Full Press Release Details
Bicycle Therapeutics Reports Second Quarter 2022
Financial Results and Provides Corporate Update
- Continued clinical progress across pipeline, including
dosing of the first patient in expansion
cohorts of Phase I/II study of BT5528
- Expansion of Genentech
exclusive strategic collaboration, triggering a $10 million payment to
- Cash and cash equivalents of
$372.8 million as of June 30, 2022, excludes $9.8 million UK R&D
tax credit received in July and Genentech payment; expected financial
England, & BOSTON, August 4, 2022 - 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 second quarter ended June 30, 2022 and provided recent corporate updates.
"We are pleased with the progress
of our wholly owned clinical oncology pipeline of Bicycle Toxin Conjugate, or BTC , programs and Bicycle tumor-targeted
immune cell agonist , or Bicycle TICA , programs," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics.
"In the second quarter, we initiated the expansion cohorts of our Phase I/II study of BT5528, and development of BT8009 and BT7480
remains on track as these programs advance in their respective clinical trials."
we were delighted to announce the second expansion of our immuno-oncology collaboration with Genentech last month, highlighting the potential
of the platform beyond our BTCs and Bicycle TICAs," Dr Lee continued. "We are pleased to have a strong balance sheet
which helps support the advancement of our programs and which we anticipate provides a financial runway into 2025."
Second Quarter 2022 and Recent
Exploration of additional doses and frequencies continues,
and Bicycle intends to provide further updates this year.
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 Lexington, Massachusetts. 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 BT5528, BT8009 and BT7480; the
anticipated dosing in and progression of Bicycle's clinical trials; the availability of data from clinical trials; the
therapeutic potential for Bicycles in oncology and other applications; Bicycle's plans to expand its discovery efforts
and early development pipeline; 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: risks to clinical trial site initiation, patient
enrollment and follow-up, as well as to Bicycle's abilities to meet other anticipated deadlines and milestones, presented by
the ongoing COVID-19 pandemic; uncertainties inherent in the initiation 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 and may not have satisfactory 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 May 5, 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 | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Collaboration revenues | $ | 4,378 | $ | 1,785 | $ | 8,238 | $ | 3,593 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 19,854 | 11,722 | 34,138 | 21,415 | ||||||||||||
| General and administrative | 11,824 | 7,340 | 28,783 | 15,479 | ||||||||||||
| Total operating expenses | 31,678 | 19,062 | 62,921 | 36,894 | ||||||||||||
| Loss from operations | (27,300 | ) | (17,277 | ) | (54,683 | ) | (33,301 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 908 | 23 | 1,126 | 38 | ||||||||||||
| Interest expense | (883 | ) | (819 | ) | (1,701 | ) | (1,341 | ) | ||||||||
| Total other income (expense), net | 25 | (796 | ) | (575 | ) | (1,303 | ) | |||||||||
| Net loss before income tax provision | (27,275 | ) | (18,073 | ) | (55,258 | ) | (34,604 | ) | ||||||||
| Benefit from income taxes | (447 | ) | (160 | ) | (866 | ) | (500 | ) | ||||||||
| Net loss | $ | (26,828 | ) | $ | (17,913 | ) | $ | (54,392 | ) | $ | (34,104 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.90 | ) | $ | (0.74 | ) | $ | (1.84 | ) | $ | (1.48 | ) | ||||
| Weighted average ordinary shares outstanding, basic and d iluted | 29,648,564 | 24,052,168 | 29,626,974 | 23,047,745 |
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash and cash equivalents | $ | 372,769 | $ | 438,680 | ||||
| Working capital | 367,152 | 422,317 | ||||||
| Total assets | 445,482 | 479,792 | ||||||
| Total shareholders' equity | 311,392 | 346,254 |
VP, Capital Markets & Investor Relations