Cognition Therapeutics(CGTX) - 2023 Q4 - Annual Results

Press Release Overview This section summarizes Cognition Therapeutics' 2023 financial results, key clinical milestones, anticipated 2024 topline study results, and recent capital raise Summary of Key Announcements This section introduces Cognition Therapeutics' year-end 2023 financial results and business updates, highlighting key clinical milestones achieved in 2023 and anticipated topline results for Phase 2 studies in 2024, also noting the recent capital raise extending the cash runway - Topline results from SHINE Study in mild-to-moderate Alzheimer's disease expected mid-2024[13] - Topline results from SHIMMER Study in mild-to-moderate dementia with Lewy bodies (DLB) expected in 2H 2024[13] - Q1 2024 capital raise extends cash runway through May 2025[13] Business Update This section provides an overview of Cognition Therapeutics, detailing its 2023 corporate and clinical achievements and outlining key milestones and outlook for 2024 About Cognition Therapeutics Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina, with its lead candidate CT1812 targeting Alzheimer's, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD) by modulating the σ-2 receptor - Clinical-stage biopharmaceutical company developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina[6] - Lead candidate CT1812 is being investigated in clinical programs for Alzheimer's disease, dementia with Lewy bodies (DLB), and dry age-related macular degeneration (dry AMD)[6] - CT1812 and pipeline of σ-2 receptor modulators aim to regulate pathways impaired in these diseases, representing a distinct mechanism from other current approaches[6] 2023 Corporate and Clinical Highlights In 2023, Cognition Therapeutics achieved significant clinical milestones, including completing enrollment for the Phase 2 SHINE Study in Alzheimer's, initiating new Phase 2 studies for early Alzheimer's and dry AMD, and publishing key scientific research, alongside presenting at medical congresses - Completed enrollment of 153 adults in the Phase 2 SHINE Study of CT1812 in mild-to-moderate Alzheimer's disease[15] - Continued enrollment in the Phase 2 SHIMMER Study in mild-to-moderate dementia with Lewy bodies (DLB)[15] - Initiated site activation and recruitment in Phase 2 START Study (early Alzheimer's disease) and Phase 2 MAGNIFY Study (geographic atrophy secondary to dry AMD)[15] - Published two manuscripts and made 11 presentations at medical and scientific congresses, advancing understanding of foundational science and clinical implications[14][15] - Appointed John Doyle to the role of chief financial officer[15] Outlook and Key Milestones for 2024 Building on the momentum from recent FDA approvals in Alzheimer's, Cognition Therapeutics anticipates two major milestones in 2024: topline readouts from the Phase 2 SHINE study (Alzheimer's) and SHIMMER study (DLB), with an expectation to identify candidate biomarkers of CT1812 activity to inform future development - Expects topline readouts from two Phase 2 studies in 2024: SHINE (mild-to-moderate Alzheimer's disease) and SHIMMER (mild-to-moderate DLB)[16] - Plans to analyze samples from study participants to identify candidate biomarkers of CT1812 activity, which will inform the next phase of evolution[16] - Notes the FDA approval of disease-modifying biologics for Alzheimer's disease in 2023 re-invigorated research and investment interest in the sector[16] Financial Results This section presents Cognition Therapeutics' 2023 financial performance, including operating expenses, balance sheet, liquidity, and recent financing activities Summary of 2023 Financial Performance Cognition Therapeutics reported an increased net loss for the year ended December 31, 2023, primarily due to higher operating expenses, despite an increase in grant income Consolidated Statements of Operations Data (Year Ended December 31) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :----------------------------- | :------------------ | :------------------ | :----------- | | Total operating expenses | $50,724 | $43,551 | +16.47% | | Loss from operations | $(50,724) | $(43,551) | +16.47% | | Grant income | $24,805 | $22,217 | +11.65% | | Net loss | $(25,788) | $(21,397) | +20.52% | | Net loss per share (Basic/Diluted) | $(0.86) | $(0.91) | -5.49% | | Weighted-average common shares outstanding (Basic/Diluted) | 30,029,087 | 23,640,199 | +27.02% | Operating Expenses Analysis This section analyzes Cognition Therapeutics' research and development and general and administrative expenses for the year ended December 31, 2023 Research and Development Expenses Research and development expenses increased significantly in 2023, primarily driven by higher costs associated with Phase 2 trial activities, personnel, and preclinical research, partially offset by decreased manufacturing costs Research and Development Expenses (Year Ended December 31) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :----------- | | Research and development | $37,196 | $30,324 | +22.67% | - Increase primarily related to higher costs for Phase 2 trial activities with contract research organizations, personnel, and preclinical research[2] - Partially offset by decreased manufacturing costs[2] General and Administrative Expenses General and administrative expenses saw a slight increase in 2023, mainly due to higher employee compensation and benefits resulting from increased headcount and equity-based compensation, partially offset by reduced Director & Officer Liability insurance and other expenses General and Administrative Expenses (Year Ended December 31) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :--------------------------- | :------------------ | :------------------ | :----------- | | General and administrative | $13,528 | $13,227 | +2.28% | - Increase primarily related to higher employee compensation and benefits driven by increased headcount and equity-based compensation[3] - Partially offset by decreased Director & Officer Liability insurance and other expenses[3] Balance Sheet and Liquidity As of December 31, 2023, Cognition Therapeutics reported a decrease in cash and cash equivalents and total assets compared to the previous year, while total liabilities slightly increased, and the company also had significant grant funds remaining Consolidated Balance Sheet Data (As of December 31) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change (YoY) | | :-------------------------- | :------------------ | :------------------ | :----------- | | Cash and cash equivalents | $29,922 | $41,562 | -28.01% | | Total assets | $35,163 | $50,425 | -30.27% | | Total liabilities | $10,689 | $10,176 | +5.04% | | Accumulated deficit | $(141,189) | $(115,401) | +22.35% | | Total stockholders' equity | $24,474 | $40,249 | -39.19% | - Total grant funds remaining from the NIA were $67.5 million as of December 31, 2023[1] Recent Financing and Cash Runway In March 2024, Cognition Therapeutics completed an underwritten public offering, raising approximately $10.4 million in net proceeds, which is expected to extend the company's cash runway to fund operations and capital expenditures through May 2025 - In March 2024, the Company issued and sold 6,571,428 shares of common stock at $1.75 per share in an underwritten public offering[17] - Received net proceeds of approximately $10.4 million after deducting underwriting discounts and commissions and estimated offering expenses[17] - With the additional capital from the March 2024 offering, the Company estimates sufficient cash to fund operations and capital expenditures through May 2025[1] Additional Information This section provides details on the conference call, forward-looking statements, and contact information for Cognition Therapeutics Conference Call Information Management hosted a conference call and live webcast on March 26, 2024, at 8:00 a.m. ET to discuss the financial results, with an archived recording available afterward - Management hosted a conference call and live webcast on March 26, 2024, at 8:00 a.m. ET to discuss Cognition's financial results[5][13] - Participants could dial (800) 715-9871 (U.S.) or (646) 307-1963 (international) and provide conference ID number 6295507, or connect via a live webcast link[5] Forward-Looking Statements This section contains a standard disclaimer regarding forward-looking statements, emphasizing that actual results may differ materially due to known and unknown risks, uncertainties, and other factors, and the company does not plan to publicly update or revise these statements unless required by law - All statements in this press release, other than statements of historical facts, are forward-looking statements subject to known and unknown risks, uncertainties, and other important factors[8] - Factors that may cause actual results to differ materially include competition, ability to secure grant funding, clinical trial success, regulatory approvals, economic factors, and intellectual property defense[8] - The company does not plan to publicly update or revise any forward-looking statements contained herein, except as required by applicable law[8] Contact Information Provides contact details for Cognition Therapeutics, including general inquiries, media relations, and investor relations - Contact information provided for general inquiries (info@cogrx.com), media (Casey McDonald, cmcdonald@tiberend.com), and investors (Mike Moyer, mmoyer@lifesciadvisors.com)[19]