Form 8-K
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
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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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- Definition
The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
Local phone number for entity.
+ References
No definition available.
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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 pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
+ Details
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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
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
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- Definition
Title of a 12(b) registered security.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
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- Definition
Name of the Exchange on which a security is registered.
+ References
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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- Definition
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.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
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- Definition
Trading symbol of an instrument as listed on an exchange.
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No definition available.
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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.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
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