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MapLight Therapeutics(MPLT) - 2025 Q4 - Annual Results
2026-01-09 12:06
Financial Position - As of December 31, 2025, MapLight Therapeutics, Inc. reported cash and cash equivalents of approximately $450 million[6] - The preliminary cash and cash equivalents figure is subject to change upon completion of the financial closing procedures and the preparation of audited financial statements[7] - The financial information provided is preliminary and has not been audited, indicating potential variations from actual financial results[7] - The corporate presentation includes selected preliminary financial information for the fiscal year ended December 31, 2025[6] Clinical Trials - The company announced that topline results from its ongoing Phase 2 ZEPHYR and IRIS clinical trials are now expected in the third quarter of 2026[9] - The press release regarding the update on clinical trial results was issued on January 9, 2026[9] Corporate Governance - MapLight Therapeutics is classified as an emerging growth company under the Securities Act[5] - The company has not elected to use the extended transition period for complying with new or revised financial accounting standards[5] - The independent registered public accounting firm has not conducted an audit or review of the preliminary estimate provided[7] Investor Relations - The company updated its corporate presentation for investor meetings, which is available on its website[10]
MapLight Therapeutics Updates Expected Timing of Topline Results for Ongoing Phase 2 Studies to Q3 2026
Globenewswire· 2026-01-09 12:00
Core Insights - MapLight Therapeutics, Inc. has updated the expected timing for topline results from its Phase 2 ZEPHYR and IRIS clinical studies, which are progressing ahead of schedule [1] Group 1: ZEPHYR Trial - The Phase 2 ZEPHYR trial is evaluating ML-007C-MA for treating schizophrenia and is expected to report topline results in Q3 2026 [2] - The ZEPHYR study is a randomized, double-blind, placebo-controlled trial enrolling approximately 300 hospitalized adult participants experiencing acute exacerbation of psychosis [2][3] - The accelerated enrollment pace in the ZEPHYR trial has allowed the company to narrow its timing guidance to Q3 2026, reflecting disciplined execution and commitment to quality [3] Group 2: IRIS Trial - The Phase 2 IRIS trial for ML-004 in autism spectrum disorder has completed enrollment, with topline results also expected in Q3 2026 [3] - The IRIS study is a double-blind, placebo-controlled trial that randomized around 160 adult and adolescent participants [3] Group 3: Company Overview - MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with central nervous system disorders [4] - The company was founded by leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies [4] - MapLight's discovery platform aims to identify neural circuits linked to diseases and target them for therapeutic modulation [4]
MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer's Disease Psychosis
Globenewswire· 2026-01-05 12:00
Core Viewpoint - MapLight Therapeutics has received Fast Track designation from the FDA for its investigational drug ML-007C-MA, aimed at treating hallucinations and delusions associated with Alzheimer's disease psychosis, highlighting the significant unmet medical need in this area [1][2][3] Group 1: Drug Development and Clinical Trials - ML-007C-MA is an oral, extended-release, fixed-dose combination of an M1/M4 muscarinic agonist and a peripherally acting anticholinergic, designed to mitigate peripheral cholinergic side effects while activating central nervous system receptors [4] - The drug has shown a favorable safety and tolerability profile in a Phase 1 clinical trial, with ongoing enrollment in a Phase 2 randomized, double-blind, placebo-controlled trial expected to include 300 participants, with topline results anticipated in the second half of 2027 [3][4] Group 2: Alzheimer's Disease Psychosis (ADP) - Alzheimer's disease psychosis is a common neuropsychiatric complication affecting approximately 40% of individuals with Alzheimer's disease, leading to poorer outcomes such as faster cognitive decline and increased mortality [5] - The lack of currently approved treatment options for ADP underscores the importance of developing new therapies like ML-007C-MA [3][5] Group 3: Company Overview - MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on addressing central nervous system disorders, founded by leaders in psychiatry and neuroscience research [6] - The company's discovery platform aims to identify and target neural circuits linked to diseases, potentially filling a significant gap in available pharmacotherapies [6]
MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis
Globenewswire· 2026-01-05 12:00
SAN FRANCISCO and BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (“MapLight”) (Nasdaq: MPLT) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an investigational novel M1/M4 muscarinic agonist, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The Fast Track process is intended to facilitate the development and expedite the review of investigational therapies for serio ...
SandboxAQ and MapLight Therapeutics Announce Strategic Collaboration to Discover and Develop Novel CNS Therapies
Globenewswire· 2025-12-16 12:00
Core Insights - SandboxAQ and MapLight Therapeutics have entered a strategic collaboration to develop therapies targeting a novel G protein-coupled receptor (GPCR) for central nervous system (CNS) disorders [1][2] Financial Terms - SandboxAQ received an upfront payment and is eligible for additional milestone payments totaling up to $200 million, covering preclinical, development, regulatory, and commercial stages [2] Research Collaboration - The collaboration involves joint preclinical research, with MapLight holding exclusive rights for clinical development and commercialization of the compounds [2] - SandboxAQ will utilize its AI platform to enhance the discovery and development of therapies, focusing on receptor structure-functional activity and ligand-receptor interactions [3][4] Technological Advancements - SandboxAQ's AQBioSim platform allows for precise simulation and prediction of molecular interactions with GPCRs, facilitating a systematic exploration of chemical space [4] - The collaboration aims to accelerate the generation and optimization of potential drug candidates through rapid Design-Make-Test-Analyze (DMTA) cycles [3][4] Company Backgrounds - SandboxAQ is a B2B company that integrates AI and quantum techniques, emerging from Alphabet Inc. and focusing on various sectors including life sciences [5] - MapLight Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing CNS disorders through circuit-specific pharmacotherapies, leveraging expertise in psychiatry and neuroscience [6]
SandboxAQ and MapLight Therapeutics Announce Strategic Collaboration to Discover and Develop Novel CNS Therapies
Globenewswire· 2025-12-16 12:00
Core Insights - SandboxAQ and MapLight Therapeutics have entered a strategic collaboration to develop therapies targeting a novel G protein-coupled receptor (GPCR) for central nervous system (CNS) disorders [1][2] Financial Terms - SandboxAQ received an upfront payment and is eligible for additional milestone payments totaling up to $200 million, which includes preclinical, development, regulatory, and commercial milestones [2] Research Collaboration - The collaboration will involve joint preclinical research activities, with MapLight holding exclusive rights for clinical development and commercialization of the compounds [2] - SandboxAQ will utilize large-scale AI models and high-fidelity molecular simulations to explore receptor structure-functional activity and optimize drug properties [3][4] Technological Advancements - The AQBioSim platform from SandboxAQ allows for precise simulation and prediction of molecular interactions with GPCRs, enhancing the exploration of chemical space and accelerating drug candidate optimization [4] Company Backgrounds - SandboxAQ is a B2B company focused on AI and quantum techniques, emerging from Alphabet Inc. and backed by leading investors [5] - MapLight Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing CNS disorders through circuit-specific pharmacotherapies [6]
MapLight Therapeutics(MPLT) - 2025 Q3 - Quarterly Report
2025-12-04 12:07
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-42914 FORM 10-Q (Mark One) MapLight Therapeutics, Inc. (Exact Name of Registrant as Specified in its Chart ...
MapLight Therapeutics(MPLT) - 2025 Q3 - Quarterly Results
2025-12-04 12:03
Exhibit 99.1 MapLight Therapeutics Reports Third Quarter Financial Results and Highlights Corporate Progress SAN FRANCISCO and BOSTON, Dec. 4, 2025 (GLOBE NEWSWIRE) -- MapLight Therapeutics, Inc. (Nasdaq: MPLT), a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today reported financial results for the third quarter of 2025 and highlighted recent progress and upcoming milestones. "2025 was a year of exceptional ...
MapLight Therapeutics Reports Third Quarter Financial Results and Highlights Corporate Progress
Globenewswire· 2025-12-04 12:00
Core Insights - MapLight Therapeutics reported significant progress in its clinical pipeline and financial results for Q3 2025, highlighting advancements in treatments for central nervous system disorders [2][3][4]. Financial Highlights - The company raised $296.5 million in gross proceeds from its initial public offering (IPO) and concurrent private placement in October 2025, with net proceeds of $269.8 million after expenses [4][6]. - As of September 30, 2025, MapLight had $227.2 million in cash, cash equivalents, and short-term investments, which are expected to fund operations through 2027 [10][15]. - Research and development expenses for Q3 2025 were $27.1 million, up from $16.8 million in Q3 2024, primarily due to increased clinical trial costs [10][13]. - The net loss for Q3 2025 was $29.4 million, compared to a net loss of $19.0 million in Q3 2024 [10][13]. Clinical Development Progress - The Phase 2 ZEPHYR trial for ML-007C-MA in schizophrenia is expected to yield topline results in the second half of 2026, with 300 participants enrolled [4][5]. - The Phase 2 VISTA trial for ML-007C-MA in Alzheimer's disease psychosis is anticipated to report topline results in the second half of 2027, also enrolling 300 participants [4][5]. - Enrollment in the Phase 2 IRIS study for ML-004, targeting autism spectrum disorder, has been completed, with results expected in the second half of 2026 [4][5]. - The company plans to complete IND-enabling studies for ML-021, aimed at treating motor deficits in Parkinson's disease, in the second half of 2026 [5]. Company Overview - MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for patients with debilitating central nervous system disorders, founded by leaders in psychiatry and neuroscience [8].
MapLight Therapeutics (NasdaqGS:MPLT) Earnings Call Presentation
2025-12-04 12:00
Corporate Presentation December 4, 2025 Innovation-Driven Company Globally Recognized Scientific Founders Established in 2018 to >100 Employees Broad & Diversified Product Pipeline Safe Harbor and Forward-Looking Statements This presentation and any accompanying oral commentary have been prepared by MapLight Therapeutics, Inc. ("MapLight", "we," "us," "our," the "Company", or similar terms) for informational purposes only and not for any other purpose. This presentation contains trademarks, service marks, t ...