Armistice Capital and other institutional investors increased Bicycle Therapeutics positions during 2025. Investors maintained exposure to the clinical-stage biopharmaceutical company ahead of regulatory milestones.
Bicycle Therapeutics announced in January 2026 that the company expects to provide dose selection updates and potential approval pathway information for zelenectide pevedotin following meetings with multiple regulatory agencies during the first quarter. The Cambridge, UK-based biopharmaceutical company is seeking regulatory feedback on its lead drug candidate targeting metastatic urothelial cancer.
Third-quarter 2025 revenue totalled $11.73 million, exceeding consensus estimates of $8.25 million. The company reported a net loss of $59.1 million, or $0.85 per share, compared to a net loss of $50.8 million in the same period of 2024.
“We are currently seeking broad regulatory feedback to make an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer,” CEO Kevin Lee said in October 2025.
Phase 2/3 trial progresses amid regulatory discussions
Bicycle Therapeutics is conducting the Phase 2/3 Duravelo-2 registrational trial evaluating zelenectide pevedotin in combination with pembrolizumab versus chemotherapy in first-line metastatic urothelial cancer, alongside evaluations of zelenectide pevedotin monotherapy and combination therapy in late-line patients.
Updated Phase 1 Duravelo-1 data presented in January 2025 showed a 60% overall response rate among 20 evaluable first-line cisplatin-ineligible patients with metastatic urothelial cancer receiving zelenectide pevedotin plus pembrolizumab. The treatment demonstrated what the company characterized as a differentiated safety profile, with all Grade 3 treatment-related adverse events proving reversible and no patient withdrawals due to zelenectide-related adverse events.
The company initiated Phase 1/2 Duravelo-3 and Duravelo-4 trials during 2025, expanding zelenectide pevedotin development into NECTIN4-amplified breast cancer and non-small cell lung cancer, respectively. Initial data from the Duravelo-3 breast cancer trial is expected during the second half of 2026.
Radiopharmaceutical pipeline gains momentum
Bicycle Therapeutics advanced its radiopharmaceutical development program throughout 2025, presenting imaging data for early Bicycle Radioconjugate molecules targeting MT1-MMP at the European Association of Nuclear Medicine Congress and the American Association for Cancer Research Annual Meeting. The imaging data from two patients represented findings across 12 of 14 patients with various solid tumours.
Meanwhile, the company established supply chain partnerships with the United Kingdom Nuclear Decommissioning Authority, UK National Nuclear Laboratory, and SpectronRx to support potential end-to-end production of 212Pb-based radiotherapeutics, complementing existing supply arrangements for 177Lu and 68Ga radioisotopes.
Company-sponsored clinical trials for radioconjugate candidates are planned for 2026, with additional EphA2 human imaging data expected during the first half of the year.
Financial position and clinical spending
Bicycle Therapeutics held $648.3 million in cash and cash equivalents as of September 30, 2025, providing an expected financial runway into 2028. The company received a $38.2 million UK R&D tax credit in October 2025, excluded from the September balance.
Research and development expenses reached $58.4 million for the third quarter, up from $48.3 million in the prior-year period, reflecting increased clinical trial activity across the zelenectide pevedotin program and radiopharmaceutical pipeline development. Operating expenses totalled $72.8 million for the quarter.
Institutional investment and analyst coverage
In addition to Armistice Capital, other major institutional holders include Westfield Capital Management, Long Focus Capital Management, and Principal Financial Group, which increased its stake substantially during the third quarter of 2025. Institutional investors collectively own approximately 86% of outstanding shares.
Thirteen research analysts cover Bicycle Therapeutics with a consensus “Hold” rating, comprising seven buy ratings, five hold ratings, and one sell rating. The average 12-month price target stands at $19.73, compared to the stock’s January 2026 trading range near $6.51.
The company’s market capitalization stood at approximately $452 million in mid-January 2026, with shares trading in a 52-week range of $6.03 to $13.90.
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