Cognition Therapeutics (CGTX) Q2 2024 earnings summary

Executive summary

• CT-1812, an oral drug for CNS and retinal degenerative diseases, is in multiple Phase 2 trials for Alzheimer's, dementia with Lewy bodies (DLB), and dry AMD, with ongoing and completed studies including SHINE, SHIMMER, START, and MAGNIFY.

• The SHINE Phase 2 trial in Alzheimer's showed a 39% slowing of cognitive decline versus placebo, with consistent positive trends across cognitive and functional measures, favorable safety at 100 mg, and significant reduction in neurofilament light chain at 300 mg.

• SHIMMER Phase 2 trial in DLB enrolled 130 patients, completed enrollment, and topline results are expected by year-end 2024; the trial is supported by NIH funding.

• Additional trials (START for early Alzheimer's and MAGNIFY for dry AMD) are actively enrolling, with an intermediate 200 mg dose being tested.

• No discontinuations due to adverse events in the 100 mg group; safety profile generally favorable, though liver enzyme elevations were observed at higher doses.

Financial highlights

• Cash and cash equivalents were $28.5 million as of June 30, 2024; remaining NIA grant funds totaled $57.3 million, with total cash and grant funds at $85.8 million.

• Research and development expenses rose to $11.6 million for Q2 2024, up from $8.5 million year-over-year, mainly due to increased clinical activity.

• General and administrative expenses decreased to $3.1 million from $3.3 million year-over-year.

• Net loss for Q2 2024 was $7.0 million ($0.18 per share), compared to $4.7 million ($0.16 per share) in Q2 2023.

• Cash runway is expected to fund operations into Q2 2025.

Outlook and guidance

• Sufficient cash to fund operations and capital expenditures into Q2 2025, but substantial additional funding will be required to continue operations and advance clinical programs beyond this period.

• Topline results from the SHIMMER trial in DLB are anticipated by year-end 2024; ongoing analysis of biomarker data from SHINE.

• Planning for larger, longer trials based on SHINE learnings, with focus on optimal dosing and safety.