Reported positive results from the potentially registrational Phase 2 ZEPHYR trial of ML-007C-MA in schizophrenia, supporting advancement into a Phase 3 ZEPHYR-2 trial
Continued advancement of ML-007C-MA in ADP, with enrollment ongoing in the Phase 2 VISTA trial and topline results expected in the second half of 2027
Reported Phase 2 IRIS results for ML-004 in autism spectrum disorder, with clinically meaningful improvements in irritability observed in a prespecified adolescent subgroup
Primarily focusing resources on the advancement of ML-007C-MA
Ended the quarter with $351.3 million in cash, cash equivalents and investments, which, together with the Company's recent $150 million private placement, is expected to extend cash runway through 2028, including through the projected readouts for both VISTA and ZEPHYR-2
SAN FRANCISCO and BOSTON, Aug. 13, 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 second quarter ended June 30, 2026, and provided a business update.
"With positive Phase 2 data from ZEPHYR and continued progress in VISTA, we are focusing our efforts on advancing ML-007C-MA in both schizophrenia and ADP," said Chris Kroeger, Co-Founder and Chief Executive Officer of MapLight. "In schizophrenia, ZEPHYR met its primary endpoint and achieved meaningful efficacy results, an encouraging cognitive signal and a tolerability profile designed to translate into real-world use, supporting our planned registrational Phase 3 ZEPHYR-2 trial. In ADP, enrollment in VISTA remains ongoing, with topline results expected in the second half of 2027. Together with our recent private placement and continued focus on capital discipline, we believe we are well positioned to execute on both programs through these key milestones."
Business Update and Upcoming Milestones
ML-007C-MA (M(1) /M(4) Muscarinic Agonist) for the Treatment of Schizophrenia
-- Reported positive topline results in July 2026 from the Phase 2 ZEPHYR
trial of ML-007C-MA in adults with schizophrenia experiencing an acute
exacerbation of psychosis. The trial met its primary endpoint, with the
210/3 mg twice-daily dose demonstrating a statistically significant and
clinically meaningful reduction in PANSS total score compared with
placebo at Week 5.
-- ML-007C-MA also demonstrated improvement on a prespecified
cognitive-function endpoint in participants with baseline cognitive
impairment and significant separation on key secondary endpoints,
including CGI-S and the PANSS Marder positive factor.
-- ML-007C-MA was generally well tolerated, with no serious or drug-related
severe adverse events and low rates of GI-related discontinuations. Its
clinical profile, including simple initiation, 99% of patients reaching
the target dose and no fasting requirement, is designed to translate into
real-world use.
-- The Company plans to engage with the FDA at an End-of-Phase 2 meeting to
discuss the registrational path forward, including the planned Phase 3
ZEPHYR-2 trial, with topline results expected in 2028.
ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis $(ADP)$
-- Continued enrollment in the Phase 2 VISTA trial, a randomized,
double-blind, placebo-controlled study evaluating ML-007C-MA in
approximately 300 participants with ADP.
-- ML-007C-MA received Fast Track designation from the FDA in December 2025
for the treatment of hallucinations and delusions associated with ADP.
-- Topline results from VISTA are expected in the second half of 2027.
ML-004 (5-HT(1B/1D) Agonist) for the Treatment of Autism Spectrum Disorder $(ASD)$
-- Reported topline results in June 2026 from the Phase 2 IRIS trial of
ML-004 in autism spectrum disorder. While the study did not meet its
primary endpoint in social communication, a prespecified analysis
demonstrated clinically meaningful improvements in irritability among
adolescents with moderate or greater baseline irritability.
-- ML-004 was generally well tolerated in the IRIS trial, with no severe or
serious adverse events in the active treatment arm. This profile is
relevant in a treatment setting with limited approved options, where
antipsychotic-associated tolerability concerns can present challenges for
long-term use, particularly in younger patients.
-- Following its planned End-of-Phase 2 discussion with the FDA, the Company
intends to evaluate the path forward for ML-004, including potential
strategic collaborations and/or funding alternatives.
Corporate Updates
-- In August 2026, the Company announced a $150 million private placement,
with participation from new and existing institutional investors.
Proceeds from the financing are expected to primarily support the
continued advancement of ML-007C-MA, including funding the planned Phase
3 ZEPHYR-2 trial and ongoing Phase 2 VISTA trial, and for working capital
and other general corporate purposes. Based on its current operational
plans and assumptions, MapLight expects that its existing cash, cash
equivalents and investments, together with the net proceeds from the PIPE,
will be sufficient to fund the continued advancement of ML-007C-MA
through 2028.
-- The Company is focusing resources on the advancement of ML-007C-MA,
including pausing further investment in preclinical and discovery-stage
programs and foregoing advancement of those programs into clinical
development under the current operating plan.
Second Quarter 2026 Financial Results
-- Cash Position: Cash, cash equivalents and investments were $351.3 million
as of June 30, 2026. Based on current operational plans and assumptions,
the Company expects that its existing cash, cash equivalents and
investments, together with the net proceeds from the recent private
placement, will be sufficient to fund the continued advancement of
ML-007C-MA through the end of 2028.
-- R&D Expenses: Research and development (R&D) expenses were $53.4 million
for the second quarter of 2026, as compared to $26.8 million for the
second 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 $5.6 million.
-- G&A Expenses: General and administrative (G&A) expenses were $10.1
million for the second quarter of 2026, as compared to $3.8 million for
the second quarter of 2025. G&A expenses increased primarily due to
increases in employee-related expenses, including an increase in
stock-based compensation expense of $2.9 million, and increases in
professional fees and other expenses.
-- Net Loss: Net loss was $60.2 million for the second quarter of 2026, as
compared to $29.8 million for the second 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 clinical development and potential benefits of ML-007C-MA and ML-004, the design, timing and conducting of future clinical trials, the registrational pathway for the Company's product candidates, including holding EOP2 meetings with the FDA for ML-007C-MA and ML-004 and planned regulatory submissions, the availability and timing of results from the Company's Phase 2 VISTA trial and the Company's Phase 3 ZEPHYR-2 trial, and the potential benefits of the Company's discovery platform. 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: the unpredictable relationship between preclinical study results and clinical study 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 other risks and uncertainties identified in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and subsequent disclosure documents the Company may
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