CASSAVA SCIENCES INC (SAVA)·Q2 2025 Earnings Summary
Executive Summary
- Cassava pivoted toward TSC-related epilepsy and recorded a $31.25M estimated loss contingency tied to securities litigation, driving a Q2 2025 net loss of $44.2M and EPS of $(0.92); cash was $112.4M at quarter-end .
- R&D expense fell 66% YoY to $5.1M as the Alzheimer’s program was phased out; G&A rose to $40.3M, including legal-related costs and non-cash stock-based comp, reflecting litigation accruals .
- Management guided H2 2025 net cash used in operations to $47–$51M and year-end 2025 cash to $61–$65M, framing liquidity and cash burn expectations into the litigation resolution and program transition .
- Operational narrative improved with positive preclinical data in TSC mouse models (dose-responsive seizure activity attenuation) and leadership appointments (CMO and SVPs in neuroscience and clinical), positioning simufilam for a proof-of-concept clinical study in H1 2026 .
- Street EPS and revenue consensus were unavailable for Q2 2025; only a single target price datapoint was observed, limiting “beat/miss” framing; stock narrative catalysts center on litigation resolution, cash runway, and validation of TSC program milestones .
What Went Well and What Went Wrong
What Went Well
- Positive preclinical results: simufilam reduced seizure activity with a dose-responsive effect in Tsc1-CKO mice; prior Yale work showed ~60% seizure frequency reduction vs. vehicle in another model, supporting a first-in-class approach .
- Strategic hires strengthen CNS expertise and clinical planning: appointment of Dr. Joseph Hulihan (CMO, epilepsy experience), Dr. Angélique Bordey (SVP, Neuroscience), and Dr. Jack Moore (SVP, Clinical Development) .
- Management conviction on program pivot: “2025 has been transformational…Two encouraging animal model studies…support the exploration of simufilam as a novel, first-in-class approach…” — Rick Barry, CEO .
What Went Wrong
- Large net loss driven by a $31.25M litigation loss contingency; Q2 2025 net loss was $(44.2)M vs. +$6.2M in Q2 2024 (prior-year profit driven by non-cash warrant liability revaluation) .
- G&A elevated: $40.3M in Q2 2025, including legal-related costs and ~$3.4M non-cash stock-based comp; liabilities for accounts payable/other accrued expenses climbed to $42.8M at 6/30/2025, reflecting accruals and program transition costs .
- Street estimate context lacking: consensus EPS and revenue unavailable for Q2 2025, limiting beat/miss characterization; company does not hold quarterly earnings calls, reducing traditional guidance/Q&A transparency .
Financial Results
Notes: Cassava is pre-revenue; the company’s condensed statements present operating expenses without a revenue line item . Prior-year Q2 2024 net income was driven by non-cash warrant liability fair-value changes .
KPIs and Balance Sheet Trends
Guidance Changes
Rationale: H2 cash-use guidance reflects anticipated litigation settlement cash impact and the Alzheimer’s program wind-down; YE cash estimate frames runway through the TSC pre-IND and trial initiation planning .
Earnings Call Themes & Trends
Note: The company indicated it will not hold traditional quarterly earnings calls going forward; hence, themes are extracted from press releases and 8-Ks .
Management Commentary
- “2025 has been transformational…Two encouraging animal model studies…support the exploration of simufilam as a novel, first-in-class approach to this disease.” — Rick Barry, President & CEO .
- “We are excited…this independent study bolsters previous findings…we believe that simufilam could represent a new approach to addressing the persistent unmet need in the TSC community.” — Dr. Angélique Bordey, SVP Neuroscience .
- “We are pleased to welcome Dr. Hulihan…As we prepare to initiate the clinical program…Joe’s experience will play a vital role in the program’s success.” — Rick Barry, President & CEO .
- “Cassava remains committed…while maintaining continued strategic expense management.” — Eric Schoen, CFO .
Q&A Highlights
- Cassava did not conduct a traditional quarterly earnings call; the company stated it will host investor calls focused on corporate/clinical updates rather than quarterly earnings calls .
- Guidance clarifications were provided in press releases: H2 2025 cash use ($47–$51M) and YE 2025 cash ($61–$65M) ; legal loss contingency recorded ($31.25M) .
- Clinical timeline clarified: proof-of-concept study for TSC-related epilepsy expected to begin H1 2026 .
Estimates Context
- S&P Global Street consensus for Q2 2025 EPS and revenue was unavailable; Cassava is pre-revenue and covered primarily via corporate updates rather than earnings calls .
- A single target price datapoint was observed.
Values retrieved from S&P Global.*
Implications: Without consensus EPS/Revenue, analysts may focus on cash runway, litigation resolution timing/impact, and TSC program milestones (pre-IND and PoC initiation) for model updates .
Key Takeaways for Investors
- The quarter’s loss was primarily driven by a $31.25M estimated litigation contingency; cash guidance to YE 2025 ($61–$65M) implies adequate runway through pre-IND and into H1 2026 PoC initiation if cash use tracks guidance .
- R&D spend has structurally reset with AD program discontinuation; expect near-term R&D to reflect preclinical/TSC planning, with potential re-acceleration as PoC study starts in H1 2026 .
- Legal overhang appears to be moving toward resolution (advanced settlement negotiations); watch for settlement terms and timing as a near-term stock catalyst .
- Positive, dose-responsive preclinical data and consortium collaboration are de-risking elements for simufilam in TSC-related epilepsy; upcoming scientific disclosures could further validate the thesis .
- Leadership additions (CMO Hulihan, SVPs) strengthen clinical execution capability in epilepsy, supporting trial design and site engagement .
- With no quarterly call and limited Street quarterly estimates, narrative/clinical milestones and legal clarity will drive sentiment and potential re-rating more than “beat/miss” optics .
- Trading: near-term moves likely tied to litigation resolution headlines and any additional preclinical data releases or regulatory interactions; medium-term thesis rests on successful pre-IND/IND path and execution of PoC in H1 2026 .
Appendix: Other Relevant Press Releases in Q2 2025
- Positive preclinical study (Tsc1-CKO model) showing dose-responsive seizure activity attenuation; PoC study planned H1 2026 .
- TSC conference poster highlighting ~60% seizure reduction in mouse model and favorable human safety profile from AD Phase 3 .
- CMO appointment (Dr. Hulihan) with deep epilepsy development experience .
- Conference participation (H.C. Wainwright, Sept. 8) .