CNS Pharmaceuticals, Inc. 10-Q
Table of Contents
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2025
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________ to
______________
Commission file number: 001-39126
CNS Pharmaceuticals, Inc.
(Name of registrant as specified in its charter)
Nevada
82-2318545
(State or other jurisdiction of Incorporation or Organization)
(I.R.S. Employer identification No.)
2100 West Loop South , Suite 900
Houston , Texas
77027
(Address of principal executive offices
(Zip Code)
800 - 946-9185
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address and former fiscal
year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol
Name of Each Exchange on Which Registered
Common Stock
CNSP
The NASDAQ Stock Market LLC
Indicate by check mark whether the registrant (1) filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No
☐
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth
company” in Rule 12b-2 of the Exchange Act:
Large accelerated Filer ☐
Accelerated Filer ☐
Non-accelerated Filer ☒
Smaller reporting company ☒
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of the registrant’s common stock,
par value $0.001 per share, as of May 15, 2025 was 5,461,951 .
TABLE OF CONTENTS
Page
PART I FINANCIAL INFORMATION
Item 1.
Financial Statements
3
Balance Sheets as of March 31, 2025 and December 31, 2024 (unaudited)
3
Statements of Operations for the three months ended March 31, 2025 and 2024 (unaudited)
4
Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2025 and 2024 (unaudited)
5
Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (unaudited)
6
Notes to the Financial Statements (unaudited)
7
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations
14
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
19
Item 4.
Controls and Procedures
20
PART II OTHER INFORMATION
Item 1.
Legal Proceedings
21
Item 1A.
Risk Factors
21
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
21
Item 3.
Defaults Upon Senior Securities
21
Item 4.
Mine Safety Disclosures
21
Item 5.
Other Information
21
Item 6.
Exhibits
22
Signatures
23
2
PART I - FINANCIAL INFORMATION
ITEM 1.
FINANCIAL STATEMENTS
CNS Pharmaceuticals, Inc.
Balance Sheets
(Unaudited)
March 31, 2025
December 31,
2024
Assets
Current Assets:
Cash and cash equivalents
$ 13,047,592
$ 6,461,378
Deferred offering costs
20,637
20,637
Subscription receivable
–
882,539
Prepaid expenses and other current assets
653,797
1,293,954
Total current assets
13,722,026
8,658,508
Noncurrent Assets:
Prepaid expenses, net of current portion
22,384
36,430
Property and equipment, net
4,905
6,005
Total noncurrent assets
27,289
42,435
Total Assets
$ 13,749,315
$ 8,700,943
Liabilities and Stockholders' Equity (Deficit)
Current Liabilities:
Accounts payable and accrued expenses
$ 2,568,520
$ 2,198,260
Notes payable
210,673
326,072
Total current liabilities
2,779,193
2,524,332
Total Liabilities
2,779,193
2,524,332
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 2,944,381 and 1,413,556 shares issued and outstanding, respectively
2,945
1,414
Additional paid-in capital
99,693,201
90,599,901
Accumulated deficit
( 88,726,024 )
( 84,424,704 )
Total Stockholders' Equity (Deficit)
10,970,122
6,176,611
Total Liabilities and Stockholders' Equity (Deficit)
$ 13,749,315
$ 8,700,943
See accompanying notes to the unaudited financial
statements.
3
CNS Pharmaceuticals, Inc.
Statements of Operations
(Unaudited)
Three Months Ended
Three Months Ended
March 31, 2025
March 31, 2024
Operating expenses:
General and administrative
$ 1,094,755
$ 1,114,442
Research and development
3,242,905
2,430,412
Total operating expenses
4,337,660
3,544,854
Loss from operations
( 4,337,660 )
( 3,544,854 )
Other income (expenses):
Interest income
42,548
6,731
Interest expense
( 6,208 )
( 6,625 )
Total other income (expense)
36,340
106
Net loss
$ ( 4,301,320 )
$ ( 3,544,748 )
Loss per share - basic
$ ( 1.58 )
$ ( 1,020.48 )
Loss per share - diluted
$ ( 1.58 )
$ ( 1,020.48 )
Weighted average shares outstanding - basic
2,726,636
3,474
Weighted average shares outstanding - diluted
2,726,636
3,474
See accompanying notes to the unaudited financial
statements.
4
CNS Pharmaceuticals, Inc.
Statements of Stockholders' Equity (Deficit)
For the three months ended March 31, 2025 and
2024
(Unaudited)
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders'
Shares
Amount
Capital
Deficit
Equity (Deficit)
Balance December 31, 2024
1,413,556
$ 1,414
$ 90,599,901
$ ( 84,424,704 )
$ 6,176,611
Common stock issued for cash, net
1,530,985
1,531
9,031,490
–
9,033,021
Stock cancelled during stock split rounding
( 160 )
–
( 557 )
–
( 557 )
Stock-based compensation
–
–
62,367
–
62,367
Net loss
–
–
–
( 4,301,320 )
( 4,301,320 )
Balance, March 31, 2025
2,944,381
$ 2,945
$ 99,693,201
$ ( 88,726,024 )
$ 10,970,122
Balance December 31, 2023
2,486
$ 2
$ 65,134,786
$ ( 69,566,903 )
$ ( 4,432,115 )
Common stock issued for cash, net
886
1
3,330,999
–
3,331,000
Exercise of warrants
895
1
12,404
–
12,405
Stock-based compensation
–
–
202,933
–
202,933
Net loss
–
–
–
( 3,544,748 )
( 3,544,748 )
Balance, March 31, 2024
4,267
$ 4
$ 68,681,122
$ ( 73,111,651 )
$ ( 4,430,525 )
See accompanying notes to the unaudited financial
statements.
5
CNS Pharmaceuticals, Inc.
Statements of Cash Flows
(Unaudited)
Three Months Ended
Three Months Ended
March 31, 2025
March 31, 2024
Cash Flows from Operating Activities:
Net loss
$ ( 4,301,320 )
$ ( 3,544,748 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
62,367
202,933
Depreciation
1,100
818
Gain on disposal of fixed assets
–
( 190 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
623,163
102,994
Accounts payable and accrued expenses
372,783
46,136
Net cash used in operating activities
( 3,241,907 )
( 3,192,057 )
Cash Flows from Financing Activities:
Payments on notes payable
( 86,882 )
( 87,702 )
Proceeds from exercise of warrants
–
12,405
Payments to stockholders for stock split round
( 557 )
–
Proceeds from subscription receivable
882,539
–
Proceeds from equity issuance
9,033,021
3,533,859
Net cash provided by financing activities
9,828,121
3,458,562
Net change in cash and cash equivalents
6,586,214
266,505
Cash and cash equivalents, at beginning of period
6,461,378
548,721
Cash and cash equivalents, at end of period
$ 13,047,592
$ 815,226
Supplemental disclosures of cash flow information:
Cash paid for interest
$ 6,208
$ 6,625
Cash paid for income taxes
$ –
$ –
Supplemental disclosure of non-cash investing and financing activities:
Prepaid insurance financed with note payable
$ 31,040
$ –
Reclassification of deferred offering costs to equity
$ –
$ 202,859
See accompanying notes to the unaudited financial
statements.
6
CNS Pharmaceuticals, Inc.
Notes to the Financial Statements
(Unaudited)
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 a 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 a 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
Basis of Presentation - The accompanying unaudited financial
statements of the Company have been prepared in accordance with accounting principles generally accepted in the United Stated of America
(“U.S. GAAP”) for interim unaudited financial information. Accordingly, they do not include all of the information and footnotes
required by generally accepted accounting principles for complete financial statements. The unaudited financial statements include all
adjustments (consisting of normal recurring adjustments) which are, in the opinion of management, necessary in order to make the condensed
financial statements not misleading. Operating results for the three months ended March 31, 2025 are not necessarily indicative of the
final results that may be expected for the year ending December 31, 2025. For more complete financial information, these unaudited financial
statements should be read in conjunction with the audited financial statements for the period ended December 31, 2024 included in our
Form 10-K filed with the SEC on March 31, 2025 (“Form 10-K”). Notes to the financial statements which would substantially
duplicate the disclosures contained in the audited financial statements for the most recent fiscal period, as reported in the Form 10-K,
have been omitted.
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 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.
7
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 as of March 31, 2025 was $ 12,797,592 . 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.
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 for stock options and restricted stock units.
Restricted Stock Units (“RSUs”) - Our RSUs vest over
two to 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 March 31, 2025, 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 March 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 15,969 common shares, unvested restricted stock units of 6 common shares, unvested performance
units of 19 and options for 162 common shares, respectively.
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.
Note 3 – Note Payable
On November 18, 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 March 31, 2025 the Company’s
note payable balance was $ 210,673 .
8
Note 4 – Equity
The Company has authorized 300,000,000 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 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.
Common Stock
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 (which amount includes $6.4 million remaining from the $30.2 million set forth
above). During the period ended March 31, 2025, the Company has sold 1,530,985 shares of common stock pursuant to the AGP ATM Sales Agreement
for net proceeds of approximately $ 9 million. As of March 31, 2025, the Company has sold 2,522,758 shares of common stock pursuant to
the AGP ATM Sales Agreement for net proceeds of approximately $ 22.8 million.
9
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.
During the three months ended March 31, 2025 and 2024, the Company
recognized $ 44,943 and $ 192,375 of stock-based compensation, respectively, related to outstanding stock options. At March 31, 2025, the
Company had $ 50,646 of unrecognized expenses related to outstanding options.
The following table summarizes
the stock option activity for the three months ended March 31, 2025:
Schedule of stock option activity
Options
Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2024
270
$ 33,000.37
Granted
–
–
Exercised
–
–
Forfeited
–
–
Expired
–
–
Outstanding, March 31, 2025
270
$ 33,000.37
Exercisable, March 31, 2025
181
$ 48,631.52
As of March 31, 2025, the outstanding stock options have a weighted
average remaining term of 7.91 years and no aggregate intrinsic value. As of March 31, 2025, there were no awards remaining to be issued
under the 2017 Plan and 27 shares of common stock remaining to be issued under the 2020 Plan.
Stock Warrants
The following table summarizes the stock warrant
activity for the three months ended March 31, 2025:
Schedule of stock warrant
activity
Warrants
Weighted-Average Exercise Price Per Share
Outstanding, December 31, 2024
59,579
$ 465.88
Granted
–
–
Exercised
–
–
Forfeited
–
–
Expired
–
–
Outstanding, March 31, 2025
59,579
$ 465.88
Exercisable, March 31, 2025
59,579
$ 465.88
10
As of March 31, 2025, the outstanding and exercisable warrants have
a weighted average remaining term of 3.85 years and had no aggregate intrinsic value.
Restricted Stock Units
During the three months ended March 31, 2025,
the Company recognized $ 17,424 of stock-based compensation, related to outstanding stock RSUs. At March 31, 2025, the Company had $ 50,851
of unrecognized expenses related to outstanding RSUs.
The following table summarizes
the RSUs activity for the three months ended March 31, 2025:
Schedule of RSUs activity
RSUs
Weighted-Average Grant Date Fair Value
Non-vested, December 31, 2024
114
$ 1,932.55
Granted
–
–
Vested
–
–
Forfeited
–
–
Non-vested, March 31, 2025
114
$ 1,932.55
Performance Units
During the three months ended March 31, 2025,
the Company recognized $ 0 related to outstanding stock PUs. At March 31, 2025, the Company had $ 0 of unrecognized expenses related
to PUs.
The following table summarizes
the PUs activity for the three months ended March 31, 2025:
Schedule of PUs activity
PUs
Weighted-Average Grant Date Fair Value
Non-vested, December 31, 2024
5
$ 9,750.00
Granted
–
–
Vested
–
–
Cancelled
–
–
Non-vested, March 31, 2025
5
$ 9,750.00
11
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 February 6, 2021, the compensation committee of the board of directors set Mr. Climaco’s 2021 annual base salary
to $ 525,000 . On March 6, 2025, the compensation committee of the board of directors set Mr. Climaco’s annual base salary to $ 580,000 ,
retroactive to January 1, 2025.
On June 28, 2019, we entered into employment letters with Drs. Silberman
and Picker. 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 January 1, 2025, Dr. Silberman agreed to commit 100% of her time to our matters. On March 11, 2025, the compensation committee of the
board of directors set Drs. Silberman and Picker annual base salaries to $ 495,000 and $ 120,000 , respectively, retroactive to January 1,
2025.
In March 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
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 Dr. Sigmond
Hsu. Under this compensation policy, each scientific advisory board member was to receive annual cash compensation of $68,600. As of
August 25, 2022, Dr. Waldemar Priebe was no longer a member of the Scientific Advisory Board. On March 14, 2024, the Board of Directors
terminated the cash compensation program for the Scientific Advisory Board. As of March 31, 2025, the Company has accrued $ 177,309 related
to Mr. Hsu’s Scientific Advisory Board compensation.
12
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. During the
year ended December 31, 2024, the Company issued 11,468 Shares with a fair value of $ 596,303 pursuant to the Cortice Agreement. As of
March 31, 2025, there were no accruals related to the milestone payments.
Note 6 – Subsequent Events
On May 13, 2025, the Company entered into a placement agency
agreement (the “Placement Agency Agreement”) with A.G.P./Alliance Global Partners (the “Placement Agent”) for
the public offering by the Company of (i) 325,000 shares of the Company’s common stock (ii) pre-funded warrants to purchase 3,627,570
shares of common stock (the “Pre-Funded Warrants”); and (iii) Series F Warrants to purchase up to an aggregate of 3,952,570
shares of Common Stock (the “Common Warrants”). The combined purchase price of one share of common stock and one accompanying
Common Warrant was $1.265 and the combined purchase price of one Pre-Funded Warrant and one accompanying Common Warrant was $1.264. In
connection with the Offering, the Company entered into a Securities Purchase Agreement with the institutional investor that participated
in the Offering. The gross proceeds to the Company from the Offering were approximately $5.0 million, before deducting the Placement
Agent fees and other estimated offering expenses payable by the Company.
On May 14, 2025, the Company received $2,193 in net cash proceeds from
the exercise of 2,192,570 Pre-Funded Warrants with an exercise price of $0.001.
13
ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing
elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks
and uncertainties. See Item 1A. “Risk Factors” of our Form 10-K for the year ended December 31, 2024, available on the Security
and Exchange Commission's (“SEC”) EDGAR website at www.sec.gov, for a discussion of the uncertainties, risks and assumptions
associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking
statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
We make forward-looking statements under the “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this Form 10-Q. In some cases,
you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,”
“could,” “expect,” “plan,” “anticipate,” “intend,” “believe,”
“estimate,” “predict,” “potential” or “continue,” and the negative of these terms and
other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions
about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business.
These statements are only predictions based on our current expectations and projections about future events. There are important factors
that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity,
performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks
and uncertainties described under Item 1A. “Risk Factors” of our Form 10-K for the year ended December 31, 2024 and in other
filings made by us from time to time with the SEC.
While we believe we have identified material risks,
these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors that could adversely
impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks
and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact
of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially
from those contained in any forward-looking statements.
Although we believe the expectations reflected
in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements.
Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking
statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend
to do so.
Forward-looking statements include, but are not
limited to, statements about:
·
our ability to maintain our listing on the Nasdaq Capital Market;
·
our ability to obtain additional funding to develop our product candidates;
14
·
the need to obtain regulatory approval of our product candidates;
·
the success of our clinical trials through all phases of clinical development;
·
compliance with obligations under intellectual property licenses with third parties;
·
any delays in regulatory review and approval of product candidates in clinical development;
·
our ability to commercialize our product candidates;
·
market acceptance of our product candidates;
·
competition from existing products or new products that may emerge;
·
potential product liability claims;
·
our dependency on third-party manufacturers to supply or manufacture our products;
·
our ability to establish or maintain collaborations, licensing or other arrangements;
·
our ability and third parties’ abilities to protect intellectual property rights;
·
our ability to adequately support future growth; and
·
our ability to attract and retain key personnel to manage our business effectively.
We caution you not to place undue reliance on the
forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this
Form 10-Q.
You should not rely upon forward-looking statements
as predictions of future events. Our actual results and financial condition may differ materially from those indicated in the forward-looking
statements. We qualify all of our forward-looking statements by these cautionary statements. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Therefore, you should not rely on any of the forward-looking statements. In addition, with respect to all of our forward-looking statements,
we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of
1995.
Overview
We are a clinical pharmaceutical company organized
as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment of brain and central
nervous system tumors, based on intellectual property that we license under license agreements with Cortice Biosciences, Inc. (“Cortice”)
and own pursuant to a collaboration and asset purchase agreement with Reata Pharmaceuticals, Inc. (“Reata”).
15
We believe our drug candidates, TPI 287 and Berubicin,
may be significant developments in the treatment of Glioblastoma and other CNS malignancies, and if approved by the U.S. Food and Drug
Administration (“FDA”), could give Glioblastoma patients important new therapeutic alternatives to the current standard of
care. Glioblastomas are tumors that arise from astrocytes, which are star-shaped cells making up the supportive tissue of the brain. These
tumors are usually highly malignant (cancerous) because the cells reproduce quickly, and they are supported by a large network of blood
vessels. Berubicin is an anthracycline, which is a class of drugs that are among the most powerful and extensively used chemotherapy drugs
known. TPI 287 is an abeotaxane, and is related to the family of common chemotherapy drugs known as taxanes. Based on limited clinical
and preclinical data, we believe TPI 287 is the first taxane that appears to cross the blood brain barrier (“BBB”) in significant
concentrations targeting brain cancer cells. Based on clinical and preclinical data, Berubicin is the first anthracycline that appears
to cross the BBB in significant concentrations targeting brain cancer cells. While our focus is currently on the development of TPI 287
and Berubicin, we are also in the process of attempting to secure intellectual property rights to additional compounds that we plan to
develop into drugs to treat CNS and other cancers.
TPI 287 has been granted Orphan Drug Designation
(“ODD”) status by the FDA. 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 New Drug Application (“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 strengthens our intellectual property protections although the Company is exploring if there are other patents that could
be filed related to TPI 287 to extend additional protections.
TPI 287 is an abeotaxane and is an investigational
chemotherapy agent classified as a third-generation taxane derivative. It was developed to address some of the limitations of earlier
taxanes like paclitaxel (Taxol) and docetaxel (Taxotere), particularly issues related to drug resistance and poor penetration of the BBB.
As a synthetic, lipophilic compound, TPI 287 is designed to be brain-penetrant, potentially allowing it to reach CNS tumors more effectively
than its predecessors. Like other taxanes, TPI 287’s mechanism of action is to stabilize microtubules, which disrupts cell division
and induces apoptosis. However, one of its notable advantages is its reduced susceptibility to drug efflux pumps such as P-glycoprotein
(P-gp), a common mechanism by which cancer cells develop resistance to chemotherapy. This feature gives TPI 287 potential utility in treating
drug-resistant cancers in the CNS.
TPI 287 has been studied in early-phase clinical
trials (Phase I and II) in over 300 patients for several indications, including Glioblastoma, metastatic breast cancer with brain metastases,
non-small cell lung cancer (“NSCLC”), castration-resistant prostate cancer, and neuroblastoma. TPI 287 represents a promising
candidate for treating cancers involving the CNS, as well as those that have become resistant to traditional taxane therapies. While it
has shown promise in limited clinical trials, further clinical development is necessary to determine its future in neuro-oncology.
Berubicin was discovered at The University of Texas
M.D. Anderson Cancer Center (“UTMDACC”) by Dr. Waldemar Priebe, the founder of the Company. Through a series of transactions,
Berubicin was initially licensed to Reata. Reata initiated several Phase I clinical trials with Berubicin for CNS malignancies, one of
which was for malignant gliomas, but subsequently allowed their Investigational New Drug (“IND”) with the FDA to lapse for
strategic reasons. This required us to obtain a new IND for Berubicin before beginning further clinical trials. On December 17, 2020,
we announced that our IND application with the FDA for Berubicin for the treatment of Glioblastoma Multiforme was in effect. We initiated
this trial for patient enrollment during the second quarter of 2021 with the first patient dosed during the third quarter of 2021 to investigate
the efficacy of Berubicin in adults with Glioblastoma Multiforme who have failed first-line therapy. The first patient on the trial was
treated during the third quarter of 2021. Correspondence between the Company and the FDA resulted in modifications to our initial trial
design, including designating overall survival (OS) as the primary endpoint of the study. OS is a rigorous endpoint that the FDA has recognized
as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
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On March 25, 2025, CNS released topline data from
a primary analysis of a clinical trial being conducted to evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme
who have failed primary treatment for their disease. The trial, compares the efficacy of Berubicin to that of Lomustine, a current standard
of care in this setting, with a 2 to 1 randomization of the 252 patients to Berubicin or Lomustine. Patients receiving Berubicin were
administered a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily for three consecutive days followed by 18 days off (a 21-day
cycle). Lomustine is administered orally once every six weeks. The trial design included a pre-planned, non-binding interim futility analysis.
We reached the criteria required by the study protocol to conduct this interim futility analysis, which an independent Data Safety Monitoring
Board (“DSMB”) was responsible for conducting. The DSMB’s charter mandated that they review the primary endpoint, Overall
Survival, as well as secondary endpoints and safety data to determine whether the efficacy data for the risk-benefit profile warrants
modification or discontinuation of the study. On December 18, 2023, we released the DSMB’s recommendation which was to continue
the study without modification. The recently released topline data showed that although Berubicin produced clinically relevant outcomes
that appear to be comparable (although the trial was not powered to determine non-inferiority) to Lomustine across multiple endpoints,
it did not demonstrate a statistically significant difference in overall survival, the primary endpoint. Nevertheless, given the dearth
of alternative approved therapies for GBM, we believe Berubicin has demonstrated potential value as a possible treatment for Glioblastoma.
As such we are currently evaluating whether any potential paths forward exist for the program. Any such path will be planned and executed
in consultation with the FDA. Even if Berubicin is approved, there is no assurance that patients will choose an infusion treatment, as
compared to the current standard of care, which requires oral administration.
We do not have manufacturing facilities and all
manufacturing activities are contracted out to third parties. Additionally, we do not have a sales organization.
On November 21, 2017, we entered into a Collaboration
and Asset Purchase Agreement with Reata (the “Reata Agreement”). Pursuant to the Reata Agreement we purchased all of Reata’s
intellectual property and development data regarding Berubicin, including all trade secrets, knowhow, confidential information and other
intellectual property rights.
On December 28, 2017, we obtained the rights to
a worldwide, exclusive royalty-bearing, license to the chemical compound commonly known as Berubicin from Houston Pharmaceuticals, Inc.
(“HPI”) in an agreement we refer to as the HPI License. HPI is affiliated with our founder, Dr. Priebe. Under the HPI License
we obtained the exclusive right to develop certain chemical compounds for use in the treatment of cancer anywhere in the world. In the
HPI License we agreed to pay HPI: (i) development fees of $750,000 over a three-year period beginning November 2019; (ii) a 2% royalty
on net sales; (iii) a $50,000 per year license fee; (iv) milestone payments of $100,000 upon the commencement of a Phase II trial and
$1.0 million upon the approval of a New Drug Application (“NDA”) for Berubicin; and (v) 3 shares of our common stock. The
patents we licensed from HPI expired in March 2020. On March 23, 2025, the Company terminated the HPI License.
On June 10, 2020, the FDA granted Orphan Drug Designation
for Berubicin for the treatment of malignant gliomas. The ODD now constitutes our primary intellectual property protections related to
Berubicin although the Company is exploring other patents that could be filed related to Berubicin to extend additional protections. We
believe we have all rights and intellectual property necessary to develop Berubicin. As stated earlier, it is our plan to obtain additional
intellectual property covering other compounds which, subject to the receipt of additional financing, may be developed into drugs for
brain and other cancers.
On July 29, 2024, we entered into an Exclusive
License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice Biosciences, Inc. (“Cortice”)
pursuant to which Cortice granted us 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.
17
Results of Operations for the Three Months Ended March 31, 2025
Compared to the Three Months Ended March 31, 2024
General and Administrative Expense
General and administrative expense was approximately
$1,095,000 for the three months ended March 31, 2025 compared to approximately $1,114,000 for the comparable period in 2024. The decrease
in general and administrative expense was attributable to increases of approximately $76,000 in legal and professional expenses, $54,000
in compensation expense, $80,000 in travel expenses, and $13,000 in other expenses, which were offset by decreases of approximately $120,000
in stock-based compensation, $103,000 in marketing, advertising expenses and $19,000 in insurance expense.
Research and Development Expense
Research and development expense was approximately
$3,243,000 for the three months ended March 31, 2025 compared to approximately $2,430,000 for the comparable period in 2024. The increase
in research and development expenses during the period were mainly attributed to the costs of data clean-up, preparation and analysis
for the topline primary data release on the Berubicin trial.
Net Loss
The net loss for the three months ended March 31,
2025 was approximately $4,301,000 compared to approximately $3,545,000 for the comparable period in 2024. The change in net loss is attributable
to license expenses related to the Cortice Agreements entered in July 29, 2024 as well as the costs of data preparation and analysis for
the topline data release on the Berubicin trial.
Liquidity and Capital Resources
On March 31, 2025, we had cash of approximately
$13,048,000 and we had a working capital of approximately $10,943,000. We fund our operations from proceeds from equity sales.
On July 26, 2024, we entered into a Sales Agreement
(the “AGP ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”). During the period ended March 31,
2025, we sold 1,530,985 shares of common stock pursuant to the Agreement for net proceeds of approximately $9 million. As of March 31,
2025, we had sold 2,522,758 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $22.8 million.
Subsequent to March 31, 2025, on May 13, 2025,
the Company completed a public offering with net proceeds to the Company of approximately $4.5 million,
Including the capital raised in the public offering
on May 13, 2025, we estimate that we have sufficient capital to take us into the second half of 2026. At that point, we expect to have
already initiated a trial of TPI 287, as well as completed the Berubicin trial including its final analysis. In addition, we have working
capital to fund our operations during the intervening period (with such operations estimated at $4.5 to $5.0 million per annum). We do
not currently have a firm trial design for TPI 287 so estimates of development cost are not available, however, regardless of trial design,
the cost of bringing TPI 287 to regulatory approval for marketing will require significant additional financing. The timing and costs
of clinical trials are difficult to predict and as such the foregoing estimates may prove to be inaccurate. We have no commitments for
such additional needed financing and will likely be required to raise such financing through the sale of additional equity or debt securities.
18
We will need to raise significant
additional capital in the future in order to meet our future obligations and execute our business plan. If we are unable to raise sufficient
funds, we will be required to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our
business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan
will be successful and if it is not successful we may need to cease operations entirely.
Summary of Cash Flows
Cash used in operating activities
Net cash used in operating activities was approximately
$3,242,000 and $3,192,000 for the three months ended March 31, 2025 and 2024, respectively, and mainly included payments made for clinical
trial costs, officer compensation, insurance, marketing and professional fees to our consultants, attorneys and accountants.
Cash provided by financing activities
Net cash provided by financing activities was approximately
$9,828,000 for the three months ended March 31, 2025, related to the sale of common stock, which were offset by the repayment of notes
payable. Net cash provided by financing activities was approximately $3,459,000 for the three months ended March 31, 2024, related to
the sale of common stock and exercise of warrants, which were offset by the repayment of notes payable.
Off-balance Sheet Arrangements
As of March 31, 2025, we did not have any relationships
with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities,
established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Purchase Commitments
We do not have any material commitments for capital
expenditures, although we are required to pay certain milestones fees to Reata and Cortice as described in the section “Overview”
above.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity
with accounting principles generally accepted in the United States of America requires management to make estimates, assumptions and judgments
that affect the amounts reported in the financial statements, including the notes thereto. As a result, management is required to routinely
make judgments and estimates about the effects of matters that are inherently uncertain. Actual results may differ from these estimates
under different conditions or assumptions. Management determined there were no critical accounting estimates.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by
Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
19
Item 4.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures and
Changes in Internal Control over Financial Reporting
We maintain a set of disclosure controls and procedures
designed to ensure that material information required to be disclosed in our filings under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the SEC’s rules and forms and that material information is accumulated and communicated
to our management, including our chief executive officer, who serves as our principal executive officer, and our chief financial officer,
who serves as our principal financial officer, as appropriate, to allow timely decisions regarding required disclosures.
Under the supervision, and with the participation
of our management, including our chief executive officer and our chief financial officer, we conducted an evaluation of the effectiveness,
as of March 31, 2025, of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934, as amended, or the Exchange Act. Disclosure controls and procedures include, without limitation, controls
and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and
principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Based upon such evaluation, our chief executive
officer and our chief financial officer have concluded that, as of March 31, 2025, our disclosure controls and procedures were, and continue
to be, ineffective because of the material weaknesses in our internal control over financial reporting due to lack of segregation of duties
(resulting from the limited number of personnel available), limited access to timely and complete information regarding the status of
costs incurred in the activation of investigational sites and costs from treating patients in our study which is a result of the use of
a third-party Contract Research Organization (“CRO”) to manage the study, and the lack of formal documentation of our control
environment. Management is commencing actions to address the lack of formal documentation of our control environment, although this will
not address the lack of segregation of duties. Management is also working with the CRO to improve the timeliness and completeness of the
data reported to the Company to address this material weakness, as well as conducting increased analytical analysis of such data to be
performed by the Company.
In light of the material weakness described above,
we continue to perform additional analysis and other post-closing procedures to ensure our financial statements are prepared in accordance
with GAAP. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our
financial condition, results of operations and cash flows for the periods presented. Additional experienced personnel will be hired in
the accounting and finance department, appropriate consultants will be retained, and our accounting system will be upgraded as soon as
it becomes economically feasible and sustainable.
Other than as described above, there has been no
change in our internal control over financial reporting during our most recent calendar quarter that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
20
PART II - OTHER INFORMATION
Item 1.
Legal Proceedings
From time to time in the ordinary course of our
business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently
unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant
amounts of management time and result in diversion of significant resources. We are not able to estimate an aggregate amount or range
of reasonably possible losses for those legal matters for which losses are not probable and estimable. We have insurance policies covering
potential losses where such coverage is cost effective.
We are not at this time involved
in any legal proceedings.
Item 1A.
Risk Factors
In addition to the other information set forth
in this report, you should carefully consider the factors set forth in the section entitled “Risk Factors” in our 2024 Annual
Report on Form 10-K, filed with the SEC, which are incorporated herein by reference. The risks described in such reports are not
the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial
also may materially adversely affect our business, financial condition and/or operating results.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
We have not issued any unregistered securities
during the quarter ended March 31, 2025.
Item 3.
Defaults Upon Senior Securities
None.
Item 4.
Mine Safety Disclosures
Not applicable.
Item 5.
Other Information
During the period covered by this Quarterly Report,
none of the Company’s directors or executive officers has adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule
10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).
21
Item 6.
Exhibits
INDEX TO EXHIBITS
Exhibit
Number
Description
31.1*
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
31.2*
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
32.1*(1)
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*(1)
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover Page Interactive Data File (formatted in iXBRL, and included in exhibit 101).
______________
*
Filed herewith.
(1)
The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
22
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CNS PHARMACEUTICALS, INC.
SIGNATURE
TITLE
DATE
/s/ John Climaco
Chief Executive Officer and Director
May 15, 2025
John Climaco
(principal executive officer)
/s/ Christopher Downs
Chief Financial Officer
May 15, 2025
Christopher Downs
(principal financial and accounting officer)
23
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.