CASI Pharmaceuticals (CASI) AI Stock Analysis

• Market Cap: $20.61M
• Dividend Yield: N/A
• Average Volume (3M): 219.83K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.08
• Revenue Growth: 26.20%
• EPS Growth: -42.26%
• Country: US
• Employees: 233
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.40
• Shares Outstanding: 15,492,681
• 10 Day Avg. Volume: 60,876
• 30 Day Avg. Volume: 219,829
• PEG Ratio: -0.04
• Price to Book (P/B): 23.45
• Price to Sales (P/S): 1.52
• P/FCF Ratio: -1.47
• Enterprise Value/Market Cap: 1.47
• Enterprise Value/Revenue: 1.13
• Enterprise Value/Gross Profit: 3.15
• Enterprise Value/Ebitda: -0.73
• 1Y Price Target: $4.00
• Price Target Upside: 308.16% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 1
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 39 Underperform
• Price Target: $0.95 ▼(-2.65% Downside)

CASI Pharmaceuticals has a low overall stock score due to significant financial challenges, including declining revenue and increasing losses, coupled with bearish technical indicators and poor valuation metrics. The absence of positive earnings call data or corporate events further weighs on the score.

Positive Factors

Strategic Board Appointments

The addition of experienced directors strengthens CASI's strategic direction and governance, potentially enhancing its development programs and growth strategy.

FDA Clearance for CID-103

FDA clearance for CID-103 allows CASI to advance in a significant therapeutic area, potentially improving its market position and product pipeline.

Strategic Asset Divestiture

Divesting non-core assets allows CASI to focus resources on strategic priorities, potentially improving operational efficiency and financial health.

Negative Factors

Declining Revenue

A consistent decline in revenue suggests challenges in market penetration and product adoption, impacting long-term growth prospects.

High Leverage

High leverage increases financial risk and limits flexibility, potentially affecting CASI's ability to invest in growth opportunities.

Negative Cash Flow

Persistent negative cash flow indicates operational inefficiencies and financial strain, challenging CASI's sustainability and growth capacity.

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, including sales from its oncology therapies. The company may also earn income through licensing agreements, partnerships, and collaborations with larger pharmaceutical firms, which can involve upfront payments, milestone payments, and royalties on sales. Additionally, CASI may receive funding from research grants or investment capital to support its clinical development programs. Significant partnerships, particularly those that enhance its product pipeline or expand its market reach, can also contribute to its overall earnings.

CASI Pharmaceuticals Financial Statement Overview

Summary

CASI Pharmaceuticals faces significant financial challenges with declining revenue, negative profit margins, high leverage, and consistently negative cash flows. These factors contribute to a weak financial performance.

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	26.85M	28.54M	33.88M	43.11M	30.17M	15.14M
Gross Profit	9.61M	11.15M	20.05M	27.28M	17.61M	5.63M
EBITDA	-41.37M	-34.87M	-21.54M	-24.07M	-33.40M	-31.35M
Net Income	-49.38M	-39.26M	-26.94M	-41.01M	-36.65M	-48.29M
Balance Sheet
Total Assets	24.46M	53.67M	75.27M	96.23M	138.30M	127.73M
Cash, Cash Equivalents and Short-Term Investments	4.68M	16.09M	30.77M	51.34M	48.57M	66.37M
Total Debt	18.86M	22.14M	21.24M	1.34M	4.33M	3.20M
Total Liabilities	53.05M	51.82M	51.10M	29.30M	30.34M	24.16M
Stockholders Equity	-28.59M	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: 0.98
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Positive
• 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 0.98 is below the 20-day moving average (MA) of 1.25, below the 50-day MA of 1.51, and below the 200-day MA of 1.82, indicating a bearish trend. The MACD of -0.15 indicates Positive momentum. The RSI at 26.50 is Positive, neither overbought nor oversold. The STOCH value of 5.96 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	$16.40M	―	-79.47%	―	-99.97%	35.59%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
MBRX	44 Neutral	$24.59M	-0.11	―	―	―	79.31%
CRIS	40 Underperform	$18.25M	-0.30	―	―	13.56%	52.92%
CASI	39 Underperform	$20.61M	-0.44	―	―	26.20%	-42.26%
GOVX	34 Underperform	$11.18M	-0.20	-377.44%	―	8.52%	79.51%
ELEV	33 Underperform	―	―	―	―	―	47.73%

CASI Pharmaceuticals Corporate Events

CASI Pharmaceuticals Appoints James Huang as Non-Executive Chairman

On November 19, 2025, CASI Pharmaceuticals announced a significant change in its board governance with the appointment of James Huang as the Non-Executive Chairman of the Board, effective November 17, 2025. This move is part of a strategic effort to enhance governance and drive growth, as Dr. Wei-Wu He steps down from the Executive Chairman role but remains on the board. The appointment reflects confidence in Huang’s vision and leadership as the company advances its CID-103 development, particularly in addressing organ transplant rejection. This governance change is expected to align with shareholder interests and sustain the company’s long-term success.

CASI Pharmaceuticals Reports Q3 2025 Results Amid Nasdaq Delisting Appeal

On November 14, 2025, CASI Pharmaceuticals announced its third-quarter 2025 business and financial results, highlighting ongoing advancements in its CID-103 clinical program. The company is preparing for a Phase 1 study in the U.S. for renal allograft antibody-mediated rejection (AMR) and is conducting a Phase 1 study for immune thrombocytopenia (ITP). Financially, CASI reported a 60% decrease in revenue to $3.1 million compared to the previous year, primarily due to changes in the distribution agreement for EVOMELA®. The company also faced a net loss increase to $10.9 million and received a Nasdaq delisting determination due to non-compliance with market value requirements, which it is appealing.

CASI Pharmaceuticals Appeals Nasdaq Delisting Determination

CASI Pharmaceuticals announced that it received a delisting determination from Nasdaq due to its market value of listed securities falling below the minimum requirement for an extended period. The company has appealed the decision and is working on a compliance plan to maintain its Nasdaq listing, which is crucial for its operations and investor confidence.

CASI Pharmaceuticals Strengthens Board with Industry Veteran James Huang

On September 26, 2025, CASI Pharmaceuticals announced the appointment of James Huang as an Independent Director to its Board, effective October 1, 2025. Huang, with over 35 years of experience in the biotech industry, is expected to enhance CASI’s development program for CID-103, an anti-CD38 monoclonal antibody. This strategic appointment aligns with CASI’s focus on advancing its clinical development in autoimmune diseases and organ transplant rejection, marking a pivotal chapter in its U.S.-centric growth strategy. Additionally, Panacea Venture, where Huang is a managing partner, plans to acquire up to 1.5 million shares of CASI, indicating strong stakeholder confidence.

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.