Jaguar Health, Inc. · NASDAQ:JAGX
Jaguar Health — Jaguar Animal Health — Investor Presentation (May 2016)
30 slides from Jaguar Health's investor presentation, May 5, 2016
Slide 1: Forward-Looking Statements
This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding the anticipated timing of the commercial launch of Canalevia, and the timing of expanding the indication for Canalevia to acu
Slide 2: GI Product Development Strategy
GI Product Development Strategy Approved for use in humans Fulyzaq1 (crofelemer) Intellectual property applies globally to all products across species 2 1Fulyzaq was approved by the FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Th
Slide 3: Investment Highlights
Investment Highlights The only FDA-approved human anti-secretory diarrhea product1 Significant animal and human data Natural products from Croton lechleri First-in-Class GI Products for Animals Conditional Approval in dogs for Canalevia for CID Complete clinical development program for acute diarrhe
Slide 4: Common Pathway and MOA in Mammals
Common Pathway and MOA in Mammals Canalevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals, regardless of cause Acts locally in the gut and is minimally absorbed systemically P P Intestinal Lumen Intestinal Epithelial Cell Cl-
Slide 5: Intellectual Property Portfolio
Intellectual Property Portfolio Exclusive worldwide veterinary license to all Napo IP for all veterinary treatment uses and indications for all species of animals Zero to low royalties Exclusive global veterinary license to 2,300+ medicinal plants Eight provisional patent applications, three pending
Slide 6: Rx Drug Product Candidates
Rx Drug Product Candidates Product Candidate Species Indication Completed/Anticipated Milestones 2015 2016 Canalevia CID Submitted all major technical sections for NADA Expect NADA in 2H (with commercial launch in 1H 2017) Acute Diarrhea Product development meeting with FDA, protocol concurrence Ini
Slide 7: Canalevia: Diarrhea in Dogs
Canalevia: Diarrhea in Dogs Diarrhea is one of the most common reasons for veterinary and emergency visits for dogs in the US Six million cases annually of acute and chronic watery diarrhea No FDA-approved anti-secretory products for dogs Current treatments Rehydration Diet change Absorbents/binding
Slide 8: Canalevia: Chemotherapy-Induced Diarrhea (CID) in Dogs
Canalevia: Chemotherapy-Induced Diarrhea (CID) in Dogs Over 230,000 dogs receive chemotherapy in the US Approximately 25% suffer from CID Received MUMS designation MUMS designation is similar to ‘‘orphan drug’’ status Submitted all required major technical sections to FDA Same manufacturers as human
Slide 9: Canalevia: Acute Diarrhea Proof of Concept Study
Canalevia 2-4 mg/kg or Placebo 2X/3 Days Canalevia: Acute Diarrhea Proof of Concept Study -- 39 dogs evaluated Bacterial Infection Pancreatitis Dietary Indiscretion Giardia Infection 9 Treatment: All dogs received “standard of care” for diarrhea (oral/IV fluids for rehydration or disease-specific me
Slide 10: Canalevia: Clinical Results
Canalevia: Clinical Results Response in Canalevia arm is greater than placebo on all days by >10% Responsiveness: 92% vs. 44% p = 0.046 10 Day 1 Day 2 Day 3 Day 4 Placebo 6.7% 33.3% 53.3% 44.4% Canalevia 17.4% 50.0% 69.6% 91.7% 6.7% 33.3% 53.3% 44.4% 17.4% 50.0% 69.6% 91.7% 0.0% 10.0% 20.0% 30.0% 40
Slide 11: Number of Dogs Achieving Resolution of Diarrhea
Number of Dogs Achieving Resolution* of Diarrhea 11 *Resolution of diarrhea is defined as achieving a fecal score of 1 or 2 and no relapse during the study The difference in proportions for crofelemer and control is 32% The Chi-square p-value = 0.0470
Slide 12: Canalevia: Pathway to Commercialization
Canalevia: Pathway to Commercialization 12 Expand label indication for Canalevia to acute diarrhea, regardless of cause Development Meeting with FDA, Protocol Concurrence, 2015 Pivotal efficacy initiation in 2015 Commercial launch for CID expected in 2017 Commercial launch expected in 2017
Slide 13: Equine Ulcer Opportunity (SB-300)
Equine Ulcer Opportunity (SB-300) Positive top-line EGUS POC data 97% of high performance horses have either gastric or colonic ulcers* 63% of high performance horses have colonic ulcers* 87% of high performance horses have gastric ulcers* 54% of high performance horses have both colonic and gastric
Slide 14: SB-300 Proof-of-Concept Study for Equine Ulcers
Study Objective: Evaluate the safety and effectiveness of SB-300 for treatment of equine gastrointestinal ulcers SB-300 Proof-of-Concept Study for Equine Ulcers 14 Placebo 2.5BID 10QID 30 racehorses were randomized to one of three groups (10 horses per group). Horses in the TRT5 group received 5 gra
Slide 15: SB-300 Proof-of-Concept Study for Equine Ulcers: Additional Advantages
SB-300 Proof-of-Concept Study for Equine Ulcers 15 Drug testing in horses that received SB-300 did not detect any substances commonly disallowed in horse racing—enabling continued therapy SB-300 acts locally in the gut with minimal systemic absorption Feed does not appear to interfere with local ava
Slide 16: Neonorm: Non-Prescription Products
Neonorm: Non-Prescription Products Products Species Use Anticipated Milestones 2015 2016 Neonorm Calf Improve gut health and normalize stool formation in pre-weaned dairy calves with scours Field studies: Include evaluation of herd-wide prophylactic & prebiotic benefits. Initial results support preb
Slide 17: A new and unique anti-diarrheal for foals
17 A new and unique anti-diarrheal for foals Commercial launch in Q1 2016 Premiered product at Dec. 2015 American Association of Equine Practitioners Trade Show There are currently no other anti-secretory products commercially available for the foal market
Slide 18: Neonorm Foal Proof-of-Concept
Study Objective: Determine the safety, tolerability, and efficacy of Neonorm Foal Neonorm Foal Proof-of-Concept Study Conclusion: This exploratory study demonstrated the effectiveness of Neonorm Foal vs. placebo in the treatment of diarrhea amongst foals from birth to 16 weeks. 1Responder: A foal wh
Slide 19: Neonorm Calf E. coli Challenge Study
19 Study Objective: Evaluate severity and incidence of diarrhea, mortality and weight gain. Conclusion: The total economic benefit from health endpoints, such as weight gain, from Neonorm could be ~$110 per calf. Neonorm Calf E. coli Challenge Study* Average Daily Calf Fecal Scores Neonorm significa
Slide 20: Neonorm Calf: Field Studies
Neonorm Calf: Field Studies1 Two recently completed field studies: Study conducted in association with Cornell University College of Veterinary Medicine and field study in Wisconsin further supports benefits related to supporting reductions in water loss associated with diarrhea and supporting weigh
Slide 21: Jaguar Commercial Strategy
Jaguar Commercial Strategy Focused direct sales force, unique Mechanism of Action Educational outreach to key opinion leaders and decision makers Complement major distribution partnerships Transferable as we expand from production to companion animals Meaningful partnerships in international markets
Slide 22: US Market Opportunity
US Market Opportunity Canalevia Market SB-300 Market Rx Companion Animals US Population: 74.0M Cats, 70.0M Dogs Rx Horses Total Cases Acute Cases 6.0M Dogs ~ 2/3 2.9M cats ~ 2/3 3.9M Performance Horses 22 US Population: Total horses: 9.2M Race horses: 844,531 Show horses: 2.7M Incidence: 54% of perf
Slide 23: Selected Milestones
Selected Milestones 2014 2015 2016 Companion Animals (Rx) Production Animals (Non-Prescription) Neonorm Field Study Results in Dairy Calves Neonorm Launch in Dairy Calves Canalevia CID in Dogs Initiate Regulatory Filing Horse Foals Safety & Efficacy Results Commercial Launch of Neonorm Foal Virend C
Slide 24: Jaguar Commercialization Horizon
Jaguar Commercialization Horizon R&D/GI Expertise First-in-class products ONGOING LAUNCH: Neonorm Calf Pivotal Trial: Canalevia-Dogs- Acute Diarrhea Canalevia - CID in Dogs - Initiate NADA LAUNCH: Neonorm Foal LAUNCH:* Canalevia – CID in Dogs LAUNCH:* Diarrhea Associated with Acute Colitis in Horses
Slide 25: Investment Highlights
Investment Highlights The only FDA-approved human anti-secretory diarrhea product1 Significant animal and human data Natural products from Croton lechleri First-in-Class GI Products for Animals Conditional Approval in dogs for Canalevia for CID Complete clinical development program for acute diarrhe
Slide 26: Potential Merger
26 Jaguar and Napo Pharmaceuticals are engaged in discussions to review a potential merger and/or other ways to cooperate with their respective business endeavors. Potential Merger
Slide 27: Management Team
Management Team Lisa Conte Founder, Chief Executive Officer & President 25+ years of industry experience Obtained first anti-secretory human product FDA approval Karen Wright Chief Financial Officer 30+ years of financial experience with biotech companies Former head of finance for Clene Nanomedicin
Slide 28: Board of Directors
Board of Directors James Bochnowski Chairman Founder of Delphi Ventures, one of the first VC firms to focus exclusively on investing in life sciences companies Co-founded Technology Venture Investors Lisa Conte Founder, CEO & President 25+ years of industry experience Obtained first anti-secretory h
Slide 29: Board of Directors
Board of Directors James Bochnowski Chairman Founder of Delphi Ventures, one of the first VC firms to focus exclusively on investing in life sciences companies Co-founded Technology Venture Investors Lisa Conte Founder, CEO & President 25+ years of industry experience Obtained first anti-secretory h
Slide 30: Jaguar Animal Health
Jaguar Animal Health — Investor Presentation (May 2016) on 6ix