# EDGAR Filing Document

**Accession Number:** 0001430306
**File Stem:** 0001387131-23-000041
**Filing Date:** 2023-1
**Character Count:** 46106
**Document Hash:** f3414ca5f8e19d19db4106d4dbe9af8e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001387131-23-000041.hdr.sgml**: 20230104

**ACCESSION NUMBER**: 0001387131-23-000041

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 44

**CONFORMED PERIOD OF REPORT**: 20230104

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230104

**DATE AS OF CHANGE**: 20230104

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Tonix Pharmaceuticals Holding Corp.
- **CENTRAL INDEX KEY:** 0001430306
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 261434750
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36019
- **FILM NUMBER:** 23504336

**BUSINESS ADDRESS:**
- **STREET 1:** 26 MAIN STREET, SUITE 101
- **CITY:** CHATHAM
- **STATE:** NJ
- **ZIP:** 07928
- **BUSINESS PHONE:** 212-980-9155

**MAIL ADDRESS:**
- **STREET 1:** 26 MAIN STREET, SUITE 101
- **CITY:** CHATHAM
- **STATE:** NJ
- **ZIP:** 07928

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** TAMANDARE EXPLORATIONS INC.
- **DATE OF NAME CHANGE:** 20080320

?xml version="1.0" encoding="utf-8"?

**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of report (date of earliest event reported): January 4, 2023**

**TONIX PHARMACEUTICALS HOLDING CORP.**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Nevada** | **001-36019** | **26-1434750** |
| **(State or Other Jurisdiction** <br> **of Incorporation)**  | **(Commission** <br> **File Number)** | **(IRS Employer** <br> **Identification No.)**  |

---

26 Main Street, Chatham, New Jersey 07928

**(Address of principal executive offices) (Zip Code)**

**Registrant's telephone number, including area code:** (862) 904-8182

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock | TNXP | The NASDAQ Capital Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 7.01** | **&nbsp;&nbsp;&nbsp;&nbsp; Regulation FD Disclosure.** |

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On January 4, 2023, Tonix Pharmaceuticals Holding Corp. (the "Company") announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its Executive Vice President, Medical. A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference.

The Company updated its investor presentation, which is used to conduct meetings with investors, stockholders and analysts and at investor conferences, and which the Company intends to place on its website, which may contain nonpublic information. A copy of the presentation is filed as Exhibit 99.02 hereto and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

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| | |
|:---|:---|
| **Item 8.01.** | **Other Events.** |

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On January 4, 2023, the Company announced the appointment of Dr. Rosenberg, M.D., M.P.H. as its Executive Vice President, Medical. Dr. Rosenberg will be responsible for leading the Company's clinical development strategy efforts for vaccines and antivirals.

*Forward- Looking Statements*

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

---

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| | | |
|:---|:---|:---|
| (d) | **Exhibit**<br> **No.** | **Description.** |
|  | [99.01](ex99-01.htm)<br> [99.02](ex99-02.htm)<br> 104 | Press release of the Company, dated January 4, 2023<br> Corporate Presentation by the Company for January 2023<br> Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURE**

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **TONIX PHARMACEUTICALS HOLDING CORP.** | **TONIX PHARMACEUTICALS HOLDING CORP.** |
| Date: January 4, 2023 | By: | /s/ Bradley Saenger |
|  | Bradley Saenger | Bradley Saenger |
|  | Chief Financial Officer | Chief Financial Officer |

---

## Exhibit 99.01

[Tonix Pharmaceuticals Holding Corp. 8-K](tnxp_8k-010423.htm)

**Exhibit 99.01**

**Tonix Pharmaceuticals Appoints Zeil Rosenberg, M.D., M.P.H., as Executive Vice President, Medical for Infectious Disease Programs**

 

*Dr. Rosenberg Will Lead Clinical Development of Tonix's Vaccine and Antiviral Programs*

 

CHATHAM, N.J., January 4, 2023 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical. In this role, Dr. Rosenberg will be responsible for leading Tonix's clinical development efforts for vaccines and antivirals. Dr. Rosenberg will be based in the Company's Chatham, N.J. headquarters, and as part of his role will oversee the clinical development of Tonix's vaccine for smallpox and monkeypox, TNX-801, the vaccine for COVID-19, TNX-1850, and the antiviral anti-SARS-CoV-2 spike protein monoclonal antibodies, TNX-3600 and TNX-3800, to protect immunocompromised individuals from severe COVID-19.

"We are pleased to welcome Dr. Rosenberg to Tonix's clinical team to lead the development of our infectious disease programs at a time when Tonix continues to make meaningful progress in the clinical development of multiple programs within its robust pipeline," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

"Dr. Rosenberg brings to our team expertise as an infectious disease drug developer and we are fortunate to have someone with Dr. Rosenberg's skills, vision and operational expertise join at a pivotal time in the evolution of our infectious disease product portfolio, with our vaccine candidate for monkeypox, TNX-801, expected to enter clinical testing in 2023, and TNX-3600 and TNX-3800 moving ahead in pre-clinical development to address the need for anti-SARS-CoV-2 monoclonal antibodies for immune-compromised individuals," said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. "At Becton, Dickinson and Company (BD), Dr. Rosenberg worked on the development of the BD Bifurcated Needleä, a safety-engineered improved bifurcated needle device for the percutaneous administration of live virus vaccinia vaccines, as well as BD VaxiNetä, a data monitoring system to improve patient safety in smallpox vaccine mass immunization efforts, which we believe have direct relevance to our recombinant poxvirus (RPV) platform."

"I am thrilled to join Tonix's executive management team and lead the clinical development of its infectious disease portfolio," said Dr. Rosenberg. "I look forward to working together with the talented Tonix team to advance the Company's portfolio of promising vaccines and antiviral therapies and help bring them to as many appropriate patients as possible."

Dr. Rosenberg was most recently at PPD, part of Thermo Fisher Scientific, serving as Executive Director, Biotech and as Therapeutic Area Head for Vaccines at its Accelerated Enrollment Solutions Group, where he provided leadership on multiple successful COVID-19 vaccine clinical trials. At BD he was Worldwide Business Leader and Medical Director for Immunization, and was Vice President for Medical Affairs at Admera Health, a medical diagnostics company focused on precision medicine. He was key to the launch of a global public private partnership, including UNICEF and WHO, to help eliminate maternal and neonatal tetanus through immunization, resulting in the significant reduction of neonatal mortality. He served as National Immunization Advisor to the Indonesian Ministry of Health in Jakarta, sponsored by the U.S. Agency for International Development (USAID), and as Chief Technical Officer for Immunization at USAID, Washington, D.C.

Dr. Rosenberg received his B.A. with Honors and Distinction at Stanford University, earned his M.D. at the University of California, San Francisco and completed his internship and residency at Mount Sinai and Cornell University Medical College, respectively. He holds a Masters of Public Health from Columbia University. Dr. Rosenberg is an elected Fellow of both the American College of Preventive Medicine and the New York Academy of Medicine, and Specialty Fellow of the American Academy of Pediatrics. He has served as AAS Science, Engineering and Diplomacy Fellow.

**Tonix Pharmaceuticals Holding Corp.<sup>\*</sup>**

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix's rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix's infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix's vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023.

*<sup>\*</sup>All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.*

This press release and further information about Tonix can be found at www.tonixpharma.com.

**Forward Looking Statements**

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the "SEC") on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

**Contacts**

Jessica Morris (corporate)

Tonix Pharmaceuticals

investor.relations@tonixpharma.com

(862) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners

Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)

ICR Westwicke

peter.vozzo@westwicke.com

(443) 213-0505

## Exhibit 99.02

[Tonix Pharmaceuticals Holding Corp. 8-K](tnxp_8k-010423.htm)

**Exhibit 99.02**

![](ex99-02_img001.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P04034 January 4, 2023 (Doc 11 46)

![](ex99-02_img002.jpg)

2© 2023 Tonix Pharmaceuticals Holding Corp. Cautionary Note on Forward - Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are "forward - looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward - looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward - looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward - looking statements. These factors include, but are not limited to, the risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID - 19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. The forward - looking statements in this presentation are made as of the date of this presentation, even if subsequently made available by Tonix on its website or otherwise. Tonix does not undertake an obligation to update or revise any forward - looking statement, except as required by law. Investors should read the risk factors set forth in the Annual Report on Form 10 - K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the "SEC") on March 14, 2022, and periodic reports and current reports filed with the SEC on or after the date thereof. All of Tonix's forward - looking statements are expressly qualified by all such risk factors and other cautionary statements.

![](ex99-02_img003.jpg)

3© 2023 Tonix Pharmaceuticals Holding Corp. Who We Are Tonix Pharmaceuticals is committed to improving population health by inventing and developing innovative therapies and vaccines, through broad in - house capabilities and creative collaborations , to help address important unmet needs. OUR MISSION Tonix strives to be a leader in providing novel drug therapies and vaccines to improve population health around the world. OUR VISION

![](ex99-02_img004.jpg)

4© 2023 Tonix Pharmaceuticals Holding Corp. Investment Highlights DIVERSE PIPELINE Tonix's c ore focus is on central nervous system disorders , but we also target unmet needs across multiple therapeutic areas including immunology, infectious disease and rare disease. STRATEGIC PARTNERSHIPS Partnering strategically with other biotech companies , world - class academic and non - profit research organizations to bring innovative therapeutics to market faster. IN - HOUSE CAPABILITIES Investment in domestic , in - house, R&D and manufacturing to accelerate development timelines and improve the ability to respond to pandemics. FINANCIAL POSITION Tonix had $140 M of cash as of 9/30/22. Tonix has no debt .

![](ex99-02_img005.jpg)

5© 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Programs Candidates\* Indication Status/Next Milestone TNX - 102 SL 1 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (PASC 2) Mid - Phase 3 - >50% enrolled Phase 2, Targeted 2Q 2023 Start Phase 2 - enrolling TNX - 1300 3 Cocaine Intoxication - FDA Breakthrough Designation Mid - Phase 2, Targeted 1Q 2023 Start TNX - 1900 4 Migraine, Craniofacial Pain and Binge Eating Disorder Phase 2, Targeted 1Q 2023 Start 5 TNX - 601 ER Depression, PTSD, Neurocognitive Dysfunction from Steroids Phase 2, Targeted 1Q 2023 Start 6 TNX - 1600 7 Depression, PTSD and ADHD Preclinical TNX - 2900 8 Prader - Willi Syndrome - FDA Orphan Drug Designation Preclinical TNX - 1500 9 Organ Transplant Rejection/ Autoimmune Conditions Phase 1, Targeted 1H 2023 Start TNX - 1700 10 Gastric and colorectal cancers Preclinical TNX - 801 11 Smallpox and monkeypox vaccine Phase 1, Targeted 2H 2023 Start TNX - 1850 12 COVID - 19 Vaccine (horsepox - based live virus vaccine) Preclinical TNX - 2300 13 COVID - 19 Vaccine Preclinical TNX - 3600 14 COVID - 19 Therapeutic Platform (fully human monoclonal antibodies) Preclinical TNX - 3700 15 COVID - 19 Vaccine (zinc nanoparticle mRNA technology) Preclinical TNX - 3800 16 COVID - 19 Therapeutic/Preventative (humanized monoclonal antibodies) Preclinical \*All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. 1 TNX - 102 SL (cyclobenzaprine HCl sublingual tablets) is also in development for Agitation in A lzheimer's Disease (AAD) and Alcohol Use D isorder (AUD). Both indications are Phase 2 ready. 2 Post - Acute Sequelae of COVID - 19. 3 TNX - 1300 (double - mutant cocaine esterase) was licensed from Columbia University . 4 Acquired from Trigemina ; license agreement with Stanford University; IND cleared for the prevention of migraine indication; Planned Binge Eating Dis ord er study is expected to be investigator initiated. 5 A Phase 2 trial under an investigator - initiated IND has been completed in the U.S. using TNX - 1900; Phase 2 for the prevention of migraine headache expected to start 1Q 2023 6 Phase 1 trial for formulation development was completed outside of the U.S; Phase 2 expected to start 1Q 2023 7 Acquired from TRImaran Pharma; license agreement with Wayne State University 8 Co - exclusive license agreement with French National Institute of Health and Medical Research (Inserm) 9 anti - CD40L humanized monoclonal antibody 10 Recombinant trefoil factor 2 (rTFF2) based protein; licensed from Columbia University 11 Live attenuated vaccine based on horsepox virus 12 Live attenuated vaccine based on horsepox virus vector, expressed SARS - CoV - 2 spike protein. TNX - 1850 is based on the BA.2 variant spike protein. 13 Live attenuated vaccine based on bovine parainfluenza (BPI) virus 14 Fully human monoclonal antibody generated from COVID - 19 convalescent patients 15 COVID vaccine based on mRNA in zinc nanoparticle (ZNP) formulation with CD40L molecular trigger 16 Humanized monoclonal antibody generated from mice immunized with SARS - CoV02 spike protein

![](ex99-02_img006.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES

![](ex99-02_img007.jpg)

7© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Four CNS drugs 1 entering Phase 2 trials in 1H23 Three Potential Pivotal Studies in addition to two enrolling studies • In Phase 3: ‒ TNX - 102 SL for fibromyalgia (>50% enrolled) Potential Pivotal Study • In Phase 2: ‒ TNX - 102 SL for fibromyalgia - type Long COVID Potential Pivotal Study • Entering Phase 2 in 1H23 ‒ TNX - 1300 for cocaine intoxication (breakthrough therapy designation) Potential Pivotal Study ‒ TNX - 601 CR for major depressive disorder (new mechanism for US patients) Potential Pivotal Study ‒ TNX - 1900 for migraine headache (new mechanism for US patients) Potential Pivotal Study ‒ TNX - 102 SL for PTSD 7 1 Not approved for any indication

![](ex99-02_img008.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL\* Cyclobenzaprine (Protectic®) Pipeline in a Product Fibromyalgia Status: Mid - Phase 3 • One positive Phase 3 study (RELIEF) completed • Second Phase 3 study (RALLY) missed primary endpoint • Confirmatory Phase 3 study (RESILIENT) is currently enrolling • >50% enrolled Next Steps: Interim analysis results expected 2Q 2023 Long COVID Status: Phase 2 • Phase 2 study (PREVAIL) is currently enrolling Next Steps: Interim analysis results expected 3Q 2023 Patents Issued \*TNX - 102 SL has not been approved for any indication. Posttraumatic Stress Disorder (PTSD) Status: Mid - Phase 2 • One Phase 2 study (AtEase) completed • Two Phase 3 studies (HONOR, RECOVERY) conducted Next Steps: Initiate Phase 2 trial 2Q 2023 A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption Potent binding and antagonist activities at the serotonin - 5 - HT2A, α1 - adrenergic, histaminergic - H1, and muscarinic - M1 receptors to facilitate restorative sleep Innovative and proprietary PROTECTIC® Rapid drug exposure following nighttime administration Differentiators: Relative to Oral Cyclobenzaprine • Lower daytime exposure • Avoids first - pass metabolism • Reduces risk of pharmacological interference from major metabolite Relative to Standard of Care • Potential for better tolerability while maintaining efficacy

![](ex99-02_img009.jpg)

9© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL\*: Fibromyalgia Cyclobenzaprine Protectic® Sublingual Tablets CNS PORTFOLIO Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS • A fflicts an estimated 6 - 12 million adults in the U.S., approximately 90% of whom are women 1 • Symptoms include chronic widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction • Patients struggle with daily activities, have impaired quality of life, and frequently are disabled • Physicians and patients report common dissatisfaction with currently marketed products Market Entry: Fibromyalgia Additional Indications: Long COVID, PTSD, Agitation in Alzheimer's, Alcohol Use Disorder Status: One Positive Phase 3 study RELIEF completed Second Phase 3 study RALLY missed primary endpoint Confirmatory Phase 3 study RESILIENT is currently enrolling Next Steps: Interim analysis results expected 2Q 2023 \*TNX - 102 SL has not been approved for any indication. 1 American Chronic Pain Association (www.theacpa.org, 2019) When the check engine light malfunctions, the light is on even though the car is not malfunctioning

![](ex99-02_img010.jpg)

10© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 3 R ESILIENT Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in fibromyalgia • U.S. sites only, expected to enroll approximately 470 patients • One unblinded interim analysis based on 50% of randomized participants Primary Endpoint: • Daily diary pain severity score change from baseline to Week 14 (TNX - 102 SL vs. placebo) • Weekly averages of the daily numerical rating scale scores • Analyzed by mixed model repeated measures with multiple imputation (MMRM with MI) Placebo once - daily at bedtime 14 weeks TNX - 102 SL once - daily at bedtime 5.6 mg (2 x 2.8 mg tablets) \* \* Two week run in at 2.8 mg dose at bedtime, followed by 12 weeks at 5.6 mg dose

![](ex99-02_img011.jpg)

11© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL\*: Long COVID (PASC) Cyclobenzaprine Protectic® Sublingual Tablets • Occurs in approximately 13% of recovered COVID - 19 patients 1 • As many as 40% of Long COVID patients experience multi - site pain, a hallmark of fibromyalgia 2,3 Market Entry : Fibromyalgia - Type Long COVID (PASC) Status: Phase 2 study PREVAIL is currently enrolling Next Steps: Interim analysis results expected 3Q 2023 1 September 1, 2022 - CDC - https://www.cdc.gov/coronavirus/2019 - ncov/long - term - effects/index.html 2 Harris, H, et al. Tonix data on file. 2022 3 TriNetX Analytics \*TNX - 102 SL has not been approved for any indication. CNS PORTFOLIO Additional Indications: Fibromyalgia, PTSD, Agitation in Alzheimer's, Alcohol Use Disorder Multisite pain Memory issues Fatigue Sleep disturbances

![](ex99-02_img012.jpg)

12© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 2 PREVAIL Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in fibromyalgia - type Long COVID • Approximately 30 sites in the U.S. and is expected to enroll approximately 470 patients • One unblinded interim analysis based on 50% of randomized participants Primary Endpoint: • Daily self - reported worst pain intensity change from baseline at Week 14 (TNX - 102 SL vs. placebo) - Weekly averages of the daily numerical rating scale scores - Analyzed by mixed model repeated measures with multiple imputation (MMRM with MI) Placebo once - daily at bedtime 14 weeks TNX - 102 SL once - daily at bedtime 5.6 mg (2 x 2.8 mg tablets) \* \* Two week run in at 2.8 mg dose at bedtime, followed by 12 weeks at 5.6 mg dose

![](ex99-02_img013.jpg)

13© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX 102 SL\*: Posttraumatic Stress disorder (PTSD) Cyclobenzaprine Protectic® Sublingual Tablets PTSD is a serious chronic psychiatric illness • Defined as maladaptive prolonged stress response which occurs after experiencing severely injurious traumatic event(s) Affects approximately 12 million Americans adults 1,2 Large unmet clinical need and limited effective therapies available • Advances in pharmacological treatments beyond the currently approved SSRIs (e.g., Zoloft® (sertraline), Paxil® (paroxetine)) are needed 3 Market Entry: PTSD Additional Indications: Fibromyalgia, Long COVID, Agitation in Alzheimer's, Alcohol Use Disorder Status: One Phase 2 study (AtEase) completed Two Phase 3 studies (HONOR, RECOVERY) conducted Next Steps: 2Q 2023 Initiate Phase 2 Trial 1 Goldstein RB, et al. The epidemiology of DSM - 5 posttraumatic stress disorder in the United States: results from the National Epi demiologic Survey on Alcohol and Related Conditions - III. Soc Psychiatry Psychiatr Epidemiol. 2016;51(8):1137 - 1148. 2 Pietrzak RH, et al. Prevalence and Axis I comorbidity of full and partial posttraumatic stress disorder in the United States: re sults from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions. J Anxiety Disord . 2011;25(3):456 - 465. \*TNX - 102 SL has not been approved for any indication. 3 Cain, C. K., et al. Targeting memory processes with drugs to prevent or cure PTSD. Expert Opin Investig Drugs. 2012; 21(9), 1323 - 1350

![](ex99-02_img014.jpg)

14© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1300\*: Cocaine Intoxication Cocaine Esterase (CocE) Cocaine is the main cause for drug - related ED visits 1 CocE is a recombinant protein that degrades cocaine in the bloodstream • Rapidly reverses physiologic effects of cocaine • Drops plasma exposure by 90% in 2 minutes Differentiators: Rapidly metabolizes cocaine in the bloodstream; no other product currently on the market for this indication Market Entry: Cocaine Intoxication Status: Mid - Phase 2 Next Steps: Initiate new Phase 2 1Q 2023 pending FDA agreement • S ingle - blind, placebo (+ usual care) controlled, randomized, potentially pivotal study 1 Havakuk O et al. J Am Coll Cardiol . 2017;70:101 - 113. ED = emergency department. FDA Breakthrough Therapy Designation Awarded Cooperative Agreement Grant from National Institute on Drug Abuse (NIDA) \*TNX - 1300 has not been approved for any indication. CNS PORTFOLIO CocE Cocaine

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15© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 E R\*: Depression Tianeptine Hemioxalate Extended - Release Tablets CNS PORTFOLIO • A novel, oral, extended - release once - daily tablet • Indirectly modulates the glutamatergic system • Treatment effect of tianeptine in depression is well - established Differentiators: Relative to Tianeptine IR: • Once daily dosing Relative to traditional anti - depressants: • U nique mechanism of action • Tianeptine sodium IR has similar efficacy but fewer side effects than traditional anti - depressants Market Entry: Major Depressive Disorder Additional Indications: PTSD, Neurocognitive Disorder From Corticosteroids Status: Phase 2 ready Next Steps: Initiate a Phase 2 potentially pivotal study 1Q 2023 • Double - blind, placebo - controlled, parallel - group, randomized, • Expected to enroll approximately 300 patients across 30 sites in the US AMPA= α - amino - 3 - hydroxy - 5 - methyl - 4 - isoxazolepropionic acid; MAOI=monoamine oxidase inhibitors; NMDA=N - methyl - D - aspartate. \*TNX - 601 ER has not been approved for any indication.

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16© 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 1900\*: Migraine Intranasal Potentiated Oxytocin (OT) with Magnesium CNS PORTFOLIO • Intranasal OT has potential utility in treating migraine 1 • Magnesium is known to potentiate the binding of OT to its receptor 2,3 • One billion individuals worldwide suffer from migraines Differentiator: Novel non - CGRP antagonist approach to treatment Market Entry: Chronic Migraine Additional Indications: Acute Migraine, Craniofacial Pain, Insulin Resistance, Binge Eating Disorder Status: Phase 2 ready 4 Next Steps: 1 Q 2023 Initiate Phase 2 Trial and Investigator Initiated Phase 2 Trial in Binge Eating Disorder 1 Tzabazis A, et al. Oxytocin and Migraine Headache. Headache. 2017 May;57 Suppl 2:64 - 75. doi : 10.1111/head.13082. PMID: 28485846. 2 Antoni FA, Chadio SE. Essential role of magnesium in oxytocin - receptor affinity and ligand specificity. Biochem J. 1989 Jan 15;257(2):611 - 4. doi : 10.1042/bj2570611. PMID: 2539090; PMCID: PMC1135623. 3 Meyerowitz , J.G., et al. The oxytocin signaling complex reveals a molecular switch for cation dependence. Nat Struct Mol Biol (2022). (https://doi.org/10.1038/s41594 - 022 - 00728 - 4) 4 A Phase 2 trial under an investigator - initiated IND has been completed in the U.S. using TNX - 1900 \*TNX - 1900 has not been approved for any indication. CGRP = calcitonin gene - related peptide. Oxytocin receptor Oxytocin

![](ex99-02_img017.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE: KEY CANDIDATES

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18© 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Patents Issued PROFILE DEVELOPMENT PROGRAM TNX - 2900\*: Hyperphagia in Prader - Willi Syndrome Intranasal Potentiated Oxytocin (OT) with Magnesium Prader - Willi Syndrome is the most common genetic cause of life - threatening childhood obesity • Rare disease occurring in 1 in 10,000 to 1 in 30,000 births Differentiator: No approved therapeutic currently on the market for hyperphagia in PWS Dangers of PWS Hyperphagia: Market Entry: Hyperphagia in Prader - Willi Syndrome Additional Indications: Rare Hyperphagia Conditions Status: P re - IND Next Steps: IND preparation \*TNX - 2900 is in the pre - IND stage of development and has not been approved for any indication. Caretaker Burden 1 - 4 : Unhealthy behaviors around food 1 - 4 Consequences such as obesity, type 2 diabetes, cardiovascular disease 1 - 5 1 Miller JL, et al. Am J Med Genet A . 2011;155A(5):1040 - 1049. 2 Butler MG, et al. Genet Med. 2017;19(6):635 - 642. 3 Butler MG. NORD. Updated 2018. Accessed May 25, 2022. https://rarediseases.org/rare - diseases/prader - willi - syndrome/ 4 Prader - Willi Syndrome Association USA. Accessed May 25, 2022. https://www.pwsausa.org/what - is - prader - willi - syndrome/ 5 Muscogiuri G, et al. J Endocrinol Invest . 2021;44(10):2057 - 2070.

![](ex99-02_img019.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES

![](ex99-02_img020.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1500\* Next Generation ߙ - CD40 Ligand (CD40L) Antibody The CD40 - CD40L pathway is a pivotal immune system modulator and a well - established and promising treatment target First Generation: Development halted due to thromboembolic (TE) complications — blood clots — traced to Fc gamma receptor (Fc ઻ R) Prevention of Allograft Rejection Status: Preclinical • Collaborations ongoing with Mass General Hospital on heart and kidney transplantation in non - human primates Next Steps: Initiate Phase 1 study 1H 2023 SELECTIVELY MODIFIED anti - CD40L AB Ruplizumab full Fab Contains the full ruplizumab Fab and the engineered Fc region that modulates Fc γ R - binding, while preserving FcRn function. Mutated Fc γ R - binding region FcRn - binding region Fc γ R - modulated Fc region Second Generation: Eliminated the Fc ઻ R TE complication but potency and half life was reduced, limiting utility Third Generation (TNX - 1500): Re - engineered to better modulate the binding of Fc ઻ R while preserving FcRn function. \*TNX - 1500 is in the pre - IND stage of development and has not been approved for any indication. Patents filed. Differentiators: Expected to deliver efficacy without compromising safety Autoimmune Disease Status: Potential future indication • These indications require large studies, but represent large target markets

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21© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700\*: Gastric and Colorectal Cancers Recombinant Trefoil Factor 2 (rTFF2) Fusion Protein Potential New Cancer Treatment • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment • Mechanism of action: suppresses myeloid - derived suppressor cells and activates anti - cancer CD8+ T cells • Potential synergy with anti - PD - 1 or anti - PD - L1 monoclonal antibodies (mAbs) Preclinical Evidence for Inhibiting Growth of Cancer Cells • Data showed that TFF2 - CTP augmented the efficacy of mAb anti - PD - 1 therapy. Anti - PD - 1 in combination with TFF2 - CTP showed greater anti - tumor activity in PD - L1 - overexpressing mice Licensed from Columbia University • Developing in partnership under sponsored research agreement Market Entry: Immuno - oncology, combination therapy with PD1 blockers for gastric and colorectal cancer Status: Preclinical Next Steps: Animal studies ongoing \*TNX - 1700 is in the pre - IND stage of development and has not been approved for any indication. Differentiator: No product yet identified consistently augments PD1 effects on cold tumors

![](ex99-02_img022.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES

![](ex99-02_img023.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801 & TNX - 1850\* Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology Monkeypox and Smallpox Vaccine Status: Preclinical • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture Next Steps: Developing GMP manufacturing; Initiate Phase 1 Trial 2H 2023 COVID - 19 Vaccine Status: Preclinical • First version TNX - 1800 encodes spike protein from SARS - CoV - 2, Wuhan strain • Planned new version TNX - 1850 encode spike protein from SARS - CoV - 2 BA.2 strain 2 Next Steps: Developing TNX - 1850 (BA.2) version \*TNX - 801 and TNX - 1850 are in the pre - IND stage of development and has not been approved for any indication. Patents filed. • Live virus vaccines are the most established vaccine technology ‒ Starting with Edward Jenner's smallpox vaccine, the first vaccine, which eradicated smallpox ‒ Prevents forward transmission ‒ Effective in eliciting durable or long - term immunity • Economical to manufacture at scale ‒ Low dose because replication amplifies dose in vivo ‒ Single shot administration • Standard refrigeration required for shipping and storage 1 Noyce RS, et al. Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments. PLoS One. 2018 Jan 19;13(1):e0188453. 2 Brennan, Z. Endpoints March 2, 2022 (https://endpts.com/weaker - omicron - variant - is - great - news - for - the - world - but - bad - news - for - covid - related - clinical - trials/) Differentiators: TNX - 801\* scHPXV (Horsepox) 212,811 bp TNX - 1800 rHPXV /SARS - CoV - 2 S 210,963 bp

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24© 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Additional Infectious Disease Therapeutics in Development TNX - 2300\*: Live Virus Vaccine Based on Bovine Parainfluenza (BPI) Virus Market Entry: COVID - 19 Vaccine Status: Preclinical Next Steps: Animal studies with Kansas State University (KSU) to test the effect of co - expression of CD40 - ligand to stimulate T cell immunity TNX - 3600 \* : (Fully Human Monoclonal Antibody Platform) and TNX - 3800 (Humanized Mouse Monoclonal Antibodies) Market Entry: COVID - 19 Therapeutic and P reventative for Immuno - compromised I ndividuals Status: Preclinical Next Steps: Study inhibition of SARS CoV - 2 variants in tissue culture; initiate animal studies TNX - 3700\*: Zinc Nanoparticle (ZNP) Formulation for mRNA Vaccines Market Entry: Booster for COVID - 19 Vaccines Status: Preclinical Next Steps: Research at KSU on CoV - 2 spike based vaccine in tissue culture and animals; initiate animal studies \*TNX - 2300, TNX - 3600 and TNX - 3700 are in the pre - IND stage of development and has not been approved for any indication.

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25© 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Monkeypox and Smallpox Future Pandemics & New Infectious Diseases COVID - 19 Biodefense Using Proven Science To Address Challenging Disease States, We Have Created A Programmable Technology Platform Aimed At Combating Future Threats To Public Health Vaccinia Horsepox ANTIGEN CODING Oncology RPV VECTOR BELIEVED SIMILAR TO EDWARD JENNER'S VACCINE 1 - 3 1 Shrick, L. N Engl J Med 2017; 377:1491 - 1492. DOI: 10.1056/NEJMc1707600 2 Esparza, J. Vaccine. 2020 Jun 19; 38(30): 4773 – 4779. doi : 10.1016/j.vaccine.2020.05.037 3 Brinkmann, A. Genome Biol. 2020; 21: 286. doi : 10.1186/s13059 - 020 - 02202 - 0

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26© 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities Infectious Disease R&D Center (RDC) – Frederick, MD • Function: Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other infectious diseases • Description: ~48,000 square feet, BSL - 2 with some areas designated BSL - 3 • Status: Operational Advanced Development Center (ADC) – North Dartmouth, MA • Function: Development and clinical scale manufacturing of biologics • Description: ~45,000 square feet, BSL - 2 • Status: Operational Commercial Manufacturing Center (CMC) – Hamilton, MT • Function : Phase 3 and Commercial scale manufacturing of biologics • Description: ~44 - acre green field site, planned BSL - 2 • Status: Planning for site enabling work in 2023 Architectural Rendering

![](ex99-02_img027.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

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28© 2023 Tonix Pharmaceuticals Holding Corp. Management Team Seth Lederman, MD Co - Founder, CEO & Chairman Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer

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29© 2023 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming\* Expected Clinical Trial Initiations □ 1 st Quarter 2023 Phase 2 study start of TNX - 1900 for the treatment of migraine □ 1 st Quarter 2023 Phase 2 study start of TNX - 1300 for the treatment of cocaine intoxication □ 1 st Quarter 2023 Phase 2 study start of TNX - 601 ER for the treatment of major depressive disorder □ 2 nd Quarter 2023 Phase 2 study start of TNX - 102 SL for the treatment of PTSD □ 2 nd Quarter 2023 Phase 1 study start of TNX - 1500 for prevention of allograft rejection □ 2 nd Half 2023 Phase 1 study start of TNX - 801 for prevention of monkeypox and smallpox \* We cannot predict whether the global COVID - 19 pandemic will impact the timing of these milestones. □ 2 nd Quarter 2022 Phase 3 RESILIENT study start of TNX - 102 SL for the management of fibromyalgia □ 3rd Quarter 2022 Phase 2 PREVAIL study start of TNX - 102 SL for the treatment of Long COVID x x Expected Data □ 2 nd Quarter 2023 Interim analysis results of Phase 3 RESILIENT study of TNX - 102 SL in fibromyalgia □ 3 rd Quarter 2023 Interim analysis results of Phase 2 PREVAIL study of TNX - 102 SL in Long COVID

![](ex99-02_img030.jpg)© 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU