Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (February 2024)
68 slides from Tonix Pharmaceuticals's investor presentation, Feb 12, 2024
Slide 1: Corporate Presentation: Tonmya in Development for Fibromyalgia
© 2024 Tonix Pharmaceuticals Holding Corp. Corporate Presentation Focus on: Tonmya Œ * (TNX - 102 SL) in Development for the Management of Fibromyalgia February 2024 NASDAQ: TNXP *Tonmya is conditionally accepted by FDA as the tradename for TNX - 102 SL for the management of fibromyalgia Version P05
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2024 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 Litigat
Slide 3: Who We Are
3 © 2024 Tonix Pharmaceuticals Holding Corp. 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,
Slide 4: CNS-Focused Biopharma with Preclinical, Clinical and Commercial Stage Products
4 © 2024 Tonix Pharmaceuticals Holding Corp. CNS - Focused Biopharma with Preclinical, Clinical and Commercial Stage Products Marketed Products • Zembrace ® and Tosymra ® indicated for the treatment of acute migraine Tonmya Œ fo r Fibromyalgia: Preparing New Drug Application (NDA) • Two positive Pha
Slide 5: Key Clinical Programs
5 © 2024 Tonix Pharmaceuticals Holding Corp. Key Clinical Programs *All of Tonix’s product candidates are investigational new drugs or biologics and none has been approved for any indication. Molecule * Indication Phase 1 Phase 2 Phase 3 NDA Submission Tonmya Œ TNX - 102 SL Cyclobenzaprine HCl Prote
Slide 6: CNS: Key Development Candidates
© 2024 Tonix Pharmaceuticals Holding Corp. CNS: KEY DEVELOPMENT CANDIDATES
Slide 7: Tonmya TNX-102 SL Cyclobenzaprine
7 © 2024 Tonix Pharmaceuticals Holding Corp. Tonmya Œ TNX - 102 SL Cyclobenzaprine ( Protectic ® ) A unique, sublingual formulation of cyclobenzaprine designed to optimize delivery and absorption
Slide 8: TNX-102 SL: Unique MOA Facilitates Restorative Sleep
TNX - 102 SL: Unique MOA Facilitates Restorative Sleep Centrally Acting Analgesic 8 Potent binding and antagonist activities at four key receptors facilitate restorative sleep • serotonergic - 5 - HT2A • adrenergic - α1 • histaminergic - H1 • muscarinic - M1 Relative to Oral Cyclobenzaprine o Lower
Slide 9: The Third Type of Pain: Nociplastic Pain
9 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO The Third Type of Pain: Nociplastic Pain 1 1 Trouvin AP, et al. Best Pract Res Clin Rheumatol . 2019;33(3):101415. Nociplastic syndrome includes : (1) widespread pain (2) fatigue (3) sleep disturbances (4) cognitive dysfunction (“brain fog”)
Slide 10: Fibromyalgia Believed to Result from Chronic Pain or Prior Stress
10 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia is Believed to Result from Chronic Pain or Prior Stress Experiences Stresses that may precede or precipitate FM include : Chronic nociceptive pain • e.g. , osteoarthritis Chronic neuropathic pain • e.g. , diabetic neuropathy In
Slide 11: Common Chronic Conditions are a Challenge for Pharma
11 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Common Chronic Conditions are a Challenge for Pharma Fibromyalgia is a common chronic disease 1 • Chronic pain syndrome that persists for years or decades No animal model is recognized for nociplastic syndromes or its component symptoms • W
Slide 12: Common Chronic Conditions are a Challenge for Society
12 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Common Chronic Conditions are a Challenge for Society The Opiate Crisis in the U.S. was driven by mistreatment of chronic pain, which was often nociplastic pain • The e pidemic of prescription pain killers was addressed by regulations which
Slide 13: About Fibromyalgia
13 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Fibromyalgia a fflicts an estimated 6 - 12 million adults in the US, predominantly women 1 1 American Chronic Pain Association (www.theacpa.org, 2019) 2 Robinson et al, Pain Medicine 2013;14:1400 3 The three drugs with FDA app
Slide 14: Fibromyalgia: Market Characteristics
14 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia: Market Characteristics Prevalence • One of the more common chronic pain disorders (2 - 4% of US Population) 1 Diagnosed population • Large population but underdiagnosed 2 relative to prevalence rate • Majority receive drug tre
Slide 15: Fewer than Half of Those Treated Receive Sustained Benefit
15 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fewer than Half of Those Treated for Fibromyalgia Receive Sustained Benefit from the Three FDA - Approved Drugs 1 Respond, but intolerant of side effects Do not respond 25% 35% 60% fa il ure rate 1 The three drugs with FDA approval for the
Slide 16: Large Need for New Fibromyalgia Therapies
16 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Large Need for New Fibromyalgia Therapies that Provide Broad Symptom Improvement with Better Tolerability • Currently - approved medications may have side effects that limit long - term use 1 • Many patients skip doses or discontinue altoge
Slide 17: Fibromyalgia Program Status
17 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Fibromyalgia Program Status Tonmya Œ (TNX - 102 SL) Cyclobenzaprine Protectic ® Sublingual Tablets Fibromyalgia Positive 2 nd Phase 3 Topline Results Reported 4Q’23 1) P ositive Phase 3 study ( RELIEF ) reported – December 2020 1 2) Second
Slide 18: Phase 3 RESILIENT Study Design
18 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya Œ (TNX - 102 SL): P hase 3 RESILIENT Study Design General s tudy c haracteristics: • Randomized, double - blind, multicenter, placebo - controlle d study in fibromyalgia • 33 U.S. sites enrolled 457 participants with fibromyalgia as
Slide 19: RESILIENT Primary Outcome: Reduction in Widespread Pain
19 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Weekly Average of Daily Diary NRS Ratings of Average Pain Over Prior 24 Hours RESILIENT Primary Outcome Measure Reduction in Widespread Pain -2.2 -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 LS Mean (SE
Slide 20: Summary of Key Pre-Specified Secondary Outcome Measures
20 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Summary of Key Pre - Specified Secondary Outcome Measures *In order of statistical serial gate - keeping hierarchy (or, “waterfall”) to control overall Type 1 error **Statistical significance met Rating Scale Week 14 Met** Patient Global Im
Slide 21: RESILIENT Safety Summary
21 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary Among participants randomized to Tonmya Œ (TNX - 102 SL) and to placebo, 81.0% and 79.6%, respectively, completed the study Tonmya Œ (TNX - 102 SL) was generally well tolerated with an adverse event (AE) profile com
Slide 22: RESILIENT Safety Summary Adverse Events Table
22 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO RESILIENT Safety Summary System Organ Class Preferred Term TNX - 102 SL N=231 Placebo N=226 Total* N=457 Oral Cavity Adverse Events Hypoaesthesia oral 55 (23.8%) 1 (0.4%) 56 (12.3%) Product taste abnormal 27 (11.7%) 2 (0.9%) 29 (6.3%) Parae
Slide 23: Tonmya (TNX-102 SL): Fibromyalgia Development Program
23 © 2024 Tonix Pharmaceuticals Holding Corp. PROFILE DEVELOPMENT PROGRAM Patents Issued CNS PORTFOLIO Tonmya Œ (TNX - 102 SL): Fibromyalgia Cyclobenzaprine Protectic ® Sublingual Tablets Fibromyalgia (FM) is a chronic pain disorder resulting from amplified sensory and pain signaling within the CNS
Slide 24: Additional Potential Indications for Tonmya
24 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Additional Potential Indications for Tonmya Œ (TNX - 102 SL) Fibromyalgia - Type Long COVID Status: Phase 2 • Phase 2 study ( PREVAIL ) completed • Topline results reported 3Q 2023 Next Steps: Meeting with FDA regarding primary endpoint Acu
Slide 25: Role of Infections in Triggering Fibromyalgia or CFS-Like Illnesses
25 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Role of Infections in Triggering Fibromyalgia or Chronic fatigue (CFS) - Like Illnesses Infection initiates an autoreactive process, which affects several functions, including brain and energy metabolism 2 - 7 • Infections can trigger any o
Slide 26: About Fibromyalgia-Type Long COVID
26 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO About Fibromyalgia - Type Long COVID Many Long - COVID symptoms overlap with core symptoms of fibromyalgia and are hallmarks of other chronic pain syndromes like myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Multisite pain Mem
Slide 27: Phase 2 PREVAIL Study Design
27 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for Fibromyalgia - Type Long COVID: 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, completed e
Slide 28: Phase 2 PREVAIL Topline Results
28 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: Phase 2 PREVAIL Topline Results 1 D id not meet the primary endpoint of multi - site pain reduction at W eek 14 However, f indings fulfill the objectives of proof - of - concept study, supporting the decision to advance the pr
Slide 29: Acute Stress Reaction / Acute Stress Disorder
29 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) ASR/ASD are acute stress conditions resulting from trauma which c an affect both civilian and military populations. Large unmet need: • According to National Center for
Slide 30: TNX-102 SL for ASR/ASD: Program Status
30 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Program Status Status: Expect to start Phase 2 in 1Q 2024 ; received IND clearance from FDA Phase 2 Trial Funded by DoD grant to University of North Carolina (UNC) • UNC Institute for Trauma Recovery awarded a $3M
Slide 31: Phase 2 OASIS Study Design
31 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL for ASR/ASD: Phase 2 OASIS Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in Acute Stress Reaction (ASR) / Acute Stress Disorder (ASD) • The proposed O ptimizing A cute S
Slide 32: Tonmya: Patents and Patent Applications
32 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonmya Œ (TNX - 102 SL): Patents and Patent Applications • U.S. Composition:* • A 75:25 cyclobenzaprine HCl - mannitol eutectic (dependent claims add a basifying agent). • 5 US Patents (Expire November 2034) • 1 Pending US Application (Woul
Slide 33: Tonix Medicines: Marketed Products
© 2024 Tonix Pharmaceuticals Holding Corp. TONIX MEDICINES: MARKETED PRODUCTS
Slide 34: Tonix Medicines: Commercial-Stage Specialty Pharma Subsidiary
34 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tonix Medicines: Commercial - Stage Specialty Pharma Subsidiary • Tonix Medicines is a w holly - owned subsidiary of Tonix ( NASDAQ: TNXP) • Currently marketing two products indicated for the treatment of acute migraine: Zembrace ® SymTouch
Slide 35: Two Marketed Proprietary Migraine Drugs
35 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Two Marketed Proprietary Migraine Drugs Non - oral Formulations of Sumatriptan • Each indicated for the tr eatment of acute migraine with or without aura in adults • Sumatriptan remains the acute migraine ‘gold standard’ treatment for many
Slide 36: Zembrace and Tosymra Bypass the GI Tract
36 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace and Tosymra Bypass the GI Tract Bypassing gastrointestinal (GI) tract is potential advantage for treating acute migraine • GI absorption may be inconsistent in migraineurs due to gastric stasis (also called “gastroparesis”) 1 - 4 •
Slide 37: Pipeline Programs and Strategy for Partnerships
37 © 2024 Tonix Pharmaceuticals Holding Corp. Pipeline Programs and Strategy for Partnerships
Slide 38: Pipeline Development Strategy
38 © 2024 Tonix Pharmaceuticals Holding Corp. Pipeline Development Strategy Focusing on government and academic collaborations • Validates Tonix’s scientific expertise and technology • Reduces internal spend • Increases number of trials • Potentially speeds tim e to market • Grants, contracts, cost
Slide 39: External Partnerships
39 © 2024 Tonix Pharmaceuticals Holding Corp. External Partnerships Government partners providing direct funding, cost sharing or in - kind support include: • National Institutes of Health (NIH) • National Institute of Allergy and Infectious Disease (NIAID) ▪ TNX - 1800 selected for Project NextGen
Slide 40: Key Partnerships by Program
40 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION Key Partnerships TNX - 1500: ALLOGRAFT REJECTION TNX - 1800 : COVID - 19 VACCINE TNX - 2900: PRADER - WILLI SYNDROME TNX - 102 SL: ACUTE STRESS DISORDER
Slide 41: TNX-2900 Intranasal Potentiated Oxytocin with Magnesium
41 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 2900 Intranasal Potentiated Oxytocin with Magnesium A n ovel, non - CGRP antagonist approach to treatment
Slide 42: TNX-2900: Novel Formulation of Intranasal Oxytocin
TNX - 2900: Novel Formulation of Intranasal Oxytocin (OT) Potentiated with Magnesium 42 Magnesium is known to potentiate the binding of OT to its receptor 1 ,2 Key Differentiators © 2023 Tonix Pharmaceuticals Holding Corp. Oxytocin receptor Oxytocin o Targeted intranasal delivery • Low systemic expo
Slide 43: About Prader-Willi Syndrome
43 © 2024 Tonix Pharmaceuticals Holding Corp. RARE DISEASE PORTFOLIO Rare genetic diseas e that afflicts 10 - 20 thousand individuals in the US About Prader - Willi Syndrome Prader - Willi Syndrome (PWS) is the most common genetic cause of life - threatening childhood obesity. PWS causes unhealthy b
Slide 44: TNX-1300 Cocaine Esterase
44 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1300 Cocaine Esterase Fast acting antidote for life threatening cocaine intoxication
Slide 45: TNX-1300: Recombinant Protein Rapidly Degrades Cocaine
TNX - 1300: Recombinant Protein Rapidly Degrades Cocaine in the Bloodstream 45 Drops plasma exposure by 90% in 2 minutes Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. o Rapidly metabolizes cocaine within matter of minutes o N o other product currently on the market for this indicati
Slide 46: About Cocaine Intoxication
46 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO CNS PORTFOLIO Over 500,000 emergency department visits for cocaine, annually 3,4 About Cocaine Intoxication Over 5 million Americans reported current cocaine use in 2020, which is almost 2% of the population 1 . In 2021, more than 24,900 in
Slide 47: Immunology: Key Candidates
© 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES
Slide 48: TNX-1500 Anti-CD40L Monoclonal Antibody
48 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Anti - CD40L Monoclonal Antibody Next Generation mAb preserves efficacy without risk of thrombosis
Slide 49: TNX-1500: Next Generation anti-CD40L mAb
TNX - 1500: Next Generation anti - CD40L mAb 49 Re - engineered to better modulate the binding of Fc R and mitigate risk of thrombosis Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. Selectively Modified anti - CD40L AB Ruplizumab full Fab Contains the full ruplizumab Fab and the en
Slide 50: TNX-1500 Strategy and Status
50 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Strategy and Status Third Indication (and beyond): Autoimmune Diseases ( e.g., Multiple Sclerosis, Sj ö gen’s Syndrome, Systemic Lupus Erythematosus) • These indications require large studies, but represent large target ma
Slide 51: TNX-1500 Preclinical Data and Publications
51 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Preclinical Data and Publications Non - human Primate Kidney Allo - Transplantation • TNX - 1500 monotherapy consistently prevents kidney transplant rejection with n o thrombosis observed • April 2023 Publication: Lassiter
Slide 52: TNX-1700 Recombinant Trefoil Factor Family Member
52 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1700 Recombinant Trefoil Factor Family Member 2 (rTFF2 - HSA) Fusion Protein Targeting the toxic tumor micro - environment
Slide 53: TNX-1700: Targeting the Tumor Micro-Environment
TNX - 1700: Fighting Cancer by Targeting the Tumor Micro - Environment 53 S uppresses myeloid - derived suppressor cells (MDSCs) and activates anti - cancer CD8+ T cells o Different MOA than checkpoint inhibitors o Potential synergy with anti - PD - 1 or anti - PD - L1 monoclonal antibodies Key Diff
Slide 54: About Gastric and Colorectal Cancer
54 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO People living with colorectal cancer in the US 2 About Gastric and Colorectal Cancer Gastric and colorectal cancer are both leading cancers in the US. C olorectal cancer is the 3 rd leading cause of cancer - related deaths in both me
Slide 55: Infectious Disease: Key Candidates
© 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES
Slide 56: Internal Development & Manufacturing Capabilities
56 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities R&D Center (RDC): Frederick, MD • Research advancing CNS and immunology drugs • Accelerated development of vaccines and antiviral drugs against infectious diseases • ~48,000 s
Slide 57: Broad-Spectrum Antiviral Discovery Programs
57 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Broad - Spectrum Antiviral Discovery Programs Host - directed antiviral discovery programs CD45 targeted therapeutics • Small molecule therapeutics that reduce endogenous levels of CD45, a protein tyrosine phosphatase • Reduc
Slide 58: Live Virus Vaccine Platform
58 © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801 Live Virus Vaccine Live virus vaccine platform with multitude of potential applications
Slide 59: TNX-801: Recombinant Pox Vaccine Platform
TNX - 801: Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology 59 C loned version of horsepox 1 purified from cell culture Key Differentiators © 2024 Tonix Pharmaceuticals Holding Corp. TNX - 801* (Horsepox) *TNX - 801 is in the pre - IND stage of development and has not been approved
Slide 60: TNX-1800: Designed to Express the SARS-CoV-2 Spike Protein
60 © 2024 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 1800: Designed to Express the SARs - CoV - 2 Spike Protein TNX - 1800 (recombinant horsepox virus) is a live virus vaccine based on Tonix’s TNX - 801 that is designed to express the spike protein of the SARS - CoV - 2 v
Slide 61: Team, Network, & Upcoming Milestones
© 2024 Tonix Pharmaceuticals Holding Corp. TEAM, NETWORK, & UPCOMING MILESTONES
Slide 62: Management Team
62 © 2024 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
Slide 63: Milestones: Recently Completed and Upcoming
63 © 2023 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming □ 4 th Quarter 2023 Positive t opline results of Phase 3 RESILIENT study for Tonmya Œ for the management of fibromyalgia x Upcoming Milestones □ 1 st Quarter 2024 Initiate Phase 2 study of TNX - 102 SL for acut
Slide 64: Thank You
© 2024 Tonix Pharmaceuticals Holding Corp. THANK YOU
Slide 65: Zembrace Important Safety Information (1 of 2)
65 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (1 of 2) Zembrace SymTouch ( Zembrace ) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs
Slide 66: Zembrace Important Safety Information (2 of 2)
66 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Zembrace ® Important Safety Information (2 of 2) Zembrace may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, na usea or v
Slide 67: Tosymra Important Safety Information (1 of 2)
67 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra® Important Safety Information (1 of 2) Tosymra® can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart att
Slide 68: Tosymra Important Safety Information (2 of 2)
68 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Tosymra may cause serious side effects including: • Changes in color or sensation in your fingers and toes; sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea,
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