2025-05-06T10:32:11-05:00 2024-12-31 410746749 CLIFTONLARSONALLEN LLP 8215 GREENWAY BOULEVARD SUITE 600 MIDDLETON WI 53562 990 2024-01-01 471349730 USONA INSTITUTE INC USON 6082787662 2881 WOODS HOLLOW ROAD MADISON WI 53711 JOHN LEBLANC TREASURER 6082787662 2025-05-02 1 1 LAURA SCHWEITZER CPA P01760010 6086628600 2025-05-02 2024 2025-03-06 01:10:19Z WILLIAM A LINTON 2881 WOODS HOLLOW ROAD MADISON WI 53711 33020385 0 X USONAINSTITUTE.ORG X 2014 WI USONA INSTITUTE IS A MEDICAL RESEARCH ORGANIZATION DEDICATED TO SUPPORTING AND CONDUCTING BASIC, PRE-CLINICAL AND CLINICAL RESEARCH TO FURTHER THE SCIENTIFIC UNDERSTANDING AND THERAPEUTIC APPLICATION OF CONSCIOUSNESS-EXPANDING MEDICINES.OUR FOCUS IS THE TREATMENT OF SOCIETY'S MOST CHALLENGING MENTAL HEALTH CONDITIONS FOR WHICH EXISTING TREATMENTS FALL SHORT. 5 3 3 50 0 0 53766608 5020285 76753 211597 564774 288752 472864 2428902 54880999 7949536 214670 167150 0 0 4863659 6306751 0 0 0 12214861 27263558 17293190 33737459 37587809 -25787923 180248504 148230819 109128421 102614654 71120083 45616165 X USONA INSTITUTE HAS BEEN ORGANIZED TO OPERATE EXCLUSIVELY FOR CHARITABLE, SCIENTIFIC, AND EDUCATIONAL PURPOSES, INCLUDING, BUT NOT LIMITED TO, CONDUCTING AND SUPPORTING MEDICAL, SCIENTIFIC, AND SOCIAL SCIENCE RESEARCH AND EDUCATION ON MEDICINES AND PRACTICES TO RELIEVE MENTAL AND PHYSICAL SUFFERING AND TO IMPROVE THE QUALITY OF LIFE AND MANAGEMENT OF HEALTH CARE THROUGH THE APPLICATION OF TREATMENTS USING SAFE AND EFFECTIVE PRODUCTS, INCLUDING THOSE DERIVED FROM PLANTS AND RELATED MATERIALS. IN ADDITION, THE INSTITUTE QUALIFIES AS A "MEDICAL RESEARCH ORGANIZATION" UNDER SECTION 170(B)(1)(A)(III), AS IT HAS A PRINCIPAL PURPOSE OF CONDUCTING MEDICAL RESEARCH AND WILL BE PRIMARILY ENGAGED IN MEDICAL RESEARCH IN CONJUNCTION WITH UNIVERSITY OF WISCONSIN HOSPITALS AND CLINICS. 0 0 27713437 0 0 PSIL301 STUDYUSONA INSTITUTE IS CONDUCTING A PHASE 3 CLINICAL TRIAL, "A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PSILOCYBIN IN ADULTS WITH MAJOR DEPRESSIVE DISORDER (MDD)," ALSO KNOWN AS THE UASPIRE TRIAL. THIS RESEARCH SEEKS TO INVESTIGATE THE POTENTIAL BENEFITS AND SAFETY OF PSILOCYBIN AS A TREATMENT OPTION FOR INDIVIDUALS WITH MAJOR DEPRESSIVE DISORDER AS QUICKLY AND SAFELY AS POSSIBLE.2024 ACCOMPLISHMENTSTHE UASPIRE PSIL301 PHASE 3 TRIAL ADDED NEW SITES ACROSS NORTH AMERICA, INCLUDING VETERANS AFFAIRS (VA) SITES, TO ENHANCE PATIENT DIVERSITY AND STRENGTHEN DATA RELIABILITY TO SUPPORT REGULATORY APPROVAL AND ENSURE BROAD APPLICABILITY OF FINDINGS. ONGOING COLLABORATION WITH THE FDA UNDER OUR BREAKTHROUGH THERAPY DESIGNATION, IN PREPARING FOR NDA SUBMISSION UPON COMPLETION OF PHASE 3. THE CMC TEAM SCALED UP API PRODUCTION, MAINTAINED STRINGENT QUALITY CONTROLS, AND SECURED NEW MANUFACTURING PARTNERSHIPS TO SUPPORT HIGH-QUALITY PSILOCYBIN PRODUCTION IN ANTICIPATION OF MARKET ACCESS. FACILITATOR TRAINING EXPANDED ACROSS ALL PHASE 3 SITES TO ENSURE CONSISTENT IN-PATIENT CARE. EARLY MARKET ACCESS EFFORTS INCLUDED PARTNERSHIPS WITH DIVERSE STAKEHOLDERS FOCUSING ON UNDERSERVED POPULATIONS, ENHANCING INFRASTRUCTURE AND SUPPLY CHAIN RESILIENCE FOR EQUITABLE ACCESS.GUIDED BY A DIVERSITY STEERING COMMITTEE, THE PLAN INCORPORATED INSIGHTS FROM COMMUNITY OUTREACH AND DIVERSITY EXPERTS TO RECRUIT UNDERREPRESENTED POPULATIONS AND FOSTER INCLUSION IN THE PSIL301 PHASE 3 STUDY. 3149254 0 0 5-MEO-DMT PHASE 2 STUDYUSONA INSTITUTE IS CONDUCTING A TWO-PART (PHASE 2A/2B) CLINICAL TRIAL (MEO201) TO EVALUATE THE EFFICACY AND SAFETY OF 5-MEO-DMT FOR THE TREATMENT OF POST-TRAUMATIC STRESS DISORDER (PTSD) IN ADULTS. THE GOALS IN PART A (PHASE 2A) ARE TO OBTAIN SAFETY DATA AND EFFECT SIZE ESTIMATES IN A PTSD PATIENT POPULATION AND GAIN KNOWLEDGE AND EXPERIENCE TO OPTIMIZE PART B (PHASE 2B) DESIGN. THE GOAL IN PART B (PHASE 2B) IS TO EVALUATE THE SAFETY AND EFFICACY OF THE 5-MEO-DMT REGIMEN SELECTED FROM PART A. 2024 ACCOMPLISHMENTSREFINED PHASE 2 PROTOCOLS USING PHASE 1 DATA, OPTIMIZING SAFETY AND DOSING TO IMPROVE PATIENT OUTCOMES. INITIATED SITE SELECTION AND DEVELOPING FACILITATOR TRAINING PROGRAM TO ENSURE HIGH STANDARDS AND TRIAL QUALITY. PLANNING FOR A 2025 TRIAL LAUNCH TO EVALUATE 5-MEO-DMT'S EFFICACY WITH MULTIPLE SITES IN THE U.S. AND CANADA. 629851 167150 485115 EVENTS & PROGRAMSUSONA'S EDUCATION PROGRAMS ARE INTENTIONALLY DESIGNED TO PROVIDE IMMERSIVE AND INTERACTIVE LEARNING EXPERIENCES. THESE PROGRAMS FOCUS ON PREPARING CLINICAL, SCIENTIFIC, AND ACADEMIC LEADERS WITH THE CRITICAL KNOWLEDGE NEEDED TO ADVANCE PSYCHEDELIC THERAPY IN CLINICAL RESEARCH AND PREPARATION FOR FUTURE DELIVERY OF CARE, UPON APPROVAL. THROUGH A CAREFULLY TAILORED CURRICULUM, DIVERSE FACULTY, EXPERIENTIALS, AND GUEST SPEAKERS, PARTICIPANTS GAIN THE EXPERTISE AND FOUNDATIONAL KNOWLEDGE REQUIRED TO PAVE THE WAY FOR BEST PRACTICES IN FUTURE CARE DELIVERY MODELS. 2024 ACCOMPLISHMENTSHOSTED OVER 300 ATTENDEES AT TEN EVENTS AT THE USONA CAMPUS IN 2024, BROADENING USONA'S IMPACT IN PSYCHEDELIC THERAPY EDUCATION. EXPANDED THE PROGRAM OFFERINGS AND CURRICULUM WITH IMMERSIVE PROGRAMS DESIGNED TO PREPARE SCIENTIFIC, CLINICAL, AND ACADEMIC LEADERS. AWARDED FULL AND PARTIAL SCHOLARSHIPS FOR PARTICIPATION IN USONA'S IMMERSIVE EDUCATION PROGRAMS, EXPANDING ACCESS AND DIVERSITY OF PARTICIPANTS. LAUNCHED ENHANCED FACILITATOR TRAINING TO SUPPORT THE PHASE 3 PSILOCYBIN CLINICAL TRIAL. STRENGTHENED PARTNERSHIPS WITH RESEARCH AND ACADEMIC INSTITUTIONS TO PREPARE PRACTITIONERS AND FACULTY FOR FUTURE CARE DELIVERY. 31492542 1 1 0 0 0 0 0 0 0 0 1 0 0 1 1 0 0 1 0 1 1 0 1 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 0 1 70 0 1 3 1 0 1 GM 0 0 0 0 1 5 0 0 0 0 0 X 5 3 1 0 0 0 0 0 0 1 0 0 0 1 1 1 0 0 0 0 0 0 AR CA FL MA MD MN NC NH NJ NY OR RI VA X MELISSA TAYLOR 6082787662 2881 WOODS HOLLOW ROAD MADISON WI 53711 WILLIAM A LINTON PRESIDENT 10.00 1.00 X X 0 0 0 MATHEW SAUR SECRETARY 1.00 1.00 X X 0 0 0 PONCHO MEISENHEIMER BOARD MEMBER/DIRECTOR OF CHEMISTRY 5.00 1.00 X 24000 0 0 RACHELLE SAMPSON BOARD MEMBER 1.00 1.00 X 0 0 0 RICHARD LANGER BOARD MEMBER 5.00 1.00 X 0 0 0 JOHN LEBLANC TREASURER 24.00 1.00 X 306326 0 34160 DAVID JUDSON DIRECTOR QUALITY ASSURANCE 40.00 0.00 X 221589 0 9374 MIKE DAVIS CHIEF MEDICAL OFFICER 40.00 0.00 X 447398 0 49408 THERAYSA GAPASIN SENIOR CLINICAL PROGRAM LEAD 40.00 0.00 X 222002 0 32785 KATARZYNA WARCHOL CLINICAL OPERATIONS MANAGER 40.00 0.00 X 211533 0 31226 ROBERT EZZELL DIRECTOR RA PHARMACEUTICAL PRODUCTS 40.00 0.00 X 259071 0 32846 TURA PATTERSON DIRECTO OF STRATEGIC PARTNERSHIPS 36.00 0.00 X 262041 0 27913 1953960 0 217712 7 0 1 0 CHARLES RAISON 2841 EAST PLAZA ENCANTADA TUSCON AZ 85718 CONSULTING 150000 1 5020285 5020285 SERVICE REVENUE 541700 211597 211597 211597 282146 282146 49765 0 49765 49765 49765 25000000 6606 25000000 0 0 6606 6606 6606 250867 70849 180018 180018 GREEN ENERGY CREDIT 900099 2105619 2105619 MATERIAL SUPPLY PROGRAM PROCESSIN 900099 93500 93500 2199119 7949536 485115 0 2444136 X 24150 24150 66500 66500 76500 76500 595411 535869 59542 4684036 3826614 857422 351694 290137 61557 674266 557787 116479 1344 1344 46732 46732 82751 82751 17606900 17555899 51001 81864 81864 209760 95130 114630 26646 13323 13323 254036 244432 9604 272414 136207 136207 84646 84646 1558223 1480312 77911 2858669 2681490 177179 195958 104801 91157 INVENTORY EXPENSES 3369098 3369098 REPAIRS AND MAINTENANCE 152464 144841 7623 DUES AND SUBSCRIPTIONS 95225 38807 56418 LAB EQUIPMENT SUPPLIES 70731 70731 297441 12060 285381 33737459 31492542 2244917 0 8028586 4173319 181352 223320 5492708 7456369 2022867 1830081 82091853 4066998 79428956 78024855 31000000 6000000 16879 22417 54077156 50500458 180248504 148230819 7479972 4460038 99047 0 6290 7500 47681587 46460866 53861525 51686250 109128421 102614654 X 68032246 44231335 3087837 1384830 71120083 45616165 180248504 148230819 X -25787923 284005 X X 0 1 X 1 0 X UNIVERSITY OF WI AND THE UW HOSPITALS AND CLINICS AUTHORITY MADISON WI RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 5110000 5110000 64417711 1984000 62433711 445657 5925 439732 10771162 2077073 8694089 1347323 1347323 78024855 RIGHT OF USE ASSET 50500458 50500458 LEASE LIABILITIES 51226381 LIABILITIES FOR SPLIT INTEREST AGREEMENTS 459869 51686250 1 EUROPE 1 1 PROGRAM SERVICES PRE-CLINICAL AND CLINICAL RESEARCH TO FURTHER THE UNDERSTANDING OF THE THERAPEUTIC EFFECTS OF PSILOCYBIN AND OTHER CONSCIOUSNESS-EXPANDING MEDICINES 270780 1 1 0 0 1 1 270780 0 270780 SCHOLARSHIPS NORTH AMERICA 8 41500 WIRE DISTRIBUTION 0 SCHOLARSHIPS EUROPE 6 30000 WIRE DISTRIBUTION 0 SCHOLARSHIPS SOUTH AMERICA 1 5000 WIRE DISTRIBUTION 0 1 0 1 0 0 0 PART I, LINE 2: USONA INC REQUIRES A PROJECT STATUS REPORT EACH YEAR FOR ONGOING CONTRIBUTIONS 1 MCKENNA ACADEMY OF NATURAL PHILOSPHY INC 4460 REDWOOD HWY SUITE 16 NO 547 SAN RAFAEL CA 94903 851313799 501(C)(3) 20000 0 CONFERENCE SUPPORT 1 0 SCHOLARSHIPS 23 66500 0 PART I, LINE 2: MOST OF THE GRANT FUNDS PROVIDED BY USONA ARE TO LEADING ACADEMIC INSTITUTIONS FOR SCHOLARSHIPS TO STUDENTS ENROLLED IN PROGRAMS IN LINE WITH OUR MISSION. INDIVIDUAL STUDENTS AT THESE ACADEMIC INSTITUTIONS COMPLETE COMPREHENSIVE APPLICATIONS WHICH ARE THEN ANALYZED, RANKED AND THEN AWARDED TO STUDENTS WHO BEST MEET THE SELECTION CRITERIA. WE REQUEST UPDATES FROM THE STUDENTS AWARDED THE SCHOLARSHIPS. 0 0 0 0 0 0 0 0 0 MIKE DAVIS CHIEF MEDICAL OFFICER 446768 0 0 0 630 0 13800 0 35608 0 496806 0 0 0 JOHN LEBLANC TREASURER 300992 0 0 0 5334 0 13005 0 21155 0 340486 0 0 0 ROBERT EZZELL DIRECTOR RA PHARMACEUTICAL PRODUCTS 250418 0 0 0 8653 0 10385 0 22461 0 291917 0 0 0 TURA PATTERSON DIRECTO OF STRATEGIC PARTNERSHIPS 261172 0 0 0 869 0 11456 0 16457 0 289954 0 0 0 THERAYSA GAPASIN SENIOR CLINICAL PROGRAM LEAD 221036 0 0 0 966 0 10324 0 22461 0 254787 0 0 0 KATARZYNA WARCHOL CLINICAL OPERATIONS MANAGER 211155 0 0 0 378 0 8765 0 22461 0 242759 0 0 0 DAVID JUDSON DIRECTOR QUALITY ASSURANCE 212937 0 0 0 8652 0 9374 0 0 0 230963 0 0 0 FORM 990, PART VI, SECTION A, LINE 2 WILLIAM A LINTON AND PONCHO MEISENHEIMER HAVE A BUSINESS RELATIONSHIP. FORM 990, PART VI, SECTION A, LINE 8B THERE ARE NO COMMITTEES WITH THE AUTHORITY TO ACT ON BEHALF OF THE GOVERNING BODY. FORM 990, PART VI, SECTION B, LINE 11B THE TREASURER PROVIDES A DRAFT COPY OF THE FORM 990 TO ALL BOARD MEMBERS ONE OR MORE WEEKS IN ADVANCE OF FINALIZING THE RETURN. EACH BOARD MEMBER RESPONDS AFFIRMATIVELY TO THE TREASURER WITH QUESTIONS ABOUT THE FORM 990 OR INDICATES THEY HAVE NO QUESTIONS. AN AUDIT COMMITTEE WAS FORMED IN 2024 AND WE WILL ASK THE 2 MEMBERS OF THE BOARD WHO ARE AUDIT COMMITTEE MEMBERS IF THEY WANT ANY ADDITIONAL REVIEW GOING FORWARD. FORM 990, PART VI, SECTION C, LINE 19 POLICIES ARE AVAILABLE UPON REQUEST FORM 990, PART IX, LINE 11G OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 69,848. MANAGEMENT AND GENERAL EXPENSES 203. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 70,051. CLINICAL PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 13,686,070. MANAGEMENT AND GENERAL EXPENSES 39,758. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 13,725,828. CMC PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 1,254,274. MANAGEMENT AND GENERAL EXPENSES 3,644. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,257,918. NON-CLINCIAL PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 2,068,632. MANAGEMENT AND GENERAL EXPENSES 6,009. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,074,641. REGULATORY PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 266,719. MANAGEMENT AND GENERAL EXPENSES 775. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 267,494. PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 173,688. MANAGEMENT AND GENERAL EXPENSES 505. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 174,193. CONSULTANT: PROGRAM SERVICE EXPENSES 36,668. MANAGEMENT AND GENERAL EXPENSES 107. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 36,775. FORM 990, PART XI, LINE 9: INCOME/LOSS FROM GERMAN SUBSIDIARY -5,627. SPLIT LIFE AGREEMENT CHANGE IN VALUE 289,632. FORM 990, PART XII, LINE 2C THE ORGANIZATION CREATED AN AUDIT COMMITTEE IN 2024 FOR OVERSIGHT OF THE AUDIT PROCESS. CINQUE TERRE LLC 2800 WOODS HOLLOW RD MADISON WI 53711 471349730 REAL ESTATE HOLDINGS WI 0 76197057 USONA INSTITUTE INC PORTA SOPHIA LLC 2800 WOODS HOLLOW RD MADISON WI 53711 471349730 SEARCH TOOL FOR INNOVATORS AND PATENT REVIEWERS IN THE FIELD OF PSYCHEDELICS WI 152642 147899 USONA INSTITUTE INC WILLIAM A LINTON CHARITABLE FOUNDATION INC 2800 WOODS HOLLOW ROAD MADISON WI 53711 352602257 SUPPORT MEDICAL RESEARCH ORGANIZATIONS WI 501(C)(3) LINE 12A, I USONA INSTITUTE INC 0 USONA INSTITUTE EUROPA GMBH GUTENBERGRING 10 WALDORF GM 69190 SCIENCE RESEARCH GM USONA INSTITUTE INC C 11687 5604 1.00000 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0