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REVENUE AND SEGMENT INFORMATION (Tables)

3 Months Ended

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

X

- Definition

Tabular disclosure of receivable, contract asset, and contract liability from contract with customer. Includes, but is not limited to, change in contract asset and contract liability.

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Tabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor.

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-Topic 606
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Tabular disclosure of the profit or loss and total assets for each reportable segment. An entity discloses certain information on each reportable segment if the amounts (a) are included in the measure of segment profit or loss reviewed by the chief operating decision maker or (b) are otherwise regularly provided to the chief operating decision maker, even if not included in that measure of segment profit or loss.

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