MapLight Therapeutics, Inc.

MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial for ML-007C-MA in schizophrenia. The 210/3 mg BID dose met the primary endpoint, demonstrating a statistically significant improvement in PANSS total score (effect size 0.37, p=0.015) and also showed clinically meaningful improvement in cognitive performance (effect size 0.51, p=0.041). The drug was generally well-tolerated with a favorable safety profile. These results support advancing ML-007C-MA into an additional confirmatory pivotal study, with plans to engage the FDA for an End-of-Phase 2 meeting.

MapLight Therapeutics announced positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA for acute exacerbation of schizophrenia. The 210/3 mg BID dose met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in PANSS total score compared to placebo. The trial also showed robust improvement in cognitive performance and a favorable tolerability profile. The company plans to engage with the FDA for an End-of-Phase 2 meeting to discuss the path forward for a registrational Phase 3 trial.

MapLight Therapeutics, Inc. announced the appointment of Martin Babler and Troy Cox to its Board of Directors following their election at the Annual Meeting of Stockholders. Mr. Babler will join the Audit Committee, and Mr. Cox will chair the Nominating and Corporate Governance Committee. They succeed Robert Malenka and Jim Trenkle, who did not seek re-election, bringing substantial strategic, operational, and governance experience to the company.

MapLight Therapeutics announced topline results from its Phase 2 IRIS trial for ML-004 in autism spectrum disorder (ASD), which did not meet its primary endpoint for social communication deficits. However, a prespecified analysis in adolescents with moderate to severe baseline irritability demonstrated a clinically meaningful improvement over placebo (effect size 1.33, nominal p=0.013). ML-004 was generally well-tolerated with no severe adverse events. The company plans to engage with the FDA for an End-of-Phase 2 meeting and remains well-capitalized ahead of ML-007C-MA Phase 2 results in mid-August 2026.

MapLight Therapeutics announced the immediate separation of its Chief Financial Officer, Vishwas Setia, on June 18, 2026, following a human resources violation. The company clarified that the separation was unrelated to its financial performance or internal controls. Mr. Setia will not receive severance but will get up to three months of COBRA health coverage. Jonathan Gillis, the company's Chief Administrative and Accounting Officer, has been appointed interim CFO and will continue his existing roles.

MapLight Therapeutics reported a net loss of $(60.7) million for Q1 2026, a significant increase from $(22.3) million in Q1 2025, driven by a 171% rise in research and development expenses. The clinical-stage biopharmaceutical company's operating expenses more than doubled. Despite the increased cash burn, the company maintains a strong liquidity position with $395.2 million in cash and investments, expected to fund operations for at least 12 months following its October 2025 IPO.

MapLight Therapeutics, Inc. reported its first quarter 2026 financial results, with a net loss of $60.7 million, up from $22.3 million in Q1 2025, driven by increased R&D and G&A expenses. The company announced significant clinical progress, including the completion of enrollment for its Phase 2 ZEPHYR trial in schizophrenia and the last patient visit for its Phase 2 IRIS trial in autism spectrum disorder, with topline results for both expected by mid-August 2026. MapLight ended the quarter with $395.2 million in cash, cash equivalents, and investments, which is projected to fund operations through 2027.

MapLight Therapeutics, Inc. announced that its management team will participate in two upcoming investor conferences. The company will present and host one-on-one meetings at the 2026 RBCCM Global Healthcare Conference on May 19th and the 2026 Jefferies Global Healthcare Conference on June 3rd. Both events will take place in New York, NY, with webcasts available on the company's investor relations website.

MapLight Therapeutics, Inc. announced the completion of enrollment for its Phase 2 ZEPHYR trial evaluating ML-007C-MA for schizophrenia, involving 307 participants. The company also completed the final patient visit for its Phase 2 IRIS trial evaluating ML-004 for autism spectrum disorder, which randomized 161 participants. Topline results from both randomized, double-blind, placebo-controlled trials are anticipated by mid-August 2026, marking a significant milestone for the clinical-stage biopharmaceutical company.

MapLight Therapeutics, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 23, 2026. Stockholders will vote on the election of three Class I Director nominees, which includes new nominees Martin Babler and Troy Cox, and the re-election of George Pavlov. Additionally, the appointment of RSM US LLP as the independent registered public accounting firm for the year ending December 31, 2026, will be ratified.