COGNITION THERAPEUTICS INC

Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics for age-related degenerative diseases and disorders of the central nervous system (CNS) and retina ¹. The company's primary goal is to develop disease-modifying treatments for patients with these degenerative disorders, as currently available therapies are limited, with many diseases having no approved treatments ².

The core business model revolves around the development of its lead product candidate, zervimesine (CT1812), an orally delivered small molecule designed to protect neuronal synapses by preventing the binding of oligomers of pathogenic proteins like β-amyloid (Aβ) and α-synuclein ³. These protein oligomers are linked to the progression of degenerative diseases such as Alzheimer’s disease (AD) and dementia with Lewy bodies (DLB) ⁴. The company generates revenue primarily through non-dilutive grants, with cumulative grants awarded primarily by the National Institute of Aging (NIA) totaling approximately $171.0 million ⁵.

Zervimesine is being developed for multiple indications. For Alzheimer's Disease, the company has completed Phase 2 COG0201 (SHINE) and COG0202 (SEQUEL) studies, and Phase 1 COG0105 (SPARC) and COG0104 (SNAP) studies ⁶. Enrollment is ongoing in the COG0203 (START) Phase 2 study for Mild Cognitive Impairment (MCI) and early-stage AD, which has enrolled 545 participants ⁷. The SHINE study reported top-line results in July 2024, indicating that participants treated with zervimesine (pooled 100 mg and 300 mg) with baseline plasma p-tau217 levels below 1.0 pg/mL experienced a 95% reduction of cognitive decline at week 26 as measured by ADAS-Cog 11 relative to placebo ⁸. For Dementia with Lewy Bodies (DLB), the Phase 2 COG1201 (SHIMMER) clinical trial in 130 adults with mild-to-moderate DLB concluded in 2024, showing efficacy signals across symptom domains, with notable treatment effects in hallucinations and delusions ⁹. An Expanded Access Program (COG1202) for DLB participants, which enrolled 32 eligible individuals, concluded enrollment in December 2025 ¹⁰. The company also initiated the Phase 2 COG2201 (MAGNIFY) clinical study for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), which was voluntarily concluded in January 2025 after approximately 100 participants were enrolled, to focus resources on dementia programs ¹¹. Topline results from MAGNIFY showed zervimesine treatment slowed GA lesion growth rates by 29% compared to placebo, with a mean change in lesion area 28% less for zervimesine-treated participants ¹².

For the fiscal year ended December 31, 2025, the company reported a net loss of $23.487 million ¹³, an improvement from a net loss of $33.971 million in the prior year ¹⁴. Total operating expenses decreased to $47.799 million in 2025 from $53.966 million in 2024 ¹⁵. Research and development expenses were $37.187 million in 2025, down from $41.676 million in 2024 ¹⁶. General and administrative expenses were $10.612 million in 2025, compared to $12.290 million in 2024 ¹⁷. Grant income increased to $23.406 million in 2025 from $19.549 million in 2024 ¹⁸. Other income, net, was $0.919 million in 2025, compared to $0.666 million in 2024 ¹⁹. Interest expense was less than $0.1 million in both periods ²⁰. The company had cash, cash equivalents, and restricted cash equivalents of $37.0 million as of December 31, 2025 ²¹, and an accumulated deficit of $198.6 million ²². Net cash used in operating activities was $24.588 million in 2025, an improvement from $28.474 million in 2024 ²³. Net cash provided by financing activities was $36.570 million in 2025, up from $23.565 million in 2024 ²⁴.

Year-over-year, research and development expenses decreased by $4.489 million ²⁵, primarily due to a $2.542 million decrease in clinical programs related to decreased Phase 2 trial activities, a $1.917 million decrease in personnel costs, and a $0.364 million decrease in preclinical programs ²⁶. This was partially offset by a $0.302 million increase in manufacturing costs for clinical trial supply replenishment ²⁷. General and administrative expenses decreased by $1.678 million ²⁸, driven by a decrease in equity-based compensation, partially offset by an increase in professional fees ²⁹. Grant income increased by $3.857 million ³⁰, correlated with an increase in eligible reimbursable clinical trial costs and grant income from donations ³¹.

Significant operational developments during the period include the conclusion of enrollment in the COG0203 (START) Phase 2 study for MCI and early-stage AD in December 2025, with top-line results expected after all participants complete 18 months of treatment ³². In July 2025, an end-of-Phase 2 meeting with the FDA for the COG0201 (SHINE) study discussed proposed Phase 3 plans, with FDA concurring on randomizing participants to 100 mg of oral zervimesine or placebo daily for at least six months and enriching the study population with AD patients having lower plasma p-tau217 at screening ³³. The company also received scientific advice from the European Medicines Agency (EMA) indicating a preference for a longer trial than proposed ³⁴. The Phase 2 COG2201 (MAGNIFY) study for geographic atrophy was voluntarily concluded in January 2025 to focus resources on dementia programs ³⁵. In January 2026, the company conducted a Type C meeting with the FDA focusing on clinically meaningful endpoints for future DLB studies, and plans to develop zervimesine for DLB psychosis based on FDA feedback and Phase 2 results ³⁶. An expanded access program (COG1202) for DLB participants was initiated in June 2025 and fully enrolled 32 eligible participants by December 2025 ³⁷.

Management's current business plans indicate that existing cash, cash equivalents, restricted cash, and income from non-dilutive grants and donations, along with net proceeds from the March 2024 follow-on public offering and August 2025 registered direct offering, are expected to be sufficient to fund operating expenses and capital expenditures through the second quarter of 2027 ³⁸. This estimate assumes no usage from the $75.0 million available under the 2025 ATM ³⁹. The company expects to continue incurring significant and increasing expenses and net losses for the foreseeable future as it advances product candidates, seeks regulatory approval, expands its intellectual property portfolio, and hires additional personnel ⁴⁰.

A major growth area for the company is the continued clinical development of zervimesine in mild-to-moderate AD and earlier stages of the disease ⁴¹. The COG0203 (START) clinical trial in patients with mild dementia associated with early-stage AD is funded by an approximately $81 million grant from the NIA ⁴². The company plans to advance zervimesine for the treatment of DLB psychosis, based on efficacy signals observed in the 130-patient Phase 2 COG1201 (SHIMMER) study, which showed notable treatment effects in hallucinations and delusions ⁴³. Cognition is planning to meet with the FDA Division of Psychiatry to discuss a DLB psychosis program and align on study design ⁴⁴.

The company intends to expand its pipeline through internal development, in-licensing, and acquisitions, leveraging its expertise in drug development and business development to evaluate additional product candidates and bring forward novel chemical matter using proprietary molecule generation and screening strategies ⁴⁵. This may involve selective in-licensing arrangements, strategic collaborations, and partnerships ⁴⁶. The company currently retains all worldwide rights to zervimesine for all indications and plans to develop and pursue approval in major markets, potentially using strategic collaborations or partnerships to accelerate development and maximize commercial potential ⁴⁷. Management believes zervimesine can also be used in combination with other therapeutics, offering partnering opportunities ⁴⁸.

Operationally, the company expects research and development expenses to increase substantially for the foreseeable future as product candidates advance into later stages of development, larger clinical trials are conducted, regulatory approvals are sought, the product pipeline expands, and intellectual property is maintained and enforced ⁴⁹. The company also anticipates increased expenses associated with hiring additional personnel to support these efforts ⁵⁰. The company's manufacturing strategy involves overseeing and managing third-party contract manufacturing organizations for clinical trial supplies and, if marketing approval is received, for commercial demand ⁵¹. This strategy aims to maintain an efficient infrastructure by avoiding investment in proprietary manufacturing facilities ⁵². The company relies on a single third-party contract manufacturer for zervimesine drug substance and another for clinical trial supplies, with plans to transition to a larger third-party manufacturer for late-stage clinical and commercial supply ⁵³.

Planned capital allocation includes continued pursuit of non-dilutive funding opportunities, with approximately $171 million in cumulative grants awarded primarily by the NIA to date ⁵⁴. As of December 31, 2025, approximately $35.7 million was available from NIA funds for future applicable expenses ⁵⁵. The company also has access to up to $75.0 million in common stock sales through an at-the-market (ATM) offering program with Jefferies LLC, established in December 2025, though no shares were sold under this program as of December 31, 2025 ⁵⁶. The Lincoln Park Purchase Agreement, which provided for the right to sell up to $35.0 million of common stock, expired on March 10, 2026, with $34.8 million available to draw as of December 31, 2025 ⁵⁷.

Management explicitly flagged several structural headwinds and execution risks to the growth plan. These include the need for substantial additional capital to meet future financial obligations and pursue business objectives, with the risk of being forced to curtail planned operations if unable to raise capital ⁵⁸. The company's reliance on non-dilutive grants carries the risk of failing to continue receiving such funding or being subject to audits and repayment obligations ⁵⁹. The inherent uncertainty and expense of preclinical and clinical development, with no guarantee of successful completion or favorable results in future clinical trials, is a significant risk ⁶⁰. The company has no history of commercializing products, which makes assessing future viability difficult ⁶¹. There is also a risk that the market opportunities for zervimesine, if approved, may be smaller than anticipated ⁶².

Geographic, regulatory, and macro factors identified as constraints include the potential for changes in funding for, or disruptions to the staffing and operations of the FDA and other government agencies, which could hinder timely product development and approval ⁶³. The company conducts clinical trials outside the United States, and there is no assurance that the FDA or comparable foreign regulatory authorities will accept data from such trials ⁶⁴. Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost of obtaining marketing approval and commercializing product candidates ⁶⁵. The Inflation Reduction Act of 2022 and other drug pricing proposals could limit sales and increase costs ⁶⁶. Adverse developments affecting the financial services industry, including liquidity constraints or failures, could impair the company's access to funding ⁶⁷.

The company faces material risks including the need for substantial additional capital to fund operations, with existing cash and grants projected to last only through the second quarter of 2027 ⁶⁸. Failure to raise additional capital could force curtailment of planned operations and growth strategy ⁶⁹. The business is heavily dependent on the successful development, regulatory approval, and commercialization of zervimesine, which is still in clinical development, and may never receive approval or be successfully commercialized ⁷⁰. Preclinical and clinical development is lengthy, expensive, and uncertain, with no guarantee that current or future clinical trials will be successful or that results will be predictive of future outcomes ⁷¹. The company has not conducted pivotal clinical trials and may be unable to do so for any product candidates ⁷². Undesirable and unforeseen side effects from product candidates could halt clinical development, delay or prevent regulatory approval, or limit commercial potential ⁷³. The market opportunities for zervimesine, if approved, may be smaller than anticipated ⁷⁴. Reliance on single third-party suppliers for manufacturing creates risks of supply disruption, quality control problems, or failure to comply with regulatory requirements ⁷⁵. The company faces significant competition from companies with greater financial resources and expertise, potentially leading to competitors achieving regulatory approval sooner or developing superior therapies ⁷⁶. Changes in healthcare legislation, including unfavorable pricing regulations or reform initiatives like the Inflation Reduction Act of 2022, could increase costs and limit market access ⁷⁷. Cybersecurity threats, including phishing attacks, and data breaches pose risks to information technology systems, confidential information, and clinical trial data, potentially leading to legal claims, financial loss, and reputational harm ⁷⁸. Compliance with evolving health and data protection laws, such as GDPR and state privacy laws, could lead to government enforcement actions, civil or criminal penalties, and private litigation ⁷⁹. The use of new technologies like artificial intelligence may introduce intellectual property risks, increased regulatory burdens, and security challenges ⁸⁰.

Management's message to shareholders emphasizes the company's focus as a clinical-stage biopharmaceutical company dedicated to developing innovative, small molecule therapeutics for age-related degenerative diseases of the CNS and retina, with a primary objective to develop its lead product candidate, zervimesine ⁸¹. They highlight the significant unmet medical needs in diseases like Alzheimer's disease and dementia with Lewy bodies, where currently available therapies are limited ⁸². Management explicitly states that, based on current business plans, existing cash, cash equivalents, restricted cash, and income from non-dilutive grants and donations, along with net proceeds from the March 2024 follow-on public offering and August 2025 registered direct offering, are expected to fund operating expenses and capital expenditures through the second quarter of 2027 ⁸³. The three strategic priorities emphasized for the period ahead are: advancing clinical development of zervimesine in mild-to-moderate AD and earlier stages of the disease, prioritizing the development of zervimesine for DLB psychosis, and expanding the pipeline through internal development, in-licensing, and acquisitions ⁸⁴. They also stress the importance of optimizing the value of zervimesine in major markets and continuing to pursue non-dilutive funding opportunities ⁸⁵.