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Cue Biopharma, Inc. (CUE)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024: Collaboration revenue $1.576M (down 13% y/y), net loss $(9.496)M, EPS $(0.13); y/y declines in R&D and G&A reflect cost discipline .
  • Versus estimates: EPS beat (consensus $(0.145) vs actual $(0.128)), revenue slight miss (consensus $1.701M vs actual $1.576M). Drivers include timing of Ono collaboration revenue recognition and reduced manufacturing/clinical trial costs .
  • Strategic pivot: Regained worldwide rights to lead autoimmune program CUE-401; advanced CUE-501; added senior leaders (CBO Warren, interim CDO Baker, new director Sarraf), reinforcing autoimmune focus .
  • Near-term catalysts: Business update call “within the next couple of weeks” from Q4 release; continued maturation of oncology survival data (CUE-101/102) showcased at SITC with ORR 46% and mOS 21.8 months in 1L HPV+ HNSCC .
  • Liquidity: Cash and cash equivalents $22.5M at 12/31/24; cautionary going-concern disclosure highlights need for financing/partnership milestones to extend runway .

What Went Well and What Went Wrong

What Went Well

  • Regained worldwide development and commercialization rights for CUE-401, enabling strategic control and potential optionality across autoimmune indications .
  • Oncology data momentum: At SITC 2024, CUE-101 + pembrolizumab delivered ORR 46%, 12-month OS 91.3%, mOS 21.8 months; CPS 1–19 subgroup ORR 50%—durable benefit and favorable tolerability .
  • Cost discipline: Q4 R&D $7.2M (from $10.9M y/y) and G&A $4.0M (from $4.6M y/y), primarily lower manufacturing, clinical trial costs, and professional fees .
  • CEO tone: “Significant progress shaping the company for success…prioritized autoimmune programs…focused strategic business model” .

What Went Wrong

  • Revenue contraction: Q4 collaboration revenue $1.576M vs $1.821M y/y; decrease tied to timing of Ono collaboration revenue under the agreement executed in Q1 2023 .
  • Continued losses: Q4 net loss $(9.496)M; loss from operations $(9.633)M reflects limited revenue base with ongoing R&D investment .
  • Liquidity/risk: Cash $22.5M at year-end and explicit going-concern language—company forecasts require financing and partnership milestones to continue operations beyond 12 months .

Financial Results

P&L vs prior periods (USD)

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Collaboration Revenue ($USD Millions)$1.821 $2.658 $3.336 $1.576
Net Loss ($USD Millions)$(13.434) $(10.171) $(8.660) $(9.496)
Loss from Operations ($USD Millions)$(13.832) $(10.383) $(8.815) $(9.633)
R&D Expense ($USD Millions)$10.887 $9.530 $9.381 $7.184
G&A Expense ($USD Millions)$4.609 $3.511 $2.867 $4.021
Diluted EPS ($USD)$(0.28) $(0.20) $(0.17) $(0.13)

Balance Sheet

MetricQ4 2023Q3 2024Q4 2024
Cash & Cash Equivalents ($USD Millions)$48.514 $32.420 $22.459
Total Assets ($USD Millions)$61.530 $44.810 $32.191
Liabilities ($USD Millions)$24.445 $19.444 $14.692
Stockholders’ Equity ($USD Millions)$37.085 $25.366 $17.499

Estimates vs Actuals (S&P Global consensus)

MetricQ2 2024Q3 2024Q4 2024
Revenue Consensus Mean ($USD)$1.289M*$1.519M*$1.701M*
Revenue Actual ($USD)$2.658M$3.336M$1.576M
Primary EPS Consensus Mean ($USD)$(0.28)*$(0.19)*$(0.145)*
Primary EPS Actual ($USD)$(0.20)$(0.17094)$(0.128)
Primary EPS – # of Estimates3*3*2*
Revenue – # of Estimates4*4*5*

Values retrieved from S&P Global.*

Clinical KPIs (selected)

KPIQ2 2024Q3 2024Q4 2024
CUE-101 + pembrolizumab ORR (1L HPV+ R/M HNSCC)46% 46% 46%
12-month OS (combo, CPS ≥1)90–91.3% 91.3% 91.3%
mOS (combo, CPS ≥1)21.8 months 21.8 months 21.8 months
ORR (combo, CPS 1–19)50% 50% 50%
CUE-102 pancreatic DCR—67% 67%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayAs of Q2 2024Fund operations through Q2 2025 — (no update provided in Q4 PR)N/A
Cash runwayAs of Q3 2024Fund operations into Q4 2025 — (no update provided in Q4 PR)N/A
Burn rate commentaryQ2 2024 callTargeting reduced annual burn (~$40M to ~$30M) via prioritization/partnering Continued cost reductions reflected in lower R&D/G&A in Q4 Maintained strategic focus
Revenue/EPS guidanceQ4 2024Not providedNot providedMaintained (no quantitative guidance)
Operating expenses guidanceQ4 2024Not providedNot providedMaintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Autoimmune prioritizationStrategic shift to autoimmune; CUE-401 with Ono; 501 partnering in discussions Continued progress, positioned towards candidate selection Regained CUE-401 rights; adding senior autoimmune-focused leadership Increasing focus/optionality
Oncology survival dataEmphasis on maturing survival metrics; combo mOS 21.8m; ORR 46%; CPS-low benefit SITC update confirms ORR 46%, mOS 21.8m, 12-mo OS 91.3% Reiterated progress; enabling data to mature to support partnerships Stable-positive
Partnering strategyActive dialogues for CUE-101; plan randomized Phase 2; 501 partner discussions —Business update call planned; subsequent BI collaboration announced in April 2025 Advancing
Funding/cash runwayExtend runway via milestones, non-dilutive support, modest dilution if needed Cash ~$32.4M; runway into Q4 2025 Cash $22.5M; going-concern risk cautioned Tightening liquidity
Organizational changes—Appointed CBO Warren; strategy updates Added interim CDO Baker; director Sarraf Building development capacity

Management Commentary

  • “During 2024 and Q1 2025, we made significant progress shaping the company for success…ongoing advancement of our prioritized autoimmune programs and…highly focused strategic business model” — CEO Daniel Passeri .
  • “The combination [CUE-101 + pembrolizumab] has been well-tolerated and demonstrates durable clinical benefit…potential to improve response rates and quality of life” — Dr. Christine Chung, Moffitt Cancer Center (SITC oral) .
  • “12-month OS of 90% and mOS of 21.8 months…substantially better than historical pembrolizumab monotherapy” — CMO Matteo Levisetti .
  • “Measures…extended our runway to mid-2025, reduced…cash burn from approximately $40M per year to approximately $30M per year…additional partnering will further enhance our cash position” — CEO Daniel Passeri .

Q&A Highlights

  • CUE-501 design/clinical logistics: CMV seropositivity ~65–70%; alternative viral epitopes (SARS-CoV-2 near-universal); prior Immuno-STAT imaging supports tissue penetration—implications for trial screening/target engagement .
  • CUE-101 partnering interest: Maturing survival data viewed as key differentiator; randomized Phase 2 critical for de-risking; ongoing dialogues with multiple potential partners .
  • Competitive landscape: Compared survival metrics against LEAP-010 and other agents; emphasized durability and survival over response-rate headline comparisons .
  • Funding strategy: Layered milestones (ONO, prospective 501 partner) to bridge runway; avoid massively dilutive financing given sector valuations .
  • 501 partnering: Active diligence with several pharma; aim for upfront + FTE support; retain optionality over certain cell-type programs .

Estimates Context

  • Q4 2024: EPS beat (consensus $(0.145) vs actual $(0.128)); revenue miss (consensus $1.701M vs actual $1.576M). Sequentially, revenue fell versus Q3 due to timing/recognition under Ono agreement; expenses decreased on manufacturing/clinical trial and professional fee reductions .
  • Q3 2024: EPS modest beat; revenue beat vs consensus driven by Ono collaboration revenue .
  • Q2 2024: EPS beat and revenue beat, reflecting higher collaboration revenue vs consensus .
    Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Autoimmune strategy now central: Regained CUE-401 rights and advancing CUE-501; expect continued BD flow—monitor for structured deals to de-risk cash needs .
  • Oncology value remains: SITC efficacy/survival signals in HNSCC could catalyze partner interest; survival durability may be more persuasive than ORR alone .
  • Near-term events: Company signaled a business update call post-Q4; subsequent BI collaboration and financing in April 2025 strengthened validation/funding—watch for additional preclinical/IND steps .
  • Liquidity risk vs execution: Year-end cash $22.5M and going-concern language underline urgency of milestones/partnerships; operating expense reductions are visible, but non-dilutive capital remains key .
  • Estimates likely converge lower on revenue but improve on EPS: Lower Q4 revenue vs consensus and reduced OpEx suggest EPS sensitivity to expense discipline; consensus may recalibrate collaboration revenue timing.*
  • Trading lens: Headlines around autoimmune pivot and oncology survival updates can drive sentiment; confirmation of BD/partnering and any IND/clinical starts in autoimmune could be upside catalysts .
  • Risk management: Regulatory timelines, financing environment, and partner negotiations remain critical; explicit focus on partnering to mitigate capital access risk .

Source Documents Reviewed

  • Q4 2024 8-K (Item 2.02) including Exhibit 99.1: press release; full financials and commentary .
  • Q4 2024 press release: financial results; strategic and leadership updates .
  • Other Q4 press releases and updates: SITC data update ; Strategic Organizational Transition .
  • Prior two quarters: Q3 2024 results press release ; Q2 2024 results press release and earnings call transcript -.

Values retrieved from S&P Global.*