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COGNITION THERAPEUTICS INC (CGTX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered a net loss of $8.48M and diluted EPS of $(0.14), with grant income offsetting R&D and G&A, and no product revenue reported; EPS missed Wall Street consensus of $(0.116) by $0.024, while revenue aligned at $0 as expected *.
  • Management advanced regulatory strategy: requested an end-of-Phase 2 FDA meeting for Alzheimer’s (SHINE) and initiated a commercial IND process for DLB to enable a separate EOP2 meeting .
  • Cash and equivalents were $16.43M at quarter-end, with $47.0M in obligated NIA grant funds; runway guided “into the fourth quarter of 2025,” aided by pipeline prioritization .
  • Clinical momentum continues: DLB SHIMMER results accepted for AAIC podium, additional biomarker presentations planned at AD/PD 2025; manufacturing scale-up advances with a published process and provisional patents .
  • Listing risk mitigated: Nasdaq granted an additional 180 days to regain $1.00 bid compliance (transfer to Nasdaq Capital Market), with reverse split as a contingency—an overhang that could be a stock reaction catalyst near the compliance deadline .

What Went Well and What Went Wrong

What Went Well

  • Regulatory path clarity: “A request was made with the U.S. Food and Drug Administration to schedule an end-of-Phase 2 (EOP2) meeting to review the results from the SHINE study in Alzheimer’s disease and discuss plans for a registrational study.”
  • Dual-indication planning: “We recently initiated the process of securing a commercial investigational new drug (IND) application for zervimesine (CT1812) in DLB. Once that process is complete, we will request an EOP2 for DLB.”
  • Runway preserved: Cash guided into 4Q25, supported by $47M remaining NIA obligated grants; operating discipline evident in lower G&A YoY and focused clinical prioritization .

What Went Wrong

  • Earnings miss: Diluted EPS of $(0.14) missed consensus of $(0.116) by $0.024; net loss remained sizable at $8.48M *.
  • Cash drawdown: Cash declined sequentially from $25.01M (12/31/24) to $16.43M (3/31/25), reflecting continued trial and corporate spend despite grant inflows .
  • Listing pressure: Transfer to Nasdaq Capital Market and extension underscore ongoing minimum bid price noncompliance risk; reverse split may be required if share price does not recover by the extended deadline .

Financial Results

P&L and EPS vs prior periods and estimates

MetricQ1 2024Q3 2024Q1 2025
Net Loss ($USD Millions)$9.15 $9.94 $8.48
Diluted EPS ($USD)$(0.27) $(0.25) $(0.14)
Total Operating Expenses ($USD Millions)$14.10 $14.46 $13.78
Grant Income ($USD Millions)$4.91 $4.29 $5.09
Revenue (Reported)— (no revenue line reported) — (no revenue line reported) — (no revenue line reported)
EPS Consensus Mean ($USD)N/AN/A$(0.116)*
Revenue Consensus Mean ($USD Millions)N/AN/A$0.00*

Values with asterisks were retrieved from S&P Global.

Operating expense breakdown

MetricQ1 2024Q3 2024Q1 2025
R&D ($USD Millions)$10.55 $11.39 $10.79
G&A ($USD Millions)$3.55 $3.07 $2.99

Balance sheet and liquidity

MetricSep 30, 2024Dec 31, 2024Mar 31, 2025
Cash & Equivalents ($USD Millions)$22.01 $25.01 $16.43
Total Assets ($USD Millions)$27.58 $30.23 $23.50
Total Liabilities ($USD Millions)$13.10 $11.48 $11.23
Stockholders’ Equity ($USD Millions)$14.48 $18.75 $12.27

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayFY 2025Into 2Q25 (as of Q3 2024) Into 4Q25 (as of Q1 2025) Raised/extended
Regulatory Milestone – Alzheimer’s (SHINE)2025Plan to request EOP2 in early 2Q25 EOP2 meeting requested Advanced
Regulatory Milestone – DLB (SHIMMER)2025Plan to request separate EOP2 Initiated commercial IND to enable EOP2 Advanced/process defined
Nasdaq Listing Compliance2025Initial 180-day window to regain ≥$1.00 bid Additional 180 days; transferred to Nasdaq Capital Market; reverse split considered if needed Extended window; contingency added

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in source documents; themes derive from press releases and prior quarter communications .

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Alzheimer’s (SHINE) efficacy and biomarker subgroup95–108% slowing in low p‑tau217 subgroup; plan to request EOP2 EOP2 requested; AD/PD podium on biomarkers (NfL, GFAP, Aβ, p‑Tau217/218) Advancing to registrational planning; deepening biomarker evidence
DLB (SHIMMER) efficacyUp to 91% slowing across endpoints; ILBDC presentation AAIC podium accepted; commercial IND process initiated to enable separate EOP2 Continued momentum; regulatory preparation
Manufacturing/CMC readinessNovel chemical process developed; provisional patents planned Process published; polymorph with improved room‑temperature stability; provisional patents filed Strengthening Phase 3/commercial readiness
Capital allocation/prioritizationReprioritize to Alzheimer’s & DLB; conclude dry AMD MAGNIFY to extend runway MAGNIFY futility analysis positive masked signal; study concluded to preserve capital Focus maintained; resource optimization
Listing/complianceMinimum bid price notice (Sep 2024) Extension/transfer to Nasdaq Capital Market; reverse split contingency Ongoing listing overhang

Management Commentary

  • “During our first quarter of 2025 and in recent weeks, we continued to advance our Alzheimer’s disease and dementia with Lewy bodies (DLB) programs.” – Lisa Ricciardi, President & CEO .
  • “A request was made…to schedule an end-of-Phase 2 (EOP2) meeting to review the results from the SHINE study…and discuss plans for a registrational study.” – Lisa Ricciardi .
  • “We recently initiated the process of securing a commercial investigational new drug (IND) application for zervimesine (CT1812) in DLB…Once that process is complete, we will request an EOP2 for DLB.” – Lisa Ricciardi .
  • “Zervimesine delivered positive clinical data…Looking ahead, we will meet with the FDA on plans to start Phase 3 studies in Alzheimer’s disease and DLB.” – Lisa Ricciardi (FY 2024 release) .
  • “We can gain insight on the impact of zervimesine on disease biology by assessing changes in these biomarkers…” – Mary Hamby, Ph.D., VP of Research (AD/PD biomarker presentation) .
  • “The chemical process…more efficiently and safely synthesize zervimesine…identified a novel crystal form…with improved stability at room temperature.” – Steven A. Weissman, Ph.D., Head of CMC .
  • “Zervimesine-treated participants tested higher across behavioral, cognitive, functional and motor symptoms…” – Anthony O. Caggiano, MD, PhD, CMO .

Q&A Highlights

  • No Q1 2025 earnings call transcript found in available documents; FY 2024 call details were provided, but transcript not available in sources .
  • Guidance clarifications and tone changes cannot be assessed without the Q1 transcript.

Estimates Context

  • Q1 2025 diluted EPS of $(0.14) vs S&P Global consensus $(0.116); result was a miss of $0.024 per share*.
  • Revenue consensus was $0; reported results contained no revenue line item, consistent with expectation*.

Values with asterisks were retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory catalysts in 2H 2025: EOP2 outcomes for Alzheimer’s and DLB plus AAIC podium (DLB) and recent AD/PD biomarker presentations could reshape the registrational path and sentiment .
  • EPS miss reflects the timing of grant income and steady R&D execution; operating expenses decreased YoY and G&A declined, signaling cost control while advancing programs .
  • Cash runway guided into 4Q25, underpinned by $47.0M remaining obligated grants; continued prioritization (e.g., MAGNIFY conclusion) is key to sustaining runway without dilutive measures .
  • Manufacturing/CMC execution (published process, polymorph stability) supports Phase 3 readiness and potential future commercialization—an underappreciated de‑risking element .
  • Nasdaq listing extension and potential reverse split remain stock overhangs; traders should monitor compliance milestones and any corporate actions near the deadline .
  • Clinical narrative: strong DLB efficacy signals across behavior, function, fluctuations, and motor domains; Alzheimer’s subgroup biomarker (low p‑tau217) coherence strengthens patient selection thesis for Phase 3 .
  • Near-term: expect incremental data visibility (biomarker details, conference outputs); medium-term thesis depends on FDA alignment and funding solutions/partnering for registrational trials .