CASI Pharmaceuticals, Inc. (CASI): Business Model Canvas [Dec-2025 Updated]

You're digging into CASI Pharmaceuticals, Inc. right now because they've made a sharp turn, shedding China assets for a laser focus on clinical development, and that shift changes everything about their valuation. As a seasoned analyst, I can tell you the core story is in how they fund the CID-103 trials-they closed 3Q 2025 with \$4.7 million in cash, while burning through operating costs like G&A at \$4.9 million that quarter alone, even as they banked proceeds from that \$20.0 million China divestiture. This Business Model Canvas lays out exactly how CASI Pharmaceuticals, Inc. is structuring its partnerships, activities, and revenue streams to push that anti-CD38 antibody through the clinic; check out the nine blocks below to see the mechanics of this clinical-stage play.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Key Partnerships

You're looking at the core relationships CASI Pharmaceuticals, Inc. (CASI) relies on to execute its focused strategy post-China divestiture. These aren't just names on a contract; they represent critical access points to markets and necessary expertise for pipeline progression.

Distribution and Commercialization Alliances

The relationship with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. (CRPCGIT) remains central for the commercial performance of EVOMELA${\text{®}}$ in China, even as CASI Pharmaceuticals, Inc. (CASI) pivots its focus. CRPCGIT acts as the sole distributor for EVOMELA${\text{®}}$ (melphalan) for Injection in China under a renewed exclusive agreement.

The financial performance tied to this partnership shows variability. EVOMELA${\text{®}}$ achieved $30 million in revenue in 2021. However, for the third quarter of 2025, revenues were reported at $3.1 million, marking a 60% decrease compared to the $7.8 million reported in the third quarter of 2024. This Q3 2025 revenue dip was mainly attributed to the Company's estimation of goods return for EVOMELA${\text{®}}$ in June 2025.

Key metrics related to the EVOMELA${\text{®}}$ distribution partnership:

• - Sole Distributor in China: CRPCGIT.
• - Product Launch in China: August 12, 2019.
• - EVOMELA${\text{®}}$ Revenue (2021): $30 million.
• - Q3 2025 Revenue (EVOMELA${\text{®}}$ related): $3.1 million.
• - Q3 2025 Revenue Change vs. Q3 2024: -60%.

Strategic Divestiture Partner

The transaction with Kaixin Pharmaceuticals, an entity wholly owned by CASI Pharmaceuticals, Inc. (CASI)'s Chairman and CEO, Dr. Wei-Wu He, is a major structural partnership defining the current business scope. This definitive Equity and Assets Transfer Agreement, announced May 12, 2025, involved the sale of 100% equity interests in two Chinese subsidiaries and specific licensing rights.

The financial terms anchor this relationship:

This deal allows CASI Pharmaceuticals, Inc. (CASI) to retain rights to key assets, including CID-103 in Japan and non-Asian regions, EVOMELA${\text{®}}$, FOLOTYN${\text{®}}$, CNCT19, and CB-5339.

Clinical Development Collaborators

Advancing CID-103, the company's focus, requires external expertise, typically through Contract Research Organizations (CROs) for managing global clinical trials. CASI Pharmaceuticals, Inc. (CASI) is actively running trials for CID-103 in two indications.

For Immune Thrombocytopenic Purpura (ITP), a Phase 1 dose-escalation study is ongoing. This multicenter study enrolled an estimated maximum of approximately 30 adults. The dose cohorts tested included 30 mg, 150 mg, 300 mg, 600 mg, and 900 mg, with priming doses of either 30 mg or 150 mg.

For renal allograft antibody-mediated rejection (AMR), CASI received FDA IND clearance and plans to initiate a Phase 1 study in the third quarter of 2025. Research and development expenses, which support this advancement, were $1.4 million in the third quarter of 2025.

The key clinical development partnership elements are:

• - CID-103 ITP Study Doses Tested: 30 mg, 150 mg, 300 mg, 600 mg, 900 mg.
• - CID-103 AMR Phase 1 Initiation Target: Q3 2025.
• - Q3 2025 R&D Spend (Supporting trials): $1.4 million.

Licensors for Retained Commercial Products

CASI Pharmaceuticals, Inc. (CASI) maintains partnerships with original licensors for the products it is keeping post-divestiture, which include EVOMELA${\text{®}}$ and CID-103 outside of the divested Asian territories. The divestiture agreement itself necessitates entering into novation and/or assignment agreements with relevant licensors to effect the transfer of the divested rights.

The retained portfolio relies on these underlying agreements:

• - Retained Product Example: EVOMELA${\text{®}}$ (Melphalan for Injection).
• - Retained Product Example: CID-103 (Rights in Japan and non-Asian regions).
• - Financial Impact of Retained Products: Cost of revenue for Q3 2025 decreased 35% year-over-year, mainly due to a decrease in royalty costs for EVOMELA${\text{®}}$.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Key Activities

You're looking at the core actions CASI Pharmaceuticals, Inc. (CASI) is taking right now to pivot its business focus, which is heavily weighted toward its lead asset, CID-103. This involves a lot of clinical execution and a major corporate restructuring via divestiture.

Advancing CID-103 Clinical Development (ITP Phase 1, AMR Phase 1)

The primary activity is driving CID-103, the anti-CD38 monoclonal antibody, through its clinical stages. For Immune Thrombocytopenia (ITP), the Phase 1 dose-escalation study is actively enrolling and dosing patients, having reached the highest cohort dose of 900 mg. This multicenter, randomized, open-label study is designed to include an estimated maximum of approximately 30 adults between 18 and 65 with primary ITP who have received at least two previous lines of treatment and whose mean platelet count was less than or equal to 35 x 10⁹/L. You can expect data from this ongoing Phase 1 study to be presented at the American Society of Hematology (ASH) 2025 meeting on December 7, 2025. For Antibody-Mediated Rejection (AMR) in renal allografts, CASI Pharmaceuticals has achieved FDA IND clearance to conduct a Phase 1 study in the U.S., with preparation ongoing.

CASI Pharmaceuticals is also assessing multiple technologies toward a subcutaneous (SQ) delivery formulation for future registration trials, which is a key activity to make the drug more patient-friendly.

Managing Regulatory Submissions (FDA IND Clearance, China NMPA)

Regulatory navigation is critical, especially given the dual focus on U.S. and China development pathways for CID-103. The company successfully secured FDA IND clearance for the AMR indication. In parallel, for the proposed Phase 1/2 study of CID-103 in China for AMR, the regulatory package has been submitted and is currently under review by the China Center for Drug Evaluation (CDE) (China NMPA). The ITP study itself was conducted under a Clinical Trial Application (CTA) approved by the Chinese CDE.

Commercializing Retained Products like EVOMELA${\text{®}}$ and FOLOTYN${\text{®}}$

While the focus shifts to CID-103, CASI Pharmaceuticals is still managing the commercial aspects of its retained products, though revenue has seen a significant drop. This activity is directly reflected in the Q3 2025 financial performance, which shows the strain of this transition.

To be fair, FOLOTYN${\text{®}}$ is proprietary to Acrotech Biopharma Inc and its affiliates, meaning CASI Pharmaceuticals' involvement is likely tied to royalty or distribution agreements, which are subject to ongoing legal proceedings mentioned in filings.

Executing the Strategic Divestiture of China Subsidiaries and Pipeline Assets

A major operational activity is the execution of the strategic divestiture of the China business, announced via a definitive Equity and Assets Transfer Agreement on May 12, 2025. The company is targeting completion of this divestiture in Q2 2026. This transaction involves selling 100% equity interests in two China subsidiaries and Asian rights (excluding Japan) to CID-103, BI-1206, and Thiotepa for an aggregate purchase price of $20.0 million, which includes the assumption of up to $20.0 million of indebtedness. Following this, CASI Pharmaceuticals retains rights to CID-103 in Japan and non-Asian regions, alongside EVOMELA${\text{®}}$, FOLOTYN${\text{®}}$, CNCT19, and CB-5339. This move is clearly designed to sharpen the strategic focus on core priorities.

The financial reality underscores this pivot; as of September 30, 2025, cash and cash equivalents stood at $4.7 million, down from $13.5 million at the end of 2024. The company raised approximately $5.7 million from its at-the-market (ATM) facility during 3Q 2025 to support operations during this transition period.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Key Resources

You're looking at the core assets CASI Pharmaceuticals, Inc. (CASI) is relying on right now to drive value, especially given the recent financial pressures. These aren't just line items; they are the tangible and intangible things the company absolutely must have to execute its strategy.

The most critical tangible asset, as of the latest filing, is the company's liquidity position.

This cash balance is being managed while the company works through near-term risks, including a recent Nasdaq delisting determination appeal. To bolster this, CASI Pharmaceuticals raised approximately $5.7 million from its at-the-market (ATM) facility during the third quarter of 2025.

On the intellectual property and asset side, the focus is heavily weighted toward the lead candidate, CID-103, and the existing commercial products.

• - Exclusive global rights for CID-103 (ex-Asia/Japan).
• - Intellectual property protecting the anti-CD38 monoclonal antibody, CID-103.

Regarding the rights, following a recent transaction, CASI Pharmaceuticals expects to retain the rights related to CID-103 specifically in Japan and non-Asian regions, alongside EVOMELA${\text{®}}$, FOLOTYN${\text{®}}$, CNCT19, and CB-5339.

The commercial-stage products provide the current, albeit volatile, revenue base. The performance of these assets directly impacts the operating cash flow.

The intellectual property around CID-103 is a key intangible resource. This asset is a fully human IgG1, potentially best-in-class, clinical stage, anti-CD38 monoclonal antibody that targets a unique epitope.

Key features of this IP include:

• - Demonstrates strong antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.
• - Reduces complement-dependent cytotoxicity (CDC) activity.
• - Binding to a distinct epitope (R78) on the CD38 glycoprotein reduces red blood cell binding.
• - The company is actively working to develop a subcutaneous formulation of CID-103.

Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Value Propositions

You're looking at the core value CASI Pharmaceuticals, Inc. (CASI) is offering to its customers and stakeholders as of late 2025. This is centered on novel pipeline assets and the residual value from established commercial products, even as the company pivots.

Potential Best-in-Class Anti-CD38 Monoclonal Antibody (CID-103)

The primary value proposition rests on CID-103, a fully human IgG1 anti-CD38 monoclonal antibody that targets a unique epitope, positioning it as a potential best-in-class therapy.

The clinical development for this asset is actively progressing:

• Phase 1 dose-escalation study in Immune Thrombocytopenia (ITP) dosing at the highest cohort of 900 mg.
• The ITP Phase 1 study enrolled adults with a mean platelet count $\le$ 35 x 109/L.
• Dose cohorts tested included 30 mg, 150 mg, 300 mg, 600 mg, and 900 mg.
• The company is assessing multiple technologies toward a subcutaneous (SQ) delivery formulation for registration trials.

Addressing Urgent Unmet Need in Renal Allograft Antibody-Mediated Rejection (AMR)

CASI Pharmaceuticals, Inc. (CASI) is targeting Antibody-Mediated Rejection (AMR) in organ transplants, where current options are lacking. This represents a critical need for transplant patients.

The scale of the unmet need is significant:

• Approximately 12% of kidney transplant patients experience acute or chronic AMR.
• This affects more than 30,000 people in the United States alone.
• Currently, there is no FDA-approved treatment for AMR.

The company has secured the regulatory pathway to address this, having received FDA clearance of its IND application for CID-103 in AMR.

Providing Established Therapies for Hematology Oncology Patients

While pivoting, CASI Pharmaceuticals, Inc. (CASI) still generates revenue from established products, which supports the ongoing development of CID-103. This revenue stream is currently undergoing restructuring due to strategic divestitures.

Financial performance related to existing products shows volatility:

The revenue decrease in Q3 2025 was mainly due to the estimation of goods return for EVOMELA®. The company is targeting completion of the divestiture of its China business in Q2 2026.

Focused Pipeline for Autoimmune Diseases like Immune Thrombocytopenia (ITP)

CASI Pharmaceuticals, Inc. (CASI) is advancing CID-103 for autoimmune indications, specifically chronic Immune Thrombocytopenia (ITP), where it is a focus area alongside organ transplant rejection.

The value here is the progress in a Phase 1/2 study, which is designed to deliver safety and dose-response data to guide future development for other autoimmune indications with unmet needs. The company planned to present results from this study at the American Society of Hematology (ASH) 2025 meeting on December 7, 2025.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Customer Relationships

You're looking at how CASI Pharmaceuticals, Inc. (CASI) manages its connections with the outside world, which is critical given their clinical-stage focus and reliance on partnerships.

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators.

• Investigational drug CID-103 targets Antibody-Mediated Rejection (AMR) in kidney transplants, an area affecting over 30,000 people in the U.S. alone, where approximately 12% of kidney transplant patients experience acute or chronic AMR.
• CASI Pharmaceuticals is actively conducting a Phase 1/2 dose-escalation study for CID-103 in chronic immune thrombocytopenia (ITP).
• The company is preparing to initiate a Phase 1 study in the U.S. for renal allograft AMR following FDA IND clearance.
• Anticipated presentation of Phase 1 ITP study results at the American Society of Hematology (ASH) 2025 meeting on December 7, 2025.

Managed relationships with distributors for commercial product sales.

CASI Pharmaceuticals manages commercial product relationships through agreements that allow for product flow and inventory management. For EVOMELA®, the company has a sole distributor relationship that was recently modified.

• In June 2025, CASI Pharmaceuticals entered a modified distribution agreement with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd.
• This agreement, concerning EVOMELA®, allows the distributor to return goods that are close to expiration dates and cannot be sold.

Investor relations for capital market communication and transparency.

Communication with the capital markets centers on providing timely financial updates and maintaining transparency regarding corporate structure and share base, especially while appealing a Nasdaq delisting determination.

Here's the quick math on ownership structure as of November 2025:

As of September 30, 2025, CASI Pharmaceuticals had total shares outstanding of 20,548,273.

The company reported raising approximately $5.7M (after commissions) from its at-the-market (ATM) facility during the third quarter of 2025.

Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Channels

The Channels component for CASI Pharmaceuticals, Inc. (CASI) centers on product distribution, clinical development site engagement, and the commercial outreach structure, all underpinned by navigating global regulatory bodies.

Distribution Network for Commercial Products

For the commercial product EVOMELA${\circledR}$, CASI Pharmaceuticals, Inc. relies on specialized pharmaceutical distributors. As of June 2025, the Company entered into a modified distribution agreement with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. ('CRPCGIT'), which serves as the Company's sole distributor for EVOMELA${\circledR}$.

The financial impact of this channel is visible in the Q3 2025 revenue, which was $3.1 million, a 60% decrease from $7.8 million in the same period last year. This decrease was mainly attributable to the estimation of goods return for EVOMELA${\circledR}$ under the modified agreement, which allows CRPCGIT to return goods close to expiration dates.

Clinical Trial Site Engagement for CID-103 Development

The development channel for the lead candidate, CID-103, involves active engagement with clinical trial sites across the U.S. and internationally. The Phase 1 dose-escalation study for CID-103 in chronic immune thrombocytopenic purpura (ITP) was actively enrolling and dosing patients up to the highest dose of 900 mg as of September 30, 2025. This study is being conducted under an FDA-approved Investigational New Drug (IND) application and a Clinical Trial Application (CTA) approved by the Chinese Center for Drug Evaluation (CDE).

For the renal allograft antibody-mediated rejection (AMR) indication, CASI Pharmaceuticals, Inc. has FDA IND clearance for a Phase 1 study in the U.S., with plans to enroll the first patient in Q1 2026. Furthermore, a proposed Phase 1/2 study in China for AMR has its regulatory submission currently under review by the relevant authority.

Direct Sales and Marketing Reach

The commercial channel for existing products involves direct sales and marketing teams, though the focus appears to be shifting toward pipeline development post-divestiture planning. Selling and marketing expenses for the third quarter of 2025 totaled $4.6 million, representing a 6% decrease compared to $4.9 million in the third quarter of 2024. To give you a sense of the prior quarter's activity, Selling and marketing expenses for the second quarter of 2025 were $5.0 million, which was up 14% from $4.4 million in the second quarter of 2024, driven by increased marketing and promotion efforts against local melphalan generic competition.

Regulatory Pathways as a Critical Channel

Navigating regulatory pathways is a core channel for market access. CASI Pharmaceuticals, Inc. maintains engagement with both the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA).

Key regulatory channel milestones as of late 2025 include:

• FDA IND clearance secured for the CID-103 Phase 1 study in AMR.
• NMPA regulatory submission for the proposed CID-103 Phase 1/2 study in China is under review.
• The NMPA issued the 'Good Clinical Practice for Drugs (2025) (Revised Draft for Comments)' on October 27, 2025, which aims to streamline clinical trial approvals.

The following table summarizes key financial and operational data related to these channels:

The Company is targeting completion of the divestiture of its China business in Q2 2026. This strategic move affects the future commercial channel structure in that region, as rights related to CID-103 (in Asia excluding Japan) and Thiotepa (in China excluding Hong Kong, Macau and Taiwan) were part of a definitive agreement announced in May 2025.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Customer Segments

You're looking at the core groups CASI Pharmaceuticals, Inc. (CASI) targets as they push their pipeline forward, especially with CID-103. This isn't about selling existing blockbusters; it's about engaging the specific communities that will adopt their novel anti-CD38 monoclonal antibody.

The primary patient groups are highly specialized, reflecting CASI's pivot toward niche, high-need areas. For the patients with chronic Immune Thrombocytopenia (ITP), CASI is actively recruiting and dosing in a Phase 1 dose-escalation study. As of late 2025, they were dosing at the highest level of 900 mg and planned to present results at the American Society of Hematology (ASH) 2025 meeting on December 7.

For the second patient group, organ transplant patients suffering from Antibody-Mediated Rejection (AMR) for Renal Allografts, the focus is on U.S. clinical initiation. CASI received FDA Investigational New Drug (IND) application clearance and was preparing for a Phase 1 study in the U.S., with the first patient dosing targeted for the first quarter of 2026. The China Phase 1/2 study regulatory submission is under review.

These patient populations directly connect to the next segment: the prescribers and dispensers. You're talking about:

• - Hematology-oncology specialists managing ITP patients.
• - Transplant specialists and nephrologists managing AMR.
• - Hospital pharmacies and specialty pharmacies handling the distribution of the eventual commercial product.

The financial health and future of CASI Pharmaceuticals, Inc. depend heavily on the fourth segment: the capital providers. These are the institutional and retail investors funding the clinical pipeline, especially the CID-103 development. You need to know where the ownership stands to gauge market confidence.

Here's the quick math on the ownership structure as of November 2025, which gives you a clear picture of who is backing the company right now. What this estimate hides is the retail float, but the institutional picture is quite clear.

The company's cash position as of September 30, 2025, was tight at $4.7 million, which underscores the importance of continued investor support to fund the ongoing Phase 1 studies for CID-103. Also, note that the stock traded recently between a 52-week low of $0.93 and a high of $4.05. Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Cost Structure

You're looking at the core expenses for CASI Pharmaceuticals, Inc. (CASI) as of the third quarter of 2025. For a biopharma company in this stage, the cost structure is heavily weighted toward clinical development and supporting the existing commercial base, even when revenue takes a hit. Honestly, when revenue drops significantly, as CASI's did-down to $3.1 million in 3Q 2025-you watch these operating expenses very closely to see if they scale down proportionally.

Here's the quick math on the major cost buckets for the quarter ended September 30, 2025. These figures represent the cash burn outside of the net loss, which was reported at $10.9 million for the period.

The R&D spend is a key area for CASI Pharmaceuticals, Inc. as they push the CID-103 program forward. You want to see that money going directly into the clinical trials, like the ongoing Phase 1 dose-escalation study for ITP and the IND-cleared work for renal allograft AMR in the U.S. The R&D expense for 3Q 2025 was reported at $1.4 million, which was relatively stable compared to the $1.5 million spent in the same period last year.

The commercial side of the house still carries significant weight, even with the revenue challenges. Selling and Marketing expenses were $4.6 million for the quarter. This spend supports the existing commercial products, though the revenue decrease was partly due to an estimated goods return for EVOMELA®.

General and Administrative (G&A) overhead is where you see the costs for keeping the lights on, including executive functions and, importantly, legal fees related to ongoing matters. For 3Q 2025, G&A was $4.9 million. This was actually a decrease, down 14% from $5.7 million in 3Q 2024, showing some cost control efforts in the overhead structure.

Finally, the direct cost associated with the revenue CASI did bring in-the Cost of Revenue for commercial products-was $2.4 million in the third quarter of 2025. This figure saw a 35% decrease year-over-year, which aligns with the drop in top-line revenue and was partly due to lower royalty costs for EVOMELA®.

To map these operational costs against the revenue base, consider the breakdown of the major operating expense components:

• Research and Development (R&D): $1.4 million
• Selling and Marketing: $4.6 million
• General and Administrative (G&A): $4.9 million
• Total Operating Expenses (excluding Cost of Revenue): $1.4M + $4.6M + $4.9M = $10.9 million

The total operating expenses, when you add the Cost of Revenue, hit $13.3 million ($10.9M + $2.4M), which is a substantial figure against the $3.1 million in revenue reported for the quarter.

Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Canvas Business Model: Revenue Streams

You're looking at the core income sources for CASI Pharmaceuticals, Inc. (CASI) as of late 2025. The revenue picture is currently dominated by product sales, but significant one-time events and financing activities are also material to the cash position.

The primary ongoing revenue streams come from the commercial sales of established products. Specifically, this includes revenue generated from EVOMELA${\text{®}}$ and FOLOTYN${\text{®}}$. For the third quarter ending September 30, 2025, CASI Pharmaceuticals reported total revenues of $3.1 million. This quarterly figure reflects a substantial 60% decrease compared to the $7.8 million reported in the same period last year. Honestly, that drop was largely due to the company estimating goods returns for EVOMELA${\text{®}}$ under a modified distribution agreement entered into in June 2025.

Looking at the broader picture, the Trailing Twelve Month (TTM) revenue, as of September 30, 2025, stood at $26.85 million. This represents a year-over-year increase of 21.72% for the TTM period.

The business model also incorporates significant, non-recurring financial events that bolster liquidity. You need to track these carefully as they aren't sustainable product sales.

Here's a quick look at the key financial events impacting the revenue and cash flow streams:

The divestiture of the China assets, agreed upon in May 2025, is a major component. This deal with Kaixin Pharmaceuticals involved an aggregate purchase price of $20.0 million, which notably included the assumption of up to $20.0 million of CASI Pharmaceuticals' indebtedness. This transaction allows CASI Pharmaceuticals to sharpen its focus on developing CID-103 outside of the divested Asian territories.

Furthermore, the company actively manages its capital structure through equity raises. CASI Pharmaceuticals successfully raised approximately $5.7 million after commissions through its At-The-Market (ATM) facility during the third quarter of 2025. This financing was critical, especially given that cash and cash equivalents stood at only $4.7 million as of September 30, 2025.

To summarize the non-product related cash inflows:

• - Proceeds from the $20.0 million divestiture of China assets.
• - Equity financing through At-The-Market (ATM) offerings, raising ~$5.7 million in 3Q 2025.

Finance: draft 13-week cash view by Friday.