Tonix Pharmaceuticals : May 2026 Investor Deck

Published: 2026-05-14 12:52:11 ET TNXP

Published on 05/14/2026 at 12:52 pm EDT

NASDAQ: TNXP

PO6142 May1, 2026 1659

Tonix is a commercial stage company committed to solving complex, chronic, and sometimes invisible conditions

Commercial Execution Lyme Disease Human mAb Broad Opportunistic Pipeline

Prioritizing

Launched Nov. 17, 2025

First new FDA-approved fibromyalgia treatment in 15+ years1

Plan to initiate adaptive Ph. 2 field study of TNX-4800 for the prevention of Lyme disease in the

U.S. in 1H'272

Clinical and earlier-stage portfolio

CNS, infectious disease, immunology, and rare disease expertise

~$185.5M cash and cash equivalents as of March 31, 2026, no debt; expected runway into early Q2'27

Tonix owns worldwide rights to TONMYA® with no royalty obligations. In the U.S., issued

composition of matter patent extends to 2034; pending method of use patents may extend exclusivity to 2044.

Pending FDA agreement. 3

MOLECULE*

INDICATION

PRECLINICAL

PHASE 1

PHASE 2

PHASE 3

CNS

TNX-102 SL

Cyclobenzaprine HCl Sublingual Tablets

Treatment of Major Depressive Disorder

Phase 2 Study Plan

ned Mid-'26

Treatment of Acute Stress Disorder/Acute Stress Reaction

Phase 2 Topline Dat

a Planned 2H'26**

Infectious disease

TNX-4800

Anti-Borrelia OspA Human Monoclonal Antibody (mAb)

Prevention of Lyme Disease in the U.S.

Adaptive Phase 2 Field Study Planned 1H'27+

Immunology

TNX-1500

Anti-CD40L mAb

Prevention of Organ Transplant Rejection

Phase 2 Study Planned Mid-'26**++

Rare disease

TNX-2900

Intranasal Potentiated Oxytocin (OT) With Magnesium

Treatment of Prader-Willi Syndrome

Phase 2 Study Planned 1Q'27

CNS

TNX-1300

Recombinant Cocaine Esterase

Treatment of Cocaine Intoxication

Mid-Phase 2

*All of Tonix Pharmaceuticals' product candidates are investigational new drugs or biologics; their safety and efficacy have not been established for the listed indication.

**Investigator-initiated study.

+Pending FDA agreement. 4

++Pending FDA clearance of Investigational New Drug (IND) application.

About Fibromyalgia

Chronic pain disorder

Results from amplified sensory and pain signaling in the CNS

Core symptoms: chronic widespread pain, nonrestorative sleep, fatigue

Causes significant economic impact1

Patients

More than 10 million patients in the U.S.4

Only 2.7 million patients diagnosed and treated annually5

Patients and prescribers are dissatisfied with currently available therapies2,3

85% of first-line treatments fail with patients, citing efficacy and tolerability issues3

~6.42 years to official diagnosis from 1st complaint6

Predominantly women

79% of patients are on multiple therapies3

Healthcare Providers

~15 million prescriptions are written (on- and off-label usage) each year7

Whack-a-mole, trial and error approach8

National Fibromyalgia Association. https://www.fmaware.org/fibromyalgia-the-economic-burden/

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

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

Fibromyalgia. American College of Rheumatology. https://www.ACRPatientInfo.org.

Fibromyalgia prevalence. National Fibromyalgia Association.

Gendelman O. et al. Best Pract Res Clin Rheumatol.

2018:32(4):489-499

Symphony Market data, May 2025. Prescription data includes on-label FM prescriptions and patients with FM diagnoses who received commonly prescribed off-label therapies.

Market research commissioned by Tonix, January 2025.

2016

Revised ACR Guidelines4: Fibromyalgia Not a Diagnosis of Exclusion

2019-2023

Tonix Runs 3

Ph. 3 Studies with ~1,000 Patients8

Aug 2025

FDA Approval10

May 2026

1st Commercial Coverage Agreement11

2007

Lyrica approval1

2008

Cymbalta approval2

2009

Savella

2012

Tonix Begins TNX-102 SL

Sublingual

2017

IASP5

Recognizes Nociplastic Pain

2024

NASEM:

Fibromyalgia is a

Nov 2025

U.S. Launch

approval3

Development with Eutectic Technology

as the 3rd

Primary Type of Pain6,7

"Diagnosable Condition" in Long Covid9

Generic launched July 2019.

Generic launched December 2013.

Generic launched March 2026.

ACR = American College of Rheumatology.

IASP= International Association for the Study of Pain.

Kosek, E. et al. Pain. 2016;157(7):1382-1386.

Clauw DJ. Ann Rheum Dis. 2024;83(11):1421-1426.

Two pivotal Phase 3 studies demonstrated statistically significant improvement in pain compared with placebo; rapid onset of benefit, sustained efficacy, and known safety profile.

NASEM = National Academies of Sciences, Engineering, and Medicine. Ely EW. N Engl J Med 2024;391:1746-1753.

In the U.S., issued composition of matter patent extending to 2034; pending method of use patents may extend exclusivity to 2044.

With leading Group Purchasing Organization (GPO); effective May 1, 2026.

First-in-class, first-line, non-opioid medicine approved for the treatment of fibromyalgia in adults; designed for bedtime administration and long-term use

Patent-protected eutectic formulation1 to provide the first and only sublingual medication for fibromyalgia

Two pivotal Phase 3 studies demonstrated statistically significant improvement in pain compared with placebo; rapid onset of benefit, sustained efficacy, and known safety profile2

FDA Approval: Aug 2025

U.S. Commercial Launch: Nov 2025

Tonix owns worldwide rights to TONMYA® with no royalties. In the U.S., issued

composition of matter patent extends to 2034; pending method of use patents may extend exclusivity to 2044.

Most common adverse events were transient local oral reactions.

Tonix designed a unique, sublingual, proprietary formulation of cyclobenzaprine HCI intended to optimize efficacy, tolerability, delivery, and absorption

Non-opioid analgesic designed for long-term, daily bedtime use

Distinct mechanism of action vs. current therapies and oral cyclobenzaprine

Improves multiple symptoms of fibromyalgia

Avoids first-pass metabolism and reduces exposure to persistent active major metabolite, norCyclobenzaprine (norCBP) as compared to oral cyclobenzaprine

Rapid drug exposure

Robust and durable efficacy

Generally well tolerated

Established safety profile

Other Treatment Options

× High rate of patient and HCP dissatisfaction:

× Limited options with durability of efficacy

× Problematic side effects and poor tolerability

× Off-label opioid use is detrimental to condition

× Oral cyclobenzaprine was developed as a short-term (2-3) week treatment for acute muscle spasm and leads to accumulation of active major metabolite, norCBP

× Do not fully address the interconnected symptom burden of fibromyalgia1

Giorgi V, et al. Curr Pain Headache Rep. 2024;28(12)-:1349-1363.

Off-label opioids are commonly prescribed within 18 months of fibromyalgia diagnosis3

Nociplastic pain conditions such as fibromyalgia are not responsive to opioid therapy4,5,6

Long-term opioid use may worsen pain sensitivity via opioid-induced hyperalgesia in chronic pain conditions, including fibromyalgia7,8

Evidence-based consensus strongly discourages the use of opioids (e.g. oxycodone, hydrocodone) due to risk of dependence and poor evidence of efficacy2,9

Robinson RL, et al. Pain Med. 2013;14:1400-1415.

Macfarlane GJ, et al. Ann Rheum Dis. 2017;76(2):318-328.

Eversana analysis of claims database, May 2024.

Clauw DJ. Ann Rheum Dis. 2024;83(11):1421-1427.

Harris RE, et al. J Neurosci. 2007;27(37):10000-10006.

Peng X, et al. Clin J Pain. 2015;31(1):7-13.

Hooten EM, et al. Pain. 2015;156(6):1145-1152.

Clauw DJ. JAMA. 2014;311(15):1547-1555.

Dowell D, et al. MMWR Recomm Rep. 2022;71(3):1-95.

Off-label Opioids are Commonly Prescribed within 18 Months of Fibromyalgia Diagnosis

CBP, cyclobenzaprine; NSAID, nonsteroidal anti-inflammatory drug; SNRI, serotonin norepinephrine reuptake inhibitor; TCA, tricyclic antidepressant. Eversana analysis of claims database, May 2024.

TONMYA has 100% share of voice as the only marketed fibromyalgia prescription drug1

Data-Driven HCP Targeting

~5% of 470K fibromyalgia diagnosing HCPs write

~70% of prescriptions1

Targeting these 25K HCPS initially

Rheumatology, primary care, pain management, neurology

Experienced Sales Team

~100 TONMYA reps2 in the field since Oct 25

Commercial infrastructure from our approved migraine products, TOSYMRA and ZEMBRACE

Extensive CNS commercial and launch expertise

Managed Care Engagement

Ongoing education and value proposition work

First commercial coverage agreement signed

Ongoing engagement with commercial payers, Medicare, and Medicaid

Patient Access and Support

TONMYA savings card, copay assistance, and prior authorization support

Digital and traditional pharmacy savings programs

Intended to reduce patient access barriers

Medical Affairs Education

Drive diagnosis with 2016 ACR criteria

Build understanding for TONMYA's unique MOA

Continue evidence generation, medical congress visibility, and KOL engagements/symposia

Marketing

Move Fibro Forward disease awareness campaign

Speaker training and peer-to-peer programs

Omnichannel patient and HCP targeted reach

Paid Rx (APLD) in the recent 12 months (Feb'24 to Jan'25); Rx (FACT) in the recent 12 months

(Feb'24 to Jan'25); FBM DX 2020-2025. This 5% also diagnoses 70% of fibromyalgia patients. 12

force.

Summary of Branded Ecosystems

Welcome kit

Patients

Digital media

Influencer program

Paid search

Patient testimonials

Website

Social ads

AI optimization

KOL

programming

HCP emails

Social/digital ads

HCPs

Website

Field leave behind materials

Paid search

We are committed to offering product support to appropriate patients and their HCPs

Payer Education and Engagement

1st commercial coverage agreement with leading GPO, effective May 1, 20262; ~35 mil

U.S. commercial lives (20% of

~177 mil commercial lives in U.S.)

Medicaid coverage in 38 states for approximately 55 mil lives (73% of

~75 million Medicaid lives

Ongoing dialogue3

Digital Pharmacy Experience

Bridge programs

Streamlined enrollment

Enhanced prior authorization support

Refill and consultative services

Free home delivery, enhancing convenience and access

Traditional Pharmacy Savings Program

Copay support and savings program for eligible patients

Digital and text enrollment

Programs are for patients after their HCP has determined TONMYA is appropriate for them

GPO = Group Purchasing Organization.

With commercial payers, Medicare, and Medicaid. 14

Nov 17, 2025-Apr 17, 2026

>2,600 unique prescribers have prescribed TONMYA to patients

1Q'26

$3.7 million

Net Sales Metrics

Nov 17, 2025-Apr 17, 2026:2

>2,600 unique prescribers have prescribed TONMYA to patients

Nov 17, 20251-Mar 31, 2026

$5.1 million

TONMYA launched on November 17, 2025.

Includes bridge prescriptions.

1Q'26

2,145 unique HCPs

3,588 unique patients

~5,400 prescriptions2

Nov 17, 2025-Apr 24, 2026

2,700+ unique HCPs

~5,618 unique patients

Nov 17, 2025-May 1, 2026

~11,016 prescriptions2

TONMYA is administered sublingually

The sublingual tablet rapidly disintegrates, dissolves, and releases solubilized cyclobenzaprine ("CBP") into the saliva adjacent to the mucosal membrane

tongue

The base drives formation of CBP free-base, which enters the bloodstream across the mucosal membrane (transmucosal absorption)

Sublingual CBP enters the bloodstream directly through the mucosal membrane

Tonix's proprietary formulation contains a basic ingredient which drives transmucosal absorption and a cyclobenzaprine-mannitol eutectic that results in a stable tablet with a 4-year shelf-life.

N CH3

Sublingual vasculature

CH3

Basic excipient

Transmucosal CBP administered sublingually bypasses "first-pass" liver metabolism, leading to faster absorption and reduced norCBP

Tertiary amine tail

CH3

Proprietary Cyclobenzaprine HCl Eutectic Mixture Stabilizes Sublingual Tablet Formulation

Cyclobenzaprine-HCl (CBP-HCl)

Mannitol (inactive)

Eutectic formulation1

Base particle (K2HPO4)

Cyclobenzaprine free base

Base particle (K2HPO4)

Pure CBP-HCl interacts with base and tablet disintegrates

1. U.S. Patent issued May 2, 2017.

Eutectic formulation protects CBP-HCl from base and makes stable tablet with rapid absorption properties

Primary Efficacy Endpoint: Mean Change from Baseline in Weekly Average of Daily 24-Hour Recall Pain Intensity Scores at Week 14 in Adult Subjects with Fibromyalgia (Studies 1 and 3)

Study 1 (RELIEF) Study 3 (RESILIENT)

Placebo

TONMYA

Visit / Statistics

Value

Change from

baseline

Value

Change from

baseline

Trial 1

Baseline

255

248

Mean (SD)

6.0 (1.08)

6.1 (1.06)

(Minimum, Maximum)

(4, 9)

Week 14

LS mean (SE)1

4.6 (0.12)

-1.5 (0.12)

4.2 (0.12)

-1.9 (0.12)

95% CI1

(4.3, 4.8)

(-1.7, -1.3)

(3.9, 4.4)

(-2.1, -1.7)

Difference in LS mean

(SE)

-0.4 (0.16)

95% CI for difference in LS

mean

(-0.7, -0.1)

p-value for difference

0.010

Placebo

TONMYA

Visit / Statistics

Value

Change from baseline

Value

Change from baseline

Trial 3

Baseline

225

231

Mean (SD)

5.9 (1.08)

5.9 (1.05)

(Minimum, Maximum)

(4, 9)

Week 14

LS mean (SE)1

4.7 (0.12)

-1.2 (0.12)

4.1 (0.12)

-1.8 (0.12)

95% CI1

(4.5, 5.0)

(-1.4, -0.9)

(3.8, 4.3)

(-2.0, -1.6)

Difference in LS mean (SE)

-0.7 (0.16)2

95% CI for difference in LS

mean

(-1.0, -0.3)

p-value for difference

<0.001

CI = confidence interval; LS = least squares; SD = standard deviation; SE = standard error

LS means, differences and CIs were based on a mixed model for repeated measures with fixed, categorical effects of treatment, center, study week, and treatment-by-study week interaction, as well as the fixed covariates of baseline value and baseline value-by-study week interactions. An unstructured covariance matrix was used.

Difference of -0.7 is due to a rounding effect: TONMYA: -1.82, placebo: -1.16, and the difference in LS mean is -0.66. 18

Pivotal Studies Included in Label Demonstrate Statistically Significant Mean Change from Baseline in Weekly Average of Daily 24-hour Recall Pain Intensity Scores at Week 14

Study 1 (RELIEF) n=503

Study 3 (RESILIENT)

n=457

Greater Percentage of Study Participants Taking TONMYA Experienced a Clinically

Meaningful (≥30%) Improvement in their Pain after Three Months, Compared to Placebo

100

≥ 0

Placebo

30% Responders

(47% TONMYA vs

35% placebo)

TONMYA

≥ 10% ≥ 20% ≥ 30% ≥ 40% ≥ 50% ≥ 60% ≥ 70% ≥ 80%

Percentage Reduction in Pain

≥ 90% ≥ 100%

Percent of Subjects

Study 1 (RELIEF)* n=503

Study 3 (RESILIENT)*

100

≥ 0

Placebo

30% Responders

(46% TONMYA vs

27% placebo)

TONMYA

≥ 10% ≥ 20% ≥ 30% ≥ 40% ≥ 50% ≥ 60% ≥ 70% ≥ 80%

Percentage Reduction in Pain

≥ 90% ≥ 100%

n=457

*The figures shows the percentage of patients in Trials 1 and 3 who achieved various degrees of improvement in the change from baseline to Week 14 in the weekly averages of daily diary pain scores. The figures are cumulative so that patients whose change from baseline is, for example, 30%, are also included at every level of improvement below 30%. Patients who did not complete the trial were assigned 0% improvement.

Disclaimer

Tonix Pharmaceuticals Holding Corp. published this content on May 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2026 at 16:51 UTC.