σ2 receptor

Topline Results from SHINE Study in Mild-to-Moderate Alzheimer’s Expected mid-2024 On Track to Report Topline Results from SHIMMER Study in Mild-to-Moderate DLB in 2H 2024 1Q 2024 Capital Raise Extends Cash Runway Through May 2025 Webcast Conference Call Scheduled Today at 8:00 a.m. ET PURCHASE, N.Y., March 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update. Management will host a live webcast conference call at 8:00am ET to review 2023 accomplishments. Details of the call are provided below. A number of important clinical milestones were achieved in 2023, including the completion of enrollment in the Company’s Phase 2 SHINE Study in people with mild-to-moderate Alzheimer’s disease. In addition, the company initiated clinical studies in early Alzheimer’s disease and dry age-related macular degeneration (dry AMD). Cognition scientists published two manuscripts and made 11 presentations at medical and scientific congresses in 2023, advancing the understanding of its foundational science and clinical implications. “We achieved a number of critical clinical objectives in 2023,” said Lisa Ricciardi, Cognition’s president and CEO. “We are pleased with the progress being made with our clinical trial partners to advance our Phase 2 studies. In addition, the scientific data generated by our team has continued to provide insights into proteins and biological processes impacted by CT1812 in Alzheimer’s and Parkinson's diseases as well as dry AMD.” 2023 Corporate and Clinical Highlights: Completed enrollment of 153 adults in the Phase 2 SHINE Study of CT1812 in mild-to-moderate Alzheimer’s disease; topline results expected mid-2024 Continued enrollment in the Phase 2 SHIMMER Study in mild-to-moderate dementia with Lewy bodies (DLB); topline results expected in 2H2024 Initiated site activation and recruitment in Phase 2 START Study in early Alzheimer’s disease and Phase 2 MAGNIFY Study in geographic atrophy secondary to dry AMD Completed Phase 2 SEQUEL Study; reported quantitative electroencephalogram (qEEG) results at Clinical Trials in Alzheimer's Disease congress Published manuscripts that provide an extensive review of sigma-2 receptor biology in the International Journal of Molecular Science Published results from the Phase 1b SNAP Study of CT1812, which measured target engagement in the journal, Translational Neurodegeneration Presented extensive research at scientific and medical congresses from our proteomics research elucidating the pathways involved in sigma-2 receptor modulation in Alzheimer’s and Parkinson’s diseases and dry AMD Appointed John Doyle to the role of chief financial officer “The FDA approval in 2023 of the first disease-modifying biologics for Alzheimer’s disease was a much-needed advance for the development of new drugs to treat Alzheimer’s and other neurological conditions,” said Ms. Ricciardi. “The approval confirmed the role of Aβ oligomers and protofibrils as disease drivers, re-invigorated research into complementary therapeutic approaches, and re-established investment interest in the sector. Building on this momentum, Cognition looks forward to two key milestones in 2024, namely the topline readout from two Phase 2 studies: SHINE in mild-to-moderate Alzheimer's disease and SHIMMER in mild-to-moderate DLB. In addition to cognitive findings, samples from study participants will be analyzed with an expectation that candidate biomarkers of CT1812 activity can be identified. We expect these clinical and biomarker results will inform the next phase of our evolution.” Recent 2024 Financing In March 2024, the Company issued and sold 6,571,428 shares of its common stock in an underwritten follow-on public offering, at $1.75 per share. The Company received net proceeds of approximately $10.4 million after deducting underwriting discounts and commissions and estimated offering expenses. 2023 Financial Results Cash and cash equivalents as of December 31, 2023, were approximately $29.9 million, and total grant funds remaining from the NIA were $67.5 million. With the additional capital from the March 2024 offering, the Company estimates that it has sufficient cash to fund operations and capital expenditures through May of 2025. Research and development expenses were $37.2 million for the year ended December 31, 2023, compared to $30.3 million for 2022. The increase was primarily related to higher costs associated with Phase 2 trial activities with contract research organizations, personnel, and preclinical research, partially offset by decreased manufacturing costs. General and administrative expenses were $13.5 million for the year ended December 31, 2023, compared to $13.2 million for 2022. The increase was primarily related to higher employee compensation and benefits driven by increased headcount and equity-based compensation, partially offset by decreased Director & Officer Liability insurance and other expenses. The Company reported a net loss of $25.8 million, or $(0.86) per basic and diluted share for the year ended December 31, 2023, compared to a net loss of $21.4 million, or $(0.91) per basic and diluted share for 2022. Conference Call Information Management will host a conference call and live webcast to discuss Cognition’s financial results today at 8:00 a.m. ET. To participate in the conference call, dial (800) 715-9871 (U.S.) or (646) 307-1963 (international) and provide conference ID number 6295507. Alternatively, you may connect to the live webcast via this link: or by visiting the Investor Relations page of the Cognition website at . An archived webcast recording will be available approximately one hour after the conclusion of the live call. About Cognition Therapeutics: Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials, and cash runway, involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data and pre-clinical studies being predictive of the results of clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks and uncertainties described in the “Risk Factors” section of our annual and quarterly reports filed the Securities Exchange Commission. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Cognition Therapeutics, Inc. Unaudited Selected Financial Data (in thousands, except share and per share data) For the Year Ended December 31, Consolidated Statements of Operations Data: 2023 2022 Operating Expenses: Research and development $ 37,196 $ 30,324 General and administrative 13,528 13,227 Total operating expenses 50,724 43,551 Loss from operations (50,724 ) (43,551 ) Other income (expense): Grant income 24,805 22,217 Other income (expense), net 158 (35 ) Interest expense (27 ) (28 ) Total other income, net 24,936 22,154 Net loss $ (25,788 ) $ (21,397 ) Unrealized gain (loss) on foreign currency translation 4 (1 ) Total comprehensive loss $ (25,784 ) $ (21,398 ) Net loss per share: Basic $ (0.86 ) $ (0.91 ) Diluted $ (0.86 ) $ (0.91 ) Weighted-average common shares outstanding: Basic 30,029,087 23,640,199 Diluted 30,029,087 23,640,199 As of (in thousands) December 31, 2023 December 31, 2022 Consolidated Balance Sheet Data: Cash and cash equivalents $ 29,922 $ 41,562 Total assets 35,163 50,425 Total liabilities 10,689 10,176 Accumulated deficit (141,189 ) (115,401 ) Total stockholders’ equity 24,474 40,249 Contact Information: Cognition Therapeutics, Inc. info@cogrx.com Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@tiberend.com Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com

PITTSBURGH, March 06, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics Inc. (NASDAQ: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), is presenting results of proteomic and correlation analyses of two completed clinical studies at the AD/PD™ 2024 Alzheimer's & Parkinson's Diseases Conference (March 5-9, 2024 in Lisbon, Portugal). The three posters, which are listed below, summarize proteomic analyses from the completed SEQUEL and SPARC studies, which were conducted in adults with mild-to-moderate Alzheimer’s disease. VIRTUAL Identification of New Pharmacodynamic Biomarkers of CT1812 that Correlate with Favorable Functional Connectivity of the Brain Di Caro V, Pandey K, Cho E, Duong D, de Haan W, Grundman M, Seyfried N, Caggiano AO, Vijverberg EG, Hamby ME. (e-Poster) MARCH 6-7 Analysis of CSF Samples from a Phase 2 Clinical Trial in Alzheimer’s Patients Show that CT1812 can Modulate α-synuclein Di Caro V, Pandey K, Duong D, Seyfried N, Grundman M, Vijverberg EG, Caggiano AO, Teunissen C, Hamby ME. (Poster shift 1 – 0164) MARCH 8-9 Plasma Proteomic Analysis from Alzheimer's Patients in SPARC Clinical Trial to Identify Pharmacodynamic Biomarkers of the S2R Modulator CT1812 Lizama B, Duong D, Pandey K, Di Caro V, Mecca A, O’Dell R, van Dyck C, Grundman M, Caggiano AO, Seyfried N, Hamby ME. (Poster shift 2 – 0140) Two posters summarize proteomic analyses from the Phase 2 SEQUEL study which measured the impact of CT1812 on synapse function as determined by changes in brain wave patterns recorded by quantitative electroencephalogram (EEG). These posters identify candidate protein biomarkers that correlate with improvements observed in SEQUEL participants treated with CT1812, Cognition’s lead candidate. Among the proteins identified, those that were strongly correlated with CT1812 treatment effects were associated with protein trafficking, autophagy, neuroinflammation and microglial response. The third poster summarizes proteomic analyses from the Phase 1 SPARC study, which was designed to measure the impact of CT1812 on synaptic density. Pathways identified in these proteomic analyses support a role for CT1812 in modulating Aβ biology and neuroinflammation, among other disease-relevant processes. “Analyses of CSF samples from these studies build on our efforts to identify candidate biomarkers of CT1812 treatment effect,” explained Mary Hamby, Ph.D., VP of research at Cognition Therapeutics. “These results are consistent with published evidence that the normalization of aberrant pathways can protect neurons from toxic disease drivers. Further, we believe they support our understanding of CT1812’s mechanism of action. We look forward to analyzing samples from our SHINE study in 153 people with Alzheimer's disease so that we can build a more robust set of biomarkers of CT1812 treatment.” The posters will be available on the AD/PD™ 2024 virtual conference platform for up to 6 months for registered delegates. Following the conclusion of the conference, the posters will be made available on our website on the Publications webpage. About CT1812 CT1812 is an experimental orally delivered small molecule that penetrates the blood-brain barrier and binds selectively to the sigma-2 (σ-2) receptor complex. Preclinical and clinical data demonstrate that this binding results in the displacement of toxic Aβ oligomers. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression. About Cognition Therapeutics, Inc. Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including CT1812, and any expected or implied benefits or results, including that initial clinical results observed with respect to CT1812 will be replicated in later trials and our clinical development plans, including statements regarding our Phase 2 SEQUEL and Phase 1b SPARC studies of CT1812 and any analysis of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials, involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data and pre-clinical studies being predictive of the results of later stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks and uncertainties described in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at These risks are not exhaustive, and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information: Cognition Therapeutics, Inc. info@cogrx.com Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@tiberend.com Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com

The FDA has declined to approve Minerva Neurosciences' roluperidone (MIN-101) to treat negative symptoms in patients with schizophrenia. In its complete response letter (CRL), the agency cited a number of clinical deficiencies and called for Minerva to conduct at least one more study before it would reconsider the drug for approval."We are disappointed… and will request a meeting to discuss the issues raised and attempt to address FDA's feedback," said CEO Remy Luthringer in a statement Tuesday. Company shares toppled 59% on the news.Back-to-back RTF lettersThis marks the latest roadblock in Minerva's quest to get the US regulator to sign off on the 5-HT2A and σ₂ receptor antagonist. It had previously run into challenges getting the FDA to even agree to review the application, receiving a refusal-to-file letter in October 2022 that was upheld that December. The biotech succeeded in appealing early last year, allowing the application to move forward with an FDA review.While positive symptoms of schizophrenia are generally well managed with antipsychotics, Minerva says negative symptoms – characterised by blunted affect, alogia, avolition, anhedonia and asociality – are often the main burden of illness, and can impact a patient's quality-of-life.The company's original filing contained results from two studies in patients with moderate-to-severe negative symptoms and stable positive symptoms of schizophrenia. Roluperidone significantly reduced negative symptoms in the Phase IIb MIN-101C03 trial, but "marginally" missed the bar in the primary analysis for the Phase III MIN-101C07 study.However, Minerva did highlight a "nominal statistically significant improvement" with roluperidone in a modified patient population of the Phase III study once "implausible results" from one of the clinical trial sites had been excluded.Combo routeStill, the FDA said that having only one study demonstrating statistical significance on the primary efficacy endpoint "is insufficient on its own to establish substantial evidence of effectiveness." The FDA submission also lacked data on concurrent use of antipsychotics and on the clinical significance of negative symptom improvement. Moreover, the safety data submitted didn't have enough people who took the recommended 64mg dose of roluperidone for at least a year.While the CRL was not unexpected, H.C. Wainwright analysts noted that Minerva might now be considering going the combination route. It recently started evaluating the potential of roluperidone with olanzapine for adults with moderate-to-severe negative symptoms of schizophrenia. The company is expected to report results in the first quarter."Recall, privately-held Boehringer Ingelheim, which owns ~18% of Minerva, invested in Minerva through a $20-million PIPE in 2Q23, indicating Boehringer recognised roluperidone's commercial potential and was well aware of the FDA's concerns about the existing data package," the analysts said. "We think Boehringer's investment in Minerva reflects interest in acquiring the company outright and is a potential outcome, perhaps likely outcome, if FDA issues a CRL as we expect."