| SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES |
The
table below summarizes the significant expense categories regularly reviewed by the CODM (in thousands):
SCHEDULE OF SIGNIFICANT EXPENSE CATEGORIES
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For the three months ended
September 30,
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For the nine months ended
September 30,
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2025 |
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2024 |
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2025 |
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2024 |
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| License and other revenues |
|
$ |
— |
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|
$ |
— |
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|
$ |
400 |
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|
$ |
— |
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| Research and development costs |
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| Salaries & related costs |
|
$ |
1,689 |
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|
$ |
3,492 |
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|
$ |
8,605 |
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|
$ |
11,488 |
|
| Non-cash stock-based compensation |
|
|
223 |
|
|
|
485 |
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|
|
1,125 |
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|
|
1,055 |
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| Other research and development costs (a)
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|
|
2,304 |
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|
|
4,964 |
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|
|
10,370 |
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|
|
12,823 |
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| Total research and development costs |
|
$ |
4,216 |
|
|
$ |
8,941 |
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|
$ |
20,100 |
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|
$ |
25,366 |
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| Selling, general and administrative costs |
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| Salaries & related costs |
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$ |
6,975 |
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|
$ |
2,235 |
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|
$ |
18,084 |
|
|
$ |
7,931 |
|
| Non-cash stock-based compensation |
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|
2,466 |
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|
|
1,320 |
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|
|
7,095 |
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|
|
3,619 |
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| Pre-commercial preparation costs |
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|
2,138 |
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|
|
814 |
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|
5,635 |
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|
|
3,625 |
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| Other selling, general and administrative costs (b)
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|
|
7,735 |
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|
|
2,035 |
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|
|
15,435 |
|
|
|
6,998 |
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| Total selling, general and administrative costs |
|
$ |
19,314 |
|
|
$ |
6,404 |
|
|
$ |
46,249 |
|
|
$ |
22,173 |
|
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| Other segment items (c)
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|
(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. |
|