| Operating Segments |
Note 7. Operating Segments The Company operates in two reportable segments: | ● | Specialized BioTherapeutics – Focuses on developing and commercializing products for orphan diseases and areas of unmet medical need in oncology and inflammation. |
| ● | Public Health Solutions – Concentrates on vaccines and therapeutics for biodefense and infectious diseases. |
The Company’s CODM evaluates segment performance and allocates resources primarily based on the ability of the Specialized BioTherapeutics segment to advance its product development pipeline through a combination of government grants and contracts as well as shareholder investment. This segment represents the Company’s primary focus and strategic priority. In contrast, the Public Health Solutions segment is fully funded by government sources, with no investor capital used. The ability of this segment to secure government grants and contracts is a key determinant of its sustainability and its contribution to the Company’s overall financial position. Funding from Public Health Solutions enables the Company to cover employee salaries, allocate funds to certain overhead costs such as rent and utilities, and supplement working capital. Secondary to this, the CODM considers Adjusted Loss from Operations, which excludes non-cash share-based compensation and depreciation/amortization from operating expenses (R&D and G&A), and Net Loss Before Income Taxes, which incorporates these costs along with other income and expenses. Segment Revenues and Profit (Loss) The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the three months ended June 30, 2025: | | | | | | | | | | | | | | | | | | | | | | | | Specialized
BioTherapeutics | | Public Health
Solutions | | Total
Segments | | Adjustments | | Corporate | | Adjustments | | Consolidated | Revenues | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | Cost of revenues | | | - | | | - | | | - | | | - | | | - | | | - | | | - | Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - | Significant expenses: | | | | | | | | | | | | | | | | | | | | | | Research and development | | | 1,523,099 | | | 3,332 | | | 1,526,431 | | | 27,819 | | | 122,764 | | | - | | | 1,677,014 | General and administrative | | | - | | | - | | | - | | | - | | | 1,014,468 | | | 72,397 | | | 1,086,865 | Adjusted loss from operations | | | (1,523,099) | | | (3,332) | | | (1,526,431) | | | (27,819) | | | (1,137,232) | | | (72,397) | | | (2,763,879) | Share-based compensation | | | 26,487 | | | 839 | | | 27,326 | | | (27,326) | | | 72,187 | | | (72,187) | | | - | Depreciation and amortization | | | 423 | | | 70 | | | 493 | | | (493) | | | 210 | | | (210) | | | - | Loss from operations | | | (1,550,009) | | | (4,241) | | | (1,554,250) | | | - | | | (1,209,629) | | | - | | | (2,763,879) | Other (expenses) income, net | | | - | | | - | | | - | | | - | | | 61,903 | | | - | | | 61,903 | Net loss before income taxes | | $ | (1,550,009) | | $ | (4,241) | | $ | (1,554,250) | | $ | - | | $ | (1,147,726) | | $ | - | | $ | (2,701,976) |
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the three months ended June 30, 2024: | | | | | | | | | | | | | | | | | | | | | | | | Specialized
BioTherapeutics | | Public Health
Solutions | | Total
Segments | | Adjustments | | Corporate | | Adjustments | | Consolidated | Revenues | | $ | 2,342 | | $ | - | | $ | 2,342 | | $ | - | | $ | - | | $ | - | | $ | 2,342 | Cost of revenues | | | (2,342) | | | - | | | (2,342) | | | - | | | - | | | - | | | (2,342) | Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - | Significant expenses: | | | | | | | | | | | | | | | | | | | | | | Research and development | | | 261,313 | | | 61,276 | | | 322,589 | | | 22,669 | | | 155,900 | | | - | | | 501,158 | General and administrative | | | - | | | - | | | - | | | - | | | 1,206,923 | | | 36,594 | | | 1,243,517 | Adjusted loss from operations | | | (261,313) | | | (61,276) | | | (322,589) | | | (22,669) | | | (1,362,823) | | | (36,594) | | | (1,744,675) | Share-based compensation | | | 20,940 | | | 617 | | | 21,557 | | | (21,557) | | | 36,118 | | | (36,118) | | | - | Depreciation and amortization | | | 953 | | | 159 | | | 1,112 | | | (1,112) | | | 476 | | | (476) | | | - | Loss from operations | | | (283,206) | | | (62,052) | | | (345,258) | | | - | | | (1,399,417) | | | - | | | (1,744,675) | Other (expenses) income, net | | | (31,346) | | | - | | | (31,346) | | | - | | | 131,519 | | | - | | | 100,173 | Net loss before income taxes | | $ | (314,552) | | $ | (62,052) | | $ | (376,604) | | $ | - | | $ | (1,267,898) | | $ | - | | $ | (1,644,502) |
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the six months ended June 30, 2025: | | | | | | | | | | | | | | | | | | | | | | | | Specialized
BioTherapeutics | | Public Health
Solutions | | Total
Segments | | Adjustments | | Corporate | | Adjustments | | Consolidated | Revenues | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | | $ | - | Cost of revenues | | | - | | | - | | | - | | | - | | | - | | | - | | | - | Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - | Significant expenses: | | | | | | | | | | | | | | | | | | | | | | Research and development | | | 3,273,701 | | | 61,667 | | | 3,335,368 | | | 55,572 | | | 227,754 | | | - | | | 3,618,694 | General and administrative | | | - | | | - | | | - | | | - | | | 2,062,842 | | | 108,851 | | | 2,171,693 | Adjusted loss from operations | | | (3,273,701) | | | (61,667) | | | (3,335,368) | | | (55,572) | | | (2,290,596) | | | (108,851) | | | (5,790,387) | Share-based compensation | | | 52,975 | | | 1,679 | | | 54,654 | | | (54,654) | | | 108,458 | | | (108,458) | | | - | Depreciation and amortization | | | 787 | | | 131 | | | 918 | | | (918) | | | 393 | | | (393) | | | - | Loss from operations | | | (3,327,463) | | | (63,477) | | | (3,390,940) | | | - | | | (2,399,447) | | | - | | | (5,790,387) | Other (expenses) income, net | | | - | | | - | | | - | | | - | | | 137,143 | | | - | | | 137,143 | Net loss before income taxes | | $ | (3,327,463) | | $ | (63,477) | | $ | (3,390,940) | | $ | - | | $ | (2,262,304) | | $ | - | | $ | (5,653,244) |
The following table presents the revenues, significant expenses, and operating results of the Company's reportable segments for the six months ended June 30, 2024: | | | | | | | | | | | | | | | | | | | | | | | | Specialized
BioTherapeutics | | Public Health
Solutions | | Total
Segments | | Adjustments | | Corporate | | Adjustments | | Consolidated | Revenues | | $ | 119,371 | | $ | - | | $ | 119,371 | | $ | - | | $ | - | | $ | - | | $ | 119,371 | Cost of revenues | | | (119,371) | | | - | | | (119,371) | | | - | | | - | | | - | | | (119,371) | Gross profit | | | - | | | - | | | - | | | - | | | - | | | - | | | - | Significant expenses: | | | | | | | | | | | | | | | | | | | | | | Research and development | | | 1,100,292 | | | 106,526 | | | 1,206,818 | | | 45,041 | | | 344,339 | | | - | | | 1,596,198 | General and administrative | | | - | | | - | | | - | | | - | | | 2,189,797 | | | 75,771 | | | 2,265,568 | Adjusted loss from operations | | | (1,100,292) | | | (106,526) | | | (1,206,818) | | | (45,041) | | | (2,534,136) | | | (75,771) | | | (3,861,766) | Share-based compensation | | | 41,612 | | | 1,205 | | | 42,817 | | | (42,817) | | | 74,819 | | | (74,819) | | | - | Depreciation and amortization | | | 1,906 | | | 318 | | | 2,224 | | | (2,224) | | | 952 | | | (952) | | | - | Loss from operations | | | (1,143,810) | | | (108,049) | | | (1,251,859) | | | - | | | (2,609,907) | | | - | | | (3,861,766) | Other (expenses) income, net | | | (23,806) | | | - | | | (23,806) | | | - | | | 325,743 | | | - | | | 301,937 | Net loss before income taxes | | $ | (1,167,616) | | $ | (108,049) | | $ | (1,275,665) | | $ | - | | $ | (2,284,164) | | $ | - | | $ | (3,559,829) |
The following table provides a reconciliation of total segment loss to consolidated loss before income taxes for the three months ended June 30: | | | | | | | | | 2025 | | 2024 | Loss from operations - reportable segments | | $ | (1,554,250) | | $ | (345,258) | Loss from operations - corporate | | | (1,209,629) | | | (1,399,417) | Interest income (expense), net | | | 69,823 | | | 35,925 | Other income (expense), net | | | (7,920) | | | 64,248 | Net loss before income taxes | | $ | (2,701,976) | | $ | (1,644,502) |
The following table provides a reconciliation of total segment loss to consolidated loss before income taxes for the six months ended June 30: | | | | | | | | | 2025 | | 2024 | Loss from operations - reportable segments | | $ | (3,390,940) | | $ | (1,251,859) | Loss from operations - corporate | | | (2,399,447) | | | (2,609,907) | Interest income (expense), net | | | 145,851 | | | 64,767 | Other income (expense), net | | | (8,708) | | | 237,170 | Net loss before income taxes | | $ | (5,653,244) | | $ | (3,559,829) |
Segment Assets The Company’s total assets by segment as of June 30, 2025, are presented below: | | | | | | | | | | | | | | | | | | Specialized BioTherapeutics | | Public Health
Solutions | | Total
Segments | | Corporate | | Consolidated | Total assets | | $ | 112,342 | | $ | 2,705 | | $ | 115,047 | | $ | 5,645,600 | | $ | 5,760,647 |
The Company’s total assets by segment as of June 30, 2024, are presented below: | | | | | | | | | | | | | | | | | | Specialized BioTherapeutics | | Public Health Solutions | | Total
Segments | | Corporate | | Consolidated | Total assets | | $ | 183,858 | | $ | 2,917 | | $ | 186,775 | | $ | 9,678,304 | | $ | 9,865,079 |
Significant Expense Categories Considered by CODM The CODM regularly reviews the following significant expense categories when assessing segment performance and resource allocation: | ● | Government Grant and Contract Funding – Both the Specialized BioTherapeutics and Public Health Solutions segments apply for and receive government grants and contracts. However, Public Health Solutions is exclusively funded by government sources, whereas Specialized BioTherapeutics utilizes a mix of government funding and shareholder investment. |
| ● | Research & Development – Includes expenses for clinical trials, regulatory compliance, and R&D-related payroll. |
| ● | General & Administrative – Comprises salaries, professional fees, and facility costs. |
| ● | Share-Based Compensation – Represents non-cash stock option and restricted stock unit expenses. |
| ● | Depreciation & Amortization – Costs related to the use of tangible and intangible assets. |
| ● | Other Income/Expenses – Includes interest income and one-time gains/losses. |
CODM and Use of Multiple Measures of Segment Profit/Loss The Company's CODM primarily evaluates segment performance based on two key financial measures: | ● | Advancement of Specialized BioTherapeutics Through a Combination of Funding Sources – Assesses the effectiveness of shareholder investment and government grants in progressing product development. |
| ● | Ability to Secure Government Grants and Contracts (Public Health Solutions Only) – Determines segment sustainability and funding for shared resources. |
| ● | Adjusted Loss from Operations – Excludes non-cash share-based compensation and depreciation/amortization expenses for a clearer picture of operating performance. |
| ● | Net Loss Before Income Taxes – Incorporates all expenses, including non-cash charges and other income/expenses, for a comprehensive profitability analysis. |
|