Announcement • Jul 27

Maplight Therapeutics Announces Positive Topline Results from Phase 2 Zephyr Trial of Ml-007C-Ma in Schizophrenia

MapLight Therapeutics, Inc. announced positive topline results from its Phase 2 ZEPHYR trial evaluating ML-007C-MA, an oral M1/M4 muscarinic agonist (betovumeline) co-formulated with a peripherally acting anticholinergic (fesoterodine), in adults with an acute exacerbation of schizophrenia. The trial met its primary endpoint, with the 210/3 mg twice-daily (BID) dose demonstrating a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5. In the modified intent-to-treat (mITT) population, the BID arm achieved an effect size of 0.37 (Cohen’s d) and these participants experienced a mean 4.5-point improvement in PANSS total score versus placebo (p=0.015). In a prespecified analysis of participants who completed five weeks of treatment, in which there are no modelled assumptions for missing data, the effect size was 0.50 (LS mean difference from placebo -6.0, p=0.002), driven by greater improvement in the treatment arm rather than the placebo arm. ML-007C-MA also achieved significance on key secondary endpoints in the BID arm, including Clinical Global Impression of Severity (CGI-S) (effect size=0.48; p=0.002), PANSS positive Marder factor (effect size=0.39; p=0.012), and multiple other secondary and exploratory outcomes. ML-007C-MA demonstrated a robust and clinically meaningful improvement in cognitive performance in the BID arm, based on the pre-specified secondary endpoint assessed via the Cogstate battery in participants with baseline cognitive impairment (effect size=0.51; 0.44 points versus placebo; p=0.041). This cognitive benefit did not demonstrate correlation with the change in PANSS score, suggesting the effect was independent of, and not secondary to, improvement in psychotic symptoms. The 330/6 mg once-daily (QD) dose, which results in lower daily exposure than BID dosing, demonstrated numerical improvement over placebo, but did not achieve statistical significance on the primary endpoint. However, it did demonstrate separation on CGI-S (p=0.036), PANSS positive Marder factor (p=0.045), and Readiness for Discharge Questionnaire (p=0.027) and numerical separation on several other endpoints. The Company is conducting further analyses to inform the potential path forward for a once-daily regimen. ML-007C-MA was generally well tolerated across all doses studied. Treatment-emergent adverse events (TEAEs) were mostly mild and primarily cholinergic in nature, and there were no serious adverse events or drug-related severe TEAEs with either dose. The only severe TEAE in an active arm was a case of pneumonia, which was assessed as unrelated to study treatment. One serious TEAE of worsening schizophrenia occurred in the placebo arm. All-cause discontinuation across both active arms was low, at 19.9%. At the 210/3 mg BID dose, TEAEs were reported in 74.7% of participants compared with 48.1% receiving placebo, with most events mild in severity. Gastrointestinal events were mostly mild and rarely associated with discontinuation (two participants, 2.0%), and there were low rates of moderate GI events. No participant failed to reach target dose due to tolerability, and dose reductions due to TEAEs were infrequent (four participants, or 4.0%, three of whom completed treatment). The rates of anticholinergic events were low, and no clinically meaningful signals were observed with ML-007C-MA for urinary retention, metabolic or hepatic parameters, extrapyramidal symptoms, or blood pressure. Small increases in heart rate were observed, consistent with the known profile of fesoterodine. With no fasting requirement and a short, one-dose titration, these clinical trial results are expected to translate into real-world use, supporting patient adherence and compliance. The Company plans to engage with the FDA at an End-of-Phase 2 (EOP2) meeting to discuss the path forward for ML-007C-MA in schizophrenia, including the design of a Phase 3 trial which, together with ZEPHYR, would support an initial New Drug Application (NDA) submission. Planning and site identification for this additional, confirmatory trial are already underway ahead of the MapLight's EOP2 FDA interactions. The Company is also planning a separate confirmatory trial to evaluate the BID dose used in ZEPHYR along with other dosing regimens, including a possible QD option. VISTA, MapLight’s ongoing trial designed to support registration for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis, is also evaluating ML-007C-MA 210/3 mg BID (the same dose associated with the cognitive effect in ZEPHYR), with topline results expected in the second half of 2027. ZEPHYR is a randomized, double-blind, placebo-controlled trial at 25 US sites that evaluated the efficacy, safety, and tolerability of ML-007C-MA in inpatient adult participants with schizophrenia experiencing an acute exacerbation of psychosis. A total of 307 participants 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 was the change in PANSS total score from baseline to Week 5. Key secondary endpoints included change in CGI-S score and PANSS-Marder positive and negative factor scores from baseline to Week 5. Change in cognitive function in participants with baseline cognitive impairment from baseline to Week 5 was assessed as a prespecified secondary endpoint. ML-007C-MA is an oral, extended-release, fixed-dose combination of the investigational M1/M4 muscarinic agonist ML-007 (betovumeline), co-formulated with a peripherally acting anticholinergic (fesoterodine). ML-007C-MA is designed to activate both M1 and M4 muscarinic receptors in the central nervous system to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. Additionally, the Company recently reported results for IRIS, a Phase 2 trial evaluating ML-004, an 5-HT1B/1D agonist in autism spectrum disorder (ASD), where a prespecified subgroup analysis in adolescents with significant baseline irritability demonstrated meaningful improvement over placebo on both caregiver- and clinician-rated scales alongside a favorable safety and tolerability profile. Based on these results, the Company intends to engage with the FDA in an EOP2 meeting to determine the next steps for development of ML-004 in irritability associated with ASD.

Biotechs Industry Growth	17.04%
Revenue growth rate	n/a
Return on equity	-65.99%
Net Margin	n/a
Last Earnings Update	30 Jun 2026

Date	Earnings	G+A Expenses	R&D Expenses
30 Jun 26	-230	44	199
31 Mar 26	-199	38	172
31 Dec 25	-161	31	138
30 Sep 25	-103	14	94
30 Jun 25	-92	14	84
31 Mar 25	-81	14	73
31 Dec 24	-78	14	69
31 Mar 24	-63	10	54
31 Dec 23	-56	8	50

Data	Last Updated (UTC time)
Company Analysis	2026/09/09 16:09
End of Day Share Price	2026/09/09 00:00
Earnings	2026/06/30
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Malcolm Hoffman	BMO Capital Markets Equity Research
Sumant Satchidanand Kulkarni	Canaccord Genuity
Adam Vogel	Craig-Hallum Capital Group LLC

MapLight Therapeutics Past Earnings Performance

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Insider recently bought US$149k worth of stock

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New minor risk - Share price stability

Co-Founder recently sold US$260k worth of stock

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Independent Director recently bought US$253k worth of stock

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