Cassava Sciences, Inc. (SAVA): History, Ownership, Mission, How It Works & Makes Money

Given the dramatic pivot in its core strategy, how do you even begin to value Cassava Sciences, Inc. (SAVA) today?

The company is shifting away from its high-profile Alzheimer's program-which saw R&D expenses plummet 78% to just $4.0 million in Q3 2025-to focus its lead drug, simufilam, on Tuberous Sclerosis Complex (TSC)-related epilepsy, a new and defintely less crowded indication.

This strategic move comes as the stock price has fallen sharply from over $32.18 in late 2024 to $2.63 per share by November 20, 2025, but with a strong cash position of $106.1 million as of September 30, 2025, you need to understand the new business model before making a move.

Cassava Sciences, Inc. (SAVA) History

You're looking for the real story behind Cassava Sciences, Inc., and honestly, it's a textbook example of a biotech company's high-stakes pivot. The direct takeaway is this: Cassava Sciences has completely shifted its focus in 2025, moving from a high-profile, high-risk Alzheimer's drug program to a more focused, rare-disease strategy following major clinical and legal setbacks in 2024.

The company you see today, with its focus on Tuberous Sclerosis Complex (TSC)-related epilepsy, is a result of a dramatic and costly reorientation. They are now banking on a new indication for their core compound, simufilam, a move that is defintely a near-term opportunity, but still carries the inherent risks of a clinical-stage firm.

Given Company's Founding Timeline

Year established

The company was established in May 1998, originally incorporated as Pain Therapeutics, Inc.

Original location

The original founding location was South San Francisco, California, U.S., with the initial focus on chronic pain treatments. The company's current headquarters is in Austin, Texas.

Founding team members

The company was founded by Remi Barbier, who served as President, CEO, and Chairman. His early vision was shaped by research into analgesic drugs, particularly from work by Stanley M. Crain around 1993.

Initial capital/funding

Remi Barbier launched the company with an initial investment of $1 million. Later, the company received grants from the National Institutes of Health (NIH) totaling $20 million between 2015 and 2021 to support its research efforts.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's history is defined by two massive, market-shaking pivots. The first was a calculated strategic shift; the second was a forced, existential correction.

• The 2019 Alzheimer's Pivot: Changing the name from Pain Therapeutics to Cassava Sciences was more than a rebrand; it was a complete business model overhaul. They transitioned from pursuing drugs like Oxytrex and Remoxy for pain to focusing all resources on simufilam (then PTI-125) for Alzheimer's disease. This single decision, based on the potential of simufilam to target the filamin A protein, created the high-growth, high-volatility stock story that defined the company until 2024.
• The 2024 Legal and Leadership Crisis: In a period of less than a year, the company faced significant legal and governance challenges. In June 2024, an advisor was charged with fraud over research results, leading to the resignation of founder Remi Barbier and his wife, Lindsay Burns, a senior vice president. This culminated in a September 2024 settlement with the U.S. Securities and Exchange Commission (SEC), where Cassava agreed to pay fines of $40 million without admitting wrongdoing. Rick Barry was named CEO in September 2024 to steer the company through this turmoil.
• The 2025 Rare Disease Pivot: The definitive failure of both Phase 3 Alzheimer's trials in late 2024 forced the company to completely discontinue its Alzheimer's program by the end of Q2 2025. The immediate, transformative action was the February 2025 license agreement with Yale University to repurpose simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy. This pivot is a clear action: move from a crowded, high-cost market (Alzheimer's) to a rare disease indication with a clearer, faster regulatory path. The company is now projecting a year-end 2025 cash position between $92 million and $96 million, which is expected to fund operations into 2027.

To be fair, the company's ability to maintain a strong balance sheet-ending Q3 2025 with $106.1 million in cash despite the setbacks and a Q3 net loss of $10.8 million-shows a resilient financial core. You can drill down into the cost-cutting and liquidity measures in Breaking Down Cassava Sciences, Inc. (SAVA) Financial Health: Key Insights for Investors.

Cassava Sciences, Inc. (SAVA) Ownership Structure

Understanding who owns Cassava Sciences, Inc. is key to analyzing its strategic direction, especially for a clinical-stage biotechnology company with a high-risk profile. The company's governance is driven by a mix of institutional funds, a significant retail investor base, and a core group of insiders, making it a dynamic and defintely closely watched stock.

Given Company's Current Status

Cassava Sciences is a publicly traded company, listed on the Nasdaq Stock Market under the ticker symbol SAVA. As of November 2025, it remains a clinical-stage biopharmaceutical firm, meaning its focus is on drug development, not commercial revenue generation. The company's financial runway is strong, with cash and cash equivalents totaling $106.1 million as of September 30, 2025, which is expected to support operations into 2027. For the third quarter of 2025, Cassava Sciences reported a net loss of $10.8 million, or $0.22 per share. This financial structure means its valuation and strategic decisions are highly sensitive to clinical trial progress and investor sentiment, which is why the ownership mix is so important.

Given Company's Ownership Breakdown

The ownership structure of Cassava Sciences is notable for the substantial proportion held by public and individual investors (retail), which can lead to higher stock price volatility compared to companies dominated by institutional holders. For a detailed breakdown of the decision-making framework that guides this structure, you can review the Mission Statement, Vision, & Core Values of Cassava Sciences, Inc. (SAVA).

The high insider ownership, at nearly 13%, is a signal that the leadership team has a vested interest in the long-term success of the company. This is a strong alignment of incentives, but still, the retail investor base is the dominant force. The recent open-market purchases by the President & CEO in November 2025 further reinforce this insider confidence.

Given Company's Leadership

The company is steered by an executive team with deep experience in drug development, though the average tenure of the management team is relatively short, around 1.2 years, suggesting a recently reshaped leadership focused on the new strategic direction toward Tuberous Sclerosis Complex (TSC)-related epilepsy. The key leaders as of November 2025 include:

• Richard J. Barry: President & Chief Executive Officer (CEO). He was appointed CEO in September 2024 and has a background in investment management, including being a founding member of Eastbourne Capital Management LLC.
• Joseph Hulihan, MD, MSHP: Chief Medical Officer (CMO). He joined the company in August 2025, bringing extensive experience in clinical development for neurological disorders, particularly epilepsy.
• Eric Schoen: Chief Financial Officer (CFO). He has served in this role since 2018, providing financial continuity.
• R. Christopher Cook: Chief Operating and Legal Officer.
• Dawn C. Bir: Independent Director. She was appointed to the Board of Directors in October 2025, adding significant biopharmaceutical executive and commercial expertise.

This leadership structure shows a clear effort to bolster clinical and commercial expertise, especially with the recent appointments of Dr. Hulihan and Ms. Bir, as the company pivots to its new lead program. Their collective experience is crucial for navigating the complex regulatory landscape of a clinical-stage biotech.

Cassava Sciences, Inc. (SAVA) Mission and Values

Cassava Sciences, Inc.'s core purpose centers on developing novel treatments for serious Central Nervous System (CNS) disorders, a mission recently refined following the discontinuation of its primary Alzheimer's program in late 2024. This shift highlights a focus on scientific rigor and patient impact, even as the company manages a tight cash position, with estimated year-end 2025 cash in the $92-$96 million range.

You're looking at a biotech firm that had to pivot hard after its lead drug, simufilam, failed to meet co-primary endpoints in its Phase 3 Alzheimer's trials in November 2024. So, the mission now has a new, focused target: Tuberous Sclerosis Complex (TSC)-related epilepsy, which requires a new strategic lens.

Given Company's Core Purpose

The company's cultural DNA is built on the high-risk, high-reward nature of drug discovery, demanding a commitment to science and transparency to justify their burn rate-net cash used in operations was $22.5 million during the first nine months of 2025. This is about more than just a stock price; it's about a defintely difficult path to market for a new class of medicine.

Official mission statement

Cassava Sciences' formal mission statement is concise, reflecting their current, broader focus on neurological conditions:

• Developing transformative medicines to improve the lives of patients with Central Nervous System (CNS) disorders.

This mission is supported by clear operational values, the things that drive the team every day.

• Pursue rigorous science.
• Ensure transparent communication.
• Foster meaningful partnerships with patients, caregivers, clinicians, and research collaborators.

Here's the quick math on their shift: R&D expenses for Q3 2025 dropped to just $4.0 million, a 78% decrease compared to the prior year, directly reflecting the phase-out of the costly Alzheimer's program and the pivot to the new, smaller-scale TSC-related epilepsy study.

Vision statement

While Cassava Sciences does not widely publicize a formal, single-sentence vision statement, their actions and recent corporate updates point to a clear, near-term strategic vision. The goal is to successfully re-purpose their investigational drug, simufilam, for a new indication.

• Become a leader in developing novel treatments for TSC-related epilepsy, leveraging preclinical data that showed simufilam reduced seizure frequency by 60% in a mouse model.
• Initiate a clinical proof-of-concept study for simufilam in TSC-related epilepsy in the first half of 2026.
• Maintain a strong balance sheet, with $106.1 million in cash as of September 30, 2025, to fund operations into 2027.

The vision is now less about a single blockbuster drug and more about validating their core scientific platform in a smaller, more manageable patient population. For a deeper dive into who is betting on this vision, you should read Exploring Cassava Sciences, Inc. (SAVA) Investor Profile: Who's Buying and Why?

Given Company slogan/tagline

Cassava Sciences does not use a widely-marketed slogan or tagline, which is common for clinical-stage biotechs focused on communicating scientific data over branding. Their messaging is currently all about the science.

• The operative tagline is the focus on 'Advancing novel treatments for serious CNS disorders,' a statement of current action over aspirational marketing.

Cassava Sciences, Inc. (SAVA) How It Works

Cassava Sciences, Inc. operates as a clinical-stage biotechnology company, pivoting its focus from a failed late-stage Alzheimer's disease program to repurposing its lead drug candidate, Simufilam, for a rare central nervous system (CNS) disorder.

The company creates value by advancing its proprietary small molecule drug, Simufilam, through preclinical and clinical development for Tuberous Sclerosis Complex (TSC)-related epilepsy, a strategy that leverages its core scientific understanding of the filamin A protein in a new, less crowded therapeutic area.

Cassava Sciences, Inc.'s Product/Service Portfolio

Cassava Sciences, Inc.'s Operational Framework

The company's operational framework shifted dramatically in 2025, moving from a large, costly Phase 3 clinical operation to a lean, early-stage development model focused on a new indication.

• R&D Expense Reduction: Research and development (R&D) expenses dropped sharply to $4.0 million in Q3 2025, a 78% decrease from the prior year, directly reflecting the phase-out of the Alzheimer's program.
• Strategic Repurposing: The core process involves taking Simufilam, which targets altered filamin A protein, and applying it to TSC-related epilepsy, supported by a February 2025 licensing agreement with Yale University for intellectual property rights.
• Workforce Streamlining: A cost-curtailment program was implemented in Q1 2025, including a workforce reduction of approximately 33%, to align resources with the smaller, preclinical-focused pipeline.
• New Program Timeline: The company is currently conducting necessary preclinical studies and developing a regulatory strategy, with the goal to initiate the first clinical study in TSC-related epilepsy in the first half of 2026.

Here's the quick math: The net loss for Q3 2025 was $10.8 million, a significant narrowing from the previous year, but the company is defintely burning cash to fund its new discovery work.

Cassava Sciences, Inc.'s Strategic Advantages

Cassava Sciences' market success now hinges on its ability to execute this pivot, leveraging its financial stability and a unique mechanism of action in a rare disease space.

• Financial Runway: The company reported a strong cash and cash equivalents balance of $106.1 million as of September 30, 2025, with estimated year-end 2025 cash between $92 million and $96 million, which is expected to support operations into 2027. This runway buys them time to prove the new indication.
• Novel Mechanism in a Niche: Simufilam's mechanism-targeting the filamin A protein-is distinct from traditional approaches, offering a potential first-in-class treatment for TSC-related epilepsy, a market with high unmet need and less competition than Alzheimer's.
• Intellectual Property Foundation: The company holds proprietary rights to Simufilam, and the new Yale University license strengthens its intellectual property (IP) position specifically for TSC-related epilepsy.

What this estimate hides is the high risk inherent in any early-stage biotech program; preclinical success doesn't guarantee a positive clinical outcome in a rare disease. You can find more detail on their financial position in Breaking Down Cassava Sciences, Inc. (SAVA) Financial Health: Key Insights for Investors.

Cassava Sciences, Inc. (SAVA) How It Makes Money

Cassava Sciences, Inc. is a clinical-stage biotechnology company, meaning it does not currently generate revenue from the sale of any approved commercial products. The company's financial model is entirely dependent on its ability to raise capital and manage its cash reserves to fund the research and development (R&D) of its investigational drug, Simufilam, for central nervous system disorders.

Cassava Sciences' Revenue Breakdown

To be clear, as of November 2025, Cassava Sciences reports essentially $0.00 in product revenue. This is the reality for a company focused on drug development; the entire business model is built on a single, massive future revenue event-regulatory approval and commercial launch-not on current sales. Any minor revenue recorded is typically from interest income on its cash reserves, which is negligible compared to its operating expenses. For the purpose of this breakdown, we must reflect the pre-commercial reality.

Business Economics

The economics of a clinical-stage biotech like Cassava Sciences are fundamentally different from a commercial business; it operates on a 'cash burn' model, where the main economic driver is the successful advancement of its drug candidate, Simufilam, through clinical trials to regulatory approval.

The company's value is derived from its intellectual property (IP) and the potential market size of its drug, not its current cash flow. The recent strategic pivot of Simufilam from Alzheimer's disease to Tuberous Sclerosis Complex (TSC)-related epilepsy, a rare disease, changes the target market from a massive, highly competitive one to a smaller, more defined orphan drug market. This is a classic risk-mitigation move, but it still requires significant capital.

• Pricing Strategy: Future pricing for Simufilam, if approved for TSC-related epilepsy, would likely follow the high-margin, premium pricing model typical of orphan drugs, which treat rare diseases.
• Cost Structure: The primary cost is R&D, which accounted for $4.0 million in Q3 2025, a 78% decrease from the prior year as the Alzheimer's program concluded. This cost control is defintely critical.
• Economic Gate: The key economic gate is the initiation of the proof-of-concept study for Simufilam in TSC-related epilepsy, expected in the first half of 2026. Until then, the economics are purely about expense management and cash runway.

Cassava Sciences' Financial Performance

Looking at the Q3 2025 results, reported on November 12, 2025, you can see a company in a significant transition, aggressively controlling costs to extend its runway after the discontinuation of the Alzheimer's program. Here's the quick math on their financial health:

• Cash Position: The company reported $106.1 million in cash and cash equivalents with no debt as of September 30, 2025. Management estimates year-end 2025 cash will be in the range of $92 million to $96 million.
• Cash Burn Rate: Net cash used in operations for the first nine months of 2025 was $22.5 million. This is a much lower burn rate than in previous years, reflecting the strategic cost curtailment.
• Net Loss: The net loss for Q3 2025 narrowed significantly to $10.8 million, or $0.22 per share, compared to a net loss of $27.9 million in the same period in 2024. Less spending equals a smaller loss, which is a good sign for near-term liquidity.
• Cash Runway: Based on current projections, the company expects its cash reserves to support operations into 2027. This runway provides the necessary time to execute the clinical study for the new TSC-related epilepsy indication.

What this estimate hides is the potential $31.25 million loss contingency related to a potential securities litigation settlement recorded in Q2 2025, the timing of which remains uncertain but could impact the cash position. To be fair, the company's ability to manage its R&D and G&A expenses down to $4.0 million and $7.9 million, respectively, in a single quarter is a strong signal of fiscal discipline. For a deeper dive into the balance sheet and liquidity, you can check out Breaking Down Cassava Sciences, Inc. (SAVA) Financial Health: Key Insights for Investors.

Cassava Sciences, Inc. (SAVA) Market Position & Future Outlook

Cassava Sciences, Inc. is fundamentally resetting its corporate strategy, pivoting from the colossal, but ultimately unsuccessful, Alzheimer's disease program to focus its lead drug, simufilam, on a rare neurological disorder: Tuberous Sclerosis Complex (TSC)-related epilepsy. This shift moves the company from a high-stakes, high-failure mega-market to a niche, orphan drug landscape, which offers a clearer, though still challenging, path to clinical validation and potential market exclusivity.

Competitive Landscape

The company is now competing in the specialized Tuberous Sclerosis drug market, which was valued at approximately $0.85 billion in 2025 globally, a significant drop from the multi-billion dollar Alzheimer's space. Since simufilam is currently in preclinical development for this new indication, Cassava Sciences' market share is 0%, putting it up against two established, FDA-approved therapies.

Opportunities & Challenges

The strategic pivot to TSC-related epilepsy presents both a focused opportunity and a set of high-impact risks that investors need to weigh. The clarity of the new clinical endpoint-seizure frequency-is a huge improvement over the subjective cognitive metrics used in the failed Alzheimer's trials.

Industry Position

Cassava Sciences is now positioning itself as a preclinical-stage developer in the specialized Central Nervous System (CNS) rare disease sector, having completely exited the Alzheimer's race after the unambiguous failure of its Phase 3 trials in 2025. They are a pure-play bet on a single drug's novel mechanism, which is a major risk.

• The company's R&D expenses dropped sharply to $4.0 million in Q3 2025, a 78% decrease, reflecting the phase-out of the expensive Alzheimer's program. This is defintely a necessary cost-cutting measure.
• The focus on TSC-related epilepsy, which affects approximately 50,000 people in the US, means the company is chasing a smaller, more manageable market with a potential first-in-class mechanism.
• Simufilam's new clinical study is expected to begin in H1 2026, meaning the company will operate without any product revenue for the foreseeable future.
• The company's financial health, with over $106.1 million in cash as of September 30, 2025, is critical; it provides a runway into 2027 to execute the new strategy.

To understand the full financial context of this pivot, you should read Breaking Down Cassava Sciences, Inc. (SAVA) Financial Health: Key Insights for Investors.