Theralase(Technologies(Inc.( Roger(Dumoulin5White...

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Chapter TitleSection Theralase Technologies Inc. Roger DumoulinWhite President, Chief Executive Officer AGM Corporate Presentation February 17, 2015 CONFIDENTIAL Theralase Technologies Inc. Corporate Presentation 1Q2016

Transcript of Theralase(Technologies(Inc.( Roger(Dumoulin5White...

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Chapter    Title  Section

Theralase  Technologies  Inc.  Roger  Dumoulin-­‐White    President,  Chief  Executive  OfficerAGM  Corporate  Presentation

February  17,  2015CONFIDENTIAL

Theralase  Technologies  Inc.Corporate  Presentation 1Q2016  

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Certain  statements  contained  or  incorporated  in  this  presentation,  which  deal  with  the  financial  condition  and  operating  results of  Theralase  Technologies  Inc.  (“Theralase”  or  the  “Company”),  include  information,  analyses  and  projections  as  to  future  corporate  developments  which  are  currently  in  the  planning  stage,  and  on  the  projected  operating  financial  performance  of  the  Company,  which  constitute  forward-­‐looking  statements.  Such  forward-­‐looking  statements,  made  with  special  reference  to  the  Company’s  ongoing  technologically  complex  healthcare  and  medical  device  research  and  development  efforts,  which  may  include  in-­‐house  and  independent  clinical  trials,  testing  new  medical  technologies  and  their  applications,  involve  known  and  unknown  risks  and  uncertainties  that  could  cause  actual  events  and  results  to  differ  materially  from  those  estimated  or  anticipated  and  which  may  have  been  implied  or  expressed  in  such  forward-­‐looking  statements.  No  conclusions  as  to  the  successful  outcome  of  the  ongoing  and  planned  research  and  development  projects  in  which  the  Company  is  involved  are  intended  or  implied  nor  can  they  be  foreseen  or  predicted  prior  to  definitive  corporate  announcements  as  to  their  outcome.  Certain  forward  looking  statements  are  identified  by  words  such  as  “believe”,  “anticipate”,  “estimate”,  “expect”,  “intend”,  “plan”,  “expect”,  “project”,  “may”,  and  “will”  and  the  negative  of  such  expressions,  although  not  all  forward  looking  statements  contain  these  identifying  words,  any  statements  that  refer  to  expectations,  projections  or  other  characterizations  of  future  events  or  circumstances  are  forward  looking  statements.  Although  Theralase  believes  that  the  expectations  reflected  in  any  forward  looking  statements  made  in  this  presentation  are  reasonable,  such  statements  are  based  on  a  number  of  assumptionswhich  may  prove  to  be  incorrect.  

Accordingly,  no  assurances  can  be  given  that  any  of  the  events  or  circumstances  contemplated  by  any  such  forward  looking  statements  will  transpire  or  occur  or,  if  any  of  them  transpire  or  occur  what  impact  they  will  have  on  Theralase’s  results  of  operations  or  financial  condition.  A  more  complete  list  of  risks  and  uncertainties  inherent  to  the  Company’s  industry  can  be  found  in  the  Company’s  regulatory  and  financial  filings.  

Furthermore,  the  forward-­‐looking  statements  contained  in  this  presentation  are  made  as  of  the  date  hereof.  The  Company  does  not  undertake  any  obligation  to  update  publicly  or  to  revise  any  of  the  included  forward-­‐looking  statements,  whether  as  a  result  of  new  information,  future  events,  or  otherwise,  unless  required  by  applicable  laws.  The  forward-­‐looking  statements  contained  in  this  presentation  are  expressly  qualified  by  this  cautionary  statement.

All  references   to  dollars  herein  are  to  Canadian  dollars  except  as  otherwise  indicated.

Forward  Looking  Statements

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Therapeutic  Laser  Technology  (“TLT”)  Division:  Cold   laser  technology  using   laser  light  to  penetrate  into  tissue  up  to  4”  to  heal  nerve,  muscle,   and  joint  conditions   at  the  source  of  injury

Effective  in  eliminating  pain,   reducing  inflammation  and  healing  tissue  

TLC-­‐1000  series,  Legacy  business   that  generates  $2  M  revenue  per  year  (70%  effective)

TLC-­‐2000  series,Next  generation  patented  biofeedback   cloud  based  therapeutic  laser  system  launched   in  Canada  and  the  US  in  1Q2016  and  in  Europe  in  2Q2016  (90%  effective)

Photo  Dynamic  Therapy  (“PDT”)  Division:  Laser  light  activated  Photo  Dynamic  Compounds   (“PDCs”)  able  to  destroy  cancer

TLC-­‐3000,  Laser  light  activated  PDCs  proven  to  destroy  numerous   cancers  pre-­‐clinically.  Clinical   evaluation  commences  with  Non  Muscle  Invasive  Bladder  Cancer  (“NMIBC”)  in  a  Phase  Ib  clinical  trial  in  1Q2016

Theralase  (TLT:  TSXV)  (TLTFF:  OTC)  develops  and  commercializes  medical  laser  technology  ,  which  heals  patients  safer,  faster,  and  more  effectively  than  any  competitive  product.  

Corporate  Overview

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Manufacture  medical  laser  technology  that  is  clinically  proven  to:• Eliminate  pain• Reduce  inflammation  • Accelerate  tissue  healing

70%  success  in  healing  nerve,  muscle  and  joint  conditions  • Low  back  pain• Knee  pain• Hundreds  of  other  pain  conditions

Legacy  business  generates  $2  M  annually

Therapeutic  Laser  Division  

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US  pain  market  exceeds  $100  B  annually  and  growing  rapidly  1

45%  of  this  population  remain  in  significant  pain  post  surgery  or  during  prescribed  pain  medicine2

TLC-­‐2000  expected  to  be  eligible  for  a  unique  reimbursable  Current  Procedural  Terminology  (“CPT”)  code  in  the  U.S.  for  national  reimbursement  due  to  Cell  Sensing®  technology

Pain  Market

1  Institute  of  Medicine  of  the  National  Academies  Report.  Relieving  Pain  in  America:  A  Blueprint  for  Transforming  Prevention,  Care,  Education,  and  Research,  2011.  The  National  Academies  Press,  Washington  DC.

2  Peter  D.  Hart  Research  Associates.  Page  3.  KEY  FINDINGS.  Americans  in  Pain.

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• Dramatically  increase  efficacy  over  existing  technologies  by  targeting  injured  tissue  with  patented  “Cell  Sensing®”  technology

• Canada,  U.S.  and  European  patents

• 90%  success  in  healing  nerve,  muscle  and  joint  conditions  

• 2000%  ROI  for  healthcare  practitioners

• Targeted  to  generate  $50  M  annually  within  5  years  of  launch

• Recurring  revenue  model

Next  Generation  Technology  -­‐ TLC-­‐2000

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Business  Model

Business Model Overview

Up  Front  /  Recurring  Revenue

• 60  month  lease  =  $400  to  $800  per  month depending   on  number  of  laser  probes  (Higher  investment  equals  less  treatment  time)

• Lease  includes:   product,   training,  warranty,  marketing,  patient  referrals  and  software  updates  for  term  of  lease

• At  end  of  lease,  practitioner  has  the  following  options:• Return  equipment  to  Theralase  and  discontinue   use• Pay  10%  residual   to  Theralase,  keep  technology  and  discontinue   support• Pay  $200  to  $400  per  month  ad  infinitum   to  maintain  warranty  and  marketing  support• Purchase  latest  Theralase  technology  and  recommence  lease  process

Illustrative  Example:  (Average  Sale  Price:  $25,000)

§ 400  units  sold  equates  to  $10  M  in  revenue.

§ 800  units  sold  equates  to  $20  M  in  revenue.

Moving  away  from  a  capital  equipment  model  to  a  recurring  revenue  model

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Practitioner’s  Incentive

• 8  to  16  treatments  /month  @  $50  per  treatment  covers  cost  of  lease• Clinic   retains  all  revenue  in  excess  of  $400  to  $800  per  month  (average  $500  per  month)• Clinics   generate  > $10,000  /  month  (200  patient  treatments  @  $50)• 2000%  Return  on  Investment

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• Effective  – Patented3 anti-­‐cancer  drugs  able  to  destroy  cancer  cells  >  99%  when  light  activated

• Safe -­‐ 0%  toxicity  to  healthy  tissue  

• Targeted  –Targets  only  cancer  cells

• Immune  Response -­‐ Proven  ability  to  prevent  recurrence  of  cancer  even  after  repeated  exposures

• Diagnostic -­‐ Proven  ability  to  detect  cancer  cells  

• Versatile – Able  to  be  activated  at  a  various  tissue  depths

• Highly  Accredited  – Research  performed  at  the  number  3  cancer  research  institute  in  the  world  

Photo  Dynamic  Therapy  Division  (Anti-­‐Cancer)

83  Issued  U.S.  Patents:    6,962,910,  7,612,057,    8,148,360,  8,445,475,  Pending  U.S.  Patent  Applications:    PCT/US14/30194,  13/863,089,  PCT/US13/36595

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Bladder  Cancer  PDT  Treatment

• Insert  catheter  into  urethra• 60  minute  installation  of  PDC  to  

localize  drug  inside  bladder  cancer  cells

• Flush  bladder  three  times  to  remove  loose  PDC

• Insert  fibre  optic  bundle• Activate  PDC  for  30  minutes• Void  bladder  to  remove  

destroyed  bladder  cancer  cells

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Safety Efficacy

0

20

40

60

80

100

120

0.001250.0025 0.005 0.01 0.02 0.04

Cell  Kill  (%)

Concentration  (mM)

45  J  cm-­‐290  J  cm-­‐2

0

20

40

60

80

100

120

0.00125 0.0025 0.005 0.01 0.02 0.04

Cell  Kill  (%)

Concentration  (mM)

45  J  cm-­‐290  J  cm-­‐2

Safety  and  Efficacy  Profile

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4  Research   performed  at  Princess  Margaret  Cancer  Centre,  University  Health  Network  by  Theralase  research  scientists  under  the  direction  of  Dr.  Lothar  Lilge  Ph.D.,  UHN  and  Dr.  Arkady  Mandel  Ph.D.,  M.D.,  D.  Sc.,  Chief  Scientific  Officer   of  Theralase,  HT1376  Human  Bladder  Cancer  Line   Safety  and  Efficacy  of  PDC

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020406080100

0.0001 0.0002 0.0005 0.017

Cell  Kill  (%)

Concentration  (mM)

020406080100

0.00016 0.0003 0.0008 0.025

Cell  Kill  (%)

Concentration  (mM)

020406080100

0.0001 0.0002 0.0005 0.017

Cell  Kill  (%)

Concentration  (mM)

020406080100

0.00016 0.0003 0.0008 0.025

Cell  Kill  (%)

Concentration  (mM)

Safety EfficacyMouse  colon  cancer  (carcinoma)

ALATPDC

Rat  brain  cancer(glioma)

Human  brain  cancer  (glioblastoma)

Dramatically  Better  Than  Two  FDA  Approved  Drugs  5

ALATPDC

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5 Research  performed   at  Princess  Margaret  Cancer  Centre,  University  Health  Network  by  Theralase  research  scientists  under  the  direction  of  Dr.  Lothar  Lilge  Ph.D.  and  Dr.  Arkady  Mandel  Ph.D.,  M.D.,  D.  Sc.,  Chief  Scientific  Officer   of   Theralase

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Mechanism  of  Action

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Transferrin  combines  with  PDC  to  target  cancer  cells  and  destroy  them

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PDC  injection  of  53  mg  kg-­‐1 4hr  Post  PDC  Injection  (Pre  Light  Activation)

24hr  Post  Light  Activation20  Months  Post  Treatment  (No  

recurrence)

Tumour  induced  in  mice

Mice  survive  20  months  cancer  free  after  only  1  Anti-­‐Cancer  treatment

Immune  Response  6

136 Research  performed   at  Princess  Margaret  Cancer  Centre,  University  Health  Network  by  Theralase  research  scientists  under  the  direction  of  Dr.  Lothar  Lilge  Ph.D.  and  Dr.  Arkady  Mandel  Ph.D.,  M.D.,  D.  Sc.,  Chief  Scientific  Officer   of   Theralase

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Rat  Orthotopic  Model

Anti-­‐Cancer  drug  preferentially  accumulates  in  bladder  tumour  and  pre-­‐tumourous  tissue  versus  healthy  urothelium  (180  times  higher)

>99%  destruction  of  bladder  cancer  tumours

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Therapeutic  Laser  Divisionü Health  Canada  Approval  of  TLC-­‐2000  Therapeutic  Laserü FDA  Approval  of  TLC-­‐2000  Therapeutic  Laser§ CE  Approval  of  TLC-­‐2000  Therapeutic  Laser  (1Q2016)

Anti-­‐Cancer  Divisionü Health  Canada  Clinical  Trial  Application  (“CTA”)  approvalü University  Health  Network  Research  Ethics  Board  (“UHN  REB”)  approval§ Health  Canada  Investigational  Trial  Application  (“ITA”)  approval§ FDA  pre-­‐Investigational  New  Drug  Application  (“IND”)  Approval  (1Q2016)§ FDA  IND  Application  Approval  (1Q2016)§ Commence  enrolling  subjects  into  Health  Canada  Phase  Ib  clinical  study  for  

NMIBC  (1Q2016)

Next  Steps

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Ownership  /  Capitalization  Table

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OWNERSHIP  TABLE  as  Jan  4,  2016

Holder  Name #  of  Common  Shares%  of  Common  

Shares  #  of  Fully  Diluted  

Shares%  of  Fully  Diluted  

Shares

Officers  &  DirectorsRoger  Dumoulin-­‐White  (CEO) 5,343,306 5.0% 10,495,806 7.6%

Kristina  Hachey   (CFO) 913,410 0.9% 1,413,410 1.0%Randy  Bruder  (Director) 1,410,324 1.3% 1,980,324 1.4%

Matthew  Perraton  (Director) 42,699 0.0% 552,065 0.4%Guy  Anderson   (Director) 20,000 0.0% 540,000 0.4%

Total  Officers  &  Directors 7,729,739   7.2% 14,981,605   10.9%

Public  Float 99,317,621   92.8% 122,697,695   89.1%

TOTAL  Shares 107,047,360   100.00% 137,679,300   100.0%

CAPITALIZATION   TABLE  

Description#  of  Common  Shares  

Equivalent

Common  Shares  Outstanding   107,047,360  

Options  (Weighted  Average  Price  $0.50) 10,105,000  

Warrants  (Weighted  Average  Price  $0.53) 20,526,940  

Total  Fully  Diluted  Shares  Outstanding 137,679,300

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1945  Queen  Street  EastToronto,  Ontario,  M4L  1H7,  CANADA

Michael  BorovecDirector,  Investor  Relations647-­‐230-­‐[email protected]

Roger  Dumoulin-­‐WhitePresident  &  CEO1-­‐866-­‐THE-­‐LASE  (843-­‐5273)   [email protected]

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TLT:  TSXV          TLTFF:  OTC