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Cassava Sciences (SAVA) investor relations material
Cassava Sciences H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Leadership and strategic direction
New executive leadership was established in July 2024 following regulatory investigations and a management transition.
The company resolved an SEC investigation with a settlement, closing a challenging chapter.
Focus shifted to leveraging a strong board and scientific team, including recent key hires with deep expertise in neuroscience and drug development.
The board chair and new executives bring significant experience in drug approvals and clinical trial management.
Pipeline and research focus
After phase 3 failure in Alzheimer's, attention turned to TSC-related epilepsy, supported by promising preclinical data.
Simufilam showed significant seizure reduction in mouse models, with up to 60% reduction and some mice becoming seizure-free.
The drug demonstrated a strong safety profile in over 1,200 patients with no drug-related serious adverse events.
Intellectual property for simufilam is secured through 2040, with broad patent coverage.
Clinical and commercial plans
A phase 2A proof-of-concept trial in TSC-related epilepsy is planned for the first half of 2026.
The company is preparing an IND submission, with approval expected by year-end.
TSC represents a significant unmet need, with 50,000 US patients and over 60% inadequately controlled by current therapies.
The company owns the drug outright for this indication, with licensing and royalty agreements in place with Yale.
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