Continued progress across pipeline, including
advancing BT8009, BT5528, and BT7480 in ongoing clinical trials;
clinical and regulatory updates remain on track for BT8009 in
2H23
Entered into strategic collaborations with
Novartis, Bayer, and broadened an ongoing collaboration with DKFZ
in radiopharmaceuticals
Strengthened balance sheet with gross proceeds
of approximately $230M, from July 2023 public offering and $45M
Bayer upfront payment; pro-forma cash balance is over $600M
Enhanced leadership team with new CFO hire,
Alethia Young, who brings to Bicycle over 20 years of experience in
the biopharma industry
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 second quarter ended June 30,
2023 and provided recent corporate updates.
“We have made significant progress in the first half of 2023
executing on our plan to become one of the world’s leading solid
tumor medicines companies,” said Kevin Lee, Ph.D., Chief Executive
Officer of Bicycle Therapeutics. “Not only have we continued to
advance our three clinical trial candidates - BT5528, BT8009 and
BT7480 – but we have also entered into multiple research and
development collaborations with pioneers in the radiopharmaceutical
space to develop Bicycle® radio-conjugates (BRCs). These
collaborations enable us to advance a broad pipeline of partnered
and wholly owned BRCs that represents the third pillar of our
oncology strategy beyond our Bicycle toxin conjugate (BTC™) and
Bicycle tumor-targeted immune cell agonist® (Bicycle TICA™)
programs. Our clinical programs remain on track for us to provide
updates in the second half of 2023. Additionally, we are excited to
welcome Alethia Young, our new Chief Financial Officer, who brings
over 20 years of experience in the healthcare and biotech industry
to Bicycle. The advancement of our programs and platform in
oncology and beyond are supported by a strong balance sheet that
has been further enhanced by the recent proceeds from a public
equity offering completed in July.”
Second Quarter 2023 and Recent Highlights
- Raised Gross Proceeds of $230.0 Million in Public
Offering. In July 2023, Bicycle 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 $215.5 million. In addition, the company also
received gross proceeds from Bicycle’s at-the-market (ATM) offering
program during the second quarter of 2023 totaling $12.5
million.
- Continued Progress with Clinical and Regulatory Programs
Including BT8009, BT5528, and BT7480. Enrollment in the
company’s clinical trial of BT8009, as well as discussions with the
U.S. Food and Drug Administration (FDA) remain ongoing. The company
expects to provide clinical and regulatory updates on BT8009 in the
second half of 2023.
- Enhanced Leadership Team with Appointment of Alethia Young
as Chief Financial Officer. In June 2023, Bicycle announced the
appointment of Alethia Young as its new Chief Financial Officer,
effective July 17. Ms. Young brings to Bicycle more than 20 years
of experience in the healthcare and biotech industry, most recently
serving as the Chief Financial Officer at Graphite Bio. Prior to
Graphite Bio, she served as a senior biotech analyst and head of
research at Cantor Fitzgerald, and previously held senior biotech
analyst positions at Credit Suisse and Deutsche Bank.
- Presented Potent Anti-Tumor Activity of a Lead-212 Labelled
MT1-MMP Targeting Bicycle Radionuclide Conjugate™ at TIDES
2023. In May 2023, Bicycle presented preclinical results from a
preclinical research collaboration with OranoMed. In these studies,
Pb-BCY20603, a prototype BRC™ that binds with high affinity to the
tumor antigen MT1-MMP and carries a chelate of lead-212, showed
potent anti-tumor activity in rodent tumor xenograft studies and
achieved complete tumor regressions after 3 dosing cycles of 10
µCi, given two weeks apart. Median survival was increased for each
dosing group with 90% survival observed for the 3 cycles of 10 μCi,
treatment at the end of the 100-day study.
- Announced Multiple Strategic Collaborations for Developing
BRCs for Potential Oncology Targets
- Strategic Collaboration with Bayer. In May 2023, Bicycle
announced that it has entered into a strategic collaboration
agreement with Bayer to discover, develop, manufacture, and
commercialize BRCs for multiple agreed upon oncology targets.
Bicycle will use its proprietary phage platform to develop bicyclic
peptides, while Bayer will be responsible for, and fully fund, all
further preclinical and clinical development, manufacturing, and
commercialization activities. Bicycle received a $45 million
upfront payment in July 2023 and, with potential development and
commercial-based milestone fees, payments under the collaboration
to Bicycle could total up to $1.7 billion. Bicycle will also be
eligible to receive tiered royalties on Bicycle-based medicines
commercialized by Bayer.
- Expanded Collaboration with the German Cancer Research
Center. In May 2023, Bicycle announced the extension of a
collaboration with the German Cancer Research Center (DKFZ) to
develop and discover BRCs for potential oncology targets. This
enhanced relationship will provide a more continuous and
purpose-driven commitment towards advancing Bicycle’s wholly owned
BRC candidates. Bicycle intends to commence initial testing of its
wholly owned BRCs in patients during 2024.
- Strategic Collaboration with Novartis. In March 2023,
Bicycle announced a strategic collaboration with Novartis to
collaborate on the discovery, development and commercialization of
BRCs for multiple agreed upon oncology targets. Bicycle will
utilize its proprietary phage platform to discover Bicycles to be
developed into BRCs. Novartis will be responsible for and fund
further development, manufacture and commercialization of the BRCs.
Under the collaboration, Bicycle received a $50 million upfront
payment in April 2023 and is eligible for development and
commercial-based milestone payments totaling up to $1.7 billion.
Bicycle will also be eligible to receive tiered royalties on
Bicycle-based medicines commercialized by Novartis.
Financial Results
- Cash and cash equivalents were $340.4 million as of June 30,
2023, compared to $339.2 million as of December 31, 2022. The
increase in cash and cash equivalents is primarily due to $50.0
million received from our collaboration agreement with Novartis and
$14.8 million of net proceeds from our ATM offering program, offset
by cash used in operating activities. Our cash and cash equivalents
at June 30, 2023 do not include the upfront payment from Bayer or
proceeds from our public offering received in July 2023.
Additionally in July, the company strengthened its balance sheet
with gross proceeds of $230.0 million, or net proceeds of
approximately $215.5 million, from the July 2023 public
offering.
- Research and development expenses were $39.7 million for the
three months ended June 30, 2023, compared to $19.9 million for the
three months ended June 30, 2022. The increase in expense of $19.9
million was primarily due to increased clinical program expenses
for BT8009, BT7480 development expenses, and other discovery and
platform related expenses, as well as increased personnel-related
expenses, including incremental non-cash share-based compensation
expense of $1.3 million, offset by incremental UK research and
development incentives.
- General and administrative expenses were $14.8 million for the
three months ended June 30, 2023, compared to $11.8 million for the
three months ended June 30, 2022. The increase of $3.0 million for
the three months ended June 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 $1.2 million, offset by a favorable impact of foreign
exchange rates.
- Net loss was $42.6 million, or $(1.41) basic and diluted net
loss per share, for the three months ended June 30, 2023, compared
to net loss of $26.8 million, or $(0.90) basic and diluted net loss
per share, for three months ended June 30, 2022.
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
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; the availability of and timing of
announcement of data from clinical trials and regulatory updates
for clinical candidates; statements regarding Bicycle’s
collaborations with Bayer, 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; 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; 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 May 4, 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
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Collaboration revenues
$
11,397
$
4,378
$
16,293
$
8,238
Operating expenses:
Research and development
39,720
19,854
71,931
34,138
General and administrative
14,788
11,824
29,276
28,783
Total operating expenses
54,508
31,678
101,207
62,921
Loss from operations
(43,111
)
(27,300
)
(84,914
)
(54,683
)
Other income (expense):
Interest income
812
908
3,741
1,126
Interest expense
(821
)
(883
)
(1,629
)
(1,701
)
Total other income (expense), net
(9
)
25
2,112
(575
)
Net loss before income tax provision
(43,120
)
(27,275
)
(82,802
)
(55,258
)
Benefit from income taxes
(517
)
(447
)
(1,135
)
(866
)
Net loss
$
(42,603
)
$
(26,828
)
$
(81,667
)
$
(54,392
)
Net loss per share, basic and diluted
$
(1.41
)
$
(0.90
)
$
(2.71
)
$
(1.84
)
Weighted average ordinary shares
outstanding, basic and diluted
30,191,693
29,648,564
30,097,234
29,626,974
Balance Sheets Data
(In thousands)
(Unaudited)
June 30,
December 31,
2023
2022
Cash and cash equivalents
$
340,433
$
339,154
Working capital
336,164
316,041
Total assets
454,170
410,609
Total shareholders’ equity
220,097
270,783
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803132124/en/
Investors: Alethia Young Chief Financial Officer
alethia.young@bicycletx.com 617-945-8155
Media: Argot Partners Sarah Sutton
bicycle@argotpartners.com 212-600-1902
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