Cassava Sciences Reports Topline Phase 3 REFOCUS-ALZ Data
Simufilam continued to demonstrate an overall favorable safety profile
Cassava's Alzheimer's disease development program with simufilam will be completely discontinued by the end of Q2 2025
AUSTIN, Texas, March 25, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, 'Cassava', the 'Company'), a clinical-stage biotechnology company focused on developing a novel, investigational treatment for central nervous system disorders, including Alzheimer's disease (AD) dementia and tuberous sclerosis complex (TSC)-related epilepsy, today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD.
Topline data indicate that REFOCUS-ALZ did not meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints. The co-primary endpoints were 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 simufilam to placebo. REFOCUS-ALZ enrolled 1,125 patients and was discontinued on November 25, 2024, following the report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints. A large portion of subjects enrolled in REFOCUS-ALZ completed their final study visit prior to the termination of the trial. Simufilam continued to demonstrate an overall favorable safety profile.
'We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer's disease. These results were unambiguous. Working with patients, their families and their caregivers has brought a special dignity to our Phase 3 Alzheimer's disease clinical trial program and to each of us at Cassava. We are deeply grateful for the dedication and committed efforts of study investigators and site teams, who enabled us to conduct these trials with integrity and scientific rigor and whose efforts provided a clear data read out,' said Rick Barry, President and Chief Executive Officer of Cassava.
'Cassava will discontinue all efforts to develop simufilam for Alzheimer's disease and we expect to phase out the program by the end of Q2 2025,' continued Mr. Barry. 'We remain dedicated to our mission of developing novel medicines for central nervous system disorders. While we have initiated preclinical studies to evaluate simufilam's potential as a treatment for TSC-related epilepsy, we maintain ongoing strategic expense management efforts.'
Eric Schoen, Chief Financial Officer of Cassava commented, 'We remain focused on the interests of Cassava shareholders and are committed to enhancing shareholder value. Cassava is well-capitalized with approximately $128.6 million in cash and cash equivalents as of December 31, 2024.'
Summary Study Results:
Primary Endpoint Data
Co-Primary Endpoints
LS means change from baseline to the end of the double-blind treatment period
N=372 N=376 N=372
ADAS-COG12 (±SE) 4.97 (± 0.46) 4.70 (± 0.46) 0.27 (± 0.63) P=0.67
5.26 (± 0.46) 4.70 (± 0.46) 0.56 (± 0.63) P=0.37
N=373 N=376 N=373
ADCS-ADL (±SE) - 6.27 (± 0.57) - 5.32 (± 0.57) - 0.95 (± 0.79) P=0.23
- 6.43 (± 0.57) - 5.32 (± 0.57) - 1.10 (± 0.79) P=0.16
*Based on the intent-to-treat population
BID = twice daily
ADAS-COG12 = The Alzheimer's Disease Assessment Scale – Cognitive Subscale (a lower number represents less cognitive impairment)
ADCS-ADL = Alzheimer's Disease Cooperative Study – Activities of Daily Living (a higher number represents less functional impairment)
Safety Data:
The table below provides a high-level summary of the patient demographic and safety data. Simufilam continued to demonstrate an overall favorable safety profile.
Metrics for Simufilam and Placebo Simufilam 100 mg BID Simufilam 50 mg BID Placebo BID
Baseline*
N=374 N=376 N=375
Age, mean (SD), in years 73.6 ± 8.2 74.5 ± 7.6 73.7 ± 7.9
Sex, n (%) female 208 (55.6%) 207 (55.1%) 214 (57.1%)
MMSE Score (No.%,)
21-27 240 (64.2%) 242 (64.4%) 235 (62.7%)
16-20 134 (35.8%) 134 (35.6%) 138 (36.8%)
Race/Ethnicity
White 326 (87.2%) 326 (86.7%) 313 (83.5%)
Black 17 (4.5%) 23 (6.1%) 21 (5.6%)
Asian 28 (7.5%) 21 (5.6%) 32 (8.5%)
Other 3 (0.8%) 6 (1.6%) 9 (2.4%)
Safety**
N=374 N=376 N=373
Any Adverse Event (AE) 286 (76.5%) 288 (76.6%) 282 (75.6%)
Serious AEs 43 (11.5%) 61 (16.2%) 45 (12.1%)
Death 2 (0.5%) 6 (1.6%) 3 (0.8%)
AEs leading to discontinuation from the study 32 (8.6%) 34 (9.0%) 17 (4.6%)
Most Frequent AEs ≥ 5.0%
1: COVID-19 45 (12.0%) 49 (13.0%) 40 (10.7%)
2: Urinary Tract Infection 32 (8.6%) 41 (10.9%) 34 (9.1%)
3: Fall 32 (8.6%) 43 (11.4%) 51 (13.7%)
4: Dizziness 26 (7.0%) 11 (2.9%) 23 (6.2%)
5: Diarrhea 14 (3.7%) 19 (5.1%) 15 (4.0%)
*Based on the intent-to-treat population
**Based on the safety population
BID = twice daily
AD = Alzheimer's disease
MMSE = Mini-Mental State Examination
About REFOCUS-ALZ
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. On November 25, 2024, the Company announced plans to discontinue the REFOCUS-ALZ study and its intention to report topline data from that trial, including the complete 52-week dataset and a large portion of 76-week data.
The prespecified 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-tau217 (phosphorylated tau at threonine 217), GFAP (glial fibrillary acidic protein) and NFL (neurofilament light chain), as well as an evaluation of various brain volumes using MRI (magnetic resonance imaging) and amyloid and tau deposition using PET (positron emission tomography) scans from baseline to week 76.
About Simufilam
Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein.
About Cassava Sciences, Inc.
Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system disorders, including Alzheimer's disease and tuberous sclerosis complex (TSC)-related epilepsy. Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein. The Company is based in Austin, Texas.
For More Information Contact:
Investors
Sandya von der Weid
Media
Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
Cautionary Note Regarding Forward-Looking Statements:
This news release contains forward-looking statements that include but are not limited to statements regarding: REFOCUS-ALZ and RETHINK-ALZ, the timing for discontinuation of our Alzheimer's disease development program, our plans for the development of investigational treatments for central nervous system disorders, our plans to conduct preclinical studies of simufilam relating to seizures in TSC, the potential for simufilam as a treatment for TSC-related epilepsy, our strategic expense management efforts and the timing of anticipated milestones. 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 efficiently discontinue the Company's Alzheimer's disease development program, the ability to advance preclinical studies related to TSC-related epilepsy, 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, 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. They 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.
Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.
We are in the business of new drug discovery, development and commercialization. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery, development and commercialization, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.
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Capital expenditure guidance for 2026 and production guidance for 2029, including HVC MLE, will be disclosed when we issue our annual guidance in January 2026, consistent with our usual process. Guidance reflecting these updates is disclosed in our Q2 2025 News Release and Management's Discussion and Analysis issued on July 23, 2025. Quotes: David Eby, Premier of British Columbia – 'We promised British Columbians we would move big projects forward faster to counter the threats we face. This multi-billion dollar project represents 2,900 new jobs and a $500 million increase to GDP. It's just one example of how British Columbia can drive our country's economy forward even in challenging times. Congratulations to everyone involved - let's keep going!' Christine Walkem, Chair of CNA's Board of Directors, Chief of Cook's Ferry Indian Band – 'The Citxw Nlaka'pamux Assembly (CNA) recognizes the Teck Board's approval of the Highland Valley Copper Mine Life Extension project as a defining moment — not just for industry, but for the 8 Participating Bands of the CNA. This project is moving forward because of the unwavering leadership and community members participation. Through our nłeʔképmx Impact Assessment and as authors of our own sections into the Environmental Assessment application, the CNA established a new precedent in Canada — one where Indigenous law, Indigenous governance, and Indigenous authority are not just consulted, but embedded at the heart of decision-making about our lands, waters, and people. Our communities are not bystanders to development — we are decision-makers. We are forging a new path with Industry and the Crown for how major projects unfold in our territory: grounded in respect, guided by our values, and focused on long-term benefit for our people. As the project enters construction, we remain firm in our expectations. Our voices must continue to be heard. Our laws must continue to guide the process. Our people must continue to share in the benefits — now, and for generations to come.' Chief Matt Pasco, Chair of the Nlaka'pamux Nation Tribal Council – 'The Highland Valley Copper expansion reflects a sharing of Nlaka'pamux resources which was agreed upon based on a principled path forward grounded in rights recognition, technical rigour, and respectful partnership,' said Chief Pasco, Tribal Chair of the Nlaka'pamux Nation Tribal Council. 'With Teck, we are demonstrating that mining can align with Nlaka'pamux jurisdiction, advancing both responsible stewardship and a resilient economy for our people.' Honourable Tim Hodgson, Minister of Energy and Natural Resources, Government of Canada – 'Canada has the natural resources that the world wants – and it is projects like these that put us on the map. By extending the life of Canada's largest copper mine, we are strengthening our critical minerals sector here at home and becoming the international supplier of choice when it comes to critical metals and minerals.' Kyle Wolff, president, USW local 7619 – 'The expansion is wonderful news for the employees at Teck HVC. This secures good employment for over 1500 workers in a great place to live. Investment into safer systems will ensure that we continue to put worker safety at the top of all our agendas.' Robin Smith, Mayor of Logan Lake – 'Our long-standing partnership with Highland Valley Copper has shaped Logan Lake for generations. The extension is more than a milestone for the mine—it's a reaffirmation of our shared history and a renewed commitment to building a strong, sustainable future together. It's about more than jobs; it's about legacy, continuity, and a shared vision for generations to come.' Forward-Looking Statements This news release contains certain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information as defined in the Securities Act (Ontario). Forward-looking statements and information can be identified by statements that certain actions, events or results 'may', 'could', 'should', 'believe', 'would', 'expect', 'continue', 'might' or 'will' be taken, occur or achieved. Forward-looking statements include qualifications and limitations relating to the estimated capital cost of the HVC MLE; Teck's projections and expectations regarding the HVC MLE mine life and copper production and costs, including statements, assumptions and expectations regarding expansion and optimization of the project and property; the ability of HVC MLE to receive and maintain necessary permits and certificates; the expected value that would be created; Teck's growth strategy, including the strategic objective to double copper production by the end of the decade; the continuing positive relationships with Indigenous peoples and local communities; Teck's ability to execute planned activities and execute its construction plans and the expected timing of HVC MLE completion; the community benefits of HVC MLE, including creation of jobs and the creation of annual GDP; Teck's projected IRR and expected EBITDA and the potential for additional upside; the statements concerning construction schedule, budget and outlook for the HVE MLE project generally; the ability of HVC MLE to strengthen the North American critical minerals supply chain; the profitability of Highland Valley Copper; and Teck being a well-positioned copper development company. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Teck to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based on a number of assumptions, including, but not limited to, assumptions regarding general business and economic conditions, interest rates, commodity and power prices, current conditions and expected future developments, Teck's ability to obtain and maintain permits, the regulatory framework remaining defined and understood, and other considerations that are believed to be appropriate in the circumstances. The foregoing list of assumptions is not exhaustive. Events or circumstances could cause actual results to vary materially. Factors that may cause actual results to vary include, but are not limited to, risks relating to the environmental assessment certificate being challenged, Teck's ability to successfully construct HVC MLE to expand operations within the expected timeline and cost estimate or at all, changes in regulatory framework and the presence of laws and regulations that may impose restrictions on mining, the timing and ability of Teck to obtain and maintain required approvals and permits, community, non-governmental and governmental actions, stakeholder and Indigenous peoples' actions, risks related to mining construction and operation activities, the ability to continue current operations, unanticipated geotechnical conditions or other factors affecting construction plans and budgets including supplier, transportation, logistics or labour issues, adverse weather or natural disaster, community unrest, access issues, failure of plan and equipment, disruption of financial markets, metal and commodity prices, the global economic climate, and changes or deterioration in general economic conditions. Capital cost estimates are based on assumptions described in this news release and exclude escalation; actual capital costs will depend on a number of factors and exclude a number of items; therefore, funding requirements may be higher than the predicted capital costs noted above. Teck does not assume the obligation to revise or update these forward-looking statements after the date of this document, except as may be required under applicable securities laws. The scientific and technical information regarding the HVC MLE project was reviewed, approved and verified by Terry Cadrin, P. Eng., who is an employee of Teck. Ms. Cadrin is a qualified person, as defined under National Instrument 43-101. About Teck Teck is a leading Canadian resource company focused on responsibly providing metals essential to economic development and the energy transition. Teck has a portfolio of world-class copper and zinc operations across North and South America and an industry-leading copper growth pipeline. We are focused on creating value by advancing responsible growth and ensuring resilience built on a foundation of stakeholder trust. Headquartered in Vancouver, Canada, Teck's shares are listed on the Toronto Stock Exchange under the symbols TECK.A and TECK.B and the New York Stock Exchange under the symbol TECK. Learn more about Teck at or follow @TeckResources . Investor Contact: Emma Chapman Vice President, Investor Relations +44.207.509.6576 Media Contact: Dale Steeves Director, External Communications 236.987.7405
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Jefferies Lifts Price Target for C.H. Robinson (CHRW), Keeps Hold Rating
C.H. Robinson Worldwide, Inc. (NASDAQ:CHRW) is one of the 12 Best Logistics Stocks to Buy According to Hedge Funds. On July 17, Jefferies increased its price target for C.H. Robinson Worldwide, Inc. (NASDAQ:CHRW) from $95 to $100 and kept a 'Hold' rating. The research firm pointed out that C.H. Robinson Worldwide, Inc. (NASDAQ:CHRW) is trading at about 22 times earnings and 16 times EBITDA for 2025, which are 6% and 12% above the company's historical averages, respectively. A long line of tractor trailers transporting products across the highway. According to Jefferies, this suggests that there is limited room for the stock price to rise from multiple expansion unless freight market fundamentals considerably exceed current market expectations. This analysis was part of Jefferies' broader assessment of the transportation and logistics sector. The firm noted that stock valuations for trucking and brokerage companies have bounced back from early-year lows, which reflects generally strong expectations for a recovery in the sector over the next year. C.H. Robinson Worldwide, Inc. (NASDAQ:CHRW) is an American company that specializes in freight, logistics, and supply chain solutions. The company offers truckload, less than truckload, air freight, and ocean transportation. While we acknowledge the potential of CHRW as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best American Semiconductor Stocks to Buy Now and 11 Best Fintech Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
