Bicycle Therapeutics Reports Q4 2024 Financial Results and Updates on Oncology and Radiopharmaceutical Pipelines

Bicycle Therapeutics plc (NASDAQ: BCYC) today announced its fourth quarter and full year 2024 financial results along with several updates on its pipeline and business progress. The company, which is focused on developing next‐generation precision-guided therapeutics based on its proprietary Bicycle® technology, provided detailed clinical data and strategic initiatives in its most recent press release filed as an exhibit to its Form 8-K.

In its latest update, Bicycle Therapeutics highlighted promising topline combination data from its ongoing Phase 1 Duravelo-1 trial. In a cohort of 22 first-line cisplatin-ineligible patients with metastatic urothelial cancer, 20 of whom were evaluable for efficacy, an overall response rate of 65% (13/20) was reported, with 50% achieving confirmed responses. The data noted a differentiated safety profile, with adverse events of clinical interest—such as peripheral neuropathy, skin reactions, and eye disorders—being primarily low grade and all Grade 3 events reversible.

The company also presented encouraging post-hoc analyses for NECTIN4 gene-amplified late-line breast cancer and non-small cell lung cancer patients enrolled in the Phase 1/2 Duravelo-1 trial. Enhanced anti-tumor activity in these patients has contributed to Fast Track designations from the U.S. Food and Drug Administration for both triple-negative breast cancer and NSCLC, reinforcing NECTIN4 as a potential biomarker for treatment stratification. Additional Phase 1/2 trials in NECTIN4 gene-amplified cancers are slated to launch in 2025.

Beyond oncology, Bicycle Therapeutics is advancing its radiopharmaceutical pipeline. Updated imaging data for Bicycle® Radionuclide Conjugates (BRC®), targeting MT1-MMP, were presented at the European Association of Nuclear Medicine 2024 Congress. The preliminary human imaging data, including fluorine-18 FDG-PET/CT and gallium-68 BRC MT1-MMP PET/CT, corroborated the tracer uptake in target lesions, with additional first EphA2 human imaging data expected in the second half of 2025.

On the financial front, Bicycle Therapeutics reported cash and cash equivalents of $879.5 million as of December 31, 2024, up from $526.4 million the previous year. The increase was primarily driven by net proceeds from a PIPE financing and share option exercises, which, alongside additional strategic financing moves, are expected to provide the company with a financial runway into the second half of 2027. For the quarter ended December 31, 2024, the company recorded a net loss of $51.9 million, or $(0.75) per share, while the full year net loss was $169.0 million, or $(2.90) per share.

Additional updates include the planned dose selection for the ongoing Phase 2/3 Duravelo-2 registrational trial in metastatic urothelial cancer, exploration of multiple dosing regimens, and an expanded Clinical Advisory Board appointed to further support clinical advancements. Bicycle Therapeutics management is also set to participate in an upcoming investor conference, where a fireside chat will provide further insights into the company’s progress and strategy.

Bicycle Therapeutics’ comprehensive update underscores its commitment to advancing innovative therapies across oncology and radiopharmaceutical applications while maintaining a strong balance sheet to support continued research and development efforts.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Bicycle Therapeutics’s 8K filing here.

Bicycle Therapeutics Company Profile

Bicycle Therapeutics plc, a clinical-stage biopharmaceutical company, develops a class of medicines for diseases that are underserved by existing therapeutics in the United States and the United Kingdom. Its product pipeline comprising BT8009, a bicycle toxin conjugate (BTC) which is in phase I/II/III clinical trial for the treatment of high nectin-4 expressing tumors; BT5528, a BTC which is in phase I/II clinical trial for the treatment of Ephrin type A receptor 2 expressing tumor; BT7480, a Bicycle TICA molecule which is in phase I/II targeting Nectin-4 and agonizing CD137; and BT7455, a Bicycle TICA molecule targeting Ephrin type A receptor 2 and CD137 and is in preclinical trial.