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NTHI on Nasdaq

NEONC TECHNOLOGIES HOLDINGS, INC.

NEONC TECHNOLOGIES HOLDINGS, INC. is an American pharmaceutical preparations company based in Calabasas.1 Its shares trade on Nasdaq under the symbol NTHI.1

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Last updated Oct 21, 2026.

Overview

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  • TickerNTHI on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCalabasas, California1
  • Incorporated inDE2
  • Business address23975 Park Sorrento, Suite 205, Calabasas, Ca 913022
  • Filer category, Emerging growth company2
  • Legal formCorporation

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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 meningioma, high grade gliomas, 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- 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 candidate…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-145637.5%Operating margin4
-155404.4%Net margin4
-51.8%Revenue growth, 20254

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development59¢$3.6M
  • Interest41¢$2.5M

Out of $40.0K in revenue.4 The company lost money this year.

Financial statements

Revenue4$40.0K in 2025−52% since 2024
0$25.0K$50.0K$75.0K$100.0K2024: $83.0K$83.0K20242025: $40.0K$40.0K2025−52%
Operating income4-$58.2M in 2025+715% since 2024
-$60.0M-$40.0M-$20.0M02024: -$7.1M-$7.1M20242025: -$58.2M-$58.2M2025+715%
Net income4-$62.1M in 2025+422% since 2024
-$80.0M-$60.0M-$40.0M-$20.0M02024: -$11.9M-$11.9M20242025: -$62.1M-$62.1M2025+422%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Revenue$40.0K$83.0K
Research and development$3.6M$3.0M
Legal and professional$2.5M$2.0M
General and administrative$4.8M$1.7M
Share based compensation$35.6M
Advisory fees principally related parties$11.8M$500.0K
Total Operating Expenses$58.3M$7.2M
Loss From Operations-$58.2M-$7.1M
Interest and other income$327.6K$16.1K
Grant income$71.2K
Amortization of debt issuance costs-$1.1M-$145.1K
Interest expense-$2.5M-$2.6M
Loss on extinguishment of Bridge loan related party-$2.1M
Loss on change in fair value of derivative liability related to sales of common stock through equity line of credit-$689.5K
Net Loss-$62.1M-$11.9M
Basic net loss per common share-$3.20-$0.69
Diluted net loss per common share-$3.20-$0.69
Weighted average shares used in computing basic net loss per common share19.4M shares17.3M shares
Weighted average shares used in computing diluted net loss per common share19.4M shares17.3M shares

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Corporate structure

NEONC TECHNOLOGIES HOLDINGS, INC. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of NEONC TECHNOLOGIES HOLDINGS, INC.

  • Cinctive Capital Management LP Filed SCHEDULE 13G on NEONC TECHNOLOGIES HOLDINGS, INC., latest May 15, 2026
  • Amir F. Heshmatpour Filed SCHEDULE 13D on NEONC TECHNOLOGIES HOLDINGS, INC., latest Apr 25, 2025
  • NEONC TECHNOLOGIES HOLDINGS, INC. Calabasas, California

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What NEONC TECHNOLOGIES HOLDINGS, INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Operating-lease assets (leased space)$361.0K4 Dec 31, 2025$23.5K4 Dec 31, 2024+1434.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$58.7K4 Dec 31, 2025$64.9K4 Dec 31, 2024−9.5%

Properties, in its own words

We do not currently own any properties.

On April 7, 2025, we entered into an Office Lease (“Lease”) with RREF II Calabasas Park Center LLC (“Landlord”), pursuant to which we agreed to lease from Landlord, and Landlord agreed to lease to us, approximately 1,427 square feet of office space located at 23975 Park Sorrento, Calabasas, California 91302 (the “Building”). The Lease is for our new principal executive offices. The term of the Lease commenced on April 14, 2025 and continue for sixty-three (63) months. Rent is payable monthly and began April 2025 for an initial amount of $6,778.25 per month with a 3% annual increase.

Item 2 of the 10-K filed Mar 31, 2026.3

Leadership

Who has led NEONC TECHNOLOGIES HOLDINGS, INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Thomas C. Chen2025–now

Chief financial officer

  1. Keithly Garnett2025–now

Chief operating officer

  1. Patrick Walters2025–now
Board members and other officers (12)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorAmir F. Heshmatpour named Jul 5, 2023 to Jun 25, 202621
  • Executive OfficerDavid F. Choi named Jun 25, 202621
  • DirectorBader L. Al Monawer named Jun 25, 202621
  • DirectorALAN C CHIANG named Jul 5, 202322

Timeline

  1. Oct 15, 20268-K Executive or director change; Regulation FD disclosure23
  2. Sep 28, 20268-K Regulation FD disclosure24
  3. Sep 21, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Regulation FD disclosure25
  4. Sep 17, 20268-K Regulation FD disclosure26
  5. Sep 10, 20268-K Entered a material agreement; Regulation FD disclosure27
  6. Aug 21, 20268-K Executive or director change28
  7. Aug 20, 20268-K Shareholder vote29
  8. Aug 13, 20268-K Regulation FD disclosure30
  9. Aug 12, 20268-K Regulation FD disclosure31
  10. Aug 10, 20268-K Results of operations; Regulation FD disclosure32
  11. Jul 15, 20268-K Regulation FD disclosure33
  12. Jul 2, 20268-K Executive or director change34
  13. Mar 25, 2025New chief executive Thomas C. Chen becomes CEO7

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.45) a share, on Nov 14, 2025.35

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results32
  2. May 18, 2026Reported quarterly or annual results36
  3. Apr 3, 2026Reported quarterly or annual results37
  4. Nov 14, 2025Reported quarterly or annual results38
  5. Aug 22, 2025Reported quarterly or annual results39

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

204 filings to the SEC since October 2021: 2 annual reports, 5 quarterly reports, 53 major events, 66 insider forms, 2 large holders, 7 private raises, 69 other. The latest 20:

  1. Oct 15, 20268-K EDGAR
  2. Oct 15, 20263 PRIMARY DOCUMENT EDGAR
  3. Sep 28, 20268-K EDGAR
  4. Sep 21, 20268-K EDGAR
  5. Sep 18, 20264 PRIMARY DOCUMENT EDGAR
  6. Sep 17, 20268-K EDGAR
  7. Sep 15, 2026144 EDGAR
  8. Sep 15, 20264 PRIMARY DOCUMENT EDGAR
  9. Sep 15, 20264 PRIMARY DOCUMENT EDGAR
  10. Sep 15, 20264 PRIMARY DOCUMENT EDGAR
  11. Sep 14, 20264 PRIMARY DOCUMENT EDGAR
  12. Sep 10, 20268-K EDGAR
  13. Sep 10, 2026424B5 EDGAR
  14. Aug 21, 20268-K/A EDGAR
  15. Aug 20, 20268-K EDGAR
  16. Aug 20, 20264 PRIMARY DOCUMENT EDGAR
  17. Aug 20, 20264/A PRIMARY DOCUMENT EDGAR
  18. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  19. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  20. Aug 17, 20264 PRIMARY DOCUMENT EDGAR

The 204 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

58 open-market trades by officers, directors and large owners since October 2021: 47 buys and 11 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 15, 2026GARNETT KEITHLYCFOSale5,000$3.36$16.8KForm 4
Sep 15, 2026Heshmatpour Amir FCEO, PresidentBuy35,000$3.30$115.5KForm 4
Sep 14, 2026Heshmatpour Amir FCEO, PresidentBuy15,000$3.96$59.4KForm 4
Sep 14, 2026CHEN THOMAS CCEOBuy5,242$3.82$20.0KForm 4
Sep 14, 2026GARNETT KEITHLYCFOBuy257$3.89$1.0KForm 4
Sep 11, 2026CHEN THOMAS CCEOBuy5,556$3.60$20.0KForm 4
Sep 11, 2026Heshmatpour Amir FCEO, PresidentBuy37,000$3.67$135.8KForm 4
Aug 18, 2026CHEN THOMAS CCEOBuy12,757$5.49$70.0KForm 4
Aug 18, 2026Heshmatpour Amir FCEO, PresidentBuy9,000$5.54$49.9KForm 4
Aug 17, 2026CHEN THOMAS CCEOBuy2,472$4.04$10.0KForm 4
Aug 17, 2026CHEN THOMAS CCEOBuy2,472$4.04$10.0KForm 4
Aug 17, 2026Heshmatpour Amir FCEO, PresidentBuy3,000$4.37$13.1KForm 4
Aug 14, 2026CHEN THOMAS CCEOBuy33,787$3.85$130.1KForm 4
Aug 14, 2026CHEN THOMAS CCEOBuy33,787$3.85$130.1KForm 4
Aug 14, 2026Heshmatpour Amir FCEO, PresidentBuy12,000$3.79$45.5KForm 4
May 1, 2026Heshmatpour Amir FCEO, PresidentBuy10,000$4.16$41.6KForm 4
Apr 28, 2026Heshmatpour Amir FCEO, PresidentBuy10,000$4.52$45.2KForm 4
Apr 24, 2026CHEN THOMAS CCEOBuy10,000$4.80$48.0KForm 4
Apr 23, 2026Neman-Ebrahim YoushaChief Clinical OfficerBuy500$4.88$2.4KForm 4
Apr 23, 2026Heshmatpour Amir FCEO, PresidentBuy10,000$4.90$49.0KForm 4

All 58 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Dr. Thomas C. Chen -Chief Medical Officer$212.0K$212.0K42
2025Keithly Garnett -Chief Financial Officer51$179.0K$179.0K42
2025Josh Neman -Chief Clinical Officer$165.0K$165.0K42
2025Amir Heshmatpour -Chief Executive Officer59$0$042
2024Dr. Thomas C. Chen -Chief Medical Officer$212.0K$212.0K42
2024Josh Neman -Chief Clinical Officer$0$195.0K42
2024Patrick Walters -Chief Operating Officer$195.0K$195.0K42
2024Keithly Garnett -Chief Financial Officer51$179.0K$179.0K42
2024Amir Heshmatpour -Chief Executive Officer59$0$042

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Jun 10, 2026Raised $5 million in a private offering of equity Form D: 2 investors so far Form D
  2. Jan 29, 2026Raised $10.6 million in a private offering of equity Form D: $36 million offered in all Form D
  3. Dec 1, 2025Raised $1 million in a private offering of equity Form D: 1 investor so far Form D
  4. Mar 26, 2025Raised $1.6 million in a private offering of equity Form D: $2 million offered in all Form D
  5. Mar 10, 2025Raised $10 million in a private offering of equity Form D: $10 million offered in all Form D
  6. Jul 15, 2024Raised $18.3 million in a private offering of equity Form D: $18.7 million offered in all Form D
  7. Apr 7, 2023Raised $80 million in a private offering of equity Form D: 67 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Cinctive Capital Management LP1,607,464$7.3M0.3%+181,938
Vanguard Capital Management LLC504,171$2.3M0.0%+288,471
Bank Of America Corp /de/224,412$1.0M0.0%−10,984
Westmount Partners, LLC197,178$893.2K0.2%+153,858
BlackRock, Inc.179,850$814.7K0.0%+24,012
Geode Capital Management, LLC166,120$752.8K0.0%+39,267
Vanguard Fiduciary Trust Co91,480$414.4K0.0%+35,464
State Street Corp43,170$195.6K0.0%No change
Northern Trust Corp35,871$162.5K0.0%+12,600
Global Retirement Partners, LLC27,790$125.9K0.0%New
Marshall Wace, Llp21,784$98.7K0.0%+9,206
Royal Bank Of Canada15,625$71.0K0.0%−1,000
Morgan Stanley15,647$70.9K0.0%−36,275
HCR Wealth Advisors15,000$68.0K0.0%No change
Vanguard Global Advisers, LLC4,265$19.3K0.0%No change
Ancora Advisors LLC2,075$9.4K0.0%No change
Wells Fargo & Company/mn2,000$9.1K0.0%+500
UBS Group AG1,731$7.8K0.0%+1,458
Strategic Wealth Partners, Ltd.492$2.2K0.0%No change
Barclays PLC453$2.1K0.0%−7,609
Jpmorgan Chase & Co127$5630.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How NEONC TECHNOLOGIES HOLDINGS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARNEONC TECHNOLOGIES HOLDINGS, INC.1
  • CIK0001979414
  • Employer ID (EIN)92-19548643
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address23975 Park Sorrento, Suite 205, Calabasas, CA 913021
  • Phone310 663 78311
  • Shares outstanding25,936,365 as of Aug 10, 20265
  • Public float$67.9M as of Jun 30, 20253
  • AuditorCBIZ CPAs P.C., Philadelphia, PA PCAOB ID 199; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJun 22, 20231
  • Filings204 in all: 8-K (51), 4 (38), 3 (15), 4/A (12), CORRESP (11), UPLOAD (10), 424B5 (8), EFFECT (8)1
    All 32 form types

    D (7), S-1 (6), S-1/A (6), 10-Q (5), DRS/A (3), S-3 (3), 424B4 (2), 8-K/A (2), DRS (2), 10-K (1), 10-K/A (1), 144 (1), 3/A (1), 8-A12B (1), CERT (1), DEF 14A (1), DEFA14A (1), FWP (1), NT 10-Q (1), PRE 14A (1), RW (1), S-8 (1), SCHEDULE 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Jun 23, 2026
    Latest 8-K (8-K) Oct 15, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareNTHINasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks NEONC TECHNOLOGIES HOLDINGS, INC. names in Item 1A of its 10-K filed Mar 31, 2026: 71 risks under these headings, as written.3

  • Risks Related to our Financial Position and Need for Additional Capital
  • We have incurred significant losses since our inception and anticipate that we will incur significant and increasing losses for the foreseeable future and we may never achieve or maintain profitability.
  • We will require substantial additional financing to advance the development of our product candidates, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital could force us to delay, limit, reduce or terminate our product development programs, potential commercialization efforts or other operations.
  • We have never generated any revenue from product sales other than for humanitarian uses of less than $83,000 per year and may never become profitable.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • The report of our independent registered public accounting firm included a “going concern” explanatory paragraph.
  • Risks Related to Product Discovery, Development and Regulatory Approval
  • Our development of product candidates based on our technology platform is limited, and we do not know whether we will be able to develop any products of commercial value.
  • Our product candidates are in preclinical and clinical stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable.
  • We currently have two clinical development product candidates, both of which rely in whole or in part on perillyl alcohol (NEO100 and NEO212). The failure of one of these two product candidates in clinical development would adversely affect our business. It may require us to discontinue developing other product candidates based on the same therapeutic approach.
  • Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome and stringent regulations, and delays can occur for a variety of reasons.
The other 61 risks
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials.
  • Interim, topline, and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We anticipate that many of our product candidates may be tested and, if approved, used in combination with third-party drugs and/or devices, some of which may still be in development, and we have limited or no control over the supply, regulatory status or regulatory approval of such drugs and/or devices.
  • We may not be successful in our efforts to expand our pipeline of product candidates and develop marketable products.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • If we do not achieve our product development goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and as a result our share price may decline.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any of our existing or potential future collaboration partners from obtaining approvals for the commercialization of NEO100 and any other product candidate we develop.
  • Regulatory approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted, and we may be subject to substantial fines, criminal penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of any products for unapproved or “off-label” uses, resulting in damage to our reputation and business.
  • Obtaining and maintaining marketing approval for our product candidates in one jurisdiction would not mean that we will be successful in obtaining marketing approval of that product candidate in other jurisdictions, which could prevent us from marketing our products internationally.
  • Even if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products.
  • Risks Related to Manufacturing
  • We are subject to multiple manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates.
  • Changes in product candidate manufacturing or formulation may result in additional costs or delay.
  • If we are unable to have manufactured and release any product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, any product candidates, and may lose potential revenues.
  • Risks Related to Reliance on Third Parties
  • We rely, and expect to continue to rely, on third parties to supply and quality-test the ingredients for our product candidates and components for our manufacturing process.
  • We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements, we may be unable to obtain regulatory approval for our product candidates or any other product candidates that we may develop in the future.
  • We have entered into, and may in the future enter into, certain collaboration agreements and strategic alliances to maximize the potential of our product candidates, and we may not realize the anticipated benefits of such collaborations or alliances. We expect to continue to form collaborations in the future with respect to our product candidates, but may be unable to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
  • If we are not able to establish future collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans for one or more of our other development programs.
  • Any future collaborations are not a guarantee of success, and all collaborations are as risky, or more risky, than undertaking the activities ourselves.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, delay their ability to review and act on our regulatory submissions, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
  • Risks Related to Commercialization
  • If we, or our collaboration partners, are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.
  • We face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us. If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated.
  • If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell our product candidates, if they are approved, the revenues that we generate may be limited and we may never become profitable.
  • Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community necessary for commercial success. The revenues that we generate from their sales may be limited, and we may never become profitable.
  • The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates. If the market opportunities for any product candidates we develop are smaller than we believe they are, our potential revenues may be adversely affected, and our business may suffer.
  • We may face early and aggressive generic competition for any of our product candidates for which we obtain regulatory approval.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain, maintain and protect our intellectual property rights for our technology and product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed.
  • If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
  • If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect NEO100, NEO212 and our other product candidates.
  • We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.
  • We may be subject to claims by third parties asserting that we, our employees or any future collaborators have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of third parties or are in breach of non-competition or non-solicitation agreements with our competitors.
  • If we obtain any issued patents covering our technology, such patents could be found invalid or unenforceable if challenged in court or before the USPTO or comparable foreign regulatory authority.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and our product candidates for which we intend to seek approval as pharmacological products may face competition sooner than anticipated.
  • Some intellectual property which we have licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with non-U.S. manufacturers.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
  • Risks Related to Government Regulation
  • If we fail to comply with federal and state healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.
  • If the government or third-party payors fail to provide adequate coverage, reimbursement and payment rates for our product candidates, or if health maintenance organizations or long-term care facilities choose to use therapies that are less expensive or considered a better value, our revenue and prospects for profitability will be limited.
  • We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance, and adversely affect our ability to market our products, obtain collaborators, and raise capital.
  • We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as import and export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, and other consequences, which could adversely affect our business, financial condition, results of operations, stock price and prospects.
  • We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
  • Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business.
  • Risks Related to Our Business and Operations
  • We are highly dependent on our key personnel, including our Chief Executive Officer and President. If we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
  • Our management team has limited public company experience.
  • We will need to continue to expand the size of our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
  • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • Unfavorable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, stock price and prospects.
  • Public health crises such as pandemics, including the ongoing COVID-19 pandemic, or similar future outbreaks could materially and adversely affect our preclinical studies and clinical trials, business, financial condition and results of operations.
  • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization of any approved products and/or our product candidates.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, contract manufacturing organizations (CMOs), or contract research organizations (CROs) may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business.
  • We have generated significant net operating loss (NOL) carryforwards and research and development tax credits, and our ability to utilize our net operating loss carryforwards and research and development tax credits to reduce future tax payments may be limited or restricted.
  • Risks Related to Ownership of Our Common Stock
  • An active trading market may not develop or continue to be liquid and the market price of shares of our common stock may be volatile.
  • Tariff policies and potential countermeasures could disrupt our supply chain, which could negatively impact the results of our operations.
  • Future sales of common stock by our stockholders could cause our share price to decline.
  • Our stockholders may be diluted by future issuances of preferred stock or additional common stock in connection with our incentive plans, acquisitions or otherwise; future sales of such shares in the public market, or the expectations that such sales may occur, could lower our stock price.

Legal proceedings

We may in the future be involved in actual and/or threatened legal proceedings, claims, investigations and government inquiries arising in the ordinary course of our business, including legal proceedings, claims, investigations and government inquiries involving intellectual property, data privacy and data protection, privacy and other torts, illegal or objectionable content, consumer protection, securities, employment, contractual rights, civil rights infringement, false or misleading advertising, or other legal claims relating to our business.

On November 8, 2013, the Company entered into a collaboration agreement (“Agreement”) with Orient EuroPharma Co., Ltd. (“OEP”), pursuant to which the parties will develop certain licensed products defined in the Agreement. NeOnc will license OEP the right to commercialize the Company’s drug NEO100, a highly purified form of perillyl alcohol (“Licensed Product”), in the territories specified in the license agreement (“Territory”).

In 2023, the Company sent notice to OEP indicating their intent to terminate the Agreement with OEP, after which OEP threatened litigation. On February 15, 2024, OEP and the Company entered into a settlement agreement whereas the Company and OEP terminated the Agreement in exchange for a payment in the amount of $4,000,000 payable by the Company to OEP within ten days of the date the Company completes its initial public offering. The settlement agreement provides for interest accruing on the unpaid balance. The Company has a litigation settlement payable of $4,170,000 and $4,000,000 in the accompanying consolidated balance sheets as of December 31, 2025 and 2024, respectively. As of the date of this filing, the Company has not paid the litigation settlement amount.

The opening of Item 3, Legal Proceedings.3

Sources

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