Bicycle Therapeutics Files 8-K Report
Ticker: BCYC · Form: 8-K · Filed: Jan 13, 2025 · CIK: 1761612
Sentiment: neutral
Topics: filing, regulatory
Related Tickers: BCYC
TL;DR
Bicycle Therapeutics filed an 8-K on Jan 13, 2025, mostly for financial docs & other events.
AI Summary
On January 13, 2025, Bicycle Therapeutics plc filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. Specific financial figures or material events beyond the filing's nature are not detailed in the provided text.
Why It Matters
This filing indicates Bicycle Therapeutics is providing updated information to the SEC, which could include material events or financial updates relevant to investors.
Risk Assessment
Risk Level: low — The filing is a standard 8-K for reporting purposes and does not appear to disclose any immediate negative news or significant risk factors.
Key Players & Entities
- Bicycle Therapeutics plc (company) — Registrant
- January 13, 2025 (date) — Date of Report
FAQ
What is the primary purpose of this 8-K filing by Bicycle Therapeutics plc?
The primary purpose of this 8-K filing is to report on Other Events, Regulation FD Disclosure, and Financial Statements and Exhibits.
What is the exact date of the earliest event reported in this filing?
The date of the earliest event reported is January 13, 2025.
Under which section of the Securities Exchange Act is this report filed?
This report is filed pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
What is the SEC file number for Bicycle Therapeutics plc?
The SEC file number for Bicycle Therapeutics plc is 001-38916.
Where is Bicycle Therapeutics plc incorporated?
Bicycle Therapeutics plc is incorporated in England and Wales.
Filing Stats: 735 words · 3 min read · ~2 pages · Grade level 13.5 · Accepted 2025-01-13 16:01:32
Filing Documents
- tm253122d1_8k.htm (8-K) — 32KB
- tm253122d1_ex99-1.htm (EX-99.1) — 29KB
- tm253122d1_ex99-1img01.jpg (GRAPHIC) — 3KB
- 0001104659-25-003026.txt ( ) — 292KB
- bcyc-20250113.xsd (EX-101.SCH) — 3KB
- bcyc-20250113_def.xml (EX-101.DEF) — 26KB
- bcyc-20250113_lab.xml (EX-101.LAB) — 36KB
- bcyc-20250113_pre.xml (EX-101.PRE) — 25KB
- tm253122d1_8k_htm.xml (XML) — 6KB
01 Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure On January 13, 2025, Bicycle Therapeutics, plc (the "Company") issued a press release announcing updated topline zelenectide pevedotin data and highlighting 2025 strategic priorities and milestones. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the SEC made by the Company, regardless of any general incorporation language in such filing.
01 Other Events
Item 8.01 Other Events On January 13, 2025, the Company announced updated topline results, current as of the data cut-off on January 3, 2025, from its ongoing Phase 1 Duravelo-1 trial evaluating zelenectide pevedotin. The updated topline results evaluating zelenectide pevedotin 5 mg/m 2 weekly plus pembrolizumab 200 mg once every three weeks in 22 first-line cisplatin-ineligible patients with mUC showed: 65% overall response rate (ORR) (13/20) among all efficacy-evaluable patients, and a 50% ORR (10/20) among patients with confirmed responses. Of the 3 unconfirmed responses, 1 patient remained on treatment at the time of the data cut. Median duration of response (mDOR) is not yet mature, with 12 patients still on treatment at the time of the data cut. Safety and tolerability profile continues to be broadly consistent with other Phase 1 zelenectide pevedotin monotherapy and combination cohorts. Adverse events of clinical interest such as peripheral neuropathy, skin reactions and eye disorders were primarily low grade. All cases of Grade 3 treatment-related adverse events (TRAEs) of clinical interest were reversible, and there were no Grade 4 or Grade 5 TRAEs of clinical interest. Notably, no patients withdrew from the study due to zelenectide TRAEs.
01 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits (a) Exhibits 99.1 Press Release dated January 13, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
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: January 13, 2025 BICYCLE THERAPEUTICS PLC By: /s/ Alethia Young Name: Alethia Young Title: Chief Financial Officer