TNXP on Nasdaq

Tonix Pharmaceuticals

Logo: https://www.tonixpharma.com/, Non-free logo, via Wikipedia5

Commercial pharmaceutical company

Tonix Pharmaceuticals (Tonix Pharmaceuticals Holding Corp.) is a pharmaceutical company based in Chatham, New Jersey that focuses on repurposed drugs for central nervous system conditions and as of 2020 was also pursuing a vaccine for COVID-19 and a biodefense project.3 Its shares trade on Nasdaq under the symbol TNXP.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

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  • TickerTNXP on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersNew York City1
  • Websitewww.tonixpharma.com
  • Incorporated inNV6
  • Business address200 Connell Drive, Suite 3100, Berkeley Heights, Nj 079226
  • Filer categoryNon-accelerated filer, Smaller reporting company6
  • Legal formCorporation4
  • LEI529900ACPKP9QW20GX484
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressc/o Registered Agent Inc., 769 Basque Way, Suite 300, 89706 Carson City, United States4
  • Registered withBusiness Center (Secretary of State), NV200713300414

Tonix Pharmaceuticals (Tonix Pharmaceuticals Holding Corp.) is a pharmaceutical company based in Chatham, New Jersey that focuses on repurposed drugs for central nervous system conditions and as of 2020 was also pursuing a vaccine for COVID-19 and a biodefense project.3

Financials

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

Key numbers, fiscal 2025

-959.1%Operating margin9
-946.2%Net margin9
29.8%Revenue growth, 20259
-50.6%Return on equity9
-$103.2MFree cash flow9

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Zembrace Symtouch brought in 71% of the revenue Tonix Pharmaceuticals broke down this way in fiscal 2025.

  1. Zembrace Symtouch$9.3M971%up 9% from 2024
  2. Tosymra$2.4M918%up 53% from 2024
  3. Tonmya$1.4M911%
Products and services by year
Products and services20242025
Zembrace Symtouch$8.5M$9.3M
Tosymra$1.5M$2.4M
Tonmya$1.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue5¢$6.6M
  • Research and development32¢$44.5M
  • Selling, general and admin63¢$87.7M

Out of $13.1M in revenue.9 The company lost money this year.

Financial statements

Revenue109$13.1M in 2025+69% since 2023
0$5.0M$10.0M$15.0M2023: $7.8M$7.8M20232024: $10.1M$10.1M2024+30%2025: $13.1M$13.1M2025+30%
Operating income11121314109-$125.7M in 2025+336% since 2019
-$150.0M-$100.0M-$50.0M02019: -$28.8M-$28.8M20192020: -$50.5M-$50.5M2020+75%2021: -$92.3M-$92.3M2021+83%2022: -$112.1M-$112.1M2022+21%2023: -$118.4M-$118.4M2023+6%2024: -$136.7M-$136.7M2024+15%2025: -$125.7M-$125.7M2025−8%
Net income11121314109-$124.0M in 2025+333% since 2019
-$150.0M-$100.0M-$50.0M02019: -$28.6M-$28.6M20192020: -$50.5M-$50.5M2020+76%2021: -$92.3M-$92.3M2021+83%2022: -$110.2M-$110.2M2022+19%2023: -$116.7M-$116.7M2023+6%2024: -$130.0M-$130.0M2024+11%2025: -$124.0M-$124.0M2025−5%

Every line of the income statement as filed: the last 2 fiscal years, latest first.9

Period ending2025-12-312024-12-31
Product revenue, net$13.1M$10.1M
Cost of sales$6.6M$7.8M
Research and development$44.5M$40.0M
Selling, general and administrative$87.7M$40.1M
Asset impairment charges$59.0M
Total Operating Expenses$138.8M$146.8M
Operating loss-$125.7M-$136.7M
Grant income$3.0M$2.6M
Gain on change in fair value of warrant liabilities$6.2M
Loss on extinguishment of debt-$2.1M$0
Interest income$4.1M$22.0K
Interest expense-$89.0K-$1.2M
Other expense, net-$3.3M-$867.0K
Net loss available to common stockholders-$124.0M-$130.0M
Net loss to common stockholders per common share, basic-$14.57-$176.60
Net loss to common stockholders per common share, diluted-$14.57-$176.60
Weighted average common shares outstanding, basic8.5M shares736.3K shares
Weighted average common shares outstanding, diluted8.5M shares736.3K shares

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Corporate structure

Tonix Pharmaceuticals sits at the top of its group. 8 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Tonix Pharmaceuticals

  • Tonix Pharmaceuticals New York, New York, United States
    • Jenner Institute LLC Subsidiary · Delaware, United States
    • Krele, LLC Subsidiary · Delaware, United States
    • Tonix Medicines, Inc. Subsidiary · Delaware, United States
    • Tonix Pharma Holdings Limited Subsidiary · Ireland
    • Tonix Pharma Limited Subsidiary · Ireland
    • Tonix Pharmaceuticals (Canada), Inc. Subsidiary · New Brunswick, Canada
    • Tonix R&D Center, LLC Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Tonix Pharmaceuticals 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
Property and equipment, before depreciation$50.5M9 Dec 31, 2025$46.3M9 Dec 31, 2024+8.9%
Accumulated depreciation$6.0M9 Dec 31, 2025$4.1M9 Dec 31, 2024+47.0%
Property and equipment, net$44.5M9 Dec 31, 2025$42.3M9 Dec 31, 2024+5.2%
Operating-lease assets (leased space)$1.5M9 Dec 31, 2025$565.0K9 Dec 31, 2024+173.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$207.6M9 Dec 31, 2025$98.8M9 Dec 31, 2024+110.2%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$120.0K9 Dec 31, 2025$120.0K9 Dec 31, 20240%
Indefinite-lived intangibles (excluding goodwill)$120.0K9 Dec 31, 2025$120.0K9 Dec 31, 20240%
Finite-lived intangibles, gross$10.1M9 Dec 31, 2024$10.1M10 Dec 31, 20230%
Accumulated amortization$953.0K9 Dec 31, 2024$477.0K10 Dec 31, 2023+99.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$8.4M10 Dec 31, 2024$13.6M10 Dec 31, 2023−38.4%
Raw materials$2.5M9 Dec 31, 2025$3.1M9 Dec 31, 2024−18.4%
Work in process$1.4M9 Dec 31, 2025$213.0K9 Dec 31, 2024+543.2%
Finished goods$2.1M9 Dec 31, 2025$5.1M9 Dec 31, 2024−58.3%

Properties, in its own words

We maintain our principal office at 200 Connell Drive, Suite 3, Berkeley Heights, New Jersey 07922. Our telephone number at that office is (862) 799-8599 and our fax number is (212) 923-5700. On July 24, 2025, we entered into a lease, whereby we agreed to lease new office space, commencing November 2025 and expiring January 2030. In connection therewith, we maintain a letter of credit, which has a remaining balance of $386,000 as of December 31, 2025, and such amount is deposited into the restricted cash account maintained at the bank that issued the letter of credit.

We own and operate a research and development facility in Frederick, Maryland used for process development activities.

The rest of Item 2

We own an approximately 44-acre site in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing facility. As of December 31, 2025, the facility was not ready for its intended use.

We own a 45,000 square foot facility in North Dartmouth, Massachusetts that houses our Advanced Development (“ADC”), for accelerated development and manufacturing of vaccines. The facility was decommissioned in 2024 decommissioned and may be reactivated on the earlier of 2027 or in the case of a national or international emergency.

Future minimum lease payments are as follows (in thousands):

We believe that our existing facilities are suitable and adequate to meet our current business requirements.

Item 2 of the 10-K filed Mar 12, 2026.17

The story

The company's predecessors were Tamandare Explorations Inc. which had been formed in 2007 as a mining wildcat vehicle focused on land in Nevada and the shares of which were traded over the counter, and L & L Technologies, LLC, which had been formed in 1996 by Seth Lederman and Donald Landry to repurpose drugs for CNS development. L&L had formed Janus Pharmaceuticals, Inc., which later became Vela Pharmaceuticals, Inc. to develop some of its inventions, and Vela returned those assets to L&L in 2006. L&L placed them in a subsidiary called Krele Pharmaceuticals, Inc., and that subsidiary and Tamandare Explorations Inc. performed a reverse merger in October 2011; the new entity was renamed Tonix Pharmaceuticals Holding Corp. and Lederman was named CEO. It was listed on the NASDAQ exchange in 2013 under the symbol TNXP, and in December 2021 Tonix was added to the NASDAQ Biotechnology Index (Nasdaq:NBI). Tonix regained compliance for continued listing on The Nasdaq Capital Market in June 2022 by closing at a value of at least $1.00 per share for a time frame greater than or equal to 10 consecutive business days, criteria established by Nasdaq Listing Rule 5550(a)(2).

Ernest Mario, a scientist and former CEO of Glaxo Holdings Inc, served on the board of Tonix in the past.

Tonix finalized the purchase of a 40,000 square foot facility in Massachusetts in 2020 to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19. This facility has been functional since June 2022. Tonix additionally purchased a 44-acre parcel of land in Hamilton, Montana at the end of 2020 for the construction of a vaccine production facility. In October 2021, Tonix announced the acquisition of a 48,000 square foot research and development center in Frederick, Maryland to support the Company's infectious disease pipeline. The facility was purchased from Southern Research, one of Tonix's collaborators on TNX-1800 and TNX-801 development.

Tonix licensed from University of Geneva, their technology for oxytocin-based treatments for treating insulin resistance, diabetes, and obesity allowing Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes.

In March 2021, Tonix announced the issuance of a U.S. patent for compositions and uses of tianeptine oxalate salt, the active ingredient in TNX-601 CR. The patent provides Tonix with U.S. market exclusivity until December 2037 for claims directed to pharmaceutical compositions comprising crystalline tianeptine oxalate salts, to methods of using those compositions to treat various disorders, and to methods of producing oxalate salts.

From Wikipedia’s article on Tonix Pharmaceuticals, shared under CC BY-SA 4.0.7

Leadership

Who has led Tonix Pharmaceuticals, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (22)

Products and brands

Horsepox Platform, Monkeypox and Smallpox

In July 2017 the news division of the journal, Science, reported that Tonix had sponsored research and collaborating with scientists at the University of Alberta, David Evans and Ryan Noyce, and that the work had led to the generation of an extinct horsepox virus using synthetic biology—the lab had bought pieces of DNA from a reagent company and had built the horsepox genome with them. This invention was licensed to Tonix and Tonix announced that it intended to further develop it into a smallpox vaccine, TNX-801, which is a biodefense business model. The research was published in 2018. In December 2020, Tonix announced that independent researchers reported 99.7% colinear identity between a circa 1860 U.S. smallpox vaccine and horsepox virus. Tonix's TNX-801 is a preclinical horsepox-based live virus vaccine being developed as a potential vaccine to prevent smallpox and monkeypox. Tonix's TNX-801 is also the vector on which Tonix's COVID-19 experimental vaccine is based.

The United States Patent and Trademark Office (USTPO) issued Tonix Pharmaceuticals U.S. Patent No. 11, 345, 896, entitled "Synthetic Chimeric Poxviruses" in May 2022. This patent applies to synthetic horsepox virus, the basis for the Company's TNX-801 vaccine and Recombinant Pox Virus (PRV) platform, and is anticipated to grant Tonix with U.S. market exclusivity until 2037. Upon a global surge of Monkeypox cases, the Kenya Medical Research Institute (KE\MRI) and Tonix Pharmaceuticals announced a research collaboration to develop TNX-801 as a vaccine to protect against monkeypox and smallpox in July 2022. The Phase 1 clinical study is awaiting regulatory approval in Kenya.

In preclinical studies, TNX‑801—a single‑dose, recombinant horsepox live‑virus vaccine—demonstrated durable protection against mpox and rabbitpox in animal models, including those with compromised immune systems.

It is up to 100,000‑fold less virulent than live smallpox vaccine strains.

Read the full text

Notably, subcutaneous administration provided protection equivalent to traditional percutaneous delivery, informing clinical administration strategy.

Organ Transplant

In January 2021, Tonix announced a second collaboration with Massachusetts General Hospital to work on TNX-1500, a monoclonal antibody targeting CD40-ligand with a focus on organ rejection in kidney transplantation. In August 2019, Tonix announced the signing of the first research collaboration agreement with Massachusetts General Hospital to develop TNX-1500, a humanized monoclonal antibody (mAb) that targets CD154 for the prevention and treatment of organ transplant rejection.

In January 2021, Tonix filed a patent application with the World Intellectual Property Organization covering the use of TNX-1500 for the prevention and treatment of autoimmune diseases such as multiple sclerosis (MS) and organ transplant rejection.

In September 2022, Tonix announced data from three presentations involving studies of TNX-1500 for organ transplant rejection. The data showed that TNX-1500 showed activity in preventing organ transplant rejection and was well-tolerated in non-human primates. The data also showed that TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human promate cardiac and kidney allograft models, as well as pathologic xenoimmunity in kidney xenograft models, both without clinical thrombosis.

Currently, Tonix has a sponsored research agreement with Boston Children's Hospital to study TNX-1500 for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) in animals.

From Wikipedia’s article on Tonix Pharmaceuticals, shared under CC BY-SA 4.0.7

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Jenner Institute LLC Delaware8
  • Krele, LLC Delaware8
  • Tonix Medicines, Inc. Delaware8
  • Tonix Pharma Holdings Limited Ireland8
  • Tonix Pharma Limited Ireland8
  • Tonix Pharmaceuticals (Canada), Inc. New Brunswick, Canada8
  • Tonix Pharmaceuticals, Inc. Delaware8
  • Tonix R&D Center, LLC Delaware8

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • TAMANDARE EXPLORATIONS INC.Apr 9, 2008 to Oct 17, 20116

Timeline

  1. Oct 15, 20268-K Results of operations; Other events45
  2. Oct 2, 20268-K Other events46
  3. Sep 22, 20268-K Other events47
  4. Sep 8, 20268-K Other events48
  5. Aug 18, 20268-K Executive or director change; Other events49
  6. Aug 10, 20268-K Results of operations50
  7. Aug 3, 20268-K Regulation FD disclosure; Other events51
  8. Jul 21, 20268-K Executive or director change52
  9. Jul 13, 20268-K Regulation FD disclosure; Other events53
  10. Jun 29, 20268-K Regulation FD disclosure; Other events54
  11. Jun 8, 20268-K Regulation FD disclosure; Other events55
  12. May 27, 20268-K Regulation FD disclosure; Other events56
  13. Jan 14, 2013New chief executive Seth Lederman becomes CEO18

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.59) a share, on Nov 10, 2025.57

When it reported results

  1. Oct 15, 2026Reported quarterly or annual results45
  2. Aug 10, 2026Reported quarterly or annual results50
  3. May 11, 2026Reported quarterly or annual results58
  4. May 1, 2026Reported quarterly or annual results59
  5. Mar 13, 2026Reported quarterly or annual results60
  6. Feb 3, 2026Reported quarterly or annual results61
  7. Nov 10, 2025Reported quarterly or annual results62
  8. Oct 27, 2025Reported quarterly or annual results63

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

Filings

512 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 312 major events, 84 insider forms, 27 large holders, 69 other. The latest 20:

  1. Oct 15, 20268-K EDGAR
  2. Oct 2, 20268-K EDGAR
  3. Sep 22, 20268-K EDGAR
  4. Sep 8, 20268-K EDGAR
  5. Sep 8, 20263 EDGAR
  6. Aug 31, 20264 EDGAR
  7. Aug 24, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  8. Aug 18, 20268-K EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 13, 2026SCHEDULE 13G EDGAR
  11. Aug 10, 202610-Q QUARTERLY REPORT EDGAR
  12. Aug 10, 20268-K EDGAR
  13. Aug 3, 20268-K EDGAR
  14. Jul 21, 20268-K EDGAR
  15. Jul 13, 20268-K EDGAR
  16. Jul 9, 20264 EDGAR
  17. Jul 1, 2026S-8 EDGAR
  18. Jun 29, 20268-K EDGAR
  19. Jun 15, 20264 EDGAR
  20. Jun 15, 2026SCHEDULE 13G EDGAR

The 512 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

12 open-market trades by officers, directors and large owners since October 2021: 12 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 27, 2026LEDERMAN SETHChief Executive OfficerBuy2,000$13.79$27.6KForm 4
Aug 20, 2026BAGGER RICHARD HDirectorBuy1,000$12.60$12.6KForm 4
Jun 12, 2026Taylor Carolyn E.DirectorBuy1,415$10.55$14.9KForm 4
Jun 9, 2026LEDERMAN SETHChief Executive OfficerBuy5,000$11.79$59.0KForm 4
Jun 8, 2026Stillwell Richard NewcombDirectorBuy5,000$11.65$58.2KForm 4
Mar 31, 2026LEDERMAN SETHChief Executive OfficerBuy5,000$12.62$63.1KForm 4
Mar 18, 2026LEDERMAN SETHChief Executive OfficerBuy15,000$14.89$223.3KForm 4
Aug 21, 2025Taylor Carolyn E.DirectorBuy418$36.03$15.1KForm 4
Aug 20, 2025Treco JamesDirectorBuy250$36.00$9.0KForm 4
May 15, 2025LEDERMAN SETHChief Executive OfficerBuy4,000$21.55$86.2KForm 4
Jun 29, 2022LEDERMAN SETHChief Executive OfficerBuy20,000$1.71$34.2KForm 4
Mar 25, 2022LEDERMAN SETHChief Executive OfficerBuy100,000$0.25$25.0KForm 4

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
2025Seth Lederman68$702.0K$3.2M76
2025Jessica Morris48$522.9K$1.2M76
2025Gregory Sullivan60$519.2K$1.2M76
2025Bradley Saenger52$502.9K$1.1M76
2024Chief Executive Officer$675.0K$1.8M76
2024Chief Medical Officer$499.2K$922.4K76
2024Chief Operations Officer$494.0K$887.7K76
2024Chief Financial Officer$483.6K$850.0K76

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.1,398,041$17.8M0.0%+429,864
Point72 Asset Management, L.P.1,166,752$14.9M0.0%+1,041,338
Millennium Management LLC966,932$12.3M0.0%+747,259
Aqr Capital Management LLC882,595$11.3M0.0%+721,387
Vanguard Capital Management LLC691,895$8.8M0.0%+173,245
Jones Hill Capital LP625,428$8.0M1.7%+173,312
Geode Capital Management, LLC395,260$5.0M0.0%+81,969
Ishara Investments LP338,250$4.3M3.2%New
State Street Corp271,374$3.5M0.0%+40,767
UBS Group AG231,682$3.0M0.0%+4
Citadel Advisors LLC195,859$2.5M0.0%−272,853
Essex Investment Management Co LLC165,144$2.1M0.3%New
Balyasny Asset Management L.P.132,591$1.7M0.0%−180,491
Northern Trust Corp120,386$1.5M0.0%+20,252
Nuveen, LLC117,447$1.5M0.0%+22,886
Vanguard Fiduciary Trust Co102,054$1.3M0.0%+17,784
Goldman Sachs Group Inc98,356$1.3M0.0%+45,301
Vanguard Portfolio Management LLC97,954$1.2M0.0%+19,327
Fmr LLC93,551$1.2M0.0%+91,813
Ieq Capital, LLC92,373$1.2M0.0%+78,015
Susquehanna Portfolio Strategies, LLC65,024$829.7K0.0%New
Superstring Capital Management LP63,648$812.1K0.5%+108
Trexquant Investment LP63,635$812.0K0.0%New
Bank Of America Corp /de/60,977$778.1K0.0%+19
Jacobs Levy Equity Management, Inc57,943$739.4K0.0%New

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

SEC filer profile

How Tonix Pharmaceuticals is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTonix Pharmaceuticals Holding Corp.2
  • CIK0001430306
  • Employer ID (EIN)26-143475017
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company17
  • Incorporated inNevada17
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address200 Connell Drive, Suite 3100, Berkeley Heights, NJ 079222
  • Phone212-980-91552
  • Shares outstanding17,151,024 as of Aug 7, 202616
  • Public float$271.4M as of Jun 30, 202517
  • AuditorEisnerAmper LLP, Iselin, New Jersey PCAOB ID 274; no auditor attestation of internal control over financial reporting17
  • On EDGAR sinceApr 9, 20082
  • Filings1,516 in all: 8-K (691), 4 (329), 10-Q (56), 424B5 (47), SC 13G/A (40), CORRESP (39), 3 (28), SC 13G (28)2
    All 46 form types

    UPLOAD (26), DEF 14A (23), EFFECT (22), S-1/A (20), 10-K (18), PRE 14A (14), 5 (13), S-8 (12), S-1 (11), 8-K/A (10), S-3 (10), FWP (8), SCHEDULE 13G/A (8), 424B3 (7), SCHEDULE 13G (6), 10-K/A (5), 4/A (5), 424B4 (5), D (5), ARS (4), DEFA14A (4), S-3/A (3), POS AM (2), SC 13D/A (2), SEC STAFF LETTER (2), 8-A12B (1), 8-A12G (1), AW (1), CERTNAS (1), CT ORDER (1), D/A (1), NT 10-K (1), NT 10-Q (1), POS EX (1), RW (1), S-3MEF (1), SC 13D (1), SC 14F1 (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Mar 30, 2026
    Latest 8-K (8-K) Oct 15, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par valueTNXPThe NASDAQ Stock Market LLC

From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).17

Risk factors and legal proceedings

The risks Tonix Pharmaceuticals names in Item 1A of its 10-K filed Mar 12, 2026: 70 risks under these headings, as written.17

  • RISKS RELATED TO OUR FINANCIAL CONDITION AND CAPITAL REQUIREMENTS
  • We have a history of operating losses and expect to incur losses for the foreseeable future. We may never achieve profitability.
  • We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.
  • Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.
  • We will need additional capital to fund our operations. If additional capital is not available or is available at unattractive terms, we may be forced to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail our operations.
  • RISKS RELATED TO OUR BUSINESS
  • Our prospects are highly dependent on the success of TONMYA. If we are unable to successfully commercialize or maintain approval for TONMYA, our business, financial condition, results of operations and prospects and the value of our common stock will be materially adversely affected.
  • We have a limited operating history and only recently launched TONMYA in the United States, which may make it difficult to evaluate the prospects for our future viability.
  • TONMYA and our migraine products remain subject to ongoing regulatory review, and if we fail to comply with continuing regulations, we could lose our approval and the sale of TONMYA or our migraine products could be suspended.
  • If estimates of the size of the potential market for TONMYA are overstated or data we have used to identify prescribing healthcare providers is inaccurate, our ability to earn revenue to support our business could be materially adversely affected.
  • Coverage and adequate reimbursement may not be available for our products, which could make it difficult for us to sell our products profitably.
  • Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations.
The other 60 risks
  • Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.
  • Uncertainty in Government funding and in-kind support policies and programs may adversely affect our business.
  • RISKS RELATED TO PRODUCT DEVELOPMENT, REGULATORY APPROVAL, MANUFACTURING AND COMMERCIALIZATION
  • Our product candidates are novel and still in development.
  • If preclinical and nonclinical testing or clinical studies for our product candidates are unsuccessful or delayed, we will be unable to meet our anticipated development and commercialization timelines.
  • We are subject to extensive and costly government regulation.
  • Our product candidates may cause serious adverse events, or SAEs, or undesirable side effects which may delay or prevent marketing authorization, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
  • Any breakthrough, fast track or orphan drug designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat indications that do not qualify for priority review vouchers.
  • Even if approved, our product candidates will be subject to extensive post-approval regulation.
  • Our relationships with customers, physicians and third-party payors is subject to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • If the FDA approves generic products that compete with TONMYA, sales of TONMYA would be adversely affected.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges.
  • Reductions in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our products.
  • We may never receive regulatory approval to market our current or future product candidates outside of the U.S.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business.
  • There may not be market interest in TNX-801.
  • If technology developed for the purposes of developing new medicines or vaccines can be applied to the creation or development of biological weapons, then our technology may be considered “dual use” technology and be subject to limitations on public disclosure or export.
  • Competition and technological change may make our product candidates and technologies less attractive or obsolete.
  • RISKS RELATED TO OUR INTELLECTUAL PROPERTY RIGHTS AND REGULATORY EXCLUSIVITY
  • If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected.
  • We are dependent on license relationships with third parties for certain of our drug development programs.
  • We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
  • If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation.
  • There are risks to our intellectual property based on our international business initiatives.
  • We may be unable to protect the confidentiality of our trade secrets, thus harming our business and competitive position.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • GENERAL COMPANY-RELATED RISKS
  • We rely on third parties to conduct, supervise and monitor our clinical studies, and if those third parties perform in an unsatisfactory manner, it may harm our business.
  • We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
  • We will need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.
  • Our executive officers and other key personnel are critical to our business, and our future success depends on our ability to retain them.
  • If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.
  • We rely on third parties to manufacture our marketed products and the compounds used in our studies, and we intend to rely on them in the future. If these third parties do not manufacture our products and product candidates in sufficient quantities and at an acceptable cost, clinical development and commercialization of our products and product candidates could be delayed, prevented or impaired.
  • Failure by our third-party manufacturers to comply with the regulatory guidelines set forth by the FDA with respect to our products and product candidates could delay or prevent the completion of clinical studies, the approval of any product candidates or the commercialization of our products.
  • We are exposed to cybersecurity and data privacy risks that, if realized, could expose us to legal liability, damage our reputation and harm our business.
  • Adverse global conditions, including economic uncertainty, may negatively impact our financial results.
  • Our internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Corporate and academic collaborators may take actions to delay, prevent, or undermine the success of our products.
  • Data provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading, or incomplete.
  • Our product candidates may face competition sooner than expected.
  • If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market, sell and distribute our products, we may be unable to generate significant product awareness and that lack of awareness may limit the product revenues that we generate.
  • We face the risk of product liability claims and may not be able to obtain insurance.
  • We use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could affect us and be time-consuming and costly.
  • Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.
  • If we retain collaborative partners and our partners do not satisfy their obligations, we will be unable to develop our partnered product candidates.
  • We face risks in connection with existing and future collaborations with respect to the development, manufacture, and commercialization of our product candidates.
  • We face risks in connection with the testing, production and storage of our vaccine product candidates.
  • Changes in tax laws could adversely affect our business and financial condition.
  • RISKS RELATED TO OUR STOCK
  • Sales of additional shares of our common stock could cause the price of our common stock to decline.
  • We may not be able to maintain compliance with the Listing Rules of the NASDAQ Stock Exchange.
  • An active trading market for our common stock may not be sustained.
  • The market price of our common stock has been extremely volatile in the past and may be volatile in the future due to numerous circumstances beyond our control.
  • A “short squeeze” due to a sudden increase in demand for shares of our common stock that largely could lead to extreme price volatility in shares of our common stock.
  • We do not anticipate paying dividends on our common stock and, accordingly, shareholders must rely on stock appreciation for any return on their investment.
  • The rights of the holders of common stock may be impaired by the potential issuance of preferred stock.
  • If we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures, or if we discover material weaknesses and deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.
  • If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
  • Other companies may have difficulty acquiring us, even if doing so would benefit our stockholders, due to provisions under our corporate charter and bylaws, as well as Nevada law.
  • Our bylaws designate the Eighth Judicial District Court of Clark County, Nevada as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.

Legal proceedings

From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition, operating results or cash flows.

The opening of Item 3, Legal Proceedings.17

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