UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2025
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from July 1, 2025 to September 30, 2025
Commission
File No. 001-42815
Curanex
Pharmaceuticals Inc
(Exact
name of registrant as specified in its charter)
Nevada
83-0741390
(State or other jurisdiction
of
(I.R.S. Employer
incorporation or organization)
Identification No.)
2 Jericho
Plaza , Suite 101B
Jericho ,
NY
11753
(Address of principal executive
offices)
(Zip Code)
(718)
673-6078
(Registrant’s telephone
number, including area code)
N/A
(Former
name, 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(s)
Name
of exchange on which registered
Common Stock, par value
$0.0001 per share
CURX
The Nasdaq Capital Market
LLC
Indicate
by check mark whether the registrant (1) has 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 ☒
As
of November 14, 2025, the registrant had 28,340,812 shares of common stock, par value $ 0.0001 per share, outstanding.
TABLE
OF CONTENTS
Page
PART I – FINANCIAL INFORMATION
4
Item 1.
Unaudited Financial Statements.
4
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
20
Item 3.
Quantitative and Qualitative Disclosures about Market Risk.
25
Item 4.
Controls and Procedures.
26
PART II – OTHER INFORMATION
26
Item 1.
Legal Proceedings.
26
Item 1A.
Risk Factors.
26
Item 2.
Unregistered Sales of Equity Securities.
26
Item 3.
Defaults Upon Senior Securities.
27
Item 4.
Mine Safety Disclosures.
27
Item 5.
Other Information.
27
Item 6.
Exhibits.
27
SIGNATURES
28
2
FORWARD-LOOKING
STATEMENTS
You
should read the following discussion and analysis of our financial condition and results of operations in conjunction with our financial
statements and the accompanying notes thereto included elsewhere in this quarterly report on Form 10-Q (the “Quarterly Report”).
This
Quarterly Report contains forward-looking statements. Forward-looking statements are based upon our current assumptions, expectations
and beliefs concerning future developments and their potential effect on our business. In some cases, you can identify forward-looking
statements by the following words: “may,” “will,” “could,” “would,” “should,”
“expect,” “intend,” “plan,” “anticipate,” “believe,” “approximately,”
“estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,”
or the negative of these terms or other comparable terminology, although the absence of these words does not necessarily mean that a
statement is not forward-looking. This information may involve known and unknown risks, uncertainties and other factors which may cause
our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed
or implied by any forward-looking statements.
We
cannot predict all of the risks and uncertainties. Accordingly, such information should not be regarded as representations that the results
or conditions described in such statements or that our objectives and plans will be achieved and we do not assume any responsibility
for the accuracy or completeness of any of these forward-looking statements. These forward-looking statements include information concerning
possible or assumed future results of our operations, including statements about our business strategies; future cash flows; financing
plans; plans and objectives of management; any other statements regarding future acquisitions, future cash needs, future operations,
business plans and future financial results, our ability to obtain or maintain patents or other appropriate protection for our intellectual
property, and any other statements that are not historical facts.
These
statements are only predictions and involve known and unknown risks, uncertainties and other factors. Readers are urged to carefully
review and consider the various disclosures made by us in this Quarterly Report and in our other reports filed with the Securities and
Exchange Commission (the “SEC”). Except to the extent required by law, we undertake no obligation to update or revise any
forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions
underlying such statements, or otherwise.
As
used in this Quarterly Report and unless otherwise indicated, the terms “Curanex,” “we,” “us,” “our,”
or “Company” refer to Curanex Pharmaceuticals Inc, a Nevada corporation.
3
CURANEX
PHARMACEUTICALS INC
PART
I- FINANCIAL INFORMATION
Item
1. Financial Statements.
CURANEX
PHARMACEUTICALS INC
FINANCIAL
STATEMENTS
AS
OF SEPTEMBER 30, 2025 AND DECEMBER 31, 2024
AND
FOR THREE AND NINE MONTHS ENDED
SEPTEMBER
30, 2025 AND 2024
4
INDEX
TO FINANCIAL STATEMENTS
Balance Sheets
6
Statements of Operations
7
Statements of Changes in Shareholders’ Equity
8
Statements of Cash Flows
9
Notes to Financial Statements
10
5
CURANEX
PHARMACEUTICALS INC
BALANCE
SHEETS
As of
September 30, 2025
As of
December 31, 2024
(unaudited)
ASSETS
Current assets
Cash
$ 5,830,537
$ 148,891
Prepaid Expenses
8,587,222
1,179
Other Current Assets
-
367,865
Total current assets
14,417,759
517,935
Right-of-Use Asset
60,398
-
TOTAL ASSETS
14,478,157
517,935
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities
Accrued expenses
10,316
9,575
Accounts payable
114,489
5,000
Lease Liability, current
61,150
-
Total current liabilities
185,955
14,575
TOTAL LIABILITIES
185,955
14,575
Shareholders’ equity
Common stock, 475,000,000 shares authorized; $ 0.0001 par value;
28,340,812 shares issued and outstanding as of September 30, 2025, and 24,000,000 December 31, 2024
2,834
2,400
Preferred stock, 25,000,000 shares authorized; $ 0.0001 par value; 1,000,000 shares issued and outstanding as of September 30, 2025, and December 31, 2024
100
100
Common stock to be issued
-
200,000
Additional paid-in capital
16,063,705
923,309
Accumulated deficit
( 1,774,437 )
( 622,449 )
TOTAL SHAREHOLDERS’ EQUITY
14,292,202
503,360
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 14,478,157
$ 517,935
The
accompanying notes are an integral part of these unaudited financial statements.
6
CURANEX
PHARMACEUTICALS INC
STATEMENTS
OF OPERATIONS
(unaudited)
For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
2025
2024
2025
2024
Operating expenses:
General & administrative
273,853
93,295
466,863
217,696
Research & Development
677,474
-
679,574
-
Total operating expenses
951,327
93,295
1,146,437
217,696
Loss from operations
( 951,327 )
( 93,295 )
( 1,146,437 )
( 217,696 )
Interest Expense
( 4,090 )
-
( 8,537 )
-
Other income
1,358
2,129
2,986
2,129
Net Loss
$ ( 954,059 )
$ ( 91,166 )
$ ( 1,151,988 )
$ ( 215,567 )
Net loss per common share: Basic and Diluted
$ ( 0.04 )
$ ( 0.04 )
$ ( 0.05 )
$ ( 0.05 )
Weighted average number of common shares outstanding: Basic and Diluted
25,599,673
2,400,000
24,539,084
4,200,000
T he
accompanying notes are an integral part of these unaudited financial statements.
7
CURANEX
PHARMACEUTICALS INC
STATEMENT
OF CHANGES IN SHAREHOLDERS’ EQUITY
(unaudited)
Common Stock
Preferred Stock
Common Stock
Additional
Number of Shares
Amount
Number of Shares
Amount
to be issued
Paid in Capital
Accumulated
Deficit
Total
Balance at December 31, 2023
600,000
$ 60
-
$ -
$ 200,000
$ 120,973
$ ( 260,943 )
$ 60,090
Issuance of common stock
-
-
-
-
150,000
-
-
150,000
Net loss
-
-
-
-
-
-
( 80,202 )
( 80,202 )
Balance at March 31, 2024
600,000
$ 60
-
$ -
$ 350,000
$ 120,973
$ ( 341,145 )
$ 129,888
Issuance of common stock
23,400,000
$ 2,340
-
-
$ ( 150,000 )
$ 777,103
-
$ 629,443
Issuance of preferred stock
-
-
1,000,000
$ 100
-
-
-
100
Net loss
-
-
-
-
-
-
( 44,200 )
( 44,200 )
Balance at June 30, 2024
24,000,000
$ 2,400
1,000,000
$ 100
$ 200,000
$ 898,076
$ ( 385,345 )
$ 715,231
Net loss
-
-
-
-
-
-
( 91,166 )
( 91,166 )
Balance at September 30, 2024
24,000,000
$ 2,400
1,000,000
$ 200
$ 200,000
$ 898,076
$ ( 476,511 )
$ 624,165
Balance at December 31, 2024
24,000,000
$ 2,400
1,000,000
$ 100
$ 200,000
$ 923,309
$ ( 622,449 )
$ 503,360
Net loss
-
-
-
-
-
-
( 137,583 )
( 137,583 )
Balance at March 31, 2025
24,000,000
$ 2,400
1,000,000
$ 100
$ 200,000
$ 923,309
$ ( 760,032 )
$ 365,777
Net loss
-
-
-
-
-
-
( 60,346 )
( 60,346 )
Balance at June 30, 2025
24,000,000
$ 2,400
1,000,000
$ 100
$ 200,000
$ 923,309
$ ( 820,378 )
$ 305,431
Balance
24,000,000
$ 2,400
1,000,000
$ 100
$ 200,000
$ 923,309
$ ( 820,378 )
$ 305,431
Issuance of common stock
4,340,812
$ 434
-
-
$ ( 200,000 )
$ 15,140,396
-
$ 14,940,831
Net loss
-
-
-
-
-
-
( 954,059 )
( 954,059 )
Balance at September 30, 2025
28,340,812
$ 2,834
1,000,000
$ 100
$ -
$ 16,063,705
$ ( 1,774,437 )
$ 14,292,202
Balance
28,340,812
$ 2,834
1,000,000
$ 100
$ -
$ 16,063,705
$ ( 1,774,437 )
$ 14,292,202
The
accompanying notes are an integral part of these unaudited financial statements.
8
CURANEX
PHARMACEUTICALS INC
STATEMENTS
OF CASH FLOWS
(unaudited)
For the Nine Months Ended
September 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss for the period
$ ( 1,151,988 )
$ ( 215,567 )
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
Amortization of right-of-use assets
45,102
-
Changes in operating assets and liabilities:
Prepaid expenses
( 8,586,042 )
-
Lease liabilities
( 44,350 )
-
Accounts payable
109,489
5,000
Accrued expenses
741
( 10,094 )
Other current assets
-
( 239,487 )
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
( 9,627,048 )
( 460,148 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of common stock
-
630,000
Issuance of preferred stock
-
100
Proceeds from issuance of common stock, net of underwriting costs
15,655,192
-
Payment offering costs
( 346,497 )
-
NET CASH PROVIDED BY FINANCING ACTIVITIES
15,308,695
630,100
NET INCREASE (DECREASE) IN CASH
5,681,646
169,951
Cash at beginning of period
148,891
74,366
CASH AT END OF PERIOD
$ 5,830,537
$ 244,317
Supplemental schedule of cash flow information:
Non-cash investing & financing activities:
Issuance of common stock with a non-cash payment
$ -
$ 100,000
Recognition of right-of-use asset in exchange for lease liability
105,501
-
The
accompanying notes are an integral part of these unaudited financial statements.
9
CURANEX
PHARMACEUTICALS INC
NOTES
TO FINANCIAL STATEMENTS
1. Description of Business and Summary of Significant Accounting Policies
Description
of Business
Curanex
Pharmaceuticals Inc. (the “Company”) was originally incorporated as Durand Damiel Health Inc. under the laws of the State
of New York on June 1, 2018. The Company is headquartered in Jericho, NY, with an initial focus on research and development of health
products and botanical medicines.
On
November 9, 2023, the Company was rebranded as Curanex Pharmaceuticals Inc, and shifted its focus to discovering, developing, and commercializing
innovative botanical drugs for treating major unmet medical needs in patients with inflammatory diseases.
On
June 10, 2024, Curanex Pharmaceuticals Inc., a New York corporation (“Curanex NY”), entered into an Agreement and Plan of Merger
(the “Merger Agreement”) with Curanex Pharmaceuticals Inc, (the “Surviving Corporation”), a newly formed Nevada corporation
and wholly owned subsidiary of Curanex NY. Pursuant to the Merger Agreement, on the same date, Curanex NY, as the parent in this transaction,
merged with and into the Surviving Corporation (the “Reincorporation Merger”). Upon the consummation of the Reincorporation
Merger, Curanex NY ceased its legal existence as a New York corporation, and the Surviving Corporation continued the business as the
surviving corporation under the name “Curanex Pharmaceuticals Inc”.
The
financial statements for the period ended September 30, 2025 reflect the impact of the Reincorporation Merger. In accordance with ASC
805 Business Combinations, the merger has been treated as a reorganization under common control. As such, the assets and liabilities
have been transferred to the Surviving Corporation at their historical carrying amounts, and no gain or loss has been recognized in connection
with the merger. The balance sheet now presents the Nevada corporation as the surviving entity, incorporating the combined assets and
liabilities of the predecessor and the successor entities.
This
merger did not result in any changes to the reported financial position or results of operations for prior periods, as the historical
financial information of the Company has been carried forward to the Surviving Corporation. The impact of the merger on the financial
statements is primarily legal and administrative, ensuring the continuity of the Company’s operations under the new jurisdiction without
interruption. Consequently, the financial statements include all transactions and balances of both the original and the surviving entities,
presented as if the merger had occurred at the beginning of the earliest period presented. This approach ensures consistency and comparability
in the financial reporting of the Company’s ongoing business activities.
On
August 27, 2025, the Company successfully completed its initial public offering (the “IPO”) and began trading on the Nasdaq
Capital Market under the ticker symbol “CURX.”
Following
the completion of our IPO, we incurred significant research and development (“R&D”) expense, totaling approximately $ 677,474 for the three months ended September 30, 2025. These expenditures primarily related to FDA-mandated investigational new drug
(“IND”)-enabling studies supporting programs in ulcerative colitis, atopic dermatitis, rheumatoid arthritis, gouty arthritis,
and diabetic foot. R&D activities during the period included good laboratory practice (“GLP”) toxicology and pharmacokinetic/bioanalytical
studies, chemistry, manufacturing, and controls (“CMC”) work involving formulation, stability, and method validation, as
well as fees to Contract Research Organizations (“CROs”) and Contract Development and Manufacturing Organizations (“CDMOs”).
The increase in R&D expense compared to prior periods reflects the progression of multiple investigational programs through preclinical
development toward IND submission and future clinical evaluation, consistent with the Company’s development strategy following
the IPO.
10
Basis
of Accounting
The
accompanying financial statements of the Company have been prepared on the accrual basis of accounting in accordance with Generally Accepted
Accounting Principles in the United States of America (GAAP).
Use
of Estimates
The
preparation of the financial statements requires the Company to make judgments in applying its accounting policies and estimates and
assumptions about the future. These judgments, estimates and assumptions affect the Company’s reported amounts of assets, liabilities,
and items in net income (loss), and the related disclosure of contingent assets and liabilities, if any. Such estimates are based on
various assumptions that the Company believes are reasonable under the circumstances, and these estimates form the basis for making judgments
about the carrying value of assets and liabilities and the reported amounts of items in net loss that are not readily apparent from other
sources. These estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant,
and actual results may differ from these estimates under different assumptions or conditions.
The
estimates and underlying assumptions are reviewed on an ongoing basis, and revisions to accounting estimates are recognized in the year
in which the estimate is revised if the revision affects only that year, or in the year of the revision and future years if the revision
affects both current and future years.
Going
Concern
At
the end of each reporting period, management exercises judgment in assessing the Company’s ability to continue as a going concern
by reviewing the Company’s performance, resources, and future obligations. This assessment is based on assumptions derived from
actual operating results, industry and market trends, and involves critical judgments regarding the Company’s short and long-term
operating budgets, expected profitability, investment and financing activities, and strategic planning.
In
prior periods, the Company disclosed conditions that raised substantial doubt about its ability to continue as a going concern. Management
has re-evaluated the Company’s liquidity and capital resources in accordance with ASC 205-40, Presentation of Financial Statements
Going Concern, for the twelve-month period following the issuance of these condensed consolidated financial statements. While those conditions
that initially raised substantial doubt continued to exist as of the evaluation date, management’s plans, primarily the successful
completion of the Company’s initial public offering and the resulting improvement in liquidity, were determined to mitigate the
substantial doubt regarding the Company’s ability to continue as a going concern. Accordingly, management concluded that no substantial
doubt exists about the Company’s ability to continue as a going concern.
As
of September 30, 2025, the Company had cash and cash equivalents of approximately $ 5.8
million and received net proceeds of approximately $ 13.24
million from its initial public offering completed in August 2025 and additional net proceeds of $ 2.07
million from the subsequent exercise of the underwriters’ over-allotment option in September 2025. These proceeds, together
with the Company’s current operating plan and anticipated cash flows, provide sufficient liquidity to meet the Company’s
obligations for at least the next twelve months from the issuance date of these financial statements.
Accordingly,
management concluded that the factors which previously raised substantial doubt about the Company’s ability to continue as a going
concern have been alleviated, and the accompanying condensed consolidated financial statements have been prepared on a going concern
basis.
Cash
The
Company maintains balances with multiple financial institutions, with balances periodically exceeding the Federal Deposit Insurance Corporation
(FDIC) insurance limit. The management monitors the cash balances in the operating accounts and adjusts the cash balances as appropriate;
however, these cash balances could be impacted if the underlying financial institutions fail or are subject to other adverse conditions
in the financial markets. To date, the Company has experienced no loss or lack of access to cash in the operating accounts.
11
Basic
and Diluted Net Loss per Common Share
The
Company computes loss per share in accordance with ASC 260, Earnings per Share, which requires presentation of both basic and diluted
earnings per share on the face of the statement of operations. Basic loss per share is computed by dividing net loss available to common
shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all
dilutive potential common shares outstanding during the period. During the nine months ended September 30, 2025, and 2024, the Company
had no potential dilutive instruments and accordingly basic loss and diluted loss per share are the same.
Initial
Public Offering
On
August 27, 2025, the Company completed its initial public offering (“IPO”) of 3,750,000 shares of its common stock, par value
$ 0.0001 per share, at a public offering price of $ 4.00 per share. This offering generated gross proceeds of $ 15.0 million before underwriting
discounts, commissions, and other offering expenses.
In
connection with the IPO, total offering costs were approximately $ 2.12 million, consisting of $ 1.41 million in underwriting discounts
and commissions and $ 0.71 million of other offering-related expenses (including legal, accounting, and filing fees). The Company had
previously recorded these other offering costs as deferred IPO costs prior to the effectiveness of the registration statement. Upon the
closing of the IPO, all deferred costs were reclassified and recorded as a reduction to additional paid-in capital (“APIC”)
within stockholders’ equity.
After
deducting total underwriting discounts, commissions, and offering expenses, the Company received net proceeds of approximately $ 13.24
million from its IPO.
Over-Allotment
Option
On
September 12, 2025, the underwriters exercised their option to purchase an additional 562,500 shares of the Company’s common stock
at the same public offering price of $ 4.00 per share, resulting in gross proceeds of $ 2.25 million. The Company incurred $ 0.18 million
in underwriting discounts and commissions related to the option exercise. After deducting these offering costs, the Company received
net proceeds of $ 2.07 million.
All
costs directly attributable to the over-allotment exercise were likewise recorded as a reduction of APIC within stockholders’ equity,
consistent with the accounting for the initial closing.
Fair
Value of Financial Instruments
ASC
820 Fair Value Measurements and Disclosures establishes a framework for all fair value measurements and expands disclosures related to
fair value measurement and developments. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer
a liability in an orderly transaction between market participants at the measurement date.
ASC
820 requires that assets and liabilities measured at fair value are classified and disclosed in one of the following three categories:
● Level
1 – Unadjusted quoted prices in active markets for identical assets or liabilities;
● Level
2 – Inputs other than quoted prices that are observable for the asset or liability
either directly or indirectly; and
● Level
3 – Inputs that are not based on observable market data.
The
carrying amounts of cash and accrued liabilities approximate fair value because of the short-term nature of these items.
12
Leases
& Right of Use Assets
The
Company adopted ASC 842 Leases on January 1, 2022. At inception of a contract, the Company assesses whether a contract is, or contains,
a lease. Contracts that convey the right to control the use of an identified asset for a period of time in exchange for consideration
are accounted for as leases giving rise to right-of-use assets.
At
the commencement date, a right-of-use asset is measured at cost, where cost comprises: (a) the amount of the initial measurement of the
lease liability; (b) any lease payments made at or before the commencement date, less any lease incentives received; (c) any initial
direct costs incurred by the Company; and (d) an estimate of costs to be incurred by the Company in dismantling and removing the underlying
asset, restoring the site on which it is located or restoring the underlying asset to the condition required by the terms and conditions
of the lease, unless those costs are incurred to produce inventories.
A
lease liability is initially measured at the present value of the unpaid lease payments. Subsequently, the Company measures a lease liability
by: (a) increasing the carrying amount to reflect interest on the lease liability; (b) reducing the carrying amount to reflect the lease
payments made; and (c) re-measuring the carrying amount to reflect any reassessment or lease modifications, or to reflect revised in-substance
fixed lease payments. Each lease payment is allocated between repayment of the lease principal and interest. Interest on the lease liability
in each period during the lease term is allocated to produce a constant periodic rate of interest on the remaining balance of the lease
liability. Except where the costs are included in the carrying amount of another asset, the Company recognizes in profit or loss (a)
the interest on a lease liability and (b) variable lease payments not included in the measurement of a lease liability in the period
in which the event or condition that triggers those payments occurs. The Company subsequently measures a right-of-use asset at cost less
any accumulated amortization and any accumulated impairment losses; and adjusted for any re-measurement of the lease liability. Right-of-use
assets are depreciated over the shorter of the asset’s useful life and the lease term.
Research
and Development Costs
The
Company accounts for research and development (“R&D”) costs in accordance with ASC 730, Research and Development. R&D
costs are expensed as incurred unless they represent nonrefundable advance payments for goods or services to be received in the future.
Nonrefundable advance payments to third parties—such as Contract Research Organizations (“CROs”), Contract Development
and Manufacturing Organizations (“CDMOs”), clinical sites, and other service providers—are recorded as prepaid expenses
and recognized in R&D expense as the related services are performed, generally over the contractual period of performance.
R&D
expense primarily includes employee-related costs (salaries, benefits, and stock-based compensation) for personnel engaged in R&D;
fees to CROs, CDMOs, consultants, and other third parties; clinical trial and preclinical study costs; and costs to manufacture and test
preclinical and clinical materials. The Company records accruals for services performed but not yet invoiced based on estimates of work
completed, patient enrollment/visits, manufacturing progress, and data from vendors. Up-front set-up or activation fees under executory
service arrangements are deferred and recognized over the expected period of performance. Materials, equipment, and licenses with no
alternative future use are expensed when incurred; items with alternative future use are capitalized and recognized in accordance with
the applicable guidance. Prepaid R&D balances are evaluated for recoverability and adjusted for changes in project scope, timing,
or cancellations.
Income
Taxes
The
Company accounts for income taxes under ASC 740, Income Taxes. This standard requires the Company to use the asset and liability method,
which involves making estimates and assumptions and exercising judgment regarding the carrying values of assets and liabilities. These
values are subject to inherent accounting estimates, the interpretation of income tax legislation across various jurisdictions, expectations
about future operating results, the timing of reversal of temporary differences, and potential audits of income tax filings by tax authorities.
Deferred
tax assets and liabilities are recognized for the future tax consequences of differences between the financial statement carrying amounts
of existing assets and liabilities and their respective tax bases. These assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the years when those temporary differences are expected to be recovered or settled. The impact
of changes in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
Valuation allowances are established when necessary to reduce deferred tax assets to amounts expected to be realized.
When
the Company incurs losses for income tax purposes, it assesses the probability of future taxable income based on budgeted forecasts.
These forecasts are adjusted to account for non-taxable income and expenses and specific rules on the use of unused credits and tax losses.
If the forecasts indicate that sufficient future taxable income will not be available to deduct the temporary differences, a deferred
tax asset is not recognized for all deductible temporary differences.
13
Related
Party Transactions
The
Company identifies and accounts for related party transactions, disclosing them in accordance with ASC 850, Related Party Disclosures,
and other relevant ASC standards. Parties are considered related to the Company if they, directly or indirectly, through one or more
intermediaries, control, are controlled by, or are under common control with the Company. Related parties also include the principal
owners of the Company, its management, members of the immediate families of the principal owners and management, and other parties with
which the Company may engage in transactions if one party controls or can significantly influence the management or operating policies
of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests.
Recent
Accounting Pronouncements
The
Company qualifies as an emerging growth company (“EGC”) under the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”). As an EGC, the Company is permitted to delay adoption of new or revised accounting standards issued after the enactment
of the JOBS Act until such standards apply to private companies. The Company has elected to take advantage of this extended transition
period.
The
Company also qualifies as a smaller reporting company (“SRC”) under the rules of the U.S. Securities and Exchange Commission
(“SEC”). As an SRC, the Company is eligible to provide scaled disclosures in its SEC filings, including reduced financial
statement and executive compensation disclosures. The Company has elected to adopt these scaled disclosure accommodations.
In
December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The guidance removes
certain exceptions and simplifies various aspects of the accounting for income taxes. The Company adopted this ASU, and the adoption
did not have a material impact on the condensed consolidated financial statements.
In
October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities
from Contracts with Customers. This ASU requires an acquirer in a business combination to recognize and measure contract assets and contract
liabilities using the revenue recognition guidance in ASC 606. The Company adopted this standard effective January 1, 2025, and the adoption
did not have a material impact on the Company’s financial statements.
In
November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting of Disaggregated Expenses (Topic 205). This ASU requires
entities to provide additional disclosures that disaggregate certain functional expense captions in the income statement (e.g., cost
of sales, research and development, and selling, general, and administrative expenses) into natural expense categories such as employee
compensation, depreciation, and inventory costs. The guidance is intended to improve transparency into an entity’s cost structure.
The amendments are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after
December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of this standard on its financial statements’
disclosures.
Other
than the standards described above, no newly issued accounting pronouncements are expected to have a material impact on the Company’s
consolidated financial position, results of operations, or cash flows.
14
2. Accrued Expenses
A
summary of accrued expenses is as follows:
Schedule
of Accrued Expenses
As of
September 30, 2025
As of
December 31, 2024
Accounting
fees
$ 550
$ 9,550
Payroll
expenses
9,741
-
Tax
fees
25
25
Total Accrued Expenses
$ 10,316
$ 9,575
3. Prepaid expenses
A
summary of prepaid expenses is as follows:
Schedule
of prepaid expenses
As of
September 30, 2025
As of
December 31, 2024
Insurance
$ 110,183
$ -
R&D
8,472,593
-
Other
4,445
1,179
Total Prepaid
Expenses
$ 8,587,222
$ 1,179
4. Other Current Assets
Our
other current assets primarily consisted of deferred offering costs incurred in connection with our initial public offering. These costs,
which included legal, accounting, and filing fees directly attributable to the IPO, were recorded as an asset on the balance sheet prior
to the completion of the offering. Upon the successful closing of the IPO in August 2025, the deferred offering costs were reclassified
and recorded as a reduction to additional paid-in capital within stockholders’ equity.
A
summary of other current assets is as follows:
Schedule
of Other Current Assets
As of
September 30, 2025
As of
December 31, 2024
Deferred IPO Expenses:
Legal fees
$ -
$ 200,025
Underwriting fees
-
110,000
Other IPO related expenses
-
57,840
Other Current Asset
$ -
$ 367,865
15
5. Lease
On
January 1, 2025, the Company assumed an office lease from Duraviva Pharma Inc. (“Duraviva”), a New York corporation under
common control, through a lease assignment agreement. The lease term extends through August 31, 2026. The Company classified the lease
as an operating lease. Upon adoption of ASC 842, the Company recognized right-of-use asset and corresponding lease liability for its
operating lease.
The
following summarizes information about the Company’s lease as of September 30, 2025 and December 31, 2024.
Schedule
of Lease
2025
2024
2025
2024
For
the Three Months Ended
September 30,
For
the Nine Months Ended
September 30,
2025
2024
2025
2024
Amount
recognized in the income statements
Operating
lease expense
$ 17,404
$ -
$ 52,211
$ -
As of September 30, 2025
As of December 31, 2024
Amount recognized in the balance sheets
Right-of-use assets
$ 60,398
$ -
Operating lease liabilities
61,150
-
Amount recognized in the income statements
Operating lease expense
$ 52,211
$ -
Cash paid for amounts included in the measurement of lease liabilities
Operating lease expense
$ 51,459
$ -
Lease commitment
2025
$ 17,608
$ -
2026
46,958
-
Total future minimum lease payments
64,564
-
less imputed interest
( 3,414 )
-
Present value of lease liabilities
$ 61,150
$ -
Supplement information
Discount rate
11 %
n.a.
Remaining lease term
11 months
n.a.
16
6. Income Taxes
Due
to the Company’s net losses and the valuation allowance provided on the related deferred tax assets, there were no provisions for
income taxes for the three and nine months ended September 30, 2025, and 2024.
The
difference between the income tax expense of zero shown in the statements of operations and pre-tax book net loss times the federal statutory
rate of 21 % for the nine months ended September 30, 2025, and 2024, are summarized as follows:
Schedule
of Income Taxes
2025
2024
2025
2024
For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
2025
2024
2025
2024
Pre-tax book loss
$ ( 200,352 )
$ ( 19,145 )
$ ( 241,918 )
$ ( 45,269 )
Permanent differences:
Impairment loss
-
-
-
-
Change in valuation allowance
200,352
19,145
241,918
45,269
Total tax expense
$ -
$ -
$ -
$ -
Deferred
income tax assets as of September 30, 2025 and December 31, 2024, are as follows:
Schedule
of Deferred Income Tax Assets
As of
September 30, 2025
As of
December 31, 2024
Net operating losses carry forwards
241,918
$ 130,087
Others
-
-
Total deferred tax assets
241,918
130,087
Less valuation allowance
( 241,918 )
( 130,087 )
Total deferred tax assets
$ -
$ -
In
assessing the realization of deferred tax assets, management evaluates whether it is more likely than not that some or all of these assets
will not be realized. The ultimate realization of deferred tax assets depends on generating future taxable income during the periods
when these temporary differences become deductible.
Based
on the available objective evidence, management believes it is more likely than not that the net deferred tax assets will not be realizable.
Accordingly, the Company has applied a full valuation allowance against its net deferred tax assets as of September 30, 2025 and December
31, 2024. The net change in the total valuation allowance between September 30, 2025 and December 31, 2024, was an increase of $ 111,831 .
The
Company is subject to U.S. federal and state income tax examinations by the Internal Revenue Service (IRS) and relevant state tax authorities.
The Company is incorporated in the state of Nevada, which does not impose a corporate income tax.
The
Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax
expense. As of September 30, 2025 and December 31, 2024, the Company did not have any significant uncertain tax positions or
unrecognized tax benefits. Additionally, as of September 30, 2025 and December 31, 2024, the Company has federal net operating loss
carry forwards of $ 1,774,437
and $ 622,449 ,
respectively, for tax purposes.
17
7. Related Party Transactions
On
June 17, 2024, following the completion of Reincorporation, the Company entered into an Asset Purchase Agreement and Plan of Reorganization
(the “Asset Purchase Agreement”) with Duraviva. Duraviva is a related party, as the majority shareholders, including its
President and members of the President’s immediate family, are also majority shareholders, officers, and directors in both entities.
On the same day, the Company closed the transactions outlined in the Asset Purchase Agreement (the “Closing”).
At
the Closing, Duraviva transferred and assigned to the Company four provisional patent applications, eight research and development animal
studies and reports, and the rights to use these studies for further research and development, clinical, and commercial purposes (collectively,
the “IP Assets”). In exchange for the transfer and assignment of the IP Assets, a cash consideration of $ 630,000 , and a non-cash
consideration of $ 100,000 , which together constituted substantially all of Duraviva’s assets, the Company issued an aggregate of
23,400,000 shares of common stock, adjusted retroactively for the reverse stock split, to Duraviva’s shareholders, proportionate
to their ownership in Duraviva.
In
January 2025, Duraviva also assigned its office lease to the Company. The terms of the lease, including the original lease end date,
remained unchanged upon reassignment. The Company accounted for the lease under ASC 842 as an operating lease. Please refer to Note 4
Lease.
In
February and May 2025, the Company received two $ 200,000 loans from an existing shareholder to support ongoing costs related to its initial
public offering. The loans accrue simple interest at an annual rate of 4.34 %, with both principal and interest due at maturity in February
and May 2027 .
In
September 2025, following the completion of the Company’s IPO, the shareholder loans were fully repaid, including all accrued interest.
Total interest paid upon settlement amounted to $ 8,537.32 . As a result of the repayment, there were no outstanding related-party loan
balances as of September 30, 2025.
8. Shareholders’ Equity
Common
Stock
The
Company is authorized to issue 475,000,000 shares of common stock, par value $ 0.0001 per share. Each share entitles the holder to one
vote on matters submitted to stockholders and to receive dividends as and if declared by the Board of Directors.
As
of December 31, 2024, the Company had 24,000,000 shares of common stock issued and outstanding (giving retroactive effect to the reverse
stock split described below).
During
the quarter ended September 30, 2025, the Company completed the following equity issuances in connection with its initial public offering
and related activities:
● 3,750,000
shares of common stock issued upon the closing of the IPO on August 27, 2025.
● 562,500
additional shares of common stock issued on September 12, 2025 upon the underwriters’
exercise of their over-allotment option.
● 28,312
shares of common stock issued on September 23, 2025 to satisfy a previously recorded “common
stock to be issued” balance (see “Subscriptions Received – Shares to be
Issued” below).
Following
these issuances, the Company had 28,340,812 shares of its common stock issued and outstanding as of September 30, 2025, including an
aggregate of 4,340,812 shares of common stock issued during the quarter ended September 30, 2025.
18
Reverse
Stock Split
Effective
November 19, 2024, the Board of Directors approved a three-for-five reverse stock split of the Company’s issued and outstanding
common stock. The par value of $ 0.0001 per share was not affected. All share and per-share amounts for all periods presented have been
retroactively adjusted to reflect the reverse stock split.
Subscriptions
Received – Shares to be Issued
In
2019, the Company received $ 200,000 in cash from an existing investor for a subscription to common stock representing 0.1 % of the Company’s
then-anticipated total issued and outstanding shares upon completion of the IPO. This amount was recorded as “common stock to be
issued” within stockholders’ equity and remained outstanding as of December 31,2024.
Following
the successful completion of the IPO, the Company issued 28,312 shares of common stock during the quarter ended September 30, 2025 to
settle this subscription in full. As of September 30, 2025, there were no remaining shares or amounts recorded as “common stock
to be issued.”
Preferred
Stock
The
Company is authorized to issue 25,000,000 shares of preferred stock at $ 0.0001 per share. The Company’s Board of Directors also
has the authority to issue additional preferred stock in one or more classes or series.
On
June 14, 2024, the Company’s Board of Directors approved the issuance of 1,000,000 shares of Series A Super Voting Preferred Stock
(“Series A Preferred Stock”) at the par value of $ 0.0001 per share. These shares grant the holders 40% of the total voting
power of the Company’s equity voting stock. Holders of the Series A Preferred Stock do not possess any rights to dividends.
No
shares of preferred stock were issued during the three and nine months ended September 30, 2025
9. Subsequent Events
The
Company has evaluated subsequent events through the date when the financial statements were issued and determined that no subsequent
events requiring adjustment to or disclosure in the financial statements were identified.
19
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis should be read in conjunction with our financial statements and the related notes thereto. The management’s
discussion and analysis contain forward-looking statements, such as statements of our plans, objectives, expectations, and intentions.
Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,”
“plan,” “intend,” “anticipate,” “target,” “estimate,” “expect”
and the like, and/or future tense or conditional constructions (“will,” “may,” “could,” “should,”
etc.), or similar expressions, identify certain of these forward-looking statements. These forward-looking statements are subject to
risks and uncertainties, including those under “Risk Factors,” which appear in our registration statement on Form S-1, as
amended (File No. 333-282686), filed with the SEC which was declared effective by the SEC on August 12, 2025 (the “Registration
Statement”), that could cause actual results or events to differ materially from those expressed or implied by the forward-looking
statements. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements
as a result of several factors. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances
occurring after the date of this Quarterly Report.
Overview
Curanex
was incorporated on June 1, 2018 as a New York corporation under the name “Durand Damiel Health Inc, focusing on research and development
(R&D) of health products and botanical medicines. On October 24, 2023, the Company changed its name to “Fordman Pharma Inc.,”
and on November 9, 2023, the Company changed its name to Curanex Pharmaceuticals Inc and changed the focus of its business operations
on discovering, developing, and commercializing innovative botanical drugs for major unmet needs to treat patients suffering from inflammatory
diseases.
Our
business strategy is centered on developing innovative botanical drugs, with a focus on Phyto-N as our lead candidate, for the treatment
of inflammatory diseases. By leveraging our founders’ expertise in botanical medicine, pursuing strategic partnerships, implementing
efficient development processes, building a strong IP portfolio, fostering a culture of innovation, and maintaining focus and adaptability,
we aim to establish Curanex as a leader in the field and create significant value for patients as well as our stockholders. Our current
drug development pipeline encompasses seven core indications: ulcerative colitis, atopic dermatitis, COVID-19, diabetes, nonalcoholic
fatty liver disease (“NAFLD”), and gout. If successfully developed and approved, Phyto-N may improve the lives of many patients
worldwide. However, our research to date has been limited to preclinical studies for each of these indications.
Reincorporation
On
June 10, 2024, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Curanex Pharmaceuticals Inc,
a newly formed Nevada corporation and our wholly owned subsidiary of the Company (the “Surviving Corporation”), pursuant
to which, on the same date, we, as parent in this transaction, merged with and into the Surviving Corporation (the “Reincorporation”).
Upon the consummation of the Reincorporation, we ceased our legal existence as a New York corporation, and the Surviving Corporation
continued our business as the surviving corporation in the Reincorporation under the name “Curanex Pharmaceuticals Inc” succeeding
all our rights, assets, liabilities and obligations, except that our affairs ceased to be governed by the New York Business Corporation
Law and became subject to the Nevada Revised Statutes (“NRS”).
Asset
Purchase Agreement
On
June 17, 2024, we entered into the Asset Purchase Agreement with Duraviva, a related entity in which our Chief Executive Officer and
President and members of his immediate family, including our Secretary, are also directors, officers and majority shareholders. At the
Closing, occurred on the same date, Duraviva transferred to us all of its IP Assets, which together with $730,000 consideration, constitute
all or substantially all of the assets of Duraviva. The IP Assets includes four (4) provisional patent applications (all of which expired
on March 18, 2025) and 8 research and development animal study reports for:
1.
Ulcerative Colitis
2.
Atopic Dermatitis
3.
Nonalcoholic fatty liver disease prevention
4.
Nonalcoholic fatty liver disease treatment
5.
Diabetes
6.
COVID-19 prevention and treatment
7.
Gouty nephritis
8.
Gouty arthritis
20
On
March 13, 2025, prior to the expiration, we filed with the USPTO an international PCT application for utility patent entitled “PLANT
EXTRACT COMPOSITIONS AND USES THEREOF” (application # PCT/US25/19679) which combined the following three (3) provisional patent
applications (except for the provisional patent application for treatment of acne, which the Company determined not to pursue further
due to results of experiments conducted by the Company that did not show promising results).
Reverse
Stock Split
On
November 19, 2024, our Board and our stockholders approved an amendment to our amended and restated articles of incorporation (the “Amendment”)
to effect a reverse stock split of the outstanding shares of the common stock, at a ratio of three-for-five (3-for-5) (the “Reverse
Stock Split”). The Amendment became effective on the same date, upon filing of the Amendment with the Secretary of State of the
State of Nevada. As a result of the Reverse Stock Split, every five (5) shares of our issued and outstanding common stock, automatically
and without any action of the Company or any holder thereof, were combined into three (3) validly issued and non-assessable shares of
common stock, resulting in 24,000,000 post Reverse Stock Split shares of common stock. No fractional shares were issued to any stockholder
of the Company, and in lieu of issuing any such fractional shares, any fractional shares resulting from the Reverse Stock Split were
rounded up to the nearest whole share of common stock. The shares of common stock as adjusted to the Reverse Stock Split will remain
fully paid and non-assessable. The Reverse Stock Split did not affect the number of authorized shares of common stock or the par value
of the common stock nor changed the authorized shares of preferred stock or the relative voting power of holders of the outstanding common
stock.
Recent
Developments
Initial
Public Offering
On
August 27, 2025, the Company closed its initial public offering (the “IPO”) of 3,750,000 shares (the “Shares”)
of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), at a public offering price of $4.00
per share, for gross proceeds of $15,000,000. The Shares were offered by the Company pursuant the Registration Statement. The net proceeds
to the Company from the IPO, after deducting the underwriting discount, the underwriters’ fees and expenses and the Company’s
offering expenses, were approximately $13,238,695.
Under
the terms of an underwriting agreement dated August 25, 2025 (the “Underwriting Agreement”), with Dominari Securities,
LLC, as representative of the underwriters named on Schedule I therein (the “Underwriters”), the Company granted the
Underwriters an option to purchase up to 562,500 additional shares (the “Option Shares”) at the initial public offering
price of $4.00 per share, pursuant to the over-allotment option described in the Underwriting Agreement. On September 12, 2025,
Underwriters exercised their option in full and purchased all of the Option Shares from the Company, resulting in additional gross
proceeds of $2,250,000 and net proceeds of $2,070,000 to the Company.
The
Company intends to use the net proceeds from the IPO primarily for (i) the development of its lead product candidate, Phyto-N, for the
treatment of ulcerative colitis; (ii) to conduct FDA-required good laboratory practice (“GLP”) toxicology and pharmacokinetic
studies for Phyto-N in ulcerative colitis, (iii) to prepare and submit an Investigational New Drug (IND) application, and (iv) for working
capital and other general corporate purposes.
21
Promissory
Notes to Dian Ying Jing and Repayment of these Promissory Notes
On
February 4, 2025, the Company received a loan in the amount of $200,000 from Dian Ying Jing, one of our founders, Secretary and the wife
of our Chief Executive Officer, Jun Liu. To evidence this loan, on February 4, 2025, the Company issued Ms. Jing a promissory note in
the principal amount of $200,000 (the “First Note”), with an interest rate of four and thirty-four percent (4.34%) per annum,
to be paid on maturity date of February 4, 2026, provided that the Company may prepay any amounts due under the First Note without penalty
or premium. On May 30, 2025, the Company and Ms. Jing entered into Amendment No. 1 to the Note, pursuant to which the maturity date of
the Note was extended to February 4, 2027.
On
May 21, 2025, Ms. Jing loaned an additional $200,000 to the Company. To evidence this new loan, on May 23, 2025, the Company issued Ms.
Jing a new promissory note in the principal amount of $200,000 (the “Second Note”), with an interest rate of four and thirty-four
percent (4.34%) per annum, to be paid on maturity date of May 23, 2027, provided that the Company may prepay any amounts due under the
Second Note without penalty or premium.
On
September 23, 2025, the Company prepaid the total principal amount and accrued interest on the First Note, and on September 24, 2025,
the Company prepaid the total principal amount and accrued interest on the Second Note. The total amount repaid by the Company for these
promissory notes was $408,537.32, which includes $400,000 in principal amount and $8,537.32 in total accrued interest, including (i)
$5,540.93 accrued interest on the First Note from February 4, 2025 until September 23, 2025, and (ii) $2,996.38 accrued interest on the
Second Note from May 23, 2025 until September 24, 2025.
During
the three months ended September 30, 2025 and 2024, total interest incurred under these promissory notes was $4,090.31and zero. During
the nine months ended September 30, 2025 and 2024, total interest incurred was $8,537.32 and zero.
Nasdaq
Non-Compliance
On
November 5, 2025, we received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”)
notifying the Company that the closing bid price for our Common Stock for the previous 30 consecutive business days was below $1.00 per
share, which is the minimum closing bid price (the “Minimum Bid Price”) required for continued listing on The Nasdaq Capital
Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Notice”). This Notice has no immediate effect on the listing of our
Common Stock which will continue to trade on The Nasdaq Capital Market under the symbol “CURX”, subject to the Company’s
compliance with the other Nasdaq listing requirements.
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a compliance period of 180 calendar days from the date of
the Notice, or until May 4, 2026 (the “Compliance Period”), to regain compliance with the Minimum Bid Price requirement.
If at any time during the Compliance Period, the closing bid price of the Company’s Common Stock is at least $1.00 per share for
a minimum of ten consecutive business days (unless the Nasdaq staff exercises its discretion to extend this ten business day period pursuant
to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq will provide the Company written confirmation of compliance with the Minimum Bid Price,
and the matter will be closed.
If
the Company does not regain compliance during the Compliance Period, the Company may be eligible for an additional 180-calendar day period
to regain compliance with the Minimum Bid Price, provided that it meets the applicable market value of publicly held shares requirement
for continued listing and all other applicable standards for initial listing on The Nasdaq Capital Market (except the Minimum Bid Price
requirement), and notifies Nasdaq of its intent to cure the deficiency by effecting a reverse stock split of its Common Stock, if necessary.
If Nasdaq determines that the Company is not eligible for an additional 180 calendar days compliance period or the Company will not be
able to cure the deficiency with the Minimum Bid Price requirement within the allotted compliance period, the Company’s stock will
be subject to delisting.
22
Results
of Operations
Comparison
of Results of Operations for the Three Months Ended September 30, 2025 and 2024
Revenue
and Cost of Sales
We
did not generate any revenue during the three months ended September 30, 2025, or 2024. This is consistent with our focus on advancing
the development of our botanical drug candidates and progressing toward our clinical and regulatory milestones.
We
anticipate generating revenue only upon successful commercialization of our product candidates or from entering into strategic licensing
agreements. However, there is no assurance as to the timing or likelihood of these events.
Operating
Expenses
General
and Administrative Expenses
General
and administrative expenses were $273,853 for the three months ended September 30, 2025, compared to $93,295, for the same period in
2024. The increase was primarily due to ongoing costs associated with preparing for and closing our IPO and maintaining public
company readiness.
Research
and Development Expenses
Following
our initial public offering, we continued to invest in research and development (“R&D”) activities primarily related
to FDA-mandated investigational new drug (“IND”) studies targeting ulcerative colitis, atopic dermatitis, rheumatoid arthritis,
gouty arthritis, and diabetic foot. For the three months ended September 30, 2025, R&D expenses totaled $677,474, reflecting the
portion of costs recognized under our updated accounting policy to expense R&D costs over the related contract performance periods.
As of September 30, 2025, the Company recorded $8.5 million in prepaid R&D, representing advance payments to Contract Research Organizations
(“CROs”) and Contract Development and Manufacturing Organizations (“CDMOs”) for services to be rendered under
ongoing IND studies. We expect R&D spending to remain significant as these studies progress but to moderate in future periods until
FDA approvals are obtained and clinical trial activities commence.
Other
Income (Expense)
For
the three months ended September 30, 2025, net other expense was $2,732, consisting of $2,129 of other income, primarily interest
income earned on cash and cash equivalents, offset by $4,090 of interest expense related to a shareholder loan. In the comparable
2024 period, the Company recorded no material other income or interest expense.
Net
Gain or Loss
The
Company recorded a net loss of $954,059 for the three months ended September 30, 2025, compared to $91,166 for the three months ended
September 30, 2024. The increase in net loss was primarily attributable to (i) the initiation of “R&D” activities totaling
$677,474 related to FDA-mandated IND studies and (ii) non-recurring IPO-related and public company readiness costs included in “G&A”
expenses ($273,853 in 2025 versus $44,200 in 2024).
Comparison
of Results of Operations for the Nine Months Ended September 30, 2025 and 2024
Revenue
and Cost of Sales
We
did not generate any revenue during the nine months ended September 30, 2025, or 2024. This is consistent with our focus on advancing
the development of our botanical drug candidates and progressing toward our clinical and regulatory milestones.
We
anticipate generating revenue only upon successful commercialization of our product candidates or from entering into strategic licensing
agreements. However, there is no assurance as to the timing or likelihood of these events.
23
Operating
Expenses
General
and Administrative Expenses
General
and administrative expenses were $466,863 for the nine months ended September 30, 2025, compared to $217,696 for the same period in 2024.
The increase was primarily due to ongoing costs associated with preparing for our IPO and maintaining public company readiness.
Research
and Development Expenses
Following
our initial public offering, we continued to invest in research and development (“R&D”) activities primarily related
to FDA-mandated investigational new drug (“IND”) studies targeting ulcerative colitis, atopic dermatitis, rheumatoid arthritis,
gouty arthritis, and diabetic foot. For the nine months ended September 30, 2025, R&D expenses totaled $679,574, reflecting the portion
of costs recognized under our updated accounting policy to expense R&D costs over the related contract performance periods. As of
September 30, 2025, the Company recorded $8.5 million in prepaid R&D, representing advance payments to Contract Research Organizations
(“CROs”) and Contract Development and Manufacturing Organizations (“CDMOs”) for services to be rendered under
ongoing IND studies. We expect R&D spending to remain significant as these studies progress but to moderate in future periods until
FDA approvals are obtained and clinical trial activities commence.
Other
Income (Expense)
For
the nine months ended September 30, 2025, net other expense was $5,551, reflecting $2,986 of other income (primarily interest income
on IPO-related cash balances) and $8,537 of interest expense associated with the shareholder loan, compared to net other income of $2,129
for the nine months ended September 30, 2024. The change from the prior-year period was primarily due to the recognition of interest
expense on the shareholder loan in 2025, partially offset by higher interest income resulting from increased cash balances following
the Company’s IPO.
Net
Gain or Loss
For
the nine months ended September 30, 2025, net loss was $1,151,988, compared to $215,567 for the nine months ended September 30, 2024.
The year-over-year increase was primarily driven by (i) R&D expenses of $679,574 associated with IND-enabling studies initiated in
2025 and (ii) higher G&A expenses of $466,863, reflecting IPO-related professional fees and recurring costs associated with operating
as a public company. These increases were partially offset by interest income on IPO proceeds and higher average cash balances during
the period.
Cash
Flows from Financing Activities
Net
cash provided by financing activities totaled $15,308,695 for the nine months ended September 30, 2025, reflecting proceeds from the
IPO and Option Shares closings described above.
Liquidity
and Capital Resources
Liquidity
is the ability of a company to generate funds to support its current and future operations, satisfy its obligations, and otherwise operate
on an ongoing basis. Significant factors in the management of liquidity are funds generated by operations, levels of accounts receivable
and accounts payable and capital expenditures. Since our inception through September 30, 2025, we have funded our operations, principally
with the issuance of equity and debt.
On
August 27, 2025, we closed the IPO pursuant to the Underwriting Agreement. The net proceeds to the Company from the IPO, after deducting
the underwriting discount, the underwriters’ fees and expenses and the Company’s estimated offering expenses were approximately
$13,238,695. In addition, on September 12, 2025, we had a closing of the Option Shares, resulting in the net proceeds of approximately
$2,070,000.
As of September 30, 2025, we had cash and cash equivalents totaling $5,830,537,
compared to $148,891 as of December 31, 2024. The increase was primarily attributable to the total net proceeds of $15,308,695 received
from the closings of the IPO and the Option Shares, less the total amount of $408,537.32 as the repayment of the two promissory notes
to the shareholder, R&D costs of $9,149,990, and other G&A costs.
We
believe our existing cash and access to shareholders’ support are sufficient to fund our operations for at least the next twelve
months. However, our ability to continue operating beyond this period is dependent upon the successful implementation of our business
plan, including conducting FDA-required good laboratory practice (“GLP”) toxicology and pharmacokinetic studies for Phyto-N
in ulcerative colitis, and preparation and submission of an Investigational New Drug application.
24
Going
Concern Considerations
We
have not yet achieved profitability and anticipate continued operating losses in the foreseeable future. Our financial statements include
a going concern disclosure due to our recurring losses, accumulated deficit, and reliance on external funding. However, management believes
that substantial doubt has been alleviated due to our strong cash position, receipt of the IPO proceeds.
Contractual
Obligations and Contingencies
On
January 1, 2025, the Company assumed an office lease from Duraviva, a related party under common control, pursuant to a lease assignment
agreement. The lease is classified as an operating lease and extends through August 31, 2026. In accordance with ASC 842, the Company
recognized a right-of-use asset and corresponding lease liability as of the adoption date.
The
lease liability was discounted using the Company’s incremental borrowing rate of 11%, resulting in a lease liability of $61,150
as of September 30, 2025.
Off-Balance
Sheet Arrangements
We
did not have any off-balance sheet arrangements as of September 30, 2025.
Emerging
Growth Company and Smaller Reporting Company Status
We
continue to qualify as an emerging growth company (EGC) and smaller reporting company (SRC), enabling us to utilize scaled disclosures
and defer adoption of certain accounting standards.
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
by this Item.
25
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated
to management, including our Principal Executive Officer and our Principal Financial Officer or persons performing similar functions,
as appropriate, to allow timely decisions regarding required disclosure.
Based
on that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded that, as of the end of the period
covered by this Quarterly Report, these disclosure controls and procedures were not effective to provide reasonable assurance that information
required to be disclosed in the reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within
the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management
to allow timely decisions regarding required disclosure.
Our
management does not expect that our disclosure controls and procedures will prevent all error and all fraud. A control system, no matter
how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be
no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Further, the design of
a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative
to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, within our company have been detected.
Changes
in Internal Control over Financial Reporting
During
the period covered by this Quarterly Report, there were no changes in our internal control over financial reporting that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
There
are no pending legal proceedings to which the Company is a party or in which any director, officer or affiliate of the Company, any owner
of record or beneficially of more than 5% of any class of voting securities of the Company, or security holder is a party adverse to
the Company or has a material interest adverse to the Company. The Company’s property is not the subject of any pending legal proceedings.
Item
1A. Risk Factors.
We
are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information under
this item.
Item
2. Unregistered Sales Of Equity Securities And Use Of Proceeds
There
were no sales of equity securities during the period covered by this Quarterly Report that were not registered under the Securities Act
and were not previously reported in a Current Report on Form 8-K filed by the Company.
26
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosure
Not
applicable.
Item
5. Other Information
During
the three months ended September 30, 2025, none of the Company’s directors or officers adopted or terminated any contract, instruction,
or written plan for the purchase or sale of our securities intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under
the Exchange Act or any non-Rule 10b5-1 trading arrangements as defined in Item 408(a) of Regulation S-K.
Item
6. Exhibits.
Exhibit
Number
Description
31.1*
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act
31.2*
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act
32.1*
Certification of 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*
Certification of 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
101.INS*
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 Inline XBRL and contained in Exhibit 101)
*
Filed herewith
27
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.
Date:
November 14, 2025
CURANEX
PHARMACEUTICALS INC
By:
/s/
Jun Liu
Name:
Jun
Liu
Title:
Chief
Executive Officer and President
(Principal
Executive Officer)
Dated:
November 14, 2025
By:
/s/
Haiyan Yang
Name:
Haiyan
Yang
Title:
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
28
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.