Full Press Release Details
Bicycle Therapeutics Reports Fourth Quarter
and Full Year 2020 Financial Results and Provides Corporate Update
CAMBRIDGE, England, &
BOSTON, March 11, 2021 - 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 reported financial results for the fourth quarter and full year ended December 31, 2020 and discussed recent
"Bicycle has overcome the unprecedented challenges caused
by the COVID-19 pandemic this past year, executing on our 2020 goals, including advancing multiple Bicycle Toxin Conjugates
(BTCs) in the clinic and preparing our first tumor targeted immune cell agonist (TICA) for an expected clinical start later this
year, while also thoughtfully strengthening our balance sheet," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle
Therapeutics. "We are encouraged by the progress of our pipeline and are looking forward to continuing the momentum in 2021.
With our clinical data presented to date, we believe we are closer to actualizing a world where Bicycles offer a much-needed
new treatment paradigm for people living with cancer and other serious diseases."
Fourth Quarter 2020 and Recent Highlights
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 trial. 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 Bicycle's
anticipated advancement and expansion of its pre-clinical and clinical pipelines; Bicycle's expected cash runway;
anticipated enrollment in and progression of Bicycle's and its collaborators' clinical trials; the availability
of data from clinical trials and preclinical studies; the therapeutic potential of Bicycle's product candidates; and
Bicycle's ability to achieve planned milestones. 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 and its collaboration partners' abilities to meet other
anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation
and completion of preclinical studies and clinical trials and clinical development of Bicycle's product candidates by
Bicycle or its collaboration partners; the risk that Bicycle may not realize the intended benefits of its technology;
availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies
will be predictive of clinical trial results; 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 and studies may be delayed and may not
have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates;
risks related to Bicycle's ability to maintain existing collaborations and realize the benefits thereof; expectations
for regulatory approvals to conduct trials or to market products; 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 our in our Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 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 because of any new information, future
events, changed circumstances or otherwise, except as otherwise required by law.
Bicycle Therapeutics
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except
share and per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration revenues | $ | 3,848 | $ | 5,281 | $ | 10,390 | $ | 13,801 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 10,057 | 6,649 | 33,149 | 25,540 | ||||||||||||
| General and administrative | 10,850 | 3,396 | 29,201 | 14,560 | ||||||||||||
| Total operating expenses | 20,907 | 10,045 | 62,350 | 40,100 | ||||||||||||
| Loss from operations | (17,059 | ) | (4,764 | ) | (51,960 | ) | (26,299 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 8 | 220 | 683 | 814 | ||||||||||||
| Interest expense | (437 | ) | - | (457 | ) | - | ||||||||||
| Other expense, net | - | - | - | (5,377 | ) | |||||||||||
| Total other income (expense), net | (429 | ) | 220 | 226 | (4,563 | ) | ||||||||||
| Net loss before income tax provision | (17,488 | ) | (4,544 | ) | (51,734 | ) | (30,862 | ) | ||||||||
| Benefit from income taxes | (55 | ) | (138 | ) | (724 | ) | (254 | ) | ||||||||
| Net loss | $ | (17,433 | ) | $ | (4,406 | ) | $ | (51,010 | ) | $ | (30,608 | ) | ||||
| Net loss attributable to ordinary shareholders | $ | (17,433 | ) | $ | (4,406 | ) | $ | (51,010 | ) | $ | (30,608 | ) | ||||
| Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.83 | ) | $ | (0.25 | ) | $ | (2.66 | ) | $ | (2.77 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 21,057,855 | 17,926,165 | 19,145,938 | 11,045,370 |
| December 31, | December 31, | ||||||
| 2020 | 2019 | ||||||
| Cash | $ | 135,990 | $ | 92,117 | |||
| Working capital | 132,594 | 95,325 | |||||
| Total assets | 161,152 | 110,194 | |||||
| Shareholders' equity | 95,460 | 93,198 |
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