Cassava Sciences, Inc. Q3 FY2024 earnings call

• Announced last patient/last visit of Phase 3 trial RETHINK-ALZ, database cleanup ongoing, expect top-line results by end of 2024.
• Attended CTAD conference, discussed biomarker revolution in Alzheimer's with plasma biomarkers like p-tau217 showing high predictive values.
• Expanding manufacturing capabilities and developing commercial plan with industry consultant.
• Cash balance of $149M sufficient for operations through ongoing trials and into 2026; $40M restricted cash for SEC settlement.

Cassava Sciences does not have distinct product segments in the traditional sense. Financials: Ended Q3 with $149 million in cash and cash equivalents. Net cash used in operations for 9 months ended Sept 30 was $55.7M. Net loss in Q3 2024 was $27.9 million. R&D expenses in Q3 were $17.7M vs $23.6M same period 2023, G&A expenses $12.9M vs $4.3M same period 2023 due to legal and other costs.

• Cash expected to last through ongoing Phase 3 trials and into calendar 2026.
• Net cash used in operations for H2 2024 expected $80-90M.
• Expect to announce top-line results of RETHINK-ALZ Phase 3 trial before end of 2024.

• Uncertainty in Phase 3 trial results affecting commercialization.
• Allocation of capital between developing SavaDx diagnostic and pursuing other indications.
• Dependence on FDA approval and regulatory factors for market entry.

Q: What is the status of SavaDx and detail on biomarkers in top-line results?

A: SavaDx allocation depends on trial results; capital could be allocated to diagnostics or other simufilam indications. Biomarkers in top-line include p-tau217, NfL, GFAP, total-tau, measured from baseline to last visit.

Q: Details on statistical analysis plan, endpoints, and biomarkers like p-tau?

A: SAP submitted to FDA with minor comments incorporated. Primary endpoints are ADAS-Cog12 and ADL, both must hit. Analysis includes mild, moderate, and combined patients. p-tau217 is becoming a more prominent biomarker.

Q: Potential Phase 3 results impact and drug availability?

A: Subgroup analysis considered, but relying on primary endpoints. Drug potentially available late summer/early fall 2026. Yale study on Tuberous Sclerosis as a potential indication with less resource-intensive trials.