Ampio Pharmaceuticals, Inc. · OTC:AMPE
Ampio Pharmaceuticals — Emerging Growth Conference (November 2023)
19 slides from Ampio Pharmaceuticals's conference presentation, Nov 2, 2023
Slide 1: Ampio Pharmaceuticals Emerging Growth Conference
Ampio Pharmaceuticals 1 Emerging Growth Conference November 02, 2023 iStock
Slide 2: Caution Regarding Forward-Looking Statements
Caution Regarding Forward-Looking Statements • This presentation may contain forward-looking statements. All statements other than statements of historical facts contained in this letter, including statements regarding our anticipated future clinical developments, future financial position, and plan
Slide 3: Ampio Pharma Opportunity
3 Ampio Pharma Opportunity OA-201 may alleviate Osteoarthritis knee (OAK) pain and impact the progression of the disease Value Potential • Current market cap $2-3M • Near-term value inflection points • Seasoned management, board and advisory team Clear Regulatory Pathway • Pre-IND expected Nov-23 •
Slide 4: Knee OA: 2nd Most Prevalent Source of Chronic Pain Globally
Knee OA: 2nd Most Prevalent Source of Chronic Pain Globally 4 7.1% 7.6% 9.0% 15.1% 16.1% 19.5% 28.1% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% Hip pain Finger pain Shoulder pain Neck pain Severe headache or migraine Knee pain Lower back pain Percent of Patients Reporting Chronic Pain Large Addressable
Slide 5: OAK is a Progressive, Debilitating Disease
OAK is a Progressive, Debilitating Disease No available therapies halt or reverse this progression 5 Normal Knee KL Grade 1 • Minimal cartilage disruption • Normally loss of cartilage ~ 10% Mild OA KL Grade 2 • Cartilage begins to erode • Possible joint-space narrowing Moderate OA KL Grade 3 • Gaps
Slide 6: Existing Treatments Not Effective & Don't Stop Disease Progression
Existing Treatments Not Effective & Don’t Stop Disease Progression 6 KL Grade 1=Suspected KL Grade 2=Mild KL Grade 3=Moderate KL Grade 4=Severe • Exercise • Physical therapy • Weight loss • Behavior mod • Driven by aging, obesity, diabetes • Acetaminophen • Oral NSAIDs • Topical NSAIDs • Opioids • C
Slide 7: OAK Therapeutic Market > $34 Billion in US, 5-7% CAGR
OAK Therapeutic Market > $34 Billion in US, 5-7% CAGR 7 Procedure Benefit Limitation Annual Procedures Healthcare Cost Opioids •Very strong pain relievers •Significant addiction risk •Not recommended for OAK by major scientific societies (AAOS, Arthritis Foundation) 850k $500M* Steroid Injection •Fa
Slide 8: OA-201 May Provide Substantial Benefits Over Current and Future Therapies
OA-201 May Provide Substantial Benefits Over Current and Future Therapies 8 Hyaluronic Acid X No long-term relief X Variable superiority to saline and steroid Opioids X No cartilage protection X Addictive X Not superior to saline and steroid Steroid Injection X No long-term relief X No cartilage pro
Slide 9: OA-201 Development History
Individual Components • Evaluated 3 isolated active components • One component superior for pain and cartilage preservation while the others were inactive or detrimental 2-Component Evaluation • 2 component combination s were tested to determine any potential synergies • Single active was common acr
Slide 10: OA-201 Novel Therapeutic to Treat Symptomatic OA
OA -201 Novel Therapeutic to Treat Symptomatic OA • Natural metabolite active ingredient • Formulated in a liquid, shelf-stable injectable format • In vitro preclinical studies demonstrate down regulation of inflammatory cytokines and upregulation of anti - inflammatory cytokines • Multiple in vivo
Slide 11: OA-201 Offers Increased Safety Over Opioids and Steroids
OA-201 Offers Increased Safety Over Opioids and Steroids • Risks of Current Therapies - Opioids – addiction - Steroids - Cartilage damage increasing the requirement for TKA - Increases blood sugar, an issue for diabetic patients - Delivered with local anesthetic to minimize pain on injection • OA-20
Slide 12: Single OA-201 Injection Reduces Pain Compared to Saline
0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0 2 8 11 15 17 eVF Gram Study Day OA-201 vs Controls OA-201 Saline Single OA-201 Injection Reduces Pain Compared to Saline 12 OA-201 reduces the pain response in an aggressively painful rat OA model Decreased Pain Significant over saline November 02, 202
Slide 13: OA-201 Reduces Cartilage Degeneration in Preclinical OA Model
OA-201 Reduces Cartilage Degeneration in Preclinical OA Model 13 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 Saline OA-201 Cartilage Degeneration Score Medial Tibial Cartilage Degeneration Score Total of 3 Zones Zone 1, outside Zone 2, middle Medial meniscal tear model in rats evaluates OA disease progr
Slide 14: Patent Strategy Protecting OA-201
Patent Strategy Protecting OA-201 14 May 2023 Provisional Aug 2023 2 nd Provisional May 2024 PCT TBD 1 st US Filing OA-201 Composition of Matter Application Application Application Application Methods of Use Sustained Release Formulation OAK & Chondroprotection Initial FTO completed Patent protectio
Slide 15: IND Development Strategy: Accelerate OA-201 to Clinical PoC
Study Duration Manufacturing FDA Interactions Ph 1/2 Clinical Proof of Concept IND-Enabling Preclinical Studies H2 2023 2024 2025 IND Development Strategy: Accelerate OA-201 to Clinical PoC GMP Material for Ph 1/2 Material for GLP Pre-IND Phase 1/2 Study Duration Enrollment Start 3mo Efficacy Data S
Slide 16: Experienced Management Team and Board of Directors
Experienced Management Team and Board of Directors 16 Michael Martino Chief Executive Officer • 40-year industry veteran • Public, private, small and large companies • Financings, collaborations, exits Daniel Stokely Chief Financial Officer • 25-year industry veteran • Public, private, small / mid-s
Slide 17: Scientific and Development Advisors
17 Scott Bruder, MD, PhD Founder & CEO BCVG Susan Drapeau, PhD VP Product Dev & Reg Strategy BCVG Roger Harrington, PhD Biomanufacturing & Process Dev. BCVG Niti Goel, MD, FACR Expert Consultant Ali Mobasheri, PhD Professor, Univ. Oulu Alison Bendele, DVM, PhD, DACVP Founder of Bolder BioPath/CRO •
Slide 18: Ampio Pharma Opportunity
18 Ampio Pharma Opportunity OA-201 may alleviate Osteoarthritis knee (OAK) pain and impact the progression of the disease Value Potential • Current market cap $2-3M • Near-term value inflection points • Seasoned management, board and advisory team Clear Regulatory Pathway • Pre-IND expected Nov-23 •
Slide 19: For Further Information Contact
For Further Information Contact: Michael Martino, CEO mmartino@ampiopharma.com Daniel Stokely, CFO dstokely@ampiopharma.com 19 iStock
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