| Summary of Significant Expense Categories and Consolidated Net Loss Details |
The following is a summary of the significant expense categories and consolidated net loss details provided to the CODM:
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Segment operating expenses: |
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Research and development: |
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GEM-AKI program expenses |
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$ |
(816,437 |
) |
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$ |
(286,125 |
) |
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$ |
(2,247,519 |
) |
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$ |
(1,002,127 |
) |
GEM-CKD program expenses |
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— |
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(286,125 |
) |
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(78,978 |
) |
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(1,002,128 |
) |
GEM-AKI manufacturing expenses |
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(61,684 |
) |
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— |
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(606,630 |
) |
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— |
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Other expenses(1) |
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(112,180 |
) |
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(24,897 |
) |
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(424,214 |
) |
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(69,080 |
) |
Personnel expenses (including stock-based compensation) |
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(522,597 |
) |
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(325,710 |
) |
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(1,450,842 |
) |
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(1,026,332 |
) |
General and administrative |
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(1,870,678 |
) |
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(1,020,154 |
) |
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(5,330,134 |
) |
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(3,399,559 |
) |
Change in fair value of warrant liability |
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— |
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611 |
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— |
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2,071 |
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Interest income |
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68,063 |
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35,512 |
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233,996 |
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82,901 |
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Other income and expenses, net(2) |
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— |
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(288 |
) |
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256,373 |
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11,611 |
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Net loss |
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$ |
(3,315,513 |
) |
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$ |
(1,907,176 |
) |
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$ |
(9,647,948 |
) |
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$ |
(6,402,643 |
) |
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(1) |
Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, and other unallocated costs. |
(2) |
Consists of foreign currency transaction gains and losses. In 2026, this also includes a Delaware franchise tax refund for overpaid fees. |
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