Company Description
Bicycle Therapeutics plc (NASDAQ: BCYC) is a clinical-stage pharmaceutical company focused on research and development in biotechnology. The company is developing a novel class of medicines known as Bicycle® molecules for diseases that are underserved by existing therapeutics. Bicycle Therapeutics is headquartered in Cambridge, United Kingdom, with many key functions and members of its leadership team located in Cambridge, Massachusetts.
Bicycle molecules are described as fully synthetic short peptides that are constrained with small molecule scaffolds to form two loops, stabilizing their structural geometry. According to the company, this constraint facilitates target binding with high affinity and selectivity, which makes Bicycle molecules attractive candidates for drug development. The company’s work is situated within the professional, scientific, and technical services sector, with a focus on biotechnology research and development.
Core pipeline and clinical programs
Bicycle Therapeutics is evaluating several clinical-stage product candidates built on its Bicycle technology. The company states that it is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, which it describes as a well-validated tumor antigen. Zelenectide pevedotin is being studied in multiple settings, including metastatic urothelial cancer and Nectin-4–associated solid tumors such as breast cancer and non-small cell lung cancer, in company-sponsored clinical trials.
The company is also evaluating BT5528, which it describes as a BDC molecule targeting EphA2, characterized by the company as a historically undruggable target. In addition, Bicycle Therapeutics is studying BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) that targets Nectin-4 and agonizes CD137. These programs reflect the company’s focus on oncology indications and precision-guided therapeutics based on its proprietary bicyclic peptide platform.
Bicycle® Radioconjugates and radiopharmaceutical focus
Beyond drug conjugates and immune cell agonists, Bicycle Therapeutics reports that it is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use. The company has disclosed early human imaging data for BRC molecules targeting EphA2 and MT1-MMP, and it has presented data at scientific meetings such as the American Association for Cancer Research (AACR), the European Association of Nuclear Medicine (EANM), and other conferences. These data are described by the company as supporting the potential of MT1-MMP and EphA2 as novel cancer targets and highlighting the properties of BRC molecules for radiopharmaceutical imaging and targeted radionuclide therapies.
Bicycle Therapeutics has also announced multiple strategic arrangements intended to support a wholly owned radiopharmaceutical pipeline. The company reported a long-term contract with the UK Nuclear Decommissioning Authority for access to reprocessed uranium, a collaboration with the United Kingdom National Nuclear Laboratory to extract 228Th and process it into 224Ra, and an agreement with SpectronRx to develop a bespoke 212Pb generator. The company states that these arrangements are designed to support the potential discovery, development, and commercial supply of a portfolio of BRCs containing 212Pb.
Technology platform and therapeutic focus
The Bicycle platform is described by the company as enabling fully synthetic, bicyclic peptides that can be configured into different therapeutic formats, including BDCs, BRCs, and tumor-targeted immune cell agonists. By constraining short peptides into two loops, the technology is intended to stabilize structural geometry and facilitate high-affinity, selective binding to targets. Bicycle Therapeutics states that it is using this platform primarily in oncology, including metastatic urothelial cancer, Nectin-4–amplified breast cancer, and Nectin-4–amplified non-small cell lung cancer, and is exploring additional applications through partnerships for diseases beyond oncology.
Within its oncology programs, the company has described clinical trials such as the Duravelo-1 Phase 1 study of zelenectide pevedotin, including combination cohorts with pembrolizumab in first-line cisplatin-ineligible metastatic urothelial cancer, and the Duravelo-2 Phase 2/3 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in metastatic urothelial cancer. It has also referenced the Duravelo-3 Phase 1/2 trial in Nectin-4–amplified breast cancer and the Duravelo-4 Phase 1/2 trial in Nectin-4–amplified non-small cell lung cancer. These trials illustrate how the company is applying its technology to biomarker-selected patient populations.
Geographic footprint and listing
Bicycle Therapeutics plc is incorporated in England and Wales and reports that it operates through segments in the United Kingdom and the United States. The company’s American Depositary Shares, each representing one ordinary share, trade on The Nasdaq Stock Market LLC under the symbol BCYC, as indicated in its SEC filings. The company’s ordinary shares are referenced in filings as having a nominal value of £0.01 per share, with the American Depositary Shares listed for trading on Nasdaq.
Partnerships and collaborations
In addition to its internal pipeline, Bicycle Therapeutics notes that it is working through various partnerships to explore the use of Bicycle technology to develop therapies for diseases beyond oncology. The company has highlighted collaborations related to radioisotope supply and radiopharmaceutical development, including its agreements with the UK Nuclear Decommissioning Authority, the United Kingdom National Nuclear Laboratory, SpectronRx, and a prior agreement with Eckert & Ziegler to supply radioisotopes for BRC products. It has also formed a Research and Innovation Advisory Board (RAB) composed of experts in oncology, radiopharmaceuticals, and drug development to support its discovery research programs.
Corporate development and governance
The company has reported changes and additions to its Board of Directors and advisory structures. Bicycle Therapeutics has appointed multiple individuals with backgrounds in oncology drug development, radiopharmaceuticals, and biotechnology leadership to its Board and RAB. It has also disclosed inducement grants of share options to new employees under its 2024 Inducement Plan, consistent with Nasdaq Listing Rule 5635(c)(4). These governance and compensation disclosures appear in the company’s press releases and related Form 8-K filings.
Business model context
Based on the information the company provides, Bicycle Therapeutics operates as a clinical-stage biopharmaceutical organization focused on creating and advancing medicines derived from its Bicycle technology platform. Its activities include discovery research, preclinical development, and clinical trials of BDCs, BRCs, and tumor-targeted immune cell agonists, primarily in oncology. The company has also reported collaboration revenue in its financial results, indicating that partnership arrangements contribute to its operations alongside its internal pipeline.