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Cue Biopharma, Inc. (CUE)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 revenue beat and EPS beat: collaboration revenue was $2.954M vs S&P consensus $2.000M*, and EPS was -$0.09 vs S&P consensus -$0.13*; the revenue outperformance reflected timing of Boehringer Ingelheim (BI) collaboration revenue recognition, and lower R&D supported the EPS beat .
  • Operating discipline: R&D fell to $7.9M from $9.5M YoY on lower clinical costs; G&A was $3.7M vs $3.5M YoY, with the increase primarily professional fees .
  • Liquidity strengthened: Cash and equivalents ended Q2 at $27.5M; earlier in April the company raised ~ $20M gross and received a $12M upfront from BI, and it guides cash runway into Q2 2026 .
  • Clinical catalysts: maturing CUE-101 data (in combo with pembrolizumab) showed ORR 50%, 12‑mo OS 88%, and mOS 32 months; management sees potential to establish a new standard of care in HPV+ HNSCC, a continuing narrative driver for the stock .

Note: Asterisks (*) denote S&P Global consensus values.

What Went Well and What Went Wrong

What Went Well

  • Revenue/EPS surprise: revenue of $2.954M beat S&P consensus $2.000M*, and EPS of -$0.09 beat S&P consensus -$0.13*, with management attributing revenue timing to BI collaboration and R&D savings aiding the loss per share .
  • Cost control: R&D expense declined to $7.9M from $9.5M YoY on lower clinical trial costs and employee compensation, indicating spending discipline into H2 .
  • Clinical momentum: New/updated CUE-101 data included ORR 50%, 12‑month OS 88%, mOS 32 months, and an additional complete response; CEO: “We made significant progress during the second quarter… supporting our belief that CUE‑101… has the potential to establish a new standard of care for HPV+ HNSCC patients.” .

What Went Wrong

  • Still loss‑making: Loss from operations was $(8.635)M and net loss $(8.482)M for Q2; while improved YoY, the company remains dependent on external funding and partnerships .
  • G&A uptick: G&A rose to $3.7M from $3.5M YoY, driven primarily by professional fees, a partial offset to R&D savings .
  • Financing/dilution overhang: April follow‑on (~$20M gross) and accompanying warrants increased fully diluted overhang; weighted avg shares rose notably into Q2 (95.46M), though liquidity and BI upfront improved runway to Q2 2026 .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Collaboration Revenue ($USD)$1.576M $0.421M $2.954M
Net Loss per Share (Basic & Diluted)$(0.13) $(0.17) $(0.09)
Research & Development ($USD)$7.184M $8.547M $7.910M
General & Administrative ($USD)$4.021M $4.173M $3.679M
Total Operating Expenses ($USD)$11.209M $12.720M $11.589M
Loss from Operations ($USD)$(9.633)M $(12.299)M $(8.635)M
Net Loss ($USD)$(9.496)M $(12.257)M $(8.482)M
Weighted Avg Shares (Basic & Diluted)74.238M 74.255M 95.459M
Cash & Cash Equivalents (End of Period) ($USD)$22.459M $13.136M $27.492M

Estimates vs Actuals (Q2 2025):

MetricEstimateActual
Revenue ($USD)$2.000M*$2.954M
EPS (Primary)-$0.13*-$0.09
# of EstimatesRevenue: 1*; EPS: 1*—

Values marked with * are retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayLiquidity—Funding into Q2 2026New disclosure
CUE‑401 IND TimingDevelopmentRights regained for CUE‑401 (Q4 FY24 update) FDA Pre‑IND feedback received; intends to file IND pending completion of final enabling studiesProgressing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
Autoimmune pivot / CUE‑401Prioritized autoimmune programs; regained CUE‑401 rights Positioning to advance CUE‑401 toward clinic FDA Pre‑IND feedback; intends to file IND pending final studies Improving execution
BI collaboration (CUE‑501)—Strategic collaboration with $12M upfront; up to ~$345M milestones Collaboration highlighted among Q2 biz updates Stable/expanding platform validation
Oncology/CUE‑101 dataOncology program maturation mentioned KOL event to showcase updates ORR 50%, 12‑mo OS 88%, mOS 32 mo; additional CR reported Strengthening data set
Capital & runwayCash $22.5M at YE’24 $13.1M cash at 3/31; April raise and BI upfront subsequent $27.5M cash at 6/30; runway to Q2’26 Improved liquidity
Regulatory——Pre‑IND FDA feedback for CUE‑401 Positive milestone

Management Commentary

  • “We made significant progress during the second quarter with highly encouraging clinical data… [CUE‑101] has the potential to establish a new standard of care for HPV+ HNSCC patients.” — Daniel Passeri, CEO .
  • “We are highly encouraged by the FDA’s positive feedback on our proposed development plan… [CUE‑401] is a potentially disruptive approach… to provide durable, long‑lasting immune rebalance and tolerance.” — Daniel Passeri, CEO .
  • “This patient had durable stable disease for close to two years and more recently demonstrated… a complete response… due to repeated stimulation and expansion of tumor‑specific T cells given the mechanism of action of CUE‑101.” — Matteo Levisetti, CMO .

Q&A Highlights

  • Not applicable; no Q2 earnings call transcript was available in the reviewed documents.

Estimates Context

  • Q2 2025 results beat S&P consensus on both revenue ($2.954M vs $2.000M*) and EPS (-$0.09 vs -$0.13*), with one covering estimate on each metric; consensus target price stood at $4.00* as of the period .
  • With revenue concentrated in collaboration accounting (BI), estimate dispersion is limited; mix/timing of collaboration revenue remains the key swing factor for near‑term models .

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Clean beat on revenue and EPS versus S&P consensus driven by BI collaboration revenue timing and leaner R&D, improving loss trajectory near‑term .
  • Strengthening liquidity from April financing and BI upfront supports runway into Q2 2026, reducing financing overhang for the next 12 months despite dilution optics .
  • CUE‑101’s maturing efficacy signal (ORR 50%, 12‑mo OS 88%, mOS 32 mo) remains the core upside narrative and potential partnering catalyst in HNSCC .
  • Autoimmune pipeline execution is advancing: Pre‑IND FDA feedback for CUE‑401 and an IND plan represent tangible steps toward first‑in‑human studies in a high‑need area .
  • Expense discipline evident as R&D declines YoY; watch G&A normalization as professional fees moderate vs Q2 uptick .
  • Revenue visibility remains tied to collaboration timing and milestones (BI, and any future deals), a modeling risk factor until product revenues emerge .

Additional Detail: Selected KPIs (Clinical)

KPI (CUE‑101 combo in 1L HPV+ HNSCC)Q2 2025 Status
Overall Response Rate (CPS ≥1)50%
12‑month Overall Survival88%
Median Overall Survival32 months (K‑M estimate)
Additional Complete Response ReportedYes (new CR reported July 16)

Sources

  • Q2 2025 8‑K and press release: financials, cash, business updates .
  • Q1 2025 8‑K/press release: comps and liquidity color .
  • Q4 2024 8‑K/press release: historical comps .
  • BI collaboration: terms and upfront .
  • Financing: April 2025 follow‑on pricing and structure .
  • Runway disclosure: into Q2 2026 .
  • FDA Pre‑IND feedback for CUE‑401 .
  • CUE‑101 clinical updates .