Press Release

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Sep. 14, 2020-- Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that a poster describing the design of the ongoing Phase I/II trial of BT8009 will be presented during an e-poster session at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 19-21, 2020. BT8009 is a second-generation Bicycle Toxin Conjugate (BTC), which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload. BT8009 targets Nectin-4, a tumor antigen observed to be overexpressed in several common tumor types and associated with poor disease prognosis.

“We believe BT8009 represents an important addition to the landscape of potential next-generation treatments for patients with Nectin-4-positive cancers, as it could improve on Nectin-4-targeted therapies that are based on conventional modalities,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “With our recent announcement that the first patient has been dosed in the Phase I/II trial of BT8009, we are pleased that the trial is progressing and look forward to providing an overview of its design at ESMO.”

Details on Bicycle’s poster presentation at ESMO are as follows:

Poster Title: BT8009-100 Phase I/II Study of the Safety, Pharmacokinetics, & Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
Abstract #: 3716
Presentation #: 599TiP

The poster will be available on the ESMO website, as well as in the Publications section of bicycletherapeutics.com, beginning Thursday, September 17.

About Bicycle Therapeutics
Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle’s lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership 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. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are 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; the design of Bicycle’s clinical trial of BT8009; and the potential benefits of BT8009. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to Bicycle’s abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycle’s product candidates; availability and timing of results clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials may be delayed and may not have satisfactory outcomes; expectations for regulatory approvals to conduct trials or to market product;; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2020, as well as in other filings Bicycle may make with the SEC in the future. Any 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 any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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Investor and Media Contact:
Bicycle Therapeutics
Maren Killackey
maren.killackey@bicycletx.com
+1-617-203-8300

Source: Bicycle Therapeutics plc