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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 29, 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 October 29, 2026, Bicycle Therapeutics plc issued a press release
announcing financial results for the fiscal quarter ended September 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 October 29, 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: October 29, 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 Third Quarter 2026 Financial Results
Nuzefatide pevedotin granted FDA Orphan Drug
Designation for the treatment of pancreatic cancer; further updates expected in 2027
Initiation of the first company-sponsored radioligand
clinical trial for BT1702, an MT1-MMP- targeting Bicycle® Radioconjugate, expected in 2H 2027
Cash and cash equivalents of $469.9 million
as of September 30, 2026, with expected cash runway into 2030
CAMBRIDGE, England & BOSTON, October 29, 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 third quarter ended September
30, 2026, and provided recent corporate updates.
“We are pleased with the continued
progress made across our pipeline during the third quarter, as we advance nuzefatide pevedotin in the Phase 2 clinical trial in
patients with recurrent pancreatic ductal adenocarcinoma and build our emerging pipeline of next-generation radioligands. We believe
the FDA’s Orphan Drug Designation for nuzefatide in pancreatic cancer further supports our development strategy and
underscores the significant unmet need in this patient population,” said Bicycle CEO Kevin Lee, Ph.D. “We remain focused
on disciplined execution across our prioritized programs and believe our growing clinical data continue to demonstrate the potential
of Bicycle® molecules to deliver highly targeted therapies with differentiated benefit/risk profiles. We look forward
to advancing our pipeline and reaching important clinical milestones for nuzefatide and initiating our first company-sponsored
radioligand clinical trial for BT1702 in the second half of 2027.”
Third Quarter 2026 and Recent Events
| · | Nuzefatide pevedotin (nuzefatide), a potentially
first-in-class EphA2 targeting Bicycle® Drug Conjugate (BDC®), was granted Orphan Drug Designation (ODD)
by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. In September 2026, the FDA granted nuzefatide
ODD for the treatment of pancreatic cancer. The designation is granted to investigational therapies intended to treat rare diseases affecting
fewer than 200,000 patients in the United States. The designation provides development incentives, including eligibility for tax credits
on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon
regulatory approval. |
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 pancreatic ductal adenocarcinoma (PDAC) and expects to provide further updates in 2027.
| · | Bicycle
Therapeutics continues to optimize its Bicycle® Radioconjugate (BRC®) molecules and advance its emerging
radioligand pipeline, with initiation of the first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP-targeting BRC®,
expected in the second half of 2027. |
| · | Zelenectide
pevedotin is a BDC® molecule targeting Nectin-4, a well-validated tumor antigen. Bicycle Therapeutics converted the
Duravelo-2 trial to a randomized Phase 2 trial in May 2026 and deprioritized the program for internal development. The company expects
to report Duravelo-2 survival data from the randomized Phase 2 trial in previously untreated patients with metastatic urothelial cancer
(mUC) in the second half of 2027. |
Third Quarter 2026 Financial Results
| · | Cash and cash equivalents were $469.9 million as of September 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. |
| · | Collaboration
revenue was $34.1 million for the three months ended September 30, 2026, compared to $11.7 million for the three months ended September
30, 2025. The increase in collaboration revenue was primarily due to the recognition of all remaining revenue under Bicycle Therapeutics’
collaboration with Bayer Consumer Care AG upon termination of the underlying collaboration agreement. |
| · | Research
and development (R&D) expenses were $33.4 million for the three months ended September 30, 2026, compared to $58.4 million for the
three months ended September 30, 2025. The decrease in expense of $25.0 million was primarily due to decreased clinical program expenses
for zelenectide, decreased personnel-related costs and share-based compensation due to our workforce reductions announced in August 2025
and March 2026, as well as decreased discovery, platform and other expenses, offset by lower research and development incentives associated
with the corresponding decrease in qualifying research and development expenses period over period. |
| · | General
and administrative (G&A) expenses were $14.1 million for the three months ended September 30, 2026, compared to $18.9 million for
the three months ended September 30, 2025. The decrease in expense of $4.8 million was primarily due to decreased personnel-related costs
and share-based compensation due to our workforce reductions announced in August 2025 and March 2026. |
| · | Net loss was $10.5 million, or $(0.15) basic and diluted net loss per share,
for the three months ended September 30, 2026, compared to net loss of $59.1 million, or $(0.85) basic and diluted net loss per share,
for the three months ended September 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
pancreatic cancer; the clinical and regulatory benefits anticipated from the Orphan Drug Designation granted to nuzefatide pevedotin,
including the potential for seven years of market exclusivity upon regulatory approval, eligibility for tax credits and exemption from
certain FDA user fees; the progress of Bicycle Therapeutics’ clinical trials, reporting data from Bicycle Therapeutics’ clinical
trials, including for nuzefatide pevedotin, and updates on future clinical development plans for nuzefatide pevedotin; the potential
of Bicycle molecules to deliver highly targeted therapies with differentiated benefit/risk profiles; the positive properties of Bicycle®
radioligand molecules for radiopharmaceutical use; the development of the Bicycle® radioligands pipeline, including BRCs, and the
expected initiation of the first company-sponsored radioligand clinical trial for BT1702 in the second half of 2027; 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: uncertainties related to the
benefits and potential unintended consequences of the strategic reprioritization and recent workforce reductions; 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on
July 30, 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 | | |
Nine Months Ended | |
| | |
September 30, | | |
September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Collaboration revenue | |
$ | 34,057 | | |
$ | 11,734 | | |
$ | 35,573 | | |
$ | 24,631 | |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 33,422 | | |
| 58,426 | | |
| 123,483 | | |
| 188,513 | |
| General and administrative | |
| 14,112 | | |
| 18,859 | | |
| 45,608 | | |
| 58,475 | |
| Total operating expenses | |
| 47,534 | | |
| 77,285 | | |
| 169,091 | | |
| 246,988 | |
| Loss from operations | |
| (13,477 | ) | |
| (65,551 | ) | |
| (133,518 | ) | |
| (222,357 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest and other income | |
| 4,213 | | |
| 6,700 | | |
| 13,450 | | |
| 22,587 | |
| Interest expense | |
| (45 | ) | |
| (44 | ) | |
| (137 | ) | |
| (149 | ) |
| Total other income, net | |
| 4,168 | | |
| 6,656 | | |
| 13,313 | | |
| 22,438 | |
| Net loss before income tax provision | |
| (9,309 | ) | |
| (58,895 | ) | |
| (120,205 | ) | |
| (199,919 | ) |
| Provision for (benefit from) income taxes | |
| 1,169 | | |
| 205 | | |
| 1,431 | | |
| (1,113 | ) |
| Net loss | |
$ | (10,478 | ) | |
$ | (59,100 | ) | |
$ | (121,636 | ) | |
$ | (198,806 | ) |
| Net loss per share, basic and diluted | |
$ | (0.15 | ) | |
$ | (0.85 | ) | |
$ | (1.74 | ) | |
$ | (2.87 | ) |
| Weighted average ordinary shares outstanding, basic and diluted | |
| 69,979,934 | | |
| 69,303,746 | | |
| 69,823,830 | | |
| 69,251,291 | |
Balance Sheets
Data
(In thousands)
(Unaudited)
| | |
September 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| Cash and cash equivalents | |
$ | 469,928 | | |
$ | 628,110 | |
| Working capital | |
| 493,097 | | |
| 625,901 | |
| Total assets | |
| 567,179 | | |
| 717,597 | |
| Total shareholders’ equity | |
| 505,277 | | |
| 609,977 | |
Investors:
Matthew DeYoung
Argot Partners
ir@bicycletx.com
212-600-1902
Media:
Argot Partners
media@bicycletx.com
