Company Overview

Cassava Sciences is a clinical-stage biotechnology company developing novel treatments for neurodegenerative diseases like Alzheimer’s. Their lead therapeutic candidate, simufilam, is an oral drug in Phase 3 trials for treating Alzheimer’s disease dementia. Simufilam aims to improve cognition and slow disease progression by targeting altered proteins and reducing neuroinflammation.

Cassava owns exclusive worldwide rights to simufilam and related technologies, with patent protection through 2039. The company has no royalty obligations to any third party.

Financial Results

Cassava has not yet generated revenue and has an accumulated deficit of $355.7 million as of March 31, 2024. Net loss for Q1 2024 was $25 million.

Research and development expenses were $16.2 million in Q1 2024, a 27% decrease from $22.1 million in Q1 2023, primarily due to completion of patient enrollment in the Phase 3 trials. Research costs are expected to continue decreasing modestly.

General and administrative expenses were $3.7 million in Q1 2024, a 16% decrease from $4.4 million in Q1 2023, largely due to lower legal expenses. These costs are expected to decrease in 2024.

Phase 3 Clinical Program

Cassava’s Phase 3 program consists of two large placebo-controlled trials evaluating simufilam over 52 weeks (RETHINK-ALZ) and 76 weeks (REFOCUS-ALZ). The trials have enrolled ~1,900 mild-to-moderate Alzheimer’s patients total.

Over 70% of patients enrolled have mild disease. Top-line data readouts from the Phase 3 trials are expected by end of 2024 and mid-2025. An open-label extension study is underway to provide continued access to simufilam.

Interim MRI data suggest simufilam does not have the brain swelling side effect seen with some Alzheimer’s drugs. A safety monitoring board has recommended the Phase 3 trials continue without changes.

Liquidity

Cassava has financed operations primarily through stock offerings. Cash and equivalents were $124.2 million as of March 31, 2024.

In January 2024, Cassava distributed ~16.9 million common stock warrants to shareholders. As of March 31, 2024, ~674,000 warrants have been exercised for $22.3 million in net proceeds.

An at-the-market offering program is in place allowing Cassava to sell up to $200 million in common stock. No sales have occurred yet.

Cassava believes current cash resources are sufficient to fund at least 12 months of operations. Additional financing may be sought to support long-term plans.

Risks and Uncertainties

Drug development is an expensive, complex, and risky process with uncertain outcomes. Cassava has not yet generated revenue and expects to continue using significant cash resources for the foreseeable future.

The company’s financial obligations under an incentive bonus plan could total $6.5 million currently and up to $202.3 million hypothetically if all milestones are met. No payments have been made yet.