Cognition Therapeutics, Inc. Q4 FY2023 earnings call

• Cognition's focus is on developing orally available drug candidates for age-related degenerative diseases. Leading candidate CT1812 is in clinical trials for Alzheimer's and dry AMD.
• SHINE trial (Phase 2 for mild to moderate Alzheimer's) completed enrollment of 153 patients, expects topline data mid-2024; preliminary analysis showed 3-point difference in cognitive decline slowing. Endpoints include safety, cognitive/functional scores, biomarkers.
• SHIMMER trial (Phase 2 for DLB) aims to complete enrollment and present topline data in H2 2023; CT1812 targets amyloid-beta and alpha-synuclein.
• START trial (Phase 2 for early Alzheimer's) is recruiting via ACTC network.
• MAGNIFY trial (Phase 2 for dry AMD) expects to enroll ~240 patients; assessing GA lesion size, safety, vision change.
• Scientific team published 2 manuscripts and made 11 presentations in 2023, supporting clinical development.

In 2023, research and development expenses were $37.2 million compared to $30.3 million in 2022. General and administrative expenses were $13.5 million in 2023 vs. $13.2 million in 2022. Net loss was $25.8 million or $0.86 per share in 2023 vs. $21.4 million or $0.91 per share in 2022. Cash and cash equivalents as of December 31, 2023, were approximately $29.9 million, and total grant funds remaining from the NIA were $67.5 million.

• Recently concluded an $11.5 million underwritten public offering, extending cash runway to May 2025.
• Look forward to Phase 2 data readouts in 2024 from SHINE, SHIMMER, MAGNIFY trials.

None explicitly detailed in the transcript, but general risks associated with clinical trial outcomes and forward-looking statements as per Safe Harbor provisions.

Q: Charles Duncan from Cantor Fitzgerald asked about clinically meaningful change in SHINE, completer rate, START trial update, and SHINE patient follow-up.

A: Lisa Ricciardi and Tony Caggiano responded, noting agreement on meaningful changes less than 3 points, no update on SHINE completer rate, no interim updates on START trial, and no open label extension for SHINE patients yet with plans to consider it.

Q: Jay Olson from Oppenheimer asked about SHINE patient baseline characteristics, top-line result sharing, and START study site activation.

A: Tony Caggiano said baseline characteristics not yet available, top-line results to be shared via press release and AAIC meeting, and sites for START are top ACTC network sites with enthusiasm.

Q: Mayank Mamtani from B. Riley Securities asked about ARIA expectation in SHINE, biomarker data in topline, MAGNIFY investigator feedback, and grant funding baked into runway.

A: Tony Caggiano noted no expectation of ARIA issues in SHINE, will report similar biomarkers as preliminary read, MAGNIFY has positive investigator feedback, and grant funding is drawn down as studies progress.