Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Cerecor — Investor Presentation (November 2018)
24 slides from Avalo Therapeutics's investor presentation, Nov 27, 2018
Slide 1: Forward-Looking Statements
Forward-Looking Statements This presentation may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and unc
Slide 2: Corporate Highlights
Corporate Highlights • • Emerging clinical & early-stage pipeline Focus on orphan, neurological & pediatric indications • • Building a commercial capability Pediatric franchise generating positive cash flow • • Fully-integrated commercial and R&D organization New management team with proven track re
Slide 3: Overview
Overview Management Team 1 Historical Milestones 2 3 Neurology & Pediatric Rare Disease Pipeline 4 Commercial Pediatric Portfolio 5 Strategic Growth Plans and Outlook 6 Financial Highlights 4
Slide 4: Management Team
Management Team 20+ years industry experience 25+ years industry experience • Chairman and CEO, Sucampo Pharmaceuticals CEO, Histogenics Corporation President, MedImmune Ventures Manager, Centocor Biotech (Johnson & Johnson) • • • • President and COO of Zylera Pharmaceuticals Executive Director, Vic
Slide 5: Historical Milestones
Historical Milestones 2017 2018 Acquisition TRx Pharma (Zylera) Acquisition Avadel (AVDL) Pediatric assets CERC-501 Acquired worldwide rights from Eli Lilly CERC-611 Acquired worldwide rights from Eli Lilly CERC-501 Sold to Janssen Acquisition Ichorion Rare Disease Pipeline CERC-301 Enters Phase 1 s
Slide 6: Cerecor Evolution
Cerecor Evolution Innovative Approaches to CNS Diseases FDA-Approved Products Poly-Vi-Flor® | Tri-Vi-Flor® Karbinal™ ER AcipHex® Sprinkle™ Cefaclor Flexichamber™ Millipred® | Veripred® Ulesfia® 505(b)(2) Assets & Platform Chemistry CERC-801 CERC-802 CERC-803 CERC-913 • • • • • • • • • • • CERC-301 C
Slide 7: Emerging Clinical & Early-Stage Pipeline
Emerging Clinical & Early-Stage Pipeline Each program supported by Clinical and/or Genetic Validation Enabling Receptor antagonist Hypotension (nOH) COMT inhibitor (2nd Gen) symptoms of Parkinson’s Receptor antagonist epilepsy Syndrome (MDS) CERC-700(s) Four Additional 505(b)(2) Programs utilizing M
Slide 8: Market Potential
Market Potential 40M 500 500 250 50 CERC-301 CERC-406 CERC-611 CERC-801 CERC-802 CERC-803 CERC-913 MDS nOH Parkinson’s Disease Epilepsy PGM1-CDG MPI-CDG SLC35C1-CDG 9 1.9M Ultra Rare Pediatric Orphan Diseases 700k World-Wide Estimated Number of Patients
Slide 9: Upcoming Clinical Program Milestones
Upcoming Clinical Program Milestones Multiple value generating inflection points over next 6 to 18 months Program Mechanism-of-Action Milestone IND Filing 2019 PGM1-CDG IND Filing 2019 MPI-CDG IND Filing 1H 2020 SLC35C1-CDG 10 *505(b)(2) Pathway Neurological Disorders CERC-301 Neurogenic Orthostatic
Slide 10: CERC-301 NR2B selective NMDA receptor antagonist for nOH
CERC-301 NR2B selective NMDA receptor antagonist for nOH Initiated Phase 1 study of CERC-301 in Parkinson's patients diagnosed with neurogenic Orthostatic Hypotension (nOH) • Characterized by a sudden drop in blood pressure upon standing Caused by autonomic vasoconstrictor failure, increasing risk o
Slide 11: CERC-406 COMT inhibitor for Parkinson's Disease
CERC-406 COMT inhibitor for Parkinson’s Disease 2nd generation, CNS selective COMT inhibitor to minimize toxicity & 1st enhance efficacy seen with generation therapies • COMT drives the catabolism of dopamine and levodopa Inhibition of dopamine catabolism used to treat CNS manifestations Parkinson’s
Slide 12: CERC-611 TARP-8 dependent AMPA receptor antagonist for partial onset seizures
CERC-611 TARP-8 dependent AMPA receptor antagonist for partial onset seizures Phase 1-ready candidate with therapeutic potential for partial onset seizures in patients with epilepsy • Epilepsy affects over 65 million patients worldwide 30%-40% of patients refractory; high degree of poly-pharmacy com
Slide 13: CERC-800's Substrate replacement therapies for CDGs
CERC-800’s Substrate replacement therapies for CDGs Oral, small molecule, genetically-targeted therapies Multi-system disease manifestation in PGM1-CDG D-Galactose leads to significant improvement in key clinical symptoms CERC-801 Life-threatening gastrointestinal disorder in MPI-CDG D-Mannose rapid
Slide 14: CERC-800's Substrate replacement therapies for CDGs
CERC-800’s Substrate replacement therapies for CDGs Congenital Disorders of Glycosylation (CDGs): Monogenic disorders resulting in glycosylation defects with broad clinical spectrum D-Galactose CERC-801 D-Mannose CERC-802 L-Fucose CERC-803 505(b)(2) NDA Pathway NCE 5-yrs Exclusivity ODD 7-yrs Exclus
Slide 15: CERC-913 ProTide Nucleotide for Mitochondrial DNA Depletion Syndrome
CERC-913 ProTide Nucleotide for Mitochondrial DNA Depletion Syndrome (MDS) Overcome key limitations of direct substrate replacement: stability, permeability & kinase bypass Phenotypic Rescue • • • Proof-of-concept in patient-derived & animal-based disease models ProTide similar to advanced clinical
Slide 16: Overview
Overview Management Team 1 Historical Milestones 2 3 Neurology & Pediatric Rare Disease Pipeline 4 Commercial Pediatric Portfolio 5 Strategic Growth Plans and Outlook 6 Financial Highlights 17
Slide 17: Building Commercial Capabilities in Pediatrics
Building Commercial Capabilities in Pediatrics ~50% of the Overall Market Potential Covered with 32 Territories Sales Force Expansion Underway to Increase SOV • • • • • • • • • 1 Chief Commercial Officer 1 EVP Marketing & Investor Relations 1 Director of Sales 3 Regional Sales Managers 1 Director of
Slide 18: Pediatric Franchise with Eight Product Lines
Pediatric Franchise with Eight Product Lines 19 Avadel Pediatric Assets TRX Pharmaceuticals
Slide 19: Why Pediatrics?
Why Pediatrics? Pediatrics Represents a Focused, Defined and Specific Patient Population Treated by One Specialty Segment 1. 2. 3. 4. 5. 6. 7. 8. Routine Child Health Examination Acute Upper Respiratory Infection Otitis Media Acute Pharyngitis Asthma Follow-up Exam Allergic Rhinitis Sinusitis 9. 10.
Slide 20: Net Product Sales
Net Product Sales FY18 Net Sales Guidance = $18 to $20 million 21 Net Product Sales Last 4 QTR Trend (in $000’s)
Slide 21: Balance Sheet
Balance Sheet 22 Total Assets Trend Analysis (in $000’s) Cash Trend Analysis (in $000’s)
Slide 22: 2019 Growth Plans
2019 Growth Plans 1 3 2 CERC-301 CERC-406 CERC-611 CERC-801 CERC-802 CERC-803 CERC-913 Acquire/in-license commercial-ready or marketed asset(s) Acquire/in-license complimentary pipeline assets Grow Market Share Expand Commercial Footprint 23 Advance Pipeline Accelerate Business Development Activity
Slide 23: www.cerecor.com
NASDAQ:CERC www.cerecor.com Cerecor Inc.
Slide 24: Cerecor Inc.
\. “S cerecor “iy NASDAQ:CERC www.cerecor.com Cerecor Inc.