Full Press Release Details
Bicycle Therapeutics Reports First Quarter
2020 Financial Results and Provides Corporate Update
England, & BOSTON, May 7, 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 first quarter ended March 31, 2020 and discussed recent corporate updates.
"We are very proud of the tremendous progress we've
made executing against our 2020 goals in the first few months of this year," said Kevin Lee, Ph.D., Chief Executive Officer
of Bicycle Therapeutics. "Since January, we've entered two new immuno-oncology collaborations, including a partnership
with Genentech worth up to $1.7 billion, and reached key milestones in the advancement of our clinical programs, such as establishing
a recommended Phase II dose for our most advanced Bicycle Toxin Conjugate (BTC) BT1718 and advancing BT5528, our first second-generation
BTC, through the Phase I dose escalation quickly. We also welcomed to Bicycle our General Counsel, Zafar Qadir, who brings extensive
legal expertise and experience that will be integral to the achievement of our near- and long-term objectives. Despite uncertainties
associated with the COVID-19 pandemic, we remain focused on achieving our stated goals for the year as planned. We look forward
to providing updates on our progress as we advance our novel therapeutic candidates into and through the clinic."
First Quarter 2020 and Recent Highlights
Upcoming Investor Presentation
Bicycle will present at the Bank of America 2020 Health Care
Conference on Thursday, May 14, 2020 at 3:00 p.m. ET. The conference will be held in a virtual meeting format.
A live webcast of the presentation will be accessible in the
Investors & Media section of Bicycle's website at bicycletherapeutics.com. An archived replay of the webcast will be
available for 60 days following the presentation date.
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
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 collaborations with multiple third parties; the discovery, development and potential commercialization
of product candidates using Bicycle's technology and under collaboration agreements with third parties; anticipated advancement
of preclinical development efforts and initiation and progression of clinical trials; the therapeutic potential for Bicycles
in various disease applications; the potential impacts of the ongoing COVID-19 pandemic on site initiation, patient enrollment
and treatment; Bicycle's ability to achieve planned milestones; and the potential to receive milestone payments and royalties
under our collaboration agreements. 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: the risk that Bicycle may not realize the intended benefits of its technology, including that Bicycle or its collaboration
partners may not identify, develop and commercialize additional product candidates; uncertainties inherent in the initiation
and completion of preclinical studies and clinical trials and clinical development of Bicycle's product candidates; availability
and timing of results from preclinical studies and clinical trials; 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; 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; 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 10, 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
Bicycle Therapeutics plc
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per share
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2020 | 2019 | |||||||
| Collaboration revenues | $ | 1,129 | $ | 6,384 | ||||
| Operating expenses: | ||||||||
| Research and development | 7,774 | 6,276 | ||||||
| General and administrative | 4,998 | 3,402 | ||||||
| Total operating expenses | 12,772 | 9,678 | ||||||
| Loss from operations | (11,643 | ) | (3,294 | ) | ||||
| Other income (expense): | ||||||||
| Interest and other income | 212 | 64 | ||||||
| Other expense, net | - | (3,193 | ) | |||||
| Total other income (expense), net | 212 | (3,129 | ) | |||||
| Net loss before income tax provision | (11,431 | ) | (6,423 | ) | ||||
| (Benefit from) provision for income taxes | (107 | ) | 80 | |||||
| Net loss | $ | (11,324 | ) | $ | (6,503 | ) | ||
| Net loss attributable to ordinary shareholders | $ | (11,324 | ) | $ | (6,503 | ) | ||
| Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.63 | ) | $ | (7.80 | ) | ||
| Weighted average ordinary shares outstanding, basic and diluted | 17,997,929 | 834,043 |
| March 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Cash | $ | 109,637 | $ | 92,117 | ||||
| Working capital | 107,193 | 95,325 | ||||||
| Total assets | 129,282 | 110,194 | ||||||
| Shareholders' equity | 81,813 | 93,198 |
Investor and Media Contact:
Bicycle Therapeutics