Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — ThinkEquity Conference 2022
29 slides from Tonix Pharmaceuticals's conference presentation, Oct 21, 2022
Slide 1: Investor Presentation: ThinkEquity Conference 2022
© 2022 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION ThinkEquity Conference 2022 NASDAQ: TNXP Version P0385 October 26, 2022 (Doc 1111)
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 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 Litigat
Slide 3: Who We Are
3 © 2022 Tonix Pharmaceuticals Holding Corp. Who We Are Tonix Pharmaceuticals is committed to improving patient care by advancing science and developing innovative therapies which have the potential to address important unmet needs across multiple therapeutic areas OUR MISSION Tonix strives to be a
Slide 4: What We Do
4 © 2022 Tonix Pharmaceuticals Holding Corp. What We Do 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. Tonix is currently enrolling participants
Slide 5: Pipeline: Key Programs
5 © 2022 Tonix Pharmaceuticals Holding Corp. Pipeline: Key Programs Therapeutic Area Candidates* Indication Status/Next Milestone CNS TNX - 102 SL 1 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (PASC 2 ) Mid - Phase 3 Phase 2, Targeted 4Q 2022 Start Phase 2 CNS TNX - 1300 3 Coca
Slide 6: CNS: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES
Slide 7: TNX-102 SL Pipeline in a Product
© 2022 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 current
Slide 8: TNX-102 SL: Fibromyalgia
8 © 2022 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 C
Slide 9: Phase 3 RESILIENT Study Design
9 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO 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 • One unblinded interim analysis base
Slide 10: TNX-102 SL: Long COVID (PASC)
10 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: Long COVID (PASC) Cyclobenzaprine Protectic ® Sublingual Tablets Long COVID or Post - acute Sequelae of COVID - 19 (PASC 1 ) • Symptoms can include fatigue, sleep disorders, pain, fe
Slide 11: Phase 2 PREVAIL Study Design
11 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Phase 2 PREVAIL Study Design General s tudy c haracteristics: • Randomized, double - blind, placebo - controlle d study in fibromyalgia - type Long COVID • Approximately 30 sites in the U.S. and is expected to enroll approximately 470 patie
Slide 12: TNX-102 SL: Posttraumatic Stress Disorder (PTSD)
12 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX 102 SL*: Posttraumatic Stress disorder (PTSD) Cyclobenzaprine Protectic ® Sublingual Tablets PTSD is a serious chronic psychiatric illness • Defined as maladaptive prolonged stress response whi
Slide 13: TNX-1300: Cocaine Intoxication
13 © 2022 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 Cocaine use can cause irreversible structural damage to the heart and accelerate
Slide 14: TNX-601 ER: Depression
14 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 E R*: Depression Tianeptine Hemioxalate Extended - Release Tablets CNS PORTFOLIO A novel, oral, extended - release once - daily tablet Mechanistically different from traditional monoamine
Slide 15: TNX-1900: Migraine
15 © 2022 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 • Intranasal OT reaches the trigeminal ganglion •
Slide 16: Rare Disease: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. RARE DISEASE: KEY CANDIDATES
Slide 17: TNX-2900: Hyperphagia in Prader-Willi Syndrome
17 © 2022 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 child
Slide 18: Immunology: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES
Slide 19: TNX-1500: Next Generation Anti-CD40L Antibody
© 2022 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
Slide 20: TNX-1700: Gastric and Colorectal Cancers
20 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700*: Gastric and Colorectal Cancers Recombinant Trefoil Factor 2 (rTFF2) Fusion Protein POTENTIAL NEW CANCER TREATMENT • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment • Mecha
Slide 21: Infectious Disease: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE: KEY CANDIDATES
Slide 22: TNX-801 and TNX-1850 Recombinant Pox Vaccine Platform
© 2022 Tonix Pharmaceuticals Holding Corp. TNX - 801 & TNX - 1850* Recombinant Pox Vaccine (RPV) Platform Using Live Virus Technology Monkeypox and Smallpox Vaccine Status: Preclinical • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture Next Steps: Developin
Slide 23: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology
23 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Live Virus Vaccine Platform: Recombinant Pox Vaccine (RPV) Technology for Emerging Infectious Diseases and Oncolytics Monkeypox and Smallpox Future Pandemics & New Infectious Diseases COVID - 19 Biodefense Using Proven Scienc
Slide 24: Internal Development & Manufacturing Capabilities
24 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Internal Development & Manufacturing Capabilities Infectious Disease R&D Center (RDC) – Frederick, MD • Function: Accelerated development of vaccines and antiviral drugs against COVID - 19, its variants and other infectious d
Slide 25: Future Outlook
© 2022 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK
Slide 26: Milestones: Recently Completed and Upcoming
26 © 2022 Tonix Pharmaceuticals Holding Corp. Milestones: Recently Completed and Upcoming* Expected Clinical Trial Initiations □ 4 th Quarter 2022 Phase 2 study start of TNX - 102 SL for the treatment of PTSD in Kenya □ 4 th Quarter 2022 Phase 2 study start of TNX - 1900 for the treatment of migrain
Slide 27: Key Development Partners
27 © 2022 Tonix Pharmaceuticals Holding Corp. TNX - 1300: COCAINE INTOXICATION TNX - 1700: GASTRIC AND COLORECTAL CANCERS TNX - 3600: MONOCLONAL ANTIBODIES FOR COVID - 19 TREATMENT Key Development Partners TNX - 1500: ALLOGRAFT REJECTION TNX - 1900: MIGRAINE & OTHER INDICATIONS TNX - 801: SMALLPOX A
Slide 28: Management Team
28 © 2022 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 29: Thank You
© 2022 Tonix Pharmaceuticals Holding Corp. THANK YOU
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