2026-05-11T13:50:46-05:00 2025-12-31 410746749 CLIFTONLARSONALLEN LLP 1660 OSHKOSH AVE SUITE 200 OSHKOSH WI 54902 990 2025-01-01 262849140 NATIONAL PKU ALLIANCE INC NATI 8556758211 2014 ELECTRIC ROAD 212 ROANOKE VA 24018 RHONDA CONNOLLY PRESIDENT 8556758211 2026-05-08 1 KELCEY LEITL P01584977 9202315890 2026-05-08 2025 2025-03-06 01:10:19Z X RHONDA CONNOLLY 2014 ELECTRIC ROAD 212 ROANOKE VA 24018 3673900 0 X WWW.NPKUA.ORG X 2008 DE IMPROVE THE LIVES OF INDIVIDUALS WITH PKU AND PURSUE A CURE FOR PKU. 12 12 6 150 0 0 2050617 2481858 57609 14946 439923 278337 15240 -100706 2563389 2674435 488881 459015 0 0 684090 756922 0 0 253147 958732 816901 2131703 2032838 431686 641597 5311012 6181230 356757 350810 4954255 5830420 X OUR MISSION IS TO IMPROVE THE LIVES OF INDIVIDUALS WITH PKU, PURSUE A CURE BY EXPANDING RESEARCH AND PROVIDE EDUCATION AND SUPPORT TO INDIVIDUALS LIVING WITH PKU AND THEIR CAREGIVERS. 1 0 659425 424958 0 THE NPKUA APPROVED 5 RESEARCH GRANTS FROM THE 2025 RESEARCH GRANT CYCLE FOR A TOTAL OF $425K. THE RESEARCH PROJECTS FOCUS ON PKU ASSESSMENT TOOLS AS WELL AS PKU TREATMENTS AND THERAPIES THAT DRIVE PROGRESS TOWARD A CURE. AS OF 2025, THE NPKUA HAS AWARDED $6,419,699 IN SUPPORT OF 88 RESEARCH PROJECTS. 497406 34057 28375 COMMUNITY ENGAGEMENT CONTINUES TO BE A CORE PILLAR OF THE NATIONAL PKU ALLIANCE. THE COMMUNITY ENGAGEMENT DIRECTOR IS RESPONSIBLE FOR PLANNING AND MANAGING PROGRAMS FOR THE PKU COMMUNITY, INCLUDING A MENTORING PROGRAM, COMMUNITY CALLS, SUPPORT KITS, MATERNAL PKU PATIENT SUPPORT, ADVOCACY EFFORTS AND AN AFFILIATE PROGRAM.THE DIRECTOR SCHEDULES, MANAGES AND ATTENDS VIRTUAL CALLS WITH THE COMMUNITY ACROSS DIFFERENT PKU AGE GROUPS AND PKU CAREGIVER TYPES. 48 CALLS WERE HELD IN 2025 WITH 250 ATTENDEES.IN 2025, THE NPKUA MENTOR PROGRAM GREW TO SUPPORT OVER 45 CAREGIVERS AND INDIVIDUALS WITH PKU THROUGH PERSONALIZED ONE-ON-ONE MENTORING, WITH MENTORS CONNECTING VIRTUALLY AND IN PERSON TO SHARE EXPERIENCES AND DEVELOP SKILLS TO BETTER ASSIST THEIR MENTEES.THE NPKUA ADVOCACY COMMITTEE WORKS ALONGSIDE MEMBERS OF THE BROADER RARE DISEASE COMMUNITY TO ADVANCE EFFORTS AROUND NUTRITION, EQUITY AND OTHER PRIORITIES OF THE PKU COMMUNITY. THE COMMITTEE DEVELOPED AN ADVOCACY MEDIA TOOLKIT TO HELP COMMUNITY MEMBERS SHARE THEIR STORIES. STAFF AND ADVOCACY COMMITTEE VOLUNTEERS HAVE ALSO RESPONDED TO THE TERMINATION OF THE ACHDNC (ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS AND CHILDREN) BY CALLING ON CONSTITUENTS, THROUGH DATABASE-WIDE EMAIL AND SOCIAL MEDIA OUTREACH, TO SIGN-ON TO CONTACT THEIR LEGISLATORS AND SHARE THEIR STORY AND SUPPORT OF NBS. STARTED A NEWBORN SCREENING VIDEO SERIES TO BE USED IN SEPTEMBER, RECOGNIZED AS NEWBORN SCREENING AWARENESS MONTH. THE SERIES RAISES AWARENESS ABOUT THE IMPORTANCE OF NEWBORN SCREENING, AND THE CRITICAL ROLE OF NEWBORN SCREENING IN IDENTIFYING SERIOUS CONDITIONS THAT CAN LEAD TO SEVERE DISABILITY OR DEATH IF LEFT UNDIAGNOSED. IN TOTAL, NPKUA SUPPORTED 10 STATE AND FEDERAL LEGISLATIVE ADVOCACY EFFORTS.IN 2025 NPKUA PROVIDED $34,057 TO NPKUA AFFILIATES TO SUPPORT COMMUNITY EVENTS AND CAMPS IN THEIR REGIONS. DURING THE YEAR, NPKUA ALSO MET ONE-ON-ONE WITH INDIVIDUAL AFFILIATE LEADERS TO BETTER UNDERSTAND THEIR GOALS AND NEEDS. IN 2025, 206 NEWBORN AND KINDERGARTEN KITS WERE DELIVERED TO FAMILIES WELCOMING A NEW BABY WITH PKU OR SUPPORTING A NEW KINDERGARTENER WITH PKU.IN 2025, 55 PACKAGES OF DIET-APPROPRIATE FOOD WERE DELIVERED TO MATERNAL PKU PATIENTS TO BEST SUPPORT THEIR LOW-PROTEIN DIET. 138267 0 0 THE NPKUA HELD A MULTIDISCIPLINARY SCIENCE CONFERENCE IN 2025. THIS UNIQUE CONFERENCE INCLUDED OVER 100 ACADEMIC RESEARCHERS, CLINICIANS, INDUSTRY PARTNERS IN A COLLABORATIVE FORUM TO FURTHER THE DEVELOPMENT OF TREATMENTS FOR PKU.THE KEYNOTE SPEAKER, DR. PETER MARKS FROM THE FDA, ADDRESSED NOVEL CLINICAL TRIAL DESIGNS USED IN THE APPROVAL PROCESS OF DRUGS FOR RARE DISEASES. SESSIONS AND DISCUSSIONS INCLUDED NOVEL APPROACHES TO CLINICAL TRIAL DESIGN FOR RARE DISEASES, DEVELOPING NEUROCOGNITIVE OUTCOME ASSESSMENT TOOLS TO BEST DETERMINE THE IMPACT OF NEW TREATMENTS, STRATEGIES TO OVERCOME CHALLENGES RELATED TO DIETARY DATA COLLECTION FOR CLINICAL TRIALS, AND MANAGING SUSTAINABILITY IN CLINICAL TRIALS. FOCUS ALSO INCLUDED BRINGING ADULTS BACK TO CARE AND CHALLENGES FACED WITH THE DRUG APPROVAL PROCESS. 117292 10578 NPKUA HOSTED THE TRUEPKU INITIATIVE TO SHARE THE PKU EXPERIENCE WITH U.S. FOOD AND DRUG ADMINISTRATION (FDA) STAFF, PEOPLE WORKING IN LIFE SCIENCE COMPANIES, HEALTH CARE PROFESSIONALS AND ACADEMIC RESEARCHERS TO HELP SHAPE THE DEVELOPMENT OF NEW MEDICAL THERAPIES AND APPROACHES TO TREATING AND MONITORING PKU. AS PART OF THE EXTERNALLY-LED PATIENT-FOCUSED DRUG DEVELOPMENT (EL-PFDD) PROGRAM, THIS MEETING TOOK PLACE VIRTUALLY ON MAY 8, 2025 IN PARTNERSHIP WITH OTHER PKU-RELATED ORGANIZATIONS AND SPONSORS. 31 MEMBERS FROM THE PKU COMMUNITY SHARED THEIR TESTIMONY. THE VOICE OF THE PATIENT REPORT SUMMARIZES THE MEETING INSIGHTS, PERSONAL STORIES AND KEY THEMES SHARED THROUGHOUT THE FIVE-HOUR MEETING, INCLUDING POWERFUL QUOTES FROM COMMUNITY MEMBERS AND PERSPECTIVES GATHERED BEFORE, DURING AND AFTER THE EVENT. BOTH THE LIVE MEETING AND REPORT CAN BE FOUND AT WWW.NPKUA.ORG/TRUEPKU/. THE MEETING HAS ATTRACTED 1,300 VIEWS ON YOUTUBE. 83918 0 4368 IN 2025, THE NPKUA HOSTED A REGIONAL COMMUNITY CONFERENCE ON SEPTEMBER 6 IN SAN DIEGO, CALIFORNIA. ATTENDEES INCLUDED 47 INDIVIDUALS WITH PKU, THEIR FAMILIES/CAREGIVERS, INDUSTRY PARTNERS, AND LEADING EXPERTS IN THE FIELD OF PKU RESEARCH, CLINICAL CARE, NUTRITION, AND ADVOCACY. IN TOTAL, WE WELCOMED 180 ATTENDEES. WE HELD MEANINGFUL CONVERSATIONS THROUGH EDUCATIONAL PRESENTATIONS AND ACTIVITIES DISCUSSING WHAT'S NEW IN PKU, STAYING ACTIVE WITH PKU, CLINICAL TRIALS, FOOD AND FORMULA OFFERINGS, GENE EDITING AND GENE THERAPY, TRAVELING WITH PKU AND HOME PHE MONITOR DEVELOPMENT. 67571 0 0 IN THE PKU PATIENT REGISTRY, NPKUA UPGRADED THE PLATFORM, STRENGTHENING THE REGISTRY'S ABILITY TO SUPPORT PKU RESEARCH. REGISTRY PARTICIPANTS GREW TO 1,130, WITH 864 NEW SURVEY SUBMISSIONS IN 2025. THE REGISTRY SUPPORTED RECRUITMENT FOR 4 EXTERNAL RESEARCH STUDIES AND SHARED DATA IN ITS FIRST SCIENTIFIC PUBLICATION. 268781 0 14946 1563879 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 1 1 0 0 1 0 0 1 0 1 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 1 16 0 6 1 0 0 0 0 0 0 0 0 0 0 0 0 X 12 12 0 0 0 0 0 0 0 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 AL AK AR CA CO CT DE FL GA IL IA KS KY LA ME MD MA MI MN MS NV NH NJ NM NY ND OH OK OR PA RI SC TN VA WA WV WI DC UT X X CATHERINE WARREN 8556758211 2014 ELECTRIC ROAD 212 ROANOKE VA 24018 CATHERINE WARREN EXECUTIVE DIRECTOR 40.00 X 193591 0 16723 SUSAN GRAY DIRECTOR OF DEVELOPMENT 40.00 X 147246 0 11760 SARAH GALLAGHER DIRECTOR OF COMMUNITY ENGAGEMENT 40.00 X 118056 0 10995 RHONDA CONNOLLY PRESIDENT 10.00 X X 0 0 0 ELIZABETH ASELAGE VP-THRU 3/25; DIR-AS OF 3/25 2.00 X X 0 0 0 MARK GRALEN DIR-THRU 3/25; VP-AS OF 3/25 2.00 X 0 0 0 DAN LAZZARI TREASURER 2.00 X X 0 0 0 ALISON REYNOLDS SECRETARY 2.00 X X 0 0 0 SUSAN BERRY DIRECTOR 2.00 X 0 0 0 CHARLES BUCKLAR DIRECTOR 2.00 X 0 0 0 MICHAEL FINKEL DIRECTOR 2.00 X 0 0 0 LILLIAN ISABELLA DIRECTOR - THRU 12/25 2.00 X 0 0 0 CHRISTINA LOVE DIRECTOR 2.00 X 0 0 0 DAVID MICKLE DIRECTOR 2.00 X 0 0 0 ADAM SHERMAN DIRECTOR 2.00 X 0 0 0 SARA TYE DIRECTOR 2.00 X 0 0 0 458893 0 39478 3 0 1 0 0 1115095 1366763 63318 2481858 CONFERENCE FEES 561499 14946 14946 14946 215824 215824 650869 588356 62513 62513 62513 277907 1115095 411109 -133202 -133202 RECRUITING FEES 900099 28375 28375 REBATES 900099 4121 4121 32496 2674435 43321 0 149256 X 404753 404753 54262 54262 210314 126189 52578 31547 435682 327611 10392 97679 16658 12143 1034 3481 46544 33098 4099 9347 47724 33006 5561 9157 3407 1704 851 852 94952 94952 20037 20037 303288 247815 5066 50407 47958 37588 2689 7681 14653 9048 2603 3002 80261 76010 2039 2212 171297 171297 29620 14810 7405 7405 12378 6188 3095 3095 CREDIT CARD FEES 23868 23868 ORGANIZATIONAL EXPENSES 12164 6082 3041 3041 DUES 1800 1350 225 225 BANK FEES 176 68 77 31 1042 857 68 117 2032838 1563879 215812 253147 709687 146498 5000 813186 12216 3721 10000 429113 567292 119648 179821 148100 41961 135759 106139 3799589 4254573 100000 100000 5311012 6181230 51780 64437 199977 160369 105000 126004 356757 350810 X 4923821 5799986 30434 30434 4954255 5830420 5311012 6181230 641597 234568 0 X 0 1 X 1 0 X 1676954 2253786 1513280 2050617 2481858 9976495 1676954 2253786 1513280 2050617 2481858 9976495 750718 9225777 81203 81652 103854 148048 215824 630581 5000 26786 4121 35907 10642983 162049 0.86680 0.89270 X SCHEDULE A, PART II, LINE 10, EXPLANATION OF OTHER INCOME: MISCELLANEOUS INCOME - 2023 AMOUNT: $ 5,000. 2024 AMOUNT: $ 26,786. 2025 AMOUNT: $ 4,121. RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 148100 41961 106139 106139 3072036 234568 183070 417638 2654398 20037 20037 2674435 2195871 183070 183070 2012801 20037 20037 2032838 PART XI, LINE 2D - OTHER ADJUSTMENTS: SPECIAL EVENTS EXPENSES NETTED WITH REVENUE 183,070. PART XII, LINE 2D - OTHER ADJUSTMENTS: SPECIAL EVENTS EXPENSES NETTED WITH REVENUE 183,070. 1 EUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUM 0 0 GRANTS TO RECIPIENTS 54262 0 0 0 0 0 0 54262 0 54262 EUROPE (INCLUDING ICELAND & GREENLAND) - ALBANIA, ANDORRA, AUSTRIA, BELGIUM AI4PKU STUDY: ARTIFICIAL INTELLIGENCE FOR PKU 54262 WIRE TRANSFER 0 0 1 0 0 0 0 0 0 PART I, LINE 2: GRANT RECIPIENT WILL BE REQUIRED TO REPORT ON GRANT PROGRESS AT THE HALFWAY POINT AND COMPLETE A FINAL REPORT UPON GRANT COMPLETION. LTL (NYC) 1015074 841261 173813 87358 42063 53360 16940 61292 LTL (SAN DIEGO) 377928 273834 104094 52321 26525 35000 8895 27355 1393002 1115095 277907 139679 68588 88360 25835 88647 411109 -133202 1 MARYLAND ALLIANCE OF PKU FAMILIES INC 1173 RIDGE DRIVE PASADENA MD 21122 521879326 501(C)(3) 10098 0 PKU RESEARCH BOSTON CHILDREN'S HOSPITAL 300 LONGWOOD AVE BOSTON MA 02115 042774441 501(C)(3) 71394 0 PKU RESEARCH CALIFORNIA COALITION FOR PKU AND ALLIED DISORDERS 2310 HOMESTEAD RD STEC1 LOS ALTOS CA 94024 942812295 501(C)(3) 7500 0 PKU RESEARCH EMORY UNIVERSITY SCHOOL OF MEDICINE 1510 CLIFTON ROAD NE ATLANTA GA 30322 580566256 501(C)(3) 50000 0 PKU RESEARCH GEORGIA PKU CONNECT INC POBOX 942492 ATLANTA GA 31141 263602983 501(C)(3) 7500 0 PKU RESEARCH OREGON HEALTH & SCIENCE 3181 SW SAM JACKSON PARK RD PORTLAND OR 972393098 231352685 501(C)(3) 169344 0 PKU RESEARCH PKU ORGANIZATION OF ILLINOIS POBOX 102 PALATINE IL 60078 363320115 501(C)(3) 8531 0 PKU RESEARCH UNIVERSITY OF CALIFORNIA SAN DIEGO 9452 MEDICAL CENTER DR LA JOLLA CA 92037 472452128 115 80000 0 PKU RESEARCH 8 0 PART I, LINE 2: EACH RESEARCH GRANTEE MUST PROVIDE A MID-TERM NARRATIVE REPORT AND A YEAR-END FINANCIAL REPORT TO NPKUA. ALL GRANTEES ARE REQUIRED TO ENTER INTO A GRANT AGREEMENT BETWEEN THE NPKUA AND THEIR UNIVERSITY OR ORGANIZATION. AFFILIATE ORGANIZATIONS ARE REQUIRED TO PREPARE A REQUEST FOR GRANT FUNDS THAT EXPLAINS THE PROJECT DESCRIPTION IN WHAT THE FUNDS WILL BE USED FOR. THIS REQUEST IS REVIEWED AND APPROVED BY THE ORGANIZATION. GRANTS FUNDS TO AFFILIATES ARE GIVEN OUT BASED ON THE ORGANIZATION'S BUDGET EACH YEAR. X X 0 0 0 0 0 0 0 0 0 CATHERINE WARREN EXECUTIVE DIRECTOR 176591 0 17000 0 0 0 6800 0 9923 0 210314 0 0 0 SUSAN GRAY DIRECTOR OF DEVELOPMENT 142246 0 5000 0 0 0 5481 0 6279 0 159006 0 0 0 X 2 3736 FMV X AUCTION ITEMS 90 59582 FMV 0 0 1 PART I, LINE 32B: THE NPKUA HIRES 2 VENDORS TO ASSIST WITH FUNDRAISING GALA EVENTS (2 ANNUALLY). THE AUCTIONEER IS KEITH MCLANE OF KLM AUCTIONS AND THE AUCTION PROCESSING FIRM IS C2 AUCTIONS. FORM 990, PART III, LINE 2 NPKUA HOSTED THE TRUEPKU INITIATIVE TO SHARE THE LIVED PKU EXPERIENCE WITH U.S. FOOD AND DRUG ADMINISTRATION (FDA) STAFF, PEOPLE WORKING IN LIFE SCIENCE COMPANIES, HEALTH CARE PROFESSIONALS AND ACADEMIC RESEARCHERS TO HELP SHAPE THE DEVELOPMENT OF NEW MEDICAL THERAPIES AND APPROACHES TO TREATING AND MONITORING PKU. AS PART OF THE EXTERNALLY-LED PATIENT-FOCUSED DRUG DEVELOPMENT (EL-PFDD) PROGRAM, THIS MEETING TOOK PLACE VIRTUALLY ON MAY 8, 2025 IN PARTNERSHIP WITH OTHER PKU-RELATED ORGANIZATIONS AND SPONSORS. THE VOICE OF THE PATIENT REPORT SUMMARIZES THE MEETING INSIGHTS, PERSONAL STORIES AND KEY THEMES SHARED THROUGHOUT THE FIVE-HOUR MEETING, INCLUDING POWERFUL QUOTES FROM COMMUNITY MEMBERS AND PERSPECTIVES GATHERED BEFORE, DURING AND AFTER THE EVENT. BOTH THE LIVE MEETING AND REPORT CAN BE FOUND AT WWW.NPKUA.ORG/TRUEPKU/. FORM 990, PART VI, SECTION A, LINE 1A THE EXECUTIVE COMMITTEE CONSISTS OF THE PRESIDENT, VICE PRESIDENT, SECRETARY, TREASURER, AND ANY OTHER ELECTED OFFICERS OF THE BOARD. THE EXECUTIVE COMMITTEE CAN NOT EXERCISE ANY POWERS OF THE BOARD THAT REQUIRE A SUPERMAJORITY VOTE AS DESCRIBED IN THE BYLAWS. FORM 990, PART VI, SECTION B, LINE 11B THE 990 WILL BE REVIEWED BY THE EXECUTIVE DIRECTOR AND FINANCE COMMITTEE, WHICH INCLUDES THE TREASURER. ONCE THEIR FEEDBACK IS CONSIDERED AND ALL QUESTIONS ARE CLOSED, THE FROM 990 IS PROVIDED TO THE FULL BOARD PRIOR TO FILING WITH THE IRS. FORM 990, PART VI, SECTION B, LINE 12C ANY CONFLICTS OF INTEREST FOR OFFICERS, DIRECTORS, AND KEY EMPLOYEES ARE REVIEWED ANNUALLY. IF A CONFLICT EXISTS, THE BOARD INDIVIDUAL MUST DISCLOSE ALL MATERIAL FACTS TO THE BOARD OR THE EXECUTIVE COMMITTEE, WHICH SHALL BE REFLECTED IN THE MINUTES OF THE MEETING. THE PERSON WITH A CONFLICT MAY RECUSE THEMSELF AT ANY TIME FROM INVOLVEMENT IN THE DISCUSSION OR DECISION IN WHICH A POTENTIAL CONFLICT OF INTEREST EXISTS. FORM 990, PART VI, SECTION B, LINE 15 COMPENSATION WAS DECIDED BY THE BOARD OF DIRECTORS AFTER REVIEWING COMPENSATION LEVELS OF OTHER SIMILAR ORGANIZATIONS. COMPENSATION FOR KEY EMPLOYEES IS DECIDED BY THE BOARD OF DIRECTORS AFTER REVIEWING COMPARABLES OF SIMILAR ORGANIZATIONS. THE PROCESS DESCRIBED HERE WAS LAST COMPLETED IN 2024. FORM 990, PART VI, SECTION C, LINE 19 THE GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY AND FINANCIAL STATEMENTS ARE AVAILABLE TO THE PUBLIC UPON REQUEST. NPKUA AUDITED FINANCIALS AND 990 ARE POSTED TO THE WEBSITE. FORM 990, PART IX, LINE 11G CONTRACTED FEES: PROGRAM SERVICE EXPENSES 8,526. MANAGEMENT AND GENERAL EXPENSES 414. FUNDRAISING EXPENSES 4,123. TOTAL EXPENSES 13,063. RESEARCH & DEVELOPMENT: PROGRAM SERVICE EXPENSES 172,661. MANAGEMENT AND GENERAL EXPENSES 1,414. FUNDRAISING EXPENSES 14,068. TOTAL EXPENSES 188,143. DIRECTOR OF EVENTS: PROGRAM SERVICE EXPENSES 66,628. MANAGEMENT AND GENERAL EXPENSES 3,238. FUNDRAISING EXPENSES 32,216. TOTAL EXPENSES 102,082.