Full Press Release Details
Bicycle Therapeutics Reports Third Quarter 2022
Financial Results and Provides Corporate Update
clinical progress across pipeline including BT5528 end of Phase I dose escalation update; completion of enrollment in BT5528 initial dose
expansion cohorts expected in Q4
clinical update remains on-track for Q4
$10 million option fee payment from Genentech this quarter triggered by exclusive strategic collaboration expansion option exercise in
and cash equivalents of $361.5 million as of September 30, 2022; expected financial runway into 2025
England, & BOSTON, November 3, 2022 - Bicycle Therapeutics plc (NASDAQ:
BCYC), a biotechnology 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, 2022 and provided recent corporate updates.
"We are encouraged by the continued clinical
progress across our pipeline," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "In the third
quarter, we announced top-line results from the completed dose escalation portion of the Phase I/II trial in BT5528 and expect to complete
enrollment in the initial expansion cohorts this quarter. In addition, clinical development of BT8009 remains on-track and we look forward
to providing an update this quarter following completion of the dose escalation portion of the Phase I/II clinical trial. Finally, the
dose escalation portion of our Phase I/II trial of BT7480 continues at a healthy pace and we expect to share clinical information in 2023."
"Recently, we added to our balance sheet
through Genentech's second expansion of our immuno-oncology collaboration, resulting in a $10 million payment to us this quarter.
We are pleased to have a strong balance sheet which helps support the advancement of our clinical oncology pipeline as well as our earlier
discovery and development efforts and which we anticipate provides financial runway into 2025."
Third Quarter 2022 and Recent Highlights
About Bicycle Therapeutics
Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage
biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing
therapeutics. Bicycles 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 Bicycles attractive
candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC ) targeting EphA2;
BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA targeting Nectin-4
and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in
an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge,
UK, with many key functions and members of its leadership team located in Lexington, MA. 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 advancement of its product candidates, including BT5528, BT8009
and BT7480; the anticipated dosing in and progression of Bicycle's clinical trials; the availability of and timing of announcement
of data from clinical trials; the therapeutic potential for Bicycles in oncology and other applications; Bicycle's plans
to expand its discovery efforts and early development pipeline; 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: risks to clinical trial site initiation, patient enrollment
and follow-up, as well as to Bicycle's abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19
pandemic; uncertainties inherent in the initiation 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; availability and timing of results from clinical
trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from
a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials may be delayed
and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle's product candidates;
the risk that Bicycle's projections regarding its expected financial 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 4, 2022, 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, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Collaboration revenues | $ | 3,040 | $ | 4,333 | $ | 11,278 | $ | 7,926 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 22,752 | 10,513 | 56,890 | 31,924 | ||||||||||||
| General and administrative | 10,047 | 8,114 | 38,830 | 23,596 | ||||||||||||
| Total operating expenses | 32,799 | 18,627 | 95,720 | 55,520 | ||||||||||||
| Loss from operations | (29,759 | ) | (14,294 | ) | (84,442 | ) | (47,594 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,991 | 24 | 3,117 | 61 | ||||||||||||
| Interest expense | (817 | ) | (823 | ) | (2,518 | ) | (2,164 | ) | ||||||||
| Total other income (expense), net | 1,174 | (799 | ) | 599 | (2,103 | ) | ||||||||||
| Net loss before income tax provision | (28,585 | ) | (15,093 | ) | (83,843 | ) | (49,697 | ) | ||||||||
| Benefit from income taxes | (238 | ) | (415 | ) | (1,104 | ) | (915 | ) | ||||||||
| Net loss | $ | (28,347 | ) | $ | (14,678 | ) | $ | (82,739 | ) | $ | (48,782 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.96 | ) | $ | (0.59 | ) | $ | (2.79 | ) | $ | (2.06 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 29,676,021 | 25,039,990 | 29,643,502 | 23,719,124 |
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash and cash equivalents | $ | 361,469 | $ | 438,680 | ||||
| Working capital | 339,733 | 422,317 | ||||||
| Total assets | 417,148 | 479,792 | ||||||
| Total shareholders' equity | 289,474 | 346,254 |
VP, Capital Markets & Investor Relations