Cassava Sciences SEC Filings

Cassava Sciences, Inc. reports that the U.S. Food and Drug Administration has placed its proposed proof-of-concept clinical trial of simufilam in tuberous sclerosis complex (TSC)-related epilepsy on a full clinical hold. FDA’s letter requires Cassava to provide additional information, including more pre-clinical data, and to modify the trial’s protocol design before the study can proceed. Cassava plans to work expeditiously to address FDA’s comments, but it no longer expects to start this TSC-related epilepsy trial in the first half of 2026 as previously disclosed. The timing for starting a trial will depend on the company’s ability to provide the requested information and on FDA completing its review to the agency’s satisfaction.

Cassava Sciences, Inc. reported that its Board of Directors approved cash bonus awards for calendar 2025 for two named executive officers. The President & Chief Executive Officer, Richard J. Barry, was awarded a cash bonus of $355,000, and the Chief Financial Officer, Eric J. Schoen, was awarded a cash bonus of $215,000, in recognition of their contributions to the company.

For 2025, the Board set performance measures and goals that it described as challenging yet achievable with strong management performance. These goals focus on exploring the use of simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy, building a team with appropriate expertise in TSC-related epilepsy, and managing budgeting and expenses.

Cassava Sciences Inc. (SAVA) reported an insider stock transaction by a director. On 11/24/2025, the director purchased 8,600 shares of Cassava Sciences common stock in an open-market transaction coded as a purchase (code "P"). The shares were acquired at a price of $2.90 per share, and following this transaction, the director beneficially owned 8,600 shares with direct ownership.

Cassava Sciences (SAVA) President and CEO, who is also a director, reported an open-market purchase of common stock. On 11/20/2025, a trust for the reporting person bought 150,000 Cassava shares at a weighted average price of $2.76 per share, with individual trades executed between $2.74 and $2.80.

After this transaction, the trust beneficially owns 938,060 shares of Cassava common stock, reported as indirect ownership. The filing notes that full detail on the number of shares purchased at each price within the range is available upon request.

Cassava Sciences (SAVA) reported an insider stock purchase by its President and CEO, who is also a director. On 11/19/2025, a trust associated with the reporting person bought 73,385 shares of Cassava Sciences common stock in open market transactions at a weighted average price of about $2.75 per share, with individual trade prices ranging from $2.73 to $2.75 per share. After this transaction, the trust beneficially owns 788,060 shares of Cassava Sciences common stock.

Cassava Sciences filed an S-3 shelf registration for the primary offering of up to $200,000,000 in various securities, including common stock, preferred stock, depositary shares, warrants, rights, debt securities, and units. The filing also includes an at-the-market prospectus supplement for up to $50,000,000 of common stock under a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co.

Sales under the ATM may be made from time to time in transactions deemed an “at the market offering” pursuant to Rule 415. Cassava will pay Cantor up to 3.0% of the aggregate sales price as commissions. Cassava’s common stock trades on Nasdaq as “SAVA”; the closing price was $3.11 per share on November 11, 2025. Shares outstanding were 48,307,896 as of November 10, 2025.

Unless otherwise stated in a supplement, proceeds are for general corporate purposes and working capital, and the ATM amount is included within the overall $200,000,000 shelf capacity.

Cassava Sciences reported Q3 2025 results. Operating expenses were $11.9M (R&D $3.96M, G&A $7.91M), down sharply from $30.6M a year ago. The quarter’s net loss was $10.8M (basic EPS $0.22 loss). For the nine months, net loss totaled $78.4M versus net income of $3.3M in 2024, which benefited from a large non‑cash warrant liability gain.

Cash and cash equivalents were $106.1M at September 30, 2025; net cash used in operations for the nine months was $22.5M. Total liabilities were $48.2M, primarily payables and accruals, and stockholders’ equity was $81.6M. The company recorded litigation reserves of $35.25M, including $31.25M related to potential settlement of a consolidated securities action. It previously paid a $40M SEC civil penalty in November 2024. Management believes working capital is sufficient for at least the next 12 months. Shares outstanding were 48,307,896 as of November 10, 2025.

Cassava Sciences reported a legal update: on October 23, 2025, the U.S. District Court for the District of Maryland dismissed with prejudice the criminal indictment of Dr. Hoau‑Yan Wang, a former scientific collaborator and advisor to the company. A dismissal with prejudice permanently ends the case and prevents refiling of the same charges.

The company emphasized its support for scientific integrity and noted it is continuing its current program evaluating simufilam as a potential treatment for TSC‑related epilepsy, citing research conducted at numerous institutions. This update addresses a key legal overhang involving a third party while the company maintains focus on its development work.