Tonix Pharmaceuticals : Short Investor Presentation July 2024

Corporate Presentation

Abbreviated

July 2024

NASDAQ: TNXP

Version P0578 July 15, 2024 (Doc 1475)	© 2024 Tonix Pharmaceuticals Holding Corp.

Who We Are

Tonix is committed to developing and marketing therapeutics to treat pain,

neurologic, psychiatric and addiction conditions through our central nervous system portfolio and within other areas of high unmet need, including immunology, infectious disease, and rare disease

With a Focus on:

Filing a New Drug Application (NDA) with the US Food and Drug

Administration (FDA) for Tonmya (TNX-102 SL) for the management

of Fibromyalgia (FM)

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© 2024 Tonix Pharmaceuticals Holding Corp.

Key Clinical Programs

Molecule*	Indication	Phase 1	Phase 2	Phase 3	NDA
Submission
	Fibromyalgia	Statistically Significant Phase 3 Topline Results	Submission
		Reported 4Q'23		expected 2H'24
Tonmya
TNX-102 SL	Long COVID	Phase 2 Topline Results
Cyclobenzaprine HCl Protectic®		Reported 3Q'23
Sublingual Tablets
Acute Stress Disorder	Phase 2 Study** Start
	Expected 3Q'24
TNX-1300	Cocaine Intoxication	Phase 2 Study Start
Cocaine Esterase	Expected 3Q'24
NIDA Funded
TNX-2900
Intranasal Potentiated Oxytocin	Prader-Willi Syndrome	Phase 2 Ready
FDA Orphan Drug and Rare Pediatric
Disease Designation
TNX-1500	Organ Transplant Rejection/	Phase 1 Study	Clinical Stage Completed
Anti-CD40L mAb	Autoimmune Conditions	Ongoing

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*All of Tonix's product candidates are investigational new drugs or biologics and none has been approved for any indication.
**Investigator-initiated study

© 2024 Tonix Pharmaceuticals Holding Corp.

Tonmya

(TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets)

A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption

Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not	5
been approved for any indication.

© 2024 Tonix Pharmaceuticals Holding Corp.

About Fibromyalgia

Fibromyalgia is a chronic pain disorderresulting from amplified sensory and pain signaling within the CNS1

Fibromyalgia is a syndromecomprised of the symptoms: chronic widespread pain, nonrestorative sleep, and fatigue

Fatigue

Multisite	Non-Restorative Sleep
pain

Fibromyalgia is considered a chronic overlapping pain condition (COPC)

• the only COPC with any FDA-approved drugs3

Fibromyalgia is the prototypic nociplastic syndrome

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

3CFS/ME = chronic fatigue syndrome/myalgic encephalomyelitis

3The three drugs with FDA approval for the treatment of fibromyalgia: Pregabalin (Lyrica®); Duloxetine (Cymbalta®); Milnacipran (Savella®)

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© 2024 Tonix Pharmaceuticals Holding Corp.

Fibromyalgia is a Large, Underserved and Dissatisfied Population

• ~10 million U.S. adults are affected - predominantly women1,2
• • Debilitating and life altering condition
  • Significant economic impact
• Patients are dissatisfied, despite three FDA approved drugs3,4
• • 85% of patients fail first-line therapy5: efficacy variability, tolerability issues especially when used long-term and lack of broad-spectrum activity
  • Typical for patients to rotate between drugs and be on multiple drugs at the same time; 79% of FM patients are on multiple therapies5
• ~2.7 million FM patients diagnosed and treated6
• • >22 million prescriptions are issued for the treatment of fibromyalgia (on- and off-label usage) each year7,8
• No new Rx product since 2009
• The treatment objective is to restore functionality and quality of life by broadly improving symptoms while avoiding significant side effects

1American College of Rheumatology (www.ACRPatientInfo.org accessed May 7, 2019) - prevalence rate of 2-4% for U.S. adult population (~250 million)

2Vincent A, et al. Arthritis Care Res (Hoboken). 2013 65(5):786-92. doi: 10.1002; diagnosed prevalence rate was 1.1% of adult population or 50% of the prevalent population

3Robinson RL, et al. Pain Med. 2012 13(10):1366-76. doi: 10.1111; 85% received drug treatment

4The three drugs with FDA approval for the treatment of fibromyalgia: Pregabalin (Lyrica); Duloxetine (Cymbalta); Milnacipran (Savella)

5EVERSANA primary physician research, May 2024; commissioned by Tonix

6EVERSANA analysis of claims database, May 2024; commissioned by Tonix

7Productsales derived fromIMS MIDAS; IMS NDTI used to factor usage for fibromyalgia;data accessedApril 2015.

8Market research by Frost & Sullivan, commissioned by Tonix, 2011	© 2024 Tonix Pharmaceuticals Holding Corp.

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Poor Sleep and Pain have Bi-directional Reinforcing Effects1

• Poor sleep and pain form a vicious cyclein driving fibromyalgia decompensation
• • Can't sleep → worse pain / In pain → can't sleep
  • Poor sleep and pain contribute to persistence, chronicity and severity
  • Syndrome includes symptoms of fatigue and brain fog
• Treating sleep disturbance in fibromyalgia has the potential to break the vicious cycle
• • Potential to remove an obstacle to recovery
  • Using the right medicine is important - some sedative/hypnotics don't work1,2

Fatigue PAIN

BAD	Brain Fog
SLEEP

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1Moldofsky H, et al. J Rheumatol. 1996;23:529-533.	8
2Grönbald M, et al. Clin Rheumatol. 1993;12(2):186-191	© 2024 Tonix Pharmaceuticals Holding Corp.

TNX-102 SL: Sublingual Administration and Transmucosal Delivery

• Advantages of the sublingual route
• Faster absorption provides PK that is ideal for bedtime dosing
• Bypasses "first-pass" hepatic metabolism
• Reduced metabolism of parent CBP to active metabolite norcyclobenzaprine (nCBP)

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© 2024 Tonix Pharmaceuticals Holding Corp.

Fibromyalgia Program Status

Tonmya

(TNX-102 SL)	Fibromyalgia	Statistically Significant 2nd Phase 3 Topline Results
Cyclobenzaprine Protectic®		Reported 4Q'23
Sublingual Tablets

First pivotal Phase 3 study (RELIEF) reported - December 20201

Second Phase 3 study (RALLY) missed primary endpoint - July 2021

Confirmatory pivotal Phase 3 study (RESILIENT) reported - December 2023

Type B CMC and clinical pre-NDA meetings with FDA completed with alignment on requirements for filing and potential approval

Next Steps:

• NDA filing expected 2H'24
• FDA decision on NDA approval expected 2H'25

1Lederman S, et al. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2359-2368. doi: 10.1002.

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© 2024 Tonix Pharmaceuticals Holding Corp.