Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Technical Presentation (December 2023)
25 slides from Tonix Pharmaceuticals's technical presentation, Dec 12, 2023
Slide 1: TNX-1500 Organ Transplant Rejection & Autoimmune Disorders
© 2023 Tonix Pharmaceuticals Holding Corp. TNX - 1500 Organ Transplant Rejection & Autoimmune Disorders NASDAQ: TNXP Version P0509 Dece mber 11 , 2023 (Doc 1354 )
Slide 2: Cautionary Note on Forward-Looking Statements
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 Litigat
Slide 3: TNX-1500 Next Generation Anti-CD40 Ligand Antibody
© 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
Slide 4: Anti-CD40 Ligand Market Opportunity
4 © 2023 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 5: About CD40L (Also Called CD154)
5 © 2023 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 6: Third-Generation Anti-CD40L Engineered to Decrease Risk of Thrombosis
6 © 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 thrombosi
Slide 7: CD40L is a Ligand for Both CD40 and CD11b
7 © 2023 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 an
Slide 8: CD40L inhibition offers decreased risk of graft rejection vs CD40 inhibition
8 © 2023 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 transpl
Slide 9: Anti-CD40L Treatment to Prevent Allograft Rejection
9 © 2023 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 fun
Slide 10: Non-Human Primate Kidney Allo-Transplantation
10 © 2023 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 11: Non-Human Primate Heart Heterotopic Allo-Transplantation
11 © 2023 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 12: Non-Human Primate Kidney Xenograft Transplantation
12 © 2023 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 13: Non-Human Primate Bone Marrow Transplantation
13 © 2023 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 14: Anti-CD40L Beyond Allografts: Autoimmunity
14 © 2023 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 15: Anti-CD40L for Sjögren's Syndrome
15 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO Anti - CD40L for Sjögren’s Syndrome • Sjögren's is a life - long autoimmune condition , where tear and salivary glands are initially affected • In 2019, there were an estimated 2.26 million prevalent cases of primary Sjögren's syndro
Slide 16: Key Considerations
16 © 2023 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 17: Phase 1 Study Schematic
17 © 2023 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 18: Phase 1 Enrollment and Dosing Completed
18 © 2023 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 19: Development and Regulatory Strategy
19 © 2023 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 20: TNFα Superfamily Members Are Targeted by mAbs
20 © 2023 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 21: Recent Acquisitions of Autoimmune Antibody Companies
21 © 2023 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 22: Other anti-CD40L Monoclonal Antibodies in Development
22 © 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 pego
Slide 23: mAbs Represent Top Products by 2023 Projected Sales
23 © 2023 Tonix Pharmaceuticals Holding Corp. IMMUNOLOGY PORTFOLIO mAbs Represent 5 of Top 10 Products by 2023 Projected 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 $452B in 2028 at
Slide 24: TNX-1500: Prophylaxis of Transplant Rejection, Potential Treatment for Autoimmune Conditions
24 © 2023 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 25: Thank You
© 2023 Tonix Pharmaceuticals Holding Corp. THANK YOU
Tonix Pharmaceuticals Holding — Technical Presentation (December 2023) on 6ix