CASI Pharmaceuticals (CASIF) narrows H1 loss to $20M amid Nasdaq delisting
Rhea-AI Filing Summary
CASI Pharmaceuticals reported first half 2026 results, highlighting progress on its lead antibody CID-103 while remaining deeply loss-making and highly leveraged. The company received China NMPA approval for a Phase 1/2 study in renal allograft antibody-mediated rejection and dosed the first patient in that trial, and completed Part A dose-escalation enrollment in an ongoing Phase 1/2 immune thrombocytopenia study.
Revenue was $9.8 million, down slightly from $10.4 million. Gross profit rose to $7.7 million, and net loss narrowed to $20.0 million from $24.1 million, with net loss per share improving to $(0.97) from $(1.56). Cash and cash equivalents were $3.8 million at June 30, 2026.
Total assets were $21.1 million against total liabilities of $79.3 million, resulting in shareholders’ deficit of $58.3 million. CASI disclosed recurring operating losses that have raised substantial doubt about its ability to continue as a going concern. Its shares were delisted from Nasdaq and began trading on the OTCQB market under CASIF.
Positive
- Net loss narrowed to $20.0 million for the first half of 2026 from $24.1 million a year earlier, and net loss per share improved to $(0.97) from $(1.56), indicating lower reported losses despite modest revenue decline.
- Gross profit increased to $7.7 million from $5.7 million year over year, reflecting a shift to lower-cost MAFALAN® and substantially reduced cost of revenues, which fell to $2.2 million from $4.7 million.
- Pipeline advanced with China NMPA approval for a Phase 1/2 study of CID-103 in renal allograft antibody-mediated rejection and completion of Part A enrollment in a Phase 1/2 immune thrombocytopenia trial, including dosing of the first AMR patient in China.
Negative
- Management highlighted that recurring operating losses have raised substantial doubt regarding the company’s ability to continue as a going concern, underscoring significant financial sustainability risk.
- The company’s shares were delisted from Nasdaq after failing continued listing requirements; trading moved to the OTCQB market, which can reduce liquidity and visibility for investors.
- CASI reported a shareholders’ deficit of $58.3 million at June 30, 2026, with total liabilities of $79.3 million far exceeding total assets of $21.1 million, and cash of only $3.8 million versus a $20.0 million half-year net loss.
- Current liabilities rose to $66.6 million, including an increase in convertible notes due to a related party to $19.2 million from $4.2 million, indicating heavier short-term and related-party debt obligations.
Filing Explained
At June 30, 2026, current liabilities of $66,617 thousand exceeded $3,765 thousand of cash, including $19,243 thousand of related-party convertible notes.
Form 6-K is a foreign private issuer’s interim report used to furnish material information published in its home market. CASI’s August 14 filing reports first-half 2026 results through
That balance-sheet presentation means the company’s listed current obligations substantially exceed its cash on hand, with the related-party convertible notes part of the stated obligation base. The related-party convertible-notes balance rose from
The report says its information, including Exhibit 99.1, is incorporated by reference into two existing Form F-3 registration statements, to the extent not superseded. The forward-looking section identifies a going-private proposal and a China asset-divestiture transaction as uncertain matters; this filing gives no completion statement or closing date for either.
Key Figures
Key Terms
antibody-mediated rejection medical
immune thrombocytopenia medical
going concern financial
OTCQB market market
Phase 1/2 study medical
FAQ
How did CASIF perform financially in the first half of 2026?
What is CASIF’s cash position and balance sheet strength as of June 30, 2026?
What clinical progress did CASIF report for CID-103 in H1 2026?
What happened with CASIF’s Nasdaq listing status in 2026?
Does CASIF face going concern risks based on the latest report?
How did operating expenses change for CASIF in the first half of 2026?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO
RULE
13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of August, 2026
Commission File Number 001-41666
CASI PHARMACEUTICALS, INC.
(Translation of registrant’s name into English)
1701-1702, China Central Office Tower 1
No. 81 Jianguo Road, Chaoyang District
Beijing, 100025
People’s Republic of China
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F x Form 40-F ¨
INCORPORATION BY REFERENCE
The information included in this Report on Form 6-K, including Exhibits 99.1, is hereby incorporated by reference into the Company's Registration Statements on Form F-3 (File No. 333-283998 and No. 333-281621) (including any prospectuses forming a part of such registration statement) and is to be a part thereof from the date on which this Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release of CASI Pharmaceuticals, Inc. dated August 14, 2026 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CASI Pharmaceuticals, Inc. | ||
| By: | /s/ Wei-Wu He | |
| Name: | Wei-Wu He | |
| Title: | Chairman to the Board | |
| Date: August 14, 2026 | ||
Exhibit 99.1
CASI Pharmaceuticals Announces
First Half 2026 Business and Financial Results
South San Francisco, California / August 14, 2026 / ACCESS NEWSWIRE / -- 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 |
| o | Approval of clinical trial application by China NMPA for Phase 1/2 study | |
| o | First patient dosed in Phase 1/2 study in China |
| · | CID-103 for Immune Thrombocytopenia (ITP) |
| o | 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 |
| · | 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 |
| · | 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 |
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 profile compared 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 www.casipharmaceuticals.com.
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 | ) | ||||