Tonix Pharmaceuticals Holding Corp. 8-K

Exhibit 99.04

Introduction Results aCD154mAb (TNX - 1500) alone, or in combination with rapamycin, MMF, or aCD28mAb (VEL - 101) prolongs cynomolgus cardiac allograft survival Kohei Kinoshita 1 , A Maenaka 1 , G McGrath 1 , R Chaban 1 , Z Habibabady 1 , I Rosales 2 , S Fogarty 3 , P Maguire 3 , B Daugherty 3 , S Lederman 3 , R Pierson III 1 1 Center for Transplantation Sciences, Department of Surgery, Massachusetts General Hospital, Boston, MA, United States 2 Department of Pathology, Massachusetts General Hospital, Boston, MA, United States 3 Tonix Pharmaceuticals, Inc., Chatham , NJ, United States - TNX - 1500 (TNX) is a novel humanized anti - CD154 mAb that contains the hu5c8 Fab region and an IgG4 Fc region engineered to decrease FcγR2A binding. - TNX - 1500 was designed to reduce the risk of thromboembolic events observed with hu5c8 IgG1 (ruplizumab) in previous clinical trials. - The efficacy of TNX - 1500 when combined with conventional IS has not been previously described. loTNX+Vel - 101 prolonged graft survival, but there is no significant difference in loTNX groups. All grafts of stTNX survived over 6 months, except one graft got an infection. After Rx cessation on d180, grafts kept beating for 2 - 4 months. loTNX monoRx had high ISHLT acute rejection score, but low CAV score. loTNX+MMF had high ISHLT and CAV scores. loTNX+Vel - 101 had stable low ISHLT and CAV scores. stTNX+Rapa showed no evidence of rejection at all time points DSA elaboration loTNX combined with either MMF or Vel - 101 Rx prevented class - switching (no IgG DSA); and loTNX+Vel - 101 suppressed IgM DSA elaboration. No DSA elaboration in stTNX monoRx and stTNX+Rapa . One stTNX+MMF recipient had anti - donor MHC class1 IgM. Discussion & Conclusion  The preliminary results indicates that TNX - 1500 efficacy is similar to hu5c8 parent molecule with no evidence for procoagulant phenotypes  ‘Standard’ dosing as monotherapy consistently prevents graft loss during Rx  Combination Rx with MMF is associated with higher incidence & severity of ACR score in both loTNX and stTNX  stTNX - 1500 combined with Rapa prolonged graft survival with no evidence of pathologic and humoral rejection *TNX - 1500 is an investigational new biologic and has not been approved for any indication Kohei Kinoshita has no financial relationships with commercial interests to disclose. SF, BD, and SL are Tonix employees, and PM is a Tonix consultant. This work was supported by Tonix through a Sponsored Research Agreement. Methods