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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
October 31, 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 October 31, 2024, Bicycle Therapeutics plc issued a press release
announcing financial results for the fiscal quarter ended September 30, 2024 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: October 31, 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 Third Quarter 2024 Financial Results
Presented updated clinical results across oncology
pipeline, including a 45% overall response rate (ORR) for zelenectide pevedotin monotherapy and a 45% ORR for BT5528 6.5 mg/m2 every
two weeks monotherapy, both in metastatic urothelial cancer
Progressed radiopharmaceuticals pipeline with
first human imaging data validating the potential of MT1-MMP as a novel cancer target and outlined company strategy in this area
Cash and cash equivalents of $890.9 million
as of September 30, 2024, excluding $31.7 million UK R&D tax credit received in October 2024; expected financial runway
into 2H 2027
CAMBRIDGE, England & BOSTON, October 31, 2024 –
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
third quarter ended September 30, 2024.
“In the third quarter, we continued to make significant advancements
across our business and pipeline. At ESMO, we reported updated data for our clinical-stage molecules, further supporting their promising
monotherapy response rates and differentiated safety profiles. Additionally, last week we shared exciting first human imaging data for
our first radiopharmaceuticals molecule, validating the potential of MT1-MMP as a novel cancer target and providing important information
on the ability of our Bicycle molecules to deliver radioisotopes to the tumor,” said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics.
“Altogether, we believe these data demonstrate the power and broad capabilities of our Bicycle technology platform, and we look
forward to providing additional updates later this year.”
Third Quarter 2024 and Recent Events
| · | Announced first human imaging data for a Bicycle Radionuclide Conjugate
(BRC®) targeting MT1-MMP and outlined strategy for leadership in next-generation radiopharmaceuticals. |
| o | Data presented at the European Association of Nuclear Medicine 2024
Congress validate the potential of MT1-MMP as a novel target in the treatment of cancer,
demonstrate the translatability of BRC preclinical data and highlight the potential of Bicycle®
molecules for targeted radionuclide therapy. |
| § | In an oral presentation, the German Cancer Consortium shared results of fluorine-18-labelled
FDG-PET/CT imaging and gallium-68-labelled BRC MT1-MMP PET/CT imaging in a 65-year-old male diagnosed with advanced pulmonary adenocarcinoma,
the most common type of non-small cell lung cancer, in the lung and lymph nodes confirmed by endobronchial ultrasound biopsy. Both scans
revealed multiple lymph node metastases and bone metastases in the sternum. MT1-MMP imaging demonstrated tracer uptake in the primary
tumor in the lung and lymph node and bone metastases, consistent with FDG imaging. Additionally, the MT1-MMP BRC tracer showed renal excretion,
with all other organs showing only a negligible tracer uptake. Clear imaging contrast was also observed at early time points. |
| § | In an e-poster presented by Bicycle Therapeutics, preclinical data demonstrate
the suitability of Bicycle molecules to deliver indium to tumors in vivo due to their favorable properties including specific tumor
uptake, rapid tumor penetration and rapid renal elimination. Additionally, imaging showed how the biodistribution profile of BRCs can
be optimized to maintain high tumor uptake and retention while significantly reducing kidney levels. These data build on the body of preclinical
data that the company has published in this area demonstrating the use of Bicycle molecules to effectively deliver various radioisotopes,
such as lutetium and lead, to tumors. |
| o | Bicycle Therapeutics’ strategy in radiopharmaceuticals focuses on pursuing novel targets
with first-in-class potential and selecting the isotope that best aligns with the target biology and indication. In line with this
strategy, the company selected EphA2, a novel tumor antigen that is widely expressed in many cancers, as its second BRC target and
signed a letter of intent with leading isotope technology company Eckert & Ziegler to put in place an agreement to supply a
range of radioisotopes and develop and manufacture BRC molecules. |
| · | Presented updated clinical results across oncology pipeline at the European
Society for Medical Oncology Congress 2024. |
| o | Zelenectide pevedotin (formerly BT8009) is a Bicycle Toxin Conjugate (BTC®) molecule targeting Nectin-4, a
well-validated tumor antigen. Updated results from the ongoing Phase 1/2 Duravelo-1 trial evaluating 5 mg/m2 weekly of
zelenectide pevedotin monotherapy in patients with metastatic urothelial cancer (mUC) who had not previously been treated with
enfortumab vedotin showed a 45% overall response rate (ORR) in efficacy-evaluable patients (n=38), with a median duration of
response of 11.1 months among patients with confirmed responses (n=14). Zelenectide pevedotin continued to demonstrate an emerging
differentiated safety profile, particularly around adverse events of interest such as peripheral neuropathy, skin reactions and eye
disorders. |
The global Phase 2/3 Duravelo-2 registrational trial of zelenectide
pevedotin in patients with mUC is currently enrolling. Additional data updates for zelenectide pevedotin monotherapy in other tumor types
and in combination with pembrolizumab in first-line mUC are planned by year end.
| o | BT5528 is a BTC molecule targeting tumor antigen EphA2, which has historically been difficult to target using other drug conjugate
approaches. Updated results from the ongoing Phase 1/2 trial evaluating 6.5 mg/m2 every two weeks and 5 mg/m2 weekly
of BT5528 monotherapy in patients with advanced solid tumors showed an emerging differentiated safety profile and antitumor activity,
including a 45% ORR in mUC patients enrolled in the dose expansion cohort (n=11) receiving 6.5 mg/m2 every two weeks. |
Bicycle Therapeutics is currently assessing BT5528 at 6.5 mg/m2 every
two weeks in combination with nivolumab, with results expected in 2025.
| o | An analysis of BTC clinical data showed that treatment-related peripheral neuropathy (TRPN) in patients receiving either zelenectide
pevedotin or BT5528 occurred at low rates and were primarily low grade. In 223 patients from ongoing Phase 1/2 studies, TRPN occurred
in 28% of zelenectide pevedotin-treated patients and in 19% of BT5528-treated patients, nearly all of which were low grade (Grade 1-2).
One Grade 3 event (neuralgia) was reported in a patient treated with zelenectide pevedotin following prior therapy with enfortumab vedotin,
while no Grade 3-4 events were observed for BT5528. |
These data showing low rates of TRPN at primarily low severity
with BTC molecules support the hypothesis that the antibody-drug construct may be a primary driver of peripheral neuropathy rather than
monomethyl auristatin E (MMAE) toxicity as was previously believed.
| o | BT7480 is a Nectin-4 targeted CD137 agonist designed to overcome immune agonist toxicities and activate the immune system in
Nectin-4 expressing tumors. Initial data from the Phase 1/2 dose escalation trial evaluating BT7480 in patients with advanced solid tumors
showed an emerging differentiated safety and tolerability profile, with low rates of severe adverse events among 39 patients assigned
to receive one of 10 different doses (0.002-3.5 mg/kg weekly). Preliminary biomarker analyses support BT7480 dual targeting of CD137 and
Nectin-4 as demonstrated by enhanced immune cell activation, aligned with the proposed mechanism of action of BT7480. |
As the maximum tolerated dose for BT7480 has not yet been reached,
Bicycle Therapeutics is continuing dose exploration in combination studies, starting with nivolumab.
| · | Promoted Zafar Qadir to Chief Legal Officer and General Counsel. Since
joining Bicycle Therapeutics in April 2020, Mr. Qadir has managed critical responsibilities to support the company’s growth
by leading the legal, compliance and intellectual property functions. Over the course of his career, Mr. Qadir has more than a decade
of corporate, legal, intellectual property, regulatory and compliance experience and has played a pivotal role in Bicycle Therapeutics’
key partnerships and transactions. |
Third Quarter 2024 Financial Results
| · | Cash and cash equivalents were $890.9 million as of September 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
our PIPE financing in May 2024 and share option exercises, offset by the repayment of our debt facility with Hercules Capital, Inc.
in July 2024 and cash used in operating activities. |
| · | Research
and Development (R&D) expenses were $48.3 million for the three months ended
September 30, 2024, compared to $39.9 million for the three months ended September 30,
2023. The increase in expense of $8.4 million was primarily due to increased clinical program
expenses for zelenectide pevedotin development and increased personnel-related expenses,
including incremental share-based compensation of $1.1 million, offset by decreased clinical
program expenses for Bicycle Tumor-Targeted Immune Cell Agonist® molecule development,
lower discovery, platform and other expenses, and higher U.K. R&D tax credits period
over period. |
| · | General and administrative expenses were $18.3 million for the three
months ended September 30, 2024, compared to $16.3 million for the three months ended September 30, 2023. The increase of $2.0
million was primarily due to increased personnel-related expenses, including incremental share-based compensation expense of $0.7 million. |
| · | Net loss was $50.8 million, or $(0.74) basic and
diluted net loss per share, for the three months ended September 30, 2024, compared to net loss of $49.9 million, or $(1.26)
basic and diluted net loss per share, for three months ended September 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 Radionuclide
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 business and its product candidates, including zelenectide pevedotin, BT5528 and BT7480; the anticipated progression
of Bicycle’s clinical trials and the timing of announcement of data from clinical trials and program updates for clinical candidates;
the development of potential radiopharmaceutical product candidates; the use of Bicycle’s technology through various partnerships
to develop potential therapies in diseases beyond oncology; 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 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 August 6, 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 | | |
Nine Months Ended | |
| | |
September 30, | | |
September 30, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| Collaboration revenues | |
$ | 2,676 | | |
$ | 5,352 | | |
$ | 31,567 | | |
$ | 21,645 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 48,265 | | |
| 39,868 | | |
| 123,188 | | |
| 111,799 | |
| General and administrative | |
| 18,257 | | |
| 16,281 | | |
| 50,588 | | |
| 45,557 | |
| Total operating expenses | |
| 66,522 | | |
| 56,149 | | |
| 173,776 | | |
| 157,356 | |
| Loss from operations | |
| (63,846 | ) | |
| (50,797 | ) | |
| (142,209 | ) | |
| (135,711 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest and other income | |
| 10,583 | | |
| 3,985 | | |
| 23,981 | | |
| 7,726 | |
| Interest expense | |
| (33 | ) | |
| (814 | ) | |
| (1,678 | ) | |
| (2,443 | ) |
| Loss on extinguishment of debt | |
| (954 | ) | |
| — | | |
| (954 | ) | |
| — | |
| Total other income, net | |
| 9,596 | | |
| 3,171 | | |
| 21,349 | | |
| 5,283 | |
| Net loss before income tax provision | |
| (54,250 | ) | |
| (47,626 | ) | |
| (120,860 | ) | |
| (130,428 | ) |
| (Benefit from) provision for income taxes | |
| (3,448 | ) | |
| 2,272 | | |
| (3,683 | ) | |
| 1,137 | |
| Net loss | |
$ | (50,802 | ) | |
$ | (49,898 | ) | |
$ | (117,177 | ) | |
$ | (131,565 | ) |
| Net loss per share, basic and diluted | |
$ | (0.74 | ) | |
$ | (1.26 | ) | |
$ | (2.15 | ) | |
$ | (3.95 | ) |
| Weighted average ordinary shares outstanding, basic and diluted | |
| 68,988,858 | | |
| 39,576,467 | | |
| 54,566,490 | | |
| 33,291,701 | |
Condensed Consolidated Balance Sheets Data
(In thousands)
(Unaudited)
| | |
September 30, | | |
December 31, | |
| | |
2024 | | |
2023 | |
| Cash and cash equivalents | |
$ | 890,862 | | |
$ | 526,423 | |
| Working capital | |
| 909,789 | | |
| 492,331 | |
| Total assets | |
| 996,746 | | |
| 595,344 | |
| Total shareholders’ equity | |
| 831,032 | | |
| 370,932 | |
Investors:
Stephanie Yao
SVP, Investor Relations and Corporate Communications
stephanie.yao@bicycletx.com
857-523-8544
Matthew DeYoung
Argot Partners
ir@bicycletx.com
212-600-1902
Media:
Jim O’Connell
Weber Shandwick
media@bicycletx.com
312-988-2343
v3.24.3
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- DefinitionBoolean flag that is true only for a security having no trading symbol.
| Name: |
dei_NoTradingSymbolFlag |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:trueItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
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|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- Details
| Name: |
us-gaap_StatementClassOfStockAxis=us-gaap_CommonStockMember |
| Namespace Prefix: |
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| Data Type: |
na |
| Balance Type: |
|
| Period Type: |
|
|
| X |
- Details
| Name: |
us-gaap_StatementClassOfStockAxis=bcyc_AmericanDepositarySharesMember |
| Namespace Prefix: |
|
| Data Type: |
na |
| Balance Type: |
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| Period Type: |
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|
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