Bicycle Therapeutics Announces Interim BT8009 Phase I Clinical Trial Results at the 2022 AACR Annual Meeting - 50% confirmed overall response rate, including one (13%) confirmed complete response in eight urothelial canc

Bicycle Therapeutics Announces Interim BT8009

Phase I Clinical Trial Results at the 2022 AACR Annual Meeting

- 50% confirmed overall response rate, including one (13%) confirmed complete response in eight urothelial cancer patients dosed at 5.0mg/m2 weekly

Median duration of response not yet reached in the 2.5mg/m2 and 5.0mg/m2 weekly cohorts; four of five

responders in these cohorts still on therapy after at least 24 weeks

- Tolerability profile maintained over time, with low incidence of skin, ocular and neurological toxicities showing potential for differentiation from antibody-based approaches

- Company to Host Conference Call Today at 8:30 a.m. ET

CAMBRIDGE, England, & BOSTON, April 11,

2022 - 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

interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4. The results were presented

in an oral presentation on Sunday, April 10 at the 2022 American Association for Cancer Research Annual Meeting in New

"Since our initial BT8009 Phase I/II trial interim results last

year, we are encouraged to see BT8009's promising profile endure over time. Over the last six months, the preliminary anti-tumor

findings have been confirmed, the initial responses have deepened and remained durable, and the tolerability profile remains unchanged,"

said Dominic Smethurst, MRCP, Chief Medical Officer of Bicycle Therapeutics. "We believe BT8009 has the potential to offer clinically

meaningful differentiation compared to currently available therapies and we look forward to advancing the program once the escalation

"As previously hypothesized, we believe that the differentiated

pharmacokinetic profile of BTCs has the potential to deliver improved outcomes for patients and it is pleasing to see these clinical data

mature and with it, the promise for a potentially industry-leading product profile," said Kevin Lee, Ph.D., Chief Executive Officer.

"We look forward to providing additional updates on BT8009 as well as updates from our broad Bicycle oncology pipeline this

As of March 7, 2022, thirty-seven patients have been dosed in the Phase

I/II trial of BT8009. A total of twelve response evaluable urothelial cancer (UC) patients have been dosed in monotherapy cohorts of 2.5mg/m2

and 5.0mg/m2 weekly in the ongoing trial.

Conference Call Details

Bicycle Therapeutics will host a conference call and webcast today

at 8:30 a.m. ET to review the data being presented. To access the call, please dial (800) 377-9118 (domestic) or (409) 937-8920 (international)

and provide the Conference ID 2775710. A live webcast of the presentation will be available on the Investors & Media section of the

Bicycle website, bicycletherapeutics.com.

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 is 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 agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated

in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in

Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts. 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 Bicycle's anticipated advancement of its product candidates, including BT8009, and participation in the

AACR Annual Meeting. 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 intentions disclosed in these forward-looking statements as a result of various factors, including:

Bicycle's abilities to meet other anticipated deadlines 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; and other important

factors, any of which could cause Bicycle's actual results to differ from those contained in the forward-looking statements,

and which are described in greater detail in the section entitled "Risk Factors" in Bicycle's Annual Report on

Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2022, 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 because of any new

information, future events, changed circumstances or otherwise, except as otherwise required by law.

VP, Capital Markets & Investor Relations

Consilium Strategic Communications

Sukaina Virji or Mary-Jane Elliott