Published by Redington, Inc. for investment professionals. All rights reserved. Upcoming: Interim analysis of TNX-102 SL Phase 3 study in expected in September with topline data due before year end; key data from preclinical trial of lead T cell eliciting Covid-19 candidate due 4Q20, including results of challenge study in non-human primates. Cash at June 30 was $55 million – additional $12 raised after the quarter’s close.

Key Considerations Tonix Pharmaceuticals Holding Corp. in clinical trials share a common feature. Their main function is to elicit antibodies •Tonix’s two lead candidates are (Nasdaq: TNXP) TNX-102 SL* for the treatment of to fight the virus. As such they will provide Recent Price: $0.84 only temporary immunity (generally 6 to 9 fibromyalgia and TNX-1800*, a live months). They will require multiple doses attenuated virus vaccine for Covid-19. Shares O/S: 130 Million Approx. Mkt Cap: $109 Million for extended coverage, and they have not been shown to prevent contagion. The good •TNX-102 SL is a non-opioid, Fiscal Year Ends: Dec. 31 centrally acting sublingual tablet for news: they potentially can be approved and treatment of several chronic CNS Published: September 2020 available relatively quickly. designed to produce single disorders in which poor sleep quality About TNX-102 SL is believed to be a major component dose long term immunity require TNX-102 SL is being developed by Tonix different technology. They need to elicit of the disease process -- its active to treat chronic central nervous system (CNS) predominately T cells which are known for ingredient, cyclobenzaprine, has no disorders in which poor sleep quality is a their long-term . They remember recognized addiction or dependency core symptom and believed to be involved what invading pathogens look like long risk. in the disease process. after an initial encounter – often for years •It is currently in a pivotal Phase 3 Its active ingredient is cyclobenzaprine, and in some cases a lifetime, as has been registration trial in fibromyalgia. An which is known to have a high affinity for demonstrated with the T cell eliciting interim analysis is scheduled to be three brain receptors associated with sleep vaccines against measles, and quality. several other lethal pathogens. performed in September. Topline data TNX-102 SL sublingual tablets contain 2.8 is expected 4Q20. mg of cyclobenzaprine each. Two tablets for Accomplished & Upcoming •Tonix’s previous clinical trials with a total dose of 5.6 mg are being investigated -4Q19 – Initiated Phase 3 study TNX-102 SL served to optimize the for once-daily dosing at bedtime. in fibromyalgia dose, patient enrollment criteria, and The pharmacokinetic profile of TNX-102 SL is uniquely suitable for bedtime use and -4Q19 – Expanded pipeline endpoints for the current Phase 3 to include major depressive study in fibromyalgia - see TNX-102 is different from the FDA-approved orally ingested cyclobenzaprine formulations. disorder and alcohol use disorder SL Clinical Strategy. The two tablets are placed under the -2H20 – Expanded pipeline •The company’s Covid-19 vaccine tongue, allowing the active ingredient to with acquisition of migraine and candidate, TNX-1800, is designed be transported through the oral mucosa programs to potentially elicit a strong T directly into the blood stream, avoiding GI absorption and first-pass liver metabolism -3Q20 – Interim results Phase cell response to confer long-term 3 fibromyalgia (Sept) immunity against SARS-CoV-2, the and aligning the bioavailability of the drug virus that causes Covid-19. Non- with the sleep cycle. -4Q20 – Topline Phase 3 in Tonix owns all the intellectual property fibromyalgia anticipated human primate data from a trial at rights to TNX-102 SL - no license fees or Southern Research is expected 4Q20. royalties are due to any third party. US -4Q20 – Preclinical data •TNX-1800’s design differs from patent protection extends through 2035. expected on lead Covid-19 vaccine most of the other announced Covid- Covid-19 Vaccines T cell eliciting vaccines for other diseases 19 vaccine programs which utilize With all the popular press publicity about have been proven to prevent contagion, or vaccine technologies designed mainly Covid-19 vaccines, it may be hard for the forward expression, which is mandatory to to confer temporary immunity – their average person to sort out who’s on first, and prevent the on-going spread of any virus. biggest advantage being a much why there are so many programs underway The time-tested way to elicit a quicker path to approval. (more than 150+ at last count) to develop a predominately T cell response is with live Covid-19 vaccine. •Tonix reported $55 million cash and attenuated virus technology. This technology The truth is, vaccine experts believe we in being used by Tonix in all five of its cash equivalents as of June 30, 2020. will need more than one vaccine –in fact, Covid-19 vaccine candidates and by one An additional $12 million was raised many vaccines. other US company – Merck, a world leader after the close of the quarter. Most of the vaccine candidates currently in vaccines.

Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company’s intentions, expectations, assump- tions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development mile- stones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company’s product candidates and sufficiency of the company’s cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company’s Annual Report on Form 10-K and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company’s research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. to act as the company’s investor relations firm, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein. (Southern Research, Kansas State University, the first patient in the Phase 3 RELIEF study TNX-102 SL Clinical Strategy and Columbia University) to better of TNX-102 SL for the management of Tonix conducted two earlier Phase understand how the immune systems of fibromyalgia. 3 clinical trials of TNX-102 SL in naturally infected people respond to SARS- In July, Tonix completed enrollment of fibromyalgia and PTSD. Neither CoV-2, the virus that causes Covid-19. These RELIEF with approximately 470 patients met their primary endpoints but studies will help blueprint the immune randomized 1:1 to TNX- 102 SL or placebo both showed strong activity on the response and inform vaccine design to be at roughly 40 US sites. primary analyses as well as multiple more effective. Patients in the TNX-102 SL arm are treated key secondary endpoints. The work at Columbia is intended to with two 2.8 mg tablets (5.6 mg total) daily at The failed outcome in fibromyalgia identify biomarkers that will enable the use of bedtime, which is twice the dose studied in is believed to be due to the selection precision medicine techniques to customize the earlier Phase 3 study. of a low dose and a surprising vaccines to individuals for the most robust An interim analysis of RELIEF by an imbalance in patient dropouts. immune responses possible. Independent Data Monitoring Committee The prior Phase 3 trial narrowly About Fibromyalgia (IDMC) is expected to be completed missed the 30 percent responder Fibromyalgia affects between six to this September based on unblinded primary endpoint analysis at Week 12 million adults in the US according to results from approximately 50 percent of 12 (p = 0.095), one of several the American Association. enrolled patients. The four possible IDMC primary endpoints that could have Approximately 90 percent of patients are recommendations are: (1) stop the study for been selected. women. success; (2) continue the study as planned; Fibromyalgia is devastating and expensive (3) continue to enroll with a specified A retrospective analysis, however, for individuals and society. Approximately increase in the total number of participants showed that patients experienced 70 percent of patients indicate they have in the full study; or (4) stop the study for a nominal benefit (p =.005) difficulty with routine daily activities and futility. Topline results from the full study are as measured by average pain an estimated 20 percent of patients file anticipated in 4Q20. improvement at Week 12 using claims for disability insurance. Among the numerical rating scale (NRS), The primary endpoint is weekly average those diagnosed, more than one-third have daily diary pain severity score change from as analyzed by the statistical used prescription opioids as a means of method MMRM with MI (Mixed baseline after 12 weeks of treatment using the fibromyalgia symptom management, despite 5.6 mg dose, analyzed by MMRM with MI. Model Repeated Measures-with opioids not having demonstrated efficacy as Multiple Imputation). This type a treatment. TNX-102 SL is a non-opioid, Other Pipeline Candidates* of analysis is believed to be equally centrally acting analgesic that could provide TNX-102 SL for agitation associated acceptable to the FDA, had it been a new therapeutic option for fibromyalgia with Alzheimer’s disease (granted Fast prespecified. In this Phase 3 trial patients. There is no known cure for Track designation by FDA) and for alcohol TNX-102 SL was studied at a single fibromyalgia. use disorder, TNX-801 for prevention of 2.8 mg tablet, which is a low dose. Cymbalta® from Lilly and Lyrica® from smallpox, TNX-2300 for prevention of Covid- In the currently on-going Pfizer were the two blockbuster drugs, which 19, TNX-601 for , TNX-1300 for fibromyalgia Phase 3 study, the through massive ad campaigns, became cocaine intoxication/overdose (Breakthrough TNX-102 SL dose has been doubled most instrumental in building the market for Therapy designation), TNX-1600 for daytime fibromyalgia drugs. Both are now off patent. to 5.6 mg (two 2.8 mg tablets treatment of PTSD, TNX-1500 for prevention Patients continue to report dissatisfaction daily at bedtime), and the primary of organ transplant rejection and treatment with available treatments which suggests a endpoint was changed to average of autoimmune diseases, TNX-1700 for favorable market opportunity for new FDA- treatment of gastric and pancreatic cancers, pain improvement after 12 weeks approved entries. of treatment using the NRS, as TNX-1900 for migraine and craniofacial pain analyzed by MMRM with MI. TNX-102 SL Phase 3 in Fibromyalgia and TNX-701 for protection from radiation injury. The registration of TNX-102 SL 5.6 On December 10, 2019, Tonix enrolled mg for the fibromyalgia indication * All of Tonix’s product candidates are investigational new drugs or biologics and have not been is expected to be supported by the approved for any indication. long-term safety exposure from the PTSD program for TNX-102 SL 5.6 mg. Summary Tonix’s lead candidate, TNX-1800, utilizes • Three key events are expected before year end 2020: (1) live attenuated horsepox virus technology interim analysis of Ph 3 study of TNX-102 SL in fibromyalgia that is very similar to what Edward Jenner in September; (2) topline results from the same Ph 3 study in used more than 200 years ago to develop 4Q; and (3) pre-clinical results in 4Q of TNX-1800 Covid-19 the . It can be easily vaccine in small animals and non-human primates, including manufactured at scale on conventional cell culturing systems SARS-CoV-2 challenged non-human primates. Preclinical trials of TNX-1800 are being • Tonix-sponsored research at Southern Research, Columbia conducted at Southern Research under University, and Kansas State University is expected to yield a multi-phase collaborative agreement. critical information for guiding the design of Covid-19 vaccines Topline data in small animal and non-human primates (including a virus-challenged and therapeutics. cohort) is expected 4Q20, potentially setting • At June 30, 2020, cash and cash equivalents stood at $55 the stage for human trials in 2021. million. $12 million was raised after the quarter close. Tonix has taken a lead in sponsoring research at several prominent organizations

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