PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical stage biopharmaceutical company, today announced that its Phase 2 study results of the drug CT1812 will be presented at the Alzheimer’s Association International Conference in Philadelphia, PA, scheduled from July 28 to August 1, 2024. The study, named SHINE, investigated CT1812's efficacy and safety in patients with mild-to-moderate Alzheimer’s disease.
The SHINE study is a randomized, double-blind, placebo-controlled trial that enrolled approximately 144 patients. Subjects received either a placebo or one of two doses of CT1812 (100 mg or 300 mg) taken orally daily for six months. The study's endpoints focused on safety, cognitive function as measured by the ADAS-Cog 11, and biomarker evidence of disease modification.
CT1812 is an experimental, orally delivered small molecule that penetrates the blood-brain barrier and binds selectively to the sigma-2 receptor complex. This binding is believed to displace toxic Aβ oligomers, which are associated with synaptic damage and cognitive impairment in Alzheimer's disease. The sigma-2 receptor complex is critical in regulating cellular processes such as membrane trafficking and autophagy.
The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. In addition to the SHINE study, CT1812 is being evaluated in other clinical programs, including the ongoing START study for early Alzheimer's disease and the MAGNIFY study for dry age-related macular degeneration.
Cognition Therapeutics will also host a booth at the conference to provide more information about its Alzheimer’s disease program and the lead candidate CT1812. The company is engaged in developing therapeutics targeting degenerative disorders of the central nervous system and retina, with a pipeline of sigma-2 receptor modulators.
The press release includes forward-looking statements regarding the potential benefits and results of CT1812, which are subject to risks, uncertainties, and assumptions. The actual outcomes may differ materially from those projected in the statements due to various factors, including but not limited to, the predictive nature of preliminary data and the challenges of clinical development.
This article is based on a press release statement from Cognition Therapeutics, Inc.
In other recent news, Cognition Therapeutics has made significant progress in its drug development research. The company reached its enrollment target for the Phase 2 SHIMMER study, which evaluates the safety and effectiveness of CT1812, a drug developed for adults with dementia with Lewy bodies (DLB).
The results of this study are expected to be released in the second half of 2024. In addition, Chardan Capital Markets initiated coverage on shares of Cognition Therapeutics with a Buy rating and a price target of $11.00, based on the potential of CT1812.
The company also received an Outperform rating and a $9 target from Oppenheimer, following a discussion on the unmet needs in Alzheimer's disease treatment and the promising data from the Phase 1/2 SEQUEL study supporting CT1812's unique mechanism of action.
Despite reporting a net loss of $25.8 million for the fiscal year 2023, Cognition Therapeutics maintains optimism over the potential of CT1812, with $29.9 million in cash and cash equivalents and $67.5 million in grant funds from the National Institute of Aging. These developments reflect the recent strides made by the company in addressing neurodegenerative diseases.
InvestingPro Insights
As Cognition Therapeutics, Inc. (NASDAQ: CGTX) prepares to present its Phase 2 study results at the Alzheimer’s Association International Conference, investors and industry stakeholders are closely monitoring the company’s financial health and market performance. Here are some key insights based on data from InvestingPro:
InvestingPro Data indicates that CGTX has a Market Cap (Adjusted) of $66.9 million, reflecting the company's valuation in the market. Despite the anticipation surrounding the clinical results, CGT's stock price has experienced volatility, with a Price % of 52 Week High at 56.61%, suggesting that the shares are trading significantly below their highest point in the past year.
The company's financial stability is a critical factor, especially for a clinical-stage biopharmaceutical company like CGTX. An InvestingPro Tip highlights that CGTX holds more cash than debt on its balance sheet, which could be a positive sign for the company's ability to fund ongoing research and operations without the immediate need for additional financing.
Still, InvestingPro Tips also point out that CGTX is quickly burning through cash and suffers from weak gross profit margins. These factors, combined with a lack of profitability over the last twelve months and analysts' expectations that the company will not be profitable this year, could raise concerns about the long-term financial sustainability of the company.
For those interested in a deeper dive into Cognition Therapeutics' financials and market performance, InvestingPro offers additional tips. There are currently 8 more InvestingPro Tips available at https://www.investing.com/pro/CGTX, which can provide a more comprehensive understanding of the company's outlook.
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