R&D Day on December 14 to provide clinical
updates for BT8009, BT5528 and BT7480, and highlight broad
capabilities of novel Bicycle® technology
Alignment with FDA on expedited development and
design of Phase 2/3 registrational trial for BT8009 in metastatic
bladder cancer, to be initiated in 1Q 2024
Selection of BT8009 for new FDA Chemistry,
Manufacturing and Controls (CMC) Development and Readiness Pilot
(CDRP) Program to facilitate expedited CMC development and
commercial manufacturing readiness
Cash and cash equivalents of $572.1 million as
of September 30, 2023, including approximately $215.1 million in
net proceeds from July 2023 public offering
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, 2023, and provided recent corporate updates.
“In the third quarter, we took important steps toward achieving
our goal of quickly getting our novel therapies to those who need
them. We are extremely pleased to have aligned with the FDA on an
expedited clinical development plan and regulatory pathway for
BT8009, our lead investigational therapy for metastatic bladder
cancer, and that the agency selected BT8009 to be part of a new
program that will help facilitate its expedited CMC development.
Through close collaboration with the FDA, we will work to ensure
BT8009’s commercial manufacturing readiness keeps pace with its
expedited clinical development timeframe,” said Kevin Lee, Ph.D.,
CEO of Bicycle Therapeutics. “With a strengthened balance sheet
through the proceeds of an upsized equity offering completed in
July, we believe we are well-positioned to conduct our Phase 2/3
registrational trial, scheduled to begin in the first quarter of
2024, to support the potential accelerated approval of BT8009 in a
broad metastatic bladder cancer population. Additionally, we
continue to advance our research and development efforts across our
pipeline, and we look forward to providing clinical updates on
BT8009, BT5528 and BT7480 at our R&D Day next month.”
Third Quarter 2023 and Recent Highlights
- BT8009 Selected to Participate in U.S. Food and Drug
Administration (FDA) Program to Expedite Commercial Manufacturing
Readiness. In October, Bicycle Therapeutics announced the FDA
selected BT8009 to participate in the new Chemistry, Manufacturing
and Controls (CMC) Development and Readiness Pilot (CDRP) Program,
which was created to facilitate CMC development for therapies with
expedited clinical development timeframes, based on the anticipated
clinical benefits of earlier patient access to the therapy. BT8009
is one of up to nine products selected for the inaugural cohort of
the CDRP Program.
- Announced Expedited Clinical Development Plan and Regulatory
Pathway for BT8009 in Metastatic (Urothelial) Bladder Cancer.
In September, Bicycle Therapeutics announced the company will
proceed with its plan to expedite development of BT8009 for
metastatic bladder cancer following recent discussions with the
FDA. The company aligned with the FDA on a Phase 2/3 registrational
trial, called Duravelo-2, that has an innovative design allowing
for potential accelerated approval in untreated (first-line) and
previously treated (second-line plus) metastatic bladder cancer.
The company plans to initiate the Duravelo-2 trial in the first
quarter of 2024.
- In Cohort 1, two doses of BT8009 plus standard pembrolizumab
regimen will be initially assessed. Following selection of the
optimal dose, BT8009 plus pembrolizumab will be evaluated against
chemotherapy. Potential accelerated approval will be determined by
objective response rate (ORR), and progression-free survival (PFS)
will be used to confirm clinical benefit.
- In Cohort 2, two doses of BT8009 as monotherapy will be
initially studied. Following selection of the optimal dose, an
additional arm of BT8009 plus standard pembrolizumab regimen will
be added. Potential accelerated approval for BT8009 monotherapy and
in combination with pembrolizumab will be determined by ORR
compared to historical control data. Discussions with the FDA about
the design of the confirmatory trial for previously treated
metastatic bladder cancer are ongoing.
- Raised Net Proceeds of $215.1 Million in Public
Offering. In July, Bicycle Therapeutics announced the closing
of an underwritten public offering resulting in gross proceeds of
approximately $230.0 million, including the full exercise of the
underwriters’ option to purchase additional shares. Net proceeds
were approximately $215.1 million. In addition, the company also
received net proceeds from Bicycle’s at-the-market (ATM) offering
program during the third quarter of 2023 totaling $19.4
million.
Pipeline updates planned at upcoming Research &
Development (R&D) Day on December 14, 2023, in New York
Bicycle Therapeutics will provide updates from the company’s
Phase 1/2 clinical trials for BT8009, a Bicycle Toxin Conjugate
(BTC™) targeting Nectin-4, a well-validated tumor antigen; BT5528,
a BTC targeting EphA2; and BT7480, a Bicycle TICA™ targeting
Nectin-4 and agonizing CD137. The company will also provide an
overview of its novel Bicycle® technology, the broad capabilities
of its drug discovery platform and potential future pipeline
programs.
The R&D Day will begin at 8 a.m. ET on Thursday, December
14, 2023, and will conclude at approximately 12 p.m. ET. Analysts
and investors who are interested in attending in person can RSVP to
bicycle@argotpartners.com. A webcast of the event will be
accessible from the Investor section of the company’s website,
www.bicycletherapeutics.com. A replay of the webcast will be
archived and available following the event.
Financial Results
- Cash and cash equivalents were $572.1 million as of September
30, 2023, compared to $339.2 million as of December 31, 2022. The
increase in cash and cash equivalents is primarily due to $215.1
million in net proceeds from the underwritten public offering in
July 2023, $34.2 million of year-to-date net proceeds from our ATM
offering program and $95.0 million received from our collaboration
agreements with Novartis and Bayer, offset by cash used in
operating activities.
- R&D expenses were $39.9 million for the three months ended
September 30, 2023, compared to $22.8 million for the three months
ended September 30, 2022. The increase in expense of $17.1 million
was primarily due to increased clinical program expenses for BT8009
development and other discovery and platform-related activities, as
well as increased personnel-related expenses, including incremental
non-cash share-based compensation expense of $0.7 million.
- General and administrative expenses were $16.3 million for the
three months ended September 30, 2023, compared to $10.0 million
for the three months ended September 30, 2022. The increase of $6.3
million for the three months ended September 30, 2023, as compared
to the same period in the prior year was primarily due to an
increase in professional and consulting fees as well as an increase
in personnel-related expenses, including incremental non-cash
share-based compensation expense of $1.3 million.
- Net loss was $49.9 million, or $(1.26) basic and diluted net
loss per share, for the three months ended September 30, 2023,
compared to net loss of $28.3 million, or $(0.96) basic and diluted
net loss per share, for three months ended September 30, 2022.
About Bicycle Therapeutics
Bicycle Therapeutics 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. The company is
evaluating BT8009, a Bicycle Toxin Conjugate (BTC™) targeting
Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting
EphA2; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing
CD137, in company-sponsored Phase 1/2 trials. In addition, BT1718,
a BTC that targets MT1-MMP, is being investigated in an ongoing
Phase 1/2a clinical trial sponsored by the Cancer Research UK
Centre for Drug Development. 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 advancement of its product candidates,
including BT8009, BT5528 and BT7480; the anticipated progression of
Bicycle’s clinical trials, including the timing of initiation and
design of the Duravelo-2 Phase 2/3 clinical trial and potential
accelerated approval of BT8009; anticipated clinical and other
benefits of Bicycle Therapeutics’ participation in the CDRP
Program, including potential earlier patient access to BT8009; the
ability of the company to expedite CMC readiness for BT8009,
including ensuring that commercial manufacturing readiness for
BT8009 keeps pace with its clinical development; the availability
of and timing of announcement of data from clinical trials and
regulatory updates for clinical candidates, including the planned
R&D Day on December 14, 2023; statements regarding Bicycle’s
collaborations with Bayer and Novartis; the discovery, development
and potential commercialization of potential radiopharmaceutical or
other product candidates using Bicycle’s technology under the
strategic collaboration agreements; BT8009’s potential to be a
transformative therapy for patients with metastatic bladder cancer;
and the therapeutic potential for Bicycles in oncology and other
applications. 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 or strategic collaborations;
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 have
unsatisfactory outcomes; challenges or delays in the development
and preparation of the commercial manufacturing readiness of
BT8009; potential adverse effects arising from the testing or use
of Bicycle’s product candidates; 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 3, 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)
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
Collaboration revenues
$
5,352
$
3,040
$
21,645
$
11,278
Operating expenses:
Research and development
39,868
22,752
111,799
56,890
General and administrative
16,281
10,047
45,557
38,830
Total operating expenses
56,149
32,799
157,356
95,720
Loss from operations
(50,797
)
(29,759
)
(135,711
)
(84,442
)
Other income (expense):
Interest income
3,985
1,991
7,726
3,117
Interest expense
(814
)
(817
)
(2,443
)
(2,518
)
Total other income (expense), net
3,171
1,174
5,283
599
Net loss before income tax provision
(47,626
)
(28,585
)
(130,428
)
(83,843
)
Provision for (benefit from) income
taxes
2,272
(238
)
1,137
(1,104
)
Net loss
$
(49,898
)
$
(28,347
)
$
(131,565
)
$
(82,739
)
Net loss per share, basic and diluted
$
(1.26
)
$
(0.96
)
$
(3.95
)
$
(2.79
)
Weighted average ordinary shares
outstanding, basic and diluted
39,576,467
29,676,021
33,291,701
29,643,502
Balance Sheets Data
(In thousands)
(Unaudited)
September 30,
December 31,
2023
2022
Cash and cash equivalents
$
572,086
$
339,154
Working capital
533,300
316,041
Total assets
638,683
410,609
Total shareholders’ equity
416,022
270,783
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102566789/en/
Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications ir@bicycletx.com 857-523-8544
Media: Sarah Sutton Argot Partners media@bicycletx.com
212-600-1902
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