0001628280-26-031751 | 10-Q | XBRL Viewer

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Leases - Schedule of Operating Leases (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2026 USD ($)
Other information
Operating cash flows for operating leases	$ (47)
U.S.
Other information
Operating cash flows for operating leases	$ (36)
Weighted average remaining lease term	7 years 9 months 18 days
Weighted average discount rate - operating leases	8.00%
Ireland
Other information
Operating cash flows for operating leases	$ (11)
Weighted average remaining lease term	3 months 18 days
Weighted average discount rate - operating leases	8.00%

Revenue

3 Months Ended

Mar. 31, 2026

Revenue from Contract with Customer [Abstract]

Revenue

The Company recognizes product revenue from sales of HEPZATO in the United States and CHEMOSAT in certain European countries in accordance with the five-step model in Accounting Standards Codification (ASC) 606, Revenue Recognition: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation. Under this revenue standard, the Company recognizes revenue when its customer obtains control of the promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods.

Payment terms, returns, and warranties

The Company’s revenue arrangements do not contain significant financing components as payment terms are generally 30 to 60 days. HEPZATO and CHEMOSAT have no contractual rights of returns, refunds or similar obligations beyond assurance-type quality warranties. HEPZATO or CHEMOSAT kits that are deemed defective are replaced at no cost to the hospital or treating center.

The Company does not have any contract assets or contract liabilities at March 31, 2026 or 2025 because the contracts generally do not include performance obligations satisfied over time or advance customer consideration.

HEPZATO

The Company ships and sells HEPZATO directly to hospitals and treating centers based on approved agreements. For certain customers, the inventory is considered on consignment in which the Company retains title to the product until the use of the HEPZATO. For these sales, the Company recognizes HEPZATO revenue, based on contracted or published rates, upon completion of the procedure. There is no obligation for the hospitals or treating centers to use the consigned HEPZATO, and the Company has no contractual right to receive payment until the product is used in a procedure and transfer of control is completed. See “Note 4 - Inventories” for further information regarding consignment inventory.

Hospitals and treating centers may also elect to purchase HEPZATO prior to a procedure. For these sales, the purchasing hospital or treatment center obtains control of the product once it is delivered. In these instances, the Company recognizes revenue based on contracted rates stated in an approved contract or purchase order upon delivery to the customer.

On May 22, 2025, the Company announced a plan to enter into a National Drug Rebate Agreement (“NDRA”) with the Centers for Medicare and Medicaid Services (“CMS”), which also subjected the Company to entering into a Pharmaceutical Pricing Agreement (“PPA”) with the Public Health Service and a master agreement with the U.S. Department of Veterans Affairs (“VA”). Pursuant to the NDRA, the Company must pay mandated rebates to states for Medicaid usage. The rebates are variable consideration and must be estimated at each reporting period and are treated as a reduction of revenue in the same period the related revenue is recognized. These estimates are based on historical experience and payer mix and will be adjusted as actual claims are processed. At March 31, 2026, there were no accrued rebates included in the Company’s financials.

Under the PPA, beginning on July 1, 2025, the Company began selling HEPZATO to eligible covered entities at the statutory 340B price. The Company is also obligated to make any sales to the VA at the Federal Ceiling Price. Due to the Company selling directly to the hospital or treating center, the purchase price of either wholesale acquisition cost or 340B is known at the time of revenue recognition. No chargeback estimate is recorded on the condensed consolidated balance sheets.

The NDRA, the PPA, and the agreement with the VA requires the Company to calculate and submit additional pricing calculations and subject the Company to potential penalties for failing to make timely and/or accurate reports of the required values.

CHEMOSAT

CHEMOSAT is sold directly to hospitals in the European Union and United Kingdom based on contracted rates in an approved contract or sales order. The Company recognizes product revenue from sales of CHEMOSAT upon shipment.

Revenue by product for the periods indicated were as follows:


	Three Months Ended March 31,
(In thousands)	2026		2025
CHEMOSAT	$	1,747	$	1,761
HEPZATO KIT	23,247		18,023
Total revenue	$	24,994	$	19,784

Concentration of Credit Risk

Potential credit risk exposure for both the HEPZATO KIT and CHEMOSAT has been evaluated for the Company’s accounts receivable in accordance with ASC 326, Financial Instruments - Credit Losses. The loss percentage is calculated through the use of current and historical economic and financial information. As of March 31, 2026, there were no estimated losses applied to the accounts receivables balance.

The Company’s total percentage of revenue and accounts receivable balances were comprised of the following concentrations from its largest customers, based on whose revenue and/or accounts receivable concentration is greater than 10% of the Company’s total revenue or total accounts receivable in the periods disclosed below:


For the three months ended and as of March 31, 2026	% of Revenue		% of Accounts Receivable
Customer 1	15.9	%	10.7	%
Customer 2	10.6	%	9.3	%


For the three months ended and as of March 31, 2025	% of Revenue		% of Accounts Receivable
Customer 1	15.0	%	21.3	%
Customer 2	13.1	%	8.1	%
Customer 3	10.3	%	6.7	%
Customer 4	9.4	%	10.8	%

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-7

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-10

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
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-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-13

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org/606/tableOfContent

+ Details

General	3 Months Ended
General	Mar. 31, 2026
Accounting Policies [Abstract]
General	General The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three months ended March 31, 2026 and 2025 should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “Annual Report”), which was filed with the Securities and Exchange Commission (the “SEC”) on February 26, 2026 and may also be found on the Company’s website (www.delcath.com). The information contained on, or that can be accessed through, our website is not incorporated by reference into these financial statements or in any report or document we have filed or may file with the SEC and any reference to our website address is intended to be an inactive textual reference only. In these notes to the interim condensed consolidated financial statements the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries. Description of Business The Company is an interventional oncology company focused on the treatment of cancers primary or metastatic to the liver. The Company’s lead product, the HEPZATOTM KIT (melphalan for Injection/Hepatic Delivery System), a drug/device combination product (“HEPZATO” or “HEPZATO KIT”), was approved by the U.S. Food and Drug Administration (the “FDA”) on August 14, 2023, indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection, or radiation. The first commercial use of the HEPZATO KIT for the treatment of metastatic uveal melanoma (“mUM”) occurred in January 2024. In the United States, HEPZATO is considered a combination drug and device product and is regulated as a drug by the FDA. Primary jurisdiction for regulation of HEPZATO has been assigned to the FDA’s Center for Drug Evaluation and Research. The FDA has granted Delcath six orphan drug designations (five for melphalan in the treatment of patients with ocular (uveal) melanoma, cutaneous melanoma, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and neuroendocrine tumor indications and one for doxorubicin in the treatment of patients with hepatocellular carcinoma). The Company has sufficient raw material and component constituent parts of the HEPZATO KIT to meet anticipated demand and it intends to manage supply chain risk through stockpiled inventory and, where commercially reasonable, contracting with multiple suppliers for critical components. In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO, but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan (“CHEMOSAT”), where it has been used at major medical centers to treat a wide range of cancers in the liver. On February 28, 2022, CHEMOSAT received Medical Device Regulation (“MDR”) certification under the European Medical Devices Regulation (EU) 2017/745, which may be considered by jurisdictions when evaluating reimbursement. In June 2025, CHEMOSAT was approved for reimbursement for two years in the Vastra Gotaland Region in Sweden. On October 18, 2025, the Company announced the results of the investigator-initiated CHOPIN clinical trial. The randomized Phase 2 trial was designed to compare the safety, tolerability, and efficacy of CHEMOSAT with melphalan for percutaneous hepatic perfusion (PHP) when used alone versus when combined with systemic administration of the immune checkpoint inhibitors (ICI) ipilimumab and nivolumab. Ipilimumab and nivolumab are approved by the FDA and European Union for the treatment of unresectable metastatic melanoma. The CHOPIN trial included 76 patients randomized 1:1 to receive two PHP treatments alone at weeks one and seven (PHP group) or four cycles of ICI every three weeks over approximately nine weeks with two PHP treatments at weeks one and seven (combination group). The primary study endpoint of one-year progression-free survival rate was met with 54.7% in the combination group versus 15.8% in the PHP group (adjusted HR 0.34; p=0.0002). The secondary endpoints included Safety, Overall Survival (“OS”), Progression Free Survival (“PFS”) and Overall Response Rate (“ORR”). The combination group saw an increase in median OS of 23.1 months versus 19.6 months (adjusted HR = 0.39; p = 0.0065), median PFS 12.8 months versus 8.3 months (adjusted HR = 0.34; p=0.0002) and ORR of 76.3% in the combination group versus 39.5% (p<0.001). Grade 3 or higher treatment-related adverse events were more frequent in the combination group (82% versus 41%, P=0.0006), but most were self-limiting and manageable with standard care. Overall, the combination treatment was well tolerated, with types, rates and frequencies of adverse events consistent with individual use of PHP and checkpoint inhibitors. No new safety signals were identified. To support the New Drug Application for HEPZATO the Company conducted the FOCUS Clinical Trial for Patients with metastatic hepatic dominant Uveal Melanoma (the “FOCUS Trial”), a global registration clinical trial that investigated objective response rate in patients with mUM. On May 6, 2024, the Company announced the publication of results from the pivotal FOCUS Trial in the journal Annals of Surgical Oncology. On April 9, 2025, the Company announced the publication of a comparative analysis of the randomized portion of the FOCUS Trial in the Annals of Surgical Oncology. On December 31, 2025, the Company announced the publication of subgroup analyses of the Phase 3 FOCUS Trial in the Journal of Cancer Research and Clinical Oncology. Currently, the Company’s clinical development program is seeking to generate clinical data for CHEMOSAT and HEPZATO either as a monotherapy or in combination with immunotherapy. The Company expects that this will support increased clinical adoption of and reimbursement for CHEMOSAT in Europe, and to support reimbursement in various jurisdictions, including the United States for HEPZATO. In addition to HEPZATO’s use to treat mUM, the Company believes that HEPZATO has the potential to treat other cancers in the liver, such as metastatic colorectal cancer, metastatic breast cancer, metastatic neuroendocrine tumors, metastatic pancreatic cancer, intrahepatic cholangiocarcinoma and non-small cell lung cancer. The Company believes that those and similar disease states are areas of unmet medical needs that represent significant market opportunities. The Company’s investigational new drug application (“IND”) for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (“SOC”) for liver-dominant metastatic colorectal cancer was cleared by the FDA in December 2024. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment. Approximately 90 patients will be enrolled in this randomized, controlled trial. Patient enrollment began during the third quarter of 2025, with the study expected to take place at more than 20 sites across the United States and Europe. In July 2025, the Company received authorization from the European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease. On April 28, 2025, the Company announced the clearance by the FDA of its IND application for the Phase 2 clinical trial of HEPZATO in liver-dominant metastatic breast cancer. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. We expect approximately 90 patients will be enrolled in this randomized, controlled trial. The trial will take place at more than 15 sites across the United States and Europe, with patient enrollment expected to begin in the second quarter of 2026. Risks and Uncertainties As detailed in the Company’s 2025 Annual Report filed on Form 10-K, the Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, the risks associated with developing product candidates and successfully launching and commercializing its drug/device combination products for additional indications, the Company’s ability to obtain regulatory approval of its products in the United States and other geographies for additional indications, the uncertainty of the broad adoption of its approved products by physicians and consumers, and significant competition. Factors such as geopolitical events, including war, terrorism and civil and political unrest, such as the ongoing conflicts in the Middle East and between Russia and Ukraine, global health outbreaks, adverse weather events, labor or raw material shortages, imposition of tariffs or trade restrictions and other supply chain disruptions could result in difficulties, shortages and delays in manufacturing the Company’s products, which could have an adverse impact on its results of operations or cause an increase in the cost of ongoing or planned clinical trials. The Company may also have to take inventory write-offs and incur other charges and expense for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Such developments could increase its manufacturing costs, cause it to lose revenue or market share as patients and physicians turn to competing therapeutics, diminish its profitability or damage its reputation. The United States has announced and implemented a broad range of tariffs on goods imported into the United States, many of which were then paused or cancelled. The majority of the Company’s sales are domestic, though CHEMOSAT is sold only outside of the United States, and while the Company sources certain components outside of the United States, the costs associated with imported materials needed for its operations is a modest portion of its overall manufacturing costs. The Company will continue to monitor the implementation and effect of existing and other proposed tariffs and other geopolitical events, such as the ongoing conflicts in the Middle East and between Russia and Ukraine and may take actions as a result thereof in order to attempt to alleviate certain risks and uncertainties that may be caused by such events. Liquidity The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. On March 31, 2026, the Company had cash and cash equivalents totaling $41.3 million and short-term investments totaling $48.0 million. The Company believes that the current cash on hand, cash equivalents, investments and net cash provided by operating activities will be sufficient to support current operations through at least 12 months from the issuance of these condensed consolidated financial statements. Actual future liquidity and capital requirements will depend on numerous factors, including the initiation and progress of clinical trials and research and product development programs; obtaining regulatory approvals and complying with applicable laws and regulations; the timing and effectiveness of product commercialization activities, including marketing arrangements; the timing and costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; the resolution of any disputes with third parties; and the effect of competing technological and market developments. Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all wholly owned subsidiaries and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended March 31, 2026 and 2025; however, certain information and footnote disclosures normally included in our audited consolidated financial statements which were included in the Annual Report have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period. Significant Accounting Policies Management has performed its quarterly evaluation of policies and there have been no material changes to our significant accounting policies as set forth in “Note 3 - Summary of Significant Accounting Policies” to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Recent Accounting Pronouncements No new accounting standards were adopted during the three months ended March 31, 2026. The Company’s management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40) In September 2025, the Financial Accounting Standards Board (“FASB”) issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. Such standard is intended to modernize old internal-use software guidance and expand the existing guidance on capitalizing implementation costs for cloud computing arrangements that are service contracts. The effective date for this standard is for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. Early adoption is permitted as of the beginning of an annual reporting period. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements. ASU 2024-03, Disaggregation of Income Statement Expenses In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures to improve the disclosures about a public entity’s expenses and provide more detailed information about the types of expenses in commonly presented expense captions such as inventory purchases, employee compensation, depreciation and intangible asset amortization. The disclosure requirements must be applied retrospectively to all prior periods presented in the financial statements. The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements.

Net (Loss) Income per Share - Narrative (Details) - shares	Mar. 31, 2026	Mar. 31, 2025
Earnings Per Share [Abstract]
Pre-funded warrants outstanding (in shares)	1,341,375	1,341,375

Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Assets:
Money market funds	$ 1	$ 2
U.S. government agency bonds	47,986	47,582
Total Assets	47,987	47,584
Liabilities:
Contingent Liability	845	864
Total Liabilities	845	864
Quoted Prices in Active Markets (Level 1)
Assets:
Money market funds	1	2
U.S. government agency bonds	0	0
Total Assets	1	2
Liabilities:
Contingent Liability	0	0
Total Liabilities	0	0
Significant Other Observable Inputs (Level 2)
Assets:
Money market funds	0	0
U.S. government agency bonds	47,986	47,582
Total Assets	47,986	47,582
Liabilities:
Contingent Liability	0	0
Total Liabilities	0	0
Significant Unobservable Inputs (Level 3)
Assets:
Money market funds	0	0
U.S. government agency bonds	0	0
Total Assets	0	0
Liabilities:
Contingent Liability	845	864
Total Liabilities	$ 845	$ 864

Leases - Schedule of Remaining Maturity of Operating Leases Excluding Short-term Leases (Details) $ in Thousands	Mar. 31, 2026 USD ($)
Lessee Lease Description [Line Items]
Year ended December 31, 2026	$ 123
Year ended December 31, 2027	148
Year ended December 31, 2028	152
Year ended December 31, 2029	157
Year ended December 31, 2030	158
Thereafter	486
Total	1,224
Less present value discount	(317)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2026	907
U.S.
Lessee Lease Description [Line Items]
Year ended December 31, 2026	108
Year ended December 31, 2027	148
Year ended December 31, 2028	152
Year ended December 31, 2029	157
Year ended December 31, 2030	158
Thereafter	486
Total	1,209
Less present value discount	(317)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2026	892
Ireland
Lessee Lease Description [Line Items]
Year ended December 31, 2026	15
Year ended December 31, 2027	0
Year ended December 31, 2028	0
Year ended December 31, 2029	0
Year ended December 31, 2030	0
Thereafter	0
Total	15
Less present value discount	0
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2026	$ 15

Accrued Expenses

3 Months Ended

Mar. 31, 2026

Payables and Accruals [Abstract]

Accrued Expenses

Accrued expenses consist of the following:


(In thousands)	March 31, 2026		December 31, 2025
Clinical expenses	$	2,100	$	2,065
Compensation, excluding taxes	2,810		4,248
ESPP withholding	198		396
Professional fees	1,355		736
Inventory	28		74
medac(1)	—		235
Other	652		437
Total accrued expenses	$	7,143	$	8,191

(1) The current liability due for medac is reported in Accounts Payable as of March 31, 2026. See “Note 12 - Commitments and Contingencies” for further information regarding this accrual.

Revenue (Tables)

3 Months Ended

Mar. 31, 2026

Revenue from Contract with Customer [Abstract]

Schedule of Revenue by Product

Revenue by product for the periods indicated were as follows:


	Three Months Ended March 31,
(In thousands)	2026		2025
CHEMOSAT	$	1,747	$	1,761
HEPZATO KIT	23,247		18,023
Total revenue	$	24,994	$	19,784

Schedule of Revenue and Accounts Receivable Concentrations


For the three months ended and as of March 31, 2026	% of Revenue		% of Accounts Receivable
Customer 1	15.9	%	10.7	%
Customer 2	10.6	%	9.3	%


For the three months ended and as of March 31, 2025	% of Revenue		% of Accounts Receivable
Customer 1	15.0	%	21.3	%
Customer 2	13.1	%	8.1	%
Customer 3	10.3	%	6.7	%
Customer 4	9.4	%	10.8	%

Accrued Expenses (Tables)

3 Months Ended

Mar. 31, 2026

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses consist of the following:


(In thousands)	March 31, 2026		December 31, 2025
Clinical expenses	$	2,100	$	2,065
Compensation, excluding taxes	2,810		4,248
ESPP withholding	198		396
Professional fees	1,355		736
Inventory	28		74
medac(1)	—		235
Other	652		437
Total accrued expenses	$	7,143	$	8,191

(1) The current liability due for medac is reported in Accounts Payable as of March 31, 2026. See “Note 12 - Commitments and Contingencies” for further information regarding this accrual.

Property, Plant, and Equipment - Schedule of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 9,002	$ 8,414
Accumulated depreciation	(5,340)	(5,248)
Property, plant and equipment, net	3,662	3,166
Buildings and land
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,567	1,557
Buildings
Property Plant And Equipment [Line Items]
Estimated Useful Life	30 years
Land Improvements
Property Plant And Equipment [Line Items]
Estimated Useful Life	15 years
Enterprise hardware and software
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,818	1,819
Estimated Useful Life	3 years
Leaseholds
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 1,659	1,648
Equipment
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 3,511	2,894
Estimated Useful Life	7 years
Furniture
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 258	251
Estimated Useful Life	5 years
Equipment in process
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 189	$ 245

Segment Information (Tables)

3 Months Ended

Mar. 31, 2026

Segment Reporting [Abstract]

Schedule of Revenue by Location

The following table shows the disaggregated revenue by geography for the three months ended March 31, 2026 and 2025. No individual foreign country is material to the consolidated results.


	Three Months Ended March 31,
(in thousands)	2026		2025
Foreign	$	1,747	$	1,761
United States	23,247		18,023
Total revenue	$	24,994	$	19,784

Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Inventory Disclosure [Abstract]
Raw materials	$ 5,766	$ 6,477
Work-in-process	3,088	2,809
Finished goods	954	966
Total inventory	$ 9,808	$ 10,252

Revenue - Schedule of Revenue by Product (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Disaggregation of Revenue [Line Items]
Total revenue	$ 24,994	$ 19,784
CHEMOSAT
Disaggregation of Revenue [Line Items]
Total revenue	1,747	1,761
HEPZATO KIT
Disaggregation of Revenue [Line Items]
Total revenue	$ 23,247	$ 18,023

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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+ Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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+ Details

General (Details) $ in Thousands	1 Months Ended
General (Details) $ in Thousands	Jun. 30, 2025	Mar. 31, 2026 USD ($) designation	Dec. 31, 2025 USD ($)	Oct. 18, 2025 patient	Apr. 28, 2025 patient site	Dec. 31, 2024 patient site
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Cash cash equivalents and restricted cash \| $		$ 41,300
Short-term investments \| $		$ 47,986	$ 47,582
HEPZATO KIT
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Number of orphan drug designations granted by FDA		6
Clinical trial, number of patients \| patient					90	90
Clinical trial, number of sites (more than) \| site					15	20
HEPZATO KIT, Melphalan
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Number of orphan drug designations granted by FDA		5
HEPZATO KIT, Doxorubicin
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Number of orphan drug designations granted by FDA		1
CHEMOSAT
Organization Consolidation Basis Of Presentation Business Description And Accounting Policies [Line Items]
Product reimbursement period	2 years
Clinical trial, number of patients \| patient				76

Investments

3 Months Ended

Mar. 31, 2026

Investments, Debt and Equity Securities [Abstract]

Investments

Marketable debt securities held by the Company are classified as available-for-sale pursuant to ASC 320, Investments - Debt and Equity Securities, and carried at fair value in the accompanying condensed consolidated balance sheets.

The following table summarizes the gross unrealized gains on the Company’s marketable securities as of March 31, 2026:


	March 31, 2026
(In thousands)	Amortized Cost		Gross Unrealized Gains		Estimated Fair Value
U.S. government agency bonds	$	47,411	$	575	$	47,986
Total short-term investments					$	47,986

As of March 31, 2026, there was $0.6 million of interest receivable related to the outstanding debt securities held by the Company.

The following table summarizes the gross unrealized gains on the Company’s marketable securities as of December 31, 2025:


	December 31, 2025
(In thousands)	Amortized Cost		Gross Unrealized Gains		Estimated Fair Value
U.S. government agency bonds	$	47,053	$	529	$	47,582
Total short-term investments					$	47,582

As of December 31, 2025, there was $0.5 million of interest receivable related to the outstanding debt securities held by the Company.

Stockholders' Equity (Tables)

3 Months Ended

Mar. 31, 2026

Stockholders' Equity Note [Abstract]

Schedule of Designated Preferred Shares

As of March 31, 2026, the Company has designated the following preferred stock:


Designated Preferred Shares						March 31, 2026
Series A						4,200
Series B						2,360
Series C						590
Series D						10,000
Series E						40,000
Series E-1						12,960
Series F-1						24,900
Series F-2						24,900
Series F-3						34,860
Series F-4						24,900
Total						179,670

Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model

The Company values stock options using the Black-Scholes option pricing model and used the following assumptions, on a weighted-average basis, during the reporting periods:


	Three Months Ended March 31,
	2026	2025
Expected terms (years)	5.7	5.7
Expected volatility	70.5%	90.0%
Risk-free interest rate	3.73%	4.35%
Expected dividends	0.00%	0.00%

Schedule of Stock Option Activity

The following is a summary of stock option activity for the three months ended March 31, 2026:


	Number of Options	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value (in thousands)
Outstanding at January 1, 2026	7,785,149	$	10.05	7.8	$	17,391
Granted	922,369	9.40		9.8
Exercised	(43,431)	5.30
Expired	(2,583)	16.25
Cancelled/Forfeited	(40,874)	10.82
Outstanding at March 31, 2026	8,620,630	$	10.00	7.7	$	13,933

Exercisable at March 31, 2026	5,416,653	$	9.00	7.0	$	11,392
Unvested at March 31, 2026	3,203,977	$	11.69	9.0	$	2,541

Schedule of Restricted Stock Units Granted

The following tables include information for all restricted stock units granted including inducement grants that are granted outside of the 2020 Plan.


	Number of Restricted Stock Units	Weighted Average Grant Date Fair Value
Outstanding at January 1, 2026	—	$	—
Granted	914,477	9.41
Vested	—	—
Forfeited	(7,311)	9.40
Outstanding at March 31, 2026	907,166	$	9.41

Schedule of Recognized Share-based Compensation Cost

The following is a summary of share-based compensation expense in the statement of operations:


	Three Months Ended March 31,
(In thousands)	2026		2025
Selling, general and administrative	$	3,162	$	4,529
Research and development	1,386		1,568
Cost of goods sold	398		766
Total	$	4,946	$	6,863

Schedule of Warrant Activity

The following is a summary of common stock warrant activity for the three months ended March 31, 2026:


	Warrants	Weighted Average Exercise Price
Outstanding at January 1, 2026	1,341,375	$	0.01
Warrants issued	—	—
Warrants exercised	—	—
Warrants canceled	—	—
Outstanding and exercisable at March 31, 2026	1,341,375	$	0.01

Schedule of Information Related to Stock Warrants Outstanding and Exercisable

The following table presents information related to common stock warrants outstanding at March 31, 2026:


	Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants	Weighted Average Remaining Warrant Term (in years)
$0.01 (1)	1,341,375	n/a

(1) Pre-funded warrants with a $0.01 exercise price do not expire until exercised.

- Definition

Tabular disclosure of an entity's stock, including par or stated value per share, number and dollar amount of share subscriptions, shares authorized, shares issued, shares outstanding, number and dollar amount of shares held in an employee trust, dividend per share, total dividends, share conversion features, par value plus additional paid in capital, the value of treasury stock and other information necessary to a fair presentation, and EPS information. Stock by class includes common, convertible, and preferred stocks which are not redeemable or redeemable solely at the option of the issuer. Includes preferred stock with redemption features that are solely within the control of the issuer and mandatorily redeemable stock if redemption is required to occur only upon liquidation or termination of the reporting entity. If more than one issue is outstanding, state the title of each issue and the corresponding dollar amount; dollar amount of any shares subscribed but unissued and the deduction of subscriptions receivable there from; number of shares authorized, issued, and outstanding.

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+ Details

Inventory - Narrative (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Inventory [Line Items]
Finished goods	$ 954	$ 966
Inventory reserve	500
Inventory held at hospitals and treatment centers
Inventory [Line Items]
Finished goods	$ 600

Leases - Narrative (Details) ft² in Thousands, $ in Millions			3 Months Ended
	Jan. 18, 2024 USD ($) ft²	Aug. 02, 2021 USD ($)	Mar. 31, 2026 USD ($)	Mar. 31, 2025 USD ($)
Lessee Lease Description [Line Items]
Operating lease expense			$ 0.1	$ 0.1
2021 Sub-Lease
Lessee Lease Description [Line Items]
Annual rent expense		$ 0.1
Lease term		5 years
Queensbury Lease
Lessee Lease Description [Line Items]
Annual rent expense	$ 0.2
Lease term	5 years
Area of space \| ft²	18
Extension term	5 years

Property, Plant, and Equipment (Tables)

3 Months Ended

Mar. 31, 2026

Property, Plant and Equipment [Abstract]

Schedule of Property, Plant, and Equipment

Property, plant, and equipment consist of the following:


(In thousands)	March 31, 2026		December 31, 2025		Estimated Useful Life
Buildings and land	$	1,567	$	1,557	30 years - Buildings 15 years - Land Improvements
Enterprise hardware and software	1,818		1,819		3 years
Leaseholds	1,659		1,648		Lesser of lease term or estimated useful life
Equipment	3,511		2,894		7 years
Furniture	258		251		5 years
Equipment in process	189		245
Property, plant and equipment, gross	9,002		8,414
Accumulated depreciation	(5,340)		(5,248)
Property, plant and equipment, net	$	3,662	$	3,166

Stockholders' Equity - Employee Stock Purchase Plan (Details) - May 2022 Employee Stock Purchase Plan - shares	1 Months Ended
	Aug. 31, 2021	Mar. 31, 2026
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items]
Number of shares authorized (in shares)	560,295	217,372
Purchase price of common stock (as a percent)	85.00%
Employee stock purchase plan, offering period	6 months

Income Taxes (Details) - USD ($) $ in Thousands	3 Months Ended
Income Taxes (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Mar. 31, 2025
Income Tax Disclosure [Abstract]
Income tax expense	$ 162	$ 195

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

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+ Details

General (Policies)	3 Months Ended
General (Policies)	Mar. 31, 2026
Accounting Policies [Abstract]
Risks and Uncertainties	Risks and Uncertainties As detailed in the Company’s 2025 Annual Report filed on Form 10-K, the Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, the risks associated with developing product candidates and successfully launching and commercializing its drug/device combination products for additional indications, the Company’s ability to obtain regulatory approval of its products in the United States and other geographies for additional indications, the uncertainty of the broad adoption of its approved products by physicians and consumers, and significant competition. Factors such as geopolitical events, including war, terrorism and civil and political unrest, such as the ongoing conflicts in the Middle East and between Russia and Ukraine, global health outbreaks, adverse weather events, labor or raw material shortages, imposition of tariffs or trade restrictions and other supply chain disruptions could result in difficulties, shortages and delays in manufacturing the Company’s products, which could have an adverse impact on its results of operations or cause an increase in the cost of ongoing or planned clinical trials. The Company may also have to take inventory write-offs and incur other charges and expense for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Such developments could increase its manufacturing costs, cause it to lose revenue or market share as patients and physicians turn to competing therapeutics, diminish its profitability or damage its reputation. The United States has announced and implemented a broad range of tariffs on goods imported into the United States, many of which were then paused or cancelled. The majority of the Company’s sales are domestic, though CHEMOSAT is sold only outside of the United States, and while the Company sources certain components outside of the United States, the costs associated with imported materials needed for its operations is a modest portion of its overall manufacturing costs. The Company will continue to monitor the implementation and effect of existing and other proposed tariffs and other geopolitical events, such as the ongoing conflicts in the Middle East and between Russia and Ukraine and may take actions as a result thereof in order to attempt to alleviate certain risks and uncertainties that may be caused by such events.
Liquidity	Liquidity The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. On March 31, 2026, the Company had cash and cash equivalents totaling $41.3 million and short-term investments totaling $48.0 million. The Company believes that the current cash on hand, cash equivalents, investments and net cash provided by operating activities will be sufficient to support current operations through at least 12 months from the issuance of these condensed consolidated financial statements. Actual future liquidity and capital requirements will depend on numerous factors, including the initiation and progress of clinical trials and research and product development programs; obtaining regulatory approvals and complying with applicable laws and regulations; the timing and effectiveness of product commercialization activities, including marketing arrangements; the timing and costs involved in preparing, filing, prosecuting, defending and enforcing intellectual property rights; the resolution of any disputes with third parties; and the effect of competing technological and market developments.
Basis of Presentation	Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all wholly owned subsidiaries and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim condensed consolidated financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended March 31, 2026 and 2025; however, certain information and footnote disclosures normally included in our audited consolidated financial statements which were included in the Annual Report have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period.
Recent Accounting Pronouncements	Recent Accounting Pronouncements No new accounting standards were adopted during the three months ended March 31, 2026. The Company’s management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40) In September 2025, the Financial Accounting Standards Board (“FASB”) issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. Such standard is intended to modernize old internal-use software guidance and expand the existing guidance on capitalizing implementation costs for cloud computing arrangements that are service contracts. The effective date for this standard is for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. Early adoption is permitted as of the beginning of an annual reporting period. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements. ASU 2024-03, Disaggregation of Income Statement Expenses In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures to improve the disclosures about a public entity’s expenses and provide more detailed information about the types of expenses in commonly presented expense captions such as inventory purchases, employee compensation, depreciation and intangible asset amortization. The disclosure requirements must be applied retrospectively to all prior periods presented in the financial statements. The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements.

Investments (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Debt Securities, Available-for-sale [Line Items]
Estimated Fair Value	$ 47,986	$ 47,582
Interest receivable	581	499
U.S. government agency bonds
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	47,411	47,053
Gross Unrealized Gains	575	529
Estimated Fair Value	$ 47,986	$ 47,582

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (aa)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (aaa)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)
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-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

+ Details

Net (Loss) Income per Share - Schedule of Reconciliation of Weighted Average Shares Outstanding Calculation (Details) - shares	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Earnings Per Share [Abstract]
Weighted average shares issued (in shares)	34,679,835	33,301,266
Weighted average pre-funded warrants (in shares)	1,341,375	1,341,375
Weighted average shares outstanding, basic (in shares)	36,021,210	34,642,641
Additional dilutive shares (in shares)	0	4,868,479
Weighted average shares outstanding, diluted (in shares)	36,021,210	39,511,120

Stockholders' Equity - Authorized Shares and Preferred Stock (Details) - $ / shares	Mar. 31, 2026	Dec. 31, 2025	Mar. 31, 2025	Dec. 31, 2024
Stockholders' Equity Note [Abstract]
Common stock, shares authorized (in shares)	80,000,000	80,000,000
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01

Net (Loss) Income per Share

3 Months Ended

Mar. 31, 2026

Earnings Per Share [Abstract]

Net (Loss) Income per Share

Basic net income or loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities, except for those shares that are issuable for little or no cash consideration. Diluted net income or loss per share is determined by dividing net income or loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options, convertible preferred shares, and preferred and common warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal.

At both March 31, 2026 and 2025, the Company had 1,341,375 pre-funded warrants outstanding, respectively. The following table provides a reconciliation of the weighted average shares outstanding calculation for the three months ended March 31, 2026 and 2025:


Weighted average number of basic shares outstanding
	Three months ended March 31,
	2026	2025
Weighted average shares issued	34,679,835	33,301,266
Weighted average pre-funded warrants	1,341,375	1,341,375
Weighted average shares outstanding	36,021,210	34,642,641


Weighted average number of diluted shares outstanding
	Three months ended March 31,
	2026	2025
Weighted average shares outstanding (Basic)	36,021,210	34,642,641
Additional dilutive shares	—	4,868,479
Weighted average shares outstanding (Diluted)	36,021,210	39,511,120

The following potentially dilutive securities were excluded from the computation of earnings per share as of March 31, 2026 and 2025 because their effects would be anti-dilutive:


	Three Months Ended March 31,
	2026	2025
Assumed conversion of preferred stock	1,782,843	—
Stock options and Restricted Stock Units	9,527,796	2,531,230
Assumed conversion of ESPP	48,286	22,057
Total	11,358,925	2,553,287

Property, Plant, and Equipment - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Property, Plant and Equipment [Abstract]
Depreciation expense	$ 102	$ 43

Stockholders' Equity - Restricted Stock Units (Details) $ in Millions	3 Months Ended
	Mar. 31, 2026 USD ($)
Stockholders Equity Note [Line Items]
Unrecognized compensation expense related to non-vested share-based compensation awards	$ 20.9
Cost expected to be recognized over weighted average period (in years)	1 year 1 month 28 days

Stockholders' Equity - Omnibus Equity Incentive Plan (Details)	Mar. 31, 2026 shares
2020 Plan
Class of Warrant or Right [Line Items]
Common stock, capital shares reserved (in shares)	9,325,000
Number of shares available for grant (in shares)	752,179
2023 Plan
Class of Warrant or Right [Line Items]
Common stock, capital shares reserved (in shares)	1,100,000
Number of shares available for grant (in shares)	106,836

Stockholders' Equity - Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs)	3 Months Ended
	Mar. 31, 2026 $ / shares shares
Number of Restricted Stock Units
Outstanding, beginning of period (in shares) \| shares	0
Granted (in shares) \| shares	914,477
Vested (in shares) \| shares	0
Forfeited (in shares) \| shares	(7,311)
Outstanding, end of period (in shares) \| shares	907,166
Weighted Average Grant Date Fair Value
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 0
Granted (in dollars per share) \| $ / shares	9.41
Vested (in dollars per share) \| $ / shares	0
Forfeited (in dollars per share) \| $ / shares	9.40
Outstanding, end of period (in dollars per share) \| $ / shares	$ 9.41

Stockholders' Equity - Preferred Stock (Details) - $ / shares	Mar. 31, 2026	Dec. 31, 2025	Mar. 31, 2025	Dec. 31, 2024
Class of Warrant or Right [Line Items]
Preferred stock, shares outstanding (in shares)	14,192	14,192
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Series E-1
Class of Warrant or Right [Line Items]
Preferred stock, shares outstanding (in shares)	10,957
Preferred stock, par value (in dollars per share)	$ 10.00
Series E
Class of Warrant or Right [Line Items]
Preferred stock, shares outstanding (in shares)	10,957
Preferred stock, par value (in dollars per share)	$ 10.00
Series F-2
Class of Warrant or Right [Line Items]
Preferred stock, shares outstanding (in shares)	1,085
Preferred stock, par value (in dollars per share)	$ 3.30
Series F-4
Class of Warrant or Right [Line Items]
Preferred stock, shares outstanding (in shares)	2,150
Preferred stock, par value (in dollars per share)	$ 6.00

Stockholders' Equity

3 Months Ended

Mar. 31, 2026

Stockholders' Equity Note [Abstract]

Stockholders' Equity

Stockholders’ Equity

Public and Private Placements

June 2024 Shelf Registration Statement

On June 28, 2024, the Company filed a universal shelf registration statement on Form S-3 (the “June 2024 Shelf Registration Statement”) with the SEC, pursuant to which the Company may offer, issue and sell any combination of shares of the Company’s common stock, par value $0.01 per share, shares of the Company’s preferred stock, par value $0.01 per share, debt securities, warrants to purchase common stock, preferred stock and/or debt securities, in one or more series, and units consisting of any combination of the other types of securities registered under such June 2024 Shelf Registration Statement in an aggregate amount of up to $150 million, in each case, to the public in one or more registered offerings. The June 2024 Shelf Registration Statement was declared effective on August 5, 2024.

Authorized Shares

The Company is authorized to issue 80 million shares of common stock, $0.01 par value, and 10 million shares of preferred stock, $0.01 par value. As of March 31, 2026, the Company has designated the following preferred stock:


Designated Preferred Shares						March 31, 2026
Series A						4,200
Series B						2,360
Series C						590
Series D						10,000
Series E						40,000
Series E-1						12,960
Series F-1						24,900
Series F-2						24,900
Series F-3						34,860
Series F-4						24,900
Total						179,670

Preferred Stock

As of March 31, 2026, there were an aggregate of 10,957 shares of Series E and Series E-1, 1,085 Series F-2 and 2,150 Series F-4 Convertible Preferred Stock outstanding, respectively.

Subject to limitations set forth in the Beneficial Ownership Limitation, the shares of Series E and E-1 Preferred Stock are convertible into common stock at the option of the holder at the conversion price of $10.00 per share.

Subject to limitations set forth in the Certificate of Designation, the shares of Series F-2 and F-4 Preferred Stock are convertible into common stock at the option of the holder at the conversion price of $3.30 per share and $6.00 per share, respectively, rounded down to the nearest whole share, and in each case subject to the terms and limitations contained in the Certificate of Designation.

Share Repurchase Program

On November 19, 2025, the Company’s Board of Directors authorized a share repurchase program under which the Company may repurchase up to $25.0 million of its outstanding shares of common stock, from time to time, through open market transactions, privately negotiated transactions or in such other manners approved by the Board of Directors, in accordance with all applicable securities laws and regulations, including Rule 10b-18 of the Exchange Act. The Company may enter into a pre-arranged stock trading plan in accordance with the guidelines specified under Rule 10b5-1 to effectuate all or a portion of the share repurchase program. The repurchase program does not obligate the Company to purchase any shares and does not have an expiration date. The timing and method of any repurchases, which will depend on a variety of factors, including market conditions, are subject to our results of operations, financial condition, liquidity and other factors.

As of March 31, 2026, there have been 944,595 shares of common stock repurchased and retired under the repurchase program at an average price paid per share of $9.5077 for a total aggregate purchase price of approximately $9.0 million. The Company had approximately $16.0 million remaining under the share repurchase program at March 31, 2026.

Omnibus Equity Incentive Plan

On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards, as well as other share-based awards or cash awards that are deemed to be consistent with the purposes of the plan to Company employees, directors and

consultants. As of March 31, 2026, there have been 9,325,000 shares of common stock reserved under the 2020 Plan of which 752,179 shares of common stock remained available to be issued as of March 31, 2026 under the 2020 Plan.

In addition to options granted from the 2020 Plan, the Company also grants employment inducement awards pursuant to Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The inducement grants are intended to provide incentive to certain individuals to enter into employment with the Company. Prior to December 5, 2023, the inducement awards were granted outside of the 2020 Plan, however they are governed in all respects as if they were issued under the 2020 Plan. These grants do not reduce the number of options available for issuance under the 2020 Plan.

On December 5, 2023, the Company’s 2023 Inducement Plan (the “2023 Plan”) was adopted by the Company’s Board of Directors. The 2023 Plan is administered by a Compensation Committee of two or more Independent Directors appointed by the Board of Directors and is intended to provide for the grant of non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards, as well as other share-based awards or cash awards that are deemed appropriate to incentivize employment with the Company. Awards from the 2023 Plan can only be granted to individuals who have not previously worked for the Company or have not worked for the Company for a bona fide period of time. As of March 31, 2026, there have been 1,100,000 shares of common stock reserved under the 2023 Plan, of which 106,836 remain available to be granted.

Stock Options

The following tables include information for all options granted including inducement grants that are granted outside of the 2020 Plan.

The Company values stock options using the Black-Scholes option pricing model and used the following assumptions, on a weighted-average basis, during the reporting periods:


	Three Months Ended March 31,
	2026	2025
Expected terms (years)	5.7	5.7
Expected volatility	70.5%	90.0%
Risk-free interest rate	3.73%	4.35%
Expected dividends	0.00%	0.00%

The following is a summary of stock option activity for the three months ended March 31, 2026:


	Number of Options	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value (in thousands)
Outstanding at January 1, 2026	7,785,149	$	10.05	7.8	$	17,391
Granted	922,369	9.40		9.8
Exercised	(43,431)	5.30
Expired	(2,583)	16.25
Cancelled/Forfeited	(40,874)	10.82
Outstanding at March 31, 2026	8,620,630	$	10.00	7.7	$	13,933

Exercisable at March 31, 2026	5,416,653	$	9.00	7.0	$	11,392
Unvested at March 31, 2026	3,203,977	$	11.69	9.0	$	2,541

The weighted average grant-date fair value of stock options granted during the three months ended March 31, 2026 and 2025 was $6.04 and $12.05, respectively. The aggregate intrinsic value of stock options exercised was $0.2 million and $0.8 million for the three months ended March 31, 2026 and March 31, 2025, respectively. Total cash received as a result of stock option exercises was $0.2 million and $0.6 million for the three months ended March 31, 2026 and March 31, 2025, respectively.

Restricted Stock Units

The following tables include information for all restricted stock units granted including inducement grants that are granted outside of the 2020 Plan.


	Number of Restricted Stock Units	Weighted Average Grant Date Fair Value
Outstanding at January 1, 2026	—	$	—
Granted	914,477	9.41
Vested	—	—
Forfeited	(7,311)	9.40
Outstanding at March 31, 2026	907,166	$	9.41

The following is a summary of share-based compensation expense in the statement of operations:


	Three Months Ended March 31,
(In thousands)	2026		2025
Selling, general and administrative	$	3,162	$	4,529
Research and development	1,386		1,568
Cost of goods sold	398		766
Total	$	4,946	$	6,863

At March 31, 2026, there was $20.9 million of aggregate unrecognized compensation expense related to employee and board stock option grants and restricted stock unit grants. The cost is expected to be recognized over a weighted average period of 1.16 years.

Common Stock Warrants

The following is a summary of common stock warrant activity for the three months ended March 31, 2026:


	Warrants	Weighted Average Exercise Price
Outstanding at January 1, 2026	1,341,375	$	0.01
Warrants issued	—	—
Warrants exercised	—	—
Warrants canceled	—	—
Outstanding and exercisable at March 31, 2026	1,341,375	$	0.01

The following table presents information related to common stock warrants outstanding at March 31, 2026:


	Warrants Exercisable
Range of Exercise Prices	Outstanding Number of Warrants	Weighted Average Remaining Warrant Term (in years)
$0.01 (1)	1,341,375	n/a

(1) Pre-funded warrants with a $0.01 exercise price do not expire until exercised.

Employee Stock Purchase Plan

In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan (the “ESPP”). The ESPP provides for a maximum of 560,295 shares of common stock to be purchased by participating employees, of which 217,372 have been issued as of March 31, 2026 since the inception of the benefit in

2021. Employees who elect to participate in the ESPP will be able to purchase common stock at the lower of 85% of the fair market value of common stock on the first or last day of the applicable six-month offering period.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8A
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-8A

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Cover Page - shares	3 Months Ended
Cover Page - shares	Mar. 31, 2026	Apr. 30, 2026
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2026
Document Transition Report	false
Entity File Number	001-16133
Entity Registrant Name	DELCATH SYSTEMS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	06-1245881
Entity Address, Address Line One	566 Queensbury Avenue
Entity Address, City or Town	Queensbury
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	12804
City Area Code	518
Local Phone Number	743-8892
Title of 12(b) Security	Common stock, $0.01 par value per share
Trading Symbol	DCTH
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		34,521,647
Entity Central Index Key	0000872912
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2026
Document Fiscal Period Focus	Q1
Amendment Flag	false

Stockholders' Equity - Public and Private Placements (Details) - USD ($) $ / shares in Units, $ in Millions	Mar. 31, 2026	Dec. 31, 2025	Mar. 31, 2025	Dec. 31, 2024	Jun. 28, 2024
Stockholders Equity Note [Line Items]
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01
June 2024 Shelf Registration Statement
Stockholders Equity Note [Line Items]
Common stock, par value (in dollars per share)					$ 0.01
Preferred stock, par value (in dollars per share)					$ 0.01
Maximum aggregate offering price of securities under shelf registration					$ 150

Commitments and Contingencies	3 Months Ended
Commitments and Contingencies	Mar. 31, 2026
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies medac Matter In April 2021, the Company’s wholly owned subsidiary, Delcath Systems Ltd, issued to medac GmbH, a privately held, multi-national pharmaceutical company based in Germany (“medac”), an invoice for a €1 million milestone payment under a License, Supply and Marketing Agreement dated December 10, 2018 (the “medac Agreement”) between medac and the Company. The medac Agreement provided to medac the exclusive right to market and sell CHEMOSAT in certain designated countries for which the Company was entitled to a combination of upfront and success-based milestone payments as well as a fixed transfer price per unit of CHEMOSAT and specified royalties. In response to medac’s subsequent dispute and non-payment of the invoice, on October 12, 2021, the Company notified medac in writing that it was terminating the medac Agreement due to medac’s nonpayment of the €1 million milestone payment, with the effective date of termination of the medac Agreement being April 12, 2022. On December 16, 2021, the Company initiated an arbitration proceeding pursuant to the dispute resolution procedures of the medac Agreement for the non-payment of the invoice. On December 30, 2022, the parties reached a final settlement of the matter and the Company agreed to pay medac either (a) a royalty on sales of CHEMOSAT units over a defined minimum for a period of five years or until a maximum payment has been reached, or (b) a minimum annual payment of $0.2 million in the event the annual royalty payment does not reach the agreed minimum payment amount. The Company has estimated the remaining fair value of the settlement to be $0.8 million as of March 31, 2026 and recorded $0.6 million as other liabilities, non-current and $0.2 million as accounts payable on the Company’s condensed consolidated balance sheet as of March 31, 2026. Manufacturing and Supply Agreements The Company has a License, Supply and Contract Manufacturing Agreement (as amended, the “Supply Agreement”) with Synerx Pharma, LLC and Mylan Teoranta for the supply of melphalan provided in the HEPZATO KIT. An amendment to the Supply Agreement was entered into on April 22, 2024, and effective as of May 1, 2024, which extends the term of the agreement through December 31, 2028, with an option to renew for successive five-year periods upon the mutual written consent of both parties. Although the Supply Agreement does not contain an annual minimum purchase quantity, the Agreement requires Delcath to order full lots of labeled melphalan vials. As of March 31, 2026, the Company has committed to purchase $2.5 million of melphalan under this Supply Agreement in 2026. Agreements Relating to Clinical Trial Support The Company has engaged Precision for Medicine LLC (“PfM”) a Clinical Research Organization (“CRO”) to support the Company's Phase 2 clinical trials evaluating HEPZATO in combination with standard of care in patients with liver dominant mCRC and HER2-negative mBC. In addition to the CRO engagement, the Company has also contracted with other vendors, including those relating to data management as well as clinical trial sites as the studies progress. Deposits totaling $2.3 million have been made by the Company in connection with these engagements that are to be applied to future payments due under the service agreements.

Stockholders' Equity - Schedule of Designated Preferred Shares (Details)	Mar. 31, 2026 shares
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	179,670
Series A
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	4,200
Series B
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	2,360
Series C
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	590
Series D
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	10,000
Series E
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	40,000
Series E-1
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	12,960
Series F-1
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900
Series F-2
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900
Series F-3
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	34,860
Series F-4
Class of Stock [Line Items]
Preferred stock, shares designated (in shares)	24,900

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2026
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Prepaid Expense and Other Assets, Current [Abstract]
Clinical trial expenses	$ 2,445	$ 2,405
Insurance premiums	557	547
Professional services	941	804
Interest receivable	581	499
Licenses	538	613
Software	1,072	706
Taxes	523	696
Other	346	228
Total prepaid expenses and other current assets	$ 7,003	$ 6,498

Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Payables and Accruals [Abstract]
Clinical expenses	$ 2,100	$ 2,065
Compensation, excluding taxes	2,810	4,248
ESPP withholding	198	396
Professional fees	1,355	736
Inventory	28	74
medac	0	235
Other	652	437
Accrued expenses	$ 7,143	$ 8,191

Fair Value Measurements

3 Months Ended

Mar. 31, 2026

Fair Value Disclosures [Abstract]

Fair Value Measurements

Contingent liabilities are re-measured to fair value each reporting period using projected financial targets, discount rates, probabilities of payment, and projected payment dates. Projected contingent payment amounts are discounted back to the current period using a discounted cash flow model. Projected financial targets are based on our most recent internal operational budgets and may take into consideration alternate scenarios that could result in more or less profitability for the respective service line. Increases or decreases in projected financial targets and probabilities of payment may result in significant changes in the fair value measurements. Increases in discount rates and the time to payment may result in lower

fair value measurements. Increases or decreases in any of those inputs in isolation may result in a significantly lower or higher fair value measurement.

The Company’s fair value measurements are classified and disclosed in one of the following three categories:

•Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

•Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability;

•Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value relating to the medac settlement, for the three months ended March 31, 2026:


	Level 3
(In thousands)	Contingent liabilities
Balance at January 1, 2026	$	864
Change due to liability payment	—
Liability fair value adjustment	—
Total change in foreign exchange	(19)
Balance at March 31, 2026	$	845

Contingent liabilities are re-measured to fair value each reporting period using projected financial targets, discount rates, probabilities of payment, and projected payment dates.

Significant unobservable inputs in the valuation include:

•Probability of payment: 100%

•Discount rate: 3.75%

•Timing of expected payments: 0 - 2 years

Projected contingent payment amounts are discounted back to the current period using a discounted cash flow model. Projected financial targets are based on the Company’s most recent internal operational budgets and may take into consideration alternate scenarios that could result in more or less profitability for the respective service line. Increases or decreases in projected financial targets and probabilities of payment may result in significant changes in the fair value measurements. Increases in discount rates and the time to payment may result in lower fair value measurements. Increases or decreases in any of those inputs in isolation may result in immaterially lower or higher fair value measurement.

The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of March 31, 2026 and December 31, 2025 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value.


	March 31, 2026
(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market funds	$	1	$	—	$	—	$	1
U.S. government agency bonds	—		47,986		—		47,986
Total Assets	$	1	$	47,986	$	—	$	47,987

Liabilities:
Contingent Liability	$	—	$	—	$	845	$	845
Total Liabilities	$	—	$	—	$	845	$	845


	December 31, 2025
(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
U.S. government agency bonds	—		47,582		—		47,582
Total Assets	$	2	$	47,582	$	—	$	47,584

Liabilities:
Contingent Liability	$	—	$	—	$	864	$	864
Total Liabilities	$	—	$	—	$	864	$	864

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
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-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 3: http://www.xbrl.org/2003/role/exampleRef
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-Section 55
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2E

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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

Leases (Tables)

3 Months Ended

Mar. 31, 2026

Leases [Abstract]

Schedule of Operating Leases

The following table summarizes the Company’s operating leases as of March 31, 2026:


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	(36)		$	(11)		$	(47)
Weighted average remaining lease term	7.8			0.3
Weighted average discount rate - operating leases	8		%	8		%

Schedule of Remaining Maturity of Operating Leases Excluding Short-term Leases

Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows:


(In thousands)	U.S.		Ireland		Total
Year ended December 31, 2026	$	108	$	15	$	123
Year ended December 31, 2027	148		—		148
Year ended December 31, 2028	152		—		152
Year ended December 31, 2029	157		—		157
Year ended December 31, 2030	158		—		158
Thereafter	486		—		486
Total	1,209		15		1,224
Less present value discount	(317)		—		(317)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2026	$	892	$	15	$	907

Prepaid Expenses and Other Current Assets

3 Months Ended

Mar. 31, 2026

Prepaid Expense and Other Assets, Current [Abstract]

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:


(In thousands)	March 31, 2026		December 31, 2025
Clinical trial expenses	$	2,445	$	2,405
Insurance premiums	557		547
Professional services	941		804
Interest receivable	581		499
Licenses	538		613
Software	1,072		706
Taxes	523		696
Other	346		228
Total prepaid expenses and other current assets	$	7,003	$	6,498

Net (Loss) Income per Share - Schedule of Potentially Dilutive Securities Excluded from the Computation of Earnings Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	11,358,925	2,553,287
Assumed conversion of preferred stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	1,782,843	0
Stock options and Restricted Stock Units
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	9,527,796	2,531,230
Assumed conversion of ESPP
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share (in shares)	48,286	22,057

Stockholders' Equity - Share Repurchase Program (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	4 Months Ended
	Mar. 31, 2026	Mar. 31, 2026	Nov. 19, 2025
Stockholders' Equity Note [Abstract]
Share repurchase program, authorized			$ 25,000
Stock repurchased and retired (in shares)		944,595
Shares acquired, average cost (in dollars per share)		$ 9.5077
Stock repurchased and retired	$ 3,000	$ 9,000
Share repurchase program, remaining authorized, amount	$ 16,000	$ 16,000

Commitments and Contingencies (Details) € in Millions, $ in Millions	May 01, 2024	Dec. 30, 2022 USD ($)	Mar. 31, 2026 USD ($)	Oct. 12, 2021 EUR (€)	Apr. 30, 2021 EUR (€)
Loss Contingencies [Line Items]
Milestone payment unpaid \| €				€ 1
Supply agreement, renewal option term	5 years
Purchase obligation, next fiscal year			$ 2.5
Agreements relating to clinical trial support
Loss Contingencies [Line Items]
Deposit assets			2.3
Medac
Loss Contingencies [Line Items]
Accounts receivable \| €					€ 1
Term over which the royalty is to be paid		5 years
Minimum annual payments		$ 0.2
Loss contingency accrual			0.8
Loss contingency accrual, non-current			0.6
Loss contingency accrual, current			$ 0.2

Stockholders' Equity - Schedule of Assumptions to Estimate Fair Value of Stock Options Using Black-Scholes Option Pricing Model (Details)	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Stockholders' Equity Note [Abstract]
Expected terms (years)	5 years 8 months 12 days	5 years 8 months 12 days
Expected volatility	70.50%	90.00%
Risk-free interest rate	3.73%	4.35%
Expected dividends	0.00%	0.00%

Stockholders' Equity - Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2026	Dec. 31, 2025
Number of Options
Outstanding, beginning of period (in shares)	7,785,149
Granted (in shares)	922,369
Exercised (in shares)	(43,431)
Expired (in shares)	(2,583)
Cancelled/Forfeited (in shares)	(40,874)
Outstanding, end of period (in shares)	8,620,630	7,785,149
Exercisable (in shares)	5,416,653
Unvested (in shares)	3,203,977
Weighted Average Exercise Price Per Share
Outstanding, beginning of period (in dollars per share)	$ 10.05
Granted (in dollars per share)	9.40
Exercised (in dollars per share)	5.30
Expired (in dollars per share)	16.25
Cancelled/Forfeited (in dollars per share)	10.82
Outstanding, end of period (in dollars per share)	10.00	$ 10.05
Weighted Average Exercise Price, Exercisable (in dollars per share)	9.00
Weighted Average Exercise Price, Unvested (in dollars per share)	$ 11.69
Weighted Average Remaining Contractual Term (in years) and Aggregate Intrinsic Value
Weighted Average Remaining Contractual Term (in years),	7 years 8 months 12 days	7 years 9 months 18 days
Weighted Average Remaining Contractual Term (in years), Granted	9 years 9 months 18 days
Weighted Average Remaining Contractual Term (in years), Exercisable	7 years
Weighted Average Remaining Contractual Term (in years), Unvested	9 years
Aggregate Intrinsic Value, Outstanding	$ 13,933	$ 17,391
Aggregate Intrinsic Value, Exercisable	11,392
Aggregate Intrinsic Value, Unvested	$ 2,541

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Current assets
Cash and cash equivalents	$ 41,313	$ 43,454
Short-term investments	47,986	47,582
Accounts receivable	14,159	11,744
Inventories	9,808	10,252
Prepaid expenses and other current assets	7,003	6,498
Total current assets	120,269	119,530
Property, plant and equipment, net	3,662	3,166
Right-of-use assets	907	936
Total assets	124,838	123,632
Current liabilities
Accounts payable	3,463	2,658
Accrued expenses	7,143	8,191
Lease liabilities, current	92	101
Total current liabilities	10,698	10,950
Lease liabilities, non-current	815	835
Other liabilities, non-current	615	628
Total liabilities	12,128	12,413
Commitments and contingencies (see Note 12)
Stockholders’ equity
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 14,192 and 14,192 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively	0	0
Common stock, $0.01 par value; 80,000,000 shares authorized; 34,465,087 shares and 34,691,671 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively	344	347
Additional paid-in capital	641,713	639,145
Accumulated deficit	(529,918)	(528,848)
Accumulated other comprehensive income	571	575
Total stockholders’ equity	112,710	111,219
Total liabilities and stockholders’ equity	$ 124,838	$ 123,632

Stockholders' Equity - Schedule of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 4,946	$ 6,863
Selling, general and administrative
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	3,162	4,529
Research and development
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	1,386	1,568
Cost of goods sold
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total	$ 398	$ 766

Fair Value Measurements - Narrative (Details) - Unobservable Inputs In Valuation - Valuation Technique, Discounted Cash Flow	3 Months Ended
	Mar. 31, 2026
Measurement Input Probability of Payment
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Measurement input (in percent)	1
Measurement Input, Discount Rate
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Measurement input (in percent)	0.0375
Measurement Input, Expected Term \| Minimum
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Measurement period (in year)	0 years
Measurement Input, Expected Term \| Maximum
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Measurement period (in year)	2 years

Condensed Consolidated Statements of Operations and Comprehensive Income and Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Income Statement [Abstract]
Product revenue	$ 24,994	$ 19,784
Cost of goods sold	(3,736)	(2,845)
Gross profit	21,258	16,939
Operating expenses:
Research and development expenses	9,824	5,007
Selling, general and administrative expenses	13,071	11,290
Total operating expenses	22,895	16,297
Operating (loss) income	(1,637)	642
Interest income	787	618
Other (expense) income	(58)	4
(Loss) income before income taxes	(908)	1,264
Income tax expense	162	195
Net (loss) income	(1,070)	1,069
Other comprehensive income (loss):
Unrealized gain on investments adjustments	45	239
Foreign currency translation adjustments	(49)	60
Total comprehensive (loss) income	$ (1,074)	$ 1,368
Common share data:
Basic (loss) income per common share (in dollars per share)	$ (0.03)	$ 0.03
Weighted average number of basic shares outstanding (in shares)	36,021,210	34,642,641
Diluted (loss) income per common share (in dollars per share)	$ (0.03)	$ 0.03
Weighted average number of diluted shares outstanding (in shares)	36,021,210	39,511,120

Leases

3 Months Ended

Mar. 31, 2026

Leases [Abstract]

Leases

The Company recognizes right-of-use (“ROU”) assets and lease liabilities when it obtains the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company leases its facilities under non-cancellable operating leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments.

For both the three months ended March 31, 2026 and 2025, the Company recognized less than $0.1 million of operating lease and short-term lease expense.

In 2021, the Company entered into a sub-lease agreement (the “2021 Sub-Lease”) with its previous sub-lessee pursuant to which, effective August 2, 2021, the previous sub-lessee would become the lessee and the Company would then sublease its portion of the premises in Galway, Ireland from the previous sub-lessee. The Company’s annual rent expense under the 2021 Sub-Lease is less than $0.1 million for a term of 5 years.

On January 18, 2024, the Company entered into a lease agreement (the “Queensbury Lease”) to lease approximately 18,000 square feet of manufacturing and office space in Queensbury, New York. The initial term of the lease is five years with a right to extend the lease by an additional five years, exercisable under certain conditions set forth in the Queensbury Lease. The Company’s annual rent expense under the Queensbury Lease is less than $0.2 million for a term of 5 years.

The following table summarizes the Company’s operating leases as of March 31, 2026:


(In thousands)	U.S.			Ireland			Total
Operating cash flows for operating leases	$	(36)		$	(11)		$	(47)
Weighted average remaining lease term	7.8			0.3
Weighted average discount rate - operating leases	8		%	8		%

Remaining maturities of the Company’s operating leases, excluding short-term leases, are as follows:


(In thousands)	U.S.		Ireland		Total
Year ended December 31, 2026	$	108	$	15	$	123
Year ended December 31, 2027	148		—		148
Year ended December 31, 2028	152		—		152
Year ended December 31, 2029	157		—		157
Year ended December 31, 2030	158		—		158
Thereafter	486		—		486
Total	1,209		15		1,224
Less present value discount	(317)		—		(317)
Operating lease liabilities included in the condensed consolidated balance sheets at March 31, 2026	$	892	$	15	$	907

Property, Plant, and Equipment

3 Months Ended

Mar. 31, 2026

Property, Plant and Equipment [Abstract]

Property, Plant, and Equipment

Property, plant, and equipment consist of the following:


(In thousands)	March 31, 2026		December 31, 2025		Estimated Useful Life
Buildings and land	$	1,567	$	1,557	30 years - Buildings 15 years - Land Improvements
Enterprise hardware and software	1,818		1,819		3 years
Leaseholds	1,659		1,648		Lesser of lease term or estimated useful life
Equipment	3,511		2,894		7 years
Furniture	258		251		5 years
Equipment in process	189		245
Property, plant and equipment, gross	9,002		8,414
Accumulated depreciation	(5,340)		(5,248)
Property, plant and equipment, net	$	3,662	$	3,166

Depreciation expense for the three months ended March 31, 2026 and 2025 was $0.1 million and less than $0.1 million, respectively.

Subsequent Events	3 Months Ended
Subsequent Events	Mar. 31, 2026
Subsequent Events [Abstract]
Subsequent Events	Subsequent EventsThe Company has evaluated subsequent events for adjustment to or disclosure in these condensed consolidated financial statements through the date of this report and has not identified any recordable or disclosable events not otherwise reported in these financial statements or the notes thereto.

Stockholders' Equity - Schedule of Information Related to Stock Warrants Outstanding and Exercisable (Details) - Common Warrants - $ / shares	Mar. 31, 2026	Dec. 31, 2025
Class of Warrant or Right [Line Items]
Outstanding number of warrants (in shares)	1,341,375	1,341,375
$0.01
Class of Warrant or Right [Line Items]
Warrant exercise price (in dollars per share)	$ 0.01
Outstanding number of warrants (in shares)	1,341,375

Revenue - Schedule of Revenue and Accounts Receivable Concentrations (Details) - Customer Concentration Risk	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Customer 1 \| % of Revenue
Disaggregation of Revenue [Line Items]
Concentration risk, percentage	15.90%	15.00%
Customer 1 \| % of Accounts Receivable
Disaggregation of Revenue [Line Items]
Concentration risk, percentage	10.70%	21.30%
Customer 2 \| % of Revenue
Disaggregation of Revenue [Line Items]
Concentration risk, percentage	10.60%	13.10%
Customer 2 \| % of Accounts Receivable
Disaggregation of Revenue [Line Items]
Concentration risk, percentage	9.30%	8.10%
Customer 3 \| % of Revenue
Disaggregation of Revenue [Line Items]
Concentration risk, percentage		10.30%
Customer 3 \| % of Accounts Receivable
Disaggregation of Revenue [Line Items]
Concentration risk, percentage		6.70%
Customer 4 \| % of Revenue
Disaggregation of Revenue [Line Items]
Concentration risk, percentage		9.40%
Customer 4 \| % of Accounts Receivable
Disaggregation of Revenue [Line Items]
Concentration risk, percentage		10.80%

- Definition

For an entity that discloses a concentration risk in relation to quantitative amount, which serves as the "benchmark" (or denominator) in the equation, this concept represents the concentration percentage derived from the division.

+ References + Details

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2026

Fair Value Disclosures [Abstract]

Schedule of Level 3 Investments

The table below presents activity within Level 3 of the fair value hierarchy, our liabilities carried at fair value relating to the medac settlement, for the three months ended March 31, 2026:


	Level 3
(In thousands)	Contingent liabilities
Balance at January 1, 2026	$	864
Change due to liability payment	—
Liability fair value adjustment	—
Total change in foreign exchange	(19)
Balance at March 31, 2026	$	845

Schedule of Financial Assets and Liabilities Measured at Fair Value


	March 31, 2026
(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market funds	$	1	$	—	$	—	$	1
U.S. government agency bonds	—		47,986		—		47,986
Total Assets	$	1	$	47,986	$	—	$	47,987

Liabilities:
Contingent Liability	$	—	$	—	$	845	$	845
Total Liabilities	$	—	$	—	$	845	$	845


	December 31, 2025
(In thousands)	Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
U.S. government agency bonds	—		47,582		—		47,582
Total Assets	$	2	$	47,582	$	—	$	47,584

Liabilities:
Contingent Liability	$	—	$	—	$	864	$	864
Total Liabilities	$	—	$	—	$	864	$	864

Stockholders' Equity - Schedule of Warrant Activity (Details) - Common Warrants	3 Months Ended
	Mar. 31, 2026 $ / shares shares
Warrants
Outstanding, beginning of period (in shares) \| shares	1,341,375
Warrants issued (in shares) \| shares	0
Warrants exercised (in shares) \| shares	0
Warrants canceled (in shares) \| shares	0
Outstanding, end of period (in shares) \| shares	1,341,375
Weighted Average Exercise Price
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 0.01
Warrants issued (in dollars per share) \| $ / shares	0
Warrants exercised (in dollars per share) \| $ / shares	0
Warrants canceled (in dollars per share) \| $ / shares	0
Outstanding, ending of period (in dollars per share) \| $ / shares	$ 0.01

Inventory

3 Months Ended

Mar. 31, 2026

Inventory Disclosure [Abstract]

Inventory

Inventory consists of the following:


(In thousands)	March 31, 2026		December 31, 2025
Raw materials	$	5,766	$	6,477
Work-in-process	3,088		2,809
Finished goods	954		966
Total inventory	$	9,808	$	10,252

The Company has consignment agreements with approved hospitals and treatment centers. As of March 31, 2026, there was approximately $0.6 million in finished goods held at hospitals and treatment centers.

For the three months ended March 31, 2026, the Company has included a reserve of $0.5 million for inventory expected to expire prior to usage.

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Cash flows from operating activities:
Net (loss) income	$ (1,070)	$ 1,069
Adjustments to reconcile net (loss) income to net cash used in operating activities:
Stock option compensation expense	4,946	6,863
Depreciation expense	102	43
Amortization of Right-of-Use Asset	29	24
Amortization of premiums and discounts on marketable securities	(440)	(306)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(423)	(1,421)
Accounts receivable	(2,415)	(3,052)
Inventories	444	(199)
Accounts payable and accrued expenses	(273)	(925)
Other liabilities, non-current	(43)	107
Net cash provided by operating activities	857	2,203
Cash flows from investing activities:
Purchase of investments	(15,812)	(30,060)
Maturities of investments	15,811	5,052
Purchase of property, plant and equipment	(570)	(140)
Net cash used in investing activities	(571)	(25,148)
Cash flows from financing activities:
Proceeds from the issuance of common stock relating to the employee stock purchase plan	389	238
Proceeds from exercise of warrants	0	2,385
Proceeds from exercise of stock options	230	630
Repurchase and retirement of common stock	(3,000)	0
Net cash (used in) provided by financing activities	(2,381)	3,253
Foreign currency effects on cash	(46)	56
Net decrease in total cash	(2,141)	(19,636)
Total Cash and Cash Equivalents:
Beginning of period	43,454	32,412
End of period	$ 41,313	$ 12,776

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 2026	Dec. 31, 2025	Mar. 31, 2025	Dec. 31, 2024
Statement of Stockholders' Equity [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01	$ 0.01	$ 0.01

Segment Information - Schedule of Revenue by Location (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Segment Reporting Information [Line Items]
Total revenue	$ 24,994	$ 19,784
Foreign
Segment Reporting Information [Line Items]
Total revenue	1,747	1,761
United States
Segment Reporting Information [Line Items]
Total revenue	$ 23,247	$ 18,023

- Definition

+ References

+ Details

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2026	Dec. 31, 2025
Statement of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	14,192	14,192
Preferred stock, shares outstanding (in shares)	14,192	14,192
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	80,000,000	80,000,000
Common stock, shares issued (in shares)	34,465,087	34,691,671
Common stock, shares outstanding (in shares)	34,465,087	34,691,671

Prepaid Expenses and Other Current Assets (Tables)

3 Months Ended

Mar. 31, 2026

Prepaid Expense and Other Assets, Current [Abstract]

Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:


(In thousands)	March 31, 2026		December 31, 2025
Clinical trial expenses	$	2,445	$	2,405
Insurance premiums	557		547
Professional services	941		804
Interest receivable	581		499
Licenses	538		613
Software	1,072		706
Taxes	523		696
Other	346		228
Total prepaid expenses and other current assets	$	7,003	$	6,498

Investments (Tables)

3 Months Ended

Mar. 31, 2026

Investments, Debt and Equity Securities [Abstract]

Schedule of Unrealized Gains

The following table summarizes the gross unrealized gains on the Company’s marketable securities as of March 31, 2026:


	March 31, 2026
(In thousands)	Amortized Cost		Gross Unrealized Gains		Estimated Fair Value
U.S. government agency bonds	$	47,411	$	575	$	47,986
Total short-term investments					$	47,986

The following table summarizes the gross unrealized gains on the Company’s marketable securities as of December 31, 2025:


	December 31, 2025
(In thousands)	Amortized Cost		Gross Unrealized Gains		Estimated Fair Value
U.S. government agency bonds	$	47,053	$	529	$	47,582
Total short-term investments					$	47,582

- Definition

Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
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Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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+ Details

Income Taxes	3 Months Ended
Income Taxes	Mar. 31, 2026
Income Tax Disclosure [Abstract]
Income Taxes	Income Taxes The Company has recorded a provision for income taxes of $0.2 million for both the three months ended March 31, 2026 and March 31, 2025, respectively. As discussed in “Note 14 - Income Taxes” to the notes to the consolidated financial statements contained in the Annual Report, the Company has a valuation allowance against the full amount of its net deferred tax assets. The Company currently provides a valuation allowance against deferred tax assets when it is more likely than not that some portion or all of its deferred tax assets will not be realized. The Company has not recognized any unrecognized tax benefits in its balance sheet. The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. Additional information regarding the statutes of limitations can be found in Note 14 Income Taxes of the Company’s Annual Report. On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (OBBBA), which resulted in the extension of many provisions of the current tax law as well as other rule changes, including full expensing of U.S. research and development costs under Section 174A, and retroactive expensing of unamortized U.S. research and development costs capitalized between 2022 and 2024. Additional information regarding the effect of OBBBA on the Company’s tax provision can be found in Note 14 Income Taxes of the Company’s Annual Report.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Inventory (Tables)

3 Months Ended

Mar. 31, 2026

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventory consists of the following:


(In thousands)	March 31, 2026		December 31, 2025
Raw materials	$	5,766	$	6,477
Work-in-process	3,088		2,809
Finished goods	954		966
Total inventory	$	9,808	$	10,252

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands	Total	Series F Preferred Stock	Stock options and Restricted Stock Units	Employee Stock Purchase Plan	Preferred Stock	Common Stock	Common Stock Series F Preferred Stock	Additional Paid in Capital	Additional Paid in Capital Series F Preferred Stock	Additional Paid in Capital Stock options and Restricted Stock Units	Additional Paid in Capital Employee Stock Purchase Plan	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)
Beginning balance (in shares) at Dec. 31, 2024					14,192	33,061,002
Beginning balance at Dec. 31, 2024	$ 68,746				$ 0	$ 331		$ 599,881				$ (531,548)	$ 82
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options			$ 6,813	$ 50						$ 6,813	$ 50
Issuance of common stock with the Employee Stock Purchase Plan (in shares)						35,513
Issuance of common stock with the Employee Stock Purchase Plan	238							238
Warrant Exercise - Series F (in shares)							238,500
Warrant Exercise - Series F		$ 2,385					$ 2		$ 2,383
Stock Option Exercise (in shares)						101,597
Stock Option Exercise	630					$ 1		629
Net income (loss)	1,069											1,069
Unrealized gain on investment adjustments	239												239
Foreign currency translation adjustments	60												60
Ending balance (in shares) at Mar. 31, 2025					14,192	33,436,612
Ending balance at Mar. 31, 2025	80,230				$ 0	$ 334		609,994				(530,479)	381
Beginning balance (in shares) at Dec. 31, 2025					14,192	34,691,671
Beginning balance at Dec. 31, 2025	111,219				$ 0	$ 347		639,145				(528,848)	575
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Compensation expense for issuance of stock options			$ 4,876	$ 70						$ 4,876	$ 70
Issuance of common stock with the Employee Stock Purchase Plan (in shares)						46,008
Issuance of common stock with the Employee Stock Purchase Plan	$ 389							389
Stock Option Exercise (in shares)	43,431					43,431
Stock Option Exercise	$ 230							230
Repurchase and retirement of common stock (in shares)						(316,023)
Repurchase and retirement of common stock	(3,000)					$ (3)		(2,997)
Net income (loss)	(1,070)											(1,070)
Unrealized gain on investment adjustments	45												45
Foreign currency translation adjustments	(49)												(49)
Ending balance (in shares) at Mar. 31, 2026					14,192	34,465,087
Ending balance at Mar. 31, 2026	$ 112,710				$ 0	$ 344		$ 641,713				$ (529,918)	$ 571

Net (Loss) Income per Share (Tables)

3 Months Ended

Mar. 31, 2026

Earnings Per Share [Abstract]

Schedule of Reconciliation of Weighted Average Shares Outstanding Calculation

The following table provides a reconciliation of the weighted average shares outstanding calculation for the three months ended March 31, 2026 and 2025:


Weighted average number of basic shares outstanding
	Three months ended March 31,
	2026	2025
Weighted average shares issued	34,679,835	33,301,266
Weighted average pre-funded warrants	1,341,375	1,341,375
Weighted average shares outstanding	36,021,210	34,642,641


Weighted average number of diluted shares outstanding
	Three months ended March 31,
	2026	2025
Weighted average shares outstanding (Basic)	36,021,210	34,642,641
Additional dilutive shares	—	4,868,479
Weighted average shares outstanding (Diluted)	36,021,210	39,511,120

Schedule of Potentially Dilutive Securities Excluded from the Computation of Earnings Per Share

The following potentially dilutive securities were excluded from the computation of earnings per share as of March 31, 2026 and 2025 because their effects would be anti-dilutive:


	Three Months Ended March 31,
	2026	2025
Assumed conversion of preferred stock	1,782,843	—
Stock options and Restricted Stock Units	9,527,796	2,531,230
Assumed conversion of ESPP	48,286	22,057
Total	11,358,925	2,553,287

Segment Information - Narrative (Details)	3 Months Ended
Segment Information - Narrative (Details)	Mar. 31, 2026 segment
Segment Reporting [Abstract]
Number of reportable segments	1

Stockholders' Equity - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Stockholders' Equity Note [Abstract]
Weighted average grant-date fair value of the stock options granted (in dollars per share)	$ 6.04	$ 12.05
Intrinsic value of stock options exercised	$ 200	$ 800
Proceeds from exercise of stock options	$ 230	$ 630

Fair Value Measurements - Schedule of Level 3 Investments (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2026 USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Liability fair value adjustment	Liability fair value adjustment
Contingent liabilities
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Beginning balance	$ 864
Change due to liability payment	0
Liability fair value adjustment	0
Total change in foreign exchange	(19)
Ending balance	$ 845

Segment Information

3 Months Ended

Mar. 31, 2026

Segment Reporting [Abstract]

Segment Information

The Company operates its business primarily in the United States and Europe on a consolidated basis in one reportable segment - the research, development, manufacture and distribution of hepatic delivery systems for the use in the treatment of specific conditions (the “reportable segment”). The Company’s chief operating decision maker (“CODM”) is comprised of a single management team consisting of the Chief Financial Officer, Chief Operating Officer, Chief Medical Officer and General Manager that reports to the Chief Executive Officer. The CODM uses consolidated gross profit and net income or loss, which can be found on the Condensed Consolidated Statements of Operations and Comprehensive Income and Loss, to assess financial performance. These financial metrics are used to monitor budget versus actual results. Significant segment expenses reviewed by the CODM are presented in the Company’s Condensed Consolidated Statements of Operations and Comprehensive Income and Loss. The measure of segment assets provided to the CODM is reported on the balance sheet as total consolidated assets.

Revenues from external customers are attributed to geographies based on the location of the customer. The following table shows the disaggregated revenue by geography for the three months ended March 31, 2026 and 2025. No individual foreign country is material to the consolidated results.


	Three Months Ended March 31,
(in thousands)	2026		2025
Foreign	$	1,747	$	1,761
United States	23,247		18,023
Total revenue	$	24,994	$	19,784

As of March 31, 2026 and 2025, substantially all of the Company’s long-lived assets were located in the United States; long-lived assets located in any individual foreign country were not material.

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

Stockholders' Equity - Schedule of Warrant Activity (Details) - Common Warrants	3 Months Ended
	Mar. 31, 2026 $ / shares shares
Warrants
Outstanding, beginning of period (in shares) \| shares	1,341,375
Warrants issued (in shares) \| shares	0
Warrants exercised (in shares) \| shares	0
Warrants canceled (in shares) \| shares	0
Outstanding, end of period (in shares) \| shares	1,341,375
Weighted Average Exercise Price
Outstanding, beginning of period (in dollars per share) \| $ / shares	$ 0.01
Warrants issued (in dollars per share) \| $ / shares	0
Warrants exercised (in dollars per share) \| $ / shares	0
Warrants canceled (in dollars per share) \| $ / shares	0
Outstanding, ending of period (in dollars per share) \| $ / shares	$ 0.01