Cassava Sciences Provides a Business Update
Cassava Sciences (NASDAQ: SAVA) has announced significant updates following its Phase 3 RETHINK-ALZ study's failure to meet primary endpoints in November 2024. The company is proceeding with the discontinuation of both the Phase 3 REFOCUS-ALZ and Open Label Extension studies, with topline results expected in late Q1/early Q2 2025.
As part of strategic cost-cutting measures, Cassava is implementing a 33% workforce reduction, affecting 10 employees in Q1 2025. The company is also halting planned biomarker analysis of additional plasma samples from prior Phase 2 studies. The workforce reduction will incur approximately $0.4 million in one-time costs.
The company reports unaudited cash and cash equivalents of $128.6 million as of December 31, 2024.
Cassava Sciences (NASDAQ: SAVA) ha annunciato importanti aggiornamenti dopo il fallimento del suo studio di Fase 3 RETHINK-ALZ nel raggiungere gli obiettivi primari nel novembre 2024. L'azienda procederà con la sospensione sia dello studio REFOCUS-ALZ di Fase 3 che dell'estensione in open label, con i risultati preliminari attesi per la fine del primo o l'inizio del secondo trimestre 2025.
Come parte di misure strategiche di riduzione dei costi, Cassava sta implementando una riduzione del personale del 33%, che influenzerà 10 dipendenti nel primo trimestre del 2025. L'azienda sta anche interrompendo l'analisi pianificata dei biomarcatori di ulteriori campioni di plasma provenienti da studi di Fase 2 precedenti. La riduzione del personale comporterà costi una tantum di circa 0,4 milioni di dollari.
L'azienda riporta liquidità e disponibilità liquide non verificate per un totale di 128,6 milioni di dollari al 31 dicembre 2024.
Cassava Sciences (NASDAQ: SAVA) ha anunciado actualizaciones significativas tras el fracaso de su estudio de Fase 3 RETHINK-ALZ en alcanzar los objetivos primarios en noviembre de 2024. La compañía procederá con la discontinuación tanto del estudio REFOCUS-ALZ de Fase 3 como de la Extensión Abierta, con resultados preliminares esperados para finales del primer trimestre/principios del segundo trimestre de 2025.
Como parte de medidas estratégicas de reducción de costos, Cassava está implementando una reducción del 33% en su plantilla, afectando a 10 empleados en el primer trimestre de 2025. La compañía también está deteniendo el análisis de biomarcadores de muestras de plasma adicionales de estudios de Fase 2 anteriores. La reducción de personal incurrirá en costos únicos de aproximadamente 0,4 millones de dólares.
La empresa informa de disponibilidades de efectivo y equivalentes de efectivo no auditadas de 128,6 millones de dólares a fecha del 31 de diciembre de 2024.
카사바 사이언스(Cassava Sciences, NASDAQ: SAVA)는 2024년 11월에 RETHINK-ALZ 3상 연구가 주요 목표를 달성하지 못한 후 중요한 업데이트를 발표했습니다. 이 회사는 3상 REFOCUS-ALZ 연구와 개방형 연장 연구를 중단할 계획이며, 상단 결과는 2025년 1분기 말 또는 2분기 초에 발표될 예정입니다.
전략적 비용 절감 조치의 일환으로 카사바는 33% 인력 감축을 시행하고 있으며, 2025년 1분기에 10명의 직원에게 영향을 미칩니다. 회사는 또한 이전 2상 연구에서 추가 혈장 샘플의 바이오마커 분석을 중단하고 있습니다. 인력 감축으로 약 40만 달러의 일회성 비용이 발생할 것으로 예상됩니다.
회사는 2024년 12월 31일 기준으로 1억 2860만 달러의 감사되지 않은 현금 및 현금성 자산을 보고하고 있습니다.
Cassava Sciences (NASDAQ: SAVA) a annoncé d'importantes mises à jour suite à l'échec de son étude de phase 3 RETHINK-ALZ à atteindre les objectifs principaux en novembre 2024. La société s'apprête à arrêter à la fois l'étude REFOCUS-ALZ de phase 3 et celle de l'extension en open label, avec des résultats préliminaires attendus à la fin du premier trimestre ou au début du deuxième trimestre 2025.
Dans le cadre de mesures stratégiques de réduction des coûts, Cassava va mettre en œuvre une réduction de 33% de ses effectifs, visant 10 employés au premier trimestre 2025. L'entreprise met également un terme à l'analyse des biomarqueurs prévue pour des échantillons de plasma supplémentaires issus d'études de phase 2 antérieures. Cette réduction des effectifs entraînera des coûts uniques d'environ 0,4 million de dollars.
La société rapporte des liquidités et équivalents de liquidités non audités de 128,6 millions de dollars au 31 décembre 2024.
Cassava Sciences (NASDAQ: SAVA) hat nach dem Scheitern der Phase-3-RETHINK-ALZ-Studie im November 2024 bedeutende Aktualisierungen bekannt gegeben. Das Unternehmen plant die Einstellung sowohl der Phase-3-REFOCUS-ALZ-Studie als auch der Open-Label-Extension-Studien, wobei die Ergebnisschätzungen für Ende Q1/Anfang Q2 2025 erwartet werden.
Im Rahmen strategischer Kostensenkungsmaßnahmen führt Cassava eine Reduzierung der Belegschaft um 33% durch, die 10 Mitarbeiter im ersten Quartal 2025 betrifft. Das Unternehmen stoppt auch die geplante Biomarker-Analyse zusätzlicher Plasmaproben aus früheren Phase-2-Studien. Die Reduzierung der Belegschaft wird voraussichtlich einmalige Kosten von etwa 0,4 Millionen Dollar verursachen.
Das Unternehmen berichtet von unauditierten Zahlungsmitteln und Zahlungsmitteläquivalenten in Höhe von 128,6 Millionen Dollar zum 31. Dezember 2024.
- Strong cash position with $128.6 million in cash and cash equivalents
- Cost reduction initiatives implemented to preserve capital
- Phase 3 RETHINK-ALZ study failed to meet primary endpoints
- Discontinuation of REFOCUS-ALZ and Open Label Extension studies
- 33% workforce reduction affecting 10 employees
- $0.4 million in one-time costs for Q1 2025 due to workforce reduction
Insights
The announced workforce reduction of <percent>33%</percent> and cost-cutting measures reflect a significant strategic pivot following the disappointing Phase 3 RETHINK-ALZ trial results. With <money>$128.6 million</money> in cash reserves and a <money>$0.4 million</money> one-time restructuring cost, the company is prioritizing capital preservation. This cash position, while substantial, will need careful management as the company evaluates its future direction post-trial failures.
The market cap of <money>$145.5 million</money> is now trading close to cash value, suggesting investors are assigning minimal value to the company's pipeline and intellectual property. The upcoming REFOCUS-ALZ results in Q1/Q2 2025 represent a critical inflection point that could determine the company's future trajectory and potential strategic alternatives.
The discontinuation of both Phase 3 trials and halting of biomarker analysis from Phase 2 studies signals a comprehensive reassessment of simufilam's development program. The failure to meet primary endpoints in RETHINK-ALZ raises fundamental questions about the drug's efficacy in treating Alzheimer's disease. The decision to analyze the complete 52-week dataset and partial 76-week data from REFOCUS-ALZ suggests a thorough examination to identify any potential subgroups or secondary benefits that might inform future development decisions.
In simpler terms: The company's main drug didn't work as hoped in treating Alzheimer's. They're now stopping all major trials and looking carefully at all the data they've collected to see if there's any silver lining or different way forward.
Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025
Implementing cost curtailment including a workforce reduction of approximately
Approximately
AUSTIN, Texas, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system diseases including Alzheimer’s disease dementia, today provided a business update.
In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s disease did not meet its prespecified co-primary endpoints and that the Company intended to share a detailed analysis of data from the study at a future medical meeting. The Company also outlined its plan to discontinue the Phase 3 REFOCUS-ALZ study and Open Label Extension study and to analyze the complete 52-week dataset from the REFOCUS-ALZ study, along with a large portion of 76-week data. The Company is on track to complete these efforts and plans to release top-line REFOCUS-ALZ results late first-quarter/early second-quarter 2025.
The Company today announced that it is reducing its workforce by 10 employees, or approximately
The Company’s unaudited cash and cash equivalents balance as of December 31, 2024 was approximately
“Cassava continues to be dedicated to its mission of developing novel medicines for central nervous system disorders and enhancing shareholder value. We are in the final stages of discontinuing the REFOCUS-ALZ study and expect to report topline results late first-quarter/early second-quarter 2025. In addition, we continue to carefully review the data from the RETHINK-ALZ study and plan to incorporate the results of the REFOCUS-ALZ study into our evaluation of next steps for Cassava. With that in mind, following the announcement that the RETHINK-ALZ study did not meet its primary endpoints and that the REFOCUS-ALZ and Open Label Extension studies will be discontinued, we believe it is prudent to implement additional cost saving measures, including a reduction in force,” said Rick Barry, President and Chief Executive Officer. “Cassava is a closely-knit organization, and so I want to thank each one of our employees being affected by this workforce reduction. We recognize and appreciate with deep and heartfelt gratitude your fine and dedicated service to Cassava’s mission, to our clinical programs and to patients with Alzheimer’s disease.”
About RETHINK-ALZ
RETHINK-ALZ (NCT04994483) is a Phase 3 trial designed to evaluate the safety and efficacy of simufilam compared to a placebo in a multi-center, double-blinded, placebo-controlled, randomized parallel group study involving over 75 clinical trial sites in the U.S., Canada and Australia. The trial randomized 804 people with confirmed mild or moderate Alzheimer’s disease, as defined by several well validated parameters including a mini-mental state exam (MMSE) of >16 and <27, stratified as mild or moderate. Subjects were randomized 1:1 to receive a 100 mg tablet of simufilam (n=403) or a matched placebo (n=401), dosed orally twice daily (BID) for 52 weeks. On November 25, 2024, the Company reported that the RETHINK-ALZ study did not meet the co-primary endpoints for the study. The Company also indicated that it planned to fully analyze the results and share the data at a future medical meeting.
The co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. Secondary endpoints included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated by adverse event monitoring, as well as standard laboratory and ECG assessments. The study also included a pharmacokinetic and plasma biomarker sub-study comprised of approximately 100 subjects, evaluated at three timepoints. RETHINK-ALZ was conducted under a Special Protocol Assessment (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
REFOCUS-ALZ (NCT05026177) is a Phase 3 trial designed as a multi-center, double-blinded, placebo-controlled, randomized parallel group study to evaluate the safety and efficacy of two doses of simufilam compared to a placebo in a study involving over 75 clinical trial sites in the U.S., Canada, Puerto Rico and South Korea. The clinical trial sites that conducted REFOCUS-ALZ were completely distinct from the clinical trial sites that conducted RETHINK-ALZ. REFOCUS-ALZ randomized approximately 1,125 people utilizing the same eligibility criteria as RETHINK-ALZ. Subjects were randomized 1:1:1 to receive simufilam, dosed in 50 mg or 100 mg tablets, or a matched placebo, dosed orally twice daily (BID) for 76 weeks. The Company announced on November 25, 2024 plans to discontinue the REFOCUS-ALZ study and intends to report topline data from that trial, including the complete 52-week dataset and a large portion of 76-week data. The Company expects to report topline data for this study late first-quarter/early second-quarter 2025.
The co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing each dose of simufilam to placebo. Secondary endpoints included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated by adverse event monitoring, as well as standard laboratory and ECG assessments. The study also included an evaluation of changes in plasma and cerebrospinal fluid biomarkers from baseline to week 76, including P-tau181, P-tau217 and neurofilament light chain, as well as an evaluation of various brain volumes using magnetic resonance imaging (MRI) and amyloid and tau deposition using positron emission tomography (PET) scans from baseline to week 76. REFOCUS-ALZ was also conducted under an SPA with the FDA.
About Simufilam
Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein.
About Cassava Sciences, Inc.
Cassava Sciences is a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system diseases including Alzheimer’s disease dementia. The Company is based in Austin, Texas.
For more information, please visit: https://www.CassavaSciences.com
For More Information Contact:
Investors
Sandya von der Weid
svonderweid@lifesciadvisors.com
Media
media@cassavasciences.com
Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com
ir@cassavasciences.com
Cautionary Note Regarding Forward-Looking Statements:
This news release contains forward-looking statements that include but are not limited to statements regarding: the planned discontinuation of the REFOCUS-ALZ and open-label extension studies and the status of their ongoing wind-down; our intent to share topline data from REFOCUS-ALZ; our intent to share detailed study results from RETHINK-ALZ and REFOCUS-ALZ at a future medical meeting; the timing of anticipated milestones; the reduction in force of employees at the Company; and the anticipated costs associated with the reduction in force. These statements may be identified by words such as “anticipate”, “before,” “believe”, “could”, “expect”, “forecast”, “intend”, “may”, “pending,” “plan”, “possible”, “potential”, “prepares for,” “will”, and other words and terms of similar meaning.
Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines; the clinical results related to studies of simufilam in Alzheimer’s disease, results of the RETHINK-ALZ study reported on November 25, 2024; our current expectations regarding timing of analysis of clinical data for our Phase 3 studies; the potential for unexpected costs associated with our announced reduction in force; and other risks inherent in drug discovery and development or specific to Cassava Sciences, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the period ended September 30, 2024, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov.
All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.
FAQ
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