Full Press Release Details
Bicycle Therapeutics Reports Fourth Quarter
and Full Year 2022 Financial Results and Provides Corporate Update
progress across pipeline including advancing BT8009, BT5528, and BT7480 in ongoing clinical trials
granted Fast Track Designation by the U.S. Food and Drug Administration; completed Phase I results presented at ASCO GU Cancers Symposium
position of $339.2 million at December 31, 2022 expected to provide financial runway into 2025
England, & BOSTON, February 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 reported financial results for the fourth quarter and full year ended December 31, 2022, and provided recent corporate
have made continued clinical progress across our pipeline, including advancing BT8009 and BT5528 into the ongoing dose expansion cohorts
and are encouraged by the progress of BT7480 in the ongoing dose escalation portion of its clinical trial," said Kevin Lee,
Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We are pleased to have a balance sheet that has supported the advancement
and expansion of our clinical portfolio, with an anticipated financial runway into 2025. We believe we are well-positioned ahead of multiple
potential inflection points as we pursue our goal of demonstrating the true therapeutic potential of Bicycle Toxin Conjugates and
Bicycle tumor-targeted immune cell agonists."
Fourth Quarter 2022 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 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 anticipated advancement of its product candidates, including BT8009, BT5528
and BT7480; the anticipated dosing in and progression of Bicycle's clinical trials; the availability of and timing of announcement
of data from clinical trials; the therapeutic potential for Bicycles in oncology and other applications; and Bicycle's expected
financial runway. 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: uncertainties
inherent in the initiation, progress and completion of clinical trials and clinical development of Bicycle's product candidates;
the risk that Bicycle may not realize the intended benefits of its technology; availability and timing of results from 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 may be delayed or have
unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates; the risk that
Bicycle's projections regarding its expected financial runway are inaccurate or that its conduct of its business requires more cash
than anticipated; 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-Q filed with the Securities and Exchange Commission (SEC) on November 3, 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.
Bicycle Therapeutics plc
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, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Collaboration revenues | $ | 3,185 | $ | 3,771 | $ | 14,463 | $ | 11,697 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 24,719 | 12,952 | 81,609 | 44,880 | ||||||||||||
| General and administrative | 10,677 | 8,842 | 49,507 | 32,435 | ||||||||||||
| Total operating expenses | 35,396 | 21,794 | 131,116 | 77,315 | ||||||||||||
| Loss from operations | (32,211 | ) | (18,023 | ) | (116,653 | ) | (65,618 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 2,639 | 58 | 5,756 | 120 | ||||||||||||
| Interest expense | (826 | ) | (820 | ) | (3,344 | ) | (2,984 | ) | ||||||||
| Total other income (expense), net | 1,813 | (762 | ) | 2,412 | (2,864 | ) | ||||||||||
| Net loss before income tax provision | (30,398 | ) | (18,785 | ) | (114,241 | ) | (68,482 | ) | ||||||||
| Benefit from income taxes | (420 | ) | (748 | ) | (1,524 | ) | (1,663 | ) | ||||||||
| Net loss | $ | (29,978 | ) | $ | (18,037 | ) | $ | (112,717 | ) | $ | (66,819 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.01 | ) | $ | (0.63 | ) | $ | (3.80 | ) | $ | (2.67 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 29,711,570 | 28,790,934 | 29,660,659 | 25,061,734 |
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash and cash equivalents | $ | 339,154 | $ | 438,680 | ||||
| Working capital | 316,041 | 422,317 | ||||||
| Total assets | 410,609 | 479,792 | ||||||
| Total shareholders' equity | 270,783 | 346,254 |
SVP, Capital Markets & Corporate Communications