CASI Pharmaceuticals (CASI) AI Stock Analysis

• Market Cap: $29.51M
• Dividend Yield: N/A
• Average Volume (3M): 327.14K
• Price to Earnings (P/E): ―
• Beta (1Y): 0.81
• Revenue Growth: 41.43%
• EPS Growth: -50.12%
• Country: US
• Employees: 233
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.86
• Shares Outstanding: 15,492,681
• 10 Day Avg. Volume: 71,923
• 30 Day Avg. Volume: 327,142
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 1.03
• Enterprise Value/Revenue: 1.42
• Enterprise Value/Gross Profit: 2.58
• Enterprise Value/Ebitda: -0.97
• 1Y Price Target: $4.00
• Price Target Upside: 124.72% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 1

• Rating: 46 Neutral
• Price Target: $1.50 ▼(-15.73% Downside)

CASI Pharmaceuticals' overall stock score is primarily impacted by its weak financial performance, characterized by declining revenue and high leverage. While technical analysis shows some positive momentum, poor valuation metrics due to significant losses further drag down the score.

Positive Factors

Strategic Leadership Change

The appointment of David Cory as CEO, with his extensive experience, is expected to enhance CASI's operations and focus on the CID-103 program, potentially strengthening market position and delivering long-term value.

FDA Clearance for CID-103

FDA clearance for CID-103 allows CASI to initiate clinical trials, positioning the company to address significant challenges in kidney transplantation, potentially enhancing its market presence.

Board Strengthening

The addition of Dr. Krebs-Pohl to the board brings valuable expertise in biologics development and strategic partnerships, supporting CASI's growth and development initiatives.

Negative Factors

Declining Revenue

The consistent decline in revenue indicates challenges in product sales and market penetration, potentially impacting the company's financial stability and growth prospects.

High Leverage

High leverage increases financial risk and limits flexibility, which could constrain CASI's ability to invest in growth opportunities and manage economic downturns.

Negative Cash Flow

Persistent negative cash flow indicates inefficiencies in operations and challenges in sustaining business activities without external financing, impacting long-term viability.

CASI Pharmaceuticals Business Overview & Revenue Model

Company Description

CASI Pharmaceuticals, Inc., a biopharmaceutical company, develops and commercializes therapeutics and pharmaceutical products in China, the United States, and internationally. It offers EVOMELA, an intravenous formulation of melphalan for use as a conditioning treatment prior to stem cell transplantation, and as a palliative treatment for patients with multiple myeloma. The company's product pipeline includes CNCT19, an autologous CD19 CAR-T investigative product for the treatment of patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL); BI-1206 that is in Phase I/II trial in combination with anti-PD1 therapy Keytruda for solid tumors, and in a Phase I/IIa trial in combination with MabThera (rituximab) in patients with relapsed/refractory NHL; and CB-5339, which is in Phase I clinical trial for acute myeloid leukemia and myelodysplastic syndrome. Its product pipeline also comprises CID-103 for the treatment of patients with multiple myeloma; Thiotepa, which has multiple indications including use as a conditioning treatment for various allogeneic haemopoietic stem cell transplants; and Octreotide long acting injectable formulations for the treatment of acromegaly and for the control of symptoms associated with various neuroendocrine tumors. The company has licensing agreements with Juventas Cell Therapy Ltd; BioInvent International AB; Black Belt Therapeutics Limited; and Cleave Therapeutics, Inc. It also has distribution agreements with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd; Pharmathen Global BV; and Riemser Pharma GmbH. The company was formerly known as EntreMed, Inc. and changed its name to CASI Pharmaceuticals, Inc. in June 2014. CASI Pharmaceuticals, Inc. was incorporated in 1991 and is based in Rockville, Maryland.

How the Company Makes Money

CASI Pharmaceuticals generates revenue primarily through the commercialization of its pharmaceutical products, which may include direct sales of approved therapies. Additionally, the company may engage in licensing agreements and collaborations with other biopharmaceutical companies, which can provide upfront payments, milestone payments, and royalties based on sales of partnered products. These partnerships are crucial as they can accelerate development timelines and expand market access. Furthermore, CASI could also receive funding from grants or research contracts that support its clinical trials and product development efforts.

CASI Pharmaceuticals Financial Statement Overview

Summary

CASI Pharmaceuticals faces significant financial challenges with declining revenue, negative profit margins, high leverage, and persistent negative cash flow. The financial statements indicate a need for improved operational efficiency and revenue growth.

Income Statement

CASI Pharmaceuticals has experienced a consistent decline in total revenue, from $43.1M in 2022 to $28.5M in 2024, indicating a negative revenue growth trend. The company also has negative EBIT and net income, leading to negative profit margins. These factors contribute to a weak income statement performance.

Balance Sheet

The balance sheet shows high leverage with a debt-to-equity ratio increasing to 11.96 in 2024, indicating significant financial risk. Stockholders' equity has drastically decreased over the years. However, the company maintains a significant portion of its assets in cash and cash equivalents, which provides some liquidity cushion.

Cash Flow

Cash flow from operations is consistently negative, leading to negative free cash flow. The company's free cash flow has deteriorated over time, growing more negative from $-26.7M in 2022 to $-29.5M in 2024. While financing activities have provided some cash inflow, this is not sustainable long-term. The operating cash flow to net income ratio is poor, reflecting inefficiencies in converting sales into cash.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	21.27M	28.54M	33.88M	43.11M	30.17M	15.14M
Gross Profit	11.74M	11.15M	20.05M	27.28M	17.61M	5.63M
EBITDA	-31.07M	-34.87M	-21.54M	-24.07M	-32.75M	-31.35M
Net Income	-30.35M	-39.26M	-26.94M	-39.41M	-37.77M	-62.57M
Balance Sheet
Total Assets	63.62M	53.67M	75.27M	96.23M	138.30M	127.73M
Cash, Cash Equivalents and Short-Term Investments	20.81M	16.09M	30.77M	51.34M	48.57M	66.37M
Total Debt	19.12M	22.14M	21.24M	1.34M	2.17M	1.29M
Total Liabilities	49.77M	51.82M	51.10M	29.30M	30.34M	24.16M
Stockholders Equity	13.85M	1.85M	24.16M	44.57M	84.50M	81.54M
Cash Flow
Free Cash Flow	0.00	-29.46M	-22.21M	-26.70M	-42.34M	-45.21M
Operating Cash Flow	0.00	-29.22M	-19.97M	-21.09M	-26.84M	-25.89M
Investing Cash Flow	0.00	11.24M	-9.67M	31.16M	-20.69M	-20.72M
Financing Cash Flow	0.00	15.43M	-907.00K	-3.27M	29.64M	47.15M

CASI Pharmaceuticals Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 1.78
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CASI, the sentiment is Negative. The current price of 1.78 is below the 20-day moving average (MA) of 2.26, below the 50-day MA of 1.87, and below the 200-day MA of 2.16, indicating a bearish trend. The MACD of 0.01 indicates Positive momentum. The RSI at 36.53 is Neutral, neither overbought nor oversold. The STOCH value of 4.08 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for CASI.

CASI Pharmaceuticals Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
PULM	53 Neutral	17.86M	-2.26	0.00%	―	-96.76%	26.87%
CASI	46 Neutral	$29.51M	―	-1094.50%	―	41.43%	-50.12%
CRIS	46 Neutral	20.87M	-0.35	723.39%	―	12.24%	40.74%
MBRX	44 Neutral	11.93M	-0.09	0.00%	―	0.00%	60.64%
GOVX	34 Underperform	17.24M	-0.27	0.00%	―	1943.07%	80.97%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%

CASI Pharmaceuticals Corporate Events

CASI Pharmaceuticals Strengthens Board with New Appointment

On September 2, 2025, CASI Pharmaceuticals announced the appointment of Dr. Barbara Krebs-Pohl as an Independent Director to its Board of Directors. Dr. Krebs-Pohl brings over 27 years of experience in biologics development and strategic partnerships, having played significant roles in major acquisitions in the biotech industry. Her expertise is expected to enhance CASI’s development program for CID-103 and contribute to the company’s strategic growth in developing therapies for organ transplant rejection and autoimmune diseases. This appointment marks a strategic move for CASI as it advances its CID-103 program, aiming to strengthen its position in the biopharmaceutical industry.

CASI Pharmaceuticals Reports Q2 2025 Results and Strategic Asset Divestiture

On August 29, 2025, CASI Pharmaceuticals announced its second quarter business and financial results, highlighting a strategic pivot towards developing its CID-103 program, which has received FDA clearance for a Phase 1 study in renal allograft antibody-mediated rejection. The company is also conducting a Phase 1/2 study for CID-103 in immune thrombocytopenic purpura. Additionally, CASI entered an agreement to sell its equity interests and rights related to certain products in China to Kaixin Pharmaceuticals for $20 million, a move aimed at focusing resources on core priorities. Financially, CASI reported a 5% increase in revenue to $4.2 million for the quarter, but also a significant net loss of $13.4 million, reflecting increased research, development, and marketing expenses.

CASI Pharmaceuticals Faces Setback with FOLOTYN® License Expiration in China

CASI Pharmaceuticals announced that its Import Drug Registration License for FOLOTYN® in China expired on August 25, 2025, following the denial of its renewal application by the Chinese Center for Drug Evaluation. As a result, the company will cease sales of FOLOTYN® in China but will continue clinical trials as permitted. This development may impact CASI’s market operations in China and its stakeholders, as the company navigates the regulatory landscape and adjusts its commercialization strategy.

CASI Pharmaceuticals Receives FDA Clearance for CID-103 IND Application

On August 4, 2025, CASI Pharmaceuticals announced the FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody, aimed at treating renal allograft antibody-mediated rejection (AMR) in adults. This milestone allows CASI to initiate a Phase 1 clinical trial to evaluate the safety and efficacy of CID-103, which could address the significant challenge of AMR in kidney transplantation, potentially impacting the company’s positioning in the biopharmaceutical industry.

CASI Pharmaceuticals Appoints David Cory as CEO to Drive CID-103 Program

On July 21, 2025, CASI Pharmaceuticals announced the appointment of David Cory as the new Chief Executive Officer, succeeding Wei-Wu He, who will remain as Executive Chairman. David Cory, with over 30 years of experience in biotech and large pharma companies, is expected to enhance CASI’s U.S. operations and focus on advancing the CID-103 program, a promising anti-CD38 monoclonal antibody for autoimmune diseases and organ transplant rejection. This strategic leadership change aims to strengthen CASI’s market position and deliver long-term value to patients and shareholders.