MapLight Therapeutics, Inc. (MPLT) Earnings Call Transcripts

MapLight Therapeutics, Inc.'s Latest Earnings Call - June 22, 2026

In the second quarter of 2026, MapLight Therapeutics reported mixed results from the Phase II IRIS study for ML-004, targeting irritability in autism spectrum disorder (ASD). While the primary endpoint related to social communication deficits was not met, the study demonstrated significant improvements in irritability among adolescents, with effect sizes of 1.33 and a nominal p-value of 0.013 on the caregiver-reported ABC-I scale. Management signaled a clear path forward, indicating plans to request an end of Phase II meeting with the FDA to discuss future development steps, particularly focusing on the adolescent population with moderate to severe irritability.

Reported metrics

Guidance from management

Management plans to engage with the FDA for an end of Phase II meeting to discuss the next steps in development, particularly focusing on the adolescent population with moderate to severe irritability.

What management said

Erin, maybe you can address the first 2 questions, and then I can address the ZEPHyR study. I can jump in until Erin is able to join. So with respect to 16 as the primary endpoint, so 16, we prespecified that 16 cutoff because that really is commonly perceived to be kind of the cutoff for moderate irritability in autism. So that's why we chose the 16. We also showed the cut at 18. 18 is the cut for more severe irrita...

Dose response rate. Okay. Great. We haven't released the specific numbers on that. What I can tell you is that the vast majority of participants were able to escalate to their target dose and the target dose was based on their baseline weight and whether or not they were on oral contraceptive. And most of them were able to escalate to those doses and remain on those doses. So we did have a small proportion of partici...

What analysts pressed on

Analysts are worried about the implications of failing the primary endpoint in social communication while achieving positive results in irritability. Questions were raised regarding the sensitivity of the ABI-SC endpoint and the potential need for a more focused patient population in future studies.

Main topics on the call

• Phase II IRIS Study Results — The IRIS study did not meet its primary endpoint regarding social communication deficits but showed a compelling effect on irritability in adolescents. Management noted, "ML-004 demonstrated clinically meaningful improve...
• Safety Profile of ML-004 — ML-004 was well tolerated, with no severe or serious adverse events reported in the active treatment group. Management highlighted that "the majority of treatment-emergent adverse events were mild, transient and resolved...
• Regulatory Pathway and Future Steps — Management plans to request an end of Phase II meeting with the FDA to discuss the next steps in development. They stated, "We have a clear understanding of the design requirements, the patient population and the operati...
• Commercial Opportunity — The total addressable market for irritability in ASD is substantial, with management emphasizing the high unmet need due to the side effects of current therapies. They noted, "ML-004 represents a potentially attractive a...

Read the full MapLight Therapeutics, Inc. transcript (June 22, 2026) → Summary generated from the call transcript; every figure above is stated by management on the record.

Earnings Call History

EarningsCalls.dev has 2 MapLight Therapeutics, Inc. earnings call transcripts on record, spanning June 22, 2026 to July 27, 2026. The most recent call on file is dated July 27, 2026. The full list is below — each row opens the complete, free-to-read transcript.

Ticker

MPLT

Exchange

NasdaqGS

Country

US

Sector

Health Care

Industry

Biotechnology

Calls on record

2

First call

June 22, 2026

Most recent

July 27, 2026