Form 8-K

8-K — ArriVent BioPharma, Inc.

Accession: 0001104659-26-113898

Filed: 2026-10-06

Period: 2026-10-06

CIK: 0001868279

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2627092d1_8k.htm (Primary)

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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

Date of Report (Date of earliest event reported):

October 6, 2026

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

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 October 6, 2026, ArriVent BioPharma, Inc. issued a press release

announcing an update from the Phase 3 FURVENT trial of firmonertinib in first-line EGFR exon 20 insertion mutant non-small cell lung cancer.

A copy of the press release is filed as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.

The information

in this Item 7.01 is being furnished and shall not be deemed “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 into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange

Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01

Other Events.

The information set forth in the press release referred to in Item

7.01 above, other than the second paragraph thereof, is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release dated October 6, 2026.

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

Winston Kung

Chief Financial Officer and Treasurer

Date: October

6, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2627092d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

ArriVent Announces Program Update from the Phase

3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC

NEWTOWN SQUARE, PA, October 6, 2026 (GLOBE

NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the

global development of innovative biopharmaceutical therapeutics, today announced that the FURVENT (NCT05607550) Phase 3 trial evaluating

firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer

(NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary endpoint of progression free survival (PFS) by blinded independent

central review (BICR). Clinical benefit was observed with secondary endpoints such as PFS by investigator’s assessment and confirmed

objective response rate by BICR. Although not yet mature, a trend toward an improvement in overall survival was also observed. The

safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.

“These disappointing results are not what

we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options,”

said Bing Yao, Ph.D., Chairman, Chief Executive Officer of ArriVent. “While the safety profile observed with firmonertinib was consistent

with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study. We are deeply

grateful to the patients, investigators and clinical teams who made this program possible and are evaluating the full FURVENT dataset

as we determine the most appropriate development path for firmonertinib.”

Key Results from the Phase 3 FURVENT Trial

The FURVENT key results are summarized below.

Firmonertinib

240mg

Median PFS

(months)

Firmonertinib

160mg

Median PFS

(months)

Control

Median

PFS

(months)

p-value

(240mg vs.

control)

HR (95%

CI)

240mg vs

Control

HR (95%

CI)

160mg vs

Control

Confirmed

ORR

240mg

Confirmed

ORR

160mg

Confirmed

ORR

control

BICR

11.0

months

8.4

months

9.5 months

0.0654

0.75

(0.55,

1.02)

0.91

(0.67, 1.25)

60%

35%

33%

Investigator’s Assessment

11.1

months

8.3

months

7.1

months

0.61

(0.46,

0.81)

0.86

(0.65,

1.14)

61%

41%

28%

The safety profile observed in FURVENT was consistent

with previous clinical studies of firmonertinib, with no new safety signals identified. Treatment-emergent adverse events (TEAE) Grade

≥ 3 were 52% with firmonertinib 240mg, 53% with firmonertinib 160mg, and 55% with the control arm. Treatment-related adverse events

(TRAE) Grade ≥ 3 were 26% with firmonertinib 240mg, 22% with firmonertinib 160mg, and 40% with the control arm.

About FURVENT

FURVENT (NCT05607550) is a global, pivotal 3

arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon

20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety

and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based

chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST

1.1. Secondary endpoints include overall survival (OS), PFS by investigator’s assessment, confirmed objective response rate by

BICR, and in patients with brain metastases at baseline, brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified

RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian

countries including Japan and China.

About Firmonertinib

Firmonertinib is an oral, highly brain-penetrant,

and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR

mutations, including PACC and exon 20 insertion mutations. Firmonertinib is approved in China for first-line advanced non-small-cell lung

cancer (NSCLC) patients with EGFR exon 19 deletion or L858R mutations, with previously treated locally advanced or metastatic NSCLC with

EGFR T790M mutation, both known as EGFR classical mutations, as well as for with exon 20 insertion mutations who have experienced disease

progression during or after platinum-containing chemotherapy, or who are intolerant to platinum-containing chemotherapy.

Firmonertinib was granted U.S. Food and Drug Administration

(FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous

NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC

with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.

Firmonertinib is currently being studied in a

global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase

3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA; NCT07185997).

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of

cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.

Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical

and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations.

PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC

whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of

unmet medical need.

About ArriVent

ArriVent is a clinical-stage biopharmaceutical

company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs

of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its

lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates,

through approval and commercialization.

Forward-Looking Statements

This press release includes certain disclosures

that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about

us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained

in this press release, including statements regarding our business strategy, our plans, our evaluation of the full FURVENT dataset, and

our determination of the appropriate development path for firmonertinib, are forward-looking statements. In some cases, you can identify

forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,”

“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”

“potential,” “predict,” “project,” “should,” “target,” “will,”

or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s

current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could

cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled

“Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities

and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements

contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required

under applicable law.

Contact:

Joyce Allaire

LifeSci Advisors, LLC

jallaire@lifesciadvisors.com

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