Bicycle Therapeutics plc filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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| 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.
| 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/m2 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. |
| 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
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 | |