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Bicycle Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update - Significant progress across pipeline including advancing BT8009, BT5528, and BT7480 in ongoing clinical tri

Key Takeaway: Bicycle Therapeutics reported its financial results for Q4 and full year 2022, highlighting significant progress in its drug pipeline including BT8009, BT5528, and BT7480. The company received Fast Track Designation from the FDA, enhancing its development prospects. As of December 31, 2022, Bicycle maintained a financial position of $339.2 million, which is expected to support its operations through 2025. Despite this, the company reported a notable net loss and substantial operating expenses during the quarter.

Market Sentiment Analysis

POSITIVE FACTORS

  • Advancement of multiple drug candidates (BT8009, BT5528, BT7480) in clinical trials.
  • Secured Fast Track Designation from the FDA, which could expedite development.
  • Strong financial position with $339.2 million runway into 2025.

CONCERNS & RISKS

  • Incurred a significant net loss of $29.978 million in Q4 2022.
  • Operating expenses increased to $35.396 million, raising concerns about sustainability.

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

Frequently Asked Questions

What is Bicycle Therapeutics known for?

Bicycle Therapeutics specializes in developing a novel class of therapeutics called Bicycles.

Which clinical trials are currently ongoing by Bicycle?

Bicycle is advancing BT8009, BT5528, and BT7480 in ongoing clinical trials.

What financial position does Bicycle hold as of December 2022?

Bicycle reported a financial position of $339.2 million expected to fund operations into 2025.

What is the Fast Track Designation for Bicycle's products?

Bicycle has received Fast Track Designation from the FDA for its product candidates.

What were Bicycle's total operating expenses in 2022?

Bicycle's total operating expenses for 2022 were $131.1 million.

Last updated: Feb 28, 2023