Tonix Pharmaceuticals : TNX-102 SL for Fibromyalgia, Long COVID, and PTSD

TNX-102 SL

Fibromyalgia, Long COVID & PTSD

NASDAQ: TNXP

Version P0404 January 4, 2023 (Doc 1147)

© 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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© 2022 Tonix Pharmaceuticals Holding Corp.

TNX-102 SL*: Fibromyalgia

Cyclobenzaprine Protectic® Sublingual Tablets

PROFILE	DEVELOPMENT PROGRAM
Fibromyalgia (FM) is a chronic pain disorder resulting	Market Entry: Fibromyalgia
from amplified sensory and pain signaling within the CNS
• Afflicts an estimated 6-12 million adults in the U.S., approximately	Additional Indications: Long COVID, PTSD,
Agitation in Alzheimer's, Alcohol Use Disorder
90% of whom are women1

CNS PORTFOLIO

• 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

When the check engine light malfunctions, the light is on even though the car is not malfunctioning

Patents Issued

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.

1American Chronic Pain Association (www.theacpa.org, 2019)

© 2022 Tonix Pharmaceuticals Holding Corp.

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TNX-102 SL: Fibromyalgia

Program Update

Phase 3 Study, RESILIENT, will compare TNX-102 SL 5.6 mg and placebo

• First patient enrolled in April 2022
• Interim Analysis results expected 2Q 2023
• Parallel design, double-blind, randomized placebo-controlled study, all U.S. sites
• Primary endpoint is pain at Week 14 analyzed by MMRM with MI
• Projecting adverse event-related discontinuations to decrease towards rates in RELIEF and PTSD Studies

Phase 3 Study, RALLY, comparison of TNX-102 SL 5.6 mg and placebo

• As expected from interim analysis results published in July 2021, RALLY Study missed primary endpoint
• Unexpected ~80% increase in adverse event-related discontinuations in both drug and placebo arms
• Multiple imputation approach on 'Missing Data' attenuated statistical significance of efficacy endpoints'
• TNX-102SL was generally well tolerated with overall adverse event profile comparable to prior studies; no new safety signals observed

CNS PORTFOLIO

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© 2022 Tonix Pharmaceuticals Holding Corp.

TNX-102 SL: RALLY Study

Increased Adverse Event-Related Discontinuations

Increases in AE-Related discontinuations in RALLY study compared with RELIEF study in both placebo and TNX-102 SL groups

	RALLY (F306)		RELIEF (F304)	RALLY (F306)		RELIEF (F304)
	Placebo	TNX-102 SL
Patients with at least one TEAE leading	6.2%		3.5%	15.2%		8.5%
to early discontinuation
Ratio of patients with at least one TEAE
leading to early discontinuation in F306		1.77		1.79
to F304 (F306/F304)
TEAE = treatment-emergent adverse event

Adverse events in RALLY

• TNX-102SL 5.6 mg was well tolerated.
• Among participants randomized to drug and placebo groups, 73.8% and 81.4%, respectively, completed the 14-week dosing period.
• As expected, based on prior TNX-102 SL studies, oral administration site reactions were higher in the drug treatment group, including rates of tongue/mouth numbness, pain/discomfort of tongue/mouth, and product taste abnormal (typically a transient bitter aftertaste)
• Tongue/mouth numbness or tingling and product aftertaste were local effects nearly always temporally related to dose administration and transiently expressed (<60 minutes) in most occurrences.
• Adverse events resulted in premature study discontinuation in TNX-102 SL and placebo groups at rates of 15.2% and 6.2%, respectively

• Approximately 95% of adverse events in both the drug treatment and placebo groups were rated as mild or moderate.

© 2022 Tonix Pharmaceuticals Holding Corp.

CNS PORTFOLIO

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