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Form 8-K

sec.gov

8-K — ArriVent BioPharma, Inc.

Accession: 0001104659-26-094869

Filed: 2026-08-12

Period: 2026-08-11

CIK: 0001868279

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Results of Operations and Financial Condition

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):

August 11, 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

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 1.01 Entry into a Material Definitive Agreement.

On August 11, 2026, ArriVent BioPharma, Inc. (the “Company”)

entered into a Collaboration and License Agreement (the “Allist License Agreement”) with Shanghai Allist Pharmaceuticals Co.,

Ltd. (“Allist”), a pharmaceutical company incorporated under the laws of China. Pursuant to the Allist License Agreement,

the Company granted Allist an exclusive, sublicensable (through multiple tiers), royalty-bearing license under certain intellectual property

owned or controlled by the Company to research, develop, manufacture, and commercialize ARR-002, the Company’s MUC16/NaPi2b-targeted

antibody-drug conjugate, and products containing ARR-002, for the diagnosis, prophylaxis and treatment of diseases and conditions in Greater

China, which includes the People’s Republic of China, Hong Kong, Macau, and Taiwan (the “Licensed Territory”), subject

to the Company’s retained right to manufacture ARR-002 in the Licensed Territory. The Company retains all rights to ARR-002 outside

the Licensed Territory, including all development and commercialization rights.

The Allist License Agreement establishes a collaboration committee

to oversee and coordinate the joint global development of ARR-002. The Company is responsible for supplying ARR-002 for the start of the

initial joint global clinical study and Allist is responsible for development and commercialization of ARR-002 in the Licensed Territory.

Under the Allist License Agreement, the Company may be entitled to

receive payments totaling as much as $80.6 million, comprised of a one-time upfront payment and additional payments upon achievement of

certain defined development, regulatory, and sales milestones, and tiered royalties in the mid-single digit to low double-digit percentages

on annual net sales of licensed products in the Licensed Territory. Allist is obligated to pay royalties to the Company on a product-by-product

and country-by-country basis until the latest of: (i) expiration of certain patent claims; (ii) expiration of applicable regulatory-based

exclusivity or (iii) a certain number of years following the first commercial sale (the “Royalty Term”). The royalty rate

is subject to specified reductions on a product-by-product and country-by-country basis under specified circumstances.

Unless earlier terminated, the Allist License Agreement will expire

on the expiration of the last to expire Royalty Term. Allist may, for certain uncured material breaches by the Company, in lieu of termination,

elect to keep the Allist License Agreement in force and reduce Allist’s subsequent royalty payment obligations to the Company by

amounts specified in the Allist License Agreement.

The foregoing description of the Allist License Agreement does not

purport to be complete and is qualified in its entirety by reference to the full text of the Allist License Agreement, a copy of which

will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2026.

Item 2.02 Results of Operations and Financial Condition.

On August 12, 2026, the Company issued a press release announcing its

financial results for the second quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information contained in this Item 2.02 and in the press release

furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of

1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as

amended, or incorporated by reference in any filing with the U.S. Securities and Exchange Commission made by the Company, whether made

before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release dated August

12, 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, MBA

Winston Kung, MBA

Chief Financial Officer and Treasurer

Date: August 12, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2622880d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

ArriVent BioPharma Reports Second Quarter 2026

Financial Results

· Topline global pivotal Phase 3 data for firmonertinib

in first-line EGFR exon 20 insertion mutant NSCLC expected 2H 2026

· ARR-217, a CDH17 targeted ADC for gastrointestinal

malignancies, advanced to Phase 1b dose optimization

· Dosing of first patient with ARR-002, a dual-targeting

MUC16/NaPi2b tetravalent ADC with initial focus in ovarian and endometrial cancers expected Q3 2026

· Cash and investments of $373.1 million as

of June 30, 2026 expected to fund operations into 2028

NEWTOWN SQUARE, PA, August 12, 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 reported financial results for the second quarter ended June 30,

2026, and highlighted recent Company progress.

“Our FURVENT and ALPACCA global pivotal

trials have the potential to establish firmonertinib as a first-line treatment option for uncommon EGFR mutations in non-small cell lung

cancer (NSCLC), addressing a significant unmet need for patients who remain underserved by current therapies,” said Bing Yao, CEO

of ArriVent. “In parallel, we continue to build a differentiated ADC portfolio, with ARR-217 advancing into dose optimization and

ARR-002 advancing in clinical development. We look forward to presenting pivotal topline data from our global FURVENT study for firmonertinib

and initial Phase 1 data for ARR-217.”

Second Quarter 2026 and Recent Highlights

Firmonertinib

· Phase 3 study supported by crystal structure

data presented at AACR. Ongoing pivotal Phase 3 study in frontline EGFR exon 20 insertion mutant NSCLC supported by preclinical data

for EGFR inhibitor firmonertinib showcased high resolution crystal structure data at the 2026 American Association for Cancer Research

(AACR) Annual Meeting.

Pipeline

· Initiated Phase 1b Dose Optimization of ADC

lead ARR-217 (MRG007). ArriVent has initiated Phase 1b dose optimization for ARR-217, a CDH17 targeted ADC, in patients with gastrointestinal malignancies in partnership with Lepu Biopharma Co., Ltd.

· Clinically advancing ARR-002 in ovarian and

endometrial cancer. ArriVent advancing ARR-002, a novel dual-target MUC16/NaPi2b tetravalent ADC, into the clinic through a first-in-human

study evaluating safety, dosing, and early signals of efficacy in patients with ovarian and endometrial cancers following Investigational

New Drug (IND) clearance from the Food and Drug Administration (FDA) in May 2026.

· Greater China license agreement with Allist

for ARR-002. ArriVent entered into an exclusive licensing agreement with Shanghai Allist Pharmaceuticals Co., Ltd. (Allist) to

develop and commercialize ARR-002 in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan, with all other rights

retained by ArriVent.

Upcoming Milestones

· Firmonertinib pivotal EGFR exon 20 insertion

data. Top-line data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC

is anticipated in 2H 2026.

· Initial Phase 1 data for ARR-217. Initial

Phase 1 dose escalation data for ARR-217 planned to be presented at a future medical conference.

· Dosing of first patient with ARR-002. Dosing

of first patient with ARR-002 in a Phase 1 trial expected in the third quarter of 2026.

2026 Financial Results

· As of June 30, 2026, the Company had

cash and investments of $373.1 million, which is expected to fund operations into 2028.

· Net cash used in operations was $81.5 million

and $94.1 million for the six months ended June 30, 2026 and 2025, respectively.

· Research and development expenses were $80.0

million and $89.0 million for the six months ended June 30, 2026 and 2025, respectively.

· General and administrative expenses were $18.8

million and $11.4 million for the six months ended June 30, 2026 and 2025, respectively.

· Net loss was $93.2 million and $95.8 million

for the six months ended June 30, 2026 and 2025, respectively.

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.

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. In March 2021, firmonertinib was approved in China for first-line advanced

non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced

or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.

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 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 FURVENT

FURVENT 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 (NCT05607550). 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 Response Evaluation Criteria

in Solid Tumors (RECIST) 1.1. Secondary endpoints in patients with brain metastases at baseline include 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 ALPACCA

ALPACCA is a global, pivotal 2 arm Phase 3

clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with PACC mutations being conducted

jointly with our partner Allist (NCT07185997). The ALPACCA trial is evaluating firmonertinib 240 mg once daily versus investigator’s

choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. The 240 mg dose of firmonertinib was selected for

pivotal development based on compelling data showing a 16-month median PFS and a confirmed 68% ORR by BICR in the FURTHER trial (NCT05364073).

The primary endpoints of this study are ORR and PFS by BICR per RECIST.

About ARR-217

ARR-217 (also known as MRG007) is a cadherin-17

(CDH17) targeted ADC, with a glycan-linked, exatecan-based antibody drug conjugate. CDH17 is a membranous cell adhesion molecule and is

frequently overexpressed in colorectal cancer (CRC) and several other gastrointestinal (GI) cancers, with limited expression in normal

intestinal tissue and pancreatic duct. The differential expression profile in tumor versus normal tissue makes it an attractive target

for antibody-drug conjugate (ADC) in GI cancers, particularly CRC. ARR-217 is currently being evaluated in a multi-center, phase I study

to evaluate the safety, tolerability, efficacy, and pharmacokinetics in patients with unresectable locally advanced or metastatic solid

tumors (NCT07066657).

About ARR-002

ARR-002 (also known as AV-P138-ADC) is a first-in-class,

Mucin-16 (MUC16) and sodium-dependent phosphate transport protein 2b (NaPi2b) dual-target, tetravalent (2+2 format) ADC, with site-specific

conjugation to vcMMAE at a drug-to-antibody ratio (DAR) of 4. Both these cell surface antigens are expressed in solid tumors including

ovarian and endometrial cancers with limited expression in normal tissues, making them ideal co-targets.

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 future results of

operations or financial condition, business strategy and plans, cash runway, estimates of our addressable market, activity of our

product candidates compared to available therapies, anticipated clinical milestones, the timing of, and results of, top-line pivotal

Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations, the

timing of our planned enrollment of the global pivotal Phase 3 study of firmonertinib in previously untreated NSCLC patients whose

tumors contain EGFR PACC mutations, the advancement of the Phase 1a and Phase 1b study for ARR-217 in gastrointestinal tumors and

the timing of presentation of data from that study, the timing of the advancement of the Phase 1 study for ARR-002, the expected

benefits of the exclusive license agreement with Allist for ARR-002 in Greater China, and objectives of management for future

operations, 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.

ARRIVENT BIOPHARMA, INC.

BALANCE SHEETS

(in thousands, except share and per share data)

(Unaudited)

June 30,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 154,682

$ 45,540

Short-term investments

218,437

267,281

Prepaid expenses and other current assets

21,054

20,076

Total current assets

394,173

332,897

Right of use assets – operating leases

370

13

Deferred offering costs

41

69

Other assets

134

190

Total assets

$ 394,718

$ 333,169

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 2,217

$ 5,934

Accrued expenses

25,309

19,997

Operating lease liabilities

318

14

Total current liabilities

27,844

25,945

Operating lease liabilities, net of current amount

33

Total liabilities

27,877

25,945

Stockholders’ equity:

Preferred stock $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding

Common stock $0.0001 par value, 200,000,000 shares authorized; 48,319,591 and 42,452,251 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

5

4

Additional paid-in capital

864,957

711,847

Accumulated deficit

(497,854 )

(404,641 )

Accumulated other comprehensive income (loss)

(267 )

14

Total stockholders’ equity

366,841

307,224

Total liabilities and stockholders’ equity

$ 394,718

$ 333,169

ARRIVENT BIOPHARMA, INC.

STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS

(in thousands, except

share and per share data)

(Unaudited)

Three Months Ended

Six Months Ended

June 30,

June 30,

2026

2025

2026

2025

Operating expenses:

Research and development

$ 42,339

$ 27,720

$ 79,957

$ 89,009

General and administrative

10,352

5,903

18,844

11,386

Total operating expenses

52,691

33,623

98,801

100,395

Operating loss

(52,691 )

(33,623 )

(98,801 )

(100,395 )

Interest and investment income

2,798

2,224

5,588

4,609

Net loss

(49,893 )

(31,399 )

(93,213 )

(95,786 )

Unrealized gain (loss) on marketable securities

3

(1 )

(282 )

193

Total other comprehensive gain (loss)

3

(1 )

(282 )

193

Total comprehensive loss

$ (49,890 )

$ (31,400 )

$ (93,495 )

$ (95,593 )

Share information:

Net loss per share attributable to common stockholders, basic and diluted

$ (1.05 )

$ (0.90 )

$ (2.01 )

$ (2.78 )

Weighted-average shares of common stock outstanding, basic and diluted

47,606,857

35,006,114

46,351,614

34,455,585

Contact:

Joyce Allaire

LifeSci Advisors, LLC

jallaire@lifesciadvisors.com

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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-Name Securities Act

-Number 230

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