Full Press Release Details
Bicycle Therapeutics Reports Recent Business
and Third Quarter 2024 Financial Results
Presented updated clinical results across oncology
pipeline, including a 45% overall response rate (ORR) for zelenectide pevedotin monotherapy and a 45% ORR for BT5528 6.5 mg/m2 every
two weeks monotherapy, both in metastatic urothelial cancer
Progressed radiopharmaceuticals pipeline with
first human imaging data validating the potential of MT1-MMP as a novel cancer target and outlined company strategy in this area
Cash and cash equivalents of $890.9 million
as of September 30, 2024, excluding $31.7 million UK R&D tax credit received in October 2024; expected financial runway
CAMBRIDGE, England & BOSTON, October 31, 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
third quarter ended September 30, 2024.
"In the third quarter, we continued to make significant advancements
across our business and pipeline. At ESMO, we reported updated data for our clinical-stage molecules, further supporting their promising
monotherapy response rates and differentiated safety profiles. Additionally, last week we shared exciting first human imaging data for
our first radiopharmaceuticals molecule, validating the potential of MT1-MMP as a novel cancer target and providing important information
on the ability of our Bicycle molecules to deliver radioisotopes to the tumor," said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics.
"Altogether, we believe these data demonstrate the power and broad capabilities of our Bicycle technology platform, and we look
forward to providing additional updates later this year."
Third Quarter 2024 and Recent Events
The global Phase 2/3 Duravelo-2 registrational trial of zelenectide
pevedotin in patients with mUC is currently enrolling. Additional data updates for zelenectide pevedotin monotherapy in other tumor types
and in combination with pembrolizumab in first-line mUC are planned by year end.
Bicycle Therapeutics is currently assessing BT5528 at 6.5 mg/m2 every
two weeks in combination with nivolumab, with results expected in 2025.
These data showing low rates of TRPN at primarily low severity
with BTC molecules support the hypothesis that the antibody-drug construct may be a primary driver of peripheral neuropathy rather than
monomethyl auristatin E (MMAE) toxicity as was previously believed.
As the maximum tolerated dose for BT7480 has not yet been reached,
Bicycle Therapeutics is continuing dose exploration in combination studies, starting with nivolumab.
Third 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 Radionuclide
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 business and its product candidates, including zelenectide pevedotin, BT5528 and BT7480; the anticipated progression
of Bicycle's clinical trials and the timing of announcement of data from clinical trials and program updates for clinical candidates;
the development of potential radiopharmaceutical product candidates; the use of Bicycle's technology through various partnerships
to develop potential therapies in diseases beyond oncology; 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 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 August 6, 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Collaboration revenues | $ | 2,676 | $ | 5,352 | $ | 31,567 | $ | 21,645 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 48,265 | 39,868 | 123,188 | 111,799 | ||||||||||||
| General and administrative | 18,257 | 16,281 | 50,588 | 45,557 | ||||||||||||
| Total operating expenses | 66,522 | 56,149 | 173,776 | 157,356 | ||||||||||||
| Loss from operations | (63,846 | ) | (50,797 | ) | (142,209 | ) | (135,711 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 10,583 | 3,985 | 23,981 | 7,726 | ||||||||||||
| Interest expense | (33 | ) | (814 | ) | (1,678 | ) | (2,443 | ) | ||||||||
| Loss on extinguishment of debt | (954 | ) | - | (954 | ) | - | ||||||||||
| Total other income, net | 9,596 | 3,171 | 21,349 | 5,283 | ||||||||||||
| Net loss before income tax provision | (54,250 | ) | (47,626 | ) | (120,860 | ) | (130,428 | ) | ||||||||
| (Benefit from) provision for income taxes | (3,448 | ) | 2,272 | (3,683 | ) | 1,137 | ||||||||||
| Net loss | $ | (50,802 | ) | $ | (49,898 | ) | $ | (117,177 | ) | $ | (131,565 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (1.26 | ) | $ | (2.15 | ) | $ | (3.95 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 68,988,858 | 39,576,467 | 54,566,490 | 33,291,701 |
Condensed Consolidated Balance Sheets Data
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash and cash equivalents | $ | 890,862 | $ | 526,423 | ||||
| Working capital | 909,789 | 492,331 | ||||||
| Total assets | 996,746 | 595,344 | ||||||
| Total shareholders' equity | 831,032 | 370,932 |
SVP, Investor Relations and Corporate Communications