2022-11-13T17:01:21-06:00 2021-12-31 133628255 CONDON O'MEARA MCGINTY & DONNELLY LLP ONE BATTERY PARK PLAZA 7TH FL NEW YORK NY 10004 990 2021-01-01 202014968 CHARLEY'S FUND INC CHAR 4135280400 635 MAIN STREET SUITE 3 GREAT BARRINGTON MA 01230 TRACY KRAMER SECKLER CO-FOUNDER/CEO 4135280400 2022-11-11 1 TRACY KRAMER SECKLER 999009999 ALEXANDER LAZZARUOLO P01775353 2126617777 3 AAL1 IAL1 2021 2022-09-23 18:48:47Z TRACY KRAMER SECKLER 635 MAIN STREET SUITE 3 GREAT BARRINGTON MA 01230 1919294 0 X WWW.CHARLEYSFUND.ORG X 2004 MA TO ACCELERATE THE DEVELOPMENT OF LIFE-SAVING TREATMENTS FOR DUCHENNE MUSCULAR DYSTROPHY "DMD" 8 7 3 4 0 0 1178574 1779280 0 0 2751 2144 1316 201 1182641 1781625 1328648 1250500 0 0 468424 460429 0 0 191938 105149 100937 1902221 1811866 -719580 -30241 4987686 5463767 237253 743575 4750433 4720192 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.) 0 0 1415000 1200000 SEE SCHEDULE O 56020 30000 SEE SCHEDULE O 24500 20000 WE SUPPORTED RESEACH AT THE UNIVERSITY OF MISSOURI TO COMPREHENSIVELY INVESTIGATE THE CAS9 IMMUNE RESPONSE TO THE CLINICAL APPLICATION OF CRISPR TECHNOLOGY. 500 500 1495520 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 6 0 1 3 1 0 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 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 CO-FOUNDER & CEO 40.00 X X 62769 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 & COO 55.00 X 241853 0 7340 304622 0 7340 1 0 1 0 0 66007 1713273 137466 1779280 2279 2279 137466 137601 -135 -135 -135 158 68 90 90 GAIN ON INVESTEMNT IN LLC 900099 111 111 111 1781625 201 0 2144 1250500 1250500 311962 149845 61578 100539 107436 52253 20744 34439 14090 3241 5298 5551 26941 11400 7182 8359 21223 21223 291 291 1647 1200 447 29805 13168 1518 15119 6200 2075 2019 2106 622 596 26 385 385 6582 2194 2194 2194 OTHER 26182 1048 1976 23158 SCIENTIFIC CONSULTING 8000 8000 1811866 1495520 124408 191938 1470 1097 678422 1367338 1087700 886240 10449 2462 5917 3176 12078 11158 1305 920 3202423 3202534 4987686 5463767 12283 9398 224970 734177 237253 743575 X 3651675 3880191 1098758 840001 4750433 4720192 4987686 5463767 -30241 0 X 0 1 X 1 0 X 1415266 2757831 2082116 1178574 1779280 9213067 1415266 2757831 2082116 1178574 1779280 9213067 2318294 6894773 4746 11152 13926 2547 2279 34650 38 589 111 738 9248455 102097 0.74550 0.58670 X SCHEDULE A, PART II, LINE 10, EXPLANATION OF OTHER INCOME: OTHER - 2017 AMOUNT: $ 38. 2020 AMOUNT: $ 500. NET GAIN LOSS ON INVESTMENTS OF LLC - 2020 AMOUNT: $ 89. 2021 AMOUNT: $ 111. RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 1098758 645000 903757 840001 1417892 319134 1098758 1250000 979558 811666 1417892 94621 1825000 669621 1250000 35000 205000 145379 94621 1.00000 0 0 12078 11158 920 920 INVESTMENT - DMD SOLUTIONS,LLC -6578 C INVESTMENT - TCW CATALYST,LLC -390 C INVESTMENT - WIDE VISION LLC 125000 C INVESTMENT - DART THERAPEUTICS 84502 C INVESTMENT - AKASHI THERAPEU. 3000000 C 3202534 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 UMASS MEMORIAL FOUNDATION 333 SOUTH ST SHREWSBURY MA 01545 043108190 501(C)(3) 1200000 0 RESEARCH GRANT CASIMIR LLC 36 CORDAGE PARK CIRCLE SUITE 300 PLYMOUTH MA 02360 810761070 30000 0 RESEARCH GRANT UNIVERSITY OF MISSOURI 407 REYNOLDS ALUMNI CENTER COLUMBIA MO 65211 436036792 20000 0 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. X 0 0 0 0 0 0 0 0 0 LAURA DALLE PAZZE PRESIDENT & COO 241853 0 0 0 0 0 0 0 7340 0 249193 0 0 0 X 5 137466 FMV 0 1 0 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 MUCH PROACTIVELY IDENTIFY AND KNOCK DOWN HURDLES THAT STAND IN THE WAY OF EFFICIENT DRUG DEVELOPMENT. SINCE INCEPTION, WE HAVE DIRECTED MORE THAN $47M IN FUNDING TO THESE EFFORTS, LEVERAGING BOTH OUR OWN FUNDING AS WELL AS FUNDING FROM OTHER DMD PATIENT ORGANIZATIONS TO IDENFITY AND SUPPORT THE BEST SCIENCE IN PURSUIT OF TREATMENTS AND A CURE FOR DMD. IN 2021, WE DEDICATED A TOTAL OF $1,495,523 TO OUR PROGRAMMATIC EFFORTS. OF THIS, $1,250,500 WAS DEDICATED TO GRANTS AND ALLOCATIONS, AND $245,023 WAS DEDICATED TO OTHER PROGRAMMATIC EXPENSES. PART III - LINE 4A WE CONTINUED OUR SUPPORT OF THE DUCHENNE PROGRAM AT UMASS MEDICAL SCHOOL, WHICH WE CREATED IN 2018. 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 THE LARGEST DEDICATED DUCHENNE CLINIC IN THE NORTHEAST US 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, NOW IN ITS FOURTH YEAR, HAS NEARLY 400 PATIENTS IN ITS DIRECT CARE AND CONTINUES TO BENEFIT PATIENTS WORLDWIDE EVEN IF THEY DO NOT ENTER ITS DOORS IN PERSON THROUGH SPONSORED CLINICAL TRIALS, ORIGINAL RESEARCH, AND SHARING BEST PRACTICES IN RESEARCH AND CARE WITH THE BROADER COMMUNITY. PART III - LINE 4B 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 2021 CASIMIR, LLC CONTINUED ITS WORK 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, CASMIR HAS PURSUED ACTIVITIES TO DEVELOP AND REFINE THEIR SCORING SYSTEM, GATHER KEY BASELINE DATA NEEDED TO DETERMINE ITS RELIABILITY AND CONCEPT VALIDITY. ALSO IN 2021, 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, TAKES 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. IN 2021, WE DID NOT PROVIDE FUNDING TO SUPPORT THIS WORK BUT DID DEDICATE STAFF TIME AND GUIDANCE AS WE WORKED WITH DR. RUTKOVE TO HELP OTHER PARTIES INCLUDING LABS WE COLLABORATE WITH IN ANOTHER ONE OF OUR PROGRAMS ADOPT THE APPLICATION OF EIM. WE SUPPORTED THEIR EFFORTS TO RECRUIT PARTICIPANTS FOR ONGOING DATA COLLECTION. PRECLINICAL METHODS ONE MAJOR REASON WE HAVE TROUBLE TRANSLATING PROMISING RESEARCH RESULTS INTO ACTUAL THERAPIES IS THE SHORTCOMINGS OF HOW PRECLINICAL METHODS AND MODULES 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. TO BETTER CHARACTERIZE KEY DMD MODELS WE ARE FUNDING A NATURAL HISTORY STUDY AT LEIDEN UNIVERSITY MEDICAL CENTER IN THE NETHERLANDS AND UNIVERSITA DEGLI STUDI DI BARI IN ITALY. THE STUDY IS DESIGNED TO GATHER DATA AND EXPERIENCE THAT CAN HELP DEVELOP BETTER GUIDANCE ON WHEN AND HOW TO DESIGN PRECLINICAL RESEARCH WITH THESE MODELS, AS WELL AS TO UNEARTH DISCREPANCIES IN THE PROCESSES DIFFERENT LABS UNDERTAKE AND THEN PUBLICIZE THE BEST METHODOLOGY TO ENABLE RELIABLE, CONSISTENT RESULTS. 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. TO SUPPORT CTAP'S WORK, CHARLEY'S FUND PROVIDES BOTH FUNDING AND ONGOING ADVICE AND GUIDANCE IN ROLES ON THE JOINT STEERING AND COMMUNICATIONS COMMITTEES. IN 2020, ONE CRITICAL RELEASE WAS CTAP'S PUBLICATION DOCUMENTING THE RESULTS OF A STUDY TO ASSESS WHETHER NATURAL HISTORY DATA CAN BE USED TO SUPPLEMENT OR REPLACE PLACEBO ARMS IN CLINICAL TRIALS. 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. CHARLEY'S FUND VENTURES LLC 635 MAIN STREET GREAT BARRINGTON MA 01230 275009330 FUND RAISING MA 3085599 N/A WIDE VISION DMD CAPITAL LLC 2266 WEST END NEW YORK NY 10025 202014968 INVESTMENT MA N/A RELATED 125000 0 0 DMD SOLUTIONS LLC 635 MAIN STREET GREAT BARRINGTON MA 01230 271107747 INVESTMENT MA N/A RELATED 111 -6578 0 0 TCW CATALYST LLC 4904 MERILANE AVE EDINA MN 55436 208875302 INVESTMENT MN N/A RELATED -390 0 0 DART THERAPEUTICS LLC 635 MAIN STREET GREAT BARRINGTON MA 01230 900600955 INVESTMENT MA N/A RELATED 84502 0 0 AKASHI THERAPEUTICS INC 245 FIRST ST 18TH FLOOR CAMBRIDGE MA 02142 DRUG DEVELOPMENT MA CHARLEY'S FUND C 3000000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0