Form 8-K

8-K — BICYCLE THERAPEUTICS PLC

Accession: 0001104659-26-065231

Filed: 2026-05-21

Period: 2026-05-21

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

May 21, 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 May 21, 2026, Bicycle Therapeutics plc (the

“Company”) issued a press release announcing initial Duravelo-2 data for metastatic urothelial cancer at the

2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting. 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 May 21, 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: May 21, 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: tm2615187d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Bicycle Therapeutics to Present Initial Duravelo-2

Data at 2026 ASCO Annual Meeting

In the dose optimization stage of the randomized

Phase 2 trial (Duravelo-2), zelenectide pevedotin at its optimal dose in combination with pembrolizumab demonstrated response rates comparable

to published data for standard of care (SOC) in patients with previously untreated metastatic urothelial cancer (mUC)

The optimal dose of zelenectide demonstrated

a potentially differentiated safety profile with incidence rates approximately four-fold lower for skin reactions and half that for peripheral

neuropathy as published for SOC

Further data from the randomized Phase 2 trial

are expected in 2H 2026

In a separate Phase 1 trial (Duravelo-1) in

previously untreated, cisplatin-ineligible mUC, zelenectide in combination with pembrolizumab demonstrated a clinically

meaningful median progression-free survival comparable to published data for SOC

These data provide further validation of the

potential of Bicycle® technology to deliver oncology therapeutics with improved benefit/risk profiles compared to existing modalities

CAMBRIDGE, England & BOSTON, May 21, 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 the presentation of initial data from the randomized Phase 2 trial

(Duravelo-2) evaluating zelenectide pevedotin (zelenectide) in previously untreated patients with metastatic urothelial cancer (mUC),

demonstrating encouraging response rates and a potentially differentiated safety profile both as a monotherapy and in combination with

pembrolizumab. In addition, updated data from the Phase 1 trial (Duravelo-1) in previously untreated, cisplatin-ineligible mUC patients

demonstrated encouraging median progression-free survival (PFS) comparable to published data for standard of care (SOC). The data announced

today will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2

in Chicago.

“Despite recent advances for the treatment

of bladder cancer, there remains an urgent need for more tolerable therapies. For instance, published clinical data for the current SOC

for mUC demonstrate a significant number of tolerability-related drug discontinuations, and high rates of neuropathy and skin toxicities.

In contrast, the initial Duravelo-2 data shared today demonstrate that zelenectide in combination with pembrolizumab continues to show

response rates comparable to published data for SOC for mUC, while potentially offering substantially lower toxicity and improved tolerability

for patients. We have now tested zelenectide as a monotherapy or in combination with pembrolizumab in more than 600 patients and have

consistently observed lower rates and severity of neuropathy and skin toxicities,” said Bicycle CEO Kevin Lee, Ph.D. “We

believe that the extensive data we have generated in patients continue to demonstrate the unique nature of Bicycle molecules as targeting

agents that offer a potentially differentiated tolerability profile to antibody-based approaches. We are excited to continue to explore

these advantages with novel targets and novel payloads in our mission to help patients not only live longer but live well. Meanwhile,

the Duravelo-2 trial has been converted into a randomized Phase 2 trial and we look forward to sharing further results in the second

half of 2026.”

Initial Duravelo-2 Data Results

Zelenectide is a Bicycle® Drug

Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen. The 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 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 PFS was not mature, and the results at the

optimal dose showed:

· 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).

· Median

duration of treatment (mDOT) was 6.3 months (0.7-10.6).

· 65%

of patients remain on treatment.

· Median

relative dose intensity in patients receiving the optimal dose was 97%.

· Low

rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including

peripheral neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%). There were

no reported instances of zelenectide-related hyperglycemia.

· No

zelenectide-related severe skin reactions of any grade were reported.

· The

single Grade 3 zelenectide-related AE of clinical interest, peripheral neuropathy, resolved

to Grade ≤1. There were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.

· Notably,

only one patient at the optimal dose discontinued therapy due to a zelenectide-related AE

at the time of the data cut in Cohort 1.

The Duravelo-2 trial also evaluated the 5mg dose

and 6mg dose regimens of zelenectide as a monotherapy in mUC patients with one or more prior lines of systemic therapy (Cohort 2). Cohort

2 data were extracted for the interim analysis at Week 27, on June 14, 2025. At the time of the data cut, the median PFS was not

mature, and the results at the optimal dose showed:

· 37%

(10/27) ORR regardless of confirmation and 30% confirmed ORR (8/27) was achieved among efficacy-evaluable

patients. Of the confirmed responses, 3 (11%) were complete responses (CRs) and 5 (19%) were

partial responses (PRs).

· mDOT

was 4.8 months (1.3-10.1).

· 31%

of patients remain on treatment.

· Median

relative dose intensity in patients receiving the optimal dose was 86%.

· Low

rates of zelenectide-related AEs of clinical interest were observed, including peripheral

neuropathy (38%); skin reactions (28%); eye disorders (10%); and hyperglycemia (3%).

· There

were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest.

· Notably,

no zelenectide-related severe skin reactions of any grade were reported, and no treatment

discontinuations occurred at the optimal dose.

The company plans to share additional Duravelo-2

data from the randomized Phase 2 trial in the second half of 2026.

Updated Duravelo-1 Data Results

The company also announced the presentation of

updated Phase 1 Duravelo-1 data evaluating zelenectide in mUC, including monotherapy data in enfortumab vedotin (EV)-naïve patients

and in combination with 200mg of pembrolizumab once every three weeks in previously untreated cisplatin-ineligible patients. Both cohorts

evaluated zelenectide at the 5mg dose.

Updated results as of the August 1, 2025

data cutoff evaluating zelenectide 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:

· 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 CRs and 6 (27%) were PRs.

· Median

PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of

the data cutoff.

Updated results as of the August 1, 2025

data cutoff evaluating zelenectide as a monotherapy in EV-naïve recurrent, unresectable mUC patients who had prior anti-programmed

death-1/programmed death ligand-1 (PD-1/PD-L1), had disease progression after or were ineligible for platinum-based chemotherapy showed:

· 38%

(20/53) ORR regardless of confirmation, 32% confirmed ORR (17/53) and a DCR of 66%. Of the

confirmed responses, 2 (4%) were CRs and 15 (28%) were PRs.

· Median

PFS was 5.4 months and mDOR was 10.0 months (5.3-16.6) among patients with confirmed responses.

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.

The presentations will be made available in the

Publications sections of the Bicycle Therapeutics website following each presentation.

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: Bicycle Therapeutics’ ability to explore the advantages

of Bicycle molecules, and develop Bicycle molecules, with novel targets and novel payloads; the timeline for Bicycle Therapeutics’

clinical trials, including for zelenectide pevedotin, and the release of data therefrom. 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 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 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; 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 April 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.

###

Investors:

Matthew DeYoung

Argot Partners

ir@bicycletx.com

212-600-1902

Media:

Argot Partners

media@bicycletx.com

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