Attach to Form 990 or Form 990-EZ.
Go to
www.irs.gov/Form990 for instructions and the latest information.
| (i) Name of supported organization | (ii) EIN | (iii) Type of organization (described on lines 1- 10 above (see instructions)) | (iv) Is the organization listed in your governing document? | (v) Amount of monetary support (see instructions) | (vi) Amount of other support (see instructions) | |
|---|---|---|---|---|---|---|
| Yes | No | |||||
|
Total |
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Calendar year
(or fiscal year beginning in)
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(a) 2017 | (b) 2018 | (c) 2019 | (d) 2020 | (e) 2021 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grant.") .. | 10,019,550 | 10,698,823 | 12,978,641 | 17,810,315 | 23,061,454 | 74,568,783 |
| 2 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf.... | ||||||
| 3 | The value of services or facilities furnished by a governmental unit to the organization without charge.. | ||||||
| 4 | Total. Add lines 1 through 3 | 10,019,550 | 10,698,823 | 12,978,641 | 17,810,315 | 23,061,454 | 74,568,783 |
| 5 | The portion of total contributions by each person (other than a governmental unit or publicly supported organization) included on line 1 that exceeds 2% of the amount shown on line 11, column (f) .. | 12,014,876 | |||||
| 6 | Public support. Subtract line 5 from line 4. | 62,553,907 | |||||
Calendar year
(or fiscal year beginning in)
![]() |
(a) 2017 | (b) 2018 | (c) 2019 | (d) 2020 | (e) 2021 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 7 | Amounts from line 4.. | 10,019,550 | 10,698,823 | 12,978,641 | 17,810,315 | 23,061,454 | 74,568,783 |
| 8 | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources... | 83,667 | 215,046 | 156,753 | 5,817 | 6,633 | 467,916 |
| 9 | Net income from unrelated business activities, whether or not the business is regularly carried on.. | ||||||
| 10 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part VI.).. | ||||||
| 11 | Total support. Add lines 7 through 10 | 75,036,699 | |||||
Calendar year (or fiscal year beginning in) ![]() |
(a) 2017 | (b) 2018 | (c) 2019 | (d) 2020 | (e) 2021 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") . | ||||||
| 2 | Gross receipts from admissions, merchandise sold or services performed, or facilities furnished in any activity that is related to the organization's tax-exempt purpose | ||||||
| 3 | Gross receipts from activities that are not an unrelated trade or business under section 513 ..... | ||||||
| 4 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf... | ||||||
| 5 | The value of services or facilities furnished by a governmental unit to the organization without charge | ||||||
| 6 | Total. Add lines 1 through 5 | ||||||
| 7a | Amounts included on lines 1, 2, and 3 received from disqualified persons | ||||||
| b | Amounts included on lines 2 and 3 received from other than disqualified persons that exceed the greater of $5,000 or 1% of the amount on line 13 for the year. | ||||||
| c | Add lines 7a and 7b.. | ||||||
| 8 | Public support. (Subtract line 7c from line 6.) | ||||||
Calendar year (or fiscal year beginning in) ![]() |
(a) 2017 | (b) 2018 | (c) 2019 | (d) 2020 | (e) 2021 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 9 | Amounts from line 6... | ||||||
| 10a | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources.. | ||||||
| b | Unrelated business taxable income (less section 511 taxes) from businesses acquired after June 30, 1975. | ||||||
| c | Add lines 10a and 10b. | ||||||
| 11 | Net income from unrelated business activities not included on line 10b, whether or not the business is regularly carried on. | ||||||
| 12 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part VI.) .. | ||||||
| 13 | Total support. (Add lines 9, 10c, 11, and 12.).. | ||||||
| Section A - Adjusted Net Income | (A) Prior Year |
(B) Current Year (optional) |
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| 1 | Net short-term capital gain | 1 | ||||
| 2 | Recoveries of prior-year distributions | 2 | ||||
| 3 | Other gross income (see instructions) | 3 | ||||
| 4 | Add lines 1 through 3 | 4 | ||||
| 5 | Depreciation and depletion | 5 | ||||
| 6 | Portion of operating expenses paid or incurred for production or collection of gross income or for management, conservation, or maintenance of property held for production of income (see instructions) | 6 | ||||
| 7 | Other expenses (see instructions) | 7 | ||||
| 8 | Adjusted Net Income (subtract lines 5, 6 and 7 from line 4) | 8 | ||||
| Section B - Minimum Asset Amount | (A) Prior Year |
(B) Current Year (optional) |
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| 1 | Aggregate fair market value of all non-exempt-use assets (see instructions for short tax year or assets held for part of year): | 1 | ||||
| a | Average monthly value of securities | 1a | ||||
| b | Average monthly cash balances | 1b | ||||
| c | Fair market value of other non-exempt-use assets | 1c | ||||
| d | Total (add lines 1a, 1b, and 1c) | 1d | ||||
| e |
Discount claimed for blockage or other factors (explain in detail in Part VI): |
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| 2 | Acquisition indebtedness applicable to non-exempt use assets | 2 | ||||
| 3 | Subtract line 2 from line 1d | 3 | ||||
| 4 | Cash deemed held for exempt use. Enter 0.015 of line 3 (for greater amount, see instructions). | 4 | ||||
| 5 | Net value of non-exempt-use assets (subtract line 4 from line 3) | 5 | ||||
| 6 | Multiply line 5 by 0.035 | 6 | ||||
| 7 | Recoveries of prior-year distributions | 7 | ||||
| 8 | Minimum Asset Amount (add line 7 to line 6) | 8 | ||||
| Section C - Distributable Amount | Current Year | |||||
| 1 | Adjusted net income for prior year (from Section A, line 8, Column A) | 1 | ||||
| 2 | Enter 85% of line 1 | 2 | ||||
| 3 | Minimum asset amount for prior year (from Section B, line 8, Column A) | 3 | ||||
| 4 | Enter greater of line 2 or line 3 | 4 | ||||
| 5 | Income tax imposed in prior year | 5 | ||||
| 6 | Distributable Amount. Subtract line 5 from line 4, unless subject to emergency temporary reduction (see instructions) | 6 | ||||
| Section D - Distributions | Current Year | |
|---|---|---|
| 1 Amounts paid to supported organizations to accomplish exempt purposes | 1 | |
|
2
Amounts paid to perform activity that directly furthers exempt purposes of supported organizations, in excess of income from activity |
2 | |
| 3 Administrative expenses paid to accomplish exempt purposes of supported organizations | 3 | |
| 4 Amounts paid to acquire exempt-use assets | 4 | |
| 5 Qualified set-aside amounts (prior IRS approval required - provide details in Part VI) | 5 | |
| 6 Other distributions (describe in Part VI). See instructions | 6 | |
| 7Total annual distributions. Add lines 1 through 6. | 7 | |
|
8
Distributions to attentive supported organizations to which the organization is responsive (provide details in Part VI). See instructions |
8 | |
| 9 Distributable amount for 2021 from Section C, line 6 | 9 | |
| 10 Line 8 amount divided by Line 9 amount | 10 | |
| Section E - Distribution Allocations (see instructions) |
(i) Excess Distributions |
(ii) Underdistributions Pre-2021 |
(iii) Distributable Amount for 2021 |
|
|---|---|---|---|---|
| 1 Distributable amount for 2021 from Section C, line 6 | ||||
|
2
Underdistributions, if any, for years prior to 2021 (reasonable cause required-- explain in Part VI). See instructions. |
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| 3 Excess distributions carryover, if any, to 2021: | ||||
| a From 2016....... | ||||
| b From 2017....... | ||||
| c From 2018....... | ||||
| d From 2019....... | ||||
| e From 2020....... | ||||
| fTotal of lines 3a through e | ||||
| g Applied to underdistributions of prior years | ||||
| h Applied to 2021 distributable amount | ||||
|
i
Carryover from 2016 not applied (see instructions) |
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| j Remainder. Subtract lines 3g, 3h, and 3i from line 3f. | ||||
| 4Distributions for 2021 from Section D, line 7: | ||||
| $ | ||||
| a Applied to underdistributions of prior years | ||||
| b Applied to 2021 distributable amount | ||||
| c Remainder. Subtract lines 4a and 4b from line 4. | ||||
|
5
Remaining underdistributions for years prior to 2021, if any. Subtract lines 3g and 4a from line 2. If the amount is greater than zero, explain in Part VI. See instructions. |
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|
6
Remaining underdistributions for 2021. Subtract lines 3h and 4b from line 1. If the amount is greater than zero, explain in Part VI. See instructions. |
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|
7 Excess distributions carryover to 2022. Add lines 3j and 4c. |
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| 8 Breakdown of line 7: | ||||
| a Excess from 2017..... | ||||
| b Excess from 2018..... | ||||
| c Excess from 2019..... | ||||
| d Excess from 2020..... | ||||
| e Excess from 2021..... | ||||
| Facts And Circumstances Test |
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| Return Reference | Explanation |
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| Software ID: | |
| Software Version: |
Attach to Form 990 or 990-EZ.
Go to www.irs.gov/Form990 for the latest information.
| Return Reference | Explanation |
|---|---|
| FORM 990, PART III, LINE 4A, DESCRIPTION OF PROGRAM SERVICES | THE RARE DISEASE CURES ACCELERATOR-DATA AND ANALYTICS PLATFORM (RDCA-DAP) IS AN FDA-FUNDED INITIATIVE THAT PROVIDES A CENTRALIZED AND STANDARDIZED INFRASTRUCTURE TO SUPPORT AND ACCELERATE RARE DISEASE CHARACTERIZATION, WITH THE GOAL OF ACCELERATING THERAPY DEVELOPMENT ACROSS RARE DISEASES. THIS PLATFORM IS MADE POSSIBLE THROUGH A COLLABORATIVE GRANT FROM THE FDA AND IN PARTNERSHIP WITH THE NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD). RDCA-DAP PROMOTES THE SHARING OF EXISTING PATIENT-LEVEL DATA AND ENCOURAGES THE STANDARDIZATION OF NEW DATA COLLECTION. BY INTEGRATING SUCH DATA IN A REGULATORY-GRADE FORMAT SUITABLE FOR ANALYTICS, RDCA- DAP ACCELERATES THE UNDERSTANDING OF DISEASE PROGRESSION (INCLUDING SOURCES OF VARIABILITY TO OPTIMIZE THE CHARACTERIZATION OF SUBPOPULATIONS), CLINICAL OUTCOME MEASURES AND BIOMARKERS, AND FACILITATES THE DEVELOPMENT OF MATHEMATICAL MODELS OF DISEASE AND INNOVATIVE CLINICAL TRIAL DESIGNS. RDCA-DAP IS POSITIONED TO GENERATE SOLUTIONS TO DRUG DEVELOPMENT BOTTLENECKS. ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) SIGNED 24 DATA CONTRIBUTION AGREEMENTS (DCAS), TWELVE MOUS AND THIRTEEN NDAS NEGOTIATED AND SIGNED TO DATE TO DATE; (2) THE RDCA-DAP PLATFORM CURRENTLY INCLUDES OVER 75 RARE DISEASE DATA SETS REPRESENTING 25 DISEASE STATES FROM 53,001 PATIENTS; (3) MANUSCRIPT, "INNOVATIONS IN THERAPY DEVELOPMENT FOR RARE DISEASES THROUGH THE RARE DISEASE CURES ACCELERATOR DATA AND ANALYTICS PLATFORM," SUBMITTED TO THERAPEUTIC INNOVATION & REGULATORY SCIENCE COMPLETED AND PUBLISHED WHITE PAPER ON RDCA-DAP WEBSITE TITLED "RARE DISEASES CURES ACCELERATOR DATA AND ANALYTICS PLATFORM (RDCA-DAP) BEST PRACTICES AND RECOMMENDATIONS FOR FAIR DATA, TOWARD ALIGNMENT WITH INTERNATIONAL REGULATORY AGENCIES," SHARING LESSONS LEARNED FOR STORING AND SHARING DATA AND STRATEGIES FOR COLLECTING REGISTRY DATA THAT WILL MAXIMIZE IMPACT ON THE DRUG AND DIAGNOSTIC TOOLS ECOSYSTEM; (4) TECHNICAL ADVISORY GROUP MEETING HELD WITH FDA AND NORD TO DEMONSTRATE THE PLATFORM TO A WIDER FDA AUDIENCE. |
| FORM 990, PART III, LINE 4B, DESCRIPTION OF PROGRAM SERVICES | THE GOAL OF THE CURE DRUG REPURPOSING COLLABORATORY (CDRC) IS TO BE THE CENTRAL GLOBAL SOURCE OF VALIDATED REAL-WORLD DATA OF REPURPOSED DRUGS FOR DISEASES WITH THE HIGHEST LEVELS OF UNMET MEDICAL NEED. TO ACCOMPLISH THIS GOAL, CDRC IS WORKING WITH MULTIPLE STAKEHOLDERS TO DEVELOP OPEN-SOURCED TOOLS TO AUTOMATE THE EXTRACTION, AGGREGATION, ANALYSIS AND SHARING OF KEY CLINICAL DATA ELEMENTS FROM ELECTRONIC HEALTH RECORDS IN A DEIDENTIFIED MANNER REGARDLESS OF THE VENDOR OR DATA MODEL FOR IDENTIFYING FDA APPROVED DRUGS PRESCRIBED FOR NEW INDICATIONS. IN ADDITION, CDRC IS WORKING TO DEVELOP A WEB-BASED PATIENT PORTAL FOR PATIENTS TO PROVIDE THEIR TREATMENT JOURNEY EXPERIENCE TO ALLEVIATE SYMPTOMS OF DISEASE THAT IS NOT ON THE CURRENT DRUG LABEL OR AMELIORATE SIDE EFFECTS OF EXISTING FDA APPROVED AND PRESCRIBED TREATMENTS. THE ANALYSIS OF REAL-WORLD DATA FROM BOTH CLINICIANS AND PATIENTS WILL BE USED TO GENERATE HYPOTHESIS THAT CAN SUPPLEMENT EXISTING CLINICAL TRIAL DATA OR INFORM CLINICAL TRIAL DESIGN IN HOW EXISTING FDA APPROVED DRUGS CAN BE EVALUATED IN RANDOMIZED TRIALS TO ASSESS TREATMENT EFFICACY. THE UTILITY OF SYSTEMATICALLY COLLECTING EXISTING REAL-WORLD DATA TO GENERATE REAL-WORLD EVIDENCE AND LINKAGE TO CLINICAL TRIALS WILL HELP INFORM PRESCRIBERS HOW TO MAXIMIZE THE USE OF EXISTING FDA APPROVED DRUGS AND LEVERAGE EXISTING DATA TO CHANGE CLINICAL PRACTICE AND HELP ADDRESS THE HIGH UNMET CLINICAL NEED OF PATIENTS WITH DISEASES THAT HAVE LITTLE OR NO TREATMENT OPTIONS. ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) DESIGNED AND CONSTRUCTED A BIOINFORMATIC DATA PROCESSING PIPELINE IN AMAZON WEB SERVICES (AWS) TO DIGEST DATA FROM CURE ID AND GENERATE INFORMATIVE INSIGHTS FOR DRUG REPURPOSING; (2) DEFINED RARE DISEASE PILOTS FOR ONCOLOGY (SARCOMA SUBTYPES: ANGIOSARCOMA, PERIVASCULAR EPITHELIOID CELL TUMORS AND EPITHELIOID HEMANGIOENDOTHELIOMA) AND NON-ONCOLOGY (RASOPATHIES WITH THE EXCEPTION OF NEUROFIBROMATOSIS TYPE 1), ENGAGED CLINICAL EXPERTS TO REVIEW AND DEFINE DATA ELEMENTS, ESTABLISHED DRUG REPURPOSING TASK FORCE WITH PATIENT GROUPS; (3) SECURED FUNDING FOR CREATE FROM THREE PHARMA COMPANIES WHO EXPECT TO COME TO MARKET SOON WITH NEW PRODUCTS FOR IBD BUT THE PROJECT REQUIRES ADDITIONAL INVESTMENT TO BUILD THE REGISTRY INFRASTRUCTURE; (4) FINALIZED PROTOCOL SYNOPSIS AND IDENTIFIED PILOT SITES (BAYLOR, HOPKINS AND UAB) FOR SECURING CONGENITAL CMV DATA FROM EHRS; (5) SUCCESSFULLY UPLOADED COVID-19 DATA AUTOMATICALLY EXTRACTED FROM EHR FROM FIRST PILOT SITE TO C-PATH USING THE EDGE TOOL; (6) ESTABLISHED WHO COLLABORATION ON SEXUALLY TRANSMITTED INFECTION TREATMENT FAILURES FOR GONORRHEA AND MYCOPLASMA GENETALIUM. |
| FORM 990, PART III, LINE 4C, DESCRIPTION OF PROGRAM SERVICES | THE OBJECTIVES OF C-PATH'S REAL-WORLD DATA ANALYTICS PLATFORM (RW-DAP) PROJECT ARE TO ASSIMILATE CLINICAL TRIAL DATASETS, ELECTRONIC HEALTH RECORDS (EHR), AND REGISTRY DATA FROM GLOBAL PARTNERS AND GENERATE ACTIONABLE SOLUTIONS TO ACCELERATE DRUG DEVELOPMENT IN NEONATOLOGY. THIS PROJECT ENTAILS GENERATING A REAL-WORLD DATA ANALYTICS PLATFORM (RW-DAP) THAT WILL AGGREGATE, STANDARDIZE, AND INTEGRATE PATIENT-LEVEL REAL WORLD DATA (RWD) TO (1) ESTABLISH NEONATAL LABORATORY VALUE REFERENCE RANGES BY GESTATIONAL AND POSTNATAL AGE, AND OTHER PATIENT-LEVEL CHARACTERISTICS, AND (2) DEVELOP A QUANTITATIVE DISEASE PROGRESSION MODEL FOR BRONCHOPULMONARY DYSPLASIA (ONE OF THE MOST CHALLENGING RESPIRATORY COMPLICATIONS OF PREMATURITY). ANY GAPS THAT INTERFERE WITH OPTIMAL USE OF EXISTING RWD WILL BE IDENTIFIED, AND SOLUTIONS THAT WILL IMPROVE THE USABILITY OF RWD IN THE FUTURE WILL BE PROPOSED. DURING THE PAST ONE YEAR, WE HAVE CONTINUED TO MEET AND MAKE SIGNIFICANT PROGRESS WITH PHARMACEUTICAL COMPANIES, ACADEMIC INSTITUTES, AND NEONATAL REGISTRY NETWORKS FOR THE PROJECT. DISCUSSIONS HAVE BEEN ONGOING WITH 22 ACADEMIC INSTITUTES WHO HAVE INDICATED A WILLINGNESS TO COLLABORATE WITH US. IN AGGREGATE, C-PATH HAS RECEIVED DATASETS REPRESENTING >200,000 PATIENTS AND EXPECTS 100,000 ADDITIONAL PATIENTS IN FUTURE DATASETS WITH PARTNERS AND COLLABORATORS. IN ORDER TO FOCUS AND LEVERAGE THE EXPERIENCE AND EXPERTISE OF THE LARGE INC STAKEHOLDER NETWORK, WE HAVE CREATED BPD AND LABORATORY VALUE WORKGROUPS. THE BPD WORKGROUP HAS 30 MEMBERS, COMPRISED OF ACADEMIC, INDUSTRY, AND REGULATORY RESEARCHERS WITH EXPERTISE IN BPD RESEARCH AS WELL AS PARENT MEMBERS. THE LABORATORY VALUE WORKGROUP HAS 20 MEMBERS, COMPRISED OF ACADEMIC AND INDUSTRY RESEARCHERS WHO HAVE A LONGSTANDING INTEREST IN CREATING GENERALIZABLE REFERENCE RANGES FOR LABORATORY VALUES IN NEONATES. |
| FORM 990, PART VI, SECTION A, LINE 2 | PETER HUTT AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. WAIN FISHBURN AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. JEFF JACOB AND SHAUN KIRKPATRICK HAVE A BUSINESS RELATIONSHIP. TOMAS SALMONSON AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. |
| FORM 990, PART VI, SECTION B, LINE 11B | FORM 990 IS PREPARED BY AN EXTERNAL CPA FIRM USING INFORMATION PROVIDED BY THE ORGANIZATION. THE FORM IS REVIEWED BY THE ORGANIZATION'S CFO, PRESIDENT/COO, CEO, THE BOARD AUDIT, FINANCE, AND RISK COMMITTEE, AND THE BOARD OF DIRECTORS PRIOR TO BEING FINALIZED. |
| FORM 990, PART VI, SECTION B, LINE 12C | ALL MEMBERS OF THE BOARD OF DIRECTORS AND ALL OFFICERS OF THE ORGANIZATION ARE REQUIRED TO FILL OUT A CONFLICT OF INTEREST FORM ANNUALLY. THE RESULTS ARE COMPILED AND REVIEWED BY THE BOARD'S AUDIT, FINANCE, AND RISK COMMITTEE. ANY ACTUAL OR PERCEIVED CONFLICTS THAT HAVE THE POTENTIAL TO BIAS ANY DISCUSSIONS OR DECISIONS BY THE BOARD ARE DISCUSSED BY THE BOARD. ANY DIRECTOR WITH A REAL OR POTENTIAL CONFLICT WILL RECUSE THEMSELVES FROM ANY DISCUSSION OR DECISION WHERE THE CONFLICT HAS A BEARING. |
| FORM 990, PART VI, SECTION B, LINE 15 | A BOARD OF DIRECTORS COMPENSATION COMMITTEE MEETS AND REVIEWS EXECUTIVE COMPENSATION ANNUALLY. PERIODICALLY, THE COMMITTEE REQUESTS A COMPENSATION ANALYSIS TO DETERMINE IF EMPLOYEE COMPENSATION HAS REMAINED WITHIN MARKET RANGE OR IF ADJUSTMENTS ARE REQUIRED. THIS INFORMATION IS THEN USED AS A BASIS FOR THE COMPENSATION COMMITTEE'S RECOMMENDATION TO THE BOARD OF DIRECTORS. AN OVERALL SALARY PROGRAM FOR EMPLOYEES MUST BE APPROVED BY THE BOARD OF DIRECTORS COMPENSATION COMMITTEE BEFORE IMPLEMENTATION. ALL EMPLOYEE SALARY INCREASES MUST BE APPROVED BY THE PRESIDENT/COO. |
| FORM 990, PART VI, SECTION C, LINE 19 | ARTICLES OF INCORPORATION CAN BE FOUND ON THE ARIZONA CORPORATION COMMISSION WEBSITE. THE CONFLICT OF INTEREST POLICY AND THE FINANCIAL STATEMENTS (VIA THE ANNUAL REPORT) ARE POSTED ON THE INSTITUTE'S WEBSITE. |
| FORM 990, PART IX, LINE 11G | RESEARCH SUPPORT SERVICES: PROGRAM SERVICE EXPENSES 1,481,156. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,481,156. CONSULTING: PROGRAM SERVICE EXPENSES 1,166,698. MANAGEMENT AND GENERAL EXPENSES 415,577. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,582,275. OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 400,050. MANAGEMENT AND GENERAL EXPENSES 287,427. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 687,477. |
| Software ID: | |
| Software Version: |