Full Press Release Details
Bicycle Therapeutics Reports Recent Business
Progress and Second Quarter 2024 Financial Results
Four abstracts containing data updates across
clinical pipeline accepted for poster presentation at ESMO Congress 2024
Focused R&D pipeline on clinical programs
and research areas that have the highest potential to maximize value creation
Streamlined leadership team to better align
with strategic and pipeline priorities, and enhanced oncology expertise with formation of Clinical Advisory Board
Strengthened balance sheet with gross proceeds
of approximately $555 million from May 2024 private investment in public equity (PIPE) financing
equivalents of $961.4 million as of June 30, 2024, expected to provide financial runway into 2H 2027
CAMBRIDGE, England & BOSTON, August 6, 2024 - Bicycle
Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary
bicyclic peptide (Bicycle ) technology, today reported recent business progress and financial results for the second quarter
ended June 30, 2024.
"In the second quarter, we continued
to demonstrate the ongoing progress of our pipeline and highlight the emerging differentiated profiles of our Bicycle Toxin Conjugates
zelenectide pevedotin and BT5528 compared to antibody drug conjugates. As we enter the second half of the year, we look forward to sharing
the first set of data updates from our clinical programs at the upcoming ESMO Congress," said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics.
"Additionally, I am honored to welcome renowned oncology experts from around the world to our Clinical Advisory Board. Their
advice and counsel will be critical as we work to develop therapies that can help patients live longer and live well."
Dr. Lee continued: "Bicycle Therapeutics also significantly
strengthened our balance sheet in the second quarter through the support of leading healthcare investors. Moreover, we have prioritized
our pipeline and streamlined our leadership team to enable us to focus on the clinical programs and research areas that we believe have
the highest potential for value creation and align with our strategy to support the long-term growth of our company."
Second Quarter 2024 and Recent Events
In June, the company presented two
abstracts at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting outlining clinical pharmacokinetics of
Bicycle Toxin Conjugate (BTC ) molecules zelenectide pevedotin and BT5528 compared to antibody drug
conjugate enfortumab vedotin and evaluating the emerging safety profile of both BTC molecules, along with an overview of the
company's ongoing Phase 2/3 Duravelo-2 registrational trial of zelenectide pevedotin in mUC.
Second Quarter 2024 Financial Results
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage pharmaceutical company
developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing
therapeutics. Bicycle molecules 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 Bicycle molecules attractive
candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle Toxin
Conjugate (BTC ) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically
undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA ) targeting
Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radio
Conjugates (BRC ) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology
to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with
many key functions and members of its leadership team located in Cambridge, Mass. 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 progress across its R&D pipeline and the advancement of its
product candidates, including zelenectide pevedotin, BT5528 and BT7480; the anticipated progression of Bicycle's clinical trials
and the method and timing of announcement of data from clinical trials and program updates for clinical candidates; Bicycle's beliefs
regarding the clinical programs and research areas with the highest potential to maximize value creation and the company's activities
to focus on such programs and areas; the guidance and insights provided by the Clinical Advisory Board; the development of potential radiopharmaceutical
or other product candidates using Bicycle's technology through various partnerships; 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 research and development and 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 or partnerships; timing of results from clinical trials; whether the outcomes of preclinical studies will be predictive
of clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or
use of Bicycle's product candidates; the risk that Bicycle's management have not focused the company's activities on
the clinical programs and research areas with the highest potential to maximize value creation; the risk that the Clinical Advisory Board
does not provide guidance or insights or that such guidance turns out to be deficient; the risk that Bicycle's projections regarding
its expected cash 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 2, 2024, 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, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Collaboration revenues | $ | 9,361 | $ | 11,397 | $ | 28,891 | $ | 16,293 | |||||
| Operating expenses: | |||||||||||||
| Research and development | 40,059 | 39,720 | 74,923 | 71,931 | |||||||||
| General and administrative | 15,949 | 14,788 | 32,331 | 29,276 | |||||||||
| Total operating expenses | 56,008 | 54,508 | 107,254 | 101,207 | |||||||||
| Loss from operations | (46,647 | ) | (43,111 | ) | (78,363 | ) | (84,914 | ) | |||||
| Other income (expense): | |||||||||||||
| Interest income | 7,774 | 812 | 13,398 | 3,741 | |||||||||
| Interest expense | (824 | ) | (821 | ) | (1,645 | ) | (1,629 | ) | |||||
| Total other income (expense), net | 6,950 | (9 | ) | 11,753 | 2,112 | ||||||||
| Net loss before income tax provision | (39,697 | ) | (43,120 | ) | (66,610 | ) | (82,802 | ) | |||||
| Provision for (benefit from) income taxes | 115 | (517 | ) | (235 | ) | (1,135 | ) | ||||||
| Net loss | $ | (39,812 | ) | $ | (42,603 | ) | $ | (66,375 | ) | $ | (81,667 | ) | |
| Net loss per share, basic and diluted | $ | (0.77 | ) | $ | (1.41 | ) | $ | (1.40 | ) | $ | (2.71 | ) | |
| Weighted average ordinary shares outstanding, basic and diluted | 51,992,034 | 30,191,693 | 47,276,062 | 30,097,234 |
Condensed Consolidated Balance Sheets Data
| June 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash and cash equivalents | $ | 961,364 | $ | 526,423 | |||
| Working capital | 958,645 | 492,331 | |||||
| Total assets | 1,057,355 | 595,344 | |||||
| Total shareholders' equity | 873,813 | 370,932 |
SVP, Investor Relations and Corporate Communications