Full Press Release Details
Bicycle Therapeutics Reports Recent Business
Progress and Third Quarter 2025 Financial Results
Dose selection from Phase 2/3 Duravelo-2 trial
and update on potential approval pathway expected in 1Q 2026 as company seeks feedback from multiple regulatory agencies
Enhanced clinical leadership team with appointments
to Board of Directors and Research and Innovation Advisory Board
Cash and cash equivalents of $648.3 million
as of September 30, 2025, excluding $38.2 million U.K. R&D tax credit received in October 2025; expected financial runway into 2028
CAMBRIDGE, England & BOSTON, October 30, 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 third quarter ended September 30, 2025, and provided
recent corporate updates.
"We are currently seeking broad regulatory feedback to make
an informed decision on our path forward with zelenectide pevedotin in metastatic urothelial cancer. We look forward to providing
updates in the first quarter of 2026," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We have also been executing
across the rest of our pipeline with the goal of helping patients live longer and live well. The development of zelenectide
pevedotin for multiple Nectin-4 associated cancers is ongoing, with the Phase 1/2 Duravelo-3 trial for NECTIN4-amplified breast
cancer and the Phase 1/2 Duravelo-4 trial for NECTIN4-amplified non-small cell lung cancer open and actively enrolling.
Additionally, we were pleased to welcome additional esteemed global oncology leaders to the Bicycle Board of Directors and to our
Research and Innovation Advisory Board to further strengthen our innovation and strategic growth."
Third Quarter 2025 and Recent Events
| Data for an early Bicycle Radioconjugate (BRC ) molecule targeting MT1-MMP presented at European Association of Nuclear Medicine (EANM) 2025 Congress. An e-poster presentation outlined the first clinical experience with an early Bicycle Imaging Agent (BIA) targeting MT1-MMP. An additional e-poster presented by the German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), highlighted preclinical BRC data demonstrating the potential of this approach for radiotheranostic use. Altogether, the data build on preclinical and first human imaging data previously disclosed at the American Association for Cancer Research (AACR) Annual Meeting 2025 and EANM 2024. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging. | |
| The company continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in the first half of 2026 and the initiation of the first company-sponsored clinical trial expected in 2026. |
Participation in Upcoming Investor Conference
Bicycle Therapeutics management will participate in the following investor
conference in November:
A live webcast of the fireside chat will be accessible in the Investor
section of the company's website at www.bicycletherapeutics.com. An archived replay of the webcast will be available following
Third 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 initiation of new clinical trials, the progress of Bicycle's clinical trials,
reporting data from Bicycle's clinical trials, including for BT5528 and BT7480, the timing of EphA2 human imaging data and
updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the validation of MT1-MMP as a cancer target
and BRC molecules having positive properties for radiopharmaceutical imaging; communications with and feedback from the FDA and other
regulatory agencies; 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 August 8, 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Collaboration revenue | $ | 11,734 | $ | 2,676 | $ | 24,631 | $ | 31,567 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 58,426 | 48,265 | 188,513 | 123,188 | ||||||||||||
| General and administrative | 18,859 | 18,257 | 58,475 | 50,588 | ||||||||||||
| Total operating expenses | 77,285 | 66,522 | 246,988 | 173,776 | ||||||||||||
| Loss from operations | (65,551 | ) | (63,846 | ) | (222,357 | ) | (142,209 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 6,700 | 10,583 | 22,587 | 23,981 | ||||||||||||
| Interest expense | (44 | ) | (33 | ) | (149 | ) | (1,678 | ) | ||||||||
| Loss on extinguishment of debt | - | (954 | ) | - | (954 | ) | ||||||||||
| Total other income, net | 6,656 | 9,596 | 22,438 | 21,349 | ||||||||||||
| Net loss before income tax provision | (58,895 | ) | (54,250 | ) | (199,919 | ) | (120,860 | ) | ||||||||
| Provision for (benefit from) income taxes | 205 | (3,448 | ) | (1,113 | ) | (3,683 | ) | |||||||||
| Net loss | $ | (59,100 | ) | $ | (50,802 | ) | $ | (198,806 | ) | $ | (117,177 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.85 | ) | $ | (0.74 | ) | $ | (2.87 | ) | $ | (2.15 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 69,303,746 | 68,988,858 | 69,251,291 | 54,566,490 |
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash and cash equivalents | $ | 648,325 | $ | 879,520 | ||||
| Working capital | 669,537 | 861,375 | ||||||
| Total assets | 763,954 | 956,868 | ||||||
| Total shareholders' equity | 618,479 | 793,060 |