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BICYCLE THERAPEUTICS (BCYC)

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Earnings summaries and quarterly performance for BICYCLE THERAPEUTICS.

Research analysts covering BICYCLE THERAPEUTICS.

Recent press releases and 8-K filings for BCYC.

Bicycle Therapeutics Highlights 2025 Accomplishments and 2026 Strategic Priorities
BCYC
Guidance Update
New Projects/Investments
  • Bicycle Therapeutics expects its financial runway to extend into 2028 to support its clinical and strategic priorities.
  • The company anticipates providing an update on dose selection from the Phase 2/3 Duravelo-2 trial and the potential approval pathway for zelenectide pevedotin in 1Q 2026.
  • Initial data for the Phase 1/2 Duravelo-3 trial exploring zelenectide pevedotin in NECTIN4-amplified breast cancer is expected in the second half of 2026.
  • Progress in the emerging radiopharmaceuticals pipeline includes plans for additional EphA2 human imaging data in the first half of 2026 and established collaborations for an end-to-end supply chain for 212Pb.
3 days ago
Bicycle Therapeutics Highlights Clinical Progress and Financial Runway
BCYC
Guidance Update
New Projects/Investments
Product Launch
  • Bicycle Therapeutics reported cash and cash equivalents of $648.3 million as of September 30, 2025, providing an expected financial runway into 2028.
  • The company's lead candidate, zelenectide, a Nectin-4 targeting drug conjugate, demonstrated an Overall Response Rate (ORR) of 45% and a median Duration of Response (mDOR) of 11.1 months in 2L+ EV-naïve metastatic urothelial cancer (mUC) in the Ph1/2 Duravelo-1 study. An update on Duravelo-2 dose selection and potential expedited approval pathways in mUC is anticipated in 1Q 2026.
  • Bicycle Therapeutics is advancing its oncology pipeline with BT5528 (EphA2-targeting) and BT7480 (Nectin-4/CD137 targeting), both of which have Phase 1 combination data with nivolumab expected in 1H 2026. Additionally, new EphA2 human imaging data for its radioconjugate pipeline is also expected in 1H 2026.
3 days ago
Bicycle Therapeutics Provides Pipeline and Financial Updates at Jefferies Conference
BCYC
Guidance Update
New Projects/Investments
  • Bicycle Therapeutics updated the timeline for dose selection in the pivotal Phase II/III study for zelenectide pevedotin (DV-2) in bladder cancer, now expected in Q1 2026, a slight shift from Q4 2025, to allow for global regulatory feedback.
  • The company reported a strong financial position with $648 million in cash as of September, providing a cash runway into Q1 2028.
  • Significant updates for BT5528, targeting EphA2, are anticipated at a medical conference in H1 2026.
  • Bicycle is also exploring zelenectide's potential in Nectin-4 amplified solid tumors like breast and lung cancer, with studies actively enrolling.
Nov 18, 2025, 10:30 AM
Bicycle Therapeutics Provides Updates on Zelenectide Pevedotin Development and Financial Position
BCYC
Guidance Update
New Projects/Investments
  • Bicycle Therapeutics is advancing zelenectide pevedotin, a Nectin-4 targeted MMAE drug conjugate, in a seamless Phase 2/3 pivotal study for bladder cancer, with a dose selection update now expected in Q1 2026 to allow for global regulatory feedback.
  • The company reported $648 million in cash as of September, providing a cash runway into Q1 2028.
  • Beyond its lead program, Bicycle is developing BT5528 (targeting EphA2) with a significant update anticipated in H1 2026, and is also making significant efforts in radio conjugates.
  • Zelenectide pevedotin is also being explored for Nectin-4 amplified tumors, a potential opportunity in breast and lung cancers, with studies actively enrolling.
Nov 18, 2025, 10:30 AM
Bicycle Therapeutics Updates on Zelenectide Pevedotin Development and Financial Position
BCYC
Product Launch
Guidance Update
New Projects/Investments
  • Bicycle Therapeutics is advancing its lead molecule, zelenectide pevedotin, a Nectin-4 targeted MMAE drug conjugate, in a pivotal Phase 2/3 study (Duravelo-2) for bladder cancer, aiming for comparable efficacy with a differentiated safety profile compared to Padcev.
  • The timeline for dose selection in the Duravelo-2 study for zelenectide pevedotin has been adjusted from Q4 2025 to Q1 2026 to ensure alignment with global regulatory bodies.
  • The company reported $648 million in cash as of September, providing a cash runway into Q1 2028, which is sufficient to complete the Duravelo-2 study through Phase 3.
  • Bicycle Therapeutics is also progressing BT5528, targeting EphA2, with a significant update expected in H1 2026, and exploring opportunities for zelenectide pevedotin in Nectin-4 amplified solid tumors and in radio conjugates.
Nov 18, 2025, 10:30 AM
Bicycle Therapeutics Reports Q3 2025 Financial Results and Business Progress
BCYC
Earnings
New Projects/Investments
Guidance Update
  • Bicycle Therapeutics plc reported cash and cash equivalents of $648.3 million as of September 30, 2025, excluding a $38.2 million U.K. R&D tax credit received in October 2025, and anticipates a financial runway into 2028.
  • The company expects to provide an update on dose selection for the Phase 2/3 Duravelo-2 pivotal trial and zelenectide pevedotin's potential approval pathway in metastatic urothelial cancer in the first quarter of 2026, following feedback from multiple regulatory agencies.
  • For the three months ended September 30, 2025, the company reported a net loss of $59.1 million, or $(0.85) basic and diluted net loss per share.
MetricQ3 2024Q3 2025
R&D Expenses ($USD Thousands)$48,265 $58,426
G&A Expenses ($USD Thousands)$18,257 $18,859
Net Loss ($USD Thousands)$(50,802) $(59,100)
Net Loss Per Share ($USD)$(0.74) $(0.85)
Oct 30, 2025, 11:05 AM