance of common stock for cash | |
| 69,834 | | |
| - | |
Stock based compensation for services | |
| 92,500 | | |
| 18,750 | |
Total common shares issued | |
| 962,922 | | |
| 34,219 | |
During
the six-month period ended June 30, 2023, the Company issued 69,834 shares
of common stock for $314,251 in
its common stock and warrant unit offering. Additionally, the Company converted outstanding convertible debt of $480,000 plus
interest totaling $519,712 into 164,446 shares
of common stock at a conversion price of $3.50.
The Company also received exercises of 365,001 warrants
into 365,001 shares
of common stock at an exercise price of $3.00,
for a total of $1,144,501,
which included $49,500 that
offset fees owed for services, and which also included $342,669 in
subscription receivables related to conversion notices that were executed prior to March 31, 2023 and funds that were received in
April 2023.
Additionally
during the six-month period ended June 30, 2023, the Company issued 269,102 shares
to board members and employees for their annual bonus as deferred compensation until vested. The awards are subject to
vesting and forfeiture conditions including satisfaction of certain performance-based milestones, as follows: (1)
209,102 shares were issued as incentive compensation vesting 50% upon the Company’s uplisting to Nasdaq if within three years,
with the balance vesting in eight quarterly installments commencing on the sooner of such Nasdaq uplisting or 12 months after
issuance; provided all shares shall vest upon the sale, merger or other “exit” event for the Company and its
shareholders; and (2) 60,000 shares were issued to compensate four members of the management team for acceptance of a significant
reduction in their base salaries in 2023 to help the Company conserve cash resources, and vest upon the completion of the
Company’s next funding in the amount of at least $5
million or Company exit. The awards scheduled to vest upon the occurrence of the vesting conditions will not vest in accordance with those
vesting conditions if the recipient of the award is no longer providing services to the Company at the time of vesting. The award recipient’s
status will end on the day the notice of terminiation is provided (whether by the Company or by the Participant upon resignation) and
will not be extended by any notice eriod that may be required contractually or under applicable local law.
Further, the Company issued 2,040 immediately
vested unregistered shares of common stock to its Chief Financial Officer in lieu of deferred cash compensation of approximately $10,200.
In connection
with these awards, the Board of Directors approved for 2023 an increase in the total number of shares authorized under the 2016 Omnibus
Equity Incentive Plan (the “2016 Plan”) by 350,000 additional shares, in accordance with the terms and conditions of the
shareholder-approved equity plan. As of the date of this report, there are approximately 106,000 shares available for future issuance
under the 2016 Plan.
During
the six-month period ended June 30, 2022, $35,000 of debentures and accrued interest were converted into 5,469 shares of common stock
at a price of $6.40 per share. Additionally, the Company issued 18,750 shares of common stock for services, and 10,000 shares of common
stock for services provided by one director who resigned from the Board in the same period.
Warrants
During
the six-month period ended June 30, 2023, the Company issued 69,834 warrants in connection with the common stock and warrant unit offering
(the “Common Stock Warrants”), and 50,000 warrants to a service provider totaling $91,979 in consulting services expense.
The Company did not issue any warrants in the same period in 2022.
A
summary of warrant activity and related information for the period ending June 30, 2023 is as follows:
SCHEDULE
OF ALL OUTSTANDING COMMON STOCK WARRANTS
| | |
Warrants | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | | |
| 323,543 | | |
$ | 6.15 | | |
$ | - | |
Issued | | |
| 119,832 | | |
| 4.25 | | |
| - | |
Exercised | | |
| 381,500 | | |
| 3.00 | | |
| - | |
Expired | | |
| 11,875 | | |
| 10.00 | | |
| - | |
Outstanding as of June 30, 2023 | | |
| 50,000 | | |
$ | 6.00 | | |
$ | - | |
The
aggregate intrinsic value of the warrants is the difference between the fair market value of the Company’s closing price of its
common stock at each reporting date, less the exercise price multiplied by the number of warrants outstanding, which was $0 at June 30,
2023 and December 31, 2022, respectively.
The
following is a summary of the outstanding common stock warrants as of June 30, 2023:
SCHEDULE
OF STOCKHOLDERS’ EQUITY NOTE WARRANTS OR RIGHTS
| |
Number of Warrants | | |
Exercise price per share | | |
Expiration Date |
Warrants issued in connection services agreement | |
| 50,000 | | |
$ | 6.00 | | |
January 15, 2025 |
Total outstanding as of June 30, 2023 | |
| 50,000 | | |
| | | |
|
|
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- DefinitionThe entire disclosure for equity.
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v3.23.2
STOCK OPTIONS
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK OPTIONS |
NOTE
7 – STOCK OPTIONS
In
2016 to compensate officers, directors and other key service providers with equity grants, the Board approved the 2016 Omnibus Equity
Incentive Plan (“2016 Plan”), which initially allowed for 4,000 shares of common stock, stock options, stock rights (restricted
stock units), or stock appreciation rights to be granted by the Board in its discretion. This authorized amount was increased multiple
times by Board resolution, most recently to 550,000 shares on May 23, 2023. As of June 30, 2023, there are 105,898 shares available under
the 2016 Plan for future issuance; however, the Board may increase the authorized shares under the 2016 Plan each year to an amount equal
to 5% of the total issued and outstanding common shares of the Company or such other amount in its reasonable discretion.
The
Company has not issued any stock options during the three and six-month period ended June 30, 2023; however, it did issue 269,102 shares
of restricted stock under the 2016 Plan in May 2023 (see “Common Stock” above).
A
summary of stock option activity and related information during the six-month period ended June 30, 2023 is as follows:
SUMMARY
OF STOCK OPTION ACTIVITY
| | |
Options | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | | |
| 177,815 | | |
$ | 12.57 | | |
| 8.8 | | |
$ | - | |
Granted | | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding as of June 30, 2023 | | |
| 177,815 | | |
$ | 12.57 | | |
| 8.56 | | |
$ | - | |
The
Company recorded $281,605 and $319,487 of stock-based compensation expense which is included in compensation and related expenses for
the six-month period ending June 30, 2023 and June 30, 2022, respectively, on the consolidated statement of operations.
The
aggregate intrinsic value of options is the difference between the fair market value of the Company’s closing price of its common
stock at each reporting date, less the exercise price multiplied by the number of options granted, which was $0 at June 30, 2023.
As
of June 30, 2023, there was unrecognized stock-based compensation of $393,375 which is expected to be expensed through March 2026 based
on the option vesting requirements.
We
estimate the fair value of stock-based awards on the date of grant using the Black-Scholes option pricing model using the fair market
value of our common stock on the date of grant and a number of other assumptions. These assumptions include estimates regarding the expected
term of the awards, estimates of the stock volatility over a duration that approximates the expected term of the awards, estimates of
the risk-free rate, and estimates of expected dividend rates.
|
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- DefinitionThe entire disclosure for share-based payment arrangement.
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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
8 – COMMITMENTS AND CONTINGENCIES
Employment
Agreements
The
employment agreements as amended for the Company’s Executive Chairman and CEO each contain termination provisions whereby if they
are terminated without cause or following a material change, as defined therein, they will receive salary through the date of termination
plus an additional 24 months, bonus that would be earned during the full year when the termination became effective (or a lump sum of
50% of the full target bonus), all stock options shall vest and healthcare benefits will continue for 24 months. The Company’s
General Counsel’s employment agreement, as amended, contains an 18-month severance payment in the instance of a termination without
cause or following a material change, as defined therein. In June 2023, the Company’s General Counsel was provided the additional
title of Executive Vice President – Corporate Development.
Pursuant
to amendments dated November 14, 2022 to the three employment agreements of the Company’s Executive Chairman, CEO and EVP/General
Counsel, as well as an amendment to the employment agreement for the Company’s VP Operations (the “2022 Amendments”),
each of these four employees have agreed to accept reduced salaries until the Company is successful in raising additional funds. Specifically,
when the Company raises at least $7.5 million in a single offering, each employee’s salary will be increased to the full contracted
rate; and prior to that time, the reduced salaries will be gradually increased as the Company raises $2 million and then $5 million.
During this time, the difference between the reduced salaries and the full contracted salaries will not accrue as liabilities for the
Company. As of June 30, 2023 and December 31, 2022, the accrued salary for the management team was $79,166.
Pursuant
to the 2022 Amendments, $758,748 of accrued salaries were settled with shares of common stock with an estimated fair value of $606,998
and cash payments of $151,750, of which $79,166 remains unpaid and has been accrued as of June 30, 2023. The Company issued 168,611 shares
of common stock on December 31, 2022 in connection with conversion of management salaries. The salary was converted at a price of $3.55
per share.
The
shares of common stock issued pursuant to the 2022 Amendments are restricted and shall be subject to forfeiture as follows: until such
time that the Company successfully closes $5 million in a single fundraising (the “Trigger Event”), which may be completed
in one or more closings over a period of 90 days, the shares of common stock may not be sold, transferred or otherwise disposed of by
the holder. Upon the occurrence of the Trigger Event, the shares shall be fully vested. If the Trigger Event does not occur within 36
months of November 2022, the shares of common stock shall be forfeited and returned to the Company. The shares issued with the 2022 Amendments
have been presented as issued and outstanding on the statement of stockholders’ deficit as of June 30, 2023.
The
employment agreements, as amended, for the Company’s Executive Chairman and CEO each contain a transaction bonus in the instance
any of the Company’s assets are sold or sublicensed or if the Company or its subsidiary is acquired, equal to 1.75% of the consideration
received by the Company. The employment agreement, as amended, for the Company’s EVP/General Counsel and for its VP Operations
each contain a similar transaction bonus equal to 1.0% of consideration received by the Company, pursuant to a Board consent authorized
and approved as of July 26, 2023 (see Note 9 – Subsequent Events).
Board
of Director Agreements
In
January 2022, Adriann Sax was appointed as a Director to the Board and awarded an annual retainer of $30,000 per year with an additional
$7,500 for serving as an Audit Committee member and an additional $10,000 for serving as the Nominating & Governance Committee Chair.
Ms. Sax has agreed to defer compensation for serving as a Director until the completion of the next fundraising round. As such, the Company
has accrued the director compensation for Ms. Sax monthly with a total accrued balance of $72,339 and $43,542 as of June 30, 2023 and
December 31, 2022, respectively.
In
February 2022, Charles J. Link, Jr. was appointed as a Director to the Board and awarded an annual retainer of $30,000 per year with
an additional $7,500 for serving as an Audit Committee member and an additional $15,000 for serving as the Compensation Committee Chair,
and $3,500 for serving as a member of the Nominating Committee. Dr. Link has agreed to defer compensation for serving as a Director until
the completion of the next fundraising round. As such, the Company has accrued the director compensation for Dr. Link monthly with a
total accrued balance of $85,283 and $51,333 as of June 30, 2023 and December 31, 2022, respectively.
In
May 2023, each of Ms. Sax and Dr. Link received 10,455 shares of restricted common stock as bonuses in lieu of cash. These shares vest
50% upon a Nasdaq listing of the Company’s stock if completed within three years, and 50% in eight quarterly installments upon
the sooner of the Nasdaq listing or 12 months from issuance. All shares will vest upon the sale, merger or other “exit” event
of the Company.
License
Agreement
The
License Agreement for the Technology, as amended, between the Company’s wholly-owned subsidiary QSAM Therapeutics and IGL is for
20 years or until the expiration of the multiple patents covered under the license and requires multiple milestone-based payments including:
up to $410,000 as CycloSam® advances through Phase 3 of clinical trials, and $2 million upon commercialization. IGL has
also received 12,500 shares of the Company’s common stock as additional compensation. Upon commercialization, IGL will receive
an on-going royalty equal to 4.5% of Net Sales, as defined in the License Agreement, and 5% of any consideration we receive pursuant
to a sublicense, sale of the asset, or sale of the QSAM subsidiary. The Company will also pay for ongoing patent filing and maintenance
fees, and has certain requirements to defend the patents against infringement claims.
In
connection with the License Agreement, QSAM signed a two-year Consulting and Confidentiality Agreement (the “Consulting Agreement”)
with IGL, which provided IGL with payments of $8,500 per month starting 60 days after signing through April 2022. The Consulting Agreement
provided QSAM with additional consulting and advisory services from the Technology’s founders to assist in the clinical development
of CycloSam. During the period ending March 31, 2023, the Company paid $56,854 in expense reimbursements required under the agreement.
The drug development costs to IGL which has been reflected as research and development expense on the consolidated statements of operations
was $0 and $95,988 for the period ending June 30, 2023 and June 30, 2022, respectively.
As
of June 30, 2023, $48,978 of these costs remained outstanding and included in accounts payable and accrued expenses on the consolidated
balance sheets.
On
July 1, 2022, QSAM signed a new work order under the Master Services Agreement dated August 31, 2020 with IsoTherapeutics Group, Inc.
(“ISO”), a company that has common ownership control with IGL. The new work order with ISO is a $8,500 per month consulting
contract to utilize the knowledge and expertise of Drs. Keith Frank and Jim Simon, primary scientists and owners in ISO and IGL, and
to provide scientific and manufacturing consulting support with the clinical trials as they progress through each phase. The work order
is a two year term with a 15 day cancellation notice and the Company is only obligated for fees incurred for services performed to date.
|
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v3.23.2
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
9 – SUBSEQUENT EVENTS
On
July 26, 2023, the Board approved amendments to the employment agreements of the Company’s EVP/General Counsel and its VP-Operations,
to increase the contingent compensation Transaction Bonus for both employees to 1% of the Net Proceeds received by the Company from a
Major Transaction, as such terms are defined in their respective agreements.
On
July 27, 2023, the Company issued 16,000 shares to a service provider as the second tranche of compensation pursuant to an agreement
signed in April 2023. On August 11, 2023, the Company issued 30,000 shares to a second service provider pursuant to an agreement signed
in April 2023.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Principles of Consolidation |
Principles
of Consolidation
The
unaudited consolidated financial statements include the accounts of QSAM Biosciences Inc. and its wholly-owned subsidiaries (the “Subsidiaries”)
QSAM Therapeutics Inc. and Q2Power Corp. (currently inactive). All significant inter-company transactions and balances have been eliminated
in consolidation. References herein to the Company include the Company and its Subsidiaries unless the context otherwise requires.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers cash, short-term deposits, and other investments with original maturities of no more than ninety days when acquired
to be cash and cash equivalents for the purposes of the statement of cash flows. The Company maintains cash balances at one national
financial institution and has experienced no losses with respect to amounts on deposit. Any loss incurred or a lack of access to such
funds above the FDIC limit could have a significant adverse impact on the Company’s financial condition, results of operations
and cash flows. The Company held no cash equivalents as of June 30, 2023 and December 31, 2022.
|
Revenue Recognition |
Revenue
Recognition
The
Company recognizes revenue in accordance with ASC Topic 606, “Revenue from Contracts with Customers (“ASC 606”) and
all the related amendments.
The
core principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers
in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASC
606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required
within the revenue recognition process than previously required under U.S. GAAP, including identifying performance obligations in the
contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to
each separate performance obligation.
The
Company had no revenue in 2023 and 2022.
|
Stock Based Compensation |
Stock
Based Compensation
The
Company applies the fair value method of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification
(“ASC”) 718, “Share Based Payment”, in accounting for its stock-based compensation with employees and
non-employees. This standard states that compensation cost is measured at the grant date based on the fair value of the award and is
recognized over the service period, which is usually the vesting period. The Company values stock-based compensation at the market price
for the Company’s common stock and other pertinent factors at the grant date.
The
Black-Scholes option pricing valuation method is used to determine fair value of stock options consistent with ASC 718, “Share
Based Payment”. Use of this method requires that the Company make assumptions regarding stock volatility, dividend yields,
expected term of the awards and risk-free interest rates.
|
Research and Development |
Research
and Development
Research
and development costs are expensed as incurred. Research and development costs were $654,795 for the six months ended June 30, 2023,
and are a result of the Company’s clinical trials of its drug Technology. Research and development costs were $459,053 for the
six months ended June 30, 2022, and are also a result of the clinical trials and fees owed under its License Agreement (see Note 8 –
Commitments and Contingencies).
|
Income Taxes |
Income
Taxes
Income
taxes are accounted for under the asset and liability method as stipulated by FASB ASC 740, “Income Taxes” (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit
carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities
or a change in tax rate is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced to estimated
amounts to be realized by the use of a valuation allowance. A valuation allowance is applied when in management’s view it is more
likely than not (50%) that such deferred tax will not be utilized.
In
the event that an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there
is a probability that the uncertain tax position taken would be sustained upon examination by the taxing authorities. Reserves for uncertain
tax positions would be recorded if the Company determined it is probable that a position would not be sustained upon examination or if
payment would have to be made to a taxing authority and the amount is reasonably estimated. As of June 30, 2023 and December 31, 2022,
the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authorities.
Interest and penalties related to any unrecognized tax benefits is recognized in the unaudited consolidated financial statements as a
component of income taxes.
|
Basic and Diluted Loss Per Share |
Basic
and Diluted Loss Per Share
Net
loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders
by the weighted average number of common shares outstanding during the period plus any potentially dilutive shares related to the issuance
of stock options, shares from the issuance of stock warrants, shares issued from the conversion of convertible preferred stock and shares
issued for the conversion of convertible debt.
As
of June 30, 2023, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
SCHEDULE
OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 50,000 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 244,144 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 348,420 | |
| |
| 820,379 | |
As
of June 30, 2022, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 37,083 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 110,437 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 271,490 | |
| |
| 675,409 | |
|
Significant Estimates |
Significant
Estimates
U.S.
Generally Accepted Accounting Principles (“GAAP”) requires the Company to make judgments, estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited
financial statements, the reported amounts of revenues and expenses, cash flows and the related footnote disclosures during the period.
On an on-going basis, the Company reviews and evaluates its estimates and assumptions, including, but not limited to, those that relate
to the fair value of stock-based compensation, and a valuation allowance on deferred tax assets. Actual results could differ from these
estimates.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06,
Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s
Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify accounting for certain financial instruments. ASU 2020-06 eliminates
the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies
the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard
also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s
own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for
all convertible instruments. ASU 2020-06 is effective January 1, 2022 for public business entities that are not smaller reporting companies
and for all other entities, fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The standard
should be applied on a full or modified retrospective basis, with early adoption permitted beginning on January 1, 2021. Effective January
1, 2021, the Company adopted ASU 2020-06 and noted no material impact to the consolidated financial statements.
Management
does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect
on its unaudited financial statements.
|
Concentration of Risk |
Concentration
of Risk
The
Company expects cash to be the asset most likely to subject the Company to concentrations of credit risk. The Company’s bank deposits
may at times exceed federally insured limits. The Company’s policy is to maintain its cash with high credit quality financial institutions
to limit its risk of loss exposure. The Company’s cash balance as of June 30, 2023, is in excess of FDIC limits in the amount of
approximately $139,690.
The
Company is subject to a number of risks similar to those of other companies at a clinical-stage for radiopharmaceutical drug candidates,
including dependence on key individuals; the need to develop commercially viable therapeutics; competition from other companies, many
of which are larger and better capitalized; intellectual property risks; and the need to obtain adequate additional financing to fund
the development of its products. The Company currently depends on third-party suppliers for key materials and services used in its research
and development manufacturing process, and is subject to certain risks related to the loss of these third-party suppliers or their inability
to supply the Company with adequate materials and services. The Company’s primary Technology is licensed from one party and is
subject to general risks related to contractual relationships and the performance of the parties under the contract.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
In
accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information
about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that
value. Cash is carried fair value.
Other
financial instruments, including accounts payable, accrued liabilities and short-term debt, are carried at cost, which approximates fair
value given their short-term nature.
|
Deferred Offering Cost |
Deferred
Offering Cost
Costs
incurred prior to an equity offering are capitalized until the offering occurs. Upon the equity offering, all accumulated costs are charged
against proceeds. If the Company determines that the equity offering will not occur, the accumulated costs are charged to operations.
|
Segment Reporting |
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
views its operations and manages its business as one segment.
|
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE |
As
of June 30, 2023, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
SCHEDULE
OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 50,000 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 244,144 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 348,420 | |
| |
| 820,379 | |
As
of June 30, 2022, there were the following potentially dilutive securities that were excluded from diluted net loss per share because
their effect would be anti-dilutive (all shares adjusted to reflect a 40:1 reverse stock split effected on March 9, 2022):
Shares from common stock options | |
| 177,815 | |
Shares from common stock warrants | |
| 37,083 | |
Shares from the conversion of convertible notes and accrued interest | |
| 78,584 | |
Shares from the conversion of Series A Stock inclusive of cumulative dividends | |
| 110,437 | |
Shares from the conversion of Series B Preferred Stock inclusive of dividends | |
| 271,490 | |
| |
| 675,409 | |
|
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v3.23.2
TEMPORARY EQUITY, PREFERRED STOCK, COMMON STOCK, AND WARRANTS (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
SCHEDULE OF ISSUED SHARES OF COMMON STOCK |
During
the six-month periods ended June 30, 2023 and 2022, the Company issued shares of common stock as follows:
SCHEDULE
OF ISSUED SHARES OF COMMON STOCK
| |
2023 | | |
2022 | |
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
Conversion of debentures and accrued interest | |
| - | | |
| 5,469 | |
Exercise of common stock warrants to common stock | |
| 365,001 | | |
| - | |
Stock based compensation to employees and directors | |
| 271,141 | | |
| - | |
Stock based compensation for services performed by one prior director | |
| - | | |
| 10,000 | |
Conversion of convertible debt to common stock, including “make whole” issuances | |
| 164,446 | | |
| - | |
Issuance of common stock for cash | |
| 69,834 | | |
| - | |
Stock based compensation for services | |
| 92,500 | | |
| 18,750 | |
Total common shares issued | |
| 962,922 | | |
| 34,219 | |
|
SCHEDULE OF ALL OUTSTANDING COMMON STOCK WARRANTS |
A
summary of warrant activity and related information for the period ending June 30, 2023 is as follows:
SCHEDULE
OF ALL OUTSTANDING COMMON STOCK WARRANTS
| | |
Warrants | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | | |
| 323,543 | | |
$ | 6.15 | | |
$ | - | |
Issued | | |
| 119,832 | | |
| 4.25 | | |
| - | |
Exercised | | |
| 381,500 | | |
| 3.00 | | |
| - | |
Expired | | |
| 11,875 | | |
| 10.00 | | |
| - | |
Outstanding as of June 30, 2023 | | |
| 50,000 | | |
$ | 6.00 | | |
$ | - | |
|
SCHEDULE OF STOCKHOLDERS’ EQUITY NOTE WARRANTS OR RIGHTS |
The
following is a summary of the outstanding common stock warrants as of June 30, 2023:
SCHEDULE
OF STOCKHOLDERS’ EQUITY NOTE WARRANTS OR RIGHTS
| |
Number of Warrants | | |
Exercise price per share | | |
Expiration Date |
Warrants issued in connection services agreement | |
| 50,000 | | |
$ | 6.00 | | |
January 15, 2025 |
Total outstanding as of June 30, 2023 | |
| 50,000 | | |
| | | |
|
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- DefinitionTabular disclosure of warrants or rights issued. Warrants and rights outstanding are derivative securities that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. Warrants are often included in a new debt issue to entice investors by a higher return potential. The main difference between warrants and call options is that warrants are issued and guaranteed by the company, whereas options are exchange instruments and are not issued by the company. Also, the lifetime of a warrant is often measured in years, while the lifetime of a typical option is measured in months. Disclose the title of issue of securities called for by warrants and rights outstanding, the aggregate amount of securities called for by warrants and rights outstanding, the date from which the warrants or rights are exercisable, and the price at which the warrant or right is exercisable.
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v3.23.2
STOCK OPTIONS (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
SUMMARY OF STOCK OPTION ACTIVITY |
A
summary of stock option activity and related information during the six-month period ended June 30, 2023 is as follows:
SUMMARY
OF STOCK OPTION ACTIVITY
| | |
Options | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value | |
Outstanding as of December 31, 2022 | | |
| 177,815 | | |
$ | 12.57 | | |
| 8.8 | | |
$ | - | |
Granted | | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding as of June 30, 2023 | | |
| 177,815 | | |
$ | 12.57 | | |
| 8.56 | | |
$ | - | |
|
X |
- DefinitionTabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value.
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- DefinitionAggregate cash proceeds received from a combination of transactions in which noncurrent assets are sold, which may include the sale of a business, an investment in an affiliate (including an equity method investee), property, plant and equipment and intangible assets. Excludes sales of trading, available-for-sale, and held-to-maturity securities.
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v3.23.2
BASIS OF PRESENTATION AND GOING CONCERN (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Apr. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Net cash used in operating activities |
|
|
|
$ 1,244,833
|
$ 1,105,513
|
|
Loss from operations |
|
$ 1,237,882
|
$ 1,283,446
|
2,744,924
|
$ 3,071,692
|
|
Working capital |
|
915,278
|
|
915,278
|
|
|
Cash |
|
389,690
|
|
389,690
|
|
$ 225,276
|
Accumulated deficit |
|
$ 38,469,938
|
|
$ 38,469,938
|
|
$ 35,177,625
|
Common Stock and Warrant [Member] |
|
|
|
|
|
|
Proceeds for issuance |
$ 2,850,000
|
|
|
|
|
|
Subscriptions receivables, value |
$ 342,667
|
|
|
|
|
|
X |
- DefinitionAmount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Excludes cash and cash equivalents within disposal group and discontinued operation.
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v3.23.2
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares
|
|
|
3 Months Ended |
6 Months Ended |
Mar. 09, 2022 |
Mar. 04, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
|
Reverse stock split description |
all shares adjusted to reflect a 40:1 reverse stock split
|
the Company completed a 40:1 reverse stock split of its common shares.
|
40:1 Reverse Split
|
|
|
Antidilutive securities, shares |
|
|
|
820,379
|
675,409
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
|
Antidilutive securities, shares |
|
|
|
177,815
|
177,815
|
Warrant [Member] |
|
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
|
Antidilutive securities, shares |
|
|
|
50,000
|
37,083
|
Convertible Debt Securities [Member] |
|
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
|
Antidilutive securities, shares |
|
|
|
|
78,584
|
Conversion of Series A Stock Inclusive of Cumulative Dividends [Member] |
|
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
|
Antidilutive securities, shares |
|
|
|
244,144
|
110,437
|
Conversion of Series B Preferred Stock Inclusive of Dividends [Member] |
|
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
|
Antidilutive securities, shares |
|
|
|
348,420
|
271,490
|
X |
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)
|
|
|
3 Months Ended |
6 Months Ended |
|
Mar. 09, 2022 |
Mar. 04, 2022 |
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Mar. 31, 2022 |
Jun. 30, 2023
USD ($)
Segment
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Accounting Policies [Abstract] |
|
|
|
|
|
|
|
|
Cash equivalents |
|
|
$ 0
|
|
|
$ 0
|
|
$ 0
|
Revenue |
|
|
|
|
|
0
|
$ 0
|
|
Research and development costs |
|
|
448,256
|
$ 204,216
|
|
$ 654,795
|
$ 459,053
|
|
Income tax likely hood percentage, description |
|
|
|
|
|
A valuation allowance is applied when in management’s view it is more
likely than not (50%) that such deferred tax will not be utilized.
|
|
|
Reverse stock split description |
all shares adjusted to reflect a 40:1 reverse stock split
|
the Company completed a 40:1 reverse stock split of its common shares.
|
|
|
40:1 Reverse Split
|
|
|
|
Cash in excess of FDIC limits |
|
|
$ 139,690
|
|
|
$ 139,690
|
|
|
Number of operating segments | Segment |
|
|
|
|
|
1
|
|
|
X |
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v3.23.2
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2020 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Research and development related expenses |
$ 448,256
|
$ 204,216
|
$ 654,795
|
$ 459,053
|
|
|
Compensation expense |
|
|
|
|
$ 30,000
|
|
Accrued director fees |
157,622
|
|
157,622
|
|
101,991
|
|
Audit Committee [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Annual fees |
|
|
7,500
|
|
20,000
|
|
Compensation Committee [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Annual fees |
|
|
5,000
|
|
15,000
|
|
Nominating And Governance Committee [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Annual fees |
|
|
3,500
|
|
|
|
IGL Pharma Inc [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Research and development related expenses |
0
|
$ 9,355
|
|
|
|
|
IGL Pharma Inc [Member] | Service [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Due to related party |
11,658
|
|
11,658
|
|
13,900
|
|
Officers and Directors [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Proceeds from short-term notes payable |
|
|
|
|
|
$ 45,500
|
Bearing interest |
|
|
|
|
|
10.00%
|
Short-term notes payable outstanding |
$ 7,500
|
|
$ 7,500
|
|
7,500
|
|
Nominating And Governance Committee [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Annual fees |
|
|
|
|
$ 10,000
|
|
IGL Pharma Inc [Member] | President [Member] |
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
Non-controlling equity interest |
1.00%
|
|
1.00%
|
|
|
|
Annual fees |
|
|
$ 500
|
|
|
|
X |
- DefinitionThe average effective interest rate during the reporting period.
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v3.23.2
CONVERTIBLE PROMISSORY NOTES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Mar. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Short-Term Debt [Line Items] |
|
|
|
|
|
Fair value shares issued for the conversion |
|
|
|
$ 519,712
|
|
Convertible Promissory Notes [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Proceeds from convertible notes payable |
|
|
$ 605,000
|
|
|
Debt conversion, shares issued |
148,621
|
|
|
186,601
|
|
Maturity date |
|
|
Dec. 31, 2023
|
|
|
Interest rate, stated percentage |
|
|
6.00%
|
|
|
Stock price |
$ 4.00
|
|
$ 24.00
|
|
|
Unamortized debt discount |
|
$ 36,300
|
|
$ 0
|
|
Value of notes converted |
$ 519,712
|
|
|
|
|
Debt conversion price |
$ 3.50
|
|
|
|
|
Inducement interest expense |
$ 397,937
|
|
|
|
|
Fair value shares issued for the conversion |
$ 594,484
|
|
|
|
|
Interest expense on amortization of discount |
|
|
|
$ 36,300
|
$ 9,075
|
Convertible Promissory Notes [Member] | Two Note Holders [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Debt conversion, shares issued |
15,825
|
22,155
|
|
|
|
Value of notes converted |
|
$ 132,932
|
|
|
|
Debt conversion price |
|
$ 6.00
|
|
|
|
Convertible Promissory Notes [Member] | Warrant [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Unamortized debt discount |
|
|
$ 72,600
|
|
|
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v3.23.2
SCHEDULE OF ISSUED SHARES OF COMMON STOCK (Details) - shares
|
3 Months Ended |
6 Months Ended |
Mar. 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
962,922
|
34,219
|
Common Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
69,834
|
|
|
Common Stock [Member] | Conversion of Debentures and Accrued Interest [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
|
5,469
|
Common Stock [Member] | Exercise of Common Stock Warrants to Common Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
365,001
|
|
Common Stock [Member] | Stock Based Compensation to Employees and Directors [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
271,141
|
|
Common Stock [Member] | Stock Based Compensation For Services Performed By One Prior Director [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
|
10,000
|
Common Stock [Member] | Conversion of Convertible Debt to Common Stock, including Make Whole Issuances [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
164,446
|
|
Common Stock [Member] | Issuance of Common Stock For Cash [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
69,834
|
|
Common Stock [Member] | Stock Based Compensation For Services [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Total common shares issued |
|
92,500
|
18,750
|
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v3.23.2
SCHEDULE OF ALL OUTSTANDING COMMON STOCK WARRANTS (Details) - Warrant [Member]
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
Warrants outstanding, Beginning | shares |
323,543
|
Warrants Weighted Average Exercise Price, Beginning | $ / shares |
$ 6.15
|
Warrants Aggregate Intrinsic Value, Beginning | $ |
|
Warrants Issued | shares |
119,832
|
Warrants Weighted Average Exercise Price, Issued | $ / shares |
$ 4.25
|
Warrants Aggregate Intrinsic Value, Issued | $ |
|
Warrants Exercised | shares |
381,500
|
Warrants Weighted Average Exercise Price, Exercised | $ / shares |
$ 3.00
|
Warrants Expired | shares |
11,875
|
Warrants Weighted Average Exercise Price, Expired | $ / shares |
$ 10.00
|
Warrants outstanding, Ending | shares |
50,000
|
Warrants Weighted Average Exercise Price, Ending | $ / shares |
$ 6.00
|
Warrants Aggregate Intrinsic Value, Ending | $ |
|
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v3.23.2
TEMPORARY EQUITY, PREFERRED STOCK, COMMON STOCK, AND WARRANTS (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
Mar. 09, 2022 |
Mar. 04, 2022 |
Dec. 06, 2021 |
Aug. 24, 2021 |
Jan. 31, 2021 |
Dec. 31, 2020 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Dec. 03, 2020 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Temporary equity, shares issued |
|
|
|
|
|
|
480
|
|
|
480
|
|
480
|
|
Temporary equity, shares outstanding |
|
|
|
|
|
|
480
|
|
|
480
|
|
480
|
|
Temporary equity, liquidation preference |
|
|
|
|
|
|
$ 735,600
|
|
|
$ 735,600
|
|
$ 721,200
|
|
Temporary equity, value |
|
|
|
|
|
|
$ 735,600
|
|
|
735,600
|
|
721,200
|
|
Recognized stock based compensation |
|
|
|
|
|
|
|
|
|
$ 291,803
|
$ 747,937
|
|
|
Reverse stock split, description |
all shares adjusted to reflect a 40:1 reverse stock split
|
the Company completed a 40:1 reverse stock split of its common shares.
|
|
|
|
|
|
|
40:1 Reverse Split
|
|
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
|
|
962,922
|
34,219
|
|
|
Number of issuance, value |
|
|
|
|
|
|
|
$ 314,246
|
|
|
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
|
|
|
|
|
$ 3.00
|
|
|
$ 3.00
|
|
|
|
[custom:OffsetFees] |
|
|
|
|
|
|
|
|
|
$ 49,500
|
|
|
|
Common Stock, Share Subscribed but Unissued, Subscriptions Receivable |
|
|
|
|
|
|
$ 342,669
|
|
|
342,669
|
|
|
|
Consulting services expense |
|
|
|
|
|
|
|
|
|
91,979
|
|
|
|
Service [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants outstanding |
|
|
|
|
|
|
$ 50,000
|
|
|
$ 50,000
|
|
|
|
2016 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
|
|
350,000
|
|
|
|
Shares available for future issuance |
|
|
|
|
|
|
106,000
|
|
|
106,000
|
|
|
|
Common Stock and Warrant Unit Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
|
|
69,834
|
|
|
|
Number of issuance, value |
|
|
|
|
|
|
|
|
|
$ 314,251
|
|
|
|
Number of warrants outstanding |
|
|
|
|
|
|
$ 69,834
|
|
|
$ 69,834
|
|
|
|
Board Members and Employees [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
|
|
269,102
|
|
|
|
Share based compensation award, description |
|
|
|
|
|
|
|
|
|
(1)
209,102 shares were issued as incentive compensation vesting 50% upon the Company’s uplisting to Nasdaq if within three years,
with the balance vesting in eight quarterly installments commencing on the sooner of such Nasdaq uplisting or 12 months after
issuance; provided all shares shall vest upon the sale, merger or other “exit” event for the Company and its
shareholders; and (2) 60,000 shares were issued to compensate four members of the management team for acceptance of a significant
reduction in their base salaries in 2023 to help the Company conserve cash resources, and vest upon the completion of the
Company’s next funding in the amount of at least $5
million or Company exit. The awards scheduled to vest upon the occurrence of the vesting conditions will not vest in accordance with those
vesting conditions if the recipient of the award is no longer providing services to the Company at the time of vesting. The award recipient’s
status will end on the day the notice of terminiation is provided (whether by the Company or by the Participant upon resignation) and
will not be extended by any notice eriod that may be required contractually or under applicable local law.
|
|
|
|
Cash and Cash Equivalents, at Carrying Value |
|
|
|
|
|
|
$ 5,000,000
|
|
|
$ 5,000,000
|
|
|
|
Chief Financial Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
|
|
2,040
|
|
|
|
Number of issuance, value |
|
|
|
|
|
|
|
|
|
$ 10,200
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated fair value of common stock |
|
|
|
|
|
|
|
|
|
$ 4.00
|
|
|
|
Debt conversion, original debt, amount |
|
|
|
|
|
|
|
|
|
$ 480,000
|
$ 35,000
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
69,834
|
|
|
|
|
|
Number of issuance, value |
|
|
|
|
|
|
|
$ 7
|
|
|
|
|
|
Interest and Debt Expense |
|
|
|
|
|
|
|
|
|
$ 519,712
|
|
|
|
Debt conversion, shares issued |
|
|
|
|
|
|
|
|
|
164,446
|
5,469
|
|
|
Debt conversion price |
|
|
|
|
|
|
$ 3.50
|
|
|
$ 3.50
|
$ 6.40
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number |
|
|
|
|
|
|
1,144,501
|
|
|
1,144,501
|
|
|
|
Additional stock issued for services |
|
|
|
|
|
|
|
|
|
|
18,750
|
|
|
Stock issued during period shares, issued for services |
|
|
|
|
|
|
76,000
|
16,500
|
28,750
|
|
|
|
|
Common Stock [Member] | Exercise of Common Stock Warrants to Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares, issuance |
|
|
|
|
|
|
|
|
|
365,001
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number |
|
|
|
|
|
|
365,001
|
|
|
365,001
|
|
|
|
Common Stock [Member] | Director [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period shares, issued for services |
|
|
|
|
|
|
|
|
|
|
10,000
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants outstanding |
|
|
|
|
|
|
$ 0
|
|
|
$ 0
|
|
$ 0
|
|
Warrant [Member] | Exercise of Common Stock Warrants to Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number |
|
|
|
|
|
|
365,001
|
|
|
365,001
|
|
|
|
Series A Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Temporary equity, shares issued |
|
|
|
|
|
|
480
|
|
|
480
|
|
480
|
|
Temporary equity, shares outstanding |
|
|
|
|
|
|
480
|
|
|
480
|
|
480
|
|
Temporary equity, liquidation preference |
|
|
|
|
|
|
$ 480,000
|
|
|
$ 480,000
|
|
|
|
Temporary equity, dividend rate |
|
|
|
|
|
|
|
|
|
6.00%
|
|
|
|
Accrued dividends |
|
|
|
|
|
|
255,600
|
|
|
$ 255,600
|
|
$ 241,200
|
|
Temporary equity, value |
|
|
|
|
|
|
$ 735,600
|
|
|
$ 735,600
|
|
$ 721,200
|
|
Conversion price |
|
|
|
|
|
|
$ 3.00
|
|
|
$ 3.00
|
|
$ 3.33
|
|
Incremental value due to the conversion price reduction |
|
|
|
|
|
|
$ 96,245
|
|
|
$ 96,245
|
|
$ 342,497
|
|
Estimated fair value of common stock |
|
|
|
|
|
|
|
|
|
|
|
$ 3.33
|
|
Series A Stock [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued per share |
|
|
|
|
|
|
|
|
|
|
|
4.50
|
|
Series A Stock [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
$ 3.33
|
|
|
$ 3.33
|
|
6.40
|
|
Series A Stock [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
$ 3.00
|
|
|
$ 3.00
|
|
3.33
|
|
Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
$ 6.40
|
|
|
|
|
|
$ 6.19
|
|
Incremental value due to the conversion price reduction |
|
|
|
|
|
|
$ 168,835
|
|
|
$ 168,835
|
|
$ 30,938
|
|
Common stock issued per share |
|
|
|
|
$ 1,000
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
2,500
|
2,500
|
|
|
2,500
|
|
2,500
|
|
Preferred stock, par value per share |
|
|
|
|
|
$ 0.001
|
$ 0.001
|
|
|
$ 0.001
|
|
$ 0.001
|
|
Preferred stock, dividend rate, percentage |
|
|
|
|
|
10.00%
|
|
|
|
|
|
|
|
Preferred stock, liquidation preference per share |
|
|
|
|
|
$ 1,000
|
|
|
|
|
|
|
|
Proceeds from private offering |
|
|
|
|
$ 2,500,000
|
|
|
|
|
|
|
|
|
Debt conversion, original debt, amount |
|
|
|
|
156,000
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
|
|
1,509
|
|
|
1,509
|
|
1,509
|
|
Preferred stock, shares outstanding |
|
|
|
|
|
|
1,509
|
|
|
1,509
|
|
1,509
|
|
Series B Preferred Stock [Member] | Fifteen Holders [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued dividends |
|
|
|
$ 53,061
|
|
|
$ 379,480
|
|
|
$ 379,480
|
|
$ 304,653
|
|
Shares converted |
|
|
|
991
|
|
|
|
|
|
|
|
|
|
Common stock issued during conversion |
|
|
|
163,134
|
|
|
|
|
|
|
|
|
|
Series B Preferred Stock [Member] | Warrant [Member] | Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt conversion, original debt, amount |
|
|
|
|
$ 23,000
|
|
|
|
|
|
|
|
|
Series B Preferred Stock [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
|
$ 6.19
|
|
|
|
|
|
Preferred stock, conversion price, decrease |
|
|
|
|
|
|
|
|
|
|
|
$ 6.40
|
|
Series B Preferred Stock [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
|
$ 5.42
|
|
|
|
|
|
Preferred stock, conversion price, decrease |
|
|
|
|
|
|
|
|
|
|
|
$ 6.19
|
|
Series E-1 Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
|
8,500
|
|
|
8,500
|
|
8,500
|
|
Preferred stock, par value per share |
|
|
|
|
|
|
$ 0.0001
|
|
|
$ 0.0001
|
|
$ 0.0001
|
|
Preferred stock, shares issued |
|
|
|
|
|
|
0
|
|
|
0
|
|
0
|
|
Preferred stock, shares outstanding |
|
|
|
|
|
|
0
|
|
|
0
|
|
0
|
|
Series E-1 Preferred Stock [Member] | Exchange Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued per share |
|
|
$ 12.00
|
|
|
|
|
|
|
|
|
|
|
Common stock issued during conversion |
|
|
720,986
|
|
|
|
|
|
|
|
|
|
|
Fair value of shares converted |
|
|
$ 8,650,000
|
|
|
|
|
|
|
|
|
|
|
Common shares vested |
|
|
|
|
|
|
|
|
|
720,986
|
|
|
|
Series E-1 Preferred Stock [Member] | Employees and Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognized stock based compensation |
|
|
|
|
|
|
|
|
|
$ 0
|
$ 428,450
|
|
|
Series E-1 Preferred Stock [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
|
|
|
|
|
|
|
8,500
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse stock split, description |
|
|
|
|
|
|
|
|
|
|
|
40:1 reverse stock split
|
|
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v3.23.2
SUMMARY OF STOCK OPTION ACTIVITY (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] |
|
|
Option outstanding, beginning balance |
177,815
|
|
Weighted average exercise price outstanding, balance |
$ 12.57
|
|
Weighted average remaining contractual term outstanding |
8 years 6 months 21 days
|
8 years 9 months 18 days
|
Aggregate Intrinsic Value, Beginning balance |
|
|
Options, granted |
|
|
Weighted average exercise price, granted |
|
|
Option outstanding, ending balance |
177,815
|
177,815
|
Weighted average exercise price outstanding, ending balance |
$ 12.57
|
$ 12.57
|
Aggregate intrinsic value, ending balance |
|
|
X |
- DefinitionGross number of share options (or share units) granted during the period.
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v3.23.2
STOCK OPTIONS (Details Narrative) - USD ($)
|
1 Months Ended |
6 Months Ended |
|
|
May 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
May 23, 2023 |
Dec. 31, 2016 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Issuance of common stock for cash, shares |
|
962,922
|
34,219
|
|
|
Share based compensation expense |
|
$ 281,605
|
$ 319,487
|
|
|
Options granted, amount |
|
|
|
|
|
Unrecognized stock-based compensation |
|
$ 393,375
|
|
|
|
2016 OmniBus Equity Incentive Plan [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Shares authorized under plan |
|
105,898
|
|
550,000
|
4,000
|
Shares authorized under plan outstanding, percent |
|
|
|
|
5.00%
|
2016 OmniBus Equity Incentive Plan [Member] | Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Issuance of common stock for cash, shares |
269,102
|
|
|
|
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v3.23.2
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jul. 01, 2022 |
May 31, 2023 |
Feb. 28, 2022 |
Jan. 31, 2022 |
Apr. 30, 2017 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Termination agreement description |
|
|
|
|
|
|
|
|
The
employment agreements as amended for the Company’s Executive Chairman and CEO each contain termination provisions whereby if they
are terminated without cause or following a material change, as defined therein, they will receive salary through the date of termination
plus an additional 24 months, bonus that would be earned during the full year when the termination became effective (or a lump sum of
50% of the full target bonus), all stock options shall vest and healthcare benefits will continue for 24 months. The Company’s
General Counsel’s employment agreement, as amended, contains an 18-month severance payment in the instance of a termination without
cause or following a material change, as defined therein. In June 2023, the Company’s General Counsel was provided the additional
title of Executive Vice President – Corporate Development.
|
|
|
Employment agreements description |
|
|
|
|
|
|
|
|
Pursuant
to amendments dated November 14, 2022 to the three employment agreements of the Company’s Executive Chairman, CEO and EVP/General
Counsel, as well as an amendment to the employment agreement for the Company’s VP Operations (the “2022 Amendments”),
each of these four employees have agreed to accept reduced salaries until the Company is successful in raising additional funds. Specifically,
when the Company raises at least $7.5 million in a single offering, each employee’s salary will be increased to the full contracted
rate; and prior to that time, the reduced salaries will be gradually increased as the Company raises $2 million and then $5 million.
During this time, the difference between the reduced salaries and the full contracted salaries will not accrue as liabilities for the
Company.
|
|
|
Accrued salary amount |
|
|
|
|
|
$ 79,166
|
|
|
$ 79,166
|
|
$ 79,166
|
Estimated fair value |
|
|
|
|
|
|
$ 314,246
|
|
|
|
|
Stock issued during period, value forfeitures |
|
|
|
|
|
|
|
|
5,000,000
|
|
|
Individual compensation expense |
|
|
|
|
|
|
|
|
|
|
30,000
|
Professional fees |
|
|
|
|
|
449,365
|
|
$ 218,006
|
$ 908,499
|
$ 857,411
|
|
Employee agreement related description |
|
These shares vest
50% upon a Nasdaq listing of the Company’s stock if completed within three years, and 50% in eight quarterly installments upon
the sooner of the Nasdaq listing or 12 months from issuance. All shares will vest upon the sale, merger or other “exit” event
of the Company.
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for cash, shares |
|
|
|
|
|
|
|
|
962,922
|
34,219
|
|
Research and development expenses |
|
|
|
|
|
448,256
|
|
$ 204,216
|
$ 654,795
|
$ 459,053
|
|
Chairman and CEO [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Description of nature and effects |
|
|
|
|
|
|
|
|
The
employment agreements, as amended, for the Company’s Executive Chairman and CEO each contain a transaction bonus in the instance
any of the Company’s assets are sold or sublicensed or if the Company or its subsidiary is acquired, equal to 1.75% of the consideration
received by the Company. The employment agreement, as amended, for the Company’s EVP/General Counsel and for its VP Operations
each contain a similar transaction bonus equal to 1.0% of consideration received by the Company, pursuant to a Board consent authorized
and approved as of July 26, 2023 (see Note 9 – Subsequent Events).
|
|
|
Adriann Sax [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Individual compensation expense |
|
|
|
$ 30,000
|
|
|
|
|
|
|
|
Accrued compensation |
|
|
|
|
|
|
|
|
$ 72,339
|
|
43,542
|
Adriann Sax [Member] | Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Restricted stock issued as bonuses |
|
10,455
|
|
|
|
|
|
|
|
|
|
Audit Committee [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Professional fees |
|
|
$ 7,500
|
7,500
|
|
|
|
|
|
|
|
Nominating and Governace Commmittee [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Professional fees |
|
|
3,500
|
$ 10,000
|
|
|
|
|
|
|
|
Charles J. Link [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Individual compensation expense |
|
|
30,000
|
|
|
|
|
|
|
|
|
Accrued compensation |
|
|
|
|
|
|
|
|
85,283
|
|
$ 51,333
|
Charles J. Link [Member] | Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Restricted stock issued as bonuses |
|
10,455
|
|
|
|
|
|
|
|
|
|
Compensation Committee Chair [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Professional fees |
|
|
$ 15,000
|
|
|
|
|
|
|
|
|
Settlement Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Accrued salaries |
|
|
|
|
|
$ 758,748
|
|
|
758,748
|
|
|
Estimated fair value |
|
|
|
|
|
|
|
|
606,998
|
|
|
Cash payments |
|
|
|
|
|
|
|
|
151,750
|
|
|
Unpaid salaries |
|
|
|
|
|
|
|
|
$ 79,166
|
|
|
Shares issued |
|
|
|
|
|
|
|
|
|
|
168,611
|
Converted price per share |
|
|
|
|
|
$ 3.55
|
|
|
$ 3.55
|
|
|
License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
|
|
|
|
|
|
$ 0
|
$ 95,988
|
|
Accounts payable and accrued expenses |
|
|
|
|
|
$ 48,978
|
|
|
$ 48,978
|
|
|
License Agreement [Member] | IGL Pharma Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Agreement term |
|
|
|
|
|
|
|
|
20 years
|
|
|
License Agreement [Member] | QSAM Therapeutics Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Other expenses |
|
|
|
|
|
|
|
|
$ 56,854
|
|
|
Royalty percentage |
|
|
|
|
4.50%
|
|
|
|
|
|
|
Sublicense percentage |
|
|
|
|
5.00%
|
|
|
|
|
|
|
Consulting fee |
$ 8,500
|
|
|
|
|
|
|
|
$ 8,500
|
|
|
License Agreement [Member] | QSAM Therapeutics Inc [Member] | Upon Commercialization [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Other expenses |
|
|
|
|
$ 2,000,000
|
|
|
|
|
|
|
Issuance of common stock for cash, shares |
|
|
|
|
12,500
|
|
|
|
|
|
|
License Agreement [Member] | QSAM Therapeutics Inc [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Other expenses |
|
|
|
|
$ 410,000
|
|
|
|
|
|
|
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