CO
GNOVEMBER 4, 2013 GN
ITIVE
FASTER LEARNING
ENHANCED MEMORY
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ENHANCED MEMORY
IMPROVED MENTAL PERFORMANCE
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A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH
PERFORMANCE
A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH FORMULATIONS SUPPORTING MEMORY, LEARNING AND INTELLECTUAL PERFORMANCE
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TODAY’S MEETING
Welcome to the brave new world of Synapsa™!
MARKET OPPORTUNITY • Cognitive Healthg• The information age demographic
ABOUT SYNAPSA™• A unique, proprietary ingredientA unique, proprietary ingredient
DEEP DIVE ON THE RESEARCH• 30 years of study• Highlights of 4 clinical studies
WE’RE PLEASED TO HAVE THE Highlights of 4 clinical studies
CLAIMS, IP & MORE
DISCUSSION
OPPORTUNITY TO MEET WITH YOU TODAY!
DISCUSSION
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THE COGNITIVE HEALTH SEGMENTH ge opport nit for gro th
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CONSUMER CONCERN OVER MENTAL ABILITY GREW 47% OVER THE PAST DECADE – HEALTH Attention
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Huge opportunity for growth
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FOCUS INTERNATIONAL• Broad range of the population is concerned about
mental functioning• 33% over 65
MemoryLanguage LearningReasoning
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• 26% 18-29
“COGNITIVE HEALTH SUPPLEMENT SALES ARE POISED TO SKYROCKET” – NBJ
gProblem solvingMoodSleep
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• 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 WITHHIGH GROWTH PROSPECTS
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PEAK PERFORMANCEA i ti d i t it
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MOST COGNITIVE HEALTH SUPPORT STUDIES & SUPPLEMENTS FOCUS ON
PEAK PERFORMERS IN THE USA
An existing and growing opportunity
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PSTUDIES & SUPPLEMENTS FOCUS ON ISSUES OF COGNITIVE DECLINE
VAST NEED & MARKET OPPORTUNITY
IN THE USA
Knowledge workersOver 100 million in 2014(Infotrends 2011)
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VAST NEED & MARKET OPPORTUNITY FOR SUPPORT IN AREAS OF COGNITIVE PERFORMANCE RELATED TO STUDY & WORK
(Infotrends, 2011)
College & University Students21.8 million in 2013 (US Dept of Education)
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40% of
WORK (US Dept. of Education)
40% of US population
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ALREADY AN ACTIVE MARKETC ff i & th “ ti l t ”
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STUDENTS
Caffeine & other “stimulants”
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UndergraduatePost GraduateMedicalLegal
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KNOWLEDGE WORKERS
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WORKERSSoftwareArchitectsEngineers
Nearly 63% of medical students report ‘academic performance’ as
ScientistsFinancial servicesLegalMedia/Social Media
reason for consuming caffeine (Lee K-H, et al 2009)
Media/Social Media
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A PLATFORM FOR ‘PEAK PERFORMANCE’S ™ N t l M S t
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Safe, natural support Quality
Synapsa™ Natural Memory Support
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P, ppfor healthy adults looking for ‘peak performance’
Q yControl
Cli i lO
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• Learning• Memory• Academic
Clinical Support
Ongoing Research
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performance• Workplace
performanceIP
New Product IPProduct
Concepts
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ING
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THE FUTURE OF QUALITY
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OF QUALITY
LITY
PATENTED EXTRACTSEED-TO-SHELF QUALITY
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A UNIQUE COMPOSITIONCli i ll t di d i di t d d b t t d
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MULTI-PATENTED PROCESS
Clinically studied ingredient produced by patented process
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The unique method• India 185078 (2961/DEL/1996): extraction
of a formulations mainly containing bacosides
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,
The unique method of making Synapsa™ – the clinically-studied ingredient – LITY
gis patented.
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SEED-TO-SHELF QUALITYKe to reprod cible clinical trial res lts
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Each step can influence th fi l d t’
Synapsa™ is a unique extract of Bacopa monnieri, with a wide range of Seed
Key to reproducible clinical trial results
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the final product’s complex phytochemical profile and therapeutic action
p , gactive constituents that contribute to its therapeutic properties
Result of over 30 years extensive
Planting
Growing
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Putting farming & manufacturing controls in place across each step allows for consistency of the
yresearch & development at the Central Drug Research Institute (CDRI) in India
Consistent farming & manufacturing
Harvesting
Extraction
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consistency of the entire product & results in a product that can be clinically studied
g gprocesses from to ensure a standardized level of quality Production
Storage
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CLINN
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THE FUTURE OF COGNITIVE
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CCOGNITIVE RESEARCH
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A FOCUS ON HEALTHY ADULTS
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COGNITIVE BENEFIT AREASD t f li i l t i l h t ti ti ll i ifi t lt
VALU
FASTER INFORMATION PROCESSING These studies focus
Data from clinical trials show statistically significant results UE
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IMPROVED LEARNING RATE
DECREASED FORGETTING RATE
,These studies focus on healthy adults from 18 to 65
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IMPROVED MEMORY CONSOLIDATION
BETTER MULTI-TASKING ACCURACY
ON
SYNAPSA™ STUDIES SHOW BOTH CHRONIC AND ACUTE EFFICACY
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COGNITIVE STUDY BACKGROUNDSt li i l t
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• 7 ‘foundational’ clinical trials The scientific
Strong clinical support
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• 6 ‘targeted’ randomized, double-blind, placebo-controlled clinical trials
• Additional clinical trials underway and ,
evidence for the cognitive enhancing effect of S ™ N t l
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planned
• Synapsa™ has been shown to be safe, well tolerated and devoid of
,Synapsa™ Natural Memory Support is based on 30 years of research
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undesirable side effects in clinical studies
years of research
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SUMMARY OF CLINICAL PROGRAMCh i d t ff t f S ™
CLIN
Chronic Use of Synapsa™ – Key StudiesStough et al. The chronic effects of an extract of Bacopa monnieri on cognitive function in healthy human subjects Psychopharmacology 2001; 156:481 484
Chronic and acute effects of Synapsa™
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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
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Cmemory impairment, Indian Journal of Psychiatry, 2006; 48:238-242. 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
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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 ( ) gPhytotherapy 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 2013y py
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STOUGH, ET AL. 2001Vi l i l i t & lid ti
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Details Summary of Results• Double-blind placebo-controlled, Significant improvement in:
Visual processing, learning rate & memory consolidation
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Double blind placebo controlled, • 46 healthy participants, 18-60 yrs • 3 months, 300 mg/d Synapsa™• Independent-group design
Significant improvement in:• Information processing• Memory consolidation• Reduction in state anxiety
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• t = baseline, 5 & 12 weeksMaximal effects evident after 12 weeks
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ROODENRYS, ET AL. 2002I f ti t ti
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Details Summary of Results• Double-blind placebo-controlled, Significant effect on:
Information retention
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• 76 healthy participants, 40-65 yrs• 3 months, 300 mg/d Synapsa™,
followed by 6 week post-trial assessment
• Retention of new information, • Verbal and visual short-term
memory.
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Cassessment• t = baseline, 90 days & 6 weeks post
treatment
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STOUGH, ET AL. 2008W ki i l i f ti i &
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Details Summary of Results
Working memory, visual information processing & accuracy
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y• Double-blind, placebo-controlled• 107 healthy participants, 18-60
3 months, 300 mg/d Synapsa™t b li d 90 d
Significant improvements in:• Working Memory • Visual Information Processing
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• t = baseline and 90 days
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DOWNEY, ET AL. 2012I d f iti l d di t t ( t )
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Details Summary of Results
Improved performance on cognitively demanding tests (acute)
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• Double-blind, placebo-controlled, cross-over
• 24 healthy adults subjects• 320mg 640mg acute doses Synapsa™
Improved performance on cognitively demanding tests from 320 mg dose (Cognitive Demand Battery)
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C• 320mg, 640mg acute doses Synapsa™ Battery)
THE CDR SYSTEM:
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• 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
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ON-GOING STUDIES CLIN
One of the most
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Additional indications/targets:
aggressive & comprehensive research programs
f iti h lth
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• Inattention• Acute dosing• Cognition enhancement• fMRI
of a cognitive health ingredient in the industry
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• fMRI • Dementia/Alzheimer’s• Basic pharmacology
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THE FUTURE OF EXCITING NEW
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NEW INDICATIONSNEW IPNEW CLAIMS
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ADDRESSING THE AGING POPULATIONS ™ A t li R h C il’ Ch i f B
CLIN
ARCLI (AUSTRALIAN RESEARCH Aging population h ld t
Synapsa™: Australian Research Council’s Choice of Bacopa
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COUNCIL LONGEVITY INTERVENTION)• 465 cognitively healthy older adults (60-75
years old) are being randomized to receive Synapsa™ (300 mg) Pycnogenol (150 mg)
should want Synapsa™ now… and even more in the future
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CSynapsa (300 mg), Pycnogenol (150 mg), or placebo daily for 12 months
• Participants will be evaluated at baseline, 3, 6 and 12 months post-randomization for a
the future CH
variety of cognitive, cardiovascular, and biochemical parameters
• Design published in the Nutrition Journal, 20122012
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PATENT PENDING FILINGA t t S ™ f t
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APPLICATION PATENT Patented support for t t t ki & th
A new patent on Synapsa™ for acute use
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• Pending: Methods for acutely improving/enhancing cognitive performance in a human subject
i i d i i t ti f t t
test taking & other peak performance cognitive environments
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comprising administration of an extract of Bacopa monnieri.
• Filing December 2013
environments
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POTENTIAL PRODUCT CLAIMSCli i l t f diff t k t ff i
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• Clinically shown to improve the speed of information processing The scientific
Clinical support for different market offerings
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• Supports the transition of short term memory to long term memory
• Aids in the retention of new information
The scientific evidence for the cognitive enhancing effect
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• Helps improve learning rate & memory
• A single ingredient that can support learning, memory, and mental performance
enhancing effect of Synapsa™ is based on 30 years of research
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• One ingredient. Better, faster learning.
• Better performance on cognitively demanding tests
years of research
• Improved mental performance when it counts
*The above claims are intended as suggestions only. Use of claims on product labeling and marketing materials should be vetted and approved by your regulatory and legal departments.
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TWO DISTINCT PRODUCT TYPESD il & P k P f t 320 /d
VALU
Daily
Daily & Peak Performance at 320 mg/d UE
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Supplementation to Improve Learning & Memory Same Day
OP
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ITISame Day Supplementation for Improved Mental Performance in Cognitively
ON
Cognitively Demanding Environments
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CO
GGN
ITIVE
FASTER LEARNING
ENHANCED MEMORY
E H
EA
LT
ENHANCED MEMORY
IMPROVED MENTAL PERFORMANCE
H
A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH
PERFORMANCE
A FOUNDATIONAL INGREDIENT FOR COGNITIVE HEALTH FORMULATIONS SUPPORTING MEMORY, LEARNING AND INTELLECTUAL PERFORMANCE
24
APPENDIX
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COGNITIVE FUNCTIONING GLOSSARY CLINN
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Learning/Learning rate Acquisition new information or reinforcement of existing knowledge or skills. May involve synthesizing different types of information.
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synthesizing different types of information.
Working Memory Process that provides temporary storage and manipulation of the information necessary for complex cognitive tasks such as learning C
Hcomplex cognitive tasks such as learning,reasoning and language comprehension.
Memory Consolidation Transition of information from short-term to long-term memory.
Information Retention The second stage of memory after encoding and before retrieval.
Visual Information Processing
A measure of the ability to sustain attention.
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BACOPA MONNIERI ALTERNATIVESF i & th L k f bli h d d/ t di
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Focus on aging & other. Lack of published and/or new studies.
• Studies focusing on trauma & children
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BACOPIN™ • Few published studies• No recent studies• Website not updated since 2005• 3 Studies, 2 focusing on elderly & 1 on
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BACOMIND™3 Studies, 2 focusing on elderly & 1 on children with low IQ
• No ongoing support
BACOGNIZE™ • No clinical studies actually published
ALY
SIS
BACOGNIZE™ No clinical studies actually published • Borrowed science (from Synapsa™)
Generic • No published clinical studiesGeneric p• Lack of transparency on sourcing/quality
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