COGNITION THERAPEUTICS INC (CGTX)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 EPS of $(0.11) missed Wall Street consensus of $(0.105) by $0.005; revenue was not reported and consensus modeled $0, consistent with CGTX’s pre-revenue status. Values retrieved from S&P Global* .
• Cash runway extended to the second quarter of 2026 (from Q1 guidance of into the fourth quarter of 2025), supported by disciplined OpEx and ongoing grant funding; cash and restricted cash were $11.6M at quarter-end with $41.9M in obligated NIA grant funds remaining .
• Regulatory catalysts advanced: FDA EOP2 meeting minutes confirmed that two six‑month Phase 3 studies could support an NDA in Alzheimer’s, with p‑tau217‑based enrichment affirmed; DLB breakthrough therapy designation application filed (decision expected Q3 2025) .
• Clinical execution: START Phase 2 study surpassed 50% enrollment; DLB Expanded Access Program launched and sites onboarding; positive AAIC data highlighted behavioral improvements in DLB and biomarker shifts in AD—key narrative drivers heading into Phase 3 planning .

What Went Well and What Went Wrong

What Went Well

• START Phase 2 AD study enrollment exceeded 50% with ACTC collaboration and $81M NIA grant support; management highlighted strong interest in oral zervimesine and potential for greater benefit in lower pathology patients (“we expect that patients with less disease pathology may experience the most benefit”) .
• FDA alignment: EOP2 minutes confirmed enriched Phase 3 design using plasma p‑tau217; CEO emphasized “aligned with the FDA on a registrational plan... two six-month Phase 3 studies could support a new drug application” (cost-effective and faster path) .
• DLB EAP launched with philanthropic funding and initial site activated; onboarding of additional sites underway, strengthening real‑world access and patient momentum .

What Went Wrong

• EPS missed consensus by $0.005 and the company remains pre‑revenue, underscoring funding dependence and the importance of grants/financing to sustain trials. Values retrieved from S&P Global* .
• Cash declined sequentially to $11.6M from $16.4M in Q1 2025 as clinical activities progressed, highlighting the need to maintain external capital sources alongside grants .
• Continued net losses (Q2 net loss of $6.7M), albeit improved year‑over‑year due to lower G&A; ongoing operating loss reflects clinical investment ahead of potential Phase 3 starts .

Financial Results

P&L and EPS (quarterly, $USD Thousands unless noted)

Notes:

• Company did not report product revenues; operating model remains grant-supported with no recognized sales .

Balance Sheet Liquidity (end of period, $USD Thousands)

Consensus vs Actual (Q2 2025)

Values retrieved from S&P Global*

KPIs and Clinical Execution

Segment breakdown: Not applicable (no product revenue) .

Guidance Changes

No revenue/margin/OpEx guidance ranges provided (beyond qualitative cash runway). Tax rate, OI&E, dividends not applicable .

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available in the document catalog; themes synthesized from company 8‑K and press releases .

Management Commentary

• “The second quarter of 2025 has been very productive, with milestones from each of our clinical programs… These accomplishments highlight the potential for zervimesine to slow the progression of age‑related degenerative diseases” — Lisa Ricciardi, President & CEO .
• “Later this month we anticipate receiving the FDA’s minutes from our end‑of‑Phase 2 meeting… we expect FDA will have a decision on breakthrough designation for zervimesine in DLB in the third quarter 2025” — Lisa Ricciardi .
• “FDA concurred with our plan to enrich the Phase 3 study population with Alzheimer’s patients who have lower p‑tau217… This enrichment strategy may increase the power of the study and reduce trial costs” — Anthony Caggiano, CMO & Head of R&D .
• “Among the NPI‑12 components, hallucinations, delusions, and anxiety… This made zervimesine’s impact even more notable” — Dr. James E. Galvin (AAIC presentation) .

Q&A Highlights

• No earnings call transcript for Q2 2025 was found; management’s clarifications came through regulatory and clinical press releases (EOP2 minutes, START enrollment, DLB EAP) .
• Key clarifications: Phase 3 design elements (six months; p‑tau217 enrichment; endpoints affirmed), open‑label extension planned, and breakthrough designation timing for DLB (Q3 2025 decision) .
• Financing and capital plans were subsequently disclosed in late August via a $30M registered direct offering to prepare for Phase 3 programs (post‑quarter catalyst) .

Estimates Context

• Q2 2025: EPS $(0.11) vs consensus $(0.105) — a small miss of $0.005; consensus revenue $0 with no product revenue reported. Values retrieved from S&P Global* .
• Implication: With G&A continuing to decline YoY and R&D broadly stable, forward estimates may modestly reflect lower OpEx trajectory and extended cash runway, while near‑term EPS variability will remain a function of grant income and clinical cadence .

Key Takeaways for Investors

• FDA EOP2 minutes de‑risk AD registrational path; the affirmation that two six‑month Phase 3 studies could support NDA is a material catalyst and should aid partnering discussions and capital access .
• DLB program has tangible momentum (breakthrough application filed; EAP launched), providing a second potential registrational path and real‑world exposure ahead of Phase 3 .
• Cash runway extended into Q2 2026 with $41.9M obligated grants remaining, reducing near‑term financing pressure; post‑quarter $30M offering further supports Phase 3 preparation .
• Clinical signals are strengthening: AAIC data underscored robust behavioral benefits in DLB and biomarker effects in AD subgroups (p‑tau217‑low), enhancing the mechanistic and clinical narrative heading into Phase 3 .
• Near term trading: Watch for DLB breakthrough designation decision, Phase 3 AD protocol finalization, and incremental START enrollment updates as share‑price catalysts .
• Medium term thesis: Zervimesine’s differentiated σ‑2 receptor mechanism and p‑tau217 enrichment strategy could deliver competitive efficacy with an oral profile; partnership optionality remains a key strategic lever .
• Risk management: Continued lack of product revenue and ongoing net losses necessitate disciplined OpEx and grant/financing support; trial execution and regulatory timelines remain critical to valuation .

Footnote: Values retrieved from S&P Global* for consensus estimates.