Form 8-K

8-K — ArriVent BioPharma, Inc.

Accession: 0001104659-26-116736

Filed: 2026-10-19

Period: 2026-10-19

CIK: 0001868279

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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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 19, 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 19, 2026, ArriVent BioPharma, Inc. issued a press release

announcing the publication of FURTHER Phase 1b (FURMO-002; NCT05364073) results of firmonertinib in Cancer Cell. 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 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release dated October 19, 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

19, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2627799d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

ArriVent Announces Cancer Cell Publication

Highlighting Firmonertinib in EGFR PACC-Mutant Non-Small Cell Lung Cancer

NEWTOWN SQUARE, PA, October 19, 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 the publication of FURTHER Phase 1b (FURMO-002; NCT05364073)

results of firmonertinib in Cancer Cell, highlighting the preclinical and clinical findings supporting its potential, if approved,

as the first oral, chemotherapy-free targeted therapy for treatment-naïve patients with advanced EGFR PACC-mutant non-small cell

lung cancer (NSCLC).

EGFR PACC-mutant NSCLC is one of the largest underserved

patient populations within EGFR-driven lung cancer. Accounting for approximately 12% of EGFR-mutant tumors, these patients currently have

no established targeted standard of care, and are typically treated with therapies that were not designed for their unique biology, resulting

in limited clinical benefit. This longstanding treatment gap underscores the significant opportunity for a targeted therapy purpose-built

for EGFR PACC mutations.

“The publication demonstrated that

firmonertinib’s unique molecular structure fits the EGFR PACC mutations very well, so this TKI has a unique potential high anti-tumor

activity for this lung cancer patient population” said Xiuning Le, MD, Ph.D., associate professor of Thoracic/Head and Neck Medical

Oncology at the University of Texas MD Anderson Cancer Center, Houston, Texas. “Now the preclinical findings translated to prospective

clinical trial data, resulting in robust confirmed response and progression-free survival. We believe this is very encouraging to EGFR

PACC-mutant NSCLC patients”.

“We believe firmonertinib has the potential

to change the treatment paradigm for EGFR PACC-mutant NSCLC, and these findings give us a strong foundation for our global Phase 3 ALPACCA

trial,” said Bing Yao, Ph.D., CEO of ArriVent. “We continue to enroll patients in our global Phase 3 ALPACCA trial as we seek

to address this area of high unmet medical need where there is no current standard of care.”

Key Highlights for Firmonertinib from the Publication

Include:

· Enhanced in vitro potency vs. osimertinib:

Firmonertinib's unique trifluoroethoxy side chain creates additional contact points for binding to PACC-mutated EGFR's kinase domain.

· Robust, durable clinical activity: 43%

(160 mg) and 68% (240 mg) confirmed overall response rate (ORR), with 11.1- and 16.0-months median progression free survival (PFS), both

by blinded independent central review (BICR), respectively in front-line EGFR PACC-mutant NSCLC.

· Meaningful intracranial activity: 47%

(8/17) confirmed intracranial ORR, including 41% complete responses among 17 patients with baseline brain metastases.

· ctDNA clearance correlated with outcomes:

80% of evaluable patients achieved complete molecular response by cycle 3, with higher ORR (70% vs. 20%) and longer median PFS (15.1 vs.

3.0 months) than those without clearance.

· Manageable, consistent safety profile:

Treatment-related adverse event rates were consistent with firmonertinib's safety profile in prior clinical studies.

Based on these and other findings, ArriVent is

evaluating firmonertinib versus investigator's choice of osimertinib or afatinib as first-line treatment for patients with locally advanced

or metastatic EGFR PACC-mutant NSCLC (FURMO-006; NCT07185997).

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 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 EGFR PACC mutations

P-loop and αC-helix compressing (PACC) EGFR

mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar

to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed

through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly

utilized standard of care treatment for first-line PACC mutant patients.

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 and plans; the activity, safety, and tolerability of firmonertinib

compared to available therapies, including osimertinib; the intercranial activity of firmonertinib; the adverse event profile of firmonertinib;

anticipated timing and results of the global pivotal Phase 3 study of firmonertinib in previously untreated NSCLC patients whose tumors

contain EGFR PACC mutations, firmonertinib’s potential, if approved, as the first oral, chemotherapy-free targeted therapy for treatment-naïve

patients with advanced EGFR PACC-mutant NSCLC; and our determination of the appropriate development path for firmonertinib, and our estimates

of the incidence in that indication, 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, ArriVent’s evaluation of the full data set from its Phase 3 FURVENT trial of firmonertinib in first-line

EGFR exon 20 insertion mutant NSCLC as the Company determines the most appropriate development path for firmonertinib, and the 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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