PresolMD, LLC PresolMD, LLC is new joint venture in partnership with Prevacus, Inc. PresolMD, LLC has formulated and will bring to market the world?s ?rst brain injury prophylactic demulcent, branded Prevacus is a neuropharmaceutical company focusing on new treatments for concussions, Niemann-Pick Disease, ALS and Chronic Traumatic Encephalopathy (CTE). is a natural proprietary formulation designed for the protection of cerebral extracellular matrix tissue from destabilization from active events resulting in concussion. While Prevacus treatment requires FDA approval for use after a concussion is sustained, is a nutraceutical that can be given prior to engaging in contact sports or any high-risk contact events and be onboard in the brain, ready to halt the pathological cascade associated with concussion. PresolMD, LLC Formed: July 2019 Company: Consumer Products Markets: Health Wellness Organized Sports Integrative Medicine Sport Medicine Injury Prevention Military Geriatrics Initial Product Suite: Capital Sought: $2,000,000 Equity Pre-Ma rket Valuation: $20,000,000 Experienced Team: Jake VanLandingham, CEO, Prevacus, Inc. Mike Lewandowski, Chief Scienti?c Of?cer, Prevacus, Inc. David Lee, MD Chief Medical Of?cer Neurologist Product Launch: 4?'1 Quarter 2019 The Problem Concussions causing Traumatic Brain Injury (TBI) are not preventable and are caused by motor vehicle accidents, falls, sports injuries, military duty and other at?risk work environments. Among children, most concussions happen on the playground, bike riding, skateboarding, or playing football, basketball, or soccer. Each year, TBI causes a substantial number of deaths and leads to life-long disability for many Americans. in fact, TBl?s contribute to about 30% of all injury deaths in the United States. Annually there are: Approximately 5 million concussion-related physician visits Approximately 288,000 hospitalizations from TBI Nearly 57,000 deaths related to and Lifetime economic cost of in the US is over $76.5 Billion a year The exact short-term and long-term effects of concussion are still evolving. Data shows concussions are cumulative, and repetitive head trauma from participation in contact sports and military service can lead to permanent decrease in brain function. Long-term effects include vision problems, memory deterioration, impaired balance, loss of coordination, and persistent headaches. Concussions lead to disorders such as early Alzheimer?s disease, Dementia, Parkinson?s disease, PTSD, and anxiety disorders. Currently there exists no means of preventing traumatic brain injury resulting from concussion. Our Solution Protection by transdermal application may be the most important deterrent to post-concussion PTSD, ALS and CTE. WW tau? Presence of active ingredients prior to a concussive event can protect the brain?s delicate BRAIN wiring against the resultant neuro-in?ammatory cascade that causes damage to the delicate structural integrity. - lcn' I natarri 1351333 4 . Breakthrough Support for Concussions . The Only Choice in Prevention Protection . Clinically Tested for Safety No Steroids, No Opioids, No Banned Substance and Traumatic Brain Iniuries Increasing concern has been directed toward traumatic brain injury (TBI) especially that which occurs during contact driven sports (NFL football). In particular, post-concussion PTSD and Chronic Traumatic Encephalopathy (CTE) are three TBI attributed conditions which have gained notoriety. Trauma induced injury to the brain involves a complex series of events divided into two major components: 1) primary injury which occurs at the time of impact and 2) secondary injury which involves delayed cell damage. Delayed cell damage results from a cascade of in?ammatory processes which promote overcorrections by the body?s repair mechanism. They include but are not limited to COX, anappaB, and resultant cytokines which are activated and released into the brain?s extracellular matrix (ECM) providing a feed forward destructive process of neurons and axons. Additionally, the blood brain barrier can be compromised resulting in a ?leaky? brain scenario leading to further damage of neural function The microenvironment of the brain?s extra-cellular matrix (ECM) concerned with maintaining homeostasis, immune response and repair involves both astrocytes and glial cells. These cells are involved in amyloid /Tau protein over production which adversely effects the ECM. In a similar fashion, we can further extrapolate from the patent that concussions and sub concussive blows (CTE) impact the delicate structural integrity and electrical wiring of the brain by disturbing the ECM. A remedy to this problem requires restoration or stabilization of the ECM allowing for repair and interruption of overcompensating repair mechanisms. Preliminary studies indicate that natural compounds contained in such as EGCG, resveratrol, curcumin, and sulforaphane can stabilize the brain?s ECM. Ideally, using transdermal preparation should be accomplished beforehand in order to limit immediate and delayed cell damage. cream has a distinct advantage in delivery of these natural ingredients by providing physiologically active micromolar dosing as opposed to the lower nano/pico molar oral levels. Applying the transdermal preparation to the neck at the anatomical site of the carotid artery permits a direct conduit to the brain especially with a compromised or ?at risk? Consideration as to the timing of application would suggest that if the compounds were onboard prior to the occurrence of a concussive event, they would be most bene?cial. Since sub- concussive events are thought to play a role in pathological conditions such as post-concussion PTSD, ALS and CTE, applying the cream should be prior to contact events (military duty, sports, and leisure activities) in an effort to prevent resultant neuro-in?ammatory cascades. Prevention by transdermal application stands to be one of the most important deterrents to poor outcomes following concussion. Executive Leadership Experience Dr. Jake Vanlandingham, Founder CEO. Prevacus, Inc. Founder and President of Prevacus, Inc., to develop the world?s ?rst FDA-approved pos- concussion treatment as a nasal-inhalant neurosteroid (24M valuation.) Jake has a BS. in Physical Therapy and spent 3- years working with neurologically impaired children with brain injuries in and around the time of birth. His Ph. is in Neuroscience from Florida State University with a molecular biology focus on disease. His Post-doctoral work was in translational research and neurobehavioral aspects of diseases at Emory University. At Emory he also oversaw the clinical biomarker study for the clinical trial using progesterone for acute treatment of severe to moderate TBI as the Assistant Director of the Brain Research Laboratory the largest laboratory in the Emergency Medicine Department. Jake has an excellent teaching record and has won multiple awards with both graduate and undergraduate students. He was a Year One Director of the Florida State University Medical School for 8 years before devoting all his? time to Prevacus, Inc. starting in 2015. Michael Lewandowski - Chief Scienti?c Of?cer Mike Lewandowski is a toxicologist turned entrepreneur with over 38 years of pharmaceutical development experience working with pharmaceutical companies and clinical research organizations to develop small and large molecule drugs. He is currently the Founding Principal and President of Global BioDevelopment, a consulting ?rm that specializes in pharmaceutical and medical device development services through strategic partnerships in the areas of manufacturing, formulation development, analytical and bio-analytical chemistry, pharmacology and toxicology, pharmacokinetics and drug metabolism, histopathology, experimental veterinary surgery, clinical pathology, regulatory affairs, and clinical affairs. Mike?s experience includes creation of a histopathology company that has since been absorbed into a mid-sized CRO, serving as Director of Safety Evaluation at Scios, Inc., and Manager of Toxicology Studies at Genentech. While at Genentech, he was an important contributor for the preclinical development of several biotech drugs that ultimately made it to the marketplace. Mike started in the preclinical development business in 1975 with Baxter Laboratories, after graduating with a BS degree from Southern Illinois University. David Lee MD, F.A.C.S Chief Medical Of?cer Orthopedic Spinal Surgery A Member of American Association of Neurological Surgeons, Congress of Neurological Surgeons, Southern Neurosurgical Society, American Medical Association, Southern Medical Association, Southern Pain Society, North American Spine Society, American College of Spine Surgeons, American College of Surgeons and Mississippi Neurosurgical Society. Brett Favre? Former American Football Quarterback Professional Football Hall of Fame, Super Bowl Champion Bowl Champion Hattiesburg, Mississippi Competition PresolMD, LLC is the first mover into the market of concussion prophylactic preparations- currently has no competition. We estimate that an aggressive national and international mass?marketing and distribution effort will result in market entry by big-pharma and other large multi- national consumer products companies within 2 years. Sales 8: Marketing Strategy 8; Financial Proiections The Company is finalizing the novel formulated and clinically testing in partnership with the NFL Affiliate Groups currently. Pre-launch sales activities and planning for a national, mass-media campaign leading to a Fourth Quarter 2019 launch in the United States are also undenivay. The Company has already engaged with several prominent NCAA athletic programs, Professional Sports Teams as well as youth sports organizations. Future international connections and a novel focus on protecting the elderly will begin in the new year. Revenue/Income (SMillions) ($Millions) YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 includes a revolutionary group of natural botanical extracts that will invent the pre- concussion prophylactic market. Our network of nationally recognized, iconic sports ?gures and aggressive mass-media PR campaign will catapult into the national spotlight. Our timing is perfect as global awareness has heightened regarding the long-term dangers of TBI, CTE, PTSD, and other conditions caused by concussions. Military applications alone can relieve billions in long-term health care burden. The Revenue displayed are anticipated, based on an average of 10,000 units sold per month initially, with growth projections based on industry highs and lows. The Company will initially focus on three outlets for product distribution and sales: Direct Sales through a PreVPro Distribution Network Internet Online Sales driven by proprietary customized software, that distributors will utilize for training, certi?cation, marketing, and order processing. Military registration, approval and sales on the GSA and 2 other fee schedules. PreSolMD. LLC Milestones Achieved to Date Since inception in June of this year, the Company has achieved the following: Completed a unique formulation of botanical ingredients that provide a cascade of bene?ts to the brain. Met the production and manufacturing timeline for the ?rst 10,000 units of to be released in November 2019. Designed and completed two dog studies to demonstrate entry into the brain, peaking at 2 hours and remaining there for 6 hours. Conducted 3 Voluntary Safety Studies on 63 children Provided Product Samples and cultivated relationships with 6 NFL Active Teams and 100 NFL Retired Players. Next Target is the NBA and College teams. Recruited NFL Active and College Players and Spokespersons to serve as Ambassadors for the product including Brett Favre, Byron Williams, Mark Rypien, David Ross, Abby Wambach, Steve Mariucci, Ed ?Too Tall? Jones, Kurt Warner and others. Recruited an Executive Management Team to launch operations in July of 201 9 Trademarked Raised $650,000 in investor funds Introduced Prevacus and to the DOD through discussions with Dr. Dwayne Taliaferro, Head of all Congressionally Directed Research. A presentation to his team on and Prevacus at Fort Meade is being scheduled for by year end. Funding The Company is seeking $2 Million for the initial funding that will allow it to fully execute the Company?s business and growth plan. The Company continues to attract investors including strategic partners that add value and expertise that bene?ts the Company and the Company?s stakeholders. Use of Proceeds: Sales Operations Manufacturing/Inventory Multi-media Marketing Activities Research Growth Capital Value Proposition/Highlights - First mover into a vast market with no competition. 0 Partners are nationally recognized celebrities and professional sports ?gures and with signi?cant marketing power and social media following. 0 Cross and multi-channel distribution model in a vast global market provide initial stability and great revenue growth potential. 0 Novel product backed by decades of clinical research and proprietary ingredients and processing methods that are technically dif?cult and cost prohibitive to duplicate, create signi?cant barriers to market entry by competition. .. prevocus LLC Contact: Jake Vanlandingham Mobile: 850.544.2962 jvan@prevacus.com prevocus ?a prevocus Prevacus, Inc. is developing a nasally delivered novel neuroprotectant (PRV-002) to treat concussion a.k.a. mild traumatic brain injury With no approved therapeutics for the accepted standard of care is rest and observation; for more severe cases, lying quietly in a dark room for days or weeks at a time. Mild head trauma is linked to long-term cognitive impairment, Chronic Traumatic Encephalopathy (CTE) and Amyotrophic Lateral Sclerosis (ALS). With over 5 million documented annually and annual increases in identi?ed incidences due to concussion awareness, the identi?cation of therapeutic approaches for represents a signi?cant unmet medical need. Development of PRV-002 will reduce recovery time allowing patients a speedier return to normal activities, reduce risk of ALS and CTE associated with repeat concussions, and reduce the ?nancial burden on the healthcare industry due to High risk groups include elderly (falls), military personnel, motor vehicle accident victims and athletes. PRV-002 is a ?rst-in-class neuro-protectant that improves behavioral (working memory, motor performance, and depression- anxiety levels) and molecular (in?ammation, oxidative stress and swelling) outcomes following brain injury in lab animals. It also enhances pro-survival molecular mechanisms (edema, apoptosis, in?ammation, anti-oxidant defense, glial-immune cell in?ltration) following TBI. Rapid onset of action is due to intranasal delivery allowing direct access to the brain and ease of delivery in the ?eld. As illustrated: 400'! . 4am.- I Treatment of TBI compromised rats results 350} i 2000i in improved memory and motorscore vs 300} I vehicle (injury, no treatment) 250! 1500! - - 200i 2? . 0 Intranasal delivery of both solutlon and . 1 1000. lSolutIon . . . . 150 i . suspensmn formulations results 1n rapid 100: mm, lSuspenSIon absorption into the brain (less than 5- soj 1, 50?? . mmutes) I ?m d. Vehicle PRU-0024 mg/kg Vehicle PRV-ODZ 4 mg/kg In addition to the above, IND-enabling toxicology shows no signi?cant test material related toxicity with up to a 380-fold safety margin. Finally, intranasal delivery of PRV-002 will allow for the following: 0 Field deliverable for ambulance patients, athletes (sidelines) and military personnel (active duty) 0 Reduced side effects due to lower systemic exposure vs oral or iv administration 0 Self-administered (TriVair, delivery platform) 14-day treatment/twice daily ensures no long term effects of the injury Intellectual Property: The Prevacus patent estate, led and managed by our patent counsel (Lewis-Brisbois), currently consists of 140 ?led and issued patents as follows: Filed/Issued In Preparation 0 Composition of matter for PRV-002 and analogs - Solid state chemistry I- methods for and PRV-002 Formulation I Use of and PRV-002 . Next-generation analogs Current development status (re?ected in the timeline below): Completion of Pre-clinical development: l6-Q1/ 19 Completion of Phase l-related CMC activities: 19 Phase 1A and Clinical Trials: Phase 2-related CMC activities: Phase 2 Clinical Trials: IND-enabling toxicology is complete Manufacture of Phase 1 clinical PRV-002 is complete Prototype formulations are complete Completion of phase 1 formulation development and device compatibility is expected in 19 Phase 1 clinical trials are planned for 19 Qprevocus Financials and Valuation: To date, Prevacus Inc. has raised approx.11 million dollars of private and State funding in support of API manufacturing, preclinical research and development, formulation and toxicology/safety studies. We are currently seeking $8.75 million dollars in funding to initiate and complete Phase Clinical Trials and all drug needed and FDA requirements for Phase 2 Clinical Trials. The current tranche which covers Phase lA/Formulation/Fill and Finish is 3.5M of the 8.75M at $1 .25/share. We are currently working with members of a public and private alliance to complete this raise including Large Angel Groups, Venture Capital, NCAA, the Department of Defense, Hospitals, Foundations and Professional Sports Leagues. Management Team: Dr. Jacob W. VanLandingham- President 0 in Neuroscience (Florida State University) 0 Assistant Director of Brain Research Laboratory, Emory University 0 Over 18 years of experience in Neuroscience research 0 Published on effects of neurosteriods on recovery following head trauma 0 Professor at Florida State University College of Medicine Michael Lewandowski- Chief Scienti?c Of?cer 0 BS. in Biological Sciences (Southern Illinois University Carbondale) 43 years biopharmaceutical experience 0 12 NDA approved drugs a President and Founder of Global BioDevelopment Marc Cantillon, MD- Acting Chief Medical Of?cer 0 M.D., Medicine (Karolinska Institutet Sweden) 0 20 years of experience as a pharmaceutical executive and 0 7 IND and 4 NDA approvals in neurology, and pain Dr. Robin Allgren- Clinical Advisor 0 M.D., in Internal Medicine (Stanford University School of Medicine) 0 MBA in Health Services Management (Golden Gate University) 0 Over 25 years of experience in product development, clinical trials and FDA interactions 0 Past VP of Clinical Development and Senior VP of Product Development pre-IND through NDA Dr. Deepa Deshpande- Regulatory Affairs Specialist 0 in Pharmaceutical Sciences (West Virginia University) 0 20 years of experience 0 Domestic and international regulatory expertise ti I Key Advisory Members and Associates: Medical I Jack Khattar ?President and CEO of Supemus Pharmaceuticals Alex Lin-Neuroradiologist, Brigham and Women?s Hospital in association with Harvard University Derrick Henneke MBA, President and CEO of Xcellience Steve Jordan? Orthopedic Surgeon, Andrew?s Institute James Andrews- Orthopedic Surgeon, Andrew?s Institute Jay Alberts Bioengineer, Cleveland Clinic Frank Carruba CEO Neurologix Ronald Hayes Neuroscientist, Banyan Biomarkers I Michael Hoffer Navy Of?cer and Neuroscientist, Miami University I Dorothy Kozlowski Neuroscientist, DePaul University I Jay Clugston-Team Physician University of Florida, PI CARE Consortium I Joseph Story-Founder and Chairman of Andrew?s Orthopedic Institute I Matthew Lee-Orthopedic Spine Surgeon, Tallahassee Orthopedic Center I David Lee- Neurosurgeon, Forest General Hospital Contact: Dr. Jacob Van Landingham, President 850544-2962 jvan@prevacus.com Military I egg prevocus - Ben Siebert- Physical Medicine and Rehabilitation, Neuroscience Group Uzma Samadani- Neurosurgeon, Minneapolis Medical Center Brett Favre-Former NFL Player Leigh Steinberg?NFL Agent James ?Bus? Agent Steve Mariucci-Former NFL Coach Eddie DeBartolo Jr.- Former NFL Owner Abby Wambach- Former US Olympic Soccer Player Keri Walsh-Jennings-US Olympic Volleyball Player Dale Jarrett- Former NASCAR Driver Kurt Warner- Former NFL Player Mike Ditka?Former NFL Player Ed Werder?Sports Journalist Jamie Dukes-Former NFL Player David Ross-Former MLB Player Steve Bono- Former NFL Player Mark Rypien- Former NFL Player General James Amos, 35?h Commandant of the United States Marine Corps Colonel Mike Prendergast, USA Executive Director, Florida Dept. of Veterans? Affairs Dallas Hack, Former Director of Combat Casualty Care Research, Department of Defense, Current Lead Consultant for CARE Consortium James Kelly Neurologist, Former Director of National Intrepid Center of Excellence (N iCoE) Tobias Rodill, Command Strategies, Federal Defense Appropriations Liason Congressman Matthew Gaetz, Member of Budget, Armed Forces and Judiciary Committees Other Contacts Jeff Miller Head of Health and Safety at the NFL Dr. Geoff Manley, Neurosurgeon with TED Dr. Jerry Petty and David Wiercisiewski from Carolina Neurosurgery and NASCAR Dr. Brian Haneline the Medical Director of the NCAA Dr. Michael McDermott-NFL Independent Neurologist Dr. Allen Sills-Chief Medical Of?cer of the NFL Future Non-Dilute Funding Opportunities Department of Defense; Combat Casualty Care?Neurotrauma Division NFL Grant Mechanisms Australian Government Rebate Program Health and Human Services, Mississippi Qprevocus prevocus Prevacus, Inc. is developing a nasally delivered novel neuroprotectant (PRV-OOZ) to treat concussion a.k.a. mild traumatic brain injury With no approved therapeutics for the accepted standard of care is rest and observation; for more severe cases, lying quietly in a dark room for days or weeks at a time. Mild head trauma is linked to long-term cognitive impairment, Chronic Traumatic Encephalopathy (CTE) and Amyotrophic Lateral Sclerosis (ALS). With over 5 million documented annually and annual increases in identi?ed incidences due to concussion awareness, the identi?cation of therapeutic approaches for represents a signi?cant unmet medical need. Development of PRV-002 will reduce recovery time allowing patients a speedier return to normal activities, reduce risk of ALS and CTE associated with repeat concussions, and reduce the ?nancial burden on the healthcare industry due to High risk groups include elderly (falls), military personnel, motor vehicle accident victims and athletes. PRV-002 is a ?rst?in-class neuro-protectant that improves behavioral (working memory, motor performance, and depression- anxiety levels) and molecular (in?ammation, oxidative stress and swelling) outcomes following brain injury in lab animals. It also enhances pro-survival molecular mechanisms (edema, apoptosis, in?ammation, anti-oxidant defense, glial-immune cell in?ltration) following TBI. Rapid onset of action is due to intranasal delivery allowing direct access to the brain and ease of delivery in the ?eld. NEURosc0RE'?'24h'PosrsN1unv' As illustrated: 400.- .. 40.0w . - 1 0 Treatment of TBI compromlsed rats results 350: 1 2000} - in improved memory and motorscore vs 30?! 3? 09" . . . 250. 1500! vehicle (1njury, no treatment200. - - Intranasal dellvery of both solution and . 100m '50lutlon . . . . 150 suspensmn formulatlons results in rapld mum I [SuspenSIon . . . 100 I 500! absorptlon into the braln (less than minutes) 0. a- Vehicle 4 rug/kg Vehicle PRV7002 4 mg/kg In addition to the above, IND-enabling toxicology shows no signi?cant test material related toxicity with up to a 380-fold safety margin. Finally, intranasal delivery of PRV-002 will allow for the following: a Field deliverable for ambulance patients, athletes (sidelines) and military personnel (active duty) 0 Reduced side effects due to lower systemic exposure vs oral or iv administration I Self-administered (TriVair, delivery platform) 14-day treatment/twice daily ensures no long term effects of the injury Intellectual Property: The Prevacus patent estate, led and managed by our patent counsel (Lewis-Brisbois), currently consists of 140 ?led and issued patents as follows: Filed/Issued In Preparation 0 Composition of matter for PRV-OOZ and analogs 0 Solid state chemistry 0 methods for PRV-OOI and PRV-002 Formulation - Use of PRV-OOI and PRV-002 I Next-generation analogs Current development status (re?ected in the timeline below): Completion of Pre-clinical development: Completion of Phase l-related CMC activities: Phase 1A and Clinical Trials: Phase 2-related CMC activities: Phase 2 Clinical Trials: IND-enabling toxicology is complete Manufacture of Phase 1 clinical PRV-002 is complete Prototype formulations are complete Completion of phase 1 formulation development and device compatibility is expected in Phase 1 clinical trials are planned for prevccus Financials and Valuation: To date, Prevacus Inc. has raised approx.11 million dollars of private and State funding in support of API manufacturing, preclinical research and development, formulation and toxicology/safety studies. We are currently seeking $8.75 million dollars in funding to initiate and complete Phase Clinical Trials and all drug needed and FDA requirements for Phase 2 Clinical Trials. The current tranche which covers Phase 1A/Formulation/Fill and Finish is 3.5M of the 8.75M at $1 .25/share. We are currently working with members of a public and private alliance to complete this raise including Large Angel Groups, Venture Capital, NCAA, the Department of Defense, Hospitals, Foundations and Professional Sports Leagues. Management Team: Dr. Jacob W. VanLandingham- President 0 in Neuroscience (Florida State University) 0 Assistant Director of Brain Research Laboratory, Emory University 0 Over 18 years of experience in Neuroscience research 0 Published on effects of neurosteriods on recovery following head trauma 0 Professor at Florida State University College of Medicine Michael Lewandowski? Chief Scienti?c Of?cer 0 BS. in Biological Sciences (Southern Illinois University Carbondale) 0 43 years biopharmaceutical experience 0 12 NDA approved drugs 0 President and Founder of Global BioDevelopment Marc Cantillon, MD- Acting Chief Medical Of?cer 0 M.D., Medicine (Karolinska Institutet Sweden) 0 20 years of experience as a pharmaceutical executive and 7 IND and 4 NDA approvals in neurology, and pain Dr. Robin Allgren- Clinical Advisor - M.D., in Internal Medicine (Stanford University School of Medicine) 0 MBA in Health Services Management (Golden Gate University) 0 Over 25 years of experience in product development, clinical trials and FDA interactions a Past VP of Clinical Development and Senior VP of Product Development pre-IND through NDA Dr. Deepa Deshpande? Regulatory Affairs Specialist 0 in Pharmaceutical Sciences (West Virginia University) 0 20 years of experience 0 Domestic and international regulatory expertise Key Advisory Members and Associates: Medical I Jack Khattar ?President and CEO of Supernus Pharmaceuticals Alex Lin-Neuroradiologist, Brigham and Women?s Hospital in association with Harvard University Derrick Henneke MBA, President and CEO of Xcellience Steve ordan? Orthopedic Surgeon, Andrew?s Institute James Andrews- Orthopedic Surgeon, Andrew?s Institute Jay Alberts Bioengineer, Cleveland Clinic Frank Carruba CEO Neurologix Ronald Hayes Neuroscientist, Banyan Biomarkers Michael Hoffer Navy Of?cer and Neuroscientist, Miami University Dorothy Kozlowski Neuroscientist, DePaul University Jay Clugston-Team Physician University of Florida, PI CARE Consortium Joseph Story-Founder and Chairman of Andrew?s Orthopedic Institute Matthew Lee-Orthopedic Spine Surgeon, Tallahassee Orthopedic Center David Lee- Neurosurgeon, Forest General Hospital Contact: Dr. Jacob VanLandingham, President 850544-2962 jvan@prevacus.com Sports Military I I -- Qprevocus Ben Siebert? Physical Medicine and Rehabilitation, Neuroscience Group Uzma Samadani- Neurosurgeon, Minneapolis Medical Center Brett Favre-Former NFL Player Leigh Steinberg-NFL Agent James ?Bus? Agent Steve Mariucci-Former NFL Coach Eddie DeBartolo Jr.- Former NFL Owner Abby Wambach- Former US Olympic Soccer Player Keri Walsh-Jennings-US Olympic Volleyball Player Dale arrett- Former NASCAR Driver Kurt Warner- Former NFL Player Mike Ditka-Former NFL Player Ed Werder-Sports Journalist Jamie Dukes-Former NFL Player David Ross-Former MLB Player Steve Bono- Former NFL Player Mark Rypien- Former NFL Player General James Amos, 35th Commandant of the United States Marine Corps Colonel Mike Prendergast, USA Executive Director, Florida Dept. of Veterans? Affairs Dallas Hack, Former Director of Combat Casualty Care Research, Department of Defense, Current Lead Consultant for CARE Consortium James Kelly - Neurologist, Former Director of National Intrepid Center of Excellence Tobias Rodill, Command Strategies, Federal Defense Appropriations Liason Congressman Matthew Gaetz, Member of Budget, Armed Forces and Judiciary Committees Other Contacts Jeff Miller Head of Health and Safety at the NFL Dr. Geoff Manley, Neurosurgeon with TED Dr. Jerry Petty and David Wiercisiewski from Carolina Neurosurgery and NASCAR Dr. Brian Haneline the Medical Director of the NCAA Dr. Michael McDermott-NFL Independent Neurologist Dr. Allen Sills-Chief Medical Of?cer of the NFL Future Non-Dilute Funding Opportunities Department of Defense; Combat Casualty Care-Neurotrauma Division NFL Grant Mechanisms Australian Government Rebate Program Health and Human Services, Mississippi C70 1 aw? prevocus I, ,3 I 3 PREVACUS, INC. A clinical stage company developing therapeutic agents for concussion and related disorders Lead molecule is a proprietary neurosteroid with proven in vivo efficacy in animal concussion models and safety in toxicology studies in rat, monkey and dog. i 15 other novel analogs are available for future research and generations lntranasal delivery of allows rapid targeted delivery to the brain I ABOUT mTBl? Concussion - a type of traumatic brain injury, or TBI, caused by a to the head or upper body causing the brain to shake inside of the skull ?the slinky effect? - and Outcome - a change in mental status such as amnesia, disorientation, mental fogginess, confusion, nausea or vomiting, blurred vision, headaches . at least 21 distinct are known to be caused by concussion low 4N ?is? 1 CONCUSSION . Mild Traumatic Brain Injury (mTBl or concussion) represents a significant unmet medical need - 5 Million reported incidences per year in the US alone I - Estimated medical costs in the US is $10-15 Billion per year .t - Current standard of care is rest, analgesics for headache and anti-depressants and ADHD medications when needed - Repeat concussions lead to early dementia and suicidal ideation related to Chronic Traumatic Encephalopathy AN i 1 A HIGH RISK GROUPS - Athletes - Athletes that sustain one concussion are 75% more likely to sustain a subsequent head injury Military personnel Isl - Military personnel have a 25x higher frequency of developing Post Traumatic Stress Disorder (PTSD) following a concussion - Elderly - One-third of individuals over 65 fall each year. One-half of deaths associated with falling are from brain injury Estimated costs for non-pharmaceutical treatment of a single concussion patient is $1 2, 000 PRV-002 API-MANUFACTURING The cost of the Final Drug Product for a 14-day treatment of is estimated to be about $300. Cost to manufacture API, About for 5 kg 0 Average amount need per 14-day treatment regimen @0613 mg (0.322 mg/kg/day 70kg 14 days 315 3 mg) ?i 0 5kg of API 15,873 14-day treatment regimens 0 Cost of API per 14-day treatment $94.50 the cost of the excipients: Included in cost above . 1. 1 MARKET POTENTIAL Estimated cost per treatment . $2,000 margin per dose regimen (14 days) with an ?4 estimated cost of goods of $300 Revenue to Prevacus . Capturing 1.5M concussions per year, annual revenue from PRV-002 is estimated at $2.253 1 Savings to Healthcare Industry If reduces concussion recovery time by an average of 30% for 1.5M patients per year, the estimated annual savings to the healthcare industry could be as high TIMELINE Formulation/Fill and Finish in Applicator .- Phase 1A Clinical Trial Q2/20-Q3/20-Phase 18 Clinical Trial . Phase 2A (Athletic Setting-NCAA) Phase 23 (Emergency Hospital Setting) TBD- Phase .l ABOUT PRV-002 - is a First-in-Class neurosteroid for the treatment of concussion (mTBl) - Lipophilic with easy transport across the - Administered intra-nasally - Highly efficacious in animal studies with demonstrated improved functional outcomes (memory, mood, motor) - 380-fold safety margin in laboratory animals 1 - No observed drug-related toxicity - Composition of matter, routes and methods of use owned by Prevacus r, 60- 1, I ham a Conc us 5 ion 6 (aas) Kauaw] W?xmxx?Time (hours) .. Our proprietary concussion model leads to memory and learning impairment for 48 hours. Published: VanLandingham et al, Florida State University i TREATING CONCUSSION PRV-OOZ - MEMORY SCORE Morris Water Maze Memory Score I Subject rats were trained in a Morris 400 1 Water Maze 350 1 - Subject rats were then subjected to concussion model I Post injury, rats were treated with either vehicle or PRV-002 intranasally 200 administered as a solution 150 I Memory score was established based 100 on performance in the Morris Water h?aze 300 250 *1 so *denotes significance at p<0.05, n=8, time at VthC'e PRV-0024 mg/kg 48hr post-injury AM, i TREATING 24h POST-INJURY Sensory-motor function was scored me? using the neuroscore i? neurobehavioral battery . 4 separate movement behaviors are analyzed 2W - Vestibular damage associated with concussion is the primary . predictor for PCS and PTSD 10.00? I Vehicle PRV-002 4 mg/kg TREATING CONCUSSION Thigmotaxia: Anxiety Cerebral Edema i?i?T ?zoom. OLD 0 L0 In (spuoaas) awgl anssu 01 1313M 40 0! LO 0 1 L0 138 Loo Sham Vehicle PRV-002 (4mg/kg) Vehicle (4mg/kg) ?t I Edema or swelling can occur after TBI and result in increased intracranial pressure (ICP) I Elevated ICP is associated with poor outcomes including increased mortality I PRV-OOZ reduces mTBI-related edema I Thigmotaxia a.k.a. wall-hugging represents fear- like anxiety in animals with brain injury I reduces mTBl?related thigmotaxia -. I *denotes significance at p<0.Signl Icance a . ?n . wr??f?r I I Lu; PRV-OOZ MECHANISM binds to the Pregnane Receptor (PXR) - The PXR is an intracellular receptor found in neurons, glia and the endothelium of the blood brain-barrier - Binding of to the PXR activates multiple gene response elements promoting transcription of anti-inflammatories (CD55), anti-oxidants (gluthione s-transferase) and "4 efflux channels (P-Glycoprotein) for toxins and . 4' A. PRV-002 - Acute and sub-acute dose ranging studies were executed in rats and dogs SC, IN, IV routes - MTD (IV) 38 mg/kg . - Signs of toxicity were limited to vehicle ll - 14-Day GLP toxicology in rats and dogs - Rat: MTD 46 mg/kg I Dog: MTD 46 mg/kg - No drug-related effects noted in hematology, blood chemistry, BW, F0, or histopathology (except for slight nasal turbinate irritation) PRV-002 ADMINISTRATION Breath-propelled lntranasal (IN) administration allows rapid and ?1 direct accessibility to the brain . - requires patients to blow into the device which closes the in soft palate eliminating the flow of drug to the lungs or i II esophagus . I - Minimizes systemic exposure and side effects :1 - Maximizes patient compliance - Enhances dosing efficiency . Compact and lightweight-Field Deliverable PHASE I I To be run in Australia (Healthy and Concussed) I Tax benefits hull I Ability to execute before filing IND with FDA I format in healthy volunteers I lntranasal administration I 4 cohorts (8 subjects/cohort) I 6 subjects randomized to dosages 0 - I 2 subjects randomized to vehicle I Dose levels set at 0, 0.samples to be taken at 1, 2, 4, 8 and 24-hours post dose I Patients to be observed for 5 days post final dosing ?u . I. PHASE II CLINICAL TRIAL - To be run in United States - Subjects to be college athletes - 18-24 years of age - Pre-injury baseline established at beginning of sports season - Allows each patient to serve as own baseline control - Baseline to include King Devick, vestibular balance 1 and biomarker measurements - 3 proposed cohorts (vehicle, low dose, high dose) - 14 days of BID dosing via proprietary nasal device Over 25 universities and clinics identified as study sites of interest aN - i. -3 4 PRV-OOZ SUMMARY - PRV-OOZ a First-in-Class neurosteroid for the L. treatment of concussion - IP covers composition of matter, methods of preparation and methods of use - No competing products currently available :tl - Pre-clinical efficacy established 3 - No drug-related toxicity observed 1 - Nasal formulation finalization in progress - Phase I clinical trial planned for - Phase II clinical trials planned for