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CASSAVA SCIENCES INC (SAVA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was dominated by clinical developments: RETHINK-ALZ failed co-primary endpoints on Nov 25, 2024, leading Cassava to discontinue REFOCUS-ALZ and the open-label extension; FY24 results were reported Mar 3, 2025 with YE cash of $128.6M and no debt .
  • Operating profile remained pre-revenue and expense-driven; Q4 operating loss was $29.5M and EPS was $(0.57), broadly similar to Q3, with R&D up sequentially and G&A down as SEC settlement effects rolled off .
  • Management pulled forward timing for REFOCUS-ALZ topline to late Q1/early Q2 2025 (from “mid-year 2025”), and guided H1’25 net cash use of $16–$20M; YE 2024 cash slightly exceeded prior guidance range high-end ($128.6M vs prior $117–$127M) .
  • Strategic optionality emerged via a Yale license to explore simufilam in TSC-related seizures; management will cease regular earnings calls and instead host investor updates focused on corporate/clinical matters .

What Went Well and What Went Wrong

  • What Went Well

    • Liquidity and expense control: YE 2024 cash $128.6M, no debt; H1’25 cash use guided to $16–$20M, with non-recurring Phase 3 wind-down costs falling in H1 .
    • YE cash slightly above guidance range issued in Q3 ($128.6M actual vs $117–$127M guided) .
    • Strategy expansion: license with Yale to explore simufilam in TSC-related seizures. CEO: “We…build on the promising research…to explore simufilam’s potential as a treatment for TSC-related seizures” .
  • What Went Wrong

    • Efficacy miss: RETHINK-ALZ did not meet co-primary (or secondary/biomarker) endpoints; management discontinued REFOCUS-ALZ and the OLE program .
    • Q4 YoY deleverage in G&A vs prior-year Q4 due to SEC settlement and legal/comp increases; FY24 G&A $71.8M vs $16.5M in FY23 (includes $40M SEC settlement) .
    • Management context on placebo trajectory: “loss of cognition in the placebo group was less pronounced than…previously reported…We are working to understand this better” .

Financial Results

Quarterly P&L snapshot (oldest → newest)

Metric ($USD Millions, except per share and shares)Q2 2024Q3 2024Q4 2024
Research & Development Expense$15.20 $17.68 $20.53
General & Administrative Expense$46.20 $12.95 $8.96
Total Operating Expenses$61.40 $30.62 $29.49
Operating Loss$(61.40) $(30.62) $(29.49)
Interest Income$2.32 $2.62 $1.80
Net Income (Loss)$6.16 $(27.94) $(27.60)
EPS (Basic)$0.13 $(0.58) $(0.57)
Wtd Avg Shares (Basic, Millions)46.20 47.98 48.10
Cash & Cash Equivalents (period end)$207.29 $148.98 $128.57

Notes: Q2 net income/EPS was driven by non-cash warrant fair value gains; subsequent quarters reflect core operating losses without similar gains .

Q4 2024 vs Q4 2023 (YoY)

Metric ($USD Millions, except per share)Q4 2024Q4 2023
Research & Development Expense$20.53 $18.73
General & Administrative Expense$8.96 $4.06
Total Operating Expenses$29.49 $22.79
Interest Income$1.80 $1.58
Net Loss$(27.60) $(20.92)
EPS (Basic)$(0.57) $(0.50)

No segment revenue reported; Cassava remains a clinical-stage, pre-commercial biotech .

Actuals vs S&P Global Consensus (Q4 2024)

MetricActualS&P Global ConsensusVariance
Revenue ($)Not disclosed (pre-commercial) N/AN/A
EPS (Basic)$(0.57) N/AN/A

Notes: S&P Global consensus for Q4 2024 was not retrievable at the time of analysis due to data access limits. We cannot provide estimate comparisons for revenue/EPS this quarter.

KPIs and Balance Sheet

KPIQ2 2024Q3 2024Q4 2024 / YE 2024
Cash & Cash Equivalents$207.29M $148.98M $128.57M
YE Cash Guidance (from Q3) vs Actual$117–$127M guided $128.6M actual (beat)
Net Cash Used in Operations (FY)$116.9M (FY24)
H1 2025 Net Cash Use Guide$16–$20M
Shares Outstanding48.3M (as of Feb 27, 2025)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
REFOCUS-ALZ topline timing2025“Mid-year 2025” (Q2 update) “Late Q1/early Q2 2025” Pulled forward
AD clinical studies statusOngoing/2024–2025Two Phase 3 trials ongoing; OLE planned REFOCUS-ALZ discontinued; OLE discontinued following RETHINK miss Discontinued
H1 2025 net cash used in operationsH1 2025Not provided prior$16–$20M New
YE 2024 cash2024$117–$127M guided (Q3) $128.6M actual Above prior guide

Earnings Call Themes & Trends

Note: Management stated it will discontinue routine quarterly earnings calls and instead host investor updates focused on corporate/clinical developments .

TopicQ2 2024 (prior)Q3 2024 (prior)Q4 2024 (current)Trend
Phase 3 readoutsRETHINK readout by YE’24; REFOCUS mid-2025 RETHINK before YE’24; DSMB continue as planned RETHINK failed; REFOCUS discontinued; REFOCUS topline late Q1/early Q2’25 Negative efficacy; accelerated REFOCUS topline reporting
SEC/legal$40M loss contingency recorded; advanced discussions Plan to pay $40M settlement; escrow excluded from cash FY24 G&A includes $40M SEC settlement Resolved and absorbed in G&A
Cash runwayBalance sheet strengthened by warrant exercise YE cash guide $117–$127M YE cash $128.6M; H1’25 cash use $16–$20M Cash trending down as trials wind down; spend moderating
Strategy/pipelineYale license to explore TSC-related seizures New diversification
Investor communicationsWebcast scheduled Webcast scheduled Ending quarterly earnings calls; investor updates instead Format change

Management Commentary

  • “We intend to evaluate the next steps for simufilam in Alzheimer’s disease after reviewing the REFOCUS-ALZ results in conjunction with the results of the RETHINK-ALZ study, reported in November 2024, which did not meet the prespecified co-primary endpoints.” — Rick Barry, President & CEO .
  • “We are pleased to have entered a licensing agreement with Yale University…to explore simufilam’s potential as a treatment for TSC-related seizures.” — Rick Barry .
  • “The results are disappointing…We have made the difficult decision to discontinue ReFocus-ALZ…We will also be discontinuing the Open Label Extension study.” — Rick Barry (Nov 25, 2024) .
  • “Going forward, rather than conducting quarterly earnings conference calls, the Company plans on hosting investor calls that focus on corporate or clinical updates.” — Company statement .
  • “Cassava is well-capitalized with approximately $149.0 million in cash and cash equivalents as of the end of the third quarter of 2024.” — Eric Schoen, CFO (Nov 25, 2024) .

Q&A Highlights

  • Cassava did not hold a traditional Q4 earnings call and indicated it will cease regular quarterly earnings calls, opting for investor updates on corporate/clinical topics going forward .
  • No Q&A transcript is available for Q4 2024 within the covered period (none found) and no clarifying Q&A tied to the FY24 press release was provided .

Estimates Context

  • S&P Global consensus for Q4 2024 EPS and revenue was not retrievable at the time of analysis due to data access limits, so we cannot quantify beats/misses versus Street for this quarter. Actual EPS (basic) was $(0.57) and the company remains pre-commercial with no product revenue reported .
  • Given the magnitude of the clinical outcome miss in November and the pivot to discontinuing AD trials, we would expect estimate revisions to continue to reflect lower AD program probability and a reduced operating expense run-rate as Phase 3 wind-down completes (qualitative; no numerical consensus available in this analysis window) .

Key Takeaways for Investors

  • Clinical inflection dominated: RETHINK-ALZ failed; REFOCUS-ALZ discontinued; detailed REFOCUS topline disclosure is expected late Q1/early Q2 2025, which may further inform asset paths and expense structure .
  • Cash tracked slightly better than guided at YE ($128.6M vs $117–$127M) and H1’25 cash use drops to $16–$20M as Phase 3 wind-down reduces spend; watch for second-half spend normalization post wind-down .
  • G&A normalized in Q4 from Q2/Q3 peaks as SEC settlement effects roll off; FY24 G&A elevated due to $40M settlement and higher legal/compensation .
  • Strategic optionality introduced via TSC-related seizures license with Yale; pipeline diversification beyond AD can change narrative but early-stage and preclinical—timelines and milestones will matter .
  • Communications cadence is shifting to investor updates instead of quarterly earnings calls; near-term catalysts likely clinical or corporate rather than financial .
  • With no product revenue and a pre-commercial profile, valuation will be driven by clinical data readouts, strategic pivots, and cash runway discipline; REFOCUS-ALZ topline timing pull-forward provides a nearer-term data point to watch .

Citations:

  • FY24/Q4 8-K and press release (filed Mar 3, 2025):
  • RETHINK-ALZ failure press release (Nov 25, 2024):
  • Q3 2024 results press release (Nov 7, 2024):
  • Q2 2024 results press release/8-K (Aug 8, 2024):