Bicycle Therapeutics Announces Publication of Paper Highlighting Preclinical Data from BT8009 Molecular Cancer Therapeutics Program

CAMBRIDGE, England, & BOSTON, September 19, 2022–(BUSINESS WIRE)–Bike Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new, differentiated class of therapeutics based on its proprietary bicyclic peptide (Bike®) technology, today announced that a paper highlighting preclinical data from BT8009, a Nectin-4 targeting Bike Toxin Conjugate, was published in Molecular Cancer Therapeutics. The article, entitled “BT8009: targeting Nectin-4 Bike® Toxin Conjugate for treatment of solid tumors” is available online via this link.

“Having already announced positive interim results from our ongoing Phase I trial of BT8009, we are pleased to describe the work leading to its identification and the preclinical studies that support its potential to rapidly diffuse into solid tumor cells and kill them.” said Nicholas Keen, Ph.D., chief scientific officer of Bicycle Therapeutics. “The data published in Molecular Cancer Therapeutics describe the preclinical efficacy of BT8009 in a wide range of cell-derived xenograft and patient-derived xenograft tumor models, with complete tumor regression frequently observed in large and small tumors. We look forward to providing additional clinical data on BT8009 later this year.”

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a new class of drugs, called Bicycles, for diseases underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained by scaffolds of small molecules to form two loops that stabilize their structural geometry. This constraint facilitates binding to the target with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is currently evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC®) targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA® targeting Nectin-4 and stressful CD137, in company-sponsored Phase I/II trials. Additionally, BT1718, a BTC that targets MT1-MMP, is being studied in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Center for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its management team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

Forward-looking statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as “aims”, “anticipates”, “believes”, ” could, “estimate”, “expect”, “plan”, “goal”, “intend”, “may”, “plan”, “possible”, “potential”, “seek”, “will” and variations of these words or similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical development of BT8009 and Bicycle’s expectations regarding the availability of additional clinical data from the ongoing Phase I/II clinical trial of BT8009; and the potential for BT8009 to diffuse into s solid tumors and to kill solid tumor cells. Bicycle may not achieve the plans, intentions or expectations disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements due to a variety of factors, including: risks relating to the opening of the site, the start of the clinical trial, recruitment and follow-up patients, as well as Bicycle’s ability to meet other anticipated timelines and milestones presented by the ongoing COVID-19 pandemic; the uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycle’s product candidates; availability and timing of clinical trial results; whether the results of preclinical studies will be predictive of the results of clinical trials; whether the initial or interim results of a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies will be delayed and will not yield satisfactory results; and other important factors, each of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are more fully described in the section titled “Risk Factors” in Bicycle’s Quarterly Report on Form 10. -Q filed with the Securities and Exchange Commission (SEC) on August 4, 2022, as well as in other filings Bicycle may make with the SEC in the future. All forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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