On May 1, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported recent business progress and financial results for the first quarter ended March 31, 2025 (Press release, Bicycle Therapeutics, MAY 1, 2025, View Source [SID1234652425]).
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"In the first quarter, we continued to advance our business priorities and our pipeline of oncology therapeutics. We were pleased to share additional human imaging data that continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of our Bicycle Radioconjugate molecules for radiopharmaceutical use," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "Our work to develop zelenectide pevedotin for various Nectin-4 associated cancers continues to progress, as we recently initiated our Phase 1/2 Duravelo-3 trial for NECTIN4 gene-amplified breast cancer and remain on track for dose selection in our Phase 2/3 Duravelo-2 trial for metastatic urothelial cancer in the second half of this year. Additionally, with new members on our leadership team, Board of Directors and Clinical Advisory Board, and expected financial runaway extending to the second half of 2027, we remain focused on continuing to execute our strategy and make meaningful advances for patients."
First Quarter 2025 and Recent Events
Additional human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting MT1-MMP presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical use. Importantly, the imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors. Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026.
Two abstracts accepted for poster presentation at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Bicycle Therapeutics will present two abstracts highlighting the development of zelenectide pevedotin for metastatic urothelial cancer (mUC). The first abstract outlines previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1 Duravelo-1 trial, while the second abstract provides an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC. Dose selection in Duravelo-2 remains on track for the second half of the year.
Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer open and actively recruiting patients. Bicycle Therapeutics previously announced a development strategy leveraging NECTIN4 amplification for zelenectide pevedotin in breast cancer, lung cancer and multiple tumor types. The strategy is based on the company’s discovery that the NECTIN4 gene sits on a commonly amplified chromosomal site in cancer, creating more copies of the gene and often translating to more protein expression. Data from post-hoc analyses of late-line breast cancer and lung cancer patients enrolled in Duravelo-1 showed enhanced anti-tumor activity of zelenectide pevedotin in patients with NECTIN4 amplification and/or polysomy. Based on these data, the U.S. Food and Drug Administration granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4-amplified, advanced or metastatic triple-negative breast cancer and non-small cell lung cancer. The Duravelo-3 breast cancer trial is the first of several planned trials to expand the development of zelenectide pevedotin for additional solid tumors.
Announced new Board of Directors and key clinical leadership appointments. Felix J. Baker, Ph.D., will succeed Pierre Legault, MBA, CPA, as chairman of the Bicycle Therapeutics Board of Directors as Mr. Legault and Richard Kender, MBA, will retire from the Board following the company’s Annual General Meeting on June 17, 2025. In addition, world-renowned oncology experts Alessandro Riva, M.D., and Fabrice André, M.D., Ph.D., have joined the company’s Board of Directors and Clinical Advisory Board, respectively. Furthermore, Eric Westin, M.D., has been promoted to chief medical officer and Jim MacDonald-Clink has been promoted to senior vice president, head of business development, following the transitions of Santiago Arroyo, M.D., Ph.D., chief development officer, and Nigel Crockett, Ph.D., chief business officer, to advisor roles as distinguished fellows.
Participation in Upcoming Investor Conferences
Bicycle Therapeutics management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference on Tuesday, May 20, at 2:05 p.m. ET. A live webcast of the fireside chat will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.
First Quarter 2025 Financial Results
Cash and cash equivalents were $793.0 million as of March 31, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities.
Research and development (R&D) expenses were $59.1 million for the three months ended March 31, 2025, compared to $34.9 million for the three months ended March 31, 2024. The increase in expense of $24.2 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased personnel-related expenses and lower U.K. R&D tax credits period over period.
General and administrative expenses were $21.1 million for the three months ended March 31, 2025, compared to $16.4 million for the three months ended March 31, 2024. The increase in expense of $4.7 million was primarily due to increased professional and consulting fees as well as increased personnel-related costs, including incremental share-based compensation expense of $0.5 million for the three months ended March 31, 2025.
Net loss was $60.8 million, or $(0.88) basic and diluted net loss per share, for the three months ended March 31, 2025, compared to net loss of $26.6 million or $(0.62) basic and diluted net loss per share, for three months ended March 31, 2024.