-- Enrollment completed in ML-007C-MA's Phase 2 ZEPHYR trial in
schizophrenia, with topline results expected by mid-August 2026
-- Last patient visit completed for ML-004's Phase 2 IRIS trial in autism
spectrum disorder, with topline results expected by mid-August 2026
-- Enrollment ongoing in ML-007C-MA's Phase 2 VISTA trial in Alzheimer's
disease psychosis, with topline results expected in the second half of
2027
-- Ended the quarter with $395.2 million in cash, cash equivalents and
investments, which is expected to fund operations through 2027
SAN FRANCISCO and BOSTON, May 14, 2026 (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 first quarter ended March 31, 2026, and provided a business update.
"We are continuing to see strong momentum across our clinical portfolio, including completion of enrollment in the Phase 2 ZEPHYR and IRIS trials, " said Chris Kroeger, co-Founder and Chief Executive Officer of the Company. "With topline results from both studies expected by mid-August, continued advancement of our VISTA trial in Alzheimer's disease psychosis and progress across our early-stage pipeline, MapLight is entering an important inflection point in our mission to improve the lives of patients living with debilitating neuropsychiatric disorders."
Business Update and Upcoming Milestones
-- ML-007C-MA (M1/M4 Muscarinic Agonist) for the Treatment of Schizophrenia
and Alzheimer's Disease Psychosis $(ADP)$:
-- Completed enrollment of 307 participants in the Phase 2 ZEPHYR
trial for schizophrenia, with topline results expected by
mid-August of 2026. ZEPHYR is a randomized, double-blind,
placebo-controlled trial evaluating the efficacy, safety, and
tolerability of ML-007C-MA in inpatient adult participants with
schizophrenia experiencing an acute exacerbation of psychosis.
Participants in the trial were randomized 1:1:1 to receive either
placebo, ML-007C-MA 210/3 mg twice daily, or ML-007C-MA 330/6 mg
once daily. The primary endpoint for the trial is the change in
Positive and Negative Syndrome Scale (PANSS) total score from
baseline to Week 5. Key secondary endpoints include change in
PANSS-Marder positive and negative factor scores and CGI-S score
from baseline to Week 5. Exploratory endpoints include change in
cognitive function, assessed across multiple domains commonly
impacted in schizophrenia, from baseline to Week 5.
-- Topline results from Phase 2 VISTA trial for ADP expected in the
second half of 2027. VISTA is a randomized, double-blind,
placebo-controlled trial evaluating ML-007C-MA for the treatment
of ADP. The Company expects to enroll approximately 300
participants in the trial. In December 2025, ML-007C-MA was
granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) for the treatment of hallucinations and
delusions associated with ADP.
-- ML-004 (5-HT1B/1D Agonist) for the Treatment of Autism Spectrum Disorder
(ASD): The last patient visit in ML-004's Phase 2 IRIS trial in autism
spectrum disorder has been completed, with topline results expected by
mid-August 2026. IRIS is a randomized, double-blind, placebo-controlled
trial evaluating the efficacy, safety, and tolerability of ML-004 in
adults and adolescents with autism spectrum disorder. 161 participants
were randomized in the trial, consistent with the enrollment target of
over 100 adolescents (aged 12-17). The primary endpoint is the change in
Autism Behavioral Inventory $(ABI)$-Social Communication Domain Score from
baseline to Week 12. Key secondary endpoints include change in CGI-I,
ABI-C and Aberrant Behavior Checklist-Irritability (ABC-I) score from
baseline to Week 12.
-- Preclinical and Discovery: The Company continues to advance preclinical
and discovery-stage programs across its broader neuropsychiatric
portfolio.
First Quarter 2026 Financial Results
-- Cash Position: Cash, cash equivalents and investments were $395.2 million
as of March 31, 2026. Based on current operational plans and assumptions,
the Company expects that its current cash, cash equivalents and
investments will be sufficient to fund operations through 2027.
-- R&D Expenses: Research and development (R&D) expenses were $53.7 million
for the first quarter of 2026, as compared to $19.8 million for the first
quarter of 2025. R&D expenses increased primarily due to increases in
clinical trial expenses and employee-related expenses, including an
increase in stock-based compensation expense of $5.3 million.
-- G&A Expenses: General and administrative (G&A) expenses were $10.8
million for the first quarter of 2026, as compared to $3.8 million for
the first quarter of 2025. G&A expenses increased primarily due to
increases in employee-related expenses, including an increase in
stock-based compensation expense of $4.2 million, and increases in
professional fees and other expenses.
-- Net Loss: Net loss was $60.7 million for the first quarter of 2026, as
compared to $22.3 million for the first quarter of 2025.
About MapLight Therapeutics
MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The Company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. The Company's discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation.
For more information, please visit www.maplightrx.com.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, the Company's expectations regarding plans for and potential benefits of its current and future product candidates and programs, enrollment in and results from the Company's clinical trials, including topline results from ML-007C-MA's Phase 2 ZEPHYR trial, ML-004's Phase 2 IRIS trial and ML-007C-MA's Phase 2 VISTA trial, the potential that topline results, continued clinical and preclinical progress or other business developments will represent value inflection points, and the sufficiency of the Company's cash, cash equivalents and investments to fund its operations through 2027. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would, " "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in the Company's filings with the U.S. Securities and Exchange Commission (SEC), many of which are beyond the Company's control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of the Company's preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical trial results; the risk that results obtained in any clinical trials to date may not be indicative of results obtained in ongoing or future trials; the timing or likelihood of regulatory filings and approvals; expectations regarding the Company's ability to fund its current operations and to secure sufficient additional capital, when required, to fund product development or future commercialization efforts; and other risks and uncertainties identified in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and subsequent disclosure documents the Company may file with the SEC. The Company claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The Company expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
MapLight Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended March 31,
2026 2025
Operating expenses:
Research and development $ 53,684 $ 19,787
General and administrative 10,819 3,756
Total operating expenses 64,503 23,543
Loss from operations (64,503) (23,543)
Other income, net:
Interest income 2,472 811
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