Item 8. Financial Statements and Supplementary Data
Item 8.
Financial Statements and Supplementary Data.
CNS Pharmaceuticals, Inc.
Index to Financial Statements
Page
Report of Independent Registered
Public Accounting Firm (PCAOB ID: 206 )
43
Balance Sheets as of December 31, 2022 and 2021
44
Statements of Operations for the years ended December 31, 2022 and 2021
45
Statements of Stockholders’ Equity for the years ended December 31, 2022 and 2021
46
Statements of Cash Flows for the years ended December 31, 2022 and 2021
47
Notes to Financial Statements
48
42
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Shareholders
and Board of Directors of
CNS Pharmaceuticals,
Inc.
Opinion
on the Financial Statements
We have
audited the accompanying balance sheets of CNS Pharmaceuticals, Inc. (the “Company”) as of December 31, 2022 and 2021, and
the related statements of operations, stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively
referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the
years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going
Concern Matter
The accompanying
financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial
statements, the Company has suffered recurring losses from operations and negative cash flows from operations that raise substantial
doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These financial
statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted
our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not
required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we
are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits
included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud,
and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts
and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a
reasonable basis for our opinion.
/s/ MaloneBailey,
LLP
www.malonebailey.com
We have
served as the Company's auditor since 2019.
Houston,
Texas
March 31,
2023
43
CNS Pharmaceuticals, Inc.
Balance Sheets
December 31,
2022
December 31,
2021
As Revised
Assets
Current Assets:
Cash and cash equivalents
$ 10,055,407
$ 5,004,517
Prepaid expenses and other current assets
2,509,238
2,472,933
Total current assets
12,564,645
7,477,450
Noncurrent Assets:
Prepaid expenses, net of current portion
482,806
929,688
Property and equipment, net
5,664
16,109
Deferred offering costs
–
334,138
Total noncurrent assets
488,470
1,279,935
Total Assets
$ 13,053,115
$ 8,757,385
Liabilities and Stockholders' Equity
Current Liabilities:
Accounts payable
$ 3,681,900
$ 1,981,445
Accrued expenses
828,391
224,949
Notes payable
409,968
387,794
Total current liabilities
4,920,259
2,594,188
Total Liabilities
4,920,259
2,594,188
Commitments and contingencies
–
–
Stockholders' Equity:
Preferred stock, $ 0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding
–
–
Common stock, $ 0.001 par value, 75,000,000 shares authorized and 1,617,325 and 949,052 shares issued and outstanding, respectively
1,617
949
Additional paid-in capital
58,846,916
41,603,791
Accumulated deficit
( 50,715,677 )
( 35,441,543 )
Total Stockholders' Equity
8,132,856
6,163,197
Total Liabilities and Stockholders' Equity
$ 13,053,115
$ 8,757,385
See accompanying notes to
the financial statements.
44
CNS Pharmaceuticals, Inc.
Statements of Operations
Year Ended
Year Ended
December 31, 2022
December 31, 2021
As Revised
Operating expenses:
General and administrative
$ 5,967,052
$ 4,680,840
Research and development
9,300,055
9,805,075
Total operating expenses
15,267,107
14,485,915
Loss from operations
( 15,267,107 )
( 14,485,915 )
Other expenses:
Interest expense
( 7,027 )
( 9,285 )
Total other expenses
( 7,027 )
( 9,285 )
Net loss
$ ( 15,274,134 )
$ ( 14,495,200 )
Loss per share - basic
$ ( 11.22 )
$ ( 16.50 )
Loss per share - diluted
$ ( 11.22 )
$ ( 16.50 )
Weighted average shares outstanding - basic
1,361,737
878,443
Weighted average shares outstanding - diluted
1,361,737
878,443
See accompanying notes to
the financial statements.
45
CNS Pharmaceuticals, Inc.
Statements of Stockholders’
Equity
For the years ended December
31, 2022 and 2021
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders'
Shares
Amount
Capital
Deficit
Equity
Balance December 31, 2020
813,350
$ 813
$ 34,893,514
$ ( 20,946,343 )
$ 13,947,984
Common stock issued for cash, net
68,784
69
4,653,752
–
4,653,821
Exercise of warrants
63,585
64
332,686
–
332,750
Stock-based compensation
3,333
3
1,723,839
–
1,723,842
Net loss
–
–
–
( 14,495,200 )
( 14,495,200 )
Balance December 31, 2021 - As revised
949,052
949
41,603,791
( 35,441,543 )
6,163,197
Common stock issued for cash, net
463,316
463
16,037,630
–
16,038,093
Exercise of warrants
204,957
205
2,529
–
2,734
Stock-based compensation
–
–
1,202,966
–
1,202,966
Net loss
–
–
–
( 15,274,134 )
( 15,274,134 )
Balance December 31, 2022
1,617,325
$ 1,617
$ 58,846,916
$ ( 50,715,677 )
$ 8,132,856
See accompanying notes to
the financial statements.
46
CNS Pharmaceuticals, Inc.
Statements of Cash Flows
Year Ended
Year Ended
December 31, 2022
December 31, 2021
As Revised
Cash Flows from Operating Activities:
Net loss
$ ( 15,274,134 )
$ ( 14,495,200 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
1,202,966
1,723,842
Depreciation
11,756
13,070
Write off of deferred offering cost
334,138
–
Loss on disposal of fixed assets
3,111
–
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
860,451
( 1,520,281 )
Accounts payable
1,700,455
1,035,115
Accrued expenses
603,442
( 294,855 )
Net cash used in operating activities
( 10,557,815 )
( 13,538,309 )
Cash Flows from Investing Activities:
Purchase of property and equipment
( 4,422 )
( 5,748 )
Net cash used in investing activities
( 4,422 )
( 5,748 )
Cash Flows from Financing Activities:
Payments on notes payable
( 427,700 )
( 477,490 )
Proceeds from exercise of warrants
2,734
332,750
Proceeds from sale of common stock
16,038,093
4,653,821
Net cash provided by financing activities
15,613,127
4,509,081
Net change in cash and cash equivalents
5,050,890
( 9,034,976 )
Cash and cash equivalents, at beginning of period
5,004,517
14,039,493
Cash and cash equivalents, at end of period
$ 10,055,407
$ 5,004,517
Supplemental disclosures of cash flow information:
Cash paid for interest
$ 8,094
$ 9,774
Cash paid for income taxes
$ –
$ –
Supplemental disclosure of non-cash investing and financing activities:
Cashless exercise of warrants
$ –
$ 1,756
Prepaid expense financed with note payable
$ 449,874
$ 425,990
See accompanying notes to
the financial statements.
47
CNS Pharmaceuticals, Inc.
Notes to the Financial Statements
Note 1 – Nature of Business
CNS Pharmaceuticals, Inc. (“we”, “our”, the “Company”)
is a clinical pharmaceutical company organized as a Nevada corporation on July 27, 2017 to focus on the development of anti-cancer
drug candidates.
On August 25, 2022, the stockholders of the Company approved an amendment
to the Company’s amended and restated articles of incorporation (the “Amendment”) to effect the reverse stock split
at a ratio in the range of 1-for-2 to 1-for-30. The reverse stock split became effective on November 28, 2022 on a 1-for-30 basis without
any change in the par value per share, which remained at $0.001. The reverse stock split has been retroactively
adjusted throughout these financial statements and footnotes.
Note 2 – Correction of Previously Issued Financial Statements
In the course of preparing its fiscal year 2022 financial statements,
the Company identified errors in the financial statements for the year ended December 31, 2021 and its unaudited financial statements
for the periods ended March 31, 2022, June 30, 2022, and September 30, 2022. The errors pertain to understatements in research and development
expenses and accrued expenses amounting to $458,622 for the year ended December 31, 2021 and $367,439 for the three months ended March
31, 2022, the six months ended June 30, 2022 and the nine months ended September 30, 2022 resulting from additional trial sites costs
which were not reported to the Company by our CRO.
The Company assessed the materiality of these misstatements on prior
periods’ financial statements in accordance with SEC Staff Accounting Bulletin (“SAB”) No. 99, Materiality, codified in
ASC 250 (“ASC 250”), Presentation of Financial Statements, and concluded that these misstatements were not material to any prior
annual or interim periods. Accordingly, in accordance with ASC 250 (SAB No. 108, Considering the Effects of Prior Year Misstatements when
Quantifying Misstatements in Current Year Financial Statements), the Financial Statements as of December 31, 2021, and the year then ended,
which are presented herein, have been revised. The following are selected line items from the Company's balance sheets, statements of
operations and statements of cash flows for the affected periods illustrating the effect of these corrections:
Schedule of restatements
Balance Sheet
As of December 31,
2021
As Reported
Adjustment
As Revised
Accounts payable
$ 1,522,823
$ 458,622
$ 1,981,445
Total current liabilities
2,135,566
458,622
2,594,188
Total liabilities
2,135,566
458,622
2,594,188
Accumulated deficit
( 34,982,921 )
( 458,622 )
( 35,441,543 )
Total stockholders' equity
6,621,819
( 458,622 )
6,163,197
Balance Sheet
(Unaudited)
As of March 31,
2022
As Reported
Adjustment
As Revised
Accounts payable
$ 489,716
$ 826,061
$ 1,315,777
Total current liabilities
1,069,300
826,061
1,895,361
Total liabilities
1,069,300
826,061
1,895,361
Accumulated deficit
( 37,767,260 )
( 826,061 )
( 38,593,321 )
Total stockholders' equity
14,802,567
( 826,061 )
13,976,506
48
Balance Sheet
(Unaudited)
As of June 30,
2022
As Reported
Adjustment
As Revised
Accounts payable
$ 490,886
$ 826,061
$ 1,316,947
Total current liabilities
923,856
826,061
1,749,917
Total liabilities
923,856
826,061
1,749,917
Accumulated deficit
( 41,333,212 )
( 826,061 )
( 42,159,273 )
Total stockholders' equity
11,523,456
( 826,061 )
10,697,395
Balance Sheet
(Unaudited)
As of September 30,
2022
As Reported
Adjustment
As Revised
Accounts payable
$ 1,005,043
$ 826,061
$ 1,831,104
Total current liabilities
1,244,303
826,061
2,070,364
Total liabilities
1,244,303
826,061
2,070,364
Accumulated deficit
( 44,752,765 )
( 826,061 )
( 45,578,826 )
Total stockholders' equity
8,393,624
( 826,061 )
7,567,563
Statement of Operations
For the year ended December 31,
2021
As Reported
Adjustment
As Revised
Research and development
$ 9,346,453
$ 458,622
$ 9,805,075
Total operating expenses
14,027,293
458,622
14,485,915
Loss from operations
( 14,027,293 )
( 458,622 )
( 14,485,915 )
Net loss
( 14,036,578 )
( 458,622 )
( 14,495,200 )
Loss per share - basic and diluted
( 15.98 )
( 0.52 )
( 16.50 )
Statement of Operations
(Unaudited)
For the three months ended March 31,
2022
As Reported
Adjustment
As Revised
Research and development
$ 1,521,364
$ 367,439
$ 1,888,803
Total operating expenses
2,781,773
367,439
3,149,212
Loss from operations
( 2,781,773 )
( 367,439 )
( 3,149,212 )
Net loss
( 2,784,339 )
( 367,439 )
( 3,151,778 )
Loss per share - basic and diluted
( 2.15 )
( 0.28 )
( 2.44 )
49
Statement of Operations
(Unaudited)
For the six months ended June 30,
2022
As Reported
Adjustment
As Revised
Research and development
$
3,742,703
$
367,439
$
4,110,142
Total operating expenses
6,346,114
367,439
6,713,553
Loss from operations
( 6,346,114
)
( 367,439
)
( 6,713,553
)
Net loss
( 6,350,291
)
( 367,439
)
( 6,717,730
)
Loss per share - basic and diluted
( 4.83
)
( 0.28
)
( 5.11
)
Statement of Operations
(Unaudited)
For the nine months ended September 30,
2022
As Reported
Adjustment
As Revised
Research and development
$
5,950,616
$
367,439
$
6,318,055
Total operating expenses
9,765,129
367,439
10,132,568
Loss from operations
( 9,765,129
)
( 367,439
)
( 10,132,568
)
Net loss
( 9,769,844
)
( 367,439
)
( 10,137,283
)
Loss per share - basic and diluted
( 7.40
)
( 0.27
)
( 7.67
)
Statement of Cash Flows
For the year ended December 31,
2021
As Reported
Adjustment
As Revised
Cash Flows from Operating Activities:
Net loss
$ ( 14,036,578 )
$ ( 458,622 )
$ ( 14,495,200 )
Accounts payable
576,493
458,622
1,035,115
Net cash used in operating activities
( 13,538,309 )
–
( 13,538,309 )
Statement of Cash Flows
(Unaudited)
For the three months ended March 31,
2022
As Reported
Adjustment
As Revised
Cash Flows from Operating Activities:
Net loss
$ ( 2,784,339 )
$ ( 367,439 )
$ ( 3,151,778 )
Accounts payable
( 1,033,107 )
367,439
( 665,668 )
Net cash used in operating activities
( 3,077,199 )
–
( 3,077,199 )
Statement of Cash Flows
(Unaudited)
For the six months ended June 30,
2022
As Reported
Adjustment
As Revised
Cash Flows from Operating Activities:
Net loss
$ ( 6,350,291 )
$ ( 367,439 )
$ ( 6,717,730 )
Accounts payable
( 1,031,937 )
367,439
( 664,498 )
Net cash used in operating activities
( 6,439,733 )
–
( 6,439,733 )
50
Statement of Cash Flows
(Unaudited)
For the nine months ended September 30,
2022
As Reported
Adjustment
As Revised
Cash Flows from Operating Activities:
Net loss
$ ( 9,769,844 )
$ ( 367,439 )
$ ( 10,137,283 )
Accounts payable
( 517,780 )
367,439
( 150,341 )
Net cash used in operating activities
( 8,252,492 )
–
( 8,252,492 )
Note 3 – Summary of Significant Accounting Policies
The accompanying financial statements and related notes have been prepared
in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and in accordance
with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). The Company’s fiscal
year end is December 31.
Use of Estimates in Financial Statement Presentation - The
preparation of these financial statements in conformity with accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Liquidity and Going Concern - These financial statements have been
prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the
normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain equity
or debt financings to continue operations. The Company has a history of and expects to continue to report negative cash flows from operations
and a net loss. Management believes that the cash on hand at period end combined with the funds raised subsequent to year end is sufficient
to fund its planned operations into but not beyond the near term. These factors raise substantial doubt regarding the Company’s
ability to continue as a going concern. These financial statements do not include any adjustments to the recoverability and classification
of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going
concern. The Company may seek additional funding through a combination of equity offerings, debt financings, government or other third-party
funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements
and delay planned cash outlays or a combination thereof. Management cannot be certain that such events or a combination thereof can be
achieved.
Cash
and Cash Equivalents - The Company considers all highly liquid accounts with original maturities of three months or less
at the date of acquisition to be cash equivalents. Periodically, the Company may carry cash balances at financial institutions in
excess of the federally insured limit of $ 250,000 .
The amount in excess of the FDIC insurance at December 31, 2022 was $ 9,805,407 .
The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial
institutions, that the credit risk with regard to these deposits is not significant.
51
Property and Equipment - Property and equipment is recorded
at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows:
Schedule of estimated useful lives
Leasehold improvement
Shorter of estimated useful lives or the term of the lease
Computer equipment
3 years
Machinery and equipment
5 years
Furniture and office equipment
7 years
Repairs and maintenance costs are expensed as incurred.
Impairment of Long-lived Assets - The Company evaluates its
long-lived tangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets
may not be recoverable. Recoverability of a long-lived asset is measured by comparison of the carrying amount to the expected future undiscounted
cash flows that the asset is expected to generate. Any impairment to be recognized is measured by the amount by which the carrying amount
of the asset exceeds its fair value.
Fair Value of Financial Instruments - The carrying value of
short-term instruments, including cash and cash equivalents, accounts payable and accrued expenses, and short-term notes approximate fair
value due to the relatively short period to maturity for these instruments.
Fair value is defined as the exchange price that would be received for
an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an
orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the
use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a three-level valuation hierarchy for disclosures
of fair value measurements, defined as follows:
Level 1 - inputs to the valuation methodology are quoted prices (unadjusted)
for identical assets or liabilities in active markets.
Level 2 - inputs to the valuation methodology include quoted prices for
similar assets and liabilities in active markets, and inputs that are observable for the assets or liability, either directly or indirectly,
for substantially the full term of the financial instruments.
Level 3 - inputs to the valuation methodology are unobservable and significant
to the fair value.
The Company does not have any assets or liabilities that are required to
be measured and recorded at fair value on a recurring basis.
Related Parties - The Company
follows ASC 850, Related Party Disclosures, for the identification of related parties and disclosure of related party
transactions.
Income Taxes - The Company uses the asset and liability method
of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between
the financial reporting and the tax bases of reported assets and liabilities and are measured using the enacted tax rates and laws that
will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred
tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred
tax asset will not be realized.
52
The Company accounts for uncertain tax positions in accordance with the
provisions of Accounting Standards Codification (ASC) 740-10 which prescribes a recognition threshold and measurement attribute for financial
statement disclosure of tax positions taken, or expected to be taken, on its tax return. The Company evaluates and records any uncertain
tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement
with the tax authorities in the tax jurisdictions in which it operates.
Stock-based Compensation - Employee and non-employee share-based
compensation is measured at the grant date, based on the fair value of the award, and is recognized as an expense over the requisite service
period.
Restricted Stock Units (“RSUs”) - Our RSUs vest over
four years from the date of grant. The fair value of RSUs is the market price of our common stock at the date of grant.
Performance Units (“PUs”) - The PUs vest based on our
performance against predefined share price targets and the achievement of Positive Interim, Clinical Data as defined by the Board.
Loss Per Common Share - Basic loss per common share is computed
by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted
loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the
dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding
excludes common stock equivalents, because their inclusion would be anti-dilutive. As of December 31, 2022, the Company’s potentially
dilutive shares and options, which were not included in the calculation of net loss per share, included warrants to purchase 4,133,252
common shares, and options for 93,001 common shares. As of December 31, 2021, the Company’s potentially dilutive shares and options,
which were not included in the calculation of net loss per share, included warrants to purchase 140,512 common shares, and options for
95,501 common shares.
Research and Development Costs - Research and development costs
are expensed as incurred. The Company recognized the benefit of refundable research and development tax credits as a reduction of research
and development expenses when there is reasonable assurance that the amount claimed will be recovered.
Recent Accounting Pronouncements
The Company does not believe that any other recently issued effective
pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial
statements.
53
Note 4 – Note Payable
On November 14, 2022, the Company entered into a short-term note payable
for an aggregate of $ 449,874 , bearing interest at 5.88 % per year to finance certain insurance policies. Principal and interest payments
related to the note will be repaid over a 11-month period with the final payment due on October 31, 2023 . As of December 31, 2022, the
Company’s note payable balance was $ 409,968 .
On November 8, 2021, the Company entered into a short-term note payable
for an aggregate of $ 425,990 , bearing interest at 3.3 % per year to finance certain insurance policies. Principal and interest payments
related to the note will be repaid over a 11-month period with the final payment due on September 30, 2022 . During the year ended December
31, 2022, the Company repaid the full balance of the note. As of December 31, 2022 and 2021, the Company’s note payable balance
was $0 and $ 387,794 , respectively.
Note 5 – Equity
The Company has authorized 75,000,000 shares of common stock having a par
value of $ 0.001 per share. In addition, the Company authorized 5,000,000 shares of preferred stock to be issued having a par value of
$ 0.001 . The specific rights of the preferred stock shall be determined by the board of directors.
On August 25, 2022, the stockholders of the Company
approved an amendment to the Company’s amended and restated articles of incorporation (the “Amendment”) to effect the
reverse stock split at a ratio in the range of 1-for-2 to 1-for-30, with such ratio to be determined in the discretion of the Company’s
board of directors and with such reverse stock split to be effected at such time and date, if at all, as determined by the Company’s
board of directors in its sole discretion prior to the one-year anniversary of the annual meeting.
Pursuant to such authority granted by the Company’s stockholders,
the Company’s board of directors approved a one-for-thirty
(1:30) reverse stock split of the Company’s common stock and the filing of the Amendment to effectuate the reverse
split. The reverse stock split became effective on November 28, 2022 on a 1-for-30 basis without any change in the par value
per share, which remained at $0.001.
Common Stock
2022
The Company engaged H.C. Wainwright & Co., LLC (“Wainwright”),
to act as placement agent related to the Securities Purchase Agreement described below. The Company agreed to pay Wainwright an aggregate
fee equal to 7.0% of the gross proceeds received by the Company from the sale of the securities in the transaction. The Company also issued
to Wainwright or its designees warrants to purchase up to 5.0% of the aggregate number of shares of Common Stock sold in the transactions
(the “Placement Agent Warrants”), or 20,176 Placement Agent Warrants. The Placement Agent Warrants have substantially the
same terms as the Common Warrants, except that the Placement Agent Warrants have an exercise price equal to 125% of the offering price,
or $35.625 per share. The Company also paid Wainwright $ 50,000 for non-accountable expenses and $ 10,000 for legal fees and expenses.
On January 5, 2022, the Company entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with several institutional investors for the sale by the Company of (i) 316,316 shares (the “Shares”)
of the Company’s common stock, (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of
87,193 shares of common stock and (iii) warrants to purchase up to an aggregate of 403,509 shares of common stock (the “Common Warrants”
and, collectively with the Pre-Funded Warrants, the “Warrants”), in a private placement offering. The combined purchase price
of one share of common stock (or one Pre-Funded Warrant) and the accompanying Common Warrant is $28.50.
54
Subject to certain ownership limitations, the Warrants are exercisable
upon issuance. Each Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $0.001 (as adjusted from
time to time in accordance with the terms thereof). Each Common Warrant is exercisable into one share of common stock at a price per share
of $24.60 (as adjusted from time to time in accordance with the terms thereof) and will expire on the fifth anniversary of the date of
issuance. The gross proceeds from the Purchase Agreement were $ 11,497,385 resulting in net proceeds, after payment of commissions and
expenses, received by the Company of $ 10,625,786 .
On November 30, 2022, the Company entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with an institutional investor for the sale by the Company of (i) 147,000 shares (the “Shares”)
of the Company’s common stock, par value $0.001 per share (the “Common Stock”), (ii) pre-funded warrants (the “Pre-Funded
Warrants”) to purchase up to an aggregate of 1,742,764 shares of Common Stock and (iii) warrants to purchase up to an aggregate
of 1,889,764 shares of Common Stock (the “Common Warrants” and, collectively with the Pre-Funded Warrants, the “Warrants”),
in a public offering. The combined purchase price of one share of Common Stock and accompanying Common Warrant is $3.175 and the combined
purchase price of one Pre-Funded Warrant and accompanying Common Warrant is $3.174.
Subject to certain ownership limitations, the Warrants are exercisable
upon issuance. Each Pre-Funded Warrant is exercisable into one share of Common Stock at a price per share of $0.001 (as adjusted from
time to time in accordance with the terms thereof). Each Common Warrant is exercisable into one share of Common Stock at a price per share
of $3.03 (as adjusted from time to time in accordance with the terms thereof) and will expire on the fifth anniversary of the date of
issuance. Each Pre-Funded Warrant is exercisable into one share of Common Stock at a price per share of $0.001 (as adjusted from time
to time in accordance with the terms thereof). The gross proceeds to the Company from the offering were $ 5.998 million, resulting in net
proceeds, after payment of commissions and expenses, received by the Company of $ 5,412,308 .
On November 30, 2022, in connection with the offering, the Company also
entered into a warrant amendment agreement (the “Warrant Amendment Agreement”) with the investor in the offering. Under the
Warrant Amendment Agreement, the Company agreed to amend certain existing warrants (the “Existing Warrants”) to purchase up
to an aggregate of (i) 16,667 shares of common stock at an exercise price of $ 66.00 per share and an expiration date of December 28, 2025
and (ii) 210,527 shares of common stock at an exercise price of $ 24.60 per share and an expiration date of January 10, 2027, as follows:
(i) to lower the exercise price of the Existing Warrants to $3.03 per share, and (ii) to extend the expiration date of the Existing Warrants
to five years following the closing of the offering.
On November 30, 2022, the Company entered into a placement agency agreement with H.C. Wainwright & Co., LLC (“Wainwright”)
and Brookline Capital Markets, a division of Arcadia Securities, LLC (“Brookline” and collectively with Wainright, the “Placement
Agents”) (the “Placement Agreement”), pursuant to which the Company has agreed to pay the Placement Agents an aggregate
fee equal to 7.0% of the gross proceeds received by the Company from the sale of the securities in the transaction. Pursuant to the Placement
Agreement, the Company will also issue to the Placement Agents or their designees warrants to purchase up to 5.0% of the aggregate number
of shares of Common Stock issued in the offering and issuable upon the exercise of the pre-funded warrants issued in the offering (the
“Placement Agent Warrants”), or 94,488 Placement Agent Warrants. The Placement Agent Warrants have substantially the same
terms as the Common Warrants, except that the Placement Agent Warrants have an exercise price equal to 125% of the offering price, or
$3.7875 per share, subject to adjustments. The Company also agreed to reimburse certain expenses of Wainwright, including a non-accountable
expense allowance of $ 50,000 , legal fees and expenses in an amount up to $ 100,000 and clearing fees of $ 15,950 . The Company also agreed
to pay Wainwright a tail fee equal to the cash compensation in this offering, if any investor, who was contacted or introduced to the
Company by Wainwright during the term of its engagement, provides the Company with capital in any public or private offering or other
financing or capital raising transaction during the nine-month period following expiration or termination of our engagement of Wainwright.
In addition, with certain exceptions, for a period of seven month following the closing of the offering, the Company has granted Wainwright
the right to act as sole book-runner, sole manager, sole placement agent or sole agent with respect to any financing or refinancing of
indebtedness; and if the Company decides to raise funds by means of a public offering (including at-the-market facility) or a private
placement or any other capital-raising financing of equity, equity-linked or debt securities, the Company has granted Wainwright the right
to act as sole book-running manager, sole underwriter or sole placement agent for such financing.
As consideration for entering into a purchase agreement with Lincoln
Park Capital Fund, LLC in fiscal year 2020, the Company recorded as deferred offering costs of $440,902, on the balance sheet. As of December
31, 2021, unamortized deferred offering costs totaled $334,138. During the year ended December 31, 2022, the Company wrote off the remaining
$ 334,138 deferred offering costs to the statement of operations.
55
2021
In January 2021, the Company entered into a twelve-month agreement with
an investor relations firm that includes the issuance of 834 restricted shares of common stock. Upon signing the agreement, 209 shares
vested immediately, and the remaining 625 shares will vest quarterly over the remainder of the agreement. The Company may terminate the
agreement at any time during the twelve-month period with a fifteen-day notice. During the year ended December 31, 2021, the Company issued
834 common shares and recognized $ 50,500 of stock-based compensation related to the agreement and will issue the remaining shares over
the service period.
During the year ended December 31, 2021, the Company
issued 2,500 shares of common stock and recognized $ 140,250 of expense for investor relations services for a four month period ending
September 2021.
On February 12, 2021, the Company entered into a Capital on Demand™
Sales Agreement (the “Agreement”) with JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of
Arcadia Securities, LLC (collectively, the “Agent”). Pursuant to the terms of the Agreement, the Company may sell from time
to time, through the Agent, shares of the Company’s common stock with an aggregate sales price of up to $20.0 million. During the
year ended December 31, 2021, the Company sold 68,784 shares of common stock to the Agent for net proceeds of $ 4,653,821 .
Stock Options
In 2017, the Board of Directors of the Company approved the CNS Pharmaceuticals,
Inc. 2017 Stock Plan (the “2017 Plan”). The 2017 Plan allows for the Board of Directors to grant various forms of incentive
awards for up to 66,667 shares of common stock. No key employee may receive more than 16,667 shares of common stock (or options to purchase
more than 16,667 shares of common stock) in a single year.
In 2020, the Board of Directors of the Company approved the CNS Pharmaceuticals,
Inc. 2020 Stock Plan (the “2020 Plan”). The 2020 Plan allows for the Board of Directors to grant various forms of incentive
awards for up to 100,000 shares of common stock. No key employee may receive more than 25,000 shares of common stock (or options to purchase
more than 25,000 shares of common stock) in a single year.
During the year ended December 31, 2021, the Board
of Directors approved grants of 24,633 options to officers, employees, board of directors and a consultant. The exercise price of the
options ranges from $54.00 to $100.80 and the options expire ten-years following issuance. The total fair value of these option
grants at issuance was $ 1,969,712 . Of the 24,633 options issued, 4,267 options vest on the first anniversary date of issuance, 2,500 options
have a vesting term of 25% vest upon issuance, 50% vest upon Board approving a business development acquisition and 25% vest over a three
year period in equal installments on each of the succeeding three anniversary dates. The remaining options issued vest in four equal annual
installments beginning on the first anniversary following issuance.
During the years ended December 31, 2022 and 2021, the Company recognized
$ 1,149,364 and $ 1,533,092 of stock-based compensation, respectively, related to outstanding stock options. At December 31, 2022, the Company
had $ 1,318,183 of unrecognized expenses related to options.
56
The following table summarizes the stock option activity for the year ended
December 31, 2022 and 2021:
Schedule of Stock Option Activity
Options
Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2020
73,368
$ 60.00
Granted
24,633
89.70
Exercised
–
–
Forfeited
( 2,500 )
61.80
Expired
–
–
Outstanding, December 31, 2021
95,501
67.50
Granted
–
–
Exercised
–
–
Forfeited
( 2,500 )
70.50
Expired
–
–
Outstanding, December 31, 2022
93,001
$ 67.42
The aggregate fair value of the options measured during the year ended
December 31, 2021 were calculated using the Black-Scholes option pricing model based on the following assumptions:
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions
Year Ended
December 31, 2021
Fair value of common stock on measurement date
$54.00 to $100.80 per share
Risk free interest rate (1)
0.28 % to 1.28 %
Volatility (2)
128.17 % to 130.72 %
Dividend yield (3)
0 %
Expected term (in years)
5.5 – 6.3
(1)
The risk-free interest rate was determined by management using the market yield on U.S. Treasury securities with comparable terms as of the measurement date.
(2)
The trading volatility was determined by calculating the volatility of the Company’s peer group.
(3)
The Company does not expect to pay a dividend in the foreseeable future.
As of December 31, 2022, the outstanding stock options have a weighted
average remaining term of 6.73 years and the aggregate intrinsic value of options vested and outstanding were $ 9,626 . As of December 31,
2022, there were no awards remaining to be issued under the 2017 Plan and 35,580 awards remaining to be issued under the 2020 Plan.
57
Stock Warrants
The following table summarizes the stock warrant activity for the years
ended December 31, 2022 and 2021:
Schedule of warrant activity
Warrants
Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2020
228,740
$ 97.20
Granted
–
–
Exercised
( 88,228 )
24.60
Forfeited
–
–
Expired
–
–
Outstanding, December 31, 2021
140,512
142.83
Granted
4,237,900
2.88
Exercised
( 204,957 )
0.01
Forfeited
–
–
Expired
( 40,203 )
330.00
Outstanding, December 31, 2022
4,133,252
$ 4.35
During the year ended December 31, 2022, the Company received $ 2,734
in cash proceeds from the exercise of 204,957
warrants previously issued at an exercise price range of $0.01 to $0.03.
During the year ended December 31, 2021, the
Company received $ 332,750
in cash proceeds from the exercise of 5,041
warrants previously issued at an exercise price of $66.00. In addition, the Company received notices to exercise 83,187
warrants on a cashless basis resulting in the issuance of 58,544
shares of common stock.
As of December 31, 2022 the outstanding and exercisable warrants have a
weighted average remaining term of 4.84 years and with an intrinsic value of $ 3,898,375 .
Restricted Stock Units
On April 28, 2022, the Compensation Committee approved cash bonuses totaling
$ 213,000 to the officers of the Company. In addition, the officers and employees were awarded a total of 9,523 Restricted Stock Units
that partially vest over 4 years. The Company valued the RSUs based on the stock price at grant which total $ 95,399 .
During the year ended December 31, 2022, the Company recognized $ 17,887
of stock-based compensation, related to outstanding stock RSUs. At December 31, 2022, the Company had $ 77,512 of unrecognized expenses
related to outstanding RSUs.
58
The following table summarizes the RSUs activity for
the year ended December 31, 2022:
Schedule of RSU activity
RSUs
Weighted-Average Grant Date Fair Value
Non-vested, December 31, 2021
–
$
–
Granted
9,523
10.02
Vested
–
–
Forfeited
–
–
Non-vested, December 31, 2022
9,523
$
10.02
Performance Units
On April 28, 2022, the Compensation Committee approved, the officers
and employees were awarded a total of 28,563 PUs.
For awards granted in 2022, they vest as follows: (i) 9,521 of the PU grant will vest if within 24 months from issuance the average
the closing price of the Company’s common stock over a ten trading day period exceeds $60.00 (subject to pro rata adjustment
for stock splits or similar events), (ii) 9,521 of the PU grant will vest if within 36 months from issuance the average the closing
price of the Company’s common stock over a ten trading day period exceeds $120.00 (subject to pro rata adjustment for stock
splits or similar events) and (iii) 9,521 of the PU grant will vest if within 24 months from issuance the Company achieves
“Positive Interim, Clinical Data” as defined by the Board of Directors. To the extent that the market and/or
“Positive Interim Clinical Data” conditions are not met, the applicable portions of the PUs will not vest and will be
cancelled. The fair value at grant date of these performance units was $ 169,663 .
Compensation expense is recognized over the derived service period for the PUs with market conditions and over the requisite service
period for PUs with performance conditions on the date when achievement of such conditions are deemed probable.
The fair value of each performance unit with market conditions (vesting
terms (i) and (ii)) is estimated at the date of grant using a Monte Carlo simulation with the following assumptions: underlying stock
price $10.02, hurdle prices ranging from $60.00 -$120.00, expected terms ranging from 2-3 years, cost of equity 18.7% and risk-free rate
of 2.8%.
During the year ended December 31, 2022, the Company recognized $ 21,928
for vesting term (i), $ 13,787 for vesting term (ii) and $ 0 for vesting term (iii), related to outstanding stock PUs. At December 31, 2022,
the Company had $ 133,948 of unrecognized expenses related to PUs.
The following table summarizes the PUs activity for
the year ended December 31, 2022:
Schedule of performance units activity
PUs
Weighted-Average Grant Date Fair Value
Non-vested, December 31, 2021
–
$
–
Granted
28,563
5.94
Vested
–
–
Forfeited
–
–
Non-vested, December 31, 2022
28,563
$
5.94
59
Note 6 – Commitments and Contingencies
Executive Employment Agreements
On September 1, 2017, the Company entered into an employment agreement
with Mr. John Climaco pursuant to which Mr. Climaco agreed to serve as Chief Executive Officer and Director of the Company commencing
on such date for an initial term of three years. On September 1, 2020, the Company entered into an amendment to the employment agreement
with Mr. Climaco. The amendment extends the term of employment under the Employment Agreement, which was originally for a three-year period,
for additional twelve-month periods, unless and until either the Company or Mr. Climaco provides written notice to the other party not
less than sixty days before such anniversary date that such party is electing not to extend the term. If the Company provides notice of
its election not to extend the term, Mr. Climaco may terminate his employment at any time prior to the expiration of the term by giving
written notice to the Company at least thirty days prior to the effective date of termination, and upon the earlier of such effective
date of termination or the expiration of the term, Mr. Climaco shall be entitled to receive the same severance benefits as are provided
upon a termination of employment by the Company without cause. Pursuant to the Amendment, the severance benefits shall be twelve months
of Mr. Climaco’s base salary. Such severance payment shall be made in a single lump sum sixty days following the termination, provided
that Mr. Climaco has executed and delivered to the Company and has not revoked a general release of the Company. Pursuant to the employment
agreement, the compensation committee of the board of directors reviews the base salary payable to Mr. Climaco annually during the term
of the agreement. On February 6, 2021, the compensation committee of the board of directors set Mr. Climaco’s 2021 annual base salary
to $ 525,000 .
On June 28, 2019, we entered into employment letters with Drs. Silberman
and Picker pursuant to which Dr. Silberman agreed to commit 50% of her time to our matters; and Dr. Picker agreed to commit 25% of his
time to our matters. On February 6, 2021, the compensation committee of the board of directors set Drs. Silberman and Picker 2021 annual
base salaries to $ 200,000 and $ 115,000 , respectively.
On September 14, 2019, the Company, entered into an employment agreement
with Christopher Downs to serve as its Chief Financial Officer commencing on the closing date of the Company’s IPO, which occurred
on November 13, 2019. The initial term of the Employment Agreement will continue for a period of three years. Pursuant to the employment
agreement, the compensation committee of the board of directors reviews the base salary payable to Mr. Downs annually during the term
of the agreement. On February 6, 2021, the compensation committee of the board of directors set Mr. Downs’ 2021 annual base salary
to $ 340,000 .
Scientific Advisory Board
On July 15, 2021, our Board approved the following compensation policy
for the Scientific Advisory Board members. The Scientific Advisory board consisted of Dr. Waldemar Priebe, our founder and related party,
and Dr. Sigmond Hsu. Each scientific advisory board member shall receive annual cash compensation of $68,600. During the year ended December
31, 2022, the Company paid $ 76,087 related to the Scientific Advisory Board compensation. As of August 25, 2022, Dr. Waldemar Priebe is
no longer a member of the Scientific Advisory Board. As of December 31, 2022, the Company has accrued $100,134 related to Mr. Hsu’s
Scientific Advisory Board compensation.
WP744 Portfolio (Berubicin)
On November 21, 2017, the Company entered into a Collaboration and
Asset Purchase Agreement with Reata Pharmaceuticals, Inc. (“Reata”). Through this agreement, the Company purchased all of
Reata’s rights, title, interest and previously conducted research and development results in the chemical compound commonly known
as Berubicin. In exchange for these rights, the Company agreed to pay Reata an amount equal to 2.25% of the net sales of Berubicin for
a period of 10 years from the Company’s first commercial sale of Berubicin plus $10,000. Reata also agreed to collaborate with the
Company on the development of Berubicin, from time to time.
60
On December 28, 2017, the Company entered into a Technology Rights and
Development Agreement with Houston Pharmaceuticals, Inc. (“HPI”). HPI is affiliated with Dr. Waldemar Priebe, our founder.
Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound commonly known as WP744. In exchange
for these rights, the Company agreed to pay consideration to HPI as follows: (i) a royalty of 2% of net sales of any product utilizing
WP744 for a period of ten years after the first commercial sale of such; and (ii) $100,000 upon beginning Phase II clinical trials (paid
in 2021); and (iii) $200,000 upon the approval by the FDA of a New Drug Application for any product utilizing WP744; and (iv) a series
of quarterly development payments totaling $750,000 beginning immediately after the Company’s raise of $7,000,000 of investment
capital. In addition, the Company issued 6,667 shares of the Company’s common stock valued at $1.35 per share to HPI upon execution
of the agreement. On November 13, 2019, the Company closed its IPO, thereby fulfilling all conditions precedent and completing the acquisition
of the intellectual property discussed in the HPI agreement. During the years ended December 31, 2022 and 2021, the Company recognized
$ 275,000 and $ 450,000 related to this agreement, respectively. Unrelated to this agreement, from time to time, the Company purchases pharmaceutical
products from HPI which are necessary for the manufacturing of Berubicin API and drug product in related party transactions which are
reviewed and approved by the Company’s audit committee based upon the standards of providing superior pricing and time to delivery
than that available from unrelated third parties. During the years ended December 31, 2022 and 2021, the Company expensed $ 41,075 and
$ 441,075 respectively related to the purchase of pharmaceutical products from HPI.
On August 30, 2018, we entered into a sublicense agreement with WPD Pharmaceuticals,
Inc. (“WPD”). Pursuant to the agreement, the Company granted WPD an exclusive sublicense, even as to us, for the patent rights
we licensed pursuant to the HPI License within the following countries: Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova,
Romania, Bulgaria, Serbia, Macedonia, Albania, Armenia, Azerbaijan, Georgia, Montenegro, Bosnia, Croatia, Slovenia, Slovakia, Czech Republic,
Hungary, Chechnya, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Greece, Austria, and Russia. The sublicense agreement
provides that WPD must use commercially reasonable development efforts to attempt to develop and commercialize licensed products in the
above mentioned territories, which means the expenditure of at least $2.0 million on the development, testing, regulatory approval or
commercialization of the licensed products during the three year period immediately following the date of the sublicense agreement. In
the event that WPD fails to use commercially reasonable development efforts by the foregoing three-year deadline, we have the right to
terminate this sublicense agreement. As of December 31, 2021, the Company has received reports of the WPD expenditures related to this
agreement, has conducted due inquiry into validating those expenditures, and has determined that WPD has exercised commercially reasonable
development efforts and has therefore fulfilled the terms of the agreement necessary to secure their rights under the sublicense in perpetuity
subject to the ongoing obligations of the sublicense. In consideration for the rights granted under the sublicense agreement, to the extent
we are required to make any payments to HPI pursuant to the HPI License as a result of this sublicense agreement, WPD agreed to advance
us such payments, and to pay us a royalty equal to 1% of such payments. WPD is a Polish corporation that is majority-owned by an entity
controlled by Dr. Priebe, our founder.
On February 19, 2021, CNS entered into an Investigational Medicinal
Product Supply Agreement with WPD, a related party. CNS agreed to sell the Berubicin drug product to WPD at historical cost of
manufacturing without markup so that WPD may conduct the clinical trials contemplated by the sublicense agreement. WPD agreed to pay
CNS the following payments: (i) an upfront payment of $131,073 upon
execution of the agreement, (ii) a payment of $262,145
upon final batch release and certification performed by WPD's subcontractor, and (iii) a final payment of $262,145 upon
Clinical Trial Application acceptance by the relevant regulatory authority. All three milestones have been met as of December 31,
2021. In addition, as of December 31, 2021, the drug product with a cost of approximately $ 655,000
has been delivered to WPD and is being held at a third party depot. As such, the full amount of approximately $655,000 is due from
WPD. As of December 31, 2021, CNS has invoiced the three amounts plus pass through cost for a total of $ 656,938 . As of December 31,
2022, the Company has received payments for the first and second amounts due for a total of $ 393,182
and has entered into a settlement agreement whereby WPD agreed to return 168 vials (approximately 40% of the total) to us in
settlement of the final amount owed. On October 24, 2022, the Company received confirmation from our third party depot service
provider that the vials had been transferred into our inventory. As such, this matter is now fully resolved.
61
On November 21, 2022, CNS entered into an Investigational Medicinal
Product Supply Agreement with Pomeranian Medical University (“PUM”) in Szczecin, Poland. CNS agreed to sell berubicin hydrochloride
drug product (and related reference standards) to PUM at a discount to the historical cost of manufacturing so that PUM may conduct an
investigator-initiated clinical trial of Berubicin in CNS lymphomas. PUM agreed to pay CNS the following payments: (i) PLN 5,870.27 upon
delivery of 2 vials each of berubicin and berubicinol reference standards, (ii) PLN 873,201.00 upon delivery of a first batch of 150 berubicin
drug product vials, and (iii) PLN 873,201.00 upon delivery of a second batch of 150 berubicin drug product vials. As of December
31, 2022, the reference standards had been delivered and were recognized in Accounts Receivable and as a reduction to research & development
expense. As of March 29, 2023, the first batch of berubicin drug product vials have been ordered but not yet delivered.
On August 31, 2018, the Company entered into a sublicense agreement with
Animal Life Sciences, LLC (“ALI”), a related party, pursuant to which we granted ALI an exclusive sublicense, even as to us,
for the patent rights we licensed pursuant to the HPI License solely for the treatment of cancer in non-human animals through any type
of administration. In consideration for the rights granted under the sublicense agreement, ALI agreed to issue us membership interests
in ALI equal to 1.52% of the outstanding ALI membership interests. As additional consideration for the rights granted, to the extent we
are required to make any payments to HPI pursuant to the HPI License as a result of this sublicense agreement, ALI agreed to advance us
such payments, and to pay us a royalty equal to 1% of such payments. Dr. Waldemar Priebe, our founder, is also the founder and a shareholder
of ALI, holds 38% of the membership interests of ALI.
On June 10, 2020, the FDA granted Orphan Drug Designation (“ODD”)
for Berubicin for the treatment of malignant gliomas. ODD from the FDA is available for drugs targeting diseases with less than 200,000
cases per year. ODD may enable market exclusivity of 7 years from the date of approval of a NDA in the United States. During that period
the FDA generally could not approve another product containing the same drug for the same designated indication. Orphan drug exclusivity
will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient
for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing
a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand. The ODD now constitutes
our primary intellectual property protections although the Company is exploring if there are other patents that could be filed related
to Berubicin to extend additional protections.
On July 24, 2021, the Company received Fast Track Designation from the
FDA for Berubicin. Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need.
WP1244 Portfolio
On January 10, 2020, Company entered into a Patent and Technology License
Agreement (“Agreement”) with The Board of Regents of The University of Texas System, an agency of the State of Texas, on behalf
of The University of Texas M. D. Anderson Cancer Center (“UTMDACC”). Pursuant to the Agreement, the Company obtained a royalty-bearing,
worldwide, exclusive license to certain intellectual property rights, including patent rights, related to the Company’s recently
announced WP1244 drug technology. In consideration, the Company must make payments to UTMDACC including an up-front license fee, annual
maintenance fee, milestone payments and royalty payments (including minimum annual royalties) on sales of licensed products developed
under the Agreement. The term of the Agreement expires on the last to occur of: (a) the expiration of all patents subject to the Agreement,
or (b) fifteen years after execution; provided that UTMDACC has the right to terminate this Agreement in the event that the Company fails
to meet certain commercial diligence milestones. The commercial diligence milestones are as follows (i) initiated PC toxicology to support
filing of Investigational New Drug Application (“IND”) or New Drug Application (“NDA”) for the Licensed Product
within the eighteen (18) month period following the Effective Date (ii) file and IND for the Licensed Product within three (3) year period
following the Effective Date and (iii) Commencement of Phase I Study within the five (5) year period following the Effective Date. During
the years ended December 31, 2022 and 2021, the Company paid $ 58,222 and $ 48,668 , respectively.
On May 7, 2020, pursuant to the WP1244 Portfolio license agreement described
above, the Company entered into a Sponsored Research Agreement with UTMDACC to perform research relating to novel anticancer agents targeting
CNS malignancies. The Company agreed to fund approximately $1,134,000 over a two-year period. During the year ended December 31, 2020,
the Company paid $ 334,000 and accrued $ 400,000 related to this agreement in research and development expenses in the Company’s Consolidated
Statements of Operations. During the year ended December 31, 2021, the Company paid $ 800,000 to UTMDACC related to this agreement.
The Company has no further payment obligations as of December 31, 2021. This agreement was extended and now expires on March 31, 2023.
The principal investigator for this agreement is Dr. Waldemar Priebe, our founder.
62
Anti-Viral Portfolio
On March 20, 2020, the Company entered into a Development Agreement (“Agreement”) with WPD Pharmaceuticals (“WPD”),
a company founded by Dr. Waldemar Priebe, the founder of the Company. Pursuant to the Agreement, WPD agreed to use its commercially reasonable
efforts in good faith to develop and commercialize certain products that WPD had previously sublicensed, solely in the field of pharmaceutical
drug products for the treatment of any viral infection in humans, with a goal of eventual approval of in certain territories consisting
of: Germany, Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Romania, Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary,
Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland,
Finland, Luxembourg, Iceland.
Pursuant to the Agreement, the Company agreed to pay WPD the
following payments: (i) an upfront payment of $ 225,000
to WPD (paid in April 2020); and (ii) within thirty days of the verified achievement of the Phase II Milestone, (such verification
shall be conducted by an independent third party mutually acceptable to the parties hereto), the Company will make a payment of
$ 775,000 to WPD. WPD agreed
to pay the Company a development fee of 50% of the net sales for any products in the above territories; provided that Poland shall
not be included as a territory after WPD receives marketing approval for a product in one-half of the countries included in the
agreed upon territories or upon the payment by WPD to the Company of development fees of $1.0
million. The term of the Agreement will expire on the expiration of the sublicense pursuant to which WPD has originally sublicensed
the products.
Nasdaq Capital Markets Listing Qualifications
On February 18, 2022, the Company received a deficiency letter from the
Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive
business days the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued
inclusion in Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). The deficiency letter
does not result in the immediate delisting of the Company’s common stock from Nasdaq.
The Company was initially provided an initial period of 180 calendar days,
or until August 17, 2022, to regain compliance with the Bid Price Rule. The Company was granted a second 180 calendar day period, or until
February 13, 2023, to regain compliance since it met the continued listing requirement for market value of publicly held shares and all
other initial listing standards required by Nasdaq, except for the minimum bid price requirement.
On November 28, 2022, the Company’s Board of Directors effected a
one-for-thirty (1:30) reverse stock split of the Company’s common stock pursuant to such
authority granted by the Company’s stockholders at the Company’s annual meeting of stockholders completed on August 25, 2022.
On December 13, 2022, the Company received a letter from Nasdaq notifying the Company that it had regained compliance with Bid Price Rule
5550(a)(2) as a result of the closing bid price of the Company’s common stock being at $1.00 per share or greater for the 10 consecutive
business days from November 29, 2022 through December 12, 2022. Accordingly, the Company is in compliance with the Bid Price Rule and
Nasdaq considers the matter closed.
63
Note 7 – Income Taxes
The Company is subject to United States federal income taxes at an approximate
rate of 21 %. The reconciliation of the provision for income taxes at the United States federal statutory rate compared to the Company’s
income tax expense as reported is as follows:
Schedule of Effective Income Tax Rate Reconciliation
Year Ended
Year Ended
December 31,
December 31,
2022
2021
Income tax benefit computed at the statutory rate
$ 3,206,000
$ 3,042,000
Tax effect of:
True-ups and non-deductible expenses
( 194,000 )
( 100,000 )
Change in valuation allowance
( 3,012,000 )
( 2,942,000 )
Provision for income taxes
$ –
$ –
Significant components of the Company’s deferred tax assets and liabilities
after applying enacted corporate income tax rates are as follows:
Schedule of Deferred Tax Assets
As of
As of
December 31,
December 31,
2022
2021
Deferred income tax assets
Net operating losses
$ 8,603,000
$ 5,860,000
Stock-based compensation
715,000
533,000
Deferred income tax liability
Prepaid expenses
( 628,000 )
( 715,000 )
Valuation allowance
( 8,690,000 )
( 5,678,000 )
Net deferred income tax assets
$ –
$ –
As of December 31, 2022, the Company has an operating loss carry
forward of approximately $ 40,966,000 ,
which expires commencing in 2037.
Note 8 – Subsequent Events
Subsequent to December 31, 2022, a total of 609,000
Pre-Funded Warrants (exercisable into one share of common stock at a price per share of $0.001) were exercised by investors in the financing
completed on November 30, 2022.
On March 29, 2023, the Board of Directors approved,
based upon the recommendation of the Compensation Committee, cash bonuses totaling $550,750 to the officers of the Company. In addition,
the officers were awarded a total of 29,988 Options that partially vest over 4 years, partially vest upon the Company’s common stock
price exceeding various closing prices ranging from $6.00 - $24.00 per share.
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Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures.
None.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.