Capstone Holding Corp. · NASDAQ:CAPS
Capstone — Capstone Therapeutics — Corporate Update (April 2011)
24 slides from Capstone's corporate update, Apr 27, 2011
Slide 1: Capstone Therapeutics Clinical & Operating Update
AZX100 Capstone Therapeutics Clinical & Operating Update April 28, 2011 AZX100
Slide 2: Safe Harbor Statement
Safe Harbor Statement u Statements in this presentation or otherwise attributable to Capstone 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
Slide 3: Agenda
Agenda A. Final Results : AZX100 OL-ASCAR-03 - Trocar Sites of Arthroscopic Shoulder Surgery Patients B. Status : Stockholder Put Right C. Status : NASDAQ Listing D. Operating Results : December 31, 2010 E. Summary
Slide 4: A) Twelve-Month Results: AZX100 OL-ASCAR-03
A) Twelve-Month Results : AZX100 OL-ASCAR-03 - Trocar Sites of Arthroscopic Shoulder Surgery Patients
Slide 5: Dermal Scarring: Range of Indications
Dermal Scarring: Range of Indications 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 ini
Slide 6: Evidence of AZX100 Impact on Dermal Scarring
Evidence of AZX100 Impact on Dermal Scarring u Cellular ( in vitro ) (2007) ► AZX100 decreased expression of CTGF & Type 1 collagen ► AZX100 decreased stress fiber formation & altered morphology of human dermal keloid fibroblasts* u Pre-Clinical (2007) ► AZX100 significantly improved collagen organi
Slide 7: Goals of Dermal Scar Therapy
u Appearance ► Aesthetic improvement u Scar Strength ► Reduce risk of dehiscence/scar splitting & subsequent infection u Acceleration of Time to Maximum Healing / Improvement ► Avoid post-surgical risks Goals of Dermal Scar Therapy
Slide 8: Goals of Phase 2a
Goals of Phase 2a u Safety & Tolerability u Initial Investigation of Dose & Administration u Analyses to Detect Any Signal or Trend of Efficacy u Phase 2a is not a registration trial
Slide 9: AZX100 Phase 2a Pilot Clinical Trial in Surgical (Trocar Site) Scars
AZX100 Phase 2a Pilot Clinical Trial in Surgical (Trocar Site) Scars u One Study: ► OL-ASCAR-03: 3.0 mg, 10.0 mg or placebo u Objective: ► Scar reduction in trocar sites u Study Design: ► Comparison of three trocar site scars following arthroscopic shoulder surgery ► Placebo-controlled; n = 150 dose
Slide 10: AZX100 Dermal Scarring Phase 2a Clinical Program
AZX100 Dermal Scarring Phase 2a Clinical Program Deliverables OL-ASCAR-03 (Trocar Sites) Final Data: 2Q2011 OL-ASCAR-04 / -05 (Keloids) Final Data: 4Q2010 3D Digital Photography Height, Length, Volume, Width Safety (Subjective) (Objective) (“Sub/Objective”) POSAS* @ 12 months 2D Digital Photography
Slide 11: Final Analysis Reveals Signals of Efficacy
u Final Analysis Reveals Signals of Efficacy ► Monthly statistical tests performed: Months 3-12 ► 8 tests yielded statistically significant or near significant results; 7 of these 8 favored AZX100 ► Significant or nearly significant findings occurred early; slightly more often at 3.0 mg than at 10.0
Slide 12: Is AZX100 a Viable Candidate for Clinical & Commercial Development?
Is AZX100 a Viable Candidate for Clinical & Commercial Development? u Novel Mechanism: Anti-fibrotic u Strong Patent Position u Phase 2a - Early Human Efficacy Trials ► Demonstrated Safety ► Observed Signal of Efficacy Across Multiple Metrics & Time Points u Cost-Effective Manufacturing Process u Ma
Slide 13: Is AZX100 a Viable Candidate? Answer: YES
Is AZX100 a Viable Candidate for Clinical & Commercial Development? u Answer: YES ► Capstone believes the AZX100 development program in dermal scarring should be continued u To this end… ► Capstone is pursuing a pharma or biotech collaboration to fund development ► Internal planning & development pr
Slide 14: B) Status: Stockholder Put Right
B) Status : Stockholder Put Right
Slide 15: Novel Corporate Governance
Novel Corporate Governance u Stockholder Put Right - Approved May-2010 u Mechanics: ► Gives all CAPS Stockholders as of record date (30- Jun-2011) the right to “put” their shares of common stock to the Company on or about 31-Jul-2011 for cash redemption at formula-based price* ● *Net Liquid Assets l
Slide 16: Stockholder Put Right Status
Stockholder Put Right Status u 4Q2009 - CAPS publicly disclosed that OrthoLogic (OLGC), its predecessor legal entity, was named as a defendant in a “qui tam” action against the orthopedic device industry ► CAPS joined group defense and sought summary dismissal u Dec-2010 - Judge allowed case to cont
Slide 17: CAPS Legal Position re: Qui Tam
CAPS Legal Position re: Qui Tam u Aggressive defense u Legacy Issue ► CAPS/OLGC exited bone stimulation device business Nov-2003 with sale to DJ Orthopedics ► Notice of lawsuit received six years after selling the business u OLGC under regulatory compliance mandate with U.S. Dept. of Health during p
Slide 18: C) Status: NASDAQ Listing
C) Status : NASDAQ Listing
Slide 19: NASDAQ Listing Compliance
NASDAQ Listing Compliance u Timing ► Compliance period ends 02-May-2011 ● NASDAQ discretion regarding length of grace period ► Appeal process of two to three weeks ► Reverse stock split is sole NASDAQ-accepted plan ► CAPS may move to CAPS.OB listing u Board opposes reverse stock split ► Less float ►
Slide 20: D) Key Financial Facts
D) Key Financial Facts
Slide 21: Capstone Financial Summary
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 (incl. $1.041MM stock repurchase) 2009 $14.0 - $16.0MM $12.8MM 2010 ~$13.0MM $10.8MM Capstone Financial Summary Capstone Key Financial Facts u $24.4MM cash (31-Dec-2010); within gui
Slide 22: Capstone
oN CAPSTONE
Slide 23: Summary
Summary u AZX100 shows safety and signal of efficacy in dermal scarring u CAPS believes AZX100 is a viable commercial candidate ► Industry will cast deciding vote through partnering ● If AZX100 is partnered, clinical trials proceed ● If AZX100 is not partnered, CAPS optimizes clinical program value
Slide 24: NASDAQ CM: CAPS
N ASDAQ CM: CAPS www.capstonethx.com Capstone Therapeutics 1275 West Washington Street - Suite 101 Tempe, AZ 85281 (602) 286-5520
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