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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
July 30, 2026
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 July 30, 2026, Bicycle Therapeutics plc issued a press release announcing
financial results for the fiscal quarter ended June 30, 2026 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
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release issued July 30, 2026 |
| 104 |
|
Cover Page Interactive Data File (formatted in Inline XBRL) |
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: July 30, 2026 |
BICYCLE THERAPEUTICS PLC |
| |
|
|
| |
By: |
/s/ Travis Thompson |
| |
Name: |
Travis Thompson |
| |
Title: |
Chief Financial Officer |
Exhibit 99.1
Bicycle Therapeutics Reports Recent Business
Progress and Second Quarter 2026 Financial Results
Data presented at AACR and ASCO provide further
validation of the potential of Bicycle® technology to deliver oncology therapeutics with improved benefit/risk profiles
compared to existing modalities
Expanded Clinical Advisory Board with the addition
of Thomas Powles, MBBS, MRCP, M.D.
Cash and cash equivalents of $510.1 million
as of June 30, 2026, with expected cash runway into 2030
CAMBRIDGE, England & BOSTON, July 30,
2026 – 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 financial results for the second quarter
ended June 30, 2026, and provided recent corporate updates.
“We are pleased with the progress we made
during the second quarter. Our financial discipline with refined focus on nuzefatide pevedotin and our next-generation Bicycle conjugate
pipeline, including Bicycle® Radioconjugates (BRC®), leaves us well capitalized to pursue our mission to
help patients to not only live longer, but also live well,” said Bicycle CEO Kevin Lee, Ph.D. “The encouraging data we presented
during the quarter continue to deepen our belief in the potential of our technology to deliver oncology therapeutics with a superior benefit/risk
profile against high-value targets like EphA2 and Nectin-4, the former being historically considered undruggable using antibody-based
approaches. We believe this profile provides a strong rationale for developing nuzefatide in recurrent pancreatic cancer, where we successfully
dosed our first patient in the ongoing Phase 2 trial in April. We remain on track to begin the Phase 1 trial for BT1702, our MT1-MMP targeting
BRC, in 2027, backed by compelling human imaging data validating the targeting precision and translatability of our Bicycle®
technology.”
Dr Lee added: “It is an honor to welcome
world-renowned oncologist Professor Thomas Powles to our Clinical Advisory Board. His deep clinical insights and distinguished leadership
in urothelial cancers will be instrumental as we accelerate our efforts to deliver precision-targeted therapies for patients.”
Second Quarter 2026 and Recent Events
| · | Data presented at the American
Association for Cancer Research (AACR) Annual Meeting 2026 highlights significant opportunities for nuzefatide pevedotin (nuzefatide),
a potentially first-in-class EphA2 targeting Bicycle®
Drug Conjugate (BDC®), in EphA2 expressing cancers. |
| o | As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2
once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with metastatic urothelial cancer (mUC) who
had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed a differentiated safety profile as well as
promising anti-tumor activity. |
| o | Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of pancreatic ductal adenocarcinoma
(PDAC). Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models
were sensitive to nuzefatide, six of which showed high sensitivity. |
| o | Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing cell-line-derived xenograft models of head and
neck squamous cell carcinoma. |
Altogether, Bicycle Therapeutics believes
that these data underscore the therapeutic potential for nuzefatide in EphA2-expressing cancers, including pancreatic cancer.
Bicycle Therapeutics is actively enrolling
patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent
PDAC. The first patient was successfully dosed in April 2026 at the 8mg/m2 Q2W preferred dose for the trial.
| · | Additional human imaging data of a Bicycle®
Imaging Agent (BIA) targeting EphA2 in patients with PDAC presented at AACR Annual Meeting 2026. The German Cancer Consortium (DKTK),
part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle®
molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA) in seven patients with histologically confirmed PDAC. Bicycle Therapeutics
believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical
data and highlight the potential of Bicycle® molecules for targeted radioligand therapies and radiopharmaceutical imaging. |
Bicycle Therapeutics continues to advance
its emerging radioligand pipeline, with the initiation of the first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP
targeting BRC, expected in 2027.
| · | Initial Duravelo-2 data presented at 2026
American Society of Clinical Oncology (ASCO) Annual Meeting demonstrates encouraging response rates comparable to published data for standard
of care (SOC) and a potentially differentiated safety profile in previously untreated patients with mUC. Zelenectide pevedotin (zelenectide)
is a BDC targeting Nectin-4, a well-validated tumor antigen. The dose optimization stage of the randomized Phase 2 Duravelo-2
trial evaluated two doses of zelenectide – 5mg/m2 weekly (5mg dose) and 6mg/m2 (6mg dose) two weeks
on, one week off – in combination with 200mg of pembrolizumab once every three weeks in previously untreated patients with mUC (Cohort
1). Bicycle Therapeutics reached regulatory alignment on the zelenectide 6mg dose as optimal both in combination with pembrolizumab and
as a monotherapy. Cohort 1 data were extracted for the interim analysis at Week 27, on July 23, 2025. At the time of the data
cut, the median progression-free survival (PFS) was not mature, and the results at the optimal dose showed: |
| o | 65% (17/26) overall response rate (ORR) regardless of confirmation and blinded independent central review
(BICR) confirmed ORR of 58% (15/26) at the 27-week cutoff. Subsequent to the 27-week cutoff, an additional confirmed BICR response was
observed, which would result in an ORR of 62% (16/26). |
| o | Low rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including peripheral
neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%). |
| o | There were no reported instances of zelenectide-related hyperglycemia and no zelenectide-related severe
skin reactions of any grade. |
| · | Updated Duravelo-1 data presented at 2026
ASCO Annual Meeting demonstrates encouraging median PFS comparable to published data for SOC in previously untreated, cisplatin-ineligible
mUC patients. Updated Phase 1 Duravelo-1 results as of the August 1, 2025 data cutoff evaluating zelenectide at the 5mg dose
in combination with pembrolizumab in previously untreated cisplatin-ineligible patients, 45% of whom were classified as Eastern Cooperative
Oncology Group (ECOG) performance status of 2, showed: |
| o | 59% (13/22) ORR regardless of confirmation, 50% confirmed ORR (11/22), and a disease control rate (DCR)
of 82%. Of the confirmed responses, 5 (23%) were complete responses and 6 (27%) were partial responses. |
| o | Median PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of the data
cutoff. |
Across all patients, the safety and
tolerability profile was consistent with other zelenectide data to date. No new safety signals were observed and there were no Grade 4
or Grade 5 zelenectide-related AEs of clinical interest reported.
| · | Expanded Clinical Advisory Board with the
addition of Thomas Powles, MBBS, MRCP, M.D. Dr. Powles is a Professor of Genitourinary Oncology and Director of Barts Cancer
Centre at St Bartholomew’s Hospital, and Lead for Solid Tumor Research at Barts Cancer Institute, London. Dr. Powles is an
international leader in the treatment of urothelial cancers, with a research focus spanning from Phase 1 to randomized Phase 3 clinical
trials, particularly in translational Phase 2 studies investigating novel targeted and immune therapies. He has played a critical role
in leading over twenty randomized clinical trials, resulting in multiple U.S. Food and Drug Administration (FDA) and European Medicines
Agency approvals. |
Second Quarter 2026 Financial Results
| · | Cash and cash equivalents were $510.1 million
as of June 30, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily
due to cash used in operations, including cash payments for clinical program activities. |
| · | Research and development (R&D) expenses were $41.2
million for the three months ended June 30, 2026, compared to $71.0 million for the three months ended June 30, 2025. The
decrease in expense of $29.8 million was primarily due to decreased clinical program expenses for zelenectide, decreased personnel-related
costs and share-based compensation due to our recent workforce reduction announced in March 2026, as well as decreased discovery,
platform and other expenses, offset by lower U.K. R&D tax credits period over period. |
| · | General and administrative (G&A) expenses
were $14.0 million for the three months ended June 30, 2026, compared to $18.5 million for the three months ended June 30,
2025. The decrease in expense of $4.5 million was primarily due to decreased professional and consulting fees and decreased personnel-related
costs and share-based compensation due to our recent workforce reduction announced in March 2026. |
| · | Net loss was $50.3 million, or $(0.72)
basic and diluted net loss per share, for the three months ended June 30, 2026, compared to net loss of $79.0 million, or $(1.14)
basic and diluted net loss per share, for the three months ended June 30, 2025. |
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 nuzefatide pevedotin, formerly BT5528,
a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of
other bicycle-based conjugate molecules, including Bicycle® Radioconjugates (BRC®) for radiopharmaceutical
use; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various
partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases in additional therapeutic
areas.
Bicycle Therapeutics is headquartered in Cambridge,
UK, with many key functions and members of its leadership team located in Lexington, 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,”,
“promising”, “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: the potential therapeutic benefit of nuzefatide
pevedotin, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical
trials, and the potential development of nuzefatide pevedotin in a number of cancers, including pancreatic cancer; the progress of Bicycle
Therapeutics’ clinical trials, reporting data from Bicycle Therapeutics’ clinical trials, including for nuzefatide pevedotin,
the timing of EphA2 human imaging data and updates on future clinical development plans for nuzefatide pevedotin; the potential of EphA2
as a novel cancer target and the positive properties of Bicycle® radioligand molecules for radiopharmaceutical use; the
development of the Bicycle® radioligands pipeline, including BRCs and BIAs; communications with and feedback from the FDA
and other regulatory agencies; Bicycle Therapeutics’ expected financial runway; and the use of Bicycle Therapeutics’ technology
through various partnerships to develop therapies for diseases in additional therapeutic areas. Bicycle Therapeutics 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: the workforce reduction may take longer or result in more
significant charges or cash expenditures than anticipated or otherwise negatively impact Bicycle Therapeutics’ and its business
plans during and after the period during which the workforce reduction is being executed; uncertainties related to the benefits of the
strategic reprioritization; uncertainties inherent in research and development and in the initiation, progress and completion of clinical
trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics may not realize
the intended benefits of its technology or partnerships; the risk that Bicycle Therapeutics may not achieve any of its clinical development
strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive
of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing
or use of Bicycle Therapeutics’ product candidates; the risk that Bicycle Therapeutics’ 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 Therapeutics’ 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 Therapeutics’ Annual Report on Form 10-K filed
with the Securities and Exchange Commission (SEC) on March 17, 2026, as well as in other filings Bicycle Therapeutics 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 Therapeutics 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
(In thousands, except share and per share data)
(Unaudited)
| | |
Three Months Ended | | |
Six Months Ended | |
| | |
June 30, | | |
June 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Collaboration revenue | |
$ | 629 | | |
$ | 2,920 | | |
$ | 1,516 | | |
$ | 12,897 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 41,160 | | |
| 71,029 | | |
| 90,061 | | |
| 130,087 | |
| General and administrative | |
| 14,028 | | |
| 18,493 | | |
| 31,496 | | |
| 39,616 | |
| Total operating expenses | |
| 55,188 | | |
| 89,522 | | |
| 121,557 | | |
| 169,703 | |
| Loss from operations | |
| (54,559 | ) | |
| (86,602 | ) | |
| (120,041 | ) | |
| (156,806 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest and other income | |
| 4,360 | | |
| 7,473 | | |
| 9,237 | | |
| 15,887 | |
| Interest expense | |
| (44 | ) | |
| (54 | ) | |
| (92 | ) | |
| (105 | ) |
| Total other income, net | |
| 4,316 | | |
| 7,419 | | |
| 9,145 | | |
| 15,782 | |
| Net loss before income tax provision | |
| (50,243 | ) | |
| (79,183 | ) | |
| (110,896 | ) | |
| (141,024 | ) |
| Provision for (benefit from) income taxes | |
| 90 | | |
| (231 | ) | |
| 262 | | |
| (1,318 | ) |
| Net loss | |
$ | (50,333 | ) | |
$ | (78,952 | ) | |
$ | (111,158 | ) | |
$ | (139,706 | ) |
| Net loss per share, basic and diluted | |
$ | (0.72 | ) | |
$ | (1.14 | ) | |
$ | (1.59 | ) | |
$ | (2.02 | ) |
| Weighted average ordinary shares outstanding, basic and diluted | |
| 69,804,828 | | |
| 69,252,009 | | |
| 69,744,485 | | |
| 69,224,629 | |
Balance Sheets Data
(In thousands)
(Unaudited)
| | |
June 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| Cash and cash equivalents | |
$ | 510,052 | | |
$ | 628,110 | |
| Working capital | |
| 527,601 | | |
| 625,901 | |
| Total assets | |
| 606,578 | | |
| 717,597 | |
| Total shareholders’ equity | |
| 510,255 | | |
| 609,977 | |
Investors:
Matthew DeYoung
Argot Partners
ir@bicycletx.com
212-600-1902
Media:
Argot Partners
media@bicycletx.com
