Pet Vivo Holdings Inc November 2020 ForwardLooking Statements
Pet. Vivo Holdings, Inc. November 2020
Forward-Looking Statements This presentation and the accompanying oral commentary contains forward-looking statements within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties that could cause actual results to differ materially from those anticipated or projected by the forward-looking statements. Forward-looking statements include all statements that are not statements of historical facts and can be identified by words such as “anticipates, ” “believes, ” “seeks, ” “estimates, ” “expects, ” “intends, ” will, ” “would, ” “may, ” “plans, ” “potential, ” “predicts, “projects, ” “should, ” “could, ” or similar expressions and the negatives of those expressions. In particular, forward -looking statements contained in this presentation and the accompanying oral commentary relate to, among other things, the effectiveness of our Kush™ therapeutic well as our ability to develop and successfully commercialize other companion animal or human therapeutics, our future or assumed financial condition, results of operations, strategic plans and objectives, product development plans, use of proceeds, competitive position, and potential opportunities. Forward-looking statements represent our management’s current beliefs and assumptions based on information currently available. Forward looking statements involve numerous known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss these risks, uncertainties and other factors in the section entitled “Risk Factors” in our Annual Report on Form 10 -K that we filed with the Securities and Exchange Commission (“SEC”) on June 29, 2020, as well as in our other filings with the SEC. Except as required by law, we assume no obligation to update any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward looking statements, even if new information becomes available in the future. Certain of the information provided in this presentation, and the accompanying oral commentary, has been obtained from independent industry sources, publications or research reports. This information has been obtained from sources we believe to be reliable. However, we have not independently verified such information. 2
Overview: Pet. Vivo Holdings, Inc. (OTCQB: PETV) A commercial stage pet therapeutics company Focus on osteoarthritis (OA) in companion animals ($4. 8 B Market) Kush™ is a veterinary device that mimics and reinforces articulating cartilage tissue for the treatment of osteoarthritis and other joint-related afflictions Kush comprises the same components & structure as natural cartilage to provide additional support and functionality to protect the joint from pain Offers significant benefits for the management of OA by protecting the joint over current treatments: NSAIDs, Corticosteroids, HA, stem cell and PRP therapies Vet exclusivity with enhanced margins; cost effective solution for pet owners 3
Overview: Pet. Vivo Holdings, Inc. (OTCQB: PETV) A commercial stage pet therapeutics company Mucoadhesive Drug Delivery Patch: patented system to be commercially used initially for the delivery of caffeine, vitamins and other nutritional supplements Extensive product pipeline Experienced management and Board of Directors Full capacity commercial production – Q 1 2021 Strong IP portfolio with nine U. S. and nine foreign issued patents Neither FDA PMA nor 510(k) approval is required for medical devices used in veterinary medicine 4
Pet. Vivo Osteoarthritis (OA) Opportunity: ($4. 8 B Companion Animal OA Therapeutics Market) Osteoarthritis: a common affliction of the joints - Current treatments manage symptoms, but do not treat cause - OA affects 1 out of 4 dogs and over half of all horses Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are often used to alleviate pain and inflammation § NSAIDs are known to cause liver and kidney problems § NSAIDs do not halt or slow joint degeneration § NSAIDS do not protect or prevent further joint degeneration OA causes pain and inflammation from degenerated cartilage of stressed joints Steroid and/or HA injections are slow acting, have short duration or minimal effect OA lameness worsens with time from ongoing loss of cartilage and the further incorporation of bone inflammation Stem Cell, PRP require painful tissue harvesting and are timesensitive, time-consuming, expensive and provide limited effects Kush Canine: Osteoarthritis Market Estimate 20, 000 dogs with Osteoarthritis (US-EU) $4 B US-EU Market Kush Equine: Lameness Market Estimate 1, 000 lame horses (US-EU) $800 M US-EU Market 5
Veterinarian Business Model Is Changing § Vets are experiencing declining sales of high margin scripts that can now be filled at brick and mortar and online pharmacies § Vets are looking for additional ways to drive revenue, customer traffic and better OA outcomes § Kush can offer veterinarians higher margin opportunity at the same price point as existing OA products while providing better outcomes with less side effects for animals § According to DVM News Magazine, veterinarians estimated the total dollar amount at which most of their clients would refuse or stop treatment for their pets has increased from $576 in 1997 to $1, 704 in 2012 Source: DVM Newsmagazine’s State of the Profession Report for 2012 6
Market Overview: Companion Animal/Veterinarian U. S. Pet Owners Spend* $100 $91 $80 $67 $60 $48 $51 $53 $56 $58 $96 $99 § Large and growing market q 2020 US Pet Spend $99 B § U. S. Pet medication sales $9 B (2018) - 8. 5% Increase Over 2017 § Recession Proof Business § 68% of US Households own a pet $70 $60 q $40 q q 94 M Cats 90 M Dogs 7. 6 M Horses § Vet care is a leading growth driver $20 q q Source: APPA; USD in Billions * Agricultural and professional equine markets not included 20 20 19 20 18 20 17 20 16 20 15 20 14 20 13 20 12 20 11 20 20 10 $0 $29. 3 B in US (2019 E) 31% of Pet Spend § Market ripe for better and more effective therapeutics 7
The Superior OA Solution: Kush™ § Kush™ provides a biocompatible lubricious cushion, which reinforces the cartilage barrier between the bones to protect the remaining cartilage and bone and improve joint function § Same components/function found in natural cartilage (i. e. collagen, elastin and heparin) § Easily administered: Kush™ particles are injected into the Synovial Space with standard intra-articular injection technique; multiple joints can be treated simultaneously § Case studies indicate long-lasting (e. g. approx. 12 -months and longer) improvement in lameness; numerous cases with multi-year post-treatment success records § Probable discontinuation of NSAIDs; avoids potential toxic NSAID side effects § Kush™ is an effective and economical solution for treating OA 8
The Kush™ Technology § Kush is a unique new therapy addressing the root cause of affliction, not just the symptoms § Purified components self-assemble to form an insoluble, hydrated matrix §Protein source bovine tissues (i. e. collagen and elastin) from isolated herds §Carbohydrate source porcine tissues (i. e. heparin) from isolated herds §No inflammatory or foreign body response § Companion animal use supported by underlying 145 human patient FDA dermal-filler clinical trial § In clinic treatments grow vet practice revenues; offering high margins § Established IP portfolio with nine U. S. and nine foreign patents 9
Unique Solution: Kush™ vs. Current Treatments Treatment Kush Canine Rimadyl (NSAID) Pet. Vivo Hyaluronic Acid Injections Elanco Galliprant® Polyacrylamide Injections Joint (Arthramid and Replacement Noltrex) Protects Joint, Increases Activity, Temporary Pain Reduces Pain, Relief Excellent Safety Profile Con Potential for Effectiveness Only treating OA gastric ulcers and diminishes over pain without Minimally Invasive kidney problems 30 days - Minimally Invasive treating OA does not treat Minimally condition invasive Increases Lubricity in the Joint Total Joint Replaced Invasive and expensive surgical procedure requiring rehabilitation Typically injected Dosing/ Typically injected Once or twice daily Monthly injection once per 4 Surgery and Daily by owner Treatment once per year by owner at vet clinic months to 12 Rehab months Typical Owner Cost* Annual Owner $400 -$600 per joint $400 - $600 $0. 90 - $2. 40 per $150 - $250 per day (toxicity joint monitoring extra) $400 - $700 $1, 800 - $3, 000 $80 -$120 per month $960 -$1440 $350 to $700 per joint ($350/1 cc) $350 -$1400 $2, 000 - $4, 000 per joint $2, 000 - 10
Kush™ Competitive Distinctions: • • Superior Outcomes Price/Cost Advantage No Competitors & Little Competitive Innovation Ease of Delivery Vet Clinic Exclusivity & Enhanced Margins Current Treatments rely on Biologic Activity with NO Structural Components Approximately 100 dogs and horses successfully treated with Kush EQUINE Kush CANINE 11
Production Strategy: Overview § Kush product is manufactured in a twophased approach as follows: q Phase 1 - Sterile Kush particles are produced by Pet. Vivo personnel q Phase 2 – Pet. Vivo personnel or a Pet. Vivo strategic partner performs aseptic syringe filling, packaging, analytics and QA of Kush particles for final sale and distribution § Initial batch runs of 500 syringes are planned to increase to runs of 5, 000+ syringes in 12 months § Production facility annual capacity is approximately 500, 000 syringes generating revenue over $100 M annually Pet. Vivo Cleanroom (ISO 8 to ISO 7 to ISO 5) – Edina, MN 12
Production Vet Production Facility Construction and Setup (Q 3 -2020) Pre. Commercialization Runs (Q 4 -2020/Q 1 -2021) Commercialization Scaled-Up Runs (Q 42021/ongoing) Second Facility Construction and Setup (Q 42022/Q 1 -2023) Production and Commercialization Timelines Commercialization Runs (Q 2/Q 3 -2021) Commercialization Production and Commercialization Timelines Vet Initial Launch in Key Regional Markets (Q 3/Q 4 -2020) Select National Partners (Q 1/Q 2 -2021) Full National Rollout (Q 3 -2021/ongoing) International Launch in select countries (Q 3/Q 4 -2021) Full International Rollout (Q 12022/ongoing) 13
Mucoadhesive Drug Delivery Technology § The Mucoadhesive Device is a drug delivery platform technology based on a mucosal tissue adhering protein matrix that contact erodes for the delivery of active agents (e. g. caffeine, vitamins and other nutritional supplements) § FDA-GRAS materials § In wafer form, our Mucoadhesive Devices stick firmly and comfortably to buccal mucosal tissue, which covers the roof of mouth, cheeks and gums Residency time: 5 -15 minutes 1 cm § Increases bioavailability of active agents by up to 10 x § Patent protection in the United States, Canada and European Union 14
Seasoned Leadership Team John Lai, CEO/President. Mr. Lai has over 30 years of senior operations and financial experience and has served as CEO of Genesis Capital Group, Inc. , President of Viper Powersports and CFO of Buyitnow. com. He has extensive experience in capital structure, financial analysis, business formation, mergers, acquisitions and driving revenue growth. John F. Dolan, General Counsel, Director. Mr. Dolan has over 20 years of experience as corporate and IP counsel for companies ranging from early-stage growth companies to fortune 500 companies. Mr. Dolan was an attorney and partner at the firm of Fredrikson & Byron for 12 years. Mr. Dolan currently advises early-stage and growth companies on all aspects of IP asset protection and corporate matters, as well as new technology development and commercialization, corporate development, secondary offerings, private equity and M&A and licensing transactions. Early in his career he was employed by government entities as a litigator, as well as employed by the United States Patent and Trademark Office as a patent examiner. John Carruth, CFO. Mr. Carruth’s financial accounting experience includes expertise in financial reporting internal controls, SEC reporting, SOX and GAAP compliance. He graduated from the University of Minnesota with a Masters in Accountancy. 15
Seasoned Leadership Team David B. Masters, Ph. D. , Director of Science and Technology. Dr. Masters is a seasoned entrepreneur executive, biochemist, biomaterials expert and inventor with credentials from Rutgers, Harvard, University of Minnesota and the Mayo Clinic. Dr. Masters has over 30 years of experience in biomaterials development and commercialization, including a successful FDA clinical trial, over thirtyfive issued or pending patents, over 70 publications, many FDA biomaterial/device regulatory documents, DOD product research & development and more than $7 million in government grant awards as a principal investigator. David Deming. Director of Investor Relations. Mr. Deming has over 35 years of institutional investment management experience with pensions, endowments, family offices and high net worth investors in roles as: CIO at BBIC (Business Brokers Investment Company); Director of Marketing and Investor Relations at BCCM Advisors; Director of Business Development and Chief Compliance Officer (CCO) at Asymmetric Capital Management; Partner, Director of Marketing, COO and CCO at Arbor Capital Management; President and Marketing Director at Leuthold, Weeden & Associates, L. P. ; Account Executive at Paine Webber and Merrill Lynch; PM, Analyst at Windsor Financial, and Floor Trader at the Chicago Board of Trade (CBOT). Gregory Cash, Board Chairman. Greg has more than 35 years senior management and/or key sales and marketing executive experience in the life sciences industry, including being Chief Executive Officer or Division President of leading cardiovascular medical device companies. Since 2011, he has been the Chief Executive Officer and principal owner of Argent International LLC, Minneapolis, MN. Prior to founding Argent, Mr. Cash served for over thirty years in senior executive management or marketing roles with leading medical device companies, including five years with Boston Scientific Corporation and over twelve years with Medtronic, Incorporated. 16
Pet. Vivo™ Holdings, Inc. OTCQB: PETV 5251 Edina Industrial Blvd. Edina, Minnesota 55439 Phone: 952 -405 -6216 Email: info 1@petvivo. com www. petvivo. com
Appendix Commercial Product Packaged in Syringes Particles in Saline 100 um_ 18
Kush™ Mechanism of Action § An animal suffering from osteoarthritis generally exhibits damaged and/or lost cartilage thereby creating bone on bone contact that results in an increase of joint inflammation, pain and further loss of cartilage § Kush reinforces synovial membrane function, without pharmaceutical, chemical or metabolic action § Biocompatible Kush particles are lubricious, “cushioning” and reside in joint synovial space § These spongy cartilage reinforcing particles mimic the protective function of cartilage – providing both a slippery cushion and a protective barrier between bones § Particles are slippery, wet, permeable, durable and resilient § Particles mimic natural cartilage in composition, structure, hydration and function 19
Kush™ Equine Success: Sarge Hudson was given away by his owner to his trainer in summer 2016 because he pulled up lame. Sarge's new owner had Dr. Brad Gordon treat him with one injection of Kush on August 17, 2016. Sarge, as an 8 -year-old, came out strong for the 2017 Race Season. He had (3) Win’s, Placed 2 nd twice and Showed 3 rd in a race. Overall, Sarge Won, Placed or Showed 6 out of 10 races that season. Source: Dr. Brad Gordon, DVM 20
Kush™ Equine Success: Fender Bender was claimed by his owner for $3, 000 following a claiming race in June, 2020. The horse was exhibiting lameness, which prompted the owner to look for therapeutic treatments. Fender Bender's new owner had his race-track veterinarian treat him with an injection of Kush in early August, 2020. Fender Bender, as a 7 -year-old, came out strong a few weeks later in its first race following injection. After a stumble early in the race he came from a 10 -length deficit to capture the lead and win the race. 21
Kush™ Canine Success: Kona's condition worsened to a “normal” Grade III lameness (significant head tilt, severe limp). 11 days after her owner, a veterinarian, gave her a Kush injection, she improved daily and demonstrated a Grade I lameness, which would worsen a bit after a hard run. She is back to chasing rabbits off-trail and generally looks to be improving. Source: Dr. Michael Larson, DVM 22
Kush™ Canine Success: Hope was having problems with the rear left leg, which was diagnosed as a congenital hip defect. The condition worsened and muscles had atrophied exhibiting significant lameness (e. g. significant head tilt, severe limp). The owner’s veterinarian gave her a Kush injection, which provided steady improvement in daily activity over the next few weeks. Hope has steadily improved since the injection and is still walking and running at normal levels over five years later. Source: Chris Cottone, Owner of Hope 23
Pet & Human Product Pipeline VD-01 VD-02 VD-03 VD-04 VD-06 HD-05 HD-07 HD-08 HD-09 HD-10 HD-11 HD-12 HD-13 HD-14 HD-15 HD-16 HD-17 Pet Therapeutics Osteoarthritis Digital Cushion Lameness Urinary Incontinence Osteoarthritis Species Canine (Kush) Equine & Bovine Canine Feline (Kush) Human Therapeutics Dermal Filler Osteoarthritis Dermal Filler - Lip Spinal Disc Repair Arteriovenous (AV) Shunt Limb Salvage Shunt Female Urinary Incontinence Peripheral Vascular Graft Coronary Artery Bypass Graft Drug Eluting Stent Coating Mucoadhesive Fentanyl Vasculitus Wound Closure Particle Based Devices Biomaterial Safety Proof of Concept Pilot Preclinical Studies Molded Vascular Devices Efficacy Commercial Q 4 2020 2021 2022 Pivotal Trial FDA Submission Launch 2022 2023 2023 2024 2024 Drug Delivery Devices 24
Unique Solutions: Competitive Landscape Treatments for Canine OA Pet. Vivo Kush™ Device collagen matrix § No competitors and little competitive innovation § Current Treatments rely on biologic activity with no structural components commercial Possibly Source: Company websites, CVM 25
Experienced Board of Directors § § § § § Gregory Cash, Chairman James Martin John Lai, CEO and President John F. Dolan, JD David Deming Joseph Jasper, CFA David B. Masters, Ph. D. Randall Meyer Robert Rudelius Scott Johnson, P. E. KOL Advisory Board § Dr. Tracy Turner, DVM, MS, Dipl. ACVSMR § Dr. Brad Gordon, DVM, MS § Dr. Michael Sterns, DVM, MBA § Patrick Halliday 26
Regulatory Environment & Strategy § Neither FDA PMA nor 510(k) approval is required for medical devices used in veterinary medicine § FDA defines a medical device as an apparatus or other item that does not achieve its intended purpose through chemical reaction in the body and is not dependent on being metabolized in the body § Demonstrated Human Safety & Efficacy q Classified as a Medical Device by the FDA – no chemical reactions with Kush particles and they are not metabolized in the body q Pivotal FDA Human Trial Successfully Completed q Multiple Years of Safety & Efficacy in Many Species § Commercial Ready in Pet/Vet Market q Particles meet definition as a Medical Device q No FDA PMA or 510(k) Clearance Required for Kush Vet Devices § There are strong precedents of comparable medical devices marketed under this exemption in the veterinary market: q Polyglycan® - solution used to supplement and replace synovial fluid in the joints of animals q Peridan™ - a sterile veterinary device for reduction of surgical adhesions in horses 27
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