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): June 23, 2025

ARRIVENT BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-41929		86-3336099
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

18 Campus Boulevard, Suite 100

Newtown Square, PA

19073

(Address of principal executive offices)

(zip code)

Registrant’s telephone number, including area code: (628) 277-4836

N/A

(Former name or former address, if changed since last report.)

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
Common Stock, $0.0001 par value per share		AVBP		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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging Growth Company x

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 7.01

Regulation FD Disclosure.

On June 23, 2025, ArriVent BioPharma, Inc. (the “Company”) issued a press release announcing positive interim firmonertinib monotherapy data from its global Phase 1b study in epidermal growth factor receptor (“EGFR”) P-loop and-alpha-c-helix compressing (“PACC”) mutant non-small cell lung cancer (“NSCLC”) and plans to advance into a global pivotal study. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01

Other Events.

On June 23, 2025, the Company announced additional follow-up proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC mutations. In this interim readout, patients treated with 240 mg of firmonertinib were observed to experience 16.0 months median progression free survival (mPFS) and 14.6 months median duration of response by blinded independent central review (BICR) as of March 3, 2025. Majority of the patients treated at 240 mg remained on study after one year as of March 3, 2025. In this interim readout, 68.2% of patients treated in first-line at 240 mg and 43.5% of patients treated in first-line at 160 mg as of March 3, 2025 were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by BICR utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, which measurement of reduction is the threshold in this trial for determination of the overall response rate (ORR). In addition, 41% (n = 7/17) of first-line patients with brain metastases at baseline were observed to experience a confirmed response utilizing modified RECIST 1.1 by BICR as of March 3, 2025 and 53% (n = 9/17) of first line patients with brain metastases at baseline were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by BICR utilizing RECIST 1.1 criteria, which measurement of reduction is the threshold in this trial for determination of the ORR. Firmonertinib was generally well-tolerated with interim safety results as of March 24, 2025 consistent with prior firmonertinib data, and the most frequent treatment-related adverse events (TRAEs) in the study were diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin. No Grade 4 or 5 TRAEs were observed, and there were no treatment discontinuations due to TRAEs. Based on the data observed to date, the Company believes firmonertinib showed promising dose-dependent activity in NSCLC patients across a broad range of EGFR PACC mutations in the first-line metastatic setting and central nervous system antitumor activity consistent with its high brain penetrance.

The Company plans to initiate ALPACCA (FURMO-006), the first randomized global Phase 3 study in first-line NSCLC in patients across PACC mutations, with firmonertinib 240 mg selected as the dose for pivotal Phase 3 development. Enrollment of the first patient in this trial is expected in the second half of 2025.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release dated June 23, 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 thereunto duly authorized.

	ARRIVENT BIOPHARMA, INC.

	By:	/s/ Winston Kung, MBA
		Winston Kung, MBA
		Chief Financial Officer and Treasurer

Date: June 23, 2025

ArriVent BioPharma Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits