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Bicycle Therapeutics Announces a Strategic Collaboration with Novartis to Discover, Develop and Commercialize Bicycle Radio-Conjugates - Bicycle and Novartis will collaborate on the discovery and development of multiple

Key Takeaway: Bicycle Therapeutics has entered into a strategic collaboration with Novartis to develop and commercialize Bicycle radio-conjugates for multiple oncology targets. Novartis will fund all aspects of development and commercialization, with Bicycle receiving a $50 million upfront payment and potential milestone payments of up to $1.7 billion. This partnership aims to leverage Bicycle's innovative technology to advance cancer treatment options, indicating strong validation for the company's approach in the biopharmaceutical sector. The collaboration presents numerous opportunities, along with inherent risks related to dependency on Novartis and the success of product development.

Market Sentiment Analysis

POSITIVE FACTORS

  • Collaboration with Novartis provides significant funding and support for development.
  • Potential for innovative cancer treatments using Bicycle's proprietary technology.
  • Opportunity for substantial milestone payments totaling up to $1.7 billion.
  • Bicycle's technology has shown promise in its clinical work.

CONCERNS & RISKS

  • Dependence on Novartis for development and commercialization may limit Bicycle's control.
  • Risks associated with the successful identification of viable product candidates.

Full Press Release Details

Bicycle Therapeutics Announces a Strategic
Collaboration with Novartis to Discover, Develop and Commercialize Bicycle Radio-Conjugates
& BOSTON, March 28, 2023 - 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 it has entered into a strategic collaboration agreement with Novartis to develop, manufacture and commercialize
Bicycle radio-conjugates (BRCs) for multiple agreed upon oncology targets.
"This collaboration builds on the groundbreaking
clinical work we have been doing in the toxin conjugate field and provides new and additional validation for this unique technology,"
said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We look forward to working closely with Novartis to pioneer
the discovery and development of potential new cutting-edge radiopharmaceutical cancer treatments based on Bicycles. We believe
the properties of Bicycles make them well suited for the development of precision guided radiopharmaceuticals and represents the
next leg in the application of our proprietary discovery platform in oncology."
Under the terms of the agreement, Bicycle will
utilize its proprietary phage platform to discover Bicycles to be developed into BRCs. Novartis will be responsible for further
development, manufacture and commercialization of the BRCs. Novartis will fund all pre-clinical and clinical development and commercialization
activities. Bicycle will receive a $50 million upfront payment and is eligible for development and commercial-based milestone payments
totaling up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties on Bicycle-based medicines commercialized
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 Cambridge, 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 Bicycle's collaboration with Novartis; the discovery,
development and potential commercialization of potential radiopharmaceutical or other product candidates using Bicycle's technology
under the strategic collaboration agreement; the therapeutic potential for Bicycles in oncology and other applications; and the potential
to receive milestone payments under the strategic collaboration agreement. 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: the risk that Bicycle may not realize the intended benefits of its technology or of the collaboration
agreement with Novartis, including that Bicycle and Novartis may not successfully identify, develop and commercialize additional product
candidates; the risk that Bicycle may not be able to maintain its collaboration with Novartis and realize the benefits thereof; and other
important factors, any of which could cause Bicycle's 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-K filed
with the Securities and Exchange Commission (SEC) on February 28, 2023, 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.
SVP, Capital Markets & Corporate Communications

Frequently Asked Questions

What is the collaboration between Bicycle Therapeutics and Novartis?

Bicycle Therapeutics has partnered with Novartis to develop and commercialize Bicycle radio-conjugates for oncology.

What technology do Bicycle Therapeutics Bicycles utilize?

Bicycles are based on fully synthetic short peptides that form constrained loops for better target binding.

How much upfront payment will Bicycle receive from Novartis?

Bicycle will receive a $50 million upfront payment under the collaboration agreement.

What are some of the drug candidates Bicycle is evaluating?

Bicycle is evaluating BT5528, BT8009, and BT7480 in ongoing Phase I/II trials.

Where is Bicycle Therapeutics headquartered?

Bicycle Therapeutics is headquartered in Cambridge, UK, with key functions in Cambridge, MA.

Last updated: Mar 28, 2023