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Balance Sheet Details

12 Months Ended

Dec. 31, 2023

Disclosure Text Block Supplement [Abstract]

Note 4 — Balance Sheet Details

Inventories

Inventories primarily relate to ENTADFI® product and consisted of the following as of December 31, 2023 and 2022:

	December 31, 2023		December 31, 2022
Raw materials	$	139,208	$	—
Work-in-process		194,805		—
Finished goods		30,039		—
Total	$	364,052	$	—

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of December 31, 2023 and 2022:

	December 31, 2023		December 31, 2022
Prepaid insurance	$	122,004	$	148,789
Prepaid regulatory fees		312,551		—
Prepaid research and development		89,195		231,981
Prepaid professional fees		70,708		—
Prepaid other		175,695		88,462
Total	$	770,153	$	469,232

Intangible Assets

Intangible assets, which were recorded during the year ended December 31, 2023 in connection with the ENTADFI and Proteomedix acquisitions (see Note 5), is comprised of customer relationships, product rights for developed technology, and a trade name, and consisted of the following as of December 31, 2023:

	Cost		Impairment			Effect of Currency Translation		Balance
Cost basis:
Trade name	$	9,018,000	$	—		$	294,739	$	9,312,739
Product rights for developed technology		28,447,771		(14,610,128	)		344,514		14,182,157
Customer relationships		1,891,000		—			61,803		1,952,803
Total	$	39,356,771	$	(14,610,128	)	$	701,056	$	25,447,699

	Amortization			Balance
Accumulated amortization:
Trade name	$	—		$	—
Product rights for developed technology		(31,213	)		(31,213	)
Customer relationships		(5,599	)		(5,599	)
Total	$	(36,812	)	$	(36,812	)
Intangible assets, net				$	25,410,887

The finite lived intangible assets held by the Company, which includes customer relationships and product rights for developed technology, are being amortized over their estimated useful lives, which is 15 years for customer relationships, and 15 and 6 years for product rights for developed technology related to Proclarix and ENTADFI, respectively. Amortization expense related to intangible assets was approximately $37,000 for the year ended December 31, 2023, of which approximately $31,000 and $6,000 was recorded as cost of revenue and selling, general, and administrative expenses, respectively, in the accompanying consolidated statements of operations and comprehensive loss.

During the fourth quarter of 2023, the Company determined that there were certain triggering events that indicated that the carrying amount of the assets recorded in connection with the ENTADFI acquisition (see Note 5) may not be fully recoverable. Specifically, as a result of the Proteomedix acquisition (see Note 5) and continued significant cash constraints, the Company decided to pause the commercialization of ENTADFI until a later date, and consider strategic alternatives, which combined, decreased the cash flows expected to be generated from these assets. The Company performed an undiscounted cash flow analysis over the ENTADFI asset group and determined that the carrying value of the asset group is not recoverable. The Company then estimated the fair value of the asset group to measure the impairment loss. Significant assumptions used to determine this non-recurring fair value measurement include projected sales driven by market share and product sales price estimates, associated expenses, growth rates, the discount rate used to measure the fair value of the net cash flows associated with this asset group, as well as Management’s estimates of the probability of each potential strategic alternative taking place. The Company recorded an impairment charge of $14.7 million during the year ended December 31, 2023, which was allocated on a pro rata basis across the assets within the asset group as follows: approximately $14.6 million and approximately $0.1 million was allocated to the product rights intangible asset and other assets, respectively. After recording this impairment charge, the long-lived assets in the ENTADFI asset group have a remaining carrying amount of approximately $3.3 million as of December 31, 2023. In addition, the Company also recorded an impairment charge on acquired ENTADFI inventory, see Note 3.

Future annual amortization expense related to the Company’s finite lived intangible assets is as follows as of December 31, 2023:

Years ending December 31,
2024	$	1,012,870
2025		1,326,837
2026		1,326,837
2027		1,326,837
2028		1,326,837
Thereafter		9,777,930
Total	$	16,098,148

As of December 31, 2023, the weighted-average remaining amortization period for intangible assets was approximately 13.5 years.

Trade names, which do not have legal, regulatory, contractual, competitive, economic, or other factors that limit the useful lives are considered indefinite lived assets and are not amortized but are tested for impairment on an annual basis or whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. As of December 31, 2023, $9.3 million of intangible assets relate to a trade name that has been identified as having an indefinite life.

Goodwill

Goodwill was recorded during the year ended December 31, 2023, in connection with the Proteomedix acquisition (see Note 5), and consisted of the following as of December 31, 2023:

	December 31, 2023
Balance as of December 31, 2022	$	—
PMX Transaction goodwill		53,914,055
Effect of currency translation		1,762,087
Balance as of December 31, 2023	$	55,676,142

Accrued Expenses

Accrued expenses consisted of the following as of December 31, 2023 and 2022:

	December 31, 2023		December 31, 2022
Accrued research and development	$	616,707	$	847,747
Accrued compensation		487,579		1,132,859
Accrued deferred offering costs		125,000		125,000
Accrued professional fees		550,415		—
Accrued implementation fees		93,787		—
Other accrued expenses		265,849		125,922
Accrued franchise taxes		60,530		177,600
Total	$	2,199,867	$	2,409,128