Here are two analogies to describe Cassava Sciences (SAVA):

Analogy 1: A clinical-stage biotechnology company focused on Alzheimer's, akin to a much smaller, earlier-stage Biogen, but with its lead drug candidate under intense scrutiny and allegations regarding the integrity of its scientific data, creating an extremely high-risk, high-reward investment.

Analogy 2: Like a pharmaceutical startup, reminiscent of an early-stage Nikola (NKLA), where its entire market valuation is tied to a single, experimental Alzheimer's drug whose foundational claims are battling serious public allegations of scientific misconduct and data integrity issues.

• Simufilam: An investigational oral drug candidate currently in Phase 3 clinical trials for the treatment of Alzheimer's disease.
• SavaDx: An investigational blood-based diagnostic test being developed to detect Alzheimer's disease.

Cassava Sciences (SAVA) is a clinical-stage biotechnology company focused on developing novel treatments for neurodegenerative diseases, primarily simufilam for Alzheimer's disease. As a clinical-stage company, it does not currently have any commercialized products on the market.

Therefore, Cassava Sciences does not have "major customers" in the traditional sense, whether they be other companies or individual consumers. Its activities are primarily research and development, funded by investors, and it is not generating revenue from product sales. Consequently, there are no customer companies or categories of individual customers to list at this time.

• Catalent, Inc. (CTLT)

Richard J. Barry, President & Chief Executive Officer

Richard J. Barry was appointed Chief Executive Officer of Cassava Sciences in September 2024, after serving as Executive Chairman of the Board since July 2024. He has been a Director of Sarepta Therapeutics, Inc. since June 2015. Mr. Barry has extensive experience in investment management, having been a founding member, Managing General Partner, and Portfolio Manager of Eastbourne Capital Management LLC from 1999 to 2010. Prior to that, he was a Portfolio Manager and Managing Director of Robertson Stephens Investment Management.

Eric Schoen, Chief Financial Officer

Eric Schoen has served as Cassava Sciences' Chief Financial Officer since 2018. Before joining the company, Mr. Schoen was Vice President, Senior Vice President, Finance, and Chief Accounting Officer of Aspira Women's Health Inc. (formerly Vermillion, Inc.), a publicly-held women's health company, from 2011 to 2017. He began his career at PricewaterhouseCoopers, where he spent nine years in audit and assurance, transaction services, and global capital markets practices.

Joseph Hulihan, Chief Medical Officer

Dr. Joseph Hulihan was appointed Chief Medical Officer in August 2025. He brings over 25 years of industry experience, specializing in the development of therapeutics for epilepsy and other neurological disorders. From 2019 to 2025, he served as Chief Medical Officer at Marinus Pharmaceuticals, where he led development programs in rare pediatric epilepsies and for the treatment of status epilepticus. Marinus Pharmaceuticals was acquired by Immedica Pharma in March 2025. Dr. Hulihan also held senior leadership roles in neuroscience drug development and medical affairs at Johnson & Johnson for 15 years.

R. Christopher Cook, Chief Operating and Legal Officer

R. Christopher Cook became Cassava Sciences' Chief Operating and Legal Officer in April 2025, having initially joined the company as Senior Vice President and General Counsel in October 2022. His prior experience includes serving as the Global Head of Litigation and Government Investigations for Alcon, a publicly traded medical device and pharmaceutical company. He also held the position of Vice President and division General Counsel for Walmart Central America and was a litigation partner at Jones Day for seventeen years.

Michael Zamloot, Senior Vice President, Technology Operations

Michael Zamloot has been Cassava Sciences' Senior Vice President, Technology Operations since 2000. He possesses 35 years of pharmaceutical industry experience with multinational firms and development-stage biopharmaceutical companies. His responsibilities encompass all aspects of Pharmaceutical Development, Quality, and Supply Chain Management. Mr. Zamloot is also an inventor on more than 25 patents.

The key risks to Cassava Sciences (SAVA) are as follows:

1. Clinical Trial Failure and Discontinuation of Lead Drug Candidate: Cassava Sciences' primary drug candidate, simufilam, failed to meet its primary and secondary endpoints in its Phase 3 RETHINK-ALZ clinical trial for mild-to-moderate Alzheimer's disease. This led to the discontinuation of all development efforts for simufilam in Alzheimer's, including another Phase 3 trial and an open-label study, effectively ending its most significant program. The trial's results showed no significant improvement in cognition or daily functioning compared to a placebo.
2. Regulatory Scrutiny and Allegations of Data Manipulation: The company has faced intense regulatory scrutiny from the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ). Cassava Sciences agreed to pay $40 million to resolve an SEC investigation into allegations of misleading investors with doctored data from a Phase 2b clinical trial of simufilam. Additionally, a co-developer of the drug was separately charged by the SEC for allegedly manipulating data. These issues have raised significant concerns about the company's scientific credibility.
3. Financial Vulnerability and Lack of Revenue Prospects: With the discontinuation of simufilam for Alzheimer's, Cassava Sciences currently has no approved products and no immediate revenue streams. The company has been burning cash, with operational losses of $63.1 million in 2024. While Cassava has cash and cash equivalents, its cash runway is projected into 2026 or early 2027, and it may require additional funding, which could lead to shareholder dilution. The company is exploring a new indication for simufilam (TSC-related epilepsy), but this program is in preclinical stages and remains unproven.

• Ongoing scientific and regulatory investigations into allegations of data manipulation and scientific misconduct related to Cassava Sciences' lead drug candidate, simufilam. These investigations, involving bodies like the FDA and NIH, could lead to adverse findings, impacting simufilam's clinical trials, regulatory approval prospects, and the company's overall viability.
• The increasing market penetration and regulatory validation of competing amyloid-targeting Alzheimer's drugs, such as Biogen/Eisai's Leqembi (lecanemab) and Eli Lilly's donanemab. These therapies are establishing a clear benchmark for efficacy and a validated treatment paradigm in Alzheimer's, creating a high competitive barrier for Cassava Sciences' simufilam, which utilizes a different, less established mechanism of action, especially if its Phase 3 results do not demonstrate superior efficacy or safety.

1. Regulatory Approval and Commercial Launch of Simufilam: The most significant driver of future revenue for Cassava Sciences is the potential regulatory approval and subsequent commercial launch of simufilam as a novel treatment for Alzheimer's disease. The company has completed the last patient visit for its Phase 3 RETHINK-ALZ trial, with top-line results anticipated before the end of 2024. Successful trial outcomes are crucial for gaining regulatory approval and initiating sales. Cassava Sciences has already begun preparing for potential commercialization, indicating their readiness to bring the drug to market if approved.
2. Market Penetration and Patient Adoption of Simufilam: Following a potential regulatory approval, the growth in revenue will depend on the company's ability to effectively penetrate the Alzheimer's treatment market and drive patient adoption of simufilam. The size of the Alzheimer's market presents a substantial opportunity. The company's discussions on the implications of their trials for Alzheimer's treatment suggest a focus on positioning simufilam competitively to gain market share.
3. Expansion of Manufacturing and Commercial Infrastructure: In anticipation of successful trial results and commercialization, Cassava Sciences is expanding its manufacturing capabilities. An increase in research and development (R&D) spending is also expected in the second half of 2024 to support commercial launch preparations. These investments in infrastructure are essential to meet the demand and facilitate the distribution of simufilam, thereby enabling revenue growth.
4. Development and Commercialization of Companion Diagnostics: Beyond the drug itself, Cassava Sciences has indicated a focus on diagnostics development. If simufilam requires or benefits from a companion diagnostic to identify suitable patients or monitor treatment efficacy, the commercialization of such diagnostics could represent an additional, albeit likely smaller, revenue stream.