Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (December 2024)
31 slides from Tonix Pharmaceuticals's investor presentation, Dec 3, 2024
Slide 1: TNX-1500 Organ Transplant Rejection & Autoimmune Disorders
© 2024 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Organ Transplant Rejection & Autoimmune Disorders NASDAQ: TNXP Version P06026 December 3, 2024 (Doc 1542)
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: TNX-1500 Next Generation Anti-CD40L Antibody
© 2024 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 4: Six-month data in non-human primates; two published papers
4 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 (anti - CD40L) for Organ Transplant Six - month (+) data in Non - human primates Two papers published in the August edition of the American Journal of Transplantation • Lassiter, G., et al. (2023). TNX - 1500, a crystalliza
Slide 5: CNS Portfolio: Anti-CD40L Headlines (Sanofi frexalimab)
5 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ࢻ - CD40L Headlines • Sanofi recently published their Phase 2 data on their frexalimab in multiple sclerosis in the the New England Journal of Medicine 1 • Sanofi projects its Fc - modified humanized anti - CD40L mAb frexalimab will exceed €
Slide 6: CNS Portfolio: Anti-CD40L Headlines (pig kidney transplant)
6 © 2024 Tonix Pharmaceuticals Holding Corp. CNS PORTFOLIO ࢻ - CD40L Headlines • Mass General Hospital just transplanted a genetically engineered pig kidney into a living human 1 • Boston Globe, March 21, 2024 • Patient’s death announced May 11, 2024 2 • The patient is being treated with anti - CD40
Slide 7: Preclinical Data and Publications
7 © 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 8: Anti-CD40L Market Opportunity
8 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 ( ߙ - CD40 Ligand) 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 d
Slide 9: About CD40L (Also Called CD154)
9 © 2024 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 fun
Slide 10: Third-Generation Anti-CD40L Engineered to Decrease Risk of Thrombosis
10 © 2024 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 thrombos
Slide 11: CD40L is a Ligand for Both CD40 and CD11b
11 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO CD40L is a Ligand for Both CD40 and CD11b CD40 B Cell Activated CD4+ T cell Anti - CD40L • Anti - CD40L antibodies may offer the advantage of blocking interaction with both CD40 and CD11b Anti - CD40 • Blocking interaction of CD40L a
Slide 12: CD40L inhibition vs CD40 inhibition: graft rejection and survival
12 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO CD40L inhibition offers decreased risk of graft rejection and increased survival vs CD40 inhibition 1 • A meta - analysis of nonhuman primate studies compared anti - CD40 and anti - CD40L treatments for the prevention of renal transp
Slide 13: Anti-CD40L Treatment to Prevent Allograft Rejection
13 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ߙ - 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 fu
Slide 14: Non-Human Primate Kidney Allo-Transplantation
14 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Non - Human Primate Kidney Allo - Transplantation 1 Dr. Tatsuo Kawai, Mass General Hospital TNX - 1500 monotherapy consistently prevents kidney transplant rejection ‒ Superior to results with conventional triple drug immunosuppressiv
Slide 15: Non-Human Primate Heart Heterotopic Allo-Transplantation
15 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Non - Human Primate Heart Heterotopic Allo - Transplantation 1 Dr. Richard Pierson, Mass General Hospital TNX - 1500 monotherapy consistently prevents heart transplant rejection 1 ‒ Prolonged acceptance after cessation of therapy (in
Slide 16: Non-Human Primate Kidney Xenograft Transplantation
16 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Non - Human Primate Kidney Xenograft Transplantation Dr. Tatsuo Kawai, Mass General Hospital TNX - 1500 therapy is part of a regiment to prevent rejection in kidney xenograft transplants ‒ Prolonged acceptance October 11, 2023 - Publ
Slide 17: Non-Human Primate Bone Marrow Transplantation
17 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Non - Human Primate Bone Marrow Transplantation Dr. Leslie Kean 1 , Boston Children’s Hospital/Dana Farber Studying TNX - 1500 in combination with other drugs for preventing rejection and graft versus host disease (GvHD) in bone marr
Slide 18: Anti-CD40L Beyond Allografts: Autoimmunity
18 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO ߙ - 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 evidenc
Slide 19: Anti-CD40L for Systemic Lupus Erythematosus
19 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Anti - CD40L for Systemic Lupus Erythematosus (SLE) • SLE is a chronic autoimmune condition • Immune system targets : M ultiple systems, including the skin, joints, kidneys, heart, lungs, brain, and blood vessels • Leads to end - org
Slide 20: Anti-CD40L for Sjögren's Syndrome
20 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Anti - CD40L for Sjögren’s Syndrome 1 https://www.biospace.com/article/releases/horizon - therapeutics - plc - announces - phase - 2 - trial - evaluating - dazodalibep - for - the - treatm ent - of - sjoegren - s - syndrome - meets -
Slide 21: Anti-CD40L for Multiple Sclerosis
21 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Anti - CD40L for Multiple Sclerosis (MS) • Multiple Sclerosis (MS) is a chronic autoimmune condition • Immune system targets : Protective coating (myelin sheath) of nerve fibers • Leads to end - organ damage : Neurological disorders
Slide 22: Immunology Portfolio: Key Considerations
22 © 2024 Tonix Pharmaceuticals Holding Corp. - Confidential 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 molecule with similar activ
Slide 23: Phase I Study Schematic
23 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Phase I Study Schematic Day - 1 Tx Period Day 1 Screening Day 2 Check - In Up to 28 Days Follow - Up 120/E T To include Visit Days 3 through 120 Discharged Day 2 Day 29 Check - in Day at CRC TNX - 1500/Placebo Administration KLH Admi
Slide 24: Phase 1 Enrollment and Dosing Completed
24 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 Phase 1 Enrollment and Dosing Completed Dose Level (IV) Number of Subjects Cohort 3 mg/kg 6 (4 active, 2 placebo) Cohort 1 10 mg/kg 10 (8 active, 2 placebo) Cohort 2 30 mg/kg 10 (8 active, 2 placebo) Cohort 3
Slide 25: Immunology Portfolio Strategy and Status
25 © 2024 Tonix Pharmaceuticals Holding Corp. - Confidential IMMUNOLOGY PORTFOLIO TNX - 1500 Strategy and Status Third Indication (and beyond): Autoimmune Diseases ( e.g., Multiple Sclerosis, Sjögen’s Syndrome, Systemic Lupus Erythematosus) • These indications require large studies, but represent la
Slide 26: TNFα Superfamily Members Are Targeted by mAbs
26 © 2024 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 - TNFα
Slide 27: Immunology antibody company acquisitions
27 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO 2020 October 2021 March - April Momenta acquired by Johnson & Johnson for $6.5B 1 • Nipocalimab (M281) is a clinically validated anti - FcRn antibody with a rare pediatric disease designation from the US FDA • J&J called nipocalimab
Slide 28: Selected Other Anti-CD40L Monoclonal Antibodies in Development
28 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Selected Other ࢻ - CD40L Monoclonal Antibodies in Development Sanofi – Multiple Sclerosis (MS), Systemic Lupus Erythematosus (SLE) • Sjögren’s Syndrome ( SjS ) (NCT04572841) program discontinued 1 • Phase 2 Trial in Relapsing MS repo
Slide 29: mAbs Represent Top Products by 2024 Projected Sales
29 © 2024 Tonix Pharmaceuticals Holding Corp. - Confidential IMMUNOLOGY PORTFOLIO mAbs Represent 5 of Top 10 Products by 2024 Projected Sales • Over 100 mAbs have been approved by the US FDA, and significant growth potential remains 1 • The global monoclonal antibodies market size was estimated at $
Slide 30: TNX-1500: Prophylaxis of Transplant Rejection, Potential Autoimmune Treatment
30 © 2024 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO TNX - 1500 ( ߙ - CD40L mAb ): Prophylaxis of Transplant Rejection Potential Treatment for Autoimmune Conditions Phase 1 Candidate Significant Unmet Need Targeted as a first - line monotherapy for autoimmunity and add - on therapy for
Slide 31: Thank You
© 2024 Tonix Pharmaceuticals Holding Corp. THANK YOU
Tonix Pharmaceuticals Holding — Investor Presentation (December 2024) on 6ix