Full Press Release Details
Bicycle Therapeutics Reports Recent Business
Progress and Second Quarter 2025 Financial Results
Continued advancement across research and development
pipeline, with key program updates expected in 2H 2025
Phase 1/2 Duravelo-4 trial for zelenectide pevedotin
in NECTIN4-amplified non-small cell lung cancer open and actively recruiting patients
Strengthened clinical leadership and bolstered
roster of scientific advisors with additions to Board of Directors and creation of Research and Innovation Advisory Board
Strategic cost realignment of approximately
30%, primarily through a workforce reduction
Cash and cash equivalents of $721.5 million
as of June 30, 2025, with expected financial runway extended into 2028
CAMBRIDGE, England & BOSTON, August 8, 2025 - 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 financial results for the second quarter ended June 30, 2025, and provided
recent corporate updates.
"We continue to execute on our strategy, which is grounded in
scientific rigor and focused on fulfilling our mission to develop next-generation precision-guided therapeutics that have the potential
to help patients live longer and live well," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We are energized by the progress
we are making across our pipeline, and with this momentum, we are pleased to welcome our new Research and Innovation Advisory Board members,
as well as new Board member Charles Swanton, to further our innovation and strategic growth."
Dr. Lee continued: "As we advance our various pipeline programs
that hold strong potential for changing the treatment paradigm for patients with cancer and creating value for shareholders, Bicycle remains
committed to disciplined capital allocation. Today we announced organizational streamlining efforts that provide us with operational flexibility
to deliver potentially value-generating datasets while strengthening our financial position in uncertain market conditions. Saying goodbye
to talented team members is very difficult, and we sincerely thank them for their dedication to our company. We believe Bicycle is strongly
positioned to realize our strategic priorities and milestones and look forward to providing key program updates over the second half of
Second Quarter 2025 and Recent Events
Participation in Upcoming Investor Conferences
Bicycle Therapeutics management will participate in the following investor
conferences in September:
Live webcasts of the fireside chats will be accessible in the Investor
section of the company's website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available following
the fireside chat dates.
Second Quarter 2025 Financial Results
In recognition of the evolving macroeconomic environment and the importance
of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and
extend the company's expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially
high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle
Drug Conjugates and the company's wholly owned pipeline of Bicycle Radioconjugates. Bicycle Therapeutics anticipates
total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the
financial runway into 2028 and strengthen the company's ability to weather continued market uncertainty as it advances clinical
programs through key milestones.
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 Drug
Conjugate (BDC ) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC 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 Radioconjugates
(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 the validation of MT1-MMP as a cancer target and BRC molecules having positive properties
for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle's ongoing clinical trials and the
timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the
outcome of Bicycle's strategic cost realignment efforts and Bicycle's expected financial runway; and the use of Bicycle Therapeutics'
technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics 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 Therapeutics' product candidates;
the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; 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 Therapeutics' 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 Therapeutics'
Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other
filings Bicycle Therapeutics 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 Therapeutics 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
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, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Collaboration revenue | $ | 2,920 | $ | 9,361 | $ | 12,897 | $ | 28,891 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 71,029 | 40,059 | 130,087 | 74,923 | ||||||||||||
| General and administrative | 18,493 | 15,949 | 39,616 | 32,331 | ||||||||||||
| Total operating expenses | 89,522 | 56,008 | 169,703 | 107,254 | ||||||||||||
| Loss from operations | (86,602 | ) | (46,647 | ) | (156,806 | ) | (78,363 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 7,473 | 7,774 | 15,887 | 13,398 | ||||||||||||
| Interest expense | (54 | ) | (824 | ) | (105 | ) | (1,645 | ) | ||||||||
| Total other income, net | 7,419 | 6,950 | 15,782 | 11,753 | ||||||||||||
| Net loss before income tax provision | (79,183 | ) | (39,697 | ) | (141,024 | ) | (66,610 | ) | ||||||||
| (Benefit from) provision for income taxes | (231 | ) | 115 | (1,318 | ) | (235 | ) | |||||||||
| Net loss | $ | (78,952 | ) | $ | (39,812 | ) | $ | (139,706 | ) | $ | (66,375 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.14 | ) | $ | (0.77 | ) | $ | (2.02 | ) | $ | (1.40 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 69,252,009 | 51,992,034 | 69,224,629 | 47,276,062 |
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash and cash equivalents | $ | 721,451 | $ | 879,520 | ||||
| Working capital | 726,840 | 861,375 | ||||||
| Total assets | 832,184 | 956,868 | ||||||
| Total shareholders' equity | 668,915 | 793,060 |
SVP, Investor Relations and Corporate Communications