Ampio Pharmaceuticals, Inc. · OTC:AMPE
Ampio Pharmaceuticals — Investor Presentation (July 2012)
23 slides from Ampio Pharmaceuticals's investor presentation, July 2012
Slide 1: Corporate Presentation: July 2012
NASDAQ: AMPE Corporate Presentation: July 2012
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain “forward‐looking statements” (statements as to matters other than historical facts) as defined in the Private Securities Litigation Reform Act and in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1
Slide 3: Corporate History
Corporate History July 2011 May / June 2012 Over $50M contributed Commenced Clinical Held pre-IND meetings to product development Trial Development of with FDA on Ampion™ plus ~$50M PIK Ampion™ and Zertane™ March 2010 DMI Merges with September 2011 July 2012 April 2011 DMI Founded in 1990 Chay Enter
Slide 4: Experienced Management Team
Experienced Management Team • World recognized researcher and clinician David Bar‐Or, MD • Discovered over 300 new therapeutic candidates including Optina™ and Ampion™ Founder & CSO • Head of the Trauma Research Units of two of Colorado’s three “Level One” trauma centers • Serial Entrepreneur Michae
Slide 5: Business Plan & Value Proposition
Business Plan & Value Proposition • For over 22 years at DMI, Dr. David Bar‐Or, MD discovered over 100 novel compounds and new findings related to existing compounds • Ampio identified three drugs within Bar‐Or’s portfolio to start that met four characteristics – Large potential market – Unmet medic
Slide 6: Product Portfolio
Product Portfolio AmpionTM ZertaneTM OptinaTM Premature Market Innate biological Oral therapy to treat Ejaculation, a larger anti‐inflammatory diabetic macular Opportunity patient population product edema than ED DADKP, a cyclic Active dipeptide derivative Tramadol ODT Ulta low‐dose Compound of huma
Slide 7: Ampion: Understanding The Opportunity
AmpionTM: Understanding The Opportunity • Estimated 80M OA sufferers worldwide and the market is forecasted to reach $7B by 2015 – Over 20M OA patients in the US; 10M have OA of the knee • Only effective treatment for OA is joint replacement – Oral analgesics are largely ineffective in treating mode
Slide 8: Ampion: The Solution
AmpionTM: The Solution • The active ingredient, DA‐DKP, is a small molecule with non‐ steroidal, anti‐inflammatory and analgesic properties that is naturally produced by humans in response to injury – A derivative of Human Serum Albumin (“HSA”) which is approved for intravenous administration and ha
Slide 9: Ampion: Mechanism of Action
AmpionTM: Mechanism of Action • Multiple pathways that are both acute and chronic – Biochemical pathway identified that downmodulates T‐ lymphocytes’ pro‐inflammatory cytokine production. • Decreases levels of IL‐23 and IL‐17 (pro‐inflammatory cytokines) stimulated CXCL1 production from splenic cell
Slide 10: Ampion: Clinical Experience
AmpionTM: Clinical Experience 84 days post injection, Ampion proved statistically significant (p=0.04) difference in pain relief when compared to saline (n=32); there were no SAEs, and TEAE were all minor and not different than saline 10
Slide 11: Ampion: Established and Defined Development Plan
AmpionTM: Established and Defined Development Plan • Market exclusivity: biologic with up to 12 years in the US • Intellectual property in all major markets – Composition (expire 2021), manufacturing of synthetic (expire 2021), filtrate composition (expire 2024), multitude of use patents (expiring 2
Slide 12: Optina: Understanding The Opportunity
OptinaTM: Understanding The Opportunity • DME is a non‐proliferative form of diabetic retinopathy caused by increased vascular permeability and leakage of plasma constituents resulting in edema in the macula surrounding retinal tissue – Effective drug treatment of the DME component of diabetic retin
Slide 13: Optina: New Oral Therapy
OptinaTM: New Oral Therapy • Very low dose of danazol, given orally, that works inside the vessels to decrease leakage – Entirely unexpected finding that significantly inhibits inflammation‐induced vascular permeability in human tissues – Effect is reversed at normal doses • Danazol is a weak androg
Slide 14: Optina: Mechanism of Action
OptinaTM: Mechanism of Action • Unanticipated activity at low doses: – Inhibit vascular permeability, including that occurring in macular edema – Modulate cytoskeleton rearrangement of endothelial cells thereby improving tight junctions • Not a steroid effect though danazol is a sex related steroid
Slide 15: Optina: Clinical Experience
OptinaTM: Clinical Experience 32 patient, proof‐of‐concept trial results confirm a significant interaction between the patient’s BMI and efficacy of central retinal thickness and retinal volumes at the different doses 15
Slide 16: Optina: Established and Defined Development Plan
OptinaTM: Established and Defined Development Plan • Market exclusivity: up to 5 years in US and up to 7 in EU • Intellectual property – US, EU, CA, HK issued and allowed applications for method of use expiring in 2030 and pending in all other major markets – No prior art teaches these uses and ther
Slide 17: Zertane: Understanding The Opportunity
ZertaneTM: Understanding The Opportunity • PE is the most common sexual complaint among males* – PE can be a life‐long disorder and can worsen over time and has a major impact on the quality of life for many men and their sexual partners – PE is a recognized complication of patients receiving PDE‐5
Slide 18: Zertane: Restoring Confidence in the Bedroom
ZertaneTM: Restoring Confidence in the Bedroom • A specific dose, ODT formulation, of tramadol HCl – A centrally acting synthetic opioid analgesic originally approved for treating moderate to severe pain – Excellent 30 year safety record with no SAEs • Max daily dose 400mg orally or 600mg parenteral
Slide 19: Zertane: Clinical Experience
ZertaneTM: Clinical Experience Statistical significance achieved for 1) intravaginal ejaculation latency time (“IELT”), and 2) premature ejaculation profile questionnaire (“PEP”) in Phase III trials in Europe LS Mean change in IELT, LS Mean change in PEP index score, < 1 minute subgroup < 1 minute s
Slide 20: Zertane: Established and Defined Development Plan
ZertaneTM: Established and Defined Development Plan • Market Exclusivity: up to 5 years in US and up to 7 in EU • Intellectual Property – Use patents issued in 30 countries and expire in 2022 • Regulatory Pathway – 505(b)(2) US pathway and “hybrid abridged” procedure in EU – IND submission to FDA an
Slide 21: Ampio Financial Snapshot, Ownership & Liquidity
Ampio Financial Snapshot, Ownership & Liquidity Ticker symbol AMPE (NASDAQ) Share price (7/5/12) $4.87 Cash and cash equivalents (3/31/12) $8,292,039 Current fixed burn rate $600,000 per month Market value (7/5/12) $154,676,893 Board, Management and Non Executive Officers 30.8% fully diluted benefic
Slide 22: Near-Term US Milestones
Near‐Term US Milestones 2012 2013 Two Phase III trials AmpionTM Pre‐IND Meeting Pre‐IND Two Phase III trials ZertaneTM* Meeting Phase II trial OptinaTM Pre‐IND Phase III trial Meeting *We are in the process of preparing our regulatory dossier for ZertaneTM and expect to submit the dossier to the Aus
Slide 23: NASDAQ: AMPE
Ampio PHARMACEUTICALS NASDAQ: AMPE
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