Latest news with #CASIPharmaceuticals
Associated Press
19-05-2025
- Business
- Associated Press
CASI Pharmaceuticals Provides Business and Clinical Update
BEIJING, CHINA / ACCESS Newswire / May 19, 2025 / CASI Pharmaceuticals, Inc. (Nasdaq:CASI), ('CASI' or the 'Company'), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced that it will host a live conference call and webcast at 8:00 a.m. PT/11:00 a.m. ET on Wednesday, May 21, 2025 to provide business and clinical update. A registration link and live webcast of the call is available below: The presentation materials will be available in the Investors section of CASI's website after the conference call. Further information regarding the Company can be found at About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its focus on hematology oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease, as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at CASI 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 possibility that 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 possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; 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 result 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; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; 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 and CEO that differ from our other shareholders; risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. and risks related to our disagreement with Acrotech with respect to the termination of agreements regarding EVOMELA®. 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® is proprietary to Acrotech Biopharma Inc. and its proprietary to Acrotech Biopharma Inc and its affiliates. The Company is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA® and refer to the Company's filings with the U.S. Securities and Exchange Commission for further information. COMPANY CONTACT: Rui Zhang CASI Pharmaceuticals, Inc. 240.864.2643 [email protected] SOURCE: CASI Pharmaceuticals press release
Yahoo
02-04-2025
- Business
- Yahoo
CASI Pharmaceuticals Full Year 2024 Earnings: US$2.56 loss per share (vs US$2.02 loss in FY 2023)
Revenue: US$28.5m (down 16% from FY 2023). Net loss: US$39.3m (loss widened by 46% from FY 2023). US$2.56 loss per share (further deteriorated from US$2.02 loss in FY 2023). We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. All figures shown in the chart above are for the trailing 12 month (TTM) period CASI Pharmaceuticals shares are down 11% from a week ago. Before we wrap up, we've discovered 3 warning signs for CASI Pharmaceuticals (1 is a bit unpleasant!) that you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
Yahoo
02-04-2025
- Business
- Yahoo
CASI Pharmaceuticals Full Year 2024 Earnings: US$2.56 loss per share (vs US$2.02 loss in FY 2023)
Revenue: US$28.5m (down 16% from FY 2023). Net loss: US$39.3m (loss widened by 46% from FY 2023). US$2.56 loss per share (further deteriorated from US$2.02 loss in FY 2023). We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. All figures shown in the chart above are for the trailing 12 month (TTM) period CASI Pharmaceuticals shares are down 11% from a week ago. Before we wrap up, we've discovered 3 warning signs for CASI Pharmaceuticals (1 is a bit unpleasant!) that you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Yahoo
27-02-2025
- Business
- Yahoo
BioInvent International AB: Year-End Report January 1 - December 31, 2024
LUND, SWEDEN / / February 27, 2025 / BioInvent International (STO:BINV) "2024 was a year with several exciting developments reported from across our broad portfolio of clinical programs. We now have two Phase 2 and four Phase 1 trials running in our six clinical programs leveraging the TNFR2 and FcyRIIB targets. Throughout the year, we pursued building our business by expanding our management team and signing important clinical collaboration and supply agreements with key partners." - Martin Welschof CEO of BioInvent. EVENTS IN THE FOURTH QUARTER First patient enrolled in Phase 1b/2a study of the company's second anti-FcyRIIB antibody, BI-1607, in combination with ipilimumab and KEYTRUDA® (pembrolizumab) in patients with unresectable or metastatic melanoma Expanded management team with appointment of Ashley Robinson as SVP of Strategy and Finance EVENTS AFTER THE END OF THE PERIOD (R) Positive initial efficacy data from Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab and Calquence® for the treatment of non-Hodgkin's Lymphoma (NHL) (R) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 as monotherapy for the treatment of solid tumors BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency Composition of matter patent for the BI-1808 antibody granted in Japan. It also covers the use of the antibody in the treatment of cancer. EARLIER DURING 2024, IN BRIEF (R) Additional positive efficacy data with single agent BI-1808 from the Phase 2a anti-TNFR2 program (R) Phase 1 data for BI-1206 in combination with KEYTRUDA in patients with solid tumors presented at ASCO 2024 (R) Clinical efficacy and excellent safety for anti-TNFR2 agent BI-1808 presented at ASCO 2024 (R) Phase 1/2a data presented at EHA 2024 for BI-1206 with rituximab in NHL (R) CASI Pharmaceuticals reported positive interim Phase 1 data for BI-1206 in the treatment of relapsed/refractory indolent NHL in China ESMO presentations highlighting progress from the Phase 1 trial of BI-1910 monotherapy in solid tumors and Phase 1 trial of the oncoloytic virus BT-001 (anti-CTLA-4) as a single agent and in combination with KEYTRUDA® (pembrolizumab) in patients with solid tumors Two clinical trial collaboration and supply agreements signed with MSD to evaluate BI-1607 in combination with KEYTRUDA and ipilimumab, and to evaluate BI-1910 in combination with KEYTRUDA PAGE 2024 presentation showcased model-informed development of BI-1808 Clinical supply agreement signed with AstraZeneca (LSE/STO/Nasdaq: AZN) to evaluate BioInvent's anti-FcyRIIB antibody, BI-1206, in combination with rituximab and Calquence (acalabrutinib), in a Phase 1/2a study in NHL ANTICIPATED 2025 MILESTONES Additional Phase 2a monotherapy data of BI-1808 in solid tumors and T-cell lymphoma to be shared in mid-2025 Data from the ongoing Phase 2a trial of BI-1206 in combination with rituximab and Calquence (acalabrutinib) in NHL expected in mid-2025 Phase 1 data of BI-1206 as a subcutaneous formulation in combination with KEYTRUDA in solid tumors anticipated in mid-2025 First BI-1910 Phase 2a single agent data expected H2 2025 Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab expected H2 2025 Data from Phase 2a dose-expansion study of BI-1808 in combination with KEYTRUDA in patients with advanced solid tumors and T-cell lymphoma anticipated in H2 2025 Initial data from the Phase 1b trial evaluating BI-1607 in combination with ipilimumab and KEYTRUDA in patients with unresectable or metastatic melanoma expected in H2 2025 (R)= Regulatory event FINANCIAL INFORMATIONFourth quarter 2024• Net sales SEK 21.4 (15.3) million.• Profit/loss after tax SEK -116.9 (-97.2) million.• Profit/loss after tax per share before and after dilution SEK -1.78 (-1.48) • Cash flow from operating activities SEK -98.3 (-72.4) million. January - December 2024• Net sales SEK 44.7 (71.5) million.• Profit/loss after tax SEK -429.4 (-330.3) million.• Profit/loss after tax per share before and after dilution SEK -6.53 (-5.02).• Cash flow from operating activities SEK -380.5 (-341.7) million.• Liquid funds, current and long-term investments as of December 31, 2024: SEK 867.2 (1,283.0) million. The complete interim report is available for download below and on the company's website under Financial reports . INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2024BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in Thursday February 27, 2025, at 4:00 pm CET The webcast can be reached at If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the The conference call will be made available on the company website after the call. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory drug candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at For further information, please contact:Cecilia Hofvander, VP Investor Relations+46 (0)46 286 85 BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 Attachments BioInvent Q4, 2024 EN Final SOURCE: BioInvent International View the original press release on ACCESS Newswire Sign in to access your portfolio
