UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For
the quarterly period ended
For the transition period from July 1, 2025 to September 30, 2025
Commission
File No.
(Exact name of registrant as specified in its charter)
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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:
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The
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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 ☐
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).
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 |
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Smaller reporting company |
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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 shares of common stock, par value $ 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 |
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| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ |
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$ |
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| Prepaid Expenses |
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| Other Current Assets |
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| Total current assets |
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| Right-of-Use Asset |
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| TOTAL ASSETS |
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| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accrued expenses |
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| Accounts payable |
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| Lease Liability, current |
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| Total current liabilities |
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| TOTAL LIABILITIES |
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| Shareholders’ equity | ||||||||
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Common stock,
shares authorized; $
par value;
shares issued and outstanding as of September 30, 2025, and December 31, 2024 |
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| Preferred stock, shares authorized; $ par value; shares issued and outstanding as of September 30, 2025, and December 31, 2024 |
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| Common stock to be issued |
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| Additional paid-in capital |
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| Accumulated deficit |
(
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) |
(
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| TOTAL SHAREHOLDERS’ EQUITY |
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| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ |
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$ |
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The accompanying notes are an integral part of these unaudited financial statements.
| 6 |
CURANEX PHARMACEUTICALS INC
STATEMENTS OF OPERATIONS
(unaudited)
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For the Three Months Ended
September 30, |
For the Nine Months Ended
September 30, |
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| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| General & administrative |
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| Research & Development |
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| Total operating expenses |
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| Loss from operations |
(
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) |
(
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(
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(
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| Interest Expense |
(
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) |
(
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) | ||||||||||||
| Other income |
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| Net Loss | $ |
(
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) | $ |
(
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) | $ |
(
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) | $ |
(
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) | ||||
| Net loss per common share: Basic and Diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average number of common shares outstanding: Basic and Diluted | ||||||||||||||||
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 |
|
$ |
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$ | $ |
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$ |
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$ |
(
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) | $ |
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|||||||||||||||||||
| Issuance of common stock | - |
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| Net loss | - | - |
(
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) |
(
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) | ||||||||||||||||||||||||||
| Balance at March 31, 2024 |
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$ |
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$ | $ |
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$ |
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$ |
(
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) | $ |
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| Issuance of common stock |
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$ |
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- | $ |
(
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) | $ |
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$ |
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| Issuance of preferred stock | - |
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$ |
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| Net loss | - | - |
(
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(
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| Balance at June 30, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
(
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) | $ |
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| Net loss | - | - |
(
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) |
(
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) | ||||||||||||||||||||||||||
| Balance at September 30, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
(
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) | $ |
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| Balance at December 31, 2024 | 24,000,000 | $ |
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1,000,000 | $ |
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$ |
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$ |
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$ |
(
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) | $ |
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| Net loss | - | - |
(
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) |
(
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) | ||||||||||||||||||||||||||
| Balance at March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
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$ |
(
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) | $ |
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| Net loss | - | - |
(
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) |
(
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) | ||||||||||||||||||||||||||
| Balance at June 30, 2025 |
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$ |
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$ |
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$ |
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$ |
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$ |
(
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) | $ |
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| Issuance of common stock |
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$ |
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- | $ |
(
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) | $ |
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$ |
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| Net loss | - | - |
(
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) |
(
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| Balance at September 30, 2025 |
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$ |
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$ |
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$ | $ |
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$ |
(
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) | $ |
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The accompanying notes are an integral part of these unaudited financial statements.
| 8 |
CURANEX PHARMACEUTICALS INC
STATEMENTS OF CASH FLOWS
(unaudited)
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For the Nine Months Ended September 30, |
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| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss for the period | $ |
(
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) | $ |
(
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) | ||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||
| Amortization of right-of-use assets |
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| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses |
(
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) | ||||||
| Lease liabilities |
(
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| Accounts payable |
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| Accrued expenses |
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(
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| Other current assets |
(
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| NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES |
(
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(
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| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Issuance of common stock |
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| Issuance of preferred stock |
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| Proceeds from issuance of common stock, net of underwriting costs |
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| Payment offering costs |
(
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) | ||||||
| NET CASH PROVIDED BY FINANCING ACTIVITIES |
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| NET INCREASE (DECREASE) IN CASH |
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| Cash at beginning of period |
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| CASH AT END OF PERIOD | $ |
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$ |
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| Supplemental schedule of cash flow information: | ||||||||
| Non-cash investing & financing activities: | ||||||||
| Issuance of common stock with a non-cash payment | $ | $ |
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| Recognition of right-of-use asset in exchange for lease liability |
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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 $
| 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 $
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 |
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
shares of its common stock, par value
$
per share, at a public offering price of $
per share. This offering generated gross proceeds of $
In
connection with the IPO, total offering costs were approximately $
After
deducting total underwriting discounts, commissions, and offering expenses, the Company received net proceeds of approximately $
Over-Allotment Option
On
September 12, 2025, the underwriters exercised their option to purchase an additional
shares of the Company’s common stock
at the same public offering price of $
per share, resulting in gross proceeds of $
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:
|
As of September 30, 2025 |
As of December 31, 2024 |
|||||||
| Accounting fees | $ |
|
$ |
|
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| Payroll expenses |
|
|||||||
| Tax fees |
|
|
||||||
| Total Accrued Expenses | $ |
|
$ |
|
||||
3. Prepaid expenses
A summary of prepaid expenses is as follows:
|
As of September 30, 2025 |
As of December 31, 2024 |
|||||||
| Insurance | $ |
|
$ | |||||
| R&D |
|
|||||||
| Other |
|
|
||||||
| Total Prepaid Expenses | $ |
|
$ |
|
||||
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:
|
As of September 30, 2025 |
As of December 31, 2024 |
|||||||
| Deferred IPO Expenses: | ||||||||
| Legal fees | $ | $ |
|
|||||
| Underwriting fees |
|
|||||||
| Other IPO related expenses |
|
|||||||
| Other Current Asset | $ | $ |
|
|||||
| 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
The following summarizes information about the Company’s lease as of September 30, 2025 and December 31, 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 | $ |
|
$ | $ |
|
$ | ||||||||||
| As of September 30, 2025 | As of December 31, 2024 | |||||||
| Amount recognized in the balance sheets | ||||||||
| Right-of-use assets | $ |
|
$ | |||||
| Operating lease liabilities |
|
|||||||
| Amount recognized in the income statements | ||||||||
| Operating lease expense | $ |
|
$ | - | ||||
| Cash paid for amounts included in the measurement of lease liabilities | ||||||||
| Operating lease expense | $ |
|
$ | |||||
| Lease commitment | ||||||||
| 2025 | $ |
|
$ | |||||
| 2026 |
|
|||||||
| Total future minimum lease payments |
|
|||||||
| less imputed interest |
(
|
) | ||||||
| Present value of lease liabilities | $ |
|
$ | |||||
| Supplement information | ||||||||
| Discount rate |
|
% | n.a. | |||||
| Remaining lease term |
|
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 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
|
For the Three Months Ended
September 30, |
For the Nine Months Ended
September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Pre-tax book loss | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||
| Permanent differences: | ||||||||||||||||
| Impairment loss | ||||||||||||||||
| Change in valuation allowance |
|
|
|
|
||||||||||||
| Total tax expense | $ | $ | $ | $ | ||||||||||||
Deferred income tax assets as of September 30, 2025 and December 31, 2024, are as follows:
|
As of September 30, 2025 |
As of December 31, 2024 |
|||||||
| Net operating losses carry forwards |
|
$ |
|
|||||
| Others | ||||||||
| Total deferred tax assets |
|
|
||||||
| Less valuation allowance |
(
|
) |
(
|
) | ||||
| 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 $
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 $
| 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 $
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 $
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. Shareholders’ Equity
Common Stock
The Company is authorized to issue shares of common stock, par value $ 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 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:
| ● | shares of common stock issued upon the closing of the IPO on August 27, 2025. | |
| ● | additional shares of common stock issued on September 12, 2025 upon the underwriters’ exercise of their over-allotment option. | |
| ● | 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 shares of its common stock issued and outstanding as of September 30, 2025, including an aggregate of 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
Subscriptions Received – Shares to be Issued
In
2019, the Company received $
in cash from an existing investor for a subscription to common stock representing
Following the successful completion of the IPO, the Company issued shares of common stock during the quarter ended September 30, 2025 to settle this subscription in full. As of September 30, 2025, there were remaining shares or amounts recorded as “common stock to be issued.”
Preferred Stock
The Company is authorized to issue shares of preferred stock at $ 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
shares of Series A Super Voting Preferred Stock
(“Series A Preferred Stock”) at the par value of $
per share.
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
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 |