as of 08-14-2026 4:00pm EST
MapLight Therapeutics Inc is a clinical-stage biopharmaceutical company focused on developing treatments for central nervous system disorders. Its discovery platform identifies neural circuits causally linked to disease and targets them for therapeutic modulation, aiming to improve efficacy, safety, tolerability, and ease of use. The company was founded by leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies. Its product candidate, ML-007C-MA, is a fixed-dose combination of an M1/M4 muscarinic agonist and a peripherally acting anticholinergic, being developed for schizophrenia and Alzheimer's disease psychosis, designed to activate central receptors while mitigating peripheral side effects.
| Founded: | 2018 | Country: | United States |
| Employees: | N/A | City: | REDWOOD CITY |
| Market Cap: | 1.7B | IPO Year: | 2025 |
| Target Price: | $32.67 | AVG Volume (30 days): | 1.3M |
| Analyst Decision: | Strong Buy | Number of Analysts: | 7 |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -2.66 | EPS Growth: | 82.39 |
| 52 Week Low/High: | $9.10 - $40.43 | Next Earning Date: | 05-28-2026 |
| Revenue: | N/A | Revenue Growth: | N/A |
| Revenue Growth (this year): | N/A | Revenue Growth (next year): | N/A |
| P/E Ratio: | -8.64 | Index: | N/A |
| Free Cash Flow: | -138610000.0 | FCF Growth: | N/A |
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SEC 8-K filings with transcript text
Aug 13, 2026 · 100% conf.
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Exhibit 99.1
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
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, August 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 (M1/M4 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.
(5-HT1B/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 ZEPH
May 14, 2026
2 mplt-ex99_1.htm
Exhibit 99.1
MapLight Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
• 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/M4Muscarinic Agonist) for the Treatment of Schizophrenia and Alzheimer’s Disease Psychosis (ADP):
o 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.
o 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 primar
Mar 26, 2026
2 mplt-ex99_1.htm
Exhibit 99.1
MapLight Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
• 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 M1/M4 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):
o 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.
o 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.
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