Item 1. Financial Statements
Item 1. Financial Statements
PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31,
2025
December 31,
2024
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 5,341,278
$ 6,922,729
Prepaid expenses
621,208
302,641
Other current assets
162,454
142,945
Total current assets
6,124,940
7,368,315
Property and equipment, net
117,522
122,343
Intangibles, net
7,153,609
7,311,150
Goodwill
1,262,911
1,262,911
Total assets
$ 14,658,982
$ 16,064,719
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$ 1,325,925
$ 1,119,871
Financed director and officer insurance premiums
268,969
-
Total current liabilities
1,594,894
1,119,871
Non-current liabilities
Warrant liabilities
85,305
162,172
Total non-current liabilities
85,305
162,172
Total liabilities
1,680,199
1,282,043
Stockholders’ equity:
Preferred stock, par value $ 0.0001 , 5,000,000 shares authorized; 0 issued and outstanding
-
-
Common stock, par value $ 0.0001 , 100,000,000 shares authorized; 2,705,263 and 1,394,263 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively
270
139
Additional paid-in capital
66,124,529
64,372,486
Accumulated other comprehensive loss
-
( 7,171 )
Accumulated deficit
( 53,146,016 )
( 49,582,778 )
Total stockholders’ equity
12,978,783
14,782,676
Total liabilities and stockholders’ equity
$ 14,658,982
$ 16,064,719
See accompanying notes to the unaudited condensed
consolidated financial statements.
1
PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
For the Three Months Ended March 31,
2025
2024
Operating expenses:
General and administrative
$ 1,950,328
$ 2,291,646
Research and development
1,729,851
1,749,128
Loss from operations
( 3,680,179 )
( 4,040,774 )
Other income (expense):
Change in fair value of warrant liabilities
76,867
26,716
Realized foreign currency translation loss from dissolution of subsidiaries
( 7,171 )
-
Interest and dividends, net
47,245
153,218
Other income, net
116,941
179,934
Loss before income taxes
( 3,563,238 )
( 3,860,840 )
Provision for income taxes
-
-
Net loss
$ ( 3,563,238 )
$ ( 3,860,840 )
Weighted-average common shares outstanding, basic and diluted
2,211,207
1,042,479
Basic and diluted loss per share
$ ( 1.61 )
$ ( 3.70 )
Comprehensive loss:
Net loss
$ ( 3,563,238 )
$ ( 3,860,840 )
Foreign currency translation
-
( 620 )
Comprehensive loss
$ ( 3,563,238 )
$ ( 3,861,460 )
See accompanying notes to the unaudited condensed
consolidated financial statements.
2
PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN STOCKHOLDERS’ EQUITY
(Unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Loss
Deficit
Equity
Balance at January 1, 2024
1,041,582
$ 104
$ 58,721,538
$ ( 4,652 )
$ ( 35,318,538 )
$ 23,398,452
Stock-based compensation:
-restricted stock units
1,666
-
48,088
-
-
48,088
-stock options
-
-
297,602
-
-
297,602
-warrants
-
-
787
-
-
787
Foreign currency translation
-
-
-
( 620 )
-
( 620 )
Net loss
-
-
-
-
( 3,860,840 )
( 3,860,840 )
Balance at March 31, 2024
1,043,248
$ 104
$ 59,068,015
$ ( 5,272 )
$ ( 39,179,378 )
$ 19,883,469
Balance at January 1, 2025
1,394,263
$ 139
$ 64,372,486
$ ( 7,171 )
$ ( 49,582,778 )
$ 14,782,676
Stock-based compensation:
-stock options
-
-
96,985
-
-
96,985
-warrants
-
-
1,573
-
-
1,573
Issuance of common stock at-the-market for cash, net of offering costs
440,000
44
1,652,701
-
-
1,652,745
Issuance of common stock from the exercise of pre-funded warrants, net
871,000
87
784
-
-
871
Foreign currency translation
-
-
-
7,171
-
7,171
Net loss
-
-
-
-
( 3,563,238 )
( 3,563,238 )
Balance at March 31, 2025
2,705,263
$ 270
$ 66,124,529
$ -
$ ( 53,146,016 )
$ 12,978,783
See accompanying notes to the unaudited condensed
consolidated financial statements.
3
PASITHEA THERAPEUTICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the Three Months Ended March 31,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 3,563,238 )
$ ( 3,860,840 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
4,166
4,717
Amortization expense
157,541
157,541
Stock-based compensation
98,558
346,477
Change in fair value of warrant liabilities
( 76,867 )
( 26,716 )
Loss on asset write-off
655
-
Realized foreign currency translation loss from dissolution of subsidiaries
7,171
-
Changes in operating assets and liabilities:
Prepaid expenses
129,712
( 822,507 )
Other current assets
( 19,509 )
58
Accounts payable and accrued liabilities
206,054
( 118,369 )
Lease liabilities
-
( 1,446 )
Net cash used in operating activities
( 3,055,757 )
( 4,321,085 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments on financed director and officer insurance
( 179,310 )
-
Proceeds from exercises of pre-funded warrants
871
-
Proceeds from at-the-market common stock sales
1,652,745
-
Net cash provided by financing activities
1,474,306
-
Effect of foreign currency translation on cash
-
( 620 )
NET CHANGE IN CASH
$ ( 1,581,451 )
$ ( 4,321,705 )
Cash - Beginning of period
6,922,729
16,331,052
Cash - End of period
$ 5,341,278
$ 12,009,347
Supplemental disclosure of cash flow information:
Cash paid for interest
$ 7,892
$ -
Cash paid for taxes
$ -
$ -
Supplemental disclosures of non-cash activity:
Amount due from sale of assets
$ -
$ 40,500
See accompanying notes to the unaudited condensed
consolidated financial statements.
4
PASITHEA THERAPEUTICS CORP.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2025 AND
2024
NOTE 1 – NATURE OF THE ORGANIZATION AND
BUSINESS
Pasithea Therapeutics Corp. (“Pasithea”
or the “Company”) was incorporated in the State of Delaware on May 12, 2020 and completed an Initial Public Offering (the
“Initial Public Offering”) on September 17, 2021. The Company is a clinical-stage biotechnology company focused on the discovery,
research and development of innovative treatments for central nervous system (CNS) disorders and other diseases, including RASopathies.
The Company’s primary operations (the “Therapeutics”
segment) are focused on developing the Company’s lead product candidate, PAS-004, a next-generation macrocyclic mitogen-activated
protein kinase, or MEK inhibitor that the Company believes may address the limitations and liabilities associated with existing drugs
targeting a similar mechanism of action. In December 2023, the U.S. Food and Drug Administration (the “FDA”) cleared the Company’s
Investigational New Drug application (the “IND”) for PAS-004 and the Company received a study may proceed letter from the
FDA for the Company’s Phase 1 multicenter, open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced
tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (the “FIH Phase 1 Dose Escalation
Study”). The Company is currently conducting the FIH Phase 1 Dose Escalation Study at four clinical sites in the United States and
three sites in Eastern Europe. The Company expects to complete the FIH Phase 1 Dose Escalation Study in 2026. The Company’s clinical
development plan for PAS-004 is to begin a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated
plexiform and/or cutaneous neurofibromas followed by pediatric patients and ultimately seek FDA marketing approval in these patient populations.
Additionally, the Company has two programs that
are in the discovery stage, which the Company believes address limitations in the treatment paradigm of the indications the Company plans
to address with these programs, which are currently amyotrophic lateral sclerosis (“ALS”) for PAS-003 and schizophrenia for
PAS-001.
Throughout this report, the terms “our,” “we,”
“us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Limited
(U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC (“Alpha-5”),
AlloMek Therapeutics, LLC (“AlloMek”) and Pasithea MacroMEK Pty Ltd. Pasithea Therapeutics Limited (U.K.), legally dissolved
as of January 2, 2024 was a private limited Company, registered in the United Kingdom (U.K.). Pasithea Therapeutics Portugal, Sociedade
Unipessoal Lda is a private limited Company registered in Portugal. Pasithea Clinics Inc. is incorporated in Delaware. Alpha-5 and AlloMek
are both Delaware limited liability companies. Pasithea MacroMEK Pty Ltd is registered in Australia. The operations of Pasithea Therapeutics
Limited (U.K.), Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, and Pasithea Clinics Inc. have been discontinued.
Basis of Presentation
The accompanying unaudited condensed consolidated
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”).
Emerging Growth Company
The Company is an “emerging growth company,”
as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”),
and it may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that
are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports
and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and approval
of any golden parachute payments not previously approved. Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies
from being required to comply with new or revised financial accounting standards until private companies are required to comply with the
new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period
and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company
has elected not to opt out of such extended transition period.
5
Liquidity and Capital Resources
As of March 31, 2025, the Company had approximately
$ 5.3 million of cash and cash equivalents and working capital of approximately $ 4.5 million. The Company’s major sources
of cash have been comprised of proceeds from various private and public offerings, the Initial Public Offering and the exercise of warrants. The
Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue
to execute its development plans and continue operations. Based on the foregoing, management believes that the Company will not have
sufficient working capital to meet its needs through twelve months from the date of these financial statements if additional funding cannot
be obtained.
Going Concern Uncertainty
The accompanying condensed consolidated
financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant
operating losses and negative cash flows from operations since inception. On March 31, 2025, the Company had cash and cash
equivalents of approximately $ 5.3 million and an accumulated deficit of approximately $ 53.1 million. The Company has
incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to
execute its business plans. Historically, the Company’s major sources of cash have been comprised of proceeds from various
public and private offerings of its capital stock. The Company is dependent on obtaining additional working capital funding from the
sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Without
additional funding, there is substantial doubt about the Company’s ability to continue as a going concern through twelve
months from the date of these financial statements.
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Principles of Consolidation
The Company evaluates the need to
consolidate affiliates based on standards set forth in Accounting Standards Codification (“ASC”) 810,
“Consolidation,” (“ASC 810”). The condensed consolidated financial statements include the accounts of the
Company and its wholly owned subsidiaries, Alpha-5 Integrin, LLC, AlloMek Therapeutics, LLC, Pasithea Therapeutics Limited (U.K.),
Pasithea Clinics Inc. and Pasithea MarcoMEK Pty Ltd. All significant intercompany transactions and balances have been eliminated in
consolidation.
These condensed consolidated financial statements
are presented in U.S. Dollars.
Use of Estimates
The preparation of financial statements in conformity
with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statement and the reported amounts of revenues
and expenses during the reporting period.
Making estimates requires management to
exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set
of circumstances that existed at the date of the financial statements, which management considered in formulating its estimate,
could change in the near term due to one or more future confirming events. Management regularly makes estimates related to the fair
value of warrant liabilities; the recoverability of long-lived assets; the fair values and useful lives of intangible assets
acquired in business combinations; the potential impairment of goodwill; and income taxes. The Company bases its estimates on
historical experience and on various assumptions that are believed to be reasonable, the results of which form the basis for the
amounts recorded in the condensed consolidated financial statements. As appropriate, the Company obtains reports from third-party
valuation experts to inform and support estimates related to fair value measurements.
6
Research and Development
Research and development
costs are charged to operations when incurred and are included in operating expense, except for goodwill related to intellectual
property & patents. Research and development costs consist principally of compensation of employees and consultants that perform the
Company’s research activities, payments to third parties for preclinical and non-clinical activities, costs to acquire drug product
from contract development and manufacturing organizations and third-party contractors relating to chemistry, manufacturing and controls
(“CMC”) efforts, the fees paid for and to maintain the Company’s intellectual property, and research and development
costs related to our discovery programs. Depending upon the timing of payments to the service providers, the Company recognizes prepaid
expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the
work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these
factors and adjusts estimates accordingly.
Research and development also includes contra
expense related to costs reimbursed under the Company’s grant agreement. For the three months ended March 31, 2025 and 2024, the
Company recorded grant income of $ 43,029 and zero as a contra expense within research and development, respectively.
General and Administrative
Our general and administrative expenses primarily
consist of personnel and related costs, including stock-based compensation, legal fees relating to both intellectual property and corporate
matters, accounting and audit related costs, insurance, corporate communications and public company expenses, information technology,
office and facility rents and related expenses, including depreciation, amortization and maintenance, and fees for consulting, business
development and other professional services.
Grants
In connection with the
acquisition of Alpha-5, the Company legally assumed rights under a grant agreement with FightMND, which was entered into by Alpha-5 on
September 23, 2021. FightMND supports pre-clinical research, development and assessment of therapeutics for motor neuron disease, including
ALS. Under the grant agreement, the Company is entitled to reimbursements for costs incurred for research related to its monoclonal antibody
targeting a5 b 1 integrin as a potential treatment for ALS.
Cash and Cash Equivalents
The Company considers all short-term investments
with an original maturity of three months or less when purchased to be cash equivalents, classified as trading securities. The Company
had cash equivalents of $ 4.1 million and $ 6.1 million as of March 31, 2025 and December 31, 2024, respectively.
Property and Equipment, net
Property and equipment is recorded at cost. Depreciation
is computed using straight-line and accelerated methods over the estimated useful lives of the related assets which range from three to
ten years. Expenditures that enhance the useful lives of the assets are capitalized and depreciated. Maintenance and repairs are expensed
as incurred. When properties are retired or otherwise disposed of, related costs and related accumulated depreciation are removed from
the accounts. Leasehold improvements are amortized over the shorter of the estimated useful life of those leasehold improvements and the
remaining lease term.
Warrant Liability
The Company accounts for the publicly traded
warrants issued in its Initial Public Offering (the “Public Warrants”) and the warrants issued as compensation to the
underwriters in its Initial Public Offering (the “Representative Warrants” and together with the Public Warrants, the
“IPO Warrants”) in accordance with the guidance contained in ASC 815, “Derivatives and Hedging,” under which
the IPO Warrants do not meet the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the
Company classifies the IPO Warrants as liabilities at their fair value. This liability is subject to re-measurement at each balance
sheet date until the IPO Warrants are exercised or expire, and any change in fair value is recognized in the Company’s
condensed consolidated statements of operations and comprehensive loss. The fair value of the IPO Warrants was initially measured
using a Black-Scholes pricing model. Currently, the fair value of the Public Warrants is measured using quoted market prices, and
the fair value of the Representative Warrants is based on an estimate of the relative fair value to the Public Warrants, accounting
for a small difference in the exercise price.
7
Income Taxes
The Company follows the asset and liability
method of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax assets and liabilities are recognized
for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The
effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that included the
enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be
realized. As of March 31, 2025 and December 31, 2024, respectively, the Company had deferred tax assets related to certain net
operating losses. A valuation allowance was established against these deferred tax assets at their full amount, resulting in a zero
balance of deferred tax assets on the condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024.
ASC 740 prescribes a recognition threshold and
a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax
return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities.
The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. There were no unrecognized
tax benefits and no amounts accrued for interest and penalties as of March 31, 2025 and December 31, 2024. The Company is currently not
aware of any issues under review that could result in significant payments, accruals or material deviation from its position. The Company
is subject to income tax examinations by major taxing authorities since inception.
Concentration of Credit Risk
Financial instruments that potentially subject
the Company to concentrations of credit risk consist of a cash account in a financial institution, which, at times, may exceed the Federal
Depository Insurance Coverage of $ 250,000 . As of March 31, 2025, the Company has not experienced losses on this account and management
believes the Company is not exposed to significant risks on such account.
Fair Value of Financial Instruments
With the exception of liabilities related to the
IPO Warrants, described in the table below, the fair value of the Company’s assets and liabilities, which qualify as financial instruments
under ASC 820, “Fair Value Measurements and Disclosures,” approximates the carrying amounts represented in the accompanying
balance sheet, primarily due to their short-term nature.
Fair Value Measurements
Fair value is defined as the price that would
be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement
date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives
the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
●
Level 1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;
●
Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
●
Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
8
The following table presents information
about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value
hierarchy of the valuation inputs the Company utilized to determine such fair value:
Fair value
Quoted prices in active markets for identical liabilities (Level 1)
Significant other observable inputs (Level 2)
Significant unobservable inputs (Level 3)
Assets:
Cash equivalents, March 31, 2025
$ 4,148,181
$ 4,148,181
$ -
$ -
Cash equivalents, December 31, 2024
$ 6,093,044
$ 6,093,044
$ -
$ -
Liabilities:
Public warrant liabilities, March 31, 2025
$ 80,081
$ 80,081
$ -
$ -
Representative warrant liabilities, March 31, 2025
$ 5,224
$ -
$ -
$ 5,224
Liabilities:
Public warrant liabilities, December 31, 2024
$ 152,240
$ 152,240
$ -
$ -
Representative warrant liabilities, December 31, 2024
$ 9,932
$ -
$ -
$ 9,932
The following tables present a reconciliation of the Level 3 Representative
Warrants liabilities:
Three Months Ended
March 31,
2025
2024
Representative warrant liabilities, January 1
$ 9,932
$ 5,166
Issuances
-
-
Exercises
-
-
Change in fair value
( 4,708 )
( 1,636 )
Representative warrant liabilities, March 31
$ 5,224
$ 3,530
The change in fair value of the
Representative Warrants liabilities is recorded in change in fair value of warrant liabilities on the condensed consolidated
statements of operations and comprehensive loss.
The fair value of the cash equivalents is based
on the fair value of marketable securities invested in U.S. government money market funds.
The fair value of the liability associated with
the Public Warrants as of March 31, 2025 and December 31, 2024, was based on the quoted closing price on The Nasdaq Capital Market and
is classified as Level 1. The fair value of the liability associated with the Representative Warrants as of March 31, 2025 and December
31, 2024, was based on an estimate of the relative fair value to the Public Warrants, accounting for a small difference in the exercise
price, and is classified as Level 3.
In some circumstances, the inputs used to measure
fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is
categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.
9
Net Loss Per Share
Net loss per share is computed by dividing net
loss by the weighted average number of common shares outstanding during the reporting period. Diluted earnings per share is computed similarly
to the basic earnings per share, except the weighted average number of common shares outstanding are increased to include additional shares
from the assumed exercise of share options, if dilutive. The following outstanding shares issuable upon exercise of stock options and
warrants and vesting of restricted stock units were excluded from the computation of diluted net loss per share for the periods presented
because including them would have had an anti-dilutive effect:
Three Months Ended
March 31,
2025
2024
Stock options
164,846
203,433
Warrants
3,293,692
769,300
Restricted stock units
-
2,502
Foreign Currency Translations
The Company’s functional and reporting currency
is the U.S. dollar. All transactions initiated in other currencies are translated into U.S. dollars using the exchange rate prevailing
on the date of transaction. Monetary assets and liabilities denominated in foreign currencies are translated into the U.S. dollar at the
rate of exchange in effect at the balance sheet date. Unrealized exchange gains and losses arising from such transactions are deferred
until realization and are included as a separate component of stockholders’ equity (deficit) as a component of comprehensive income
or loss. Upon realization, the amount deferred is recognized in income in the period when it is realized.
Translation of Foreign Operations
The financial results and position of foreign
operations whose functional currency is different from the Company’s presentation currency are translated as follows:
●
assets and liabilities are translated at period-end exchange rates prevailing at that reporting date;
●
equity is translated at historical exchange rates; and
●
income and expenses are translated at average exchange rates for the period.
Exchange differences arising on translation of foreign operations are transferred
directly to the Company’s accumulated other comprehensive loss in the condensed consolidated financial statements. Transaction gains
and losses arising from exchange rate fluctuation on transactions denominated in a currency other than the functional currency are included
in the condensed consolidated statements of operations and comprehensive loss. During the three months ended March 31, 2025, the Company
had no operating subsidiaries with functional currencies other than the US dollar. A loss related to the now dissolved subsidiaries which
were previously operating in functional currencies not that of the US Dollar as the parent were realized in the consolidated statements
of operations within other income (expense) in the amount of $ 7,171 .
The relevant translation rates are as follows:
As of
March 31,
2025 *
As of
December 31,
2024
Closing rate, British Pound (GBP) to $USD at period end
N/A
1.2529
Average rate, GBP to $USD for the period ended
N/A
1.2783
Closing rate, Euro (EUR) to $USD at period end
N/A
1.0355
Average rate, EUR to $USD for the period ended
N/A
1.0818
* Not applicable due to the Company
having no operating subsidiaries with functional currencies other than that of the parent company U.S. Dollar
10
Comprehensive Loss
ASC 220, “Comprehensive Income,” establishes
standards for reporting and display of comprehensive income (loss) and its components in a full set of general-purpose financial statements.
During the three months ended March 31, 2025 and 2024, the Company had no material items of other comprehensive income (loss) except for
the unrealized foreign currency translation adjustment.
Acquisitions, Intangible Assets and Goodwill
The condensed consolidated financial
statements reflect the operations of an acquired business beginning as of the date of acquisition. Assets acquired and liabilities
assumed are recorded at their fair values at the date of acquisition; goodwill is recorded for any excess of the purchase price over
the fair value of the net assets acquired. Significant judgment is required to determine the fair value of certain tangible and
intangible assets and in assigning their respective useful lives. Accordingly, we typically obtain the assistance of third-party
valuation specialists for significant tangible and intangible assets. The fair values are based on available historical information
and on future expectations and assumptions deemed reasonable by management but are inherently uncertain and could affect the
accuracy or validity of the estimates and assumptions. Determining the useful life of an intangible asset also requires judgment.
Intangible assets are amortized over their estimated lives. Any intangible assets associated with acquired in-process research and
development activities (“IPR&D”) are not amortized until a product is available for sale.
Impairment of Long-Lived Assets and Goodwill
Long-lived and amortizable intangible assets are
assessed annually for impairment or sooner should impairment indicators exist. Significant events or changes in business circumstances
indicate that the carrying value of the assets may not be recoverable. Such circumstances may include a significant decrease in the market
price of an asset, a significant adverse change in the manner in which the asset is being used or in its physical condition or a history
of operating or cash flow losses associated with the use of an asset. An impairment loss is recognized when the carrying amount of an
asset exceeds the anticipated future undiscounted cash flows expected to result from the use of the asset and its eventual disposition.
The amount of the impairment loss is the excess of the asset’s carrying value over its fair value. There were no charges related
to impairments of long-lived assets for all periods presented.
Goodwill is assessed for impairment annually during
the fourth quarter, or more frequently if impairment indicators exist. Impairment exists when the carrying amount of goodwill exceeds
its implied fair value. The Company may elect to assess goodwill for impairment using a qualitative or a quantitative approach, to determine
whether it is more likely than not that the fair value of goodwill is greater than its carrying value. There were no charges related to
goodwill impairment for all periods presented.
Leases
The Company’s has leases related to office
space. The Company determines whether a contract is or contains a lease at the time of the contract’s inception based on the presence
of identified assets and the Company’s right to obtain substantially all the economic benefit from or to direct the use of such
assets. When the Company determines a lease exists, it records a right-of-use (“ROU”) asset and corresponding lease liability
on its balance sheet. ROU assets represent the Company’s right to use an underlying asset for the lease term. Lease liabilities
represent the Company’s obligation to make lease payments arising from the lease. ROU assets are recognized at the lease commencement
date at the present value of the remaining future lease payments the Company is obligated for under the terms of the lease. Lease liabilities
are recognized concurrently with the recognition of the ROU asset and represent the present value of lease payments to be made under
the lease. These ROU assets and liabilities are adjusted for any prepayments, lease incentives received, and initial direct costs incurred.
As the discount rate implicit in the lease is not readily determinable in most of the Company’s leases, the Company uses its incremental
borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments.
If the Company’s lease terms include an option to extend the lease for a set period, the Company evaluates the renewal option and
should it be reasonably certain that the Company will exercise that option, adjusts the ROU asset and liability accordingly.
11
Stock-Based Compensation
The Company accounts for its stock-based compensation
awards to employees and members of its Board of Directors (the “Board”) in accordance with ASC Topic 718, Compensation—Stock
Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees and Board members, including grants of employee
stock options, to be recognized in the statements of operations by measuring the fair value of the award on the date of grant and recognizing
this fair value as stock-based compensation using a straight-line method over the requisite service period, generally the vesting period.
Financed Director and Officer Insurance Premiums
In January 2025, the Company finalized a financing arrangement for its
Director and Officer Insurance policy. The total amount financed was approximately $ 379,000 after a down payment of approximately $ 68,000
or a total amount of $ 447,000 . The note bears an annual interest rate of 9.2 %, to be paid over a period of twelve months. As
of March 31, 2025, the remaining payable balance on the note was approximately $ 269,000 .
Segment Information
Operating segments are defined as components of
an enterprise for which separate discrete information is available for evaluation by the Chief Operating Decision Maker (“CODM”)
or decision-making group in deciding how to allocate resources and in assessing performance. The Company views its operations and manages
its business as one operating and reporting segment, which is the business of research and development of innovative treatments for central
nervous system (CNS) disorders and other diseases, including RASopathies and certain cancers. See Note 11 Segment Information for further
information.
Recent Accounting Pronouncements
The Company does not believe that any recently
issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial
statements.
Recently
Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment
Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires incremental disclosure of segment information
on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim
periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial
statements is required for public entities. The Company adopted ASU 2023-07 as of January 1, 2024, which resulted in additional disclosures
of significant segment expenses and other segment items as well as incremental qualitative disclosures.
12
NOTE 3 – PROPERTY AND EQUIPMENT, NET
Property and equipment, net consists of the following:
As of
March 31,
2025
As of
December 31,
2024
Leasehold improvements
$ -
$ 3,193
Medical equipment
155,363
155,363
Office equipment
6,140
6,140
Property and equipment, gross
161,503
164,696
Less: accumulated depreciation
( 43,981 )
( 42,353 )
Property and equipment, net
$ 117,522
$ 122,343
Depreciation expense was $ 4,166 and $ 4,717 for the three months ended March 31,
2025 and 2024, respectively. During the three months ended March 31, 2025, the Company wrote off gross leasehold improvements of $ 3,193
and related accumulated amortization of $ 2,538 , resulting in a loss of $ 655 recorded in general and administrative in the condensed consolidated
statements of operations and comprehensive loss.
NOTE 4 – LEASES
Laboratory Lease – South San Francisco,
California
In August 2022, the Company, as a lessee, entered into an amended sublease agreement to sublease laboratory and office space in South
San Francisco, California. The lease term was from August 15, 2022 through May 15, 2024, and month-to-month through June 2024. Monthly
rent was $ 16,656 during 2024.
This lease was accounted for as an operating lease
under ASC 842, Leases, which resulted in the recognition of a right of use asset (“ROU asset”) and liability of approximately
$ 332,000 at inception. The ROU asset was separately presented as a non-current asset, and the liability is recorded as a component of
current and non-current liabilities on the Company’s Consolidated Balance Sheets. The Company discounted the future lease payments
of this lease using the prevailing collateralized lending rate which would be extended to the Company based on its credit profile relative
to the period of inception, and the duration of the lease from inception. The interest rate used in calculating the fair value listed
above was 7.8 %.
As of March 31, 2025 and December 31, 2024, the
Company had no recognized ROU assets and lease liabilities.
The following table summarizes ROU asset and lease
liability activity for the periods presented:
Three Months Ended
March 31,
2025
2024
Operating lease expense
$ -
$ 42,516
Cash paid for amounts included in the measurement of operating lease liabilities
$ -
$ -
There are no additional lease payments as of March 31, 2025.
NOTE 5 – INTANGIBLE ASSETS
Intangible assets, net consists of the following:
March 31, 2025
December 31, 2024
Gross Carrying Amount
Accumulated Amortization
Net
Gross Carrying Amount
Accumulated Amortization
Net
In-process research and development
$ 2,900,000
$ -
$ 2,900,000
$ 2,900,000
$ -
$ 2,900,000
Patents and intellectual property
5,671,478
( 1,417,869 )
4,253,609
5,671,478
( 1,260,328 )
4,411,150
Intangible assets, net
$ 8,571,478
$ ( 1,417,869 )
$ 7,153,609
$ 8,571,478
$ ( 1,260,328 )
$ 7,311,150
13
As of March 31, 2025, future expected amortization expense of Intangible
assets was as follows:
2025 (remaining)
472,623
2026
630,164
2027
630,164
2028
630,164
2029
630,164
Thereafter
1,260,330
Remaining future amortization expense
$ 4,253,609
There were no changes to goodwill for the three
months ended March 31, 2025 and 2024.
NOTE 6 – STOCKHOLDERS’ EQUITY
The Company has an aggregate of 105,000,000 authorized
shares. The authorized shares are divided into: (i) 100,000,000 shares of Common Stock having a par value of $ 0.0001 per share and (ii)
5,000,000 shares of preferred stock having a par value of $ 0.0001 per share.
Common Stock
The Company had 2,705,263 and 1,394,263 shares
of its Common Stock issued and outstanding at March 31, 2025 and December 31, 2024, respectively.
Each holder of Common Stock is entitled to one
vote for each share of Common Stock held on all matters submitted to a vote of the stockholders. Our Charter and Amended and Restated
Bylaws (the “ Bylaws ”) do not provide for cumulative voting rights.
In addition, the holders of our Common Stock will
be entitled to receive ratably such dividends, if any, as may be declared by the Board out of legally available funds; however, the current
policy of our Board is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders
of our Common Stock will be entitled to share ratably in all assets that are legally available for distribution.
Holders of our Common Stock have no preemptive,
conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights,
preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders
of shares of any series of our preferred stock that we may designate and issue in the future.
Effective January 2, 2024, the Company amended
its certificate of incorporation to effect a one-for-twenty ( 1 : 20 ) reverse stock split of our outstanding shares of Common Stock. No fractional
shares were issued as a result of the reverse stock split. Any fractional shares resulting from the reverse stock split were paid in cash.
The reverse stock split did not otherwise affect any of the rights currently accruing to holders of our Common Stock.
14
2023 Stock Incentive Plan
The Board and stockholders have adopted and approved
the 2023 Plan which took effect on December 19, 2023. The 2023 Plan allows for the issuance of securities, including stock options, restricted
stock, and restricted stock units (“RSUs”) to employees, Board members and consultants. The initial number of shares
of Common Stock available for issuance under the 2023 Plan was 125,000 shares plus 28,389 unused shares reserved under the 2021 Plan,
which will, on January 1 of each calendar year, beginning on January 1, 2024 and ending on and including January 1, 2033, unless the Board
decides otherwise, automatically increase to equal to the lessor of (A) three percent ( 3 %) of the number of shares of Common Stock outstanding
on the final day of the immediately preceding calendar year or (B) such smaller number of Shares as is determined by the Board.
On January 1, 2025, the number of shares of Common Stock available
for issuance under the 2023 Plan automatically increased by 41,828 shares. As of March 31, 2025, 254,221 total shares were available
under the 2023 Plan, of which 93,596 shares were issued and outstanding and 160,625 shares were available for potential issuances.
Total stock-based compensation related to the
Company’s stock options was $ 96,985 and $ 297,602 , respectively, for three months ended March 31, 2025 and 2024.
September
2024 Offering
On September 26, 2024, the Company entered into
a securities purchase agreement (the “ September 2024 Offering”) with an institutional
investor, pursuant to which the Company agreed to sell pre-funded warrants (“Pre-Funded Warrants”) to purchase up to an aggregate
of 1,219,513 shares of common stock at an exercise price of $ 0.001 per share, Series A warrants to purchase up to an aggregate of 1,219,513
shares of common stock at an exercise price of $ 3.85 per share, and Series B warrants (together with the Series A Warrants, the “September
2024 PIPE Warrants”) to purchase up to an aggregate of 1,219,513 shares of common Stock with an exercise price of $ 3.85 per share.
The combined purchase price per Pre-Funded Warrant and accompanying September 2024 PIPE Warrants was $ 4.099 . Aggregate gross proceeds
from the September 2024 Offering were approximately $ 4.5 million and the September 2024 Offering closed on September 30, 2024.
The Pre-Funded Warrants are exercisable immediately
upon issuance and expire when exercised in full. The Series A Warrants are exercisable immediately upon issuance and have a term of exercise
equal to five ( 5 ) years from the date of issuance. The Series B Warrants are exercisable immediately upon issuance and have a term of
exercise equal to eighteen ( 18 ) months from the date of issuance.
A holder of the Pre-Funded Warrants and the September
2024 PIPE Warrants may not exercise any portion of such holder’s Pre-Funded Warrants or September 2024 PIPE Warrants to the extent
that the holder, together with its affiliates, would beneficially own more than 4.99 % (or, at the election of the holder, 9.99 %) of the
Company’s outstanding shares of Common Stock immediately after exercise, except that upon at least 61 days’ prior notice from
the holder to the Company, the holder may increase the beneficial ownership limitation to up to 9.99 % of the number of shares of Common
Stock outstanding immediately after giving effect to the exercise. In the event of certain fundamental transactions, holders of the September
2024 PIPE Warrants will have the right to receive the Black Scholes Value of their Warrant calculated pursuant to a formula set forth
in the Warrant, payable either in cash or in the same type or form of consideration that is being offered and being paid to the holders
of Common Stock.
In connection with the September
2024 Private Placement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”),
dated as of September 26, 2024, with the investor, pursuant to which the Company agreed to prepare and file a registration statement with
the Securities and Exchange Commission (the “SEC”) registering the resale of the shares of Common Stock underlying the Pre-Funded
Warrants and the September 2024 PIPE Warrants no later than fifteen (15) days after the date of the Registration Rights Agreement (the
“Registration Statement”), and to use its best efforts to have the registration statement declared effective as promptly as
practical thereafter, and in any event no later than forty-five (45) days following the date of the Registration Rights Agreement (or
ninety (90) days following the date of the Registration Rights Agreement in the event of a “full review” by the SEC). The
Registration Statement was declared effective by the SEC on October 11, 2024.
15
The net proceeds to the Company from the September
2024 Private Placement were approximately $ 4.5 million, after deducting placement agent fees and offering expenses payable by the
Company. In addition, the Company issued to the placement agent or its designees warrants (the “Placement Agent Warrants”)
to purchase up to an aggregate of 85,366 shares of Common Stock at an exercise price equal to $ 5.125 per share. The Placement Agent Warrants
have substantially the same terms as the September 2024 PIPE Warrants, are exercisable immediately upon issuance and have a term of exercise
equal to five ( 5 ) years from the date of issuance. The Company intends to use the net proceeds received from the September
2024 Private Placement for working capital and general corporate purposes.
The September
2024 PIPE warrants met the requirement for equity classification. The Company computes the fair value of warrants and options using a Black-Scholes model.
The expected term used for warrants is the contractual life. The Company is utilizing an expected volatility figure based on a review
of the historical volatilities, over a period of time, equivalent to the expected life of the instrument being valued, of similarly positioned
public companies within its industry. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon
bonds with a remaining term consistent with the expected term of the instrument being valued.
As of March 31, 2025, all 1,219,153 of the Pre-Funded Warrants
were paid, issued and exercised. In addition, the September 2024 PIPE Warrants have not been exercised as of March 31, 2025.
Common Stock Issuances for the Three Months
Ended March 31, 2025
During the quarter ended March 31, 2025, we sold 440,000 shares
of Common Stock under our ATM Agreement at an average price of $ 3.88 for gross proceeds of $ 1,705,528 and net proceeds of $ 1,652,745 .
During the quarter ended March 31, 2025, all remaining 871,000 Pre-Funded
Warrants were exercised resulting in 871,000 shares of Common Stock being issued and there are no Pre-Funded Warrants outstanding.
Common
Stock Issuances for the Three Months Ended March 31, 2024
During the three months ended March 31, 2024,
the Company issued 1,666 shares of Common Stock due to the vesting of restricted stock units (“RSUs”) and recognized approximately
$ 48,000 of stock-based compensation expense related to its outstanding RSUs. Stock-based compensation expense related to the Company’s
RSUs is recognized within general and administrative expense on the condensed consolidated statements of operations and comprehensive
loss.
As of March 31, 2024, the remaining unamortized
RSU stock-based compensation expense was approximately $ 69,000 .
At The Market Agreement with H.C. Wainwright
On November 26, 2024, the Company entered into
an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”),
as sales agent, pursuant to which the Company may issue and sell, from time to time, through Wainwright, shares of its Common Stock, and
pursuant to which Wainwright may sell its Common Stock by any method permitted by law deemed to be an “at the market offering”
as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Wainwright a commission
of 3.0 % of the aggregate gross proceeds from each sale of Common Stock. As of December 31, 2024, the Company was authorized to offer
and sell up to $ 2,076,000 of its Common Stock pursuant to the ATM Agreement. During the quarter ended March 31, 2025, we sold 440,000
shares of Common Stock under our ATM Agreement at an average price of $ 3.88 for gross proceeds of $ 1,705,528 and net proceeds of $ 1,652,745 .
Restricted Stock Units
During the three months ended March 31, 2025 and
2024, the Company did not grant any RSUs or restricted stock awards. During the three months ended March 31, 2025 and 2024, the Company
issued a total of 0 and 4,166 shares of Common Stock, respectively, pursuant to the vesting of RSUs. The Company recognized approximately
$ 0 and $ 48,000 of stock-based compensation expense for the three months ended March 31, 2025 and 2024, respectively, in relation to the
vesting of historically granted RSUs. As of March 31, 2025, there were no outstanding RSUs and no more remaining unamortized RSU compensation
expense.
16
NOTE 7 – STOCK OPTIONS
Stock Options Issued, Vested and Cancelled
During the three months ended March
31, 2025 , the Company did not issue any stock options. During the three months ended March 31, 2025, stock options to purchase
an aggregate of 22,899 shares of Common Stock, subject to time-based milestone vesting conditions, vested.
During the three months ended March 31, 2024,
the Company issued stock options under the 2023 Plan to employees, to purchase an aggregate of 104,433 shares of Common Stock
with a strike price equal to $ 8.13 per share and a term of ten years . Of the stock options granted, stock options to purchase
an aggregate of 37,433 shares of Common Stock were fully vested at issuance and the remaining stock options are subject to time-based
vesting over a term ranging between one to three years . These stock options had a total fair value of approximately $ 657,000 , as calculated
using the Black-Scholes pricing model with the following assumptions: volatility of 88.41 %, discount rate of 4.20 %, expected
term of 6.5 years, and an exercise price of $ 8.13 .
During the three months ended March 31, 2024,
stock options to purchase an aggregate of 42,767 shares of Common Stock, subject to time-based milestone vesting conditions, vested.
Stock-Based Compensation
For the three months ended March
31, 2025 and 2024, total stock-based compensation expense related to the Company’s stock options was approximately $ 97,000 and $ 298,000 ,
respectively. For the three months ended March 31, 2025, the Company recognized approximately $ 92,000 of stock-based compensation related
to its stock options within general and administrative expense, and approximately $ 5,000 within research and development expense on
the condensed consolidated statements of operations and comprehensive loss. For the three months
ended March 31, 2024, the Company recognized approximately $ 184,000 of stock-based compensation related to its stock options within general
and administrative expense, and approximately $ 114,000 within research and development expense on the condensed consolidated statements
of operations and comprehensive loss.
The following
table summarizes the activity related to the Company’s stock options for the three months ended March 31, 2025:
Number of Options Weighted average exercise price per share Weighted average remaining contractual term (years) Aggregate intrinsic value (in thousands)
Outstanding, January 1, 2025 182,034 $ 21.17 8.98 $ -
Granted -
-
-
-
Expired/Cancelled ( 17,188 ) 9.24 -
-
Exercised -
-
-
-
Outstanding, March 31, 2025 164,846 $ 22.41 8.18 -
Exercisable, March 31, 2025 112,247 $ 28.20 7.94 $ -
As of March
31, 2025 , the remaining unamortized stock-based compensation expense related to the stock options was approximately $ 196,000 with
22 months of amortization remaining.
17
NOTE 8 – WARRANTS
As of March
31, 2025 , the fair value of the Public Warrants was approximately $ 0.364 per Public Warrant based on the closing price of the warrants
on The Nasdaq Capital Market. The fair value of the Representative Warrants was approximately $ 0.379 per Representative Warrant, which
was based on the relative fair value to the Public Warrants.
The following table summarizes the Company’s
outstanding warrants:
Exercise Price Number of warrants Weighted-average remaining contractual term (years) Weighted average exercise price
$ 3.85 2,439,026 2.76
$ 5.13 85,366 4.51
$ 8.13 1,500 8.92
$ 20.00 433,999 1.65
$ 37.60 100,001 2.38
$ 120.00 13,800 1.46
$ 125.00 220,000 1.46
3,293,692 2.55 15.62
For the
three months ended March 31, 2025 and 2024, total stock-based compensation expense related to the Company’s warrants was approximately
$ 1,573 and $ 787 , respectively, and is recognized within general and administrative expense on the condensed consolidated statements
of operations and comprehensive loss .
During the three months ended March 31, 2025,
the Company issued no warrants.
During the three months ended March 31, 2024,
the Company issued warrants to purchase an aggregate of 1,500 shares of Common Stock in exchange for consulting services. The
warrants were issued on March 1, 2024 and became exercisable in twelve equal monthly installments commencing on April 1, 2024 at $ 8.13 per
share. The warrants expire ten years from the date of issuance.
No warrants were expired/cancelled or exercised
during the three months ended March 31, 2025 and 2024 .
NOTE 9 – COMMITMENTS AND CONTINGENCIES
Legal and Regulatory Environment
The healthcare industry is subject to numerous
laws and regulations of federal, state and local governments. These laws and regulations include, but are not limited to, matters such
as licensure, accreditation, government healthcare program participation requirement, reimbursement for patient services and Medicare
and Medicaid fraud and abuse. Government activity has increased with respect to investigations and allegations concerning possible violations
of fraud and abuse statutes and regulations by healthcare providers.
Violations of these laws and regulations could
result in expulsion from government healthcare programs, together with the imposition of significant fines and penalties, as well as significant
repayments for patient services previously billed. Management believes that the Company is in compliance with fraud and abuse regulations,
as well as other applicable government laws and regulations. While no material regulatory inquiries have been made, compliance with such
laws and regulations can be subject to future government review and interpretation, as well as regulatory actions unknown or unasserted
at this time.
NOTE 10 – RELATED PARTY TRANSACTIONS
Consulting Agreement with Prof. Lawrence Steinman
The Steinman Consulting Agreement memorializes the compensation arrangements
pursuant to which Prof. Steinman has been compensated for his services to the Company, as previously disclosed in our public filings.
Pursuant to the Steinman Consulting Agreement, Prof. Steinman provides a variety of consulting and advisory services relating principally
to the clinical and commercial development of our product candidates, including our research and development strategy through all phases
of discovery and preclinical development, identifying potential partners for our pre-clinical assets, and business development efforts
related to our pre-clinical assets, among other things. Pursuant to the Steinman Consulting Agreement, Prof. Steinman receives $ 25,000 per
quarter for his services.
18
NOTE 11 – SEGMENT INFORMATION
The Company views its operations and manages its
business as one operating and reportable segment, which is the business of research and development of innovative treatments
for central nervous system (CNS) disorders and other diseases, including RASopathies and certain cancers. The determination of a single
operating segment is consistent with the consolidated financial information regularly provided to the CODM. Consistent with the operational
structure, the Chief Executive Officer, as the CODM, reviews and evaluates net loss for purposes of assessing performance, making operating
decisions, allocating resources available and how to best deploy these resources across functions, therapeutic areas and research and
development projects, and planning and forecasting for future periods on a consolidated basis. Operating expenses are used to monitor
budget versus actual results in assessing performance of the segment. Total assets are monitored by the CODM on a consolidated basis which
is reported on the face of the consolidated balance sheets. All the Company’s long-lived assets are held in the United States.
The following table is representative of the significant
expense categories regularly provided to the CODM when managing the Company’s single reporting segment. A reconciliation to
the consolidated net loss for the three months ended March 31, 2025 and 2024 is included at the bottom of the table below.
For the Three Months
Ended March
31,
Significant segment expenses
2025
2024
General and administrative (1)
$ 1,696,425
$ 1,897,719
Pre-clinical research (1)
61,993
430,384
CMC (1)
224,597
377,820
Clinical development (1)
1,434,804
826,117
Depreciation and amortization
161,708
162,257
Share based compensation expense
98,558
346,477
Other segment items (2)
2,094
-
Total operating and segment expenses
3,680,179
4,040,774
Reconciliation of net loss
Change in fair value of warrant liabilities
76,867
26,716
Realized foreign currency translation loss from dissolution of subsidiaries
( 7,171 )
-
Interest and dividends, net
47,245
153,218
Segment and consolidated net loss
$ 3,563,238
$ 3,860,840
(1) includes personnel costs and excludes
share-based compensation expense
(2) includes loss from sale of assets,
and loss on asset write offs
NOTE 12 – SUBSEQUENT EVENTS
The Company has evaluated events and transactions
subsequent to March 31, 2025 through the date these condensed consolidated financial statements were included on Form 10-Q and filed with
the SEC. During this period, the Company did not have any material reportable subsequent events, except as disclosed below.
ATM Agreement
Subsequent to the quarter ended March 31, 2025, we sold 252,600 shares
of Common Stock under our ATM Agreement at an average price of $ 1.47 for gross proceeds of $ 370,160 and net proceeds of $ 358,037 .
19
May 2025 Public Offering
On May 7, 2025, the Company closed a public offering
of 3,571,428 shares of Common Stock (or pre-funded warrants in lieu thereof) and accompanying Series C warrants to purchase up to 3,571,428
shares of Common Stock and Series D warrants to purchase up to 3,571,428 shares of Common Stock, at a combined offering price of $ 1.40
per share of Common Stock (or per pre-funded warrant in lieu thereof) and accompanying warrants. The Series C warrants have an exercise
price of $ 1.40 per share, are exercisable upon issuance and will expire five years thereafter. The Series D warrants have an exercise
price of $ 1.40 per share, are exercisable upon issuance and will expire 18 months thereafter. Additionally, in connection with the consummation
of the offering, certain investors exercised Series D warrants to purchase an aggregate of 914,286 shares of Common Stock resulting in
gross proceeds of approximately $ 1.3 million to the Company.
Total gross proceeds to the Company from the
offering were $ 5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
Aggregate gross proceeds from the offering and the exercise of the Series D warrants were approximately $ 6.3 million. The Company
intends to use the net proceeds from this offering for general corporate purposes, which includes, without limitation, ongoing
research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in
or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related
to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies
that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.
20
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.