Bicycle Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Collaboration revenue was $34.1 million for the three months ended September 30, 2026, compared to $11.7 million for the same period in 2025, driven by the recognition of remaining revenue from the terminated collaboration with Bayer Consumer Care AG.
• Research and development expenses decreased to $33.4 million for the three months ended September 30, 2026, from $58.4 million in 2025, primarily due to reduced clinical program expenses for zelenectide, lower personnel-related costs, and reduced share-based compensation following workforce reductions in August 2025 and March 2026.
• General and administrative expenses decreased to $14.1 million for the three months ended September 30, 2026, from $18.9 million in 2025, attributed to decreased personnel-related costs and share-based compensation from workforce reductions.
• Net loss was $10.5 million, or $(0.15) per share, for the three months ended September 30, 2026, compared to a net loss of $59.1 million, or $(0.85) per share, in 2025.
• Cash and cash equivalents stood at $469.9 million as of September 30, 2026, down from $628.1 million as of December 31, 2025, due to cash used in operations including clinical program activities.
• For the nine months ended September 30, 2026, collaboration revenue was $35.6 million compared to $24.6 million in 2025; R&D expenses were $123.5 million compared to $188.5 million; G&A expenses were $45.6 million compared to $58.5 million; and net loss was $121.6 million compared to $198.8 million.

Business Segments and Product Lines:

• Nuzefatide pevedotin, a potentially first-in-class EphA2-targeting Bicycle Drug Conjugate (BDC), received FDA Orphan Drug Designation (ODD) for pancreatic cancer in September 2026, providing development incentives including tax credits, fee exemptions, and potential seven years of market exclusivity.
• The company is actively enrolling patients in a Phase 2 clinical trial for nuzefatide in recurrent pancreatic ductal adenocarcinoma (PDAC) and expects further updates in 2027.
• Bicycle Therapeutics is optimizing its Bicycle Radioconjugate (BRC) pipeline and expects to initiate the first company-sponsored radioligand clinical trial for BT1702 (an MT1-MMP-targeting BRC) in the second half of 2027.
• Zelenectide pevedotin, a BDC targeting Nectin-4, had its Duravelo-2 trial converted to a randomized Phase 2 trial in May 2026; the program was deprioritized for internal development, with survival data expected in the second half of 2027 for previously untreated metastatic urothelial cancer patients.

Management Commentary and Tone:

• CEO Kevin Lee, Ph.D., expressed satisfaction with continued pipeline progress, emphasizing the FDA's Orphan Drug Designation as support for the development strategy and the significant unmet need in pancreatic cancer.
• Management stated a continued focus on disciplined execution across prioritized programs and confidence in the potential of Bicycle molecules to deliver highly targeted therapies with differentiated benefit/risk profiles.
• The company highlighted its expectation to reach important clinical milestones for nuzefatide and initiate the BT1702 trial in the second half of 2027.

Other Key Points:

• The company reported a cash runway extending into 2030 based on $469.9 million in cash and cash equivalents as of September 30, 2026.
• Workforce reductions were announced in August 2025 and March 2026, contributing to decreased operating expenses.
• The collaboration with Bayer Consumer Care AG was terminated, resulting in the recognition of all remaining revenue under that agreement.
• Forward-looking statements include risks related to clinical trial outcomes, the accuracy of cash runway projections, and the impact of strategic reprioritization and workforce reductions.