Full Press Release Details
Bicycle Therapeutics Reports Third Quarter 2021
Financial Results and Provides Corporate Update
CAMBRIDGE, England, & BOSTON,
November 4, 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 third quarter ended September 30, 2021 and provided recent corporate updates.
"We recently provided a clinical update for our ongoing Phase
1 dose escalation trials in BT5528 and BT8009, the data from which support our conviction that the Bicycle platform offers a potentially
differentiated approach to traditional targeted payload delivery," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle
Therapeutics. "We were encouraged to see preliminary anti-tumor activity in both trials and across two tumor types, providing further
insights as we continue to expand the application of our technology. We look forward to providing additional clinical data on BT5528 and
"Beyond our Bicycle Toxin Conjugates (BTC), we are
also making progress across our other programs, including BT7480, our novel, fully synthetic Bicycle tumor-targeted immune cell
agonist (Bicycle TICA ), which recently entered the clinic, as well as in our partnership with Genentech, which is now being
expanded to include a new program under the collaboration. In addition, we recently entered into a collaboration agreement with Ionis
Pharmaceuticals to develop targeted oligonucleotide therapeutics, which we believe further demonstrates the potential of the platform
outside of oncology. Our plans to advance our programs and platform in oncology and beyond are supported by a strong balance sheet that
has been further enhanced by the recent proceeds from an upsized public equity offering completed in October.
Third Quarter 2021 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 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 of its product candidates, including BT5528, BT8009 and BT7480; the
advancement of Bicycle's product candidate pipeline; the anticipated design of, initiation of, enrollment in and progression
of Bicycle's and its collaboration partners' clinical trials; the availability and timing of data from clinical trials;
the therapeutic potential of Bicycle's product candidates; the development and potential commercialization of potential
product candidates using Bicycle's technology and under its license and collaboration agreements with Ionis and Genentech; the
potential for Bicycle to receive milestone payments and royalties under its license and collaboration agreement with Ionis;
potential site expansions in CRUK's ongoing clinical trial of BT1718; the therapeutic potential
for Bicycles in multiple applications; the potential of Bicycle's platform to develop potential precision
medicines; 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 Bicycle's
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, 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
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Collaboration revenues | $ | 4,333 | $ | 3,842 | $ | 7,926 | $ | 6,542 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 10,513 | 7,363 | 31,924 | 23,091 | ||||||||||||
| General and administrative | 8,114 | 7,154 | 23,596 | 18,351 | ||||||||||||
| Total operating expenses | 18,627 | 14,517 | 55,520 | 41,442 | ||||||||||||
| Loss from operations | (14,294 | ) | (10,675 | ) | (47,594 | ) | (34,900 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 24 | 72 | 61 | 655 | ||||||||||||
| Interest expense | (823 | ) | - | (2,164 | ) | - | ||||||||||
| Total other income (expense), net | (799 | ) | 72 | (2,103 | ) | 655 | ||||||||||
| Net loss before income tax provision | (15,093 | ) | (10,603 | ) | (49,697 | ) | (34,245 | ) | ||||||||
| Benefit from income taxes | (415 | ) | (465 | ) | (915 | ) | (668 | ) | ||||||||
| Net loss | $ | (14,678 | ) | $ | (10,138 | ) | $ | (48,782 | ) | $ | (33,577 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.59 | ) | $ | (0.52 | ) | $ | (2.06 | ) | $ | (1.81 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 25,039,990 | 19,426,833 | 23,719,124 | 18,504,013 |
| September 30, | December 31, | |||||
| 2021 | 2020 | |||||
| Cash | $ | 259,524 | $ | 135,990 | ||
| Working capital | 242,695 | 132,594 | ||||
| Total assets | 281,333 | 161,152 | ||||
| Total shareholders' equity | 170,823 | 95,460 |
VP, Capital Markets & Investor Relations
Consilium Strategic Communications
Sukaina Virji or Mary-Jane Elliott