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Cognition Therapeutics, Inc. (NASDAQ: CGTX) is a clinical-stage biopharmaceutical company based in Pittsburgh, Pennsylvania. Established in 2007, the company is dedicated to discovering and developing small-molecule therapeutics aimed at treating age-related degenerative diseases and disorders of the central nervous system and retina.
At the heart of Cognition Therapeutics' innovation is its proprietary biology and chemistry platforms, which are utilized to identify novel drug targets and create disease-modifying therapies. The company's flagship product candidate, CT1812, is an orally administered small-molecule antagonist designed to breach the blood-brain barrier. CT1812 binds selectively to the S2R complex, potentially offering a unique therapeutic approach for patients.
Current Projects and Achievements:
- CT1812 is currently being evaluated in Phase 2 clinical trials for conditions such as Alzheimer’s disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD).
- Recent 2023 milestones include completing enrollment for the SHINE Study in mild-to-moderate Alzheimer's disease and initiating new clinical studies for early Alzheimer's and dry AMD.
- The SHIMMER study for mild-to-moderate DLB has also reached its target enrollment, with top-line results anticipated in the latter half of 2024.
The company has made significant strides in advancing its clinical programs. In 2023, the FDA approved the first disease-modifying biologics for Alzheimer’s disease, which has rejuvenated research and investment in this critical area. Cognition Therapeutics is leveraging this momentum in its ongoing research and clinical trials.
Financial Overview:
For the year ending December 31, 2023, Cognition Therapeutics reported cash and cash equivalents of approximately $29.9 million. Additional capital from a March 2024 offering has bolstered their financial position, providing the company with sufficient funds to support operations and capital expenditures through May 2025.
Research and development expenses for 2023 were $37.2 million, an increase from $30.3 million in 2022, reflecting higher costs associated with Phase 2 trials and personnel. General and administrative expenses remained relatively stable at $13.5 million.
The company continues to foster collaborations and partnerships to advance its scientific goals. Notably, the SHIMMER study is supported by a significant grant from the National Institute on Aging (NIA), totaling approximately $30 million.
For ongoing updates and detailed information about Cognition Therapeutics, visit their website at cogrx.com.
Cognition Therapeutics supports Lewy Body Dementia Awareness Month, highlighting the need for improved treatments for dementia with Lewy bodies (DLB), the second most common form of progressive dementia. DLB affects approximately 1.4 million people in the U.S. with no approved treatments available. The company is advancing CT1812 in the Phase 2 'SHIMMER' clinical trial for DLB treatment, with data readout expected in Q4 2024.
DLB is caused by the buildup of alpha-synuclein protein, forming Lewy bodies inside neurons. Symptoms include impaired cognition, visual hallucinations, REM sleep behavior disorder, and movement issues. Cognition Therapeutics partnered with the Lewy Body Dementia Association (LBDA) and the University of Miami Miller School of Medicine to design the SHIMMER trial, which has enrolled 130 patients with mild-to-moderate DLB across the U.S.
The DLB community will convene at the first Externally Led Patient-Focused Drug Development (EL-PFDD) Meeting on October 15, 2024, where patients and care partners will share their experiences with the FDA.
Cognition Therapeutics (NASDAQ: CGTX), a clinical-stage company developing drugs for neurodegenerative disorders, announced its participation in two upcoming investor conferences in September 2024. CEO Lisa Ricciardi will attend the Chardan Capital Markets Leadership Call on September 5 and the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11.
The company recently presented results from the Phase 2 SHINE study, showing that their orally delivered CT1812 slowed the progression of mild-to-moderate Alzheimer's disease after six months of treatment. Cognition is advancing its clinical programs for CT1812 in Alzheimer's disease, with the SHIMMER Phase 2 study readout expected by year-end 2024. Archived webcasts of the presentations will be available on Cognition's investor relations site.
Cognition Therapeutics (NASDAQ: CGTX) has published results from the SEQUEL study of CT1812, their lead candidate for Alzheimer's disease treatment, in The Journal of Prevention of Alzheimer's Disease. The single-site study measured brain wave patterns in 16 adults with mild-to-moderate Alzheimer's after 29 days of treatment. CT1812-treated participants showed consistent trends of improvement across all prespecified EEG parameters, with significant changes in relative theta power and AEC-c, which assesses brain region connectivity.
The study suggests CT1812 may normalize brain wave patterns and facilitate communication between brain regions by protecting synapses as an Aβ oligomer antagonist. Treatment produced a reduction in global relative theta power across various brain regions and improved global alpha AEC-c. CT1812 was well-tolerated with mostly mild to moderate adverse events reported.
Cognition Therapeutics (Nasdaq: CGTX) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Phase 2 SHINE trial showed ~40% mean improvement in ADAS-Cog 11 vs placebo for CT1812 in mild-to-moderate Alzheimer's disease.
2. Topline results from SHIMMER study in mild-to-moderate DLB expected by year-end 2024.
3. Q2 2024 financials: $28.5 million in cash and cash equivalents, $57.3 million in remaining NIA grant funds.
4. R&D expenses increased to $11.6 million in Q2 2024 from $8.5 million in Q2 2023.
5. Net loss of $7.0 million ($0.18 per share) in Q2 2024 compared to $4.7 million ($0.16 per share) in Q2 2023.
6. Cash runway estimated into Q2 2025.
Cognition Therapeutics (Nasdaq: CGTX), a clinical-stage biopharmaceutical company, has announced it will release its Q2 2024 financial results on August 8, 2024, before market open. The company will host a conference call and live audio webcast at 8:30 a.m. ET on the same day to discuss the results and provide a business update.
Cognition Therapeutics focuses on developing treatments for neurodegenerative disorders. Their lead candidate, CT1812, is being investigated for Alzheimer's disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD). The company believes CT1812 and its pipeline of σ-2 receptor modulators can regulate impaired pathways in these diseases, offering a potentially distinct approach from other treatments in development.
Cognition Therapeutics (NASDAQ: CGTX) reported positive results from its Phase 2 SHINE trial for CT1812, an oral treatment for mild-to-moderate Alzheimer's disease. The study showed:consistent cognitive improvement compared to placebo across all measures, with a ~40% mean improvement in cognitive outcomes. CT1812 demonstrated a favorable safety profile with mostly mild or moderate adverse events. Significant changes were observed in neurofilament light chain, a marker of neurodegeneration. The 100mg dose showed particularly promising results, informing future dose selection. These findings suggest that CT1812's amyloid oligomer antagonism mechanism may have potential as a monotherapy or in combination with approved drugs for Alzheimer's and related dementias.
Cognition Therapeutics (NASDAQ: CGTX) will host an investor webcast on July 29, 2024, to discuss results from the Phase 2 SHINE study of CT1812 in mild-to-moderate Alzheimer's disease. The study enrolled 153 adults, randomized to receive 100mg or 300mg of CT1812 or placebo daily for six months. Clinical findings, safety, cognitive and functional endpoints will be presented at the Alzheimer's Association's International Conference in Philadelphia. Additional presentations will cover biomarker and proteomic analyses from CSF samples, and results of a meta-analysis from the SPARC study and SHINE-A participants. The webcast will feature company management, study investigator Dr. Everard Vijverberg, and Alzheimer's expert Dr. Martin J. Sadowski.
Cognition Therapeutics (NASDAQ: CGTX) announced that their Phase 2 SHINE study results for CT1812, a drug targeting mild-to-moderate Alzheimer’s disease, will be presented at the Alzheimer’s Association's International Conference (AAIC) in Philadelphia from July 28 to August 1, 2024.
The study's abstracts cover clinical efficacy, safety, and biomarker findings. Key abstracts include:
- Clinical efficacy results from the Phase 2 SHINE study (Abstract #89115).
- CSF phosphoproteomics biomarker analysis (Abstract #95147).
- Topline CSF biomarker outcomes (Abstract #95767).
- Exploratory CSF proteomics biomarker outcomes (Abstract #95770).
Cognition will also provide additional information about their Alzheimer’s disease program and CT1812 at booth #731 in the Exhibit Hall.
Cognition Therapeutics (NASDAQ: CGTX) released the eighth episode of its Conversations video podcast titled “Protecting the Synapse from Amyloid Toxicity in Alzheimer's Disease.” This episode explores how beta amyloid (Aβ) oligomers lead to synaptic dysfunction and cognitive decline. The podcast discusses recent research showing Aβ oligomers binding to synapses in Alzheimer's patients and how CT1812 can reverse this binding and reduce toxicity. Highlights include the use of quantitative EEG as a biomarker in the Phase 2 ‘SEQUEL’ study, which showed improvements in synaptic function and brain connectivity after four weeks of CT1812 treatment. Dr. Hamby presented proteomic analysis results demonstrating CT1812's positive effects on proteins and pathways linked to Alzheimer's. The discussion was moderated by Dr. Anthony Caggiano, featuring Dr. Mary Hamby, Dr. Everard Vijverberg, and Dr. Tara Spires-Jones.
Cognition Therapeutics, Inc. (Nasdaq: CGTX) reported financial results for Q1 2024 and provided business updates. They completed enrollment of 130 participants in the SHIMMER study for Alzheimer's and DLB, with topline results expected mid-2024. The company also raised $11.9 million in a public offering and presented research findings at conferences.
Financially, the company has $34.7 million in cash and $62.3 million in grant funds. Research and development expenses increased to $10.6 million, leading to a net loss of $9.2 million for the quarter.
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