Bicycle Therapeutics(BCYC) - 2025 Q1 - Quarterly Results

Q1 2025 Business Progress and Financial Results Bicycle Therapeutics highlights Q1 2025 clinical progress, corporate developments, and financial results, projecting a strong cash runway into 2027 CEO's Remarks The CEO highlighted significant Q1 progress, validating MT1-MMP as a novel cancer target and advancing clinical trials, supported by a strong financial position - Human imaging data continues to validate MT1-MMP as a novel cancer target and demonstrates the positive properties of Bicycle Radioconjugate (BRC) molecules[2] - The Phase 1/2 Duravelo-3 trial for NECTIN4 gene-amplified breast cancer has been initiated[2] - Dose selection in the Phase 2/3 Duravelo-2 trial for metastatic urothelial cancer is on track for the second half of 2025[2] - The company has an expected financial runway extending to the second half of 2027[2] Key Business and Clinical Updates The company presented positive BRC imaging data, advanced the zelenectide pevedotin program, and strengthened its leadership team with key appointments and promotions Pipeline Progress The company presented additional BRC imaging data, advanced zelenectide pevedotin with ASCO abstract acceptances, and initiated the Phase 1/2 Duravelo-3 trial - Presented additional human imaging data for a Bicycle Radioconjugate (BRC) targeting MT1-MMP at the AACR 2025 meeting, reinforcing its potential. Initial human imaging data for EphA2 is expected in 2H 2025[3] - Two abstracts on zelenectide pevedotin for metastatic urothelial cancer (mUC) were accepted for presentation at ASCO 2025, covering Phase 1 combination data and the ongoing Phase 2/3 Duravelo-2 trial[6] - The Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer is now open and actively recruiting patients, following FDA Fast Track designation for this indication[6] Corporate Developments The company strengthened its leadership team by appointing a new Chairman, adding new Board and Clinical Advisory Board members, and promoting key internal talent - Felix J. Baker, Ph.D., will succeed Pierre Legault as chairman of the Board of Directors[6] - 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[6] - Key leadership promotions include Eric Westin, M.D., to Chief Medical Officer and Jim MacDonald-Clink to SVP, Head of Business Development[6] Financial Performance Bicycle Therapeutics reported a Q1 2025 net loss of $60.8 million, primarily due to increased R&D expenses and decreased collaboration revenue, while maintaining a strong cash position Financial Summary Key financial metrics for Q1 2025 show an increased net loss and higher R&D and G&A expenses, alongside a decrease in cash and cash equivalents compared to Q4 2024 Q1 2025 Financial Summary (in millions) | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash & Cash Equivalents | $793.0M | - | -$86.5M (vs Q4'24) | | R&D Expenses | $59.1M | $34.9M | +$24.2M | | G&A Expenses | $21.1M | $16.4M | +$4.7M | | Net Loss | $60.8M | $26.6M | +$34.2M | | Net Loss Per Share | $(0.88) | $(0.62) | +$0.26 | Statement of Operations The condensed consolidated statement of operations for Q1 2025 reflects a significant increase in net loss and operating loss, driven by higher expenses and reduced collaboration revenue Q1 2025 Statement of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $ 9,977 | $ 19,530 | | Research and development | 59,058 | 34,864 | | General and administrative | 21,123 | 16,382 | | Loss from operations | (70,204) | (31,716) | | Net loss | $ (60,754) | $ (26,563) | | Net loss per share, basic and diluted | $ (0.88) | $ (0.62) | Balance Sheet Data The balance sheet highlights a decrease in cash and cash equivalents, working capital, total assets, and total shareholders' equity as of March 31, 2025, compared to December 31, 2024 Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $ 792,973 | $ 879,520 | | Working capital | 798,463 | 861,375 | | Total assets | 883,894 | 956,868 | | Total shareholders' equity | 740,333 | 793,060 | Outlook and Future Events The company projects a strong financial position with a cash runway into the second half of 2027 and plans to participate in the RBC Capital Markets Global Healthcare Conference - The company possesses cash and cash equivalents of $793.0 million as of March 31, 2025, which is expected to fund operations into the second half of 2027[1][5] - Management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference on May 20, 2025[4]