CASI Pharmaceuticals, Inc. (CASI): History, Ownership, Mission, How It Works & Makes Money

When you look at CASI Pharmaceuticals, Inc. (CASI), are you seeing a clinical-stage biotech pivoting toward high-value indications or a commercial operation facing serious headwinds?

The reality is complex: the company is aggressively advancing its CID-103 program for organ transplant rejection, but its commercial revenue took a hit, dropping to just $3.1 million in the third quarter of 2025, a 60% year-over-year decrease that contributed to a $10.9 million net loss. We need to understand how a company with a promising pipeline product like CID-103-a potential best-in-class anti-CD38 monoclonal antibody-navigates such financial stress, especially while appealing a Nasdaq delisting determination received in November 2025.

This deep dive will map out CASI Pharmaceuticals' history, its current ownership structure, and the critical shift in its business model, so you can clearly see the near-term risks and long-term opportunities in this volatile biopharma story.

CASI Pharmaceuticals, Inc. (CASI) History

If you're looking at CASI Pharmaceuticals, Inc. today, you need to understand its long, winding history. It didn't start as the China-focused oncology company you see now; it began as a pioneering US biotech firm called EntreMed. The company's journey is a classic biotech narrative of high-stakes drug development, strategic pivots, and a recent, dramatic shift to focus on a single, core asset, CID-103.

Given Company's Founding Timeline

Year established

The company was established in 1991, originally under the name EntreMed.

Original location

The original headquarters were located in Rockville, Maryland, United States.

Founding team members

EntreMed was co-founded by a team that included Peter C. Farrell, Bart Chernow, and John Holaday.

Initial capital/funding

Specific details on the initial seed capital are not publicly available, but the company's first institutional funding round occurred in 2006.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company has gone through a few defintely transformative moments, moving from a US-centric, early-stage oncology pipeline to a commercial-stage company with a dual China/US focus, and now a hyper-focused clinical-stage company centered on a single, high-potential asset.

The most significant shifts were strategic, not just clinical:

• The 2014 Pivot to China: Renaming to CASI Pharmaceuticals and moving the headquarters to Beijing was a massive bet on the rapidly growing Chinese pharmaceutical market. This move allowed them to commercialize products like EVOMELA and FOLOTYN in China, generating revenue. In 2024, CASI reported a full-year revenue of $28.5 million, largely from this market.
• The 2025 Divestiture and CID-103 Focus: The decision in May 2025 to sell the China business to Kaixin Pharmaceuticals Inc. represents the latest, and perhaps most dramatic, strategic pivot. This move is designed to simplify operations, reduce commercial complexity, and concentrate capital on advancing the anti-CD38 monoclonal antibody, CID-103.
• The CID-103 Clinical Advancement: This singular focus is already showing results. The FDA cleared the Investigational New Drug (IND) application for CID-103 in renal allograft Antibody-Mediated Rejection (AMR) in the third quarter of 2025. This action refocuses the company from a broad hematology/oncology portfolio to a specialized area with high unmet need: organ transplant rejection and autoimmune diseases.

Here's the quick math on the near-term financial reality: the third quarter of 2025 saw revenues of only $3.1 million, a 60% decrease year-over-year, leading to a net loss of $10.9 million. This highlights the financial pressure and the urgency behind the strategic pivot to CID-103, as cash and cash equivalents stood at just $4.7 million as of September 30, 2025. For a deeper look at the company's guiding principles, you can explore: Mission Statement, Vision, & Core Values of CASI Pharmaceuticals, Inc. (CASI).

CASI Pharmaceuticals, Inc. (CASI) Ownership Structure

CASI Pharmaceuticals, Inc. is a publicly traded, clinical-stage biopharmaceutical company whose ownership is mostly distributed among retail investors, but with a significant minority stake held by institutions and insiders. This structure means the company's stock price and strategic direction are highly sensitive to both broad market sentiment and the actions of a few key institutional and executive stakeholders.

Given Company's Current Status

CASI Pharmaceuticals, Inc. is a public company traded on the NASDAQ under the ticker CASI, but it currently faces a significant operational risk regarding its listing status. As of November 2025, the company is appealing a NASDAQ delisting determination after failing to meet the minimum $35 million market value of listed securities (MVLS) requirement. The appeal temporarily stays the suspension of its securities.

The company's market capitalization stands at approximately $20.76 million USD as of November 2025, with total shares outstanding at 20,548,273 as of September 30, 2025. This low valuation and compliance issue create a challenging environment for raising capital, even as the company advances its key anti-CD38 monoclonal antibody, CID-103, through clinical trials.

Given Company's Ownership Breakdown

The ownership structure is typical for a small-cap biopharma company, showing a high level of retail investor interest and a moderate, but influential, insider stake. This dispersion of ownership, where no single entity holds a majority, means strategic decisions must balance the interests of a large public base against the concentrated knowledge of the internal team.

To be fair, the institutional stake of nearly 15% is concentrated among a small number of funds, giving them outsized influence despite the larger retail percentage. You should be defintely Exploring CASI Pharmaceuticals, Inc. (CASI) Investor Profile: Who's Buying and Why? to understand the capital flow.

Given Company's Leadership

The leadership team is currently focused on navigating the clinical development of CID-103 and stabilizing the company's financial position, including the appeal to maintain the NASDAQ listing. The executive team has seen recent changes, signaling a pivot toward new strategic priorities, specifically the divestiture of its China business targeted for the second quarter of 2026.

Here's the quick math on the leadership's immediate task: the company's net loss for the third quarter of 2025 was $10.9 million, so cash preservation and clinical milestones are critical to regaining investor confidence and compliance.

• David Cory, RPh, MBA: Chief Executive Officer (CEO) and Director, appointed in November 2025, leading the company's strategic pivot to focus on the CID-103 program in the U.S. and China.
• Alex Zukiwski, MD: Chief Medical Officer (CMO), steering the clinical development and regulatory strategy for the pipeline.
• Jim Goldschmidt, Ph.D.: Chief Business Officer (CBO), responsible for business development and commercial strategy.
• Larry Zhang: Senior Vice President, a key member of the US management team.
• Recent Board Appointments: James Huang and Barbara Krebs-Pohl were appointed as Independent Directors in October/November 2025, adding external expertise to the board.

CASI Pharmaceuticals, Inc. (CASI) Mission and Values

CASI Pharmaceuticals, Inc. is fundamentally driven by a commitment to address urgent, unmet medical needs in organ transplant and autoimmune diseases, focusing its resources on developing its lead asset, CID-103. This patient-centric mission is the core strategic driver, especially as the company navigates a challenging financial landscape, reporting a net loss of $10.9 million in the third quarter of 2025.

Given Company's Core Purpose

The company's core purpose is to bring innovative, potentially best-in-class therapies to patients facing life-threatening conditions where current treatments fall short. This focus is a clear pivot, concentrating resources on the CID-103 clinical program for indications like renal allograft antibody-mediated rejection (AMR) and immune thrombocytopenia (ITP).

Official mission statement

CASI's mission is not a single corporate platitude but a clear mandate: to develop and commercialize innovative therapeutics, specifically anti-CD38 monoclonal antibodies, to address high-need therapeutic areas and improve patient outcomes globally. You can see this dedication in their R&D spending, which was $1.4 million in 3Q 2025, even as they faced a 60% revenue decrease to $3.1 million.

• Develop CID-103 as a potential best-in-class, anti-CD38 monoclonal antibody.
• Target organ transplant rejection and autoimmune diseases with urgent unmet medical needs.
• Advance clinical programs in the U.S. and China to bring therapies to market.

Vision statement

The vision is to transform the treatment paradigm for organ transplant and autoimmune diseases by delivering differentiated, patient-centric therapies. This is a high-stakes vision, but the potential market for a first-in-class treatment for conditions like AMR-which affects over 30,000 kidney transplant patients in the U.S. alone-is substantial.

• Become a leader in transforming transplant care and autoimmune disease treatment.
• Deliver long-term value for both patients and shareholders by concentrating resources on CID-103.
• Achieve a stable, high-concentration subcutaneous formulation of CID-103 for patient convenience.

Given Company slogan/tagline

The company's direct, action-oriented messaging powerfully encapsulates their urgency and focus. This is the kind of clear communication that cuts through the noise. For a deeper dive into the capital structure supporting this mission, you should be Exploring CASI Pharmaceuticals, Inc. (CASI) Investor Profile: Who's Buying and Why?

• TRANSPLANT PATIENTS CAN'T WAIT.

CASI Pharmaceuticals, Inc. (CASI) How It Works

CASI Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical company that creates value by developing and commercializing innovative therapeutics, primarily focusing on its lead asset, CID-103, for organ transplant rejection and autoimmune diseases. The company generates revenue through limited commercial sales of existing oncology products while aggressively investing in the research and development (R&D) of its pipeline to capture high-value, unmet medical needs.

Given Company's Product/Service Portfolio

Given Company's Operational Framework

You can see CASI's operational framework is undergoing a sharp, strategic pivot, moving away from a broader commercial focus in China toward a concentrated, global R&D model centered on its CID-103 program. This is defintely a high-risk, high-reward strategy.

The company creates value through a three-part process:

• Focused R&D Investment: CASI directs its resources to advance CID-103, a fully human anti-CD38 monoclonal antibody, in mid-stage clinical trials. For example, R&D expenses for Q3 2025 were $1.4 million, maintaining a steady burn rate to push these programs forward.
• Strategic Divestiture and Capitalization: In May 2025, CASI sold its equity in its China subsidiaries and certain regional rights for pipeline products for an aggregate purchase price of $20.0 million, which included the assumption of indebtedness. This move streamlined operations and provided capital for the CID-103 focus.
• Commercial Product Sales: The company still generates revenue from commercial products like EVOMELA® and FOLOTYN® in its retained markets (Japan and non-Asian regions for CID-103; global for EVOMELA® and FOLOTYN®). However, Q3 2025 revenue was only $3.1 million, a 60% year-over-year decrease, primarily due to changes in the EVOMELA® distribution agreement.

Here's the quick math: With a Q3 2025 net loss of $10.9 million and cash/cash equivalents of just $4.7 million as of September 30, 2025, the company must execute its CID-103 strategy flawlessly to secure its long-term financial viability. You can learn more about the market's reaction by Exploring CASI Pharmaceuticals, Inc. (CASI) Investor Profile: Who's Buying and Why?

Given Company's Strategic Advantages

CASI's strategic advantage is tied directly to the clinical promise and intellectual property surrounding its lead candidate, CID-103, which is a potential best-in-class therapy in a high-unmet-need area.

• Targeting Unmet Needs: CID-103 is being developed for renal allograft Antibody-Mediated Rejection (AMR), a condition affecting approximately 12% of kidney transplant patients in the U.S. alone, with no current FDA-approved treatment.
• Potential Best-in-Class Profile: The drug is designed to deplete persistent plasma cells, which other anti-B-cell therapies (like anti-CD19 or anti-CD20) often miss. This mechanism gives it a differentiated profile for organ rejection and autoimmune diseases.
• Global Rights Control: CASI retains exclusive global rights to CID-103 for its core indications (AMR and ITP) outside of the divested Asian territories, giving it full control over the lucrative U.S. and European markets.
• Internal Manufacturing Capability: The company started production at its CASI Pharmaceuticals (Wuxi) Co., Ltd. facility in June 2025, moving $0.9 million in related costs from General and Administrative (G&A) into inventory. This transition gives them greater control over the supply chain and cost of goods for their commercial products.

CASI Pharmaceuticals, Inc. (CASI) How It Makes Money

CASI Pharmaceuticals, Inc. makes money primarily through the commercial sale of its approved hematology-oncology products, such as EVOMELA® (melphalan for injection), within the Greater China market, though this focus is currently shifting. The company is actively moving toward a clinical-stage model, aiming for future revenue from its lead development candidate, CID-103, an anti-CD38 monoclonal antibody, in non-Asian markets after divesting significant Chinese assets.

CASI Pharmaceuticals' Revenue Breakdown

The company's near-term revenue is highly concentrated and volatile, as seen in the third quarter of 2025. The overall revenue for Q3 2025 was $3.1 million, a sharp 60% decrease year-over-year, largely due to product return estimates for its key commercial asset, EVOMELA®. This product mix is in flux following the strategic decision to sell off certain China-based assets and pipeline rights to focus on the CID-103 program.

Here's the quick math on the product mix: The significant Q3 2025 revenue decline is explicitly tied to EVOMELA® returns, so it's defintely the primary commercial driver right now. I estimate it accounts for roughly 80% of the remaining revenue, with other commercial products like FOLOTYN® filling the rest. The key takeaway is that the commercial revenue base is shrinking and highly unstable.

Business Economics

The economics of a biopharmaceutical company like CASI Pharmaceuticals are defined by high upfront research and development (R&D) costs and the eventual high-margin revenue from successful commercialized drugs, but CASI is still in the cash-burn phase. The company's current commercial operations show a tight margin profile, which is a concern.

• Gross Margin: The gross profit margin for Q3 2025 was very low, at approximately 22.58%. This is calculated from the $3.1 million in revenue and the $2.4 million in cost of revenue. For a specialty pharma company, this margin is thin and suggests significant royalty or distribution costs are eating into profitability, even before operating expenses.
• Pricing Strategy: CASI uses a specialty pharmaceutical pricing model, which involves high list prices for niche, life-saving oncology and rare disease treatments like EVOMELA® (used for multiple myeloma). However, the gross-to-net revenue realization is heavily impacted by market access costs, rebates, and, critically, the estimated product returns that hit Q3 2025 results.
• R&D Focus: The strategic pivot is clear: CASI is trading its existing, low-margin China commercial business for a high-risk, high-reward bet on its pipeline, specifically CID-103. This is a classic biotech move.

The business is effectively a clinical development company with a small, volatile commercial revenue stream funding part of its R&D. You can read more about this strategic challenge here: Breaking Down CASI Pharmaceuticals, Inc. (CASI) Financial Health: Key Insights for Investors.

CASI Pharmaceuticals' Financial Performance

Looking at the broader financial health as of November 2025, the picture is one of significant financial stress and a need for immediate capital. The company is in a precarious position, evidenced by its appeal against a Nasdaq delisting determination.

• Total Revenue (TTM): The Trailing Twelve Months (TTM) revenue as of September 30, 2025, is approximately $26.86 million. This is a decline from the TTM revenue of $31.56 million reported as of June 30, 2025, reflecting the Q3 revenue drop.
• Net Loss: The company's net loss for Q3 2025 widened to $10.9 million, up from a net loss of $8.4 million in the same period last year. This growing loss is a direct result of the revenue decline combined with persistent operating expenses.
• Cash Position: Cash and cash equivalents stood at only $4.7 million as of September 30, 2025. This is a critical near-term risk. The company did raise about $5.7 million through an at-the-market (ATM) facility during Q3 2025, but the cash burn rate is high, and this runway is short.
• Operating Expenses: Selling and marketing expenses were $4.6 million in Q3 2025, and General and Administrative (G&A) expenses were $4.9 million, indicating a substantial fixed cost base that is disproportionate to the current revenue. The G&A is high, partly due to ongoing legal fees related to disputes.

The company is burning cash fast; the $4.7 million cash balance is barely enough to cover one quarter of the combined G&A and Selling & Marketing expenses, which totaled $9.5 million in Q3 2025.

CASI Pharmaceuticals, Inc. (CASI) Market Position & Future Outlook

CASI Pharmaceuticals is at a critical inflection point in late 2025, shifting its focus from legacy oncology products to its lead clinical asset, CID-103, an anti-CD38 monoclonal antibody, which positions the company in the high-growth organ transplant rejection and autoimmune disease markets. This strategic pivot is happening against a backdrop of significant financial pressure, including a net loss of $10.9 million in the third quarter of 2025 and an ongoing appeal against a Nasdaq delisting determination.

Competitive Landscape

The company is transitioning from a small-scale oncology commercial model to a clinical-stage biotech competing in the highly lucrative, but dominated, anti-CD38 monoclonal antibody (mAb) space. While CASI's current revenue is from products like EVOMELA, its future hinges on CID-103, which will compete with established, multi-billion-dollar anti-CD38 therapies. The global anti-CD38 mAb market was valued at $5.1 billion in 2023 and is projected to grow significantly.

Opportunities & Challenges

The company's strategic decision to divest its China business by the second quarter of 2026 is intended to streamline operations and focus capital on the CID-103 pipeline, which represents the primary near-term opportunity. Here's the quick math: R&D expenses for Q3 2025 were only $1.4 million, so every dollar is critical for advancing the pipeline.

Industry Position

CASI Pharmaceuticals operates as a small-cap, clinical-stage biopharmaceutical company, which puts it in a high-risk, high-reward bracket. Its current industry standing is defined by the promise of its pipeline, not its commercial sales. The company's total revenue for the trailing 12 months ending June 30, 2025, was $31.56 million, a tiny fraction of the overall $1.6 trillion global pharmaceutical market.

• Pipeline Focus: The pivot to CID-103 for non-oncology indications like AMR and ITP is a smart move, targeting areas where anti-CD38 mAbs are less saturated than in Multiple Myeloma.
• Financial Leverage: The company's negative P/E ratio and high leverage point to significant financial challenges, making the successful divestiture of the China business a defintely critical near-term financial action.
• Competitive Differentiation: CID-103 is being developed as a potential best-in-class anti-CD38 with a unique epitope and better preclinical safety profile, which is the only way to compete with giants like Johnson & Johnson.

For a deeper dive into the company's foundational principles, you can review its Mission Statement, Vision, & Core Values of CASI Pharmaceuticals, Inc. (CASI).