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REVENUE AND SEGMENT INFORMATION (Tables) | 3 Months Ended
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Mar. 31, 2025
REVENUE AND SEGMENT INFORMATION |
Schedule of disaggregation of revenue | The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2025:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
Product revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 62,607 | ​ | $ | — | ​ | $ | 62,607
Germany | ​ |  | 2,796,237 | ​ | ​ | — | ​ | ​ | 2,796,237
All other countries | ​ |  | 1,889,370 | ​ | ​ | 3,979,024 | ​ | ​ | 5,868,394
​ | ​ |  | ​ | ​ | ​ | ​ | ​ | ​ | ​
Product revenue | ​ | $ | 4,748,214 | ​ | $ | 3,979,024 | ​ | $ | 8,727,238
​ The following table disaggregates the Company’s revenue by customer type and geographic area for the three months ended March 31, 2024:
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ | ​ | ​ | ​ | ​ | Distributors/ | ​ | ​ | ​
​ |  | Direct |  | Strategic Partners |  | Total
Product revenue: |  | ​ |  |  | ​ |  |  | ​ |
United States | ​ | $ | 21,616 | ​ | $ | 18,000 | ​ | $ | 39,616
Germany | ​ |  | 3,537,727 | ​ | ​ | — | ​ | ​ | 3,537,727
All other countries | ​ |  | 1,750,541 | ​ | ​ | 3,661,636 | ​ | ​ | 5,412,177
​ | ​ |  | ​ | ​ | ​ | ​ | ​ | ​ | ​
Product revenue | ​ | $ | 5,309,884 | ​ | $ | 3,679,636 | ​ | $ | 8,989,520
Schedule of receivables and contract liabilities from contracts with customers | ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | March 31, 2025 |  | December 31, 2024
Contract receivables, which are included in grants and accounts receivable | ​ | $ | 5,861,678 | ​ | $ | 4,426,890
Contract liabilities, which are included in accrued expenses and other current liabilities | ​ | $ | 729,742 | ​ | $ | 596,042
Schedule of segment information | ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended |
​ | ​ | March 31, |
​ | ​ | 2025 | ​ | 2024 |
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
Product revenue | ​ | $ | 8,727,238 | ​ | $ | 8,989,520 | ​
Gross profit | ​ | $ | 6,207,597 | ​ | $ | 6,873,610 | ​
Gross margin | ​ |  | 71 | % |  | 76 | %
Total operating expenses | ​ | $ | 10,094,805 | ​ | $ | 11,529,978 | ​
EBITDA and Adjusted EBITDA (both non-GAAP measures): | ​ |  |  | ​ |  |  | ​
Net loss attributable to common stockholders | ​ | $ | (1,478,358) | ​ | $ | (6,088,711) | ​
Interest expense, net | ​ |  | 605,134 | ​ |  | 6,653 | ​
Benefit from income taxes | ​ |  | — | ​ |  | — | ​
Depreciation and amortization expense | ​ |  | 368,503 | ​ |  | 397,286 | ​
Loss before interest expense, income taxes, depreciation and amortization (“EBITDA”), a non-GAAP measure | ​ |  | (504,721) | ​ |  | (5,684,772) | ​
Stock-based compensation | ​ |  | 818,426 | ​ |  | 959,465 | ​
Loss (gain) on foreign currency transactions | ​ | ​ | (3,013,984) | ​ |  | 1,425,690 | ​
Adjusted EBITDA, a non-GAAP measure | ​ | $ | (2,700,279) | ​ | $ | (3,299,617) | ​
Adjusted net loss, a non-GAAP measure: | ​ |  |  | ​ |  |  | ​
Net loss attributable to common stockholders | ​ | $ | (1,478,358) | ​ | $ | (6,088,711) | ​
Stock-based compensation | ​ |  | 818,426 | ​ |  | 959,465 | ​
Loss (gain) on foreign currency transactions | ​ | ​ | (3,013,984) | ​ | ​ | 1,425,690 | ​
Adjusted net loss, a non-GAAP measure | ​ | $ | (3,673,916) | ​ | $ | (3,703,556) | ​
Total cash used in operating and investing activities | ​ | $ | (3,512,197) | ​ | $ | (4,956,777) | ​
​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | March 31, 2025 |  | December 31, 2024
Total assets | ​ | $ | 50,781,684 | ​ | $ | 47,371,500
​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | Three Months Ended
​ | ​ | March 31,
​ | ​ | 2025 | ​ | 2024
​ | ​ | ​ | ​ | ​ | ​ | ​
Research and development: |  | ​ |  |  | ​ |
Clinical expenses | ​ | $ | 979,113 | ​ | $ | 1,627,449
Other research and development expenses | ​ |  | 683,812 | ​ |  | 619,462
Total research and development | ​ | $ | 1,662,925 | ​ | $ | 2,246,911
​ | ​ | ​ | ​ | ​ | ​ | ​
Selling, general and administrative | ​ |  |  | ​ |  |
Royalty expense | ​ |  | 257,883 | ​ |  | 712,385
Stock-based compensation | ​ |  | 626,641 | ​ |  | 959,465
Legal, financial and consulting | ​ |  | 637,981 | ​ |  | 680,706
Other general and administrative | ​ |  | 6,909,375 | ​ |  | 6,930,511
Total selling, general and administrative | ​ | $ | 8,431,880 | ​ | $ | 9,283,067

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