AVBP 8-K
ArriVent BioPharma, Inc. (AVBP)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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CURRENT REPORT
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| 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
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