Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP

Tonix Pharmaceuticals — Technical Presentation (September 2022)

11 slides from Tonix Pharmaceuticals's technical presentation, Sep 15, 2022

  1. Slide 1: Monotherapy with TNX-1500 prolongs cardiac allograft survival in cynomolgus monkeys

    Monotherapy with TNX - 1500, an Fc - modified anti - CD154 mAb , prolongs cardiac allograft survival in cynomolgus monkeys Kohei Kinoshita 1 , Shuhei Miura 1 , Zahra Habibabady 1 ,Madelyn Ma 1 , Gannon McGrath 1 , Ryan Chaban 1 , Siobhan Fogarty 2 , Patrick Maguire 2 , Bruce Daugherty 2 , Seth Leder

  2. Slide 2: Disclosures and funding

    Kohei Kinoshita , MD, Research fellow Center for Transplantation Sciences, Massachusetts General Hospital, Boston MA I have no financial relationships with commercial interests to disclose AND SF, BD and SL are Tonix employees, and PM is a Tonix consultant This work was supported by Tonix through a

  3. Slide 3: Emerging Costimulation Blockade: aCD154

    Emerging Costimulation Blockade: aCD154 Zhang et al. Immunotherapy 2015 MHC + Ag TCR B7 - 1 CTLA - 4 B7 - 2 CD28 CD40 CD154 APC T cell

  4. Slide 4: Third generation Fc-modified aCD154 mAb

     1 st generation a nti - CD154 mAb prolonged graft survival in NHP Tx model( Hrt /Kid /islet/skin )  Major thrombotic events in the clinical trial ∵ Activate platelets via Fc γ RIIa express CD154 ｍ Ab form immune complexes with soluble - CA154 and them  3 rd generation Fc - mod aCD154 mAb hu5c8 h

  5. Slide 5: Methods - Heterotopic abdominal heart allotransplant model

    0 3 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 147 154 161 168 175 140 1 80 S tandard - dose TNX - 1500 m onoRx (sTNX, n=5) 30 mg/kg Twice weekly 20 mg/kg W eekly MMF 200 mg PO daily Low - dose TNX - 1500 + MMF (loTNX - 1500 + MMF, n=4) 10 mg/kg Weekly 30 mg/kg Twice weekly 20 mg/k

  6. Slide 6: Results - Heart allograft survival significantly prolonged with standard dose

    hu5c8 (n=4) (Rx off d90) loTNX (n=4) loTNX + MMF (n=4) stTNX (n=5) (Rx off d175) MST (range) 133 days (90 - 173) 99 days (35 - 183) 88 days (58 - 146) >265 days (116 - 305) P<0.05 for all comparisons against stTNX Rejection after cessation of all IS treatment Explant of beating graft EOS Results - H

  7. Slide 7: Results - Platelet counts stable, no thromboembolic complications

    Results - Platelet counts were stable and No thromboembolic complications were observed

  8. Slide 8: Results - stTNX suppressed rise in Teff/Treg ratio

    (defined as CD4 + CD25 + CD127loFoxp3 + ) Ratio of T eff /T reg Results - stTNX suppressed the rise in Teff/Tregs ratio at the final time - point more effectively than loTNX+MMF

  9. Slide 9: Results - CAV significantly more severe with lo + MMF

    CAV; Cardiac Allograft Vasculopathy ISHLT; International Society for Heart and Lung Tx ISHLT scores CAV severity scores Results - CAV significantly more severe with loTNX - 1500+MMF * P<0.05 ** P<0.01 *** P<0.005 **** p<0.001

  10. Slide 10: Results - Suppresses anti-donor alloantibody elaboration

    Positive 1/4 animals Positive 2/4 animals Positive 0/5 animals Positive 0/5 animals Positive 0/5 animals Positive 0/5 animals Positive 0/4 animals Positive 0/4 animals Positive 1/4 animals IgM IgG loTNX (n=4) loTNX+MMF (n=4) sTNX (n=5) Positive 2/4 animals Positive 2/4 animals Positive 0/4 animals C

  11. Slide 11: Conclusions

    Conclusions  Standard - dose TNX - 1500 inhibits pathologic alloimmunity in NHPs • Consistently prolonged NHP heart allograft survival • No clinical thrombotic events • Relative expansion of Tregs in peripheral blood • No CMV activation (no prophylaxis)  MMF does not improve heart results with low

Tonix Pharmaceuticals Holding — Technical Presentation (September 2022) on 6ix