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BICYCLE THERAPEUTICS PLC (BCYC)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered a double beat: revenue of $11.73M vs $8.25M consensus and EPS of $(0.85) vs $(1.07) consensus, driven by higher collaboration revenue and disciplined cost actions *.
  • Management pushed the Duravelo-2 dose selection and potential approval-pathway update to Q1 2026 (from Q4 2025), reflecting ongoing multi-agency regulatory feedback; BT5528 and BT7480 combo data now targeted for 1H 2026 .
  • Cash and cash equivalents were $648.3M at quarter-end (excluding $38.2M U.K. R&D tax credit received in October), with runway into 2028; OpEx included severance from an August workforce reduction .
  • Near-term catalysts center on Q1 2026 regulatory clarity (Duravelo-2), 2026 clinical initiations in radioconjugates, and mid-2026 combo readouts; timeline shifts may temper near-term sentiment but improve regulatory de-risking .

What Went Well and What Went Wrong

What Went Well

  • Collaboration revenue increased to $11.73M, up sharply year over year, supporting the beat vs Street expectations *.
  • Cash runway “into 2028” reaffirmed, bolstered by October receipt of $38.2M U.K. R&D tax credit; balance sheet remains robust to fund pivotal programs .
  • Pipeline execution continues: Duravelo-3 (NECTIN4-amplified breast cancer) and Duravelo-4 (NECTIN4-amplified NSCLC) are open and actively enrolling; CEO: “We look forward to providing updates in the first quarter of 2026” regarding zelenectide pevedotin’s path in mUC .

What Went Wrong

  • Timelines slipped: Duravelo-2 dose selection/approval-path update pushed to Q1 2026 (from Q4 2025), and BT5528/BT7480 combo data moved to 1H 2026, extending the near-term catalyst window .
  • R&D expense rose to $58.4M (vs $48.3M YoY), with severance from August workforce reduction; G&A also ticked up, widening the net loss to $(59.1)M YoY .
  • Revenue volatility remains evident across quarters (Q2 down to $2.92M), indicating lumpy collaboration timing that can complicate near-term modeling .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Collaboration Revenue ($USD Millions)$2.68 $9.98 $2.92 $11.73
R&D Expense ($USD Millions)$48.27 $59.06 $71.03 $58.43
G&A Expense ($USD Millions)$18.26 $21.12 $18.49 $18.86
Total Operating Expenses ($USD Millions)$66.52 $80.18 $89.52 $77.29
Net Loss ($USD Millions)$(50.80) $(60.75) $(78.95) $(59.10)
Net Loss per Share (Basic & Diluted, $)$(0.74) $(0.88) $(1.14) $(0.85)
Cash & Cash Equivalents ($USD Millions)n/a$793.0 $721.5 $648.3

Estimates comparison (S&P Global consensus):

MetricQ3 2025 ActualQ3 2025 ConsensusSurprise
Collaboration Revenue ($USD Millions)$11.73 $8.25*Beat
EPS ($)$(0.85) $(1.07)*Beat

Forward estimates (S&P Global consensus):

MetricQ3 2025Q4 2025EQ1 2026E
EPS ($)$(0.85) $(0.95)*$(0.82)*
Revenue ($USD Millions)$11.73 $7.31*$7.25*
# of EPS Estimates9*9*3*
# of Revenue Estimates12*11*5*

Values with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Duravelo-2 dose selection + potential approval-path update (zelenectide pevedotin in mUC)Regulatory updateFDA meeting Q4 2025; update thereafter Update expected 1Q 2026 after multi-agency feedback Delayed
Financial runwayThroughInto 2H 2027 (Q1) Into 2028 (Q2 and reaffirmed Q3) Extended
EphA2 human imaging (BRC pipeline)Data timingInitial human imaging data expected 2H 2025 Initial human imaging data expected 1H 2026 Delayed
BT5528 (EphA2 BDC) combo data in mUCData timingNot previously dated in Q1/Q2Presentation now in 1H 2026 Newly scheduled (later window)
BT7480 (Nectin-4 CD137 TICA) combo dataData timingNot previously dated in Q1/Q2Presentation now in 1H 2026 Newly scheduled (later window)
Operating savings / cost actionsMulti-year runwayNot specifiedStrategic cost realignment ~30% savings over runway period Initiated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1, Q2)Current Period (Q3)Trend
Regulatory/approval pathway (Duravelo-2, mUC)Q1: Dose selection “on track” for 2H 2025 ; Q2: FDA meeting planned for Q4 2025 Update now expected 1Q 2026 after multi-agency consultations Timeline extended to allow broader regulatory alignment
R&D execution – Radioconjugates (MT1-MMP, EphA2)Q1: Additional human imaging data at AACR; initial EphA2 imaging 2H 2025 ; Q2: More imaging data; 2026 trials planned EANM 2025 data; initial EphA2 imaging now 1H 2026; first company-sponsored clinical trial expected 2026 Continued technical progress; revised data timing
Capital allocation / runwayQ1: Runway into 2H 2027 Q2/Q3: Runway into 2028; workforce reduction and ~30% savings Strengthened liquidity and focus on priority assets
Workforce & leadershipQ1: New board and clinical leadership appointments Q2/Q3: Expanded Board and formed/expanded RAB; added global oncology leaders Deeper external expertise and governance maturation
Pipeline breadth (Nectin-4 in breast/NSCLC)Q1: Duravelo-3 initiation and strategy leveraging NECTIN4 amplification Q3: Duravelo-3 and -4 trials actively enrolling; Fast Track in TNBC and NSCLC reiterated via post-hoc analyses Execution across biomarker-driven expansion

Management Commentary

  • CEO Kevin Lee: “We are currently seeking broad regulatory feedback to make an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer. We look forward to providing updates in the first quarter of 2026” .
  • On pipeline breadth: “The development of zelenectide pevedotin for multiple Nectin-4 associated cancers is ongoing… Duravelo-3 [breast] and Duravelo-4 [NSCLC] are open and actively enrolling” .
  • On radioconjugates: EANM 2025 data “further supports the potential of MT1-MMP as a novel target… and highlights the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging” .
  • On talent: Added prominent oncology leaders to the Board and expanded RAB to “strengthen our innovation and strategic growth” .

Q&A Highlights

  • Q3 2025 earnings call transcript was not available in the document set or company repository; therefore, Q&A themes and any guidance clarifications from live discussion could not be synthesized [ListDocuments showed 0 earnings-call-transcript; see above].
  • Upcoming investor touchpoint: Jefferies Global Healthcare Conference fireside chat on Nov. 18; webcast/replay to be available on the investor site .

Estimates Context

  • Q3 2025 revenue and EPS exceeded consensus, with collaboration revenue the primary driver of upside; EPS beat reflects lower-than-expected OpEx vs Q2 and interest income tailwinds *.
  • Forward Street numbers imply continued losses with modest collaboration revenue cadence in Q4 2025–Q1 2026; timeline push-outs may prompt small near-term estimate trims but de-risk regulatory narrative for 2026 *.
    Values with * retrieved from S&P Global.

Key Takeaways for Investors

  • Double beat this quarter (revenue and EPS) driven by collaboration revenue and OpEx discipline; near-term prints likely remain volatile given partnership timing *.
  • Regulatory timeline extension to Q1 2026 for Duravelo-2 suggests prudence and broader alignment; expect this update to be a key stock catalyst .
  • Cash runway into 2028 remains a cornerstone of the thesis, supported by cost realignment and October U.K. R&D tax credit, enabling multiple 2026 milestones without near-term financing .
  • BT5528 and BT7480 combo data now slated for 1H 2026; these readouts, along with BRC clinical initiation, form a mid-2026 catalyst cluster .
  • Biomarker-led expansion (NECTIN4 amplification) continues across breast and NSCLC; Fast Track designations and Duravelo trial momentum underpin medium-term optionality .
  • Trading lens: watch for estimate revisions following timeline adjustments; near-term sentiment tied to clarity on Duravelo-2 in Q1 2026 and any interim collaboration updates *.
  • Medium-term: Funding runway plus mUC pathway clarity and multi-indication strategy position BCYC for asymmetric outcomes contingent on 2026 data/regulatory milestones .