Full Press Release Details
Bicycle Therapeutics Reports Second Quarter
2020 Financial Results and Provides Corporate Update
England, & BOSTON, August 5, 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
second quarter ended June 30, 2020 and discussed recent corporate updates.
"Despite the challenges presented by the ongoing COVID-19
pandemic, we have made significant progress towards achieving our 2020 objectives," said Kevin Lee, Ph.D., Chief Executive
Officer of Bicycle Therapeutics. "In the coming months, we look forward to initiating the Phase IIa trial of BT1718 and the
Phase I/II trial of BT8009. We are also continuing to advance BT5528 in the dose escalation portion of a Phase I/II trial, and
we will be deploying our proprietary EphA2 immunohistochemistry, or IHC, assay to select and enroll EphA2-positive patients in
the Phase I trial. We remain confident in our ability to achieve our near-term milestones, which should help enable our vision
of pioneering the development of novel therapies for patients suffering from cancer and other serious diseases."
Second Quarter 2020 and Recent Highlights
Upcoming Investor Conferences
Bicycle will be participating in the
following virtual investor conferences in the third quarter of 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 the design and anticipated
initiation or progression of Bicycle's clinical trials; the therapeutic potential of Bicycle's product candidates;
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; 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 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 7, 2020, 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 plc
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per share
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration revenues | $ | 1,571 | $ | 1,522 | $ | 2,700 | $ | 7,906 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,958 | 6,537 | 15,728 | 12,813 | ||||||||||||
| General and administrative | 6,196 | 2,973 | 11,197 | 6,375 | ||||||||||||
| Total operating expenses | 14,154 | 9,510 | 26,925 | 19,188 | ||||||||||||
| Loss from operations | (12,583 | ) | (7,988 | ) | (24,225 | ) | (11,282 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 371 | 90 | 583 | 154 | ||||||||||||
| Other expense, net | - | (2,184 | ) | - | (5,377 | ) | ||||||||||
| Total other income (expense), net | 371 | (2,094 | ) | 583 | (5,223 | ) | ||||||||||
| Net loss before income tax provision | (12,212 | ) | (10,082 | ) | (23,642 | ) | (16,505 | ) | ||||||||
| (Benefit from) provision for income taxes | (97 | ) | 135 | (204 | ) | 215 | ||||||||||
| Net loss | $ | (12,115 | ) | $ | (10,217 | ) | $ | (23,438 | ) | $ | (16,720 | ) | ||||
| Net loss attributable to ordinary shareholders | $ | (12,115 | ) | $ | (10,217 | ) | $ | (23,438 | ) | $ | (16,720 | ) | ||||
| Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.67 | ) | $ | (1.40 | ) | $ | (1.30 | ) | $ | (4.08 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 18,077,770 | 7,298,139 | 18,024,314 | 4,101,564 |
| June 30, | December 31, | |||||
| 2020 | 2019 | |||||
| Cash | $ | 96,910 | $ | 92,117 | ||
| Working capital | 95,553 | 95,325 | ||||
| Total assets | 118,602 | 110,194 | ||||
| Shareholders equity | 71,026 | 93,198 |
Investor and Media Contact:
Bicycle Therapeutics