Ankündigung • Apr 22
CASI Pharmaceuticals, Inc. announced delayed 20-F filing On 04/21/2026, CASI Pharmaceuticals, Inc. announced that they will be unable to file their next 20-F by the deadline required by the SEC. Ankündigung • Apr 21
CASI Pharmaceuticals, Inc. announced that it has received $20 million in funding from ETP Global III Fund LP On April 20, 2026. CASI Pharmaceuticals, Inc. announced that it has closed the transaction. Ankündigung • Feb 27
CASI Pharmaceuticals, Inc.(OTCPK:CASI.F) dropped from NASDAQ Composite Index CASI Pharmaceuticals, Inc. has been dropped from the NASDAQ composite Index. New Risk • Feb 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 24% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Negative equity (-US$29m). Shareholders have been substantially diluted in the past year (33% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Market cap is less than US$100m (US$16.4m market cap). Ankündigung • Jan 23
CASI Pharmaceuticals Reports the Failure to Renew the Import Drug Registration License for FOLOTYN in China CASI Pharmaceuticals, Inc. reported that, following prior correspondence from the Chinese Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) that the Company's renewal application submitted in May 2025 for the Import Drug Registration License for FOLOTYN was not granted, the Company received a formal notice from the NMPA that the Company's renewal application was not approved. Ankündigung • Dec 11
CASI Pharmaceuticals, Inc. announced that it expects to receive $20 million in funding from Emerging Technology Partners, LLC CASI Pharmaceuticals, Inc. announced that has entered into a convertible note purchase agreement pursuant to which the Company will issue and sell convertible notes in an aggregate principal amount of $20,000,000 to the Purchaser through a private placement on December 11, 2025. The transaction includes participation from returning investor ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He. The sale of the convertible notes will be in tranches and subject to multiple closings with certain closing conditions, including Purchaser being satisfied with the business results and financials status of the Company and the use of proceeds upon each closing. Each convertible note issued pursuant to the Purchase Agreement will mature in 36 months, bearing interest of 12% per annum from the issuance date. Upon maturity, each note may, at the Company’s option, be convertible into ordinary shares of the Company, par value $0.0001 per share (the “Shares”), at a conversion price of the volume weighted average closing price of the Company’s Shares during the five consecutive trading days immediately preceding the maturity date. The Purchaser also has the right to convert each note into Shares at any time from and including the 91st day after the issuance thereof to and including the maturity date at a conversion price of the volume weighted average closing price of the Company’s Shares during the five consecutive trading days immediately preceding the date of conversion notice by the Purchaser. In no event shall the conversion price be higher than $2 per ordinary Share or lower than $1 per Share. Major Estimate Revision • Dec 10
Consensus EPS estimates fall by 12% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$2.31 to -US$2.58 per share. Revenue forecast of US$13.5m unchanged since last update. Biotechs industry in the US expected to see average net income decline 7.4% next year. Consensus price target of US$4.00 unchanged from last update. Share price fell 10% to US$0.84 over the past week. New Risk • Nov 20
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 37% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$29m). Shareholders have been substantially diluted in the past year (37% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$24.7m market cap). Reported Earnings • Nov 17
Third quarter 2025 earnings released: US$0.68 loss per share (vs US$0.55 loss in 3Q 2024) Third quarter 2025 results: US$0.68 loss per share (further deteriorated from US$0.55 loss in 3Q 2024). Revenue: US$3.08m (down 61% from 3Q 2024). Net loss: US$10.9m (loss widened 30% from 3Q 2024). Revenue is expected to decline by 35% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 22%. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 12% per year, which means it is performing significantly worse than earnings. Ankündigung • Sep 28
CASI Pharmaceuticals, Inc. Announces Appointment of James Huang as an Independent Director Effective as of October 1, 2025 CASI Pharmaceuticals, Inc. announced the appointment of James Huang as an Independent Director to the CASI Board of Directors, effective as of October 1, 2025. Mr. Huang brings over 35 years of experience building and investing in biopharma companies globally. As Founder and Managing Partner of Panacea Venture, and previously Managing Partner at Kleiner Perkins (KPCB) China and Vivo Ventures, he has guided numerous cross-border companies through critical stages of growth, financing, and global expansion. Earlier in his career, he held senior roles in business development, sales & marketing, and research & development at Tularik Inc. (acquired by Amgen), GlaxoSmithKline LLC, Bristol-Myers Squibb and ALZA Corp. (acquired by Johnson & Johnson). Mr. Huang serves as a member of the board of directors of Kindstar Globalgene Technology, Inc., Connect Biopharma Holdings Limited, Lee’s Pharmaceutical Holdings Limited, Atara Biotherapeutics, Inc., and several private companies. He received an M.B.A. from the Stanford Graduate School of Business and a B.S. degree in chemical engineering from the University of California, Berkeley. Major Estimate Revision • Sep 05
Consensus revenue estimates fall by 17% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$12.5m to US$10.4m. Forecast losses increased from -US$2.07 to -US$2.31 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$4.00 unchanged from last update. Share price was steady at US$2.34 over the past week. Reported Earnings • Aug 31
Second quarter 2025 earnings: EPS and revenues miss analyst expectations Second quarter 2025 results: US$0.86 loss per share (further deteriorated from US$0.52 loss in 2Q 2024). Revenue: US$4.18m (up 4.9% from 2Q 2024). Net loss: US$13.4m (loss widened 92% from 2Q 2024). Revenue missed analyst estimates by 33%. Earnings per share (EPS) also missed analyst estimates by 83%. Revenue is expected to decline by 42% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. New Risk • Aug 04
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$29m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Minor Risks Negative equity (-US$8.1m). Currently unprofitable and not forecast to become profitable over next 3 years (US$31m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$20.0m market cap). Ankündigung • Jul 23
CASI Pharmaceuticals, Inc., Annual General Meeting, Aug 20, 2025 CASI Pharmaceuticals, Inc., Annual General Meeting, Aug 20, 2025. Location: 3500 - 1133 melville street, british columbia, v6e4e5, vancouver Canada New Risk • Jun 17
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$29m free cash flow). Minor Risks Negative equity (-US$8.1m). Currently unprofitable and not forecast to become profitable over next 3 years (US$31m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$28.5m market cap). Major Estimate Revision • May 23
Consensus revenue estimates decrease by 33% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$18.8m to US$12.5m. EPS estimate unchanged from -US$2.07 per share at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$4.00 unchanged from last update. Share price fell 3.7% to US$1.87 over the past week. New Risk • May 18
New minor risk - Negative shareholders equity The company has negative equity. Total equity: -US$8.1m This is considered a minor risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. It should be noted that some of the negative equity could be due to large buybacks of stock, which is not as much of a risk as a company with overwhelming debt, but likewise is not sustainable in the long-term. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$29m free cash flow). Minor Risks Negative equity (-US$8.1m). Currently unprofitable and not forecast to become profitable over next 3 years (US$26m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$30.1m market cap). Reported Earnings • May 18
First quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2025 results: US$0.69 loss per share. Revenue: US$6.24m (up 83% from 1Q 2024). Net loss: US$10.8m (loss widened 13% from 1Q 2024). Revenue exceeded analyst estimates by 2.3%. Earnings per share (EPS) missed analyst estimates by 13%. Revenue is expected to decline by 44% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 17%. Ankündigung • Apr 10
Discontinuation of Litigation and Arbitration Demand with Acrotech CASI Pharmaceuticals, Inc. announced the recent developments on its dispute with Acrotech Biopharma Inc. (“Acrotech”). As the Company previously disclosed, Acrotech filed a complaint against the Company on March 4, 2025 in New York state court in New York County (the “Court”) in relation to Acrotech’s purported termination of certain License Agreement (the “License Agreement”), dated September 17, 2014, between Spectrum Pharmaceuticals, Inc. and the Company granting the exclusive rights to the Company to commercialize Evomela® in China, which was later assigned to Acrotech on March 1, 2019. Following the Court’s decisions on March 10, 2025 that denied Acrotech’s application for a temporary restraining order and granted the Company additional time to respond to Acrotech’s application for a preliminary injunction, the Company submitted its opposition to Acrotech’s preliminary injunction application on April 1, 2025. While the Court scheduled a hearing on April 10, 2025 regarding Acrotech’s preliminary injunction application and CASI’s opposition, Acrotech filed a Notice of Voluntary Discontinuance without Prejudice with the Court on April 7, 2025, voluntarily dismissing its complaint against the Company without prejudice. Separately, on April 7, 2025, the International Centre for Dispute Resolution of the American Arbitration Association (the “AAA”) issued a letter acknowledging receipt of CASI’s Demand for Arbitration against Acrotech in relation to its purported termination of the License Agreement among other things. The AAA arbitration proceedings are in their initial stage. The Company will continue to take all other necessary legal actions to assert and protect its legal rights. The Company cannot predict right now the final outcome of the arbitration proceedings or how the parties’ dispute would ultimately be resolved. Reported Earnings • Apr 01
Full year 2024 earnings released: US$2.56 loss per share (vs US$2.02 loss in FY 2023) Full year 2024 results: US$2.56 loss per share (further deteriorated from US$2.02 loss in FY 2023). Revenue: US$28.5m (down 16% from FY 2023). Net loss: US$39.3m (loss widened 46% from FY 2023). Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 33% per year, which means it is significantly lagging earnings. Ankündigung • Jan 06
CASI Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 1/2 Clinical Trial of CID-103 in Immune Thrombocytopenia CASI Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monOClonal antibodies. Ankündigung • Dec 27
CASI Pharmaceuticals, Inc. Announces Clinical Hold of CID-103 for Antibody Mediated Rejection (AMR) of Kidney Transplant On December 26, 2024, CASI Pharmaceuticals, Inc. announced that it was was informed via a teleconference with the FDA that CID-103, anti-CD38 antibody, Investigational New Drug (IND) for the treatment of AMR has been placed on clinical hold. FDA plans to provide a formal written response before the statutory deadline. The CID-103 IND application supporting a phase 1-2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP) remains open and accrual to the study is expected to commence in first quarter of 2025. New Risk • Nov 26
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$27m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (US$76.7m market cap). Reported Earnings • Nov 17
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: US$0.55 loss per share (further deteriorated from US$0.35 loss in 3Q 2023). Revenue: US$7.79m (down 12% from 3Q 2023). Net loss: US$8.40m (loss widened 81% from 3Q 2023). Revenue exceeded analyst estimates by 71%. Earnings per share (EPS) also surpassed analyst estimates by 11%. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. Ankündigung • Oct 25
CASI Pharmaceuticals, Inc. Receives CTA Approval From China's NMPA for CID-103 in Immune Thrombocytopenia CASI Pharmaceuticals, Inc. announced that the Center for Drug Evaluation (CDE) of China'sNational Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to proceed with a phase 1/2 study of CID-103 in adults patients with chronic Immune Thrombocytopenia (ITP) in China. This China study is part of the global study that was approved by the US FDA in May 2024.CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. Ankündigung • Sep 12
CASI Pharmaceuticals, Inc. Announces Change of Senior Management Positions CASI Pharmaceuticals, Inc. announced that, to support the strategic pivot of business operations and streamline the internal management reporting, effective from September 10, 2024, the position of President of the Company was removed, and instead a Senior Vice President in charge of coordination and management of synergistic projects between China and US and management of certain key projects was created. Mr. Wei (Larry) Zhang was appointed as the Senior Vice President. Reported Earnings • Aug 18
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: US$0.52 loss per share (improved from US$0.77 loss in 2Q 2023). Revenue: US$3.98m (down 60% from 2Q 2023). Net loss: US$6.97m (loss narrowed 32% from 2Q 2023). Revenue missed analyst estimates by 10%. Earnings per share (EPS) exceeded analyst estimates by 17%. Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. New Risk • Aug 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (18% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (US$97.8m market cap). Ankündigung • Jun 05
CASI Pharmaceuticals, Inc. to Report Q3, 2024 Results on Nov 14, 2024 CASI Pharmaceuticals, Inc. announced that they will report Q3, 2024 results on Nov 14, 2024 Major Estimate Revision • May 21
Consensus revenue estimates fall by 67% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$59.2m to US$19.8m. Forecast losses increased from US$0.00 to -US$2.56 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target down from US$12.00 to US$6.00. Share price fell 2.5% to US$3.09 over the past week. Reported Earnings • May 16
First quarter 2024 earnings: EPS and revenues miss analyst expectations First quarter 2024 results: US$0.71 loss per share (further deteriorated from US$0.45 loss in 1Q 2023). Revenue: US$3.41m (down 59% from 1Q 2023). Net loss: US$9.53m (loss widened 59% from 1Q 2023). Revenue missed analyst estimates by 72%. Earnings per share (EPS) also missed analyst estimates significantly. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 40% per year, which means it is significantly lagging earnings. Breakeven Date Change • May 16
No longer forecast to breakeven The analyst covering CASI Pharmaceuticals no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$37.0k in 2024. New forecast suggests the company will make a loss of US$28.4m in 2026. Ankündigung • May 16
CASI Pharmaceuticals Receives FDA Clearance on the Investigational New Drug (IND) Application for CID-103 in Immune Thrombocytopenia CASI Pharmaceuticals, Inc. announced the following: On April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP). On May 13, 2024 CASI received a letter from FDA indicating that study may proceed. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique. New Risk • May 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$27m Forecast net loss in 3 years: US$28m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$41.2m market cap). Ankündigung • Apr 09
CASI Pharmaceuticals, Inc. to Report Q2, 2024 Results on Aug 20, 2024 CASI Pharmaceuticals, Inc. announced that they will report Q2, 2024 results on Aug 20, 2024 Reported Earnings • Apr 01
Full year 2023 earnings: EPS and revenues miss analyst expectations Full year 2023 results: US$2.02 loss per share (improved from US$3.01 loss in FY 2022). Revenue: US$33.9m (down 21% from FY 2022). Net loss: US$27.0m (loss narrowed 34% from FY 2022). Revenue missed analyst estimates by 7.0%. Earnings per share (EPS) also missed analyst estimates by 4.7%. Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 45% per year, which means it is significantly lagging earnings. Ankündigung • Mar 06
CASI Pharmaceuticals Report Positive Interim Phase 1 Data for BI-1206 in the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma in China CASI Pharmaceuticals, Inc. and BioInvent International AB announced preliminary encouraging efficacy data for BI-1206 in combination with rituximab in patients with relapsed/refractory (R/R) indolent Non-Hodgkin's Lymphoma (iNHL) in the ongoing development program in China. The results are consistent with the clinical data that have been previously reported by BioInvent. BI-1206 is being developed to re-establish the clinical efficacy of cancer therapies such as rituximab by addressing fundamental resistance mechanisms to cancer treatments. The clinical efficacy results reported, including a long-lasting complete response, reinforce previously reported data. Ankündigung • Feb 16
Casi Pharmaceuticals Announces First Dose of Folotyn in China CASI Pharmaceuticals, Inc. announced the administration of the first dose of FOLOTYN® (Pralatrexate Injection) to a patient in China. This remarks a pivotal step in CASI's commitment to addressing critical medical needs in peripheral T-cell lymphoma in China market. FOLOTYN® (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL"). Compared with methotrexate, pralatrexate could be more effectively internalized into tumor cells which may translate to a greater anti-cancer effect. Clinical studies have demonstrated that pralatrexate has significant activity against PTCL1. With the results of an overall response rate ("ORR") of 52% and a median progression-free survival ("PFS") of 4.8 months from the Chinese registrational study2, in comparison to an ORR of 29% and a median PFS of 3.5 months from the PROPEL study3 in the US. Pralatrexate was approved in the United States, Japan and China as treatment for PTCL. Pralatrexate is a promising treatment option for Chinese patients with relapsed or refractory PTCL. Ankündigung • Feb 12
CASI Pharmaceuticals, Inc. Announces Resignation of Fuqiang Zhang as Chief Commercial Officer CASI Pharmaceuticals, Inc. announced On February 8, 2024, Mr. Fuqiang Zhang tendered his resignation as the Chief Commercial Officer (the “COO”) of the company, with immediate effect. Mr. Zhang’s decision to resign was not a result of any disagreements with the Company on any matter related to the operations, policies, or practices of the Company. The Company currently has no plan to appoint a new COO. The Company’s Global Chief Commercial Officer will continue to lead the efforts of the Company on the establish of business system and market expansion. Ankündigung • Jan 31
CASI Pharmaceuticals, Inc. Appoints of Mr. Huang Hai as the Global Chief Commercial Officer CASI Pharmaceuticals, Inc. announced the appointment of Mr. Huang Hai as the Global Chief Commercial Officer (Executive Vice President) of CASI China, effective January 29, 2024. Mr. Huang will be instrumental in leading the development of CASI's global commercialization strategy, overseeing the establishment of a global business system, and managing market expansion and strategic business partnerships. Mr. Huang, holding a Bi-MBA from Peking University and an undergraduate degree in Biochemistry from Lanzhou University, has over 27 years of experience in the pharmaceutical industry. Prior to joining CASI, Mr. Huang held the CEO role at Fosun Kite and senior executive roles at multinational pharmaceutical companies such as Pfizer China, Medtronic and Sanofi, where he was accountable for general business operation and management, and earlier marketing, sales and brand management, to drive business growth and market share. Mr. Huang currently also holds positions as the Executive Director of the Shanghai CGT Special Committee and as a member of the Shanghai Industry-Academia-Research Expert Group Committee. Reported Earnings • Nov 17
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: US$0.35 loss per share (improved from US$0.38 loss in 3Q 2022). Revenue: US$8.84m (down 14% from 3Q 2022). Net loss: US$4.64m (loss narrowed 11% from 3Q 2022). Revenue missed analyst estimates by 15%. Earnings per share (EPS) exceeded analyst estimates by 38%. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings. Breakeven Date Change • Nov 16
Forecast to breakeven in 2024 The analyst covering CASI Pharmaceuticals expects the company to break even for the first time. New forecast suggests losses will reduce by 37% to 2023. The company is expected to make a profit of US$37.0m in 2024. Average annual earnings growth of 64% is required to achieve expected profit on schedule. Reported Earnings • Aug 13
Second quarter 2023 earnings: EPS and revenues miss analyst expectations Second quarter 2023 results: US$0.77 loss per share (further deteriorated from US$0.56 loss in 2Q 2022). Revenue: US$9.82m (up 14% from 2Q 2022). Net loss: US$10.2m (loss widened 33% from 2Q 2022). Revenue missed analyst estimates by 2.7%. Earnings per share (EPS) also missed analyst estimates by 54%. Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 50% per year, which means it is significantly lagging earnings. Ankündigung • Aug 08
CASI Pharmaceuticals, Inc. to Report Q3, 2023 Results on Nov 01, 2023 CASI Pharmaceuticals, Inc. announced that they will report Q3, 2023 results on Nov 01, 2023 Ankündigung • Jun 20
CASI Pharmaceuticals, Inc.(NasdaqCM:CASI) dropped from S&P TMI Index CASI Pharmaceuticals, Inc.(NasdaqCM:CASI) dropped from S&P TMI Index Major Estimate Revision • May 24
Consensus EPS estimates upgraded to US$1.88 loss, revenue downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$44.2m to US$43.4m. 2023 losses expected to reduce from -US$2.24 to -US$1.88 per share. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target of US$10.00 unchanged from last update. Share price fell 18% to US$2.05 over the past week. Reported Earnings • Apr 27
Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2022 results: US$3.01 loss per share (further deteriorated from US$2.69 loss in FY 2021). Revenue: US$43.1m (up 43% from FY 2021). Net loss: US$41.0m (loss widened 12% from FY 2021). Revenue exceeded analyst estimates by 12%. Earnings per share (EPS) missed analyst estimates by 82%. Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. Board Change • Mar 26
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 6 highly experienced directors. Independent Director Quan Zhou was the last director to join the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Ankündigung • Jan 07
CASI Pharmaceuticals, Inc. Announces Clinical Trial Application Approval for CB-5339 in Patients with Multiple Myeloma in China CASI Pharmaceuticals, Inc. announced that the China National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) for CB-5339, a first-in-class VCP/p97 inhibitor from Cleave Therapeutics. CASI is planning a Phase 1 development program in China of CB-5339 as a single agent to evaluate the PK/safety profile, select the Recommended Phase 2 Dose, and assess early signs of clinical efficacy. The Phase 1 development program is expected to start in 2023. CB-5339 is an oral second-generation, small molecule VCP/p97 inhibitor, and is currently being evaluated by Cleave Therapeutics in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (NCT04402541). VCP/p97 inhibitors exploit molecular features that define cancer cell growth and metabolism. VCP/p97 plays a critical role in protein homeostasis processes such as endoplasmic reticulum associated degradation (ERAD) and chromatin-associated degradation (CAD), as well as the DNA damage response (DDR). These key cellular stress pathways are known to represent sensitivities critical to cancer cell survival. Cellular stress provides an attractive means of targeting non-oncogene addiction as a way to combat tumor heterogeneity and emerging resistance to targeted therapies. Such an approach has the added benefit of broad applicability, not dependent on a single driver mutation and potential efficacy across cancer types. Major Estimate Revision • Nov 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$1.33 to -US$1.65 per share. Revenue forecast unchanged at US$39.7m. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target down from US$22.67 to US$18.33. Share price was steady at US$1.87 over the past week. Breakeven Date Change • Nov 17
Forecast to breakeven in 2024 The 3 analysts covering CASI Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 19% per year to 2023. The company is expected to make a profit of US$5.46m in 2024. Average annual earnings growth of 78% is required to achieve expected profit on schedule. Price Target Changed • Nov 16
Price target decreased to US$18.33 Down from US$22.67, the current price target is an average from 3 analysts. New target price is 870% above last closing price of US$1.89. Stock is down 81% over the past year. The company is forecast to post a net loss per share of US$2.16 next year compared to a net loss per share of US$2.69 last year. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 6 highly experienced directors. Independent Director Quan Zhou was the last director to join the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Major Estimate Revision • Aug 19
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$2.15 to -US$1.33 per share. Revenue forecast steady at US$40.0m. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target down from US$37.00 to US$22.67. Share price was steady at US$3.50 over the past week. Price Target Changed • Aug 16
Price target decreased to US$22.67 Down from US$37.00, the current price target is an average from 3 analysts. New target price is 600% above last closing price of US$3.24. Stock is down 74% over the past year. The company is forecast to post a net loss per share of US$1.33 next year compared to a net loss per share of US$2.69 last year. Reported Earnings • Aug 12
Second quarter 2022 earnings: EPS and revenues exceed analyst expectations Second quarter 2022 results: US$0.56 loss per share (down from US$0.50 loss in 2Q 2021). Revenue: US$8.57m (up 20% from 2Q 2021). Net loss: US$7.68m (loss widened 11% from 2Q 2021). Revenue exceeded analyst estimates by 8.9%. Earnings per share (EPS) also surpassed analyst estimates by 12%. Over the next year, revenue is forecast to grow 55%, compared to a 51% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Recent Insider Transactions • Jun 19
Chairman & CEO recently bought US$273k worth of stock On the 15th of June, Wei-Wu He bought around 88k shares on-market at roughly US$3.09 per share. This was the largest purchase by an insider in the last 3 months. Wei-Wu has been a buyer over the last 12 months, purchasing a net total of US$1.3m worth in shares. Price Target Changed • Jun 03
Price target decreased to US$37.00 Down from US$43.33, the current price target is an average from 3 analysts. New target price is 1,028% above last closing price of US$3.28. Stock is down 81% over the past year. The company is forecast to post a net loss per share of US$2.15 next year compared to a net loss per share of US$2.69 last year. Breakeven Date Change • May 16
No longer forecast to breakeven The 3 analysts covering CASI Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$12.6m in 2024. New consensus forecast suggests the company will make a loss of US$28.6m in 2024. Reported Earnings • May 13
First quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2022 results: US$0.062 loss per share (up from US$0.11 loss in 1Q 2021). Revenue: US$9.06m (up 58% from 1Q 2021). Net loss: US$8.60m (loss narrowed 38% from 1Q 2021). Revenue missed analyst estimates by 2.0%. Earnings per share (EPS) exceeded analyst estimates by 31%. Over the next year, revenue is forecast to grow 50%, compared to a 25% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Price Target Changed • Apr 27
Price target increased to US$4.67 Up from US$4.20, the current price target is an average from 3 analysts. New target price is 890% above last closing price of US$0.47. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.27 last year. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 4 highly experienced directors. Independent Director Quan Zhou was the last director to join the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Major Estimate Revision • Apr 04
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$0.25 to -US$0.34 per share. Revenue forecast unchanged at US$41.5m. Biotechs industry in the US expected to see average net income decline 47% next year. Consensus price target of US$4.67 unchanged from last update. Share price fell 22% to US$0.71 over the past week. Reported Earnings • Mar 29
Full year 2021 earnings: EPS misses analyst expectations Full year 2021 results: US$0.27 loss per share (up from US$0.44 loss in FY 2020). Revenue: US$30.2m (up 99% from FY 2020). Net loss: US$36.7m (loss narrowed 24% from FY 2020). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 11%. Over the next year, revenue is forecast to grow 31%, compared to a 65% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 31% per year, which means it is significantly lagging earnings. Price Target Changed • Feb 19
Price target increased to US$4.67 Up from US$4.20, the current price target is an average from 3 analysts. New target price is 425% above last closing price of US$0.89. Stock is down 68% over the past year. The company is forecast to post a net loss per share of US$0.30 next year compared to a net loss per share of US$0.44 last year. Breakeven Date Change • Jan 01
Forecast to breakeven in 2024 The 4 analysts covering CASI Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$27.8m in 2024. Average annual earnings growth of 62% is required to achieve expected profit on schedule. Recent Insider Transactions • Nov 25
Chairman & CEO recently bought US$394k worth of stock On the 18th of November, Wei-Wu He bought around 400k shares on-market at roughly US$0.98 per share. This was the largest purchase by an insider in the last 3 months. Wei-Wu has been a buyer over the last 12 months, purchasing a net total of US$1.0m worth in shares. Reported Earnings • Nov 13
Third quarter 2021 earnings released: US$0.073 loss per share (vs US$0.14 loss in 3Q 2020) The company reported a solid third quarter result with reduced losses, improved revenues and improved control over expenses. Third quarter 2021 results: Revenue: US$8.11m (up 91% from 3Q 2020). Net loss: US$10.2m (loss narrowed 40% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 5% per year but the company’s share price has fallen by 36% per year, which means it is performing significantly worse than earnings. Recent Insider Transactions • Aug 22
Chairman & CEO recently bought US$614k worth of stock On the 19th of August, Wei-Wu He bought around 480k shares on-market at roughly US$1.28 per share. This was the largest purchase by an insider in the last 3 months. Wei-Wu has been a buyer over the last 12 months, purchasing a net total of US$1.1m worth in shares. Reported Earnings • Aug 14
Second quarter 2021 earnings released: US$0.05 loss per share (vs US$0.086 loss in 2Q 2020) The company reported a solid second quarter result with reduced losses, improved revenues and improved control over expenses. Second quarter 2021 results: Revenue: US$7.16m (up 168% from 2Q 2020). Net loss: US$6.95m (loss narrowed 20% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 44% per year, which means it is performing significantly worse than earnings. Price Target Changed • Aug 13
Price target increased to US$4.45 Up from US$3.95, the current price target is an average from 5 analysts. New target price is 240% above last closing price of US$1.31. Stock is down 32% over the past year.