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Cogent Biosciences, Inc. (COGT)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 operating expenses were $73.7M, other income was $5.8M, and net loss was $67.9M; year-end cash, cash equivalents and marketable securities were $287.1M, augmented by $25.0M ATM proceeds in Feb-2025, supporting a runway into late 2026 .
  • Management reiterated three pivotal readouts in 2025: SUMMIT (NonAdvSM) in July 2025, APEX (AdvSM) in 2H 2025, and PEAK (2nd-line GIST) by year-end 2025, with a planned NDA submission for bezuclastinib by end of 2025 .
  • December ASH updates highlighted strong clinical signals: SUMMIT showed 56% mean TSS improvement at 24 weeks and 89% achieving >50% tryptase reduction; APEX Part 1 showed 83% ORR at 100 mg BID (mIWG) and 100% ORR per PPR at 100 mg BID .
  • Additional February 2025 AAAAI update reported 65% mean TSS improvement at 48 weeks in SUMMIT OLE, reinforcing symptomatic benefit durability and tolerability .

What Went Well and What Went Wrong

What Went Well

  • Management emphasized a “transformational year” with three pivotal readouts and targeted NDA submission by end-2025; strong cash position supports execution .
  • SUMMIT OLE data demonstrated rapid and durable symptomatic improvements (56% mean TSS at 24 weeks; 65% at 48 weeks), with high rates of serum tryptase normalization and favorable tolerability .
  • PEAK trial enrollment completed (413 patients) and continued per IDMC recommendation; program timelines reaffirmed for year-end 2025 readout .

What Went Wrong

  • Cash runway guidance tightened versus earlier periods (Q2 2024 guided “into 2027” vs Q3/Q4 guiding “into late 2026”), reflecting higher development spend to accelerate pivotal programs .
  • APEX top-line timing moved from “mid-2025” (Q3) to “2H 2025” (Q4), suggesting modest schedule slippage for AdvSM readout .
  • Net loss widened year-over-year (Q4 2024: $67.9M vs Q4 2023: $54.4M) driven by higher R&D and G&A aligned to accelerated enrollment and pipeline expansion .

Financial Results

Income Statement Comparison (Quarterly)

Metric ($USD Millions)Q4 2023Q2 2024Q3 2024Q4 2024
Research & Development$48.7 $54.3 $63.6 $62.0
General & Administrative$9.5 $10.1 $11.8 $11.7
Total Operating Expenses$58.2 $64.4 $75.4 $73.7
Loss from Operations$(58.2) $(64.4) $(75.4) $(73.7)
Total Other Income, net$3.9 $5.4 $4.8 $5.8
Net Loss$(54.4) $(59.0) $(70.6) $(67.9)

EPS (as reported)

MetricQ2 2024Q3 2024Q4 2024
Net Loss per Share (Basic & Diluted)$(0.59) $(0.64) N/A (not provided in Q4 press release)

Balance Sheet (Quarter-end)

Metric ($USD Millions)Dec 31 2023Jun 30 2024Sep 30 2024Dec 31 2024
Cash, Cash Equivalents & Marketable Securities$273.2 $389.9 $345.5 $287.1
Working Capital$232.6 $330.0 $288.5 $240.8
Total Assets$313.4 $429.9 $384.0 $327.9
Total Liabilities$55.6 $56.7 $69.4 $71.6
Total Stockholders’ Equity$257.8 $373.2 $314.7 $256.3

KPIs (Clinical)

KPIPeriodValue
SUMMIT: Mean TSS improvement (24 weeks)ASH Dec-202456%
SUMMIT: Patients with >50% TSS reduction (24 weeks)ASH Dec-202476%
SUMMIT: >50% tryptase decrease by 4 weeksASH Dec-202489%
SUMMIT: Mean TSS improvement (48 weeks)AAAAI Feb-202565%
SUMMIT: Patients with >50% TSS reduction (48 weeks)AAAAI Feb-202588%
APEX (AdvSM) ORR per mIWGASH Dec-202452%; 83% at 100 mg BID
APEX ORR per PPRASH Dec-202488%; 100% at 100 mg BID
APEX median time to responseASH Dec-20242.2 months; median DoR/PFS not reached; 24-month PFS rate 82%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SUMMIT top-line20252H 2025 (Q3 2024) July 2025 (Q4 2024) Accelerated
APEX top-line2025Mid-2025 (Q3 2024) 2H 2025 (Q4 2024) Pushed later
PEAK top-line2025By end-2025 (Q2/Q3 2024) By end-2025 (Q4 2024) Maintained
Cash runwayMulti-yearInto 2027 (Q2 2024) Into late 2026 (Q3/Q4 2024) Lowered
Bezuclastinib NDA2025Not explicitly priorSubmit by end-2025 (Q4 2024) New
Expanded Access Programs (SM, GIST)Q1 2025Not explicitly priorInitiate in Q1 2025 (Q4 2024) New

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript for Cogent Biosciences was not available via our tools at the time of writing; themes are derived from press releases across quarters.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D execution and enrollmentPEAK enrollment to complete in Q3; SUMMIT/PEAK/APEX on track PEAK enrollment completed; accelerated SUMMIT; APEX ongoing SUMMIT Part 2 completed enrollment early; APEX enrollment complete Accelerating execution
Regulatory/PRO alignmentFDA alignment on MS2D2 for SUMMIT Part 2 Preparing registrational datasets across programs NDA planned by end-2025 Advancing toward filing
Pipeline expansion (KRAS, PI3Kα, FGFR2)Initiate FGFR2 Phase 1 in 2H 2024 Added KRAS program; CGT6297 PI3Kα data KRAS and PI3Kα updates reiterated; FGFR2 Phase 1 ongoing Building breadth
Patient accessNot highlightedInvestor webcasts and ASH data dissemination EAP initiation in Q1 2025 Positive access step

Management Commentary

  • “Cogent is preparing to report data from three bezuclastinib pivotal clinical trials this year… we are poised for a transformational year culminating with the planned submission of Cogent’s first NDA for bezuclastinib by the end of 2025.” — Andrew Robbins, President & CEO .
  • “The rapid, deep, and sustained symptomatic improvement reported by SUMMIT patients receiving bezuclastinib is very impressive… bezuclastinib has clear potential to establish itself as the best-in-class KIT inhibitor for systemic mastocytosis patients.” — Dr. Daniel J. DeAngelo (Dana-Farber/Harvard) .
  • “These results show the enormous promise that a highly potent, highly selective, non-brain penetrant KIT inhibitor may provide to this patient population.” — Andrew Robbins (APEX Part 1) .

Q&A Highlights

A Q4 2024 earnings call transcript for Cogent Biosciences could not be located via our document tools or internet sources during this analysis window; therefore, detailed Q&A themes and guidance clarifications from the call are unavailable at this time.

Estimates Context

  • Wall Street consensus estimates (S&P Global) for Q4 2024 EPS and revenue were unavailable due to request constraints at the time of analysis; as a development-stage biotech, Cogent’s reported results center on operating expenses, cash runway, and clinical timelines rather than product revenues [GetEstimates error].
  • Given the lack of available S&P Global consensus data for this period, we cannot assess beat/miss versus Street for EPS or revenue.

Key Takeaways for Investors

  • Three pivotal catalysts in 2025: SUMMIT (July), APEX (2H), PEAK (year-end), plus a planned NDA filing—these are likely the dominant stock drivers over the next 6–12 months .
  • Strong and durable symptomatic efficacy signals in SUMMIT (24–48 weeks) with favorable tolerability bolster confidence into July readout; positive APEX Part 1 ORR and biomarker reductions support AdvSM opportunity .
  • Cash runway into late 2026, enhanced by $25M ATM proceeds, supports execution through multiple readouts; watch spending cadence as R&D/G&A remain elevated .
  • APEX timing shift from mid-2025 to 2H 2025 introduces schedule risk; monitor enrollment completion and any further timeline updates .
  • EAP initiation in Q1 2025 may provide real-world exposure and patient support ahead of pivotal data, potentially de-risking access logistics .
  • Pipeline breadth beyond bezuclastinib (FGFR2, PI3Kα, KRAS) creates optionality; near-term valuation remains tightly tied to SUMMIT/APEX/PEAK outcomes .
  • Tactical positioning: anticipate heightened volatility into July and 2H readouts; risk-manage around clinical event path with runway-supported optionality .