EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm
1
AZX100
Overview &
Corporate Development Strategy
February 2009
 
 

 
2
Safe Harbor Statement
u Statements in this presentation or otherwise attributable to Capstone Therapeutics (trade
 name of OrthoLogic Corp.) regarding our business that are not historical facts are made
 pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of
 1995. These forward-looking statements, which include the timing and acceptability of FDA
 filings and the efficacy and marketability of potential products, involve risks and
 uncertainties that could cause actual results to differ materially from predicted results.
 These risks include: delays in obtaining or inability to obtain FDA, institutional review board
 or other regulatory approvals of pre-clinical or clinical testing; unfavorable outcomes in our
 pre-clinical and clinical testing; the development by others of competing technologies and
 therapeutics that may have greater efficacy or lower cost; delays in obtaining or inability to
 obtain FDA or other necessary regulatory approval of our products; our inability to
 successfully and cost effectively develop or outsource manufacturing and marketing of any
 products we are able to bring to market; changes in FDA or other regulations that affect our
 ability to obtain regulatory approval of our products, increase our manufacturing costs or
 limit our ability to market our product; affects on our stock price and liquidity if we are unable
 to meet the requirements for continued listing on the NASDAQ Global Market; our possible
 need for additional capital in the future to fund the continued development of our product
 candidates; and other factors discussed in our Form 10-K for the fiscal year ended
 December 31, 2007, and other documents we file with the Securities and Exchange
 Commission.
 
 

 
3
Capstone Overview
Capstone is a Clinical-Stage Biopharmaceutical Company
u AZX100 - Entering Phase 2 in Dermal Scarring 1Q2009
  Synthetic peptide with demonstrated effects
  Anti-fibrotic
  Smooth muscle relaxation
u Chrysalin® (TP508) - Pre-Clinical Proof-of-Concept in
 Acute Myocardial Infarction
  Synthetic peptide with demonstrated effect in vascular endothelial dysfunction
  Excellent safety profile in 565 human subjects in other indications
u Strong IP portfolio
u Internal Product Development Capabilities
  26 FTEs (10 PhD and/or MD)
  Experienced management, public company infrastructure
  Expertise in science, pre-clinical, regulatory, clinical, administration
 
 

 
4
Capstone 2008 Summary
Capstone Report Card 2008
u Achieved All Corporate Objectives
u AZX100
  Successful Phase 1a safety study (30 subjects)
  Met safety endpoint
  Successful Phase 1b safety study (40 subjects)
  Met safety endpoint
  Significant pharmacologic effect
  Trend of efficacy in scar reduction
  Pre-clinical progress in additional high-value indications
  Published fibroblast mechanism data
u Chrysalin (TP508)
  Completed landmark pre-clinical proof-of-concept AMI study
  Published key studies on cellular effects / mechanism of action
  Initiated corporate partnering process
 
 

 
5
AZX100
AZX100
 
 

 
6
Keloid Scars
 Overgrowth of dense fibrous
 tissue
 Extend beyond borders of
 original wound
 Do not regress
 spontaneously
 Tend to recur after excision
Hypertrophic Scars
 Red, itching, raised fibrous lesions
 Typically do not expand beyond
 boundaries of initial injury
 May undergo partial spontaneous
 resolution
 Common after thermal and other
 injuries that involve deep dermis
Atrophic (Normal) Scars
 Various types:
  Flat, pale
  Sunken
  Red, dark, raised
  Result from surgery, burns
  acne
Dermal Scarring: Range of Indications
 
 

 
7
AZX100 Dermal Scarring - Compelling Rationale
u Cellular (in vitro)
  AZX100 decreased expression of CTGF & Type 1 collagen
  AZX100 decreased stress fiber formation & altered morphology of
 human dermal keloid fibroblasts
u Pre-Clinical
  AZX100 significantly improved collagen organization in Siberian
 hamster scarring model
u Clinical
  Phase 1a & 1b Safety Profile
  Phase 1b - Strong pharmacologic signal & early signal of efficacy
u Commercial Potential
  21 million surgical procedures performed annually in the U.S. that
 can result in some form of dermal scarring
u Conclusion: Initiate Phase 2 Program
 
 

 
8
AZX100 Phase 2 Dermal Scarring
u Initiation: 1Q2009
u Four clinical trial sites; n~150
u Arthroscopic shoulder surgery subjects
u Multiple doses, administrations
 Intra-patient control
u Efficacy endpoints
 Use of validated criteria
 2D/3D digital photography; visual, other scoring scales
u Biopsies of scar sites
u Interim analysis late 2009; 12-month follow-up
 
 

 
9
AZX100 Phase 2 Keloid Pilot Study
u Initiation: 1Q2009
u Two clinical trial sites; n~30
u Volunteers - keloid scar excision
u Multiple doses, administrations
u Placebo control
u Efficacy endpoints
 Use of validated measurement criteria
 2D/3D digital photography; visual, other scoring scales
u Informal observational analysis late 4Q2009 for
 internal purposes; 12-month follow-up
 
 

 
10
Capstone Pipeline
AZX100 Status Report
Under Existing Dermal IND
 
 

 
11
Chrysalin®
 
 

 
12
 
 

 
13
Capstone Financial Summary
Capstone Key Financial Facts
u $48.0MM cash (31-Dec-2008)
 Favorable to guidance
u No long-term debt
u 52-wk Range: $0.40 - $1.29
u Mkt Cap as of February 5, 2009 : ~$18.3MM
 
 

 
14
Capstone Cash Burn
Guidance
Actual
2006
Orig: $35.0MM
Rev: $15.0-$17.5MM
$13.4MM
2007
$18.0 - $19.0MM
$9.6MM
2008
$13.0 - $15.0MM
$12.6MM
(includes $1.041MM
stock repurchase)
2009
$14.0 - $16.0MM
Capstone Manages Cash with Discipline
 
 

 
15
Capstone Therapeutics - Value Potential
uUnique molecules targeting high-value
 indications
uNear-term value-creating events
uCash resources
uValue Creation in 2009
 AZX100 Phase 2 Program in Dermal Scarring
 AZX100 Keloid Pilot Study
 Chrysalin Corporate Partnering in AMI
 
 

 
16
 
NASDAQ: CAPS
 
www.capstonethx.com
 
Capstone Therapeutics
 
1275 West Washington Street - Suite 101
 
Tempe, AZ 85281
 
(602) 286-5520