MapLight Completes $150 Million Private Placement
The clinical-stage biopharmaceutical company said cash plus the PIPE should fund ML-007C-MA through 2028 after ZEPHYR met its schizophrenia endpoint.
MapLight Therapeutics, Inc. (MPLT), a clinical-stage biopharmaceutical company focused on central nervous system disorders, reported that the 210/3 mg twice-daily dose of ML-007C-MA met the primary endpoint in the Phase 2 ZEPHYR trial of schizophrenia and said it plans a registrational Phase 3 ZEPHYR-2 study, with topline results expected in 2028.
The July 2026 topline, released ahead of the mid-August date the company had given in May, showed a statistically significant and clinically meaningful reduction in PANSS total score versus placebo at Week 5, with an effect size of 0.37 in the mITT population and 0.50 in a prespecified completer analysis. The same dose also produced significant separation on CGI-S and the PANSS Marder positive factor, and a prespecified cognitive composite improved with an effect size of 0.51 among participants with baseline cognitive impairment. The cognitive change was independent of PANSS movement.
The drug was generally well tolerated, with no serious or drug-related severe adverse events, low rates of GI-related discontinuations, 99% of patients reaching the target dose, and no fasting requirement. Co-Founder and Chief Executive Officer Chris Kroeger said the profile is designed to translate into real-world use. The company plans an End-of-Phase 2 meeting with the FDA to discuss the registrational path, including ZEPHYR-2.
In Alzheimer’s disease psychosis, enrollment in the Phase 2 VISTA trial of about 300 participants remained ongoing, with topline results still expected in the second half of 2027. ML-007C-MA holds FDA Fast Track designation for hallucinations and delusions associated with ADP.
The June 2026 IRIS topline for ML-004 in autism spectrum disorder did not meet its primary social-communication endpoint. A prespecified adolescent subgroup with moderate or greater baseline irritability showed clinically meaningful improvements in irritability. ML-004 was generally well tolerated, with no severe or serious adverse events in the active arm. After a planned End-of-Phase 2 discussion, the company intends to evaluate the path forward for ML-004, including potential strategic collaborations and/or funding alternatives.
MapLight is primarily focusing resources on ML-007C-MA and is pausing further investment in preclinical and discovery-stage programs and forgoing their advancement into clinical development under the current operating plan. That marked a shift from the first-quarter update, which said the company continued to advance those earlier-stage programs.
Cash, cash equivalents, and investments were $351.3 million as of June 30, 2026, down from $395.2 million at March 31, 2026. In August, the company announced a $150 million private placement, selling 9,197,887 shares at $11.38 and, in lieu of common stock to certain investors, pre-funded warrants for up to 3,983,168 shares at $11.3799 each. The PIPE was expected to close August 14, 2026. Proceeds are expected to primarily support ML-007C-MA, including ZEPHYR-2 and VISTA, plus working capital. Based on current operational plans, MapLight expects existing cash plus net PIPE proceeds to be sufficient to fund continued advancement of ML-007C-MA through 2028, extending the prior through-2027 runway.
Research and development expenses were $53.4 million for the second quarter of 2026, compared with $26.8 million a year earlier, increasing primarily due to higher clinical-trial and employee-related costs, including a $5.6 million increase in stock-based compensation. General and administrative expenses were $10.1 million, compared with $3.8 million a year earlier, on higher employee-related costs, including a $2.9 million increase in stock-based compensation, and higher professional fees.
Net loss was $60.2 million for the second quarter of 2026, compared with $29.8 million a year earlier. Net loss per share was $1.32, versus $39.11 a year earlier, as weighted-average shares outstanding rose to 45.4 million from 0.76 million.
Kroeger said that with positive ZEPHYR data and continued VISTA progress, the company is focusing efforts on advancing ML-007C-MA in both schizophrenia and ADP, and that, together with the private placement and continued capital discipline, it believes it is well positioned to execute through those milestones.