CASI Pharmaceuticals, Inc. (CASI): ANSOFF MATRIX [Dec-2025 Updated]

You're looking at a company making a massive shift, and as an analyst who's seen a few pivots in my time, CASI Pharmaceuticals is essentially hitting the reset button right now. They are trading their established China commercial business for a laser focus on their lead candidate, CID-103, for global development, which is a huge bet given their Q3 2025 financials-only $4.7 million in cash and a recent revenue of just $3.1 million suggests this pivot isn't optional; it's survival. We need to see if their Product Development drive on CID-103, funded by the upcoming asset sale, can outpace the immediate risk of running low on capital while trying to maximize near-term sales of EVOMELA before the Q2 2026 divestiture. Below, I map out exactly where CASI Pharmaceuticals is placing its bets across the Ansoff grid, from maximizing current sales to building a brand-new US infrastructure.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Market Penetration

You're looking at maximizing the value capture from the existing China business before the planned exit. This Market Penetration quadrant is all about squeezing every last dollar from the current assets-EVOMELA® and FOLOTYN®-in the territory you already serve, China, before the divestiture closes in Q2 2026.

The immediate challenge is the overhang from EVOMELA®. The third quarter of 2025 revenue was just $3.1 million, which is a steep 60% decrease year-over-year from the $7.8 million seen in the third quarter of 2024. This drop is directly tied to the Company's estimation of goods return for EVOMELA®, meaning you need to manage the remaining inventory and sales pipeline very carefully over the next few quarters. The goal now is to leverage that existing China commercial team to push for maximum revenue in Q4 2025, building on that weak $3.1 million base.

To fight the generic melphalan competition that has already been pressuring EVOMELA® sales since 2024, the current spending level on selling and marketing is $4.6 million for the third quarter of 2025. Honestly, that figure is actually a 6% decrease from the $4.9 million spent in the third quarter of 2024, which suggests the team might need a tactical increase in spend to drive volume, or perhaps the focus has shifted to cost control ahead of the divestiture. You need to focus on those high-volume hospital accounts for EVOMELA® to absorb the financial hit from those estimated returns.

For FOLOTYN®, the focus remains on driving volume in the relapsed/refractory peripheral T-cell lymphoma (PTCL) segment, building on the initial commercialization efforts that started with the first patient dosed on February 15, 2024. While I don't have the specific Q3 2025 pricing or volume data for FOLOTYN®, the commitment to spend time and resources on its commercialization in China is still stated. The key here is negotiating the most favorable pricing structure possible now, as that will directly impact the final realized revenue before the asset transfer.

Here's a quick look at the financial context surrounding this Market Penetration push as of September 30, 2025:

The current cash position of $4.7 million as of September 30, 2025, underscores the urgency of maximizing near-term cash flow from these existing products. The company also raised approximately $5.7 million from its ATM facility during the quarter, which helps bridge the gap while you execute this final push in China. The focus must be on immediate cash conversion from EVOMELA® sales, even as you manage the returns provision, and pushing FOLOTYN® volume through the existing commercial infrastructure.

You need to review the current sales force allocation between EVOMELA® and FOLOTYN® immediately. Finance: draft 13-week cash view by Friday, incorporating the latest EVOMELA® return estimates.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Market Development

You're looking at how CASI Pharmaceuticals, Inc. can grow by taking its existing products into new geographical markets. This is the Market Development quadrant of the Ansoff Matrix, and given the recent strategic pivot, it's where a lot of the near-term focus must lie.

The recent divestiture of assets in China provides a clear financial anchor for these non-Asian market explorations. You need to know exactly what capital is available for these studies.

The retained portfolio forms the basis of this strategy, so understanding the current rights landscape is key.

• Retained EVOMELA $\text{}{\circledR}$ rights are for non-Asian regions, including the US (Source 2).
• EVOMELA $\text{}{\circledR}$ is currently commercialized by Acrotech in the United States for multiple myeloma (Source 12).
• CASI retains rights to CNCT19 and CID-103 globally outside of the divested Asian territories (Source 4).
• The majority of CASI Pharmaceuticals, Inc.'s revenue was historically generated from EVOMELA $\text{}{\circledR}$ product sales (Source 11, 13).

Assessing the feasibility of launching retained EVOMELA rights in non-Asian regions, like the US, for multiple myeloma requires looking at the existing landscape. Since Acrotech Biopharma Inc. commercializes EVOMELA in the US (Source 12), CASI Pharmaceuticals, Inc.'s path is likely through a licensing or partnership deal, rather than direct commercial launch, to enter this market with its retained rights. In China, prior to the divestiture, EVOMELA treated over 2,600 patients in 2020 (Source 12), showing the product's potential in a large market, which suggests a significant opportunity in other developed markets like the US, where the estimated incidence of multiple myeloma is 5.6 cases per 100,000 persons in Western countries (Source 12).

Regarding CNCT19 (CAR-T), the focus for North America hinges on partnership. This asset already has Orphan Drug Designation by the U.S. FDA (Source 8, 9). The development is primarily handled by its partner, Juventas Cell Therapy Ltd., with CASI set to co-commercialize (Source 10). To expedite a North American launch, you'd need to secure a US-based commercial entity, as CASI's recent financial position shows cash and cash equivalents of only $4.7 million as of September 30, 2025 (Source 6), making a standalone launch challenging.

For FOLOTYN $\text{}{\circledR}$, leveraging existing approvals for a European submission is a strategy, but you face historical headwinds. FOLOTYN $\text{}{\circledR}$ has existing approvals from both the FDA and NMPA for Peripheral T-cell Lymphoma (PTCL) (Source 14). However, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended a refusal of marketing authorization in April 2012, citing insufficient data to establish benefits for PTCL (Source 18). Any new submission would need to address these historical concerns, likely requiring new data generation, which ties back to funding.

The $20.0 million from the China asset sale is explicitly earmarked for strategic focus, which includes funding market entry studies in new territories (Source 3, 4). This capital infusion is critical, especially with Q3 2025 net loss at $10.9 million (Source 6) and cash reserves at $4.7 million (Source 6).

Exploring licensing EVOMELA $\text{}{\circledR}$ to a new distributor to re-enter the China market post-divestiture is indeed a long-shot, especially since the Import Drug Registration License for FOLOTYN $\text{}{\circledR}$ in China expired on August 25, 2025 (Source 19), indicating a shifting regulatory environment. Furthermore, CASI Pharmaceuticals, Inc. is currently involved in legal proceedings related to pipeline products, including EVOMELA $\text{}{\circledR}$ (Source 5, 6, 20). This situation suggests that any re-entry would be complex and likely require significant legal and regulatory investment.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Product Development

You're looking at the core of CASI Pharmaceuticals, Inc.'s near-term strategy, which is heavily weighted on advancing CID-103, their anti-CD38 monoclonal antibody. This is pure Product Development in the Ansoff sense-taking an existing asset into new indications or optimizing its delivery.

For the Immune Thrombocytopenia (ITP) indication, development is accelerating. The Phase 1 dose-escalation study has successfully reached and dosed patients at the highest cohort level, which is 900 mg. The Safety Monitoring Committee recommended proceeding to this 900 mg target dose after reviewing cohort 4 (which had a 600 mg target dose). This trial is designed to include an estimated maximum of approximately 30 subjects with primary ITP.

On the Antibody-Mediated Rejection (AMR) program for renal allografts, a major hurdle has been cleared. CASI Pharmaceuticals, Inc. announced the FDA clearance of its Investigational New Drug (IND) application for CID-103 in this indication. This clearance allows for the preparation of a Phase 1 study in the U.S., with plans for the first patient in the first quarter of 2026. This advancement resolves the prior clinical hold status that was reported for the AMR program.

Financially, the commitment to these clinical efforts is clear in the spending figures. Research and development expenses for the third quarter of 2025 were reported at $1.4 million. This spend directly supports the advancement of the CID-103 clinical programs in both AMR and ITP.

To improve patient convenience and potential market adoption, CASI Pharmaceuticals, Inc. is actively working on the delivery method. The company is currently Assessing multiple technologies toward a SQ delivery formulation for CID-103, aiming for a subcutaneous injection suitable for registration trials.

Regarding expansion into new indications, the strategy includes seeking a strategic partner. The goal is to co-develop CID-103 for a malignant hematology indication in the US. While the development pipeline includes other hematological malignancy uses, the specific action item is securing that US partnership.

Here's a quick look at the Q3 2025 financial context surrounding this R&D investment:

The development pathway for CID-103 involves several concurrent tracks, which you can see laid out here:

• Accelerate CID-103 ITP development, with dosing reaching 900 mg.
• Advance AMR program via FDA IND clearance for U.S. Phase 1 study preparation.
• Allocate R&D focus, with Q3 2025 R&D spend at $1.4 million.
• Assess multiple technologies for a subcutaneous formulation of CID-103.
• Pursue a strategic partner for co-development in a US malignant hematology indication.

Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Ansoff Matrix: Diversification

You're looking at a company making a hard pivot, shedding the China-centric model to focus almost entirely on the US market with CID-103. That's a classic diversification move, but with cash running tight, the execution has to be surgical. Let's look at the numbers grounding this strategy.

The commitment to the CID-103 program for Antibody-Mediated Rejection (AMR) in the US is the core of this new path. Antibody-mediated rejection is a serious hurdle; among kidney transplant patients, about 12% experience acute or chronic AMR, which translates to over 30,000 people in the United States alone needing better options, since there is currently no FDA-approved treatment for AMR. CASI Pharmaceuticals has secured FDA IND clearance for a Phase 1 study in renal allograft AMR, with the plan to dose the first patient in the first quarter of 2026. This focus is reinforced by the fact that the Phase 1/2 study for Immune Thrombocytopenic Purpura (ITP) is ongoing, having reached a dose of 900 mg, with data presentation set for December 7, 2025, at ASH 2025.

This strategic shift away from the China model is being formalized. The proposed transaction from May 2025 valued the entire China business, including Asian rights to CID-103, at an aggregate purchase price of $20.0 million, which included the assumption of up to $20.0 million of indebtedness. The company is now targeting the divestiture of this China business by the second quarter of 2026. This move is critical because the cash position as of September 30, 2025, was only $4.7 million, down significantly from $13.5 million at the end of 2024. You need that cash runway to fund the US build-out.

To build out the US-centric commercial infrastructure, the company must allocate its limited resources carefully. The remaining cash, which stood at $4.7 million at the end of the third quarter, must now fund the next steps. The Research and Development expenses for Q3 2025 were $1.4 million, which is stable compared to the prior year. The plan is to use this remaining capital to fund pre-clinical work for a new indication, which is a high-risk allocation given the low cash balance. Honestly, the Q3 2025 revenue of $3.1 million-a 60% decrease year-over-year-shows the pressure on the existing revenue stream from EVOMELA^® returns.

The diversification strategy isn't just about focusing on AMR; it involves actively expanding the pipeline beyond the current focus areas of oncology and autoimmune disease. The strategy explicitly calls for two external additions to create a truly diversified revenue stream for the US market:

• Acquire a new, early-stage asset in the autoimmune disease space to build a CID-103-adjacent pipeline.
• License in a non-oncology, non-autoimmune product for the US market.

These moves, coupled with establishing the US commercial team, are funded by the expected proceeds from the China divestiture and the $5.7 million raised via the ATM facility during the third quarter of 2025. The operating expenses for Q3 2025 were significant, with General and administrative expenses at $4.9 million and Selling and marketing expenses at $4.6 million.

Finance: draft 13-week cash view by Friday.