Full Press Release Details
Bicycle Therapeutics Reports Recent Business
Progress and First Quarter 2024 Financial Results
Multiple preclinical and clinical abstracts
accepted for presentation at 2024 ASCO Annual Meeting and AACR Annual Meeting underscore breadth of Bicycle platform
technology and pipeline
Continued progress across research and development
(R&D) pipeline, with numerous clinical data readouts and updates expected in 2H 2024
Mike Hannay, D.Sc., FRPharmS, promoted
to Chief Product and Supply Chain Officer
Cash and cash equivalents of $457.0 million
as of March 31, 2024, expected to provide financial runway into 2026
CAMBRIDGE, England & BOSTON, May 2, 2024 - Bicycle
Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical 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, 2024.
"During the first quarter, we focused on execution across all
aspects of our business. We were pleased to initiate our Phase 2/3 Duravelo-2 registrational trial for BT8009 in metastatic urothelial
cancer, and we are actively working on patient enrollment and site activation. We continue to make progress across the rest of our pipeline
of differentiated, precision-guided therapeutic candidates, and look forward to a catalyst-rich second half of the year," said Kevin
Lee, Ph.D., CEO of Bicycle Therapeutics. "Additionally, I am thrilled to congratulate Mike Hannay on his promotion to Chief
Product and Supply Chain Officer. Since joining the company two years ago, he has significantly advanced our manufacturing capabilities
and priorities, and I look forward to seeing him excel in this new position."
First Quarter 2024 and Recent Events
Participation in Upcoming Investor Conferences
Bicycle Therapeutics management will participate in a fireside chat
at the Citizens JMP Life Sciences Conference on May 13, 2024, at 9 a.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
First Quarter 2024 Financial Results
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage biopharmaceutical 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 BT8009, a Bicycle Toxin Conjugate (BTC ) targeting
Nectin-4, a well-validated tumor antigen; BT5528, a BTC 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 BT8009, BT5528 and BT7480; the anticipated progression of Bicycle's clinical trials and the availability
of and timing of announcement of data from clinical trials and program updates for clinical candidates; 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; availability and 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 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 Annual Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on February 20, 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 | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Collaboration revenues | $ | 19,530 | $ | 4,896 | ||||
| Operating expenses: | ||||||||
| Research and development | 34,864 | 32,211 | ||||||
| General and administrative | 16,382 | 14,488 | ||||||
| Total operating expenses | 51,246 | 46,699 | ||||||
| Loss from operations | (31,716 | ) | (41,803 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 5,624 | 2,929 | ||||||
| Interest expense | (821 | ) | (808 | ) | ||||
| Total other income (expense), net | 4,803 | 2,121 | ||||||
| Net loss before income tax provision | (26,913 | ) | (39,682 | ) | ||||
| Benefit from income taxes | (350 | ) | (618 | ) | ||||
| Net loss | $ | (26,563 | ) | $ | (39,064 | ) | ||
| Net loss per share, basic and diluted | $ | (0.62 | ) | $ | (1.30 | ) | ||
| Weighted average ordinary shares outstanding, basic and diluted | 42,560,091 | 30,001,725 |
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash and cash equivalents | $ | 456,997 | $ | 526,423 | ||||
| Working capital | 466,452 | 492,331 | ||||||
| Total assets | 547,143 | 595,344 | ||||||
| Total shareholders' equity | 356,048 | 370,932 |
SVP, Investor Relations and Corporate Communications