Cognition Therapeutics (CGTX) investor relations material

Executive summary

• Zervimesine advanced through multiple Phase 2 trials in Alzheimer's, DLB, and GA, meeting primary safety and tolerability endpoints and showing promising efficacy signals, including cognitive and biomarker benefits in Alzheimer's and significant improvements in DLB.

• Productive quarter included surpassing 50% enrollment in the Phase 2 START Alzheimer's study and positive topline results in the dry AMD study, with a 28.6% reduction in GA lesion growth at 18 months.

• Initiated expanded access program for DLB, received a philanthropic donation to support it, and applied for FDA breakthrough designation for zervimesine in DLB.

• Anticipates FDA feedback on end-of-Phase 2 meeting and breakthrough designation decision in Q3 2025.

• Zervimesine was generally well tolerated, with transient liver enzyme elevations and balanced adverse event rates.

Financial highlights

• Net loss was $6.7 million for Q2 2025, or $(0.11) per share, compared to $7.0 million, or $(0.18) per share, in Q2 2024; net loss for the six months ended June 30, 2025 was $15.2 million, down from $16.2 million year-over-year.

• Research and development expenses were $11.5 million for Q2 2025, nearly flat year-over-year; general and administrative expenses decreased to $2.5 million from $3.1 million.

• Grant income was $7.1 million for Q2 2025 and $12.2 million for the six months, primarily from NIH/NIA grants; obligated grant funds from the National Institute of Aging totaled $41.9 million.

• Cash, cash equivalents, and restricted cash were $11.6 million as of June 30, 2025.

• Sufficient cash runway projected into Q2 2026.

Outlook and guidance

• Existing cash, grant income, and recent offering proceeds are expected to fund operations into Q2 2026, assuming no further ATM or Lincoln Park equity line usage.

• Expects FDA minutes from end-of-Phase 2 meeting for Alzheimer's and breakthrough designation decision for DLB in Q3 2025.

• Ongoing evaluation of partnership opportunities to support zervimesine development.

• Substantial additional funding will be needed for ongoing and future clinical, regulatory, and commercialization activities.

• Company expects to continue incurring significant net losses and expenses as it advances its pipeline.