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Bicycle Therapeutics plc (symbol: BCYC) is a pioneering clinical-stage biotechnology company with a mission to transform the pharmaceutical industry through its innovative Bicycle® product platform. This revolutionary platform focuses on developing a new class of medicines known as Bicycles, which are synthetic short peptides constrained to form two loops. These loops stabilize their structural geometry, granting them superior targeting abilities and efficiency compared to existing drug conjugate modalities.
The core business of Bicycle Therapeutics centers around creating transformational new therapies to enhance treatment options in oncology and other serious diseases. The company’s leading product candidate, BT1718, is a Bicycle Toxin Conjugate (BTC) designed to maximize tumor penetration while minimizing adverse effects on healthy tissues. Bicycles combine the beneficial properties of multiple therapeutic entities in a single modality – showcasing the affinity and selective pharmacology typical of antibodies, the rapid distribution kinetics of small molecules, and the adjustable pharmacokinetic half-life of peptides.
Bicycle Therapeutics is committed to addressing high unmet medical needs, particularly in oncology. Their proprietary IP is grounded in the groundbreaking work of scientific founders, and the company has made significant strides with their unique approach. Recent achievements include successful clinical trials and strategic partnerships aimed at advancing their robust pipeline of product candidates.
This innovative approach ensures that Bicycles exhibit a favorable safety profile and improved tolerability, making them a promising alternative to traditional therapies. As the company continues to evolve, it remains dedicated to enhancing patient outcomes and pioneering new treatment paradigms in the biotech space.
Bicycle Therapeutics (NASDAQ: BCYC) announced significant data updates for its zelenectide pevedotin program. The drug showed a 60% overall response rate when combined with pembrolizumab in first-line metastatic urothelial cancer. In breast cancer patients with NECTIN4 gene amplification, the drug demonstrated a 62.5% response rate, while NSCLC patients with NECTIN4 gene amplification showed a 40% response rate.
The company plans to advance its development strategy focusing on NECTIN4 gene amplification, with Phase 1/2 trials in breast cancer, lung cancer, and multi-tumor planned for 2025. Dose selection and topline data from the Phase 2/3 Duravelo-2 trial are expected in 2H 2025.
Bicycle Therapeutics (NASDAQ: BCYC) has expanded its Clinical Advisory Board with three distinguished oncology experts to support its clinical oncology programs development. The new members include: Howard A. 'Skip' Burris III, president and chief medical officer of Sarah Cannon Research Institute; Markus Eckstein, senior consultant pathologist at University Hospital Erlangen; and Niklas Klümper, senior consultant for Urology & Genitourinary Oncology at University Hospital Bonn.
Each expert brings specialized experience: Burris in first-in-human therapies and FDA-approved treatments, Eckstein in genitourinary pathology and systems immunology, and Klümper in precision oncology and drug conjugate development.
Bicycle Therapeutics (NASDAQ: BCYC) announced that its Compensation Committee granted inducement awards to thirteen new employees on December 2, 2024. The awards consist of non-qualified share options to purchase 62,400 ordinary shares at an exercise price of $20.40 per share. The options will vest over four years, with 25% vesting after one year and the remaining balance vesting monthly over 36 months. These grants were made under the company's 2024 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
Bicycle Therapeutics (NASDAQ: BCYC) announced upcoming presentations of data for zelenectide pevedotin at the 2024 San Antonio Breast Cancer Symposium. The company will present findings showing enhanced anti-tumor activity in triple-negative breast cancer patients with NECTIN4 gene amplification.
Additionally, Bicycle will announce topline data for zelenectide pevedotin plus pembrolizumab combination in first-line metastatic urothelial cancer patients, and monotherapy results in non-small cell lung cancer patients. The poster presentation, led by Dr. Niklas Klümper from University Hospital Bonn, is scheduled for December 12. A conference call to discuss these updates will be held on December 13.
Bicycle Therapeutics (NASDAQ: BCYC), a pharmaceutical company developing innovative therapeutics using its proprietary bicyclic peptide technology, has announced its participation in the upcoming Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on November 19, 2024, at 10:30 a.m. GMT. Investors and interested parties can access a live webcast of the presentation through the company's website, with a replay available after the event.
Bicycle Therapeutics (NASDAQ: BCYC) announced that its Compensation Committee granted inducement awards to twelve new employees on November 1, 2024. The awards consist of non-qualified share options to purchase 56,700 ordinary shares under the company's 2024 Inducement Plan. The options have an exercise price of $23.44 per share, based on the closing price on October 31, 2024. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months, subject to continued employment.
Bicycle Therapeutics (NASDAQ: BCYC) reported Q3 2024 financial results and business updates. Key highlights include a 45% overall response rate for both zelenectide pevedotin and BT5528 in metastatic urothelial cancer trials. The company's cash position stands at $890.9 million as of September 30, 2024, with runway extending into 2H 2027. Q3 showed a net loss of $50.8 million, or $(0.74) per share. R&D expenses increased to $48.3 million, up from $39.9 million in Q3 2023, while G&A expenses rose to $18.3 million from $16.3 million year-over-year.
Bicycle Therapeutics (NASDAQ: BCYC) presented the first human imaging data at EANM 2024 Congress, validating MT1-MMP as a novel cancer treatment target. The data came from a case study of a 65-year-old male with pulmonary adenocarcinoma, where the Bicycle Radionuclide Conjugates (BRC®) demonstrated positive imaging properties and specific tumor uptake. The company also presented preclinical data showing optimized biodistribution of BRCs with high tumor uptake and reduced kidney retention.
The company announced EphA2 as its second BRC target and plans to collaborate with Eckert & Ziegler for radioisotope supply and BRC development.
Bicycle Therapeutics (NASDAQ: BCYC) will present data on its Bicycle Radionuclide Conjugates (BRC®) at the European Association of Nuclear Medicine (EANM) 2024 Congress in Hamburg, Germany, from October 19-23. The German Cancer Consortium (DKTK) will reveal the first human imaging data for a BRC targeting MT1-MMP, a tumor antigen common in many cancers, on October 22. Additionally, Bicycle Therapeutics will share an e-poster on BRCs for radioisotope delivery to solid tumors. A conference call and webcast will be held on October 23 at 8 a.m. ET to discuss the data and the company's radiopharmaceutical strategy. The call can be accessed by dialing +1-833-816-1408 (U.S.) or +1-412-317-0501 (international) and requesting the Bicycle Therapeutics call. A live webcast and replay will be available on the company's website.
Bicycle Therapeutics (NASDAQ: BCYC) has announced the granting of inducement awards to eight new employees on October 1, 2024. These awards consist of non-qualified share options to purchase a total of 47,600 ordinary shares. The options were granted under the company's 2024 Inducement Plan and approved by the Compensation Committee in accordance with Nasdaq Listing Rule 5635(c)(4).
Each option has an exercise price of $22.63 per share, which was Bicycle Therapeutics' closing trading price on September 30, 2024. The options will vest over four years, with 25% vesting on the one-year anniversary of the vesting commencement date and the remaining 75% vesting monthly over the following 36 months, subject to continued employment.
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