TONIX PHARMACEUTICALS HOLDING CORP.
8-K
Exhibit 99.01

© 2023 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION
NASDAQ: TNXP Version P0447 June 1, 2023 (Doc 1236 )

2 © 2023 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, 2022, as filed with the Securities and Exchange
Commission (the “SEC”) on March 13, 2023, 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.

3 © 2023 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

4 © 2023 Tonix Pharmaceuticals Holding Corp. Investment Highlights
DIVERSE PIPELINE Tonix’s c ore 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 $72 M in cash and cash
equivalents as of 3/31/23. Tonix has no debt .

5 © 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Clinical
Programs Status/Next Milestone Indication Candidates* Mid - Phase 3
- >50% enrolled Phase 2 enrollment complete Fibromyalgia (FM)
Long COVID (PASC 2 ) TNX - 102 SL 1 Mid - Phase 2, Targeted 3Q 2023
Start Cocaine Intoxication - FDA Breakthrough Designation TNX -
1300 3 Phase 2 - enrolling 5 Prevention of Chronic Migraine TNX -
1900 4 Phase 2 - enrolling 6 Depression TNX - 601 ER Phase 2 ready
Prader - Willi Syndrome - FDA Orphan Drug Designation TNX - 2900 7
Phase 1, Targeted 3Q 2023 Start Organ Transplant Rejection/
Autoimmune Conditions TNX - 1500 8 Phase 1, Targeted 1Q 2024 Start
Smallpox and mpox vaccine TNX - 801 9 *All of Tonix’s product
candidates are investigational new drugs or biologics and none has
been approved for any indication. 1 TNX - 102 SL (cyclobenzaprine
HCl sublingual tablets) also has active INDs for Agitation in
Alzheimer’s Disease (AAD), Alcohol Use Disorder (AUD), and
Posttraumatic Stress Disorder (PTSD). All indications are Phase 2
ready. 2 Post - Acute Sequelae of COVID - 19. 3 TNX - 1300 (double
- mutant cocaine esterase) is licensed from Columbia University . 4
Acquired from Trigemina ; license agreement with Stanford
University; Planned investigator - initiated Binge Eating Disorder
(BED) study is expected start 2Q 2023. 5 A Phase 2 trial under an
investigator - initiated IND has been completed in the U.S. using
TNX - 1900 6 Phase 1 trial for formulation development was
completed outside of the U.S.; Other potential indications include
PTSD and neu roc ognitive d ysfunction from steroids 7 Co -
exclusive license agreement with French National Institute of
Health and Medical Research ( Inserm ) 8 anti - CD40L humanized
monoclonal antibody – IND cleared 9 Live attenuated vaccine based
on horsepox virus

© 2023 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES

7 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Five
Late - Stage CNS Programs to be in the Clinic in 2023 1 Three
studies Enrolling Now Active Studies • In Phase 3: ‒ TNX - 102 SL
for fibromyalgia (>50% enrolled) Potential Pivotal Study • In
Phase 2: ‒ TNX - 102 SL for fibromyalgia - type Long COVID
(enrollment complete) ‒ TNX - 1900 for migraine headache (new
mechanism for US patients) ‒ TNX - 601 ER for major depressive
disorder (new mechanism for US patients) Potential Pivotal Study
Entering Phase 2 • In 3Q 2023: ‒ TNX - 1300 for cocaine
intoxication (FDA Breakthrough Therapy Designation) Potential
Pivotal Study 1 Not approved for any indication

© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 102 SL*
Cyclobenzaprine ( Protectic ® ) Pipeline in a Product Fibromyalgia
Status: Mid - Phase 3 • One positive Phase 3 study (RELIEF)
completed • Second Phase 3 study (RALLY) missed primary endpoint •
Confirmatory Phase 3 study (RESILIENT) is currently enrolling •
>50% enrolled Next Steps: Topline results expected 4Q 2023
Fibromyalgia - Type Long COVID Status: Phase 2 • Phase 2 study
(PREVAIL) has completed enrollment of 60 patients Next Steps:
Topline results expected 3Q 2023 Patents Issued *TNX - 102 SL has
not been approved for any indication. A unique, sublingual
formulation of cyclobenzaprine designed to optimize delivery and
absorption Potent binding and antagonist activities at the
serotonergic - 5 - HT2A, adrenergic - α1, histaminergic - H1, and
muscarinic - M1 cholinergic receptors to facilitate restorative
sleep Innovative and proprietary PROTECTIC ® Rapid drug exposure
following nighttime administration Differentiators: Relative to
Oral Cyclobenzaprine • Lower daytime exposure • Avoids first - pass
metabolism • Reduces risk of pharmacological interference from
major metabolite Relative to Standard of Care • Potential for
better tolerability while maintaining efficacy • Not scheduled with
no recognized abuse potential

9 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE
DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia
Cyclobenzaprine Protectic ® Sublingual Tablets CNS PORTFOLIO
Fibromyalgia (FM) is a chronic pain disorder resulting from
amplified sensory and pain signaling within the CNS • A fflicts an
estimated 6 - 12 million adults in the U.S., approximately 90% of
whom are women 1 • 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 Market Entry:
Fibromyalgia Additional Indications: Long COVID, PTSD, Agitation in
Alzheimer’s, Alcohol Use Disorder Status: One Positive Phase 3
study RELIEF completed 2 Second Phase 3 study RALLY missed primary
endpoint Confirmatory Phase 3 study RESILIENT is currently
enrolling Next Steps: Topline results expected 4Q 2023 *TNX - 102
SL has not been approved for any indication. 1 American Chronic
Pain Association (www.theacpa.org, 2019) 2 Lederman et al., (2023)
Arthritis Care & Research "Efficacy and Safety of TNX - 102 SL
(Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia:
Results From the RELIEF Trial", in press When the check engine
light malfunctions, the light is on even though the car is not
malfunctioning

10 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
102 SL (Sublingual Cyclobenzaprine HCl tablets*) Proprietary
cyclobenzaprine HCl e utectic m ixture s tabilizes s ublingual t
ablet f ormulation Base particle (K 2 HPO 4 ) Base particle (K 2
HPO 4 ) Base particle (K 2 HPO 4 ) C y cl o be n z a p r i n e -
HCl (CBP - HCl) Eutectic formulation protects CBP - HCl from base
and makes stable tablet with rapid absorption properties Pure CBP -
HCl interacts with base and tablet disintegrates Cy c l ob en zapr
ine free base Protectic Œ Eutectic formulation 1 ANGSTRO - T E C H
NO L O G Y Œ Mannitol (inactive) * U.S. Patent issued May 2,
2017

11 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
102 SL Sublingual Administration* Transmucosal absorption a voids
first pass hepatic metabolism * U.S. Patent issued May 2, 2017
Swallowed Oral Dose Sublingual Oral Dose

12 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
102 SL: Phase 3 R ESILIENT Study Design General s tudy c
haracteristics: • Randomized, double - blind, placebo - controlle d
study in fibromyalgia • U.S. sites only, expected to enroll
approximately 470 patients Primary Endpoint: • Daily diary pain
severity score change from baseline to Week 14 (TNX - 102 SL vs.
placebo) • Weekly averages of the daily numerical rating scale
scores Key Secondary Endpoints: • Fibromyalgia Impact Questionnaire
- Revised (FIQ - R) Symptom Domain score • Patient Global
Impression of Change responder analysis • FIQ - R Function Domain
score • PROMIS Sleep Disturbance instrument • PROMIS Fatigue
instrument • Weekly average of the daily diary assessment of sleep
quality Placebo once - daily at bedtime 14 weeks TNX - 102 SL once
- daily at bedtime 5.6 mg (2 x 2.8 mg tablets) * * Two week run in
at 2.8 mg dose at bedtime, followed by 12 weeks at 5.6 mg dose
ClinicalTrials.gov Identifier: NCT05273749 A Phase 3 Study to
Evaluate the Efficacy and Safety of TNX - 102 SL Taken Daily in
Patients With Fibromyalgia (RESILIENT)

13 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE
DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Fibromyalgia -
Type Long COVID (PASC) Cyclobenzaprine Protectic ® Sublingual
Tablets • Occurs in approximately 13% of recovered COVID - 19
patients 1 • As many as 40% of Long COVID patients experience multi
- site pain, a hallmark of fibromyalgia 2,3 • Symptoms of Long
COVID, like multi - site pain, fatigue and insomnia, are the
hallmarks of chronic pain syndromes like fibromyalgia and myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS) • In August
2022, the HHS released the National Research Action Plan on Long
COVID 4 which endorses the connection between Long COVID and
chronic fatigue syndrome Market Entry : Fibromyalgia - Type Long
COVID (PASC) Status: Phase 2 study PREVAIL has completed enrollment
of 60 patients Next Steps: Topline results expected 3Q 2023 1
September 1, 2022 - CDC - https://www.cdc.gov/coronavirus/2019 -
ncov/long - term - effects/index.html 2 Harris, H, et al. Tonix
data on file. 2022 3 TriNetX Analytics *TNX - 102 SL has not been
approved for any indication. CNS PORTFOLIO Additional Indications:
Fibromyalgia, PTSD, Agitation in Alzheimer’s, Alcohol Use Disorder
4 Department of Health and Human Services, Office of the Assistant
Secretary for Health. 2022. National Research Action Plan on Long
COVID.

14 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO
Fibromyalgia - Type Long COVID • Long COVID is a heterogeneous
condition that displays elements of nociplastic pain in many
individuals, who experience otherwise unexplained symptoms 1 - 2
Symptoms (multi - site pain, fatigue, sleep disorders and cognitive
dysfunction) overlap with the key symptoms of fibromyalgia
Multisite pain Memory issues Fatigue Sleep disturbances 1 Bierle et
al., 2021. J Prim Care Community Health. 12:21501327211030826 2
Moghimi et al., 2021. Curr Neurol Neurosci Rep . 21(9):44 3 Trouvin
et al., 2019. Best Pract Res Clin Rheumatol . 33(3):101415
Nociceptive pain Nociplastic pain Neuropathic pain Nociplastic pain
3 : ( new term for “Central and Peripheral Sensitization”) Pain
that arises from altered nociception despite no clear evidence of
tissue damage, or for disease or lesion of the somatosensory system
causing the pain Central and Peripheral Sensitization

15 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
102 SL: Phase 2 PREVAIL Study Design Study c haracteristics: •
Randomized, double - blind, placebo - controlle d study of TNX -
102 SL in fibromyalgia - type Long COVID • U.S. sites only, has
enrolled approximately 60 patients Primary Endpoint: • Daily diary
pain severity score change from baseline to Week 14 (TNX - 102 SL
vs. placebo) − Weekly averages of the daily numerical rating scale
scores Placebo once - daily at bedtime 14 weeks TNX - 102 SL once -
daily at bedtime 5.6 mg (2 x 2.8 mg tablets) * * Two week run in at
2.8 mg dose at bedtime, followed by 12 weeks at 5.6 mg dose
ClinicalTrials.gov Identifier: NCT05472090 “A Phase 2 Study to
Evaluate the Efficacy and Safety of TNX - 102 SL in Patients With
Multi - Site Pain Associated With Post - Acute Sequelae of SARS -
CoV - 2 Infection (PREVAIL)”

16 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE
DEVELOPMENT PROGRAM Patents Issued TNX - 601 E R*: Depression
Tianeptine Hemioxalate Extended - Release Tablets (39.4 mg) CNS
PORTFOLIO • A novel, oral, extended - release once - daily tablet •
Treatment effect of tianeptine sodium immediate release t.i.d. in
depression is well - established • Tianeptine restores
neuroplasticity in animal models • PPAR - β / δ and PPAR - γ
agonist Differentiators: Relative to tianeptine IR available ex -
US: • Once daily dosing Relative to traditional antidepressants: •
Unique mechanism of action – beyond neurotransmitter modulation •
Tianeptine sodium IR has similar efficacy but fewer side effects
than traditional antidepressants Market Entry: Major Depressive
Disorder (MDD) Additional Indications: PTSD, Neurocognitive
Disorder From Corticosteroids, Alzheimer’s Disease 1 Status: Phase
2 MDD study UPLIFT is currently enrolling Next Steps: Interim
analysis results on first 50% of sample expected 4Q 2023 1 García -
Alberca et al., 2022. J Alzheimers Dis . 88(2):707 - 720 *TNX - 601
ER has not been approved for any indication.

17 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
601 ER - Phase 2 UPLIFT* Study Design General s tudy c
haracteristics: • Randomized, double - blind, placebo - controlle d
study in Major Depressive Disorder to evaluate monotherapy with TNX
- 601 ER versus placebo • Parallel design with two arms – treatment
with tianeptine hemioxalate 39.4 mg or placebo • ~30 U.S. sites
only, expected to enroll approximately 300 patients • One unblinded
interim analysis based on 50% of randomized participants expected
4Q’2 3 Primary Endpoint: • Mean change from baseline in the
Montgomery - Åsberg Depression Rating Scale (MADRS) total score at
Week 6 *ClinicalTrials.gov Identifier: NCT05686408 Abbreviations:
Dx, diagnosis; ER, extended - release; F/U, follow - up; MDD, major
depressive disorder; MDE, major depressive episo de; N, number

18 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
601 ER – Racemic Tianeptine – Composed of Two Isomers Racemic
tianeptine : • Approved in Europe and ex - US • 1:1 mixture of 2
mirror r - image isomers 1,2 • Weak µ - o pioid receptor agonism 2
• Risk of abuse or diversion for euphoric effects 3 (S) -
Tianeptine: PPAR - β / δ agonist, no opiate liability • Both (S) -
and (R) - tianeptine are agonists of PPAR - γ • New mechanism of
action for treating depression (S) - t ianeptine (R) - tianeptine
1. Stablon . Summary of product characteristics. Les Laboratoires
Servier Industrie ; 2014. 2. PubChem. Accessed November 10, 2022.
https://pubchem.ncbi.nlm.nih.gov/compound/Tianeptine 3. Drug
Enforcement Administration. May 2019. Accessed November 11, 2022.
https://www.deadiversion.usdoj.gov/drug_chem_info/tianeptine.pdf
(R) - Tianeptine (S) - Tianeptine TNX - 4300 Racemic - Tianeptine +
- + µ - Opioid Receptor - + + PPAR - β / δ + + + PPAR - γ

19 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE
DEVELOPMENT PROGRAM Patents Issued TNX - 4300*: Depression,
Alzheimer’s & Parkinson’s diseases Estianeptine (Single (S) -
isomer of Tianeptine) CNS PORTFOLIO • Single isomer, oral treatment
• Proposed mechanism of action from lab studies indicates
estianeptine is the active ingredient of TNX - 601 ER • PPAR - β /
δ and PPAR - γ agonist • Free of µ - opioid receptor activity •
Estianeptine restores neuroplasticity in tissue culture
Differentiators: Relative to racemic tianeptine IR or TNX - 601 ER:
• Lack of opioid liability Relative to traditional antidepressants:
• Unique mechanism of action – beyond neurotransmitter modulation •
Racemic tianeptine sodium IR has similar efficacy but fewer side
effects than traditional antidepressants Market Entry: Major
Depressive Disorder (MDD) Additional Indications: PTSD,
Neurocognitive Disorder From Corticosteroids, Alzheimer’s Disease 1
Status: Pre - clinical Next Steps: Expect IND can be supported by
pre - clinical and clinical data from TNX - 601 (racemic
tianeptine) development 1 García - Alberca et al., 2022. J
Alzheimers Dis . 88(2):707 - 720 *TNX - 4300 has not been approved
for any indication.

20 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO While
Monoaminergic Antidepressants Work at the Synapse, (S) - Tianeptine
“Cuts in Line” to More Directly Affect Neuroplasticity Depressed
Decreased connectivity and neuroplasticity Monoaminergic
antidepressants Tianeptine + + mRNA ( eg , BDNF) BDNF=brain -
derived neurotrophic factor.

21 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE
DEVELOPMENT PROGRAM Patents Issued TNX - 1900*: Migraine Intranasal
Potentiated Oxytocin (OT) with Magnesium CNS PORTFOLIO • Intranasal
OT has potential utility in treating migraine 1 • Magnesium is
known to potentiate the binding of OT to its receptor 2,3 • One
billion individuals worldwide suffer from migraines Differentiator:
Novel non - CGRP antagonist approach to treatment Market Entry:
Chronic Migraine Additional Indications: Acute Migraine,
Craniofacial Pain, Insulin Resistance, Binge Eating Disorder
Status: Phase 2 study PREVENTION is currently enrolling 4 Next
Steps: Topline results expected 4Q 2023 Investigator initiated
Phase 2 t rial in obesity - associated binge e ating disorder 2Q
2023 1 Tzabazis et al., 2017. Headache . 57 Suppl 2:64 - 75 2
Antoni et al., 1989. Biochem J . 257(2):611 - 4 3 Meyerowitz et
al., 2022. Nat Struct Mol Biol . (3):274 - 281 4 A Phase 2 trial
under an investigator - initiated IND has been completed in the
U.S. using TNX - 1900 *TNX - 1900 has not been approved for any
indication. CGRP = calcitonin gene - related peptide. Oxytocin
receptor Oxytocin

22 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX -
1900: Phase 2 PREVENTION Study Design General s tudy c
haracteristics: • Randomized, double - blind, placebo - controlle d
study (three arms – two treatment regimens and one placebo) in
chronic migraine • U.S. sites only, expected to enroll
approximately 150 patients • Topline results expected 4Q’23 Primary
Endpoint: • M ean change in the number of migraine headache days
between the 28 - day Run - In phase and the last 28 - days of the
Treatment phase (TNX - 1900 vs. placebo) ClinicalTrials. gov
Identifier: NCT05679908 A Study to Evaluate the Efficacy and Safety
of TNX - 1900 in Patients With Chronic Migraine (PREVENTION) N = 50
N = 50 N = 50

23 © 2023 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE
DEVELOPMENT PROGRAM Patents Issued TNX - 1300*: Cocaine
Intoxication Cocaine Esterase ( CocE ) Cocaine is the main cause
for drug - related ED visits 1 CocE is a recombinant protein that
degrades cocaine in the bloodstream • Rapidly reverses physiologic
effects of cocaine • Drops plasma exposure by 90% in 2 minutes
Differentiators: Rapidly metabolizes cocaine in the bloodstream; no
other product currently on the market for this indication Market
Entry: Cocaine Intoxication Status: Mid - Phase 2 Next Steps:
Initiate new Phase 2 trial 3Q 2023 • S ingle - blind, placebo (+
usual care) controlled, randomized, potentially pivotal study •
Expected to enroll approximately 60 emergency department patients
at sites in the US 1 Havakuk et al., 2017. J Am Coll Cardiol .
70:101 - 113 ED = emergency department. FDA Breakthrough Therapy
Designation Awarded Cooperative Agreement Grant from National
Institute on Drug Abuse (NIDA) *TNX - 1300 has not been approved
for any indication. CNS PORTFOLIO CocE Cocaine

© 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE: KEY
CANDIDATES

25 © 2023 Tonix Pharmaceuticals Holding Corp. RARE DISEASE
PORTFOLIO Patents Issued PROFILE DEVELOPMENT PROGRAM TNX - 2900*:
Hyperphagia in Prader - Willi Syndrome Intranasal Potentiated
Oxytocin (OT) with Magnesium Prader - Willi Syndrome is the most
common genetic cause of life - threatening childhood obesity • Rare
disease occurring in 1 in 10,000 to 1 in 30,000 births
Differentiator: No approved therapeutic currently on the market for
hyperphagia in PWS Dangers of PWS Hyperphagia: Market Entry:
Hyperphagia in Prader - Willi Syndrome Additional Indications: Rare
Hyperphagia Conditions Status: Phase 2 ready Next Steps: IND
submission *TNX - 2900 is in the pre - IND stage of development and
has not been approved for any indication. Caretaker Burden 1 - 4 :
Unhealthy behaviors around food 1 - 4 Consequences such as obesity,
type 2 diabetes, cardiovascular disease 1 - 5 1 Miller et al.,
2011. Am J Med Genet A . 1 55A(5):1040 - 1049 2 Butler et al.,
2017. Genet Med. 19(6):635 - 642 3 Butler MG. NORD. Updated 2018.
Accessed May 25, 2022. https://rarediseases.org/rare -
diseases/prader - willi - syndrome/ 4 Prader - Willi Syndrome
Association USA. Accessed May 25, 2022.
https://www.pwsausa.org/what - is - prader - willi - syndrome/ 5
Muscogiuri et al., 2021. J Endocrinol Invest . 44(10):2057 - 2070
FDA Orphan Drug Designation

© 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY
CANDIDATES

© 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: Phase 1 ready – IND cleared •
Collaborations ongoing with Mass General Hospital on heart and
kidney transplantation in non - human primates Next Steps: Initiate
Phase 1 study 3 Q 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
preserving 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. *TNX - 1500
has not been approved for any indication. Patents filed.
Differentiators: Expected to deliver efficacy without compromising
safety Autoimmune Diseases Status: Potential future indications
include: Sjögren’s Syndrome, Systemic Lupus Erythematosus • These
indications require large studies, but represent large target
markets

28 © 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 proteins Second - generation anti
- CD40L proteins exhibited dramatically reduced binding to FcγRIIA
3 - 6 but had other issues, including decreased efficacy, shortened
half - life, or engendering of anti - drug antibodies (ADAs). 7 - 9
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 - 9 TNX - 1500 *Sanofi’s frexalimab
(formerly SAR441344) and Eledon’s tegoprubart (formerly AT - 1501)
also are Fc modified 1 Inwald et al., 2003. Circ Res . 92(9):1041 -
1048 2 Robles - Carrillo et al., 2010. J Immunol . 185(3):1577 -
1583 3 Shock et al., 2015. Arthritis Res Ther . 17(1):234 4 Xie et
al., 2014. J Immunol . 192(9):4083 - 4092 5 Ferrant et al., 2004.
Int Immunol . 16(11):1583 - 1594 6 Karnell et al., 2019. Sci Transl
Med. 11(489):eaar6584 7 ClinicalTrials.gov identifier: NCT02273960.
Updated July 16, 2019. Accessed June 1, 2021.
https://clinicaltrials.gov/ct2/show /re
sults/NCT02273960?view=results 8 Waters, 2018. Biocentury . 9
Company data Dazodalibep

29 © 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
(being 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) • 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 Lundbeck and
AprilBio – Neurology • Phase 1 Trial Currently Enrolling in Healthy
Adults (NCT05136053) • APB - A1 or Lu AG22515 (HAS fusion
protein)

© 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY
CANDIDATES

© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 801* Recombinant
Pox Vaccine (RPV) Platform Using Live Virus Technology Mpox and
Smallpox Vaccine Status: Preclinical • TNX - 801 is a cloned
version of horsepox 1 (without any insert) purified from cell
culture Next Steps: Initiate Phase 1 Trial 1Q 2024 Vaccine for
Future Emerging Infectious Diseases Example: TNX - 1850 for COVID -
19 Status: Model System *TNX - 801 is in the pre - IND stage of
development and has not been approved for any indication. Patents
filed. • Live virus vaccines are the most established vaccine
technology ‒ Starting with Edward Jenner’s smallpox vaccine, the
first vaccine, which eradicated smallpox ‒ Prevents forward
transmission ‒ Effective in eliciting durable or long - term
immunity • Economical to manufacture at scale ‒ Low dose because
replication amplifies dose in vivo ‒ Single shot administration •
Standard refrigeration required for shipping and storage 1 Noyce et
al., 2018. PLoS One . 13(1):e0188453. Differentiators: TNX - 801*
scHPXV (Horsepox) 212,811 bp

32 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE
PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine
(RPV) Technology for Emerging Infectious Diseases and Oncolytics
Mpox and Smallpox Future Pandemics & New Infectious Diseases
COVID - 19 Biodefense Using Proven Science To Address Challenging
Disease States, We Have Created A Programmable Technology Platform
Aimed At Combating Future Threats To Public Health Vaccinia
Horsepox ANTIGEN CODING Oncology RPV VECTOR BELIEVED SIMILAR TO
EDWARD JENNER’S VACCINE 1 - 3 1 Shrick, 2017. N Engl J Med 377:1491
- 1492 2 Esparza, 2020. Vaccine . 38(30): 4773 – 4779 3 Brinkmann,
2020. Genome Biol . 21: 286

33 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE
PORTFOLIO Internal Development & Manufacturing Capabilities
R&D Center (RDC) – Frederick, MD • Functions: ‒ Accelerated
development of vaccines and antiviral drugs against COVID - 19, its
variants and other infectious diseases ‒ Research advancing CNS and
immunology drugs • Description: ~48,000 square feet, BSL - 2 with
some areas designated BSL - 3 • Status: Operational Advanced
Development Center (ADC) – North Dartmouth, MA • Function:
Development and clinical scale manufacturing of biologics •
Description: ~45,000 square feet, BSL - 2 • Status: Operational
Commercial Manufacturing Center (CMC) – Hamilton, MT • Function :
Phase 3 and Commercial scale manufacturing of biologics •
Description: ~44 - acre green field site, planned BSL - 2 • Status:
Planning for site enabling work in 2023 Architectural Rendering

© 2023 Tonix Pharmaceuticals Holding Corp. PRECLINICAL PIPELINE

35 © 2023 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Pre -
Clinical Programs Preclinical COVID - 19 (horsepox - based live
virus vaccine platform) TNX - 1850 3 Preclinical COVID - 19 (bovine
parainfluenza virus - based live virus vaccine) TNX - 2300 4
Preclinical COVID - 19 (zinc nanoparticle mRNA technology) TNX -
3700 5 Preclinical Filoviruses (broad spectrum antiviral) TNX -
3900 Preclinical Filoviruses (broad spectrum antiviral) TNX - 4000
Preclinical Depression ( estianeptine ) TNX - 4300 Preclinical
Attention Deficit Hyperactivity Disorder (ADHD) TNX - 1610 1
Preclinical Gastric and colorectal cancers TNX - 1700 2 1 Acquired
from TRImaran Pharma; license agreement with Wayne State University
2 Recombinant trefoil factor 2 (rTFF2) based protein; licensed from
Columbia University 3 Live attenuated vaccine based on horsepox
virus vector, expressed SARS - CoV - 2 spike protein. TNX - 1850 is
based on the BA.2 varian t spike protein. 4 Live attenuated vaccine
based on bovine parainfluenza (BPI) virus 5 COVID vaccine based on
mRNA in zinc nanoparticle (ZNP) formulation with CD40L molecular
trigger Status/Next Milestone Indication Candidates*

36 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO
Patents Filed TNX - 1700*: Gastric and Colorectal Cancers
Recombinant Trefoil Factor 2 (rTFF2 - HSA) Fusion Protein Potential
New Cancer Treatment • TNX - 1700 (rTFF2 - HSA) has effects on
cancer by altering the tumor micro - environment • Mechanism of
action: suppresses myeloid - derived suppressor cells and activates
anti - cancer CD8+ T cells • Potential synergy with anti - PD1 or
anti - PD - L1 monoclonal antibodies ( mAbs ) Preclinical Evidence
for Inhibiting Growth of Cancer Cells • In an MC38 mouse model of
colorectal cancer, mTNX - 1700 (murine TNX - 1700) alone inhibited
tumor growth by 50%, and combination therapy with anti - PD1
inhibited tumor growth by 87% 1 • In an advanced mouse model of
gastric cancer, mTNX - 1700 combination therapy with anti - PD1
inhibited tumor growth by 78% 2 • Mechanistically, the combination
therapy reduced intratumoral MDSCs, profoundly increased tumor -
infiltrating CD8+ T cells, and significantly reduced spontaneous
metastasis 2 Market Entry: Immuno - oncology, combination therapy
with PD1 blockers for gastric and colorectal cancer Status:
Preclinical Next Steps: Animal studies ongoing *TNX - 1700 is in
the pre - IND stage of development and has not been approved for
any indication. Differentiator: No product yet identified
consistently augments PD1 effects on cold tumors Licensed from
Columbia University • Developing in partnership under sponsored
research agreement 1 Daugherty, 2023. AACR Annual Meeting.
https://www.tonixpharma.com/wp - content/uploads/2023/04/MDSC -
Targeted - mTFF2 - MSA - mTNX - 1700 - S uppresses - Tumor - Growth
- and - Increases - Survival - in - Anti - PD - 1 - Treated - MC38
- and - CT26.wt - Murine - Colorectal - Cancer - Models.pdf 2 Qian,
2023. AACR Annual Meeting. https://www.tonixpharma.com/wp -
content/uploads/2023/04/MDSC - targeted - TFF2 - MSA - synergizes -
with - P D - 1 - blockade - therapy - in - advanced - gastric -
cancer - models.pdf

37 © 2023 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE
PORTFOLIO Preclinical Infectious Disease Therapeutics in
Development TNX - 2300*: Live Virus Vaccine Based on Bovine
Parainfluenza (BPI) Virus Market Entry: COVID - 19 Vaccine Status:
Preclinical Next Steps: Animal studies with Kansas State University
(KSU) to test the effect of co - expression of CD40 - ligand to
stimulate T cell immunit y TNX - 3700*: Zinc Nanoparticle (ZNP)
Formulation for mRNA Vaccines Market Entry: Booster for COVID - 19
Vaccines Status: Preclinical Next Steps: Research at KSU on CoV - 2
spike based vaccine in tissue culture and animals; initiate animal
studies in 1H 2023 *TNX - 2300, TNX - 3700, TNX - 3900 and TNX -
4000 are in the pre - IND stage of development and have not been
approved for any indication . TNX - 3900*: Host - Directed Broad -
Spectrum Antiviral Market Entry: Coronaviruses and Filoviruses
Status: Preclinical Next Steps: Further in - house development TNX
- 4000*: Direct - Acting Broad - Spectrum Antiviral Market Entry:
Coronaviruses, Retroviruses, and Filoviruses Status: Preclinical
Next Steps: Further in - house development

© 2023 Tonix Pharmaceuticals Holding Corp. TONIX TEAM, NETWORK AND
FUTURE OUTLOOK

39 © 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE
INTOXICATION TNX - 1700: GASTRIC AND COLORECTAL CANCERS Key
Development Partners TNX - 1500: ALLOGRAFT REJECTION TNX - 1900:
MIGRAINE & OTHER INDICATIONS TNX - 801: SMALLPOX AND MONKEYPOX
VACCINE TNX - 1850: COVID - 19 VACCINE TNX - 2900: PRADER - WILLI
SYNDROME TNX - 3700 : COVID - 19 VACCINE (ZINC NANOPARTICLE mRNA
TECHNOLOGY ) TNX - 2300 : BOVINE PARAINFLUEZNA VIRUS

40 © 2023 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

41 © 2023 Tonix Pharmaceuticals Holding Corp. Milestones: Recently
Completed and Upcoming Expected Clinical Trial Initiations □ 3 rd
Quarter 2023 Phase 1 study start of TNX - 1500 for prevention of
allograft rejection □ 3 rd Quarter 2023 Phase 2 study start of TNX
- 1300 for the treatment of cocaine intoxication □ 1 st Quarter
2024 Phase 1 study start of TNX - 801 for prevention of mpox and
smallpox □ 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
fibromyalgia - type Long COVID □ 1 st Quarter 2023 Phase 2
PREVENTION study start of TNX - 1900 for the treatment of migraine
□ 1st Quarter 2023 Phase 2 UPLIFT study start of TNX - 601 ER for
major depressive disorder x x Expected Data □ 3 rd Quarter 2023
Topline results of Phase 2 PREVAIL study of TNX - 102 SL for
fibromyalgia - type Long COVID □ 4 th Quarter 2023 Topline results
of Phase 2 PREVENTION study of TNX - 1900 for chronic migraine □ 4
th Quarter 2023 Interim Analysis results of Phase 2 UPLIFT study of
TNX - 601 ER for major depressive disorder □ 4 th Quarter 2023
Topline results of Phase 3 RESILIENT study of TNX - 102 SL for
fibromyalgia x x

© 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU
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