2021-11-23T07:31:39-06:00 2021-06-30 431985162 SMITH SULLIVAN & BROWN PC 80 FLANDERS ROAD - SUITE 200 WESTBOROUGH MA 01581 990 2020-07-01 471981973 COHEN VETERANS BIOSCIENCE INC COHE 6469704325 1 BROADWAY 14TH FLOOR CAMBRIDGE MA 02142 MAGALI HAAS MD PHD CEO & PRESIDENT 6469704325 2021-11-23 1 MAGALI HAAS MD PHD 999009999 SANDRA M BROWN CPA P01614103 5088717178 2021-11-23 2 AAL1 IAL1 2020 2022-09-23 18:48:47Z MAGALI HAAS MD PHD 1 BROADWAY 14TH FLOOR CAMBRIDGE MA 02142 16252270 0 X WWW.COHENVETERANSBIOSCIENCE.ORG X 2014 MA BIOMEDICAL RESEARCH AND TECHNOLOGY ORGANIZATION DEDICATED TO ADVANCING BRAIN HEALTH BY FAST-TRACKING PRECISION DIAGNOSTICS AND TAILORED THERAPEUTICS. 6 4 40 15 0 0 16316026 16160581 0 0 154639 59585 0 32104 16470665 16252270 1112861 235660 0 0 7099520 8452791 0 50600 676082 9950539 9371369 18162920 18110420 -1692255 -1858150 18865456 17952584 8431760 6826523 10433696 11126061 X COHEN VETERANS BIOSCIENCE, INC. IS A NON-PROFIT 501(C)(3) BIOMEDICAL RESEARCH AND TECHNOLOGY ORGANIZATION DEDICATED TO ADVANCING BRAIN HEALTH BY FAST-TRACKING PRECISION DIAGNOSTICS AND TAILORED THERAPEUTICS. 0 0 15292239 235660 0 BRAIN HEALTH PLATFORMS:IN ORDER TO FAST-TRACK PRECISION DIAGNOSTICS AND PERSONALIZED THERAPEUTICS AND WELLNESS APPROACHES FOR MAINTENANCE AND RESTORATION OF BRAIN HEALTH, CVB IS LEVERAGING INNOVATION AND TECHNOLOGY TO BUILD PLATFORMS THAT ENABLE DISCOVERY AND DEVELOPMENT ACROSS BRAIN DISEASES. THESE PLATFORMS ALLOW RESEARCHERS FROM ACADEMIA AND INDUSTRY TO ACCESS AND UTILIZE BEST-IN-CLASS TOOLS AND ALLOW EFFORTS TO BE SCALED WITH RIGOR AND REPRODUCIBILITY.(SEE SCHEDULE O FOR FULL DETAIL OF OUR PROGRAMS)PLATFORM EFFORTS FOCUS ON CAPACITY THAT ENABLES RELIABLE DISCOVERY OF BIOMARKERS AND BIOLOGICAL PATHWAYS THAT ARE TRANSLATIONALLY RELEVANT FOR THE DEVELOPMENT OF DIAGNOSTICS AND THERAPEUTIC TARGETS FOR DRUG AND OTHER MEDICAL INTERVENTIONS. EACH PLATFORM IS CREATING RESEARCH TOOLS (E.G. ANIMAL MODELS, DATA STANDARDS, COMPUTATIONAL MODELS, REFERENCE DATABASES, ETC.) THAT WILL ACCELERATE/FOSTER THESE DISCOVERIES. WITHIN THIS FRAMEWORK, CVB HAS ESTABLISHED BOTH INTRAMURAL (RESEARCH CONDUCTED BY, OR INCLUDING, CVB STAFF OR CONTRACTORS) AND EXTRAMURAL RESEARCH PROGRAMS (RESEARCH CONDUCTED VIA GRANTS OR IN COLLABORATION WITH EXTERNAL ACADEMIC, INDUSTRY, FOUNDATION AND GOVERNMENT PARTNERS) AND ALSO OPERATES SEVERAL PUBLIC-PRIVATE PARTNERSHIPS. THESE COOPERATIVE ALLIANCES ORGANIZE AND FUND A NETWORK OF PARTNERS WHO EACH CONTRIBUTE COMPLEMENTARY AND SYNERGISTIC DATA, CAPABILITIES, OR EXPERTISE TO SUPPORT A COMMON ROADMAP FOR IDENTIFYING DIAGNOSTIC BIOMARKERS, BUILDING PREDICTIVE BRAIN DISEASE MODELS, DEVELOPING ROBUST STANDARDIZED TRANSLATIONAL TOOLS, AND CATALYZING PHARMACEUTICAL DRUG DEVELOPMENT. THE EMPHASIS IS ON TEAM SCIENCE WITH COHEN VETERANS BIOSCIENCE SERVING AS ITS HUB.OUR PLATFORM PROGRAMS CURRENTLY INCLUDE THE BRAIN COMMONS (CLOUD-BASED DATA SHARING), EARLYSIGNAL (WEARABLE AND HOME SENSORS FOR MONITORING HEALTH STATUS), RAPID-DX (ESTABLISHING BEST PRACTICES FOR DISCOVERY AND VALIDATION OF BIOMARKERS) AND AMP-IT-UP (FOR PRECLINICAL DISCOVERY AND TRANSLATION).BRAINCOMMONS:WE ARE IN A NEW ERA OF BRAIN RESEARCH, WHERE POWERFUL DATA ACQUISITION TECHNOLOGIES ARE GENERATING MULTIMODAL DATA AT INCREASING SCALES. OUR PRIMARY CHALLENGE TODAY EXTENDS BEYOND DATA GENERATION; RATHER, IT LIES IN DATA UTILIZATION AND KNOWLEDGE EXTRACTION. TO ENABLE DISEASE MODELING EFFORTS, AS WELL AS THE DISCOVERY AND REPLICATION OF BIOMARKERS, THERE IS A CRITICAL NEED FOR A PLATFORM THAT CAN HOUSE MULTI-MODAL DATA TYPES, ACROSS DIAGNOSTIC CATEGORIES, IN CONJUNCTION WITH DATA PIPELINES TO ENSURE REPRODUCIBLE ANALYSIS, AND WITH AN ABILITY TO APPLY STATE-OF-THE-ART, MACHINE-LEARNING ALGORITHMS. THE BRAINCOMMONS AIMS TO DELIVER ON THIS POTENTIAL, AS THE FIRST BIG-DATA CLOUD-BASED PLATFORM FOR COMPUTATIONAL INNOVATION DISCOVERY IN BRAIN DISEASES THAT SUPPORTS RAW DATA INTEGRATION, INTEROPERABILITY BETWEEN SYSTEMS AND A DATA MODEL THAT OFFERS A COMPATIBLE FORMAT ADHERING TO COMMON STANDARDS WHERE ALL THE DATA, NO MATTER THE SIZE OR TYPE, CAN BE COMBINED FOR RE-USE, FUELING DISCOVERY AND COLLABORATION ACROSS THE MULTIDISCIPLINARY AND MULTI-SECTOR RESEARCH COMMUNITY, AND DRIVING DIAGNOSTIC AND THERAPEUTIC INNOVATION TO REDUCE THE BURDEN OF BRAIN-BASED DISORDERS. EARLYSIGNAL:WEARABLE AND SENSOR TECHNOLOGIES HOLD PROMISE IN THE ASSESSMENT AND CONTINUOUS MONITORING OF PATIENTS IN ORDER TO BETTER SCREEN AND DIAGNOSE, MONITOR DISEASE PROGRESSION, AND OBSERVE INTERVENTION RESPONSE OR LACK THEREOF. DIGITAL HEALTH MONITORING ALSO ALLOWS US TO STUDY BRAIN HEALTH AND DISEASE IN UNPRECEDENTED WAYS, BY TRACKING VARIABLES SUCH AS SLEEP, PHYSICAL ACTIVITY, STRESS AND COGNITION, WE MAY BE ABLE TO BETTER UNDERSTAND WHAT CHANGES OVER TIME, AND TO DEVELOP EARLIER AND PREVENTIVE DIAGNOSTICS AND TREATMENTS TO MAKE A DIFFERENCE IN PATIENTS' LIVES. MEDICAL-GRADE DATA IS NEEDED FOR FDA APPROVAL OF SUCH PLATFORMS FOR USE IN MEDICAL DECISION MAKING AND DATA INTEGRATION IS NECESSARY FOR CLINICIANS' WORKFLOW. THIS PROGRAM SUPPORTS MULTIPLE PARTNERS TO TEST AND VALIDATE WEARABLES, SENSORS, APPS AND OTHER DIGITAL HEALTH TECHNOLOGIES FOR USE IN MONITORING BRAIN HEALTH. A CURRENT EXAMPLE OF SUCH WORK IS CVB'S PARTNERSHIP WITH UNIVERSITY OF PENNSYLVANIA, CONDUCTING A STUDY TO TEST AND VALIDATE THE PERFORMANCE OF WEARABLE AND SENSOR DEVICES, USING CVB DESIGNED SECURE AUTOMATED DEIDENTIFIED DATA COLLECTION AND CVB'S STUDY MANAGER TOOL TO SUPPORT CONDUCT OF THE TRIAL. IN 2021, WE HAVE ELABORATED THIS PLATFORM FURTHER WITH OUR TRIAL-IN-A-BOX INTEGRATED SYSTEM. TRIAL-IN-A-BOX IS A FULLY AUTOMATED CLINICAL TRIAL SOLUTION FOR THE COLLECTION AND AUTOMATED PROCESSING AND ANALYSIS OF DIGITAL HEALTH DATA IN TRADITIONAL, HYBRID, AND FULLY DECENTRALIZED TRIAL FORMATS. IN THE FULLY DECENTRALIZED SETTING, THIS ALLOWS STUDY SPONSORS TO SEND WEARABLE AND HOME SENSOR TECHNOLOGY STUDY KITS DIRECTLY TO ELIGIBLE STUDY PARTICIPANTS WITHOUT REQUIRING THEM TO VISIT A STUDY CENTER, ENABLING A MORE DIVERSE AND OFTEN LESS-STUDIED POPULATION TO PARTICIPATE. THE PROVIDED DEVICES ARE PAIRED WITH A DOWNLOADABLE STUDY APP ON THE PARTICIPANT'S OWN DEVICE TO COLLECT RELATED SUBJECTIVE OUTCOMES SUCH AS TRADITIONAL SCALES OF DEPRESSION, FUNCTION, AND ACTIVITY AS WELL ECOLOGICAL MOMENTARY ASSESSMENTS.RAPID-DIAGNOSTICS (RAPID-DX):A BIOMARKER IS A CHARACTERISTIC THAT IS OBJECTIVELY MEASURED AND EVALUATED AS AN INDICATOR OF A NORMAL OR PATHOLOGIC BIOLOGICAL PROCESS OR A RESPONSE TO A THERAPEUTIC INTERVENTION. DEVELOPING BIOMARKER-BASED DIAGNOSTICS IS ESSENTIAL TO SHIFTING DIAGNOSIS AND TREATMENT OF PSYCHIATRIC AND NEUROLOGIC CONDITIONS (SUCH AS PTSD AND TBI) FROM A SYNDROMIC OR SYMPTOM-BASED APPROACH TO A BIOLOGICAL, MECHANISTICALLY-BASED ONE THAT TARGETS THE EFFECTS OF TRAUMA AT THEIR MOLECULAR ROOTS. MANY POTENTIAL BRAIN-RELATED BIOMARKERS PUBLISHED IN THE LITERATURE HAVE NOT BEEN INDEPENDENTLY REPLICATED OR ADVANCED THROUGH A QUALIFICATION PROCESS FOR REGULATORY APPROVAL AND USE.RAPID-DX IS A PUBLIC-PRIVATE PARTNERSHIP PROGRAM INCLUDING GOVERNMENT, FOUNDATIONS, AND LEADING ACADEMIC CENTERS ESTABLISHED FOR COLLECTING DATA AND PERFORMING STUDIES NECESSARY TO DISCOVER AND REPLICATE BIOMARKERS AND QUALIFY SUCCESSFUL AND RELEVANT CANDIDATES FOR DEVELOPMENT AS CLINICAL DIAGNOSTICS.THROUGH THIS PROGRAM CVB HAS ESTABLISHED THE CVB BRAIN BIOREPOSITORY IN PARTNERSHIP WITH INDIANA UNIVERSITY. THE GOAL OF THE BIOREPOSITORY IS TO ESTABLISH A CENTRALIZED RESOURCE FOR TISSUE AND BIOSAMPLE STORAGE FOR ENABLING BIOMARKER DISCOVERY, REPLICATION, AND VALIDATION ACROSS A NUMBER OF BRAIN CONDITIONS, INCLUDING POST-TRAUMATIC STRESS DISORDER ("PTSD"), TRAUMATIC BRAIN INJURY ("TBI"), SUICIDE, DEMENTIA, MAJOR DEPRESSIVE DISORDER AND OTHER MENTAL HEALTH DISORDERS, AMONG OTHERS.THE CVB BRAIN BIOREPOSITORY HOUSES BLOOD AND SALIVA SAMPLES THAT WERE COLLECTED AS PART OF BIOMARKER STUDIES DIRECTLY SPONSORED BY COHEN VETERANS BIOSCIENCE OR THROUGH KEY PARTNERSHIP PROGRAMS. OUR BIOREPOSITORY BANKS A VARIETY OF BIOLOGIC SAMPLES INCLUDING, PLASMA, SERUM, AND SALIVA, AND WILL ENCOURAGE FUTURE COLLABORATIONS WITH RESEARCHERS FROM ACADEMIA, INDUSTRY, GOVERNMENT AND FOUNDATIONS.IN 2021, CVB COMPLETED AND PUBLISHED OUR CROSS-PLATFORM COMPARISON OF METABOLOMIC ASSAYS. THIS 'BAKE-OFF' STUDY IS THE SECOND IN A SERIES THAT EVALUATES THE PERFORMANCE OF FLUID-BASED ASSAYS AND BUILDS ON OUR FORMER WORK ON CYTOKINE ASSAYS. METABOLOMICS CAN CHARACTERIZE THE GLOBAL BIOCHEMICAL ACTIVITY OF AN INDIVIDUAL AND IS SENSITIVE TO EXTERNAL FACTORS, INCLUDING LIFESTYLE AND MEDICINES USED. ACCURATE AND STANDARDIZED MEASUREMENT PLATFORMS ARE IMPORTANT TOOLS TO ADVANCE BIOMARKER RESEARCH, UNDERSTAND DISEASE MECHANISMS, AND ASSIST IN IDENTIFYING THERAPEUTIC TARGETS. CURRENTLY, THERE IS SIGNIFICANT VARIABILITY IN THE TECHNIQUES USED TO MEASURE METABOLITES. PERFORMANCE VARIES GREATLY BY METABOLITE AND METABOLITE CLASS, AND THE NUMBER AND TYPE OF METABOLITES MEASURED CAN ALSO VARY OVER TIME. VARIABILITY IN THE PLATFORMS USED FOR MEASUREMENT MAKES CROSS-STUDY COMPARISONS AND RELIABILITY OF THE OUTPUT DIFFICULT. IN OUR PROGRAM, INVESTIGATORS DESIGNED AND CONDUCTED A BLINDED EVALUATION OF PERFORMANCE METRICS SUCH AS INTRA/INTER-ASSAY PRECISION, ACCURACY, AND LINEARITY, BASED ON DATA RECEIVED FROM FIVE PROMINENT COMMERCIAL VENDORS WHO WERE PROVIDED BLINDED BLOOD SAMPLES FROM INDIVIDUALS WITH NEUROPSYCHIATRIC DISEASE AND A HEALTHY CONTROL GROUP. THE FINDINGS DEMONSTRATE IMPORTANT VARIABILITY ACROSS PLATFORMS THAT SHOULD BE CONSIDERED WHEN DESIGNING EXPLORATORY OR CONFIRMATORY BIOMARKER STUDIES.BRAIN TRAUMA PROGRAMS:POST-TRAUMATIC STRESS DISORDER AND TRAUMATIC BRAIN INJURYTHIS CVB PROGRAM WAS FOUNDED IN 2015 TO ESTABLISH A NATIONAL RESEARCH ROADMAP FOR PTSD, TBI AND RELATED CONDITIONS (E.G. SUICIDALITY). BRAIN TRAUMA BLUEPRINT - STATE OF THE SCIENCE SUMMITSTHE BRAIN TRAUMA BLUEPRINT IS A SERIES OF STATE OF THE SCIENCE SUMMITS AIMED TO BUILD CONSENSUS AROUND KNOWLEDGE GAPS AND DEVELOP STRATEGIES TO MOVE THE FIELD FORWARD FOR TRAUMA-RELATED CONDITIONS BY LEVERAGING THE COMBINED INTELLECTUAL RESOURCES OF THE FULL RESEARCH COMMUNITY.THE STATE OF THE SCIENCE SUMMITS ARE DESIGNED AS RETREATS FOR 100 TO 200 STAKEHOLDERS TO COME TOGETHER TO REALIZE TRUE IMPACT. THE STAKEHOLDERS ENCOMPASS A BROAD SWATH OF THE COMMUNITY FROM ACADEMIC INSTITUTIONS TO GOVERNMENT AGENCIES, FOUNDATIONS SUPPORTING TRANSLATIONAL RESEARCH, AND INDUSTRY.EACH SUMMIT SERVES AS A LAUNCHPAD FOR ONGOING WORKING GROUPS TO DEVELOP EVIDENCE-BASED STRATEGIES AND RECOMMENDATIONS ON HOW TO FILL THOSE GAPS, IDENTIFY NEW GAPS AS OTHERS ARE FILLED, AND DISSEMINATE THESE FINDINGS BACK TO THE COMMUNITY AT LARGE THROUGH WHITE PAPERS AND PROCEEDINGS.THE INAUGURAL STATE OF THE SCIENCE SUMMIT ("SOSS"), HELD IN 2018, FOCUSED ON DIAGNOSIS OF TRAUMA-RELATED BRAIN DISORDERS WITH A MAJOR FOCUS ON POST-TRAUMATIC STRESS DISORDER. THE TRAUMA-RELATED BRAIN DISORDERS RESEARCH COMMUNITY HAS IDENTIFIED A NEED TO ESTABLISH A MECHANISM-BASED TAXONOMY FOR THESE CONDITIONS TO ADVANCE BIOMARKER DISCOVERY AS WELL AS DIAGNOSIS AND THERAPEUTIC DEVELOPMENT. A SHIFT FROM A SYNDROMIC CLASSIFICATION SYSTEM TO A MECHANISTIC ONE NECESSITATES A REVIEW OF THE CURRENT SCIENTIFIC KNOWLEDGE, ADOPTION OF NEW SCIENTIFIC MODELS, AND IDENTIFICATION OF RESEARCH AND KNOWLEDGE GAPS. THE SOSS BROUGHT TOGETHER MULTIDISCIPLINARY STAKEHOLDERS WITH DEEP SCIENTIFIC AND CLINICAL EXPERTISE TO ADDRESS THIS PRESSING NEED.THE THEME OF THE SECOND STATE OF THE SCIENCE SUMMIT, HELD IN 2019 WAS PATHS TO TREATMENT FOR TRAUMATIC BRAIN INJURY(S) WITH A FOCUS ON THE TAXONOMY AND NOSOLOGY OF THE CHRONIC SEQUELAE, CHALLENGES AND OPPORTUNITIES IN CLINICAL PRACTICE AND DEVELOPMENT, AND ETIOLOGY AND MECHANISM OF PERSISTENT SYMPTOMS. AS MEASUREMENT TOOLS ADVANCE, RESEARCH HAS BEEN ABLE TO FOCUS ON DIFFERENT TYPES OF INJURY, BEYOND THE MILD, MODERATE, AND SEVERE CLASSIFICATIONS OF TBI. TO AUGMENT AND SUPPORT THE MANY EFFORTS ACROSS FIELDS AND ORGANIZATIONS OVER THE PAST DECADE, IN 2020 WE WORKED WITH THOUGHT LEADERS ACROSS TBI TO PREPARE A CONSENSUS BLUEPRINT TO DRIVE TRANSLATIONAL SCIENCE FOR TBI. IN 2021, WE PUBLISHED SIX CONSENSUS ARTICLES FROM THE TBI SUMMIT IN THE JOURNAL OF NEUROTRAUMA OUTLINING GAPS AND RECOMMENDATIONS FOR FUTURE RESEARCH.BEST BIOMARKER PTSD STUDY:DESPITE THE EFFICACY OF PSYCHOTHERAPY AS FIRST-LINE TREATMENT FOR PTSD, LARGE INTER-INDIVIDUAL DIFFERENCES IN OUTCOMES EXIST, WITH ROUGHLY 50% OF PATIENTS RESPONDING TO TREATMENT AND FEWER THAN THAT FULLY REMITTING. THIS GRANT SUPPORTED THE DEVELOPMENT OF A RESPONSE DIAGNOSTIC TEST BASED ON PRELIMINARY FINDINGS FOR A COMBINATION COGNITIVE/IMAGING MARKER RESULTING FROM CVB'S INVESTMENT IN THE COHEN VETERANS CENTER STUDY AT NYU/STANFORD. THE PROGRAM INCLUDED A CLINICAL STUDY AT TWO CENTERS OF OVER 200 SUBJECTS TO REPLICATE THE INITIAL FINDING, AND IS SEEKING QUALIFICATION VIA THE FOOD AND DRUG ADMINISTRATION ("FDA") GUIDANCE TO SUPPORT THE COMMERCIALIZATION AND/OR AVAILABILITY OF THE TEST FOR CLINICAL PRACTICE AND RESEARCH AND DEVELOPMENT. THIS STUDY COMPLETED RECRUITMENT IN DECEMBER 2019 AND SEMINAL RESULTS WHICH DEMONSTRATE THAT AN EEG BASED BIOMARKER CAN PREDICT TREATMENT RESPONSE FOR INDIVIDUALS WITH PTSD OR MAJOR DEPRESSIVE DISORDER ("MDD") WERE PUBLISHED IN 2020 AND 2021.PTSD GENETICS PROGRAM:THE PSYCHIATRIC GENETICS CONSORTIUM-PTSD WORKING GROUP - BROAD INSTITUTE COLLABORATION IS SUPPORTING THE LARGEST GLOBAL GENOME WIDE ASSOCIATION STUDY ("GWAS") OF PTSD TO DATE WITH DATA FROM OVER 200,000 INDIVIDUALS ANALYZED. THE MAIN GOAL IS TO UNCOVER THE GENETIC UNDERPINNINGS OF PTSD RISK AND PUBLISH ALL RESULTS. SEMINAL FINDINGS OF THE FIRST PTSD GENETIC RISK LOCI FROM THIS PROGRAM WERE PUBLISHED IN NATURE COMMUNICATIONS IN OCTOBER 2019.IN 2021, MULTIPLE SECONDARY ANALYSES OF THIS SEMINAL DATABASED HAVE BEEN PUBLISHED.IN 2021, WE EXTENDED OUR PROGRAM WITH THE BROAD INSTITUTE TO CONDUCT FUNCTIONAL GENOMICS STUDIES OF IDENTIFIED GENETIC MARKERS AS WELL AS GENETIC EXPRESSION ANALYSIS OF AMYGDALA CELLULAR CIRCUITS IN ORDER TO INITIATE THE IDENTIFICATION OF POTENTIAL TARGETS FOR THERAPEUTIC INTERVENTION IN PTSD.PSYCHIATRIC RATINGS USING INTERMEDIATE STRATIFIED MARKERS 2 ("PRISM2"):IN 2021, WE JOINED THE INNOVATIVE MEDICINES INITIATIVE AND EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS ("EFPIA") AS A FUNDER AND COLLABORATOR IN THE PRISM2 STUDY PROGRAM. BUILDING ON THE SUCCESS OF INNOVATIVE RESEARCH BY THE PRISM PROJECT, THE INNOVATIVE MEDICINE INITIATIVE 2, A JOINT UNDERTAKING BETWEEN THE EU AND EFPIA, HAS BACKED THE PROGRAM WITH FUNDING FOR A NEW PROJECT TO EXPLORE THE UNDERLYING BIOLOGY OF ALZHEIMER'S DISEASE, SCHIZOPHRENIA AND MDD. THE NEW PRISM2 PROJECT AIMS TO IDENTIFY QUANTITATIVE BIOLOGICAL FEATURES COMMON ACROSS THE DISEASES, OPENING THE POSSIBILITY OF DEVELOPING TARGETED TREATMENTS IRRESPECTIVE OF TRADITIONAL DIAGNOSIS.PRISM WAS A PAN-EUROPEAN RESEARCH PROJECT THAT RAN FROM 2016 TO 2021 AND RECEIVED 16.5 MILLION FUNDING FROM THE INNOVATIVE MEDICINES INITIATIVE 2 JOINT UNDERTAKING UNDER GRANT AGREEMENT NO 115916, SUPPORTED BY THE EUROPEAN UNION'S HORIZON 2020 RESEARCH AND INNOVATION PROGRAMME AND EFPIA. THE RESULTS OF PRISM CONSTITUTE THE FOUNDATION FOR THE CURRENT PRISM2 PROJECT.NATIONAL NORMATIVE NEUROIMAGING LIBRARY PROGRAM:CVB HAS CREATED AN IMAGING REFERENCE LIBRARY ESSENTIAL TO THE DEVELOPMENT OF EFFECTIVE CLINICAL IMAGING TOOLS FOR DIAGNOSING AND MANAGING PATIENTS WITH BRAIN DISORDERS. ADVANCED NEUROIMAGING CAN NOW DETECT MICROSCOPIC CHANGES IN BRAIN STRUCTURE CAUSED BY TRAUMA OR DISEASE. THESE ADVANCED IMAGING APPROACHES INCLUDE DIFFUSION TENSOR IMAGING ("DTI"), FUNCTIONAL CONNECTIVITY, PERFUSION WEIGHTED IMAGING, AND VOLUMETRIC IMAGING. DESPITE THEIR PROMISE, THESE ADVANCED APPROACHES ARE CURRENTLY PRIMARILY CONFINED TO RESEARCH USE. THE NUMERICAL NATURE OF THE INFORMATION THESE ADVANCED IMAGING APPROACHES YIELD IS DIFFICULT TO TRANSLATE FROM THE STUDY OF GROUPS OF INDIVIDUALS TO A SINGLE PATIENT WITHOUT A REFERENCE. THE IMAGING DATABASE IS BASED ON THE RESULTS OF A NATIONAL STUDY OF NORMATIVE INDIVIDUALS, SPONSORED BY CVB AT UNIVERSITY OF VIRGINIA, BAYLOR UNIVERSITY AND UNIVERSITY OF UTAH AND TWO MILITARY SITES. STANDARDIZED ADVANCED NEUROIMAGING SCANS ON 3,000 ADULT VOLUNTEERS, THE RESULTING IMAGING DATA, ALONG WITH DEMOGRAPHIC INFORMATION AND THE RESULTS OF NEUROCOGNITIVE ASSESSMENTS, IS FORMING A LIBRARY DOCUMENTING POPULATION VARIATION IN BRAIN STRUCTURE AND FUNCTION AS MEASURED BY THESE ADVANCED IMAGING METHODS.THROUGH THIS IMAGING DATABASE, IT IS OUR GOAL TO ADVANCE NEUROIMAGING TO DRAMATICALLY IMPROVE THE IDENTIFICATION OF AFFECTED INDIVIDUALS AND ALLOW PHYSICIANS TO OBJECTIVELY AND EFFICIENTLY DIAGNOSE CONDITIONS SUCH AS TBI, DEMENTIA AND OTHER BRAIN DISORDERS WHERE BRAIN STRUCTURE IS DETECTED VIA MAGNETIC RESONANCE IMAGING ("MRI").IN 2021, WE CONTINUED RECRUITMENT INTO THE LIBRARY REACHING MORE THAN1,000 ENROLLED SUBJECTS AND ALSO CONDUCTED A SERIES OF WORKSHOPS TO EVALUATE NEUROIMAGING NORMATIVE DATABASES, STANDARDIZATION, AVAILABLE PIPELINES AND EVIDENCE FOR IMAGING-BASED TBI BIOMARKERS.PTSD AND TBI PRECLINICAL MODELING PROGRAM:ANIMAL MODELS OF PSYCHIATRIC DISORDERS OFFER A COMPLEMENTARY RESEARCH MODALITY THAT SUPPORTS CLINICAL RESEARCH. IN ORDER TO ACHIEVE A SATISFACTORY DEGREE OF VALIDITY AND RELIABILITY, ANIMAL MODELS OF COMPLEX AND INTRICATE PSYCHIATRIC DISORDERS, SUCH AS PTSD, MUST FULFILL CERTAIN CRITERIA: PATHOGENIC PROCESSES MUST BE OBSERVABLE AND MEASURABLE, AND MUST RELIABLY REFLECT CLINICAL SYMPTOMATOLOGY, AND PHARMACOLOGICAL AGENTS THAT ARE KNOWN TO AFFECT SYMPTOMS IN HUMAN SUBJECTS, SHOULD MODULATE THESE PROCESSES. CVB HAS ESTABLISHED THE ALLIANCE FOR MODELS OF PTSD, INNOVATIVE TECHNOLOGIES AND UNIFORM PRACTICES ("AMP-IT- UP") TO SUPPORT PRECLINICAL MODEL DEVELOPMENT. MULTIPLE SUB-GRANT AWARDS COMPLETED AND PUBLISHED THEIR FINDING THIS YEAR IN SUPPORT THE MISSION OF THIS PROGRAM. IN 2021, WE PUBLISHED OUR SYSTEMATIC REVIEW TO DETERMINE METHODOLOGICAL VARIABILITY IN STUDIES THAT APPLIED A PROMINENT ANIMAL MODEL OF TRAUMA-LIKE STRESS, SINGLE PROLONGED STRESS ("SPS"). THE SPS MODEL HAS BEEN UTILIZED TO EVALUATE A MYRIAD OF PTSD-RELEVANT OUTCOMES INCLUDING EXTINCTION RETENTION. RODENTS EXPOSED TO SPS EXPRESS AN EXTINCTION RETENTION DEFICIT, A PHENOTYPE IDENTIFIED IN HUMANS WITH PTSD, IN WHICH FEAR MEMORY IS ABERRANTLY RETAINED AFTER FEAR MEMORY EXTINCTION. THE CURRENT SYSTEMATIC REVIEW EXAMINES METHODOLOGICAL VARIATION ACROSS ALL PHASES OF THE SPS PARADIGM, AS WELL AS STRATEGIES FOR BEHAVIORAL CODING, DATA PROCESSING, STATISTICAL APPROACH, AND THE DEPICTION OF DATA. SOLUTIONS FOR KEY CHALLENGES AND SOURCES OF VARIATION WITHIN THESE DOMAINS ARE DISCUSSED. IN RESPONSE TO METHODOLOGICAL VARIATION IN SPS STUDIES, AN EXPERT PANEL WAS CONVENED TO GENERATE METHODOLOGICAL CONSIDERATIONS TO GUIDE RESEARCHERS IN THE APPLICATION OF SPS AND THE EVALUATION OF EXTINCTION RETENTION AS A TEST FOR A PTSD-LIKE PHENOTYPE. MANY OF THESE GUIDELINES ARE APPLICABLE TO ALL RODENT PARADIGMS DEVELOPED TO MODEL TRAUMA EFFECTS OR LEARNED FEAR PROCESSES RELEVANT TO PTSD, AND NOT LIMITED TO SPS. EFFORTS TOWARD OPTIMIZING PRECLINICAL MODEL APPLICATION ARE ESSENTIAL FOR ENHANCING THE REPRODUCIBILITY AND TRANSLATIONAL UTILITY OF PRECLINICAL MODELS FOR THERAPEUTIC RESEARCH AND DEVELOPMENT.COMPUTATIONAL MODELING & DATA SCIENCES:CVB HAS ESTABLISHED AN INTRAMURAL DATA SCIENCES PROGRAM TO BUILD MACHINE-LEARNING AND ARTIFICIAL INTELLIGENCE BASED PREDICTIVE MODELS OF DISEASE. THESE PROGRAMS BUILD ON OUR ORIGINAL ORION MS BIO-MODELLING PROGRAM AND FOCUSES ON MODELS OF PTSD, TBI, PARKINSONS AND DEMENTIA AND OTHER CONDITIONS.MULTIPLE SCLEROSIS ("MS") 1.0:THE ORION BIONETWORKS FLAGSHIP PROGRAM SUCCESSFULLY PILOTED THE ESTABLISHMENT OF A MULTIPLE SCLEROSIS BIONETWORK COMPRISED OF ACADEMIC (NEUROSCIENCE INSTITUTE OF THE BRIGHAM AND WOMEN'S HOSPITAL), ADVOCACY (ACCELERATED CURE PROJECT FOR MS), COMPUTATIONAL (GNS HEALTHCARE, METACELL, THOMSON REUTERS), INFORMATICS (CONVERGE BY DELOITTE, RANCHO BIOSCIENCES, EXAPTIVE), AND ONLINE PATIENT COMMUNITY PARTNERS (PATIENTSLIKEME [PLM]). DE-IDENTIFIED HIPPA-COMPLIANT DATA FROM THREE DATABASES WERE CURATED AND LOADED INTO A CLOUD-BASED DATA KNOWLEDGE MANAGEMENT SYSTEM. THE INTEGRATED REPOSITORY INCLUDES 9,000 SUBJECTS WITH MS AND RELATED CONDITIONS. THE ALLIANCE DEVELOPED A ROADMAP FOR JOINT EXECUTION WITH SPECIFIC SCIENTIFIC AIMS. THE ALLIANCE HAS GENERATED MULTIPLE MODELS BASED ON THE DATA REPOSITORY USING DIFFERENT ALGORITHMIC APPROACHES: PHENOTYPIC PROGNOSTIC MODEL AND TWO MOLECULAR PROGNOSTIC MODELS.PARKINSON'S PROGRESSION MARKERS INITIATIVE ("PPMI") DATA SCIENCE MODELING GROUP:EXISTING DIAGNOSES FOR COMPLEX BRAIN DISORDERS SUCH AS PARKINSON'S DISEASE FOCUS ON UNDERSTANDING CLUSTERS OF MAJOR SYMPTOMS. IN ORDER TO DRIVE PROGRESS IN THE DEVELOPMENT OF NEW TREATMENTS IT IS IMPORTANT TO UNDERSTAND THE ROLE OF SPECIFIC BIOLOGICAL PROCESSES IN DETERMINING PATIENT OUTCOMES. IN THIS PROGRAM WE MODEL THE MICHAEL J. FOX FOUNDATION ("MJFF") SPONSORED PARKINSON'S PROGRESSION MODEL INITIATIVE STUDY. THE STUDY HAS EVALUATED PARTICIPANTS' CLINICAL STATUS WHILE COLLECTING IMAGING, BEHAVIORAL, 'OMICS AND OTHER ASSESSMENTS LONGITUDINALLY SINCE 2010. IN OUR ALIGNED MISSIONS TO ADVANCE BRAIN HEALTH, MJFF SELECTED CVB'S DATA SCIENCE TEAM TO LEVERAGE THIS COHORT TOGETHER WITH A MULTI-DISCIPLINARY APPROACH TO QUANTITATIVELY EXPLORE, EVALUATE, AND PREDICT DISEASE TRAJECTORY, RISK FACTORS, AND SUBTYPES. GIVEN THE BREADTH AND DEPTH OF THE PPMI DATA AND RICH OPPORTUNITIES TO DEVELOP IMPACTFUL DISEASE MODELS, THE TEAM USE THEIR SUBJECT MATTER EXPERTISE ACROSS TRANSLATIONAL SCIENCE TO GENERATE INSIGHTS FROM 'OMICS, IMAGING, GENETIC AND CLINICAL DATA BY INTEGRATING TECHNIQUES ACROSS ADVANCED STATISTICS, MACHINE LEARNING, AND COMPUTATIONAL MODELING TO FACILITATE PD BIOMARKER DISCOVERY AND DEEPEN OUR UNDERSTANDING OF DISEASE PROGRESSION. GLOBAL PRECLINICAL DATA FORUM (TRADEMARKED):THE GLOBAL PRECLINICAL DATA FORUM ("GPDF") IS A JOINTLY SPONSORED US AND EUROPEAN INITIATIVE THAT ENCOURAGES GLOBAL COLLABORATION TO ADDRESS THE CHALLENGE OF ENSURING THAT PRECLINICAL RESEARCH IS REPRODUCIBLE, ROBUST AND TRANSLATABLE TO SUPPORT DISEASE RESEARCH UTILITY FOR CLINICAL RESEARCH & DEVELOPMENT ("R&D"). IT SUPPORTS BEST RESEARCH PRACTICES, THE DEVELOPMENT AND IMPLEMENTATION OF DATA QUALITY STANDARDS, PRECLINICAL DATA & TECHNOLOGICAL PLATFORMS, AND TRAINING PROGRAMS FOR THE NEUROSCIENCE COMMUNITY WITH THE GOAL OF ENHANCING THE DATA UTILITY DERIVED FROM PRECLINICAL MODELS. THIS IS OUR FOURTH YEAR SUPPORTING WITH THE EUROPEAN COLLEGE OF NEUROPHARMACOLOGY ("ECNP") THE WORLD'S FIRST NEGATIVE DATA PRIZE AS AN INCENTIVE FOR PRECLINICAL RESEARCHERS TO PUBLISH "NEGATIVE DATA" RESULTS TO ENSURE ALL NEUROSCIENCE STUDIES PROPERLY ADVANCE KNOWLEDGE. THE PRIZE IS AWARDED TO THE RESEARCHER OR RESEARCH GROUP WHOSE NEUROSCIENCE STUDY BEST EXEMPLIFIES DATA WHERE THE OUTCOMES DO NOT CONFIRM THE EXPECTED RESULTS OR WORKING HYPOTHESIS. THE PRECLINICAL AWARD WAS PRESENTED DURING THE 2020 VIRTUAL ECNP CONFERENCE.IN 2021, WE EXTENDED THE BEST NEGATIVE PRIZE AWARDS PROGRAM TO CLINICAL RESEARCHERS WHOSE NEUROSCIENCE STUDY BEST EXEMPLIFIES DATA WHERE THE OUTCOMES DO NOT CONFIRM THE EXPECTED RESULTS OR WORKING HYPOTHESIS.EQIPD QUALITY SYSTEM:THE GPDF AND COHEN VETERANS BIOSCIENCE ARE BOTH MAJOR CONTRIBUTORS TO THE EUROPEAN UNION INNOVATIVE MEDICINE INITIATIVE-FUNDED CONSORTIUM CALLED EQIPD (EQIPD.ORG). THE EQIPD CONSORTIUM HAS DEVELOPED A NOVEL PRECLINICAL RESEARCH QUALITY SYSTEM THAT CAN BE APPLIED IN BOTH PUBLIC AND PRIVATE SECTORS AND IS FREE FOR ANYONE TO USE. THE EQIPD QUALITY SYSTEM WAS DESIGNED TO BE SUITED TO BOOST INNOVATION BY ENSURING THE GENERATION OF ROBUST AND RELIABLE PRECLINICAL DATA WHILE BEING LEAN, EFFECTIVE AND NOT BECOMING A BURDEN THAT COULD NEGATIVELY IMPACT THE FREEDOM TO EXPLORE SCIENTIFIC QUESTIONS. EQIPD DEFINES RESEARCH QUALITY AS THE EXTENT TO WHICH RESEARCH DATA ARE FIT FOR THEIR INTENDED USE. FITNESS, IN THIS CONTEXT, IS DEFINED BY THE STAKEHOLDERS, WHO ARE THE SCIENTISTS DIRECTLY INVOLVED IN THE RESEARCH, BUT ALSO THEIR FUNDERS, SPONSORS, PUBLISHERS, RESEARCH TOOL MANUFACTURERS AND COLLABORATION PARTNERS SUCH AS PEERS IN A MULTI-SITE RESEARCH PROJECT. THE ESSENCE OF THE EQIPD QUALITY SYSTEM IS THE SET OF 18 CORE REQUIREMENTS THAT CAN BE ADDRESSED FLEXIBLY, ACCORDING TO USER-SPECIFIC NEEDS AND FOLLOWING A USER-DEFINED TRAJECTORY. THE EQIPD QUALITY SYSTEM PROPOSES GUIDANCE ON EXPECTATIONS FOR QUALITY-RELATED MEASURES, DEFINES CRITERIA FOR ADEQUATE PROCESSES (I.E., PERFORMANCE STANDARDS) AND PROVIDES EXAMPLES OF HOW SUCH MEASURES CAN BE DEVELOPED AND IMPLEMENTED. IN 2021, WE JOINED IN INITIATING EFFORTS TO ESTABLISH A GUARANTORS GROUP FOR THE EQIPD SOCIETY TO ENSURE DURABILITY OF THE ASSETS AND CERTIFICATION SYSTEMS CREATED THROUGH THE IMI PROGRAM. POLICY & ADVOCACY INITIATIVES:IN 2020, WE FORMALLY ESTABLISHED OUR DEPARTMENT OF POLICY AND ADVOCACY UNDER THE DIRECTION OF DR. CHANTELLE FERLAND-BECKHAM. WE ARE COMMITTED TO ADVOCATING FOR POLICY REFORMS AT THE FEDERAL LEVEL THAT BUILD UPON EVIDENCE-BASED PRECISION MEDICINE APPROACHES AND HAVE THE POWER TO BRING NEW SOLUTIONS FOR PTSD AND TBI IN YEARS, NOT DECADES. AS PART OF OUR ADVOCACY EFFORTS, WE CO-FOUNDED THE COALITION TO HEAL INVISIBLE WOUNDS (THE "COALITION"), A COLLABORATIVE INITIATIVE AIMED AT ADVOCATING FOR POLICY REFORMS TO WIDEN AND EXPEDITE THE PIPELINE FOR NEW THERAPIES AND DIAGNOSTICS FOR PTSD AND TBI - WHICH CAN BOTH DRASTICALLY INCREASE THE RISK OF SUICIDE AMONG VETERANS. THIS YEAR, WE MADE SIGNIFICANT PROGRESS ON THE COALITION'S LARGEST ADVOCACY PUSH - IMPROVING VETERANS' ACCESS TO CLINICAL TRIALS. VA CLINICAL TRIALS HAVE THE POTENTIAL TO BRING NEW PRECISION MEDICINE THERAPIES FOR PTSD AND TBI TO VETERANS, BUT VA FACILITIES OFTEN FACE CHALLENGES INITIATING AND COMPLETING CLINICAL TRIALS, MEANING THAT MANY CLINICAL TRIAL SPONSORS DO NOT ATTEMPT TO BRING TRIALS TO THE VA AND HAVE NOT DONE SO FOR YEARS. WE, LIKE MANY OTHERS, BELIEVE THAT THE VA CAN BE A LEADER IN CLINICAL RESEARCH AND HAVE COMMITTED TO SUPPORTING THE VA THROUGH THE "100 DAYS FASTER" INITIATIVE, AN INITIATIVE SPEARHEADED THROUGH OUR ADVOCACY EFFORTS WITH THE COALITION AND SUPPORTED AND ENDORSED BY BOTH THE NATIONAL ASSOCIATION OF VETERANS RESEARCH AND EDUCATION FOUNDATIONS ("NAVREF") AND THE VA OFFICE OF RESEARCH AND DEVELOPMENT (ORD"). IN 2021, CVB BECAME A CHAMPION SPONSOR FOR NAVREF FURTHER EXTENDING ITS COMMITMENT TO THE BRAIN HEALTH OF VETERANS BY SUPPORTING THEIR NEW VA ORD-LED PARTNERED RESEARCH PROGRAM ("PRP"). AS AN OUTCOME OF THE ACCESS TO CLINICAL TRIALS ("ACT") FOR VETERANS INITIATIVE, THE PRP INCREASES VETERANS' ACCESS TO HIGH-QUALITY CLINICAL TRIALS AND STREAMLINES THE START-UP OF NEW INNOVATIVE TRIALS, GIVING VETERANS ACCESS TO WORLD-CLASS HEALTH SOLUTIONS. THE PRP IS HELPING AGENCIES AND ORGANIZATIONS TO PARTNER MORE RAPIDLY ON CRITICAL RESEARCH TRIALS, SPECIFICALLY TARGETING THE ENHANCED INCLUSION OF VETERANS. ADDITIONALLY, CVB OFFICIALLY JOINED AS A MEMBER OF THE AMERICAN BRAIN COALITION POLICY AND HELPED TO SPEARHEAD EFFORTS TO ESTABLISH A NEW FOOD AND DRUG ADMINISTRATION NEUROSCIENCE CENTER OF EXCELLENCE. 15292239 1 1 0 1 0 0 0 0 0 0 1 0 0 0 1 1 1 0 0 1 1 1 0 1 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 45 0 40 1 0 0 0 0 0 0 0 0 0 0 0 0 X 6 4 0 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MA NY X X GELMAN ROSENBERG AND FREEDMAN CPA 3019519090 4550 MONTGOMERY AVENUE SUITE 650N BETHESDA MD 20814 MAGALI HAAS MD PHD CEO & PRESIDENT 60.00 X X 627497 0 17100 THERESA FRANGIOSA SECRETARY 9.00 X X 0 0 0 MICHAEL SULLIVAN TREASURER 1.00 X X 0 0 0 DAVID BIONDI BOARD MEMBER/FORMER ED, CLINICAL PROGRAM 40.00 X 120489 0 13022 DOUGLAS HAYNES BOARD MEMBER 1.00 X 0 0 0 DAVE DEMARCO BOARD MEMBER 1.00 X 0 0 0 DANIEL PLOWDEN FORMER CHIEF FINANCIAL OFFICER 40.00 X 355283 0 37374 ANDREAS JEROMIN PHD CHIEF SCIENTIFIC OFFICER 40.00 X 490231 0 14957 LEE LANCASHIRE CHIEF INFORMATION OFFICER 40.00 X 207380 0 36818 ALLYSON GAGE PHD CHIEF MEDICAL OFFICER 40.00 X 495295 0 24463 AMANDA NICOLE HARMON EXECUTIVE DIRECTOR, COMMUNITY PARTNERSHIPS 40.00 X 300586 0 37961 LAUREN GOLDSMITH SENIOR DIRECTOR, CONTRACTING & GRANTS MANAGEMENT 40.00 X 208155 0 19451 EVGENY RAKHMATULIN CHIEF TECHNOLOGY OFFICER 40.00 X 195921 0 28007 TIMOTHY VAUGHAN DEPUTY DIRECTOR, DATA SCIENCES 40.00 X 225695 0 21099 MARYAN ZIRKLE EXECUTIVE DIRECTOR, BRAINCOMMONS 40.00 X 269424 0 14166 3495956 0 264418 29 0 1 0 HITACHI VANTARA LLC 2535 AUGUSTINE DRIVE SANTA CLARA CA 950543003 CLOUD-BASED ARCHITECTURE BUILD AND MANAG 2485945 GRF CPA'S & ADVISORS 4550 MONTGOMERY AVENUE SUITE 800 NORTH BETHESDA MD 20814 ACCOUNTING AND BOOKKEEPING 422062 MORGAN LEWIS AND BOCKIUS LLP 1701 MARKET STREET PHILADELPHIA UK 19103 LEGAL SERVICES 388757 CLARIVATE ANALYTICS US LLC 1500 SPRING GARDEN STREET PHILADELPHIA PA 191304067 LSPS DISCOVERY AND TRANSLATIONAL 383670 METACELL 117 PARK DRIVE UNIT 20 BOSTON MA 02215 BRAIN COMMONS PROGRAM MANANGEMENT SUPPOR 366077 11 396376 15764205 16160581 59585 59585 HRA FORFEITURES 900099 28475 28475 STIMULUS/COVID CREDITS 900099 3629 3629 32104 16252270 32104 0 59585 X 53600 53600 182060 182060 2618102 2149177 368631 100294 4803610 4038095 355145 410370 264732 219927 26404 18401 338433 279001 34515 24917 427914 353963 43218 30733 307964 307964 341383 316752 24631 358370 358370 90000 90000 50600 50600 6688287 6506189 180475 1623 407030 222977 177864 6189 425252 315067 106405 3780 562167 453435 85201 23531 44868 34805 10063 5815 5815 50064 42514 4412 3138 62662 28862 31294 2506 BAD DEBT EXPENSE 27507 27507 18110420 15292239 2142099 676082 690470 654129 15130098 11484429 2302389 4776718 88022 268785 319955 85701 284318 234254 370159 534269 18865456 17952584 2942644 2078653 5348290 4606870 9022 131804 141000 8431760 6826523 X 3045971 3420094 7387725 7705967 10433696 11126061 18865456 17952584 X -1858150 2550515 X X 0 1 X 1 0 X 4366629 16828176 20795052 16316026 16160581 74466464 4366629 16828176 20795052 16316026 16160581 74466464 66178268 8288196 17365 98872 154639 59585 330461 32104 32104 74829029 0.11080 0.10510 X COHEN VETERANS BIOSCIENCE, INC. ("CVB") IS A PUBLIC CHARITY DEDICATED TO FAST-TRACKING THE DEVELOPMENT OF DIAGNOSTIC TESTS AND PERSONALIZED THERAPEUTICS FOR THE MILLIONS OF VETERANS AND CIVILIANS IN THE US WHO SUFFER THE DEVASTATING EFFECTS OF TRAUMA-RELATED AND OTHER BRAIN DISORDERS. GLOBALLY, 2 BILLION INDIVIDUALS ARE DIRECTLY AFFECTED BY BRAIN DISORDERS. THE WORLD HEALTH ORGANIZATION ATTRIBUTES 38% OF THE TOTAL YEARS LOST TO DEATH AND DISABILITY TO BRAIN DISORDERS, A FIGURE WELL AHEAD OF THE NEXT-CLOSEST AND HIGHER-PROFILE DISEASES OF CANCER (12.7%) AND CARDIOVASCULAR DISEASE (11.8%). THIS MEMO PROVIDES EVIDENCE OF QUANTITATIVE AND QUALITATIVE MEASURES WHICH SUPPORT CONTINUED PUBLIC CHARITY STATUS. CVB MEETS THE QUANTITATIVE PERCENTAGE TEST CRITERION FOR SUPPORTING FACTS AND CIRCUMSTANCES. CVB ENGAGES WITH AND MAKES AVAILABLE TO RESEARCHERS, POLICY MAKERS, AND THE GENERAL PUBLIC A BROAD ARRAY OF PROGRAMS, TOOLS, SERVICES, AND INFORMATION WHICH ADVANCE THE STATE OF BRAIN SCIENCE, GUIDED BY AN INDEPENDENT BOARD AND ADVISORY COUNSELS IN CONJUNCTION WITH CVB'S RENOWNED EXPERTS IN RELEVANT FIELDS OF NEUROSCIENCE, DATA SCIENCE AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT. FOLLOWING ARE MORE DETAILED EVIDENCE OF THESE FACTS AND CIRCUMSTANCES. COHEN VETERANS BIOSCIENCE, INC. EARLY ORIGINS WERE AS AN ORGANIZATION UNDER THE FISCAL SPONSORSHIP OF THE MARIN COUNTY COMMUNITY FOUNDATION, LATER ESTABLISHED AS A STAND-ALONE 501(C)3 IN 2014 UNDER THE NAME ORION BIONETWORKS. CVB'S FOUNDER AND CEO HAS A PERSONAL CONNECTION TO THE PUBLIC WORK THE ORGANIZATION CARRIES OUT BY VIRTUE OF HER HUSBAND BEING A VETERAN OF THE US AIRFORCE SERVICE AND HER SISTER SERVING AS AN AIRFORCE COLONEL, WITH ACTIVE DEPLOYMENTS TO OEF/OIF. THE FORMAL NAME CHANGE TO COHEN VETERANS BIOSCIENCE TOOK PLACE IN 2015 IN CONCERT WITH GENEROUS SEED FUNDING FROM STEVEN A. COHEN. CVB QUALIFIES AS A PUBLIC CHARITY UNDER THE "FACTS AND CIRCUMSTANCES" TEST OF 1.170A-9(F)(3) OF THE TREASURY REGULATIONS, BASED UPON THE FOLLOWING:CVB IS ORGANIZED AND OPERATED SO AS TO ATTRACT NEW AND ADDITIONAL FUNDING ON A CONTINUOUS AND BONA FIDE BASIS; CVB HAS HAD DONATION BUTTON ON ITS WEBSITE AND ALL SOCIAL MEDIA SINCE INCEPTION. THE ORGANIZATION HAS RUN SEVERAL ONLINE DONATION CAMPAIGNS INCLUDING A "CROWDSOURCED" APPROACH IN 2017 THAT RAISED MORE THAN $100,000 FROM NUMEROUS INDIVIDUAL DONORS. THE ORGANIZATION HAS ACTIVELY PURSUED AND RECEIVED GRANTS FROM GOVERNMENT AND PUBLIC CHARITIES AND FOUNDATIONS FOCUSED ON BRAIN DISEASES. IN CVB'S EARLY YEARS OF EXISTENCE THE SCOPE OF ITS SOLICITATION WAS MORE LIMITED TO PERSONS DEEMED MOST LIKELY TO PROVIDE EARLY FUNDING IN AN AMOUNT SUFFICIENT TO ENABLE IT TO COMMENCE ITS CHARITABLE ACTIVITIES AND EXPAND THE SOLICITATION PROGRAM. DIRECT OUTREACH TO POTENTIAL SUPPORTERS IS INCREASINGLY CONDUCTED BY CVB'S CEO AND OTHER EXECUTIVE TEAM AND SCIENTIFIC STAFF. CVB NOW REGULARLY CONDUCTS BROAD OUTREACH CAMPAIGNS, HAS STAFF DEDICATED TO FUNDRAISING AND SUPPORTER ENGAGEMENT TO SOLICIT CHARITABLE CONTRIBUTIONS FROM THE GENERAL PUBLIC, AND CARRIES ON ACTIVITIES DESIGNED TO ATTRACT SUPPORT FROM GOVERNMENT SOURCES AND PUBLIC CHARITIES. IN FY 2021, CVB HIRED AN EXPERIENCED EXECUTIVE DIRECTOR OF DEVELOPMENT TO FURTHER EXPAND FUNDRAISING INFRASTRUCTURE AND OUTREACH. CVB REGULARLY APPLIES FOR RELEVANT FUNDING FROM GOVERNMENT AGENCIES AND NONPROFIT ORGANIZATIONS. CVB HAS DEVELOPED MATERIALS TO SUPPORT POTENTIAL DONOR ENGAGEMENT, AND WORKS DILIGENTLY TO EXPAND THE NETWORK OF POTENTIAL SUPPORTERS BY ENGAGING WITH BOARD MEMBERS AND STAFF TO CONNECT WITH THEM. CVB'S PUBLIC SUPPORT PERCENTAGE, AS REPORTED FOR 2019, WAS 10.51%, AND HAS GROWN TO 11.08% AS REPORTED FOR 2020, AND WE ANTICIPATE SIGNIFICANT FUTURE INCREASES AS A RESULT OF EXPANDED FUNDRAISING INFRASTRUCTURE AND OUTREACH. THE 2020 RESULT WHEN COMPARED TO THE 2018 PERCENTAGE OF 8.94% IS EVIDENCE OF THE INCREASING BREADTH OF PUBLIC SUPPORT AS CVB FURTHER BUILDS UPON ITS FUNDRAISING EFFORTS. CVB HAS RECEIVED SUPPORT FROM A DIVERSITY OF DONORS AND SOURCES DURING ITS INITIAL START-UP PERIOD AND WILL CONTINUE TO EXPAND ITS DONOR BASE. DONORS INCLUDE US GOVERNMENT AGENCIES SUCH AS THE NATIONAL INSTITUTES OF HEALTH AND THE DEPARTMENT OF DEFENSE; A NUMBER OF NONPROFIT ORGANIZATIONS AND FOUNDATIONS INTERESTED IN MEDICAL RESEARCH AND ISSUES IMPACTING VETERANS; AND MORE THAN 100 INDIVIDUAL DONORS. CVB'S CURRENT FUNDRAISING PLANS ARE TARGETED AT A BROAD BASE OF DONORS, INCLUDING FOUNDATIONS, INDIVIDUALS, AND GOVERNMENT AGENCIES. STARTING IN 2020, WE ALSO ENGAGED IN PARTNERSHIPS WITH VETERANS SERVICE ORGANIZATIONS WHO HAVE COMMITTED TO RAISE AWARENESS OF INDIVIDUALLY DRIVEN FUNDRAISING CAMPAIGNS LIKE 22JUMPS FOR SUICIDE AND EVERESTING MARATHONS FOR VETERANS PTSD & TBI.AS EVIDENCED BY THE EXTENSIVE PROGRAMS SPONSORED BY CVB SUPPORTING RESEARCH COLLABORATIONS AND SCIENTIFIC BEST PRACTICE ADOPTION, CVB REMAINS AN ORGANIZATION COMMITTED TO SERVING THE PUBLIC THROUGH ITS WORK. EXAMPLES WHICH DEMONSTRATE OUR COMMITMENT TO THE PUBLIC BENEFIT AND PUBLIC PARTICIPATION IN OUR EFFORTS INCLUDE CVB'S VETERANS ADVISORY COUNCIL, STATE OF THE SCIENCE SUMMITS, NUMEROUS EXPERT WORKSHOPS, ENSURING OUR RESEARCH IS PUBLISHED IN OPEN ACCESS PUBLICATIONS, AND DATA SHARING POLICIES ENCOURAGING RESEARCH COLLABORATION ACROSS ORGANIZATIONAL BOUNDARIES. CVB PROGRAM ACTIVITIES, WITH TEAM SCIENCE AND COLLABORATION AS A CORE BELIEF, PROVIDES DIRECT PUBLIC BENEFIT THROUGH ITS RESEARCH AND EDUCATIONAL ACTIVITIES. CVB SPEARHEADS RESEARCH WITH MULTI-SECTOR PARTNERS INCLUDING ACADEMIA, GOVERNMENT, FOUNDATION RESEARCH, AND INDUSTRY ORGANIZATIONS TO ADVANCE COLLECTIVE UNDERSTANDING OF AND APPROACHES TO IMPROVING BRAIN HEALTH. FOR EXAMPLE, CVB SPONSORED THE BRAIN TRAUMA BLUEPRINT IN PARTNERSHIP WITH THE VETERANS ADMINSITRATION, NATIONAL INSTITUTES OF HEALTH AND DEPARTMENT OF DEFENSE TO ESTABLISH A RESEARCH ROADMAP FOR THE ADVANCEMENT OF PRECISION THERAPEUTIC SOLUTIONS FOR TRAUMATIC BRAIN INJURY (HTTPS://WWW.BRAINTRAUMABLUEPRINT.ORG/).CVB ALSO BROADLY DISSEMINATES RESEARCH AND EDUCATIONAL INFORMATION ABOUT PTSD, TRAUMATIC BRAIN INJURY (TBI) AND SUICIDE DIRECTLY TO THE PUBLIC THROUGH ITS WEBSITE AND SOCIAL MEDIA. THE INFORMATION IS PROVIDED IN AN ACCESSIBLE AND UNDERSTANDABLE FORMAT FOR ANY NON-MEDICAL READER, HELPING VETERANS AND OTHERS SUFFERING FROM PTSD OR TBI TO UNDERSTAND THEIR CONDITIONS AND THE SYMPTOMS AND CAUSES ASSOCIATED WITH THEM. THESE MATERIALS ALSO SERVE TO EDUCATE THE PUBLIC ABOUT PTSD AND TBI AND THE EFFECTS OF THESE CONDITIONS ON OUR VETERANS AND FAMILIES. THESE EVENTS, PROCEEDINGS, AND OTHER EDUCATIONAL OUTREACH SERVE TO ADVANCE BRAIN SCIENCE IN THE PUBLIC INTEREST. SEE WWW.COHENVETERANSBIOSCIENCE.ORG AND THE FORM 990 PROGRAM DESCRIPTIONS FOR MORE DETAILS ON THE EXPANSIVE NATURE OF THESE PROGRAMS. CVB ALSO ENLISTS THE ACTIVE SUPPORT AND PARTICIPATION OF EXPERTS, PUBLIC OFFICIALS, AND COMMUNITY LEADERS. CVB'S VETERANS ADVISORY COUNCIL ("VAC") INCLUDES SENIOR LEADERS WHO SERVED IN MILITARY LEADERSHIP ROLES AND/OR HAVE VETERAN FAMILY MEMBERS AND HAVE A DEEP PERSONAL COMMITMENT TO VETERANS' CONCERNS RELATED TO BRAIN HEALTH. VAC HELPS REPRESENT, ADVOCATE AND SUPPORT MILITARY AND VETERANS' INTERESTS TO CVB TO AID CVB IN DELIVERING MEANINGFUL RESULTS FOR VETERANS THROUGH DATA-DRIVEN SCIENCE AND ADVOCACY. MORE INFORMATION ABOUT VAC IS AVAILABLE HERE: HTTPS://WWW.COHENVETERANSBIOSCIENCE.ORG/VETERANS-ADVISORY-COUNCIL/ IN 2020, CVB EXPANDED ITS GLOBAL FOOTPRINT BY FORGING A PARTNERSHIP WITH THE EUROPEAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY TO ESTABLISH THE GLOBAL PRECLINICAL DATA FORUM, IN SUPPORT OF REPRODUCIBLE RESEARCH EFFORTS (HTTPS://WWW.PRECLINICALDATAFORUM.ORG/). CVB ALSO JOINED THE EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS TO CO-SPONSOR RESEARCH WITH THE INNOVATIVE MEDICINES INITIATIVE (HTTPS://WWW.IMI.EUROPA.EU/PROJECTS-RESULTS/PROJECT-FACTSHEETS/PRISM-2) AT AN INTERNATIONAL LEVEL.FINALLY, CVB HAS A REPRESENTATIVE GOVERNING BODY THROUGH ITS BOARD OF DIRECTORS CONSISTING OF SIX MEMBERS WITH EQUAL VOTING RIGHTS. FIVE OF THE SIX MEMBERS ARE INDEPENDENT OF THE LARGEST DONOR. ALL OF THE BOARD MEMBERS ARE INDIVIDUALS WITH SPECIAL KNOWLEDGE AND EXPERTISE RELEVANT TO THE ORGANIZATION'S CHARITABLE ACTIVITIES IN BRAIN SCIENCE AND HEALTH, AS WELL AS MEMBERS WITH LONGSTANDING DEDICATION TO THE NEEDS OF VETERANS AND OTHERS WHO SUFFER FROM BRAIN DISEASES THROUGH BOTH PAID AND UNPAID WORK WITH GOVERNMENT AND OTHER NONPROFIT AGENCIES. THE QUALIFICATIONS OF THE BOARD MEMBERS INCLUDE: BOARD CHAIR AND CEO, MAGALI HAAS, MD, PHD FOUNDED ORION BIONETWORKS (RENAMED TO COHEN VETERANS BIOSCIENCE IN 2015) WITH SPONSORSHIP FROM JANSSEN RESEARCH & DEVELOPMENT TO UNLOCK THE POWER OF SHARED DATA AND PREDICTIVE MODELING TO HELP TRANSFORM OUR UNDERSTANDING OF BRAIN DISEASES AND ACCELERATE THE SEARCH FOR CURES. SCHEDULE A, PART II, LINE 10, EXPLANATION OF OTHER INCOME: HRA FORFEITURES - 2020 AMOUNT: $ 28,475. STIMULUS/COVID CREDITS - 2020 AMOUNT: $ 3,629. PART II SECT C LINE 17A FACTS & CIRCUMSTANCES TEST (CONT): DR. HAAS HAS OVER 20 YEARS OF PHARMACEUTICAL EXECUTIVE AND CLINICAL RESEARCH EXPERIENCE INCLUDING DEVELOPMENT LEADERSHIP ROLES IN MEDICAL MARKETING, FULL CLINICAL DEVELOPMENT, EARLY DEVELOPMENT, AND TRANSLATIONAL AND BIOMARKER SCIENCES IN PSYCHIATRY AND NEUROLOGY. DURING HER TENURE AT JOHNSON & JOHNSON, SHE SUCCESSFULLY FILED NDAS IN THE US AND EUROPE FOR RISPERIDONE INDICATIONS IN AUTISM, ADOLESCENT SCHIZOPHRENIA, JUVENILE BIPOLAR DISORDER AND CONDUCT DISORDERS. SHE ALSO LED DEVELOPMENT TEAMS EVALUATING COMPOUNDS FOR DEPRESSION, NEUROPATHIC PAIN, EPILEPSY, AND MIGRAINE DISORDER. SHE SERVED 3 YEARS AS CHIEF SCIENCE AND TECHNOLOGY OFFICER FOR ONE MIND FOR RESEARCH, A NONPROFIT ORGANIZATION LAUNCHED IN MAY 2012 BY PATRICK J KENNEDY. SHE ORCHESTRATED THE LAUNCH OF ONE MIND'S SEMINAL PROGRAMS, APOLLO, AN INFORMATICS RESEARCH PORTAL AND, GEMINI, AN INTERNATIONAL TBI/PTSD RESEARCH PROGRAM. AS AN "INTRAPRENEUR" AT J&J SHE ESTABLISHED THE FIRST NEUROSCIENCE TRANSLATIONAL MEDICINE & INTEGRATIVE SOLUTIONS DEPARTMENT, AND CO-FOUNDED THE FIRST COMPANION DIAGNOSTICS CENTER OF EXCELLENCE AS WELL AS J&J'S HEALTHCARE INNOVATION TEAM. SHE SERVES ON SEVERAL ADVISORY BOARDS INCLUDING ALTO NEUROSCIENCE, KREMBIL CENTRE FOR NEUROINFORMATICS, VIRTUALBRAINCLOUD, PARTNERSHIP FOR ASSESSMENT AND ACCREDITATION OF SCIENTIFIC PRACTICE (PAASP) AND INTERUNIVERSITY MICROELECTRONICS CENTRE (IMEC) AN INTERNATIONAL RESEARCH & DEVELOPMENT AND INNOVATION HUB. DR. HAAS EARNED HER BS IN BIOENGINEERING FROM THE UNIVERSITY OF PENNSYLVANIA, AN MS IN BIOMEDICAL ENGINEERING FROM RUTGERS UNIVERSITY, NEW JERSEY, AND HER MD PHD WITH DISTINCTION IN NEUROSCIENCE FROM ALBERT EINSTEIN COLLEGE OF MEDICINE, NEW YORK. BOARD MEMBER, SECRETARY, THERESA FRANGIOSA HAS EXTENSIVE EXECUTIVE EXPERIENCED BASED ON HER 25 YEAR CAREER WITH THE PHARMACEUTICAL SECTOR. IN HER ROLES WITHIN PHARMA, SHE WAS A GLOBAL LAUNCH LEADER AS WELL AS OVERSEEING EARLY COMMERCIAL STRATEGY IN NEUROSCIENCES. SHE LED LARGE SCALE TEAMS, CROSS-FUNCTIONAL TEAMS TO DEFINE DISEASE AND THERAPEUTIC AREA STRATEGIES FOR JANSSEN AND GLAXOSMITHKLINE. SHE HAS ALSO LED INDICATION PRIORITIZATION EFFORTS AND DEVELOPMENT OF OVER 200 TARGET PRODUCT PROFILES OVER A VARIETY OF DISEASE STATES, LEVERAGING WELL-ESTABLISHED PROCESSES AND FRAMEWORKS, INCLUDING DEEPER UNDERSTANDING OF PATIENT JOURNEYS TO CREATE KEY INSIGHTS. SHE HAS APPLIED HER PROFESSIONAL CAREER EXPERIENCE AND HER PASSION FOR ADVOCACY TO HELP CREATE A CHANNEL FOR FEEDBACK FROM THOSE DIAGNOSED WITH OR AT RISK FOR ALZHEIMER'S DISEASE OR DEMENTIA, THEIR CARE PARTNERS AND INDIVIDUALS WHO ARE 'WORRIED WELL', CALLED THE A-LIST. SHE IS THE LEAD INVESTIGATOR FOR THIS RESEARCH STUDY WITH IRB OVERSIGHT. MS. FRANGIOSA OBTAINED HER BACHELOR OF ADMINISTRATION, ACCOUNTING CONCENTRATION FROM URSINUS COLLEGE (COLLEGEVILLE, PA) IN 1988 AND HER MASTERS OF BUSINESS ADMINISTRATION, PHARMACEUTICAL MARKETING FROM ST. JOSEPH'S UNIVERSITY IN 1996. BOARD MEMBER, TREASURER, MICHAEL C. SULLIVAN IS THE CHIEF OF STAFF AND HEAD OF EXTERNAL AFFAIRS OF POINT72 ASSET MANAGEMENT. MR. SULLIVAN PREVIOUSLY SERVED AS A SENIOR AIDE IN THE UNITED STATES SENATE, FOCUSING ON TELECOM, TECHNOLOGY, AND FINANCE ISSUES. MR. SULLIVAN ALSO SERVED AS A STAFF MEMBER IN THE U.S. HOUSE OF REPRESENTATIVES WORKING ON SIMILAR ISSUES. BEFORE COMING TO CAPITOL HILL, MR. SULLIVAN WAS THE HEAD OF STRATEGIC DEVELOPMENT FOR A TELECOMMUNICATIONS FOCUSED TRADE ASSOCIATION. MR. SULLIVAN IS INVOLVED WITH SEVERAL VETERANS' MENTAL HEALTH-RELATED NON-PROFIT ORGANIZATIONS. HE HELPED ESTABLISH AND SERVES ON THE BOARD AND AS TREASURER OF THE COHEN VETERANS NETWORK, WHICH OPERATES A NATIONAL NETWORK OF CLINICS TO TREAT VETERANS AND THEIR FAMILY MEMBERS AFFECTED BY POST-TRAUMATIC STRESS. MR. SULLIVAN IS AN ASSOCIATE AT THE NYU-STERN ENDLESS FRONTIER LABS, WHERE HE MENTORS START-UP COMPANIES IN ARTIFICIAL INTELLIGENCE, MACHINE LEARNING, AND RELATED FIELDS. HE IS ALSO A MEMBER OF THE EXECUTIVE COMMITTEE OF STUDENTS FIRST NEW YORK, A NONPROFIT ORGANIZATION ADVOCATING FOR EDUCATIONAL REFORM IN NEW YORK STATE. MR. SULLIVAN IS A GRADUATE OF VANDERBILT UNIVERSITY. BOARD MEMBER, DAVID BIONDI, MD HAS OVER 20 YEARS OF CLINICAL EXPERIENCE IN MEDICAL PRACTICE AND HELD MEDICAL DIRECTORSHIPS AT THE US NAVAL HOSPITAL IN OKINAWA JAPAN, THE PAIN MANAGEMENT PROGRAM & HEADACHE INSTITUTE AT MARYVIEW MEDICAL CENTER IN PORTSMOUTH VA, THE PAIN DIVISION OF THE MICHIGAN HEAD PAIN & NEUROLOGICAL INSTITUTE IN ANN ARBOR MI, AND THE INTERDISCIPLINARY HEADACHE & PAIN REHABILITATION PROGRAM AT SPAULDING REHABILITATION HOSPITAL IN BOSTON, MA. HE WAS PREVIOUSLY AN ASSISTANT NEUROLOGIST AT THE MASSACHUSETTS GENERAL HOSPITAL AND AN INSTRUCTOR IN NEUROLOGY AT HARVARD MEDICAL SCHOOL. DR. BIONDI SERVED AS A TRUSTEE FOR THE UNIVERSITY OF NEW ENGLAND AND WAS CHAIR OF ITS ACADEMIC AND RESEARCH AFFAIRS COMMITTEE AND VICE-CHAIR OF ITS LONG-RANGE PLANNING COMMITTEE. HE ALSO SERVED AS A DIRECTOR AND MEDICAL ADVISOR FOR THE AFTER ACTION NETWORK, A NONPROFIT VETERAN SERVICE ORGANIZATION IN KANSAS CITY, MO. HE IS A FELLOW OF THE AMERICAN ACADEMY OF NEUROLOGY. DR. BIONDI HAS OVER 15 YEARS OF EXPERIENCE IN CLINICAL RESEARCH AND DEVELOPMENT OF PHARMACEUTICALS AND MEDICAL DEVICES IN THE NEUROLOGY, PSYCHIATRY, AND PAIN THERAPEUTIC AREAS. HIS EXPERIENCES INCLUDE THE DESIGN, IMPLEMENTATION, MONITORING, AND INTERPRETATION OF PHASE 2 TO PHASE 4 CLINICAL TRIALS AND IN-HOUSE AND FIELD-BASED ACTIVITIES ASSOCIATED WITH INSIGHTS GENERATION, NEW BUSINESS OPPORTUNITIES, EMERGING HEALTH POLICY, KNOWLEDGE TRANSLATION AND IMPLEMENTATION, AND ORGANIZATIONAL EFFECTIVENESS. HE PREVIOUSLY SERVED AS EXECUTIVE DIRECTOR FOR CLINICAL PROGRAMS WITH COHEN VETERANS BIOSCIENCE. DR. BIONDI RECEIVED HIS MEDICAL DEGREE FROM THE UNIVERSITY OF NEW ENGLAND, COLLEGE OF OSTEOPATHIC MEDICINE IN BIDDEFORD, ME. HE COMPLETED RESIDENCY TRAINING IN NEUROLOGY AT THE NATIONAL NAVAL MEDICAL CENTER IN BETHESDA, MD AND IS BOARD-CERTIFIED IN NEUROLOGY WITH SUBSPECIALTY EXPERTISE IN HEADACHE AND PAIN MEDICINE. HE RECEIVED HIS BACHELOR OF SCIENCE - MAGNA CUM LAUDE IN PHARMACY FROM THE LONG ISLAND UNIVERSITY, SCHWARTZ COLLEGE OF PHARMACY & HEALTH SCIENCE IN BROOKLYN, NY. BOARD MEMBER, DR. DAVE DEMARCO IS A SENIOR ADVISOR TO C-SUITE LEADERS IN THE LIFE SCIENCES AND HEALTHCARE INDUSTRIES. HE SERVES AS CHIEF STRATEGY OFFICER FOR MATERIAL HEALTH STRATEGIES AND WORKS WITH C-SUITE EXECUTIVES ON GROWTH STRATEGIES AND TEAM PERFORMANCE IN BOTH THE FOR-PROFIT AND NOT-FOR-PROFIT INDUSTRIES. HE PREVIOUSLY SERVED AS CHAIR OF THE BOARD OF THE AMERICAN DIABETES ASSOCIATION, LED ERNST & YOUNG'S (EY'S) NORTHEAST LIFE SCIENCES PRACTICE AND WAS THE DEPUTY LEADER OF THE US HEALTHCARE PRACTICE. WITH OVER 25 YEARS OF LEADERSHIP EXPERIENCE, DAVE ADVISES, COACHES AND SHARES INSIGHTS ON STRATEGY AND TRANSFORMATION, COMMERCIAL OPERATIONS, HEALTHCARE POLICY, GOVERNANCE, PUBLIC-PRIVATE-PARTNERSHIPS, AND ENTREPRENEURIAL GROWTH. WHILE SERVING ON THE BOARD OF THE AMERICAN DIABETES ASSOCIATION, HE LED BOARD INITIATIVES INVOLVING: CEO SUCCESSION, PRINCIPAL OFFICER SUCCESSION, BOARD DEVELOPMENT, POLICY CREATION, STRATEGIC PLAN IMPLEMENTATION AND TECHNOLOGY PARTNERSHIPS. DAVE HAS HELD KEY EXECUTIVE POSITIONS, INCLUDING: GLOBAL AESTHETIC FRANCHISE LEADER, SANOFI AVENTIS; US HEALTH DEPUTY LEADER, NORTHEAST REGION LIFE SCIENCES PRACTICE LEADER AND JOHNSON & JOHNSON GLOBAL CLIENT SERVICES PARTNER, EY; RESEARCH SCIENTIST, INTERNAL VENTURE LEADER, AMOCO CHEMICAL; AND COFOUNDER, IDEA CONNECTION SYSTEMS. DAVE WORKED CLOSELY WITH THE AVENTIS NA LEADERSHIP TEAM TO DEVELOP POST-MERGER INTEGRATION GROWTH STRATEGIES AND LAUNCH KEY BLOCKBUSTER PRODUCTS AIMED AT, AND SUCCEEDING IN, DOUBLING THE SIZE OF THE BUSINESS IN FOUR YEARS. AS A SENIOR PARTNER IN EY'S GLOBAL LIFE SCIENCES TEAM, DAVE PILOTED A NEW P&L ACCOUNTABLE, GO-TO-MARKET MODEL, GROWING THE NORTHEAST PRACTICE AT 30% CAGR, RESULTING IN A $400 MILLION BUSINESS. IN HIS SERVICE TO JOHNSON & JOHNSON, HE PARTNERED WITH J&J LEADERSHIP IN DEVELOPING JANSSEN HEALTHCARE INNOVATION, CHARGED WITH CREATING FUTURE BUSINESS UNITS. DAVE LED THE TRANSFORMATION OF EY'S US HEALTH PRACTICE, RESULTING IN A $750 MILLION BUSINESS. PART II SECT C LINE 17A FACTS & CIRCUMSTANCES TEST (CONT): AS A MEMBER OF THE SANOFI AVENTIS NA DERMATOLOGY LEADERSHIP TEAM, DAVE DEVELOPED THE GLOBAL AESTHETIC FRANCHISE STRATEGY AND SERVED AS THE COMMERCIAL HEAD FOR EUROPE. FOR THIS TURNAROUND PROJECT, HE CREATED A PLAN TO TRIPLE EBITDA, IMPLEMENT NEW GLOBAL PRICING POLICIES AND DOUBLE CUSTOMER ACQUISITION. DAVE RECEIVED HIS B.S. FROM GROVE CITY COLLEGE AND PH.D. IN CHEMISTRY FROM PURDUE UNIVERSITY. BOARD MEMBER, DOUG HAYNES IS AN ACTIVE COMMUNITY MEMBER, DEDICATING A SIGNIFICANT PORTION OF HIS EFFORTS TO SUPPORTING VETERANS' INITIATIVES. IN ADDITION TO SERVING ON THE BOARD OF THE ROBIN HOOD FOUNDATION, MR. HAYNES HELPED LAUNCH ITS VETERANS ADVISORY BOARD WHICH RAISED OVER $12 MILLION TO SUPPORT THE INCREASE IN VETERANS RETURNING FROM IRAQ AND AFGHANISTAN, AND ALSO WORKS WITH NEW YORK-BASED COMPANIES TO CREATE MORE JOB OPPORTUNITIES FOR VETERANS. MR. HAYNES SERVES ON THE CORPORATE ADVISORY BOARD OF THE DARDEN GRADUATE SCHOOL OF BUSINESS, THE BOARD OF THE CANTERBURY SCHOOL, SINGTEL'S TECHNOLOGY ADVISORY BOARD, AND THE BOARD OF THE CENTER FOR GLOBAL ENTERPRISE. MR. HAYNES FORMERLY SERVED AS THE PRESIDENT OF POINT72 ASSET MANAGEMENT, L.P., ORIGINALLY JOINING THE FIRM AS MANAGING DIRECTOR OF HUMAN CAPITAL IN FEBRUARY 2014. PRIOR TO JOINING POINT72, MR. HAYNES WAS A DIRECTOR AT MCKINSEY & COMPANY. BEFORE JOINING MCKINSEY, MR. HAYNES WORKED FOR THE CENTRAL INTELLIGENCE AGENCY AND THEN GE'S ADVANCED MATERIALS BUSINESS. MR. HAYNES EARNED A BS SUMMA CUM LAUDE IN MECHANICAL ENGINEERING FROM WEST VIRGINIA UNIVERSITY, AND RECEIVED HIS MBA AT THE UNIVERSITY OF VIRGINIA'S DARDEN GRADUATE BUSINESS SCHOOL, WHERE HE WAS A SHERMET SCHOLAR. RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 90000 90000 18020420 18110420 1000000 250000 0 0 893383 1000000 1000000 1000000 3893383 5840075 90000 87500 90000 90000 357500 223346 250000 250000 250000 973346 1460019 134362 29501 104861 174076 45963 128113 11517 10237 1280 234254 DEFERRED RENT 141000 141000 X 16252270 0 16252270 0 16252270 18110420 0 18110420 0 18110420 PART X, LINE 2: TAX POSITION: THE ORGANIZATION CURRENTLY EVALUATES ALL TAX POSITIONS, AND MAKES A DETERMINATION REGARDING THE LIKELIHOOD OF THOSE POSITIONS BEING UPHELD UNDER REVIEW. THE PRIMARY TAX POSITION MADE BY THE ORGANIZATION IS THE EXISTENCE OF UNRELATED BUSINESS INCOME TAX AND THE ORGANIZATION'S STATUS AS A TAX-EXEMPT ORGANIZATION UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE. FOR THE YEAR PRESENTED, THE ORGANIZATION HAS NOT RECOGNIZED ANY TAX BENEFITS OR LOSS CONTINGENCIES FOR UNCERTAIN TAX POSITIONS BASED ON THIS EVALUATION. 1 EUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUM 0 0 GRANTS TO RECIPIENTS LOCATED IN REGION N/A 182060 0 0 0 0 0 0 182060 0 182060 EUROPE (INCLUDING ICELAND & GREENLAND) PLATFORM FOR THE EXCHANGE OF EXPERIMENTAL RESEARCH STANDARDS (PEERS) 72433 WIRE TRANSFER N/A N/A EUROPE (INCLUDING ICELAND & GREENLAND) PLATFORM FOR THE EXCHANGE OF EXPERIMENTAL RESEARCH STANDARDS (PEERS) 40000 WIRE TRANSFER N/A N/A EUROPE (INCLUDING ICELAND & GREENLAND) ADDRESSING SEX AS A BIOLOGICAL VARIABLE IN PRECLINICAL PHARMACOLOGY 5420 WIRE TRANSFER N/A N/A EUROPE (INCLUDING ICELAND & GREENLAND) PLATFORM FOR THE EXCHANGE OF EXPERIMENTAL RESEARCH STANDARDS (PEERS) 64207 WIRE TRANSFER N/A N/A 2 2 0 0 0 0 0 0 PART I, LINE 2: THE ORGANIZATION REQUIRES GRANTEES TO REGULARLY PROVIDE QUALITATIVE AND QUANTITATIVE REPORTS DESCRIBING HOW FUNDS ARE BEING SPENT AND THE RESULTS THE GRANTEE HAS ACHIEVED. PROGRESS IS MEASURED AGAINST ORIGINAL AND REVISED GRANT PROPOSALS. CONTINUATION OF FUNDING IS DEPENDENT ON RESULTS AND ACCURATE, TIMELY REPORTING. PART III ACCOUNTING METHOD: X X X 1 360 PHILANTHROPY GROUP 1405 CLINTON STREET APT 204 HOBOKEN NJ 07030 FUNDRAISING CONSULTING 0 0 38000 0 LORI ROBBINS 30 ABBOTT ROAD HAMILTON NJ 08690 FUNDRAISING CONSULTING 0 0 12600 0 50600 MA NY 1 UNIVERSITY OF CALIFORNIA SAN DIEGO 9500 GILMAN DRIVE LA JOLLA CA 92093 956006144 501(C)3 64021 N/A N/A PRECLINICAL MODELING OF PTSD AND ALCOHOL ABUSE BOSTON VA RESEARCH INSTITUTE 5 POST OFFICE SQUARE BOSTON MA 02109 043081524 501(C)3 0 -10421 N/A REPURPOSED GRANT FUNDS ADVANCING THE STUDY OF DEPLOYMENT TRAUMA IN THE TRACTS COHORT 2 0 PART I, LINE 2: THE ORGANIZATION REQUIRES GRANTEES TO REGULARLY PROVIDE QUALITATIVE AND QUANTITATIVE REPORTS DESCRIBING HOW FUNDS ARE BEING SPENT AND THE RESULTS THE GRANTEE HAS ACHIEVED. PROGRESS IS MEASURED AGAINST ORIGINAL AND REVISED GRANT PROPOSALS. CONTINUATION OF FUNDING IS DEPENDENT ON RESULTS AND ACCURATE, TIMELY REPORTING. X X X 0 0 0 0 0 0 0 0 0 MAGALI HAAS MD PHD CEO & PRESIDENT 467497 0 160000 0 0 0 17100 0 0 0 644597 0 0 0 ALLYSON GAGE PHD CHIEF MEDICAL OFFICER 369048 0 126247 0 0 0 17100 0 7363 0 519758 0 0 0 ANDREAS JEROMIN PHD CHIEF SCIENTIFIC OFFICER 351403 0 138828 0 0 0 0 0 14957 0 505188 0 0 0 DANIEL PLOWDEN FORMER CHIEF FINANCIAL OFFICER 267283 0 88000 0 0 0 16513 0 20861 0 392657 0 0 0 AMANDA NICOLE HARMON EXECUTIVE DIRECTOR, COMMUNITY PARTNE 251661 0 48925 0 0 0 17100 0 20861 0 338547 0 0 0 MARYAN ZIRKLE EXECUTIVE DIRECTOR, BRAINCOMMONS 228024 0 41400 0 0 0 6803 0 7363 0 283590 0 0 0 TIMOTHY VAUGHAN DEPUTY DIRECTOR, DATA SCIENCES 203195 0 22500 0 0 0 6142 0 14957 0 246794 0 0 0 LEE LANCASHIRE CHIEF INFORMATION OFFICER 207380 0 0 0 0 0 8295 0 28523 0 244198 0 0 0 LAUREN GOLDSMITH SENIOR DIRECTOR, CONTRACTING & GRANT 207155 0 1000 0 0 0 12088 0 7363 0 227606 0 0 0 EVGENY RAKHMATULIN CHIEF TECHNOLOGY OFFICER 160483 0 35438 0 0 0 11992 0 16015 0 223928 0 0 0 FORM 990, PART VI, SECTION B, LINE 11B THE BOARD OF DIRECTORS REVIEWED AND APPROVED THE FORM 990 PRIOR TO ITS FILING. THE FORM 990 WAS THEN AUTHORIZED AND SIGNED BY THE ORGANIZATION'S CEO & PRESIDENT. FORM 990, PART VI, SECTION B, LINE 12C THE BOARD OF DIRECTORS REQUIRES AN ANNUAL DECLARATION FROM ALL BOARD MEMBERS AND SENIOR MANAGEMENT AS TO THE EXISTENCE AND DISCLOSURE OF ANY POTENTIAL CONFLICTS OF INTEREST. THE BOARD MEMBERS SIGN A DISCLOSURE STATEMENT. ANY POTENTIAL CONFLICTS ARE DISCUSSED BY THE DIS-INTERESTED BOARD MEMBERS, WHILE THE PARTY IN POTENTIAL CONFLICT IS REQUIRED TO LEAVE THE ROOM. BOARD MEETING MINUTES WILL DOCUMENT THE DISCUSSION AND DECISION MAKING PROCESS. IN THE EVENT OF A POTENTIAL CONFLICT, PROCEDURES TO OBTAIN COMPETITIVE BIDS AND DILIGENCE ON FAIR MARKET VALUE WILL BE ESTABLISHED. FORM 990, PART VI, SECTION B, LINE 15 CVB'S EXECUTIVE COMPENSATION PROGRAM IS ADMINISTERED BY THE BOARD OF DIRECTORS. THE BOARD IS RESPONSIBLE FOR ESTABLISHING AND MAINTAINING A COMPETITIVE COMPENSATION PROGRAM FOR THE KEY EXECUTIVES OF THE ORGANIZATION. THE BOARD MEETS AS NEEDED TO REVIEW THE COMPENSATION PROGRAM AND MAKE RECOMMENDATIONS FOR ANY CHANGES, AS APPROPRIATE. A PERFORMANCE EVALUATION IS CONDUCTED AND REVIEWED EACH YEAR AND IS INTENDED TO ENSURE THAT THE COMPENSATION PROGRAM FALLS WITHIN A REASONABLE RANGE OF COMPETITIVE PRACTICES FOR COMPARABLE POSITIONS AMONG SIMILARLY SITUATED ORGANIZATIONS. FOLLOWING THIS REVIEW, THE BOARD REVIEWS AND APPROVES, FOR SELECTED KEY EXECUTIVES, BASE SALARIES AND ANNUAL INCENTIVE OPPORTUNITY ADJUSTMENTS, AND OBJECTIVES AND GOALS UPCOMING YEAR'S ANNUAL INCENTIVE PLAN. THE BOARD REVIEWS AND RECOMMENDS TO THE BOARD SALARY APPROVAL AND INCENTIVE AWARDS FOR THE CEO/PRESIDENT AND SELECTED KEY SENIOR STAFF. FORM 990, PART VI, SECTION C, LINE 19 UPON REQUEST AND FORMS AVAILABLE THROUGH CHARITY NAVIGATOR WEBSITE AS WELL. FORM 990, PART IX, LINE 11G RESEARCH COLLABORATION EXPENSES: PROGRAM SERVICE EXPENSES 1,866,118. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,866,118. CONTRACTED SERVICES: PROGRAM SERVICE EXPENSES 4,640,071. MANAGEMENT AND GENERAL EXPENSES 180,475. FUNDRAISING EXPENSES 1,623. TOTAL EXPENSES 4,822,169. FORM 990, PART XI, LINE 9: CANCELLATION OF GRANT OBLIGATION 2,550,515. EARLY SIGNAL LLC 1 BROADWAY 14TH FLOOR CAMBRIDGE MA 02142 TO HOLD INTELLECTUAL PROPERTY MA 0 0 COHEN VETERANS BIOSCIENCE INC