2019-11-13T18:56:26-06:00 2018-12-31 133628255 CONDON O'MEARA MCGINTY & DONNELLY LLP ONE BATTERY PARK PLAZA 7TH FL NEW YORK NY 10004 990 2018-01-01 202014968 CHARLEY'S FUND INC CHAR 4135280400 635 MAIN STREET SUITE 3 GREAT BARRINGTON MA 01230 EARL KRAMER TREASURER 4135280400 2019-11-08 1 JAMES J REILLY P00183769 2126617777 184.74.172.82 2019-11-08 11:23:08 ES P DA39A3EE5E6B4B0D3255BFEF95601890AFD80709 22603B5F3D0F044F5E1D98A58B2AA5892463CC73 2018 2020-03-31 21:24:44Z EARL KRAMER 635 MAIN STREET SUITE 3 GREAT BARRINGTON MA 01230 2812052 0 X WWW.CHARLEYSFUND.ORG X 2004 MA TO ACCELERATE THE DEVELOPMENT OF LIFE-SAVING TREATMENTS FOR DUCHENNE MUSCULAR DYSTROPHY "DMD" 8 7 4 8 0 0 1415266 2757831 0 0 4682 12225 1131 -1312 1421079 2768744 830522 1522481 0 0 521216 478333 0 0 281135 289753 260701 1641491 2261515 -220412 507229 5479080 5773778 436974 224443 5042106 5549335 X CHARLEY'S FUND'S SINGULAR MISSION IS TO SUPPORT THE DEVELOPMENT OF TREATMENTS AND A CURE FOR DUCHENNE MUSCULAR DYSTROPHY (DMD). WE IDENTIFY AND DIRECT FUNDING TO THE MOST COMPELLING RESEARCH AND TREATMENT PROGRAMS RELATED TO DMD AND, (CONT. ON SCH. O.) 1 0 1330017 1300000 SEE SCHEDULE O 125000 125000 THE GRANT TO AKASHI THERAPEUTICS, INC., WAS TO SUPPORT FOR THE CONTINUED DEVELOPMENT OF THEIR RESEARCH PIPELINE, INCLUDING CLINICAL DEVELOPMENT OF HT-100 (DELAYED RELEASE HALOFUGINONE), AN ORALLY AVAILABLE SMALL MOLECULE DEVELOPED TO REDUCE FIBROSIS AND INFLAMMATION AND PROMOTE HEALTHY MUSCLE REGENERATION IN BOYS WITH DMD; AN ORAL SARM (SELECTIVE ANDROGEN RECEPTOR MODULATOR), AND AT-300, A NEW THERAPY THAT HAS THE POTENTIAL TO INHIBIT THE CALCIUM INFLUX THAT RESULTS FROM THE LACK OF DYSTROPHIN IN BOYS WITH DMD. 179648 97481 SEE SCHEDULE O 224590 OTHER 224590 1859255 1 1 0 0 0 0 0 0 0 1 1 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1 0 0 0 1 13 0 1 4 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 X 8 7 1 0 0 0 0 0 0 1 1 0 0 0 1 1 1 1 1 1 1 1 0 CA CT FL IL MA NJ NY OH WA X SARAH DONALDSONTHE FUND 4135280400 635 MAIN ST STE 3 GREAT BARRINGTON MA 01230 BENJAMIN SECKLER MD BOARD CHAIRMAN 15.00 X X 0 0 0 EARL KRAMER TREASURER 2.00 X X 0 0 0 KAREN CLIMO CLERK 2.00 X X 0 0 0 KATHE KRAMER CHASE BOARD MEMBER 2.00 X 0 0 0 RANDY REIFF BOARD MEMBER 2.00 X 0 0 0 TRACY KRAMER SECKLER BOARD MEMBER 40.00 X 71510 0 0 ELLEN WILNER BOARD MEMBER 2.00 X 0 0 0 MARK AVAGLIANO BOARD MEMBER 2.00 X 0 0 0 LAURA DALLE PAZZE PRESIDENT & CHIEF OPERATING OFFICER 55.00 X 224523 0 6737 296033 0 6737 1 0 1 0 0 2757831 42225 2757831 12477 12477 41973 42225 -252 -252 -252 183 1083 -900 -900 LOSS ON INVESTEMNT IN LLC 900099 -412 -412 -412 2768744 -900 0 11813 1522481 1522481 302770 129615 53093 120062 131745 57027 22820 51898 16706 3656 4503 8547 27112 10816 4755 11541 10062 8912 707 443 22700 650 22050 1325 1325 19853 4454 15399 44877 2492 2008 40377 20871 8023 3361 9487 18844 14911 758 3175 1100 1100 364 364 6706 2236 2235 2235 SCIENTIFIC CONSULTING 74620 74620 OTHER 39379 18262 3146 17971 2261515 1859255 121125 281135 9339 10103 1998113 1106648 247111 1432833 14021 12938 4248 4234 10485 9688 1161 797 3202537 3202775 2550 3450 5479080 5773778 26011 30358 410963 194085 436974 224443 X 4947485 4299335 94621 1250000 5042106 5549335 5479080 5773778 507229 0 X 0 1 X 1 0 X 1249979 1550470 1054965 1415266 2757831 8028511 1249979 1550470 1054965 1415266 2757831 8028511 1620690 6407821 126004 1178 3119820 4746 11152 3262900 38 38 11291449 0.56750 0.59360 X SCHEDULE A, PART II, LINE 10, EXPLANATION OF OTHER INCOME: OTHER - 2017 AMOUNT: $ 38. RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 94621 1825000 669621 1250000 35000 205000 145379 94621 64707 40000 69707 35000 130000 65293 64707 1.00000 0 0 10485 9688 797 797 INVESTMENT - DMD SOLUTIONS,LLC -6667 C INVESTMENT - TCW CATALYST,LLC -235 C INVESTMENT - WIDE VISION LLC 125000 C INVESTMENT - DART THERAPEUTICS 84677 C INVESTMENT - AKASHI THERAPEU. 3000000 C 3202775 PART V, LINE 4: TEMPORARILY RESTRICTED NET ASSETS CONSIST OF CONTRIBUTIONS THAT ARE RESTRICTED BY THE DONOR FOR A SPECIFIC PURPOSE OR RELATE TO FUTURE PERIODS. 1 AKASHI THERAPUTICS LLC 145 FIRST ST CAMBRIDGE MA 02142 N/A 125000 RESEARCH GRANT CASIMIR LLC 36 CORDAGE PARK CIRCLE PLYMOUTH MA 02360 N/A 97481 RESEARCH GRANT UMASS MEMORIAL FOUNDATION 333 SOUTH ST SHREWSBURY MA 01545 043108190 501(C)(3) 1300000 RESEARCH GRANT 1 2 PART I, LINE 2: ALL GRANTS ARE PROVIDED UNDER CONTRACTS WITH THE GRANT RECIPIENTS. THE CONTRACTS REQUIRE GRANTEES TO MEET CERTAIN EVENT AND PERFORMANCE MILESTONES AND PERIODIC PROGRESS REPORTS TO CHARLEY'S FUND, INC. ARE REQUIRED. THE BOARD OF DIRECTORS REVIEWS AND APPROVES GRANTS ACCORDING TO THE ORGANIZATION'S POLICY ON FUNDING AND EXPENSE APPROVALS. 0 0 0 0 0 0 0 0 0 LAURA DALLE PAZZE PRESIDENT & CHIEF OPERATING OFFICER 192566 0 31957 0 0 0 0 0 6737 0 231260 0 0 0 X 6 42225 FMV 0 1 0 CONT. FROM PART III - LINE 1 IMPORTANTLY, AMPLIFY THE IMPACT OF THAT FUNDING WITH STRATEGIC PROBLEM-SOLVING SUPPORT TO BOTH AWARDEES AND THE BROADER DMD RESEARCH COMMUNITY. TO BEAT DMD, IT'S NOT ENOUGH TO FIND THE BEST RESEARCH; WE ALSO MUST PROACTIVELY IDENTIFY AND KNOCK DOWN HURDLES THAT STAND IN THE WAY OF EFFICIENT DRUG DEVELOPMENT. SINCE INCEPTION, WE HAVE DIRECTED ALMOST $45M IN FUNDING TO THESE EFFORTS, LEVERAGING BOTH OUR OWN FUNDING AS WELL AS FUNDING FROM OTHER DMD PATIENT ORGANIZATIONS TO IDENTIFY AND SUPPORT THE BEST SCIENCE IN PURSUIT OF TREATMENTS AND A CURE FOR DMD. IN 2018, WE DEDICATED A TOTAL OF $1,859,254 TO OUR PROGRAMMATIC EFFORTS. OF THIS, $1,522,481 WAS DEDICATED TO GRANTS AND ALLOCATIONS AND $336,773 WAS DEDICATED TO OTHER PROGRAMMATIC EXPENSES. FORM 990, PART III, LINE 2 IN 2018 WE FOUNDED THE DUCHENNE PROGRAM AT UMASS MEDICAL SCHOOL, AN INITIATIVE DESIGNED TO ADVANCE COMPREHENSIVE CARE AND RESEARCH FOR DMD PATIENTS IN THE REGION, ACROSS THE COUNTRY, AND EVEN AROUND THE WORLD. OUR SUPPORT ENABLES THE ESTABLISHMENT OF A BEST-IN-CLASS CLINICAL FACILITY AND PROGRAM THAT ADVANCES OUR MISSION TO STOP DMD BY PURSUING THREE MUTUALLY ENHANCING PILLARS OF WORK: PROVIDING MULTIDISCIPLINARY, INTEGRATIVE CARE TO BOYS LIVING WITH DMD TODAY, HOSTING CUTTING-EDGE CLINICAL TRIALS, AND CONDUCTING ORIGINAL RESEARCH. WE PROVIDED $1.3MM TO UMASS SUPPORT THIS INITIATIVE IN 2018. THE DUCHENNE PROGRAM OPENED ITS DOORS IN JULY. PART III - LINE 4A IN 2018 WE CREATED THE DUCHENNE PROGRAM AT UMASS MEDICAL SCHOOL. THE PROGRAM IS POWERED BY A UNIQUE COLLABORATION AMONG THE MEDICAL, RESEARCH, AND PATIENT COMMUNITIES. FOUNDING CLINIC DIRECTOR DR. BRENDA WONG, HOST INSTITUTION UMASS MEDICAL CENTER AND MEDICAL SCHOOL, AND CHARLEY'S FUND WORK JOINTLY TO ENSURE THAT THE DUCHENNE PROGRAM DELIVERS WORLD-CLASS RESULTS ON THREE KEY GOALS: DELIVER COMPREHENSIVE, INTEGRATED CARE TO PATIENTS HOST CUTTING-EDGE CLINICAL TRIALS DRIVE ORIGINAL RESEARCH AND DISCOVERIES TO POWER THE NEXT WAVE OF BREAKTHROUGHS THE DUCHENNE PROGRAM ALREADY IN ITS FIRST YEAR IS SEEING MORE PATIENTS THAN ANY OTHER CLINIC IN THE WORLD. IT CURRENTLY HOSTS TWO ACTIVE CLINICAL TRIALS AND IS IN DISCUSSIONS TO ADD MORE. IT ALSO CURRENTLY HAS ONE ORIGINAL RESEARCH PROJECT UNDERWAY AND IS WELL INTO DEVELOPING THE DATABASE THAT WILL PROVIDE A KEY RESOURCE IN FURTHER RESEARCH TO FOLLOW. PART III - LINE 4C THROUGH OUR IMPACT INITIATIVE WE WORK WITH PARTNERS IN THE FIELD TO DEVELOP THEIR SCIENTIFIC PROGRAMS AND TO IDENTIFY RESEARCH ROADBLOCKS AND POTENTIAL SOLUTIONS. THE IMPACT INITIATIVE SPEEDS AND IMPROVES ALL RESEARCH NOT JUST ONE PARTICULAR THERAPY BY IDENTIFYING AND THEN SOLVING SYSTEMIC PROBLEMS THAT MAKE DRUG DEVELOPMENT SLOWER, MORE DIFFICULT AND MORE COSTLY. CURRENTLY THE IMPACT INITIATIVE FOCUSES ON THREE AREAS: 1) IMPROVING OUTCOME MEASURES, 2) IMPROVING PRECLINICAL METHODS AND DECISION-MAKING, AND 3) IMPROVING THE DESIGN, EXECUTION, AND ANALYSIS OF CLINICAL TRIALS FOR DMD. WE DEVELOPED THE IMPACT INITIATIVE BECAUSE RIGOROUS SCIENCE UNDERTAKEN WITH URGENCY AND FOCUS IS THE ONLY WAY WE GET TO THE OUTCOMES WE AND ALL DUCHENNE FAMILIES WANT: DRUGS THAT WORK, AND WORK WELL. SOLVING THESE FIELD-WIDE PROBLEMS AND IMPROVING OUR TOOLS AND RESOURCES IS AN ABSOLUTE MUST TO GET RESULTS. OUTCOME MEASURES: ONE ASPECT OF THE DRUG DEVELOPMENT PROCESS THAT CONCERNS US IS THE LACK OF RELIABLE OUTCOME MEASURES THAT CAN DETERMINE THE EFFICACY OF AN INTERVENTION OVER A REASONABLY SHORT PERIOD OF TIME. IN 2018 WE COMMITTED FUNDS TO CASIMIR, LLC WHICH WAS FORMED TO ADDRESS THIS IMPORTANT NEED BY DEVELOPING A SERIES OF OUTCOME MEASURES DESIGNED TO QUANTIFY PATIENT QUALITY OF MOVEMENT USING VIDEOS OF BOYS WITH DMD PERFORMING DAILY TASKS. WITH OUR SUPPORT, CASIMIR HAS PURSUED ACTIVITIES TO DEVELOP AND REFINE THEIR SCORING SYSTEM, GATHER KEY BASELINE DATA NEEDED TO DETERMINE ITS RELIABILITY AND CONCEPT VALIDITY, AND BEGUN ENGAGING WITH THE FDA TO ENSURE ACCEPTANCE OF THIS DEVELOPING TOOL. ALSO, IN 2018, WE CONTINUED OUR SUPPORT FOR ELECTRICAL IMPEDANCE MYOGRAPHY (EIM), COLLABORATING WITH EIM FOUNDER DR. SEWARD RUTKOVE TO ASSESS ITS SUITABILITY AS AN OUTCOME MEASURE FOR DMD. EIM UTILIZES A SMALL, HAND-HELD DEVICE TO RUN A HIGH-FREQUENCY CURRENT THROUGH A MUSCLE. IT IS PAINLESS, RELATIVELY INEXPENSIVE, TAKE SECONDS TO PERFORM AND CAN BE USED ON PATIENTS OF ANY AGE. WITH OUR SUPPORT, DR. RUTKOVE HAS COMPLETED CRITICAL STUDIES TO CONFIRM EIM'S RELIABILITY, CONSISTENCY AND ABILITY TO DIFFERENTIATE HEALTHY MUSCLE FROM DISEASED MUSCLE. PRECLINICAL METHODS: ONE MAJOR REASON WE HAVE TROUBLE TRANSLATING PROMISING RESEARCH RESULTS INTO ACTUAL THERAPIES IS THE SHORTCOMINGS IN HOW PRECLINICAL METHODS AND MODELS ARE USED BY DMD RESEARCHERS. OUR "OF MICE AND MEASURES" PROGRAM (OMAM) IS A COLLABORATIVE, ONGOING EFFORT THAT BRINGS TOGETHER EXPERTS FROM ACADEMIA AND INDUSTRY TO IMPROVE THE DECISION-MAKING PROCESS FOR WHICH DRUGS SHOULD ADVANCE TO CLINICAL TESTING. CLINICAL TRIALS: THE COLLABORATIVE TRAJECTORY ANALYSIS PROJECT (CTAP) IS A COLLABORATIVE EFFORT AMONG KEY STAKEHOLDERS IN THE INDUSTRY, ACADEMIC, AND PATIENT COMMUNITIES TO IMPROVE THE WAY WE DESIGN, EXECUTE, AND ANALYZE CLINICAL TRIALS IN DUCHENNE. IT MAKES USE OF A GROWING BODY OF DMD NATURAL HISTORY AND CLINICAL TRIAL DATA AND CUTTING-EDGE BIOSTATISTICAL ANALYSIS APPROACHES TO IMPROVE OUR UNDERSTANDING OF THE NATURAL HISTORY OF DUCHENNE AND THUS, HOW SPONSORS CAN BETTER DESIGN TRIALS TO IDENTIFY WHEN THEIR TREATMENT SUCCEEDS IN CHANGING THAT NATURAL HISTORY. CTAP WORKS TO PROVIDE 1) ONGOING INVESTIGATION AND PUBLICATION ON KEY QUESTIONS FACING THE FIELD AND IMPACTING CLINICAL TRIAL DESIGN, AND 2) TARGETED SUPPORT FOR SPONSORS DESIGNING AND RUNNING TRIALS TODAY. FORM 990, PART VI, SECTION A, LINE 2 BENJAMIN SECKLER, MD (BOARD CHAIRMAN), IS HUSBAND TO TRACY KRAMER SECKLER (BOARD MEMBER). EARL KRAMER (TREASURER), IS FATHER TO TRACY KRAMER SECKLER (BOARD MEMBER) AND KATHE KRAMER CHASE (BOARD MEMBER). KATHE KRAMER CHASE (BOARD MEMBER), AND TRACY KRAMER SECKLER (BOARD MEMBERS), ARE SISTERS. FORM 990, PART VI, SECTION B, LINE 11B NO REVIEW WAS OR WILL BE CONDUCTED. FORM 990, PART VI, SECTION B, LINE 12C OFFICERS, DIRECTORS AND KEY EMPLOYEES MUST REVIEW THE POLICY ANNUALLY AND SIGN A DECLARATION THAT THEY HAVE COMPLIED WITH THE POLICY. FORM 990, PART VI, SECTION B, LINE 15 COMPENSATION OF TOP MANAGEMENT AND OFFICERS OF THE ORGANIZATION IS DEVELOPED IN CONSIDERATION OF PERFORMANCE AND REVIEW OF RELEVANT COMPETITIVE BENCHMARKS AND SUBMITTED TO FINANCE BOARD MEMBERS FOR APPROVAL. FORM 990, PART VI, SECTION C, LINE 19 THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON REQUEST. 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