Cassava Sciences, Inc. (SAVA): ANSOFF MATRIX [Dec-2025 Updated]

You're looking at Cassava Sciences, Inc. (SAVA) and wondering how this clinical-stage company actually turns its lead Alzheimer's asset, simufilam, into a commercial success story. Honestly, mapping that journey requires a clear plan, so I've broken down their growth options using the Ansoff Matrix-a classic tool for managing risk when you're sitting on a potentially massive market opportunity in neurodegeneration. We're looking at four distinct paths: aggressively capturing the US market with a co-pay under $50, expanding globally by filing in Europe within six months of FDA approval, developing next-gen formulations or new indications, or diversifying entirely by acquiring a non-Alzheimer's asset. This framework shows you exactly where the near-term actions are, from building a specialized sales force to exploring spin-offs for their diagnostic intellectual property. It's about turning potential into profit, and here's how Cassava Sciences, Inc. (SAVA) can play it safe or swing for the fences.

Cassava Sciences, Inc. (SAVA) - Ansoff Matrix: Market Penetration

You're hiring before product-market fit, and for Cassava Sciences, Inc. (SAVA), the market for simufilam in Alzheimer's disease has effectively closed following the discontinuation of the Phase 3 program by the end of Q2 2025. The current focus for Market Penetration shifts entirely to establishing a foothold in the new indication: TSC-related epilepsy, leveraging the existing asset.

The strategy now centers on operational efficiency and preparing the groundwork for the next clinical step, rather than immediate large-scale commercial launch activities for Alzheimer's. The company's financial reality in late 2025 reflects this pivot.

Here's a look at the operational and financial metrics as of the third quarter of 2025:

The previous commercialization planning, such as securing rapid formulary inclusion or investing in a specialized sales force, is now paused or repurposed for the new indication. The focus is on the next clinical milestone.

• The proof-of-concept study for simufilam in TSC-related epilepsy is planned to initiate in H1 2026.
• The company is advancing its development capabilities with key leadership appointments, such as Dr. Joseph Hulihan as Chief Medical Officer.
• Research and development (R&D) expenses for Q3 2025 were $4.0 million, a 78% decrease from Q3 2024, largely due to the phase out of the Alzheimer's program.

The outline's points regarding payer co-pays below $50, a $150 million sales force investment, and covering 75% of Medicare/Medicaid out-of-pocket costs are not applicable to the current late-2025 operational reality, which is pre-commercial for TSC-related epilepsy. The current penetration effort is purely scientific and regulatory for the new indication.

Instead of a DTC campaign for Alzheimer's, the current activity involves presenting data and analyses at scientific conferences for the TSC program. The company is focused on leveraging its existing intellectual property rights, including a license from Yale University secured in February 2025.

The supply chain focus is currently on supporting the next clinical trial, not broad market distribution. The company's cash position of $106.1 million as of September 30, 2025, is expected to support operations into 2027, based on current expense levels.

Finance: Review Q4 2025 cash burn projection against the $92 to $96 million year-end estimate by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Ansoff Matrix: Market Development

You're looking at how Cassava Sciences, Inc. (SAVA) could expand its market reach beyond its current focus, even as the company has recently pivoted its primary clinical development efforts. Based on the Q3 2025 results, the company ended September 30, 2025, with $106.1 million in cash and cash equivalents, expecting this to support operations into 2027, though year-end 2025 cash was estimated in a range from $92 to $96 million.

Market Development strategies focus on taking the existing product, simufilam, into new geographic territories or new patient segments. For Cassava Sciences, Inc., this involves international expansion and moving into earlier-stage indications, though the Alzheimer's disease program was discontinued by the end of Q2 2025.

International Regulatory Expansion

A key component of market development is accessing new patient populations through international regulatory bodies. The stated goal is to initiate regulatory filings in the European Union (EMA) and Japan (PMDA) within six months of US FDA approval. While the FDA approval for Alzheimer's has not been secured, the company's current focus is on Tuberous Sclerosis Complex (TSC)-related epilepsy, which will dictate the next set of international regulatory targets.

Strategic Licensing in Asia-Pacific

To penetrate complex markets like China and the broader Asia-Pacific region, strategic partnerships are essential. The target for these licensing deals is a minimum 20% royalty rate. This aligns with recent industry activity; for example, a late 2024 out-licensing deal for a hepatitis B treatment candidate in Asian markets included structured royalties ranging from 15-22% based on sales thresholds. The growth in China as a partnership destination is significant, with deals involving Chinese companies increasing 56% year-over-year, and Chinese out-licensing deals reaching 80 in number in 2024.

Expanding the Addressable Patient Pool

Market development also means targeting earlier-stage patients within the existing therapeutic area. The plan was to fund additional clinical trials to demonstrate simufilam's efficacy in earlier-stage Alzheimer's patients, specifically Mild Cognitive Impairment (MCI), which would expand the addressable market by an estimated 3 million people. To give context to this potential market size, the global MCI market size was over USD 2.51 billion in 2025, and the market across the top 7 major markets (US, EU4, UK, and Japan) reached USD 2,978.10 Million in 2024. However, you should note that Cassava Sciences, Inc. reported a 78% decrease in Research and Development expenses to $4.0 million in Q3 2025, primarily due to the phase out of the Alzheimer's disease development program.

The company's current financial structure, with a Q3 2025 net loss of $10.8 million, suggests that any new, large-scale clinical trials would require significant partnership funding or external capital.

The market development strategy also includes tactical regulatory maneuvers:

• Present compelling real-world evidence data at international neurology conferences to build physician confidence outside the US.
• Seek Orphan Drug Designation in smaller, high-need international markets where the regulatory path is streamlined.

Here is a quick look at the financial context for funding these market development activities, based on the latest reported figures:

Cassava Sciences, Inc. (SAVA) - Ansoff Matrix: Product Development

You're looking at the next phase of Cassava Sciences, Inc.'s pipeline now that the Alzheimer's disease development program has been phased out by the end of the second quarter of 2025. This shift frees up resources to focus on other indications, like the one you mentioned.

The original dosing for simufilam in the discontinued Phase 3 Alzheimer's trials involved oral tablets administered twice daily (BID) for 76 weeks in the REFOCUS-ALZ study, which enrolled approximately 1,125 patients. The elimination half-life for simufilam is reported as 4.5 hours.

Cassava Sciences, Inc. is now advancing simufilam as a potential treatment for TSC-related epilepsy, building on preclinical proof-of-concept data. This new focus supports the exploration of simufilam's potential application for other neurodegenerative or CNS diseases, though specific Parkinson's disease or Lewy body dementia studies aren't detailed in recent updates.

The preclinical data presented for TSC-related epilepsy showed compelling results in a mouse model of focal onset seizures:

• Treatment with simufilam reduced seizure frequency by 60% compared to vehicle.
• 11/32 simufilam treated mice achieved seizure freedom versus 3/29 vehicle treated mice ($p=0.0343$).
• The Company intends to initiate a proof-of-concept study in TSC-related epilepsy in the first half of 2026.

The second-generation compound, PTI-125, is the former name for simufilam itself; the drug targets the filamin A protein. The Phase 1 safety study for PTI-125 tested doses of 50, 100, or 200 mg. The Phase 2a trial utilized 100 mg capsules twice daily for 28 days. Since the Alzheimer's program is discontinued, the focus is now on the existing molecule, simufilam, in the new indication.

Regarding companion diagnostics, the Phase 3 REFOCUS-ALZ trial included an investigation into the effect of simufilam treatment on SavaDx, a novel plasma biomarker, which serves as an example of the type of diagnostic work Cassava Sciences, Inc. has incorporated into its development efforts.

Instead of a specific forward-looking investment commitment of $50 million, here's the quick math on recent Research and Development (R&D) spending, which reflects the shift in focus:

What this estimate hides is the significant reduction in R&D spending following the discontinuation of the Phase 3 Alzheimer's trials, which was completed in the second quarter of 2025. The cash position as of September 30, 2025, was $106.1 million, with an estimated year-end 2025 cash balance between $92 to $96 million.

Cassava Sciences, Inc. (SAVA) - Ansoff Matrix: Diversification

You're looking at Cassava Sciences, Inc. (SAVA) post-Alzheimer's program wind-down, which means the capital allocation strategy needs a sharp pivot. Diversification here isn't just a nice-to-have; it's about deploying that remaining capital base into non-Alzheimer's avenues to stabilize the enterprise value. The company finished Q3 2025 with $106.1 million in cash and cash equivalents, which is a solid foundation, though down from $128.6 million at the end of 2024. The net cash used in operations was $22.5 million over the first nine months of 2025, and they project year-end 2025 cash to be between $92 to $96 million. This cash runway, expected to support operations into 2027, gives you a window to execute on these diversification plays.

Here's how the suggested diversification avenues map against the current financial reality:

• Acquire a complementary, non-Alzheimer's focused asset in Phase 1 or 2, such as a treatment for chronic pain or a rare neurological disorder, to diversify pipeline risk.
• Establish a contract research organization (CRO) subsidiary focused on central nervous system (CNS) trials, leveraging their in-house expertise to generate a new revenue stream.
• Partner with a major technology firm to develop a digital therapeutic platform for cognitive assessment and patient monitoring, integrating it with simufilam treatment.
• License out their proprietary assay technology for detecting altered filamin A to academic and industry researchers for non-therapeutic use, generating low-risk revenue.
• Explore a spin-off or joint venture for their diagnostic intellectual property, aiming to raise $75 million in external funding for that new entity.

The shift in spending already reflects this pivot. Research and development (R&D) expenses for the third quarter of 2025 dropped to $4.0 million, a 78% reduction from the $17.7 million spent in Q3 2024, largely because the Alzheimer's program concluded in Q2 2025. General and administrative (G&A) costs also fell 39% to $7.9 million in Q3 2025, down from $12.9 million the prior year. This cost discipline is key for funding new ventures.

Consider the capital structure context before you model any M&A or new entity formation. You need to factor in the existing liability overhang.

The CRO subsidiary idea leverages the existing focus on CNS trials, which is where simufilam is now being directed for TSC-related epilepsy, with a proof-of-concept study planned for H1 2026. Generating external revenue from CNS trial management could provide a steady, non-drug-development-risk income stream. The licensing of assay technology is a classic low-capital diversification play; it uses existing IP without requiring further clinical investment. The spin-off idea, aiming for $75 million in external funding, would immediately de-risk the balance sheet by monetizing the diagnostic IP, separate from the core drug development risk, especially given the $31.25 million estimated loss contingency from litigation they are carrying.

You should also note the prior operational adjustments that freed up cash for these strategic moves. Cassava Sciences, Inc. reduced its workforce by 10 employees, or approximately 33%, in Q1 2025. Plus, they paid a $40 million civil monetary penalty in November 2024. These events shape the current financial capacity for aggressive diversification.

Finance: draft 13-week cash view by Friday.