Cassava Sciences, Inc. (SAVA): Business Model Canvas [Dec-2025 Updated]

You're trying to make sense of Cassava Sciences, Inc. following their sharp pivot away from Alzheimer's and into the high-stakes world of rare diseases like TSC-related epilepsy. Honestly, the current business model is a classic pre-revenue biotech gamble: they are burning cash-with Q3 2025 operating costs hitting $11.9 million combined for R&D and G&A, plus that massive $31.25 million loss contingency recorded earlier-but they still hold a solid $106.1 million in cash as of September 30, 2025. This canvas lays out the precise roadmap for how they plan to use their key resource, Simufilam, and their partnerships with groups like the TSC Alliance to target a niche market of roughly 50,000 US patients, so read on to see the full structure of this calculated risk.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Key Partnerships

You're looking at the strategic alliances Cassava Sciences, Inc. is leaning on as it pivots its focus to Tuberous Sclerosis Complex (TSC)-related epilepsy. These relationships are critical for advancing simufilam into the clinic, especially after the discontinuation of the Alzheimer's program.

Key Partnerships

• - Yale University: License agreement for Simufilam's use in TSC-related disorders, executed February 26, 2025.
• - TSC Alliance's Preclinical Consortium: Collaboration for preclinical studies in TSC mouse models.
• - Contract Research Organizations (CROs): Research partner PsychoGenics, Inc. conducted a key preclinical study.
• - Scientific and Clinical Key Opinion Leaders (KOLs): New executive appointments guiding the TSC development strategy.

The license agreement with Yale University, effective February 26, 2025, secured exclusive worldwide rights to intellectual property, including US method of treatment patent US 12,186,307 for simufilam in TSC-related seizures. This deal is structured with financial obligations tied to performance.

The preclinical work supporting this new indication involved the TSC Alliance's Preclinical Consortium. The study, conducted by the Consortium's research partner, PsychoGenics, Inc., provided compelling proof-of-concept data. The results showed simufilam reduced seizure frequency by 60% in a mouse model of focal onset seizures. Furthermore, seizure freedom was observed in 11/32 treated mice, compared to 3/29 vehicle-treated mice.

Cassava Sciences has also fortified its internal leadership, bringing in experts to guide the TSC development. These appointments represent the company's engagement with top-tier scientific and clinical expertise.

• - Dr. Angélique Bordey appointed SVP of Neuroscience (announced Q1 2025).
• - Dr. Jack Moore appointed SVP of Clinical Development (announced Q1 2025).
• - Dr. Joseph Hulihan appointed Chief Medical Officer (announced Q2 2025).
• - Dawn C. Bir appointed to the Board of Directors (announced Q3 2025).

Financially, this partnership-heavy strategy is being executed while the company manages a transition. Cassava Sciences ended Q3 2025 with $106.1 million in cash and cash equivalents. The net cash used in operations for the first nine months of 2025 totaled $22.5 million, with an estimate of cash at year-end 2025 falling between $92 to $96 million. Research and development expenses for Q3 2025 were $4.0 million. The company plans to initiate a proof-of-concept study for simufilam in TSC-related epilepsy in the first half of 2026.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Key Activities

The Key Activities for Cassava Sciences, Inc. (SAVA) in late 2025 center on a strategic pivot and cost containment following the discontinuation of its Alzheimer's disease program.

The focus is now heavily on the preclinical and clinical development for TSC-related epilepsy, with a stated goal to initiate the first clinical study in this indication in the first-half 2026. Preclinical data supporting this new direction included a reported 60% reduction in seizure frequency in mouse models.

Regulatory strategy development involves active communication with the FDA. On December 2, 2025, Cassava Sciences was informed by the FDA of the need for more data for its simufilam Investigational New Drug application for TSC-related epilepsy. The company expects a formal letter detailing the issues required to assess potential risks and support the start of the proposed clinical study. Despite this, Cassava Sciences maintains its plan to initiate the proof-of-concept trial in the first half of 2026.

Intellectual Property (IP) protection and maintenance for Simufilam is being secured through new agreements. Cassava Sciences entered into a license agreement with Yale University granting intellectual property rights, including rights to an issued US method of treatment patent for potential treatment with simufilam of seizures related to rare neurodevelopmental disorders.

Strategic expense management and workforce reduction are critical activities supporting the pivot. The company implemented a cost curtailment program that included a workforce reduction of 10 employees, which represented approximately 33% of its total workforce, during the first quarter of 2025. The one-time cost associated with this reduction was approximately $0.4 million in Q1 2025. The company also halted a planned biomarker analysis of additional plasma samples from prior Phase 2 studies to save money.

Financial metrics reflecting these activities as of late 2025 include:

The shift away from the prior focus is quantified by the discontinuation of the Alzheimer's disease program by the end of Q2 2025. The R&D expense for Q1 2025 was $13.7 million, compared to $16.2 million for the same period in 2024.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Key Resources

You're looking at the core assets Cassava Sciences, Inc. (SAVA) is relying on right now to push its pipeline forward, especially after pivoting focus following the Alzheimer's program. These aren't just items on a balance sheet; they are the tangible and intangible drivers of future value in late 2025.

The most critical resource is Simufilam, which is Cassava Sciences, Inc. (SAVA)'s proprietary, investigational oral small molecule drug candidate. This molecule is specifically designed to restore the normal shape and function of altered filamin A (FLNA), a scaffolding protein in the brain, which is the basis of their mechanism of action for CNS disorders.

Financially, Cassava Sciences, Inc. (SAVA) maintains a solid liquidity position, though it is being drawn down as they advance their new focus area. As of September 30, 2025, the company reported $106.1 million in cash and cash equivalents, with no debt outstanding. Management estimates this cash position is expected to support operations into 2027, with an estimated year-end 2025 cash range between $92 million and $96 million. Here's a quick look at some key financial figures from that period:

The scientific expertise within Cassava Sciences, Inc. (SAVA) is centered on Central Nervous System (CNS) disorders and, specifically, the modulation of the filamin A protein. The underlying science supporting Simufilam has been published across several peer-reviewed journals, including Drug Development Research and Journal of Neuroscience. The company has also enhanced its development capabilities with top-tier experts in neuroscience and medicine.

A crucial intangible asset is the intellectual property secured for the new indication. Cassava Sciences, Inc. (SAVA) secured exclusive license rights to Simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy through an agreement with Yale University, effective February 26, 2025. This includes:

• Exclusive worldwide rights, with rights to sublicense, to Yale's interest in relevant intellectual property.
• An exclusive license to an issued US method of treatment patent (US 12,186,307) for treating seizures related to rare neurodevelopmental disorders, including TSC.
• The licensed IP is based on research by Angélique Bordey, PhD, at Yale, which showed simufilam reduced seizure frequency in an animal model.

The company is prioritizing initial development efforts on TSC-related seizures, aiming to initiate a proof-of-concept study in the first half of 2026.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Value Propositions

Cassava Sciences, Inc. is positioning Simufilam as a potential first-in-class oral treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy.

The target market addresses a rare disease with a high unmet medical need, as TSC affects approximately 50,000 people in the US.

Epilepsy is a major feature of this condition, occurring in 84% of patients with TSC. Further, nearly two-thirds of TSC patients experience refractory epilepsy and life-long seizures.

The value proposition is strengthened by the drug candidate's profile:

• Preclinical proof-of-concept showed treatment with simufilam reduced seizure frequency by 60% compared to vehicle in a mouse model of focal onset seizures.
• Simufilam attenuated the progression of seizure activity with a statistically significant correlation between simufilam dose and the number of seizures in a well-accepted mouse model of TSC-related epilepsy.
• Data from two human Phase 3 studies in 1,929 patients with mild-to-moderate Alzheimer's disease demonstrated a favorable safety profile.
• An independent Data and Safety Monitoring Board recommended both of the prior Phase 3 studies continue as planned, without modification.
• The company is advancing towards a proof-of-concept clinical study for TSC-related epilepsy, which is expected to begin in H1 2026.

Current therapeutic options for TSC-related epilepsy, including antiepileptic drugs and mTOR inhibitors, are not fully effective and are associated with serious adverse events.

Here's a quick look at the financial and operational context supporting the continued development of this value proposition as of late 2025:

The focus on a novel mechanism of action, filamin A modulation, offers a distinct approach compared to existing treatments for CNS disorders. This strategic pivot is supported by disciplined spending, with R&D expenses for the quarter ending September 30, 2025, at $4.0 million, a 78% decrease year-over-year due to the phase out of the Alzheimer's disease development program.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Customer Relationships

You're looking at how Cassava Sciences, Inc. (SAVA) manages its key external relationships as of late 2025, which is heavily centered around its pivot to Tuberous Sclerosis Complex (TSC)-related epilepsy.

High-touch, specialized engagement with patient advocacy groups (e.g., TSC Alliance).

Cassava Sciences, Inc. engages closely with patient groups to support its new focus area. This relationship is foundational for the simufilam program in TSC-related epilepsy. The company explicitly states it is working with the TSC Alliance to create a proof-of-concept study. This collaboration is built upon preclinical work, including one animal model study conducted in partnership with the TSC Alliance and the TSC Preclinical Consortium. The goal is to advance simufilam as a potential first-in-class treatment for a condition where 84% of patients with TSC experience seizures.

Key aspects of this engagement include:

• Collaboration on preclinical studies supporting simufilam's potential use.
• Plans to initiate a proof-of-concept clinical study in H1 2026.
• Preclinical data showed simufilam attenuated seizure activity in a dose-dependent manner.

Collaborative relationships with clinical investigators and research institutions.

The scientific foundation for the TSC program stems from academic collaboration. Cassava Sciences, Inc. has a license agreement with Yale University, secured in February 2025, based on groundbreaking work from the lab of Dr. Angélique Bordey. Dr. Bordey, who joined as SVP, Neuroscience in May 2025, continues her academic position at Yale on a part-time basis. This relationship is defintely critical for the ongoing research and development efforts. The preclinical work in a mouse model showed that simufilam reduced seizure frequency by 60% compared to vehicle.

The company has also fortified its clinical development team with appointments like Dr. Joseph Hulihan as Chief Medical Officer in August 2025.

Investor Relations (IR) for transparent communication on clinical and financial updates.

Cassava Sciences, Inc. maintains communication with investors through regular financial updates, such as the Q3 2025 report released on November 12, 2025. The company emphasizes transparent communication as part of its driving principles. The shift away from the Alzheimer's program, which was fully discontinued in Q2 2025, has significantly altered the financial narrative shared with investors.

Here's a look at the financial position shared with investors as of late 2025:

The company projects its current cash reserves will support operations into 2027.

Transactional, future-focused relationship with potential pharmaceutical partners for commercialization.

The primary transactional relationship currently evident is the license agreement with Yale University in February 2025 for simufilam in TSC-related epilepsy, which includes milestone and royalty payments. This structure is future-focused, contingent on the success of the upcoming clinical trials. Historically, Cassava Sciences, Inc. had agreements with King Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc., for the REMOXY program, but the current strategic focus is on the TSC indication. The company's stated mission includes pursuing meaningful partnerships to advance its novel treatments.

Finance: review cash burn projections against the $10 to $14 million Q4 2025 expected cash use by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Channels

You're looking at how Cassava Sciences, Inc. gets its critical information out to the world-from the lab bench to the SEC filing cabinet. For a clinical-stage, pre-revenue biotech like Cassava Sciences, Inc., these channels are everything; they bridge the gap between scientific progress and investor confidence.

Scientific Publications and Medical Conferences

Disseminating data is non-negotiable for Cassava Sciences, Inc. This is how they validate their science, simufilam, particularly in the new focus area of Tuberous Sclerosis Complex (TSC)-related epilepsy. The company actively uses these venues to share preclinical findings, which is crucial since the Alzheimer's program concluded in 2025.

• - Presented preclinical simufilam data at the TSC Alliance Meeting on June 30, 2025.
• - Data showed simufilam reduced seizure activity in a preclinical mouse model.
• - The company is preparing for a proof-of-concept study in TSC-related epilepsy, planned for H1 2026.

Direct-to-Investor Communication

The financial community relies on timely, official releases to gauge the company's runway and strategic execution. Cassava Sciences, Inc. uses standard filings to manage expectations, especially following its strategic pivot. Honesty about cash burn and runway is key here.

Here's the quick math on their Q3 2025 financial status, which was communicated via press release on November 12, 2025:

The company also disclosed maintaining a $31.25 million estimated loss contingency related to potential securities litigation settlement recorded in Q2 2025. That's a big number to watch. Total shares outstanding as of November 10, 2025, were 48.3 million.

Regulatory Submissions

Direct interaction with the Food and Drug Administration (FDA) dictates the pace of development. This channel is currently active and requires careful management. Cassava Sciences, Inc. is working to initiate its proof-of-concept trial for simufilam in TSC-related epilepsy in the first half of 2026.

• - The company was informed by the FDA on December 2, 2025, that additional information is required for the Investigational New Drug (IND) application.
• - The FDA needs more data to assess risks to human subjects before supporting the initiation of the proposed clinical study.
• - Cassava Sciences, Inc. expects to receive a formal letter detailing the issues soon and plans to work collaboratively with regulators.

The market reacted to this news on December 3, 2025, with the stock initially plunging 13% premarket before rebounding.

Academic and Research Collaborations

External validation from academic institutions helps de-risk the science and explore new indications. These collaborations are a vital, albeit less frequent, channel for Cassava Sciences, Inc. to build its scientific foundation.

The groundwork for the TSC-related epilepsy program was laid through a license agreement with Yale University for intellectual property rights to potential treatments for certain rare diseases, including TSC-related epilepsy. Also, the preclinical work involved a study conducted in collaboration with the TSC Alliance using a Tsc1-knockout model.

Finance: review the Q4 2025 cash burn projection against the $10 to $14 million incremental cash use expected in Q4 2025 by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Cassava Sciences, Inc. (SAVA) right now, late in 2025, following their strategic pivot. The focus is clearly on a niche, high-need patient population, which dictates the other segments we need to watch, especially the investors funding the journey.

Patients with Tuberous Sclerosis Complex (TSC)-related epilepsy.

This is the primary target for the investigational drug, simufilam. The need here is substantial, given the current treatment landscape. Epilepsy is present in about 85% of patients with TSC. To be frank, more than 60% of these individuals do not achieve seizure control with standard treatments like antiepileptic drugs.

The addressable population size is small but defined. In the United States, it is estimated that between 40,000 to 80,000 people have TSC. The birth incidence in the US is reported around 1 in 6,000 newborns. Preclinical work showed promise, with simufilam reducing seizure frequency by 60% in a mouse model. The next step for this segment is the planned proof-of-concept clinical study expected to begin in the first half of 2026.

Neurologists and epilepsy specialists treating TSC patients.

These specialists are the gatekeepers to the patient segment. They are the ones who will ultimately prescribe simufilam, assuming it gains approval. Their segment is defined by the rarity of the condition and the high rate of refractory seizures among their patients.

• - Specialists treating patients with TSC-related epilepsy.
• - Key opinion leaders (KOLs) involved in rare CNS disorder research.
• - Researchers collaborating on preclinical data, such as the work with the TSC Alliance\'s Preclinical Consortium.

The company has also been actively building its clinical development team, appointing Dr. Joseph Hulihan, who brings experience advancing therapies for TSC-related epilepsy, as Chief Medical Officer in August 2025. That's management directly aligning with this customer group.

Institutional and retail investors funding the pre-revenue biotech model.

Since Cassava Sciences, Inc. is pre-revenue, this segment is critical for sustaining operations until a potential commercial launch. The financial health metrics as of September 30, 2025, are what these investors are focused on right now.

The cash position of $106.1 million, with no debt, is guided to support operations into 2027. This runway is the primary value proposition for current investors, de-risking near-term financing concerns. Analysts forecast the 2025 earnings to average around -$95,098,924.

Regulatory bodies (e.g., FDA) overseeing drug development for CNS disorders.

The Food and Drug Administration (FDA) is the ultimate arbiter of market access. For Cassava Sciences, Inc., this segment is currently engaged through the pre-Investigational New Drug (IND) process for simufilam in TSC-related epilepsy.

• - FDA review of pre-IND meeting requests.
• - Adherence to Good Clinical Practice (GCP) standards for the planned H1 2026 study.
• - Oversight of clinical trial design for rare CNS disorders.

The company is focused on developing its regulatory strategy to support the planned first clinical study in the first half of 2026. Finance: you should track the cash burn against the projected R&D spend needed to satisfy regulatory milestones by Q4 2025.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Cost Structure

You're looking at the hard numbers that drive Cassava Sciences, Inc.'s operations as of late 2025, post-pivot. The cost structure reflects a significant shift away from the large Alzheimer's program and toward the new focus on Tuberous Sclerosis Complex (TSC)-related epilepsy.

The primary operating expenses for the third quarter ended September 30, 2025, show a leaner structure compared to the prior year, largely due to the completion of the prior large-scale clinical trials.

Legal costs are a notable, non-recurring expense that hit the books in the prior quarter. Cassava Sciences, Inc. recorded a $31.25 million estimated loss contingency in Q2 2025 related to the potential settlement of certain securities litigation. This accounting entry signals management's assessment that resolution is probable and estimable.

Personnel costs are managed tightly following the strategic realignment earlier in the year. You'll recall the company implemented a cost curtailment program in Q1 2025:

• Workforce reduced by approximately 33%, affecting 10 employees.
• This reduction incurred approximately $0.4 million in one-time costs in Q1 2025 for severance.
• In Q3 2025, compensation costs decreased by $1.3 million because severance costs recorded in the prior year period were not repeated.

The current R&D spend of $4.0 million in Q3 2025 reflects the shift in focus. The company is now preparing for the next major cost driver: clinical trials for simufilam in TSC-related epilepsy. They plan to initiate a proof-of-concept study in the first half of 2026. Honestly, the cost of that study isn't itemized yet, but the current cash position of $106.1 million as of September 30, 2025, is guided to support operations into 2027, which should cover the preclinical ramp and initial setup for that trial.

Here's a quick look at how the G&A components shifted in Q3 2025 compared to the prior year:

• Legal related costs decreased by $2.5 million compared to Q3 2024.
• Severance-related compensation costs recorded in Q3 2024 were not repeated in Q3 2025.

Finance: review the Q4 2025 cash burn guidance against the Q3 actuals by next Tuesday.

Cassava Sciences, Inc. (SAVA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Cassava Sciences, Inc. (SAVA) as of late 2025, and honestly, it's what you'd expect from a company deep in the clinical development phase. The core reality is that Cassava Sciences currently reports zero product revenue because, as of the third quarter ending September 30, 2025, the company remains pre-commercial. The lead drug candidate, simufilam, has seen its Alzheimer's disease program discontinued following the failure to meet co-primary endpoints in both the RETHINK-ALZ and REFOCUS-ALZ Phase 3 studies.

The current revenue picture is entirely reliant on non-operating income sources, which is typical for a development-stage biotech. For the three months ended September 30, 2025, the reported net loss was $10.8 million, or -$0.22 per share. This means the company is currently operating at a net loss, consuming cash rather than generating revenue from sales.

Still, the potential for future revenue streams is being actively pursued through a pivot in focus. This is where the licensing and partnership element comes into play, specifically for the TSC-related epilepsy indication.

• - Potential future milestone payments from the February 26, 2025, License Agreement with Yale University for simufilam in TSC-related epilepsy.
• - Potential future product sales revenue if simufilam gains approval for TSC-related epilepsy, with a proof-of-concept clinical study anticipated to start in the first half of 2026.

To give you a sense of the non-dilutive funding that has supported operations in the past, here's a look at the government grant history, which is a key non-product revenue component for many clinical-stage firms. Note that the most recent large grant mentioned was awarded in 2021, and no new grant revenue for 2025 is explicitly reported in the Q3 2025 results.

The company's ability to fund its ongoing operations, including the new TSC program, is currently supported by its balance sheet strength, not sales. As of September 30, 2025, Cassava Sciences held $106.1 million in cash and cash equivalents with no debt. Management estimates the cash position at year-end 2025 will be in the range of $92 to $96 million. This cash runway is expected to support operations into 2027.

The potential for product sales revenue is entirely contingent on the success of the TSC-related epilepsy program. The company is preparing for a proof-of-concept open-label clinical trial, aiming to initiate in the first half of 2026. Any revenue from this stream is definitely not factored into the current 2025 financial reporting, as it is entirely dependent on future clinical and regulatory success.