COGNITION THERAPEUTICS INC Q4 FY2021 earnings call

• Completed upsized IPO in November 2021, raising $52 million.
• Primary focus on developing orally available drug candidates for neurodegenerative diseases, leveraging sigma-2 receptor expertise.
• CT1812 in multiple trials: SNAP study showed rapid displacement of Aβ oligomers in Alzheimer's patients; SHINE study biomarker analysis showed protein changes in Alzheimer's/Parkinson's; SEQUEL study ongoing for mild to moderate AD with data readout anticipated by year-end.
• $80 million grant for early AD Phase II trial starting in second half of 2022.
• $30 million grant for DLB Phase II trial, initiated with primary investigator Dr. Jim Galvin; study design is three-arm with two doses of CT1812 vs. placebo, 6-month treatment with cognitive function and biomarker monitoring.
• Plan to initiate dry AMD clinical program in second half of 2022; leveraging AD trial patients for recruitment.
• Awarded second grant from Michael J. Fox Foundation for Parkinson's research, focusing on sigma-2 modulation of α-synuclein oligomers.

Research and development expenses for 2021 totaled $18.6 million compared to $12.9 million in 2020, an increase of $5.7 million primarily due to manufacturing expenses for preclinical and clinical trial materials. General and administrative expenses in 2021 were $10 million vs. $4.5 million in 2020, driven by equity-based compensation and D&O insurance. Net loss in 2021 was $11.7 million or $3.13 per share vs. $7.8 million or $23.76 per share in 2020. Cash and cash equivalents at December 31, 2021 were $54.7 million with available grant funding of $110 million, and the company estimates sufficient cash to fund operations into the second half of 2023.

• Anticipate data readout from SEQUEL study by year-end.
• Plan to initiate 540-patient Phase II trial for early AD in the second half of 2022.
• DLB Phase II trial is ongoing.
• Plan to initiate dry AMD clinical program in the second half of 2022.
• Sufficient cash to fund operations into the second half of 2023.

Q: Feedback from physicians and KOLs on CT1812, biomarker readout potential for cognitive benefit, and accelerated approval pathway.

A: Lisa Ricciardi noted positive feedback on biomarker work, and Tony Caggiano stated they are aware of FDA expedited programs and will discuss accelerating approval including use of biomarkers.

Q: Details on DLB study design, timelines, α-synucleinopathies, SHINE study, and dry AMD.

A: Tony Caggiano explained DLB study is three-arm with two doses of CT1812 vs. placebo, 6-month treatment with cognitive and biomarker monitoring; interest in other α-synuclein related diseases due to sigma-2 modulation of α-synuclein oligomers; SHINE study is ongoing with primary outcome measure ADAS Cog-11; dry AMD trial to initiate in second half of 2022, leveraging AD trial patients for recruitment.