Ampio Pharmaceuticals, Inc. · OTC:AMPE
Ampio Pharmaceuticals — Investor Presentation (February 2014)
29 slides from Ampio Pharmaceuticals's investor presentation, February 2014
Slide 1: Investor Presentation February 2014
Investor Presentation February 2014
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in
Slide 3: Offering Summary
Offering Summary Offering Amount $71.8mm (8.0mm shares) Option to Purchase 15% Ticker / Exchange AMPE (NYSE) • Continuation and completion of Ampion and Optina clinical trials • Submission of BLA relating to Ampion and a NDA Use of Proceeds relating to Optina • Manufacturing facility for Ampion • Wo
Slide 4: Today's Presenters
Today’s Presenters • World recognized researcher and clinician David Bar-Or, MD • Discovered over 300 new therapeutic candidates including Optina and Ampion Founder & CSO • Head of Trauma Research Units of two of Colorado’s three “Level One” trauma centers Michael Macaluso • Lead investor in Ampio C
Slide 5: Company Background
Company Background Portfolio is based on the work of Dr. David Bar-Or, the Director of Trauma Research for both the Swedish Medical Center and St. Anthony Central Hospital in Denver, CO • Develop therapies that decrease inflammation by: – Inhibiting specific pro-inflammatory compounds by affecting s
Slide 6: Ampio's Pipeline Overview
Ampio’s Pipeline Overview Ampio Pharmaceuticals is focused on the discovery and development of novel therapies treating common inflammatory conditions where there is no established therapy Ampio has advanced its lead asset into late-stage, pivotal clinical trials in the US Ampion Phase 1 Phase 2 Pha
Slide 7: Investment Summary
Investment Summary Ampio has a portfolio of innovative late-stage assets • Lead products address underserved, large markets • Issued patents protecting products and methods of treatment • Well-defined, efficient clinical development plans with late-stage trials underway Ampion is positioned for a ne
Slide 8: Ampion
Ampion
Slide 9: Ampion for Acute Treatment of Osteoarthritis of the Knee (OA-Knee)
Ampion for Acute Treatment of Osteoarthritis of the Knee (OA-Knee) Ampion is a novel biologic • Low molecular weight fraction, < 5 kDA, of commercial human serum albumin • Aspartyl-alanyl diketopiperazine (DA-DKP), active ingredient1 • Demonstrates efficacy across broad spectrum of acute treatment o
Slide 10: Ampion Addresses a Clear Unmet Medical Need in the Treatment of Osteoarthritis of the Knee
Ampion Addresses a Clear Unmet Medical Need in the Treatment of Osteoarthritis of the Knee Ampion NSAIDs, COX-2 Inhibitors, IA Steroids, HA Severe Surgery Mild Moderate Large osteophytes, Arthroscopic, Osteophyte Multiple osteophytes narrowing of joint osteotomy, total or development and and possibl
Slide 11: The OA-Knee market is large, growing, with few competitive entrants expected to gain approval
The OA-Knee market is large, growing, with few competitive entrants expected to gain approval in the near-term 2012 Annual US OA-Knee Revenue by Pharma Class 1 $232M The OA-Knee competitive pipeline COX-2 faces significant regulatory and Hyaluronic Acid commercial scrutiny and challenges. $1.0B Othe
Slide 12: The First Ampion Pivotal SPRING Study is Complete, with Robust Data
The First Ampion Pivotal SPRING Study is Complete, with Robust Data SPRING Study Design Summary: • 9 centers, N=329, randomized 1:1:1:1, double-blind, parallel group • Ampion 4 mL vs. saline 4mL & Ampion 10 mL vs. saline 10 mL • Rapid completion – enrollment completed in less than 4 weeks – Study in
Slide 13: The Ampion SPRING Study Confirmed Clinically Meaningful, Statistically Significant Improvement
The Ampion SPRING Study Confirmed Clinically Meaningful, Statistically Significant Improvement Across Multiple Endpoints Versus Placebo Control with No Treatment Related AEs • Patients receiving Ampion achieved: – Greater reduction in pain (WOMAC A) from baseline to 12 weeks compared to saline place
Slide 14: A significant and appropriate percentage of K-L III & IV patients were enrolled in the SPRING Study
A significant and appropriate percentage of K-L III & IV patients were enrolled in the SPRING Study 1 1. Relationship between patient-reported disease severity in osteoarthritis and self-reported pain, function and work productivity. Sadosky et al. Arthritis Research & Therapy 2012. 14
Slide 15: The Spring Study Showed Efficacy in Previously Untreatable Severe OA Patients
The Spring Study Showed Efficacy in Previously “Untreatable” Severe OA Patients Key Prim ary and Secondary 12 Week Results: ITT Population Random ized Arm s Com bined Arm s Type Control, 4ml Control, 10 ml LWFA-5A, 4ml LWFA-5A, 10 ml Control LWFA-5A, N of Group 83 81 83 82 164 165 WOMAC A -0.71(0.75
Slide 16: The Ampion SPRING Study Demonstrated Clinically Meaningful Improvement in Pain
The Ampion SPRING Study Demonstrated Clinically Meaningful Improvement in Pain Across a Broad Spectrum of OA-Knee Patients Source: Debjit Chattopadhyay, Ph.D. , MBA| Director, Healthcare Equity Research Emerging Growth Equities, LTD The SPRING study patient demographics are similar and clinical resu
Slide 17: What The SPRING Studied Showed
What The SPRING Studied Showed • Ampion is safe: very few adverse events, no drug related SAE’s • Ampion is effective: A Single Injection of 4 ml was effective from 2 to 12 weeks with evidence of continuing improvement to 20 Weeks. • The overall pain reduction was approximately 42% • Ampion showed e
Slide 18: STEP Study: Final Pivotal Trial Design
STEP Study: Final Pivotal Trial Design Overview • 17 centers, N=500, randomized 1:1, double-blind • Ampion 4 mL vs. saline 4 mL placebo control • Primary efficacy endpoint: difference in pain reduction as measured by WOMAC A subscale at 12 weeks • Secondary endpoint: 20 week follow-up to determine d
Slide 19: Ampio Pharmaceuticals Denver Manufacturing Facility for Ampion
Ampio Pharmaceuticals Denver Manufacturing Facility for Ampio • Facility will have an annual production capacity of ~10 million doses of Ampion • Source material, human serum albumin (HSA), required to meet this capacity has already been secured through a long- term, non-exclusive agreement • cGMP c
Slide 20: Rapid Progress to Commercialization
Rapid Progress to Commercialization • Completed extensive market study with Campbell Alliance, 27 million patients have no effective therapy prior to joint replacement • Commenced construction of manufacturing facility, on schedule to produce commercial product July 2014 for BLA • Signed 5 year supp
Slide 21: Optina
Optina
Slide 22: Optina: A Novel, Oral Treatment Poised to Enter the Diabetic Macular Edema Market
Optina: A Novel, Oral Treatment Poised to Enter the Diabetic Macular Edema Market • Diabetic Macular Edema Market – 26 million diabetics in the US 1 – 285 million diabetics worldwide 2 – Approximately 30% of patients with diabetes > 20 years have DME 3 – Up to 75,000 new cases of DME each year 4 – M
Slide 23: Optina (ultra low-dose danazol)
Optina (ultra low-dose danazol) Optina has a demonstrated clinical effect in diabetic macular edema • Optina (danazol) is a fat soluble low molecular weight weak androgen that affects vascular permeability through the endothelial barrier in a biphasic manner1 • Inhibits vascular permeability by stim
Slide 24: The Optina OPTIMEYES Study
The Optina OPTIMEYES Study Placebo 12 Week 450 patients 0.5 mg per BMI Washout Open Label randomized Extension 1.0 mg per BMI Washout 4 week interim 12 week analysis analysis Announced 4Q 2013 Anticipate 3Q 2014 Overview of the OPTIMEYES STUDY • Primary endpoint: Improvement in Best Corrective Visua
Slide 25: Summary
Summary
Slide 26: Ampio-Specific Upcoming Milestones
Ampio-Specific Upcoming Milestones Completion of Additional Expected BLA filing for Ampion Studies Ampion in OA-Knee Phase IIb Trial Results for Optina in Patients with DME Q3 2014 Q4 2014 Phase III Trial Results for Ampion Pivotal Study 26
Slide 27: Financial Overview
Financial Overview Stock Information As of 02/21/2014 Symbol AMPE Company is now funded through: Market Cap: $378MM • Ampion US Phase III Final Pivotal Trial Shares Outstanding 42.1MM • Construction of new facility Shares Fully Diluted 47.7MM • Ampion BLA filing 52-Week High $10.86 • Optina Phase II
Slide 28: Investment Summary
Investment Summary Ampio has a portfolio of innovative late-stage assets • Lead products address underserved, large markets • Issued patents protecting products and methods of treatment • Well-defined, efficient clinical development plans with late-stage trials underway Ampion is positioned for a ne
Slide 29: Headquarters: 5445 DTC Pkwy Suite 925 Greenwood Village, CO 80111
Headquarters: 5445 DTC Pkwy Suite 925 Greenwood Village, CO 80111 www.ampiopharma.com
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