Core Insights - Cognition Therapeutics, Inc. has completed a $30 million registered direct offering to support the next stage of development for its drug zervimesine (CT1812) [2][8] - The company has aligned with the U.S. FDA on a registrational path for zervimesine in Alzheimer's disease, which is seen as a significant achievement [2][8] - An ongoing expanded access program for zervimesine in dementia with Lewy bodies is in place [8] Financial Highlights - As of September 30, 2025, the company reported cash, cash equivalents, and restricted cash equivalents of approximately $39.8 million, with total obligated grant funds remaining from the National Institute of Aging at $36.3 million [4] - Research and development expenses for Q3 2025 were $3.8 million, a decrease from $11.4 million in Q3 2024, attributed to the completion of clinical trials [5] - General and administrative expenses were $2.6 million for Q3 2025, down from $3.1 million in Q3 2024, primarily due to reduced stock-based compensation [6] - The net loss for Q3 2025 was $4.9 million, or $(0.06) per share, compared to a net loss of $9.9 million, or $(0.25) per share, for the same period in 2024 [6][11] Business Developments - The company has surpassed 75% enrollment in the Phase 2 'START' study of zervimesine in early Alzheimer's disease, which is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium [8] - Clinical pharmacology and bioavailability studies are being executed to prepare zervimesine for the next stage of development across various indications [8] - The proposed registrational study design for Alzheimer's disease has been accepted for presentation at the Clinical Trials in Alzheimer's Disease (CTAD) Conference scheduled for December 1-4, 2025 [8]

Core Viewpoint - Cognition Therapeutics, Inc. (CGTX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Stock Ratings - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating system is beneficial for investors as it focuses on objective earnings estimate revisions rather than subjective analyst ratings [3][7]. Impact of Earnings Estimates on Stock Prices - Changes in a company's future earnings potential, reflected in earnings estimate revisions, are strongly correlated with near-term stock price movements [5]. - Rising earnings estimates and the upgrade for Cognition Therapeutics suggest an improvement in the company's underlying business, which could lead to higher stock prices [6]. Specifics on Cognition Therapeutics - For the fiscal year ending December 2025, Cognition Therapeutics is expected to earn -$0.40 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 1.2% over the past three months [9]. - The upgrade to Zacks Rank 2 places Cognition Therapeutics in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [11].

Industry Overview - Biotech and healthcare stocks are responding positively to clinical trial progress, regulatory developments, and economic indicators, particularly with the Federal Reserve's first rate cut of 2025, which is expected to improve funding conditions for capital-intensive sectors like biotechnology [1] Company Highlights - **Sonnet BioTherapeutics Holdings Inc. (SONN)**: Shares increased by 11.19% in after-hours trading, reaching $7.85 after a regular session close of $7.06. The stock has a 52-week range of $1.08 - $19.30. The company expanded clinical evaluation of its lead candidate, SON-1010, for ovarian cancer, reporting a strong safety profile and a partial response at the highest dose level [2][3] - **Akari Therapeutics Plc (AKTX)**: Shares surged 11.58% in after-hours trading to $0.8855 after closing at $0.7936. The stock has a 52-week range of $0.5710 - $3.8500. The increase follows a provisional patent filing for its antibody-drug conjugate platform aimed at cancer treatment, which is expected to enhance its intellectual property and support the development of first-in-class ADCs [4][5] - **Safety Shot Inc. (SHOT)**: Shares rose 9.75% in after-hours trading to $0.3333 after closing at $0.3037. The company announced a strategic refresh of its Board of Directors with three new members to strengthen its capabilities in digital assets and operations [6][7] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares climbed 10.09% in after-hours trading to $0.4451 after closing at $0.4043. The stock has a 52-week range of $0.3000 - $4.2800. The price movement follows a revised analyst rating maintaining a "Speculative Buy" while lowering the price target from $14.00 to $7.00. Reviva's lead candidate, brilaroxazine, is being developed for multiple neuropsychiatric and respiratory indications [8][9][10] - **Cognition Therapeutics Inc. (CGTX)**: Shares rose 7.48% in after-hours trading to $1.58 after closing down at $1.47. The company is focused on its lead candidate, Zervimesine, for Alzheimer's disease, and recently closed a $30 million offering to support its Phase 3 development [12][13]

Core Insights - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has reached 75% enrollment, targeting approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer's disease [1][2] - The study is evaluating the efficacy of zervimesine (CT1812) over 18 months, in collaboration with the Alzheimer's Clinical Trials Consortium and funded by the National Institute of Aging [1][4] Study Details - The START Study (NCT05531656) aims to assess the efficacy and tolerability of once-daily oral zervimesine in individuals with MCI or early Alzheimer's disease who have elevated Aβ levels [3] - Participants are randomized to receive either zervimesine or placebo, with cognitive and executive function measured using validated tools such as the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales [3] Funding and Support - The START Study is supported by an $81 million grant from the National Institute of Aging [4] - The study is conducted in collaboration with the Alzheimer's Clinical Trials Consortium, which includes 35 leading academic sites specializing in Alzheimer's clinical trials [4] Previous Studies - The SHINE Study, a Phase 2 trial, enrolled 153 adults with mild-to-moderate Alzheimer's disease and met its primary endpoints of safety and tolerability [5][6] - The SHINE Study demonstrated that zervimesine slows cognitive deterioration in patients with lower levels of p-tau217 [2] Product Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating CNS diseases like Alzheimer's and dementia with Lewy bodies [7] - The drug targets the toxic effects of protein buildup in the brain, potentially slowing disease progression and improving patient quality of life [7]

Core Viewpoint - Cognition Therapeutics, Inc. has successfully closed a registered direct offering of 14,700,000 shares of common stock at a price of $2.05 per share, raising approximately $30 million in gross proceeds to advance its drug zervimesine for neurodegenerative disorders [1][2]. Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6]. - The company has completed Phase 2 studies for its lead candidate, zervimesine (CT1812), targeting dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [6]. Product Information - Zervimesine (CT1812) is an investigational oral medication designed for the treatment of CNS diseases, specifically Alzheimer's disease and dementia with Lewy bodies [4]. - The drug aims to interrupt the toxic effects of Aβ and ɑ-synuclein proteins, which are associated with neurodegeneration, potentially slowing disease progression and improving patient quality of life [4]. Financial Details - The offering was facilitated by Titan Partners Group, which acted as the sole placement agent [2]. - The shares were offered under a shelf registration statement previously filed with the U.S. Securities and Exchange Commission, which was declared effective on January 3, 2023 [2].

Core Viewpoint - Cognition Therapeutics, Inc. has announced a registered direct offering of 14,700,000 shares of common stock, expected to generate approximately $30 million in gross proceeds to fund Phase 3 programs of zervimesine for neurodegenerative disorders and for general corporate purposes [1][2]. Group 1: Offering Details - The offering is made to two new fundamental institutional investors, including a prominent global investment manager [2]. - The closing of the offering is anticipated to occur on or about August 29, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the preparation of Phase 3 programs of zervimesine in neurodegenerative disorders, as well as for working capital and general corporate purposes [2]. Group 3: Company Background - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [5]. - The company has completed Phase 2 studies of zervimesine in conditions such as dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [5]. - The ongoing Phase 2 START study in early Alzheimer's disease is supported by $81 million in grant funding from the National Institute of Aging [5].

Core Points - Cognition Therapeutics, Inc. has regained compliance with Nasdaq's minimum share price requirement under Rule 5550(a)(2) [1][2] - The company achieved a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, with the requirement fulfilled on August 25, 2025 [2] - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for neurodegenerative disorders [3] Company Overview - Cognition Therapeutics is currently developing zervimesine (CT1812), targeting dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [3] - The Phase 2 START study in early Alzheimer's disease is ongoing, supported by $81 million in grants from the National Institute of Aging [3] - The mechanism of zervimesine involves interaction with the sigma-2 receptor, which is distinct from other treatment approaches for degenerative diseases [3]

Company Overview - Cognition Therapeutics (NASDAQ: CGTX) is advancing several clinical drug candidates, with a focus on zervimesine [CT1812] for treating patients [2]. Product Pipeline - The lead program under development is zervimesine [CT1812], which is being evaluated for its efficacy in treating specific patient populations [2]. Investment Insights - The Biotech Analysis Central service offers a comprehensive analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2].

Core Insights - Cognition Therapeutics received FDA confirmation on the design of its Phase 3 program for zervimesine (CT1812) as a treatment for Alzheimer's disease, which may support a New Drug Application (NDA) filing [1][4] - The Phase 3 program will focus on enrolling adults with mild-to-moderate Alzheimer's disease who have lower levels of p-tau217, a biomarker indicating potential treatment efficacy [2][3] - Zervimesine has demonstrated a 95% reduction in cognitive deterioration compared to placebo in previous studies, supporting its potential effectiveness in the targeted population [2][4] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for neurodegenerative disorders [9] - The company has completed Phase 2 studies for zervimesine in conditions such as dementia with Lewy bodies and mild-to-moderate Alzheimer's disease, with ongoing studies supported by significant grant funding [9][8] - Zervimesine is designed to interrupt the toxic effects of proteins associated with neurodegenerative diseases, potentially improving patient outcomes [5][9] Study Design and Strategy - The Phase 3 study will randomize participants to receive either 100mg of zervimesine or a placebo daily for six months, with efficacy and safety endpoints confirmed by the FDA [3][4] - The study will incorporate biomarker and imaging assessments to further support clinical outcomes, enhancing the robustness of the trial [3] - The FDA's agreement on the study design allows for faster and more cost-effective enrollment, expediting the regulatory filing process [4]

Executive Summary & Recent Developments [Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) Cognition Therapeutics reported Q2 2025 financial results, highlighting zervimesine's clinical progress in Alzheimer's, DLB, and dry AMD - The second quarter of 2025 was productive, with milestone achievements across all clinical programs[2](index=2&type=chunk) - Zervimesine shows promise in slowing the progression of age-related neurodegenerative diseases such as Alzheimer's, DLB, and dry AMD[2](index=2&type=chunk) [Business and Corporate Highlights](index=1&type=section&id=Business%20and%20Corporate%20Highlights) Cognition Therapeutics achieved key Q2 2025 milestones, advancing Alzheimer's, DLB, and dry AMD clinical programs, alongside regulatory and scientific activities [Alzheimer's Disease Program](index=1&type=section&id=Alzheimer's%20Disease%20Program) The company held an EOP2 meeting with the FDA for zervimesine's Alzheimer's registration plan and completed over **50%** patient enrollment in the Phase 2 'START' study - A productive End-of-Phase 2 (EOP2) meeting was held with the FDA regarding zervimesine (CT1812) Phase 2 'SHINE' study results in Alzheimer's disease[5](index=5&type=chunk) - Minutes from the FDA End-of-Phase 2 meeting on zervimesine's Alzheimer's disease registration plan are expected later this month[4](index=4&type=chunk) - Enrollment in the zervimesine early Alzheimer's disease Phase 2 study, in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC), has exceeded **50%**[1](index=1&type=chunk)[5](index=5&type=chunk) [Dementia with Lewy Bodies (DLB) Program](index=1&type=section&id=Dementia%20with%20Lewy%20Bodies%20(DLB)%20Program) Cognition launched an EAP for DLB patients, announced Phase 2 'SHIMMER' study results, and applied for zervimesine's Breakthrough Therapy Designation in DLB - An Expanded Access Program (EAP) for patients with Dementia with Lewy Bodies (DLB) has been initiated, with three clinical sites onboarded[1](index=1&type=chunk)[5](index=5&type=chunk) - Phase 2 'SHIMMER' study results for zervimesine in DLB were presented at the Alzheimer's Association International Conference (AAIC) in Toronto, Canada, on July 29[5](index=5&type=chunk) - A Breakthrough Therapy Designation application for zervimesine in DLB has been submitted to the FDA, with a decision anticipated in **Q3 2025**[4](index=4&type=chunk)[5](index=5&type=chunk) [Dry Age-Related Macular Degeneration (dry AMD) Program](index=1&type=section&id=Dry%20Age-Related%20Macular%20Degeneration%20(dry%20AMD)%20Program) The company announced positive Phase 2 dry AMD study results, showing a **28.6% reduction** in GA lesion growth, and submitted a manuscript on zervimesine's mechanism of action - Positive topline results from the Phase 2 dry AMD study reported a **28.6% reduction** in geographic atrophy (GA) lesion growth compared to placebo after 18 months of once-daily oral zervimesine[5](index=5&type=chunk) - A comprehensive manuscript describing zervimesine's proposed mechanism of action in treating dry AMD/GA has been submitted to a peer-reviewed journal[5](index=5&type=chunk) [Other Corporate Activities](index=1&type=section&id=Other%20Corporate%20Activities) The company received a philanthropic donation for the DLB EAP and continues to evaluate potential partnership options for zervimesine's development - A philanthropic donation was received to support the EAP for former Phase 2 'SHIMMER' participants and other DLB patients[5](index=5&type=chunk) - Evaluation of potential partnership options to support zervimesine's development continues[4](index=4&type=chunk) Financial Results [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Cognition Therapeutics reported a net loss of **$6.7 million** in Q2 2025, an improvement from **$7.0 million** in Q2 2024, driven by reduced R&D and G&A expenses Net Loss and Loss Per Share (Q2 2025 vs Q2 2024) | Indicator | Q2 2025 (Thousands of USD) | Q2 2024 (Thousands of USD) | | :----------------------- | :--------------------- | :--------------------- | | Net Loss | $(6,734) | $(7,041) | | Basic Loss Per Share | $(0.11) | $(0.18) | | Diluted Loss Per Share | $(0.11) | $(0.18) | Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (Thousands of USD) | Q2 2024 (Thousands of USD) | Year-over-Year Change (Thousands of USD) | Primary Drivers of Change | | :----------------------- | :--------------------- | :--------------------- | :--------------------------------------- | :------------------------------ | | Research and Development Expenses | $11,481 | $11,577 | $(96) | Decrease in professional services fees | | General and Administrative Expenses | $2,497 | $3,101 | $(604) | Decrease in stock-based compensation expense | Grant Revenue (Q2 2025 vs Q2 2024) | Indicator | Q2 2025 (Thousands of USD) | Q2 2024 (Thousands of USD) | | :----------- | :--------------------- | :--------------------- | | Grant Revenue | $7,106 | $7,311 | [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) As of June 30, 2025, Cognition Therapeutics held **$11.6 million** in cash, with existing funds and **$41.9 million** in NIA grants projected to support operations through **Q2 2026** Cash Position (As of June 30, 2025 vs December 31, 2024) | Indicator | As of June 30, 2025 (Thousands of USD) | As of December 31, 2024 (Thousands of USD) | | :-------------------------------------- | :----------------------------- | :------------------------------- | | Cash, Cash Equivalents, and Restricted Cash Equivalents | $11,557 | $25,009 | - Remaining committed grant funding from the National Institute on Aging (NIA) totals **$41.9 million**[6](index=6&type=chunk) - The company estimates its existing cash is sufficient to fund operations and capital expenditures through **Q2 2026**[6](index=6&type=chunk) Balance Sheet Data (As of June 30, 2025 vs December 31, 2024) | Indicator | As of June 30, 2025 (Thousands of USD) | As of December 31, 2024 (Thousands of USD) | | :------------------ | :----------------------------- | :------------------------------- | | Total Assets | $19,622 | $30,234 | | Total Liabilities | $12,593 | $11,484 | | Accumulated Deficit | $(190,374) | $(175,160) | | Total Stockholders' Equity | $7,029 | $18,750 | Company Overview [About Cognition Therapeutics](index=2&type=section&id=About%20Cognition%20Therapeutics) Cognition Therapeutics is a clinical-stage biopharmaceutical company developing small molecule therapeutics for age-related CNS neurodegenerative diseases, with zervimesine completing Phase 2 studies and an ongoing Phase 2 START study funded by an **$81 million** NIA grant - Cognition Therapeutics is a clinical-stage biopharmaceutical company dedicated to discovering and developing innovative small molecule therapeutics for age-related neurodegenerative diseases of the central nervous system[9](index=9&type=chunk) - The lead product candidate is zervimesine (CT1812), which has completed Phase 2 studies in Dementia with Lewy Bodies (DLB), mild-to-moderate Alzheimer's disease, and dry Age-related Macular Degeneration secondary to geographic atrophy[9](index=9&type=chunk) - The ongoing early Alzheimer's disease Phase 2 START study (NCT05531656) is funded by an **$81 million** grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH)[9](index=9&type=chunk) - Zervimesine modulates impaired pathways in these diseases by interacting with the sigma-2 receptor, offering a functionally distinct mechanism of action from other approaches to treating neurodegenerative diseases[9](index=9&type=chunk) Forward-Looking Statements [Disclaimer on Forward-Looking Information](index=2&type=section&id=Disclaimer%20on%20Forward-Looking%20Information) This press release contains forward-looking statements subject to known and unknown risks and uncertainties, where actual results may differ materially, and no public updates are planned unless legally required - This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, pertaining to cash flows, clinical studies of zervimesine (CT1812) and analysis of their results, anticipated or implied benefits or results of zervimesine, clinical development plans, and regulatory approval plans[10](index=10&type=chunk) - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements[10](index=10&type=chunk) - Factors that could cause actual results to differ materially from current expectations include competition, the ability to obtain and retain grant funding, the ability to successfully advance product candidates, the timing and likelihood of regulatory filings and approvals, changes in laws and regulations, economic factors, and intellectual property[10](index=10&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements contained in this press release unless required by applicable law[11](index=11&type=chunk)