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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
November 2, 2023
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 November 2, 2023, Bicycle Therapeutics plc issued a press release
announcing financial results for the fiscal quarter ended September 30, 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 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: November 2, 2023 |
BICYCLE THERAPEUTICS PLC |
|
|
|
|
|
By: |
/s/
Alethia Young |
|
Name: Alethia Young |
|
Title: Chief Financial Officer |
Exhibit 99.1
Bicycle Therapeutics Reports Recent Business
Progress and Third Quarter 2023 Financial Results and Announces Upcoming R&D Day
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
CAMBRIDGE, England & BOSTON, November
2, 2023 – 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. |
| o | 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. |
| o | 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 | |
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
v3.23.3
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Bicycle Therapeutics (NASDAQ:BCYC)
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