Summary

  • Cassava Sciences is a clinical-stage biopharmaceutical company focused on neuroscience.
  • The company's novel science is based on stabilizing – but not removing – a critical protein in the brain to detect and treat neurodegenerative diseases, such as Alzheimer’s disease.
  • Cassava Sciences recently completed a $50 Million direct offering.

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Cassava Sciences (Nasdaq: SAVA) is a clinical-stage biopharmaceutical company focused on neuroscience.  Key focus of its R&D is to develop first-in-class medicines for people with debilitating neurodegenerative conditions

Recent Developments

Cassava Sciences Announces Completion of Dosing in Open-label Study of Simufilam for Alzheimer’s Disease1

Dec 06, 2022; Cassava Sciences, Inc. announced the completion of drug administration in an open-label study of simufilam for Alzheimer’s disease. This study was designed to evaluate long-term drug safety and to measure cognitive changes (ADAS-cog) over 12 months in approximately 200 patients with mild-to-moderate Alzheimer’s disease treated with open-label simufilam 100 mg twice daily. Simufilam is Cassava Sciences’ oral drug candidate for Alzheimer’s disease dementia.

Cassava Sciences is evaluating simufilam for Alzheimer’s disease dementia in two Phase 3 clinical studies. Both studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. Over 750 patients are now enrolled in the Phase 3 program.

Cassava Sciences’ RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily.

Cassava Sciences’ REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or placebo twice daily.

Cassava Sciences Announces Closing of $50 Million Registered Direct Offering2

Nov 22, 2022; Cassava Sciences, Inc. announced the closing of its previously announced registered direct offering of 1,666,667 shares of its common stock, at a purchase price per share of $30, for gross proceeds of approximately $50 million.

The net proceeds of the offering are estimated to be approximately $47.3 million, after deducting placement agent fees and other estimated offering expenses. Cassava Sciences intends to use the net proceeds from this offering for working capital and general corporate purposes, including development of simufilam, the Company’s lead drug candidate for the treatment of Alzheimer’s disease.

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Financial Highlights

Third Quarter Financial 2022 Results

Nov. 07, 2022; Cassava Sciences, Inc.  announced financial results for the third quarter ended September 30, 2022.3

Net loss for third quarter 2022 was $20.3 million, or $0.51 per share, compared to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net cash used in operations was $56.2 million during the first nine months of 2022. Net cash use for operations for full-year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance. Cash and cash equivalents were $174.7 million as of September 30, 2022, with no debt.

  • At September 30, 2022, cash and cash equivalents were $174.7 million, with no debt.
  • Net loss was $20.3 million, or $0.51 per share. This compares to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in its R&D activities for a Phase 3 program of simufilam in Alzheimer’s disease.
  • Net cash used in operations was $56.2 million during the first nine months of 2022.
  • Net cash use in operations for full year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance.
  • Research and development (R&D) expenses were $18.5 million. This compared to $8.0 million for the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical and pre-clinical studies and support functions.
  • General and administrative (G&A) expenses were $2.8 million. This compared to $1.7 million for the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services as well as depreciation and amortization.

On-going Phase 3 Clinical Program

Cassava Sciences’ Phase 3 program consists of two randomized controlled trials of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. The two studies are named RETHINK-ALZ and REFOCUS-ALZ. In 2021, both studies received Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration.

Over 650 patients are now enrolled in its Phase 3 studies. Studies are being conducted in over 100 clinical trial sites across the U.S., Canada, Puerto Rico, South Korea and Australia.

Cassava Sciences’ RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily.

Cassava Sciences’ REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or matching placebo twice daily.

Both of Cassava Sciences’ Phase 3 studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.

Open-label Study – closed enrollment

In March 2020, the company initiated a long-term, open-label study to evaluate simufilam, its lead drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily for 12 or more months. The open-label study has reached its final target enrollment of approximately 200 patients with Alzheimer’s disease. The company expect to announce open-label study results approximately yearend 2022, consistent with its prior guidance.

Cognition Maintenance Study (CMS) – on-going

In May 2021, the company initiated a Cognition Maintenance Study (CMS). This is a randomized, double-blind, placebo-controlled study of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily for six months. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam. The CMS is designed to evaluate simufilam’s effects on in Alzheimer’s patients who continue with drug treatment versus patients who discontinue drug treatment. Over 100 patients are now enrolled in the CMS and over 65 patients have completed this study. The company expect to announce CMS study results approximately Q3 2023, consistent with its prior guidance.

SavaDx – on-going

This earlier-stage program refers to the detection of Alzheimer’s disease with a simple blood test. SavaDx was initially designed as an antibody-based detection system for altered filamin A (FLNA). Cassava Sciences is currently evaluating a new approach—based on mass spectrometry—to detect FLNA in plasma without the use of antibodies. Mass spectrometry is an analytical tool that measures the mass-to-charge ratio (m/z) of a molecule present in a sample.

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Company Overview

Cassava Sciences, Inc. is a clinical-stage biotechnology company based in Austin, Texas.  The company's novel science is based on stabilizing – but not removing – a critical protein in the brain to detect and treat neurodegenerative diseases, such as Alzheimer’s disease.4

Over the past 10 years, Cassava Sciences has combined  technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease and other neurodegenerative diseases. The company's strategy is to leverage its unique scientific/clinical platform to develop a first-in-class program for treating neurodegenerative diseases, such as Alzheimer’s.

The company currently have two biopharmaceutical assets under development:

  • Lead therapeutic product candidate, called simufilam, is a novel treatment for Alzheimer’s disease; and
  • Lead investigational diagnostic product candidate, called SavaDx, is a novel way to detect the presence of Alzheimer’s disease from a small sample of blood.

Properties

The company lease approximately 6,000 square feet of office space pursuant to a non-cancelable operating lease in Austin, Texas that expires April 30, 2024. The company also lease an additional 3,600 square feet of office space in Austin, Texas that expires on April 30, 2022.

On August 4, 2021, the company completed the purchase of a two-building office complex in Austin, Texas, which will serve as its future corporate headquarters. This property is intended to accommodate its anticipated growth and expansion of its operations in the coming years. Maintenance, physical facilities, leasing, property management and other key responsibilities related to property ownership are being outsourced to professional real-estate 74 managers.

References

  1. ^ https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-completion-dosing-open-label-study
  2. ^ https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-closing-50-million-registered-direct
  3. ^ https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-reports-third-quarter-financial-results-2022
  4. ^ https://fintel.io/doc/sec-cassava-sciences-inc-1069530-10k-2022-march-01-19052-5100
Tags: US:SAVA USA
Created by Asif Farooqui on 2022/12/10 07:10
     
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