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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 (NASDAQ: CGTX) announced positive topline results from its Phase 2 'SHIMMER' study of CT1812 in dementia with Lewy bodies (DLB). The study, which enrolled 130 patients with mild-to-moderate DLB, met its primary endpoint of safety and tolerability.
Key findings include:
- 82% slowing in total neuropsychiatric inventory with strong reduction in anxiety, hallucinations, and delusions
- Marked reduction in caregiver distress
- 91% decline in fluctuations in attention
- Improvements across behavioral, functional, cognitive, and movement measures
The company plans to advance CT1812 into late-stage trials, with detailed data to be presented at the International Lewy Body Dementia Conference in January 2025.
Cognition Therapeutics (NASDAQ: CGTX) announced the completion of final patient visits in their Phase 2 SHIMMER study evaluating CT1812 for mild-to-moderate dementia with Lewy bodies (DLB). The company expects to report topline results in December 2024. The study was conducted in partnership with the National Institute of Aging and the Lewy Body Dementia Association. The trial aims to assess CT1812's tolerability profile and identify efficacy signals in cognition and function measures for DLB patients.
Cognition Therapeutics (NASDAQ: CGTX) reported new biomarker analysis from their Phase 2 'SHINE' study in mild-to-moderate Alzheimer's disease. The analysis revealed that patients with lower baseline plasma p-tau217 levels treated with CT1812 showed a 95% reduction in cognitive decline compared to placebo, representing a 2.7-point improvement on ADAS-Cog11 over six months. The study demonstrated normalization of key Alzheimer's disease indicators, including reductions in GFAP (neuroinflammatory biomarker), NfL (neurodegenerative biomarker), and impacts on amyloid biology through reductions in Aβ42 and Aβ40 proteins. The company plans to present complete biomarker results at scientific conferences in 2025.
Cognition Therapeutics (NASDAQ: CGTX) reported significant results from its Phase 2 SHINE study, showing CT1812 slowed cognitive decline by 95% in Alzheimer's patients with lower p-tau217 levels. The company expects to report topline results from Phase 2 SHIMMER study in DLB patients by end of 2024. Financial results show cash position of $22.0 million as of September 30, 2024, with additional $53.6 million in NIA grant funds. Q3 2024 resulted in a net loss of $9.9 million, or $(0.25) per share, compared to $6.7 million loss in Q3 2023. R&D expenses were $11.4 million, slightly down from $11.7 million in the previous year.
Cognition Therapeutics (NASDAQ: CGTX) announced that CEO Lisa Ricciardi will present at the virtual Zacks SCR Life Sciences Investor Forum on November 14, 2024, at 11:00 a.m. ET. The presentation will highlight results from the successful Phase 2 'SHINE' study of CT1812 in Alzheimer's disease and provide updates on ongoing clinical programs, including the Phase 2 'SHIMMER' study in dementia with Lewy bodies. Topline results from 'SHIMMER' are expected by year-end 2024.
The live, interactive event will allow real-time Q&A with management. An archived webcast will be available on Cognition's Investor Relations webpage for those unable to attend live. Pre-registration is recommended for interested investors.
Cognition Therapeutics (NASDAQ: CGTX) presented baseline characteristics of participants in their Phase 2 'SHIMMER' study for dementia with Lewy bodies (DLB) at the CTAD conference. The study includes 130 participants with these key characteristics: mean age of 72.8 years, 81.5% male, 91.5% white, with mild-to-moderate cognitive impairment. Participants showed mean scores of 24.0 for MMSE, 18.4 for MoCA, and various other clinical measurements indicating mild movement impairment and attention fluctuations consistent with DLB diagnosis. The company expects to announce study results later this year.
Cognition Therapeutics (NASDAQ: CGTX) presented promising results from their Phase 2 SHINE study of CT1812 in Alzheimer's disease patients at the CTAD conference. The study demonstrated significant cognitive benefits in patients with lower plasma p-tau217 levels, showing a 95% slowing of cognitive decline measured by ADAS-Cog 11 and a 108% slowing measured by MMSE. These results were observed in participants treated with CT1812 (pooled 100mg and 300mg doses).
Dr. Michael Woodward, presenting at CTAD, highlighted that these findings align with anti-amyloid immunotherapeutics' effectiveness in people with low p-tau. The company plans to discuss potential Phase 3 approaches with the FDA in an end-of-Phase 2 meeting.
Cognition Therapeutics (NASDAQ: CGTX) announced that Dr. Michael Woodward will present analyses from the Phase 2 'SHINE' trial of CT1812 in mild-to-moderate Alzheimer's disease at the CTAD conference in Madrid. The company reports positive results from the trial, highlighting consistent efficacy signals in patients treated with CT1812 for six months and a favorable tolerability profile. Additionally, the company will present baseline characteristics from the Phase 2 'SHIMMER' trial in DLB patients, focusing on symptoms like cognitive and movement impairment, fluctuating attention, and sleep disorder.
Cognition Therapeutics (NASDAQ: CGTX) has released a new episode of its "Conversations" video podcast titled "Executing Clinical Research in Dementia with Lewy Bodies (DLB)" during DLB Awareness Month. The episode features a panel of experts discussing:
- Similarities and differences between DLB and Alzheimer's disease
- Unique symptoms experienced by DLB patients
- Design of the SHIMMER study of CT1812 in mild-to-moderate DLB
- Importance of identifying clinical and functional benefit signals in DLB, which currently lacks approved disease-modifying therapies
The podcast is moderated by Cognition's CMO, Dr. Anthony Caggiano, and includes three leading experts in the field. It is available on the Cognition website under the Conversations tab, presented in three chapters covering comparisons between Alzheimer's and DLB, SHIMMER study design, and metrics for success in signal-finding studies.
Cognition Therapeutics (NASDAQ: CGTX), a clinical-stage company developing drugs for neurodegenerative disorders, announced its participation in the 3rd Annual Roth Healthcare Opportunities Conference on October 9, 2024. The company's president and CEO, Lisa Ricciardi, will take part in a panel discussion titled Frontiers in Neuroscience.
Additionally, Ms. Ricciardi will host one-on-one investor meetings to discuss recent achievements and clinical development plans for CT1812, Cognition's lead candidate for treating Alzheimer's disease, dementia with Lewy bodies, and dry age-related macular degeneration. Interested investors can register for the conference through their Roth Capital Partners' sales representative.
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