重大事件即時報告 8-K 2026-05-21

Bicara Therapeutics公佈Ficerafusp Alfa聯合療法頭頸癌三年

AI 繁中摘要

Bicara Therapeutics Inc. (NASDAQ: BCAX) 於2026年5月21日向SEC提交8-K表格，報告一項重大事件：公司發佈新聞稿，公佈其候選藥物Ficerafusp Alfa聯合Pembrolizumab在一線復發/轉移性HPV陰性頭頸部鱗狀細胞癌（1L R/M HPV-negative HNSCC）的臨床數據。結果顯示該聯合療法實現了具有差異化的三年總生存期（3-Year Overall Survival），並由TGF-β抑制驅動深度應答（Deep Responses）。🗞️

此項8-K申報並未提供具體數字細節或管理層展望，僅為披露新聞稿的存在。新聞稿全文已作為附件99.1提交。對投資者而言，此消息凸顯Bicara在頭頸癌領域的潛在競爭優勢，尤其是在HPV陰性患者群體中，該群體治療選擇有限。若後續監管或商業化進展順利，可能對公司估值產生正面影響。然而，現階段仍屬臨床階段數據，後續需關注監管溝通及規模更大試驗的結果。📊

展開英文正文

bcax-20260521FALSE000202365800020236582026-05-212026-05-21

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

Date of Report (date of earliest event reported): May 21, 2026

___________________________________
Bicara Therapeutics Inc.
(Exact name of registrant as specified in its charter)
___________________________________

Delaware
(State or other jurisdiction of 
incorporation or organization)
001-42271
(Commission File Number)
83-2903745
(I.R.S. Employer Identification Number)

116 Huntington Avenue,
Suite 703 Boston, MA 02116

(Address of principal executive offices and zip code)

(617) 468-4219

(Registrant's telephone number, including area code)

___________________________________
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
Name of each exchange on which registered

Common Stock, $0.0001 par value
BCAX
The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 12b-2 of the Exchange Act.
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. o

Item 8.01 - Other Events.

On May 21, 2026, Bicara Therapeutics Inc. issued a press release entitled “Ficerafusp Alfa Plus Pembrolizumab Demonstrated Differentiated Three-Year Overall Survival and Deep Responses Driven by TGF-β Inhibition in 1L R/M HPV-Negative HNSCC.” A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 - Financial Statements and Exhibits
(d) The following exhibits are being filed herewith:

Exhibit No.
Description

99.1
Press Release, dated May 21, 2026.

104
Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Bicara Therapeutics Inc.

Date: May 21, 2026
By:
/s/ Claire Mazumdar

Name:
Claire Mazumdar, Ph.D.

Title:
Chief Executive Officer