COGNITION THERAPEUTICS INC Q4 FY2022 earnings call

• Clinical trial progress: Completed enrollment in Phase II SEQUEL study for mild to moderate Alzheimer's disease, expect top line data later in 2023; SHINE trial expanded internationally; SHIMMER trial enrolling patients with mild to moderate dementia with Lewy bodies; START trial preparing to enroll early Alzheimer's patients; Phase 2 dry AMD geographic atrophy trial (MAGNIFY) to commence in 2023.
• Grant funding: Received approximately $171 million in non-dilutive funding since founding, including grants from NIA, Michael J. Fox Foundation, etc.
• Financial position: Entered 2023 with solid financial footing, cash runway extended into second half of 2024; new agreement with Lincoln Park Capital provides potential liquidity.
• Podcast launch: Launched Cognition Conversations podcast to communicate mission and educate public on neuroscience research.

For the year ended December 31, 2022, research and development expenses totaled $30.3 million, general and administrative expenses were $13.2 million. The net loss was $21.4 million or $0.91 per basic and diluted share. Cash and cash equivalents at December 31, 2022 were $41.6 million, with $89 million in grant funding remaining. No specific product segment revenue contributions are detailed as the company focuses on clinical programs.

• Cash runway extended into the second half of 2024 due to expense control and capital strategies.
• Lincoln Park Capital agreement provides potential access to liquidity, enhancing optionality to access capital for continuing cash runway management.
• Anticipation of milestone-rich 2023 with ongoing clinical trial progress and expansion of indications.

Actual results could differ materially from forward-looking statements due to risks and uncertainties associated with the company's business, as cautioned by Safe Harbor provisions. No specific operational failures discussed in detail in the transcript.

Q: On SEQUEL, could you give sense of what's being looked for in EEG data and predictive value?

A: Completed enrollment, looking for top line data later in 2023; seeking shift in relative data power as measure of acute activity, which is believed to have predictive value for candidate's potential.

Q: On geographic atrophy program, connection of σ-2 receptor modulation and potential in neurodegenerative diseases?

A: Moved into geographic atrophy based on proteomic data from Alzheimer's study; σ-2 receptor regulates processes in retina and CNS, common features exist, but how they predict each other's success remains to be seen.

Q: On grants, is this a strategy going forward, percentage of R&D spend covered by existing grants?

A: Larger trials not much grant supported, looking at smaller grants going forward; 2022 grants covered approximately half operating expenses; grant revenue recognized as income as trials progress.

Q: On ADPD proteomic data and Alzheimer's mechanism, what to look for?

A: Presenting meta-analysis of Phase 2 SHINE study and SPARC study at ADPD, giving good candidate biomarkers for treatment effect, details to be seen in posters.

Q: On dry AMD, human genetic data on Sigma-2 receptor, patients in Alzheimer's study with dry AMD, and CT1812 in treatment landscape?

A: Genome wide studies show Sigma-2 receptor involvement in dry AMD; no screening for dry AMD in Alzheimer's study patients; oral drug has advantage over intravitreal injections, potential for combination regimens to be studied.

Q: On GA Phase 2 trial design, treatment period and Visual Equity?

A: Two-year treatment period based on FDA discussions; measuring visual acuity as safety measure but not primary endpoint.

Q: On Alzheimer's program, CSF biomarkers in SEQUEL and SHINE studies?

A: Using CSF biomarkers, identifying candidate biomarkers predictive of change, need data from acute studies to determine which markers are acute vs. chronic.