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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934
February 20, 2024
Date of Report (Date of earliest event reported)
Bicycle Therapeutics plc
(Exact name of registrant as specified in its charter)
England and Wales |
|
001-38916 |
|
Not applicable |
(State or other jurisdiction
of
incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
Blocks
A & B, Portway Building, Granta
Park Great Abington, Cambridge United
Kingdom
|
CB21
6GS |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: +44 1223
261503
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
Trading
Symbol(s) |
Name
of each exchange on which registered |
Ordinary shares, nominal value £0.01 per share |
n/a |
The Nasdaq Stock Market LLC* |
American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share |
BCYC |
The Nasdaq Stock Market LLC |
* Not for trading, but only in connection
with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.
Indicate by check mark whether
the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or
Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. |
Results of Operations and Financial Condition |
On February 20, 2024, Bicycle Therapeutics plc (the “Company”)
issued a press release announcing financial results for the fiscal quarter and the year ended December 31, 2023 and other business
highlights. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
The information contained in Item 2.02 in this Current Report
on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth
by specific reference in such a filing.
Item 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On February 20, 2024, the Board of Directors (the
“Board”) of the Company, upon the recommendation of the Nominating & Corporate Governance Committee of the
Board, appointed Stephen Sands to the Board, effective as of the close of business on February 20, 2024, New York City time.
The Board has determined that Mr. Sands is “independent” pursuant to the rules of the Nasdaq Stock Market LLC
and other governing laws and applicable regulations.
Mr. Sands will serve as a Class III director until the Company’s
2025 annual general meeting of shareholders and until his successor has been duly elected and qualified or until his earlier death, resignation
or removal. Mr. Sands will also serve as a member of the Audit and Strategic Committees.
There are no arrangements or understandings between Mr. Sands
and any other person pursuant to which Mr. Sands was elected as a director. Mr. Sands does not have any family relationships with
any of the Company’s directors or executive officers, and he does not have a direct or indirect material interest in any transaction
required to be disclosed pursuant to Item 404(a) of Regulation S-K.
As a non-employee director of the Company, Mr. Sands is eligible
to participate in the Company’s Amended and Restated Non-Employee Director Compensation Policy (the “Policy). Pursuant to
the Policy, Mr. Sands will receive (i) annual cash compensation of $50,000 for his service as a director, (ii) annual cash
compensation of $10,500 for his service as a member of the Audit Committee and (iii) annual cash compensation of $33,000 for his
service as a member of the Strategic Committee. Additionally, Mr. Sands is eligible for an option to purchase 24,000 ordinary shares of the Company and a restricted share unit (“RSU”) of 12,000 ordinary shares of the Company.
The options and RSUs will vest in three equal annual installments on the first, second and third anniversaries of the date of grant, subject
to continued service as a director through the applicable vesting dates.
In connection with his appointment to the Board, Mr. Sands will
also enter into the Company’s standard form of deed of indemnity, a copy of which was filed as Exhibit 10.12 to the Company’s
Current Report on Form 8-K filed with the Securities and Exchange Commission on November 12, 2019.
Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Date: February 20,
2024 |
BICYCLE THERAPEUTICS PLC |
|
|
|
By: |
/s/ Alethia Young |
|
Name: |
Alethia Young |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
Bicycle Therapeutics
Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results
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
CAMBRIDGE,
England & BOSTON, February 20, 2024 – 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: |
| o | 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. |
| o | 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: |
| o | 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. |
| o | 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. |
| o | 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: |
| o | Continuing
the company’s strong track record of collaboration. |
| o | 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: |
| o | 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. |
| o | 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. |
| o | 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:
| o | BT8009
5 mg/m2 weekly in late-line, EV-naive mUC; |
| o | Ovarian,
TNBC and NSCLC cancer; and |
| o | 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: |
| o | 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. |
| o | Two
unconfirmed partial responses in heavily pre-treated patients with cervical cancer. |
| o | 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: |
| o | 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. |
| o | 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. |
| o | 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 | |
Investors:
Stephanie
Yao
SVP, Investor
Relations and Corporate Communications
ir@bicycletx.com
857-523-8544
Media:
Deborah Elson
Argot Partners
media@bicycletx.com
v3.24.0.1
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Bicycle Therapeutics (NASDAQ:BCYC)
Gráfico Histórico do Ativo
De Dez 2024 até Jan 2025
Bicycle Therapeutics (NASDAQ:BCYC)
Gráfico Histórico do Ativo
De Jan 2024 até Jan 2025