Cognition Therapeutics, Inc. (NASDAQ: CGTX) has successfully closed a $30 million registered direct offering to advance its lead candidate zervimesine (CT1812) for the treatment of neurodegenerative disorders. The clinical-stage biopharmaceutical company issued 14,700,000 shares of common stock at $2.05 per share to two new fundamental institutional investors, including what the company describes as a preeminent global investment firm.
"We believe that this level of support from leading institutional investors validates our efforts and the positive data we have generated to date in three major age-related degenerative disorders," stated Lisa Ricciardi, president and CEO of Cognition Therapeutics. "With this additional capital, we look forward to advancing zervimesine for the treatment of serious neurodegenerative disorders."
Novel Mechanism Targeting Multiple Neurodegenerative Conditions
Zervimesine represents a potentially breakthrough approach to treating central nervous system diseases, particularly Alzheimer's disease and dementia with Lewy bodies (DLB). The investigational oral, once-daily pill targets the underlying pathology of these conditions by interrupting the toxic effects of amyloid-beta (Aβ) and α-synuclein proteins that accumulate in the brain.
These protein buildups bind to receptors on neuron surfaces, causing progressive damage and ultimately destroying brain cells. This neuronal destruction leads to the characteristic symptoms of these diseases: progressive loss of learning ability, memory recall, motor function, and communication skills. Both conditions progress relentlessly and ultimately result in death.
The drug's mechanism of action centers on its interaction with the sigma-2 receptor, which the company believes can regulate pathways impaired in these degenerative diseases. This approach is functionally distinct from other treatment strategies currently being pursued for neurodegenerative disorders.
Comprehensive Clinical Development Program
Cognition Therapeutics has built an extensive clinical portfolio around zervimesine, having recently completed Phase 2 studies across multiple indications. The company has evaluated the drug in dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry age-related macular degeneration (AMD).
Currently, the company is conducting the Phase 2 START study (NCT05531656) in early Alzheimer's disease, which has received substantial backing from the National Institute of Aging (NIA) at the National Institutes of Health with $81 million in grant support. This significant federal funding underscores the potential importance of the research and the unmet medical need in early-stage Alzheimer's treatment.
Clinical studies conducted to date have shown that zervimesine has been generally well tolerated, an important safety consideration for a drug intended to treat chronic, progressive conditions requiring long-term administration.
Regulatory Recognition and Market Position
The United States Adopted Name (USAN) Council has officially adopted "zervimesine" as the USAN for CT1812, providing the drug with its standardized nomenclature for regulatory and clinical use. This designation represents an important milestone in the drug's development pathway.
Titan Partners Group, a division of American Capital Partners, served as the sole placement agent for the offering. The transaction was conducted under a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission and declared effective on January 3, 2023.
The successful fundraising positions Cognition Therapeutics to advance zervimesine through the next critical phase of clinical development, potentially bringing a novel therapeutic approach closer to patients suffering from devastating neurodegenerative conditions that currently have limited treatment options.
