COGNITION THERAPEUTICS INC (CGTX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 delivered a narrower net loss of $4.93M (EPS $(0.06)) versus $9.94M (EPS $(0.25)) a year ago, driven by a sharp reduction in R&D spend as two Phase 2 trials wound down; EPS was above S&P Global consensus of $(0.09)* .
• Cash runway extended materially following a $30M registered direct offering: cash rose to $39.8M with remaining NIA grant funds of $36.3M; management now guides runway into Q2 2027 (vs Q2 2026 previously) .
• Strategic progress: alignment with FDA on a registrational path in Alzheimer’s disease (p‑tau217–enriched Phase 3 design, two six‑month studies could support NDA), and continued momentum in the START early AD study (surpassed 75% enrollment in Q3 period) .
• Near-term stock catalysts center on regulatory clarity (registrational strategy), capital runway de‑risking, and clinical execution (START trajectory, DLB EAP), with no revenue recognized (grant income only) .

What Went Well and What Went Wrong

What Went Well

• FDA alignment on registrational path for zervimesine in AD: “The alignment we achieved with the FDA on a registrational path in Alzheimer’s disease was an important accomplishment… [supporting] faster, more cost-effective studies” — Lisa Ricciardi, CEO .
• Operating leverage: R&D fell to $3.8M (from $11.4M YoY) as SHINE and SHIMMER completed; G&A fell to $2.6M (from $3.1M) on lower stock comp, supporting the EPS beat vs consensus* .
• Balance sheet strengthened: closed $30M financing; quarter-end cash $39.8M; runway now into Q2 2027, de‑risking the next development stage .

What Went Wrong

• Grant income declined to $1.2M (from $4.3M YoY), reducing the offset to OpEx and partially limiting the net loss improvement versus a scenario with higher grant draw .
• No product revenue; the model remains dependent on grants and capital markets while advancing registrational studies (no top-line sales contribution) .
• Shares outstanding increased materially (WASO 77.95M vs 40.42M YoY), reflecting financing needs and dilutive capital raises typical of development-stage biotech .

Financial Results

P&L, Cash and Grants (USD Millions, except per-share)

Notes: No product revenue reported; “Other income, net” and interest expense were not primary drivers of the sequential change .

Q3 YoY Reference (select items)

Results vs S&P Global Consensus

Interpretation: Q3 EPS was above consensus (less negative than $(0.09)), aided by lower R&D and G&A; revenue was expected at zero (biotech stage)*.
*Values retrieved from S&P Global.

Share Count and Financing

KPIs / Operating Milestones

Note: “Margins” and segment breakdown are not applicable given no commercial revenue.

Guidance Changes

Earnings Call Themes & Trends

(No Q3 earnings call transcript was found; themes reflect company press releases and 8‑K disclosures.)

Management Commentary

• “The $30 million registered direct offering enables us to begin preparations for the next stage of development for zervimesine (CT1812)… The alignment we achieved with the FDA on a registrational path in Alzheimer’s disease was an important accomplishment… [supporting] faster, more cost-effective studies.” — Lisa Ricciardi, President & CEO .
• “In the meeting minutes, 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, MD, PhD, CMO .
• “One of the most important outcomes… was the FDA’s view that two six-month Phase 3 studies could support a new drug application for zervimesine.” — Lisa Ricciardi, President & CEO .

Q&A Highlights

• No Q3 2025 earnings call transcript was available in our document set; no additional Q&A clarifications to report beyond press releases and the 8‑K [earnings-call-transcript search returned none].

Estimates Context

• EPS beat: Q3 actual $(0.06) vs S&P Global consensus $(0.09); prior quarters were in line to slightly below: Q2 actual $(0.11) vs $(0.105); Q1 actual $(0.14) vs $(0.116). Coverage count at 4–5 estimates across quarters, with revenue expected at $0 given stage [GetEstimates table above].
• Implication: With OpEx declining from trial completions and lower SBC, near‑term EPS trajectories can remain sensitive to R&D cadence, grant draw timing, and any pre‑Phase 3 spend. Model updates likely lift near‑term runway assumptions and reduce dilution risk assumptions post‑raise .
  *Values retrieved from S&P Global.

Key Takeaways for Investors

• Strategic de‑risking: FDA alignment on a registrational path (including p‑tau217 enrichment and a potentially streamlined 2×6‑month Phase 3 package) is a pivotal step toward NDA eligibility .
• Balance sheet extended: The $30M raise and $39.8M quarter‑end cash push runway into Q2 2027, reducing near‑term financing overhang as Phase 3 preparations begin .
• Execution momentum: START enrollment advanced past 75% during Q3 period and DLB EAP is active, supporting both breadth and depth across indications .
• P&L inflection drivers: Lower R&D (end of SHINE/SHIMMER) and lower SBC in G&A reduced quarterly losses; grant income variability remains a swing factor .
• Trading lens: Near‑term share moves likely tied to registrational plan clarity, Phase 3 start logistics/timing, and any partnership catalysts; dilution risk is moderated but not eliminated in a non‑revenue biotech.
• Medium-term thesis: Non‑amyloid mechanism (sigma‑2) with biomarker-enriched design may position zervimesine for complementary use and broader patient reach if efficacy replicates in Phase 3 .
• Monitoring items: Phase 3 initiation timing/design finalization, START data cadence, DLB regulatory interactions (e.g., breakthrough designation status), and grant utilization pace .

Citations:

• Q3 2025 8‑K and press release (financials, highlights, and tables)
• Q2 2025 8‑K and press release (prior-quarter comps)
• Q1 2025 8‑K and press release (trend analysis)
• EOP2 minutes/registrational plan press release (FDA alignment details)
• Financing press releases ($30M registered direct)
• START enrollment progress (75% in Q3 period)

S&P Global Estimates: All values with an asterisk (*) are retrieved from S&P Global.