Full Press Release Details
Bicycle Therapeutics Reports Recent Business
Progress and First Quarter 2025 Financial Results
Multiple abstracts accepted for presentation
at 2025 ASCO and AACR annual meetings underscore breadth of Bicycle technology and potential of oncology pipeline
Phase 1/2 Duravelo-3 trial for zelenectide pevedotin
in NECTIN4-amplified breast cancer open and actively recruiting patients
Bolstered business and clinical expertise with
appointments to Board of Directors, Clinical Advisory Board and company management team
Cash and cash equivalents of $793.0 million
as of March 31, 2025, with expected financial runway into 2H 2027
CAMBRIDGE, England & BOSTON, May 1, 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 recent business progress and financial results for the first quarter
ended March 31, 2025.
"In the first quarter, we continued to advance our business priorities
and our pipeline of oncology therapeutics. We were pleased to share additional human imaging data that continue to validate the potential
of MT1-MMP as a novel cancer target and demonstrate the positive properties of our Bicycle Radioconjugate molecules for radiopharmaceutical
use," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "Our work to develop zelenectide pevedotin for various Nectin-4 associated
cancers continues to progress, as we recently initiated our Phase 1/2 Duravelo-3 trial for NECTIN4 gene-amplified breast cancer and remain
on track for dose selection in our Phase 2/3 Duravelo-2 trial for metastatic urothelial cancer in the second half of this year. Additionally,
with new members on our leadership team, Board of Directors and Clinical Advisory Board, and expected financial runaway extending to the
second half of 2027, we remain focused on continuing to execute our strategy and make meaningful advances for patients."
First Quarter 2025 and Recent Events
Participation in Upcoming Investor Conferences
Bicycle Therapeutics management will participate in a fireside chat
at the 2025 RBC Capital Markets Global Healthcare Conference on Tuesday, May 20, at 2:05 p.m. ET. A live webcast of the fireside
chat will be accessible from the Investor section of the company's website at www.bicycletherapeutics.com. A replay of the webcast
will be archived and available following the event.
First Quarter 2025 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 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 BRCs having positive properties for radiopharmaceutical
use; the initiation of new clinical trials, the progress of Bicycle's ongoing clinical trials and the timing of dose selection in
the Duravelo-2 clinical trial; 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 partnerships; the risk that Bicycle Therapeutics may 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-K
filed with the Securities and Exchange Commission (SEC) on February 25, 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 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 | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Collaboration revenue | $ | 9,977 | $ | 19,530 | ||||
| Operating expenses: | ||||||||
| Research and development | 59,058 | 34,864 | ||||||
| General and administrative | 21,123 | 16,382 | ||||||
| Total operating expenses | 80,181 | 51,246 | ||||||
| Loss from operations | (70,204 | ) | (31,716 | ) | ||||
| Other income (expense): | ||||||||
| Interest and other income | 8,414 | 5,624 | ||||||
| Interest expense | (51 | ) | (821 | ) | ||||
| Total other income, net | 8,363 | 4,803 | ||||||
| Net loss before income tax provision | (61,841 | ) | (26,913 | ) | ||||
| Benefit from income taxes | (1,087 | ) | (350 | ) | ||||
| Net loss | $ | (60,754 | ) | $ | (26,563 | ) | ||
| Net loss per share, basic and diluted | $ | (0.88 | ) | $ | (0.62 | ) | ||
| Weighted average ordinary shares outstanding, basic and diluted | 69,196,945 | 42,560,091 |
| March 31, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Cash and cash equivalents | $ | 792,973 | $ | 879,520 | |||
| Working capital | 798,463 | 861,375 | |||||
| Total assets | 883,894 | 956,868 | |||||
| Total shareholders' equity | 740,333 | 793,060 |
SVP, Investor Relations and Corporate Communications