Cassava Sciences Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Cassava Sciences Inc. filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

CASSAVA SCIENCES INC (FLNA) filed a Annual Report (10-K) with the SEC on February 28, 2024. Cassava Sciences Inc. filed its 2023 Form 10-K on February 28, 2024. The company's fiscal year ends on December 31st. Cassava Sciences Inc. is incorporated in Delaware. The company's principal executive offices are located in Austin, Texas. The SIC code for Cassava Sciences Inc. is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking CASSAVA SCIENCES INC, this filing contains several important signals. This filing provides a comprehensive overview of Cassava Sciences' financial health and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's performance, risks, and future prospects in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — CASSAVA SCIENCES INC shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing significant risks related to drug development, clinical trials, and regulatory approvals, as evidenced by the nature of its business and industry.

Analyst Insight

Monitor future SEC filings for updates on clinical trial progress, regulatory submissions, and financial performance, particularly revenue generation and cash burn rate.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed Period of Report)
• 2024-02-28 — Filing Date (As of Date)
• 001-41905 — SEC File Number (SEC Act of 1934)
• 659,000 — Total Assets (As of December 31, 2023)

Key Players & Entities

• CASSAVA SCIENCES INC (company) — Filer name
• 0001069530 (company) — Central Index Key
• 2834 (company) — Standard Industrial Classification
• DE (company) — State of Incorporation
• AUSTIN (company) — City of Business Address
• TX (company) — State of Business Address
• PAIN THERAPEUTICS INC (company) — Former Company Name
• 20000309 (date) — Date of Name Change

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, manufacturing, and marketing.
• Need for Additional Funding [high — financial]: The company may require substantial additional capital to fund its ongoing operations and research and development activities.
• Dependence on Key Personnel [medium — operational]: The success of the company depends on the continued service of its key scientific and management personnel.
• Competition [medium — market]: The pharmaceutical market is highly competitive, with many companies developing treatments for similar diseases.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-02-28: Filing Date — Date the 10-K was officially filed with the SEC.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value SAVA NASDAQ Capital Marke
• $24.52 — by reference to the last sales price of $24.52 as reported on the Nasdaq Capital Marke

Filing Documents

• sava20231231_10k.htm (10-K) — 1743KB
• ex_630601.htm (EX-4.2) — 44KB
• ex_573342.htm (EX-21.1) — 3KB
• ex_573343.htm (EX-23.1) — 6KB
• ex_573344.htm (EX-31.1) — 12KB
• ex_573345.htm (EX-31.2) — 12KB
• ex_573346.htm (EX-32.1) — 5KB
• ex_611641.htm (EX-97) — 22KB
• alz.jpg (GRAPHIC) — 70KB
• cab1ac4300e0img001.jpg (GRAPHIC) — 28KB
• chgbsl.jpg (GRAPHIC) — 22KB
• deccog.jpg (GRAPHIC) — 48KB
• ex_611641img001.jpg (GRAPHIC) — 11KB
• pg01.jpg (GRAPHIC) — 38KB
• pic1.jpg (GRAPHIC) — 34KB
• pic2.jpg (GRAPHIC) — 39KB
• slide02.jpg (GRAPHIC) — 22KB
• slide03.jpg (GRAPHIC) — 27KB
• slide04.jpg (GRAPHIC) — 26KB
• slide05.jpg (GRAPHIC) — 44KB
• 0001437749-24-005894.txt (&nbsp;) — 7312KB
• sava-20231231.xsd (EX-101.SCH) — 52KB
• sava-20231231_cal.xml (EX-101.CAL) — 39KB
• sava-20231231_def.xml (EX-101.DEF) — 346KB
• sava-20231231_lab.xml (EX-101.LAB) — 317KB
• sava-20231231_pre.xml (EX-101.PRE) — 377KB
• sava20231231_10k_htm.xml (XML) — 755KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 77 Item 1C. Cybersecurity 77 Item 2.

Properties

Properties 77 Item 3.

Legal Proceedings

Legal Proceedings 77 Item 4. Mine Safety Disclosures 79 PART II Item 5. Market for Registrant ' s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 79 Item 6. [Reserved] 80 Item 7. Management ' s Discussion and Analysis of Financial Condition and Results of Operations 81 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 89 Item 8. Consolidated Financial Statements and Supplementary Data 89 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 110 Item 9A.

Controls and Procedures

Controls and Procedures 111 Item 9B. Other Information 113 Item 9C. Disclosure Regarding Foreign Jurisdiction that Prevent Inspection 113 PART III Item 10. Directors and Executive Officers and Corporate Governance 113 Item 11.

Executive Compensation

Executive Compensation 115 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 115 Item 13. Certain Relationships and Related Transactions, and Director Independence 116 Item 14. Principal Accountant Fees and Services 116 PART IV Item 15. Exhibits and Consolidated Financial Statement Schedules 116 Item 16. Form 10-K Summary 118

Signatures

Signatures 119 3 Table of Contents PART I

FORWARD-LOOKING STATEMENTS AND NOTICES

FORWARD-LOOKING STATEMENTS AND NOTICES This Annual Report on Form 10-K, including the portions of our definitive Proxy Statement incorporated by reference herein, contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. We intend that such forward-looking statements be protected by the safe harbor created thereby. All statements other than statements of present or historical facts contained in this Annual Report, including statements anticipating or otherwise relating to our future results of operations and financial position, future results of ongoing clinical trials, business strategy, plans and objectives for future operations, and anticipated events or trends, are forward-looking statements. In some cases, forward-looking statements are identified by terms such as "aim," "anticipate," "believe," "could," "drive," "estimate," "expect," "forecast," "future," "goal," "intend," "may," "objective," "plan," "potential," "project," "seek," "should," "strategy," "will" and "would" or the negatives of these terms or other comparable terminology. Examples of forward-looking statements include, but are not limited to, statements about: the expected safety profile or treatment benefits, if any, of simufilam for people with Alzheimer's disease in our on-going Phase 3 studies; our reliance on third-party contractors to conduct all of our clinical and non-clinical trials and to make drug supply on a large-scale for our Phase 3 clinical program, or their ability to do so on-time or on-budget; limitations around data interpretation from results of any of the three clinical phases of our 2-year safety study of simufilam in patients with Alzheimer's disease, as compared to clinical results from randomized controlled trials; the ability of clinical scales to assess cognition or health in our trials of Alzheimer's disease; any significant changes we may make, or anticipate making, to the design of any of our on-going Phase 3 stu

Business

Item 1. Business Overview Cassava Sciences, Inc. is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer's disease. Our novel science is based on stabilizing – but not removing – a critical protein in the Alzheimer's brain. Our lead therapeutic drug candidate, simufilam, is under clinical evaluation for the proposed treatment of Alzheimer's disease dementia in Phase 3 clinical studies. For over 12 years, we have combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer's disease and other neurodegenerative diseases. Our strategy is to leverage our unique scientific/clinical platform to develop a first-in-class program for treating neurodegenerative diseases, such as Alzheimer's—a degenerative disease of the brain, where a patient's cognition and health functions decline over time as the disease progresses and the patient moves from mild to moderate to, eventually, severe Alzheimer's disease. We currently have two biopharmaceutical assets under development: our lead therapeutic product candidate, called simufilam, is a novel oral treatment for Alzheimer's disease dementia; and our lead investigational diagnostic product candidate, called SavaDx, is a novel way to detect the presence of Alzheimer's disease from a small sample of blood. Our scientific approach for the treatment of Alzheimer's disease seeks to simultaneously suppress both neurodegeneration and neuroinflammation. We believe our ability to potentially improve multiple vital functions in the brain represents a new, different and crucial approach to address Alzheimer's disease. Our lead product candidate, simufilam, is a proprietary small molecule drug. Simufilam was discovered and designed in-house and was characterized by our academic collaborators during research activities that were conducted from approximately 2008 to date. Simufilam targets an alte

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View this 10-K filing on SEC EDGAR