On April 29, 2019 Cassava Sciences, Inc. (Nasdaq: SAVA), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2019 (Press release, Pain Therapeutics, APR 29, 2019, View Source [SID1234535562]). . Net loss was $1.4 million, or $0.08 per share . This compared to a net loss of $2.2 million, or $0.33 per share, for the same period in the prior year. Cash and cash equivalents were $19.1 million as of March 31, 2019. The Company has no debt. Cassava Sciences utilized $0.7 million of cash during the first quarter of 2019 and expects cash use to be $5.0 – $6.0 million for full year 2019.
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"As we enter 2019, our financial expectations reflect a thoughtful balance between maintaining fiscal discipline and advancing our series of product candidates aimed at Alzheimer’s disease", said Remi Barbier, President & CEO. "One thing that won’t change is our focus on developing potential breakthrough innovations and an unwavering dedication to improve people’s lives. This emphasis has characterized our history and remains core to our strategy for 2019 and beyond."
Cassava Sciences is conducting a Phase 2 clinical program with its investigational drug, PTI-125, in patients with Alzheimer’s disease. PTI-125 is designed to exert anti-neuroinflammatory effects and to restore the function of three key receptors in the brain. The National Institutes of Health (NIH) is providing substantial scientific and financial support for the Company’s clinical program.
Cassava Sciences expects to announce results of its Phase 2a study in the second half of 2019, after study participants complete drug treatment and their data are analyzed.
Financial Highlights for First Quarter 2019
At March 31, 2019, cash and cash equivalents were $19.1 million, compared to $19.8 million at December 31, 2018. The company has no debt. Net cash utilized during the first quarter 2019 was $0.7 million.
Net loss was $1.4 million compared to $2.2 million for the same period in the prior year, representing a 37% decrease. Net loss per share was $0.08 compared to $0.33 for the same period in the prior year.
We received research grant funding reimbursements of $0.8 million from NIH and recorded this as a reduction in research and development expenses ("R&D"). This compared to $0.4 million of NIH grant receipts received for the same period in the prior year.
R&D expenses were $0.6 million. This compared to $1.1 million for the same period in the prior year, representing a 46% decrease. The decrease was due primarily to the increase in NIH grant funding in 2019 compared to the prior year combined with a decrease in non-cash stock-based compensation expense. R&D expenses included non-cash stock related compensation costs of $0.1 million compared to $0.4 million for same period in the prior year.
General and administrative ("G&A") expenses were $0.9 million. This compared to $1.1 million for the same period in the prior year, representing a 20% decrease. G&A expenses included non-cash stock-based compensation costs of $0.2 million compared to $0.5 million for the same period in the prior year.
Our Scientific Approach
The target of PTI-125 is an altered form of filamin A (FLNA). FLNA is a scaffolding protein found throughout the body. The function of a scaffolding protein is to bring multiple proteins together and to ensure they interact properly. However, an altered and highly toxic form of FLNA is found in the Alzheimer’s brain. Altered FLNA disrupts the normal function of neurons, leading to neurodegeneration and brain inflammation. Our investigational drug candidate, PTI-125, is designed to restore the normal shape & function of FLNA in the brain. This drug effect exerts powerful anti-neuroinflammatory effects and improves the function of multiple brain receptors.
In animal models of disease, treatment with PTI-125 resulted in dramatic improvements in brain health, such as improved learning and memory; improved insulin receptor signaling; and significant reductions in levels of inflammatory cytokines in the brain.
We are also developing a biomarker/diagnostic to detect Alzheimer’s disease with a simple blood test. This program, called PTI-125Dx, also receives scientific and financial support from NIH.
The underlying science for our programs in neurodegeneration is published in several prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. As previously announced, NIH awarded us two research grants in 2018 following an in-depth, confidential review of our science and technology. These two NIH grants represent up to $6.7 million of non-dilutive financing.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Eventually, a person with Alzheimer’s disease may be unable to carry out even simple tasks. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course.
An estimated 5.8 million Americans of all ages are living with Alzheimer’s disease in 2019.