Corporate PresentationNovember 2011
Disclosures     Forward-­‐looking	  Statements	       The	  statements	  and	  discussions	  contained	  in	  this	  prese...
TONIX Pharmaceuticals Summary   	     •  Specialty	  pharmaceuCcal	  company	  developing	  innovaCve	        products	  f...
Experienced Leadership                                                    Management	  Team	                              ...
Accomplished Independent Board                              Board	  of	  Directors	                               Seth	  L...
Fibromyalgia Market Opportunity      •  Approximately	  5	  million	  U.S.	  fibromyalgia	  (FM)	  paCents*	        •  U.S....
Fibromyalgia: Vicious Cycle   •  MedicaCons	  that	  target	  pain	  or	  depressed	  mood	  are	        approved	  for	  ...
Comparison of Fibromyalgia Drugs      •  Physicians	  ocen	  switch	  drugs	  when	  paCents	  are	  dissaCsfied	        • ...
Cyclobenzaprine Has an Impressive        Safety Record and is Widely Used       •  Merck	  developed	  and	  launched	  Fl...
VLDC FM Pilot Study Results:      Symptom Measures*      •  Study	  published	  in	  Journal	  of	  Rheumatology	  Dec.	  ...
TNX-102: VLDC New Formulation    •  Designed	  for	  the	  treatment	  of	  fibromyalgia	              -­‐  Muscle	  relaxa...
TNX-102: Development Plan      •  PK	  trial	  to	  begin	  4Q	  2011	  and	  clinical	  phase	  will	  be	             co...
TNX-102: CompellingRisk / Reward Profile  •  Low	  risk	  –	  safety,	  efficacy	  and	  demand	  established	  Risk	  Facto...
TNX-102: CompellingRisk / Reward Profile•  Short-­‐term	  MoneCzaCon	  Focus	  	     -­‐  The	  first	  of	  two	  pivotal	...
TNX-105: VLDC for PTSD      •  3.5%	  of	  U.S.	  adult	  populaCon	  will	  have	  suffered	  from	  PTSD	           in	  ...
FM & PTSD - Related Conditions     •  PTSD,	  like	  FM	  is	  characterized	  by	  groups	  of	  symptoms	              -...
TONIX Pharmaceuticals Pipeline•  TONIX	  has	  a	  comprehensive	  pipeline	  of	  CNS	  products	    Product	      Indica...
Exclusivity & Patents     •  TNX-­‐102	              -­‐  Issued	  Methods	  of	  Use	  patents	  for	  use	  of	  VLDC	  ...
Upcoming Milestones•  Short	  and	  intermediate	  term	  value	  inflecCon	  milestones	  	  Timing	                Milest...
Why Invest in TONIX?   •  Capital	  efficient	  drug	  development	  strategy	  focused	  on	          high-­‐value,	  first-...
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Tonix Presentation November 2011

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Tonix Pharmaceuticals (OTCBB: TNXP.OB) develops new treatments for challenging disorders of the central nervous system (CNS).The Company’s lead programs are potential new treatments for fibromyalgia and post-traumatic stress disorder, which are chronic CNS syndromes.

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Tonix Presentation November 2011

  1. 1. Corporate PresentationNovember 2011
  2. 2. Disclosures Forward-­‐looking  Statements   The  statements  and  discussions  contained  in  this  presenta1on  that  are  not  historical  facts  cons1tute  forward-­‐looking  statements.    These  can   be  iden1fied  by    the  use  of  forward-­‐looking  words,  such  as  “believes”,  “expects”,  “may”,  “intends”,  “an1cipates”,  “plans”,  “es1mates”,  or  any   other  analogous  or  similar  expressions  intended  to  iden1fy  forward-­‐looking  statements.    These  forward-­‐looking  statements  and  es1mates  as   to  future  performance,  es1mates  as  to  future  valua1ons,  and  other  statements  contained  herein  regarding  maAers  that  are  not  historical   facts,  are  only  predic1ons  and  actual  events  or  results  may  differ  materially.    We  cannot  assure  or  guarantee  that  any  future  results  described   in  this  presenta1on  will  be  achieved,  and  actual  results  could  vary  materially  from  those  reflected  in  such  forward-­‐looking  statements.       Informa1on  contained  in  this  presenta1on  has  been  complied    from  sources  believed  to  be  credible  and  reliable.    However,  we  cannot   guarantee  such  credibility  and  reliability.    The  forecasts  and  projec1ons  of  events  contained  herein  are  based  upon  subjec1ve  valua1ons,   analyses,  and  personal  opinions.   InformaCon  Regarding  Disclosures   The  Common  Stock  and  Warrants  have  not  and  will  not  be  registered  under  the  Securi1es  Act  of  1933,  as  amended  (the  “Act”),  or  under  any   state  securi1es  laws,  nor  has  the  Securi1es  and  Exchange  Commission  (the  “Commission”)  or  any  state  regulatory  authority  endorsed  the   Offering.    Any  representa1on  to  the  contrary  is  a  criminal  offense.   In  making  an  investment  decision,  investors  must  rely  upon  their  own  examina1on  of  the  company  and  the  terms  of  the  Offering,  including   the  merits  and  risks  involved.    The  acquisi1on  of  the  Stock,  if  offered,  should  be  considered  only  by  persons  who  can  bear  the  economic  risk   of  their  investment  of  ran  indefinite  period  of  1me  and  can  afford  a  total  loss  of  their  investment.    Each  prospec1ve  investor  in  the  Offering   should,  prior  to  purchasing  any  Stock,  consult  his  own  aAorney  and  business  advisor  as  to  the    legal,  business,  tax,  and  related  maAers   concerning  its  investment  and  is  urged  to  ask  ques1ons  of,  and  receive  answers  from,  the  Company  concerning  the  terms  and  condi1ons  of   the  Offering  and  request  any  addi1onal  informa1on  they  may  consider  Necessary  in  making  an  informed  investment  decision.   This  presenta1on  does  not  cons1tute  an  offer  to  sell  or  a  solicita1on  of  an  offer  to  purchase  any  securi1es  of  any  nature  whatsoever,  nor  do   the  contents  of  the  presenta1on  cons1tute  legal,  tax,  or  business  advice.   This  presenta1on  and  the  offering  of  the  Companys  Stock  shall  be  kept  confiden1al.    The  recipient  agrees  not  to  disclose  to  any  third  party   any  informa1on  contained  herein,  or  any  terms,  condi1ons,  or  other  facts  with  respect  to  he  Offering,  including,  without  limita1on,  that  the   Company  is  or  may  be  contempla1ng  the  Offering.     Informa1on  included  herewith  has  been  obtained  from  the  Company  and  other  sources  believed  to  be  reliable,  but  the  accuracy  or   completeness  of  such  informa1on  is  not  guaranteed  by,  and  should  not  be  construed  as  a  representa1on  by  the  Company.    Any   representa1ons  and  warran1es  will  be  contained  only  in  a  defini1ve  agreement  signed  by  the  investor  and  the  Company.     2CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  3. 3. TONIX Pharmaceuticals Summary   •  Specialty  pharmaceuCcal  company  developing  innovaCve   products  for  high-­‐value  CNS  indicaCons   •  Lead  programs  target  fibromyalgia  syndrome  (FM)  and   post  traumaCc  stress  disorder  (PTSD)   -­‐  Reformulated  cyclobenzaprine   -­‐  Capital-­‐efficient,  low-­‐risk  development  pathway   -­‐  High  ROI  commercial  strategy   -­‐  Expect  to  follow  successes  of  Lyrica®  and  Cymbalta®  in  FM   •  Fibromyalgia  Phase  2(a)  demonstrated  staCsCcally   significant  improvements  in  core  symptoms   •  Pipeline  of  addiConal  CNS  product  candidates   3CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  4. 4. Experienced Leadership Management  Team   Seth  Lederman,  MD   Founder,  CEO,  Chairman   Co-­‐founder,  Vela,  Targent,  Validus,  Fontus   Benjamin  Selzer   Chief  OperaCng  Officer   Aton,  Reliant,  investment  banking    (Lehman  Brothers  &  Banc  of  America  SecuriCes)   Rhonda  Rosen,  CPA   Chief  Financial  Officer   CFO,  Validus,  Fontus  ,  two  divisions  of  CIGNA  ,  PricewaterhouseCoopers   4CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  5. 5. Accomplished Independent Board Board  of  Directors   Seth  Lederman,  MD   Founder,  CEO,  Chairman   Stuart  Davidson   Former  CEO  of  Alkermes  &  Combion   Patrick  Grace   WR  Grace,  Chemed,  Grace  InsCtute   Donald  W.  Landry,  MD,  PhD   Columbia  Chair  of  Medicine   Ernest  Mario,  PhD   Former  CEO  of  Glaxo,  Alza  &  Reliant   Charles  Mather   Janney  SecuriCes,  Cowen,  Smith  Barney   John  Rhodes   Former  Partner  at  Booz  Allen    Hamilton   5CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  6. 6. Fibromyalgia Market Opportunity •  Approximately  5  million  U.S.  fibromyalgia  (FM)  paCents*   •  U.S.  FM  drug  market  esCmated  at  $1.2  billion**   -­‐  2007-­‐2010  CAGR  of  18.4%**   •  UnCl  2007,  there  were  no  FDA  approved  FM  drugs   -­‐  Lyrica®  (Pfizer)  was  approved  for  FM  in  2007  and  is  replacing  off-­‐ label  generic  analgesics   -­‐  Cymbalta®  (Lilly)  was  approved  for  FM  in  2008  and  is  replacing  off-­‐ label  generic  an1-­‐depressants   •  TNX-­‐102  is  expected  to  be  FDA  approved  as  a  first-­‐in-­‐class   drug  for  FM  and  to  replace  off-­‐label  generic  muscle   relaxants  * National Institutes of Health, U.S. Department of Health and Human Services** Source: Frost & Sullivan Fibromyalgia Market Study, December 2010 6        TONIX  PHARMACEUTICALS   TONIX  PHARMACEUTICALS      
  7. 7. Fibromyalgia: Vicious Cycle •  MedicaCons  that  target  pain  or  depressed  mood  are   approved  for  the  maintenance  of  FM   •  TNX-­‐102  will  be  a  first-­‐in-­‐class  medicaCon  targeCng   disturbed  or  non-­‐restoraCve  sleep  (NRS)  in  FM   Pain   Lyrica   Sleep   Depressed   Disturbance   Mood   TNX-­‐102   No  approved   Cymbalta   medicaCons   7CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  8. 8. Comparison of Fibromyalgia Drugs •  Physicians  ocen  switch  drugs  when  paCents  are  dissaCsfied   •  TNX-­‐102  is  a  first-­‐in-­‐class  bedCme  treatment  and  is  not   expected  to  compete  with  approved  treatments   Pipeline  Treatments   Approved  Treatments       •  Analgesic  category   • NonrestoraCve  Sleep  category   •  DEA  scheduled   • 1  dose   •  Taken  2  Cmes  a  day   •  Interferes  with  sleep   • Not  restricted  by  DEA   • Should  be  available  at  all     pharmacies   •  AnCdepressant  category   •  Suicidality  warning     •  Taken  1-­‐2  Cmes  a  day     •  Interferes  with  sleep   • Nonrefreshing  Sleep  category   • 2  doses  (bedCme  &  4  hours  later)     • Amnesia  liability   •  AnCdepressant  category   • Strongest  DEA  schedule  limits   •  Suicidality  warning     pharmacy  and  paCent  accessibility   •  Taken  1-­‐2  Cmes  a  day   •  Interferes  with  sleep  * Jazz recently announced they are discontinuing the development of Rekinla 8        TONIX  PHARMACEUTICALS  
  9. 9. Cyclobenzaprine Has an Impressive Safety Record and is Widely Used •  Merck  developed  and  launched  Flexeril®  in  1977   •  Over  one  billion  tablets  prescribed  in  2010   •  Extensive  safety  &  efficacy  studies  conducted  by  Merck   in  1990s   •  FDA  approved  controlled  release  products  in  2007  (15   mg  and  30  mg)   •  No  DEA  scheduling,  no  recognized  addicCve  potenCal   •  Off-­‐label  Cyclobenzaprine  is  the  third  most  widely   prescribed  medicaCon  for  FM*  * Source: Frost & Sullivan Fibromyalgia Market Study, December 2010 9 CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  10. 10. VLDC FM Pilot Study Results: Symptom Measures* •  Study  published  in  Journal  of  Rheumatology  Dec.  2011   •  Lead  invesCgator  Harvey  Moldofsky  thought  leader  in  FM   15%   10%   Pecrent  Change  from   5%   Pain   0% FaCgue   Tenderness   HAD   HAD  Depression   0%   Baseline   -­‐5%   VLDC   -­‐10%   -­‐15%   Placebo   p=0.039   -­‐20%       -­‐25%   p=0.017   p=0.010   p=0.012   -­‐30%   p=0.006   -­‐35%   Change  from  Baseline  (week  8):  tenderness  measured  by  dolorimetry;  HAD  is  the  Hospital   Anxiety  and  Depression  Scale;  HAD  Depression  is  the  HAD  depression  subscale  * Moldofsky et al., J. Rheum. December 2011: http://jrheum.org/content/early/2011/08/30/jrheum.110194.full.pdf+html 10 TONIX  PHARMACEUTICALS  
  11. 11. TNX-102: VLDC New Formulation •  Designed  for  the  treatment  of  fibromyalgia   -­‐  Muscle  relaxant  products  aim  for  stable  high  blood  levels  over  24  hours   -­‐  Aiming  for  faster  and  more  reliable  absorp1on  for  FM   -­‐  Designed  for  high  blood  levels  during  the  night  and  lower  levels  the  next   day  to  reduce  next  day  somnolence   •  DifferenCated  from,  but  not  compeCCve  with  other  FM   therapies   -­‐  First-­‐in-­‐class  sleep  quality  treatment  for  fibromyalgia   -­‐  Bed1me  versus  day1me  (Cymbalta,  Lyrica,  Savella)   -­‐  Physicians  switch  pa1ents  between  different  classes  when  they  are   dissa1sfied   11CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  12. 12. TNX-102: Development Plan •  PK  trial  to  begin  4Q  2011  and  clinical  phase  will  be   completed  by  year-­‐end   -­‐  30  subjects;  three  week  study   -­‐  To  be  conducted  by  PharmaNet  Canada,  a  division  of  inVen1ve  Health   -­‐  TNX-­‐102  vs.  generic  5  mg  tablet   -­‐  TNX-­‐102  fed/fasted   -­‐  Expect  differen1a1on  in  1me-­‐concentra1on  curve  rela1ve  to  generic   •  Following  PK  trial,  plan  is  to  begin  first  pivotal  trial   -­‐  2  arm,  12  week  study  with  approximately  150  pa1ents  per  arm   -­‐  Study  design  and  endpoints  to  mirror  those  used  by  Lyrica  and  Cymbalta   •  Pain  and  a  composite  endpoint  of  other  FM  symptoms   -­‐  Results  expected  mid-­‐2013   12CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  13. 13. TNX-102: CompellingRisk / Reward Profile •  Low  risk  –  safety,  efficacy  and  demand  established  Risk  Factor   Commentary  FDA  Risk   •  Cyclobenzaprine  is  one  of  the  more  widely  prescribed  pharmaceu1cals;  1  billion  tablets    -­‐  Safety   per  year  in  the  U.S.   •  FDA  approved  and  prescribed  since  the  1970’s   •  Widely  studied  in  modern  safety  trials   •  505(b)(2)  registra1on;  TONIX  to  benefit  from  exis1ng  safety  data  FDA  Risk   •  Off-­‐label  Cyclobenzaprine  is  third  most-­‐widely-­‐prescribed  drug  for  FM    -­‐  Efficacy   •  Phase  2a  study  demonstrated  strong  efficacy  with  very  low  dose  cyclobenzaprine  Commercial  Risk   •  Off-­‐label  cyclobenzaprine  already  has  market  acceptance  by  physicians  and  pa1ents   despite  never  having  been  marketed  for  FM   •  TNX-­‐102  would  be  approved  as  a  first-­‐in-­‐class  treatment  for  FM  and  is  expected  to   replace  off-­‐label  use  of  muscle  relaxants   •  Widely  used  off  label  for  FM;    48.3  million  tablets  in  2010  (Frost  &  Sullivan)  Reimbursement   •  TNX-­‐102  is  expected  to  be  approved  as  a  first-­‐in-­‐class  treatment  for  FM  Risk   •  Currently  no  generic  FM  products  Generic   •  New,  differen1ated  formula1on  rela1ve  to  generic  cyclobenzaprine  Compe11on   •  Lyrica  and  Cymbalta  took  market  share  from  cheaper  off-­‐label  generics  once  they   obtained  FDA  approval  for  FM   13        TONIX  PHARMACEUTICALS   TONIX  PHARMACEUTICALS      
  14. 14. TNX-102: CompellingRisk / Reward Profile•  Short-­‐term  MoneCzaCon  Focus     -­‐  The  first  of  two  pivotal  clinical  trials  to  commence  Q3  2012   -­‐  Ini1al,  “interim”,  data  should  be  available  by  Q1  2013,  with  final  study   report  available  Q2-­‐Q3  2013   -­‐  Somewhere  between  those  two  milestones,  TONIX  plans  seek  a  major   pharmaceu1cal  partner  or  to  mone1ze  the  company   14        TONIX  PHARMACEUTICALS   TONIX  PHARMACEUTICALS      
  15. 15. TNX-105: VLDC for PTSD •  3.5%  of  U.S.  adult  populaCon  will  have  suffered  from  PTSD   in  past  12  months*   -­‐  Any  trauma  can  lead  to  PTSD   •  UnsaCsfied  market   -­‐  Only  Zolor®  and  Paxil®  have  FDA  approval   •  Widespread  painkiller  abuse  and  addicCon   •  Leveraging  formulaCon  and  clinical  work  from  TNX-­‐102  to   advance  TNX-­‐105  * National Institutes of Mental Health & National Institutes of Health 15 TONIX  PHARMACEUTICALS  
  16. 16. FM & PTSD - Related Conditions •  PTSD,  like  FM  is  characterized  by  groups  of  symptoms   -­‐  Some  pa1ents  with  FM  meet  PTSD  criteria   -­‐  Some  pa1ents  with  PTSD  meet  FM  criteria   -­‐  Some  are  believed  to  suffer  from  both  condi1ons  simultaneously   •  Overlap  of  PTSD  and  FM  symptoms  suggests  VLDC  may   treat  PTSD   -­‐  PTSD  is  thought  to  be  exacerbated  by  non-­‐restora1ve  sleep   •  PTSD  has  both  combat  and  civilian  forms   -­‐  Zolor  and  Paxil  are  approved  for  PTSD  but  market  is  unsa1sfied   -­‐  Brand  prescrip1ons  are  now  filled  by  generic  sertraline  and  paroxe1ne   -­‐  DOD  has  a  strong  interest  in  promo1ng  research  on  therapeu1cs   16CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  17. 17. TONIX Pharmaceuticals Pipeline•  TONIX  has  a  comprehensive  pipeline  of  CNS  products   Product   IndicaCon   Status   TNX-­‐102   Fibromyalgia   •  Very  low  dose  cyclobenzaprine  in  novel  formula1on   •  Phase  2a  successfully  completed   •  PK  trial  in  new  formula1on  expected  comple1on  YE  2011   •  First  of  two  pivotal  trials  expected  to  begin  Q3  2012   TNX-­‐105   Post-­‐Trauma1c   •  Low  dose  cyclobenzaprine  in  novel  formula1on   Stress  Disorder   •  Will  leverage  data  from  TNX-­‐102  PK  trial   •  Pivotal  trials    an1cipated  to  start  2012   •  Applying  for  Department  of  Defense  funding   TNX-­‐201   Headache   •  NDA  to  be  filed  for  exis1ng  DESI  product   •  Poten1ally  shortened  process  for  FDA  approval   •  DESI  to  NDA  switch  products  enjoy  mandated  exclusivity   TNX-­‐301   Alcoholism   •  US  patent  allowed   •  Poten1al  for  government  funding   17        TONIX  PHARMACEUTICALS   TONIX  PHARMACEUTICALS      
  18. 18. Exclusivity & Patents •  TNX-­‐102   -­‐  Issued  Methods  of  Use  patents  for  use  of  VLDC  in  treatment  of  fibromyalgia   with  expira1on  mid-­‐2020   -­‐  Two  issued  formula1on  patents  with  expira1on  in  mid-­‐2021   -­‐  Further  patents  on  pharmacokine1cs  expected  to  be  filed  in  near  term   •  TNX-­‐105   -­‐  Filed  Methods  of  Use  patent  for  use  of  VLDC  in  treatment  of  PTDS   -­‐  Two  issued  formula1on  patents  with  expira1on  in  mid-­‐2021   •  AcCve  patenCng  strategy  to  extend  exclusivity   -­‐  Plan  to  file  patents  around  TONIX  products’  unique  PK  profiles,  which  are   difficult  to  circumvent   •  Hatch-­‐Waxman  exclusivity  3  years  post  launch  for  new   indicaCons   18CONFIDENTIAL   TONIX  PHARMACEUTICALS  
  19. 19. Upcoming Milestones•  Short  and  intermediate  term  value  inflecCon  milestones    Timing   Milestones  Related  to  TNX-­‐102  December  2011   •  Pharmacokine1c  (PK)  trial  Jan-­‐Feb  2012   •  PK  data  analysis  and  new  patent  filings  Q1  2012   •  Announcement  of  pharmacokine1c  trial  comple1on  Q3  2012   •  Commencement  of  ini1al  pivotal  trial  Q1  2013   •  Interim  look  at  ini1al  pivotal  trial  data  Q2-­‐Q3  2013   •  Comple1on  of  ini1al  pivotal  trial   •  Partnering  or  mone1za1on  event   19        TONIX  PHARMACEUTICALS   TONIX  PHARMACEUTICALS      
  20. 20. Why Invest in TONIX? •  Capital  efficient  drug  development  strategy  focused  on   high-­‐value,  first-­‐in-­‐class  products     •  FM  and  PTSD  are  significant  unmet  needs  with  large   market  opportuniCes   •  TNX-­‐102  is  expected  to  be  a  first-­‐in-­‐class  treatment  for   FM  and  differenCated  from  generic  cyclobenzaprine   •  Low  risk,  low-­‐cost  development  pathway •  Short-­‐term  moneCzaCon   •  Experienced  management  and  Board   20CONFIDENTIAL          TONIX  PHARMACEUTICALS   TONIX  PHARMACEUTICALS  
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