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About Cognition Therapeutics Inc.
Cognition Therapeutics Inc. (NASDAQ: CGTX) is a clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative small-molecule therapeutics targeting age-related degenerative disorders of the central nervous system (CNS) and retina. Founded in 2007 and headquartered in Pittsburgh, Pennsylvania, the company leverages proprietary biology and chemistry platforms to address unmet medical needs in neurodegenerative diseases.
Core Focus and Pipeline
The company’s lead candidate, zervimesine (formerly CT1812), is an orally administered small molecule designed to penetrate the blood-brain barrier and selectively bind to the sigma-2 (σ-2) receptor complex. This novel mechanism aims to displace toxic oligomers of amyloid beta (Aβ) and α-synuclein, which are implicated in the progression of Alzheimer’s disease (AD) and dementia with Lewy bodies (DLB). By protecting synapses and restoring cellular function, zervimesine offers a potentially disease-modifying approach distinct from symptomatic treatments.
Cognition Therapeutics is advancing zervimesine through multiple clinical programs:
- Alzheimer’s Disease: The Phase 2 SHINE study demonstrated a 95% reduction in cognitive decline in a biomarker-defined subgroup.
- Dementia with Lewy Bodies (DLB): The SHIMMER Phase 2 trial showed significant improvements across behavioral, cognitive, and motor symptoms, with a favorable safety profile.
- Dry Age-Related Macular Degeneration (dry AMD): The MAGNIFY study explores zervimesine’s potential in slowing lesion growth and addressing retinal degeneration.
Innovative Mechanism of Action
The sigma-2 receptor complex, targeted by zervimesine, regulates key cellular processes such as membrane trafficking and autophagy. These processes are disrupted in neurodegenerative conditions due to toxic protein interactions and oxidative stress. By modulating this receptor, zervimesine aims to normalize synaptic function, protect neurons, and slow disease progression. This mechanism is functionally distinct from other approaches, such as anti-amyloid immunotherapies, positioning Cognition Therapeutics as a pioneer in sigma-2 receptor modulation.
Clinical and Industry Impact
With a strong focus on CNS disorders, Cognition Therapeutics addresses significant unmet needs in Alzheimer’s disease and DLB, which collectively affect millions worldwide. The company’s approach aligns with the growing demand for disease-modifying therapies that go beyond symptomatic relief. Its clinical programs are supported by substantial grant funding from the National Institute on Aging (NIA) and partnerships with leading research institutions.
Challenges and Opportunities
As a clinical-stage company, Cognition Therapeutics faces challenges typical of the biopharmaceutical industry, including high R&D costs, regulatory complexities, and competition from established players. However, its differentiated sigma-2 receptor approach and promising early-phase results provide a strong foundation for future growth. The company’s ability to secure additional funding and advance its pipeline into late-stage trials will be critical to its success.
Conclusion
Cognition Therapeutics Inc. represents a compelling player in the biopharmaceutical sector, leveraging innovative science to address the urgent need for disease-modifying therapies in neurodegenerative disorders. With its lead candidate zervimesine showing promising clinical results, the company is well-positioned to make a meaningful impact on the lives of patients and caregivers affected by Alzheimer’s disease, DLB, and other age-related conditions.
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.
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.
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