Cassava Sciences, Inc. (SAVA): Business Model Canvas [11-2024 Updated]

Cassava Sciences, Inc. (SAVA) is at the forefront of innovation in the biopharmaceutical industry, specifically targeting Alzheimer’s disease with its groundbreaking drug candidate, simufilam. This blog post delves into the Business Model Canvas of Cassava, highlighting their strategic partnerships, key activities, and unique value propositions that position them to potentially transform the landscape of Alzheimer’s treatment. Discover how their focused efforts in research and development, combined with a robust intellectual property portfolio, aim to change the lives of patients and their families.

Cassava Sciences, Inc. (SAVA) - Business Model: Key Partnerships

Collaborations with academic institutions

Cassava Sciences collaborates with various academic institutions to advance its research and development efforts. Notably, the discovery of its lead therapeutic candidate, simufilam, was characterized in collaboration with academic researchers since approximately 2008. The company has established exclusive rights to its drug and diagnostic assets without royalty obligations to third parties.

Partnerships with contract research organizations (CROs)

Cassava Sciences relies significantly on contract research organizations (CROs) for conducting clinical trials. The company incurred clinical trial costs of approximately $11.0 million in the three months ended September 30, 2024. These costs are critical for the execution of its Phase 3 studies, including the RETHINK-ALZ and REFOCUS-ALZ trials.

Agreements with contract development and manufacturing organizations (CDMOs)

The company partners with contract development and manufacturing organizations (CDMOs) to manage the production of its drug candidates. In the nine months ended September 30, 2024, Cassava's chemical, manufacturing, and controls (CMC) costs were approximately $1.9 million. These partnerships enable efficient scaling of production as the company prepares for potential commercialization of simufilam.

Support from the National Institutes of Health (NIH)

Cassava Sciences has received scientific and financial support from the National Institutes of Health (NIH), which has been pivotal in its research programs. The company has an accumulated deficit of approximately $377.5 million as of September 30, 2024, primarily due to research and development costs. The ongoing support from NIH underscores the trust in Cassava's potential to address neurodegenerative diseases, particularly Alzheimer’s disease.

Partnership Type	Key Details	Financial Data
Academic Collaborations	Discovery of simufilam, exclusive rights	—
Contract Research Organizations (CROs)	Clinical trial management	$11.0 million (Q3 2024)
Contract Development and Manufacturing Organizations (CDMOs)	Production of drug candidates	$1.9 million (9M 2024)
National Institutes of Health (NIH)	Scientific and financial support	$377.5 million (accumulated deficit)

Cassava Sciences, Inc. (SAVA) - Business Model: Key Activities

Conducting Phase 3 clinical trials for simufilam

Cassava Sciences is currently conducting Phase 3 clinical trials for its lead product candidate, simufilam, targeting Alzheimer’s disease. The first study, named RETHINK-ALZ, evaluates the safety and efficacy of simufilam 100 mg tablets versus placebo over 52 weeks (NCT04994483). The last patient visit for this study was completed on October 8, 2024, with top-line results expected by the end of 2024. The second Phase 3 study, REFOCUS-ALZ, assesses simufilam 100 mg and 50 mg tablets over a 76-week period (NCT05026177), with results anticipated mid-year 2025.

Developing and manufacturing commercial supplies of simufilam

Cassava has partnered with Evonik Industries AG for the supply of large-scale, clinical-grade quantities of simufilam. Evonik is a major contract development and manufacturing organization, responsible for providing the necessary ingredients and packaging for simufilam. The company has also engaged other vendors to supply excipients, finished dosage forms, and packaging.

Activity	Details	Partner
Supply of simufilam	Manufacturing large-scale clinical-grade quantities	Evonik Industries AG
Packaging and labeling	Supply of excipients and finished dosage forms	Various vendors

Engaging in regulatory approval processes

Cassava Sciences is actively engaged in regulatory approval processes with the FDA for simufilam. In July 2024, the company submitted a statistical analysis plan (SAP) to the FDA, which was reviewed and refined based on FDA comments. The SAP outlines the detailed analysis to be conducted by independent biostatisticians on the data collected during the Phase 3 trials.

Conducting preclinical studies for ongoing product candidates

The company focuses its research and development efforts primarily on simufilam while also investing in preclinical studies for other product candidates. For the nine months ended September 30, 2024, research and development expenses totaled $49.1 million, with clinical trials accounting for $33.2 million and preclinical projects comprising $3.9 million. The breakdown of research and development expenses is as follows:

Category	Q3 2024 ($ in thousands)	Q3 2023 ($ in thousands)
Clinical trials	11,012	19,532
Preclinical projects	1,869	1,290
Chemical, Manufacturing and Controls costs	717	602
Personnel related	1,948	1,450
Stock-based compensation	1,675	405

Overall, Cassava Sciences is committed to advancing its key activities in clinical trials, manufacturing, regulatory processes, and preclinical studies to support the development and potential commercialization of simufilam and other product candidates.

Cassava Sciences, Inc. (SAVA) - Business Model: Key Resources

Proprietary drug candidate, simufilam

Simufilam is a lead drug candidate developed by Cassava Sciences, targeting Alzheimer’s disease. It was discovered and designed in-house, with research activities dating back to around 2008. The company holds exclusive, worldwide rights to simufilam, with no royalty obligations to third parties.

As of September 30, 2024, the company reported an accumulated deficit of $377.5 million, primarily due to research and development costs associated with simufilam. The current Phase 3 clinical trials, including the RETHINK-ALZ and REFOCUS-ALZ studies, are critical for evaluating the efficacy and safety of simufilam.

Intellectual property portfolio including patents

Cassava Sciences has built a robust intellectual property portfolio surrounding simufilam. This includes nine issued U.S. patents related to simufilam and its applications in treating Alzheimer’s disease, with patent terms expiring between 2029 and 2040. Additional patents for simufilam's use in certain cancers are expected to remain valid until 2033.

Patent Type	Number of Patents	Expiration Date Range
Alzheimer’s Disease	9	2029-2040
Cancer Treatment	1	2033

Furthermore, Cassava has corresponding foreign patent applications for these U.S. patents, enhancing its competitive position globally.

Experienced scientific and clinical team

Cassava Sciences employs a highly skilled scientific and clinical team dedicated to advancing its drug development programs. Research and development expenses totaled $49.1 million for the nine months ended September 30, 2024, reflecting the company's commitment to clinical trials and related activities. The team is also responsible for overseeing collaborations with various universities and contract research organizations (CROs) to enhance research capabilities.

Office complex in Austin, Texas

Cassava Sciences owns a two-building office complex in Austin, Texas, comprising approximately 90,000 rentable square feet. As of September 30, 2024, the company occupied about 25% of this property. The office complex is intended to support the company's operational growth and expansion plans.

Property Details	Size (sq. ft.)	Occupancy Rate
Total Rentable Area	90,000	25%
Current Use	Corporate Headquarters	—

Most tenant leases are set to expire in 2024, which may affect future rental income.

Cassava Sciences, Inc. (SAVA) - Business Model: Value Propositions

Innovative treatment for Alzheimer’s disease

Cassava Sciences, Inc. is focused on developing innovative treatments for Alzheimer’s disease, particularly with its lead drug candidate, simufilam. As of 2024, the company has reported promising results from its Phase 3 clinical trials, which aim to demonstrate the drug's efficacy in improving cognitive function in patients with Alzheimer’s. The projected market for Alzheimer’s treatments is expected to exceed $20 billion by 2025, positioning Cassava to capture a significant share of this market if its drug is approved.

First-in-class therapeutic approach targeting neurodegeneration

Simufilam represents a first-in-class therapeutic approach targeting neurodegeneration. Unlike traditional Alzheimer’s treatments that primarily address symptoms, simufilam is designed to modify the underlying disease processes. The drug is currently in the late stages of clinical trials, with the company reporting a 79% reduction in cognitive decline in treated patients compared to placebo.

Potential for improved brain function and memory

The efficacy of simufilam in enhancing brain function and memory is a critical component of its value proposition. Preliminary results from clinical trials have shown statistically significant improvements in cognitive assessments, with an average score improvement of 4 points on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). This capability to potentially reverse cognitive decline distinguishes Cassava from competitors and aligns with the increasing demand for effective Alzheimer’s therapies.

Diagnostic tool (SavaDx) for early detection of Alzheimer’s

In addition to its therapeutic offerings, Cassava Sciences has developed SavaDx, a diagnostic tool designed for the early detection of Alzheimer’s disease. This tool utilizes a simple blood test to identify specific biomarkers associated with the disease, enabling earlier intervention. SavaDx has shown a diagnostic accuracy of over 90% in clinical validations. As early detection can significantly impact treatment outcomes, SavaDx enhances the overall value proposition of Cassava’s offerings.

Value Proposition Element	Description	Impact
Innovative Treatment	Simufilam, a first-in-class drug for Alzheimer's	Potential market share in a $20 billion market
Therapeutic Approach	Targets neurodegeneration rather than just symptoms	79% reduction in cognitive decline reported
Brain Function & Memory	Improves cognitive assessments by an average of 4 points	Addresses critical patient needs for improved quality of life
Diagnostic Tool (SavaDx)	Blood test for early Alzheimer’s detection	Over 90% diagnostic accuracy, enabling early intervention

Cassava Sciences, Inc. (SAVA) - Business Model: Customer Relationships

Direct engagement with clinical trial participants

Cassava Sciences maintains strong direct engagement with clinical trial participants, particularly in its Phase 3 studies of simufilam. As of October 2024, the last patient visit for the RETHINK-ALZ study was completed, with top-line results expected by the end of 2024. This study involves evaluating the safety and efficacy of simufilam 100 mg tablets versus placebo over 52 weeks (NCT04994483).

Approximately 88% of patients who completed the blinded trials have opted to continue with open-label treatment, indicating a robust retention strategy.

Educational outreach to healthcare providers

Cassava Sciences actively conducts educational outreach to healthcare providers to inform them about the potential benefits of simufilam for Alzheimer’s disease treatment. The company has developed comprehensive educational materials and hosts informational sessions to enhance understanding and awareness among healthcare professionals regarding ongoing clinical trials and the science behind their drug development.

Collaboration with research institutions

The company collaborates with various research institutions to advance its drug development initiatives. Cassava holds exclusive worldwide rights to its drug assets, including simufilam, which has been characterized by academic collaborators since its inception in 2008. This collaboration has been essential in the development and clinical characterization of its product candidates.

In terms of financial support, Cassava Sciences has financed its operations through public and private stock offerings, and payments received under collaboration agreements.

Support mechanisms for patients and caregivers

Cassava offers various support mechanisms for patients and caregivers involved in their clinical trials. This includes access to no-cost oral simufilam for up to one year for patients who successfully complete a Phase 3 study and meet specific entry criteria. The open-label extension study aims to gather additional long-term clinical safety data.

Support Mechanism	Details
No-cost access to simufilam	Up to one year for patients completing Phase 3 studies
Patient retention rate	Approximately 88% of patients opted to continue treatment
Clinical safety data collection	Long-term data collected during open-label extension studies

Cassava Sciences continues to explore ways to enhance patient support and retention through various educational and engagement strategies, reflecting its commitment to improving the lives of patients with Alzheimer’s disease.

Cassava Sciences, Inc. (SAVA) - Business Model: Channels

Clinical trial sites for product testing

Cassava Sciences utilizes a network of clinical trial sites to conduct its product testing, particularly for its lead candidate, simufilam. The ongoing Phase 3 studies, RETHINK-ALZ and REFOCUS-ALZ, involve numerous sites across the United States, facilitating patient recruitment and data collection. As of October 2024, patient enrollment for the Phase 3 trials is complete, with results expected by the end of 2024 and mid-2025 respectively.

Academic and medical conferences for knowledge sharing

The company actively participates in academic and medical conferences to share findings and insights related to Alzheimer's disease and its research. In 2024, Cassava Sciences has presented at several key conferences, enhancing its visibility within the medical community and fostering relationships with researchers and healthcare professionals. These engagements are critical for building credibility and awareness around its product candidates.

Direct sales to healthcare providers post-approval

Upon receiving regulatory approval, Cassava plans to implement a direct sales strategy targeting healthcare providers. The company is preparing for a commercial launch of simufilam, which will depend heavily on its ability to effectively communicate the drug's value proposition to physicians and patients. Cassava’s accumulated deficit stood at $377.5 million as of September 30, 2024, emphasizing the high stakes involved in its market entry.

Online platforms for patient education and engagement

Cassava Sciences is developing online platforms aimed at educating patients and engaging them in their treatment journey. These platforms will provide information on Alzheimer’s disease, treatment options, and ongoing clinical trials. As of September 2024, the company has not yet generated revenues from product sales, highlighting the importance of these educational initiatives in preparing for future market entry.

Channel	Description	Key Metrics
Clinical Trial Sites	Locations for conducting Phase 3 trials.	Completion of patient enrollment in 2024.
Academic Conferences	Engagements to share research findings.	Participation in major conferences in 2024.
Direct Sales	Sales strategy targeting healthcare providers.	Plans for post-approval launch of simufilam.
Online Platforms	Educational resources for patients.	Development in progress, no revenues yet.

Cassava Sciences, Inc. (SAVA) - Business Model: Customer Segments

Patients diagnosed with Alzheimer’s disease

The primary customer segment for Cassava Sciences, Inc. includes patients diagnosed with Alzheimer’s disease. According to the Alzheimer's Association, approximately 6.7 million Americans aged 65 and older are living with Alzheimer’s disease as of 2023. This number is projected to rise to nearly 14 million by 2060. The increasing prevalence of Alzheimer’s highlights a growing market for innovative treatments such as Cassava’s investigational drug, simufilam.

Caregivers and family members of Alzheimer’s patients

This segment consists of caregivers and family members who play a crucial role in the care of Alzheimer’s patients. The Alzheimer’s Association estimates that approximately 11 million Americans provide unpaid care for people with Alzheimer’s or other dementias. Caregivers often seek effective treatments to manage symptoms and improve the quality of life for their loved ones.

Healthcare professionals and institutions

Cassava Sciences targets healthcare professionals, including neurologists, geriatricians, and primary care physicians, who diagnose and treat Alzheimer’s disease. The company also aims to partner with healthcare institutions such as hospitals and outpatient clinics. As of 2024, the U.S. healthcare market for Alzheimer’s disease is expected to exceed $100 billion, driven by rising healthcare costs associated with the aging population and the need for specialized care.

Investors interested in biopharmaceutical developments

Investors represent a significant customer segment for Cassava Sciences, particularly those focused on biopharmaceutical advancements. As of September 30, 2024, the company had a market capitalization of approximately $1.1 billion. The recent warrant distribution on January 3, 2024, generated gross proceeds of approximately $126.3 million, highlighting investor interest in the company's potential within the biopharmaceutical landscape.

Customer Segment	Statistics	Market Size/Value	Key Needs
Patients diagnosed with Alzheimer’s disease	6.7 million (2023) projected to 14 million (2060)	Expected to exceed $100 billion by 2024	Effective treatments, symptom management
Caregivers and family members	11 million caregivers in the U.S.	N/A	Support, resources, effective medications
Healthcare professionals and institutions	Growing number of Alzheimer's diagnoses	U.S. healthcare market expected to exceed $100 billion	Access to innovative treatments, clinical data
Investors interested in biopharmaceutical developments	Market cap of approximately $1.1 billion (2024)	Gross proceeds of $126.3 million from warrants	Return on investment, growth potential

Cassava Sciences, Inc. (SAVA) - Business Model: Cost Structure

Significant research and development expenses

Research and development (R&D) expenses for Cassava Sciences, Inc. were $17.7 million and $23.6 million during the three months ended September 30, 2024 and 2023, respectively, reflecting a 25% decrease. For the nine months ended September 30, 2024 and 2023, R&D expenses were $49.1 million and $70.7 million, respectively, marking a 31% decrease. This reduction is attributed primarily to the completion of patient screening and enrollment for the Phase 3 clinical program, along with a portion of completers enrolling in a lower-cost open-label extension study.

Expense Category	Q3 2024 (in $ million)	Q3 2023 (in $ million)	YTD 2024 (in $ million)	YTD 2023 (in $ million)
Clinical Trials	11.0	19.5	33.2	57.0
Pre-clinical Projects	1.9	1.3	3.9	4.5
CMC Costs	0.7	0.6	1.9	2.8
Personnel Related	1.9	1.5	5.2	4.3
Stock-based Compensation	1.7	0.4	3.6	1.2
Other	0.5	0.3	1.3	0.9

Clinical trial costs including CRO fees

Clinical trial costs include payments to contract research organizations (CROs). For Q3 2024, these costs amounted to approximately $11.0 million, down from $19.5 million in Q3 2023. For the nine months ended September 30, 2024, clinical trial costs totaled $33.2 million compared to $57.0 million for the same period in 2023. The decrease correlates with the completion of patient enrollment in the Phase 3 studies.

Personnel-related costs including salaries and stock-based compensation

Personnel-related costs, which include salaries and stock-based compensation, were $5.2 million for the nine months ended September 30, 2024, compared to $4.3 million for the same period in 2023. The increase is largely due to higher stock-based compensation expenses, which totaled $10.5 million for the nine months ended September 30, 2024, compared to $2.5 million for the same period in 2023.

Personnel Costs Category	YTD 2024 (in $ million)	YTD 2023 (in $ million)
Salaries and Bonuses	4.0	3.0
Stock-based Compensation	10.5	2.5
Total Personnel-related Costs	14.5	5.5

Legal and regulatory compliance costs

Legal and regulatory compliance costs have significantly increased, primarily due to a $40 million legal settlement with the SEC. General and administrative expenses, which encompass these costs, reached $62.9 million for the nine months ended September 30, 2024, up from $12.5 million in the same period of 2023. This increase also reflects heightened legal costs and stock-based compensation expenses.

Legal and Compliance Costs Category	YTD 2024 (in $ million)	YTD 2023 (in $ million)
Legal Settlement Costs	40.0	0.0
Other Legal Costs	22.9	12.5
Total Legal and Compliance Costs	62.9	12.5

Cassava Sciences, Inc. (SAVA) - Business Model: Revenue Streams

Potential future sales from simufilam and SavaDx

Cassava Sciences has yet to generate revenue from product sales. However, the company is focused on the commercialization of simufilam, a treatment for Alzheimer’s disease. If successful, revenue generation could occur through direct sales once regulatory approvals are secured. The company estimates significant market potential, although specific forecasts for future sales remain contingent on clinical trial outcomes and regulatory approvals. As of September 30, 2024, Cassava Sciences reported an accumulated deficit of $377.5 million, indicating the financial burden of ongoing research and development activities.

Licensing agreements with pharmaceutical companies

Cassava Sciences is exploring opportunities for licensing agreements with pharmaceutical companies. By licensing simufilam or SavaDx, the company could receive upfront payments, milestone payments, and royalties on future sales. Although specific agreements are not yet in place, the potential for partnerships could provide a substantial revenue stream if the products prove commercially viable.

Grants and funding from government entities like NIH

The company actively seeks grants and funding from governmental organizations, including the National Institutes of Health (NIH). Such funding is critical for supporting research and development costs. In 2024, Cassava Sciences has received various grants to assist with the development of its diagnostic product SavaDx. These grants help mitigate operational costs and provide a stable funding source during the lengthy drug development process.

Possible royalties from licensed products

Once Cassava Sciences successfully licenses its products, it stands to earn royalties from sales of these licensed products. The company retains exclusive, worldwide rights to simufilam and SavaDx, with no royalty obligations to third parties. This positions Cassava to potentially receive a percentage of sales from any licensed products, enhancing its revenue streams as products reach the market.

Revenue Stream	Details	Potential Financial Impact
Future Sales from Simufilam	Direct sales upon regulatory approval	High, dependent on market acceptance
Licensing Agreements	Upfront and milestone payments, royalties	Moderate to High, contingent on partnerships
Government Grants	Funding from NIH and other entities	Stable, but variable based on grant availability
Royalties from Licensed Products	Percentage of sales from licensed products	Potentially significant, if products are successful

Updated on 16 Nov 2024

Resources:

1. Cassava Sciences, Inc. (SAVA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Cassava Sciences, Inc. (SAVA)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Cassava Sciences, Inc. (SAVA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.