Catalyst-rich 2024 with multiple clinical data
readouts and updates expected for pipeline and discovery
programs
Phase 2/3 Duravelo-2 registrational trial for
BT8009 in metastatic urothelial cancer now active and recruiting
patients
BT8009 initial clinical data showed a promising
response and differentiated safety profile
R&D Day outlined near-term strategic
priorities and highlighted breadth of Bicycle® platform technology
and ability to develop highly differentiated precision therapies
for cancer and other diseases
Stephen Sands appointed to Board of
Directors
Cash and cash equivalents of $526.4 million as
of December 31, 2023, expected to provide financial runway into
2026
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 financial results for the fourth quarter and full
year ended December 31, 2023, and provided recent corporate
updates.
“2023 was a pivotal year for our company, during which we
achieved significant progress across our Nectin-4 and EphA2
clinical oncology portfolios and our discovery pipeline of
next-generation Bicycle® molecules, including in
radiopharmaceuticals and areas beyond oncology. We continue to
demonstrate our ability to develop highly differentiated,
precision-guided therapeutics that may offer greater tolerability
and lead to enhanced benefit for patients,” said Kevin Lee, Ph.D.,
CEO of Bicycle Therapeutics. “With a catalyst-rich 2024 expected, a
strong financial position, validating partnerships and a unique
platform technology, we enter this year with significant momentum
and focus to advance our mission to help patients not only live
longer but also live well.”
“I am delighted to welcome Stephen Sands to our Board of
Directors,” said Pierre Legault, chairman of Bicycle Therapeutics.
“He brings a wealth of experience and knowledge that we believe
will provide valuable insight and additional depth to our Board as
the company enters this new stage of growth and seeks to advance
its strategic priorities across multiple key areas.”
Corporate Updates and Recent Events
Company Strategy
Outlined strategic priorities at the company’s first
Research & Development (R&D) Day in December:
- Execute plan to become a leader in next-generation solid
tumor therapeutics and combinations, which includes:
- Initiating the Phase 2/3 Duravelo-2 registrational trial for
BT8009 in metastatic urothelial cancer (mUC) in 1Q 2024. The trial
is now active and recruiting patients.
- Conducting further clinical studies to assess BT8009, BT7480
and BT5528 in emerging tumors of interest, with data from these
studies expected in 2H 2024.
- Expand opportunities in oncology, which includes:
- Advancing the company’s next generation of Bicycle Toxin
Conjugates® (BTCs). The company plans to select a BTC® clinical
candidate using next-generation technology in 2H 2024.
- Validating the company’s Bicycle® Radio Conjugates (BRC™)
pipeline and partner for success, with updates expected from its
wholly owned BRC program by mid-2024.
- Advancing the company’s Bicycle Tumor-Targeted Immune Cell
Agonist® (Bicycle TICA®) immune-oncology pipeline through
innovative partnerships.
- Explore platform potential beyond oncology, which
includes:
- Continuing the company’s strong track record of
collaboration.
- Partnering with leading academic, government and life sciences
organizations.
Nectin-4 Portfolio
BT8009 is a BTC® targeting Nectin-4 designed to overcome
the significant toxicity associated with other toxin conjugate
approaches.
- Announced Updated BT8009 Clinical Data from the Ongoing
Phase 1/2 Duravelo-1 Study Involving Heavily Pre-Treated
Patients. BT8009 showed: :
- A promising response profile with a 38% objective response rate
(ORR) in 26 patients with mUC receiving 5 mg/m2 weekly and who had
not been treated with enfortumab vedotin (EV-naïve), and a median
duration of response (mDOR) of 11.1 months in 10 patients with five
responders still on therapy.
- Encouraging initial data in other cancers such as ovarian,
triple-negative breast (TNBC) and non-small cell lung (NSCLC) that
support further expansion beyond mUC.
- An emerging differentiated safety profile seen in 113 patients
with various types of cancer receiving 5 mg/m2 weekly, with
treatment-related adverse events being primarily low in frequency
and severity.
- In 34 EV-naïve mUC patients, treatment-related adverse events
and adverse events of interest were also low, similar to the 5
mg/m2 weekly total safety study population. Notably, there were
zero cases of severe (≥Grade 3) ocular disorders, peripheral
neuropathy or skin reactions that are commonly observed with
antibody drug conjugate (ADC) therapies.
- In seven heavily pre-treated mUC patients receiving BT8009 5
mg/m2 weekly in combination with pembrolizumab, an acceptable
tolerability profile was observed with limited severe
treatment-related adverse events, including zero cases of severe
(≥Grade 3) ocular disorders, peripheral neuropathy or skin
reactions that are commonly observed with ADC therapies.
In 2H 2024, the company plans to complete the
Phase 1/2 Duravelo-1 open-label study across multiple cancers and
report data from the following cohorts: ° BT8009 5 mg/m2 weekly in
late-line, EV-naive mUCBT8009 5 mg/m2 weekly in late-line, EV-naive
mUC; ° Ovarian, TNBC and NSCLC cancer; and ° BT8009 5 mg/m2 weekly
in combination with pembrolizumab in first-line mUC.
- 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 FDA’s 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.
BT7480 is a Bicycle TICA® targeting Nectin-4 and
agonizing CD137 designed to overcome immune agonist toxicities and
activate the immune system in Nectin-4 expressing tumors.
- Announced Clinical Data from the Phase 1 Clinical Trial.
BT7480 showed:
- In 33 patients assigned to receive one of nine different doses
of BT7480, an emerging differentiated safety and tolerability
profile with a low number of severe adverse events. The majority of
the patients studied had tumors that expressed Nectin-4 and
CD137.
- Two unconfirmed partial responses in heavily pre-treated
patients with cervical cancer.
- Three prolonged stable disease (≥7 months) in NSCLC and anal
cancer.
The company will continue to define the
recommended Phase 2 dose (or maximum dose) and dose range for
BT7480, with a view to enroll combination cohorts with checkpoint
inhibitors in 2024. These data will inform the design of a Phase 2
trial that could support potential accelerated approval of
BT7480.
Ephrin-A2 (EphA2)
Portfolio
BT5528 is a BTC® targeting EphA2, a historically
undruggable target, and is designed to overcome the significant
toxicity associated with other toxin conjugate approaches.
- Announced Clinical Data from Ongoing Phase 1/2 Clinical
Trial Enrolling Patients with Various Solid Tumors. BT5528
showed:
- In 109 patients, an acceptable emerging tolerability profile
with few severe adverse events. Importantly, unlike other
EphA2-targeted agents, no bleeding events were observed in patients
treated with BT5528 at any dose.
- Encouraging early activity in mUC with a 39% ORR in 18 patients
receiving 6.5 mg/m2, 8.5 mg/m2 or 10 mg/m2 every other week, and an
mDOR of four months in seven patients with one responder still on
therapy. This includes six partial responses and one unconfirmed
response.
- Encouraging emerging data in other cancers such as ovarian,
gastric/upper gastrointestinal and head and neck that are informing
the dose optimization strategy and further development.
The company commenced further cohorts in mUC
and ovarian cancer to test 5 mg/m2 weekly, which will inform
decisions about dose optimization, potential drug combinations and
expansion into other tumor types. Data from these cohorts are
expected to be available in the second half of 2024.
Company Updates
Appointed Stephen Sands, Former Chairman of the Global
Healthcare Group at Lazard, to the Board of Directors. Mr.
Sands has spent more than 35 years at Lazard providing strategic
and financial advice to senior executives and boards of directors
at leading healthcare and life sciences companies across the globe.
Prior to joining Lazard, he was a partner in the healthcare
practice of McKinsey & Company. During his career, Mr. Sands
has co-founded two life sciences companies: Enzytech (acquired by
Alkermes) and Opta Food Ingredients (acquired by Stake Technology
and now SunOpta). Mr. Sands has served as director on the boards of
several life sciences companies and is currently a director on the
board of Cytier Therapeutics (NASDAQ: CYT, Oncology Drugs).
Fourth Quarter and Year End 2023 Financial Results
- Cash and cash equivalents were $526.4 million as of December
31, 2023, compared to $339.2 million as of December 31, 2022. The
increase in cash and cash equivalents is primarily due to the
receipt of $215.1 million in net proceeds from the underwritten
public offering in July 2023, $34.2 million of net proceeds from
our ATM offering program and $95.0 million from our collaboration
agreements with Novartis and Bayer, offset by cash used in
operating activities.
- R&D expenses were $44.7 million for the three months ended
December 31, 2023, and $156.5 million for the year ended December
31, 2023, compared to $24.7 million for the three months ended
December 31, 2022, and $81.6 million for the year ended December
31, 2022. The increases in expense of $20.0 million and $74.9
million for the three months and year ended December 31, 2023,
respectively, were primarily due to increased clinical program
expenses for BT8009 development, Bicycle TICA® development and
discovery, platform and other expenses, as well as increased
personnel-related expenses, including incremental non-cash
share-based compensation expense of $0.9 million and $5.2 million
for the three months and year ended December 31, 2023,
respectively.
- General and administrative expenses were $14.9 million for the
three months ended December 31, 2023, and $60.4 million for the
year ended December 31, 2023, compared to $10.7 million for the
three months ended December 31, 2022, and $49.5 million for the
year ended December 31, 2022. The increases of $4.2 million and
$10.9 million for the three months and year ended December 31,
2023, respectively, were primarily due to increased
personnel-related costs, including incremental non-cash share-based
compensation expense of $1.4 million and $0.5 million for the three
months and year ended December 31, 2023, respectively, as well as
increased professional and consulting fees.
- Net loss was $49.1 million, or $(1.16) basic and diluted net
loss per share, for the three months ended December 31, 2023, and
net loss was $180.7 million, or $(5.08) basic and diluted net loss
per share, for the year ended December 31, 2023, compared to net
loss of $30.0 million or $(1.01) basic and diluted net loss per
share, for three months ended December 31, 2022, and net loss of
$112.7 million or $(3.80) basic and diluted net loss per share, for
the year ended December 31, 2022..
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 advancement of its product candidates, including
BT8009, BT5528 and BT7480; the anticipated progression of Bicycle’s
clinical trials, including the timing of patient dosing in the
Duravelo-2 Phase 2/3 clinical trial; anticipated clinical and other
benefits of Bicycle Therapeutics’ participation in the CDRP
Program; the availability of and timing of announcement of data
from clinical trials and regulatory updates for clinical candidates
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; the therapeutic potential for Bicycles
in oncology and other applications; Bicycle’s goal to become a
leader in next-generation solid tumor therapeutics and
combinations; Bicycle’s expected financial runway; and the
potential benefits of appointing Stephen Sands to Bicycle’s Board
of Directors. 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; 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; the risk that the intended benefits from the
appointment of Stephen Sands to Bicycle’s Board of Directors may
not be realized; 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 November 2, 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
Year Ended
December 31,
December 31,
2023
2022
2023
2022
Collaboration revenues
$
5,331
$
3,185
$
26,976
$
14,463
Operating expenses:
Research and development
44,697
24,719
156,496
81,609
General and administrative
14,869
10,677
60,426
49,507
Total operating expenses
59,566
35,396
216,922
131,116
Loss from operations
(54,235
)
(32,211
)
(189,946
)
(116,653
)
Other income (expense):
Interest income
6,276
2,639
14,002
5,756
Interest expense
(820
)
(826
)
(3,263
)
(3,344
)
Total other income (expense), net
5,456
1,813
10,739
2,412
Net loss before income tax provision
(48,779
)
(30,398
)
(179,207
)
(114,241
)
Provision for (benefit from) income
taxes
320
(420
)
1,457
(1,524
)
Net loss
$
(49,099
)
$
(29,978
)
$
(180,664
)
$
(112,717
)
Net loss per share, basic and diluted
$
(1.16
)
$
(1.01
)
$
(5.08
)
$
(3.80
)
Weighted average ordinary shares
outstanding, basic and diluted
42,419,326
29,711,570
35,592,362
29,660,659
Balance Sheets Data
(In thousands)
(Unaudited)
December 31,
December 31,
2023
2022
Cash and cash equivalents
$
526,423
$
339,154
Working capital
492,331
316,041
Total assets
595,344
410,609
Total shareholders’ equity
370,932
270,783
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240220615660/en/
Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications ir@bicycletx.com 857-523-8544
Media: Deborah Elson Argot Partners media@bicycletx.com
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