LPCN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-04

• Although the primary endpoint in the study was not met, in a post hoc analysis of the data, numerous anomalies at one high-enrolling site raise substantive questions about the validity of the data from that site. First, about 40% of participants at this site had no evidence of study drug in the bloo…

• We believe that exclusion of the data from this outlier site signals LPCN 1154’s treatment effect – a rapid, sustained, and clinically meaningful improvement in depression symptoms - not only based on HAM-D findings, but also other scales such as MADRS and HAM-A. The results with the exclusion of th…

• Placebo-Adjusted Difference Statistical Significance Placebo-Adjusted Difference Statistical Significance

• NSS, not statistically significant. Data are least-squares means placebo-adjusted difference from mixed model for repeated measures using all timepoints. P-values are nominal.

• Based on a post hoc analysis of exclusion of data from participants from the outlier site, we plan to further evaluate these findings. We have requested a guidance meeting with the FDA and the meeting is scheduled for the third quarter of 2026. We have initiated a new placebo controlled clinical tri…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Although the primary endpoint in the study was not met, in a post hoc analysis of participants with a history of psychiatric conditions diagnosed using Mini-International Neuropsychiatric Interview (MINI, a structured diagnostic interview used to screen for and diagnose psychiatric disorders using D…

• Based on a post hoc analysis of participants with a history of psychiatric conditions identified using the MINI, we plan to further evaluate these findings. We have submitted requests for breakthrough therapy and fast track designations for LPCN 1154 in PPD; however, the FDA may not grant either des…

• We continue to explore the possibility of partnering with a third party for the further development, marketing and commercialization of LPCN 1154, although no partnering agreement has been entered into by the Company. No assurance can be given that any partnering agreement will be completed, or, if …

• LPCN 2203 is an oral candidate for management of essential tremor (“ET”) comprising a bioidentical GABAA modulating NAS. We have successfully completed oral pharmacokinetics with bioidentical GABAA and are planning to submit a protocol for a proof-of-concept Phase 2 study for ET to the FDA.

• Essential Tremor is one of the most common movement disorders in the United States, affecting an estimated 7 million in the U.S. For ET patients, uncontrollable shaking of the hands, head, voice, or legs creates difficulty eating, dressing, writing, and pursuing other day-to-day tasks. The etiology …