Form 8-K

8-K — BICYCLE THERAPEUTICS PLC

Accession: 0001104659-26-045198

Filed: 2026-04-20

Period: 2026-04-20

CIK: 0001761612

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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

April 20, 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 8.01.

Other Events

On April 20, 2026, Bicycle

Therapeutics plc (the “Company”) issued a press release providing updates on its nuzefatide pevedotin program and the Company’s

EphA2 pipeline. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this

Item 8.01 by reference.

Item 9.01.

Financial Statements and Exhibits

(d) Exhibits

Exhibit No.

Description

99.1

Press Release issued April 20, 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: April 20, 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: tm2612166d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Bicycle Therapeutics

Provides Update on Nuzefatide Pevedotin and EphA2 Pipeline at the AACR Annual Meeting 2026

Phase 1 combination

data of 6.5mg/m2 Q2W nuzefatide pevedotin plus nivolumab demonstrate an encouraging preliminary efficacy profile with a differentiated

tolerability profile in previously treated metastatic urothelial cancer

Nuzefatide pevedotin

demonstrates potent preclinical anti-tumor activity across a broad range of pancreatic ductal adenocarcinoma (PDAC) and head and neck

squamous cell carcinoma xenograft models

Dose range finding

studies identify 8mg/m2 Q2W as the preferred dose for monotherapy and first patient dosed in 2L+ PDAC Phase 2 trial

Human imaging

data provides further evidence of the potential of EphA2 as a novel cancer target and the positive properties of Bicycle®

radioligand molecules for radiopharmaceutical use

CAMBRIDGE, England & BOSTON, April

20, 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 announced updates from its EphA2 pipeline at the

American Association for Cancer Research (AACR) Annual Meeting 2026.

“EphA2 is a potentially high value

target that is widely expressed in cancer and has been considered undruggable following the failure of multiple antibody-based approaches

due to toxicity or insufficient efficacy. Encouraging results presented at AACR demonstrate the potential of our Bicycle platform to

drug this target with a generally well tolerated and differentiated safety profile and enhances our understanding of how best to deploy

EphA2-targeted therapeutics,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “Nuzefatide pevedotin has demonstrated an emerging

differentiated safety profile as a monotherapy and in combination with a checkpoint inhibitor, in over 150 patients to date. Consequently,

using a combination of expression analysis, preclinical patient-derived xenograft efficacy studies, and human patient imaging, we have

identified significant opportunities for this molecule in a number of cancers, including pancreatic cancer.”

Dr. Lee added: “We have now identified

8mg/m2 Q2W as the preferred dose for monotherapy. Our strategy is to initially develop nuzefatide in pancreatic cancer where

patients have limited available treatment options, and in parallel, to bring forward the next generation of EphA2-targeted radiotherapeutics

to build on our foundational work in bladder and other EphA2-expressing tumors. Following this strategy, I am very pleased to announce

that the first patient in our 2L+ pancreatic ductal adenocarcinoma Phase 2 study has been successfully dosed.”

AACR Annual Meeting 2026 Data Highlights

· Nuzefatide

pevedotin (nuzefatide), formerly BT5528, a potentially first-in-class EphA2 targeting Bicycle®

Drug Conjugate (BDC®), Phase 1/2 data in combination with nivolumab in metastatic

urothelial cancer (mUC) patients. 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 mUC who had previously

progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed:

o 40%

confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumors and 100% confirmed

ORR (3/3) among patients with EphA2+ tumors that were monomethyl auristatin E (MMAE)-naïve.

o Patients

who achieved a partial response (PR) or at least 16 weeks of stable disease (SD) were on

treatment for a minimum of 56 weeks and most continued on treatment at the time of the data

cut-off.

o Nuzefatide

in combination with nivolumab was generally well tolerated with no Grade ≥3 treatment-related

adverse events (TRAEs) of clinical interest and no TRAEs of haemorrhage observed. Only one

dose-limiting toxicity of Grade 3 fatigue that lasted for five days was reported and improved

to Grade 1 without dose reduction.

In contrast to other EphA2-targeted

agents, nuzefatide has demonstrated a positive emerging efficacy and safety profile in over 150 patients with hard-to-treat tumors to

date. Further work has led Bicycle Therapeutics to determine 8mg/m2 Q2W as the preferred dose for the Phase 2 trial in patients

with recurrent pancreatic ductal adenocarcinoma (PDAC).

· Additional

human imaging data of a Bicycle® Imaging Agent (BIA) targeting EphA2 in patients

with PDAC. 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). Seven patients with histologically

confirmed PDAC underwent PET/CT imaging up to three hours post injection of the EphA2 BIA.

Data demonstrated rapid tumor uptake and excretion primarily via the kidneys in six out of

seven patients. EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node,

and peritoneal metastases.

These data are representative

of the results seen in 15 out of 18 patients with PDAC who have undergone EphA2 BIA imaging to date. 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.

· Preclinical

assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of

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. These data support the potential for nuzefatide to offer a novel option

for the treatment of patients with PDAC.

In March 2026, Bicycle Therapeutics

began enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients

with recurrent PDAC, and the first patient was successfully dosed in April 2026.

· Preclinical

assessment of nuzefatide anti-tumor activity in cell-line-derived xenograft (CDX) models

of head and neck squamous cell carcinoma (HNSCC). Nuzefatide demonstrated potent preclinical

anti-tumor activity in EphA2-expressing CDX models of HNSCC.

The presentations are available in the

Publications section of the Bicycle Therapeutics website.

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; BT7480, a Bicycle

Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137; 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,” “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 potential of the Bicycle platform to drug EphA2 and to enhance understanding of how best to deploy EphA2 targeted therapeutics;

and the development of the Bicycle® radioligands pipeline, including BRCs and BIAs. 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 recently announced 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 proposed workforce reduction is being executed; uncertainties related

to the benefits of the recently announced 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.

###

Investors:

Matthew DeYoung

Argot Partners

ir@bicycletx.com

212-600-1902

Media:

Argot Partners

media@bicycletx.com

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