Company Description
MapLight Therapeutics, Inc. (Nasdaq: MPLT) is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system (CNS) disorders. According to the company, it was founded by leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients with serious neuropsychiatric and neurological conditions.
MapLight states that its discovery platform is designed to identify neural circuits that are causally linked to disease and to target those circuits for therapeutic modulation. This circuit-focused approach underpins the company’s pipeline of product candidates, which aims to address symptoms such as psychosis, social communication deficits, motor impairments, and agitation across a range of CNS disorders.
Core Focus on Central Nervous System Disorders
Across its public disclosures, MapLight describes itself as concentrating on CNS disorders that have significant unmet medical need. These include schizophrenia, Alzheimer’s disease psychosis (ADP), autism spectrum disorder (ASD), Parkinson’s disease motor deficits, and hyperactivity, impulsivity and agitation-related disorders. The company emphasizes debilitating symptom domains such as hallucinations, delusions, social communication challenges, and motor dysfunction.
The company highlights the absence of circuit-specific pharmacotherapies as a key gap in current treatment options. MapLight’s stated goal is to use its discovery platform to link specific neural circuits to disease manifestations and then develop small-molecule drug candidates that modulate those circuits.
Clinical-Stage Pipeline
MapLight reports a pipeline of product candidates at various stages of development:
- ML-007C-MA: Described as an oral, extended-release, fixed-dose combination of an investigational M1/M4 muscarinic agonist (ML-007) co-formulated with a peripherally acting anticholinergic. The company states that ML-007C-MA is being evaluated in Phase 2 clinical trials for the treatment of schizophrenia and Alzheimer’s disease psychosis.
- Schizophrenia (ZEPHYR study): The Phase 2 ZEPHYR trial is described as a randomized, double-blind, placebo-controlled trial in hospitalized adult participants with schizophrenia experiencing an acute exacerbation of psychosis. MapLight has indicated plans to enroll 300 participants and to assess outcomes using the Positive and Negative Syndrome Scale (PANSS) total score.
- Alzheimer’s disease psychosis (VISTA study): The Phase 2 VISTA trial is described as a randomized, double-blind, placebo-controlled trial evaluating twice-daily doses of ML-007C-MA for hallucinations and delusions associated with ADP, with a primary endpoint based on the Neuropsychiatric Inventory – Clinician Hallucinations and Delusions (NPI-C H+D) score.
- ML-004: Described as a 5-HT1B/1D agonist being evaluated in the IRIS Phase 2 study for autism spectrum disorder. The trial is characterized as a randomized, double-blind, placebo-controlled two-arm trial in adult and adolescent participants, focused on improvement of core social communication deficits, with change in irritability symptoms as a key secondary endpoint.
- ML-021: Described as an M4 antagonist in development for the treatment of motor deficits in Parkinson’s disease. The company has indicated that it is conducting IND-enabling studies for this candidate.
- ML-009: Described as a GPR52 positive allosteric modulator for the treatment of hyperactivity, impulsivity and agitation-related disorders, with a development candidate nominated for advancement to IND-enabling studies.
ML-007C-MA and Regulatory Designations
MapLight has disclosed that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to ML-007C-MA for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis. The company notes that Fast Track is intended for investigational therapies for serious conditions with unmet medical need and may allow for more frequent interactions with the FDA, as well as potential eligibility for accelerated approval and priority review if criteria are met.
In describing ML-007C-MA, MapLight states that the candidate is designed to activate both M1 and M4 muscarinic receptors in the central nervous system to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. The company has reported that in a Phase 1 clinical trial, ML-007C-MA demonstrated a generally favorable safety and tolerability profile with twice daily dosing in healthy elderly participants.
Discovery Platform and Collaboration
MapLight attributes its pipeline to a discovery platform that, according to the company, identifies neural circuits causally linked to disease and targets those circuits for therapeutic modulation. This approach is presented as a way to generate drug candidates that may be aligned with specific circuit dysfunctions in CNS disorders.
The company has also announced a strategic collaboration with SandboxAQ to discover and develop potential first-in-class therapies targeting a novel G protein-coupled receptor (GPCR) for CNS disorders. Under this collaboration, MapLight and SandboxAQ plan to jointly conduct preclinical research, with MapLight retaining exclusive rights for potential clinical development and commercialization of collaboration compounds. SandboxAQ has described its role as deploying large-scale AI models and molecular simulation to explore receptor structure-functional activity, predict ligand-receptor interactions, and support optimization of drug properties.
Public Listing and Capital Resources
MapLight has reported that it completed an initial public offering (IPO) of its common stock on the Nasdaq Global Select Market under the symbol MPLT, along with a concurrent private placement. The company has stated that the gross proceeds from the IPO and private placement were in the hundreds of millions of dollars before expenses and that it ended a reported quarter with a substantial balance of cash, cash equivalents and short-term investments.
In its public financial disclosures, MapLight has indicated that its cash, cash equivalents and short-term investments, together with net proceeds from the IPO and concurrent private placement, are expected by the company to fund operations for multiple years. The company also reports research and development expenses related to clinical trials, employee-related costs, formulation and chemistry, manufacturing and controls (CMC), as well as general and administrative expenses such as legal and consulting fees.
Geographic Footprint and Exchange Listing
In its news releases, MapLight lists locations in San Francisco and Boston, and states that its common stock trades on the Nasdaq Global Select Market under the ticker symbol MPLT. The company consistently describes itself as a clinical-stage biopharmaceutical company focused on CNS disorders, with programs spanning psychiatry and neurology.
Pipeline Emphasis on Unmet Need
Across its communications, MapLight emphasizes that it is targeting serious CNS conditions with significant unmet medical need. For example, in Alzheimer’s disease psychosis, the company notes that psychotic symptoms such as hallucinations and delusions affect a substantial portion of individuals with Alzheimer’s disease and are associated with poorer outcomes, including faster cognitive and functional decline, higher rates of institutionalization, and increased mortality. The company presents ML-007C-MA as a potential treatment option for these symptoms, subject to clinical development and regulatory review.
In schizophrenia, the ZEPHYR trial is focused on hospitalized adults experiencing acute exacerbation of psychosis, while in autism spectrum disorder the IRIS study is focused on core social communication deficits and irritability. For Parkinson’s disease and agitation-related disorders, the company describes preclinical and IND-enabling work on ML-021 and ML-009, respectively.
Business Model Characteristics
Based on its public statements, MapLight’s activities are centered on research and development of drug candidates rather than commercial product sales. The company describes clinical trials across multiple indications, preclinical research collaborations, and the use of proceeds from its IPO and private placement to advance its pipeline. Revenue-related details beyond these disclosures are not provided in the available information.
Position Within the Biopharmaceutical Sector
MapLight characterizes itself as a biopharmaceutical company working at the intersection of psychiatry, neuroscience, and CNS drug development. Its emphasis on circuit-specific pharmacotherapies and neural circuit identification is presented as a distinguishing feature of its approach. The company’s collaborations and regulatory designations, as described in its news releases, are tied to its focus on CNS disorders such as schizophrenia, Alzheimer’s disease psychosis, autism spectrum disorder, Parkinson’s disease motor deficits, and agitation-related conditions.