Bicycle Therapeutics Updates on Q1 2024 and Business Progress

Bicycle Therapeutics Limited, a biopharmaceutical company listed on NASDAQ under the ticker BCYC, focuses on developing a unique class of therapeutics derived from its proprietary bicyclic peptide technology known as Bicycle®. In the first quarter of 2024, the company made significant strides in its business operations and reported robust financial results.

During this period, Bicycle Therapeutics initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009, targeting metastatic urothelial cancer (mUC). The company is currently in the process of enrolling patients and activating trial sites. This is part of its broader effort to advance its pipeline of precision-guided therapeutic candidates. CEO Kevin Lee emphasized the company's commitment to execution and expressed enthusiasm for a milestone-rich second half of the year.

Additionally, the company announced the promotion of Mike Hannay to Chief Product and Supply Chain Officer. Hannay, who joined Bicycle Therapeutics in April 2022, has significantly enhanced the company’s manufacturing capabilities, particularly in preparation for the potential commercial launch of BT8009. His previous experience includes roles at Sanofi, Schwarz Pharma, Teva Pharmaceuticals, and AstraZeneca, where he played a crucial role in launching over 40 medicines.

In the first quarter of 2024, Bicycle Therapeutics also achieved recognition at major industry conferences. Two of its abstracts were accepted for poster presentations at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. These presentations focus on the clinical pharmacokinetics and safety of Bicycle Toxin Conjugates® (BTC® molecules) and the ongoing Duravelo-2 clinical trial for BT8009 in mUC. Additionally, at the American Association for Cancer Research (AACR) Annual Meeting 2024, the company presented three posters showcasing preclinical data on BTC molecules for solid tumors, Natural Killer Tumor-Targeted Immune Cell Agonist (NK-TICA®) molecules, and Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) molecules.

The company continues to make progress across its research and development (R&D) pipeline. Bicycle Therapeutics is currently evaluating BT8009, BT5528, and BT7480 in Phase 1/2 clinical trials for various tumor types. Updates on these programs are anticipated in the second half of 2024.

Financially, Bicycle Therapeutics reported significant figures for the first quarter of 2024. As of March 31, the company held $457.0 million in cash and cash equivalents, providing a financial runway expected to last into 2026. Research and development expenses for the quarter were $34.9 million, a slight increase from the $32.2 million reported in the same period the previous year. This increase was primarily due to higher clinical program expenses for BT8009 and personnel-related costs. General and administrative expenses also rose to $16.4 million, up from $14.5 million in the first quarter of 2023, due to increased personnel-related costs. The net loss for the quarter stood at $26.6 million, or $0.62 per share, compared to a net loss of $39.1 million, or $1.30 per share, in the same period of the previous year.

Bicycle Therapeutics is known for developing fully synthetic short peptides, termed Bicycle® molecules, which are constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This structure enhances target binding with high affinity and selectivity, making Bicycle molecules promising candidates for drug development. The company's current clinical trials include BT8009, which targets Nectin-4, BT5528, which targets EphA2, and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® targeting Nectin-4 and CD137. Additionally, the company is exploring the development of Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use.

Bicycle Therapeutics operates from its headquarters in Cambridge, UK, with significant functions and leadership based in Cambridge, Massachusetts. The company's ongoing efforts in both clinical and preclinical programs highlight its commitment to developing new therapies for diseases with unmet medical needs.