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As filed with the Securities and Exchange Commission on December 12, 2025

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER THE SECURITIES ACT OF 1933

NeOnc Technologies Holdings, Inc.

(Exact name of registrant as specified in its charter)

Delaware

2834

92-1954864

(State or other jurisdiction of

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer
Identification Number)

23975 Park Sorrento, Suite 205

Calabasas, CA 91302
(310) 663-7831

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Amir Farrokh Heshmatpour

Chief Executive Officer

23975 Park Sorrento, Suite 205

Calabasas, CA 91302

(310) 663-7831

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Thomas J. Poletti, Esq.

Veronica Lah, Esq.

Manatt, Phelps & Phillips LLP

695 Town Center Drive, 14^th Floor

Costa Mesa, CA 92626

(714) 371-2500

Dr. Thomas Chen
Keithly Garnett
23975 Park Sorrento, Suite 205
Calabasas, CA 91302
(310) 663-7831

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to said Section 8(a), may determine.

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The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED DECEMBER 12, 2025

PRELIMINARY PROSPECTUS

111,732 Shares

NeOnc Technologies Holdings, Inc.

This prospectus relates to the offer and sale from time to time by the selling stockholders identified herein of up to 111,732 of our shares (the “Shares”) of common stock, par value $0.0001 (“common stock”) of NeOnc Technologies Holdings, Inc, a Delaware corporation (the “Company”).

On December 1, 2025, the Company entered into a securities purchase agreement with the selling stockholder. See “Description of Private Placement”, and the section titled “Selling Stockholders” for additional information regarding the Selling Stockholder. For more information on possible methods of offer and sale by the Selling Stockholder, please see the section entitled “Plan of Distribution” beginning on page 111 of this prospectus. We will bear all fees and expenses incident to our obligation to register the offer and sale of the shares of common stock.

Our common stock is listed on The Nasdaq Global Market under the symbol “NTHI”. On December 9, 2025, the last reported sale price of our common stock on The Nasdaq Global Market was $8.96 per share.

We are an “emerging growth company” and a “smaller reporting company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and may elect to do so in future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

Investing in our common stock involves a high degree of risk. See the “Risk Factors” section beginning on page 6 of this prospectus for the risks and uncertainties you should consider before investing in our common stock.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Prospectus dated ___________, 2025

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ABOUT THIS PROSPECTUS		ii
PROSPECTUS SUMMARY		1
SUMMARY FINANCIAL AND OTHER DATA		4
RISK FACTORS		6
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS		7
MARKET AND INDUSTRY DATA		9
TRADEMARKS, SERVICE MARKS AND TRADENAMES		10
USE OF PROCEEDS		11
DIVIDEND POLICY		12
CAPITALIZATION		13
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		14
BUSINESS		28
MANAGEMENT		80
EXECUTIVE AND DIRECTOR COMPENSATION		87
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT		92
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS		94
DESCRIPTION OF SECURITIES		99
SHARES ELIGIBLE FOR FUTURE SALE		103
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS		105
DESCRIPTION OF PRIVATE PLACEMENT		109
SELLING STOCKHOLDER		110
PLAN OF DISTRIBUTION		111
LEGAL MATTERS		113
EXPERTS		113
WHERE YOU CAN FIND ADDITIONAL INFORMATION		113
INDEX TO FINANCIAL STATEMENTS		F-1

You should rely only on the information contained in this prospectus or contained in any free writing prospectus filed with the Securities and Exchange Commission. Neither we nor the Selling Stockholder have authorized anyone to provide any information different from, or in addition to, the information contained in this prospectus and in any free writing prospectuses we have prepared or that have been prepared on our behalf or to which we have referred you. Neither we nor the Selling Stockholder take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. The Selling Stockholder is offering to sell, and seeking offers to buy, shares of their common stock only under the circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date, regardless of the time of delivery of this prospectus or of any sale of our common stock. Our business, financial condition, results of operations and prospects may have changed since such date.

For investors outside the United States: Neither we nor the Selling Stockholder have done anything that would permit the use of or possession or distribution of this prospectus or any related free writing prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of our common stock by the Selling Stockholder and the distribution of this prospectus outside the United States.

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ABOUT THIS PROSPECTUS

This prospectus relates to the offer and sale by the Selling Stockholder from time to time of 111,732 of common stock. We are not selling any shares of common stock under this prospectus, and we will not receive any proceeds from the sale of shares of common stock offered hereby by the Selling Stockholder.

We may also file a prospectus supplement or post-effective amendment to the registration statement of which this prospectus forms a part that may contain material information relating to this offering. The prospectus supplement or post-effective amendment may also add, update or change information contained in this prospectus. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement or post-effective amendment, you should rely on the prospectus supplement or post-effective amendment, as applicable. Before purchasing any securities, you should carefully read this prospectus, any post-effective amendment, and any applicable prospectus supplement, together with the additional information described under the headings “Where You Can Find More Information.”

Neither we nor the Selling Stockholder have authorized anyone to provide you with any information or to make any representations other than those contained, or incorporated by reference, in this prospectus, any post-effective amendment, or any applicable prospectus supplement prepared by or on behalf of us or to which we have referred you. We and the Selling Stockholder take no responsibility for and can provide no assurance as to the reliability of any other information that others may give you. This prospectus is an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. You should not assume that the information contained in this prospectus or any applicable prospectus supplement is accurate on any date subsequent to the date set forth on the front of the document or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus or any applicable prospectus supplement is delivered, or securities are sold, on a later date.

This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed or will be filed as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described under “Where You Can Find Additional Information.”

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PROSPECTUS SUMMARY

This summary highlights certain significant aspects of our business and is a summary of information contained elsewhere in this prospectus. This summary is not complete and may not contain all the information you should consider before investing in our common stock. You should read the entire prospectus carefully, including “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and our consolidated financial statements and related notes thereto included in this prospectus, before making an investment decision.

Unless otherwise indicated, all share and per share information in this prospectus has been retroactively restated to give effect to a 1.222 for-1 forward split of our outstanding shares of common stock in April 2023 and the subsequent issuance of 10,500,000 shares of our common stock to shareholders of NeOnc Technologies, Inc. in April 2023 in a share exchange.

Unless the context otherwise requires, the terms “NeOnc”, “Company”, “we”, “us” and “our” refer to NeOnc Technologies Holdings, Inc., a Delaware corporation, and its wholly-owned subsidiary NeOnc Technologies, Inc., and “this prospectus” refers to the offering contemplated this prospectus.

General

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 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 has two lead products in development: NEO100 and NEO212. NEO100 is a purified form of perillyl acid (“POH”) which is administered to brain cancer patients via intranasal delivery. Ongoing activities for intranasal delivery of NEO100:

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We have completed human testing in a Phase I clinical trial and are currently conducting a Phase IIa trial with recurrent malignant glioma (Grade IV, IDH1 mutant and Grade III Astrocytoma, IDH1 mutant) patients.

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A similar Phase IIa trial of intranasal NEO100 (NEO 100-02) for patients with malignant skull-based meningioma is also ongoing. Meningiomas are slow-growing tumors originating in the meninges, the membranous layers surrounding the brain and spinal cord. We initiated this because these patients lack effective treatment options. These tumors are notoriously difficult to access, and conventional methods like surgery often lead to significant neurological deficits. Additionally, radiation therapy has shown limited effectiveness. The trial was officially launched in July 2023. As NEO100 uses the same treatment platform as the malignant gliomas, we bypassed the Phase I trial and received FDA approval for a Phase II trial within just 30 days.

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Separate from this single-drug application, NEO100 is further being investigated as a drug delivery vehicle, where the results of NeOnc’s preclinical studies suggest evidence that the combination of NEO100 with other drugs may enable a patient’s improved brain tumor delivery via the intranasal route. Intranasal NEO100, mixed with levodopa (L-DOPA), is in the planning stages for a clinical trial in patients with Parkinson’s disease (PD). NeOnc’s laboratory experiments showed that intranasal NEO100 mixed with levodopa was able to reverse PD symptoms in mice. A Phase I clinical trial is planned to study the impact on human patients.

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Our initial application for the Phase I/IIa trial for NEO 100 focused on an enrollment population with recurrent glioblastoma. Based on our Phase I results, NEO 100 showed more promise in patients with IDH1,2 mutant Grade IV astrocytomas. However, this patient population represented less than 5-10 percent of all patients with recurrent glioblastoma. As we planned for a total of 31 patients for Phase IIa in our initial analysis, enrollment of recurrent Grade IV, IDH1,2 mutants was limited due to the fact that only 5-10 percent of Grade IV astrocytomas have IDH1,2 mutations. Independent biostatistical review of clinical progression patterns of recurrent IDH1,2 mutated Grade III astrocytomas compared to recurrent IDH1,2 mutated Grade IV astrocytomas revealed that these two tumors have the same prognosis. As a result, in June 2023 we requested that the FDA not object to the inclusion of patients with recurrent Grade III IDH1,2 mutant astrocytomas in the Phase IIa trial. The FDA did not object and, as a result, the population of patients available to be enrolled is now much larger. Because the prognosis of recurrent Grade III IDH1,2 mutants is similar to recurrent IDH1,2 Grade IV astrocytomas, the number of patients needed to be enrolled in the Phase IIa trial to assess the clinical efficacy of NEO100 in the population of high grade astrocytomas did not change. The expanded patient population means that there are a significant number of additional patients that can be targeted for potential enrollment in the Phase IIa study; in an initial review, we have identified approximately 80 grade III IDH1,2 mutation-positive candidates. Patients with residual measurable disease are now followed via MRI scans to determine if there is progression, (recurrent disease), making them eligible for enrollment. We believe this targeted enrollment of both Grade III and IV IDH1,2 mutants may significantly expedite our trial process and we project that the readout for our Phase II studies with respect to NEO100 could now be feasibly delivered by the end of 2024, advancing our original timeline by a full year from 2025.

Our second lead product, NEO212, a covalently conjugated molecule combining the chemotherapeutic drug temozolomide with perillyl alcohol, has completed preclinical testing and has received investigational new drug (IND) approval from the United States Food and Drug Administration (FDA), i.e., it has been authorized to proceed to clinical testing in cancer patients. We have designed a Phase I/II trial for oral NEO212, which began in the fourth quarter of 2023. In this trial, NEO212 will be administered orally to patients with primary brain tumors (i.e., malignant gliomas) and secondary brain tumors (i.e., brain metastases derived from peripheral tumors, such as tumors of the lung, breast, skin/melanoma, etc.). Furthermore, NEO212 is undergoing development towards intranasal application specifically for patients with uncontrolled brain metastases derived from peripheral tumors (lung, breast, skin, etc.), but has not yet been studied in human patients.

Currently, none of our product candidates have been approved for sale in the United States or elsewhere. We have no commercial products nor do we have a sales or marketing infrastructure. In order to market and sell our products we must conduct clinical trials on patients and obtain regulatory approvals from appropriate regulatory agencies, like the FDA in the United States, and similar organizations elsewhere in the world.

We have not generated any revenue from product sales and from January 1, 2023 to September 30, 2025 have only generated revenue of $39,990. We do not anticipate generating significant revenues for the foreseeable future. We had net loss of $11,898,464 and $14,921,065 for the years ended December 31, 2024 and 2023, respectively. At December 31, 2024, we had an accumulated deficit of $50,608,445. Our net loss was $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.

Implications of Being an Emerging Growth Company

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As an emerging growth company, we are eligible to take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies and may elect to take advantage of other exemptions from reporting requirements in our future filings with the Securities Exchange Commission (“SEC”). In particular, in this prospectus, these exemptions include:

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presenting only two years of audited consolidated financial statements and only two years of related selected financial data and Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in our registration statement of which this prospectus forms a part;

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reduced disclosure about our executive compensation arrangements;

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exemption from the requirements to hold non-binding advisory votes on executive compensation (“Say on Pay”);

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extended transition periods for complying with new or revised accounting standards;

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exemption from the auditor attestation requirement in the assessment of our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”); and

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the auditor not being required to comply with the requirement in Public Company Accounting Oversight Board Auditing Standard 3101, The Auditor’s Report on an Audit of Financial Statements When the Auditor Expresses an Unqualified Opinion, to communicate critical audit matters in the auditor’s report.

We may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary our direct listing on Nasdaq or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.235 billion in annual revenue, we have more than $700 million in market value of our stock held by non-affiliates (and we have been a public company for at least 12 months and have filed one annual report on Form 10-K) or we issue more than $1 billion of non-convertible debt securities over a three-year period. We may choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of certain reduced reporting obligations in this prospectus. Further, pursuant to Section 107 of the JOBS Act, as an emerging growth company, we have elected to use the extended transition period for complying with new or revised accounting standards until those standards would otherwise apply to private companies. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock, and our consolidated financial statements may not be comparable to the consolidated financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies. See “Risk Factors-Risks Related to Ownership or Our Common Stock” which describes that we are an emerging growth company, and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.

Corporate Information

NeOnc Technologies, Inc. was incorporated in Delaware in 2008 as NAS-ONC, Inc. In April 2023, shareholders of NeOnc Technologies, Inc. completed a share exchange (the “Share Exchange”) with NeOnc Technologies Holdings, Inc. pursuant to which all shareholders of NeOnc Technologies, Inc. became shareholders of NeOnc Technologies Holdings, Inc. and NeOnc Technologies, Inc. became a wholly-owned subsidiary of NeOnc Technologies Holdings, Inc. Our executive offices are located at 23975 Park Sorrento, Suite 205, Calabasas, CA 91302 and our telephone number is (310) 633-7831. Our corporate website is www.neonctech.com. Information appearing on our corporate website is not incorporated as part of this prospectus.

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Summary Financial Data

The summary financial data set forth below should be read together with our financial statements and the related notes to those statements, as well as the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus. The consolidated statements of operations data for the years ended December 31, 2024 and 2023, and the consolidated balance sheet data as of December 31, 2024, have been derived from our audited financial statements included elsewhere in this prospectus. The consolidated statements of operations data for the nine months ended September 30, 2025 and 2024 (unaudited) and the consolidated balance sheet data as of September 30, 2025 (unaudited), have been derived from our interim financial statements included elsewhere in this prospectus. The unaudited interim financial statements were prepared on a basis consistent with our audited financial statements and include in management’s opinion, all adjustments, consisting of normal recurring adjustments, that we consider necessary for a fair presentation of the financial information set forth in those statements.

Consolidated Statements of Operations Data

	For the Nine Months Ended September 30,						For the Year ended December 31,
	2025			2024			2024			2023
Revenues:
Revenue	$	39,990		$	63,000		$	83,000		$	70,462

Operating Expenses:
Research and development		2,390,592			1,965,726			3,045,239			1,534,114
Legal and professional		1,754,287			1,652,141			2,000,623			1,907,687
General and administrative		2,736,732			973,923			1,638,410			1,488,557
Share based compensation		25,964,096						-			-
Advisory fees		11,737,806			500,000			500,000			500,000
Litigation settlement expense, net		-			-			41,250			4,100,000
License expense		-			-			-			2,737,773
Total Operating Expenses		44,583,513			5,091,790			7,225,522			12,268,131
Loss From Operations		(44,543,523	)		(5,028,790	)		(7,142,522	)		(12,197,669	)

Other Income and Expense:
Interest income		327,377			12,687			16,133			-
Amortization of debt issuance costs		(798,311	)		-			(145,097	)		-
Interest expense - related parties		(1,227,487	)		(2,559,456	)		(2,557,055	)		(2,723,396	)
Loss on extinguishment of Bridge loan		-			(2,069,923	)		(2,069,923	)		-
Loss on change in fair value of derivative liability related to sales of common stock through equity line of credit		(380,162	)		-			-			-
Net Loss	$	(46,622,106	)	$	(9,645,482	)	$	(11,898,464	)	$	(14,921,065	)

Loss per share:
Net loss per share - basic and diluted	$	(2.48	)	$	(0.56	)	$	(0.69	)	$	(1.02	)
Weighted average number of common shares outstanding during the period - basic and diluted		18,787,603			17,353,327			17,342,755			14,681,111

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Consolidated Balance Sheet Data

	As of September 30, 2025
Cash	$	1,513,224
Deferred offering costs	$	99,302
Debt issuance costs - current	$	671,804
Debt issuance costs – net of current portion	$	694,654
Prepaid expenses and other	$	677,246
Accounts payable	$	1,640,833
Accounts payable related - parties	$	499,900
Litigation settlement payable	$	4,746,250
Convertible Promissory Note	$	4,700,794
Accrued compensation	$	255,099
Additional Paid-in capital	$	85,414,333
Accumulated deficit	$	(97,230,551	)
Shareholders’ (deficit) equity	$	(11,814,270	)

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Risk Factors

Investing in our common stock involves a high degree of risk. Before you invest you should carefully consider the risks and uncertainties described below and the other information in this prospectus, and under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which is incorporated by reference, as well as the other information in this prospectus, 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. Additional risks not currently known to us or which we consider immaterial based on information currently available to us may also materially adversely affect us.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that can involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this prospectus, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

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the timing, progress and results of preclinical studies and clinical trials for our current and future product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

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the timing, scope or likelihood of regulatory submissions, filings, and approvals, including final regulatory approval of our product candidates;

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our ability to develop and advance product candidates into, and successfully complete, clinical trials;

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our expectations regarding the size of the patient populations for our product candidates, if approved for commercial use;

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the implementation of our business model and our strategic plans for our business, product candidates and technology;

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our commercialization, marketing and manufacturing capabilities and strategy;

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the pricing and reimbursement of our product candidates, if approved;

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the rate and degree of market acceptance and clinical utility of our product candidates, in particular, and cell therapy, in general;

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our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;

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our competitive position;

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the scope of protection we and/or our licensors are able to establish and maintain for intellectual property rights covering our product candidates;

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developments and projections relating to our competitors and our industry;

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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

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the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; and

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the impact of laws and regulations.

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We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this prospectus. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this prospectus, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

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MARKET AND INDUSTRY DATA

This prospectus includes estimates regarding market and industry data. Unless otherwise indicated, information concerning our industry and the markets in which we operate, including our general expectations, market position, market opportunity, and market size, are based on our management’s knowledge and experience in the markets in which we operate, together with currently available information obtained from various sources, including publicly available information, industry reports and publications, surveys, our customers, trade and business organizations, and other contacts in the markets in which we operate. Certain information is based on management estimates, which have been derived from third-party sources, as well as data from our internal research.

In presenting this information, we have made certain assumptions that we believe to be reasonable based on such data and other similar sources and on our knowledge of, and our experience to date in, the markets in which we operate. While we believe the estimated market and industry data included in this prospectus is generally reliable, such information is inherently uncertain and imprecise. Market and industry data is subject to change and may be limited by the availability of raw data, the voluntary nature of the data gathering process, and other limitations inherent in any statistical survey of such data. In addition, projections, assumptions, and estimates of the future performance of the markets in which we operate are necessarily subject to uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by us. Accordingly, you are cautioned not to place undue reliance on such market and industry data or any other such estimates.

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TRADEMARKS, SERVICE MARKS AND TRADENAMES

We own or otherwise have rights to the trademarks, including those mentioned in this prospectus, used in conjunction with the operation of our business. This prospectus includes our own trademarks, which are protected under applicable intellectual property laws, as well as trademarks, service marks and tradenames of other entities, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this prospectus may appear without the ^®, ^™ or ^SMsymbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks, service marks and tradenames. We do not intend our use or display of other entities’ trademarks, service marks or tradenames to imply a relationship with, or endorsement or sponsorship of us by, any other entities.

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USE OF PROCEEDS

The Selling Stockholder may, or may not, elect to sell shares of our common stock covered by this prospectus. To the extent the Selling Stockholder chooses to sell shares of our common stock covered by this prospectus, we will not receive any proceeds from any such sales of our common stock. See “Selling Stockholder.”

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DIVIDEND POLICY

We have never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earnings to fund the development, commercialization and growth of our business, and therefore we do not anticipate declaring or paying any cash dividends on our common stock in the foreseeable future. Any future determination as to the declaration and payment of dividends, if any, will be at the discretion of our board of directors. Any such determination will also depend upon our business prospects, operating results, financial condition, capital requirements, general business conditions and other factors that our board of directors may deem relevant. Our future ability to pay cash dividends on our common stock may also be limited by the terms of any future debt securities or credit facility.

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of September 30, 2025, as follows.

This table should be read in conjunction with, and is qualified in its entirety by reference to, our financial statements and related notes appearing elsewhere in this prospectus.

	As of September 30, 2025
Cash	$	1,513,224
Stockholders’ equity/(deficit):
Preferred Stock, $0.0001 par value per share; 10,000,000 total shares authorized, no shares issued and outstanding		-
Common Stock, $0.0001 par value per share; 100,000,000 shares authorized, 19,474,303 shares issued and outstanding		1,948
Additional paid-in capital		85,414,333
Accumulated deficit		(97,230,551	)
Total stockholders’ deficit	$	(11,814,270	)

The total number of shares of our common stock reflected in the discussion and table above excludes the following:

●

3,010,000 shares of common stock issuable upon the vesting of restricted stock.

●

4,764,507 shares of common stock (which include the 3,010,000 shares issuable upon the vesting of the restricted stock described above) currently reserved for future grant or issuance under our 2023 Plan of which, 1,754,507 shares would be available for grants.

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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 financial statements and related notes thereto included elsewhere in this prospectus. 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. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this prospectus, including those set forth in the sections of this prospectus entitled “Risk Factors” and “Cautionary Statement Concerning Forward-Looking Statements”.

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 harboring 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.

Since its inception, we have incurred significant operating losses. Our net loss was $11,898,464 and $14,921,065, for the years ended December 31, 2024 and 2023, respectively. We had an accumulated deficit of $50,608,445 at December 31, 2024. Our net loss was $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 into 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.

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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 and 2023 included an explanatory paragraph indicating that there was substantial doubt about our ability to continue as a going concern. See Note 1 to our annual financial statements appearing at the end of this prospectus for additional information on our assessment.

In December 2022, the Company signed a Letter of Intent (“LOI”) with an investment advisory firm AFH Holdings and Advisory, LLC (“AFH”) to create a newly formed corporation called NeOnc Technologies Holding Company, Inc. (“NTHI”) to facilitate future fundraising transactions. On April 7, 2023, the Company entered into share exchange agreements whereby all of the common shareholders of NTI exchanged all of their stock in NTI for a total of 10,500,000 shares of NTHI common stock in the share exchange (“Share Exchange”). At the consummation of the Share Exchange transaction, AFH and its affiliated entities, individuals, or assignees owned an aggregate of 34.4% (5,500,000 shares) of the fully diluted issued and outstanding common shares of the Company. For a period of two years after an initial public offering (“IPO”) or a direct listing, AFH will also act as an investment advisor in future financing transactions.

On October 11, 2024, the Company entered into a Line of Credit Agreement (“the Agreement”) with HCWG for borrowings of up to $10.0 million. No amounts have been borrowed under the facility through December 31, 2024.

On October 22, 2024, we 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 the investor, and the investor may purchase from the Company, up to $50,000,000 of Company’s common shares. The Company cannot draw down any funds under the Equity Purchase Agreement until the Company has an effective registration statement.

In October 2024 we issued HCWG LLC a five-year warrant to purchase up to 312,500 shares of our common stock at a per share exercise price of $12.00. In March 2025, we issued 162,500 shares of common stock to HCWG upon the cashless exercise of a common stock purchase warrant held by it.

In February 2025, our Executive Chairman advanced the Company approximately $300,000. The advances carry a 50% (or 1 times amounts borrowed) original issue discount (“OID”) on the principal. In the event of default, interest is payable at on any unpaid balance at a rate of 10% per annum. In March 2025, further to the terms of such advance, the Executive Chairman was paid a total of $600,000 upon repayment of such advances, including OID.

In March 2025, prior to our Direct Listing, we issued 625,000 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 30,000 shares of common stock upon the time of our Direct Listing.

On March 25, 2025, the Company’s common stock was listed on the Nasdaq Global Market under the stock ticker “NTHI”.

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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 March 2025 we issued 162,500 shares of common stock to HCWG upon the cashless exercise of a common stock purchase warrant held by it.

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.

On November 4, 2025, the Company sold 76,665 shares of common stock at $9.78 per share for gross proceeds of approximately $750,000 pursuant to Equity Purchase Agreement with Mast Hill Fund, LP.

On December 1, 2025, the Company entered into a Securities Purchase Agreement with Saad Naja pursuant to which the Company agreed to issue 111,732 shares of its common stock, par value $0.0001 per share, at a price of $8.95 per share, representing the closing price of the Company’s common stock on the Nasdaq Global Market on November 28, 2025, raising a total of $1.0 million.

In August 2025, the Company entered into a Share Exchange Agreement with the members (the “Members”) of JandB Holdings, LLC (“JandB”). Pursuant to the Share Exchange Agreement, the Company acquired 100% of the issued and outstanding membership interests of JandB in exchange for an amount of 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 December 12, 2025, the shares have yet to be issued.

In November 2025, 1,200,000 shares of restricted stock were granted to Amir Heshmatpour. One-half of the shares of restricted stock will vest on January 2, 2025. The remaining one-half of the shares of restricted stock will vest thereafter in twelve (12) equal monthly installments. 70,000 shares of restricted stock were granted to Grace Fisher, with half vesting immediately, and the remaining shares will vest two months later with ten (10) equal monthly installments. Dr. Henry Friedman as was also granted 15,000 additional shares of restricted stock, with half vesting immediately, and the remaining shares will vest two months later with ten (10) equal monthly installments. Dr. Henry Friendman was previously granted 10,000 shares of restricted stock in September 2025, with half vesting immediately, and the remaining shares vesting in equal installments over a ten (10) month period.

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.

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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;

●

costs of manufacturing drug product 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 pre-clinical 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 profile of the products following any regulatory approval.

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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 into 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.

Advisory Fee Expenses

The advisory fee expenses result from the advisory arrangement with AFH.

Interest Expense

Interest expense results from the bridge loan from a related party. Borrowings under the note 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.

Amortization on Debt Issuance Costs

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.

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Comparison of the 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 Nine Months Ended 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	)

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

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	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.

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 $1,762,809 was primary due to a marketing 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.

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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 nine 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

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.

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Comparison of the years ended December 31, 2024 and 2023:

Results of Operations

The following table summarizes our results of operations for the periods presented:

	For the years ended December 31,
	2024			2023			Change
Revenues
Revenue	$	83,000		$	70,462		$	12,538

Operating expenses:
Research and development		3,045,239			1,534,114			1,511,125
Legal and professional		2,000,623			1,907,687			92,936
General and administrative		1,638,410			1,488,557			149,853
Advisory fee		500,000			500,000			-
Litigation settlement expense, net		41,250			4,100,000			(4,058,750	)
License expense		-			2,737,773			(2,737,773	)
Total operating expenses		7,225,522			12,268,132			(5,042,610	)
Loss from operations		(7,142,522	)		(12,197,669	)		5,055,147

Other expense:
Interest income		16,133			-			16,133
Amortization on debt issuance costs		(145,097	)		-			(145,097	)
Interest expense		(2,557,055	)		(2,723,396	)		166,340
Loss on extinguishment of Bridge loan		(2,069,923	)		-			(2,069,923	)
Net loss	$	(11,898,464	)	$	(14,921,065	)	$	3,022,601

Revenue

Revenue was generated for fees for a “right to try” humanitarian program during 2024 and 2023 and sale of product to a licensee.

Research and Development Expenses

The following table summarizes the components of our research and development expenses for the periods presented:

	For the year ended December, 31,
	2024		2023
Research and development costs by project:
NEO100-01	$	1,200,624	$	702,226
NEO100-02		320,987		-
NEO212		870,634		279,859
Pediatric		191,593		169,777
Laboratory		460,559		326,272
Other		841		55,980
Total	$	3,045,238	$	1,534,114

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	For the years ended December 31,
	2024		2023		Change
Clinical trial expense	$	2,583,838	$	1,207,842	$	1,375,996
Research and laboratory		461,400		326,272		135,128
Total research and development expense	$	3,045,238	$	1,534,114	$	1,511,124

Research and development expenses were $3,045,239 and $1,534,114 for the years ended December 31, 2024 and 2023, respectively. A portion of these expenses amounting to approximately $460,559 and $326,272 for the years ended December 31, 2024 and 2023, respectively are from the University of Southern California (USC), where Dr. Chen is a member of the faculty. The total increase of $1,511,124 was primarily due to:

●

The addition of clinical trial sites for NEO100’s clinical trial.

●

The completion of the IND for NEO212 and the start of the clinical trial.

●

The completion and filing of the IND for NEO100-03 for a Pediatric Indication and preparation for the start of the clinical trial.

●

The start of a new clinical trial NEO100-02 for Meningiomas.

●

Increased patient recruitment efforts.

Legal and Professional Expenses

Legal and professional expenses were $2,000,623 and $1,907,687 for the years ended December 31, 2024 and 2023, respectively. The increase of $92,936 was primarily due to ending the IPO process and preparing a direct listing resulting in a writing off deferred professional fees in the amount of approximately $704,000, offset by legal expense related to litigation matters in the prior year, which were non-recurring in the current year.

General and Administrative Expenses

General and administrative expenses were $1,638,410 and $1,488,557 for the years ended December 31, 2024 and 2023, respectively. The increase of $149,853 was primary due to the rent expense related to a new lease and advertising and public relations costs. The Company did not have a lease in the prior year.

Advisory Fee

Advisory fee expenses resulting from the advisory arrangement with AFH for the years ended December 31, 2024 and 2023 were $500,000 and $500,000, respectively.

Litigation Settlement Expense

Litigation settlement expense of $4,100,000 for the year ended December 31, 2023 resulted from the settlement of legal matters with two former licensees in the amount of $4,100,000, in part offset by write off of $500,000 of deferred revenue related to one of the licenses. No such settlements were incurred during the year ended December 31, 2022.

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License Expense

For the year ended December 31, 2023, the license expense of $2,737,773 is equal to the estimated fair value of the shares to be issued to USC in accordance with the USC amended license agreement. For the year ended December 31, 2024, no additional license expense has been incurred.

Cash Flows

The following table summarizes our cash flow for the periods indicated:

	For the year ended December 31,
	2024			2023			Change
Net cash provided by (used in):
Operating activities	$	(4,213,916	)	$	(1,880,012	)	$	(2,333,904	)
Financing activities		4,246,947			1,278,576			2,968,371
Net increase (decrease) in cash	$	33,031		$	(601,436	)	$	634,467

Operating Activities

During the year ended December 31, 2024, net cash used in operating activities was $4,213,916 consisting primarily of our net loss of $11,898,464 less the non-cash charge of the accretion of the original issue discount on the bridge loan in the amount of $2,557,055, loss on the extinguishment of the bridge loan in the amount of $2,069,923 the write off of deferred offering costs in the amount of $703,796, and an increase in accounts payable of $1,798,583. We have primarily used the proceeds of the bridge loan to prepare the company for an offering of its securities and activities related thereto, while payment for operating activities has been deferred. During the year ended December 31, 2023, net cash used in operating activities was $1,880,012 consisting primarily of our net loss of $14,921,065 less the non-cash charge for license expense payable in stock of $2,507,773, increase in the bridge loan – expenses paid by the bridge loan provider on behalf of the Company of $1,997,775, and accretion of original issue discount of $2,721,747 and an offset by an increase in accounts payable of $1,059,789, accrued compensation of $678,743 and litigation settlement expense of $4,100,000.

Financing Activities

During the year ended December 31, 2024, cash provided by financing activities was $4,246,947 consisting primarily of net proceeds of $4,615,789 from the sale of common stock and $892,028 from the bridge loan, offset by the repayment of bridge loans of $791,077. During the year ended December 31, 2023, cash provided by financing activities was $1,278,576 consisting primarily of net proceeds of $3,507,972 from the bridge loans, offset by the repayment of bridge loans of $2,135,277.

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.

In March 2025 prior to our direct listing we issued 625,000 shares of common stock in a private placement at a price of $16.00 per share for gross proceeds of approximately $10,000,000. In March 2025 after our direct listing we issued 102,750 shares of common stock in a private placement at a price of $16.00 per share for gross proceeds of approximately $1,644,000.

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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 year ended December 31, 2024, we incurred a net loss of $11,898,464 and used cash in operations of $4,213,916 and had a shareholders’ deficit of $5,504,961 as of December 31, 2024. For the nine months ended September 30, 2025, the Company incurred a net loss of $46,622,106 and has 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.

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:

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the costs of conducting preclinical studies and clinical trials;

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the costs of manufacturing;

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the scope, progress, results and costs of discovery, preclinical development, laboratory testing, and clinical trials for product candidates we may develop, if any;

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the costs, timing, and outcome of regulatory review of our product candidates;

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our ability to establish and maintain collaborations on favorable terms, if at all;

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the achievement of milestones or occurrence of other developments that trigger payments under any license or collaboration agreements we might have at such time;

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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;

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the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;

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the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights, and defending intellectual property-related claims;

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our headcount growth and associated costs as we expand our business operations and research and development activities; and

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the costs of operating as a public company.

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.

Controls and Procedures

A company’s internal control over financial reporting is a process designed by, or under the supervision of, that company’s principal executive and principal financial officers, or persons performing similar functions, and effected by that company’s board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness in future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with policies or procedures may deteriorate.

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 September 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.

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We have initiated various remediation efforts, including the hiring of additional financial personnel/consultants with the appropriate public company and technical accounting expertise and other actions that are more fully described below. As such remediation efforts are still ongoing, we have concluded that the material weaknesses have not been fully remediated. Our remediation efforts to date have included the following:

We have assessed our current accounting personnel, financial reporting, and information system environments and capabilities. Based on our preliminary findings, we have found these resources and systems lacking and have concluded that these resources and systems will need to be supplemented and/or upgraded. We have hired a Chief Financial Officer and implemented accounting procedures and controls, such as a two-signature policy for all disbursements and vendor invoice/contract review processes. We have also instituted procedures to store and maintain vendor invoices, contracts and agreements for efficient retrieval, and analysis of financial reporting requirements.

We engaged external consultants with public company and technical accounting experience to facilitate accurate and timely accounting closes and to accurately prepare and review the financial statements of NeOnc Technologies Holdings, Inc. and related footnote disclosures. We plan to retain these financial consultants until such a time that our internal resources have been upgraded and the required financial controls have been fully implemented.

We have also commenced 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. Additionally, we have initiated an accounting system migration to Oracle NetSuite, and hired a third-party consulting firm to facilitate the implementation of the new system.

The actions that have been taken are subject to continued review, implementation, and testing by management, as well as audit committee oversight. While we have implemented a variety of steps to remediate these weaknesses, we cannot assure you that we will be able to fully remediate them, which could impair our ability to accurately and timely meet our public company reporting requirements.

Notwithstanding the assessment that our internal controls over financial reporting are not effective and that material weaknesses exist, we believe that we have employed supplementary procedures to ensure that the financial statements contained in this filing fairly present our financial position, results of operations, and cash flows for the reporting periods covered herein in all material respects.

Critical Accounting Estimates and Significant Judgments

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.

Off-Balance Sheet Arrangements

During the years ended December 31, 2024 and 2023, and the nine months ended September 30, 2025, we did not have, and we do not currently have, any off-balance sheet arrangements (as defined under SEC rules).

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. 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 years ended December 31, 2024 or 2023.

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BUSINESS

General

Our company was originally formed in Delaware in 2008 under the name NAS-ONC, Inc. and was renamed to NeOnc Technologies, Inc. in 2009. In 2015, the Delaware entity was merged with and into NeOnc Technologies California, Inc., a California corporation, and the surviving California corporation was renamed to NeOnc Technologies, Inc. Our company is devoted to developing new drugs with new delivery modes. As a clinical-stage biopharmaceutical company, we have focused on establishing 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 has two lead products in development: NEO100 and NEO212. NEO100, a purified form of perillyl alcohol (“POH”), is planned to be administered to brain cancer patients via intranasal delivery. Ongoing activities for intranasal delivery of NEO100:

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We have completed human testing in a Phase I clinical trial and are currently conducting a Phase IIa trial with recurrent malignant glioma (Grade IV, IDH1 mutant) patients (further details are provided below).

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A similar Phase IIa trial of intranasal NEO100 (NEO100-02) for patients with malignant skull based meningioma is also ongoing. Meningiomas are slow-growing tumors originating in the meninges, the membranous layers surrounding the brain and spinal cord. We initiated this because these patients lack effective treatment options. These tumors are notoriously difficult to access, and conventional methods like surgery often lead to significant neurological deficits. Additionally, radiation therapy has shown limited effectiveness. The trial was officially launched in July 2023. As NEO100 uses the same treatment platform as the malignant gliomas, we bypassed the Phase I trial and received FDA approval for a Phase II trial within just 30 days.

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In our ongoing effort to streamline our clinical trials, we have identified approximately 80 grade III IDH1 mutation-positive patients as potential candidates for our clinical trial. We believe this targeted enrolment pool may significantly expedite our trial process. With this refined focus, we are revising our protocol inclusion criteria to include Residual Measurable Disease (RMD) grade III IDH1 mutant patients. We believe this amendment to our enrolment criteria may markedly accelerate patient accrual, enhance the efficiency of our trials and may lead to quicker results. As a result of these changes, we project that the readout for our Phase II studies with respect to NEO100-01 could now be feasibly delivered by the end of first quarter of 2026.

Separate from this single-drug application, NEO100 is further being investigated as a drug delivery vehicle, where the results of NeOnc’s preclinical studies suggest that the combination of NEO100 with other drugs may enable a patient’s improved brain tumor delivery via the intranasal route. Our second lead product, NEO212, a covalently conjugated molecule combining the chemotherapeutic drug temozolomide with perillyl alcohol, has completed preclinical testing and has received investigational new drug (IND) approval from the United States Food and Drug Administration (FDA), i.e., it has been authorized to proceed to clinical testing in cancer patients. We have designed a Phase I/II trial for oral NEO212, which began in the fourth quarter of 2023. In this trial, NEO212 will be administered orally to patients with primary brain tumors (i.e., malignant gliomas) and secondary brain tumors (i.e., brain metastases originating from peripheral tumors, such as tumors of the lung, breast, skin/melanoma, etc.). Furthermore, NEO212 is undergoing development towards intranasal application specifically for patients with uncontrolled brain metastases derived from peripheral tumors (lung, breast, skin, etc.), but has not yet been studied in human patients.

The Pipeline of NeOnc Drug

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Lead Product: NEO100

NEO100 is our most advanced product candidate based on perillyl alcohol (POH). This naturally occurring monoterpenoid can be found as a constituent of essential oils from various botanicals, including peppermint, spearmint, lavender, bergamot, lemongrass, sage, thyme, cherries, and others. POH has been used in cosmetics, fragrances, and some cleaning products and as an ingredient in baked goods, frozen dairy, gelatine, puddings, beverages, and candies. However, clinical trials by other companies with an oral POH formulation administered to cancer patients were not successful for two presumed reasons: (i) after ingestion, not enough POH entered the bloodstream, because the liver (portal vein) quickly metabolized and thereby eliminated POH; in fact, it was not possible to demonstrate the presence of POH in the blood of these patients; and (ii) in an effort to overcome the rapid depletion of POH, physicians attempted to administer increasing amounts of oral POH, which resulted in significant gastrointestinal toxicity that became dose-limiting. As a result, efforts to introduce oral POH into the clinic were abandoned.

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Under the direction of NeOnc, a novel manufacturing and delivery pathway was investigated which we believe may avoid the drawbacks of oral POH. Using derivatization of POH with a crystalline intermediate enabled the production of ultra-pure, pharmaceutical-grade NEO100. NEO100 received fast-track status in 2016 and orphan-drug designation in 2011 from the FDA. NeOnc’s novel approach uses intranasal, rather than oral, delivery. Our completed Phase I trial of intranasal NEO100 suggested that when given via the intranasal route: (i) the drug appeared to be well tolerated with no severe adverse effects being observed, despite consistent treatment over several months; and (ii) patients’ reported quality of life was unchanged. In one patient, we were able to obtain brain tumor tissue (based on surgery immediately following intranasal delivery of a dose of NEO100), which we analyzed for the presence of NEO100 (POH). The presence of NEO100 (POH) was confirmed in the tumor tissue, thus providing proof of principle that intranasal delivery of NEO100 reaches its tumor target in the brain. This is in contrast to the above-mentioned studies with oral POH, where the presence of drug could not be demonstrated in blood or tumor tissue of any patient. Among the group of 12 patients in our Phase I trial, there were several long-term survivors: At two years after start of intranasal NEO100 treatment, five patients (37%) were still alive, which is noteworthy, because recurrent glioblastoma patients (that is, patients where the tumor has returned after one or more rounds of traditional treatment) have an average life expectancy of about six months, and 24-month survival is rare. Another result from our Phase I trial is the fact that three patients (i.e., 25% of the original cohort of 12 patients), were still alive after 3 years. These outcomes will have to be investigated with a larger number of patients to establish statistical significance. This is currently being pursued in our Phase IIa trial, where we are planning to expand our clinical trial sites and potentially enrolling the remaining Phase IIa patients. A data read out for any patient enrolled in the clinical trial is expected beginning six months from the enrollment of such patient.

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The above chart illustrates what is currently known about NEO100’s mechanism of action. The manner by which NEO100 may block tumor growth is thought to result from its pleiotropic (multi-faceted) impact on tumor cells. In in vitro tests: (i) NEO100 has been shown to inhibit the activity of the Ras protein. Ras is a (proto)onco-protein that stimulates mitogenic (growth-stimulatory) pathways inside cells. In tumor cells, it is often mutated, resulting in its increased activity and uncontrolled cell growth. Inhibition of Ras by NEO100 is thought to remove this aberrant growth stimulus from tumor cells, causing cell cycle arrest. (ii) NEO100 has been shown to block the activity of sodium/potassium (Na/K) adenosine triphosphatase (ATPase). Na/K-ATPase is an ion pump that sits in the plasma membrane and regulates the flux of ions across the membrane. In cancer cells, it can have abnormal activity and not only helps cancer cells resist chemotherapy, but also stimulates them to spread to other locations in the body. We believe that NEO100 may stunt these advantages for cancer cells. (iii) NEO100 has been shown to intercalate into the plasma membrane to disturb membrane fluidity and the function of some proteins that are located at or near the plasma membrane (including Ras and Na/K-ATPase). Among the consequences is an electrolyte imbalance that triggers endoplasmic reticulum (ER) stress. Cancer cells in general are less resistant to withstand prolonged ER stress. As a result, in combination with cell cycle arrest, they undergo apoptosis (cell death).

Therapeutic applications of NEO100 that are under development by NeOnc:

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Intranasal delivery that we hypothesize may bypasses the blood-brain barrier (BBB), which could permit delivery of drugs to the brain via cranial nerves I and V, and possibly allow delivery of other pharmaceutics to the brain. Proof of this principle has been observed in animal models, but has not yet been tested in human patients.

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At high concentrations, we are investigating whether intranasal NEO100 may be used as a therapeutic for treating brain cancers. In a Phase I trial there were preliminary signs of activity, based on several (25%) patients who have survived for at least 4 years, but validation of activity will have to await results from the ongoing Phase IIa and possible additional clinical trials.

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At low concentrations, NEO100 might act as a solvent and delivery vehicle for traditional large-molecule pharmaceutics, which could potentially bypass the BBB and enter the brain. Proof of this principle has been observed in animal models but has not yet been tested in human patients.

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Intra-arterial delivery of NEO100 could possibly create a temporary opening in the BBB, which might allow traditional large-molecule pharmaceutics to pass through and enter the brain. Proof of this principle has been observed in animal models, but has not yet been tested in human patients.

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NEO100 could potentially be covalently conjugated with other pharmaceutics to create novel fusion compounds that might enable superior BBB penetration ability and, potentially higher activity against brain cancer. Proof of this principle has been observed in animal models but has not yet been tested in human patients.

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Intranasal NEO100 for the treatment of malignant glioma:

The FDA granted NEO100 Orphan Drug Designation (ODD) for treating malignant glioma in 2011. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval. Upon approval, the exclusivity granted to orphan drugs provides seven years during which FDA may not approve any other sponsor’s application for the same drug for the same designated orphan disease or condition, regardless of whether such other sponsor files an Abbreviated New Drug Application (ANDA) for a generic version of the drug, or if another sponsor files a “full” new drug application (NDA). Orphan Drug Exclusivity does not, however, prevent FDA approval of applications for the same drug for a different indication, nor applications for a different drug for the same orphan indication. In limited circumstances, such as showing clinical superiority to the product with orphan drug exclusivity, FDA may approve a competing application during the Orphan Drug Exclusivity period. However, the process of clinical development is inherently uncertain and there is no guarantee that orphan drug designation will accelerate the timeline for approval or make it more likely that NEO100 will be approved.

For clinical testing of NEO100, a combined Phase I/IIa trial was conducted, with the first patient enrolled in April 2017. NEO100 was administered intranasally 4-times a day to patients with recurrent glioblastoma. Patients enrolled in this trial had already undergone standard therapy, but the disease had returned and was deemed untreatable.

Among the inclusion criteria were the following: (i) Radiographically confirmed progression or recurrent grade IV glioma, and on a stable dose of steroid for at least 5 days; (ii) Patients must have failed previous radiation and temozolomide treatment; (iii) Age ≥ 18 years; (iv) ECOG performance status of 0-2, or KPS ≥ 60; (v) An expected survival of at least 3 months; (vi) Baseline MRI with gadolinium within two weeks of entry into the trial; and (vii) Seizures controlled on a stable dose of anti-epileptics for two weeks prior to enrollment. Furthermore, patients were screened with MR perfusion scan if there was a possibility that progression seen on a MRI scan represented pseudo-progression. Response assessment was performed by gadolinium-enhanced MRI and assessment by RANO (Response Assessment in Neuro-Oncology) criteria every two months. Adverse events were graded for severity using NCI Common Terminology Criteria for Adverse Events v.4.0.

The institutions that participated in the trial were Cleveland Clinic, University of Washington/Seattle, University of Wisconsin, and the University of Southern California. It was sponsored by NeOnc Technologies, Inc. (Los Angeles, CA) with ClinDatrix, Inc. (Irvine, CA), as the Clinical Data Management CRO (Contract Research Organization). A total of 12 patients were enrolled in Phase I, which was completed in 2020. The patients were divided into four cohorts, three patients per cohort in a dose escalating trial (384-1152 mg/day). Patients received the intranasal dosage using a nebulizer mask four times a day. The results suggested that intranasal NEO100, even at the highest dose given, appeared to be well tolerated, and there were no serious adverse events reported in any of the patients, i.e., there were only minor side effects, such as a runny nose or nasal discomfort.

Results from Phase I preliminarily suggested that intranasal NEO100 might have exerted therapeutic activity in some of these patients, although statistical analysis was limited by the small number of 12 patients, which means that statistically firm conclusions cannot be drawn. Most patients (55%) survived for more than one year, four patients (33%) survived for over two years, and three patients (25%) remained alive at the 3-year mark.

Primary endpoints for Phase I were to determine maximum tolerated dose (MTD) and progression free survival (PFS). NEO100 did not reach MTD, as results suggested that NEO100 was well tolerated by the cohort 4 patients. The recommended Phase II dose was therefore at 1152 mg/day. PFS at 6 months was 33%.

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Survival Data from NeOnc’s Phase I Clinical Trial with Intranasal NEO100

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Patient Survival: NeOnc’s Phase I Trial

Secondary endpoints were evaluated for: a) pharmacokinetic endpoints of POH and perillic acid (PA) metabolism, b) objective tumor response according to RANO criteria, and c) adverse events.

Pharmacokinetic measurements were performed in patients at the time of trial entry and used to measure the ability of patients to properly inhale NEO100. All patients had the expected rapid elimination of NEO100 within 30 minutes from serum, and elimination of its PA within 2 hours.

Objective tumor response to NEO100 was determined by RANO criteria. NEO100 performance by RANO criteria was reported as follows:

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The third secondary endpoint was adverse events, as characterized by type, frequency, and severity (NCI common terminology for adverse events were reported as follows:

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Moreover, our Phase I clinical trial indicated that patients harboring an IDH1 mutation in their tumor cells responded to treatment more favorably than those without the mutation. Among the 12 patients, five presented with IDH1 mutant status. Among these five, four patients (80%) survived longer than the seven patients without IDH1 mutation. As of February 12, 2021 three of them were still alive four years after the recurrence of their original tumor and initiation of NEO100 treatment.

A potential advantage of intranasal NEO100 is that intranasal delivery via a nebulizer device does not require surgeries, infusions, or other invasive procedures that would require medical visits. Rather, intranasal delivery could be done conveniently at home (or while traveling) by the patients themselves. Compared to the well-known toxicities of many chemotherapeutic agents, NEO100 appeared to be well tolerated at the doses tested in the limited Phase I trial, and none of the typical side effects of other cancer pharmaceutics (nausea, debilitating fatigue, anemia, infections, diarrhea, hair loss, etc.) were observed. It, therefore, suggests that NEO100 may not lead to deterioration of quality of life for patients (Schönthal AH et al., Neuro-Oncol. Adv. 3:1, 2021).

NeOnc Phase IIa studies describe the first time NEO100 is given to the intended treatment population. The studies are undertaken to confirm dosing requirements identified in Phase I testing (such as how much, how often and to whom the drug should be given) are correct. They are sufficiently powered (statistically) to determine how well the drug performs at the prescribed dose and for the intended outcome. Work in future trials may be needed to further understand results obtained in Phase IIa testing (i.e., dosing, effect on a patient sub-population) and randomized, controlled Phase III testing may be required prior to marketing authorization. Details regarding the ongoing Phase IIa trials of NEO100 and the ongoing Phase I/II trial of oral NEO212 are as follows:

“An Open-Label, Phase I/IIa Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or IV Gliomas with IDH1 Mutation” (NEO100-01)

Enrollment

Number of Patients to be Treated: 24

Patient Sub-Populations Tested: Radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV glioma (the original study population) and radiographically-confirmed progression of, or recurrent, primary or secondary Grade III astrocytoma.

Primary Endpoint:

1. Progression free survival at six months.

NEONC TECHNOLOGIES HOLDINGS, INC. S-1