CASSAVA SCIENCES INC (SAVA)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 marked a strategic pivot away from Alzheimer’s toward TSC-related epilepsy, with Yale IP licensing finalized, new neuroscience leadership onboard, and explicit plans to initiate the first TSC clinical study in H1 2026 .
• Liquidity remained strong at $117.3M in cash and equivalents, no debt; net loss was $23.4M (diluted EPS -$0.48), narrowing versus Q4 2024 but down sharply year over year versus a prior-year non-cash warrant-related gain .
• Expense trends were mixed: R&D fell 16% YoY to $13.7M on Alzheimer’s wind-down, while G&A rose to $10.9M driven by legal expenses including a $3.0M loss accrual and absence of insurance recoveries in Q1 2025 .
• Guidance maintained: net cash used in operations expected at $16–$20M for 1H 2025; Alzheimer’s program to be completely discontinued by end of Q2 2025, framing a near-term narrative dominated by wind-down and preclinical ramp into TSC .

What Went Well and What Went Wrong

What Went Well

• Strategic refocus: License with Yale grants IP rights for simufilam in rare neurodevelopmental disorders; Cassava prioritizes TSC-related epilepsy, targeting H1 2026 for first clinical study initiation .
• Talent upgrade: Appointment of Dr. Angélique Bordey (SVP, Neuroscience) and Dr. Jack Moore (SVP, Clinical Development) to lead TSC preclinical program and clinical strategy; management emphasized positioning to advance with diligence .
• Cost actions: Workforce reduced by ~33% (10 employees) and ongoing strategic expense management initiatives supporting reduced R&D outlays .

What Went Wrong

• Alzheimer’s Phase 3 outcomes: REFOCUS-ALZ topline did not meet co-primary endpoints; combined with RETHINK-ALZ results, the program will be fully discontinued by end of Q2 2025 .
• Elevated G&A: Legal-related expenses, including a $3.0M estimated loss accrual in Q1 and lack of insurance recoveries this quarter vs $3.0M in prior-year Q1, drove G&A up to $10.9M .
• Absence of earnings call and estimates: Company stated it will not hold quarterly earnings calls going forward; Street consensus via S&P Global was unavailable for Q1 2025, limiting beat/miss analysis .

Financial Results

Summary Financials vs Prior Periods

Notes:

• Company did not report revenue lines in its condensed statements; biotech remains pre-revenue in the periods presented .
• Q1 2025 YoY comparison: prior-year Q1 reported net income due to a non-cash gain from change in fair value of warrant liabilities ($43.0M), which did not recur in Q1 2025 .

Operating Expense Composition

Balance Sheet Snapshot

Share Count

Guidance Changes

Earnings Call Themes & Trends

Note: Cassava indicated it will not conduct quarterly earnings conference calls going forward; no Q1 2025 earnings call transcript is available .

Management Commentary

• “Our goal is to initiate the first clinical study in TSC-related epilepsy in first-half 2026… With a favorable balance sheet, an enhanced team, and a new therapeutic indication for simufilam, we believe Cassava is well situated to move forward in 2025.” — Rick Barry, President & CEO .
• “Cassava remains committed to our mission… while maintaining continued strategic expense management. We look forward to updating investors on our progress.” — Eric Schoen, CFO .
• “We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit… We will discontinue all efforts to develop simufilam for Alzheimer’s disease… by the end of Q2 2025.” — Rick Barry .
• “Dr. Bordey will… guide the Company’s preclinical program to evaluate simufilam as a potential treatment for TSC-related epilepsy.” — Cassava announcement on Bordey joining as SVP, Neuroscience .
• “We plan to conduct preclinical studies… to further evaluate simufilam’s potential as a treatment for TSC-related seizures and define next steps.” — Rick Barry on Yale license .

Q&A Highlights

• No Q1 2025 earnings call or Q&A session was held; management previously indicated a shift away from quarterly earnings calls to investor calls focused on corporate/clinical updates .
• Guidance clarifications were provided via press release: 1H 2025 net cash used in operations unchanged at $16–$20M; Alzheimer’s program discontinuation timeline reiterated; TSC first clinical study targeted for H1 2026 .

Estimates Context

• Wall Street consensus via S&P Global for Q1 2025 EPS and revenue was unavailable; therefore, formal beat/miss analysis versus consensus could not be performed [GetEstimates: Q1 2025 returned empty].
• Given the pre-revenue profile and program discontinuation in AD, near-term Street models are likely to recalibrate around cash burn trajectory and timing/milestones for the TSC program .

Key Takeaways for Investors

• Cash runway remains adequate to execute the near-term wind-down of AD and preclinical build in TSC, with $117.3M cash and no debt at quarter-end .
• The complete discontinuation of the AD program by end of Q2 2025 removes a major binary but shifts the thesis to TSC-related epilepsy with first clinical study not expected until H1 2026, elongating the path to clinical readouts .
• Expense discipline is tangible (workforce reduction; lower R&D YoY), but legal overhang is real (Q1 loss accrual; no insurance recoveries), implying G&A volatility may persist near term .
• With no earnings call and limited external consensus coverage, catalysts will be company-driven disclosures: preclinical data, regulatory strategy articulation, and TSC study initiation updates .
• Share count creep is modest; monitor potential future capital needs vs. burn guidance and milestones as the TSC pipeline matures .
• Narrative is transitioning from AD to rare disease neurology; positioning and leadership hires suggest a deliberate pivot, but investor patience will be required given the preclinical-to-clinical timeline .
• Near-term trading may be event-driven around additional TSC preclinical disclosures or legal developments; medium-term thesis depends on validating simufilam’s mechanism in epilepsy and advancing to clinical proof-of-concept .