COG NOVEMBER 4, 2013 GNITIVE E HEALT FASTER LEARNING ENHANCED - PowerPoint PPT Presentation

COG NOVEMBER 4, 2013 GNITIVE E HEALT FASTER LEARNING ENHANCED MEMORY ENHANCED MEMORY H IMPROVED MENTAL PERFORMANCE PERFORMANCE A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH FORMULATIONS SUPPORTING MEMORY, LEARNING AND INTELLECTUAL PERFORMANCE 1

TODAY’S MEETING Welcome to the brave new world of Synapsa™! MARKET OPPORTUNITY • Cognitive Health g • The information age demographic ABOUT SYNAPSA™ • A unique, proprietary ingredient A unique, proprietary ingredient DEEP DIVE ON THE RESEARCH WE’RE PLEASED TO • 30 years of study HAVE THE • Highlights of 4 clinical studies Highlights of 4 clinical studies OPPORTUNITY TO CLAIMS, IP & MORE MEET WITH YOU TODAY! DISCUSSION DISCUSSION 2

THE COGNITIVE HEALTH SEGMENT MAR RKET OP Huge opportunity for growth H ge opport nit for gro th CONSUMER CONCERN OVER MENTAL ABILITY Attention GREW 47% OVER THE PAST DECADE – HEALTH PPORTU M Memory FOCUS INTERNATIONAL • Broad range of the population is concerned about Language mental functioning Learning • 33% over 65 Reasoning g UNITY • 26% 18-29 Problem solving Mood “COGNITIVE HEALTH SUPPLEMENT SALES ARE Sleep POISED TO SKYROCKET” – NBJ • 2011 U.S. cognitive health sales grew 6% to $1.4B • Ground floor opportunity: The category accounts for less than 5% of U.S supplement sales HUGE MARKET OPPORTUNITY WITH HIGH GROWTH PROSPECTS 3

PEAK PERFORMANCE MAR RKET OP An existing and growing opportunity A i ti d i t it MOST COGNITIVE HEALTH SUPPORT PEAK PERFORMERS IN THE USA IN THE USA STUDIES & SUPPLEMENTS FOCUS ON STUDIES & SUPPLEMENTS FOCUS ON PPORTU ISSUES OF COGNITIVE DECLINE Knowledge workers Over 100 million in 2014 (Infotrends 2011) (Infotrends, 2011) UNITY VAST NEED & MARKET OPPORTUNITY VAST NEED & MARKET OPPORTUNITY FOR SUPPORT IN AREAS OF COGNITIVE College & University Students 21.8 million in 2013 PERFORMANCE RELATED TO STUDY & (US Dept of Education) (US Dept. of Education) WORK WORK 40% of 40% of US population 4

ALREADY AN ACTIVE MARKET MAR RKET OP Caffeine & other “stimulants” C ff i & th “ ti l t ” STUDENTS PPORTU Undergraduate Post Graduate Medical Legal Legal UNITY KNOWLEDGE WORKERS WORKERS Software Architects Nearly 63% of medical students Engineers report ‘academic performance’ as Scientists reason for consuming caffeine (Lee K-H, et al 2009) Financial services Legal Media/Social Media Media/Social Media 5

A PLATFORM FOR ‘PEAK PERFORMANCE’ MAR RKET OP Synapsa ™ Natural Memory Support S ™ N t l M S t Safe, natural support , pp Q Quality y PPORTU Control for healthy adults looking for ‘peak performance’ UNITY Clinical Cli i l O Ongoing • Learning Research Support • Memory • Academic performance • Workplace performance New IP IP Product Product Concepts 6

INGREDIEN NT QUAL LITY 7 SEED-TO-SHELF QUALITY PATENTED EXTRACT THE FUTURE OF QUALITY OF QUALITY

A UNIQUE COMPOSITION INGR Clinically studied ingredient produced by patented process Cli i ll t di d i di t d d b t t d REDIEN MULTI-PATENTED PROCESS NT QUAL The unique method The unique method • India 185078 (2961/DEL/1996): extraction of making Synapsa™ of a formulations mainly containing – the clinically- , bacosides studied ingredient – g LITY is patented. 8

SEED-TO-SHELF QUALITY INGR Ke Key to reproducible clinical trial results to reprod cible clinical trial res lts REDIEN Synapsa™ is a unique extract of Seed Each step can influence Bacopa monnieri, with a wide range of g p , NT QUAL the final product’s th fi l d t’ active constituents that contribute to its complex phytochemical Planting therapeutic properties profile and therapeutic action Growing Result of over 30 years extensive y LITY research & development at the Central Putting farming & Harvesting Drug Research Institute (CDRI) in India manufacturing controls in place across each step allows for Extraction Consistent farming & manufacturing g g consistency of the consistency of the processes from to ensure a entire product & results Production standardized level of quality in a product that can be clinically studied Storage 9

CLINICAL R RESEARC CH 10 THE FUTURE OF HEALTHY ADULTS COGNITIVE RESEARCH COGNITIVE A FOCUS ON

COGNITIVE BENEFIT AREAS VALU D t Data from clinical trials show statistically significant results f li i l t i l h t ti ti ll i ifi t lt UE PRO FASTER INFORMATION PROCESSING These studies focus These studies focus OPOSITI on healthy adults , IMPROVED LEARNING RATE from 18 to 65 DECREASED FORGETTING RATE ON IMPROVED MEMORY CONSOLIDATION BETTER MULTI-TASKING ACCURACY SYNAPSA™ STUDIES SHOW BOTH CHRONIC AND ACUTE EFFICACY 11

COGNITIVE STUDY BACKGROUND CLIN NICAL R St Strong clinical support li i l t • 7 ‘foundational’ clinical trials The scientific RESEARC • 6 ‘targeted’ randomized, double-blind, evidence for the placebo-controlled clinical trials cognitive enhancing effect of • Additional clinical trials underway and , , CH S Synapsa™ Natural ™ N t l planned Memory Support • Synapsa™ has been shown to be is based on 30 safe, well tolerated and devoid of years of research years of research undesirable side effects in clinical studies 12

SUMMARY OF CLINICAL PROGRAM CLIN NICAL R Chronic and acute effects of Synapsa™ Ch i d t ff t f S ™ Chronic Use of Synapsa™ – Key Studies Stough et al. The chronic effects of an extract of Bacopa monnieri on cognitive function in healthy RESEARC human subjects Psychopharmacology 2001; 156:481 484 human subjects, Psychopharmacology, 2001; 156:481-484. Roodenrys et al. Chronic effects of Brahami on human memory, Neuropsychopharmacology, 2002; 27:279-281. Raghav et al. Randomized controlled trial of standardized Bacopa monnieri extract in age-associated memory impairment, Indian Journal of Psychiatry, 2006; 48:238-242. memory impairment Indian Journal of Psychiatry 2006; 48:238 242 CH Stough et al. Examining the nootropic effects of a special extract of Bacopa monniera on human cognitive functioning, Phytotherapy Research, 2008; 22:1629-1634. Acute Use of Synapsa™ – Key Studies Nathan et al. The acute effects of an extract of Bacopa monniera (Brahmi) on cognitive function in healthy normal subjects, Human Psychopharmacology, 2001; 16:345-351. Downey et al. An Acute, Double-Blind, Placebo-Controlled Crossover Study of 320 mg and 640 mg Doses of a Special Extract of Bacopa monnieri (CDRI 08) on Sustained Cognitive Performance. p p ( ) g Phytotherapy Research 2012; 27:1407-1413. Benson S, Downey LA, Stough C et al. An Acute, Double-Blind, Placebo-Controlled Cross-over Study of 320 mg and 640 mg Doses of Bacopa monnieri (CDRI 08) on Multitasking Stress Reactivity and Mood. Phytotherapy Research 21 Jun 2013 y py 13

STOUGH, ET AL. 2001 CLIN NICAL R Visual processing, learning rate & memory consolidation Vi l i l i t & lid ti Details Summary of Results RESEARC • Double-blind placebo-controlled, Double blind placebo controlled, Significant improvement in: Significant improvement in: • • 46 healthy participants, 18-60 yrs Information processing • • 3 months, 300 mg/d Synapsa™ Memory consolidation • • Independent-group design Reduction in state anxiety • t = baseline, 5 & 12 weeks CH Maximal effects evident after 12 weeks 14

ROODENRYS, ET AL. 2002 CLIN NICAL R Information retention I f ti t ti Details Summary of Results • Double-blind placebo-controlled, Significant effect on: RESEARC • 76 healthy participants, 40-65 yrs • Retention of new information, • 3 months, 300 mg/d Synapsa™, • Verbal and visual short-term followed by 6 week post-trial memory. assessment assessment CH • t = baseline, 90 days & 6 weeks post treatment 15

STOUGH, ET AL. 2008 CLIN NICAL R Working memory, visual information processing & accuracy W ki i l i f ti i & Details Summary of Results y RESEARC • Double-blind, placebo-controlled Significant improvements in: • 107 healthy participants, 18-60 • Working Memory 3 months, 300 mg/d Synapsa™ • Visual Information Processing • t t = baseline and 90 days b li d 90 d CH 16

DOWNEY, ET AL. 2012 CLIN NICAL R Improved performance on cognitively demanding tests (acute) I d f iti l d di t t ( t ) Details Summary of Results RESEARC • Double-blind, placebo-controlled, Improved performance on cross-over cognitively demanding tests from • 24 healthy adults subjects 320 mg dose (Cognitive Demand • • 320mg 640mg acute doses Synapsa™ 320mg, 640mg acute doses Synapsa™ Battery) Battery) CH THE CDR SYSTEM: • Used in worldwide clinical trials since 1984. Over 900 trials. • Attention, Concentration, Vigilance • • Working (Short Term) Memory Working (Short-Term) Memory • Episodic (Long-Term) Memory 17

ON-GOING STUDIES CLIN NICAL R One of the most RESEARC aggressive & Additional comprehensive indications/targets: research programs of a cognitive health f iti h lth CH • Inattention ingredient in the • Acute dosing industry • Cognition enhancement • fMRI • fMRI • Dementia/Alzheimer’s • Basic pharmacology 18