# EDGAR Filing Document

**Accession Number:** 0001430306
**File Stem:** 0001387131-23-001486
**Filing Date:** 2023-2
**Character Count:** 34185
**Document Hash:** 661cc589fa57abbebaaaed5098bf6197
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001387131-23-001486.hdr.sgml**: 20230207

**ACCESSION NUMBER**: 0001387131-23-001486

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 39

**CONFORMED PERIOD OF REPORT**: 20230207

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230207

**DATE AS OF CHANGE**: 20230207

**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:** 23592741

**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): February 7, 2023**

**TONIX PHARMACEUTICALS HOLDING CORP.**

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

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

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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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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;Title of each class | &nbsp;&nbsp;Trading Symbol(s) | &nbsp;&nbsp;Name of each exchange on which registered |
| &nbsp;&nbsp;Common Stock | &nbsp;&nbsp;TNXP | &nbsp;&nbsp;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** | **Regulation FD Disclosure.** |

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Tonix Pharmaceuticals Holding Corp. (the "Company") will present certain information regarding the Company and its product candidates at The Wall Street Conference on February 7, 2023. A copy of the presentation, which may contain nonpublic information, is filed as Exhibit 99.01 hereto and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 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 9.01** | **Financial Statements and Exhibits.** |

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| | | |
|:---|:---|:---|
| (d) | **Exhibit**<br> **No.** | **Description.** |
|  | [99.01](ex99-01.htm)<br> 104 | The Wall Street Conference Presentation by the Company<br> Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| | | |
|:---|:---|:---|
|  | **TONIX PHARMACEUTICALS HOLDING CORP.** | **TONIX PHARMACEUTICALS HOLDING CORP.** |
| Date: February 7, 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_020723.htm)

**Exhibit 99.01**

![](ex99-01_img001.jpg)© 2022 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION THE WALL STREET CONFERENCE NASDAQ: TNXP Version P0406 February 7, 2023 (Doc 1154)

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2© 2022 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.

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3© 2022 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

![](ex99-01_img004.jpg)

4© 2022 Tonix Pharmaceuticals Holding Corp. Investment Highlights DIVERSE PIPELINE Tonix's core 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 approximately $120 M in cash and cash equivalents as of 12/31/22. Tonix has no debt .

![](ex99-01_img005.jpg)

5© 2022 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 2Q 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 2Q 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

![](ex99-01_img006.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 2Q 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 designed to preserve 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 pharmacokinetic properties and 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 Diseases Status: Potential future indications include: Sj ö gren's Syndrome, Systemic Lupus Erythematosus • These indications require large studies, but represent large target markets

![](ex99-01_img007.jpg)

7© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 (ߙ - CD40L mAb): Prophylaxis of Transplant Rejection Potential Treatment for Autoimmune Conditions Pre - IND Candidate Significant Unmet Need Targeted as a first - line monotherapy for autoimmunity and add - on therapy for preventing and treating organ transplant rejection • Distinct mechanism of action (MOA) — TNX - 1500 blocks T cell helper function New molecular entity, biologic • US Patient Protection and Affordable Care Act provides 12 years of exclusivity for biologics Patent applications directed to composition of matter • Expected patent protection through 2039 Clinical evidence for anti - CD40L mAbs in the treatment of systemic lupus erythematosus (SLE), Sjögren's Syndrome (SjS), and allogeneic kidney transplant • Several studies have shown anti - CD40L to be active in the treatment of human SLE 1 - 3 , SjS 4,5 , and transplant rejection 6,7 1 Huang W, et al. Arthritis Rheum . 2002;46(6):1554 - 1562. 2 Boumpas DT, et al. Arthritis Rheum . 2003;48(3):719 - 727. 3 Grammer AC, et al. J Clin Invest . 2003;112(10):1506 - 1520 . 4 Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren's Syndrome Meets Primary En dpoint \| Horizon Therapeutics plc 5 Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren's Syndrome Meets Primary En dpoint in the Second Study Population; Only Phase 2 Trial to Meet Primary Endpoint in Both Patient Populations \| Horizon Therapeutics plc 6 Kawai T, et al. Nat Med . 2000;6(2):114. 7 Koyama I, et al. Transplantation . 2004;77(3):460 - 462.

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8© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 (ߙ - CD40 Ligand) Market Opportunity Autoimmune Disease $149.4 billion 6 OPPORTUNITY Kidney transplants: 24,000/year/US 2 $5.54 billion 3 Autoimmune Lupus: 1.5 M patients in US 4 1.87 billion 5 Organ transplant rejection drugs $4.7 billion 1 1 Global market as of 2018 (https://www.biospace.com/article/organ - transplant - rejection - medications - market - drug - companies - focus - on - improving - long - term - outcome - of - new - drugs/) 2 Wang, Jeffrey H. and Hart, Allyson. Kidney360 November 2021; 2(11) 1836 - 1839 3 Global market as of 2020 (https://www.grandviewresearch.com/industry - analysis/transplantation - market) 4 https://www.lupus.org/resources/lupus - facts - and - statistics 5 Global market as of 2020 (https://www.globenewswire.com/news - release/2021/02/18/2177637/0/en/Global - Lupus - Therapeutics - Market - Is - Expected - to - Reach - USD - 3 - 62 - Billion - by - 2028 - Fior - Markets.html) 6 Anticipated market size by 2025 (https://www.prnewswire.com/news - releases/the - global - autoimmune - disease - therapeutics - market - size - is - expected - to - reach - 149 - 4 - billion - by - 2025 -- rising - at - a - market - growth - of - 4 - 34 - cagr - during - the - forecast - period - 300902336.html)

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9© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO About CD40L (Also Called CD154) CD40L is a transiently expressed T cell surface molecule and is also called CD154 1 - 4 ‒ Predominantly expressed by T cells and interacts with CD40 on B cells and macrophages Mediates T cell helper function 1 - 4 ‒ Activates B cells for humoral (antibody - mediated) immune response ‒ Activates macrophages and dendritic cells ‒ Provides T cell help to activated CD8+ T cells X - linked hyper - IgM syndrome is caused by a defective CD40L gene 5 - 6 ‒ Lack of T helper function with only IgM serum antibodies but no IgG or IgE because T cells are required for B cell isotype switching ‒ If maintained on gamma globulin, patients are otherwise healthy Member of the TNF α superfamily 4 ‒ TNF α and RANKL are other family members and are drug targets for approved products 1 Lederman S, et al. J Exp Med . 1992;175(4):1091 - 1101. 2 Lederman S, et al. J Immunol . 1992;149(12):3817 - 3826. 3 Lederman S, et al. J Immunol . 1994;152(5):2163 - 2171. 4 Covey LR, et al. Mol Immunol . 1994;31(6):471 - 484. 5 Ramesh N, et al. Int Immunol . 1993;5(7):769 - 773. 6 Callard RE, et al. J Immunol . 1994;153(7):3295 - 3306.

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10© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Third - Generation α - CD40L Engineered to Decrease Risk of Thrombosis First - generation anti - CD40L mAbs Constant fragment (Fc) domain interacted with FcγRIIA (CD32A), which suggested a mechanism for the increased risk of thrombosis. 1,2 Ruplizumab Second - generation anti - CD40L mAbs Second - generation anti - CD40L mAbs exhibited dramatically reduced binding to FcγRIIA 3 - 5 but had other issues, including , shortened half - life, anti - drug antibodies (ADAs) or decreased efficacy. 6 - 8 Dapirolizumab Letolizumab Aglycosyl Ruplizumab Third - generation anti - CD40L mAbs \* TNX - 1500 is engineered to target CD40L therapeutically while reducing FcγRIIA binding and thereby lowering the potential for thrombosis. 1 - 8 TNX - 1500 \*Sanofi's frexalimab (formerly SAR441344) and Eledon's tegoprubart (formerly AT - 1501) also are Fc modified 1 Inwald DP, et al. Circ Res . 2003;92(9):1041 - 1048. 2 Robles - Carrillo L, et al. J Immunol . 2010;185(3):1577 - 1583. 3 Shock A, et al. Arthritis Res Ther . 2015;17(1):234. 4 Xie JH, et al. J Immunol . 2014;192(9):4083 - 4092. 5 Ferrant JL, et al. Int Immunol . 2004;16(11):1583 - 1594. 6 ClinicalTrials.gov identifier: NCT02273960. Updated July 16, 2019. Accessed June 1, 2021. https://clinicaltrials.gov/ct2/show /re sults/NCT02273960?view=results 7 Waters J, Biocentury ; October 26, (2018). 8 Company data.

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11© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ߙ - CD40L Treatment to Prevent Allograft Rejection • Calcineurin inhibitors (CNIs), mainly tacrolimus, are the cornerstone of immunosuppressive therapy 1,2 • However, CNIs cause irreversible and progressive deterioration of kidney function in all types of solid organ transplants 3,4 • Costimulation blockade (anti - CD40L in particular) may be more effective at protecting allografts than CNIs 5 1 Enderby C, et al. Am J Manag Care. 2015;21(1 Suppl):s12 - s23. 2 Camilleri B, et al. Exp Clin Transplant. 2016;14(5):471 - 483. 3 Naesens M, et al. Clin J Am Soc Nephrol. 2009;4(2):481 - 508. 4 Nankivell BJ, et al. N Engl J Med. 2003;349(24):2326 - 2333. 5 Cooper DKC, et al. Blood Purif. 2018;45(1 - 3):254 - 259. Concept for Human - to - Human Allotransplantation 1,2 Donor Recipient (+ CD40L blockade) Kidney Allotransplant Heart Allotransplant Donor (deceased) Recipient (+ CD40L blockade)

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12© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ߙ - CD40L Beyond Allografts: Xenografts • Allotransplantation is limited by a critical shortage of human organs; pig - to - human xenotransplantation offers a promising alternative 1,2 • Costimulation blockade (anti - CD40L in particular) is more effective at protecting xenografts than CNIs 2 • Blockade of CD40 - CD40L has been associated with some of the longest pig - to - primate xenograft survivals 1,3 1 Samy KP, et al. J Immunol Res. 2017;2017:8415205. 2 Cooper DKC, et al. Blood Purif. 2018;45(1 - 3):254 - 259. 3 Längin, M. et al. Consistent success in life - supporting porcine cardiac xenotransplantation. Nature 564, 430 – 433 (2018) Genetically Modified Pig Costimulation pathway blockers are used to manage cell - mediated immune rejection Concept for Pig - to - Human Xenotransplantation 1,2 Modifications to the pig genome greatly reduce risk of acute humoral rejection Longest Pig - to - Primate Kidney Graft Survival 1989 22 days 2004 90 days 499 days 2019

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13© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Tonix Collaboration with University of Maryland, Baltimore and United Therapeutics • Tonix has entered into a sponsored research agreement (SRA) with University of Maryland, Baltimore to study TNX - 1500 for the prevention of rejection of heart xenograft transplantation in NHPs • UMB's preclinical studies will utilize genetically - modified porcine hearts supplied by Revivicor , Inc. (subsidiary of United Therapeutics) • Primary objective is to study the activity TNX - 1500 in preventing xenograft rejection in animals to support an IND application for human studies • Previous preclinical studies in NHPs demonstrated that TNX - 1500 showed activity in preventing allograft and xenograft organ rejection and was well tolerated

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14© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Recent Xenotransplant Headlines "In a First, Surgeons Attached a Pig Kidney to a Human, and It Worked" Roni Caryn Rabin "Saved by a Pig's Heart" The Editorial Board "Pig Kidneys Transplanted Into Brain - Dead Man as Patients Face Organ Shortages" Amy Dockser Marcus "The Next Pig Thing in Medicine" Sally Satel "The Medical Miracle of a Pig's Heart in a Human Body" Rivka Galchen " The Patient Who Received a Pig Heart Dies Two Months After Transplant" Allison Prang October 19, 2021 January 12, 2022 January 20, 2022 February 9, 2022 February 21, 2022 March 9, 2022

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15© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ߙ - CD40L Beyond Allografts: Autoimmunity • Autoimmune diseases are also characterized by immune system activity that attacks "self," which can damage various parts of the body 1,2 • First - generation anti - CD40L Abs showed evidence of efficacy in autoimmunity before trials were halted due to thromboembolic events 3 1 Li P, et al. Front Pharmacol. 2017;8:460. 2 WebMD. Accessed March 3, 2020. https://www.webmd.com/a - to - z - guides/autoimmune - diseases 3 Tocoian A, et al. Lupus. 2015;24(10):1045 - 1056.

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16© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Anti - CD40L for Sjögren's Syndrome • Sjögren's is a life - long autoimmune condition , where tear and salivary glands are initially affected • In 2019, there were an estimated 2.26 million prevalent cases of primary Sjögren's syndrome worldwide. Forecasted to increase to 2.52 million prevalent cases by 2028 Horizon has announced two positive Phase 2 trials in Sjögren's Syndrome September 12, 2022: Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sj ögren's Syndrome Meets Primary endpoint 1 January 18, 2023 Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren's Syndrome Meets Primary Endpoint in the Second Study Population; Only Phase 2 Trial to Meet Primary Endpoint in Both Patient Populations 2 1 Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren's Syndrome Meets Primary Endpoint \| Horizon Therapeutics plc 2 Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren's Syndrome Meets Primary Endpoint in the Second Study Population; Only Phase 2 Trial to Meet Primary Endpoint in Both Patient Populations \| Horizon Therapeutics plc

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17© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500: Key Considerations • TNX - 1500 may be used in large markets that are not currently well served • There is a long history of use of monoclonal antibodies • Tonix has engineered a potentially safer but similarly efficacious molecule relative to first generation anti - CD40L mAbs • Intellectual property is in place (composition of matter) • Manufacturing (CMC) is in progress Key milestones: Pre - IND meeting (FDA) 3 Q 2022; Phase 1 2Q 2023 Autoimmune disorders – Planning INDs

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18© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Development and Regulatory Strategy • 1 st Indication – Kidney allotransplantation (human to human) ‒ Replacement for nephrotoxic CNI's (calcineurin inhibitors, e.g. Prograf® (tacrolimus) 1 , Neoral® (cyclosporin) 2 ‒ Similar development path to the successful development of BMS's Nulojix® (belatacept) 3 , CTLA - 4/Ig biologic ‒ Clinical development may combine with Nulojix or Rapamune® (rapamycin/sirolimus) 4 • 2 nd Indication – Heart or kidney xenotransplant (pig to human) ‒ CD40L:CD40 blockade considered essential ‒ The engineered pig organ is also considered a biologic • 3 rd Indication – Lou Gehrig's Disease, or ALS 5 ‒ Animal models show strong activity; competitor Eledon (ELDN) • 4 th Indication (and beyond) – Autoimmune disease (e.g., Sj ö gen's Syndrome, Systemic Lupus Erythematosus) ‒ Autoimmune indications require large studies and represent large target markets 1 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf 2 http://www.novartis.us/sites/www.novartis.us/files/neoral.pdf 3 https://packageinserts.bms.com/pi/pi_nulojix.pdf 4 https://labeling.pfizer.com/showlabeling.aspx?id=139 5 Amyotrophic Lateral Sclerosis

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19© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNF ߙ Superfamily Members Are Targeted by mAbs • CD40L is a member of the Tumor Necrosis Factor (TNF α) Superfamily 1 • Other TNF α Superfamily members have proven to be effective targets for antagonist (blocking) mAbs 2 anti - TNFα mAbs for the treatment of certain autoimmune conditions • infliximab (Remicade®) • adalimumab (Humira®) TNFα antagonist receptor fusion protein • etanercept (Enbrel®) anti - RANKL (CD254) mAb for the treatment of osteoporosis, treatment - induced bone loss, metastases to bone, and giant cell tumor of bone • denosumab (Prolia® or Xgeva®) No mAb against CD40L has been licensed anywhere in the world 1 Covey, L.R., et al. Mol. Immunol. 31:471 - 484. 1994. PMID: 7514269. 2 Remicade® and Simponi® are trademarks of Janssen; Humira® is a trademark of AbbVie; Cimzia® is a trademark of UCB; Enbrel® is a trademark of Amgen; and Prolia® and Xgeva® are trademarks of Amgen.

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20© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 2020 September October 2021 January Immunomedics acquired by Gilead for $21B 1 • TRODELVY TM (sacituzum ab govitecan - hziy) is an anti - Trop - 2 antibody - drug conjugate (ADC) approved for triple - negative breast cancer Momenta acquired by Johnson & Johnson for $6.5B 2 • Nipocalimab (M281) is a clinically validated anti - FcRn antibody with a rare pediatric disease designation from the US FDA • J&J called nipocalimab "a pipeline in a product" Viela Bio acquired by Horizon for $3B 3 • UPLIZNA® (inebilizumab - cdon) is an anti - CD19 (B - cell - depleting) antibody approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which is a rare and severe autoimmune disease • VIB4920 anti - CD40L is Viela's second program Kymab acquired by Sanofi for $1.1B 3 • Is an anti - Ox40L for the treatment of autoimmune disease 1 Gilead. September 13, 2020. Accessed June 3, 2021. https://www.gilead.com/news - and - press/press - room/press - releases/2020/9/gilead - sciences - to - acquire - immunomedics 2 Johnson & Johnson. October 1, 2020. Accessed June 3, 2021. https://www.jnj.com/johnson - johnson - completes - acquisition - of - momenta - pharmaceuticals - inc 3 Business Wire. February 1, 2021. Accessed June 3, 2021. https://www.businesswire.com/news/home/20210201005296/en/Horizon - Therape utics - plc - to - Acquire - Viela - Bio - Inc. - to - Significantly - Expand - Development - Pipeline - and - Grow - Rare - Disease - Medicine - Portfolio 4 BioSpace. March 29, 2022. Accessed March 29, 2022. https://www.biospace.com/article/sanofi - and - igm - partner - on - oncology - and - immun ology - in - deal - worth - more - than - 6 - billion/ 5 Genetic Engineering & Biotechnology News. December 13, 2022. Accessed Jan 30, 2023. https://www.genengnews.com/rare - and - neglecte d - diseases/amgen - to - acquire - horizon - for - 27 - 8b - expanding - rare - disease - pipeline/ Recent mAb Transactions 2022 March Sanofi and IGM Biosciences announce collaboration deal that could surpass $6B 4 • The two companies will partner on immunoglobulin M (IgM) antibody agonists against three cancer targets and three immunology/inflammation targets Horizon acquired by Amgen for $27.8B 5 • Replenish Amgen's autoimmune and inflammatory disease portfolios • Enbrel® (etanercept), faces the start of its loss of exclusivity on June 8, 2023, for patents related to its methods of treatment using aqueous formulations

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21© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Other anti - CD40L Monoclonal Antibodies in Development UCB (Co - developed with Biogen) – Systemic Lupus Erythematosus (SLE) • Phase 3 Trial Currently Enrolling (NCT04294667) - Topline results expected 1H 2024 1 • Dapirolizumab pegol (pegylated Fab) Horizon (Agreed to be acquired by Amgen) – Sjögren's Syndrome (SjS) • Two Positive Phase 2 studies reported 2,3 • Dazodalibep (tn03 fusion protein) Sanofi – Sjögren's Syndrome (SjS), Multiple Sclerosis (MS), Systemic Lupus Erythematosus (SLE) • Phase 2 Trial Currently Enrolling in SjS (NCT04572841) and SLE (NCT05039840) • Active Phase 2 Trial in Relapsing MS (NCT04879628) • Frexalimab f.k.a . SAR441344 (Fc - modified) Eledon – Amyotrophic Lateral Sclerosis (ALS) and Kidney Transplant • Phase 2 Trial Completed in ALS (NCT04322149) • Phase 1/2 Trial Currently Enrolling in Kidney Transplant (NCT05027906) • T egoprubart , f.k.a . AT - 1501 (Fc - modified) 1 https://www.ucb.com/our - science/pipeline 2 https://ir.horizontherapeutics.com/news - releases/news - release - details/horizon - therapeutics - plc - announces - phase - 2 - trial - evaluatin g 3 https://ir.horizontherapeutics.com/news - releases/news - release - details/horizon - therapeutics - plc - announces - phase - 2 - trial - evaluatin g - 0

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22© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO mAbs Represent 5 of Top 10 Products by 2023 Projected Sales • Over 100 mAbs have been approved by the US FDA, and significant growth potential remains 1 • Global mAb market is projected to grow from $179B in 2021 to $452B in 2028 at a CAGR of 14.1% 2 1. Keytruda anti - PD - 1 mAb 2. Comimaty 3. Humira anti - TNF α mAb 4. Paxlovid 5. Eliquis 6. Opdivo anti - PD - 1 mAb 7. Dupixent anti - IL4 mAb 7. Stelara anti - IL12/23 9. Spikevax 10. Biktarvy TOP 10 DRUGS WORLDWIDE BASED ON 2023 PROJECTED SALES 3 $24 B $19 B $13 B $13.5 B $13 B $11.5 B $11 B $11 B $11 B $11 B 1 Mullard A. May 5, 2021. Accessed February 24, 2022. (https://www.nature.com/articles/d41573 - 021 - 00079 - 7) 2 Forbes Business Insights. August 2021. Accessed February 24, 2022. 3 Matej Mikulic . Statista. Jan 18, 2023 . Accessed January 24, 2023. (https://www.statista.com/statistics/973523/top - drugs - by - year - on - year - sales - increase/)

![](ex99-01_img023.jpg)© 2022 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK

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24© 2022 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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25© 2022 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 - 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 Quarter 2023 Phase 2 study start of TNX - 1300 for the treatment of cocaine intoxication □ 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

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