[10-Q] NEONC TECHNOLOGIES HOLDINGS, INC. Quarterly Earnings Report
NeOnc Technologies Holdings (NTHI) filed its Q3 2025 10‑Q, reporting a net loss of $8.6 million for the quarter and $46.6 million year‑to‑date. Operating expenses rose on non‑cash items, including $5.0 million in Q3 share‑based compensation and $25.96 million year‑to‑date. Cash and cash equivalents were $1.51 million at September 30, 2025, with a shareholders’ deficit of $11.81 million and accumulated deficit of $97.23 million. The company stated that these conditions raise substantial doubt about its ability to continue as a going concern.
NeOnc completed its Nasdaq listing in March and received $11.64 million from a private placement after effectiveness. It also drew net proceeds of $3.20 million from an equity purchase agreement (447,527 shares) and issued $4.0 million of convertible notes with a 20% original issue discount, later extended once. Current liabilities include an accrued related‑party advisory fee of $3.68 million and a litigation settlement payable of $4.75 million. NIH grants of $400,000 and about $1.01 million were awarded late in the quarter; no related revenue was recognized.
- None.
- Going concern: Substantial doubt disclosed about the ability to continue operations
- Large net loss: $46.6M year-to-date; $8.6M in Q3 2025
- Low cash vs. liabilities: $1.51M cash against $15.90M total liabilities
- Costly financing: $4.0M convertible notes with 20% OID and short-term extension
- Accrued obligations: $3.68M advisory fee (related party) and $4.75M litigation payable
Insights
Losses and low cash drive a going‑concern warning.
NTHI posted a Q3 net loss of
Funding actions included release of
Future activity depends on access to capital through the equity line and potential additional financings. NIH awards of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
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For the quarterly period ended
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Explanatory Note
In this report, the term “Company”, “we”, “us”, and “our refers to NEONC TECHNOLOGIES HOLDINGS, INC. and its wholly-owned subsidiary.
This quarterly report on Form 10-Q includes forward-looking statements within the meaning of the federal securities laws. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the operating results and financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, statements about:
| ● | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
| ● | our estimates of the size of our market opportunities; |
| ● | our ability to effectively manage our growth; |
| ● | our ability to successfully enter new markets, manage our growth expansion and comply with any applicable laws and regulations; |
| ● | the effects of increased competition from our market competitors; |
| ● | significant disruption in, or breach in security of, our information technology systems and resultant interruptions in service and any related impact on our reputation; |
| ● | the attraction and retention of qualified employees and key personnel; |
| ● | the effectiveness of our internal controls; |
| ● | changes in laws and government regulation affecting our business; |
| ● | the impact of adverse economic conditions; |
| ● | the sufficiency of our cash and cash equivalents to meet our liquidity needs and service our indebtedness; and |
| ● | outcomes of legal or administrative proceedings. |
In addition, in this report, the words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “predict,” “potential” and similar expressions, as they relate to our Company, our business and our management, are intended to identify forward-looking statements. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.
Forward-looking statements speak only as of the date of this report. You should not put undue reliance on any forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
You should read this report and the documents that we reference in this report and have filed with the Securities and Exchange Commission (“SEC”) as exhibits to this report with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.
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Table of Contents
| Page | ||
| Part I - Financial Information | 1 | |
| Item 1. Financial Statements | 1 | |
| Condensed Consolidated Balance Sheet (Unaudited) | 1 | |
| Condensed Consolidated Statement of Operations (Unaudited) | 2 | |
| Condensed Consolidated Statement of Stockholders’ Deficit (Unaudited) | 3 | |
| Condensed Consolidated Statement of Cash Flows (Unaudited) | 5 | |
| Notes to Condensed Consolidated Financial Statements (Unaudited) | 6 | |
| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 22 | |
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 33 | |
| Item 4. Controls and Procedures | 33 | |
| Part II - Other Information | 35 | |
| Item 1. Legal Proceedings | 35 | |
| Item 1A. Risk Factors | 36 | |
| Item 2. Unregistered Sales of Equity Securities | 36 | |
| Item 3. Defaults Upon Senior Securities | 37 | |
| Item 4. Mine Safety Disclosures | 37 | |
| Item 5. Other Information | 37 | |
| Item 6. Exhibit Index | 38 | |
| Signatures | 39 |
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
NEONC TECHNOLOGIES HOLDINGS, INC.
Condensed Consolidated Balance Sheets
| September 30, 2025 |
December 31, 2024 |
|||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Deferred offering costs – current | ||||||||
| Debt issuance costs – current | ||||||||
| Prepaid expenses and other | ||||||||
| Total Current Assets | ||||||||
| Non-Current Assets | ||||||||
| Debt issuance costs – net of current portion | ||||||||
| Right of use asset – operating lease | - | |||||||
| Other assets | - | |||||||
| Total Assets | $ | $ | ||||||
| Liabilities and Shareholders’ Deficit | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Accounts payable – related parties | ||||||||
| Accrued advisory fee – related party | - | |||||||
| Litigation settlement payable | ||||||||
| Convertible promissory notes, net of discount | - | |||||||
| Accrued compensation | ||||||||
| Lease liability, current | - | |||||||
| Total Current Liabilities | ||||||||
| Long Term Liabilities | ||||||||
| Lease liability, net of current portion | - | |||||||
| Total Liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Shareholders’ Deficit: | ||||||||
| Preferred stock, $ |
- | - | ||||||
| Common stock, $ |
||||||||
| Additional paid in capital | ||||||||
| Accumulated deficit | ( |
) | ( |
) | ||||
| Total Shareholders’ Deficit | ( |
) | ( |
) | ||||
| Total Liabilities and Shareholders’ Deficit | $ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements.
1
NEONC TECHNOLOGIES HOLDINGS, INC.
Condensed Consolidated Statements of Operations (Unaudited)
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Revenue | $ | - | $ | - | $ | $ | ||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| Legal and professional | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Share based compensation | - | - | ||||||||||||||
| Advisory fees | - | |||||||||||||||
| Total Operating Expenses | ||||||||||||||||
| Loss From Operations | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest and other income | ||||||||||||||||
| Amortization of debt issuance, and deferred offering costs | ( |
) | - | ( |
) | - | ||||||||||
| Interest expense - related parties | ( |
) | - | ( |
) | ( |
) | |||||||||
| Loss on extinguishment of Bridge loan - related party | - | - | - | ( |
) | |||||||||||
| Loss on change in fair value of derivative liability related to sales of common stock through equity line of credit | ( |
) | - | ( |
) | - | ||||||||||
| Net Loss | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Loss per share: | ||||||||||||||||
| Net loss per share - basic and diluted | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Weighted average number of common stock outstanding during the period - basic and diluted | ||||||||||||||||
See accompanying notes to the condensed consolidated financial statements.
2
NEONC TECHNOLOGIES HOLDINGS, INC.
Condensed Consolidated Statements of Changes in Shareholders’ Deficit (Unaudited)
Three and Nine Months Ended September 30, 2024
| Common Stock | Additional Paid In |
Accumulated | Total Shareholders’ |
|||||||||||||||||
| Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||
| Balance - January 1, 2024 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Net loss | - | - | - | ( |
) | ( |
) | |||||||||||||
| Balance - March 31, 2024 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Sale of common stock, net of offering costs | - | |||||||||||||||||||
| Common stock issued for bridge loan conversion | - | |||||||||||||||||||
| Common stock issued for settlement of vendor payable | - | |||||||||||||||||||
| Common stock issued for settlement of accrued compensation | - | |||||||||||||||||||
| Net loss | - | - | - | ( |
) | ( |
) | |||||||||||||
| Balance - June 30, 2024 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Sale of common stock, net of offering costs | - | |||||||||||||||||||
| Common stock issued for settlement of vendor payable | - | |||||||||||||||||||
| Common stock issued for note payable conversion | - | - | ||||||||||||||||||
| Net loss | ( |
) | ( |
) | ||||||||||||||||
| Balance - September 30, 2024 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
See accompanying notes to the condensed consolidated financial statements.
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NEONC TECHNOLOGIES HOLDINGS, INC.
Condensed Consolidated Statements of Changes in Shareholders’ Deficit (Unaudited)
Three and Nine Months Ended September 30, 2025
| Common Stock | Additional Paid In |
Accumulated | Total Shareholders’ |
|||||||||||||||||
| Shares | Amount | Capital | Deficit | Deficit | ||||||||||||||||
| Balance - January 1, 2025 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Sale of common stock, net of offering costs | - | |||||||||||||||||||
| Common stock issued for advisory services | - | |||||||||||||||||||
| Cashless exercise of warrants | ( |
) | - | - | ||||||||||||||||
| Share based compensation, as restated | - | - | - | |||||||||||||||||
| Net loss | ( |
) | ( |
) | ||||||||||||||||
| Balance - March 31, 2025 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Share based compensation | - | - | - | |||||||||||||||||
| Other | ( |
) | - | ( |
) | |||||||||||||||
| Net loss | - | - | - | ( |
) | ( |
) | |||||||||||||
| Balance - June 30, 2025 | $ | $ | $ | ( |
) | $ | ( |
) | ||||||||||||
| Share based compensation | - | - | - | |||||||||||||||||
| Proceeds from sale of common stock pursuant to equity line of credit | - | |||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||
| Balance - September 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
See accompanying notes to the condensed consolidated financial statements.
4
NEONC TECHNOLOGIES HOLDINGS, INC.
Condensed Consolidated Statements of Cash Flows (Unaudited)
| For the Nine Months Ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Increase in bridge loan - expenses paid by bridge loan provider on behalf of the Company | - | |||||||
| Accretion of original issue discount on bridge loans - related party | ||||||||
| Accretion of original issue discount on convertible promissory note | - | |||||||
| Write off deferred issuance costs | - | |||||||
| Share based compensation - restricted stock | - | |||||||
| Loss on extinguishment of bridge loan | - | |||||||
| Loss on change in fair value of derivative liability | - | |||||||
| Amortization of debt issuance costs and deferred offering costs | - | |||||||
| Amortization of right of use asset | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses | ( |
) | ( |
) | ||||
| Other assets | ( |
) | - | |||||
| Accrued compensation | ( |
) | ( |
) | ||||
| Lease liability | ( |
) | ( |
) | ||||
| Accrued advisory fee | - | |||||||
| Accounts payable and accounts payable - related parties and accrued expenses | ( |
) | ||||||
| Net cash used in operating activities | ( |
) | ( |
) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from the sale of common stock | ||||||||
| Proceeds from related party loan | ||||||||
| Repayment of related party loan | ( |
) | ( |
) | ||||
| Deferred offering costs | - | ( |
) | |||||
| Proceeds from sale of common stock pursuant to equity purchase agreement | - | |||||||
| Proceeds from convertible notes payable | - | |||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash and cash equivalents | ||||||||
| Cash and cash equivalents - beginning of period | ||||||||
| Cash and cash equivalents - end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash financing activities: | ||||||||
| Original issue discount on bridge loan - related party | $ | $ | ||||||
| Right of use asset, at lease commencement | $ | - | $ | |||||
| Share issued in connection with advisory services | $ | - | ||||||
| Reclassified of deferred offering costs to APIC at the completion of the offering | $ | $ | - | |||||
| Increase in bridge loan payable - prepaid and deferred offering costs paid directly by bridge loan provider on behalf of the Company | $ | - | $ | |||||
| Conversion of bridge loan to common stock | $ | - | $ | |||||
| Conversion of accrued compensation | $ | - | $ | |||||
| Conversion of account payable to common stock | $ | - | $ | |||||
See accompanying notes to the condensed consolidated financial statements.
5
Note 1 – Description of Business and Liquidity
NeOnc Technologies, Inc. (“NTI”) was incorporated on April 13, 2005, as a California corporation. On April 7, 2023, NTI merged into NeOnc Technologies Holdings, Inc. (“NTHI” and the combined entities “NeOnc” or the “Company”). NTHI was incorporated January 5, 2023, as a Delaware Corporation.
NeOnc is the developer of a novel molecular technology that provides enhanced targeted delivery of technologies for treating central nervous system diseases. The Company’s lead product, NEO100 is in clinical trials treating glioblastoma, and has Orphan Drug and Fast Track designation from the United States Food and Drug Administration (“FDA”). The Company licensed the underlying technology from the University of Southern California. (“USC”).
On October 11, 2024, the Company entered into an agreement with a broker dealer to serve as placement agent and provide broker services in connection with the proposed sale of common stock up to $
Liquidity
The accompanying financial statements have been prepared on the basis that the Company is a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. At September 30, 2025, the Company had cash totaling $
The Company does not have sufficient available capital to fund operations for a period of twelve months from the issuance date of these financial statements. Although the Company has established agreements with several funding potential sources (see Notes 6, 7 and 10), the Company does not know whether additional financing will be available when needed, whether it will be available on favorable terms, or if it will be available at all. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Other risks and uncertainties
The Company is subject to risks common to biopharmaceutical companies, including, but not limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, product liability, and the uncertainty of market acceptance of products and the potential need to obtain additional financing. The Company is dependent on third-party suppliers and, in some cases, single-source suppliers. The Company’s products require approval or clearance from the FDA prior to commencing commercial sales in the United States. Approvals or clearances are also required in foreign jurisdictions where the Company may license or sell its products. There can be no assurance that the Company’s products will receive all required approvals or clearances.
There can be no assurance that the Company’s products, if approved, will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost with appropriate performance characteristics or that such products will be successfully marketed, if at all.
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Note 2 – Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation
The unaudited condensed consolidated financial statements contained herein have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and note disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to SEC rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading. Accordingly, the condensed consolidated financial statements reflect all normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the results of interim periods and may not include all disclosures required by accounting principles generally accepted in the United States (“GAAP”). The information as of September 30, 2025, and for the three and nine months ended September 30, 2025, is unaudited, whereas the consolidated balance sheet as of December 31, 2024, is derived from the Company’s audited condensed consolidated financial statements as of that date. These condensed consolidated financial statements and notes hereto should be read in conjunction with the consolidated financial statements and notes thereto included in the audited financial statements for the year ended December 31, 2024, included on Form S-1, filed with the SEC on February 26, 2025.
The results of operations for the interim periods presented are not necessarily indicative of results to be expected for any other interim period or for the year.
Principles of consolidation
The accompanying condensed consolidated financial statements and related notes to the condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All significant intercompany balances and transactions have been eliminated in consolidation.
Use of estimates
In preparing the Company’s financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Cash and cash equivalents
The Company, from time to time during the period covered by these financial statements, may have had bank account balances in excess of federally insured limits. The Company has not experienced losses in such accounts. For the statements of cash flows, the Company considers all short-term investments purchased with a maturity of three months or less to be cash equivalents. At September 30, 2025 and December 31, 2024, the Company has money market funds in the amount of approximately $
Deferred offering costs
The Company complies with the requirements of the ASC 340-10-S99-1 and SEC Staff Accounting Bulletin (“SAB”) Topic 5A “Expenses of Offering”. Offering costs consist principally of professional and registration fees incurred through the condensed consolidated balance sheet dated December 31, 2024 that are related to the planned public offering of its securities (See Note 3). These costs have been capitalized and were recognized in equity upon the completion of the securities offering. At September 30, 2025, deferred offering costs consist of the fair value of shares issued in conjunction with the issuance of an equity purchase agreement. These costs have been capitalized and are being amortized over the term of the availability of the equity purchase agreement (Note 6). If planned offerings are terminated, the related capitalized deferred offering costs are written off.
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Debt issuance costs
Debt issuance costs represent costs directly attributable to warrants issued for a line of credit commitment. Such costs represent the fair value of warrants issued to the debt facility provider and are amortized to the statement of operations on a straight-line basis which approximates the effective interest rate method, over the term of the debt instrument. The debt issuance costs, net of accumulated amortization, are classified as a long-term asset until the Company begins to draw funds from the debt facility, in accordance with ASC 815: “Derivatives and Hedging”. At such time, the pro-rata portion of amounts borrowed as compared to the total debt facility will be reclassified as a contra-debt account.
Warrants
The Company evaluates the terms of warrants issued and determines if the instrument requires liability or equity accounting classification under ASC 815: Derivatives and Hedging and ASC 480: “Distinguishing Liabilities from Equity”.
Leases
The Company classifies its leases either as operating or financing lease at inception. The company has an operating lease. This lease is recorded as an operating lease, right of use (ROU) assets and operating lease liabilities on the accompanying consolidated balance sheets.
Operating lease ROU assets and the related lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. The operating lease ROU assets also include lease incentives and initial direct costs incurred. For operating leases, interest on the lease liability and the amortization of ROU asset result in straight-line rent expense over the lease term. Leases may include options to extend or terminate the lease which are included in the ROU operating lease assets and operating lease liability when they are reasonably certain of exercise. Certain leases include lease and non-leased components, which are accounted for as one single lease component. Operating lease expense associated with minimum lease payments is recognized on a straight-line basis over the lease term.
Fair value measurements
FASB ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”), defines fair value, the methods used to measure fair value and the expanded disclosures about fair value measurements. Fair value is the price received to sell an asset or paid to transfer a liability in an orderly transaction between the buyer and the seller at the measurement date. In determining fair value, the valuation techniques consistent with the market approach, income approach and cost approach shall be used to measure fair value. ASC 820 establishes a fair value hierarchy for inputs, representing the assumptions the buyer and seller use in pricing the asset or liability. These inputs are further defined as observable and unobservable inputs. Observable inputs are those that the buyer and seller would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs reflect the Company’s assumptions about the inputs the buyer and seller would use to price the asset or liability developed based on the best information available in the circumstances.
The Company’s money market funds are valued at quoted prices in active markets and are classified as Level 1 within the fair value hierarchy. The carrying value of the Company’s accounts payable approximates its fair value because of the short-term nature of these financial instruments. The note payable - related party is reported at fair value as the Company elected the fair value option for such a note (see Note 4).
The fair value hierarchy is categorized into three levels based on the inputs as follows:
| ● | Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. Valuation adjustments and block discounts are not being applied. Since valuations are based on quoted prices that are readily and regularly available in an active market, the valuation of these securities does not entail a significant degree of judgment. |
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| ● | Level 2 — Valuations based on (i) quoted prices in active markets for similar assets and liabilities, (ii) quoted prices in markets that are not active for identical or similar assets, (iii) inputs other than quoted prices for the assets or liabilities, or (iv) inputs that are derived principally from or corroborated by the market through correlation or other means. |
| ● | Level 3 — Valuations based on unobservable inputs and significant to the overall fair value measurement. |
Revenue
The
Company recognized point-in-time revenue of $
Research and development
Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third-party contractors performing research, conducting clinical trials, and manufacturing drug supplies and materials.
Patent costs
All patent-related costs incurred in filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as legal and professional expenses in the accompanying consolidated statements of operations.
Share-based compensation
The Company has granted stock options and common stock to employees, non-employee consultants and non-employee members of our Board of Directors. The Company measures the compensation cost associated with all share-based payments based on the grant date fair values. Compensation costs associated with grants of common stock are measured at fair value at the date of grant, which has historically been the most recent price paid by investors to purchase shares of the Company’s common stock prior to such grant. The Company recognizes share-based compensation expense over the requisite service period of each award, which generally equals the vesting period, using the straight-line method for awards that contain only service conditions. If the stock grant is contingent upon events that have not yet happened, then the grant is not considered issued. If an award holder leaves the company prior to vesting, and adjustment of the compensation expense will be made to reflect only those awards that vested.
The Company recognizes the stock-based compensation expense for the restricted stock units (“RSU”) based upon the fair value of the common stock at the date of the grant. The expense is recognized over the service period provided in the RSU awards, however expense will not be recognized until the listing date (“Listing Date”), as prior to such date it was not probable that condition to commence vesting would be met.
When the vesting contingency is met, the Company will commence to recognize expense related to the RSU’s. For time based vested RSU’s, the expense will be recognized on a straight-line basis from the grant date to the last vesting date. The expense recognized will include the expense from the date of the grant over the total vesting period and reflect the portion attributable to the service provided prior to the listing. For performance based RSU’s, the Company will determine the probability of the contingency being met each quarter end based upon an assessment of progress made under such performance criteria.
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Net loss per share
Basic net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of common stock outstanding during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common stock outstanding during the period. For periods in which the Company reports a net loss, the diluted net loss per share is the same as basic net loss per share.
For the nine months ended September 30, 2025 there are potentially dilutive securities outstanding of
Income taxes
The Company recognizes federal, state, and foreign current tax liabilities or assets based on its estimate of taxes payable to or refundable by tax authorities in the current fiscal year. For the periods ended September 30, 2025 and 2024, there is no current tax provision due to losses generated. The Company also recognizes federal and state deferred tax liabilities or assets based on the Company’s estimate of future tax effects attributable to temporary differences and carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years those temporary differences are expected to be recovered or settled.
Deferred tax assets are reduced by valuation allowances if, based on the consideration of all available evidence, it is more likely than not that some portion of the deferred tax asset will not be realized. The Company evaluates deferred income taxes quarterly to determine if valuation allowances are required by considering available evidence. If the Company is unable to generate sufficient future taxable income in certain tax jurisdictions, or if there is a material change in the actual effective tax rates or time period within which the underlying temporary differences become taxable or deductible, the Company could be required to increase its valuation allowance against its deferred tax assets which could result in an increase in the Company’s effective tax rate and an adverse impact on operating results. The Company will continue to evaluate the necessity of the valuation allowance based on the remaining deferred tax assets. The difference between the statutory and effective rates for the three and nine months ended September 30, 2025 and 2024 is a result of the Company applying a full valuation allowance against any deferred tax assets as a result of net operating losses due to uncertainties surrounding the usability of such net operating losses. The ability to utilize such net operating loss carry forwards may be limited due to possible changes in ownership as defined under Internal Revenue Code section 382.
The Company follows the accounting guidance related to financial statement recognition, measurement and disclosure of uncertain tax positions. The Company recognizes the impact of an uncertain income tax position on an income tax return at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it is less than 50% likely to be sustained. Uncertain tax positions are recognized in the first subsequent financial reporting period in which that threshold is met or from changes in circumstances such as the expiration of applicable statutes of limitations. The Company will recognize interest and penalties related to tax positions in income tax expense.
Segment Reporting
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” The standard expands reportable segment disclosure requirements for public business entities primarily through enhanced disclosures about significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit (referred to as the “significant expense principle”). The standard has been adopted for our fiscal year 2024 annual financial statements and interim financial statements thereafter and have applied this standard retrospectively for all prior periods presented in the financial statements.
Reclassifications
Certain reclassifications of previously reported amounts have been made to conform to the current year presentation. Such reclassifications did not impact net income as previously reported.
10
Note 3 – Related party transactions
AFH Holdings and Advisory, LLC advisory agreement
On December 19, 2022, the Company entered into an advisory agreement with AFH Holdings and Advisory, LLC, an affiliate to assist the Company in connection with its intent to affect a public listing. AFH was retained to assist the Company with investor presentations and decks, coordinate the retention of an investment banker for an initial public offering, identify legal and accounting professionals to assist in connection with such public offering, identify investor relations/public relations firms, advise on private capital markets activities prior to the initial public offering and coordinate the closing process for the offering.
On July 12, 2024, the Company amended the AFH advisory agreement section to allow for an upfront payment on the Listing Date of $
On March 26, 2025, and as a result of the listing of the Company on Nasdaq, the Company incurred $
In addition, the Company agreed to retain AFH as an exclusive advisor to the Company on all financing and mergers and acquisitions for a period of two (2) years from the closing of the private securities offering.
Transactions with USC
The Company maintains a license agreement with USC, under which the Company will pay USC an annual patent maintenance fee of $
The Company also utilizes laboratory and patent maintenance services from USC. The Company incurred $
Accrued compensation
The amount accrued for the management team, including related payroll taxes, was $
Note 4 – Related Party Loans Payable
Bridge Loan
In April 2023, the Company entered into a non-interest bearing, non-convertible promissory note with HCWG LLC (the “Bridge Loan”). Borrowings under the Bridge Loan carry a 50% (or 1 times cash amounts borrowed) original issue discount (“OID”) on principal and through subsequent amendments the maximum cash borrowing was increased to $
11
On June 14, 2024, the Company reached an
agreement with HCWG LLC to convert the outstanding principal and interest on the Bridge Loan into
Through
June 30, 2024, the Company had received under the Bridge Loan an aggregate of $
| Schedule of convertible debt | |||||
|
For the Year Ended |
|||||
| Bridge loan – carrying value | |||||
| Balance – January 1, 2024 | $ | ||||
| Borrowings | |||||
| OID | |||||
| Repayments | ( |
) | |||
| Total principal outstanding before conversion | |||||
| Conversion to common stock (June, 14, 2024) | ( |
) | |||
| Principal outstanding – December 31, 2024 | $ | - | |||
Advances from Executive Chairman
In February 2025, our Executive Chairman advanced the Company approximately $
NOTE 5 – Convertible Debt
On July 16 and July 18, 2025, the Company entered
into a series of convertible promissory notes with a group of investors for the aggregate purchase price of $
In accordance with ASU 2020-06, the Company accounts for the convertible notes as a single liability instrument. The notes are recorded at amortized cost, and interest expense is recognized using the effective interest method. The effective interest rate on the notes is approximately 7.72% per annum, which reflects the amortization of issuance costs and original issuance discount.
Through September 30, 2025, interest expense of
$
12
The following table summarizes the Company’s outstanding Notes as of September 30, 2025:
| Schedule of convertible debt | ||||
For the Nine Months Ended | ||||
| Purchase price of convertible promissory notes | $ | |||
| Less: unamortized original issuance discount | ( | ) | ||
| Less: unamortized debt issuance cost | ( | ) | ||
| Net convertible promissory note | $ | |||
Note 6 – Leases
On February 1, 2024, the Company entered a 24-month lease for office space, which calls for a monthly base rent of $
In April 2025, the Company entered into a 63 month lease for office space which calls for a monthly base rent of $
The Company recorded lease expense of $
The following are the expected maturities of lease liabilities for operating leases as of September 30, 2025:
| Schedule of lease liabilities for operating leases | ||||
| Twelve Months Ended December 31, | ||||
| 2025 (three months) | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Thereafter | ||||
| Total | ||||
| Less: interest | ( |
) | ||
| Present value of lease liability | ||||
| Less: current portion | ( |
) | ||
| Noncurrent portion | $ |
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Note 7 – Common and Preferred Stock
NTHI is authorized to issue
During
the nine months ended September 30, 2025, the Company sold
Private Placement
On October 11, 2024, the
Under this agreement, through December 31, 2024, the Company closed on commitments from investors to purchase
In connection with the agreement, the Company paid $
14
Advisory Services
On
October 3, 2024, as amended on January 23, 2025, the Company entered into an agreement with Broker, for financial advisory
and investment banking services in connection with a direct listing of the Company’s common stock on the Nasdaq Global Market
or other major US market. The agreement provides for a one-time fee of $250,000 payable three days after the direct listing and the
issuance of 30,000 shares of common stock (which are restricted until the shares are registered by filing a resale S-1 within 30
days after the effective date of the direct listing). In addition, the Company agreed to pay up to $
Deferred Offering Costs – Direct Listing
Deferred offering costs relating to the Private Placement and direct listing at December 31, 2024 totaled $
Equity Purchase Agreement
On October 22, 2024, the Company entered into an equity purchase agreement (the “Equity Purchase Agreement”) with Mast Hill Fund, LP (“Mast Hill”) pursuant to which the Company may sell and issue to Mast Hill, and the investor may purchase from the Company, up to $50,000,000 of Company’s common stock. Under the Equity Purchase Agreement, the Company has the right, but not the obligation, to direct Mast Hill, by its delivery to the Mast Hill of a Put Notice from time to time, to purchase Put Shares (i) in a minimum amount not less than $50,000 and (ii) in a maximum amount up to the lesser of (a) $750,000 or (b) 150% of the average trading volume of the Company’s common stock during the five trading days immediately preceding the Put Date.
The actual amount of proceeds the Company receives pursuant to each Put Notice (each, the “Put Amount”) is determined by multiplying the Put Amount requested by the applicable purchase price. The purchase price for each of the Put Shares equals 95% of the Market Price, (as defined below) less the Clearing Costs (as defined below). Market Price is the lowest volume weighted average prices of the Company’s common stock on its principal market on any trading day during the Valuation Period (as defined below). The Valuation Period is the five trading days immediately following the date on which Mast Hill receives the Put Shares in its brokerage account. Clearing Costs are all the fees incurred by Mast Hill with respect to its brokerage firm, clearing firm, Company transfer agent fees, and attorney fees, with respect to the Put Shares.
The term of the Equity Purchase Agreement
commenced on the effective date of the direct listing and will terminate on the earlier of (i) the date on which the Mast Hill shall
have purchased Put Shares equal to the $50,000,000, (ii) twenty-four (24) months after the date of the Equity Purchase Agreement,
(iii) written notice of termination by the Company to Mast Hill, (iv) this Registration Statement is no longer effective after the
initial effective date of this Registration Statement, or (v) the date that, pursuant to or within the meaning of any Bankruptcy
Law, the Company commences a voluntary case or any Person commences a proceeding against the Company, a receiver, trustee, assignee,
liquidator or similar official is appointed for the Company or for all or substantially all of its property or the Company makes a
general assignment for the benefit of its creditors. For the three and nine months ended September 30, 2025, the Company sold
15
In connection with this agreement, we issued
Note 8 – Stock-Based Compensation
On April 12, 2023, the Company adopted the 2023 Equity Incentive Plan (the “2023 Plan”), which allows the issuance of up to
In January and February 2024,
On October 23, 2024, 200,000 RSUs were granted to each of the CEO and the Executive Chairman, for a total of
On March 26, 2025, 150,000 RSUs were granted to the three board members, in the amount of
Prior to March 26, 2025, the Company determined that no expense should be recognized for the RSUs since the contingency related to the commencement of vesting (i.e., the listing) of the RSUs had not been met. On March 26, 2025, the listing occurred, satisfying the contingency required for vesting to begin and defining the service period.
On June 1, 2025,
On June 5, 2025,
The Company determined the fair value of all the RSUs at their respective grant dates to be $
16
The activity related to RSUs is summarized as follows:
| Schedule of restricted stock units activity | ||||
| Restricted Stock Units | ||||
| Activity | RSUs Granted | |||
| 2024 | ||||
| January 1, 2024 | - | |||
| Granted | ||||
| Cancelled | ( |
) | ||
| December 31, 2024 | ||||
| 2025 | ||||
| Granted during nine months ended September 30, 2025 | ||||
| Forfeited | ( |
) | ||
| Balance at September 30, 2025 | ||||
| Released RSUs for nine months ended September 30, 2025 | - | |||
As of September 30, 2025,
Note 9 – Commitments and Contingencies
Line of Credit Commitment – Related Party
On
October 11, 2024, the Company entered into a Line of Credit Agreement (“the Agreement”) with HCWG for borrowings of
up to $
In connection with the agreement, the Company issued HCWG five-year warrants to purchase up to
The fair value of the warrants on the grant date was determined using the Black-Scholes valuation model, with the following key assumptions:
| ● | Fair value of common stock: $ |
| ● | Expected volatility: |
| ● | Risk-free interest rate: |
| ● | Term: |
The fair value of warrants at inception was $
17
Litigation
From time to time, the Company is involved in various disputes, claims, liens and litigation matters arising out of the normal course of business which could result in a material adverse effect on the Company’s combined financial position, results of operations or cash flows. Liabilities for loss contingencies arising from claims, assessments, litigation, fines and penalties and other sources are recorded when it is probable that liability has been incurred, and the amount of the assessment can be reasonably estimated. As of September 30, 2025 and December 31, 2024, the Company had no liabilities recorded for loss contingencies, except as below.
License Agreement - Orient EuroPharma Co., Ltd.
On November 8, 2013, the Company entered into a collaboration agreement (“Agreement”) with Orient EuroPharma Co., Ltd. (“OEP”), pursuant to which the parties will develop certain licensed products defined in the Agreement. NeOnc will license OEP the right to commercialize the Company’s drug NEO100, a highly purified form of perillyl alcohol (“Licensed Product”), in the territories specified in the license agreement (“Territory”).
In 2023, the Company sent notice to OEP indicating their intent to terminate the Agreement with OEP, after which OEP threatened litigation. On February 15, 2024, OEP and the Company entered into a settlement agreement whereas the Company and OEP terminated the Agreement in exchange for a payment in the amount of $
On June 6, 2023, a vendor filed a complaint against the Company for breach of contract in the Central District of California. The vendor alleged that the Company improperly terminated an Intellectual Property License and Supply Agreement (“IPLSA”) and that the Company also defrauded the vendor in connection with IPLSA. This matter was settled on October 16, 2023, and the Company agreed to pay the vendor $
On March 31, 2024, a vendor agreed to extend the payment until May 15, 2024 for payment of an additional $25,000, payable on demand. On July 25, 2024, the arbitrator granted the implementation of interest at the statutory rate on the unpaid balance commencing May 15, 2024 until paid, therefore an additional $
At
September 30, 2025 and December 31, 2024, an aggregate of $
In August 2025, the Company was awarded a grant
totaling $
In September 2025, the Company was awarded a
grant totaling approximately $
18
Note 10 – Segment Reporting
The Company manages its business activities on a consolidated basis and operates as a single operating segment: Biotechnology. The accounting policies of the Biotechnology segment are the same as those described in Note 1 – Summary of Significant Accounting Policies.
Our Chief Operating Decision Maker (“CODM”) is our Chief Executive Officer, Amir Heshmatpour. The CODM uses net loss, as reported on our condensed consolidated statement of operations, in evaluating the performance of the biotechnology segment and determining how to allocate resources of the Company as a whole, including investing in our research and development programs and acquisition/licensing strategy. The CODM does not review assets in evaluating the results of the biotechnology segment, and therefore, such information is not presented. The following supplemental information breaks down the research and development costs for the three and nine months ended September 30, 2025 and 2024, respectively.
| Schedule of segment reporting | ||||||||
| For the Nine Months Ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | $ | ||||||
| Less: Significant and other segment expenses: | ||||||||
| NEO100 | ||||||||
| NEO100-02 | ||||||||
| NEO212 | ||||||||
| Pediatric | ||||||||
| Laboratory | ||||||||
| Other | ||||||||
| Total research and development expense | ||||||||
| Advisory fee | ||||||||
| Legal and accounting | ||||||||
| Employee compensation expenses | ||||||||
| Amortization expense | ||||||||
| Investor relations | ||||||||
| Share based compensation | - | |||||||
| Other general and administrative expense | ||||||||
| Interest expense - related parties’ loans | ||||||||
| Loss on extinguishment of Bridge loan - related party | - | |||||||
| Loss on settlement | - | |||||||
| Interest and other income | ( |
) | ( |
) | ||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
19
| For the Three Months Ended September 30, |
||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | - | $ | - | ||||
| Less: Significant and other segment expenses: | ||||||||
| NEO100 | ||||||||
| NEO100-02 | ||||||||
| NEO212 | ||||||||
| Pediatric | ||||||||
| Laboratory | - | |||||||
| Other | ||||||||
| Total research and development expense | ||||||||
| Advisory fee | - | |||||||
| Legal and accounting | ||||||||
| Employee Expenses | ||||||||
| Amortization expense | ||||||||
| Investor relations | ||||||||
| Share based compensation | - | |||||||
| Other general and administrative expense | ||||||||
| Interest expense - related parties’ loans | ||||||||
| Loss on extinguishment of bridge loan | - | - | ||||||
| Loss on settlement | - | |||||||
| Interest and other income | ( |
) | ( |
) | ||||
| Net loss | $ | ( |
) | $ | ( |
) | ||
Note 11 – Subsequent Events
On July 24, 2025, the Company entered into an agreement with Dr. Ishwar K. Puri and Beth R. Levinson for the acquisition of all equity interests in JandB Holdings LLC, a California limited liability company (“J&B”). J&B was newly formed and held a single patented asset. No other assets, liabilities, employees or facilities were acquired. The single asset passed the “screen test” to be considered an asset acquisition. Expenses of the transaction were not significant.
Under the terms of the asset acquisition, the transaction consideration includes:
| (i) | a cash payment of $500,000 and |
| (ii) |
shares of Company common stock equal to (a) 120,000 shares of Company common stock with an attributed value of $25 per share, less (b) an amount of shares equal to (x) the aggregate transaction fees incurred by the Company in connection with all of the transactions related to the Agreement divided by (y) $25.00, rounded up to the nearest whole share. |
The Company remitted the cash payment for the patent on October 3, 2025 and received assignment of the patent effective October 8, 2025. As of November 13, 2025, the shares have yet to be issued.
20
On October 4, 2025, the Company’s wholly owned subsidiary, NuroMENA, signed a Master Services Agreement (MSA) with Insights Research Organization & Solutions (IROS), a UAE- based contract research organization (CRO) and part of the M42 group. The MSA has an initial term of three years from the first work order executed under the agreement. The first work order to be executed under the MSA covers a multi-site, randomized Phase 2b/3 study titled A Multi-Site, Randomized, Phase 2b/3 Study Evaluating Overall Survival of Intranasal NEO100 in Patients with Progressive or Recurrent Grade III Astrocytomas and Glioblastoma Multiforme (GBM), Stratified by IDH1 Mutation Status, Compared to Best Standard of Care.
On November 4, 2025, the Company sold
On November 6, 2025, the Company granted
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from these forward-looking statements as a result of certain factors. For a complete discussion of such risk factors, see the section entitled “Risk Factors”. Capitalized terms used herein, but not otherwise defined, shall have the meaning ascribed to those terms in the “Part I - Financial Information,” including the related notes to the consolidated financial statements contained therein.
Overview
Our company (f/k/a NAS-ONC, Inc.) was formed in 2008, devoted to developing new drugs with new delivery modes. As a clinical-stage biopharmaceutical company, we have focused on establishing superior treatments for intracranial malignancies, i.e., aggressive cancers located in the brain. These cancer types include primary brain cancers, such as glioblastoma, and secondary brain cancers, that have arrived through metastatic spread from other cancers throughout the body, such as melanoma or breast and lung cancer. Brain-localized malignancies are particularly difficult to treat because the blood-brain barrier prevents efficient entry of most pharmacotherapeutic agents into the brain. As a result, these patients are faced with poor prognoses and shortened average life expectancy. NeOnc is developing novel drug delivery methods to be used in combination with novel drug candidates.
NeOnc’s lead product candidate is NEO100. NEO100 is administered to patients via intranasal delivery. We have completed human safety testing in a Phase 1 clinical trial and are currently conducting preliminary efficacy testing in a Phase 2a trial with recurrent malignant glioma (Grade IV IDH1 mutant and Grade III Astrocytoma IDH1 mutant) patients. NeOnc is also developing a second product candidate, NEO212, which has completed preclinical testing, and an investigational new drug (IND) application has been filed and accepted with the United States Food and Drug Administration (FDA). The company has started Phase 1 clinical trials with patients harbouring primary and secondary malignant brain cancer types. Several additional drug candidates are in the pipeline and are undergoing preclinical development.
Since inception, our operations have focused on organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, establishing our intellectual property portfolio, identifying potential product candidates and undertaking preclinical and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product sales other than for humanitarian usage.
On October 11, 2024, the Company entered into an agreement with a broker dealer to serve as placement agent and provide broker services in connection with the proposed sale of common stock up to $10,000,000. Under this agreement, through December 31, 2024, the Company closed on commitments from investors to purchase 625,000 shares of common stock of the Company at $16 per share for total commitments of $10,000,000, which were to be held in escrow until the Company’s registration statement was declared effective. During the three months ended March 31, 2025, prior to the Company having an effective registration statement, the Company closed on an additional commitment to purchase 102,750 shares of common stock of the Company at $16.00 per share, for total commitments of $1,644,000. On March 10, 2025, the Company’s registration statement was declared effective at which time the $11,644,000 in escrow was released to the Company. On March 26, the Company was listed (“Listing”) on the NASDAQ global markets.
Investment and Joint Venture
In June 2025, the Company (through its recently formed subsidiary – Nuromena Holdings Ltd. “NuroMena”) entered into a letter of intent to form an investment and joint venture agreement with a Middle-East investor (“Investor”), Quazar Investments. At the formation date, the Company would own 10 million shares of NuroMena and contribute a license to its technology to NuroMena, and the Investor will purchase 2.5 million shares of NuroMena for a subscription price of $400,000 (“Initial Investment”). Following the formation of the entity and closing of the Initial Investment, the Investor shall source one or more future investors to purchase up to $50.0 million at $25/share in common stock of the Company, of which 70% of the proceeds will be maintained by the Company and 30% will be transferred to an operating entity to be formed under NuroMena, to conduct clinical trials in the middle-east markets. As of the date of this filing, the Initial Investment has not yet occurred.
22
Liquidity
Since its inception, we have incurred significant operating losses. Our net loss was $8,615,920 and $2,184,500, for the three months ended September 30, 2025 and 2024, respectively, and $46,622,106 and $9,645,482 for the nine months ended September 30, 2025 and 2024, respectively. We had an accumulated deficit of $97,230,551 at September 30, 2025. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing, and distribution activities.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as, and when needed, could have a material adverse effect on our business, results of operations and financial condition.
The report of our independent registered public accounting firm on our financial statements as of and for the year ended December 31, 2024 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern. See Note 1 to our financial statements for additional information on our assessment.
Components of Results of Operations
Revenue
We occasionally receive a fee from a patient for a “right to try” humanitarian program. Such revenues are not part of our core business.
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) legal and professional expenses and (iii) general and administrative expenses.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our research and development activities, including our product candidate discovery efforts and preclinical and clinical studies under our research programs, which include:
| ● | employee-related expenses, including salaries, benefits and stock-based compensation expense for our research and development personnel; |
| ● | costs of funding research performed by third parties that conduct research and development and preclinical and clinical activities on our behalf; |
23
| ● | costs of manufacturing drug products and drug supply related to our current or future product candidates; |
| ● | costs of conducting preclinical studies and clinical trials of our product candidates; |
| ● | consulting and professional fees related to research and development activities, including equity-based compensation to non-employees; |
| ● | costs of maintaining our laboratory, including purchasing laboratory supplies and non-capital equipment used in our preclinical studies; |
| ● | costs related to compliance with clinical regulatory requirements; and |
| ● | facility costs and other allocated expenses, which include expenses for rent and maintenance of facilities, insurance, depreciation and other supplies. |
Research and development costs are expensed as incurred. Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical and clinical studies or other services performed.
The successful development of our product candidates is highly uncertain. We cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete development of our current or future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if they are approved. This is due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:
| ● | the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies and clinical trials and other research and development activities; |
| ● | establishing an appropriate safety profile; |
| ● | successful enrollment in and completion of clinical trials; |
| ● | whether our product candidates show safety and efficacy in our clinical trials; |
| ● | receipt of marketing approvals from applicable regulatory authorities; |
| ● | establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; |
| ● | obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; |
| ● | commercializing product candidates, if and when approved, whether alone or in collaboration with others; and |
| ● | continued acceptable safety of the products following any regulatory approval. |
24
A change in the outcome of any of these variables with respect to the development of our current and future product candidates would significantly change the costs and timing associated with the development of those product candidates.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect research and development costs to increase significantly for the foreseeable future as we commence clinical trials and continue the development of our current and future product candidates. However, we do not believe that it is possible at this time to accurately project expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.
Legal and Professional Expenses
Legal and professional expenses consist of costs related to corporate and intellectual property legal costs and accounting and auditing fees. We also anticipate increased expenses associated with being a public company, including costs for audit, legal, regulatory and tax-related services related to compliance with the rules and regulations of the Securities and Exchange Commission, or the SEC, and listing standards applicable to companies listed on a national securities exchange, director and officer insurance premiums, and investor relations costs.
General and Administrative Expenses
General and administrative expenses include salaries and other compensation-related costs, including stock-based compensation, for personnel in executive, finance and accounting, business development, operations and administrative roles. Other significant costs include insurance costs, travel costs, facility and office-related costs not included in research and development expenses.
We anticipate that our general and administrative expenses will increase in the future as our business expands to support expected growth in research and development activities, including our future clinical programs. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside service providers, among other expenses. In addition, if we obtain regulatory approval for any of our product candidates and do not enter a third-party commercialization collaboration, we expect to incur significant expenses related to building a sales and marketing team to support product sales, marketing and distribution activities.
Share Based Compensation
Share based compensation expense result from the recognition of the fair value of restricted stock units (RSU) recorded on a straight-line basis from the date of grant to the date the RSU becomes fully vested.
Interest Expense
Interest expense primarily results from the bridge loan and a short-term loan both from related parties. Borrowings under these loans carry a 50% (or 1 times amounts borrowed) original issue discount (“OID”) on principal. The OID to be earned under the bridge loan is recognized ratably over the term of each draw-down under the loan through the maturity date.
25
Amortization
Amortization on debt issuance costs resulted from the grant of warrants for a line of credit commitment. The fair value of the warrants was determined using the Black Scholes valuation method and the fair value is being amortized over the term of the line of credit commitment.
Amortization on deferred offering costs resulted from the issuance of common stock in connection with a private equity agreement.
Loss on Change in Fair Value of Derivative Liability
Loss on change in fair value of derivative liability relates to the fair value of the discount offered to stockholders who purchased shares under the equity line of credit.
Comparison of the three and nine months ended September 30, 2025 and 2024:
Results of Operations
The following table summarizes our results of operations for the periods presented:
| For the Three Months Ended September 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Revenues: | ||||||||||||
| Revenue | $ | - | $ | - | $ | - | ||||||
| Cost of Revenues | - | |||||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 715,038 | 956,725 | (241,687 | ) | ||||||||
| Legal and professional | 276,378 | 496,803 | (220,425 | ) | ||||||||
| General and administrative | 902,985 | 243,659 | 659,326 | |||||||||
| Share based compensation | 5,040,246 | - | 5,040,246 | |||||||||
| Advisory Fee | - | 500,000 | (500,000 | ) | ||||||||
| Total Operating Expenses | 6,934,647 | 2,197,187 | 4,737,460 | |||||||||
| Loss From Operations | (6,934,647 | ) | (2,197,187 | ) | (4,737,460 | ) | ||||||
| Other Income (Expense): | ||||||||||||
| Interest and other income | 6,815 | 12,687 | (5,872 | ) | ||||||||
| Amortization expense | (438,111 | ) | - | (438,111 | ) | |||||||
| Interest expense - related parties | (869,815 | ) | - | (869,815 | ) | |||||||
| Loss on change in fair value of derivative liability related to sales of common stock through equity line of credit | (380,162 | ) | - | (380,162 | ) | |||||||
| Net Loss | $ | (8,615,920 | ) | $ | (2,184,500 | ) | $ | (6,431,420 | ) | |||
Revenue
No revenue was generated for fees for a “right to try” humanitarian program during the three months ended September 30, 2025 and 2024.
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Research and Development Expenses
The following table summarizes the components of our research and development expenses for the periods presented:
| For the Three Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Research and development costs by project: | ||||||||
| NEO100-01 | $ | 163,036 | $ | 236,607 | ||||
| NEO100-02 | 125,586 | 79,644 | ||||||
| NEO212 | 343,368 | 189,553 | ||||||
| Pediatric | 70,653 | 34,350 | ||||||
| Laboratory | - | 362,858 | ||||||
| Other | 12,395 | 53,713 | ||||||
| Total | $ | 715,038 | $ | 956,725 | ||||
| For the Three Months Ended September 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Clinical trial expense | $ | 702,643 | $ | 540,154 | $ | 162,489 | ||||||
| Research and laboratory | 12,395 | 416,571 | (404,175 | ) | ||||||||
| Total research and development expense | $ | 715,038 | $ | 956,725 | $ | (241,686 | ) | |||||
Research and development expenses were $715,038 and $956,725 for the three months ended September 30, 2025 and 2024, respectively. A portion of these expenses amounting to approximately $12,395 and $416,571 for the three months ended September 30, 2025 and 2024, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total decrease of $241,686 was primarily due to:
| ● | Pre-clinical laboratory work in 2024 was completed, such that there were no such costs in 2025. |
| ● | The recruitment for NEO212. |
Legal and Professional Expenses
Legal and professional expenses were $276,378 and $496,803 for the three months ended September 30, 2025 and 2024, respectively. The decrease of $220,425 was primarily due to the completion of the direct listing process which occurred in the first quarter of 2025.
General and Administrative Expenses
General and administrative expenses were $902,985 and $243,659 for the three months ended September 30, 2025 and 2024, respectively. The increase of $659,326 was primary due to a marketing campaign, increased employee headcount and resultant compensation and benefits, rent and travel expenses and expense incurred in pursuit of the Middle East deal.
Share Based Compensation
Share based compensation resulted from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date) during the three months ended September 30, 2025.
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Interest Expense
Interest expense was $869,815 and $0 for the three months ended September 30, 2025 and 2024, respectively. The interest for the three months ended September 30, 2025 relates primarily to the accrued interest for a litigation matter and the accretion of the convertible note payable of $820,794.
Interest and other Income
Interest income was $6,815 and $12,687 for the three months ended September 30, 2025 and 2024, respectively. The interest income for the three months ended September 30, 2025 and 2024, relates primarily interest earned on the money market account.
Loss on Change in Fair Value of Derivative Liability
Loss on change in fair value of derivative liability was $380,162 and $0 for the three months ended September 30, 2025 and 2024, respectively. The loss on settlement is related to the discount offered investors who purchased shares of common stock under the equity line of credit, which commenced in July 2025.
Amortization of Debt Issuance and Deferred Offering Costs
The amortization of debt issuance costs was approximately $438,111 and $0 for the three months ended September 30, 2025 and 2024, respectively. This represents the amortization of the debt issuance costs associated with the warrants issued for the HCWG line of credit, offering costs relating to the Mast Hill agreement and debt issuance cost associated with the convertible promissory notes.
The following table summarizes our results of operations for the periods presented:
For the September 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Revenues: | ||||||||||||
| Revenue | $ | 39,990 | $ | 63,000 | $ | (23,010 | ) | |||||
| Cost of Revenues | ||||||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 2,390,592 | 1,965,726 | 424,866 | |||||||||
| Legal and professional | 1,754,287 | 1,652,141 | 102,146 | |||||||||
| General and administrative | 2,736,732 | 973,923 | 1,762,809 | |||||||||
| Share based compensation | 25,964,096 | - | 25,964,096 | |||||||||
| Advisory fees | 11,737,806 | 500,000 | 11,237,806 | |||||||||
| Total Operating Expenses | 44,583,513 | 5,091,790 | 39,491,723 | |||||||||
| Loss From Operations | (44,543,523 | ) | (5,028,790 | ) | (39,514,733 | ) | ||||||
| Other Income (Expense): | ||||||||||||
| Interest and other income | 327,377 | 12,687 | 314,690 | |||||||||
| Amortization expense | (798,311 | ) | - | (798,311 | ) | |||||||
| Interest expense | (1,227,487 | ) | (2,559,456 | ) | 1,331,969 | |||||||
| Loss on extinguishment of Bridge loan - related party | - | (2,069,923 | ) | 2,069,923 | ||||||||
| Loss on settlement of common share purchases | (380,162 | ) | - | (380,162 | ) | |||||||
| Net Loss | $ | (46,622,106 | ) | $ | (9,645,482 | ) | $ | (36,976,624 | ) | |||
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Revenue
Revenue was generated for fees for a “right to try” humanitarian program during 2025 and 2024.
Research and Development Expenses
The following table summarizes the components of our research and development expenses for the periods presented:
| For the Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Research and development costs by project: | ||||||||
| NEO100-01 | $ | 851,664 | $ | 693,328 | ||||
| NEO100-02 | 327,373 | 203,075 | ||||||
| NEO212 | 798,997 | 549,249 | ||||||
| Pediatric | 169,663 | 103,338 | ||||||
| Laboratory | 192,377 | 362,858 | ||||||
| Other | 50,518 | 53,878 | ||||||
| Total | $ | 2,390,592 | $ | 1,965,726 | ||||
| For the Nine Months Ended September 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Clinical trial expense | $ | 2,147,697 | $ | 1,548,990 | $ | 598,707 | ||||||
| Research and laboratory | 242,895 | 416,736 | (173,841 | ) | ||||||||
| Total research and development expense | $ | 2,390,592 | $ | 1,965,726 | $ | 424,866 | ||||||
Research and development expenses were $2,390,592 and $1,965,726 for the nine months ended September 30, 2025 and 2024, respectively. A portion of these expenses amounting to approximately $242,895 and $416,736 for the nine months ended September 30, 2025 and 2024, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total increase of $424,866 was primarily due to:
| ● | The addition of clinical trial sites for NEO100’s clinical trial. |
| ● | The recruitment for NEO212. |
| ● | The start of the clinical trial for NEO100-03for a Pediatric Indication |
| ● | Increased patient recruitment efforts. |
Legal and Professional Expenses
Legal and professional expenses were $1,754,287 and $1,652,141 for the nine months ended September 30, 2025 and 2024, respectively. The increase of $102,146 was primarily due to completion of the direct listing process.
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General and Administrative Expenses
General and administrative expenses were $2,736,732 and $973,923 for the nine months ended September 30, 2025 and 2024, respectively. The increase of $,762,809 was primary due to amarketing campaign, increased employee headcount and resultant compensation and benefits, rent and travel expenses.
Share Based Compensation
Share based compensation resulted from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date) through September 30, 2025.
Advisory Fee
The advisory fee was earned on the Listing Date March 26, 2025.
Interest Expense
Interest expense was $1,227,487 and $2,559,456 for the nine months ended September 30, 2025 and 2024, respectively. The interest for the nine months ended September 30, 2025 relates to the short-term loan in March from a related party in the amount of $300,000 and $146,250 interest for a litigation matter, and the accretion of the convertible note payable of $820,794. The OID interest for the nine months ended September 30, 2024 relates to the OID for the related party bridge loan that was converted into common stock in June of 2024.
Amortization of Debt Issuance and Deferred Offering Costs
The amortization of debt issuance costs was $798,311 and $0 for the nine months ended September 30, 2025 and 2024, respectively. This represents the amortization of the warrants issued for the HCWG line of credit and deferred offering costs relating to the Mast Hill agreement.
Loss on Change in Fair Value of Derivative Liability
Loss on change in fair value of derivative liability was $380,162 and $0 for the three months ended September 2025 and 2024, respectively. The loss on settlement is related to the discount offered investors who purchased shares of common stock under the equity line of credit, which commenced in July 2025.
Cash Flows
The following table summarizes our cash flow for the periods indicated:
| For the Nine Months Ended September 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Net cash provided by (used in): | ||||||||||||
| Operating activities | $ | (16,772,777 | ) | $ | (3,259,512 | ) | $ | (13,513,265 | ) | |||
| Financing activities | 18,221,108 | 4,562,277 | 13,658,831 | |||||||||
| Net increase (decrease) in cash | $ | 1,448,331 | $ | 1,302,765 | $ | 145,566 | ||||||
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Operating Activities
During the nine months ended September 30, 2025, net cash used in operating activities was $16,772,777 consisting primarily of our net loss of $46,622,106, offset by share based compensation of $25,964,096, accretion of original issue discounts of $820,794, amortization of assets of $1,161,331 and the accrued advisory fee of $3,675,569. These were offset by decreases in accrued compensation in the amount of $479,775 and prepaid expenses in the amount of $267,161.
During the nine months ended September 30, 2024, net cash used in operating activities was $3,259,512 consisting primarily of our net loss of $9,645,482 less the non-cash charge of the accretion of the original issue discount on the bridge loan in the amount $2,558,241, less the non-cash charge for the loss on extinguishment of convertible debt of $2,069,923 and an increase in accounts payable of $957,162.
Financing Activities
During the nine months ended September 30, 2025, cash provided by financing activities was $18,221,108 consisting primarily of the sale of common stock of $11,324,522, proceeds from the issuance of the convertible note of $4,000,000 and proceeds from the sales of common stock under the equity line of credit of $3,196,736.
During the nine months ended September 30, 2024, cash used in financing activities was $4,562,277, consisting primarily of proceeds from the sale of common stock of $4,615,789.
Liquidity and Capital Resources
Sources of Liquidity/Going Concern
Since our inception, we have funded our operations through the sale and issuance of preferred and common stock and debt financing rounds from related and third parties.
During the nine months ended September 30, 2025, the Company sold 727,750 shares of common stock at a price of $16.00 per share for gross proceeds of $11,644,005 pursuant to a private placement of its securities, issued 46,000 shares as part of advisory services related to the listing and as part of the private placement fee for our equity line of credit, 162,500 shares were issued for the cashless exercise of warrants and issued 447,527 shares from the sale of shares under the equity line of credit,
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. Since our inception, we have not generated any revenue from product sales or any other sources, except humanitarian use, and we have incurred significant operating losses. We have not yet commercialized any products, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. As reflected in the accompanying consolidated financial statements, we have incurred recurring net losses since our inception. For the three and nine months ended September 30, 2025, the Company incurred a net loss of $8,615,920 and $46,622,106, respectively, and had an accumulated deficit of $97,230,551 at September 30, 2025. At September 30, 2025, the Company had cash totaling $1,513,224. These factors raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement our strategies, such as executing additional licensing contracts. The consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
The ability to continue as a going concern is dependent on us raising additional capital and attaining and maintaining profitable operations in the future to meet our obligations and repay our liabilities arising from normal business operations when they come due. Since inception, we have funded our operations primarily through equity and debt financings and licensing income and we expect to continue to rely on these sources of capital in the future.
No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our shareholders, in the case of equity financing, or grant unfavorable terms in licensing agreements.
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Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, initiate and conduct preclinical studies and clinical trials, and seek marketing approval for our current and any of our future product candidates. In addition, if we obtain marketing approval for any of our current or our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
We expect to finance our operations over the next 12 months primarily through existing cash balances and the proceeds from the aforementioned private placements and supplemented as necessary by funds available through our Line of Credit Agreement with HCWG and sales under the Equity Purchase Agreement, each as described below. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on a number of factors, including:
| ● | the costs of conducting preclinical studies and clinical trials; |
| ● | the costs of manufacturing; |
| ● | the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for product candidates we may develop, if any; |
| ● | the costs, timing, and outcome of regulatory review of our product candidates; |
| ● | our ability to establish and maintain collaborations on favorable terms, if at all; |
| ● | the achievement of milestones or the occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time; |
| ● | the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval; |
| ● | the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; |
| ● | the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims; |
| ● | our headcount growth and associated costs as we expand our business operations and research and development activities; and |
| ● | the costs of operating as a public company. |
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Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect your rights as a common stockholder. Additional debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.
If we raise funds through potential collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Critical Accounting Estimates
We account for stock-based compensation, including restricted stock units (RSUs), in accordance with ASC 718. RSUs are measured at fair value on the grant date based on our common stock price and expense over the vesting period. For awards with performance or market conditions, expense is recognized based on the probability of achievement and may be accelerated. We estimate forfeitures based on historical data and adjust these estimates periodically. Changes in forfeiture rates, stock price, or performance assumptions can materially affect stock-based compensation expenses. Management reviews these assumptions quarterly and updates estimates as necessary. We consider the accounting for RSUs a critical estimate due to the judgment involved and its material impact on our financial results.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are not currently exposed to significant market risk related to changes in foreign currency exchange rates. However, we have contracted with and may continue to contract with foreign vendors that are located in Europe and India. Our operations may be subject to fluctuations in foreign currency exchange rates in the future.
Inflation generally affects us by increasing our cost of labor. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three and nine months ended September 30, 2025 or the year ended December 31, 2024.
Item 4. Controls and Procedures
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 our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
We do not expect that our disclosure controls and procedures will prevent all errors and all instances of fraud. Disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Further, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and the benefits must be considered relative to their costs. Because of the inherent limitations in all disclosure controls and procedures, no evaluation of disclosure controls and procedures can provide absolute assurance that we have identified all of the information required to be disclosed, and that we have detected all our control deficiencies and instances of fraud, if any. The design of disclosure controls and procedures also is based partly on 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.
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Evaluation of Disclosure Controls and Procedures
As required by Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer and Chief Financial Officer carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2025. Based upon their evaluation, and due to material weaknesses in our internal control over financial reporting related to; controls over segregation of duties, entity level controls over the risk assessment, information and communication and monitoring process, financial controls over all significant transaction classes, controls over authorization and tracking of related party transactions and controls over information technology over user access and provisioning, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were not effective as of September 30, 2025.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934) during the quarter ended September 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in the Exchange Act Rule 13a-15(f). Our internal control over financial reporting is designed to provide reasonable assurance to our management and board of directors regarding the preparation and fair presentation of published consolidated financial statements. A control system, no matter how well designed and operated, can only provide reasonable, not absolute, assurance that the objectives of the control system are met. Because of these inherent limitations, management does not expect that our internal control over financial reporting will prevent all errors and all fraud. Management conducted an evaluation of our internal control over financial reporting based on the framework in Internal Control-Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission (the “2013 Framework”). Based on our evaluation under the 2013 Framework, management concluded that our internal control over financial reporting was not effective as of September 30, 2025, due to the material weakness in our internal control over duties separation, company-wide risk and communication processes, major financial transactions, related party dealings, and IT user access management. As a result, we performed additional analysis as deemed necessary to ensure that our consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles. Accordingly, management believes that the consolidated financial statements included in this Form 10-Q present fairly in all material respects our financial position, results of operations, and cash flows for the period presented.
Management has implemented remediation steps to improve our internal control over financial reporting. Specifically, we expanded and improved our review process for complex securities and related accounting standards. We plan to further improve this process by enhancing access to accounting literature, identification of third-party professionals with whom to consult regarding complex accounting applications and consideration of additional staff with the requisite experience and training to supplement existing accounting professionals. The Company can offer no assurance that these changes will ultimately have the intended effects.
This Quarterly Report on Form 10-Q does not include an attestation report on internal controls from our independent registered public accounting firm due to our status as an emerging growth company under the JOBS Act.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
On June 6, 2023, a vendor filed a complaint against the Company for breach of contract in the Central District of California. The vendor alleged that the Company improperly terminated an Intellectual Property License and Supply Agreement (“IPLSA”) and that the Company also defrauded the vendor in connection with the IPLSA. This matter was settled on October 16, 2023, and the Company agreed to pay the vendor $600,000 within 5 business days of the close of the date that the Company completes an IPO or March 31, 2024, whichever occurs first. The Company recognized this as a litigation settlement expense in the accompanying consolidated statement of operations for the year ended December 31, 2023.
On March 31, 2024, the vendor agreed to extend the payment until May 15, 2024 for payment of an additional $25,000. The Company has not made the payment as of October 28, 2024, and the settlement is payable on demand. Such an amount is included in litigation settlement payable in the accompanying consolidated balance sheet at December 31, 2024. On July 25, 2024 the arbitrator granted the implementation of interest at the statutory rate on the unpaid balance commencing May 15, 2024 until paid. This is still outstanding at September 30, 2025.
On July 1, 2022, NeOnc Technologies, Inc. and Fox Infused, LLC, a Delaware limited liability company (“Fox Infused”), entered into an Intellectual Property License and Supply Agreement effective July 1, 2022 (the “Agreement”) whereby NeOnc agreed to supply certain products to Fox Infused and license certain of our patents. We terminated the Agreement with Fox Infused on April 25, 2023. On June 6, 2023, Fox Infused filed a complaint against NeOnc in the Central District of California alleging that the termination was improper (Civil Action No. 2:23-04431). Fox Infused also filed an ex parte application for a temporary restraining order and an order to show cause on a preliminary injunction against us seeking to have the court stop the termination of the contract. Fox Infused’s temporary restraining order application was denied and the case dismissed without prejudice. Fox Infused refiled the case in arbitration before the American Arbitration Association (Case No. 01-23-0002-5020). The parties engaged in settlement discussions and agreed to settle the dispute for a $600,000 payment by us to Fox Infused within 5 business days of the closing date of the Company’s initial public offering or March 31, 2024. The Company is currently in default under the terms of such a settlement agreement.
In addition to that set forth above, we are, from time to time, party to various claims and legal proceedings arising out of our ordinary course of business, but we do not believe that any of these claims or proceedings will have a material effect on our business, consolidated financial condition or results of operations.
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Item 1A. Risk Factors
There have been no material changes to the risk factors previously disclosed under Item 1A, “Risk Factors,” of our Quarterly Report on Form 10-Q for the period ended March 31, 2025.
Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors, as well as the other information in this Quarterly Report on Form 10-Q, before deciding whether to invest in shares of our common stock. If any of the following risks actually occurs, our business, results of operations and financial condition could be materially adversely affected. In this case, the trading price of our common stock would likely decline, and you might lose part or all your investment in our common stock.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Securities
During the nine months ended September 30, 2025, the Company issued the following unregistered securities:
In February 2025, 50,000 restricted stock units were granted to each of Dr. Steven L. Giannotta, Jim Delshad and Dr. Ming-Fu Chiang. The forgoing restricted stock units vest one hundred percent (100%) seven months following March 25, 2025.
In March 2025, we issued 624,999 shares of common stock to various unaffiliated third parties in a private placement at a price of $16.00 per share for gross proceeds of approximately $10,000,000.
In March 2025, we issued to Dawson James Securities, Inc. and Mast Hill Partner LP 30,000 and 16,000 shares of common stock upon the time of our direct listing, respectively.
In March 2025, we issued 102,750 shares of common stock to various unaffiliated third parties in a private placement at a price of $16.00 per share for gross proceeds of approximately $1,644,000.
In June 2025, 200,000 restricted stock units were granted to Josh Newman. The forgoing restricted stock units vest one hundred percent (100%) thirty-six months following issuance.
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. Unless otherwise specified above, we believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(2) of the Securities Act (and Regulation D or Regulation S promulgated thereunder) or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering or under benefit plans and contracts relating to compensation as provided under Rule 701. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed on the share certificates issued in these transactions. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.
Recent Sales of Registered Securities
In July 2025, the Company sold 132,342 shares of common stock at $3.73 per share for gross proceeds of approximately $489,000 pursuant to Equity Purchase Agreement with Mast Hill Fund, LP.
In September 2025, the Company sold 315,185 shares of common stock at $7.60 – 9.53 per share for gross proceeds of approximately $2,710,000 pursuant to Equity Purchase Agreement with Mast Hill Fund, LP.
36
Use of Proceeds
Not applicable.
Repurchases
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
37
Item 6. Exhibit Index
| Exhibit Number | Description | |
| 3.1 | Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 filed on Form 8-K filed by the Registrant on March 27, 2025) | |
| 3.2 | Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 filed on Form 8-K filed by the Registrant on March 27, 2025) | |
| 4.1 | Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 filed with the Registration Statement on Form S-1 filed by the Registrant on January 3, 2025) | |
| 4.2 | Fourth Amended & Restated Promissory Note, dated December 4, 2023, by NeOnc Technologies Holdings, Inc. and Holders (incorporated by reference to Exhibit 4.2 filed with the Registration Statement on Form S-1 filed by the Registrant on January 3, 2025) | |
| 4.3 | Promissory Note, dated October 11, 2024, by NeOnc Technologies Holdings, Inc. and HCWG LLC (incorporated by reference to Exhibit 4.3 filed with the Registration Statement on Form S-1 filed by the Registrant on January 3, 2025) | |
| 4.4 | Common Stock Purchase Warrant, dated October 11, 2024, by NeOnc Technologies Holdings, Inc. and HCWG LLC (incorporated by reference to Exhibit 4.4 filed with the Registration Statement on Form S-1 filed by the Registrant on January 3, 2025) | |
| 4.5 | Promissory Note, dated February 25, 2025, by NeOnc Technologies Holdings, Inc. and Amir Heshmatpour (incorporated by reference to Exhibit 4.5 filed with the Registration Statement on Form S-1 filed by the Registrant on February 26, 2025) | |
| 4.6 | Form of Convertible Promissory Note (incorporated by reference to Exhibit 4.1 filed with the Form 8-K filed by the Registrant on July 22, 2025) | |
| 10.1 | Form of Convertible Promissory Note Purchase Agreement (incorporated by reference to Exhibit 10.1 filed with the Form 8-K filed by the Registrant on July 22, 2025) | |
| 10.2 | Letter of Intent dated July 24, 2025, between the Company, Dr. Ishwar Puri and Beth Levinson (incorporated by reference to Exhibit 10.1 filed with the Form 8-K filed by the Registrant on July 30, 2025) | |
| 10.3 |
Subscription Agreement dated June 28, 2025, between NuroMENA and Quazar (incorporated by reference to Exhibit 10.1 filed with the Form 8-K filed by the Registrant on August 1, 2025) | |
| 10.4 | Share Exchange Agreement, dated August 18, 2025 (incorporated by reference to Exhibit 10.1 filed with the Form 8-K filed by the Registrant on August 22, 2025) | |
| 10.5 | Master Services Agreement, dated October 4, 2025 (incorporated by reference to Exhibit 10.1 filed with the Form 8-K filed by the Registrant on October 9, 2025) | |
| 10.6# | Third Amendment to Employment Agreement (incorporated by reference to Exhibit 10.1 filed with the Form 8-K filed by the Registrant on November 6, 2025) | |
| 10.7# | Restricted Stock Award Agreement (incorporated by reference to Exhibit 10.2 filed with the Form 8-K filed by the Registrant on November 6, 2025) | |
| 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) | |
| 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) | |
| 32.1** | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350 | |
| 32.2** | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350 | |
| 101.INS* | Inline XBRL Instance | |
| 101.SCH* | Inline XBRL Taxonomy Extension Schema | |
| 101.CAL* | Inline XBRL Taxonomy Extension Calculation | |
| 101.LAB* | Inline XBRL Taxonomy Extension Labels | |
| 101.PRE* | Inline XBRL Taxonomy Extension Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101) |
| * | Filed herewith. | |
| ** | Furnished herewith. |
38
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Quarterly Report on Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized, in Los Angeles, California, on November 14, 2025.
| By: | /s/ Amir Heshmatpour | |
| Name: | Amir Heshmatpour | |
| Title: | Chief Executive Officer and President |
As required under the Securities Act of 1933, this Quarterly Report on Form 10-Q has been signed below by the following persons, in the capacities and on the dates indicated:
| Signature | Title | Date | ||
| /s/ Amir Heshmatpour | Chief Executive Officer | November 14, 2025 | ||
| Amir Heshmatpour | (Principal Executive Officer) | |||
| /s/ Keithly Garnett | Chief Financial Officer | November 14, 2025 | ||
| Keithly Garnett | (Principal Accounting Officer) |
39
FAQ
What was NTHI’s Q3 2025 net loss?
How much cash did NTHI have at September 30, 2025?
Did NTHI raise capital during 2025?
Is there a going concern warning in NTHI’s 10-Q?
What significant liabilities does NTHI report?
How much share-based compensation did NTHI record?
Were any grants awarded to NTHI?
