Melphalan hydrochloride

SOUTH SAN FRANCISCO, CA / ACCESS Newswire / August 14, 2026 / CASI Pharmaceuticals, Inc. (OTCQB:CASIF), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with antibody-mediated rejection (AMR) in organ transplant and various autoimmune diseases, today reported business and financial results for the first half year ended June 30, 2026. "We remained focused on advancing the development of our lead program, CID-103," said Dr. Wei-Wu He, Executive Chairman and Principal Executive Officer of CASI. "We dosed the first patient in the Phase 1/2 trial evaluating the safety and tolerability of CID-103 in adult patients with active and chronic active renal allograft antibody-mediated rejection (AMR) in China. We also completed the enrollment of Part A (the dose-escalation part) of our ongoing Phase 1/2 study in immune thrombocytopenia (ITP), with the maximum tested dose of 1,200 mg." Business Highlights Program Updates and Upcoming Milestones CID-103 for Antibody-Mediated Rejection (AMR) for Renal Allografts Approval of clinical trial application by China NMPA for Phase 1/2 study First patient dosed in Phase 1/2 study in China CID-103 for Immune Thrombocytopenia (ITP) Completed enrollment in Part A, the dose-escalation part, of the ongoing Phase 1/2 study, with the maximum tested dose of 1,200 mg Corporate Completed $15 million convertible note financing pursuant to certain convertible note purchase agreement with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He Dr. Wei-Wu He, Ph.D., assumed the role of the Company's principal executive officer while continuing to serve as Executive Chairman Subsequent to quarter-end, received a favorable final award in the Juventas arbitration, pursuant to which the tribunal rejected all of Juventas's allegations of breach, determined that Juventas had wrongfully terminated the relevant agreements, and awarded the Company amounts totaling well over RMB 100 million Entered into a Settlement Agreement with Acrotech Biopharma Inc., pursuant to which the prior purported termination of the EVOMELA ® license and related agreements was rescinded and the agreements remain in full force and effect, subject to certain revisions Ordinary shares began to be quoted for trading on the OTCQB market under the ticker CASIF First Half 2026 Financial Highlights Revenues for the first half of 2026 were $9.8 million, representing a 5.8% decrease compared to $10.4 million in the same period last year. The decline in revenue was primarily attributable to the product transition from EVOMELA ® to the locally manufactured MAFALAN ® , which remains in its market‑expansion phase. Cost of revenue for the first half of 2026 was $2.2 million, representing a 53.2% decrease compared to $4.7 million in the same period last year. The decrease was mainly attributable to lower unit cost for MAFALAN ® than that of EVOMELA ® . Research and development expenses for the first half of 2026 were $2.3 million, representing a 37.8% decrease compared to $3.7 million in the same period last year. The decrease was mainly attributable to decreased clinical studies costs for our pipeline products, as well as decreased labor cost. General and administrative expenses for the first half of 2026 were $14.3 million, representing a 3.6% increase compared to $13.8 million in the same period last year. The increase was mainly attributable to increased legal fees, partially offset by decreased labor cost. Selling and marketing expenses for the first half of 2026 were $7.5 million, representing an 18.5% decrease compared to $9.2 million in the same period last year. The decrease was mainly attributable to decreased labor cost and decreased travel and conference fees. Net loss for the first half of 2026 was $20.0 million, compared to $24.1 million in the same period last year. As of June 30, 2026, cash and cash equivalents of the Company was $3.8 million, compared to $5.6 million as of December 31, 2025. As of June 30, 2026, total outstanding shares of the Company were 20,555,873. Nasdaq Delisting and OTCQB Quotation On February 23, 2026, the Company received a determination letter from the Hearings Panel of The Nasdaq Stock Market notifying the Company that the Panel had determined to delist the Company's securities due to the Company's failure to satisfy Nasdaq's continued listing requirements. As a result, trading in the Company's securities was suspended at the opening of business on February 26, 2026. On June 23, 2026, Nasdaq filed Form 25 in relation to such delisting decision. On April 14, 2026, the Company's ordinary shares began to be quoted for trading on the OTCQB market under the ticker CASIF. About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a public biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases. CID-103 is a fully human IgG1, potentially best-in-class, clinical-stage, anti-CD38 monoclonal antibody which targets a unique epitope and has demonstrated an encouraging preclinical efficacy and clinical safety pro to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights. CASI received FDA IND clearance to conduct a Phase 1 study in renal allograft antibody-mediated rejection (AMR) in the U.S. In parallel, CASI is actively recruiting and dosing patients in two ongoing Phase 1/2 studies in immune thrombocytopenia (ITP) and active and chronic active renal allograft antibody-mediated rejection. More information on CASI is available at . Forward-Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: uncertainties related to the going-private proposal made by Dr. Wei-Wu He; uncertainties related to the possibility that the transaction for the divestiture of certain assets in China (the "Transaction") will not occur as planned if events arise that result in the termination of the Equity and Assets Transfer Agreement, or if one or more of the various closing conditions to the Transaction are not satisfied or waived; the possibility that our plan with respect to our business operations after the consummation of the Transaction can be implemented successfully; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that results in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; uncertainties regarding the timing, enforcement and collection of the amounts awarded to the Company in the Juventas arbitration; risks associated with the Company's obligations under the Settlement Agreement with Acrotech, including applicable minimum purchase obligations; the risk related to the Company's ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to interests of our largest shareholder and our Chairman that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. We caution readers not to place undue reliance on any forward-looking statements contained herein. EVOMELA ® and FOLOTYN ® are proprietary to Acrotech Biopharma Inc. and its affiliates. COMPANY CONTACT: Deanna Qian +86 6561 8789 deannaq@casi.cn Financial Table Follows CASI Pharmaceuticals, Inc. Unaudited Condensed Consolidated Balance Sheets (In USD thousands, except share and per share data) June 30, 2026 December 31, 2025 ASSETS Current assets: Cash and cash equivalents $ 3,765 $ 5,632 Accounts receivable, net of nil expected credit loss 3,437 4,092 Inventories 1,837 1,598 Prepaid expenses and other 984 2,135 Total current assets 10,023 13,457 Long-term investments 1,716 1,716 Property, plant and equipment, net 6,570 6,968 Intangible assets, net 214 221 Right of use assets 1,860 2,548 Other assets 680 740 Total assets $ 21,063 $ 25,650 LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY Current liabilities: Accounts payable $ 1,065 $ 1,065 Bank borrowings 1,474 1,001 Accrued and other current liabilities 25,055 24,171 Convertible notes due to a related party 19,243 4,243 Current portion of long-term borrowing 19,780 19,190 Total current liabilities 66,617 49,670 Other liabilities 12,712 13,262 Total liabilities 79,329 62,932 Commitments and contingencies Shareholders' (deficit) equity: Ordinary shares 2 2 Treasury shares (9,604 ) (9,604 ) Additional paid-in capital 722,308 722,238 Accumulated other comprehensive loss (2,803 ) (1,785 ) Accumulated deficit (768,169 ) (748,133 ) Total shareholders' (deficit) equity (58,266 ) (37,282 ) Total liabilities and shareholders' (deficit) equity $ 21,063 $ 25,650 CASI Pharmaceuticals, Inc. Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) Six months ended June 30, 2026 June 30, 2025 Revenues 9,817 10,415 Costs of revenues (2,154 ) (4,738 ) Gross profit 7,663 5,677 Operating income (expenses): Research and development (2,330 ) (3,660 ) General and administrative (14,265 ) (13,782 ) Selling and marketing (7,506 ) (9,183 ) Foreign exchange gain (loss) 355 (561 ) Total operating expense (23,746 ) (27,186 ) Loss from operations (16,083 ) (21,509 ) Non-operating income (expense): Interest income 5 122 Interest expense (1,342 ) (441 ) Other income 3 35 Changes in fair value of investments - (158 ) Loss before income tax expense and share of net loss in an equity investee (17,417 ) (21,951 ) Income tax benefit - - Share of net loss in an equity investee (2,616 ) (2,174 ) Net loss (20,033 ) (24,125 ) Weighted average number of ordinary shares outstanding (basic and diluted) 20,555,873 15,499,318 Net loss per share (basic and diluted) (0.97 ) (1.56 ) Comprehensive loss: Net loss (20,033 ) (24,125 ) Foreign currency translation adjustment (1,018 ) (466 ) Total comprehensive loss (21,051 ) (24,591 ) Less: comprehensive loss attributable to redeemable noncontrolling interest - - Comprehensive loss attributable to ordinary shareholders (21,051 ) (24,591 ) SOURCE: CASI Pharmaceuticals View the original press release on ACCESS Newswire

Increases 2026 Revenue Guidance to a Range of $104M to $108M Conference Call Today at 8:30 a.m. Eastern Time QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the second quarter ended June 30, 2026. Second Quarter 2026 Financial Results Total revenue of $29.1 million, compared with $24.2 million in the second quarter of 2025 HEPZATO KIT™ revenue of $27.1 million, compared to $22.5 million in the second quarter of 2025 CHEMOSAT ® revenue of $2.0 million, compared to $1.7 million in the second quarter of 2025 Gross margins of 90%, compared to 86% in the second quarter of 2025 Net income of $2.7 million for both second quarters in 2026 and 2025 Non-GAAP adjusted EBITDA of $7.6 million, compared to $9.8 million in the second quarter of 2025 Cash provided by operations of $5.7 million in the quarter; compared to $7.3 million in the second quarter of 2025 Cash and investments of $95.9 million as of June 30, 2026 Business Highlights ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Currently 31 active treatment centers Approximately 30% growth in HEPZATO volume in the second quarter 2026 compared to the second quarter 2025 Independent investigators presented retrospective data at ESMO Breast Cancer 2026 showing a 60% hepatic partial response rate with percutaneous hepatic perfusion in heavily pretreated patients with liver-dominant metastatic breast cancer Independent investigators presented two investigator-initiated Trials-in-Progress abstracts at ASCO 2026: one evaluating sequential HEPZATO followed by tebentafusp in metastatic uveal melanoma, and one evaluating HEPZATO in combination with nivolumab/relatlimab in metastatic cutaneous melanoma with liver metastases Dosed the first patient in the global Phase 2 trial of HEPZATO in combination with standard of care in patients with liver-dominant HER2-negative metastatic breast cancer “Our strong second quarter, including total revenue of $29.1 million and quarterly operating cash flow of $5.7 million, reflects continued momentum in HEPZATO procedures,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “As we grow our active treatment center network and drive physician adoption, we are seeing increased usage of HEPZATO in combination with systemic therapies to treat metastatic uveal melanoma. The growing clinical experience with this treatment strategy is strengthening physician confidence in HEPZATO and supporting its development as a multi-indication, liver-directed therapy platform, including colorectal and breast cancer.” 2026 Full Year Financial Guidance The Company’s financial outlook for fiscal year 2026: Total HEPZATO KIT and CHEMOSAT revenue to range from $104 million to $108 million, reflecting an increase in HEPZATO KIT volume of at least 28% over 2025 Full year gross margins in the range of 86% to 89% Positive adjusted EBITDA Second Quarter 2026 Results Total revenue for the quarter ending June 30, 2026 was $29.1 million compared to $24.2 million for the same period in the prior year. Revenue in the quarter includes sales of $27.1 million of HEPZATO in the U.S. and $2.0 million of CHEMOSAT in Europe. Research and development expenses for the quarter ending June 30, 2026, were $10.4 million compared to $6.9 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity. Selling, general and administrative expenses for the quarter ended June 30, 2026, were $13.4 million compared to $11.4 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities. Net income was $2.7 million for both the quarters ended June 30, 2026 and June 30, 2025. Non-GAAP adjusted EBITDA for the quarter ended June 30, 2026 was $7.6 million compared to adjusted EBITDA of $9.8 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference. As of June 30, 2026, the Company had $95.9 million in cash and investments, and no debt. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, August 6, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-800-717-1738 International: 1-646-307-1865 Webcast: A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website . GAAP v. Non-GAAP Measures Delcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT ® Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) 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. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Safe Harbor / Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. DELCATH SYSTEMS, INC. Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share data) June 30, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents $ 47,521 $ 43,454 Short-term investments 48,381 47,582 Accounts receivable 15,942 11,744 Inventories 11,713 10,252 Prepaid expenses and other current assets 6,979 6,498 Total current assets 130,536 119,530 Property, plant and equipment, net 4,019 3,166 Right-of-use assets 2,463 936 Total assets $ 137,018 $ 123,632 Liabilities and Stockholders’ Equity Current liabilities Accounts payable $ 4,011 $ 2,658 Accrued expenses 9,072 8,191 Lease liabilities, current 196 101 Total current liabilities 13,279 10,950 Lease liabilities, non-current 2,267 835 Other liabilities, non-current 327 628 Total liabilities $ 15,873 $ 12,413 Commitments and contingencies Stockholders’ equity Preferred stock, $0.01 par value; 10,000,000 shares authorized; 14,192 and 14,192 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively — — Common stock, $0.01 par value; 80,000,000 shares authorized; 34,636,252 shares and 34,691,671 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 346 347 Additional paid-in capital 647,791 639,145 Accumulated deficit (527,250 ) (528,848 ) Accumulated other comprehensive income 258 575 Total stockholders’ equity 121,145 111,219 Total liabilities and stockholders’ equity $ 137,018 $ 123,632 DELCATH SYSTEMS, INC. Condensed Consolidated Statements of Operations and Comprehensive Income (Unaudited) (in thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Product revenue $ 29,133 $ 24,156 $ 54,127 $ 43,940 Cost of goods sold (2,985 ) (3,318 ) (6,721 ) (6,163 ) Gross profit 26,148 20,838 47,406 37,777 Operating expenses: Research and development expenses 10,380 6,882 20,204 11,889 Selling, general and administrative expenses 13,373 11,366 26,444 22,656 Total operating expenses 23,753 18,248 46,648 34,545 Operating income 2,395 2,590 758 3,232 Interest income 781 649 1,568 1,267 Other expense (17 ) (34 ) (75 ) $ (30 ) Income before income taxes 3,159 3,205 2,251 4,469 Income tax expense 491 508 653 703 Net income 2,668 2,697 1,598 3,766 Other comprehensive income: Unrealized gain on investments adjustments (295 ) 57 (250 ) 296 Foreign currency translation adjustments (18 ) 154 (67 ) 214 Total comprehensive income $ 2,355 $ 2,908 $ 1,281 $ 4,276 Common share data: Basic income per common share $ 0.07 $ 0.08 $ 0.04 $ 0.11 Weighted average number of basic shares outstanding 35,891,915 35,786,813 35,956,205 35,217,887 Diluted income per common share $ 0.07 $ 0.07 $ 0.04 $ 0.09 Weighted average number of dilutive shares outstanding 39,761,480 40,262,764 39,584,329 39,890,102 DELCATH SYSTEMS, INC. Reconciliation of Reported Net Income (GAAP) to Adjusted EBITDA (NON-GAAP Measure) (Unaudited) (in thousands) Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net income $ 2,668 $ 2,697 $ 1,598 $ 3,766 Stock-based compensation expense 5,118 7,209 10,064 14,072 Depreciation 113 51 215 94 Interest income (781 ) (649 ) (1,568 ) (1,267 ) Income tax expense 491 508 653 703 Adjusted EBITDA (Non-GAAP) $ 7,609 $ 9,816 $ 10,962 $ 17,368 Contacts Investor Relations Contact: ICR Healthcare investorrelations@delcath.com