Bicycle Therapeutics(BCYC) - 2024 Q4 - Annual Results

Financial Performance - The company reported a net loss of $51.9 million, or$(0.75) basic and diluted net loss per share, for the fourth quarter of 2024, compared to a net loss of $49.1 million, or$(1.16) per share, for the same period in 2023[12]. - Collaboration revenue for Q4 2024 was $3.708 million, compared to$5.331 million in Q4 2023, representing a decrease of 30.4%[16]. - Total operating expenses for Q4 2024 were $71.371 million, up from$59.566 million in Q4 2023, an increase of 19.8%[16]. - Net loss for Q4 2024 was $51.854 million, compared to a net loss of$49.099 million in Q4 2023, reflecting an increase in loss of 5.6%[16]. - General and administrative expenses for the year ended December 31, 2024, were $72.2 million, an increase from$60.4 million in 2023, driven by higher personnel-related expenses[12]. - Research and development expenses for the year ended December 31, 2024, were $173.0 million, up from$156.5 million in 2023, primarily due to increased clinical program expenses for zelenectide pevedotin[12]. Cash and Assets - As of December 31, 2024, cash and cash equivalents were $879.5 million, an increase from$526.4 million as of December 31, 2023, providing a financial runway into the second half of 2027[12]. - Cash and cash equivalents increased to $879.520 million as of December 31, 2024, from$526.423 million in 2023, a growth of 67.0%[18]. - Total assets rose to $956.868 million in 2024, compared to$595.344 million in 2023, marking an increase of 60.6%[18]. Clinical Trials and Research - In the Phase 1 Duravelo-1 trial, a 65% overall response rate (ORR) was achieved among 20 efficacy evaluable patients treated with zelenectide pevedotin plus pembrolizumab for first-line metastatic urothelial cancer[3]. - Bicycle Therapeutics is conducting the Phase 2/3 Duravelo-2 trial evaluating the efficacy of zelenectide pevedotin in combination with pembrolizumab versus chemotherapy in first-line metastatic urothelial cancer[4]. - Among 38 breast cancer patients evaluated, a 62.5% ORR was observed in those with NECTIN4 gene amplification compared to a 14.3% ORR in all efficacy-evaluable patients[4]. - Bicycle Therapeutics plans to initiate several additional Phase 1/2 trials for zelenectide pevedotin in NECTIN4 gene-amplified cancers, including breast cancer in 1H 2025 and lung cancer in 2H 2025[6]. - The company received FDA Fast Track designations for zelenectide pevedotin in the treatment of adult patients with previously treated, NECTIN4 gene-amplified, advanced or metastatic triple-negative breast cancer and non-small cell lung cancer[5]. - The company anticipates additional MT1-MMP human imaging data in mid-2025 and initial EphA2 human imaging data in 2H 2025 as part of its radiopharmaceuticals pipeline[7]. Shareholder Information - The company reported a weighted average of 69,051,745 ordinary shares outstanding for Q4 2024, compared to 42,419,326 in Q4 2023, an increase of 62.8%[16]. Strategic Focus - The company anticipates the initiation of clinical trials for its product candidates in various cancers, including breast and lung cancer, in the near future[14]. - Bicycle Therapeutics expects to leverage its technology through partnerships to develop therapies beyond oncology, indicating a strategic expansion of its research focus[14].