v3.26.1
General (Policies)
6 Months Ended
Jun. 30, 2026
Accounting Policies [Abstract]  
Risks and Uncertainties
Risks and Uncertainties
As detailed in the Annual Report, 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, obtaining 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, obtaining and maintaining sufficient reimbursement for approved products and/or the associated procedures to healthcare professionals and treating facilities, 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.
At June 30, 2026, the Company had cash and cash equivalents totaling $47.5 million and short-term investments totaling $48.4 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 June 30, 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 six months ended June 30, 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 statements 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.