Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (March 2022)
65 slides from Tonix Pharmaceuticals's investor presentation, Mar 22, 2022
Slide 1: Investor Presentation
© 2022 Tonix Pharmaceuticals Holding Corp. INVESTOR PRESENTATION NASDAQ: TNXP Version P0343 March 22, 2022 (Doc 0979)
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: Mission, What We Do and Strategy
3 © 2022 Tonix Pharmaceuticals Holding Corp. ADVANCING THE SCIENCE AND UNDERSTANDING OF DISEASES by developing innovative therapies that improve population health by focusing on unmet needs in patient care WHAT WE DO Using our integrated development engine, we advance innovative programs across mult
Slide 4: CNS Portfolio
4 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO Candidates* INDICATIONS STATUS / NEXT MILESTONE CNS TNX - 1300 1 Cocaine Intoxication / Overdose FDA Breakthrough Designation Phase 2, Targeted 1H 2022 Start TNX - 102 SL 2 Fibromyalgia (FM) Posttraumatic Stress Disorder (PTSD) Long COVID (P
Slide 5: Immunology and Infectious Disease Portfolio
5 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY AND INFECTIOUS DISEASE PORTFOLIO *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. 1 anti - CD40L humanized monoclonal antibody 2 Recombinant trefoil factor 2 (rTFF2) ba
Slide 6: CNS: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. CNS: KEY CANDIDATES
Slide 7: TNX-102 SL: Fibromyalgia
7 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 102 SL*: FIBROMYALGIA CYCLOBENZAPRINE PROTECTIC ® SUBLINGUAL TABLETS CNS PORTFOLIO A unique formulation of cyclobenzaprine designed to optimize delivery and absorption Innovative and proprieta
Slide 8: TNX-102 SL: Fibromyalgia Program Update
8 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: FIBROMYALGIA PROGRAM UPDATE CNS PORTFOLIO Phase 3 Study, RALLY (F306) • As expected from interim results published July 2021, RALLY Study missed primary endpoint • Unexpected ~80% increase in adverse event - related discontinua
Slide 9: RALLY Study Increased Adverse Event-Related Discontinuations
9 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY STUDY INCREASED ADVERSE EVENT - RELATED DISCONTINUATIONS CNS PORTFOLIO TEAE = treatment - emergent adverse event Increases in AE - Related discontinuations in RALLY study compared with RELIEF study in both placebo and TNX
Slide 10: RALLY Study Impact of Missing Data on P-Values
10 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: RALLY STUDY IMPACT OF MISSING DATA ON P - VALUES IN RALLY MI missing data treatment attenuated p - values in RALLY • At the current time, we expect MI will be part of the statistical analysis for the RESILIENT trial CNS PORTFO
Slide 11: Comparison of RALLY and RELIEF Results: Weekly Pain
11 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: COMPARISON OF RALLY & RELIEF RESULTS WEEKLY PAIN MEASURED BY DAILY DIARY -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 Change from Baseline (SE) in NRS Pain Score Study Week Pl
Slide 12: Comparison of RALLY and RELIEF Results: Responder Analyses
12 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: COMPARISON OF RALLY & RELIEF RESULTS CONTINUOUS RESPONDER ANALYSES P e r c e n t o f S u b j e c t s 0 10 20 30 40 50 60 70 80 90 100 Percentage Redution in Pain >=0% >=10% >=20% >=30% >=40% >=50% >=60% >=70% >=80% >=90% =100%
Slide 13: TNX-102 SL: Fibromyalgia Program Update
13 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO TNX - 102 SL: FIBROMYALGIA PROGRAM UPDATE CNS PORTFOLIO Similar to RALLY, RESILIENT will compare TNX - 102 SL 5.6 mg and placebo • Parallel design, double - blind, randomized placebo - controlled study • Primary endpoint is pain at week 14
Slide 14: TNX-102 SL: Long COVID (PASC)
14 © 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 15: TNX-1300: Cocaine Intoxication
15 © 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 16: TNX-1900: Migraine
16 © 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 17: TNX-2900: Prader-Willi Syndrome
17 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 2900*: PRADER - WILLI SYNDROME INTRANASAL POTENTIATED OXYTOCIN (OT) WITH MAGNESIUM CNS PORTFOLIO Prader - Willi Syndrome is the most common genetic cause of life - threatening childhood obesi
Slide 18: TNX-601 CR: Psychiatry
18 © 2022 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO PROFILE DEVELOPMENT PROGRAM Patents Issued TNX - 601 CR*: PSYCHIATRY TIANEPTINE OXALATE AND NALOXONE CNS PORTFOLIO A novel, oral, controlled release once - daily tablet Mechanistically different from traditional monoaminergic treatments for
Slide 19: Immunology: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY: KEY CANDIDATES
Slide 20: TNX-1500 (anti-CD40L mAb): Transplant Rejection and Autoimmune Conditions
20 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 ( anti - CD40L m A b ): A POTENTIAL TREATMENT FOR ORGAN TRANSPLANT REJECTION AND AUTOIMMUNE CONDITIONS Pre - IND Candidate Significant Unmet Need Targeted as a first - line monotherapy for autoimmunity and add - on therapy
Slide 21: TNX-1500 Market Opportunity
21 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 MARKET OPPORTUNITY Autoimmune Disease $149.4 billion 6 OPPORTUNITY Kidney transplants: 24,000/year/US 2 $5.54 billion 3 Autoimmune Lupus: 1.5 M patients in US 4 1.87 billion 5 Organ transplant rejection drugs $4.7 billion
Slide 22: About CD40L (Also Called CD154)
22 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ABOUT CD40L (ALSO CALLED CD154) CD40L is a transiently expressed T cell surface molecule and is also called CD154 1 - 4 ‒ Predominantly expressed by T cells and interacts with CD40 on B cells and macrophages Mediates T cell helper fu
Slide 23: Next Generation Anti-CD40L Antibody TNX-1500
23 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed NEXT GENERATION anti - CD40 LIGAND (CD40L) ANTIBODY TNX - 1500*: PREVENTION OF ALLOGRAFT REJECTION THE CD40 - CD40L PATHWAY IS A PIVOTAL IMMUNE SYSTEM MODULATOR AND IS A WELL - ESTABLISHED AND PROMISING TREATMENT TARGET
Slide 24: Third-Generation Anti-CD40L Engineered to Decrease Risk of Thrombosis
24 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO THIRD - GENERATION anti - 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 throm
Slide 25: Anti-CD40L Treatment to Prevent Allograft Rejection
25 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO anti - CD40L TREATMENT TO PREVENT ALLOGRAFT REJECTION • Calcineurin inhibitors (CNIs), mainly tacrolimus, are the cornerstone of immunosuppressive therapy 1,2 • However, CNIs cause irreversible and progressive deterioration of kidney
Slide 26: Non-Human Primate Heart Heterotopic Allograft Study
26 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO NON - HUMAN PRIMATE HEART HETEROTOPIC ALLOGRAFT STUDY DR. RICHARD PIERSON, MASS GENERAL HOSPITAL TNX - 1500 monotherapy consistently (4/5 heart transplants) prevents heart transplant rejection 1 ‒ Graft acceptance without acute cellu
Slide 27: Non-Human Primate Kidney Allo-Transplantation Study
27 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO NON - HUMAN PRIMATE KIDNEY ALLO - TRANSPLANTATION STUDY DR. TATSUO KAWAI, MASS GENERAL HOSPITAL TNX - 1500 monotherapy consistently (5/6 kidney transplants) prevents kidney transplant rejection 1 ‒ Six recipients were treated with TN
Slide 28: Tolerance Induction with Donor Bone Marrow Transplantation
28 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TOLERANCE INDUCTION WITH DONOR BONE MARROW TRANSPLANTATION Induction of “mixed chimerism” induces allograft tolerance ‒ Long - lasting, durable tolerance — specifically to donor tissues ‒ Initial protocols required that the recipient
Slide 29: Conditioning Regimen and Kidney Biopsy Results
29 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 0 20 40 60 80 100 5 12 20 27 33 40 47 % Chimerism Days Post CKBMT Chimerism Gran Mono Lymph Keys: 1. Bone marrow transplant 2. Kidney transplant 3. Total Body Irradition 4. Venclexta ® 5. Thymoglobulin® A. CONDITIONING REGIMEN FOR BO
Slide 30: Anti-CD40L Beyond Allografts: Xenografts
30 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO anti - CD40L BEYOND ALLOGRAFTS: XENOGRAFTS • Allotransplantation is limited by a critical shortage of human organs ; pig - to - human xenotransplantation offers a promising alternative 1,2 • Costimulation blockade (anti - CD40L in pa
Slide 31: Recent Xenotransplant Headlines
31 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO RECENT XENOTRANSPLANT HEADLINES “In a First, Surgeons Attached a Pig Kidney to a Human, and It Worked” Roni Caryn Rabin “Pig - Heart Transplant Jolts Doctors Confronting Lack of Organ Donors” Amy Dockser Marcus “Saved by a Pig’s Hear
Slide 32: Anti-CD40L Beyond Allografts: Autoimmunity
32 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO anti - CD40L BEYOND ALLOGRAFTS: AUTOIMMUNITY • Autoimmune diseases are also characterized by immune system activity that attacks “self,” which can damage various parts of the body 1,2 • First - generation anti - CD40L Abs showed evid
Slide 33: TNX-1500: Key Considerations
33 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500: KEY CONSIDERATIONS • TNX - 1500 may be used in large markets that are not currently well served • There is a long history of use of monoclonal antibodies • Tonix has engineered a safer, potentially more efficacious molecu
Slide 34: Development and Regulatory Strategy
34 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO DEVELOPMENT AND REGULATORY STRATEGY • 1 st Indication – Kidney allotransplantation (human to human) ‒ Replacement for nephrotoxic CNI’s (calcineurin inhibitors, e.g. Prograf ® (tacrolimus) 1 , Neoral ® (cyclosporin) 2 ‒ Similar devel
Slide 35: TNF-alpha Superfamily Members Are Targeted by mAbs
35 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNF ߙ SUPERFAMILY MEMBERS ARE TARGETED BY mAbs • CD40L is a member of the Tumor Necrosis Factor (TNF α ) Superfamily 1 • Other TNF α Superfamily members have proven to be effective targets for antagonist (blocking) mAbs 2 anti - TN
Slide 36: Recent Biotech Acquisitions
36 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 2020 September October November December 2021 January Immunomedics acquired by Gilead for $21B 1 • TRODELVY TM ( sacituzu mab govitecan - hziy ) is an anti - Trop - 2 antibody - drug conjugate (ADC) approved for triple - negative bre
Slide 37: Monoclonal Antibodies Represent 4 of Top 10 Products by 2021 Sales
37 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO MONOCLONAL ANTIBODIES ( m A bs ) REPRESENT 4 OF TOP 10 PRODUCTS BY 2021 SALES • Over 100 mAbs have been approved by the US FDA, and significant growth potential remains 1 • Global mAb market is projected to grow from $179B in 2021 to
Slide 38: TNX-1700: Gastric and Colorectal Cancers
38 © 2022 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Patents Filed TNX - 1700*: GASTRIC AND COLORECTAL CANCERS STABILIZED RECOMBINANT TREFOIL FACTOR 2 ( r TFF2) POTENTIAL NEW CANCER TREATMENT • TNX - 1700 (rTFF2) has effects on cancer by altering the tumor micro - environment • Mechani
Slide 39: Infectious Diseases: Key Candidates
© 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASES: KEY CANDIDATES
Slide 40: COVID-19: Entering Endemic Phase in the US
40 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19: ENTERING ENDEMIC PHASE IN THE US • Delta and Omicron variant waves are waning in most parts of the US ‒ Leaving a path of morbidity and mortality, including “breakthrough” infection and disease among vaccinated an
Slide 41: COVID-19: The Missing Pieces
41 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19: THE MISSING PIECES • Vaccines : early vaccines slowed pandemic, but are showing limitations ‒ Short term protection – requirement for boosters with mRNA vaccines; ‒ Increasing focus on preventing hospitalization a
Slide 42: COVID Vaccines: Where We Are Today
42 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19 VACCINES: WHERE WE ARE TODAY Durability of protection ‒ mRNA vaccinated people lose protection, starting at 4 - 6 months 1 ‒ High rates of “breakthrough” COVID during Delta and Omicron waves ‒ Booster vaccinations
Slide 43: COVID Vaccines: Where Do We Go From Here?
43 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO COVID - 19 VACCINES: WHERE DO WE GO FROM HERE? mRNA vaccines have slowed pandemic, but may not be a long - term solution ‒ Vaccinated people lost protection and showed high rates of “breakthrough” COVID during Delta and Omicr
Slide 44: Live Virus Vaccines: Development Rationale
44 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS VACCINES: DEVELOPMENT RATIONALE • Control of smallpox, measles, mumps, rub ella, chickenpox and other viral conditions ‒ Prevent forward transmission • Effective in eliciting durable or long - term immunity • Econo
Slide 45: Vaccinia Induces a Skin Reaction Called Take
45 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO VACCINIA INDUCES A SKIN REACTION CALLED “TAKE” – DESCRIBED BY DR. EDWARD JENNER *Example of major cutaneous reaction, or “take,” resulting from a replication - competent live - virus vaccine with intradermal deli very, indica
Slide 46: Live Virus Vaccine Platform: Recombinant Pox Vaccine Technology
46 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS VACCINE PLATFORM: NEW RECOMBINANT POX VACCINE (RPV) TECHNOLOGY FOR EMERGING INFECTIOUS DISEASES AND ONCOLYTICS COVID - 19 Future Pandemics Infectious Disease Biodefense Using Proven Science To Address Challenging D
Slide 47: TNX-801: Smallpox and Monkeypox Vaccine
47 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 801: SMALLPOX AND MONKEYPOX VACCINE LIVE VIRUS PLATFORM DEVELOPMENT PROGRAM APPLICATION OF LIVE VIRUS PLATFORM • TNX - 801 is a cloned version of horsepox 1 (without any insert) purified from cell culture
Slide 48: Virus-Based Science Is Well Established
48 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO VIRUS - BASED SCIENCE IS WELL ESTABLISHED • Streamlined development • Ability to vertically integrate development and manufacturing • Multi - dose packaging, standard cold - chain products LIVE VIRUS RECOMBINANT POX VACCINE (
Slide 49: TNX-1840 and TNX-1850: COVID-19 Vaccine
49 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed TNX - 1840 AND TNX - 1850*: COVID - 19 VACCINE LIVE VIRUS PLATFORM DEVELOPMENT PROGRAM APPLICATION OF LIVE VIRUS PLATFORM • First version TNX - 1800 encodes spike protein from SARS - CoV - 2, Wuhan strain • Plan
Slide 50: What Makes TNX-1840 and TNX-1850 Different from mRNA Vaccines
50 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS PLATFORM: WHAT MAKES TNX - 1840 AND TNX - 1850 DIFFERENT FROM m RNA VACCINES CRITERIA mRNA VACCINES TNX - 1840/TNX - 1850 Number of shots Two One Duration 6 months Years / decades Boosters Recommended Likely not re
Slide 51: Internal Development and Manufacturing Capabilities
51 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO LIVE VIRUS RPV P LATFORM & COVID - 19 VACCINE INTERNAL DEVELOPMENT & MANUFACTURING CAPABILITIES Infectious Disease R&D Center (RDC) – Frederick, MD • Function : Accelerated development of vaccines and antiviral drugs against
Slide 52: American Pandemic Preparedness Plan (AP3)
52 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO AMERICAN PANDEMIC PREPAREDNESS PLAN (AP3) • “Platforms” – Foundation of Pandemic Response ‒ Key element of AP3 from White House Office of Science and Technology Policy or OSTP 1,2 ▪ 100 days to human trials ▪ Technologies tha
Slide 53: Assessing Anti-SARS-CoV-2 Protective Immunity
53 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO ASSESSING anti - SARS - C o V - 2 PROTECTIVE IMMUNITY TWO TYPES OF IMMUNITY • Antibodies – can be measured in a blood test, but anti - SARS - CoV - 2 antibodies are not predictive of protection • T cell – can be measured in a
Slide 54: TNX-2100: SARS-CoV-2 Diagnostic to Measure T Cell Immunity
54 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 2100*: SARS - C o V - 2 DIAGNOSTIC TO MEASURE T CELL IMMUNITY DESIGNED TO MEASURE THE PRESENCE AND STRENGTH OF FUNCTIONAL IN VIVO T CELL IMMUNITY • Designed to elicit delayed - type hypersensitivity in individuals who h
Slide 55: TNX-2100: Potential Uses and Development Plan
55 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO TNX - 2100*: POTENTIAL USES AND DEVELOPMENT PLAN *TNX - 2100 has not been approved for any indication. † Intracellular cytokine staining (ICS) measured by flow cytometry after in vitro stimulation of purified peripheral blood
Slide 56: Small Molecule COVID Therapeutics
56 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO SMALL MOLECULE COVID - 19 THERAPEUTICS The only COVID - 19 antiviral that is FDA approved is Remdesivir/ Veklury ® ‒ Gilead – Intravenous ( i.v. ) medicine ‒ FDA approved for patients who are at least 12 years old and require
Slide 57: TNX-3500: COVID-19 Antiviral Treatment
57 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3500*: COVID - 19 ANTIVIRAL TREATMENT SANGIVAMYCIN New variants heighten need for therapeutics NIH Treatment Guidelines for COVID - 19 are mixed on use of remdesivir Potential m
Slide 58: Monoclonal Antibody COVID-19 Therapeutics
58 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO MONOCLONAL ANTIBODY COVID - 19 THERAPEUTICS Monoclonal antibodies ( mAbs ) (EUA) – 3 with US Emergency Use Authorization 1 ‒ Vir /GSK – XEVURDY® ( sotrovimab ) 1 – ONLY mAb ACTIVE AGAINST OMICRON ‒ Lilly - bebtelovimab – EUA
Slide 59: TNX-3600: COVID-19 Therapeutic
59 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO PROFILE DEVELOPMENT PROGRAM TNX - 3600*: COVID - 1 9 THERAPEUTIC FULLY HUMAN MONOCLONAL ANTIBODY PLATFORM Collaboration with Columbia University Human monoclonal antibodies ( mAbs ) generated from COVID - 19 convalescent pati
Slide 60: TNX-3700: COVID-19 Vaccine
60 © 2022 Tonix Pharmaceuticals Holding Corp. INFECTIOUS DISEASE PORTFOLIO Patents Filed PROFILE DEVELOPMENT PROGRAM TNX - 3700*: COVID - 19 VACCINE ZINC NANOPARTICLE (ZNP) FORMULATION FOR m RNA VACCINE Collaboration with Kansas State University ZNP technology is a potential replacement for the Lipi
Slide 61: Future Outlook
© 2022 Tonix Pharmaceuticals Holding Corp. FUTURE OUTLOOK
Slide 62: Key Development Candidates and Partners
62 © 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 63: Milestones: Recently Completed and Upcoming
63 © 2022 Tonix Pharmaceuticals Holding Corp. Expected Data □ 1 st Half 2022 Topline data from first - in - human TNX - 2100 skin test study Expected Clinical Trial Initiations □ 1 st Half 2022 Phase 2 OL safety study start of TNX - 1300 in ED setting for cocaine intoxication □ 1 st Half 2022 Phase
Slide 64: Management Team
64 © 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 65: Thank You
© 2022 Tonix Pharmaceuticals Holding Corp. THANK YOU
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