-- Phase 2 ZEPHYR trial of ML-007C-MA for schizophrenia expected to reach
target enrollment (n=300) in April 2026, with topline results expected in
the third quarter of 2026
-- Phase 2 IRIS trial for ML-004 for autism spectrum disorder has completed
enrollment, with topline results expected in the third quarter of 2026
-- Received FDA Fast Track designation for ML-007C-MA for Alzheimer's
disease psychosis; topline results from Phase 2 VISTA trial expected in
the second half of 2027
-- Expanded pipeline with a next-generation M1/M4 muscarinic agonist program,
ML-055, with candidate nomination expected in 2026
-- Ended the year with $453.1 million in cash, cash equivalents and
investments, which is expected to fund operations through 2027
SAN FRANCISCO and BOSTON, March 26, 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 fourth quarter and full year ended December 31, 2025, and provided a business update.
"With a focused strategy, robust operational execution and a strong balance sheet, MapLight is well positioned to deliver on multiple key development milestones in 2026," said Chris Kroeger, co-Founder and Chief Executive Officer of the Company. "While continuing to prioritize high-quality trial execution, we have maintained a robust enrollment pace in the ZEPHYR study and expect to reach target enrollment in April 2026. This is shaping up to be an exciting year for MapLight as we look forward to reporting topline results from our Phase 2 ZEPHYR trial and ML-004 Phase 2 IRIS trial in the third quarter. In addition, we expanded our earlier-stage pipeline with the addition of ML-055, our next-generation M(1) /M(4) agonist program that we are rapidly advancing towards potential candidate nomination this year."
Business Update and Upcoming Milestones
-- ML-007C-MA (M1/M4 Muscarinic Agonist) for the Treatment of Schizophrenia
and Alzheimer's Disease Psychosis $(ADP)$:
-- Phase 2 ZEPHYR trial for schizophrenia is expected to reach target
enrollment in April 2026, with topline results expected in the
third quarter 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. The
study is expected to enroll approximately 300 participants,
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.
-- 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 Company has completed enrollment in the IRIS Phase 2 trial,
with topline results expected in the third quarter of 2026. The IRIS
study is a randomized, double-blind, placebo-controlled trial evaluating
ML-004 for the improvement of core social communication deficits, with
change in irritability symptoms as a key secondary endpoint. The trial
randomized approximately 160 adult and adolescent participants.
-- ML-055 (Next-Generation M1/M4 Muscarinic Agonist) for the Treatment of
Neuropsychiatric Conditions: Preclinical in vitro and in vivo studies
evaluating multiple potential candidates in the Company's ML-055 M1/M4
muscarinic agonist program have demonstrated significantly greater
potency relative to ML-007 and the potential for once-daily dosing and a
long-acting injectable formulation. The Company expects to nominate a
preclinical candidate to advance to IND-enabling studies in 2026.
Fourth Quarter and Full Year 2025 Financial Results
-- Cash Position: Cash, cash equivalents and investments were $453.1 million
as of December 31, 2025. 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 $64.6 million
for the fourth quarter of 2025, as compared to $20.7 million for the
prior year period. For the full year 2025, R&D expenses were $138.3
million, as compared to $68.5 million for the full year 2024. R&D
expenses increased primarily due to clinical trial and CMC expenses and
employee-related expenses, including stock-based compensation related
to the vesting of restricted stock units in connection with the
effectiveness of the IPO, which were partially offset by decreases in
preclinical program expenses.
-- G&A Expenses: General and administrative (G&A) expenses were $18.8
million for the fourth quarter of 2025, as compared to $2.1 million for
the prior year period. For the full year 2025, G&A expenses were $30.7
million, as compared to $14.4 million for the full year 2024. G&A
expenses increased primarily due to employee-related expenses, including
stock-based compensation related to the vesting of restricted stock
units in connection with the effectiveness of the IPO, in addition to
professional fees and other expenses.
-- Net Loss: Net loss was $79.5 million for the fourth quarter of 2025, as
compared to $21.2 million for the prior year period. For the full year
2025, net loss was $161.2 million, as compared to $77.6 million for the
full year 2024.
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, plans for its current and future clinical trials, plans for clinical trial design, the anticipated timing of the initiation of, enrollment in and results from the Company's clinical trials, the timing of candidate selection in the ML-055 program, the potential once-daily dosing and a long-acting injectable formulation of ML-055 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2025, 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 December
31, Year Ended December 31,
----------------------------- ---------------------------
2025 2024 2025 2024
------------------ --------- -------------- -----------
Operating expenses:
Research and
development $ 64,623 $ 20,714 $ 138,349 $ 68,523
General and
administrative 18,755 2,064 30,734 14,423
---------- ------- --------- -------
Total operating
expenses 83,378 22,778 169,083 82,946
---------- ------- --------- -------
Loss from operations (83,378) (22,778) (169,083) (82,946)
Other income
(expense), net:
Interest income 2,471 899 5,518 4,504
Loss from equity
method
investment -- -- -- (986)
Other income,
net 1,359 650 2,413 1,848
Total other income,
net 3,830 1,549 7,931 5,366
---------- ------- --------- -------
Net loss $ (79,548) $(21,229) $ (161,152) $(77,580)
========== ======= ========= =======
Net loss per share -
basic and diluted $ (2.47) $ (27.95) $ (18.56) $(105.38)
========== ======= ========= =======
Weighted-average
number of common
shares outstanding
- basic and
diluted 32,148,977 759,493 8,680,741 736,178
========== ======= ========= =======
Select Condensed Consolidated Balance Sheet Data
(Unaudited)
(in thousands)
December 31,
----------------------
2025 2024
-------- -----------
Cash, cash equivalents and investments $453,096 $ 120,175
Total assets 479,512 136,916
Total current liabilities 16,229 15,920
Total liabilities 21,140 21,721
Total stockholders' equity (deficit) 458,372 (193,628)
For investor inquiries: investors@maplightrx.com
For media inquiries: media@maplightrx.com
(END) Dow Jones Newswires
March 26, 2026 07:00 ET (11:00 GMT)
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