Bicycle Therapeutics advances drugs pipeline and extends cash runway into 2026

02 May, 2024
Tony Quested
Cambridge-based Bicycle Therapeutics, which is quoted on the US technology exchange, NASDAQ, has advanced its drugs pipeline and extended its cash runway into 2026.
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Kevin Lee. Courtesy – Bicycle Therapeutics.

The company ended Q1 with cash and equivalents of $457 million and reported continued progress across its R & D pipeline with numerous clinical data readouts and updates expected in the second half of 2024.

The company is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology.

CEO Kevin Lee praised the company’s laser focus on its technology. He said: “During the first quarter, we focused on execution across all aspects of our business. We were pleased to initiate our Phase 2/3 Duravelo-2 registrational trial for BT8009 in metastatic urothelial cancer, and we are actively working on patient enrolment and site activation.

“We continue to make progress across the rest of our pipeline of differentiated, precision-guided therapeutic candidates and look forward to a catalyst-rich second half of the year.”

He congratulated Mike Hannay on his promotion to Chief Product and Supply Chain Officer, adding: “Since joining the company two years ago, he has significantly advanced our manufacturing capabilities and priorities and I look forward to seeing him excel in this new position.”

Over the course of his career, through his work at Sanofi, Schwarz Pharma, Teva Pharmaceuticals and AstraZeneca, Professor Hannay has launched more than 40 medicines.

Two Bicycle abstracts have been accepted for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31 to June 4. These highlight the company’s clinical progress in developing Bicycle Toxin Conjugates® (BTC® molecules) as differentiated cancer therapies.

The first abstract will examine the clinical pharmacokinetics and safety of BTC molecules, while the second will outline the company’s ongoing Phase 2/3 clinical trial, called Duravelo-2, of BT8009 in metastatic urothelial cancer (mUC).

Three posters were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego last month. Bicycle shared preclinical data showcasing its work to develop BTC molecules for the treatment of solid tumours, Natural Killer Tumour-Targeted Immune Cell Agonist (NK-TICA®) molecules that can engage NK cells to directly kill malignant tumour cells and Bicycle Tumour-Targeted Immune Cell Agonist® (Bicycle TICA®) molecules that can activate the body’s immune system to enable tumour rejection.

Altogether, the posters underscore the breadth of the company’s platform technology and its capabilities to produce different modalities to target cancer.

Bicycle reports continued progress across its R & D pipeline, with numerous clinical data readouts and program updates expected in 2H 2024. Importantly, Bicycle initiated the Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC, and patient enrolment is ongoing.

The company continues to assess BT8009, BT5528 and BT7480 in Phase 1/2 clinical trials across a variety of tumour types and plans to provide updates from its wholly owned Bicycle® Radio Conjugate (BRC™) pipeline.

Q1 cash and equivalents at $457m compared to $526.4m at the end of December. The fall was primarily due to cash used in operating activities, including upfront payments associated with the initiation of the company’s Phase 2/3 Duravelo-2 registrational trial.

R & D expenses were $34.9m compared to $32.2m in the same quarter of 2023. The modest rise was primarily due to increased clinical program expenses for BT8009 development and increased personnel-related expenses.

These were largely offset by decreased clinical program expenses for Bicycle TICA® molecule development and BT5528 development, as well as $8.2m of one-time, incremental retroactive UK R & D tax credits.

The Q1 net loss was significantly down year-on-year from $39.1m to $26.6m.