Balance Sheet Components

9 Months Ended

Sep. 30, 2025

4. Balance Sheet Components

Inventory

Inventory at September 30, 2025 and December 31, 2024 consisted of the following:


	September 30,		December 31,
	2025		2024
(in thousands)	(unaudited)
Raw material	$	1,992	$	1,850
Work in process		7,406		7,407
Finished goods		1,230		1,088
Inventory	$	10,628	$	10,345

Prelaunch Inventory

Costs capitalized for the Company’s lyophilized drug amounting to $5.2 million and $4.1 million as of September 30, 2025 and December 31, 2024, respectively, are included in the prepaid expenses and other current assets account. As of November 14, 2025, the Company obtained proof of concept data in pediatric intestinal patients but not from a controlled trial. Final completion is

expected to occur in first quarter of 2026. Upon completion, the prelaunch inventory shall be reclassified as part of the Company’s inventory. Upon approval, the prelaunch inventory shall be reclassified as part of the Company’s inventory.

Property and Equipment, net

Property and equipment, net at September 30, 2025 and December 31, 2024, consisted of the following:


	September 30,			December 31,
	2025			2024
(in thousands)	(unaudited)
Land	$	396		$	396
Lab equipment		477			477
Software		63			63
Furniture and fixtures		74			18
Computers and peripherals		23			23
Total property and equipment at cost		1,033			977
Accumulated depreciation		(550	)		(513	)
Property and equipment, net	$	483		$	464

Depreciation and amortization expenses were $14,000 and $37,000 for the three and nine months ended September 30, 2025, respectively.

Depreciation and amortization expenses were $12,000 and $36,000 for the three and nine months ended September 30, 2024, respectively.

Intangible Assets, net

Intangible assets consisted of the following:


	September 30,			December 31,
	2025			2024
(in thousands)	(unaudited)
Developed technology	$	25,000		$	25,000
Accumulated developed technology amortization		(13,611	)		(12,361	)
Developed technology, net		11,389			12,639
In-process research and development		4,800			4,800
In process research and development, net		4,800			4,800
Trademarks		300			300
Accumulated trademark amortization		(163	)		(148	)
Trademarks, net		137			152
Internal use software costs - registry		1,237			1,237
Accumulated internal use software costs impairment		(371	)		(371	)
Accumulated internal use software costs amortization		(618	)		(512	)
Internal use software costs - registry, net		248			354
Patents		569			361
Accumulated patents amortization		(50	)		(36	)
Patents, net		519			325
License		215			215
Accumulated license amortization		(23	)		(6	)
License, net		192			209
Total intangible assets, net	$	17,285		$	18,479

Amortization expense of finite-lived intangible assets was $468,000 and $1.4 million for the three and nine months ended September 30, 2025, respectively. Amortization expense of finite-lived intangible assets was $461,000 and $1.4 million for the three and nine months ended September 30, 2024, respectively.

The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2025:


(in thousands)		Amounts
Remainder of 2025	$		456
2026			1,823
2027			1,823
2028			1,823
2029			1,823
Thereafter			4,737
	$		12,485