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Bicycle Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update - Continued progress across pipeline, including encouraging BT8009 Phase I dose escalation results presented in Q1'23 - Ente

Key Takeaway: Bicycle Therapeutics reported its financial results for the first quarter of 2023, highlighting positive Phase I results for its investigational drug BT8009, which showed anti-tumor activity in various cancer patients. The company also announced collaborations with Novartis and other organizations to further develop its pipeline of radioconjugates. Financially, Bicycle recorded a net loss of $39.064 million, significantly higher than the previous year, amidst increased operating expenses. The company holds $293.8 million in cash, excluding certain payments from partners, indicating a robust financial position as it advances its clinical programs.

Market Sentiment Analysis

POSITIVE FACTORS

  • Encouraging Phase I dose escalation results from BT8009 showing anti-tumor activity.
  • Median duration of response for urothelial cancer estimated at 14 months.
  • Successful collaborations with Novartis and other organizations to advance research.

CONCERNS & RISKS

  • Net loss of $39.064 million reported for Q1 2023, up from $27.564 million loss in Q1 2022.
  • Increased operating expenses, particularly in research and development.

Full Press Release Details

Bicycle Therapeutics Reports First Quarter 2023
Financial Results and Provides Corporate Update
progress across pipeline, including encouraging BT8009 Phase I dose escalation results
into a strategic collaboration with Novartis and expanded separate collaboration with
the Division of Radiopharmaceutical Chemistry, German
Cancer Research Center to develop Bicycle Radio-Conjugates
position of $293.8 million at March 31, 2023 excludes $50 million upfront payment from
Novartis, and is expected to provide financial
CAMBRIDGE, England & BOSTON, May 4,
2023 - 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 first quarter ended March 31, 2023 and provided recent corporate updates.
"The beginning of 2023 has been impactful
for Bicycle and our platform," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We reported encouraging
Phase I dose escalation results from BT8009 that showed anti-tumor activity in heavily pre-treated urothelial, lung and breast cancer
patients and a median duration of response estimated to be 14 months in the 5 mg/m2 cohort of patients with urothelial cancer.
We look forward to providing further updates on BT8009 as well as on our other clinical-stage programs later this year."
"In addition, we entered into multiple
research and development collaborations with organizations at the forefront of the development of radiopharmaceuticals to develop Bicycle
radio-conjugates (BRCs)," added Dr. Lee. "These collaborations provide further validation of our platform
and enable us to advance a broad pipeline of partnered and wholly owned BRCs. This represents the third pillar of our oncology strategy
beyond our Bicycle toxin conjugate (BTC ) and Bicycle tumor-targeted immune cell agonist (Bicycle TICA ) programs. We
are pleased with the progress we have made advancing our entire pipeline and expanding the potential applications of the Bicycle platform."
First Quarter 2023 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 Cambridge, MA. For more information, visit bicycletherapeutics.com.
Forward Looking Statements
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 BT8009, BT5528 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 and regulatory updates for clinical candidates;
statements regarding Bicycle's collaborations with Novartis, and DKFZ; the discovery, development and potential commercialization
of potential radiopharmaceutical or other product candidates using Bicycle's technology under the strategic collaboration agreements;
Bicycle's intent to commence initial testing of its wholly owned BRCs in patients by the end of 2024; 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 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; 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 or 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 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission (SEC) on February 28, 2023, 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,
2023 2022
Collaboration revenues $ 4,896 $ 3,860
Operating expenses:
Research and development 32,211 14,284
General and administrative 14,488 16,959
Total operating expenses 46,699 31,243
Loss from operations (41,803 ) (27,383 )
Other income (expense):
Interest income 2,929 218
Interest expense (808 ) (818 )
Total other income (expense), net 2,121 (600 )
Net loss before income tax provision (39,682 ) (27,983 )
Benefit from income taxes (618 ) (419 )
Net loss $ (39,064 ) $ (27,564 )
Net loss per share, basic and diluted $ (1.30 ) $ (0.93 )
Weighted average ordinary shares outstanding, basic and diluted 30,001,725 29,605,143
March 31, December 31,
2023 2022
Cash and cash equivalents $ 293,815 $ 339,154
Working capital 328,258 316,041
Total assets 428,801 410,609
Total shareholders' equity 243,163 270,783
SVP, Capital Markets & Corporate Communications

Frequently Asked Questions

What are the recent highlights from Bicycle Therapeutics?

Bicycle Therapeutics reported encouraging Phase I results for BT8009 and entered collaborations with Novartis and the German Cancer Research Center.

How much cash did Bicycle Therapeutics have as of March 31, 2023?

As of March 31, 2023, Bicycle Therapeutics had $293.8 million in cash.

What is the focus of Bicycle Therapeutics' research and development?

Bicycle Therapeutics focuses on developing Bicycles, a novel class of medicines for underserved diseases.

What clinical candidates is Bicycle Therapeutics advancing?

Bicycle is advancing BT8009, BT5528, and BT7480 in clinical-stage trials targeting specific tumor antigens.

What was Bicycle Therapeutics' net loss for the first quarter of 2023?

Bicycle Therapeutics reported a net loss of $39.1 million for Q1 2023.

Last updated: May 4, 2023