Form 8-K

8-K — BICYCLE THERAPEUTICS PLC

Accession: 0001104659-26-119858

Filed: 2026-10-29

Period: 2026-10-29

CIK: 0001761612

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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EX-99.1 — EXHIBIT 99.1 (tm2628394d1_ex99-1.htm)

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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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2628394d1_ex99-1.htm · Sequence: 2

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,

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

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