Cognition Therapeutics reports Q3 EPS (25c), consensus (22c)

“In the third quarter and recent weeks Cognition Therapeutics (CGTX) achieved one of the most important milestones in its history as the Phase 2 SHINE study results became available. Among the many findings in the SHINE study, new and compelling data presented at CTAD showed a near-total preservation of cognition in a sub-group of Alzheimer’s patients treated with CT1812 who had p-tau217 levels below median,” said Lisa Ricciardi, Cognition’s president and CEO. “We are moving rapidly to advance CT1812 in Alzheimer’s disease and plan to request an end-of-Phase 2 meeting with the FDA where we will review CT1812’s safety and tolerability profile as well as the totality of results from SHINE. We will seek alignment with the FDA on a pivotal Phase 3 program design in light of recent findings relating to lower levels of plasma p-tau217, an important biomarker of Alzheimer’s disease pathology easily measured with a blood test. In addition to the substantial progress we have made with CT1812 in Alzheimer’s disease, we expect to report top-line results from our Phase 2 SHIMMER study in mild-to-moderate dementia with Lewy bodies by the end of this year. DLB is the second most common neurodegenerative disease, yet few therapies have been studied in this indication and no disease-modifying treatments exist. SHIMMER will deliver safety and tolerability data in a second indication and potentially provide insights to be integrated into a larger clinical study in this under-studied and under-represented population.”