Form 8-K

8-K — BICYCLE THERAPEUTICS PLC

Accession: 0001104659-26-088455

Filed: 2026-07-30

Period: 2026-07-30

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 (tm2621593d1_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

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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2621593d1_ex99-1.htm · Sequence: 2

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,

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

(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

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Boolean 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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-Name Exchange Act

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-Section 12

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Boolean 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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No definition available.

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Boolean 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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