Four abstracts containing data updates across
clinical pipeline accepted for poster presentation at ESMO Congress
2024
Focused R&D pipeline on clinical programs
and research areas that have the highest potential to maximize
value creation
Streamlined leadership team to better align
with strategic and pipeline priorities, and enhanced oncology
expertise with formation of Clinical Advisory Board
Strengthened balance sheet with gross proceeds
of approximately $555 million from May 2024 private investment in
public equity (PIPE) financing
Cash and cash equivalents of $961.4 million as
of June 30, 2024, expected to provide financial runway into 2H
2027
Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical
company pioneering a new and differentiated class of therapeutics
based on its proprietary bicyclic peptide (Bicycle®) technology,
today reported recent business progress and financial results for
the second quarter ended June 30, 2024.
“In the second quarter, we continued to demonstrate the ongoing
progress of our pipeline and highlight the emerging differentiated
profiles of our Bicycle Toxin Conjugates® zelenectide pevedotin and
BT5528 compared to antibody drug conjugates. As we enter the second
half of the year, we look forward to sharing the first set of data
updates from our clinical programs at the upcoming ESMO Congress,”
said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics. “Additionally,
I am honored to welcome renowned oncology experts from around the
world to our Clinical Advisory Board. Their advice and counsel will
be critical as we work to develop therapies that can help patients
live longer and live well.”
Dr. Lee continued: “Bicycle Therapeutics also significantly
strengthened our balance sheet in the second quarter through the
support of leading healthcare investors. Moreover, we have
prioritized our pipeline and streamlined our leadership team to
enable us to focus on the clinical programs and research areas that
we believe have the highest potential for value creation and align
with our strategy to support the long-term growth of our
company.”
Second Quarter 2024 and Recent Events
- Four abstracts accepted for poster presentation at
the European Society for Medical Oncology (ESMO) Congress 2024
being held September 13-17 in Barcelona. Bicycle Therapeutics
will present four abstracts containing updated clinical data for
zelenectide pevedotin (formerly BT8009) in metastatic urothelial
cancer (mUC), BT5528 in advanced solid tumors such as mUC and
ovarian, and BT7480 in advanced solid tumors. In June, the company
presented two abstracts at the 2024 American Society for Clinical
Oncology (ASCO) Annual Meeting outlining clinical pharmacokinetics
of Bicycle® Toxin Conjugate (BTC®) molecules zelenectide pevedotin
and BT5528 compared to antibody drug conjugate enfortumab vedotin
and evaluating the emerging safety profile of both BTC molecules,
along with an overview of the company’s ongoing Phase 2/3
Duravelo-2 registrational trial of zelenectide pevedotin in
mUC.
- Focused research and development (R&D) pipeline on
clinical programs and research areas that the company believes have
the highest potential to maximize value creation. Activities
include:
- Prioritizing the clinical development of zelenectide pevedotin
and BT5528 in multiple tumor types.
- Focusing near-term research efforts on advancing the company’s
Bicycle Radionuclide Conjugate (BRC™) pipeline and the discovery of
next-generation BTC molecules.
- Except for BT7480, exploring innovative ways to continue
development of the company’s immuno-oncology portfolio, including
Bicycle Tumor-targeted Immune Cell Agonist® (Bicycle TICA®)
molecules, through collaboration.
- Streamlined leadership team to better align with strategic
and pipeline priorities.
- Michael Skynner, Ph.D., chief technology officer,
has assumed leadership of Bicycle Therapeutics’ discovery research
team, and all discovery research activities will be consolidated
and moved to the company’s headquarters in Cambridge, UK.
- Jennifer Perry, Pharm.D., promoted to chief strategy officer
and head of commercial. Since joining Bicycle Therapeutics in
August 2022, Ms. Perry has been instrumental in establishing and
growing Bicycle Therapeutics’ commercial organization. In this
expanded role, she will oversee the company’s corporate and
end-to-end portfolio strategy while also fulfilling her existing
commercial responsibilities. Ms. Perry has more than 20 years of
experience in pharma and biotech, with 15 years in oncology. Her
experience spans commercial and medical roles with a focus on
go-to-market strategies for launching oncology medicines at GSK,
Tesaro, TG Therapeutics and Pharmacyclics.
- Nick Keen, Ph.D., chief scientific officer, is
transitioning to an advisor role with the company as a
distinguished fellow, where he will advise the company as needed.
The company also hired Eric Westin, M.D., former vice president
of clinical development and translational sciences at
ImmunoGen, to an advisor role with the company as a
distinguished fellow to help refine the company’s translational and
clinical strategy.
- Formed new Clinical Advisory Board with distinguished global
oncology experts to support the advancement of clinical oncology
programs. The company expects that the advisors will provide
invaluable guidance and insights for the global clinical
development of the company’s clinical programs. Inaugural members
include:
- Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, is the
chair of Bicycle Therapeutics’ Clinical Advisory Board and
Scientific Advisory Board. He leads the Cancer Evolution and Genome
Instability Laboratory at the Francis Crick Institute in London.
Dr. Swanton’s research is focused on how tumors evolve over space
and time, and he has authored over 250 papers developing an
understanding of branching evolutionary histories of solid tumors,
processes that drive cancer cell-to-cell variation and the impact
of cancer diversity on effective immune surveillance and clinical
outcome.
- Toni K. Choueiri, M.D., is the director of the Lank
Center for Genitourinary (GU) Oncology at Dana-Farber Cancer
Institute and the Jerome and Nancy Kohlberg Chair and Professor of
Medicine at Harvard Medical School. Dr. Choueiri and colleagues
have made seminal observations that have defined and evolved the
treatment of kidney cancer and led to the approval of several
therapies. He has over 800 PubMed-indexed publications and is the
lead investigator of multiple national and international Phase 1-3
trials in GU cancers.
- Sherene Loi, MBBS (Hons), Ph.D., FRACP, FAHMS, is a
medical oncologist specialized in breast cancer treatment and a
clinician scientist (lab head) with expertise in genomics,
immunology and drug development at the Peter MacCallum Cancer
Centre in Melbourne, Australia. She is recognized internationally
as a leading clinician scientist whose work has led to new insights
into the breast cancer immunology field as well as leading
international clinical trials in breast cancer immunotherapy.
Professor Loi has published over 330 research articles, co-chairs
the International Breast Cancer Study Group and is the Inaugural
National Breast Cancer Foundation of Australia Endowed Chair. In
2021, she received the Australian Prime Minister’s Frank Fenner
Prize for Life Scientist of the Year.
- Solange Peters, M.D., Ph.D., is full professor and chair
of medical oncology and the chair of the thoracic malignancies
program in the Department of Oncology at the University Hospital of
Lausanne in Switzerland. She currently oversees teaching and
patient care in thoracic malignancies at Lausanne University, and
her main fields of interest include new biomarker discovery and
validation in preclinical and clinical settings as well as cancer
immunotherapy. She is the youngest president of ESMO, serving for
an extended period of 2020-2022. Professor Peters has authored over
500 peer-reviewed manuscripts and book chapters and is associate
editor of the Annals of Oncology, deputy editor of Lung Cancer and
serves on the editorial board of several other oncology journals.
She was the deputy editor of the Journal of Thoracic Oncology for
10 years.
- Raised gross proceeds of $555 million in private
investment in public equity (PIPE) financing. The PIPE
financing, with participation from leading healthcare investors, is
expected to extend the company’s financial runway into the second
half of 2027. The company plans to use the net proceeds of $544.1
million to fund the continued development of its proprietary
pipeline and for other R&D, as well as for general corporate
purposes.
- Repaid and voluntarily terminated outstanding debt with
Hercules. In July 2024, Bicycle Therapeutics announced the
repayment of its loan with Hercules Capital, Inc., ahead of its
2025 maturity date, with total payments of $31.9 million, including
accrued and unpaid interest, an end-of-term charge and an early
repayment fee.
Second Quarter 2024 Financial Results
- Cash and cash equivalents were $961.4 million as of June 30,
2024, compared to $526.4 million as of December 31, 2023. The
increase in cash and cash equivalents is primarily due to net
proceeds from the PIPE financing and share option exercises, offset
by cash used in operating activities.
- R&D expenses were $40.1 million for the three months ended
June 30, 2024, compared to $39.7 million for the three months ended
June 30, 2023. The increase in expense of $0.4 million was
primarily due to increased clinical program expenses for
zelenectide pevedotin development and increased personnel-related
expenses, offset by decreased clinical program expenses for Bicycle
TICA® molecule development, decreased discovery, platform and other
expenses and incremental U.K. R&D tax credits.
- General and administrative expenses were $15.9 million for the
three months ended June 30, 2024, compared to $14.8 million for the
three months ended June 30, 2023. The increase of $1.1 million was
primarily due to increased personnel-related costs.
- Net loss was $39.8 million, or $(0.77) basic and diluted net
loss per share, for the three months ended June 30, 2024, compared
to net loss of $42.6 million or $(1.41) basic and diluted net loss
per share, for three months ended June 30, 2023.
About Bicycle Therapeutics Bicycle Therapeutics is a
clinical-stage pharmaceutical 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 zelenectide pevedotin
(formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting
Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule
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 progress across its R&D pipeline and the
advancement of its product candidates, including zelenectide
pevedotin, BT5528 and BT7480; the anticipated progression of
Bicycle’s clinical trials and the method and timing of announcement
of data from clinical trials and program updates for clinical
candidates; Bicycle’s beliefs regarding the clinical programs and
research areas with the highest potential to maximize value
creation and the company’s activities to focus on such programs and
areas; the guidance and insights provided by the Clinical Advisory
Board; the development of potential radiopharmaceutical or other
product candidates using Bicycle’s technology through various
partnerships; 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 research and development and
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
partnerships; timing of results from clinical trials; whether the
outcomes of preclinical studies will be predictive of clinical
trial results; the risk that trials may have unsatisfactory
outcomes; potential adverse effects arising from the testing or use
of Bicycle’s product candidates; the risk that Bicycle’s management
have not focused the company’s activities on the clinical programs
and research areas with the highest potential to maximize value
creation; the risk that the Clinical Advisory Board does not
provide guidance or insights or that such guidance turns out to be
deficient; 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; 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 2, 2024, 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,
2024
2023
2024
2023
Collaboration revenues
$
9,361
$
11,397
$
28,891
$
16,293
Operating expenses:
Research and development
40,059
39,720
74,923
71,931
General and administrative
15,949
14,788
32,331
29,276
Total operating expenses
56,008
54,508
107,254
101,207
Loss from operations
(46,647
)
(43,111
)
(78,363
)
(84,914
)
Other income (expense):
Interest income
7,774
812
13,398
3,741
Interest expense
(824
)
(821
)
(1,645
)
(1,629
)
Total other income (expense), net
6,950
(9
)
11,753
2,112
Net loss before income tax provision
(39,697
)
(43,120
)
(66,610
)
(82,802
)
Provision for (benefit from) income
taxes
115
(517
)
(235
)
(1,135
)
Net loss
$
(39,812
)
$
(42,603
)
$
(66,375
)
$
(81,667
)
Net loss per share, basic and diluted
$
(0.77
)
$
(1.41
)
$
(1.40
)
$
(2.71
)
Weighted average ordinary shares
outstanding, basic and diluted
51,992,034
30,191,693
47,276,062
30,097,234
Condensed Consolidated Balance
Sheets Data
(In thousands)
(Unaudited)
June 30,
December 31,
2024
2023
Cash and cash equivalents
$
961,364
$
526,423
Working capital
958,645
492,331
Total assets
1,057,355
595,344
Total shareholders’ equity
873,813
370,932
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240806954596/en/
Investors: Stephanie Yao SVP, Investor Relations and
Corporate Communications ir@bicycletx.com 857-523-8544
Media: Deborah Elson Argot Partners media@bicycletx.com
212-600-1902
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