• It's like a focused, early-stage Biogen, with its main efforts on an Alzheimer's drug and diagnostic.
• Think of it as a biotech startup aiming to be the next Eli Lilly or Biogen in the fight against Alzheimer's disease.

• simufilam: A small molecule drug in clinical development for neurodegenerative diseases.
• SavaDx: A blood-based biomarker/diagnostic product candidate for the detection of Alzheimer's disease.

Based on the provided background information, Filana Therapeutics (symbol: FLNA) is identified as Cassava Sciences, Inc., a clinical-stage biotechnology company.

As a clinical-stage company, Cassava Sciences, Inc. is primarily focused on the research, development, and clinical trials of its drug candidates (such as simufilam) and diagnostic candidates (such as SavaDx) for neurodegenerative diseases. These products are not yet approved for commercial sale.

Consequently, Cassava Sciences, Inc. does not currently have major customers that purchase its therapeutic or diagnostic products. The company is in the development phase, not the commercial sales phase.

Should its products receive regulatory approval in the future, potential customer categories would typically include:

• Healthcare Providers: Hospitals, clinics, and physicians who would prescribe or administer the treatments/diagnostics.
• Pharmacies and Distributors: Entities responsible for dispensing and distributing approved pharmaceutical products.
• Patients: Individuals diagnosed with neurodegenerative diseases, who would ultimately receive the treatments via prescription.

Alternatively, the company might license its products to larger pharmaceutical companies for commercialization, in which case those companies would effectively act as partners or "customers" for the intellectual property.

Richard J. Barry, President & Chief Executive Officer

Richard J. Barry was appointed Chief Executive Officer of Filana Therapeutics (formerly Cassava Sciences) in September 2024, after serving as Executive Chairman of the Board since July 2024. He has been a director of the company since June 2021. Barry has extensive experience in investment management, having co-founded Eastbourne Capital Management LLC, where he served as a Managing General Partner and Portfolio Manager from 1999 until its closure in 2010. Prior to that, he was a Portfolio Manager and Managing Director at Robertson Stephens Investment Management. He also serves as a Director of Sarepta Therapeutics, Inc. (Nasdaq: SRPT) since June 2015, and previously served as a director of MiMedx Group Inc. (Nasdaq: MDXG) from 2019 to 2020.

Eric Schoen, Chief Financial Officer

Eric Schoen has served as Filana's 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 and spent nine years at PricewaterhouseCoopers, working in audit and assurance, transaction services, and global capital markets practices.

R. Christopher Cook, Chief Operating and Legal Officer

R. Christopher Cook was appointed Chief Operating and Legal Officer in April 2025. He joined the company in October 2022 as Senior Vice President and General Counsel. Prior to joining Filana, Cook served as the Global Head of Litigation and Government Investigations for Alcon, a publicly traded medical device and pharmaceutical company. He was also the Vice President and division General Counsel for Walmart Central America. Cook spent seventeen years as a litigation partner at Jones Day and served as an Assistant United States Attorney in Chicago.

Joseph Hulihan, MD, MS, Chief Medical Officer

Joseph Hulihan is the Chief Medical Officer of Filana Therapeutics.

Jack Moore, PhD, Senior Vice President, Clinical Development

Jack Moore joined Filana Therapeutics in April 2025 as the Senior Vice President, Clinical Development. He brings over 20 years of leadership experience in the pharmaceutical and biotech industry, having worked at companies such as Janssen, Novartis, Celgene, Bristol-Myers Squibb, and Alector. Dr. Moore holds a PhD in Neuroscience from the University of North Texas and completed a Post-doctoral Fellowship at The University of Texas Southwestern Medical Center.

Key Risks to Filana Therapeutics (FLNA)

The key risks to Filana Therapeutics (FLNA), formerly Cassava Sciences, are primarily centered around the inherent challenges of clinical-stage biotechnology development, past controversies impacting its scientific reputation, and significant financial constraints.

1. Clinical Trial Failure and Regulatory Hurdles: As a clinical-stage biotechnology company, Filana Therapeutics faces substantial risks associated with the development and approval of its investigational therapies. The company currently has no approved drugs, and its lead product candidate, simufilam, is still in development. For instance, its program for tuberous sclerosis complex (TSC)-related epilepsy recently experienced a clinical hold from the FDA, necessitating additional preclinical data and protocol modifications. Delays or failures in clinical trials, or the inability to meet regulatory requirements, pose a significant threat to the company's ability to bring products to market and generate revenue.
2. Reputational Damage and Regulatory Scrutiny from Past Allegations: Filana Therapeutics, under its former name Cassava Sciences, faced considerable scrutiny due to allegations of scientific misconduct and misleading statements concerning its simufilam research for Alzheimer's disease. Although a Department of Justice (DOJ) investigation has concluded and a class-action lawsuit has been settled, an advisor to the company was charged with fraud over research results in June 2024. This history of controversy and ongoing regulatory challenges, such as the recent FDA clinical hold, can affect investor confidence, potential partnerships, and future interactions with regulatory bodies, potentially hindering its ability to advance its pipeline.
3. Significant Financial Losses and Cash Burn: Filana Therapeutics has consistently reported net losses and has not generated product revenues for several years. In 2025, the company reported a net loss of $91.0 million and is projected to experience a significant reduction in its cash reserves by mid-2026. The delays in its clinical programs, such as the TSC-related epilepsy study, further exacerbate cash burn by extending development timelines without a corresponding increase in revenue. The company's ability to fund its ongoing research and development activities and sustain operations without approved products presents a critical financial risk.

The primary clear emerging threat for Cassava Sciences (trading as FLNA) is the ongoing and intensifying scrutiny and allegations of scientific misconduct and data manipulation concerning its core research for simufilam and SavaDx. These serious allegations have led to investigations, calls for retraction of key scientific papers, and a citizen petition to the FDA, which, if definitively substantiated and acted upon by regulatory bodies, could lead to clinical holds, rejection of data, and ultimately jeopardize the approval and commercial viability of its product candidates, fundamentally challenging the company's operational integrity and future prospects.

The addressable markets for Filana Therapeutics' (symbol: FLNA) main products, simufilam and SavaDx, which target Alzheimer's disease, are substantial within the global and North American regions.

For simufilam, a therapeutic product candidate for Alzheimer's disease, the global addressable market for Alzheimer's therapeutics was valued at approximately USD 6.49 billion in 2025 and is projected to increase to about USD 33.62 billion by 2034, with a compound annual growth rate (CAGR) of 20.06% from 2025 to 2034. Another estimate places the global Alzheimer's therapeutics market at USD 5.7 billion in 2025, growing to USD 13.13 billion by 2035 at a CAGR of 8.7% from 2026 to 2035. North America is a dominant region in this market.

For SavaDx, an investigational diagnostic product candidate for Alzheimer's disease, the global addressable market for Alzheimer's disease diagnostics is estimated at USD 9.94 billion in 2025 and is projected to reach approximately USD 27.90 billion by 2035, growing at a CAGR of 10.87% from 2026 to 2035. In 2025, the global market size was estimated at USD 9.22 billion, with projections to reach USD 21.54 billion by 2033, demonstrating a CAGR of 11.23% from 2026 to 2033. North America held the largest share of the global Alzheimer's disease diagnostics market in 2024 and 2025. Specifically, the U.S. Alzheimer's Disease Diagnostics Market is calculated at USD 2.07 billion in 2025 and is expected to reach nearly USD 5.28 billion in 2035.

Expected Drivers of Future Revenue Growth for Filana Therapeutics (FLNA)

1. Successful Clinical Development, Regulatory Approval, and Commercialization of Simufilam for Tuberous Sclerosis Complex (TSC)-related Epilepsy: Filana Therapeutics, formerly Cassava Sciences, has shifted its primary therapeutic focus to developing simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy, following the discontinuation of its Alzheimer's disease program for simufilam. The company plans to initiate a Phase 2 proof-of-concept study for this new indication. Future revenue growth is contingent on successfully advancing simufilam through clinical trials, obtaining regulatory approval, and subsequently launching and achieving market penetration in the TSC-related epilepsy market. Analysts have projected significant revenue for Filana Therapeutics starting in 2026 and 2027, which suggests an expectation of progress toward commercialization or related revenue-generating activities within this timeframe.
2. Strategic Partnerships and Licensing Agreements: As a clinical-stage biotechnology company, Filana Therapeutics' future revenue growth could be significantly driven by strategic collaborations or licensing agreements. These partnerships, particularly concerning simufilam for TSC-related epilepsy, could provide substantial upfront payments, milestone payments tied to development and regulatory achievements, and future royalties from commercial sales. Such agreements could contribute to the revenue projected by analysts within the next 2-3 years, especially given the capital-intensive nature of drug development and the potential need for broader commercial reach.
3. Advancement and Potential Commercialization of SavaDx: While currently an early-stage and lower-priority program, SavaDx, an investigational diagnostic product candidate aimed at detecting Alzheimer's disease from a blood sample, represents another potential future revenue driver. Any accelerated development, successful strategic partnership, or identification of a viable market niche for SavaDx within the next 2-3 years could contribute to the company's revenue streams.

Share Issuance

• In 2024 through February 26, 2024, Filana Therapeutics (then Cassava Sciences) received $21.8 million from the exercise of warrants, resulting in the issuance of 989,000 common shares.
• A follow-on equity offering for $50 million was filed in December 2024.

Outbound Investments

• In February 2025, Filana Therapeutics (then Cassava Sciences) entered into a License Agreement with Yale University to support the development and commercialization of simufilam for TSC-related epilepsy.

Capital Expenditures

• Net cash used in operations by Filana Therapeutics (then Cassava Sciences) was $82.0 million in 2023, $116.9 million in 2024, and $32.3 million in 2025.
• The company paid a $40 million settlement with the Securities and Exchange Commission (SEC) in 2024.
• A $31.25 million estimated loss contingency related to securities class action litigation was reserved in the second quarter of 2025, with payment anticipated in the first half of 2026.