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SEGMENT INFORMATION | 9 Months Ended
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Sep. 30, 2025
Segment Reporting [Abstract] |
SEGMENT INFORMATION | NOTE 12 – SEGMENT INFORMATION Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the Chief Operating Decision Maker (“CODM”), or decision making group, in deciding how to allocate resources in assessing performance. The Company is a commercial-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases and has one reportable segment. The Company’s CODM is the chief executive officer. The accounting policies of the clinical-stage biopharmaceutical segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the commercial-stage biopharmaceutical segment based on net income (loss), which is reported on the consolidated statements of operations and comprehensive income (loss) as consolidated net income (loss). The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. Expenditures for additions to long-lived assets, which include purchases of property and equipment, are included in total consolidated assets reviewed by the chief operating decision maker and are reported on the consolidated statements of cash flows. To date, the Company has not generated any product revenue. The Company will continue to incur significant expenses and operating losses until ZEVASKYN® can provide sufficient revenue for the Company to be profitable. As such, the CODM uses cash forecast models in deciding how to invest into the commercial-stage biopharmaceutical segment. Such cash forecast models are reviewed to make decisions about allocating resources and assessing the entity-wide operating results and performance. Net income (loss) is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used to make decisions about allocating resources, assessing the performance of the segment and in establishing management’s compensation, along with cash forecast models. The table below summarizes the significant expense categories regularly reviewed by the CODM (in thousands): SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES
|  | For the three months ended September 30, |  |  | For the nine months ended September 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
License and other revenues |  | $ | — |  |  | $ | — |  |  | $ | 400 |  |  | $ | — |
Research and development costs |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Salaries & related costs |  | $ | 1,689 |  |  | $ | 3,492 |  |  | $ | 8,605 |  |  | $ | 11,488 |
Non-cash stock-based compensation |  |  | 223 |  |  |  | 485 |  |  |  | 1,125 |  |  |  | 1,055 |
Other research and development costs (a) |  |  | 2,304 |  |  |  | 4,964 |  |  |  | 10,370 |  |  |  | 12,823 |
Total research and development costs |  | $ | 4,216 |  |  | $ | 8,941 |  |  | $ | 20,100 |  |  | $ | 25,366 |
Selling, general and administrative costs |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Salaries & related costs |  | $ | 6,975 |  |  | $ | 2,235 |  |  | $ | 18,084 |  |  | $ | 7,931 |
Non-cash stock-based compensation |  |  | 2,466 |  |  |  | 1,320 |  |  |  | 7,095 |  |  |  | 3,619 |
Pre-commercial preparation costs |  |  | 2,138 |  |  |  | 814 |  |  |  | 5,635 |  |  |  | 3,625 |
Other selling, general and administrative costs (b) |  |  | 7,735 |  |  |  | 2,035 |  |  |  | 15,435 |  |  |  | 6,998 |
Total selling, general and administrative costs |  | $ | 19,314 |  |  | $ | 6,404 |  |  | $ | 46,249 |  |  | $ | 22,173 |
Other segment items (c) |  |  | (18,369 | ) |  |  | 14,924 |  |  |  | (157,592 | ) |  |  | 6,902 |
Net income (loss) |  | $ | (5,161 | ) |  | $ | (30,269 | ) |  | $ | 91,643 |  |  | $ | (54,441 | )
(a) | Other research and development costs include, but are not limited to preclinical lab supplies, preclinical and development costs, clinical trial costs, preclinical manufacturing and manufacturing facility costs, costs associated with preclinical regulatory approvals, preclinical depreciation on lab supplies and manufacturing facilities, and preclinical consultant-related expenses.
(b) | Other selling, general and administrative costs primarily consist of office facility costs, public reporting company related costs, professional fees (e.g., legal expenses), regulatory costs, production costs not attributable to cost of sales and other general operating expenses not otherwise included in research and development expenses.
(c) | Other segment items includes cost of sales, royalties, interest income, interest expense, change in fair value of warrant and derivative liabilities, gain on sale of priority review voucher, other income and income tax (benefit) expense.

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- Definition The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 280 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 21 -Subparagraph (b) -Publisher FASB -URI https://asc.fasb.org/1943274/2147482810/280-10-50-21 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Topic 280 -SubTopic 10 -Name 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