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 )
42
Balance Sheets as of December 31, 2024 and 2023
43
Statements of Operations for the years ended December 31, 2024 and 2023
44
Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2024 and 2023
45
Statements of Cash Flows for the years ended December 31, 2024 and 2023
46
Notes to Financial Statements
47
41
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, 2024 and 2023, and the related statements of operations,
stockholders’ equity (deficit), 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, 2024 and 2023, 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 2 to the financial statements, the Company
has suffered recurring losses from operations that raises 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 audits 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, 2025
42
CNS Pharmaceuticals, Inc.
Balance Sheets
December 31,
2024
December 31,
2023
Assets
Current Assets:
Cash and cash equivalents
$ 6,461,378
$ 548,721
Deferred offering costs
20,637
202,859
Subscription receivable
882,539
–
Prepaid expenses and other current assets
1,293,954
839,590
Total current assets
8,658,508
1,591,170
Noncurrent Assets:
Prepaid expenses, net of current portion
36,430
104,750
Property and equipment, net
6,005
4,933
Total noncurrent assets
42,435
109,683
Total Assets
$ 8,700,943
$ 1,700,853
Liabilities and Stockholders' Equity (Deficit)
Current Liabilities:
Accounts payable and accrued expenses
$ 2,198,260
$ 5,832,162
Notes payable
326,072
300,806
Total current liabilities
2,524,332
6,132,968
Total Liabilities
2,524,332
6,132,968
Commitments and contingencies
–
–
Stockholders' Equity (Deficit):
Preferred stock, $ 0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding
–
–
Common stock, $ 0.001 par value, 300,000,000 shares authorized and 1,413,556 and 2,486 shares issued and outstanding, respectively
1,414
2
Additional paid-in capital
90,599,901
65,134,786
Accumulated deficit
( 84,424,704 )
( 69,566,903 )
Total Stockholders' Equity (Deficit)
6,176,611
( 4,432,115 )
Total Liabilities and Stockholders' Equity (Deficit)
$ 8,700,943
$ 1,700,853
See accompanying notes to the financial statements.
43
CNS Pharmaceuticals, Inc.
Statements of Operations
Year ended
Year ended
December 31, 2024
December 31, 2023
Operating expenses:
General and administrative
$ 5,611,800
$ 4,769,502
Research and development
9,290,143
14,095,606
Total operating expenses
14,901,943
18,865,108
Loss from operations
( 14,901,943 )
( 18,865,108 )
Other income (expenses):
Interest income
60,262
27,687
Interest expense
( 16,120 )
( 13,805 )
Total other income (expense)
44,142
13,882
Net loss
$ ( 14,857,801 )
$ ( 18,851,226 )
Loss per share - basic
$ ( 38.87 )
$ ( 12,509.11 )
Loss per share - diluted
$ ( 38.87 )
$ ( 12,509.11 )
Weighted average shares outstanding - basic
382,241
1,507
Weighted average shares outstanding - diluted
382,241
1,507
See accompanying notes to the financial statements.
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CNS Pharmaceuticals, Inc.
Statements of Stockholders' Equity (Deficit)
For the years ended December 31, 2024 and 2023
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders'
Equity
Shares
Amount
Capital
Deficit
(Deficit)
Balance December 31, 2022
636
$ 1
$ 58,848,532
$ ( 50,715,677 )
$ 8,132,856
Common stock issued for cash, net
342
–
2,317,599
–
2,317,599
Exercise of warrants
1,507
1
2,961,238
–
2,961,239
Stock-based compensation
1
–
1,007,417
–
1,007,417
Net loss
–
–
–
( 18,851,226 )
( 18,851,226 )
Balance December 31, 2023
2,486
2
65,134,786
( 69,566,903 )
( 4,432,115 )
Common stock issued for cash and warrants, net
1,113,242
1,114
24,008,828
–
24,009,942
Exercise of warrants, net
284,006
284
21,041
–
21,325
Stock-based compensation
–
–
838,957
–
838,957
Shares issued for license agreement
11,468
12
596,291
–
596,303
Stock issued for stock split rounding
2,354
2
( 2 )
–
–
Net loss
–
–
–
( 14,857,801 )
( 14,857,801 )
Balance December 31, 2024
1,413,556
$ 1,414
$ 90,599,901
$ ( 84,424,704 )
$ 6,176,611
See accompanying notes to the financial statements.
45
CNS Pharmaceuticals, Inc.
Statements of Cash Flows
Years Ended
Years Ended
December 31, 2024
December 31, 2023
Cash Flows from Operating Activities:
Net loss
$ ( 14,857,801 )
$ ( 18,851,226 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
838,957
1,007,417
Depreciation
3,306
4,134
Common stock issued for license agreement
596,303
–
Loss on disposal of fixed assets
( 190 )
498
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 59,972 )
2,377,275
Accounts payable and accrued expenses
( 3,633,902 )
1,321,871
Net cash used in operating activities
( 17,113,299 )
( 14,140,031 )
Cash Flows from Investing Activities:
Purchase of property and equipment
( 4,188 )
( 3,901 )
Net cash used in investing activities
( 4,188 )
( 3,901 )
Cash Flows from Financing Activities:
Payments of deferred offering costs
( 66,750 )
( 202,859 )
Payments on notes payable
( 300,806 )
( 438,733 )
Proceeds from exercise of warrants
21,325
2,961,239
Proceeds from sale of common stock
23,376,375
2,317,599
Net cash provided by financing activities
23,030,144
4,637,246
Net change in cash and cash equivalents
5,912,657
( 9,506,686 )
Cash and cash equivalents, at beginning of period
548,721
10,055,407
Cash and cash equivalents, at end of period
$ 6,461,378
$ 548,721
Supplemental disclosures of cash flow information:
Cash paid for interest
$ 13,599
$ 13,805
Cash paid for income taxes
$ –
$ –
Supplemental disclosure of non-cash investing and financing activities:
Prepaid expense financed with note payable
$ 326,072
$ 329,571
Reclassification of deferred offering costs to equity
248,972
–
Common stock issued for subscription receivable
882,539
–
Stock issued for stock split rounding
2
–
See accompanying notes to the financial statements.
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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 April 30, 2024, 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-50. The reverse stock split became effective on June 4, 2024 on a 1-for-50 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.
On November 26, 2024, 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-50. The reverse stock split became effective on February 21, 2025 on a 1-for-50 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 – 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 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, combined with aggressive working
capital management, will allow us to continue operating Within one year after the date that the financial statements are issued. 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.
47
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, 2023 was $ 6,211,378 . 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.
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. The 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.
48
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
two or 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, 2024, the Company’s potentially
dilutive shares and options, which were not included in the calculation of net loss per share, included warrants to purchase 59,579 common
shares, unvested restricted stock units of 114 common shares, unvested performance units of 5 and options for 270 common shares, respectively.
As of December 31, 2023, the Company’s potentially dilutive shares and options, which were not included in the calculation of net
loss per share, included warrants to purchase 1,732 common shares, unvested restricted stock units of 6 common shares, unvested performance
units of 19 and options for 157 common shares, respectively.
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.
Segments
Reporting
The Company manages its operations as a
single segment for the purpose of assessing performance and making operating decisions. The Company’s Chief Operating Decision
Maker (“CODM”) is its Chief Executive Officer. The CODM allocates resources and evaluates the performance of the Company
using information about combined net income from operations. All significant operating decisions are based upon an analysis of the
Company as one operating segment, which is the same as its reporting segment. See statement of operations for information
about combined net income from operations.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07,
“Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure.” The ASU updates reportable segment disclosure
requirements, primarily through requiring enhanced disclosures about significant segment expenses and information used to assess segment
performance. The amendments do not change how segments are determined, aggregated, or how thresholds are applied to determine reportable
segments. We adopted ASU No. 2023-07 during the year ended December 31, 2024.
In November 2024, the FASB issued ASU No. 2024-03, “Income Statement—Reporting
Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses” to
improve disclosures about the nature of expenses in commonly presented financial statement captions. ASU 2024-03 is effective for all
public business entities for annual reporting periods beginning after December 15, 2026, on either a prospective or retrospective basis.
Early adoption permitted. Management is currently evaluating the impact of this accounting standard update on its consolidated financial
statements and related disclosures.
49
Note 3 – Note Payable
On November 28, 2024, the Company entered into a short-term note payable
for an aggregate of $ 326,072 , bearing interest at 9.24 % per year to finance certain insurance policies. Principal and interest payments
related to the note will be repaid over an 11-month period with the final payment due on October 8, 2025 . As of December 31, 2024, the
Company’s note payable balance was $ 326,072 .
On November 28, 2023, the Company entered into a short-term note payable
for an aggregate of $ 329,571 ,
bearing interest at 9.74 %
per year to finance certain insurance policies. Principal and interest payments related to the note will be repaid over an 11-month period
with the final payment due on October
8, 2024 . As of December 31, 2024 and 2023, the Company’s note payable balance was $ 0
and $ 300,806 ,
respectively.
Note 4 – 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 May 2, 2024, the Company filed
a Certificate of Amendment to its Amended and Restated Articles of Incorporation with the Secretary of State of the State of Nevada to
increase the number of the Company’s authorized shares of common stock from 75,000,000 shares to 300,000,000 shares.
On April 30, 2024, 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-50, 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-fifty (1:50) 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 June 4, 2024 on a 1-for-50 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.
On April 30, 2024, the Company held its scheduled 2024 Annual Meeting
of Stockholders at which the Company’s stockholders approved amendments to the Company's 2020 Equity Plan (the “2020 Plan”)
including an increase in the number of shares of common stock, par value $0.001 per share, authorized for issuance under the 2020 Plan
by 1,400 shares. As amended, the number of shares of the common stock that may be issued under the 2020 Plan is 1,739 shares (this includes
the 1,400 share increase).
On November 26, 2024, 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-50, 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-fifty (1:50) 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 February 21, 2025 on a 1-for-50 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.
50
Common Stock
2024
On January 29, 2024, the Company entered into a placement agency agreement
with A.G.P./Alliance Global Partners (“AGP”) and Maxim Group LLC (“Maxim” and collectively with AGP, the “Placement
Agents”) (the “Placement Agreement”) for the public offering by the Company of (i) 889 shares (the “Shares”)
of the Company’s common stock, par value $0.001 per share (the “Common Stock”) (ii) pre-funded warrants to purchase
4,448 shares of Common Stock (the “Pre-Funded Warrants”); (iii) Series A Warrants to purchase up to an aggregate of 5,342
shares of Common Stock (the “Series A Warrants”); and (iv) Series B Warrants to purchase up to an aggregate of 5,342 shares
of Common Stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants)). The Common
Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”). The combined purchase price of one
share of Common Stock and accompanying Common Warrants was $750.00 and the combined purchase price of one Pre-Funded Warrant and accompanying
Common Warrants was $747.50. In connection with the offering, the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with certain institutional investors that participated in the offering. As of December 31, 2024, 4,448 of the Pre-Funded
Warrants have been exercised. The closing of the sales of these securities occurred on February 1, 2024. The net proceeds to the Company
from the offering were $ 3,331,000 , after deducting the placement agents’ fees and other offering expenses.
On June 14, 2024, the Company entered into securities purchase agreements
with institutional investors for the sale by the Company of 6,720 shares of the Company’s common stock and pre-funded warrants to
purchase 601 shares of common stock in lieu thereof (the “June 14 Pre-Funded Warrants”) in a registered direct offering. In
a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 7,321 shares
of common stock (the “June 14 Common Warrants”). The combined purchase price of one share of common stock (or pre-funded warrant
in lieu thereof) and accompanying June 14 Common Warrant was $187.50. The closing of this offering and private placement occurred on June
17, 2024.
Subject to certain ownership limitations, each of the June 14 Common
Warrants is immediately exercisable, has an exercise price of $181.00 per share, and expire five years from the date of issuance. Each
June 14 Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $0.05 (as adjusted from time to time
in accordance with the terms thereof). The gross proceeds to the Company from the offering was approximately $ 1.37 million , resulting
in net proceeds, after payment of commissions and expenses, received by the Company of $ 1,203,267 .
On June 26, 2024, the Company entered into securities purchase agreements
with institutional investors for the sale by the Company of 11,360 shares of the Company’s common stock in a registered direct offering.
In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 11,360
shares of common stock (the “June 26 Common Warrants”). The combined purchase price of one share of common stock and accompanying
June 26 Common Warrant was $122.50. The closing of the offering and private placement occurred on June 27, 2024 (the “Closing Date”).
Subject to certain ownership limitations, each of the June 26 Common
Warrants is immediately exercisable, has an exercise price of $116.00 per share, and expire five years from the date of issuance. The
June 26 Common Warrants may only be exercised on a cashless basis if there is no registration statement registering, or a prospectus contained
therein in not available for, the resale of the shares of common stock underlying the June 26 Common Warrants. The gross proceeds to the
Company from the offering were approximately $ 1.39 million resulting in net proceeds, after payment of commissions and expenses, received
by the Company of $ 1,221,146 .
On July 3, 2024, the Company entered into securities purchase agreements
with institutional investors for the sale by the Company of 28,500 shares of the Company’s common stock in a registered direct offering.
In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 28,500
shares of common stock (the “July 3 Common Warrants”). The combined purchase price of one share of common stock and accompanying
July 3 Common Warrant is $69.50. The closing of this offering and private placement occurred on July 5, 2024.
51
Subject to certain ownership limitations, each of the July 3 Common
Warrants is immediately exercisable, has an exercise price of $63.00 per share, and expire five years from the date of issuance. The gross
proceeds to the Company from the offering were approximately $ 1.98 million , before deducting the financial advisor fees and other estimated
offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Warrants. After payment
of commissions and expenses, the proceeds received by the Company was $ 1,787,000 .
On July 26, 2024, the Company entered into a Sales Agreement (the “AGP
ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the AGP ATM Sales Agreement,
the Company originally was permitted to sell from time to time through AGP, as sales agent or principal, shares of the Company’s
common stock, par value $0.001 per share with initial aggregate sales price of up to $5.2 million. On July 30, 2024, the Company increased
the aggregate sales price of common shares that may be sold under the AGP ATM Sales Agreement to $25.0 million (not including the original
$5.2 million). On March 20, 2025, the Company increased the aggregate sales price of common shares that may be sold under the AGP ATM
Sales Agreement to $43.5 million (including $6.4 million remaining from the previous increase). As of December 31, 2024, the Company has
sold 991,773 Shares pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $ 13.7 million . $ 882,539 of the net proceeds
was deposited on January 10, 2025. As of December 31, 2024, the Company recorded a subscription receivable for $ 882,539 .
On October 23, 2024, the Company entered into securities purchase agreements
with institutional investors for the sale by the Company of 74,000 shares of the Company’s common stock in a registered direct offering.
In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of 278,943
shares of common stock (the “July 3 Common Warrants”). The per share purchase price of each share of common stock was $8.50
per share and the purchase price for each Pre-Funded Warrant was $8.45 per Pre-Funded Warrant. The closing of this offering and private
placement occurred on October 23, 2024.
Subject to certain ownership limitations, each of the October 23 Common
Warrants is immediately exercisable, has an exercise price of $0.05 per share, and expire five years from the date of issuance. The gross
proceeds to the Company from the offering were approximately $ 3 million , before deducting the financial advisor fees and other estimated
offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the Common Warrants. After payment
of commissions and expenses, the proceeds received by the Company was $ 2,725,907 .
Common share issued for license agreement
On July 29, 2024, the Company entered into an Exclusive License Agreement
and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice Biosciences, Inc. (“Cortice”)
pursuant to which Cortice granted the Company an exclusive license to the intellectual property rights related to certain patents around
the compound TPI 287 in the United States, Canada, Mexico and Japan. The term of the license will expire, other than due to a breach of
the Cortice Agreements, at the end of the royalty term with respect to any licensed product in any of the included territories, which
begins upon the first commercial sale in such territory and ends on the latest of (i) ten years after such sale, (ii) the expiration of
regulatory or marketing exclusivity for such licensed product in such country, or (c) the expiration of the last to expire valid patent
claim in such country covering such licensed product.
Pursuant to the Cortice Agreements, the Company agreed to issue Cortice
11,468 shares of the Company’s common stock upon the closing of the transaction, which occurred on July 29, 2024, and 867 shares
of Company common stock upon the receipt of shareholder approval of such issuance as required by the rules of the Nasdaq Stock Market.
The Company also agreed to make milestone payments to Cortice in either cash or shares of Company common stock (at Cortice’s option)
upon: (i) meeting the primary endpoint a pivotal trial for a licensed product – either $15.0 million or 8,223 shares of Company
common stock; (ii) FDA acceptance of an New Drug Application for a licensed product – either $30.0 million or 16,446 shares of Company
common stock; (iii) the first commercial sale in the United States of a licensed product – either $45.0 million or 24,668 shares
of Company common stock; and (iv) the first commercial sale in Japan of a licensed product – either $10.0 million or 4,112 shares
of Company common stock. The Company’s obligation to pay the above milestones in Company common stock is subject to the receipt
of shareholder approval as required by the rules of the Nasdaq Stock Market. The Company also agreed to pay Cortice royalties on sales
of licensed products of between 3.0%-7.5%. Finally, to the extent Cortice is required to pay any milestone payments to the original holder
of the intellectual property rights licensed, the Company has agreed to make such payments to Cortice. As of December 31, 2024, there
were no accruals related to the milestone payments and the Company issued 11,468 Shares with a fair value of $ 596,303 pursuant to the
Cortice Agreement.
52
2023
Pursuant to the terms of the Capital on Demand™
Sales Agreement with JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC (collectively,
the “Agent”), 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, 2023, the Company sold 342 shares of common stock to
the Agent for net proceeds of $ 2,317,599 .
During the year ended December 31, 2023, the Company issued 1,497 shares
of common stock from the exercise of warrants.
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 27 shares of common stock.
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 40 shares of common stock. The 2020 Plan was amended effective as of August 9, 2023, which was approved by the Company’s
stockholders at the Company’s annual meeting on September 14, 2023. The amendment increased the 2020 Plan by 298 shares of common
stock.
2024
On January 19, 2024, the Board of Directors of the Company approved
the issuance of 5 options to Ms. Mahery as compensation for her appointment to our Board of Directors. The options have a ten-year term
at an exercise price of $ 632.50 and vest in 36 equal monthly installments succeeding the issuance date. The total fair value of these
option grants at issuance was $ 2,728 .
On April 7, 2024, the Board of Directors approved grants of 108 options
to officers, employees, and board of directors. The options have a ten-year term at an exercise price of $ 646.5 . Of the 108 options issued,
35 options vest on the first anniversary or at the time of the 2025 shareholder meeting, whichever occurs first and 73 options vest in
36 equal monthly installments over 3 years. The total fair value of these option grants at issuance was $ 58,335 .
2023
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
and an employee were awarded a total of 12 options with a ten-year term at an exercise price of $ 2,490 . Of the options issued, 50% vest
over 2 years and 50% vest upon the Company’s common stock price exceeding various closing prices ranging from $6.00 - $24.00 per
share . The total fair value of these option grants at issuance was $ 25,820 .
On May 3, 2023, the Board of Directors of the Company appointed Bettina
M. Cockroft, M.D., M.B.A as an independent member of the Company’s Board of Directors. Dr. Cockroft was granted a ten-year option
to purchase 1 share of Company common stock at an exercise price of $ 4,175 vesting in 36 equal monthly installments succeeding the issuance
date . The total fair value of these option grants at issuance was $ 3,514 .
On August 4, 2023, the Board of Directors approved the issuance of
3 options to Dr. Cockroft. The options have a ten-year term at an exercise price of $ 5,675 and vest in 36 equal monthly installments succeeding
the issuance date . The total fair value of these option grants at issuance was $ 12,771 .
53
On August 27, 2023, the Board of Directors approved the issuance of
79 options to the board of directors. The options have a ten-year term at an exercise price of $ 4,750 and vest on the first anniversary
date of issuance . The total fair value of these option grants at issuance was $ 313,846 .
During the years ended December 31, 2024 and 2023, the Company recognized
$ 684,181 and $ 949,982 of stock-based compensation, respectively, related to outstanding stock options. At December 31, 2024, the Company
had $ 94,968 of unrecognized expenses related to options.
The following table summarizes the stock option activity for the years
ended December 31, 2024 and 2023:
Schedule of stock option activity
Options
Weighted-Average Exercise Price
Per Share
Outstanding, December 31, 2022
51
$ 168,547.02
Granted
106
4,460.14
Exercised
–
–
Forfeited
–
–
Expired
–
–
Outstanding, December 31, 2023
157
56,287.36
Granted
113
645.88
Exercised
–
–
Forfeited
–
–
Expired
–
–
Outstanding, December 31, 2024
270
$ 33,000.37
Exercisable, December 31, 2024
175
$ 48,148.42
The aggregate fair value of the options measured during the years
ended December 31, 2024 and 2023 were calculated using the Black-Scholes option pricing model based on the following assumptions:
Schedule of black-scholes option assumptions
Year Ended
Year Ended
December 31, 2024
December 31, 2023
Fair value of common stock on measurement date
$632.50 to $646.50 per share
$1.00 to $2.40 per share
Risk free interest rate (1)
3.80 % to 4.39 %
3.38 % to 4.37 %
Volatility (2)
102.25 % to 118.36 %
114.13 % to 118.09 %
Dividend yield (3)
0 %
0 %
Expected term (in years)
5.5 – 6.3
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.
54
As of December 31, 2024, the outstanding stock options have a weighted
average remaining term of 8.16 years and the aggregate intrinsic value of options vested and outstanding was $ 0 . As of December 31, 2024,
there were no awards remaining to be issued under the 2017 Plan and 28 awards remaining to be issued under the 2020 Plan.
As of December 31, 2023, the outstanding stock options have a weighted
average remaining term of 8.54 years and the aggregate intrinsic value of options vested and outstanding was $ 8,217 .
Stock Warrants
The following table summarizes the stock warrant activity for the years
ended December 31, 2024 and 2023:
Warrants
Weighted-Average Exercise Price
Per Share
Outstanding, December 31, 2022
1,597
$ 8,875.44
Granted
1,544
3,220.82
Exercised
( 1,407 )
2,090.82
Forfeited
–
–
Expired
( 2 )
77,274.54
Outstanding, December 31, 2023
1,732
9,709.31
Granted
341,858
36.50
Exercised
( 284,006 )
0.13
Forfeited
–
–
Expired
( 5 )
202,500
Outstanding, December 31, 2024
59,579
$ 465.88
On October 16, 2023, the Company entered into a warrant exercise inducement
offer letter (the “Inducement Letter”) with a holder of certain existing warrants (“Holder”) to receive new warrants
to purchase up to a number of shares of common stock equal to 200% (the “Inducement Warrants”) of the number of warrant shares
issued pursuant to the exercise of such certain existing warrants to purchase shares of common stock (the “Existing Warrants”)
pursuant to which the Holder agreed to exercise for cash their Existing Warrants to purchase up to 751 shares of the Company’s common
stock, at a Reduced Exercise Price (as defined below), in exchange for the Company’s agreement to issue the Inducement Warrants
to purchase up to 1,502 shares of the Company’s common stock (the “Inducement Warrant Shares”). The Existing Warrants
consist of: (i) warrants, originally issued on December 22, 2020 and amended on December 5, 2022; (ii) warrants, originally issued on
January 10, 2022 and amended on December 5, 2022; and (iii) warrants issued on December 5, 2022. Pursuant to the Inducement Letter, the
exercise price for such Existing Warrants was reduced to $3,200 per share (the “Reduced Exercise Price”). In connection with
the warrant inducement, the Company estimated the fair value of the warrants based on the Black-Scholes option pricing model and recorded
a deemed dividend to additional paid in capital of $ 5,571,694 .
55
The aggregate fair value of the warrants measured during the year ended
December 31, 2023 were calculated using the Black-Scholes option pricing model based on the following assumptions:
Schedule of black-scholes option assumptions
Year Ended
December 31, 2023
Fair value of common stock on measurement date
$4,000 per share
Risk free interest rate (1)
4.72 %
Volatility (2)
124.66 %
Dividend yield (3)
0 %
Expected term (in years)
4.2 – 5.0
(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.
(3)
The Company does not expect to pay a dividend in the foreseeable future.
During the year ended December 31, 2024, the Company received $ 21,325
in net cash proceeds from the exercise of 4,448 warrants issued at an exercise price of $2.5, 14 warrants issued at an exercise price
of $750 and 279,944 warrants issued at an exercise price of $0.05. As of December 31, 2024, the remaining weighted average term for the
outstanding stock warrant is 4.09 years.
During the year ended December 31, 2023, the Company received $ 2,961,239
in net cash proceeds from the exercise of 753 warrants issued at an exercise price of $3,200, 96 warrants issued at an exercise price
of $7,575 and 650 warrants previously issued at an exercise price of $2.5.
As of December 31, 2023 the outstanding and exercisable warrants have
a weighted average remaining term of 4.64 years and an intrinsic value of $ 15,245 .
Restricted Stock Units
On April 7, 2024, the Board of Directors approved grants of 108 RSUs
to officers, employees, and board of directors. Of the 108 RSUs issued, 35 RSUs vest on the first anniversary or at the time of the 2025
shareholder meeting, whichever occurs first and 73 RSUs vest in 8 equal quarterly installments over 2 years. The Company valued the RSUs
based on the stock price at grant which total $ 58,335 .
During the years ended December 31, 2024 and 2023, the Company recognized
$ 54,414 and $ 23,850 of stock-based compensation, related to outstanding RSUs, respectively. At December 31, 2024, the Company had $ 68,275
of unrecognized expenses related to outstanding RSUs.
56
The following table summarizes the RSUs activity
for the years ended December 31, 2024 and 2023:
Schedule of RSUs activity
RSUs
Weighted-Average
Grant Date
Fair Value
Non-vested, December 31, 2022
–
$ –
Granted
6
25,050.00
Vested
–
–
Forfeited
–
–
Non-vested, December 31, 2023
6
25,050.00
Granted
108
648.25
Vested
–
–
Forfeited
–
–
Non-vested, December 31, 2024
114
$ 1,932.55
Performance Units
During the years ended December 31, 2024 and 2023, the Company recognized
$ 100,362 and $ 33,585 related to outstanding stock PUs, respectively. At December 31, 2024, the Company had $ 0 of unrecognized expenses
related to PUs.
The following table summarizes the PUs activity
for the years ended December 31, 2024 and 2023:
Schedule of PUs activity
PUs
Weighted-Average
Grant Date
Fair Value
Non-vested, December 31, 2022
19
$ 14,581.58
Granted
–
–
Vested
–
–
Forfeited
–
–
Non-vested, December 31, 2023
19
14,581.58
Granted
–
–
Vested
( 6 )
25,050.00
Forfeited
( 8 )
9,750.00
Non-vested, December 31, 2024
5
$ 9,750.00
57
Note 5 – 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 March 6, 2025, the compensation committee of the board of directors set Mr. Climaco’s annual base salary to
$ 580,000 .
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 March 6, 2025, the compensation committee of the board of directors set Drs. Silberman and Picker annual base
salaries to $ 247,000 and $ 120,000 , respectively.
In March 2024, the Board of Directors approved, based upon the recommendation
of the Compensation Committee, cash bonuses totaling $ 240,608 to the officers of the Company payable upon completion of a subsequent round
of financing and a determination by the Board that such financing is sufficient for the Company's needs after payment of such bonus.
On March 6, 2025, the Board of Directors approved, based upon the recommendation
of the Compensation Committee, cash bonuses totaling $ 631,243 to the officers of the Company.
Scientific Advisory Board
The Scientific Advisory board is consisted of one member, Dr. Sigmond
Hsu. Dr. Hsu receives annual cash compensation of $68,600. As of December 31, 2024 and 2023, the Company has accrued $ 177,309 and $ 168,734 ,
respectively, for 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.
58
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 3 shares of the Company’s common stock valued at $3,375 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, 2024 and 2023, the Company recognized
$ 50,000 and $ 50,000 , respectively, related to this agreement. 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. During the years ended December 31, 2024
and 2023, the Company expensed $ 0 related to the purchase of pharmaceutical products from HPI. This agreement was terminated March 23,
2025.
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 and was affiliated with
Dr. Priebe. This agreement was terminated March 23, 2025.
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 upon
delivery of 2 vials each of berubicin and berubicinol reference standards, (ii) PLN 873,201 upon delivery of a first batch of 150 berubicin
drug product vials, and (iii) PLN 873,201 upon delivery of a second batch of 150 berubicin drug product vials. As of December 31, 2022,
the reference standards were delivered, and the Company recognized $ 1,302 in accounts receivable and as a reduction to research and development
expense. In April 2023, the first batch of berubicin drug product vials were delivered, and the Company recognized $ 196,303 in accounts
receivable and as a reduction to research and development expense. As of December 31, 2023, the outstanding accounts receivable balance
of $ 197,605 was collected in full.
On August 31, 2018, the Company entered into a sublicense agreement
with Animal Life Sciences, LLC (“ALI”), 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 was an affiliate of ALI. This agreement was terminated March 23,
2025.
59
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 an 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 (the “WP1244 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 WP1244 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 WP1244 Agreement. The term of the WP1244 Agreement expires on the last to occur of: (a) the expiration
of all patents subject to the WP1244 Agreement, or (b) fifteen years after execution; provided that UTMDACC has the right to terminate
this WP1244 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. The Company has not met the commercial diligence milestones and has not paid the annual
maintenance fee required as of the date hereof. On May 25, 2024 the WP1244 Agreement was terminated. There are no termination penalty
provisions in the Agreement. During the year ended December 31, 2024 and 2023, the Company paid $ 52,537 and $ 55,092 , respectively.
Cortice Biosciences, Inc. Exclusive License Agreement
On July 29, 2024, the Company entered into an Exclusive License Agreement
with Cortice Biosciences, Inc. (“Cortice”) pursuant to which Cortice granted the Company an exclusive license to the intellectual
property rights related to certain patents around the compound TPI 287 in the United States, Canada, Mexico and Japan. The term of the
license will expire, other than due to a breach of the Cortice Agreements, at the end of the royalty term with respect to any licensed
product in any of the included territories, which begins upon the first commercial sale in such territory and ends on the latest of (i)
ten years after such sale, (ii) the expiration of regulatory or marketing exclusivity for such licensed product in such country, or (c)
the expiration of the last to expire valid patent claim in such country covering such licensed product. Pursuant to the Cortice Agreements,
the Company agreed to issue Cortice 11,468 shares of the Company’s common stock upon the closing of the transaction, which occurred
on July 29, 2024, and 867 shares of Company common stock upon the receipt of shareholder approval of such issuance as required by the
rules of the Nasdaq Stock Market. The Company also agreed to make milestone payments to Cortice in either cash or shares of Company common
stock (at Cortice’s option) upon: (i) meeting the primary endpoint a pivotal trial for a licensed product – either $15.0 million
or 8,223 shares of Company common stock; (ii) FDA acceptance of an New Drug Application for a licensed product – either $30.0 million
or 16,446 shares of Company common stock; (iii) the first commercial sale in the United States of a licensed product – either $45.0
million or 24,668 shares of Company common stock; and (iv) the first commercial sale in Japan of a licensed product – either $10.0
million or 4,112 shares of Company common stock. The Company’s obligation to pay the above milestones in Company common stock is
subject to the receipt of shareholder approval as required by the rules of the Nasdaq Stock Market. The Company also agreed to pay Cortice
royalties on sales of licensed products of between 3.0%-7.5%. Finally, to the extent Cortice is required to pay any milestone payments
to the original holder of the intellectual property rights licensed, the Company has agreed to make such payments to Cortice. As of December
31, 2024, there were no accruals related to the milestone payments and the Company issued 11,468 Shares with a fair value of $ 596,303
pursuant to the Cortice Agreement.
60
Note 6 – 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,
2024
2023
Income tax benefit computed at the statutory rate
$ 3,120,000
$ 3,959,000
Tax effect of:
True-ups and non-deductible expenses
( 585,000 )
118,000
Change in valuation allowance
( 2,535,000 )
( 4,077,000 )
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,
2024
2023
Deferred income tax assets
Net operating losses
$ 7,923,000
$ 6,672,000
Stock-based compensation
999,000
873,000
Capitalized 174 expenses
6,659,000
5,420,000
Deferred income tax liability
Prepaid expenses
( 279,000 )
( 198,000 )
Valuation allowance
( 15,302,000 )
( 12,767,000 )
Net deferred income tax assets
$ –
$ –
As of December 31, 2024, the Company currently has net operating loss
carryforwards of approximately $ 37,727,000 . Approximately $200,000 of the net operating loss carryforward will begin to expire in 2037.
The remaining net operating loss carryforward post-2017 may be carried forward indefinitely.
The Tax Reform Act of 1986 limits the use of net operating loss carryforwards
in certain situations where changes occur in the stock ownership of a company. In the event that the Company has a change in ownership,
utilization of carryforwards could be limited.
Note 7 – Subsequent Events
On November 26, 2024, the stockholders of the Company approved the
granting to the Company’s board of directors of the discretion to effect the reverse stock split at a ratio in the range of 1-for-2
to 1-for-50. Upon the approval of the Company’s board of directors, The reverse stock split became effective on February 21, 2025
on a 1-for-50 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.
On March 11, 2025, the Company approved the issuance of options to
purchase 263,537 shares of common stock to the management group, subject to approval of an increase in the Company’s equity plan
by the Company’s shareholders. Each of the options will vest as follows: (i) 50% on the six month anniversary of the issuance date;
(ii) 25% on the 12 month anniversary of the issuance date; and (iii) 25% on the 18 month anniversary of the issuance date. The exercise
price of the option is $2.50, the closing price on the date of the Board’s approval of the compensation plan.
On March 20, 2025, the Company increased the aggregate sales price
of common shares that may be sold under the AGP ATM Sales Agreement to $43.5 million. Subsequent to December 31, 2024, the Company
has sold 1,530,985 Shares pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $9.9 million.
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Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures.
None.