Slide 1: Capstone Therapeutics Quarterly Company Update
Thrombin TP508 Capstone Therapeutics Quarterly Company Update August 23, 2011 A CAPSTONE 1
Slide 2: Safe Harbor Statement
Safe Harbor Statement 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 th
Slide 3: Agenda
Agenda A. Analysis: -AZX100 OL-ASCAR-03 - Trocar Sites of Arthroscopic Shoulder Surgery Patients -AZX100 OL-ASCAR-05 Keloid Revision B. Stockholder Put Right — Expired Unexercisable 30-Jun-2011 Status of Exchange Listing D. Key Financial Facts: 30-Jun-2011 Corporate Partnering Status/Summary Oo m A
Slide 4: Goals of Dermal Scar Therapy
Goals of Dermal Scar Therapy @ Appearance > Aesthetic improvement > Physical improvement (lower height; smaller volume) @ Scar Strength >» Reduce risk of dehiscence/scar splitting & subsequent infection @ Acceleration of Time to Maximum Healing / Improvement > Avoid post-surgical risks A CAPSTONE
Slide 5: Goals of Phase 2a
Goals of Phase 2a Safety & Tolerability Early Investigation of Dose & Administration Analyses to Detect Any Signal or Trend of Efficacy Phase 2a is not a registration trial
Slide 6: ASCAR-03 Phase 2a Pilot Clinical Trial in Surgical Scars
AZX100 ASCAR-03 Phase 2a Pilot Clinical Trial in Surgical (Trocar Site) Scars @ Objective: > Scar reduction in trocar sites @ Study Design: > Comparison of three trocar site scars following arthroscopic shoulder surgery > Placebo-controlled; n = 150 dosed > Two active doses per patient (intra-patien
Slide 7: Dermal Scarring Phase 2a Clinical Program
AZX100 Dermal Scarring Phase 2a Clinical Program Metrics (Subjective) POSAS* @ Month 12 CABSTONE (“Sub/Objective) 2D Digital Photography VAS* (“Objective”) 3D Digital Photography Height, Length, Volume, Width *POSAS: Patient and Observer Scar Assessment Scale; ** VAS: Visual Analog Scale
Slide 8: Phase 2a Pilot Clinical Trial in Surgical Scars — Final Results
AZX100 Phase 2a Pilot Clinical Trial in Surgical (Trocar Site) Scars — Final Results @ 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 n
Slide 9: Baseline Month Month Month Month
Baseline Month 3 Month 6 Month 9 Month 12 AZX100 3.0 mg
Slide 10: Baseline Month Month Month Month
Baseline Month 3 Month 6 Month 9 Month 12 AZX100 3.0 mg Placebo
Slide 11: OL-ASCAR-03 12-Month Analysis — 3.0 mg/cm Dose Group vs. Placebo
AZX100 OL-ASCAR-03 - 12-Month Analysis — 3.0 mg/cm Dose Group vs. Placebo (Trocar Sites) Mean Scar Minimum Elevation (mm) by Visit by Treatment Group Mean Minimum Elevation (mm) 0.42 | (p= 0.034) Baseline n = 126 Statistically significant where noted; post hoc - for illustrative purposes only CAPSTO
Slide 12: OL-ASCAR-03 12-Month Analysis — 3.0 mg/cm Dose Group vs. Placebo
AZX100 OL-ASCAR-03 - 12-Month Analysis — 3.0 mg/cm Dose Group vs. Placebo (Trocar Sites) Mean Scar Minimum Elevation (mm) by Visit by Treatment Group p=0.041 Baseline n = 126 Statistically significant where noted; post hoc - for illustrative purposes only € £ 5 cof 5 oO & 5 £ & = 0.424 CAPSTONE Trea
Slide 13: OL-ASCAR-03 12-Month Analysis — 10.0 mg/cm Dose Group vs. Placebo
AZX100 OL-ASCAR-03 - 12-Month Analysis — 10.0 mg/cm Dose Group vs. Placebo (Trocar Sites) Mean Scar Minimum Elevation (mm) by Visit by Treatment Group —028 | ~020 | E & _owe-| S Ss 8 5 -034— in] 5 2 -036— gE = i 038 | ~o40 | (p= 0.026 Baseline n = 126 ‘Statistically significant where noted; sage pos
Slide 14: Phase 2a Pilot Clinical Trials — Keloids
AZX100 Phase 2a Pilot Clinical Trials — Keloids Two Studies: > OL-ASCAR-04: 3.0, 10.0 mg per linear cm or placebo > OL-ASCAR-05: 0.3, 1.0 mg per linear cm or placebo @ Objective: > Reduction or prevention of recurrence following keloid scar excision @ Study Design: > Placebo-controlled; n = 59 in ea
Slide 15: OL-ASCAR-05 12-Month Analysis — 1.0 mg/cm Dose Group vs. Placebo
AZX100 OL-ASCAR-05 - 12-Month Analysis — 1.0 mg/cm Dose Group vs. Placebo Keloids Mean Scar Maximum Elevation (mm) by Visit by Treatment Group 2.4 2 = E “2.0 = 1.8 1.6 = £1.44 = Ss 1.27] Vs0 SY ete oneal Baseline n= 19 for AZX100 4.0 mg/em; n = 19 for placebo Statistically significant where noted; 0
Slide 16: OL-ASCAR-05 12-Month Analysis — 1.0 mg/cm Dose Group vs. Placebo
AZX100 OL-ASCAR-05 - 12-Month Analysis — 1.0 mg/cm Dose Group vs. Placebo Keloids Mean Scar Maximum Elevation (mm) by Visit by Treatment Group 2a 4 a) = E 7, 6 = 1.8 1.6 s £1.44 = 2 1.24 = 1.0 aa Owen oF Re acee 2 Baseline n= 19 for AZX100 1.0 mg/cm; n= 19 for placebo ‘Statistically significant wher
Slide 17: OL-ASCAR-05 12-Month Analysis — 1.0 mg/cm Dose Group vs. Placebo
AZX100 OL-ASCAR-05 - 12-Month Analysis — 1.0 mg/cm Dose Group vs. Placebo Keloids Mean Scar Mean Elevation (mm) by Visit by Treatment Group 0.5 = 0.4 20.3 oe ae 002 = = ii parce ennn e Baseline n = 19 for AZX100 1.0 mg/cm; n = 19 for placebo ‘Statistically significant where noted; 5 post hoc - for l
Slide 18: Is AZX100 a Viable Candidate for Clinical & Commercial Development?
Is AZX100 a Viable Candidate for Clinical & Commercial Development? @Answer: YES > Capstone believes the AZX100 development program in dermal scarring should be continued @To this end... > Capstone is pursuing a pharma or biotech collaboration to fund development > Internal planning & development pr
Slide 19: B) Status: Stockholder Put Right
B) Status: Stockholder Put Right Qui Tam Litigation A CAPSTONE
Slide 20: Stockholder Put Right Status
Stockholder Put Right Status @ Apr-2011 - CAPS Board of Directors Determination >» Pending qui tam litigation seeks potentially significant damages that, if awarded, could exceed financial resources of the Company > Although the probability of an unsuccessful outcome is low, the magnitude of potenti
Slide 21: CAPS Legal Position re: Qui Tam
CAPS Legal Position re: Qui Tam @ Planning for aggressive defense @ 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 @ OLGC under regulatory compliance mandate with U.S. Dept. of He
Slide 22: C) Status of Exchange Listing
C) Status of Exchange Listing
Slide 23: Status of Exchange Listing
Status of Exchange Listing @ Appeals Process with NASDAQ > Meetings with NASDAQ in June 2011 > Capstone proposed a pathway to regain compliance > NASDAQ insisted on reverse split to regain $1.00/share trading minimum > Delisted effective 21-Jul-2011 @ Current Listing: OTCQB: CAPS > Listing and compl
Slide 24: D) Key Financial Facts
D) Key Financial Facts eS CAPSTONE 24
Slide 25: Capstone Financial Summary
Capstone Financial Summary Capstone Key Financial Facts @ $19.6MM cash (30-Jun-2011) @ $2.0MM cash utilized in 2Q2011 @ No long-term debt @ 52-wk NASDAQ Range: $0.24 - $1.23 (prior to de-listing) @ Market Cap as of 19-Aug-2011 : ~$10.6MM A CAPSTONE 2
Slide 26: E) Corporate Partnering / Summary
E) Corporate Partnering / Summary
Slide 27: Summary
Summary #AZX100 shows safety and signal of efficacy in dermal scarring @CAPS believes AZX100 is a viable commercial candidate > Industry will cast deciding vote through partnering elf AZX100 is partnered, clinical trials proceed elf AZX100 is not partnered, CAPS optimizes clinical program value and
Slide 28: Capstone Therapeutics contact details
~*~ APSTONF THERAPEUTIC S OTCQB: CAPS www.capstonethx.com Capstone Therapeutics 1275 West Washington Street - Suite 101 Tempe, AZ 85281 (602) 286-5520 28