Casi Pharmaceuticals Inc Stock Price, News & Analysis

CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced on March 30, 2022, that it was provisionally identified by the SEC under the Holding Foreign Companies Accountable Act (HFCAA) for using an auditor not subject to PCAOB inspection. This was expected by CASI following their recent Form 10K filing on March 28, 2022. The company is exploring strategic options to comply with HFCAA requirements. CASI focuses on developing therapeutics in oncology, particularly for the Greater China market, leveraging its subsidiary in Beijing.

CASI Pharmaceuticals reported $9.12 million in EVOMELA® revenue for Q4 2021, marking 100% growth for the year, with total revenue reaching $30 million. The company aims for continued growth through its commercial franchise in 2022, with anticipated milestones including NDA filing for CNCT19 and initiation of BI-1206 Phase I trials. Despite increased R&D and marketing costs leading to a net loss of $35.8 million, CASI’s cash position stands at $38.7 million. The company sees EVOMELA as central to its operations moving forward.

CASI Pharmaceuticals (Nasdaq: CASI) announced a conference call scheduled for March 28, 2022, at 8:00 a.m. EDT, to review its financial results for Q4 and the year ended December 31, 2021. The call will be led by the Company's Chairman & CEO, who will discuss business updates and upcoming milestones. Investors can access the call via a local and international dialing system, with a replay option available afterward.

CASI focuses on developing innovative therapeutics in hematology and oncology, primarily targeting the greater China market.

CASI Pharmaceuticals (Nasdaq: CASI) has renewed an exclusive distribution agreement with China Resources Pharmaceutical Commercial Group for EVOMELA® (melphalan) sales in China. This partnership has contributed to rapid revenue growth, reaching $30 million in 2021. The collaboration enhances distribution efficiency, increasing accessibility for healthcare providers and patients. CASI aims to strengthen its market position in China through this agreement and its dedicated hematology oncology sales team.

CASI Pharmaceuticals, Inc. (Nasdaq: CASI) reported preliminary unaudited revenues of approximately $9.12 million for Q4 2021 and $30 million for the full year, exceeding its projected $27 million guidance and marking a significant 100% increase from 2020's $15 million. The company anticipates more than 30% growth in EVOMELA revenue for 2022. Key developments include ongoing clinical trials for pipeline products, with a focus on the commercialization of CNCT-19 and approvals for CB-5339 and BI-1206 expected this year.

CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced that the FDA granted Orphan Drug Designation (ODD) to its partner BioInvent International AB for BI-1206, an investigational antibody targeting follicular lymphoma (FL). This designation supports the ongoing clinical trials for BI-1206, which is being studied in combination with rituximab and Keytruda for treating various lymphomas and solid tumors. Dr. Wei-Wu He highlighted the significance of this designation, noting the potential for innovative cancer therapies and ongoing preparations for clinical studies in China.

CASI Pharmaceuticals announced that the U.S. FDA has granted Orphan Drug Designation to its partner, Juventas Cell Therapy, for CNCT19, a CD-19 directed CAR-T therapy aimed at treating Acute Lymphoblastic Leukemia (ALL). This designation supports the ongoing Phase II trials of CNCT19, which is already approved in China for relapsed/refractory B-ALL and B-NHL. CASI holds worldwide co-commercial rights and plans to commence global commercialization as regulatory advancements occur.

CASI Pharmaceuticals, Inc. (Nasdaq: CASI) received a deficiency letter from Nasdaq on December 30, 2021, indicating its stock had closed below the $1.00 minimum bid price for 30 consecutive business days. CASI has until June 28, 2022, to regain compliance by maintaining a bid price of $1.00 or more for 10 consecutive days. If compliance isn't achieved, CASI may seek a second 180-day compliance period or face potential delisting. The company is considering options, including a reverse stock split, and will actively monitor its stock price.

CASI Pharmaceuticals (NASDAQ: CASI) has announced a stock repurchase program allowing for the buyback of up to USD 10 million worth of its shares, equating to no more than 12,500,000 shares. This initiative, approved by the board, reflects CASI's confidence in its business model and aims to enhance shareholder value. The buyback will occur through open market purchases, subject to market conditions and regulations. Funding will be sourced from corporate funds, including cash on hand.