Sign in
CT

COGNITION THERAPEUTICS INC (CGTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 recap centered on full-year reporting: CGTX ended FY 2024 with cash and equivalents of $25.0M and remaining obligated NIA grant funds of $50.0M; management reprioritized to Alzheimer’s and DLB, concluding the dry AMD study to extend runway into Q4 2025 .
  • Wall Street consensus EPS for Q4 2024 was -$0.156; reported actual was -$0.17 (miss of ~$0.01). FY 2024 EPS consensus -$0.80 vs actual -$0.86 (miss of ~$0.06). Consensus revenue was $0.00 for Q4 and FY 2024.
  • Clinical catalysts strengthened the narrative: SHIMMER topline results in DLB showed improvements across behavior, function, cognition and movement, including 82% slowing on NPI and 91% slowing in attention fluctuations; SHINE subgroup with lower p‑tau217 showed near-total preservation of cognition .
  • Near-term inflection points: end‑of‑Phase 2 FDA meetings planned for both Alzheimer’s and DLB (starting early Q2 2025) and active partnering discussions to fund Phase 3 programs; new CMC process filed via provisional patents to support Phase 3 readiness .

What Went Well and What Went Wrong

What Went Well

  • Strong DLB signal: “CT1812 produced strong therapeutic responses across behavioral, functional, cognitive, and movement measures” with 82% slowing in NPI and 91% slowing in attention fluctuations .
  • Alzheimer’s subgroup insight: “near‑total preservation of cognition (via ADAS‑Cog11 and MMSE) in zervimesine‑treated Alzheimer’s patients who had lower p‑tau217 levels” .
  • Operational readiness: “Our CMC team has developed a novel chemical process for the manufacture of zervimesine... Provisional patent applications... filed” supporting Phase 3 readiness .

What Went Wrong

  • EPS misses vs consensus: Q4 2024 EPS -$0.17 vs -$0.156 consensus; FY 2024 EPS -$0.86 vs -$0.80 consensus (driven by R&D investment and lower grant income)*.
  • Continued operating losses: FY 2024 net loss of $33.971M with total operating expenses of $53.966M, reflecting higher R&D to complete two Phase 2 trials .
  • Nasdaq minimum bid non-compliance risk persists (grace period extended; potential reverse split if needed) — a stock overhang until compliance is restored .

Financial Results

Quarterly Snapshot (Q2–Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Diluted EPS ($USD)$(0.18) $(0.25) $(0.17)*
Grant Income ($USD Millions)$7.311 $4.293 N/A
Total Operating Expenses ($USD Millions)$14.678 $14.463 N/A
Net Loss ($USD Millions)$7.041 $9.937 N/A
Cash & Equivalents ($USD Millions)$28.533 $22.011 $25.009 (year-end)

Notes:

  • Company reports grant income and no product revenue; quarterly product revenue not disclosed .
  • Values with asterisk retrieved from S&P Global.

Annual Comparison (FY 2023 vs FY 2024)

MetricFY 2023FY 2024
Net Loss ($USD Millions)$25.788 $33.971
Diluted EPS ($USD)$(0.86) $(0.86)
R&D Expense ($USD Millions)$37.196 $41.676
G&A Expense ($USD Millions)$13.528 $12.290
Cash & Equivalents ($USD Millions, year-end)$29.922 $25.009
Total Obligated NIA Grant Funds Remaining ($USD Millions)—$50.0

KPIs (Clinical Programs)

KPIQ2 2024Q3 2024Q4 2024
SHINE (AD) efficacy (ADAS‑Cog11 slowing, pooled 100/300mg)~39% slowing at 6 months Subgroup with lower p‑tau217: 95% slowing (ADAS‑Cog11), 108% (MMSE) Near‑total preservation in lower p‑tau217 subgroup reiterated
SHIMMER (DLB) toplineEnrollment complete; YE readout planned YE readout still targeted Strong signals: 82% slowing NPI; 91% slowing in attention fluctuations

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q3 2024Into Q2 2025 Into Q4 2025 Raised/extended
Regulatory Milestones2025Request end‑of‑Phase 2 FDA meetings (plan in progress) Separate end‑of‑Phase 2 meetings for AD and DLB starting early Q2 2025 Formalized timelines
Program Focus2025Continued START (early AD) and MAGNIFY (dry AMD) enrollment Concluded dry AMD (MAGNIFY) enrollment to prioritize AD & DLB and extend runway Reprioritized
CMC Readiness2024–2025—Novel zervimesine manufacturing process; provisional patents filed New capability

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Regulatory path (FDA)Planning next phase post SHINE; SHIMMER YE readout Plan end‑of‑Phase 2 meeting for AD; confirm DLB baseline characteristics Two end‑of‑Phase 2 FDA meetings (AD & DLB) starting early Q2 2025 Firming timelines
Biomarker‑driven enrichment (AD)Discussed efficacy and NfL changes; considering longer trials Lower p‑tau217 subgroup showed strong cognitive preservation Plan to enrich for “lower tau” similar to SHINE; cutoff TBD Operationalized
DLB outcome selectionDLB study designed to detect consistent trends YE readout anticipated FDA discussion to select co‑primary/composite outcomes; broad responses across subgroups Moving to pivotal design
Funding/BD strategyEvaluating options to extend runway Cash into Q2’25 Active partnering to fund Phase 3; ATM raised ~$12.8M in 2024; runway into Q4’25 Intensified
Manufacturing (CMC)——Novel process; provisional patents; domestic CMO engagement Phase 3 readiness
Listing compliance——Nasdaq granted additional 180 days; reverse split if needed Monitoring

Management Commentary

  • “We will submit [final study documents] to the FDA along with requests for 2 different end of Phase II meetings, one for Alzheimer’s and one for DLB.” — Lisa Ricciardi .
  • “We decided to conclude our dry AMD study… The reduced expense extends our runway and now 100% of our attention and resources are allocated to our Alzheimer’s and DLB programs.” — Lisa Ricciardi .
  • “We have an active business development program… The ideal scenario would be to find a partner… and obtain non‑dilutive funding for one or both indications.” — Lisa Ricciardi .
  • “Cash and cash equivalents as of December 31, 2024 were approximately $25 million and total obligated grant funds remaining from the NIA were $50 million… sufficient cash into the fourth quarter of 2025.” — John Doyle .
  • “We saw really good robust response [in DLB] across all the people that we recruited regardless of… age, gender, amyloid, alpha‑synuclein, or concomitant meds.” — Anthony Caggiano .

Q&A Highlights

  • AD enrichment strategy: Company intends to enrich next study for patients with “lower tau,” likely similar thresholds to SHINE; exact cutoff under evaluation with collaborators .
  • DLB pivotal design: FDA meeting will focus on outcome measure selection (standalone, co‑primary, or composite) given lack of standardized DLB guidance; confidence in neuropsychiatric endpoints .
  • Dose selection: Future operations likely below 300mg; similar efficacy observed at 100mg and 300mg with fewer side effects at lower doses; 200mg already studied in START and MAGNIFY .
  • Funding mix: Active partnering pursuit; ATM raised ~$12.8M in 2024; runway extended; grants expected to complete START; new grants less likely at Phase 3 stage .
  • Listing compliance: Granted six‑month grace period to regain $1 minimum bid; potential reverse split if necessary .

Estimates Context

PeriodMetricConsensusActual/ResultSurprise
Q4 2024EPS ($USD)$(0.156)*$(0.17)*Miss of ~$0.01*
Q4 2024Revenue ($USD Millions)$0.00*$0.00*In‑line*
FY 2024EPS ($USD)$(0.80)*$(0.86)*Miss of ~$0.06*
FY 2024Revenue ($USD Millions)$0.00*$0.00*In‑line*

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum: Multiple positive readouts (DLB SHIMMER; AD SHINE subgroup) de‑risk Phase 3 planning and provide clear endpoints for FDA dialogue .
  • Near‑term catalysts: End‑of‑Phase 2 meetings in early Q2 2025 for AD and DLB, plus potential partnering announcements — key stock drivers .
  • Funding runway improved: Reprioritization (dry AMD paused) and ATM proceeds extend cash runway into Q4 2025; NIA grant funds ($50M) support START trial completion .
  • Manufacturing readiness: New CMC process and domestic CMO engagement strengthen Phase 3 execution credibility .
  • Estimate alignment: Persistent non‑revenue model with grant income means EPS remains driven by R&D cadence; consensus should reflect higher development spend near pivotal transition*.
  • DLB opportunity: Broad responses across subgroups and strong neuropsychiatric signal position CT1812 well in an indication with limited competition .
  • Risk watchlist: Nasdaq bid-price compliance timeline and potential reverse split; partnering terms and dilution risk are pivotal for capital structure .