Full Press Release Details
Bicycle Therapeutics Reports Fourth Quarter
and Full Year 2019 Financial Results and Corporate Updates
activities for lead TICA BT7480 continue to progress
CAMBRIDGE, England, & BOSTON, March 10, 2020 -
Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics
based on its proprietary bicyclic peptide (Bicycles ) technology, today
reported financial results for the fourth quarter and full year ended December 31, 2019 and discussed recent corporate updates.
"Last year was transformational for Bicycle as the completion
of our initial public offering and the strengthening of corporate leadership enabled successful execution against our pipeline
development strategy," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "This year is already
off to a strong start, with two new immuno-oncology collaborations designed to expand upon our wholly owned portfolio of systemic
immune cell agonists and tumor-targeted immune cell agonists (TICAs ). We look forward to the momentum continuing as we progress
multiple Bicycle Toxin Conjugates through the clinic this year and prepare to begin clinical development of our first TICA.
We believe our anticipated near-term milestones will further demonstrate the role Bicycles could play in creating
a much-needed new treatment paradigm for people living with cancer and other serious diseases."
Fourth Quarter 2019 and Recent Highlights
Anticipated Key Events in 2020
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. 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
our collaborations with Cancer Research UK and Genentech; the possible discovery, development and commercialization of product
candidates, including with our collaboration partners; potential payments that may be made pursuant to the strategic collaboration
with Genentech; our intentions to initiate and advance clinical trials; the possible results of clinical trials; the therapeutic
potential of our product candidates; and our 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: the risk that we may not realize the intended benefits of our technology,
including that we or our collaboration partners may not identify, develop and commercialize additional product candidates; the
risk that we may not be able to maintain existing collaborations and realize the benefits thereof or develop new relationships;
uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of
Bicycle's product candidates by Bicycle or our collaboration partners; availability and timing of results from preclinical
studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk
that trials and studies 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 our Quarterly
Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 7, 2019, 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.
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, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Collaboration revenues | $ | 5,281 | $ | 1,057 | $ | 13,801 | $ | 7,136 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,649 | 6,493 | 25,540 | 20,761 | ||||||||||||
| General and administrative | 3,396 | 2,106 | 14,560 | 8,121 | ||||||||||||
| Total operating expenses | 10,045 | 8,599 | 40,100 | 28,882 | ||||||||||||
| Loss from operations | (4,764 | ) | (7,542 | ) | (26,299 | ) | (21,746 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 220 | 94 | 814 | 169 | ||||||||||||
| Other expense, net | - | 807 | (5,377 | ) | (665 | ) | ||||||||||
| Total other income (expense), net | 220 | 901 | (4,563 | ) | (496 | ) | ||||||||||
| Net loss before income tax provision | (4,544 | ) | (6,641 | ) | (30,862 | ) | (22,242 | ) | ||||||||
| Benefit from income taxes | (138 | ) | - | (254 | ) | (396 | ) | |||||||||
| Net loss | $ | (4,406 | ) | $ | (6,641 | ) | $ | (30,608 | ) | $ | (21,846 | ) | ||||
| Net loss attributable to ordinary shareholders | $ | (4,406 | ) | $ | (6,641 | ) | $ | (30,608 | ) | $ | (21,846 | ) | ||||
| Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.25 | ) | $ | (13.19 | ) | $ | (2.77 | ) | $ | (49.78 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 17,926,165 | 503,309 | 11,045,370 | 438,862 |
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Cash | $ | 92,117 | $ | 63,380 | ||||
| Working capital | 95,325 | 67,840 | ||||||
| Total assets | 110,194 | 81,626 | ||||||
| Shareholders equity (deficit) | 93,198 | (69,826 | ) |
Investor and Media Contact:
Bicycle Therapeutics